Kusajili – Centralise les essais cliniques mondiaux

Lamellar Transplant With Lyophilized Corneas - The goals of this study are to develop a lyophilization method for anterior lamellar transplants in Brasil and to make a comparative analysis among patients transplanted with lyophilized and optisol corneas

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Study of Effects of Light on the Vigilance and Cognitive Performance Following a Night Without Sleep Sleep disorders are a major public health issue, affecting 1 in 6 French. The medical impact at the individual level but also social and economic level (loss of productivity, morbidity, mortality) emphasize the need for one hand, to improve the investigators' understanding of these disorders in order to develop appropriate therapeutic tools and on the other hand, to increase the investigators' support abilities of patients with these disorders. The investigators' team of unity sleep from Strasbourg University Hospitals, in collaboration with the UPR 3212 CNRS team, is working on the development and adjustment of new concepts and tools to compensate the investigators' sleep debt in order to apply them to patients with sleep disorders and persons who face with sleep restriction.

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Effect of Exercise and Phytoestrogen on Bone, Metabolic Syndrome Criteria and Complaints of the Early Menopause The aim of the study is to compare the effect of a progressive, periodized exercise training designed to impact bone, CHD-risk-factors and menopausal complaints versus the combined effect of exercise and "phytoestrogen" (cimicifuga racemosa; CR). After randomization, 84 females 1-3 year postmenopausal with no medication or illness affecting bone metabolism exercise over 12 months (EG; 42 with, 42 without CR), 42 women serve as wellness-control. Three group training sessions/week will be performed in the EG. Both groups will be individually supplemented with calcium and Vit-D (cholecalciferol).

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Pharmacogenomic Study on PKD/PKC of Dabigatran Etexilate and Rivaroxaban The study will address the impact of genetical variation of a protein involved in the intestinal absorption of two new anticoagulants : Dabigatran etexilate and Rivaroxaban.

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Study of Montelukast on Gastrointestinal Tolerability in Patients With Relapsing Forms of Multiple Sclerosis Receiving Tecfidera The primary objective of this study is to evaluate whether montelukast can reduce the severity of gastrointestinal (GI) events, measured by the Gastrointestinal Symptom Rating Scale (GSRS), after oral administration of dimethyl fumarate (DMF) in participants with relapsing forms of Multiple Sclerosis (MS). The secondary objectives of this study are as follows: To evaluate whether montelukast after oral administration of DMF in participants with relapsing forms of MS decreases discontinuations due to GI events and reduces the number of participants taking symptomatic therapies for GI events; To investigate the effect of montelukast on the incidence of flushing events after oral administration of 240 mg DMF in participants with relapsing forms of MS.

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A randomised, controlled trial of clinical outreach education to rationalise antibiotic prescribing for dental conditions in the primary care setting Not provided at time of registration

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A Trial Comparing a Diet Including Products Aimed at Targeting Satiety This multi-centre, randomised controlled trial will be conducted over 24-weeks to evaluate the effect of a healthy diet supplemented with a product specifically developed (SATIN satiety products) to enhance feelings of satiety and reduce food intake after an initial weight loss period to assess weight maintenance. Participants will either receive the active SATIN product or a matched control product. The products contain ingredients which have been shown to positively affect satiety, satiation and/or body weight and are all accepted food ingredients approved for human consumption in Europe. They will be incorporated into different food matrices, e.g. drinks, shakes and cheeses. Corresponding control products without the active ingredients will be provided to participants allocated to the control group. The participants will be instructed in detail on how and when to consume the test products. Participants will be 300 adults (BMI >27kg/m2; Age>18years) who will be tested at three research sites (University of Liverpool, United Kingdom; University of Copenhagen, Denmark and University Rovira I Virgili, Spain). Recruitment will be divided between sites. Participants will attend assessments at one of the three research sites continually throughout the study period. The primary outcome will be weight maintenance after low calorie diet as assessed by weight, waist circumference, body composition (DXA), energy intake and subjective appetite assessments made at study test sessions. Secondary outcomes include assessing biomarkers of health outcomes (blood and urine indices), changes in physical activity as well as consumer benefits of the trial (assessed in a range of questionnaires) to determine diet efficacy.

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Induction of Fibrosis Regression on Patients With Chronic Hepatitis B Infection This study will examine whether 12 month treatment with entecavir(Baraclude®) has an effect on changes of liver stiffness measurement (LSM) and of hyaluronan measurement in patients with chronic hepatitis B infection.

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Chlorhexidine Gluconate Versus Mupirocin Ointment in the Prevention of Peritoneal Dialysis-Related Infection This pilot study aims to evaluate effectiveness, safety, and cost-utility of chlorhexidine gluconate (CHG)-soaked cloths compares to mupirocin ointment and exit site usual care (normal saline) with aseptic technique in prevention of PD-related infection. It is a pilot study, double-blind, stratified randomized controlled trial. Participants will be randomized to three arms mupirocin, usual care, or CHG-soaked cloths in a ratio of 1:1:1. They will be followed at 1,3,6,9, and 12 months or until PD-related infection, catheter removal, or death. The primary outcome is PD-related infection. Secondary outcomes are safety, adverse events related to treatments such as skin irritation, rash etc. Other outcomes are hospitalization due to PD-related infection, technical failure,change of modal of dialysis, adherence to medication, death due to PD-related infection. Costs include providers and patients expenses. Utility is assessed using the EuroQol (EQ), five-dimensional (5D), five-level (5L) version. The results of this study are anticipate nephrologists and health care professional involving to PD in decision making for a plan to prevent PD-related infection. In addition, the results will lead to clinical guideline development a prevention of PD-related infection.

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Pilot Trial of a WT-1 Analog Peptide Vaccine in Patients With Myeloid Neoplasms The purpose of this study is to determine whether the WT-1 vaccine causes an immune response and is safe. The WT-1 vaccine is made up of protein pieces that the patient's immune system can recognize as abnormal.

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