There are about 36633 clinical studies being (or have been) conducted in France. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
The primary objective of this study is to evaluate the efficacy of filgotinib as compared to placebo in establishing combined fistula response at Week 24. Participants will have the option to enter a separate Long-Term Extension (LTE) study (GS-US-419-3896; NCT02914600) if they meet eligibility requirements.
This study aims to compare the efficacy and tolerance of a new photodynamic therapy device (PHOS-ISTOS) with the conventional PDT device (Aktilite®) for the treatment of actinic keratosis of the scalp
The aim of MATRIX-DPRS is to assess the clinical and organizational impacts of the use of the medication record, opened, filled and managed by pharmacists (from private office and hospital units) by hospital physicians in private and public healthcare establishments (volunteers), for three clinical contexts: anaesthesiology visit before surgery, medications abuse and emergency hospitalization, medications and elderly hospitalisations.
The uncertainty concerning the onset and the extent of cardiac remodeling in response to intensive training hinders medical evaluation by physician. A better knowledge of the physiology of cardiac adaptation to training will enable physicians to correctly determine whether observed patterns of cardiac remodeling are physiological or pathological. This prospective study proposes to assess in a trained-athlete population the cardiac remodeling in response to intensive exercise training. This study is observational, we do not interfere with athlete's training.
Periodic leg movements during sleep is associated with microarousals and a stimulation of the sympathetic nervous system. The knowledge of this autonomic activation may help understanding the increase of cardiac risk observed in elderly. The aim of the study is to evaluate the relationship between periodic leg movements severity, age, gender, electromyographic power and heart rate response associated with periodic leg movements. Drug-free patients diagnosed with periodic leg movements were included. Clinical data and 24-h polysomnography recordings were analyzed.
This study includes an inclusion visit, 2 visits to the Rennes University Hospital and the filling of two on-line questionnaires. The first visit to the University-Hospital of Rennes, during which a blood sample will be taken, morpho-anatomic measures (height, weight, hip and size), impedancemetry and resting energy expenditure by indirect calorimetry will be carried out in the Clinical Investigation Unit. During this visit, the volunteers will also have to bring a sample of urine and faeces previously collected at home. The two on-line questionnaires (hedonic and caloric evaluation of foods and beverages on photos) will have to be completed by the volunteers between the first and the second visit to the University-Hospital. Finally, the volunteers will go to the University-Hospital of Rennes for the second visit, on the Neurinfo platform, during which they will be subjected to a cognitive two-choice test based on food and drink pictures, during fMRI. Before and after the fMRI session, an assessment of the state of hunger, thirst, and general status of the volunteer will be carried out using a numerical scale ranging from 1 to 10.
Tacrolimus is a calcineurin inhibitor widely used for the prevention of allograft rejection in solid organ and bone marrow transplantation. It is characterized by a narrow therapeutic index and large inter-individual pharmacokinetic variability. Adoport® is an immediate-release formulation of tacrolimus, to be administered twice daily. Because of a narrow therapeutic window and a better correlation between pre-dose level and effects than between dose and effect, therapeutic drug monitoring (TDM) based on trough whole blood tacrolimus concentrations is recommended for Adoport®. TDM helps to minimize the risk of acute rejection and the occurrence of adverse effects (mainly nephrotoxicity and, to a lesser extent, neurotoxicity). As reported in a consensus document from a consortium of European experts on tacrolimus TDM, the interdose area-under-the curve (AUC0-12h) is expected to be the best marker of tacrolimus exposure. However, tacrolimus monitoring based on full AUC0-12h is difficult to set up in routine, due to clinical constraints and the necessity of multiple samples. Calculation of the AUC0-12h using Bayesian estimation and a limited sampling strategy, i.e. a few blood samples collected during the early phase post-dose would represent an elegant solution, as already done for other tacrolimus formulations. Furthermore, the pharmacokinetics (PK) of tacrolimus is influenced by a single nucleotide polymorphism within intron 3 of cytochrome P450 3A5 (CYP3A5). Patients who carry at least one CYP3A5*1 allele are considered to be CYP3A5 expressors (about 12% of the Caucasian population, Hapmap project) and thus require a 1.5 to 2-fold higher starting dose than CYP3A5*3/*3 carriers to reach the predefined target exposure early after transplantation. Although this polymorphism showed no impact on the performance of the Bayesian estimators previously developed for other tacrolimus formulation, the patient status for CYP3A5*3 will be considered in this pharmacokinetic study as a potential covariate in, or confounding factor of, the PK model. Specifically, owing to a 12% frequency in the White European population, about 4 patients carriers of the CYP3A5*1 allele are expected in this study; the performance of the PK model and Bayesian estimator developed will be specifically evaluated in this subgroup.
The objective of our project is to determine the infected seminal cell types and the molecular mechanisms involved in HIV cell-associated transmission in the colo-rectal mucosa, using conditions as close as possible to real life, i.e. seminal leukocytes and seminal plasma from HIV-infected donors and tissue explants
To learn in a general Cardiac Resynchronization Therapy Defibrillators (CRT-D) population, which optimization techniques are used and how effective they are. It will compare 12-month response rates among different optimization methods and characterize which selected subject subgroups achieve better response than others. A subset of SMART Registry subjects will contribute to the NG4 Post Market Clinical Follow Up (PMCF) Cohort whose objective is collecting data on the NG4 CRT-D features and device usage in a real world setting and monitor long term safety associated with these devices to support CE Mark.
MI in elderly women seems to share the same pathophysiology than in men, especially plaque rupture associated with conventional risk factors. Therefore the questions is not solved on the pathophysiology and specific risk factors in young women whose prognosis is more severe. A complete descriptive analysis appears mandatory to understand the peculiarities, including not only morphological but also biological explorations as well. To date no systematic descriptive analysis has been performed including clinical characteristics, cardiac and extra-cardiac morphological exploration and hormonal and immunological assays, particularly in young premenopausal women presenting MI. This study will provide for the first time a complete analysis, including hormonal assays, never made in an "acute" population. The main objective of this clinical study is to systematically pool clinical, morphological and biological data of young women (< 50 years) presenting an Acute MI and to assess their short-term (in-hospital) and mid-term (12 months) prognosis. The definition of MI is the one adopted in the Third definition published in 2012. As such an event occurs in a young patient, diagnostic and treatment may vary among centres. The incidence of such cases in each centre being low and practice inhomogeneous, no conclusion could be advanced concerning the study of associated, indeed predisposing factors. The work aims to comprehensively and systematically collect all the clinical and laboratory data and the results of the all morphological explorations carried out during the care of these young women admitted for acute MI in high-volume centres. No additional invasive act, without any direct benefit for the care of patients will be realized for research purposes. All these examinations, in particular invasive morphological, are more and more integrated in the practice of modern interventional cardiology especially for complex or infrequent situations, like this setting. They afford accurate diagnosis of coronary disease on one hand and on the second hand they determine the causal or at least participating factor. A comprehensive and systematic analysis of this particular entity that is MI in young woman, would improve our knowledge of this disease and then enable to offer patients a more appropriate treatment and monitoring. It is necessary to progress in the understanding of the mechanisms of the early onset of coronary artery disease in its most acute and most serious presentation and to clearly define the specificities of coronary disease in young women. Moreover, a more precise identification of risk factors of MI in a woman under 50 will allow a better screening and even introduction of preventive strategies.