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.
Ventilator-associated pneumonia (VAP) accounts for 25% of infections in intensive care units (Réseau RAISIN 2012). A short duration (8 days; SD) vs. long duration (15 days; LD) of antibiotic therapy has a comparable clinical efficacy with less antibiotic use and less multidrug-resistant pathogens (MDR) emergence. These results have led the American Thoracic Society to recommend SD therapy for VAP, with the exception of documented VAP of non-fermenting Gram negative bacilli (NF-GNB), including Pseudomonas aeruginosa (PA-VAP), due to the absence of studies focusing specifically on PA-VAP. Thus the beneficial effect of SD therapy in PA-VAP is still a matter of debate. In a small (n=127) subgroup analysis, a higher rate of recurrence with SD therapy (n=21, 32.8%) has been observed compared with LD therapy group (n=12, 19.0%). Unfortunately, the definition of recurrence was essentially based on microbiological rather than clinical data, and the higher rate of recurrence observed could rather reflect a higher rate of colonization more than a new infection. Interestingly, a trend for a lower rate of mortality was also observed in the SD group (n=15, 23.4%) compared with the LD group (n=19, 30.2%), but this study was clearly underpowered to detect a difference of mortality between groups. The two strategies were considered as not different, for the risk of mortality in a recent meta-analysis, performed on the very few available studies (n=2), that (OR = 1.33, 95% CI [0.33 to 5.26] for SD vs. LD strategies respectively). However, this conclusion remains questionable considering the large confidence interval of the risk and the power of these studies. Primary objective and assessment criterion: To assess the non-inferiority of a short duration of antibiotics (8 days) vs. prolonged antibiotic therapy (15 days) in P. aeruginosa ventilator-associated pneumonia (PA-VAP) on a composite end-point combining Day-90 mortality and PA-VAP recurrence rate during hospitalization in the ICU. Study Design : Randomized, open-labeled non inferiority controlled trial 32 French Intensive Care Units participating to the study Research period: Total study duration: 27 months Inclusion period: 24 months Duration of participation for a patient: 90 days
"Chronic thromboembolic pulmonary hypertension (CTEPH) is a severe form of pulmonary hypertension characterized by obstruction of the pulmonary vasculature by residual organized thrombi, leading to increased pulmonary vascular resistance (PVR), progressive pulmonary hypertension, and right failure. In patients deemed operable, pulmonary endarterectomy (PEA) is the gold standard treatment and is the only potentially curative treatment. However, some patients are ineligible for surgery owing to occlusion of distal vessels. The best treatment option for these non-operable CTEPH patients is not yet established.
Investigators compare the accuracy of the SpHb and hemocue with blood Hb levels
Obesity, chronic disease, is a real public health problem because of its high prevalence but also because of the high risk of complications, including insulin resistance (IR) and type 2 diabetes (T2D). The mechanisms involved in the development of IR are not well known. Oxidative stress and inflammation induced by food overload could be the initiators IR mechanisms in skeletal muscle, responsible for the use of nearly 80% glucose in response to insulin and therefore plays a major role in the regulation of glucose metabolism. Thus, an increase in ROS (Reactive Oxygen Species), markers of oxidative stress and chronic low-grade inflammation have been demonstrated in subjects with obesity, the latter decreasing in weight loss. Therapeutically, loosing weight is still very difficult these days, because of the complexity of this chronic disease. Thus, it is well established that restrictive diets to expose weight rebound, dramatic medically as in human terms for these patients. Support for physical activity is also difficult because of reduced mobility in patients, refer to the lack of motivation among some. Finally, investigators have no treatment "against-obesity" who have demonstrated a benefit / risk enough to be used routinely. It is therefore essential to seek other means of struggle against the IR, see help in weight loss. In parallel, it is well established that the consumption of certain antioxidants, including polyphenols (PP) grape as extracts and whole foods, modulates favorably several pathways responsible for the development of IR in cell models animals. The results of antioxidants supplementation in humans are few and controversial. However, most supplementation studies in human used a PP, Resveratrol at supra nutritional doses (ie not compatible with a balanced diet of fruits and vegetables). In a previous study, investigators tested the interest of a supplementation with red grape PP nutritional doses in healthy subjects with metabolic risk (overweight subjects and related to the first degree of T2DM patients) on IR hyperinsulinemic euglycemic clamp measured. During this study, the PP have prevented the central mechanisms of muscle IR that are oxidative stress and mitochondrial dysfunction induced by a load fructose. For this project, investigators propose to test the effect of a red grape PP supplementation at nutritional doses for 8 weeks on IR and weight loss in 30 obese insulin resistant. This is a double-blind randomized placebo-controlled. This supplementation will be associated with a standard support for their obesity performed routinely in the Nutrition and Diabetes unit. Specific inclusion criteria: Female or male nondiabetic 50-65 years, BMI> 30 kg / m2 and with a HOMA> 3. The main objective is to test whether supplementation PP improves systemic insulin sensitivity (GIR: rate glucose infusion) measured by hyperinsulinemic-euglycemic clamp (gold standard for measuring insulin sensitivity) in insulin-resistant obese subjects. Secondary objectives are to: - Test whether supplementation PP improves insulin sensitivity to tissue (fat and muscle) and compare the response to supplementation in these two tissues. - Determining the cellular and molecular mechanisms involved in improving IR: regulation of inflammation, oxidative stress. - Determine whether supplementation PP optimizes weight reduction compared to a standard single support. NSN: The number of subjects required was evaluated from our previous work (2013 Hokayem et al.) Whose main objective was to assess the impact of PD versus placebo in first degree relatives of patients with diabetes type 2. Under a bilateral alternative hypothesis of a nonparametric test (Mann-Whitney), 1: 1 ratio, a power of 80% and an alpha risk of 0.05, the number of subjects was estimated at 15 per group. Methodology: Anthropometric measurements, assessment of body composition (DEXA) system application characterization (metabolism, inflammation, oxidative stress, adipokines and insulin sensitivity: clamp hyperinsulinemic-euglycemic, lipopolysaccharides: LPS) / tissue characterization (biopsies of skeletal muscle and tissue adipose): insulin sensitivity, inflammation, oxidative stress, gene regulation (sirt1), mitochondrial activity / cell characterization (adipocyte precursor and muscle) insulin sensitivity, inflammation, oxidative stress, sirt1. Investigators hope to demonstrate that a non-pharmacological treatment based on nutritional doses of PP supplementation can improve insulin sensitivity in insulin-resistant obese patients, refer to optimize weight loss compared to a standardized management of obesity and determine the mechanisms involved.
Protocol CELIM-RCD-002 is designed to evaluate the efficacy and safety of AMG 714 for the treatment of adult patients with type II refractory celiac disease (RCD-II), an in-situ small bowel T-cell lymphoma.
The purpose of the study is to determine a) if the implementation of abatacept (Orencia®) patient alert card (PAC) resulted in effective understanding of key safety messages and b) if the degree of understanding of key safety messages is associated with improved clinical and safety outcomes.
This is a global, multicenter, Phase 2b, randomized, double-blind, placebo-controlled, two-arm, parallel-group efficacy and safety study of NEOD001 as a single agent administered intravenously in adults with AL amyloidosis who had a hematologic response to previous treatment for their amyloidosis (e.g., chemotherapy, autologous stem cell transplant [ASCT]) and have persistent cardiac dysfunction.
The aim of this study is to evaluate cerebral asymmetry for face processing in a group of profoundly deaf participants and a group of hearing controls by the mean of fMRI measure. To this end, we present chimeric faces (faces split into different halves), entire faces, or faces presented in divided visual field, and subjects perform a gender categorization task while lying in a fMRI scanner. It is expected to find a reduced cerebral asymmetry in the Fusiform Face Area in deaf in comparison with hearing participants.
This is a Phase 3, open label, randomized study designed to compare the safety and efficacy of mirvetuximab soravtansine to that of selected single-agent chemotherapy (Investigator's choice) in women with platinum-resistant FR-alpha positive advanced EOC, primary peritoneal cancer and/or fallopian tube cancer.
Several studies have shown that patients with acute leukemia have many symptoms during disease These symptoms decrease the quality of life and may even appear or worsen other symptoms such as depression Several studies point to the involvement of supportive care and palliative care is delayed in these patients The aim of this study is to evaluate the impact on the quality of life of an early and standardized involvement of a support / palliative care team for patients with acute leukemia in first relapse compared to a control group .