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.
Severe and sometimes irreversible sequelae are observed in people who have developed a severe form of COVID-19 (pulmonary, cardiovascular, renal, neurological sequelae among others). More than 10% of individuals who contracted the disease, even in a mild form, still have at least one of the initial symptoms at six months, also known as prolonged symptoms or long COVID syndrome. The most frequently observed symptoms are asthenia, neurological disorders (headache, anosmia, ageusia, etc.), cardio-thoracic disorders, pain, digestive or skin disorders. Very recently, the first results of a British prospective cohort study (PHOSPCovid) indicate that more than half of the COVID-19 survivors who were hospitalised experienced a very severe to moderate deterioration in their mental and/or physical health five months after hospitalisation. Women are particularly affected. Another American study shows that 85% of non-hospitalised COVID-19 patients developed at least 4 neurological symptoms impacting their quality of life. The most common are: "brain fog" (81%), headaches (68%), numbness or tingling (60%), taste impairment (59%) and loss of smell (55%). These disabling symptoms may persist for weeks or months, deteriorating the quality of life of patients and making it difficult for some to return to a normal life. On the basis of current knowledge concerning the long-term sequelae of SARS-CoV-2 infection, it seems necessary to offer these subjects a specific care pathway and to adapt their living and working conditions beyond their medical care. The present study is aimed at measuring the impact of long COVID on the health and quality of life of the defence community (military personnel and their families).
The aims of the current study are as follow: i) Evaluate the safety, usability, and acute efficiency of a powered knee-hip dermoskeleton (MyoSuit, MyoSwiss, Zurich, Switzerland) in patients with neuromuscular disorders, ii) Elaborate recommendations regarding usability criteria for safe and efficient use the device in patients with neuromuscular disorders (e.g. type and severity of patient's functional deficits), iii) generate necessary data to foresee a future study involving a home use of the device and assessment of long-term benefits.
Emergence of vancomycin-resistant enterococci (VRE) and carbapenemase-producing enterobacteria (CPE) is nowadays a major public health concern worldwide. VRE and CPE are referred to as Emerging eXtensively Drug Resistant bacteria (eXDR). A better, faster and more accurate identification of VRE and CPE would allow faster appropriate therapy for patients and/or infection control strategies. Faster appropriate therapy could improve mortality rates, length of stay, and other patient outcomes as well as hospital costs. BD offers a variety of products, services and solutions designed to increase efficiency, streamline processes, and deliver high quality and consistent results with improved turnaround time. The primary objective of this study will be to measure the impact of the BD CPO and VRE PCRs on the turnaround time for eXDR positive detection. Study will collect criteria and compared several outcomes before and after the implementation of the BD solutions for the detection of eXDR. This is a non-interventional research with a before/after design. The study therefore consists of two periods: - 1st period of 6 months during which only the current detection technique will be used. - 2nd period of 6 months after implementation of the PCR solution (CPO and VRE) of the BD company in parallel with the usual screening technique. Advantages of using molecular assays to screen for eXDR include labor savings, faster turnaround time, and higher sensitivity than culture-based methods. In trying to reduce testing time, investigators should have better control of the eXDR transmission. this should reduce patient-to-patient transmissions. The number of contact patient in case of one positive screening should decrease. The number of days where patients are unnecessary placed in preemptive isolation should also decrease. Moreover, PCR will be use in first intention and only positive samples in PCR will be cultivated; For the laboratory, technician time saving is expected given the simplicity of the PCRs. Plate readings at 24 and 48h will be limited to a few samples. Investigators also expect a significant gain in financial terms for hospital by performing a medico-economic analysis. According to the shorter time for getting results using BD solution in diagnosing patients at risk, investigators then assume that a shorter time in making clinical decision will be a normal consequence, and will imply a better relevant organization of care with lower real costs.
Background: The aging population and the rising prevalence of musculoskeletal disorders increase resort to primary care services. Models of care integrating task sharing and shifting (TS/S) can help face challenge of access to care by strengthening the role of healthcare professionals. In France, a new TS/S model is being implemented between family physicians (FPs) and physiotherapists (PTs) for acute low back pain (LBP) patients' care. The aim of this study is to evaluate the effect of this new model of care on patient clinical outcomes, healthcare resources use and patient satisfaction. Design: Pragmatic cluster randomized controlled trial
This is a phase II randomized, open-labelled, non-comparative multicenter study in which ALK+ NSCLC patients who are naïve of treatment for advanced disease will be randomized to receive brigatinib monotherapy (Arm A) or brigatinib and carboplatin-pemetrexed therapy (Arm B). An estimated 110 patients (55 in Arm A, 55 in Arm B) will be enrolled at approximately 30 centers. A safety phase will evaluate the safety of brigatinib with carboplatin and pemetrexed treatment combination (Arm B). The first twenty-six patients enrolled in Arm B will represent the population of the safety phase. Patients will be treated until they experience progressive disease, intolerable toxicity, or another discontinuation criterion is met. Continuation of brigatinib beyond progression is permitted, at the investigator's discretion, if there is evidence of continued clinical benefit. The null hypothesis is progression free survival at 12 months ≤ 69% for Arm B, which is considered not sufficiently clinically meaningful to warrant further study. The alternative hypothesis is that 86% or more of patients in Arm B would achieve progression free survival at 12 months.
Emotional overeating is characterized by an excessive food intake in the context of intense emotional situations, such as acute stress one. Emotional overeating, as a behavioral trait, can increase the risk of to develop eating disorders or eating-related diseases, such as metabolic syndrome, obesity, type-2 diabetes. Recently, imaging modalities, such as magnetic resonance imaging (MRI) and electro-encephalography (EEG), have been adapted in order to perform neurofeedback consisting on presenting the brain activity instantaneously to the participant, that give him the possibility to modify this activity by his own mean. Neurofeedback has already shown some efficacy, either with explicit or implicit instruction. Compared with functional MRI (fMRI), functional near infra-red spectroscopy (fNIRS) is easy to handle, less expensive, and does not require a lying position. fNIRS is consequently more adapted for repeated acquisitions. Neurofeedback has already shown some promising results for neurological and psychiatric diseases. For mental states and emotion regulation, neurofeedback targeting the prefrontal cortex (PFC) has also shown promising outcomes. In this project, the investigators want to assess the effect of neurofeedback targeting the dorsolateral PFC (dlPFC) in a population of young adult women presenting emotional overeating. The investigators aim to improve the cognitive control and to reduce the episodes of emotional overeating in order to prevent the occurrence of subsequent pathologies. The intervention effect will be characterized with: (i) fMRI in order to evaluate the effect on cognitive control (with resting state fMRI or rsMRI) and on the reward system; (II) questionaries directly and one month after intervention in order to assess the behavioral effect. Besides an expected effect on emotional overeating, the investigators will evaluate whether an improvement of cognitive control can also promote positive effect on other behavioral traits that could lead to some pathologies such as food addiction. As a prerequisite to this study on emotional overeating (study B), the investigators will firstly validate on healthy subjects (study A) a reward anticipation fMRI task, which will be further used in study A in order to characterized the effect of neurofeedback on the reward system.
The purpose of this open, non-comparative, multicenter trial is to assess the impact of eye drops made of Wharton's jelly extract in the treatment of chronic keratitis that failed available therapies.
The use of tools is ubiquitous in our lives and allows us to expand the sensorimotor capacities of our body. Much research has been done on the subject in sighted people over the past decades. This work has mainly focused on the motor aspect of using the tool, neglecting the sensory aspect. However, any action involving a tool carries sensory information, for example in the use of the white cane by blind people. 26% (> 200,000) of blind people in France use a white cane to get around. By sweeping the cane on the ground, they use it as a sensorimotor extension of their body to extract information from the environment in order to locate a pedestrian crossing or possible obstacles. While it is well established that the tools increase the user's motor skills, we have only just begun to clarify how they also function as sensory extensions of the user's body and how this phenomenon is potentially dependent on constant use of the tool to compensate for a missing sense, as is the case with blind people using a cane. The aim of this study is to fill this important gap in our knowledge.
Intro: Sickle cell disease is a genetic disorder caused by a mutation of the β hemoglobin called HbS, which causes red blood cell (RBC) abnormalities responsible for hemolysis, mainly intravascular, leading to chronic anemia. Intravascular hemolysis is responsible for severe inflammation and endothelial dysfunction. Maintaining hemoglobin in its oxygenated R-conformation is one of the strategies for inhibiting the polymerization of HbS. Previous experimental therapeutic approaches having this effect have been discontinued due to poor pharmaceutical properties or toxicity. Nevertheless, they proved the validity of the concept by demonstrating an increase in oxyhemoglobin and a decrease in biomarkers of hemolysis. Voxelotor binds to the α chain of globin and maintains Hb in its R conformation, thereby inhibiting the polymerization of HbS while increasing the affinity of Hb for oxygen. Because of its mechanism of action affecting anemia and hemolysis, Voxelotor is a promising treatment for the prevention and treatment of renal and cerebral arterial disease. Hypothesis/Objective : Investigator hypothesis is that the treatment by Voxelotor (GBT440) will improve intra vascular hemolysis and will increase the total mass of hemoglobin with beneficial effects on organ function. The primary objective of the study is to evaluate the biological activity of Voxelotor on the reduction of intra vascular hemolysis measured by plasma hemoglobin. The secondary objectives of the study will aim at characterizing the effects of GBT 440 Voxelotor on: - Intra vascular hemolysis measured by plasma Heme - Total hemoglobin mass (MHb) - RBCs lifespan - Blood volumes (plasma volume (PV), red blood cell mass (RBCM), total blood volume (BV)) - Blood viscosity - Cerebral perfusion - Cerebrovascular vaso-reactivity - Cognitive function (MoCA) - Six minute walk test - Renal perfusion and iron deposits in renal cortex - Measurement of Glomerular filtration rate Estimation of glomerular filtration rate (CKD/EPI equation) - Urine albumin/creatinine ratio - Ability to decrease or stop erythropoietin in patients under EPO treatment - Safety (VOC, ACS, Priapism) and tolerability of voxelotor - RBC properties Method: This is an open-label, single-arm, single-stage phase II trial in patients treated with Voxelotor 1500 mg daily for 48 weeks. Assessments will be done during the study at week 0, week 6, week 12, week 24, week 36 and week 48.
This study will primarily evaluate the pharmacokinetics of satralizumab in pediatric patients aged 2-11 years with anti-aquaporin-4 (AQP4) antibody seropositive neuromyelitis optica spectrum disorder (NMOSD). Efficacy, safety, tolerability, and pharmacodynamics will be evaluated in a descriptive manner, given the small number of patients who will be enrolled in this study.