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.
Currently, mapping the epileptogenic zone is based on a comprehensive preoperative assessment involving clinical, imaging and electrophysiological examinations. To reduce the need for invasive stereoelectroencephalography (SEEG) explorations, electrophysiological and imaging methods have been developed, such as resting-state functional MRI (fMRI) coupled with electroencephalogram and arterial spin-labeling perfusion MRI (ASL-MRI). It has been published that these new methods enable precise delineation of the epileptogenic zone and better preparation for surgery. The aim is to determine whether, in children with focal lesional epilepsy, the combination of ASL-MRI-EEG and resting-state fMRI-EEG enables precise identification of the epileptogenic zone to be defined by SEEG, the current reference examination.
Turner syndrome affects 1/2500 female newborns. It is characterized by a short stature, gonadal dysgenesis and bone anomalies. It is secondary to X chromosome abnormality. The clinical course can be marked by various complications, including degeneration of gonadal streaks into cancer (gonadoblastoma). The risk of gonadoblastoma is increased by the presence of Y chromosome, with a risk of 19 to 43%. However, Y chromosome material may be difficult to identify due to its mosaic state, at varying rates depending on the tissue. Free circulating DNA (cfDNA) corresponds to fragments of extracellular DNA present in the plasma, released into the circulation during cell death processes by the various tissues of the body. Due to its multiple tissue origins and easy collection, cfDNA appears to be a suitable matrix for searching for low mosaic Y chromosome sequences in patients with Turner syndrome. The main objective of the study is to develop a cfDNA-based test to look for Y chromosome sequences in 50 patients with Turner syndrome. The secondary objectives are to determine the mosaic detection threshold of this test and to compare the performance of this test with the fluorescence in situ hybridization (FISH) technique used in routine diagnosis. This study will assess the detection sensitivity of this test and its relevance in a clinical context.
Pilot, controled, randomized study aiming to evaluate a plan for the prevention of risks related to epilepsy, 3 months after the last therapeutic patient education session. Two groups of patients will be compared: group "intervention" (consultation with the neurologist then a psychologist followed by a session dedicated to risk prevention ("Recognize and Manage risks") integrated into usual Therapeutic Patient Education (TPE) versus "control" group (usual consultations with the neurologist and usual TPE). 37 subjects per group will be included in this study.
Aneurysmal or occlusive abdominal aortic pathology has seen its prevalence increase over the years despite the various cardiovascular risk factor management campaigns deployed. Currently, a large proportion of these aortic pathologies require effective and definitive treatment by open surgery. In fact, minimally invasive endovascular treatment, which can provide good results in certain cases, cannot be generalized simply and can even lead to sometimes incomplete treatments requiring even more complex secondary open surgery. The preoperative assessment before open aortic surgery is relatively well coded with cardiological and respiratory assessments in particular. However, the literature has so far never focused on the overall vision of the patient with a complete functional assessment which would make it possible to consider a specific preoperative fragility scale and would thus give practitioners corrective targets before such an intervention. in order to simplify the patient's post-operative journey by limiting complications. The investigators therefore propose to collect a certain number of elements already collected in standard care in a systematic and prospective manner in order to create a risk scale. All of these elements being modifiable, they should ultimately make patients more robust for such an intervention.
Multiple sclerosis (MS) is a chronic autoimmune inflammatory disease of the central nervous system. It is characterized by complex and heterogeneous symptoms. Chronic fatigue is the most reported symptom in MS patients (80%). Current pharmacological treatments for MS patients reduce the number of relapses and their severity but do not improve symptoms such as fatigue. Physical activity is a therapy that helps reduce this fatigue, in addition to improving muscular and cardiorespiratory functions. However, the results are not optimal because MS patients remain less active than the general population. The improvement of the benefits of exercise therapy could therefore be based on three approaches: personalization of the training program, home practice and early initiation.
Since December 2019, a new coronavirus, SARS-CoV-2, has been identified in the city of Wuhan in Hubei province in China and is the cause of a global pandemic. This highly contagious virus is responsible for the COVID-19 disease, the manifestations of which can range from a simple flu-like syndrome to acute respiratory distress syndrome (ARDS). Transmission of SARS-CoV-2 is mainly linked to droplets. The mode of transmission of SARS-CoV-2 involves at least droplet-type isolation for caregivers with wearing a surgical mask and extended contact type (overcoats, caps, gloves). During procedures with a high risk of aerosolization of viral particles (intubation, aerosols, aspirations, nasopharyngeal swabs), wearing an FFP2 mask and protective glasses are recommended. In addition, oxygen therapy, particularly at a flow rate greater than 6 L/min, could also lead to airborne contamination. The occupational risk of contamination of health professionals is well identified, particularly in Chinese but also Italian studies. In Italy, 20% of healthcare workers have been contaminated. In China, a rate of 3.5 to 29% in Wuhan hospitals has been identified. Among the professionals exposed within the hospital, those in emergency services are part of the category with the greatest risk of contamination along with those in intensive care units. Recommendations from experts from the French intensive care society and foreign companies made it possible to identify the situations most at risk of contamination. In addition, the organization has made it possible to better understand patient care circuits in order to limit the risks of contamination. However, procedural errors may exist, implying the need for frequent training sessions for professionals. In addition, if the recommendations specify the need to obtain negative pressure in the rooms or at least zero, the material limits linked to reception in emergency departments with the need for intubation of a significant number of patients sometimes makes it difficult to carry out these risky actions under optimal conditions. Finally, the methods of sorting suspected cases to organize care in areas different from other emergency patients do not prevent assignment errors, a source of contamination for caregivers and patients. Thus, health professionals are among the priority people to be screened in accordance with the recommendations of the High Authority of Health. Indeed, even if symptomatic healthcare workers were mostly screened at least by taking a nasopharyngeal swab, some healthcare workers were able to develop immunity to the disease without having been symptomatic. The number of asymptomatic cases of COVID-19 is significant, but the proportion is not yet clearly identified. In addition, massive screening of symptomatic and non-symptomatic healthcare workers would make it possible to reduce the number of nososcomial contamination. Determining the serological status of healthcare workers is a priority, particularly in services on the front line of caring for patients with COVID-19, such as emergency structures.
Spinal fracture surgery is a common surgery. Post-operative pain has been reduced by the advent of so-called minimally invasive techniques. The immediate post-operative pain, however, remains relatively high, mainly because of muscle pain following the trauma. The erector spinae plane block (ESPB) is a loco-regional anesthesia technique first described in 2016. A retrospective cohort study showed an improvement in post-operative analgesia of percutaneous osteosynthesis spinal surgery through a reduction in 24-hour morphine use. In order to prove and confirm the effectiveness of this technique, we will conduct a double-blind randomized controlled study. The objective will be to demonstrate the analgesic effectiveness of the technique by reducing morphine consumption in post-operative. The expected reduction in morphine consumption is set at 30%, based on the clinical experience developed in our practice.
Waldenström macroglobulinemia (WM) is an incurable disease. BCL2 antagonist, an important anti-apoptosys molecule, is already approved for the treatment of chronic lymphocytic leukemia (CLL) and acute myeloid leukemia. Recently, a clinical trial including 32 patients with WM treated with Venetoclax showed an overall response rates of 84% and a major response rate of 81%. However, there is no in real life data, in the french population, of the efficiency of Venetoclax in WM. The aim of our multicentric retrospective study is to evaluate the efficiency and tolerance of Venetoclax in WM.
The study is being done to see if ziltivekimab can be used to treat participants living with heart failure and inflammation. Participants will either get ziltivekimab (active medicine) or placebo (inactive substance that looks like the study medicine but does not contain any medicine). The treatment participants get is decided by chance. Participant's chance of getting ziltivekimab or placebo is the same. Ziltivekimab is not yet approved in any country or region in the world. It is a new medicine that doctors cannot prescribe. The study is expected to last for up to 1 year and 4 months.
Using a MRI gait motor imagery paradigm in ALS patients in order to study how ALS affects the function of the central neural networks involved in gait function, we showed a reorganization of the motor networks that represents a compensatory response to the dysfunction of the networks involved in gait function. Our main hypothesis is that by providing coherent proprioceptive input to the sensorimotor integration areas, gait training with an exoskeleton may boost compensatory network reorganization and help to maintain function. We hypothesize that this can be achieved through a locomotion training strategy that reproduces normal gait motor patterns and appropriate sensory feedback. Gait training with an exoskeleton can meet these needs. The Atalante exoskeleton offers unique potential thanks to its cutting-edge technological features, hands-free functions and availability in numerous centers across Europe. Evaluation of its safety and efficacy in ALS is of the utmost interest in order to generalize this new approach in ALS.