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.
This is a parallel treatment, Phase 2, randomized, double-blind study to assess the efficacy, safety, tolerability, PK, and PD of twice daily (BID) oral SAR443820 compared with placebo in male and female participants, 18 to 80 years of age with ALS followed by an open-label, long-term extension period. Study ACT16970 consists of 2 parts (A and B) as follows: Part A is a 24-week, double blind, placebo-controlled part, preceded by a screening period of up to 4 weeks before Day 1. On Day 1 of Part A, participants will be randomized in a 2:1 ratio to the SAR443820 treatment arm or matching placebo arm as listed below: - Treatment arm: SAR443820, BID - Placebo arm: Placebo, BID Randomization will be stratified by the geographic region of the study site, region of ALS onset (bulbar vs other areas), use of riluzole (yes vs no), use of edaravone (yes vs no) and use of the combination of sodium phenylbutyrate and taurursodiol (named Relyvrio in the United States of America [USA] and Albrioza in Canada) (yes vs no). Participants will attend in-clinic study assessments at baseline (Day 1), Week 2, Week 4, Week 6, Week 8, Week 10, Week 12, Week 16, Week 20, Week 21, Week 22, Week 23, and Week 24. All ongoing participants at Week 24 will rollover to open-label extension Part B. The Week 24 Visit is the end of Part A and the beginning of Part B. Part B is an open-label, long-term extension period that starts from Week 24 and continues up to Week 106. The objectives of Part B are to provide extended access to SAR443820 participants in Part A and to further evaluate the safety and efficacy of long-term SAR443820 treatment. The treatment assignment of participants at randomization in Part A will remain blinded to Investigators, participants, and site personnel until the end of Part B. Every participant, except those who discontinue Investigational Medicinal Product (IMP) treatment permanently in Part A, will receive BID oral tablets of SAR443820 in Part B.
The purpose of this study is to evaluate the outcome (survival) of Adult T-cell leukemia / lymphoma (ATL) patients who receive or not specific treatment for their hemopathy (cohort 1) and the outcome (survival) of HTLV-1 chronically infected patients with / without extra-haematological disorders (cohort 2).
Extra corporeal membrane oxygenation (ECMO) is a transient supplementation technique that alleviates hemodynamic and ventilatory failure. Its implementation requires carotid arterial and jugular venous cannulation in newborns or children weighing less than 20 kg. The impact of ECMO on arterial circulation was studied by Doppler ultrasound and shows a redistribution of flows within the circle of Willis. This study aims to model cerebral flow in children who have been cared from jugulocarotid ECMO and compare cerebral hemodynamics according to the technique of reconstruction of the common carotid artery after decanulation (reconstruction or ligation).
Nephrolithiasis is a disease caused by the formation of kidney stones in the urinary tract which can then partially or completely obstruct the latter causing an extremely sharp pain called renal colic. In industrialized countries, it affects 10 to 20% of the population, and is the most common kidney disease.The primary objective of this study is to identify the clinical, biological, genetic, molecular and environmental determinants predictive of recurrence of renal lithiasis. The study follow-up visit schedule corresponds to the visits usually scheduled as part of patient care: 1 year from the inclusion visit (A1), 3 years (A3) then 5 years (A5). Samples for research (additional volume of blood, urine) will be taken by a registered nurse along with the routine check-up samples.Samples intended for research will be sent by staff to the Biobanque de Picardie (CHU Amiens-Picardie) for processing and conservation.
This study focusing on sound therapy in patients with fibromyalgia is a single-centre, prospective, randomized study which evaluates the improvement or not of painful symptoms following relaxation sessions with sound therapy.
Ankle sprains are one of the most common injuries in sports. The analysis of risk factors is a priority in order to guide rehabilitation and prevention programs. Among risk factors identified in the literature, weakness of the hip abductor muscles represent a factor favoring recurrent ankle sprains. However, only few studies have investigate the link between the strength of the hip abductor muscles and the deficits in stabilization of the ankle joint. Furthermore, these few studies analysed landing task or undisturbed balance task. It would be interesting to further understand the impact and role of hip abductor muscles on ankle stability during specific ankle-destabilizing task. The main objective of this study is to establish a link between the strength of the hip abductor muscles and the dynamic postural control performance measured by the modified Star Excursion Balance Test (SEBTm). Secondly, it will be necessary to study the kinematic and neuromuscular control characteristics of the ankle during 4 functional tests: - SEBTm - Static unipodal balance - Weight-bearing inversion test - Weight-bearing eversion test These tests will be realized with an ankle destabilizing device. The device is a sandal equipped of an articulator under the rear foot which allow movements in inversion and eversion. Furthermore, tests are realized two times, before and immediatly after a fatiguing exercise. The fatiguing exercise consists to implemented local fatigue on hip abductor muscles by repeating abductions.
This research is a case-control study aiming to characterize motor peculiarities (objective quantitative and qualitative measures) and its psycho-physiological correlates of children with ASD.
Length of hospitalization for COVID-19 infection may be increased due to the persistence of fatigue in 29-46% of cases. Its management is essential to prevent the chronic fatigue . Chronic fatigue syndrome affected between 30 and 40% of patients with SARS in 2003 or MERS in 2005 and persisted beyond 3 years. There is currently no specific treatment for acute or <4 months asthenia. To avoid the transition to chronicity, some authors recommend respecting a long rest period. However, a program combining adapted physical activity and therapeutic patient education has already shown significant benefits for combating recent or semi-recent fatigue following a cardiovascular pathology and even during cancer treatments. Therefore, the existing care pathway for hospitalized patients with COVID-19 was adapted, combining exercise training and therapeutic patient education workshops.
This is an observational study in which data from the past of children and young people with a specific cancer, called NTRK gene fusion positive infantile fibrosarcoma (IFS) is studied. IFS is a rare type of childhood cancer that commonly affects legs and arms. IFS cancers typically have specific changes in their building plans (genes) called NTRK gene fusion. NTRK stands for the specific gene that has been altered, the neurotrophic tyrosine kinase (NTRK) gene. This change to the building plan leads to the creation of an altered protein known as a TRK fusion protein, which can cause cancer cells to grow and to survive. The specific cancer is therefore also called TRK (tropomyosin receptor kinase) fusion-positive IFS. The study drug, larotrectinib (also called BAY2757556) works by blocking the altered TRK fusion protein. Larotrectinib is already available in Europe and in many other countries and is approved for doctors to prescribe to patients with NTRK gene fusion cancer which has spread to nearby tissues and/or lymph nodes or to other parts of the body. In France, HAS (the French authority in charge of evaluating health products and technologies) gave a positive opinion for the reimbursement of larotrectinib but only in the pediatric patients with IFS or another STS harboring a NTRK gene fusion, which is locally advanced or metastatic, and refractory or in relapse mainly due to the lack of comparative evidence. The main purpose of this study is to collect more data to learn how well larotrectinib works compared with current standard of care chemotherapy in people up to 21 years of age with NTRK gene fusion positive IFS that has spread to nearby tissues and/or lymph nodes (locally advanced) or other parts of the body (metastatic). To see how well larotrectinib works, researchers will make a comparison between - how long larotrectinib works well and - how long the standard of care works well. Working well means that the treatments can prevent the following from happening: - need for a new treatment for the cancer - need for radiation therapy for the cancer - need for surgery to treat the cancer, but which causes major damage to body parts - death. In addition to the above, data about medical problems related to the treatments in both groups and that may have required to stop the treatment will be compared. The data for the comparison will come from - an ongoing international study called SCOUT which was started in December 2015 (larotrectinib group) - international databases (standard of care chemotherapy group). Data will be from the year 2000 up to the present. There will be no required visits with a study doctor or required tests in this study.
Obstructive sleep apnea syndrome (OSAS) is a common disease, affecting 10-15% of the general adult population. This pathology is characterized by iterative nocturnal episodes of complete or partial obstruction of the upper airways during sleep leading to chronic intermittent nocturnal hypoxia and sleep fragmentation. The number of nocturnal respiratory anomalies per hour of sleep characterizes the severity of the disease with a gradual gradation of severity from mild (from 5 to 15 anomalies per hour) to moderate (15 to 30 anomalies per hour) and severe (over 30 anomalies per hour). The rationale for this severity classification is the increase in morbidity and mortality proportional to the severity of OSA as defined. OSA is accompanied by a fragmentation of sleep often responsible for excessive daytime sleepiness, causing an increase in occupational accidents with work stoppage and traffic accidents. The second consequence of repeated nocturnal obstructions is chronic intermittent nocturnal hypoxia which has deleterious cardiovascular effects, constituting an independent cardiovascular risk factor. Shear waves are elastic waves of low frequency (less than 1000 oscillation per second - 1000Hz). It propagates only in solids and soft solids such as the human body. The propagation of a shear wave generates a reversible micrometric displacement of the particles that make up this medium. The energy of these waves is related to the amplitude of movement of the particles. Elastography is an imaging modality for measuring the elasticity of biological tissues by shear waves. The shear wave is a mechanical wave sensitive to the change in the elasticity of its propagation medium. This sensitivity is manifested by the variation of its propagation speed. Hardness results in acceleration of the wave and softness in its slowing down. The therapeutic use of shear waves has never been used for the treatment of sleep apnea but its use could be an additional therapeutic arsenal of Continuous Positive Pressure. The technology developed by BREAS MEDICAL AB is based on the use of shear waves for the treatment of sleep apnea. The treatment is delivered using a cervical collar equipped with six sources (vibrating pistons) generating shear waves. The treatment generates shear waves at frequencies that vary from 20 to 250 Hz continuously, and at amplitudes less than 50 microns of the same order of magnitude of vibration as snoring. In view of the innovative nature of the treatment, the medico-technical team of BREAS MEDICAL AB carried out an analysis of the risks related to the device and to the propagation of waves, including the norms and standards imposed by the competent bodies. The investigators would like, in a first-dose study in humans, to assess safety in patients with sleep apnea syndrome.