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 two-step, multicenter, Phase I/II study including an open-label dose-escalation phase (Step 1) and a three-arm controlled double-masked randomized extension phase (Step 2), in subjects with advanced RCD due to a mutation in the RHO, PDE6A, or PDE6B gene.
A migraine is a moderate to severe headache on one side of the head that may be accompanied by throbbing, nausea, vomiting, sensitivity to light and sound, or other symptoms. The main goal of the study is to evaluate the tolerability (how patients handle the study treatment) and safety of atogepant compared to topiramate in participants with migraine. Atogepant is a medicine currently approved for the preventive treatment of adult patients with episodic migraine (0 to 14 migraine days per month) and is being studied for the preventative treatment of migraine globally. Topiramate is an approved medication for migraine prevention. This study is conducted in 2 periods. In Period 1, participants will be randomly put into 1 of 2 groups at the start of the study to receive atogepant or topiramate. In Period 2, eligible participants will receive atogepant. Approximately 520 participants aged 18 and older will be enrolled in this study in approximately 85 sites across the world. Participants will receive atogepant (and placebo for topiramate) or topiramate (and placebo for atogepant) for 24 weeks in Period 1. Both atogepant and placebo for atogepant are given as a tablet to take by mouth while topiramate and placebo for topiramate are given as a capsule to take by mouth. After 24 weeks, all eligible participants will receive atogepant for 52 weeks in Period 2. Participants are monitored for safety for 4 weeks after their last study treatment. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The safety and tolerability of the treatment will be checked by medical assessments, blood tests, checking for adverse events and completing questionnaires.
This prospective, randomized, multicenter, open-label Phase 2 study is designed to evaluate the superiority of InO monotherapy vs ALLR3 after 1 cycle of induction treatment in paediatric participants (between 1 and <18 years) with High Risk (HR) first bone marrow relapse CD22-positive BCP ALL, and to evaluate the safety and tolerability, PK and long-term efficacy. Treatment with study intervention will end after induction therapy; follow-up will continue for up to 5 years from randomization.
The clinical investigation is designed to primarily confirm the performance of KIO015 in improving skin hydration after superficial intradermal injection. A non-treated zone (untreated hemi-face) will be used as comparator for exact evaluation of the zones between the treated and untreated ones The safety of KIO015 will also be evaluated for confirmation of initial data. For this purpose, 80 healthy subjects will be injected in half of the face. In KIO015-PLUM, healthy subjects with signs of cutaneous aging and dehydrated skin on the face will receive either one or three dermal injections: - Cohort 1: one intradermal injection session of KIO015 device on M0, to evaluate the effect of a single injection session - Cohort 2: three intradermal injection sessions of KIO015 device on M0, M1 and M2, to evaluate the effect of 3 injection sessions as performed for state-of-the-art products.
The natural history of Systemic lupus erythematosus (SLE) is characterized by relapses or flares alternated with periods of remission. Flares are associated with accrual of organ damage independently of other risk factors, both contributing to a considerable morbidity. No useful biomarker is currently available to predict which patients with a quiescent disease are at risk of flare. The 3TR project (funded by the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 831434, and supported by European Union's Horizon 2020 research and innovation programme and EFPIA) is a transdisciplinary consortium that primary aims at identifying biosignatures as predictors of response and non-response to therapy in seven different autoimmune, allergic and inflammatory diseases, including SLE. 3TR will perform a longitudinal multi-dimensional molecular analysis in patients with these diseases. A molecular profiling approach is a modern and innovative way to investigate and stratify heterogeneous diseases on the basis of their common biomolecular pathways. The main hypothesis of the 3TR project is that data obtained from multiomic analysis across the seven different diseases will identify shared biological pathways that better predict the response or non-response to therapy despite their differences in terms of clinical phenotypes and pathogenetic mechanisms. Therefore patients from multiple European centers participating in 3TR will be recruited for a longitudinal clinical follow-up and collections of several samples that will be used to perform multi-omic analysis.
The primary objective of the study is to demonstrate the superiority of IPN-21-SENSE versus no treatment at 24 weeks after baseline for the creation or restoration of volume deficit in the mid-face.
Fasting in Ramadan is not recommended for people with type 1 diabetes. The main risk associated with fasting is dysglycemia (hypoglycemia, hyperglycemia, diabetic ketosis) and dehydration. Nevertheless, whether or not to practice Ramadan remains a personal choice and many people living with diabetes choose to perform this fast with or without their physician's approval. The purpose of this prospective observational study is to evaluate the safety and efficacy of an closed-loop hybrid insulin system on glycemic parameters and the level of hypoglycemia in patients with type 1 diabetes who wished to fast during Ramadan.
Analytical Performance Study of the SRDK0921 IVD medical device (Kit and Software)
Cenobamate is a newly-FDA and EMA approved drug used to treat -focal-onset seizures in adult patients. The aim of the current study is to analyse retrospectively the overall effectiveness and tolerability of cenobamate from real-world data collected in patients who partecipated in the Early Access Program (EAP) and were treated with cenobamate as adjunctive ASM.
The purpose of this study is to test whether prophylactic application of haemostatic gel will reduce the rate of clinically significant bleeding requiring intervention (such as blood transfusion, admission to hospital, other blood products) following endoscopic resection of advanced duodenal neoplasia compared to standard therapy.