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.
The purpose of the present observational study is to remotely reevaluate the cohort of 67 sickle cell patients with transcranial Doppler-detected cerebral vasculopathy included in the national "Sickle Cell Transplant" protocol and whose 1- and 3-year results were published in JAMA (Journal of the American Medical Association) in 2019 and in BHJ in 2020.
To examine and to compare the evolution of aqueous flare from presentation until the third postoperative month in a series of consecutive patients who underwent primary vitrectomy for rhegmatogenous retinal detachment (RRD), in 4 groups of patients : - Group 1 : 48 eyes primarily treated with gas tamponade - Group 2 : 11 eyes primarily treated with silicone oil tamponade - Sub-Group G1RG : 8 eyes among Group 1 treated with gas after relapse - Sub-Group G1RS : 3 eyes among Group 1 treated with silicone oil after relapse
Continuous positive airway pressure (CPAP) is the reference treatment for obstructive sleep apnea syndrome (OSAS) and is effective in improving symptoms of OSAS, reducing risk of accidents and improving quality of life. However, CPAP use is less than optimal. Recommended use is between 6-8 hour per night and a common clinical and empiric benchmark has been defined for CPAP use as an average of 4h per night for 70% of the night. Approximatively 30% of patients discontinue CPAP treatment during the first weeks. Thus, it is very important to identify the factors that influence CPAP adherence during the first weeks of treatment. Biomedical factors, in particular nose respiratory abnormalities, somnolence complaints and insomnia complaints, have been widely studied but explain only 4 to 25 % of the variance in CPAP use. Interestingly, "self-efficacy" (the confidence to engage in a treatment), was found to explain more than 30 % of the variance in CPAP use. The SEMSA (Self Efficacy in Sleep apnea) questionnaire is the instrument to investigate self-efficacy related to OSAS and CPAP that has received the most attention. Retrospective studies showed that the factor "self-efficacy" of the SEMSA was related to poor CPAP adherence. Prospective studies showed that the factor "self-efficacy" of the SEMSA at baseline was associated with future CPAP use when it was completed after education information. A French version of the SEMSA has been validated by investigators in a retrospective study. They have confirmed in France that the factor "self-efficacy" of the SEMSA was related to poor CPAP adherence. No prospective study using the SEMSA has been conducted in French patients with OSAS treated with CPAP. Given the specificity of the French health care system and home care system, it is thus important to evaluate the predictive value of self-efficacy on CPAP adherence in France. The generation of predictive model would enable pretreatment prediction of those likely to have difficulty with CPAP adherence, and would serve as the basis for the development of maximally effective interventions in order to enhance CPAP adherence by patients with OSAS.
This study is investigating how Mim8 works compared to other medicines in people with haemophilia A, who either have inhibitors or do not have inhibitors. Mim8 is a new medicine that will be used for prevention of bleeding episodes. Mim8 works by replacing the function of the missing clotting factor VIII (FVIII). When and how often participants will receive Mim8 is dependent on their previous treatment - but is otherwise decided by chance. Mim8 will be injected into a skinfold on the stomach with a thin needle either once a week or once a month. The study will last 54-124 weeks (12-29 months) depending on how long participants will be followed in run-in before they start treatment and if they continue in the follow period or transfer to an open label extension study. Participants will have 12-17 clinic visits.
The main objective of this study is to assess the long-term durability of response over a 24-week period following withdrawal of nemolizumab in participants with prurigo nodularis (PN) who previously responded to treatment in the Long-term-Extension (LTE) study RD.06.SPR.202699 (NCT05052983). The secondary objective of this study is to assess the safety of nemolizumab compared to placebo over a 24-week period in participants with PN who previously responded to treatment in the LTE study.
The main objective of this study is to compare efficacy of bemarituzumab combined with oxaliplatin, leucovorin, and 5-fluorouracil (5-FU) (mFOLFOX6) to placebo plus mFOLFOX6 as assessed by overall survival (OS) in participants with FGFR2b ≥10% 2+/3+ tumor cell staining (FGFR2b ≥10% 2+/3+TC)
Extracorporeal photopheresis (ECP) offers an alternative to standard immunosuppression and shows an immunomodulatory rather than an immunosuppressive effect, which is associated with less toxicities and side effects. Additionally ECP has been shown to allow tapering of steroids and immunosuppressant agents which should be a goal of GvHD therapy. ECP has been used for the management of GvHD since first described in 1994 and as its use has continued over the decades. The treatment was incorporated into a number of guidelines as a second line therapy in steroid refractory or steroid dependent GvHD patients. As well as being used in addition and after steroids, it is also used in combination with CNI Inhibitors, MMF and other immunosuppressant agents. However, despite the current widespread use of ECP in the treatment of patients with GvHD, clinical data from randomized studies is limited and small prospective and retrospective trials are the main evidence base .This is also the case for other commonly used immunosuppressant agents, which have been used in GvHD since ECP was introduced. The systematic review concluded that ECP is an effective therapy for oral, skin, and liver SR-cGVHD, with modest activity in lung and gastrointestinal SR-cGVHD. In the USA Ibrutinib is the only FDA approved agent for second line cGvHD therapy once steroid therapy has failed and Ruxolitinib had been approved in the USA for the treatment of steroid refractory GvHD. While studies have shown the effectiveness and safety of ECP in GvHD treatment, there is limited data to show how it is being used in combination with the recently approved agents. Using existing registry data targeting centres where the newer agents are being used and enhancing the capture of treatment data we believe we can undertake a larger scale study, which will include the new treatment protocols. The aim of the current study is to improve the evidence basis on the potential benefit of ECP use as treatment of GVHD.
Our study is about to follow adult congenital patients, known with systemic right ventricle (mostly correct transposition of the great arteries ou congenitally corrected transposition fo the great arteries) and systemic valve severe regurgitation which was treated with a Mitraclip device on this tricuspid valve. It's an observationnal study with a 2 years follow up with clinical (symptoms, complications, VO2 exercice test) echographic and MRI outcomes .
The aim of the study is to describe the real-world profile of patients treated with adalimumab FK in gastroenterology, dermatology or rheumatology in order to evaluate in this population the predictive factors of therapeutic response (in particular nutritional status) and generate hypothesis between nutritional status and therapeutic response.
Based on plasma and milk concentrations, a PopPK model will be performed (i) to document the average and individual exposure to amoxicillin in milk, (ii) to identify the factors explaining the inter-individual pharmacokinetic variability and (iii) to determine the daily dose ingested by the infant and its variability for different dosage regimens applied to the mother. The secondary objectives are to monitor (i) predefined adverse reactions in infants and (ii) the impact on milk production.