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.
Polymyalgia rheumatica (PMR) is an inflammatory disease causing shoulder, hip, and neck pain and stiffness, in adults aged 50 years or older. This study evaluates how safe and effective ABBV-154 is in participants with glucocorticoid-dependent PMR. Adverse events and change in disease activity will be assessed. ABBV-154 is an investigational drug being evaluated for the treatment of PMR. Participants will be randomized into 1 of 4 treatment groups or arms, each arm receiving a different treatment. There is a 1 in 4 chance that a participant will be assigned to placebo. Around 160 participants, of at least 50 years of age, with PMR will be enrolled in the study at approximately 95 sites worldwide. The study is compromised of a 52 week double-blind, placebo-controlled period and a follow-up visit 70 days after the last dose of the study drug. All participants will receive a glucocorticoid taper along with the assigned dose of ABBV-154 or placebo, subcutaneously (SC) every other week (eow). 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 effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Fecal incontinence is frequent and has a significant impact on the quality of life of individuals. Its therapeutic management is based primarily on transit regulation and rehabilitation and secondarily on neuromodulation of the sacral roots. However, this strategy is insufficient in more than one patient out of three. The patient and the clinician are often at a loss and the therapeutic possibilities are limited to the use of evacuating enemas and/or a colostomy. The practice of autologous fat injections was initially developed in plastic surgery. The studies that have evaluated the efficacy of autologous fat injections in fecal incontinence in men are preliminary and old isolated observations. However, they have shown an improvement in episodes of fecal incontinence and in sphincter parameters. In the field of proctology and autologous fat injections, 2 recent small open studies have evaluated the efficacy and morbidity of this therapy in the treatment of anal fistulas related to Crohn's disease. The primary hypothesis of the work is that autografting adipose tissue into the intersphincteric space can decrease episodes of fecal incontinence in patients with severe fecal incontinence due to sphincter failure. The secondary hypotheses are that autograft of adipose tissue in the intersphincter space improves resting anal pressures, is a well-tolerated technique for patients, and may improve their quality of life.
Dermatomyositis (DM) is a rare and disabling condition with an important impairment of quality of life and possible life-threatening complications. Treatment is based on high doses of corticosteroids but this exposes patients to adverse events (cardiovascular mortality, glucocorticoids-induced muscle and skin damages). Corticosteroids taper is associated with disease relapses. Although there is no evidence from the literature, clinical practice guidelines recommends the use of DMARDs such as methotrexate. However, response is not complete and these DMARDS take time to act. The interferon type I (IFN-I) pathway is involved in the pathophysiology of DM. Janus kinase 1 and 2 transduces IFN-I signals. In addition, JAK2 inhibition enhances muscle repair and force generation. JAK 1/2 inhibitors permitted to dramatically and rapidly improve relapsing DM patients (n=4, case series). Our hypothesis is that Janus kinase 1 and 2 (JAK1/2) inhibitors (baricitinib) will permit to obtain dermatomyositis (DM) improvement with a steroid sparing effect as compared to usual care. Our primary objective is to evaluate the efficacy of baricitinib (JAK1/2 inhibitor) to obtain prednisone-free moderate improvement (ACR/EULAR ≥ 40) of DM as compared to placebo in addition to usual care. BIRD is a multicenter phase III double blind randomized placebo-controlled trial with two parallel arms (1:1). This is an add-on trial to usual care with rapid corticoid taper. This is a multicenter trial in different medical departments in hospitals across France in different regions. Out- and in patients will be recruited in hospital departments involved in management and diagnosis of DM: departments of dermatology, rheumatology and internal medicine.
Compare the bacterial digestive microbiota during the stay in neonatal intensive care between a group of premature newborns developing a NEC (necrotizing enterocolitis) and a group of newborns free from NEC.
VISAGE-ONCO study is a qualitative transversal study aiming to identify and describe processes and mechanisms that explain in cancerology the feelings and experience of patients and health professionals with regard to the possibility of having access to secondary findings generated by the use High-speed exome sequencing . Semi-structured interviews will be conducted with patients and health professionals to answer this aims from 2 situations. The first situation is in the context of the standard practice for theranostic purposes, where somatic and constitutional analysis of the various genes involved in carcinogenesis is carried out systematically in parallel. Patients are informed that the analysis of these genes may reveal the existence of a genetic predisposition to another type of cancer than the one for which patients have consulted, with a risk for themselves or their relatives, which could modify their management. This targeted information on genetic predisposition genes to cancer is therefore provided as part of standard management for theranostic purposes, but without any detailed exploration of the reasons why patients wanted to be informed. The second situation is in the framework exome analysis position in the strategy of genetic redisposition factors identification in early-onset cancer study (EX²TRICAN NCT04141462) where all the genes identified in human pathology are part of the analysis. Patients have the possibility of accessing a result concerning a gene that may or may not be linked to a hereditary cancer risk if patients have ticked off in the consent form the wish to be informed. Therefore, two distinct questions arise: - That of understanding the wish of patients to be given back actionable data which can be identified in a fortuitous way within the framework of standard management for theranostic purposes and in EX²TRICAN, by taking into account the fact that these data can constitute an opportunity for the patient in terms of management; but patients also constitute a risk of transmission for they relatives, and a psychological risk by the anxiety generated; - The wish to have access - or not - to data which are not actively sought today within the framework of standard care for theranostic purposes and in EX²TRICAN (genetic alterations increasing the risk of cardiovascular or metabolic diseases), but which could be proposed in a systematic way in the future because of their actionable character.
This study compares arthroscopic partial menisectomy (APM) and platelet rich plasma (PRP) for degenerative meniscal injury of the knee. The current state of knowledge is poor. There are few comparative studies that have been performed and only on surgical treatment or rehabilitation. Moreover, these studies show contradictory results. The main objective of this study is to compare APM and PRPinfiltration, in terms of pain reduction, which is greater with the surgical technique than in the PRP infiltration group. The hypothesis of this study is that there is superiority of surgery over PRP infiltration. The main evaluation criterion is the pre-post-operative pain by a simplified numerical scale.
European, multicenter, prospective, observational registry in patients undergoing elective major non-cardiac surgery
One of main problems in the management of sleep-disordered breathing (SDB) in children and young adults is their screening, and the absence or the weak correlation between clinical symptoms and polysomnography (PSG). It may be useful to use additional measures together with PSG to improve the detection and characterization of respiratory events during sleep and/or correlation with clinical signs of SDB. The primary objective of the study is to determine whether psychological and neuropsychological test scores correlate with diagnostic PSG results.
The goals of this clinical study are to learn more about the study drugs, semaglutide (SEMA) with the fixed-dose combination (FDC) of cilofexor/firsocostat (CILO/FIR), and understand whether they cause fibrosis improvement and Nonalcoholic Steatohepatitis (NASH) resolution in participants with cirrhosis due to NASH.
The goal of this trial is to study, in three well-defined clinical situations responsible for cerebral hypoxia, the concentrations of biomarkers of thrombo-inflammation compared to a population of patients without cerebral hypoxia, and to study in patients with cerebral hypoxia the association between these concentrations and the clinical evolution.