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 study will consist of 2 periods: Double-blind Treatment and Open-Label Extension(OLE) Period. -Double-blind Treatment Period - This will be randomized, double-blind, placebo-controlled part of the study which will be conducted in parallel groups, ie,1 group receiving the active treatment (PXT3003) and the other group receiving placebo. Primary endpoint of the study will be assessed at Month 15. -Open-label Extension (OLE) Period - All subjects completing Double-blind Treatment Period will be given an opportunity to enter the OLE Period of the study and receive the active treatment (PXT3003). The duration of the OLE Period will be based on Sponsor discretion, ie, Sponsor intends to keep the study open until the study drug PXT3003 is commercially available. During this period, the long-term safety and efficacy of PXT3003 will be assessed as an exploratory objective. Double-blind Treatment Period Objectives: Primary: To evaluate the efficacy of treatment with PXT3003 (a fixed-dose combination of [RS]-baclofen, naltrexone hydrochloride [HCl], and D-sorbitol) compared to placebo in subjects with Charcot-Marie-Tooth disease type 1A (CMT1A). Secondary: To evaluate the safety and tolerability of PXT3003 treatment in subjects with CMT1A. Exploratory: To characterize the relationship between plasma biomarkers and response to PXT3003 treatment. OLE Period Objective: Exploratory: To evaluate the long-term safety and efficacy of PXT3003.
The primary objectives of the study are: To assess the safety profile of the study vaccines in each study intervention group. To assess the neutralizing antibody profile after primary series vaccination in SARS-CoV-2-naïve adults. To demonstrate that a booster dose of monovalent or bivalent SARS-CoV-2 vaccine given to adults previously vaccinated with an authorized/approved COVID-19 vaccine induces an immune response that is non-inferior to the response induced by a twodose priming series with the monovalent vaccine, and superior to that observed immediately before booster. The secondary objectives of the study are: To assess the neutralizing and binding antibody profiles after primary series vaccination at pre-defined time points during the study. To assess the neutralizing and binding antibody responses of booster vaccination. To describe the occurrences of laboratory-confirmed symptomatic COVID19 after primary series and booster vaccination. To describe the occurrences of serologically-confirmed SARS-CoV-2 infection after primary series vaccination.
This study is open to adults with a chronic inflammatory skin disease called hidradenitis suppurativa. The purpose of this study is to find out whether a medicine called spesolimab helps people with moderate to severe hidradenitis suppurativa. Participants are put into 2 groups by chance. One group takes spesolimab. The other group takes placebo. Every participant has twice the chance of being in the spesolimab group than in the placebo group. Participants get spesolimab or placebo as an infusion into a vein every week for the first 3 weeks. Afterwards, they get spesolimab or placebo as injections under the skin every 2 weeks. Placebo infusions and injections look like spesolimab infusions and injections but do not contain any medicine. Participants are treated in the study for about 3 months. During this time, they visit the study site about 9 times. After completing this part of the study, participants are offered to join another clinical study in which all participants get spesolimab. Participants who cannot join the other study, stay in this study for about 4 more months. During this time, participants do not take spesolimab nor placebo but they visit the study site 2 times to have their health checked. At study visits, doctors thoroughly check the skin of participants to count lumps (nodules) and boils (abscesses). The results between the spesolimab group and the placebo group are compared after 3 months of treatment. The doctors also regularly check the general health of the participants.
This is an open-label, multicenter, randomized, parallel, 2-arm, efficacy and safety study. Patients with GBM after failure of standard first line therapy will be randomized in a 2:1 ratio to receive berubicin or lomustine for the evaluation of OS. Additional endpoints will include response and progression outcomes evaluated by a blinded central reviewer for each patient according to RANO criteria. A pre-planned, non-binding futility analysis will be performed after approximately 30 to 50% of all planned patients have completed the primary endpoint at 6 months. This review will include additional evaluation of safety as well as secondary efficacy endpoints. Enrollment will not be paused during this interim analysis.
To evaluate the safety and tolerability of OCS-05 compared to placebo in patients with acute optic neuritis (AON) receiving the standard of care
The aim is to assess effectiveness (EASI, SCORAD, IGA, DLQI, pruritus, sleep loss) and safety (clinical and biological adverse events) of JAK inhibitors in adults with moderate-to-severe atopic dermatitis in a real-life French multicenter retrospective cohort
Sleep is a physiological function that plays an essential role in many somatic, cognitive and psychological processes. Although there are many criteria for the effectiveness of sleep, its quantity is unanimously recognized as a major determinant of health. Too little sleep is associated with an increase in metabolic, cardiovascular and accidental morbidity and mortality caused by drowsiness while traveling or at work. Today, the time devoted to sleep is in competition with the time devoted to work, transport or new technologies, in a professional or recreational context. Faced with the public health issues thus raised, research has highlighted the interest of studying the relationships between sleep time and socio-demographic factors, beyond the mere involvement of sleep pathologies. However, among these pathologies, the role of insomnia is not negligible: it is in fact the most frequent sleep disorder (16% of French people in 2010) and represents an important source of involuntary reduction in sleep time, likely to increase inappropriate sleepiness during periods of wakefulness, in the context of activities sometimes involving safety. Flight crews are exposed to specific operational constraints, both in civilian and military environments, which may compromise the sleep recovery function (operational fatigue, extended work amplitudes, repetition of jet lag, etc.). These constraints, which are conducive to compromising the required levels of alertness and cognitive performance, are also at risk of cardiometabolic complications. They therefore raise the issue of risk control and maintenance of air safety. The issue of fatigue in pilots remains an essential issue for the safety of flight operations. Several determinants of operational fatigue in air transport have been identified, such as irregular sleep schedules, large, irregular, and sometimes unpredictable activity amplitudes, sleep debt, night flying, and circadian disruptions related to multiple and repeated time zone changes. While these factors have to deal with rules within airlines that are more often based on "work/rest" than "sleep/wake", current legislation and regulations in the aviation industry are now moving towards scientific approaches to fatigue management in commercial aviation, emphasizing the importance of sleep and taking circadian rhythms into account. In the wake of recent work carried out in the general French population, the conduct of a specific study on sleep time, prevalence and factors associated with chronic insomnia and the complaint of drowsiness among aircrew appears relevant. Due to the specific operational constraints mentioned above, chronic insomnia and sleep debt can be assumed to be more frequent among sailors than in the general population. A better consideration of certain sleep disorders in professional aircrew could allow the adaptation of prevention strategies or countermeasures aimed at optimizing the control of risks with regard to flight safety.
Sleep is a physiological function that plays an essential role in many somatic, cognitive or psychological processes. Although the criteria for sleep effectiveness are multiple, its quantity is unanimously recognized as a major determinant of health. Too little sleep time is indeed associated with an increase in metabolic, cardiovascular and accidental morbidity and mortality, caused by sleepiness during journeys or at the workplace. In the wake of recent work in the general French population, a specific study on the prevalence and factors associated with sleeping time and chronic insomnia among flight members appears relevant. Chronic insomnia and sleep debt can thus be assumed to be more common among aircrews than in the general population, due to these specific operational constraints. Better consideration of certain sleep disorders in professional flight members could make it possible to adapt prevention or countermeasures strategies intended to optimize risk management with regard to flight safety.
Low bone mineral density affects 77% of children with severe cerebral palsy (GMFCS IV & V) with an increased fracture risk of 4%. One strategy supposed to improve bone mineral density is verticalisation with static devices. Nowadays there is no time recommendation of verticalisation however high intensity verticalisation has been shown to be effective in improving bone mineral density in childrens with cerebral palsy, but difficult to apply in real life due to lack of qualified therapists, device's complexity, and severe impairment in those children. The investigators aim to compare bone mineral density and bone remodelling factors of verticalized and non verticalized childrens with severe cerebral palsy as achieved in everyday life. The investigators conduced a retrospective study comparing bone mineral density and factors who influence bone remolling in severe cerebral palsy's according to whether they are verticalized or not.
Atypical meningiomas represent 15% of meningiomas. They present a high rate of recurrence, and therapeutic strategies are limited. There is a need for novel treatment strategies, such as immuotherapy. This is a retrospective study including 84 patients with primary diagnosis of atypical meningiomas. The presence of T cells (CD4, CD8, Treg and memory T cells) and mature dendritic cells will be quantified on whole tissue sections stained by immunohistochemistry (CD4, CD8, FOXP3, CD45RO and CD208). This could allow us to identify novel biomarkers for survival, and facilitate the selection of patients who may benefit from immunotherapeutic modalities.