There are about 36533 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 use of breast implants, both in cosmetic and restorative surgery, is common. It is a device consisting of a silicone elastomer envelope and the container of which may be silicone gel or saline. They can be texturing carriers (roughness) on the surface of their envelope. If silicone is considered inert and biocompatible, several phenomena should be noted: - Implant placement results in the formation of a periprosthetic capsule which is the product of the inflammatory reaction and will isolate it from adjacent breast tissue - The periprosthetic capsule and adjacent breast tissue are chronically exposed to implant silicone. - Silicone in implants, even intact, has been shown to diffuse through the shell into the periprosthetic compartment and adjacent breast tissue - There is a phenomenon of erosion of the surface of the implants, particularly textured, responsible for the release of silicone particles within the periprosthetic capsule - The rupture of the prosthetic envelope is a dreaded complication, due to the alteration of the aesthetic result and the possibility of leakage of silicone gel - Since 2016, macrotextured implants have been implicated in the occurrence of anaplastic large cell lymphoma associated with breast implants (LAC-AIM) The presence of silicone in contact with tissues seems to promote an inflammatory environment, and this phenomenon seems increased if the implant is textured. Chronic inflammation induced by these devices can therefore have harmful consequences in the long term. INFLAMA study interested in the consequences of the presence of a silicone implant on local inflammatory phenomena within the periprosthetic capsule.
This is a prospective, open-label, single arm 3-year clinical study to describe the short-term and long-term efficacy and safety of belimumab in participants with autoantibody positive early SLE with ongoing disease activity despite stable initial SLE therapy.
This is a long-term, multicenter, non-interventional study of children ages 2.5 to <17 years with hypochondroplasia (HCH).
Autism Spectrum Disorder (ASD) is one of the neurodevelopmental disorders described in the DSM5 (American Psychiatric Association, 2013). This heterogeneous syndrome appears in childhood and persists throughout life with different developments from one individual to another. It is clinically characterized by the combination of deficits in social communication with restricted and repetitive behaviors. The prevalence of ASD has seen a significant increase over the last 10 years, with estimates varying greatly from one country to another, ranging from 4.2/1,000 in France to 31/1,000 in Iceland. In France, prevalence has been estimated by two child disability registers set up in the departments of Haute-Garonne (RHE31), Isère, Savoie, and Haute-Savoie (RHEOP), but there is no epidemiological surveillance system to estimate the national prevalence of ASD in the general population. However, the production of reliable epidemiological data at the national and territorial levels is essential for addressing the needs of individuals with ASD and for evaluating public policies. The main objective of our project is to estimate the annual prevalence of ASD in children, adolescents, and young adults at the national and regional levels using medico-administrative databases (SNDS), to study its evolution over the period 2010-2019 and its geographical distribution in relation to socio-demographic indicators and healthcare accessibility. Our secondary objectives are to validate an algorithm for detecting ASD in the National Health Data System (SNDS) and to estimate the direct medical costs associated with ASD management. The SNDS databases contain all medical care and treatments reimbursed for Health Insurance beneficiaries provided in the private or public sector. A case detection algorithm will be tested and validated on validation samples. Then, the prevalence of ASD will be estimated, taking into account geographical, socio-economic, and healthcare accessibility indicators, in order to study the factors associated with the significant disparity in rates observed in France and abroad. An estimate of direct medical costs will be made from the health insurance perspective. Our project therefore proposes the development of reliable indicators on the management of ASD in France with the aim of providing useful indicators and tools for guiding health and disability policies in France, promoting the development of appropriate interventions, and thus contributing to the improvement of the care and support of individuals with ASD as well as reducing inequalities in access to healthcare for these vulnerable populations.
The study will look at the effects of NNC0194-0499, cagrilintide and semaglutide, on liver damage and alcohol use in participants with alcoholic liver disease. Participants will get NNC0194-0499, semaglutide, cagrilintide or "dummy" medicine in different treatment combinations. Which treatment participants get is decided by chance. The study will last for about 39 weeks.
Epithelioid hemangioendothelioma (EHE) is an ultra-rare sarcoma, marked by distinctive molecular and pathological features and with a variable clinical behavior. Its natural history is still partially understood, reliable prognostic and predictive factors are lacking and many questions are still open on the optimal management. In the context of EURACAN, a prospective registry specifically dedicated to EHE was developed and launched with the aim of providing, through high-quality prospective data collection, a better understanding of this disease. The study design is a registry-based cohort study including only new cases of patients with a pathological and molecularly confirmed diagnosis of EHE. The objectives are to improve the understanding of EHE natural history, validate and identify new prognostic and predictive factors, clarify the activity and efficacy of currently available treatment options, describe treatment pattern. It is an hospital-based registry established in centres with expertise in EHE including adult patients with a new pathological and molecularly confirmed diagnosis of EHE starting from the 1st December 2023. The characteristics of each patient in the facility who meets the above-mentioned inclusion criteria will be collected prospectively and longitudinally with follow-up at cancer progression and / or cancer relapse or patient death. The data analyses will include descriptive statistics and analytical analyses. Multivariable Cox's proportional hazards model and Hazard ratios (HR) for all-cause or cause-specific mortality will be used to determine independent predictors of overall survival, recurrence and progression. The registry has been joined by 21 sarcoma reference centers across EU and UK, covering 10 countries. Patients' recruitment started in December 2023. The estimated completion date is December 2033 upon agreement on the achievement of all the registry objectives. The already established collaboration and participation of EHE patient's associations involved in the project will help in promoting the registry and fostering accrual. This registry has been developed with the support of EHE Rare Cancer Charity UK, STATER (Grant Agreement number: 947604, HP-PJ-2019) and EURACAN 2022 (Grant Agreement number: 101085486, EU4H-2022-ERN-IBA) European Health and Digital Executive Agency (HaDEA)
Few teams in the world can reliably analyze tissue microbiota. In this regard, the present group has unique expertise in the analysis of blood and tissue microbiota, the first to describe in 2011. Having a blood biomarker of this valve microbiota could help guide the therapeutic strategy before and after the intervention. This study will be the first to test the hypothesis that the analysis of the blood microbiota makes it possible to detect the carriage of a tissue microbiota in patients undergoing aortic valve replacement (AVR) for degenerative aortic valve disease and should also lay the foundations for a prospective study. intended to evaluate the impact of the blood and valve microbiota on the post-operative prognosis of these patients and the complications at one year. This would be a first proof of concept of the role of the tissue microbiota in valvular degeneration linked to aging.
Assessment of Macrophage activation syndrome in STill's disease: retrospective chart analysis of patient History, Symptom resolution and Treatment characteristics
The aim of the study is to evaluate chemogram in patients with intermediate-grade superficial bladder cancer and patients with infiltrating bladder cancer, who are likely to be treated according to the standard procedure. This project is based on the premise that treatments - notably chemotherapy - are standard, but that each cancer is unique. It is therefore necessary to personalize the treatment for each patient, while at the same time proposing an approach that is economically bearable for the healthcare system. For both types of bladder tumor, chemotherapy is used either as an alternative to immunotherapy, or as an adjuvant to surgery. Its use is therefore based on its effectiveness in reducing post-treatment recurrence.
Indication : Adult patients with intermediate low or mid rectal adenocarcinoma to be treated with total neoadjuvant therapy (TNT) potentially eligible for rectal preservation. Primary objective is to assess efficacy of contact X-ray brachytherapy (CXB) in addition to TNT in order to increase survival with organ preservation (OP), in selected intermediate risk group of rectal adenocarcinomas (size from 3.5 to 6 cm, cT2N1 or T3N0-1, M0).