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 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.
In France, over 21 million people visit emergency departments every year, 10% of whom speak little or no French. The language barrier is a problem for patient safety and quality of care. Ethical and financial aspects are also affected. Unnecessary tests are more frequent, hospital stays more numerous and longer. Patient's management may be inappropriate. Patients are less satisfied, understand and adhere less to cmanagement and recommendations. Some solutions are available to the emergency physician, but their contribution is limited. A professional interpreter is reliable and takes cultural aspects into account, but his or her cost is high and availability incompatible with emergency care. Translation by a close relative poses the problem of confidentiality. Telephone interpreting is available at any time, but is expensive and less satisfying than direct interaction. Computerized machine translation is economical and easy to access, but does not take into account all medical terms. It also poses a data protection problem. Phraselators translate predefined phrases with precision, but are time-consuming and unsophisticated. In addition, these aids are used during the consultation. They are therefore difficult to combine and take up care time. This care time is mainly devoted to establishing medical history essential for the diagnosis, prognosis and treatment decisions. MARTI is a digital tool for pediatric emergency room consultations. Its aim is to enable the emergency physician to start the consultation with a medical history completed autonomously by the parents during their waiting time. Its content has been developed by emergency physicians. Language and cultural barriers are overcome through the use of simple phrases and pictograms developed with linguists, language schools and Immigrant organizations. MARTI was used in a pediatric emergency department. Feedback from patients and carers indicates that it is ready to be tested in real-life conditions. This pilot study is designed to evaluate how MARTI improves communication with an allophone or a person with comprehension difficulties, according to the emergency physician in charge of the consultation.
The purpose of this study is to measure the benefit of adding abemaciclib to the chemotherapy, temozolomide, for newly diagnosed high-grade glioma following radiotherapy. Your participation could last approximately 11 months and possibly longer depending upon how you and your tumor respond.
Systemic sclerosis (SSc) is a complex systemic autoimmune disease with variable phenotype and prognosis. Autoantibodies are important diagnostic biomarkers in SSc. More than 90% of patients with SSc had anti-nuclear antibodies. Autoantibodies specific to SSc (anti-topoisomerase I antibodies, anti-centromeres, anti-RNA polymerase III, anti-Th/To, anti-fibrillarin, anti-NOR90) or associated with overlap syndromes (anti-RNA polymerase III antibodies -PM/Scl, anti-KU, anti-U1RNP, anti-TRIM21) are detected in most patients. Excluding anti-TRIM21 antibodies, autoantibodies are usually mutually exclusive and are associated with distinct phenotypes. Around 5 to 10% of patients with SSc have no autoantibodies detectable with routine biological tests. Recently, new autoantibody specificities have been described in SSc (anti-eIF2B, anti-RuvBL1/2, anti-BICD2, anti-U11/U12 RNP antibodies). "Seronegative" patients could represent new specificities of autoantibodies (unknown or not currently routinely evaluated) associated with different phenotypes of the disease. Primary objective is to compare the phenotype of patients with systemic sclerosis with or without detectable specific or associated autoantibodies. Secondary objectives are: - to determine homogeneous groups of patients with systemic sclerosis without detectable specific or associated autoantibodies - to compare the phenotype of patients with systemic sclerosis without detectable specific or associated autoantibodies according to anti-nuclear antibodies status
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).
This study aims to evaluate the return to activity in younger patients under 50 years old after undergoing either total hip replacement (THR) or hip resurfacing, as performed in everyday practice. This research will be observational, meaning patients will not be randomly assigned to different treatment groups. To objectively assess participents; return to everyday, professional, and sports activities, validated questionnaires will be sent to participents in addition to routine clinical practice. The study will be prospective and comparative based on the type of prostheses used. In order to capture the current practices of surgeons performing THR in participents under 50 years old in France, the study will be conducted at multiple centers across the country. Since hip resurfacing is performed only in certain centers, approximately half of the participating centers are experienced in this technique. Participents typically resume activity between 3 and 6 months after THR. One year of post-operative follow-up allows for an accurate assessment of participents; recovery, unaffected by the surgery. Participents ; physical activity levels will be evaluated using the UCLA Activity Scale developed by surgeons to assess the activity levels of patients undergoing hip and arthroplasty.
Patients with hematologic malignancies requiring intensive chemotherapy are at risk for life-threatening complications. Organ failure may appear rapidly and delay in initiating life-sustaining interventions may result in increased mortality. This encourages great alertness although not all patients require close monitoring. It is therefore critical to identify which patients are the most at risk for clinical deterioration to consider increased surveillance in these patients. The benefit of early intensive care unit (ICU) admission, as soon as the first signs of organ dysfunction appear, must also be clarified. Such an intervention could increase survival of patients by close monitoring and early initiation of organ-specific interventions but could also be responsible for anxiety and increased use of ICU resources. Many teams have analyzed the impact of early warning systems (EWS) including vital signs to detect organ dysfunction early on. It has been shown that these EWS could positively impact survival in many medical fields (pre-hospital, medicine or surgery departments). A few retrospective studies have explored the impact of EWS in hematology, with overall good prediction for ICU admission and mortality. Until now, it has however not been formally demonstrated that early ICU admission, as soon as the first signs of organ dysfunction appear, could benefit patients with hematologic malignancies. A randomized controlled trial studying the impact of early intervention would clarify the role of such a strategy. In this study, the investigators will prospectively evaluate the implementation of the National Early Warning Score (NEWS), with systematic referral to the ICU in high-score patients, to improve the survival of patients receiving intensive chemotherapy in ten academic centers. This score is one of the most performant and most frequently used to predict organ failure. Its calculation only requires vital signs such as respiratory rate, peripheral oxygen saturation, need for oxygen therapy, body temperature, arterial pressure, heart rate, and level of consciousness. The investigators will therefore study the impact of ICU admission in patients with high NEWS in a randomized, controlled trial. A cluster randomization is planned in which the centers will be randomized between usual care (control group) and interventional care with transfer to the ICU in the event of a NEWS score ≥7 (interventional group). Each parameter used to calculate the NEWS will be collected at least three times a day by the attending nurse.
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.