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.
This study is open to adults aged 18 years and older with cystic fibrosis bronchiectasis. The purpose of this study is to find out whether a medicine called BI 1291583 is tolerated by people with cystic fibrosis bronchiectasis. Participants are put randomly into 2 groups. One group takes BI 1291583 tablets and the other group takes placebo tablets. Placebo tablets look like BI 1291583 tablets but do not contain any medicine. Participants in both groups take 1 tablet once a day for 12 weeks. Participants have twice the chance of being placed in the BI 1291583 group than in the placebo group. Participants are in the study for about 6 months. During this time, they visit the study site 7 times. At the visits, the doctors check the health of the participants and note any health problems that could have been caused by BI 1291583.
Akkermansia muciniphila is a naturally occurring bacterium found in the healthy human gastrointestinal tract. Analysis of the gut microbiota of NSCLC or RCC patients shows that the presence of Akkermansia is associated with the clinical efficacy of immunotherapy. In preclinical models, oral administration of the Akkermansia p2261 strain reverses resistance to PD-1 blockade. In the clinical setting, it is therefore hypothesized that the oral administration of Oncobax®-AK to cancer patients under immunotherapy, but whose gut microbiota is deficient in Akkermansia will restore / improve the efficacy of immunotherapy in patients with NSCLC or RCC.
The management of schizophrenia is a major public health issue, due to its particularly disabling psychotic symptoms and their onset at an early age, typically in adolescents or young adults. The physiopathological hypothesis of an anomaly relating to the renewal of cell membranes and energy metabolism in schizophrenia was proposed as early as the 1930s. This is based on anomalies at certain times in the development of the balance between phosphomonesters, precursors of membrane phospholipids, and phosphodiesters, catabolites of membrane phospholipids. Alterations of these different balances sign neurodevelopmental disorders, and can be objectified by specific techniques such as phosphorus-31 magnetic resonance spectroscopy (SMR-31P). This is used in particular to characterize the energy metabolism of the brain and allows in vivo quantification of phosphorus metabolites. The application of SMR-31P techniques to assess the metabolism of membrane phospholipids and cellular energy metabolism in subjects at high risk of psychotic transition could make it possible to objectify a difference between subjects subsequently suffering from a psychotic transition compared to those who do not suffer from it. Alterations in the metabolism of membrane phospholipids could thus represent a biomarker of psychotic transition. Secondarily, this approach would make it possible to provide elements as to the validity as a diagnosis of this category, which is very heterogeneous in its future. Among the Ultra High Risk (UHR) group, subjects with a psychotic transition (UHR-T) are compared to subjects without this transition (UHR-NT) during the two years of follow-up. The UHR group is compared to the control group. At T0, UHR patients and healthy volunteers will perform brain MRI with Phosphorus 31 magnetic resonance spectroscopy. UHR patients will then be reviewed: - at T+1 year for a clinical assessment medical interview to assess the patient's functioning and the appearance of symptoms; - at T+2 years for the realization of a follow-up interview with passing of the scales CAARMS (Comprehensive Assessment of At Risk Mental State) and SOFAS (scale of evaluation of the social and professional functioning) in order to determine if the subject belongs to the UHR-T or UHR-NT group.
Sinus venosus defect (SVD) accounts for 10% of atrial septal defects and is characterized by an anomalous pulmonary venous return in the superior vena cava associated with a high situated atrial septal defect. Since 2013, transcatheter correction of this congenital heart disease has emerged as a new treatment option. The procedure involves placement of a covered stent in the superior vena cava that tunnels the anomalous pulmonary venous return to the left atrium. Preliminary results are limited but promising. The devices to be used depend on anatomic considerations. XXL stents than 70mm are often required. Today, the availability of CE marked stents is limited. There have been recent reports of successful corrections with the specifically developed Optimus XXL 100mm covered stent (ANDRATEC) with compassionate approval from the Agence Nationale de Sûreté du Médicament in France. Setting up a feasibility study to investigate the use of medical devices in this indication was required. The objective of this project is to study the feasibility, efficacy and safety of the Optimus stent in this newly developed transcatheter procedure, in comparison with the gold-standard surgical method. A French national multicenter comparative cohort study including all eligible patients referred for transcatheter correction of SVD was designed. The feasibility of the transcatheter procedures will be investigated beforehand by virtual digital simulation and simulation on a 3D printed model. The procedures will then be performed in centers of the M3C network for complex congenital heart diseases (CARDIOGEN). The primary endpoint will be a composite of efficacy, defined as complete occlusion of the shunt, and safety, defined as the absence of major events at 6 months. The secondary endpoints will be anatomical, functional and psychosocial (quality of life). It is expected that transcatheter treatment gives comparable results to surgery on the primary endpoint. This could justify the further development of this procedure as an alternative to surgery and facilitate the validation of dedicated equipment.
The purpose of this extension study is to provide continued treatment with Roche investigational medicinal product (IMP[s]) monotherapy or Roche IMP(s) combined with other agent(s) or comparator agent(s) for eligible participants with cancer who are still on study treatment at the time of roll-over from the parent study and who do not have access to the study treatment locally.
The main goal of the Liver Biomarkers in Anorexia Nervosa (LIBAN) study is to determine the prevalence of liver fibrosis in patient with Anorexia Nervosa.
Atrial fibrillation (AF) is a common heart rhythm disorder in the intensive care unit (ICU). It can be precipitated by multiple factors but it is unclear whether AF persists after discharge from the ICU, and long term. This study will investigate whether AF recurs up to one year after ICU discharge.
This study evaluates the variation of expression of the neonatal Fc receptor (FcRn) in Natural Killer T Cells Expressing an Invariant T Receptor (iNKT) and monocytes along with the surface expression of Fc gamma type II receptor (RII) and RIII in active or newly diagnosed lupus patients compared to inactive lupus patients.
Veress techniques and open laparoscopy are the techniques most used by gynecological surgeons to date. Advantages of the direct introduction unknown because technique still little used. The research hypothesis is that very few major complications are expected showing the safety of direct introduction. A look back at the practice of direct introduction into laparoscopy from 2012 to 2022 at the CMCO (Medical-Surgical and Obstetrical Center of Strasbourg)
One of the current health challenges in the face of the COVID-19 pandemic that started in Wuhan in 2019, and still responsible for successive waves, is to better understand and diagnose the infection. The new variants - delta, then omicron, which appeared in November 2021 and then their sub-variants BA.2, then BA.4 and 5, and more recently BQ.1 and the sub-variant XBB.1.5 are increasingly transmissible and responsible for some degree of immune escape. Hence the importance of a better understanding of infection- or vaccine-induced immunity in order to optimize existing prophylactic or therapeutic strategies, or even to develop new, more effective ones. Mucosal immunity could play a particularly important role in interrupting the infection cycle at the entry point of the virus. The key role of innate immunity has been demonstrated in particular, via interferons and the composition of the microbiota. Humoral immunity is the best documented. However, it tends to be eroded within a few months. On the other hand, cellular immunity is more stable over time and would largely explain the decrease in severe forms of the disease in vaccinated individuals. The collection of biological resources that will be built up during this study will also allow us to optimize or develop new diagnostic methods, necessary as a complement to vaccination, to effectively slow down the spread of the pandemic and reduce the severity of its impact on the population. The improvement of diagnostic methods will in turn improve the understanding of the infection by providing increasingly reliable information on the characteristics of an infection, its quantification, its dynamics, and its resolution, especially since these parameters will be compared, at any time during the study, with reference methods and the immunological status of the subject. The main significant improvements expected in the field of SARS-CoV-2 diagnosis are notably the improvement of performance (reduction of false negatives in RT-PCR on nasopharyngeal samples), acceptability, simplicity of implementation in the field, and the capacity to test transmission. The objective of this study is to identify and characterize SARS-CoV-2 infection and host response, particularly mucosal immunity.