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.
Drug-Related Problems (DRP) are a variety of events or circumstances that can interfere with the expected results of a treatment. They may be due to the drug itself, its association with other treatments, its incompatibility with the patient, its misuse... When these situations result in harm, they are referred to as adverse drug events (ADEs). DRP and particularly ADE represent a major public health problem in healthcare institutions because of their impact on morbidity and health costs. DRPs are largely preventable and actions can be set up to detect and correct them. It is in this context that clinical pharmacy has expanded, with the development of new activities to help secure drug management. In our institution, the investigators have implemented several activities in different care services, including - medication reconciliation, - an ADE detection. These activities have interesting and encouraging results in terms of impact on the prevention of DRP. However, they can only be carried out on a limited number of patients, depending on the pharmaceutical resources available. The investigators therefore need tools to prioritize our activities on the most at-risk patients. In this study, the investigators seek to identify DRP risk factors and develop DRP risk scores, with the objective to improve the detection and even prevention of DRP. Translated with www.DeepL.com/Translator (free version)
Our objective is to search for clinical, biological and imaging element that would better define the patient population that could benefit from targeted prostate biopsies only (from a cohort of patients who had targeted and non-targeted prostate biopsies).
Hemorrhoidal surgery is considered potentially harmful in patients with chronic inflammatory bowel disease (IBD). Patients with Crohn's disease may have ano-perineal involvement during the course of the disease or even before diagnosis. In addition, patients with IBD (Crohn's or RectoColitis Haemorrhagic, UC) may have rectal involvement. In both cases, hemorrhoidal surgery can be harmful to the anorectal level. However, recent data from the literature has proven to be reassuring. Indeed, the latest studies published on this subject have shown that hemorrhoidal surgery can be performed in a large majority of patients with IBD, especially when the disease is quiescent. The main objective is to assess the morbidity of hemorrhoidal surgery in IBD patients who have been operated on at our center. Postoperative complications will be the main elements sought in the study. The secondary objective is to search for predictive factors of complications from hemorrhoidal surgery in patients with IBD. This requires an exhaustive collection of clinical data.
To evaluate whether Fuzuloparib plus AA-P is superior to placebo plus AA-P as first-line treatment by assessment of radiographic progression-free survival (rPFS) in mCRPC subjects unselected for deoxyribonucleic acid (DNA) damage repair deficiencies (DRD) status (Cohort 1) to evaluate whether Fuzuloparib plus AA-P is superior to placebo plus AA-P as first-line treatment by assessment of rPFS in mCRPC subjects harboring DRD (Cohort 2).
This is a safety, tolerability, pharmacokinetic and efficacy study in subjects with Parkinson's disease
Holoprosencephaly, or HPE, is the most common congenital cerebral malformation in humans and the most severe of a group of pathologies related to a deficiency of the SHH signalling pathway (Sonic Hedgehog SHH-D). It is characterized by severe cerebral and craniofacial abnormalities. The regulation of SHH concentration is therefore crucial for correct craniofacial development. Despite the recent identification of about 20 genes, 70% of cases of EHPE and craniofacial midline abnormalities of genetic origin do not have a molecular diagnosis. It is therefore important to continue the search for new candidate genes to improve the understanding of brain and facial development and to improve genetic counseling for these families. The development of Next-Generation Sequencing (NGS) technologies opens up the possibility of studying the exome or even the genome in a single manipulation. The latter type of analysis is particularly well suited to the discovery of new genes and will therefore improve the care of patients and their families.
In the Paris (France) Medical Emergency system, in the early phase of Out-of-hospital Cardiac Arrest (OHCA), the treatment of a Ventricular Fibrillation (VF) consists of delivering an External Electric Shock (EES) by a rescuer with the use of an Automated External Defibrillator (AED). This latter realizes a cardiac rhythm analysis every two minutes. This analysis requires that chest compressions (CC) be interrupted for a while. However, CC interruptions are potentially harmful due to the brain, and heart perfusions decrease. On the other hand, the recurrence of VF occurs mostly during the first minute after the shock, whereas the delay between 2 rhythm analysis is 2 minutes. The consequence is excessive time spent in VF, which is deleterious in terms of coronary and cerebral perfusion. The investigator implements a new AED algorithm whose operating principle is as follows. One minute after an EES administration, the AED realizes a cardiac rhythm analysis during which the rescuers do not need to interrupt the chest compressions (CC): this is called the rhythm analysis " in presence of CC" The detection of a VF " in presence of CC " needs to be confirmed, " in absence of CC " The CC's are therefore interrupted for new rhythm analysis. Once the presence of VF is approved, the AED proposes a shock to be administred The aim of the study Study Design: This is a prospective observational study. The eligibility criteria are as follows: - Patients in Out-Of-Hospital Cardiac Arrest. - Basic Life support care with an AED. The primary endpoint is the " chest-compression fraction (CCF) " that represents the CPR-time performance during the ten first minutes of BLS care ( or < 10 min in case of Return Of Spontaneus Circulation (ROSC))
Amyotrophic lateral sclerosis (ALS) is a disabling and rapidly progressive neurodegenerative disorder. There is no treatment that significantly slows progression. Our project aims to find new biomarkers in MRI at three levels: cerebral, medullary and muscular. These markers could allow an earlier diagnosis of the disease by showing more specific lesions of ALS and to quantify these lesions to measure the progression of the disease. This study will use advanced Magnetic Resonance Imaging (MRI) techniques High field (3T) and very high field (7T) MRI. Results from neurological and electrophysiological tests will be compared to the MRI. Subjects will be recruited from ALS center of Marseille, France. MRI will be done on ALS patients at baseline, at 3 month and at 6 month intervals.
The "SMOB" project intends to contribute to fill the gap with reliable and operational outcome measures for type III and IV SMA. In analysing the reliability in imaging (spinal and muscular), electrophysiology analysis (MUNIX), and evaluate the evolution of respiratory function for 50 patients' cohort. The investigators would also take the opportunity to collect biologic samples in order to investigate genetic markers and to assess quality of life of patients by QoL-gNMD questionnaire. The investigators aim to build a database that will allow us to evaluate the effectiveness of a new therapy for adult SMA patients by studying the natural history of the disease. The investigators have distributed the various expertise in Work Package where several centers are involved. This study is original in that it evaluates the parameters of qMRI and MUNIX in correlation with blood biomarkers. To our knowledge, there are no quantitative MRI (spinal and muscular) biomarkers and/or electrophysiological (MUNIX technique) highlighted for tracking the progression of the adult form of SMA type III and IV. This pilot study would allow identification of predictive markers of the disease progression, and to have validated, sensitive to change and relevant measurement tools that could be used as endpoints in future therapeutic trials.
Cytomegalovirus (CMV) is a ubiquitous herpesvirus that represent a major cause of morbidity in haematopoietic stem cell transplants (HSCT) recipients, mostly through reactivation of the recipient's virus. If left untreated, 40 to 80% of patients will develop CMV infection, leading to CMV disease in 30 to 35 % patients, and associated with considerable morbi-mortality. Interstitial pneumonia is the most severe and specific manifestation, although CMV replication by itself has also indirect effects such as triggering graft versus host disease and increasing immunosuppression. The current burden of CMV infection increases by 25 to 30% the cost of the graft in France. This also includes the burden for refractory - infections, that represent up to 13% of recipients with CMV infection, including 3% of cases with virological resistance in France (data from the Reference Center cohorts). Ganciclovir, or valganciclovir preemptive treatment, guided by CMV viral load follow-up allowed significant reduction of CMV disease to 2-6% but did not prevent CMV indirect effects. In addition, hematotoxicity can compromise post-transplant haematological reconstitution, thus preventing its use as prophylaxis in France. Foscarnet, iv-administered and nephrotoxic, remains less used. There is thus a high expectation from less toxic molecules for prophylaxis The development letermovir recently available for prophylaxis of CMV infection in high risk patients will modify the patients care and follow-up. This new molecule targeting CMV terminases (developed by Merck) was recently marketed in France (Jan 2020). However, the analysis of the letermovir phase III study and further publications show that the risk of emergence of resistance is low, but may occur in case of breakthrough and thus post AMM monitoring is required. A "real-life" evaluation of these new molecules in terms of efficacy, emergence of resistance, tolerance and morbimortality related to CMV infection, is useful, to propose recommendations on management strategies, in particular for the most at-risk patients i.e. CMV-seropositive recipients. To this purpose, the National Reference Center in collaboration with the French Society for marrow graft and cell therapy (SFGMTC) set up a cohort of surveillance of allografted patients, receiving, in prevention or treatment, old and new molecules.