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 main objective of this study is to carry out the psychometric validation of the PERMA-Profiler in a population representative of the general French population and in comparison with the reference questionnaire The PERMA-Profiler.
Crohn's disease (CD) is an incurable chronic inflammatory disorder of the gastrointestinal tract. This study will assess how safe and effective upadacitinib is in treating moderately to severely active CD in real world. Speed of onset and durability of effectiveness will be assessed. Upadacitinib is a drug approved for the treatment of CD. All study participants will receive upadacitinib as prescribed by their study doctor in accordance with approved local label. Approximately 1200 participants will be enrolled in approximately 230 sites across the world. Participants will receive upadacitinib as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for up to 3 years. There is expected to be no additional burden for participants in this trial. Study visits may be conducted on-site or virtually as per standard of care.
The Inserm NeuroPresage team has been using MRI for more than 20 years in the study of normal ageing and memory pathologies to further the understanding and the characterization of early diagnosis and the cerebral substrates of cognitive deficits in patients, particularly in the context of neurodegenerative diseases. Two years ago, a new 3T MRI camera was installed at the Cyceron centre. It is more efficient and should make it possible to obtain better quality images and/or to reduce the time required to acquire these images. In this context, it seems important to test the different sequences that we classically use in our studies, or that we plan to implement in our next studies (learning and text retrieval fMRI task), in order to optimize them, with a view to integrating them in our future studies.
Going back home following a stroke is a key step for the patient and his or her relatives. Due to the brutality of stroke and increasingly shorter lengths of hospital stay, patients and families must adapt quickly to the patient's new state of health and the new role of informal caregiver for family members. Currently, 70% of patients return home directly after treatment in a stroke center. Following the acute phase, the patient's care path involves many health and social workers. However, the health care system is complex and difficult for patients and informal caregivers to understand. A lack of support during the hospital/home transition has significant negative consequences for the patient (reduced functional prognosis, quality of life and reintegration, increased risk of recurrence) and his or her informal caregiver (increased perceived burden, decreased quality of life, socio-economic impact). Patients and informal caregivers report a significant need for advice and information during this transition period. They are looking for individualized, good quality information and whose nature evolves over time with the needs and recovery of the patient. Thus, the provision of information through an Internet platform could meet these characteristics, in association with individualized support by a case-manager to ensure continuity of care and improve care pathway. In France, no such program has been developed to date for stroke. Existing transition programs mainly focus on home rehabilitation and do not offer a comprehensive approach to the situation, integrating caregivers. In addition, no programs have been developed in partnership with patients and families to best meet needs. An hospital-to-home transition support program in partnership with patients and relatives using a "user-centered design" approach has been developed in order to best meet needs. A first phase of co-construction has been conducted while 4 participatory workshops for (patients, informal caregivers, healthcare assistants and professionals in the social field) were carried out to precisely define and develop the program. The program was developed in based on data from the scientific literature, an inventory of existing systems and the experience of participants. During this phase a usability testing of the platform developed during the workshops with patients and informal caregivers following a Think Aloud method has also been conducted. The hypothesis is that the implementation of this patient-centered post-stroke hospital/home transition program, combining an Internet platform and follow-up by a case-manager, is feasible within stroke center and will receive good acceptability from healthcare professionals, patients and informal caregivers.
Upper gastrointestinal (GI) cancers are one of the most common cancers worldwide. Except for cardia cancers, the incidence of gastric cancer has decreased consistently since 1980, but remains at a high level. In France, gastric cancers are the 6th most common cause of cancer-related mortality. The risk factors of upper GI cancers are well known and their control could prevent the development of cancers: smoking cessation, reduction of obesity, alcohol, eradication of Helicobacter pylori. But late presentation with upper GI cancer results in a poorer prognosis. Patients with advanced (Stage IV) gastric cancer have a five-year survival rate of 3.7% whereas patients whose gastric cancer is discovered in its early stage (Stage I) have a significantly higher five-year survival rate of 88.4%. Therefore, endoscopic detection of upper GI lesions at an earlier stage is the single most effective measure for reducing cancer mortality. But upper GI cancer is also often missed during examinations, and some studies demonstrated a missed cancer rate of 2.3-13.9% in Western populations. In the past decade, accurate diagnosis during endoscopy has become particularly important as dysplastic lesions and early gastric cancers can be treated effectively with both endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD), avoiding the morbidity and mortality associated with gastrectomy. However, these early neoplastic lesions can be sometimes difficult to distinguish from background mucosa, even with advanced imaging techniques (high definition, chromoendoscopy). In recent years, image recognition using artificial intelligence (AI) with deep learning has dramatically improved and opened the door to more detailed image analysis and real time application in various medical field, including endoscopy. For example, in the colorectal cancer screening area, real time computer-aided detection systems (CADe) can lead to significant increases in both polyp and adenoma detection rates. CADe has also shown good performance in detection of Barrett's neoplasia during live endoscopic procedures in order to more accurately locate the area to be biopsied. Recently, a Chinese study showed that CADe achieved high diagnostic accuracy in detecting upper GI cancers, with sensitivity similar to that of expert endoscopists and superior to that of non-experts. This system could support non-experts by improving their diagnostic accuracy to a level similar to that of experts and provide assistance for improving the effectiveness of upper GI cancer diagnosis and screening. Although encouraging results have been published regarding the use of AI in the diagnosis of upper GI cancers, the clinical applicability of such systems in a European population has yet to be investigated. Therefore, we want to evaluate the diagnostic capability of a recent CADx compared to endoscopists in order to improve the real-time detection of early gastric cancers in our European center Edouard Herriot Hospital, Lyon, France, as well as 3 other tertiary centers in France (Limoges, Rennes and Nancy University Hospitals). With a high prevalence of stomach cancer, Japan is a world leader in high-quality diagnostic upper GI endoscopy, and the clinical routine in this country differs substantially from Western practice, with population-based screening programs. We will use for our study a CADx developed by AI medical service Inc. (1-18-1, Higashiikebukuro, Toshima-ku, Tokyo 170-0013, Japan), a Japanese company developing AI systems that supports endoscopist's diagnosis for the digestive tract. A recent study involving AI medical service system showed good results in the diagnosis of early gastric cancer compared to endoscopists, with a significantly higher sensitivity.
The aim of the study is to demonstrate that "frail" patients, defined as having a CFS score greater than or equal to 5, and "severely" frail patients, defined as having a CFS score between [6-7] as defined by Bagshaw et al (14), constitute an independent risk factor (RF) for mortality. In the same way, as an exploratory study, we will try to find out whether clinical frailty constitutes a risk factor for extending the length of hospital stay, the risk of short/medium-term readmission, as has already been demonstrated for patients admitted to intensive care from all causes (15), or for impaired quality of life. The objective is to have a better understanding of the implications and outcomes associated with pre-hospital frailty in young critically ill patients. This analysis will also help to clarify prognoses and contribute to better decision-making on the intensity and proportionality of care, as well as providing better information and helping to manage the expectations of patients and their families in terms of survival prognosis and subsequent quality of life.
ADOmiARN is a multicentre, prospective, longitudinal, non-interventional, observational study carried out in obstetrics, gynecology and pediatrics departments in France and in Belgium. The main objective is to confirm the interest of the in vitro diagnostic medical device (EndoTest®) in adolescents with suspected endometriosis. The study population is made up of females aged 10 to 19 years with formally diagnosed endometriosis or suspected endometriosis. The patients concerned by the study are managed without any change in the care pathway, no any change in the therapeutic indications, no any change in the diagnostic examinations (imaging or biology) required according to the context, which are carried out in accordance with the national guidelines. In this study, the management and follow-up of patients : - Are not imposed by the study: the doctor remains free to make medical prescriptions (treatments and examinations) and to determine the interval between consultation visits, - Are not modified in comparison with the usual follow-up, except for the performance of : - Collection of saliva - Completion of a self-questionnaire on symptom and quality-of-life.
RNALS is a multicentre, transversal, diagnostic and non-interventional study carried out in ALS reference centers; in order to identify a diagnostic signature for Amyotrophic Lateral Sclerosis by analyzing of coding and non-coding RNA contained in patients saliva. The study population consists of patients with definite or probable amyotrophic lateral sclerosis (ALS) according to the El Escorial criteria ("ALS Subjects" group) and subjects with no neurological history (Control group). The control group will be made up of caregivers of patients with ALS, and caregivers of patients with a pathology other than ALS. The ALS patients concerned by the study already benefit from routine medical care in ALS expert centers in France. The patients concerned by the study will be managed without modification of the care pathway, nor modification of the therapeutic indications, nor modification of the diagnostic or follow-up examinations necessary according to the context, which are carried out according to the recommendations of the HAS, CNGOF.
The purpose of the study is the rate of return to sport (regardless of the sport envisaged) after a minimum of 3 years after total knee prosthesis.
The Total duration of trial participation for each participant with post-bariatric hypoglycemia will be a maximum of 59 weeks, with the following duration of trial periods - 19 weeks for the Core Phase. It is composed of: - a Screening period: a maximum of 3 weeks - a Run-in period (no treatment): 4 weeks - a Blinded Treatment Phase: 12 weeks - 36 weeks Extension Phase = an open-label Treatment period - 4 weeks for the safety follow-up period (without any treatment).