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.
Elderly adults have high rates of emergency department (ED) visits. Specificities of this population challenge organizations of care in the ED, and older adults are at risk of pejorative outcomes after an ED stay. Numerous interventions have been designed to improve quality of care and outcomes for the older population in these settings, with a specific attention to concerning discharge from the ED. These interventions are interdisciplinary, bridging emergency and geriatric care. The wide range and complexity of these interventions make them difficult to assess and compare, as highlighted by several reviews in the past ten years. Prior analyses helped to categorize different intervention strategies and three main designs: inhospital, community and transitional interventions started in the ED and pursued in collaboration with community primary care professionals . Theses analyses show that the use of multiple strategies and transitional models of care tend to lead to better outcomes, and underline that more robust studies are needed to confirm this hypothesis. In France a majority of EDs collaborate with Geriatric Mobile Teams (GMT) to improve quality of care for older patients. GMTs are dedicated to patients over 75 years old, and interventions in EDs are targeted on patients at risk of worse outcome. When ED physicians detect older patients at risk they may call for the GMT for further assessment and management. GMTs either work in a inhospital standard approach or with a transitional care management. This second strategy, less common in France, is thought to be be efficient and has never been assessed. We have designed a study to compare these methods, with the hypothesis that among at-risk older adults, hospital-community transition care initiated by GMTs during an ED visit with direct discharge home will be associated with a reduction in the risk of early readmission within 30 days, and lower risk of loss of independence at 3 and 6 months. It is a french multicentric study, with a quasi-experimental design, comparing hospitals without transitional care management to hospitals with hospital-community transitional intervention. We aim at enrolling 1322 patients aged 75 and more at risk of pejorative outcomes as determined by the Triage Risk Screening Toll (TRST). The main outcome is a revisit to the ED between day 7 and day 30, secondary outcomes are autonomy, mortality, use of hospital services and caregiving at home at 6 months.
A multi-centre, open-labelled, randomised, crossover design. The total study duration for the individual subject will be approximately 4 weeks, consisting of four site visits and two 2-week test periods at home. Visits 0 and 1 can be performed on the same day. For visit 2 and 3, 2 catheterisations will be performed in a hospital setting (one HCP catheterisation and one self-catheterisation) for bladder emptying and user experience assessments. Visit 1 and 2 are followed by a home-use test period, followed by visit 3 which terminates the study.
The purpose of this study is to evaluate the efficacy, acceptability, and safety of a simplified event-driven pre-exposure prophylaxis of HIV based on oral TAF/FTC in HIV-uninfected cisgender men who have sex with men (MSM). Primary objective: To assess the efficacy of emtricitabine 200 mg + tenofovir alafenamide 25 mg (F/TAF), taken 2 to 24 hours before sexual intercourse followed by a second dose 24 hours after the first intake, in reducing the risk of HIV acquisition in MSM relative to the background HIV incidence rate.
The primary objective of the study is to evaluate the effectiveness of a post-diagnostic psychoeducational intervention in increasing the sense of self-efficacy of adults diagnosed with Autism Spectrum Disorder-Without associated Intellectual Disability
Newborn's renal function is difficult to assess and its physiology during the first days of life is still incompletely known. Studies suggest that the newborn almost completely reabsorbs creatinine during the first 48 to 72 hours of life, while at the same time it continues to produce its own creatinine. Therefore, the initial stock of creatinine at birth still increases through this production and the non or weak clearance. A better knowledge of renal physiopathology in newborns would allow to improve the therapeutic management of the infants, particularly in case of potential nephrotoxicity. No study has attempted to assess the increase in urinary creatinine excretion in neonates from a given time. Objectives: To show when urinary creatinine excretion in newborns is efficient. Results: this study mightr show an inflection point in urinary creatinine excretion illustrating the postnatal age when renal function becomes efficient.
The First-Episode Psychosis (FPE) is a severe disorder that can include delusions, cognitive disorders and suicidal behavior. In the majority of cases (more than 80%) it evolves into schizophrenia. Numerous studies show that the rapidity of the initial management of FPE would reduce the risk of negative evolution and would have a decisive impact on the short and long term prognosis. The rapidity of this management can be measured by the duration of untreated psychosis, or DUP (Duration of Untreated Psychosis), the time interval between the appearance of the first frank psychotic symptoms and the initiation of adequate psychiatric care. The objective of this study is to show the impact of an intervention facilitating access to specialized care for PEP on the reduction of DUP. This intervention consists of an early identification program for FPE, the PRESTO program, specifically targeting 3 determining steps in the reduction of DUP: - Informing the general population about psychotic disorders - Knowledge of front line actors (APL: general practitioners, school and university medicine, teenager's house, associative networks educators, emergency services, firefighters, etc.) about FPE and its management - Articulation between APL and specialized psychiatric care
Several types of gingival phenotype can be diagnosed in the general population and their evaluation is an essential clinical criterion in periodontal practice, whether the periodontal therapies are preventive or curative, non-surgical or surgical. Moreover, several authors have shown that the gingival phenotype varies from one dental sector to another, hence the interest of a meticulous and targeted diagnostic approach in relation to the established therapeutic objectives. To date, the gingival phenotype has been not studied extensively in the mandibular incisal area. Therefore, it seems relevant to conduct an observational cross-sectional study on a cohort of patients in good general health and with a healthy and intact periodontium to assess the prevalence of the gingival phenotype in this area. The secondary objective is to highlight the associated intrinsic and extrinsic risk factors for thin gingival phenotype, to anticipate a risk of gingival recession and to propose an early personal therapy.
This study will be conducted in the Regional Emergency Room (ER) of the Dijon-Bourgogne University Hospital in Dijon, France. It is an interventional study that will have an impact on medical contact time. Patients will be identified among adult patients presenting to the ER of the Dijon University Hospital. Each patient will be followed-up for 30 days from the time of arrival at the ER (if the inclusion criteria for the study are met). A total of 337 patients will participate in this study and will be randomly allocated to 3 groups: - Group 1 "controls - FRENCH grid only": patients will receive the same care and management as any other patient admitted for the same condition. Management is based on the use of the FRENCH grid only. - Group 2 "FRENCH grid + QuickSOFA": In addition to the standard use of the FRENCH grid, a quick score called QuickSOFA is added. It consists in performing an evaluation based on 3 clinical criteria (blood pressure, respiratory rate and consciousness) to quickly establish a severity score. - Group 3 "FRENCH grid + QuickSOFA + Capillary lactate": In addition to the use of the FRENCH grid and the QuickSOFA score, capillary lactate concentrations will be measured. This involves taking a drop of blood from the fingertip (less than 1ml). For diabetic patients, there will be no second sampling act, everything will be done from the same sample. All samples will be discarded after the result is displayed on the reader. This study includes 2 visits: - D0 (adult ER visit): The patient's background, clinical and biological data will be collected. The patient will then be randomized into one of three groups. Depending on the group assigned, the triage nurse may perform QuickSOFA and lactate assessments. - Follow-up at D30: collection of follow-up information up to 30 days after inclusion in the emergency department: replacement therapy (mechanical ventilation, extracorporeal membrane oxygenation,…), dates of discharge from critical care and hospital, vital status and in case of death the date of its occurrence.
In the last decades, cancer treatment was based on surgery, radiotherapy and chemotherapy. Recently, treatments have largely evolved, first with targeted therapies (notably tyrosin kinase inhibitors, TKI) and then with immune checkpoint inhibitors (ICPI, notably anti-CTLA-4 and anti- PD1). The last ones can induce durable anti-tumoral responses in patients, even if metastases are present. Their mechanisms of action are focused on the activation of immune system in order to eliminate the tumor. ICPI, because of their mechanisms of action, target immune tolerance key components and can induce important immune toxicities (colitis, hepatitis, dermatitis, thyroiditis ...), leading to early discontinuation of treatment, severe or chronic morbidity, and can sometimes be lethal. It is of importance to detect patient at risk of irAEs, because of the increasing use of ICPI and the long- term response capacity in treated patients.
The goal of this clinical trial is to determine whether one of the two oxygenation or ventilation strategies (NIV and/or HFNO) is superior to standard oxygen to reduce 28-day mortality rate in hypoxemic acute respiratory failure (ARF) patients.