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.
Mild to moderate pulmonary hypertension is a common complication of chronic obstructive pulmonary disease (COPD); such a complication is associated with increased risks of exacerbation and decreased survival. A small proportion of COPD patients may present with severe pulmonary hypertension, defined by a mean pulmonary artery pressure more than 35 mmHg (or more than 20 mmHg with a low cardiac index < 2 l/min/m2) with pulmonary vascular resistance more than 3 Wood units, measured by right heart catheterization (RHC). In these patients, pulmonary microvessels remodeling is the main cause of increase in pulmonary arterial pressure and is thought to result from the combined effects of hypoxia, inflammation, and loss of capillaries but the mechanisms are complex. For these patients, no drugs have been approved for treatment and lung transplantation must be considered for the more severe patients who are eligible. A better characterization of these patients is needed. We hypothesize that microvesicles generation and endothelial damage could be related to the severity of pulmonary hypertension due to COPD, assessed by pulmonary hemodynamic parameters. Circulating biomarkers of vascular damage and cell activation will be measured in blood samples from 80 COPD patients who have hemodynamic assessment by RHC. To go further, the origin of the particles will be characterized.
Emergency medicine is one of the professional activities integrating a night activity into working time. Concerns about the sleep deprivation that this activity generates have been growing for the past thirty years. However, at present, the pace - duration and repetition - of this activity does not yet seem to be optimized, and therefore continues to be the subject of questions in terms of safety of care and quality of life at work. One of the peculiarities of emergency medicine is that doctors have to work in a crisis situation. A situation is qualified as critical for a patient when his state of health is unstable, and with an evolution which can be rapidly pejorative. Crisis situations are at the heart of the emergency room profession, and due to their potential seriousness for the patients, it must be managed in all circumstances. To cope with a crisis situation, a doctor needs to be efficient. However, performance calls for two types of skills: technical skills on one hand, and non-technical skills on the other. This study therefore aims to answer the following question: are the non-technical skills of emergency physicians in the management of a crisis situation affected twenty-four hours after the end of a night shift? The study assesses the performance of emergency physicians via complex simulations at two time frames : 24h after a night shift (the post recovery performance simulation) and another time were the participant did not have night shifts in less than 3 nights (usual performance simulation).
Prader-Willi syndrome (PWS) is a rare and complex genetic disease characterized by hypothalamic-pituitary axis dysfunction combining eating disorders associated with hyperphagia and satiety deficiency, mild intellectual deficit and behavioral disorders. This disease requires continuous management through specific therapeutic education to prevent metabolic and cardiorespiratory complications related to obesity. Physical activity must therefore be regular, adapted to the disability, taking into account cognitive deficits and behavioral disorders. Prader-Willi syndrome (PWS) is a rare and complex genetic disease characterized by hypothalamic-pituitary axis dysfunction combining eating disorders associated with hyperphagia and satiety deficiency, mild intellectual deficit and behavioral disorders. This disease requires continuous management through specific therapeutic education to prevent metabolic and cardiorespiratory complications related to obesity. Physical activity must therefore be regular, adapted to the disability, taking into account cognitive deficits and behavioral disorders. The Unit of Care and Rehabilitation, of the Hôpital Marin d'Hendaye, receives patients with PWS or other obesity from rare causes, at a rate of 1 to 2 annual stays of 1 to 2 months, which allow the regulation of somatic disorders and the initiation of weight loss. However, the difficulty is to keep a stable weight curve between stays. Only 20% of patients over the last 2 years managed to stabilize or decrease their BMI during the 6 months following their hospitalization. The proposed study aims to evaluate an innovative and individualized care program combining Physical activity, Nutrition and therapeutic education for adults with PWS who will be admitted to the hospital for 5 weeks. We hypothesize that this program will allow to stabilize or decrease the BMI of patients at 6 months after hospitalization by inducing a behavioral change in terms of physical activity and eating behavior. We will conduct a randomized controlled trial on 128 patients who will participate in this program, or will benefit from standard care.
This study is open to adults with head and neck cancer or liver cancer. This is a study for people for whom previous treatment was not successful or no standard treatment exists. The purpose of this study is to find out whether combining different medicines make tumours shrink in people with head and neck cancer or liver cancer. The tested medicines in this study are antibodies that act in different ways against cancer. BI 765063 and ezabenlimab may help the immune system fight cancer (checkpoint inhibitors). Cetuximab blocks growth signals and may prevent the tumour from growing. BI 836880 blocks the formation of new blood vessels that the tumour needs to grow. All participants get BI 765063 and ezabenlimab. One group gets no additional medicine. The other groups get either BI 836880, cetuximab, or chemotherapy. BI 765063, ezabenlimab, and BI 836880 are given as infusions into veins every 3 weeks. Cetuximab is given as an infusion every 1 or 2 weeks. Participants can stay in the study as long as they benefit from treatment and can tolerate it. The doctors monitor the size of the tumour. The doctors also regularly check participants' health and take note of any unwanted effects.
The pandemic forced us to develop home follow-up for patients with chronical diseases . In the same time, the new era of treatment for cystic fibrosis considerably improves the health of patients with this pathology. This study aims to assess the satisfaction of patients and care providers for an alternated follow-up between tele-consults and in-hospital consults during one year for patients with cystic fibrosis treated by Kaftrio® since at least one year and stable.
Depersonalization-derealization (DD) disorders are a clinical phenomenon characterized by feeling disconnected or detached from one's self. Individuals may report feeling as if they are an outside observer of their own thoughts or body, and often report feeling a loss of control over their thoughts or actions. Several scales have been developed to measure DD, and the Cambridge Depersonalization Scale (CDS) appears to be the most relevant and consistent to characterize the clinical symptoms of these disorders as well as their duration and frequency. This scale, originally written in English, must be translated and validated according to standardized methods that include testing steps patients with dizziness and in individuals with no vestibular disorder. Persistent postural-perceptual dizziness (PPPD) is a chronic, persistent vestibular syndrome generally preceded by acute vestibular disorders. The main symptoms are rotational dizziness, unsteadiness and / or non-rotating dizziness that are exacerbated by upright posture, walking, active or passive movement, and exposure to moving visual stimuli or complex visual patterns. To help diagnose this syndrome, a questionnaire was developed in Japan in 2019, the Niigata questionnaire, however no French version has yet been validated. Similarly, this scale needs to be validated in patient with PPPD and in control populations. The main objective of this study is to validate the French translation of these two scales, the CDS questionnaire and the Niigata PPPD questionnaire, according to standard methods (forward translation, back translation, consensus).
The main objective is to understand the lived experience of overweight/obese patients who have followed the mindful eating program at Montpellier University Hospital. Semi-structured face-to-face interviews will be conducted in the Nutrition-Diabetes service by using a questionnaire.
Hereditary epidermolysis bullosa (EBH) is a rare, orphan disease characterized by skin and mucous membrane fragility. The latest scientific data show that the proposed treatments are still in the experimental stage and that no curative treatment is available. The repercussions of this chronic disease, with neonatal onset, are major. Epidermolysis bullosa requires multidisciplinary medical management, nursing care, psychological and social care. Skin care involves preventing and treating chronic wounds and identifying their complications. The very great cutaneous-mucous fragility makes these treatments painful, long and complex, the caring hand itself being able to cause new wounds. Analgesics of different levels are not effective enough during treatment. Along with counseling and education, nursing takes a central role in multi-professional accompaniment interventions to support and relieve families. Parents became home caregivers out of necessity, and developed specific skills in epidermolysis bullosa, their child and dressings. They have great and demanding expectations of caregivers facing this rare disease, for which they are not trained in their degree course. Despite the severe nature of the disease, few studies have been carried out on the impact and psychosocial consequences on patients and their families, yet there is an expressed need for support. The burden on parents is heavy, assessed by specific scales, but to date there are no studies examining the impact of epidermolysis bullosa care on caregiver stress.
The primary objective is to evaluate the impact of Pharmaceutical Interviews in the patient self-management of non-severe side effects caused by antibiotics prescribed for the treatment of osteoarticular infections when the patient returns home.
The intervention proposed is a new organization of care, based on the EXPRIM (EXtrem PRematurity Innovative Management) protocol, involving early, standardized, and multidisciplinary management of women hospitalized for a risk of extremely preterm birth and their children. It will take place in each perinatal network for all pregnant women hospitalized between 22 and 26 weeks with a risk of preterm delivery. Setting up the protocol requires taking into account the parents' time and timing issues, and its potential for change, to plan the implementation of the protocol, especially the degree of emergency of the situation and the probability of imminent delivery. The follow-up collected for this study will take place: - At D4 post-delivery: A questionnaire about the parents' experience of the information delivered and the decisions made will be given to and collected from the parents - At the child's discharge from the hospital, or if he or she dies in the hospital: - Collection of clinical data (principal endpoint) from data in the medical file. - Data to measure practices and adherence to the intervention will be collected - When the child reaches the corrected age of 2 years: - a short questionnaire will be completed by the physician caring for the child at the corrected age of 2 years. The data collected will concern motor and sensory development, in particular, cerebral palsy, blindness, and deafness.. - Information about the child's development will also be collected with a questionnaire including a standardized assessment scale, the ASQ (Ages and Stages Questionnaire), which the parents will complete.