Baraclado, Spain
Research of the Consequences on the Digestive Tract Following the Proposed Treatments for a Urinary Infection in Children
Phase
N/ASpan
315 weeksSponsor
Centre Hospitalier Intercommunal CreteilMaisons-Alfort
Recruiting
Immersive Virtual Reality Treatment for Unilateral Spatial Neglect
Phase
N/ASpan
186 weeksSponsor
Hopitaux de Saint-MauriceSaint-Maurice
Recruiting
Evaluation of the Individual Early Psychoeducation Program for Schizophrenic Disorders in Inpatients
Phase
N/ASpan
263 weeksSponsor
University Hospital, ToursSaint-Maurice
Recruiting
Child's Study of the Impact of PF Lesion on Motor Skills, Language, Cognitive Functioning and Social Cognition
The physiopathology and the anatomo-functional correlates of motor, cognitive, and language functions after surgery of PF tumors are still rare and little known. The objective of this study is to analyze them via morphometric MRI analysis and functional and structural connectivity in children away from PF surgery, coupled with clinical data analysis.
Phase
N/ASpan
103 weeksSponsor
University Hospital, AngersSaint-Maurice
Recruiting
Healthy Volunteers
Effectiveness and Safety of Early Intramuscular Botulinum Toxin Injections to Prevent Shoulder Deformity in Babies With Obstetrical Brachial Plexus Palsy
Phase
3Span
363 weeksSponsor
University Hospital, BrestSaint-Maurice
Recruiting
Seeing-Moving-Playing: Early Rehabilitation Utilizing Visual and Vestibular Technology Following Traumatic Brain Injury
Phase
N/ASpan
157 weeksSponsor
McGill University Health Centre/Research Institute of the McGill University Health CentreSaint-Maurice
Recruiting
Healthy Volunteers
Evaluation of the Efficacy of the Injection of Botulinum Toxin A vs Scopolamine Patches in the Treatment of Drooling in Children With Cerebral Palsy
Phase
3Span
279 weeksSponsor
Hospices Civils de LyonSaint-Maurice
Recruiting
Interventional Study on Smoking Reduction in Psychiatry
The smoking rate among people with mental disorders is higher than in the general population. Greater exposure to the harmful effects of tobacco partly explains the major inequality in life expectancy observed among people with mental disorders who, depending on the disorder and the study, live 10 to 20 years less than the general population, a gap mainly due to the occurrence of cardiovascular and respiratory pathologies, notably bronchial cancers. While studies found that people under psychiatric care are as motivated as others to stop smoking, the literature also shows that psychiatric care systems tolerate, underestimate and even encourage smoking among users, despite the fact that psychiatric care, whether at hospital or in an ambulatory setting, is conducive to changes in smoking behaviour and to the implementation of a smoking cessation approach, notably because of anti-smoking regulations in hospitals. In addition, withdrawal symptoms is stronger in this population and smoking cessation would therefore need to be adapted. Against this backdrop, a smoking cessation intervention ('Tabapsy') was co-constructed with the various stakeholders (users with mental disorders, mental health professionals and general practitioners). Its aim is to encourage and support smoking cessation among people with mental disorders followed in ambulatory psychiatry by medical psychological centers (CMP). It consists of two parts: a campaign to promote smoking cessation within the CMP, and the setting up of an intervention to help people stop smoking. The latter comprises of: 1. A general information meeting, to encourage motivation to start smoking cessation; 2. An assessment workshop, to evaluate level of dependence using validated tests and establish a personalized cessation program based on the results obtained; 3. Five thematic workshops to support cessation, covering 1/ nicotine replacement treatments, electronic cigarettes and other drug treatments available for smoking cessation, 2/ emotional management, 3/ weight gain, 4/ physical activities, and 5/ manual occupations; 4. Peer support groups, based on the sharing of experiences, to encourage mutual aid and solidarity between people with mental disorders who are trying to quit smoking. The intervention also relies on a facilitator specifically recruited to set up the intervention and run the various workshops in the CMP. It is complemented by a website that will contain all the resources and information presented during the meetings/workshops. The primary objective of the study is to evaluate the effectiveness of the "Tabapsy" intervention on short-term smoking cessation (cessation for at least 7 days) at 3 months among regular smokers followed by adult psychiatric CMPs. Secondary objectives include assessing its cost-effectiveness and implementation. A cluster-randomized controlled trial will be carried out to evaluate the intervention. The cluster is the "psychiatric sector", i.e., the public care entity responsible for organizing the mental health care of a population within a pre-specified geographical area (including hospital and ambulatory care) in France. A psychiatric sector may include one or multiple CMPs depending on the size of the population it serves. Psychiatric sectors will be randomized into one of two groups (intervention or usual practice). It will be supplemented by a qualitative study to study the implementation of the intervention. All regular smokers (at least one cigarette a day) who agree to participate will be asked to complete questionnaires on a WebApp at inclusion, and again at 3 and 6 months. Additional questionnaires will be available in the intervention group. Questions will focus on user characteristics, tobacco consumption, level of nicotine dependence, motivation to quit, use of cessation aids, level of mental and physical well-being, smoking-related knowledge and representations, and in the intervention group, participation in the intervention and satisfaction. 6,250 participants will be included over 6 months, in 22 participating sectors.
Phase
N/ASpan
78 weeksSponsor
GCS-CCOMSSaint-Maurice
Recruiting
A Study of DZD9008 Versus Platinum-Based Doublet Chemotherapy in Local Advanced or Metastatic Non-small Cell Lung Cancer (WU-KONG28)
Phase
3Span
255 weeksSponsor
Dizal PharmaceuticalsSaint-Mande
Recruiting
Oral Switch During Treatment of Left-sided Endocarditis Due to Multi-susceptible Staphylococcus
The RODEO 1 study is designed to determine the safety and efficacy of partial oral treatment of IE compared with traditional full-length parenteral treatment. Our primary objective is to demonstrate that in patients with left-sided multi-susceptible Staphylococcus who have received at least 10 days of IV antibiotic treatment with or without valvular surgery, a switch to an oral combination of rifampicin and fluoroquinolones between Day 10 and Day 28 after initiation of the IV antibiotic treatment, is not inferior to the continuation of the conventional IV antibiotic treatment regarding to treatment failure within 3 months after the end of antibiotic treatment. Nationwide, noninferiority, multicenter, randomized, controlled, open-label trials. Randomisation will only be offered to patients who have received at least 10 days of IV conventional antibiotic treatment of IE, and fulfil the inclusion criteria. Randomisation will take place between Day 10 and Day 28 after initiation of parenteral antibiotic therapy or valvular surgery, thus ensuring to have at least 14 days of oral therapy in the experimental group. Patients will be eligible whether they have undergone valvular surgery or not. This will imply that surgery procedure prior to randomisation will be heterogeneous, but randomisation will be stratified on the requirement of valvular surgery as part of the treatment of the current episode of IE or not.
Phase
3Span
448 weeksSponsor
University Hospital, ToursSaint-Mande
Recruiting