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.
Since the end of 2018, the Care and Orientation Center (CASO)of Marseille corridnated by Medecins du Monde has been investigated an innovative program aimed at direct referrals to primary care for vulnerable and precarious population with access barriers to healthcare system (no being coveraged at time of the study). Patients consulting at the CASO MDM in Marseille are accompanied and were received, free of charge, by primary care professionals (general practitioners, specialists, pharmacy, analysis laboratory, etc). This is an observational, comparative study, with two arms: the CASO MDM in Marseille for the intervention site and the CASO MDM in Bordeaux for the control site (where the innovative program does not exist). A total of 610 patients will be included (305 in the innovative group / 305 in the control group). The main objective is to evaluate the effectiveness of the innovative programm (PASS de ville) compared to the standard of care by assessing the rate of emergency departement visits at one year in each group. Duration of inclusion: 12 months; Duration of follow-up: 18 months; Total duration of the study: 36 months. Both quantitative and qualitative analyses will be conducted to address overall outcomes. Univariate and multivariate analyzes will be performed on the primary outcome as well as the secondary outcomes in order to highlight significant differences between the two groups and to identify predictive factors for improved effectiveness. The analysis will be conducted in accordance with Good Epidemiological Practices, and the final report will be written according to the CONSORT (Consolidated Standards of Reporting Trials) recommendations. An intention to treat analysis will be conducted.
Staphylococcus lugdunensis is a coagulase-negative Staphylococcus (CoNS) belonging to the normal human skin flora. It is responsible for a wide variety of infections, such as skin and soft tissue infections, bone and joint infections, but also bacteraemia and endocarditis. Although the implication of S. lugdunensis in infectious diseases is proven, many questions remain both in terms of clinical and molecular epidemiology. In this context, INHOSTAL is the first prospective, bicentric study, which will comprehensively include all patients with S. lugdunensis infection (based on microbiological and clinical data) in two French university hospitals. The main objective of this study is thus to determine the incidence of S. lugdunensis infections in hospitalized patients. Moreover, the originality of this project is to compare the characteristics of S. lugdunensis infections with those of infections caused by S. aureus and other species of CoNS. Thereby, the clinical epidemiology of these infections will be compared (i.e. types of infection, mode of acquisition, host risk factors…). Finally, complete genome of all S. lugdunensis strains will be sequenced using Illumina technology and analyzed to describe the molecular epidemiology as well as the molecular mechanisms of antibiotic resistance (compared to antibiotic susceptibility evaluated by minimum inhibitory concentrations determined by Sensititre technique). This will enable to identify if predominant clones exist, and if some strains are spreading into the hospital. The duration of the study period will be 18 months, to allow the inclusion of a total of 300 patients: 100 S. lugdunensis infections, as well as 100 S. aureus infections and 100 other species of CoNS infections.
This research concerns the evaluation of the maintenance of the efficiency and incidence of adverse effects of pharmacological treatments in sex offenders with paraphilia. Despite the increasing use of pharmacological treatments in these indications, there are few data to indicate which sex offender populations benefit from which pharmacological treatments and which adverse events are observed, particularly with anti-androgens or antidepressant treatments that are widely used in these subjects. A recent Cochrane study showed that psychodynamic treatment is less effective in terms of sexual delinquency compared to probation alone and has not shown significant efficacy of cognitive behavioral therapy (CBT) compared to the lack of treatment, except for a study in which anti-androgen therapy was associated with CBT. Another recent study concluded that the tolerance, even of anti-androgenic drugs, was uncertain, as all studies were small and of limited duration, and new research is needed in the future. Further research demonstrating the efficacy of SSRIs in the treatment of paraphilic disorders is still needed and long-term studies are lacking. Their use for this indication is still off label. As far as we know, this cohort should be the largest population of paraphilic sex offenders studied for the longest time to date in a field where research is insufficient. This large sample receiving routine care and followed for 3 years should allow to analyse the maintenance of the effectiveness of the pharmacological treatments received (SSRIs or anti-androgens), and their tolerance. In addition, this analysis of clinical practices should be crucial to improve the knowledge of the indications for these treatments, which could possibly be reviewed with respect to their effectiveness and tolerance, especially in the most serious cases of paraphilic sex offenders.
The high prevalence of childhood obesity is a major public health issue, worldwide. Childhood obesity is associated with a high risk of cardiovascular events in adulthood, but recent studies also point out the development of cardiovascular complications in childhood or adolescence justifying the need for early detection and appropriate therapeutic management to prevent the development of more severe abnormalities. This project proposes to evaluate the myocardial function in a fine and comprehensive way (longitudinal, circumferential and radial linear deformations, and rotation / torsion mechanics) from the deformation imaging (MRI and high-resolution echocardiography), in obese adolescents following a lifestyle intervention combining diet and physical activity.
The Coronavirus has a major influence on stress for the general population. However, data are currently non-existent concerning the perception and knowledge of the epidemic, the feeling of information from companies / establishments / governments, the means of protection used, the feelings of fear generated and their impact on feelings of stigmatization towards certain ethnic groups or categories of patients (those who cough ...), or relationships with socio-demographic factors or lifestyle.
Recently joint and breast prostheses were placed under special post-marketing surveillance in order to prevent new occurrence of serious incidents by agency for medicines and health products safety. Few of french patient are able to identify their prosthesis in the event on health security alert. An usual postoperative pharmaceutical support (UPS) for patients with joint prosthesis has been implemented to prepare them for return home. At the request of surgeons, a new pharmaceutical support (NPS) has been developed to improve the ability of these patients to recall or find information that identify their prosthesis. Objectives : The main objective is to demonstrate that the new pharmaceutical support (NPS) increase the ability to memorize then find correct information of their prosthesis 6 months post-implantation Material and method : This study, approved by an ethic committee, takes place in the orthopedic and plastic surgery departments. The 236 adult patients included are hospitalized following the scheduled placement of either a breast or a hip or knee prosthesis. They are randomized, either in the NPS group or in the UPS comparator group. In both cases, patients benefit from the same written information: a patient-implant file and an information booklet specific to their prosthesis, validated by specialist surgeons, to prepare for their return home. The only difference between these 2 groups is that patients in the NPS group benefit from additional visual and oral information on the characteristics of their implant and on medical device vigilance during their hospitalization. In NPS group, pharmacist use specific photo and quiz. A telephone follow-up at the 6th month of the patients is carried out by a pharmacist to assess the patient's knowledge, using a standardized questionnaire. Expected results : Based on retrospective data already published, the main hypothesis is that the NPS is associated with an improvement in patient ability to remember the correct model or manufacturer of their prosthesis, compared to the UPS, 6 months after the operation.Secondary hypotheses are that NPS compared to UPS leads to an improvement in patients ability to preserve and find correct items related to theirs prosthesis at 6 months as well as an improvement in their knowledge of medical device vigilance and patient satisfaction declarations and a decrease in anxiety associated with prosthesis.
Local partnerships between schools (preschool and elementary) and mental health public services are implemented in seven sites in France. They aim to improve recognition of difficulties related to mental health problems and to provide interventions to 3 to 8 years-old pupils in need. Our hypothesis that these local partnerships and interventions enhance the role of school in supporting good mental health and wellbeing of all children and the trajectories of children with mental health service needs. Theses also facilitate community support. One of them, early-interventions involve caregivers. Our objective is to enhance knowledge of the unmet mental healthcare need at school and to explore for whom, in which local context and how partnerships and early intervention work.
Clinical studies on single-use ancillaries are still few; medico-economic benefits have to be assessed regarding their design and use. A foreseeable increase in the number of surgeries in the future, tends to change the techniques and consequently to question the medico-economic context. Single-use ancillaries attempt to provide solutions to today's imperatives and could be relevant from a global medico-economic point of view. For the moment, the conventional ancillaries for TKA are reused after sterilization. The objective of the study is to improve the fluidity of the intervention process with cost control.
A 2-years prospective, randomized and multicentric study will be performed to assess the efficacy of metformin compared to sitagliptin on benign thyroid nodules size ≥ 2 cm, in newly diagnosed patients with type 2 diabetes.
The main objective of the BREIZH-Cohorte study is to determine the incidence of recurrent short, medium and long-term thromboembolic venous disease as well as risk factors for recurrence in two specific populations: patients under 50 years of age, men and women (5 year recurrence), as well as cancer patients (all ages) (1 year recurrence).