There are about 36344 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.
Preventing the spread of multidrug-resistant bacteria (MRB) is a major challenge for hospitals today. MRB are defined as bacteria that combine several resistance mechanisms to different families of antibiotics, thus limiting therapeutic possibilities in the event of infection. The spread of MRBs is particularly prevalent in hospital units caring for fragile patients, such as neonatal units. Preventing the spread of MRBs is of prime importance in these units, in order to limit the number of infections caused by these germs. Newborns are at risk of infection due to intrinsic factors such as an immature immune system and fragile skin, as well as extrinsic factors such as mechanical ventilation and intravascular catheters. In Germany, a 2012 KRINKO agreement encourages neonatal units to monitor MRB carriage on a weekly basis. This measure enables early detection of MRB colonization outbreaks in neonatal units. In France, MRB carriage monitoring in neonatal units is not systematic. Spore-forming bacteria also require close monitoring in neonatology, as they do not strictly meet the definition of MRB, but represent a major threat to newborns. The main spore-forming bacterium of medical interest is Bacillus cereus (BC), which is responsible for serious infections in premature infants. BC is resistant to the use of hydro-alcoholic solutions. The origin of these BC infections remains controversial, with numerous studies in the international literature suggesting a link between BC infections and contamination of breast milk given to infants in neonatal units. The role of environmental contamination has also been studied. The potential seriousness of these BC infections justifies the systematic detection of the carriage of this spore-forming bacterium in routine coprocultures, in the same way as other MRB germs. In the neonatal unit at Hôpital de la Croix Rousse, MRB and BC are routinely tested on patient arrival, and then weekly until discharge. If MRB or BC germs are found in children's stools reinforced specific hygiene measures are implemented to prevent cross-transmission in this open-bay unit with little space between incubators. Reinforced specific hygiene measures represent a time constraint for the nursing team, for parents and a financial burden for the neonatal unit. However, to our knowledge, there are no international or national recommendations concerning the duration of stools reinforced specific hygiene measures. Our clinical experience has shown that the persistence of pathogenic germs in stools seems to vary in duration depending on the microorganism. To better determine the optimal duration of reinforced specific hygiene measures, as it is costly in terms of work time, parental stress, and hospital expenses due to reinforced hygiene conditions during the isolation period.
The gold standard after shoulder resection for tumors is reconstruction by reverse prosthesis and allograft. This is an intervention also performed for more frequent etiologies (revisions of prosthesis, non cancerous humeral bone loss ...). The results in these etiologies are good, and do not find any particular mechanical complications (including no osteolysis of the graft). In the case of reconstruction for cancer, the numbers of patients are lower (rare pathologies) and some studies on small numbers found osteolysis of the allograft. The aim of this study is to analyze the presence or not osteolysis in these patients, and to quantify it precisely by scanner measurement (no data yet in the literature).
Proximal humerus is a common site for primary bone tumors and metastatic disease. Reconstruction with reverse shoulder arthroplasty (RSA) after resection is a surgical challenge and presented high risk of complication. The options for reconstruction after proximal humerus tumor resection are limited, and depend on the soft tissue conditions and bone loss. The most commonly used techniques include long cemented stem alone (in case of limited resection), allograft prosthetic composite (APC), massive prosthesis. In some cases two step procedure are performed : first step is resection and RSA with cement sleeve, and second step is APC or massive prosthesis.
The prevalence of cancer with cachexia is rising sharply. More than 80% of digestive cancer patients are affected by cancer cachexia. Cachexia leads to weight loss, and reduces quality of life (QoL), cancer treatment response and survival. Exercise could counteract the deleterious effects of cachexia. The 2CAPA study aims to assess the effectiveness of a 12-week exercise program on various symptoms associated with cancer cachexia, including Health-Related QoL (HRQoL), fatigue, appetite, body composition, physical fitness, and physical activity levels. Additionally, it seeks to examine compliance with the exercise program, identify barriers to regular exercise and determine how compliance influences physical and psychological effects. Furthermore, this study aims to determine the maintenance of physical activity levels and the effects post-program for one year follow-up on cachexia-related symptoms. Methods: This study will include 31 cancer patients with cachexia. Participants will receive a supervised exercise program lasting 12-weeks with two sessions per week combining endurance and resistance training. Outcomes include HRQoL, fatigue, appetite, anthropometric parameters, physical performances, and physical activity levels at baseline, at the end of the 12-week exercise program, and at 3-, 6- and 12- months post-intervention.
Medical students are under a great deal of competitive pressure throughout their training. During their studies, medical students experience high levels of stress, sleep disorders and excessive physical inactivity. These feelings and behaviours are expected to significantly degrade their quality of life, health and performance. The PROMESS project aims to increase students' quality of life and ultimately improve their medical performance. The project aims to improve students' ability to take care of themselves from a short and long term perspective. Encouraging physical activity, reducing sedentary behaviors, reducing stress, fatigue and sleep troubles during their curriculum can promote a healthier lifestyle and reduce the risk of chronic health conditions in the future. The study seeks to quantify the impact of a complex intervention based on 3 modules (stress, sleep, physical activity) on the quality of life and academic performance of 2nd cycle medical students. This study will also have a clear insight on the influence of the complex intervention on changes in stress, sleep, physical activity and sedentary behavior markers.
Patients with IBD experience complex therapeutic pathways. The development of new treatments, more effective and free of side effects, is a therapeutic need. However, such therapeutic innovations can only be effective if they are accepted by the target populations. The objective of this study is to analyze, in patients with chronic inflammatory bowel diseases, the acceptability of 4 different treatments: chemically modified bacteria treatment, genetically modified bacteria treatment, probiotics, and fecal microbiota transplantation. The acceptability of the treatments, i.e. the patients' responses and their rationalizations, will constitute the evaluation criterion and the result of the research. This study will also allow us to evaluate the impact of IBD on quality of life and well-being. Research factors associated with quality of life and well-being, based on dedicated questions (scales validated and included in the questionnaire), evaluate the differential acceptability of the 4 treatments studied. Finally, cross-analyses between health, socio-demographic factors, quality of life and well-being will be performed.
This is a Phase 3, multicenter, double-blind, randomized, placebo-controlled study to evaluate the efficacy and safety of infigratinib in children and adolescents with achondroplasia (ACH) who have completed at least 26 weeks of participation in the QED-sponsored study PROPEL (QBGJ398-001).
The purpose of this study is to assess how well a new scoring system called the 5-SENSE score can predict where seizures start in the brain using Stereoelectroencephalography (SEEG). The 5-SENSE Score is a 5-point score based on routine presurgical work-up, designed to assist in predicting whether SEEG can identify a focal seizure onset zone, thereby sparing patients the risk of undergoing this invasive diagnostic procedure.
Continuation study to provide continued access to latozinemab for participants who have previously participated in a latozinemab study
The primary objective of the study is to evaluate the long-term safety and tolerability BIIB059 (litifilimab) in participants who completed the parent study 230LE301 (NCT05531565) with active subacute CLE and/or chronic CLE with or without systemic manifestations and refractory and/or intolerant to antimalarial therapy. The secondary objectives of the study are to evaluate the long-term effect of litifilimab on disease activity and the effect of litifilimab in preventing disease damage in participants with active subacute CLE and/or chronic CLE with or without systemic manifestations and refractory and/or intolerant to antimalarials; to evaluate the long-term effect of litifilimab on preventing lupus flare in participants with CLE with systemic lupus erythematosus (SLE); to assess long-term use of oral corticosteroid (OCS) in participants receiving litifilimab treatment; to assess the impact of litifilimab on participant-reported health-related quality of life (HRQoL); to evaluate long-term effect of litifilimab on laboratory parameters; to evaluate the immunogenicity and pharmacokinetics (PK) of litifilimab.