[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Hospices Civils de Lyon\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":704},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,366,0,25,[9,48,76,103,133,161,193,215,241,271,303,334,360,384,412,435,462,487,514,539,568,596,621,660,683],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":31,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100609341","probiotic-intervention-for-digestive-health-in-obese-patients-initiating-glp-ra-treatment-100609341",false,"NCT07213323","Probiotic Intervention for Digestive Health in Obese Patients Initiating GLP-RA Treatment","Evaluation of the Efficacy of Probiotics on Digestive Quality of Life in Patients Initiating GLP-1 Receptor Agonists for the Treatment of Obesity. A Randomized, Double-blind Trial","PROBIO-GLP1","Inclusion Criteria:\n\n* Patient who is going to start a GLP-1 RA (semaglutide or tirzepatide) for weight management\n* Men or Women\n* BMI ≥ 30 kg\u002Fm2 or BMI ≥ 27 kg\u002Fm2 associated with one or more co-morbidities (arterial hypertension, sleep apnea, dyslipidemia, arthritis)\n* Between 18 and 75 years old\n* In the opinion of the investigator, the patient must have adequate support to comply with the entire study requirements as described in the protocol (e.g. transportation to and from trial site, ability to understand and fill the self-rating scales, drug compliance, availability to attend to the scheduled visits, etc…).\n* Patient who agrees to be included in the study and who signs the informed consent form\n* Female participants of childbearing potential must agree to use effective contraception\n* Patient affiliated to a healthcare insurance plan\n\nExclusion Criteria:\n\nCriteria relating to the study population:\n\n* Patients under 18 years old\n* Patient with contraindication to semaglutide or tirzepatide according to the Summary of Product Characteristics (SPC).\n* Patients scheduled for bariatric surgery during the study period\n* Patients who have had bariatric surgery in the last 12 months\n* Patient with a current diagnosis of diabetes.\n* Patients with a current diagnosis of liver cirrhosis, short bowel syndrome or inflammatory bowel disease (IBD).\n* Patients with severely weakened immune system.\n* Clinically unstable medical disease, including cardiovascular, hepatic, renal, gastrointestinal, pulmonary, metabolic, endocrine, or other systemic disease.\n\nProduct criteria:\n\nPatient with known allergy to the product of the study\n\nProhibited treatments :\n\nCurrent associated treatments or used in the last 30 days: GLP-1 RA, Anti-obesity drugs (AOD), Corticosteroids, Atypical neuroleptics, Antibiotics, Probiotics, Prebiotics\n\nRegulatory criteria :\n\n* Persons deprived of their liberty by a judicial or administrative decision\n* Persons under psychiatric care\n* Persons admitted to a health or social institution for purposes other than research\n* Adults subject to a legal protection measure (guardianship, curatorship)\n* Persons not affiliated to a social security scheme or beneficiaries of a similar scheme\n* Subjects participating in other interventional research with an exclusion period still in progress at pre-inclusion","ALL","18 Years","75 Years",{"count":22,"type":23},50,"ESTIMATED","INTERVENTIONAL",[26],"NA","Obesity is a prevalent chronic disease affecting 17% of the French population. Treatment involves multiple factors, with pharmacotherapy playing an increasingly important role. GLP-1 receptor agonists (GLP1 RAs) are considered revolutionary in obesity treatment, with three approved molecules available in France: liraglutide, semaglutide, and tirzepatide. These treatments, combined with a healthy lifestyle, induce significant weight loss: 9% with liraglutide, 15% with semaglutide, and 20% with tirzepatide.\n\nThe most common adverse events (AEs) associated with GLP-1 RAs are gastrointestinal (GI) disorders, including nausea, vomiting, diarrhea, and abdominal pain. These AEs are dose-dependent and often decline over time. In phase 3 trials, semaglutide 2.4 mg showed higher rates of GI AEs compared to placebo, but most were mild to moderate and transient. GI AEs led to dose reduction or temporary treatment interruption in 12.5% of participants, with few permanent discontinuations.\n\nProbiotics, are live microorganisms that benefit the host by improving gut microflora. Probiotics has been clinically proven to benefit gastrointestinal health. Probiotics may reduces symptoms of irritable bowel syndrome (IBS), improves gut barrier function, reduces inflammation, and decreases the incidence of C. difficile infection (CDI) in patients taking antibiotics.\n\nProbiotics is therefore theorized to potentially reduce GI side effects associated with GLP-1 RA treatment for obesity.\n\nHypothesis Probiotics will prevent and limit the digestive disorders induced by GLP-1 R agonists, particularly during the dose escalation period. This would allow better digestive tolerance of the treatments, limiting the number of definitive treatment interruptions, facilitating compliance and dose escalation with a larger number of subjects at full dose and therefore with better systemic exposure to the compounds, a key factor in their effects on weight loss.",[29,30],"Obesity &Amp; Overweight","Digestive Disorders",[32,33,34],"GLP1 R-agonist","Probiotics","Quality of life","RECRUITING","2026-08-18",{"date":38,"type":39},"2026-08-19","ACTUAL",{"date":41,"type":39},"2026-08-05",{"date":43,"type":23},"2028-08-05",{"name":45,"class":46},"Hospices Civils de Lyon","OTHER",1,{"id":49,"slug":50,"hasResults":12,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":12,"sex":18,"minAge":56,"maxAge":19,"enrollmentInfo":57,"targetDuration":4,"studyType":24,"phases":59,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":47},"100652269","impact-of-a-targeted-nutritional-intervention-on-glycaemic-variability-and-correlation-between-glycaemic-parameters-and-satiety-100652269","NCT07771842","Impact of a Targeted Nutritional Intervention on Glycaemic Variability and Correlation Between Glycaemic Parameters and Satiety.","Impact of a Targeted Nutritional Intervention on Glycaemic Variability","APETIT","Inclusion Criteria:\n\n* Adolescents who have entered puberty (Tanner S2+ or G2+)\n* Aged over 12 and under 18 years\n* Obese, defined by an IOTF Body Mass Index (BMI) \\> 30\n* Child's assent and consent from the person(s) exercising parental authority\n\nExclusion Criteria:\n\n* Type 2 diabetes: HbA1c \\> 6.5% or fasting plasma glucose \\> 1.26 g\u002FL\n* Type 1 diabetes\n* Treatment capable of altering the glycemic profile (e.g., corticosteroids)\n* Intercurrent illness capable of significantly impacting eating behavior (e.g., Prader-Willi syndrome) or the postprandial glycemic profile\n* Hypothalamic obesity\n* Neuropsychomotor developmental disorders, intellectual disability\n* History of bariatric surgery\n* Pregnant, parturient, or breastfeeding women\n* Persons deprived of liberty by a judicial or administrative decision\n* Persons undergoing psychiatric care\n* Persons admitted to a healthcare or social care facility for purposes other than the research\n* Adults subject to a legal protection measure (guardianship, curatorship)\n* Persons not affiliated with a social security scheme or beneficiaries of a similar scheme\n* Participation in a study affecting appetite or blood glucose levels","12 Years",{"count":58,"type":23},20,[26],"Obesity affects 18% of French adults and increasingly impacts adolescents. Dietary management is challenging, particularly with eating disorders like hyperphagia. The study hypothesizes that glycaemic variability contributes to eating disorders, as blood glucose fluctuations and reactive hypoglycaemia may exacerbate compulsive eating. Currently, no data exists on the relationship between glycaemic profile and satiety in obese adolescents.\n\nThis exploratory study will establish foundation for larger research evaluating glucose sensors as therapeutic education tools in obesity management, helping patients understand diet-satiety relationships.",[62],"Obesity in Adolescents",[64,65,66,67],"Obesity","low glycaemic index nutritional intervention","glycaemic variability","satiety","NOT_YET_RECRUITING","2026-08-14",{"date":36,"type":39},{"date":72,"type":23},"2026-10-01",{"date":74,"type":23},"2028-05-01",{"name":45,"class":46},{"id":77,"slug":78,"hasResults":12,"nctId":79,"briefTitle":80,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":12,"sex":18,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":4,"studyType":87,"phases":4,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":47},"100651604","do-endocrine-disruptors-accumulate-in-children-undergoing-paediatric-dialysis-100651604","NCT07763483","Do Endocrine Disruptors Accumulate in Children Undergoing Paediatric Dialysis?","PedDIA-TOX","Inclusion Criteria:\n\n* Children aged 0 to 17 years (inclusive), followed in the Paediatric Nephrology Department of the Femme-Mère-Enfant Hospital, Hospices Civils de Lyon.\n* No objection from the parents or legal guardian(s).\n* Assent of the minor participant, when appropriate according to age and level of understanding\n* For group 1: Children with non-dialysis chronic kidney disease (CKD) stages 1-2, weighing at least 5 kg.\n* For group 2: Children with non-dialysis chronic kidney disease (CKD) stages 4-5, weighing at least 5 kg.\n* For group 3: Children receiving peritoneal dialysis, weighing at least 5 kg.\n* For group 4: Children receiving paediatric haemodialysis with pre-dilution hemodiafiltration, weighing at least 12 kg.\n* For group 5: Children receiving paediatric haemodialysis with post-dilution hemodiafiltration, weighing at least 12 kg.\n\nExclusion Criteria:\n\n* Participation in another interventional research study with an exclusion period still ongoing on the day of inclusion and deemed by the investigator to potentially interfere with the present study.\n* Individuals deprived of liberty by a judicial or administrative decision.","2 Years","17 Years",{"count":86,"type":23},15,"OBSERVATIONAL","The impact of the environment on health is becoming an increasingly important issue in public health policies. Endocrine disruptors (EDs) are substances or mixtures of substances found in many everyday products that interact with the body's endocrine functions. Although their mechanisms of action are not yet fully understood, mechanisms involving endocrine mimicry, antagonism, and epigenetic effects have been described.\n\nThe effects of the main endocrine disruptors on bone health remain poorly understood. Per- and polyfluoroalkyl substances (PFAS) constitute a large family of synthetic organic compounds used for their non-stick and heat-resistant properties. Perfluorooctanoic acid (PFOA) is a specific PFAS compound used in packaging materials and plastics. One of the known effects of PFAS is their interference with vitamin D through competition at its receptor, thereby reducing bone formation. In addition, PFAS decrease the proliferation of bone cells and reduce extracellular matrix synthesis.\n\nFrom foetal development through adolescence, early life represents a critical period for bone formation. If environmental chemicals can interfere with this process in the general paediatric population, the accumulation of endocrine disruptors may also exert an additional deleterious effect in the context of chronic kidney disease-mineral and bone disorder (CKD-MBD). Indeed, patients with chronic kidney disease (CKD) have a higher incidence of fractures and present mineral, skeletal, and cardiovascular abnormalities whose pathophysiology is extremely complex. The potential impact of endocrine disruptors on the pathophysiology of CKD-MBD in children has never been evaluated, despite the fact that during dialysis sessions, blood repeatedly circulates through a circuit composed mainly of plastics and exposed to elevated temperatures.\n\nIn adult dialysis populations, PFAS exposure has been investigated, but the results are contradictory. In 2018, Liu et al. found no evidence of PFAS removal by haemodialysis. Conversely, studies by Liu et al. (2018) and Huang et al. (2023) demonstrated a significant reduction in PFAS concentrations in patients following haemodialysis sessions and compared with patients with chronic kidney disease not receiving dialysis. Both research groups suggested that PFAS levels in dialysis patients are significantly influenced by the composition and properties of the dialysis membranes used.\n\nHowever, these studies were conducted exclusively in adults, who, by definition, do not have a growing skeleton, and were restricted to PFAS measurements. This is particularly relevant given that: (1) dialysis techniques are rapidly evolving, with hemodiafiltration increasingly replacing conventional haemodialysis and with different membrane types used in paediatric practice; and (2) children undergoing dialysis often require more frequent treatment sessions than adults. For example, according to the French national survey conducted on January 28, 2026, in preparation for discussions on a new dialysis reimbursement model, 25% of the 93 children receiving chronic haemodialysis underwent treatment more than three times per week. Furthermore, none of these studies assessed the impact of peritoneal dialysis, a modality that is relatively uncommon in adults but widely used in paediatrics, particularly among very young children.\n\nThese considerations have prompted us to evaluate PFAS serum concentrations in children with: (1) chronic kidney disease, (2) peritoneal dialysis, and (3) haemodialysis. This study is designed as a pilot project that may support the development of a larger-scale investigation depending on the results obtained.",[90],"Chronic Kidney Disease (CKD)",[92,93,94],"Endocrine disruptors","Paediatric dialysis","Chronic kidney disease","2026-08-13",{"date":97,"type":39},"2026-08-17",{"date":99,"type":23},"2026-10-10",{"date":101,"type":23},"2028-04-10",{"name":45,"class":46},{"id":104,"slug":105,"hasResults":12,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":12,"sex":18,"minAge":111,"maxAge":112,"enrollmentInfo":113,"targetDuration":4,"studyType":24,"phases":115,"briefSummary":116,"conditions":117,"keywords":122,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":132},"100652044","two-modalities-of-ventilation-on-the-occurrence-of-respiratory-complications-during-inhalational-anaesthetic-induction-in-children-100652044","NCT07767851","Two Modalities of Ventilation on the Occurrence of Respiratory Complications During Inhalational Anaesthetic Induction in Children","Comparison of Two MOdalities of VEntilation on the Occurrence of Respiratory Complications During Inhalational Anaesthetic Induction in Children: a Multicentre Randomised Controlled Trial.","PEDIAMOVE","Inclusion Criteria:\n\n* Child between 3 months and 6 years old\n* Without significant comorbidity (ASA 1 or 2)\n* Admitted for elective or emergency\u002Furgent surgery under general anesthesia\n* With induction of anaesthesia by inhalation by sevoflurane on the machine circuit\n* With airway control by intubation tube or supraglottic device\n* Consent of at least one parent or legal guardian\n\nExclusion Criteria:\n\n* Children with severe upper respiratory tract infection (severe moist cough, fever and lethargy, oxygen requirement) in the last 7 days requiring intravenous induction or postpone of the surgery\n* Thoracic surgery with selective control of intubation\n* Criteria for difficult intubation or known history of difficult intubation\n* Children with a contraindication to sevoflurane (ex: risk of malignant hyperthermia)\n* Children asking for intravenous induction or requiring rapid sequence induction\n* Children with significant cardiac disease (pulmonary hypertension, cyanotic heart disease,…)\n* Children not affiliated or beneficiary of a health insurance system\n* Children participating in other interventional research with an exclusion period still in progress at inclusion\n\nExclusion Criteria :\n\n* Failure of venous access after 30 min or more than 5 attempts\n* Parents' consent withdrawal","3 Months","6 Years",{"count":114,"type":23},2032,[26],"Induction of anesthesia by inhalation is the most common method of induction (70% in France) for young children admitted for non-emergency surgery. It has the advantage of not requiring an intravenous line.\n\nSerious respiratory adverse events such as laryngospasm or bronchospasm remain common in young children during anesthesia induction (approximately 4%) and can reach up to 30% when mild respiratory adverse events (coughing, desaturation \\\u003C 95%, airway obstruction) are included.\n\nTraditionally, inhalation induction is performed under spontaneous ventilation using the anesthesia ventilator circuit. However, modern ventilators offer the option of applying positive end-expiratory pressure (PEEP) and pressure support ventilation (PSV). Several physiological studies suggest that the use of PEEP + PSV during anesthesia may help maintain airway patency, minute ventilation, and functional residual capacity (FRC).\n\nOur hypothesis is that administering PEEP + PSV at the time of induction may reduce the risk of respiratory complications.\n\nThe primary objective is to demonstrate that induction of anesthesia using PEP + PSV, compared with induction of anesthesia under spontaneous ventilation, reduces the risk of adverse respiratory events in children requiring general anesthesia with planned inhalational induction.",[118,119,120,121],"Anaesthetic Induction","Respiratory Complications of Care","Pediatrics","Ventilation",[123,121,124,120],"Anaesthetic induction","Respiratory complications","2026-08-11",{"date":97,"type":39},{"date":128,"type":23},"2026-09-01",{"date":130,"type":23},"2029-09-01",{"name":45,"class":46},9,{"id":134,"slug":135,"hasResults":12,"nctId":136,"briefTitle":137,"officialTitle":137,"acronym":138,"eligibilityCriteria":139,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":140,"targetDuration":4,"studyType":24,"phases":142,"briefSummary":145,"conditions":146,"keywords":149,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":160},"100539605","phase-1-evaluation-of-exl01-a-new-live-biotherapeutic-product-to-prevent-recurrence-of-clostridioides-difficile-infection-in-high-risk-patients-100539605","NCT06306014","Evaluation of EXL01, a New Live Biotherapeutic Product to Prevent Recurrence of Clostridioides Difficile Infection in High-risk Patients","LIVEDIFF","Inclusion Criteria:\n\n* Adult patient ≥18 years of age\n* ≥3rd episode of proven C. difficile infection (≥3 liquid stools per day and detection of toxigenic C. difficile in stool by PCR or enzyme-linked immunosorbent assay or immunochromatography or toxigenic culture) within 6 months with an interval ≤ 12 weeks since the end of treatment of the previous episode of resolved CDI or 2nd episode of proven C. difficile infection (≥3 liquid stools per day and detection of toxigenic C. difficile in the stools by PCR or enzyme-linked immunosorbent assay or immunochromatography or toxigenic culture) within 6 months with an interval ≤ 12 weeks since the end of treatment of the previous episode of resolved CDI with at least one of the following risk factors:\n\n  * Age ≥70 years\n  * Chronic renal failure (haemodialysis or GFR\\\u003C60ml\u002Fmin\n  * History of severe or severe-complicated CDI (excluding current episode) according to ESCMID 2021 criteria\n  * ≥3 CDI in the last 12 months (including current episode)\n  * CDI associated with care defined as CDI occurring during hospitalisation (\\\u003C3 months)\n* On current or planned vancomycin treatment per os\n* Patient able to give free, informed and written consent\n* Enrolled in compulsory national social security scheme\n\nExclusion Criteria:\n\n* Currently participating or has participated in a study with an investigational compound or device within 3 months prior to the first dose of the study intervention.\n* Severe C. difficile infection severe (defined by the presence of a white blood cell count \\>15×10⁹ cells\u002FL or a body temperature \\>38.5°C or \\>50% increase in the patient's baseline creatinine related to CDI at the time of V1) and\u002For complicated (defined by any of the factors attributed to current Clostridioides difficile infection (CDI): hypotension, septic shock, elevated serum lactate, ileus, toxic megacolon, intestinal perforation or any fulminant course of the disease)\n* Refractory C. difficile infection defined as lack of response to well-conducted per os vancomycin or fidaxomicin treatment with ≥3 liquid stools per day after ≥5 days of treatment\n* Cirrhosis with Child C score\n* Hospitalization in continuing care unit or intensive care unit\n* Personal history of gastrointestinal resection other than appendectomy (gastrectomy, esophagectomy, colonic or small bowel resection, short small bowel syndrome).\n* Personal history of gastrointestinal resection resulting in chronic diarrhea (\\>3 loose stools per day)\n* Inflammatory bowel disease\n* Proven uncontrolled celiac disease\n* Current stoma (ileostomy or colostomy) or within the last 6 months, or any other intra-abdominal surgery within the 3 months prior to treatment\n* major surgery or trauma ≤ 4 weeks before the start of treatment or, if \\> 4 weeks ago, with an unresolved healing process that could affect the assessment or safety of the study treatment.\n* Antibiotic therapy in progress or planned during the study for an infection other than CDI\n* Surgery scheduled during the study requiring perioperative antibiotics.\n* -Women without contraception\\*, pregnant or breastfeeding women\n* History of hypersensitivity to EXL01 and\u002For to any of its excipients (D-mannitol, sucrose, maltodextrin, L-cysteine, L-cysteine hydrochloride, magnesium stearate and hydroxypropylmethylcellulose), and\u002For to soy or soy-containing products.\n* History of hypersensitivity to vancomycin as mentioned in local prescribing information.\n* Personal history of fecal microbiota transplantation \\\u003C 6 months\n* Persons deprived of liberty by judicial or administrative decision\n* Adults under legal protection or unable to give consent\n* Swallowing disorders making oral treatment impossible\n* Participation in another interventional study within 3 months prior to inclusion. (Patients who have entered the follow-up phase of an interventional study may participate provided that more than 3 months have elapsed since the last intervention).\n* Expected life expectancy of less than 6 months\n* Presents a known psychiatric disorder that would interfere with adequate cooperation with study requirements.\n* Regular use of illicit or recreational drugs that may interfere with the administration of the medication or the interpretation of the data\n* History of chronic diarrhea (\\> 3 watery stools per day for \\> 4 weeks) not related to gastrointestinal infection.\n* Clinically significant medical or surgical condition not mentioned in the above criteria which, in the opinion of the investigator, could interfere with the administration of study drug, the interpretation of study safety or efficacy data, or compromise the safety or well-being of the subject.",{"count":141,"type":23},56,[143,144],"PHASE1","PHASE2","Clostridioides difficile infection (CDI) is the leading cause of nosocomial diarrhea in Europe, with over 120,000 cases and almost 3,700 deaths per year. This infection is characterized by a high risk of recurrence after cure, ranging from almost 20% after a first episode to over 60% after 2 recurrences, or in the case of specific risk factors.\n\nCurrently, first-line treatment of CDI is based on oral antibiotics such as fidaxomicin or vancomycin. These antibiotic treatments, which are effective in 89% and 86% of first-episode cases respectively, do not correct the microbiological imbalance underlying the onset of CDI and may, on the contrary, encourage recurrence by contributing to the maintenance of a deleterious change in the microbiota (dysbiosis) through the elimination of bacteria other than C. difficile, due to their spectrum of activity. In a number of patients, this ecological imbalance can no longer be restored after antibiotic treatment, leading to multiple recurrences of CDI.\n\nIn this context, fecal microbiota transplantation (FMT) has been validated for over 10 years for the prevention of recurrence in multi-recurrent CDI. The principle of FMT is based on the use of a pharmaceutical preparation made from the stool of a healthy donor, administered within the digestive tract of a patient for therapeutic purposes.\n\nCurrently, in the case of multiple recurrences, it is the recommended first-line treatment (from 2 recurrences) and the most effective, with a clinical efficacy preventing recurrence of CDI in 69% to 89% of cases at 8 weeks post-treatment, with a good safety profile.\n\nAmong the microbial factors promoting CDI, the loss of the bacterial species Faecalibacterium prausnitzii constitutes a specific therapeutic target. F. prausnitzii is a commensal bacterium of the human gut, making up nearly 5% of the fecal microbiota, and has been shown to be associated with an individual's state of health. A drop in its relative abundance is associated with an increased risk of numerous diseases, such as Crohn's disease and colorectal cancer. In CDI, F prausnitzii is greatly diminished. Moreover, low abundance of F. prausnitzii is predictive of C. difficile recurrence. Its abundance in stools is increased after FMT and is also predictive of response to treatment. From a pathophysiological point of view, one of the preventive effects of F. prausnitzii on recurrence would be mediated by its ability to hydrolyze the bile acids involved in the germination of C. difficile spores.\n\nThe aim of this Phase I\u002FII trial is to assess the efficacy and safety of oral administration of EXL01, a single isolated unmodified strain of F. prausnitzii, in preventing CDI recurrence in high-risk patients at W8. The study will be conducted in 2 parts. The phase I (Part A) is planned to include 6 patients. The phase II (Part B) will include 50 patients in two arms (25 patients respectively in the placebo and EXL01 arm).",[147,148],"Clostridioides Difficile Infection","Recurrent Infection",[150,151,152,148],"Clostridioides difficile Infection","Live Biotherapeutic Product","Microbiota","2026-08-10",{"date":125,"type":39},{"date":156,"type":39},"2024-05-07",{"date":158,"type":23},"2028-01-07",{"name":45,"class":46},10,{"id":162,"slug":163,"hasResults":12,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":167,"eligibilityCriteria":168,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":169,"targetDuration":4,"studyType":24,"phases":171,"briefSummary":172,"conditions":173,"keywords":175,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":188,"completionDateStruct":190,"leadSponsor":192,"locationsCount":47},"100651347","phenotyping-acute-non-severe-anemia-in-the-emergency-department-100651347","NCT07761104","Phenotyping Acute Non-Severe Anemia in the Emergency Department","A Prospective Interventional Physiological Study for Comprehensive Phenotyping of Adults With Non-Life-Threatening Anemia Presenting to the Emergency Department","PHENOEMEMIA","Inclusion Criteria:\n\n* Adult patients aged 18 years or older.\n* Presentation to the emergency department.\n* Blood hemoglobin concentration \\\u003C10 g\u002FdL.\n* Non-life-threatening clinical condition at presentation.\n* Able to understand the study information and provide written informed consent.\n* Affiliated with a health insurance system.\n\nExclusion Criteria:\n\n* Glasgow Coma Scale score \\\u003C15.\n* Shock Index \\>0.9.\n* Acute clinically significant gastrointestinal, gynecological or other active bleeding within the previous 24 hours.\n* Oxygen saturation \\\u003C92% on room air.\n* Suspected acute myocardial ischemia.\n* Carbon monoxide poisoning.\n* Pregnancy or breastfeeding.\n* Adults lacking legal capacity to provide consent.\n* Individuals deprived of liberty by judicial or administrative decision.\n* Individuals under psychiatric care without consent.\n* Individuals under legal protection (guardianship or curatorship).\n* Individuals not affiliated with a health insurance system.",{"count":170,"type":23},59,[26],"Anemia is traditionally diagnosed and managed using circulating hemoglobin concentration (\\[Hb\\]). However, \\[Hb\\] is influenced by plasma volume and may not accurately reflect the total amount of hemoglobin available for oxygen transport. Total hemoglobin mass (Hbmass), measured using the optimized carbon monoxide rebreathing method, provides a direct assessment of the body's oxygen-carrying capacity but has never been extensively investigated in patients presenting to the emergency department with non-life-threatening anemia.\n\nThe hypothesis of the PHENOEMEMIA study is that routine blood hemoglobin concentration is only moderately correlated with Hbmass and therefore does not fully reflect the physiological severity of anemia.\n\nPHENOEMEMIA is a prospective single-center interventional physiological study including adults presenting to the emergency department with non-life-threatening anemia. Each participant undergoes routine clinical assessment, standardized symptom questionnaires, additional blood sampling for biological and hemorheological analyses, focused transthoracic echocardiography, near-infrared spectroscopy assessment of tissue oxygenation, and Hbmass measurement using the optimized carbon monoxide rebreathing technique.\n\nThe primary objective is to evaluate the correlation between blood hemoglobin concentration and Hbmass normalized to body weight. Secondary objectives include describing the relationships between Hbmass, biological markers of anemia, clinical symptoms, cardiac adaptation, blood rheology, tissue oxygenation, and physiological phenotypes of anemia.",[174],"Anemia",[174,176,177,178,179,180,181,182,183,184],"Hemoglobin Mass","Carbon Monoxide Rebreathing","Emergency Medicine","Blood Volume","Hemorheology","Tissue Oxygenation","Near Infrared Spectroscopy","Echocardiography","Physiological Phenotyping","2026-08-07",{"date":187,"type":39},"2026-08-12",{"date":189,"type":23},"2026-12",{"date":191,"type":23},"2028-12",{"name":45,"class":46},{"id":194,"slug":195,"hasResults":12,"nctId":196,"briefTitle":197,"officialTitle":197,"acronym":198,"eligibilityCriteria":199,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":200,"targetDuration":4,"studyType":24,"phases":202,"briefSummary":204,"conditions":205,"keywords":207,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":209,"startDateStruct":210,"completionDateStruct":212,"leadSponsor":214,"locationsCount":47},"100618851","phase-3-efficacy-of-prophylactic-levetiracetam-for-improving-functional-outcome-in-the-acute-phase-of-intracerebral-haemorrhage-a-randomised-double-blind-placebo-controlled-phase-3-trial-100618851","NCT07336992","Efficacy of Prophylactic Levetiracetam for Improving Functional Outcome in the Acute Phase of Intracerebral Haemorrhage: a Randomised, Double-blind, Placebo-controlled, Phase 3 Trial","PEACH2","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Spontaneous (non-traumatic) supratentorial intracerebral haemorrhage diagnosed by brain CT or MRI\n* Onset of neurologic symptoms within 24 hours\n* NIHSS score on admission ≤ 25\n* Informed consent given by the patient or his\u002Fher impartial witness\n* Patients benefiting from a social insurance system or a similar system\n* For women of childbearing age, use of highly effective contraceptive method, which will be continued until the end of relevant systemic exposure of the treatment (i.e 56 hours after end of treatment).\n\nExclusion Criteria:\n\n* Intracerebral haemorrhage known or suspected by study investigator to be secondary to trauma, vascular malformation, haemorrhagic transformation of ischaemic stroke, or tumour\n* Current use of antiseizure drugs or history of epilepsy\n* Patients with inaugural seizures at the onset of symptoms associated with intracerebral hemorrhage\n* Patients with QTc prolongation\n* Patients who have been part of a clinical study involving another investigational product in the previous 30 days or within 5 half-lives of the other investigational product prior to Screening, whichever is longer, or participant is currently receiving an investigational product\n* Severe renal insufficiency (creatinine clearance \\\u003C 30 ml\u002Fmin)\n* Pregnancy or breastfeeding\n* Previous history of severe depression or psychotic disorder or suicidal attempt\n* Known terminal illness\n* Known allergy or hypersensitivity to levetiracetam or other pyrrolidone derivatives, or any of the excipients\n* Known allergy or hypersensitivity to microcrystalline cellulose or lactose\n* Patients taking probenecid, methotrexate or macrogol\n* Being under legal protection\n* Patients with seizures occurring between the inclusion of the patient and the start of the treatment\n* Positive pregnancy test at inclusion for women of childbearing age",{"count":201,"type":23},580,[203],"PHASE3","Epileptic seizures are a common complication at the acute phase of intracerebral haemorrhage (ICH). The incidence of seizures occurring within 7 days reaches 40% when subclinical seizures are diagnosed by continuous electroencephalogram (EEG).\n\nSome studies have suggested that early seizures are associated with haematoma expansion (Vespa., Neurology 2003), worse neurological outcomes (Gilmore., Stroke 2016) or increased mortality. By contrast, other studies have shown no association of acute seizures with long-term mortality and outcome. However, the interpretation of these works is subject to bias because almost all studies were based on clinical detection of seizures only, while it has been shown that most early seizures after ICH are clinically unrecognised and can only be diagnosed with EEG monitoring.\n\nThe PEACH trial, a double-blind, randomised, placebo-controlled, showed that clinical and\u002For electrographic seizures occur in more than 40% of patients with ICH and that Levetiracetam (LVT) is safe and effective in preventing these seizures. However, it remains unclear whether preventing acute seizures might lead to improved functional outcomes after ICH. An adequately powered randomised controlled trial is needed to answer whether primary seizure prophylaxis improves functional outcome in this setting. Answering this question would result in an important change in ICH acute care guidelines, which currently do not recommend primary prophylactic antiseizure treatment. As compared to research in acute ischemic stroke management, fewer clinical trials have been conducted in acute ICH and no effective medical treatments are available in this subset of patients.\n\nThe main objective of PEACH 2 is to establish if prophylactic antiseizure therapy with LVT improves functional outcome in adults with acute spontaneous ICH. Functional outcome assessed by the modified Rankin score (mRS score) six months after acute ICH will be compared between patients receiving prophylactic antiseizure therapy with levetiracetam and patients receiving placebo.\n\nThe secondary objectives are to examine the effect of prophylactic antiseizure therapy with levetiracetam versus placebo on:\n\n* the number of early and late clinical seizures, on the short term and long term evolution of the neurologic deficit as assessed by the NIHSS, on long term functional outcome (12 months) as assessed by the mRS, on quality of life and cognitive impairment, and on haematoma expansion and mass effect on control brain imaging\n* the frequency of side effects at 1 and 6 months, pneumonia at 1 month, delirium at 1 month, irritability\u002Faggressivity, anxiety and depression at 1 and 6 months, and all-cause mortality at 1, 6 and 12 months.\n\n  580 patients will be recruited over 3 years.",[206],"Spontaneous Intracerebral Hemorrhage",[208],"supratentorial",{"date":187,"type":39},{"date":211,"type":23},"2026-10-02",{"date":213,"type":23},"2030-10-02",{"name":45,"class":46},{"id":216,"slug":217,"hasResults":12,"nctId":218,"briefTitle":219,"officialTitle":219,"acronym":220,"eligibilityCriteria":221,"healthyVolunteers":222,"sex":18,"minAge":19,"maxAge":223,"enrollmentInfo":224,"targetDuration":4,"studyType":24,"phases":225,"briefSummary":226,"conditions":227,"keywords":231,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":236,"startDateStruct":237,"completionDateStruct":238,"leadSponsor":240,"locationsCount":47},"100612088","impact-of-epilepsy-on-the-brainstem-adenosine-pathway-and-its-relation-with-arousal-and-respiratory-reactivity-100612088","NCT07249034","Impact of Epilepsy on the Brainstem Adenosine Pathway and Its Relation With Arousal and Respiratory Reactivity","BRAVE","Inclusion Criteria:\n\n* For patients\n\n  1. Written informed consent obtained from study subject and ability for study subject to comply with the requirements of the study\n  2. Aged 18 to 55 years old\n  3. Diagnosis of focal epilepsy or of idiopathic generalized epilepsy, as defined by the International League Against Epilepsy\n  4. Diagnosis of refractory epilepsy, as defined by the International League Against Epilepsy as failure of adequate trials of two tolerated, appropriately chosen and used antiseizure drug schedules (whether as monotherapies or in combination) to achieve sustained seizure freedom\n  5. Patients with ≥3 focal to bilateral tonic-clonic seizure (FBTCS) or generalized tonic-clonic seizure (GTCS) during the past 18 months\n  6. For women of childbearing potential, use highly effective contraception until the end of relevant systemic exposure (V2)\n* For healthy volunteers\n\n  1. Written informed consent obtained from study subject and ability for study subject to comply with the requirements of the study\n  2. Aged 18 to 55 years old\n  3. For women of childbearing potential, use highly effective contraception until the end of relevant systemic exposure (V2)\n\nExclusion Criteria:\n\n* For patients\n\n  1. Ongoing or chronic respiratory insufficiency defined as breathlessness Grade ≥ 2 using the modified Medical Research Council Dyspnea Scale and\u002For patient treated by a pneumologist for respiratory insufficiency\n  2. Cardiac insufficiency defined as symptoms Grade ≥ 2 using New York Heart Association Functional Classification and\u002For patient treated by a cardiologist for chronic heart failure\n  3. Ischaemic heart disease defined as history of myocardial ischemia and\u002For of typical angina confirmed by a cardiologist.\n  4. Obstructive sleep-apnea syndrome, defined as participant who had been diagnosed for Obstructive sleep apnoea by polysomnography, whether a dedicated therapy is ongoing or not\n  5. Ongoing treatment with selective serotonin reuptake inhibitor (Selective Serotonin Reuptake Inhibitors): Citalopram, Escitalopram, Fluoxetine, Fluvoxamine, Paroxetine, Sertraline and SNRIs (Serotonin-Norepinephrine Reuptake Inhibitors): Duloxetine, Milnacipran, Venlafaxine\n  6. Hypercapnic challenges contra-indication (History of stroke in the last 5 years, space-occupying lesion in the brain associated with brain oedema and\u002For mass effect on MRI\u002FCT scan)\n  7. MRI contra-indication (presence of metallic elements, claustrophobia)\n  8. Patient treated with vagal nerve stimulation or deep brain stimulation\n  9. Pregnant women, women in labor or breastfeeding women, based on declarations at V0\n  10. Patients suffering from a psychiatric disorder, regardless of its etiology, whose care is provided under compulsory measures\n  11. Persons deprived of their liberty by a judicial or administrative decision\n  12. Adults subject to a legal protection measure (guardianship, curatorship)\n  13. Persons not affiliated to a social security scheme or beneficiaries of a similar scheme\n  14. Positive urine pregnancy test at V2, if applicable\n  15. Hypersensitivity to \\[18F\\]-CPFPX\n* For healthy volunteers\n\n  1. History of epilepsy\n  2. Ongoing or chronic respiratory insufficiency defined as breathlessness Grade ≥ 2 using the modified Medical Research Council Dyspnea Scale and\u002For patient treated by a pneumologist for respiratory insufficiency\n  3. Cardiac insufficiency defined as symptoms Grade ≥ 2 using New York Heart Association Functional Classification and\u002For patient treated by a cardiologist for chronic heart failure\n  4. Ischaemic heart disease defined as history of myocardial ischemia and\u002For of typical angina confirmed by a cardiologist.\n  5. Obstructive sleep-apnea syndrome, defined as participant who had been diagnosed for Obstructive sleep apnoea by polysomnography, whether a dedicated therapy is ongoing or not\n  6. Ongoing treatment with selective serotonin reuptake inhibitor : SSRIs (Selective Serotonin Reuptake Inhibitors) : Citalopram, Escitalopram, Fluoxetine, Fluvoxamine, Paroxetine, Sertraline and SNRIs (Serotonin-Norepinephrine Reuptake Inhibitors) : Duloxetine, Milnacipran, Venlafaxine\n  7. Hypercapnic challenges contra-indication (History of stroke in the last 5 years, space-occupying lesion in the brain associated with brain oedema and\u002For mass effect on MRI\u002FCT scan)\n  8. MRI contra-indication (presence of metallic elements, claustrophobia)\n  9. Pregnant women, women in labor or breastfeeding women, based on declarations at V0\n  10. Patients suffering from a psychiatric disorder, regardless of its etiology, whose care is provided under compulsory measures\n  11. Persons deprived of their liberty by a judicial or administrative decision\n  12. Adults subject to a legal protection measure (guardianship, curatorship)\n  13. Persons not affiliated to a social security scheme or beneficiaries of a similar scheme\n  14. Positive urine pregnancy test at V2, if applicable\n  15. Hypersensitivity to \\[18F\\]-CPFPX",true,"55 Years",{"count":22,"type":23},[26],"Despite the continuous development of new antiseizure medications over the past 25 years, 30% of patients with epilepsy suffer from drug-resistant seizures and are at risk of epilepsy-related complications, like cognitive dysfunctions, sleep-disordered breathing or Sudden and Unexpected Death in Epilepsy (SUDEP). SUDEP typically occurs during sleep, after a nocturnal seizure, and primarily results from a postictal central respiratory dysfunction in patients with generalized convulsive seizure (GCS), suggesting that interaction between respiratory dysfunction and sleep state may play a role in its pathophysiology.\n\nPost-mortem data in SUDEP patients showed alteration of neuronal populations involved in respiratory control in the medulla. Accordingly, pharmacologic strategies aimed at reducing the severity of postictal respiratory dysfunction has appeared as one of the most promising way to prevent SUDEP. However, no encouraging result has hitherto been reported.\n\nInterconnections between the complex network that regulates arousal and sleep and the respiratory network are numerous. They primarily include the relation between chemosensitive regulation and arousal system to ensure asphyxia-induced arousal (i.e. arousal to elevated CO2), especially through serotonin (5HT)-dependent connections in brain stem. The link between alterations of the brainstem networks involved in arousal regulation and respiratory dysfunction has not been characterized in patients with epilepsy yet.\n\nLike 5HT, adenosine is deeply implicated in the regulation of sleep and central respiratory control.\n\nSeizures transiently increase adenosine extracellular levels. Adenosine physiological effects in the brain are mediated through the activation of two types of Adenosine receptors (ARs), A1Rs and A2ARs. Extracellular adenosine promotes sleep via A1R-dependant inhibition of glutamatergic neurons in the basal forebrain, but also via A2AR-dependant activation of neurons in the nucleus accumbens. Respiration is also inhibited by A1R and A2AR. Most importantly, it has been shown that drug-resistant epilepsy is associated with long-term alterations of ARs cortical expression. However, whether or not a similar epilepsy-related plasticity of ARs occurs in the brainstem and may participate to chronic arousal and respiratory dysfunction in epilepsy has never been investigated.\n\nConsidering the tight interplay between central respiratory control, arousal regulation and brainstem adenosine, the main hypothesis of the BRAVE study is that epilepsy might result in alterations of the distribution of A1Rs in the brainstem structures involved in respiratory regulation and\u002For arousal control, especially in the brainstem structures involved in respiratory regulation under hypercapnic condition.\n\nThe study combines clinical respiratory characterization, morphological, functional and metabolic imaging, using the hybrid simultaneous 3T MRI-PET scanner (Siemens Biograph mMR) of the CERMEP. Combining PET with anatomical and functional MR imaging enables non-invasively in vivo mapping of receptor binding and functional neuronal assessment of a physiological task in the entire brain with high spatial resolution.\n\nInvestigators already performed fMRI study of respiratory centers, showing number of functional changes in brainstem regions participating to the central control of respiration, including reduced activation during breath-holding fMRI, in patients with epilepsy. The BRAVE study will use the same respiratory paradigm as the one used in this past study.\n\nPET imaging will be focused on A1R, using \\[18F\\]CPFPX, a selective A1R antagonist.",[228,229,230],"Epilepsy","Drug-resistant Focal Epilepsy","Healthy Controls",[228,232,233,234,235],"adenosine pathway","respiratory reactivity","PET-MRI","[18F]CPFPX",{"date":125,"type":39},{"date":185,"type":23},{"date":239,"type":23},"2028-10-07",{"name":45,"class":46},{"id":242,"slug":243,"hasResults":12,"nctId":244,"briefTitle":245,"officialTitle":246,"acronym":247,"eligibilityCriteria":248,"healthyVolunteers":222,"sex":18,"minAge":249,"maxAge":250,"enrollmentInfo":251,"targetDuration":4,"studyType":87,"phases":4,"briefSummary":253,"conditions":254,"keywords":257,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":264,"lastUpdatePostDateStruct":265,"startDateStruct":266,"completionDateStruct":268,"leadSponsor":270,"locationsCount":47},"100626315","the-neurocognitive-bases-of-trust-in-intellectual-disability-100626315","NCT07434037","The Neurocognitive Bases of Trust in Intellectual Disability","The Neurocognitive Bases of Trust in Intellectual Disability: Affective Evaluation, Trait Attribution, and Epistemic Vigilance","BNConfDI","Inclusion Criteria :\n\nGroup of Down Syndrom patients\n\n* Complete chromosomal trisomy of the 21st chromosome confirmed by karyotype analysis\n* Aged 13 to 29 (chronological age)\n* French as their native language\n* Having signed an informed consent form and\u002For whose legal guardians\u002Fpatient representatives have signed the informed consent form\n* Affiliated with the French health insurance system (social security) or whose legal guardians are affiliated with the French health insurance system\n\nGroup of X-Fragile Syndrome\n\n* Complete mutation of the FMR1 gene by molecular analysis (more than 200 CGG triplet repeats)\n* Aged between 13 and 29 (chronological age)\n* Native French speakers\n* Having signed an informed consent form and\u002For whose legal guardians\u002Fpatient representatives have signed the informed consent form\n* Affiliated with the French health insurance system (social security) or whose legal guardians are affiliated with the French health insurance system\n\nGroup of chronological age-matched control\n\n* Aged between 13 and 29\n* Native French speakers.\n* Having signed an informed consent form and\u002For whose legal guardians\u002Fpatient representatives have signed the informed consent form\n* Affiliated with the French health insurance system (social security) or whose legal guardians are affiliated with the French health insurance system\n\nGroup of mental age-matched control\n\n* Aged between 3 and 9\n* Native French speakers.\n* Whose legal guardians\u002Fpatient representatives have signed the informed consent form\n* Affiliated with the French health insurance system (social security) or whose legal guardians are affiliated with the French health insurance system\n\nExclusion Criteria:\n\nGroups of Down Syndrom and X-Fragiles patients\n\n* Inability to understand tasks\n* Significant brain malformation\n* Uncontrolled epilepsy\n* Significant hearing impairment\n* Uncorrected visual impairment\n* Refusal of the subject and\u002For legal guardians\u002Frepresentative of the subject to be informed of any abnormalities detected during the neuropsychological assessment.\n* Subject participating in another interventional study with an exclusion period still ongoing at the time of pre-inclusion.\n\nRegarding the neuroimaging (MRI) study:\n\n* Having a contraindication to MRI examination (people using a pacemaker or insulin pump, people with metal prostheses or intracerebral clips, people with metal fragments in their eyes, as well as claustrophobic subjects). A comprehensive list of contraindications is provided in Appendix 5.\n* Inability to perform the MRI without anaesthesia.\n* Refusal by the subject and\u002For those exercising parental authority\u002Fthe subject's representative to be informed of any abnormalities detected during the MRI.\n\nGroups of typical development persons (chronological age-matched and mental age-matched)\n\n* Known acquired neurological disorders, including epilepsy.\n* History of head trauma requiring hospitalisation.\n* Known psychiatric disorders.\n* Birth complications requiring admission to a neonatal intensive care unit or prematurity of less than 35 weeks.\n* Ongoing treatment with drugs affecting the central nervous system.\n* Significant hearing impairment\n* Uncorrected visual impairment\n* Repeating a school year\n* Learning disorders requiring rehabilitation (speech therapy, psychomotor therapy or orthoptics) for more than one year.\n* Refusal of the subject and\u002For legal guardians\u002Frepresentative of the subject to be informed of any abnormalities detected during the neuropsychological assessment.\n* Subject participating in another interventional study with an exclusion period still ongoing at the time of pre-inclusion.\n\nRegarding the neuroimaging (MRI) study (only for chronological age-matched group):\n\n* Having a contraindication to MRI examination (people using a pacemaker or insulin pump, people with metal prostheses or intracerebral clips, people with metal fragments in their eyes, as well as claustrophobic subjects). A comprehensive list of contraindications is provided in Appendix 5.\n* Inability to perform the MRI without anaesthesia.\n* Refusal by the subject and\u002For those exercising parental authority\u002Fthe subject's representative to be informed of any abnormalities detected during the MRI.","3 Years","29 Years",{"count":252,"type":23},112,"This project studies the neurocognitive basis of trust adjustment in intellectual disability (ID), a source of significant vulnerability for these patients, focusing on two target populations chosen for their specific social characteristics: people with Down syndrome, who are often described as being hypersocial, and people with Fragile X syndrome, who are often characterized by a completely opposite social behaviour profile, with a withdrawn attitude and significant social anxiety.\n\nThe three different types of mechanisms that contribute to the adjustment of interpersonal trust: affective evaluation, trait attribution, and epistemic evaluation of informants, will be studied. Affective evaluation processes recruit subcortical structures such as the amygdala and assess potential social threats in the environment. The second mechanism for selecting whom to trust consists of forming a representation of a person's dispositions, such as benevolence and competence (also known as traits), and using it to predict that person's future behaviour. Trait attribution processes recruit a cortico-cerebellar network comprising the mPFC, CRUS I and posterior lobule VI. The third mechanism, called epistemic vigilance, allows to adjust our trust in what others communicate to us. This mechanism involves linking the assessment of the reliability of individuals who communicate (based on their benevolence and competence) with the reliability of the communicated information. Epistemic assessment involves frontal areas and areas associated with the representation of mental states in order to enable the evaluation of the truthfulness of the communicated information. All of these mechanisms become functional very early on, before a child's sixth birthday. There are reasons to expect that several of these central mechanisms supporting selective trust will behave atypically in intellectual disability.",[255,256],"Down Syndrome (Trisomy 21)","Fragile X Syndrome (FXS)",[258,259,260,261,262,263],"Trust","Intellectual disability","Eyetracking analysis","Neuroimaging","Down syndrome","Fragile X syndrome","2026-08-04",{"date":41,"type":39},{"date":267,"type":39},"2026-07-17",{"date":269,"type":23},"2030-01",{"name":45,"class":46},{"id":272,"slug":273,"hasResults":12,"nctId":274,"briefTitle":275,"officialTitle":276,"acronym":277,"eligibilityCriteria":278,"healthyVolunteers":12,"sex":279,"minAge":112,"maxAge":84,"enrollmentInfo":280,"targetDuration":4,"studyType":87,"phases":4,"briefSummary":282,"conditions":283,"keywords":291,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":296,"lastUpdatePostDateStruct":297,"startDateStruct":298,"completionDateStruct":300,"leadSponsor":302,"locationsCount":47},"100549884","study-of-the-quality-of-life-in-school-aged-children-with-posterior-urethral-valves-100549884","NCT06439862","Study of the Quality of Life in School Aged-children With Posterior Urethral Valves","Quality of Life in School Aged-children With Posterior Urethral Valves","QUALIVUP","Inclusion Criteria:\n\n* Male patients and their parents\u002Frelatives\n* Aged 6 to 17 years old\n* Treated for PUV in their first year of life between 2006 and 2018\n* Managed in the Femme-Mère-Enfant Hospital in Lyon\n\nExclusion Criteria:\n\n* Children with pre-existing severe cognitive and physical disability (physician's rating) from other condition\n* Children enable to complete QoL questionnaire due to mental or communication impairment","MALE",{"count":281,"type":23},300,"Posterior urethral valves (PUV) are the most common congenital obstructive lesion of the urethra, affecting from 1 per 3000 to 1 per 8000 live births. Valve ablation usually resolves the obstruction in PUV but patients still may suffer of deterioration in renal and urinary functions.\n\nRenal insufficiency is the most feared long-term complication. Up to 50 % of the patients will develop chronic kidney disease (CKD), and up to 20 % will develop end-stage renal disease (ESRD) and ultimately will require kidney transplantation. PUV is the first urological cause of ESRD. Progression towards CKD depends on febrile urinary tract infections (UTIs), severity of a vesicoureteral reflux and bladder dysfunction.\n\nBladder dysfunction is due to an overactive and small poorly compliant bladder during infancy. Detrusor overactivity usually decreases in childhood and bladder capacity increases. The most common symptom of this bladder dysfunction is urinary incontinence. 60 % of children are continent at the age of 5 years old and 90 % at 10 years old. In case of persistent bladder dysfunction, medical treatment (anticholinergics, alpha-blockers) may be introduced, or even intermittent catheterizations.\n\nCurrent scientific literature has very few studies on quality of life (QoL) in patients with PUV, mostly in adult patients and very small cohorts. Men treated for PUV in childhood had a good quality of life compared to the normative population, except for sleeping, eating and sexual activity. It seemed that the more severe the urological and nephrological functions were, the lower the QoL was. Children were only asked about intermittent urinary catheterization, and family point of view has never been collected. However, QoL and long-term evolution represent the first concerns of parents-to-be in prenatal counseling, or after diagnosis in an infant with PUV.\n\nHence, the aim of the study is to investigate the quality of life in school-aged children who had been treated for PUV in their first year of life, as measured by the Pediatric Quality of Life Inventory Version 4.0 (PedsQL 4.0).",[284,285,286,287,288,289,290],"Quality of Life","Posterior Urethral Valve","Renal Insufficiency","Chronic Renal Disease","End Stage Renal Disease","Bladder Dysfunction","Urinary Incontinence",[34,292,293,294,295],"Posterior Urethral Valves","Children","Adolescents","Family","2026-08-03",{"date":41,"type":39},{"date":299,"type":39},"2024-08-20",{"date":301,"type":23},"2028-08",{"name":45,"class":46},{"id":304,"slug":305,"hasResults":12,"nctId":306,"briefTitle":307,"officialTitle":308,"acronym":309,"eligibilityCriteria":310,"healthyVolunteers":12,"sex":18,"minAge":311,"maxAge":312,"enrollmentInfo":313,"targetDuration":4,"studyType":24,"phases":314,"briefSummary":315,"conditions":316,"keywords":320,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":326,"lastUpdatePostDateStruct":327,"startDateStruct":328,"completionDateStruct":330,"leadSponsor":332,"locationsCount":333},"100629047","characterization-of-the-natural-history-of-microduplication-syndrome-7q1123-100629047","NCT07469566","Characterization of the Natural History of Microduplication Syndrome 7q11.23","Characterization of the Natural History of Microduplication Syndrome","HINADU7","Inclusion Criteria:\n\n* Diagnosis of 7q11.23 microduplication confirmed by Chromosomal Microarray Analysis or qPCR.\n* Aged \\> 5 to \\\u003C 50 years\n* Whose maternal language is French\n* Having signed the informed consent and\u002For for whom parents\u002Flegal guardian have signed the informed consent.\n* Affiliated to national Health Insurance system (sécurité sociale) or parents\u002Flegal guardian affiliated to national health insurance system Each 7DUP patient will be matched to a sex- and chronological age-matched control. Data from controls will come from the CREAT\\_criteria study (NCT 06018519). Each 7DUP patient will be matched to a sex- and mental age-matched control. Data from controls will come from the CREAT\\_criteria study (NCT 06018519).\n\nExclusion Criteria:\n\n* Refusal of the subject and\u002For the subject's parents\u002Flegal guardian to sign the informed consent\n* Refusal of the subject and\u002For the subject's parents\u002Flegal guardian to be informed of possible abnormalities detected during the neuropsychological assessment.\n\nRegarding specifically the neuroimaging data (MRI):\n\n* Having a contraindication to the MRI examination (people using a pacemaker or an insulin pump, people wearing a metal prosthesis or an intracerebral clip, and claustrophobic subjects).\n* Refusal of the subject and\u002For the subject's parents\u002Flegal guardian to be informed of possible abnormalities detected by MRI.","5 Years","50 Years",{"count":86,"type":23},[26],"7q11.23 duplication syndrome (7q duplication syndrome\u002F7DUP) is caused by a microduplication of the 7q11.23 chromosomal region, encompassing 26-28 genes, including the GTF2I gene. This syndrome, often considered as a \"mirror\" phenotype of Williams-Beuren syndrome (WBS), is characterized by a wide range of neurodevelopmental impairments, including a neurodevelopmental disorder (NDD), autism spectrum disorders (ASD), selective mutism, mild dysmorphic features, and aortic dilation. Notably, one of the core clinical features of 7DUP is socialization impairment, which varies in severity across individuals.\n\nThe GTF2I gene, identified as critical in the pathogenesis of both WBS and 7DUP, exhibits opposite expression patterns in the two syndromes, with reduced expression in WBS and overexpression in 7DUP. The gene's dysregulation in 7DUP plays a pivotal role in the pathogenesis of the associated NDD and social deficits. Despite progress in characterizing the genetic underpinnings of 7DUP, there remains a critical gap in understanding the developmental trajectory of socialization impairments in affected individuals, especially during their transition through different developmental stages, from early childhood to adulthood.\n\nRecent advancements in the study of neuronal models derived from induced pluripotent stem cells (iPSCs) and brain organoids have shed light on the molecular mechanisms driving 7DUP-related NDDs. Histone deacetylase inhibitors (HDAC inhibitors), which have been widely used in oncology, have shown promising preliminary results in reducing abnormal GTF2I expression in glutamatergic neurons differentiated from 7DUP patient-derived iPSCs. Preclinical studies in mouse models further demonstrated that these drugs can ameliorate socialization deficits, highlighting their therapeutic potential in addressing the core neurodevelopmental challenges in 7DUP.\n\nHowever, despite these advancements, no longitudinal clinical studies have characterized the developmental trajectory of socialization impairments in 7DUP patients. Understanding this trajectory is critical, as it can inform the timing and potential impact of therapeutic interventions, such as HDAC inhibitors. Given the complexity and variability of the 7DUP phenotype, a comprehensive clinical characterization of socialization impairments across the lifespan is essential to improve diagnostic accuracy, optimize intervention strategies, and ultimately improve patient outcomes.\n\nThe aim of this research is to characterize the developmental trajectory of socialization impairments in patients with 7DUP, from early childhood through adulthood. By identifying patterns of socialization difficulties, this innovative study will allow to efficiently prepare future therapeutic trials, by specifying the phenotype of the patients, and by determining the most relevant outcome measures, taking into account, on one hand, their neurodevelopmental involvement and, on the other hand, the type of experimental design to be used in the context of rare diseases.",[317,318,319],"7q11.23 Microduplication Syndrome (7DUP)","Autism Spectrum Disorder (ASD)","Neurodevelopmental Disorders (NDD)",[321,322,323,324,325],"7q11.23 microduplication","7DUP syndrome","neurodevelopmental disorders","autism spectrum disorder","ASD","2026-07-31",{"date":296,"type":39},{"date":329,"type":39},"2026-07-15",{"date":331,"type":23},"2028-01-01",{"name":45,"class":46},2,{"id":335,"slug":336,"hasResults":12,"nctId":337,"briefTitle":338,"officialTitle":338,"acronym":339,"eligibilityCriteria":340,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":341,"targetDuration":4,"studyType":24,"phases":343,"briefSummary":344,"conditions":345,"keywords":348,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":326,"lastUpdatePostDateStruct":353,"startDateStruct":354,"completionDateStruct":356,"leadSponsor":358,"locationsCount":359},"100599506","autonomous-methadone-delivery-system-by-nurses-100599506","NCT07085377","Autonomous Methadone Delivery System by Nurses","DIADEME","Inclusion Criteria:\n\n* Subject 18 years of age or older,\n* With opioid use disorder (OUD) according to DSM-5 (Diagnostic and Statistical Manual of Mental Disorders) criteria (other authorized psychoactive substance use),\n* Intending to start methadone treatment for OUD in a CSAPA center within 7 days,\n* Agreeing to be followed up in a CSAPA over the next 3 months,\n\nExclusion Criteria:\n\n* Having taken methadone treatment (on prescription) in the three months prior to inclusion,\n* Simultaneous medical care in another addictology facility,\n* with a day-hospital project,\n* Referral to town prescriber or town pharmacy planned and\u002For requested by patient before 3 month,\n* Non-stabilized psychiatric disorder or cognitive impairment likely to compromise compliance and involvement in care (at investigator's discretion),\n* Inability to communicate and express themselves in French language,\n* Subject to a legal protection measure other than curatorship,\n* Pregnant or breast-feeding.",{"count":342,"type":23},182,[26],"Initiations of methadone treatment for opiode use disorder (OUD) are carried out in France in specialized centers, known as centers for care, support and prevention in addictology (CSAPA) In this way, hospital practitioners initiate the prescription of methadone, which is delivered on the spot by the nursing team. CSAPA nurses, and addictology nurses more generally, have a real range of skills which can include adapting treatment doses according to a protocol pre-established in a team, and medically validated (French law no. 2019-774 of July 24, 2019 relating to the organization and transformation of the healthcare system).\n\nThe methadone speciality used for initiation in CSAPAs is almost always the syrup form. The capsule form can only be used after one year's treatment, unless exceptionally authorized by the medical officer of the French National Health Insurance Fund. However, regulations stipulate that the prescription of methadone syrup must be renewed every fourteen days, which in theory means that a CSAPA doctor must see the patient at least twice a month to renew the prescription, throughout the entire course of treatment.\n\nIn practice, medical resources are often not sufficient for patients to be seen by a doctor at such a rate. Numerous palliative organizations exist, though they remain poorly described and documented. In some centers, doctors focus primarily on initiations, and prescriptions for patients for whom \"stability\" has been achieved are sometimes renewed for longer periods than fourteen days, with nurses in charge of assessing whether this organization is suitable for the patient. The notion of stability varies significantly from one center to another, and may mean achieving a constant dose, stopping illicit opioid use, or other criteria more focused on the patient's psychosocial reintegration. By outlining the missions of Addictology nurses, and more specifically of CSAPA nurses, the investigators can define the essential skills required of nurses to carry out these missions.\n\nThe main hypothesis of the DIADEME study is that semi-autonomous management of methadone treatment initiation by CSAPA nursing teams helps to reinforce adherence to care and thus improve retention rates in the 3 months following initiation.",[346,347],"Opioid Use Disorder (OUD)","Addictology",[349,350,351,352],"Opioid use disorder (OUD)","Methadone","Autonomous nursing system medication delivery","Nursing Care Delivery System",{"date":296,"type":39},{"date":355,"type":39},"2025-12-08",{"date":357,"type":23},"2028-04-08",{"name":45,"class":46},8,{"id":361,"slug":362,"hasResults":12,"nctId":363,"briefTitle":364,"officialTitle":365,"acronym":366,"eligibilityCriteria":367,"healthyVolunteers":12,"sex":18,"minAge":83,"maxAge":4,"enrollmentInfo":368,"targetDuration":4,"studyType":24,"phases":369,"briefSummary":370,"conditions":371,"keywords":374,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":378,"lastUpdatePostDateStruct":379,"startDateStruct":380,"completionDateStruct":381,"leadSponsor":383,"locationsCount":132},"100617474","cystinosis-and-mitochondrial-metabolism-100617474","NCT07319091","Cystinosis and Mitochondrial Metabolism","Evaluation of Mitochondrial Metabolism in Patients With Cystinosis: CYSTI-MITO Project","CYSTI-MITO","Inclusion Criteria:\n\n* Patient with genetically confirmed nephropathic cystinosis\n* Men and women, children and adults with cystinosis\n* Undergoing conservative treatment on native kidneys\n* Age ≥ 2 years\n* Patients receiving oral cysteamine\n* Patients with social security coverage\n* Informed consent signed by the participant or parents or legal guardians before participating in the study\n\nExclusion Criteria:\n\n* Patient not complying with study procedures\n* Transplant or dialysis patient\n* Patient on anticalcineurin\n* Pregnant or breast-feeding woman\n* Person deprived of liberty by a judicial or administrative decision\n* Person not affiliated to a social security scheme or beneficiaries of a similar scheme",{"count":7,"type":23},[26],"Cystinosis is a monogenic autosomal recessive lysosomal storage disease with complete penetrance, caused by a biallelic mutation in the CTNS gene (17p13.2) encoding cystinosin, a ubiquitous membrane protein whose role is to clear cystine into the cytosol. Its dysfunction in patients with cystinosis leads to systemic accumulation of cystine, an oxidised dimer of cysteines linked by a disulphide bridge, in the lysosomal space, and irreversible cellular dysfunction. Renal damage is at the forefront, with Fanconi syndrome (proximal tubulopathy) and chronic renal failure developing early in childhood\u002Fadolescence. There are also multi-systemic disorders, notably endocrine and ophthalmological. Cysteamine is an amino thiol which reduces the level of intra-lysosomal cystine by breaking the disulphide strands of cystine, giving two cysteines which complex with cysteamine to leave the lysosome. Since the late 1980s, there has been an immediate-release form of the drug, which has considerably improved overall patient survival despite having a major impact on quality of life. This improvement in survival has also led to the emergence of later complications that were not previously observed. This musculoskeletal complication (described in an international consensus in 2019), known as 'CMBD' for Cystinosis Metabolic Bone Disease, may be explained at least in part by an intrinsic defect in the osteoblast and osteoclast that contribute to the human bone phenotype. This intrinsic bone defect appears to be responsible for premature ageing. In order to identify potential future therapeutic targets for CMBD, it is essential to gain a better understanding of the underlying pathophysiological mechanisms.\n\nTo better understand premature aging in extra-renal damage in cystinosis, it seems relevant to investigate energy metabolism dysfunction, particularly mitochondrial dysfunction.",[372,373],"Cystinosis","Native Kidney",[372,375,376,377],"Mitochondria","Cystinosis Metabolic Bone Disease (CMBD)","Myopathy","2026-07-30",{"date":296,"type":39},{"date":355,"type":39},{"date":382,"type":23},"2028-07",{"name":45,"class":46},{"id":385,"slug":386,"hasResults":12,"nctId":387,"briefTitle":388,"officialTitle":389,"acronym":390,"eligibilityCriteria":391,"healthyVolunteers":12,"sex":392,"minAge":19,"maxAge":20,"enrollmentInfo":393,"targetDuration":4,"studyType":24,"phases":394,"briefSummary":395,"conditions":396,"keywords":398,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":378,"lastUpdatePostDateStruct":406,"startDateStruct":407,"completionDateStruct":409,"leadSponsor":411,"locationsCount":333},"100615657","clinical-trial-evaluating-the-efficacy-and-implementation-of-an-early-adapted-physical-activity-to-prevent-and-manage-aromatase-inhibitor-induced-musculoskeletal-pain-in-breast-cancer-apis-100615657","NCT07295457","Clinical Trial Evaluating the Efficacy and Implementation of an Early Adapted Physical Activity to Prevent and Manage Aromatase Inhibitor-induced Musculoskeletal Pain in Breast Cancer (APIS)","Randomized Clinical Trial Evaluating the Efficacy and Implementation of an Early Adapted Physical Activity to Prevent and Manage Aromatase Inhibitor-induced Musculoskeletal Pain in Breast Cancer","APIS","Inclusion Criteria:\n\nQuantitative study:\n\n* Women aged 18 to 75\n* Person with non-metastatic breast cancer\n* positive for at least one hormone receptor\n* Person treated with an Aromatase Inhibitor\n* Person with the following treatment regimen: Surgery - radiotherapy - aromatase inhibitor hormone therapy or surgery - chemotherapy (neoadjuvant or adjuvant) +\u002F- targeted therapy - +\u002F- radiotherapy - aromatase inhibitor hormone therapy.\n* Person affiliated to a social security scheme\n* Person having signed a free and informed consent\n\nQualitative study:\n\nFor patients :\n\n* Patient having given consent to participate in the APIS study\n* Patient agreeing to participate in the qualitative study (box checked on the APIS informed consent form)\n* Patient agreeing to the recording of the semi-directive interview\n\nFor healthcare professionals :\n\n* Person practicing within the Saint-Étienne University Hospital and the Croix-Rousse University Hospital as a surgeon, oncologist, radiotherapist, sports medicine physician, APA instructor, physiotherapist, head nurse, care coordinator nurse, or advanced practice nurse\n* Persons working with patients treated with aromatase inhibitors for non-metastatic breast cancer\n* Person who has received individual information\n* Person who has given consent to participate in the study\n* Person agreeing to the recording of the semi-directive interview\n* Person of legal age\n\nAncillary study :\n\n* Eligible patient who has given consent to participate in the APIS study\n* Patient agreeing to participate in the ancillary study (box checked on the APIS informed consent form)\n\nExclusion Criteria:\n\nFor all patients:\n\n* Person deprived of liberty by judicial or administrative decision\n* Person under psychiatric care (unstable pathology)\n* Person of full age under legal protection (guardianship, curatorship)\n* Person unable to receive sufficient information due to impaired higher functions, or insufficient command of the French language\n* Person participating in another interventional research study with an exclusion period still in progress at the time of pre-inclusion\n* Person with absolute contraindications to physical exercise:\n\n  * Unstable angina\n  * Decompensated heart failure\n  * Complex ventricular rhythm disorders\n  * Uncontrolled severe arterial hypertension\n  * Pulmonary arterial hypertension (\\> 60 mm Hg)\n  * Presence of large or pedunculated intracavitary thrombus\n  * Acute pericardial effusion\n  * Severe obstructive cardiomyopathy\n  * Tight and\u002For symptomatic aortic stenosis\n  * Recent thrombophlebitis with or without pulmonary embolism\n  * Diabetes with plantar perforator disease for physical activity activities involving the lower limbs\n* Persons with musculoskeletal pathologies making cycling impossible","FEMALE",{"count":342,"type":23},[26],"Aromatase inhibitors (AI) are the standard adjuvant hormone therapy for postmenopausal women with hormone-sensitive breast cancer. However, nearly half of patients experience AI-induced musculoskeletal symptoms (AIMSS), particularly pain, which compromise quality of life and treatment adherence. While adapted physical activity offers proven benefits in oncology, its specific role in preventing or managing AIMSS remains unclear. Moreover, the maintenance of physical activity during the care pathway in real-world settings is limited, highlighting the need for hybrid approaches that evaluate both clinical effectiveness and implementation. In response to these challenges, the primary study aim will be to compare the prevalence of musculoskeletal pain after six months of aromatase inhibitor therapy between patients initiating a personalized adapted physical activity program at the beginning of the care pathway and those receiving usual care. Secondary aims will be to (1) assess additional effects of the intervention on physical health, psychosocial well-being and treatment adherence, (2) explore contextual factors influencing program implementation in routine oncology care and (3) identify potential risk factors for the development of AIMSS. The APIS study is a hybrid type I effectiveness-implementation randomized controlled trial including 182 postmenopausal women with non-metastatic hormone-sensitive breast cancer. APIS will generate new evidence on the clinical and implementation effectiveness of early personalized APA (Adapted Physical Activity) in preventing AIMSS. The hybrid design will support the development of sustainable, patient-centered interventions, potentially improving quality of life, adherence to AI therapy and long-term outcomes in breast cancer survivorship.\n\nAncillary study (Groupement Hospitalier Nord, Hospices Civils de Lyon) The humero-scapulo-thoracic region is particularly exposed to functional alterations during the course of care of patients treated for breast cancer. In addition to the loss of strength and mobility associated with surgical and medical treatment, the shoulder can also be the site of pain due to AIMSS or PMDS (Post-Mastectomy Pain Syndrome).\n\nThese pains are often studied separately, depending on the treatment, but few studies offer a global vision of the functional evolution of the shoulder throughout the course of care, enabling prevention and adjustment of management. It is also relevant to assume that early APA treatment could improve functional rehabilitation in this area.\n\nThe aim of this study is therefore to evaluate the impact of an APA assessment and early referral to a personalized program (APIS protocol) on shoulder functionality, depending on the time of intervention in the therapeutic pathway.",[397],"Breast Cancer",[399,400,401,402,403,404,405],"Breast cancer","Hormonotherapy","Musculoskeletal pain","Adapted physical activity","Aromatase inhibitors","Exercise oncology","Implementation science",{"date":326,"type":39},{"date":408,"type":39},"2026-05-21",{"date":410,"type":23},"2029-07",{"name":45,"class":46},{"id":413,"slug":414,"hasResults":12,"nctId":415,"briefTitle":416,"officialTitle":417,"acronym":418,"eligibilityCriteria":419,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":420,"enrollmentInfo":421,"targetDuration":4,"studyType":24,"phases":423,"briefSummary":424,"conditions":425,"keywords":426,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":378,"lastUpdatePostDateStruct":429,"startDateStruct":430,"completionDateStruct":432,"leadSponsor":433,"locationsCount":434},"100582088","health-economic-assessment-of-robot-assisted-bariatric-surgery-100582088","NCT06858761","Health-economic Assessment of Robot-assisted Bariatric Surgery","Health Economic Impact of Robot-assisted Bariatric Surgery vs Conventional Laparoscopy: Prospective Multicenter Randomized Controlled Trial","ROBOBAR","Inclusion Criteria:\n\n* Patient aged between 18 and 70 years old,\n* Female or male patients\n* Patient eligible for one of the two situations defined below:\n\n  1. Primary bariatric or metabolic surgery, with a BMI corresponding to one of the 3 following situations, in accordance with the french National Authority for Health (HAS) recommendations published in February 2024:\n\n     * 40 kg\u002Fm² OR\n     * 35 kg\u002Fm² with at least one comorbidity that may improve after surgery (e.g.: high blood pressure, sleep apnea syndrome and other severe respiratory disorders, type 2 diabetes, disabling osteoarticular diseases, steatohepatitis not alcoholic, dyslipidemia, osteoarthritis) OR between 30 and 35 kg\u002Fm² with uncontrolled type 2 diabetes\n  2. Revision surgery for complication and\u002For side effects of a previous bariatric surgery\n* Patient who has benefited from a pluridisciplinary evaluation (medical, surgical, psychiatric), with a favorable opinion for a bariatric.\n* Patient who agrees to be included in the study and who signs the informed consent form,\n\nExclusion Criteria:\n\n* Presence of a severe and evolutive life threatening pathology, unrelated to obesity,\n* Pregnancy or desire to be pregnant during the study,\n* Patient not affiliated to a French or European healthcare insurance,\n* Patient under supervision or guardianship\n* Patient who is unable to give consent,\n* Patient who does not understand French\n* Patient who has already been included in a trial which has a conflict of interests with the present study","70 Years",{"count":422,"type":23},482,[26],"CONTEXT :\n\nObesity is a serious disease which affects 17% of the french population. Bariatric and metabolic surgery has demonstrated its efficiency and remains the treatment of reference. Over 40,000 bariatric procedures are performed per year, mainly by laparoscopy ; the robotic approach, historically developed by Intuitive Surgical increases rapidly and accounts for 18% of the procedures in the public system. Whereas the robotic approach has demonstrated its superiority toward laparoscopy for prostatectomies and rectal resections, it still has to be demonstrated for bariatric surgery ; some studies report a decrease rate of complications for complexe procedures and selected patients but the literature remains variable and the benefit of the robot in relation to its high cost must be confirmed.\n\nOBJECTIVES:\n\nTo conduct a health-economic assessment (i.e. cost-effectiveness ratio expressed as the additional cost per quality adjusted life-year gained) of the Da Vinci robot in bariatric surgery at 1 year, from the Health Care system point of view.\n\nMETHOD :\n\nRandomized (482 patients), controlled, single-blind, multicenter, superiority trial comparing two approaches for primary or revisional bariatric surgery: a group benefiting from a robotic approach and a reference group benefiting from a laparoscopic approach. Data from the trial will be matched via the social security number to the French National Health Insurance Information System (SNDS database) in order to collect care consumption. The quality of life will be assessed using the EuroQol-5 Dimension (EQ5D-5L) questionnaire.\n\nPERSPECTIVES:\n\nThis study will have a direct impact on patients care, professional practices and public health policy either by validating the value of the robot in bariatric surgery or conversely, by promoting the laparoscopic approach.\n\nHYPOTHESIS :\n\nRobot-assisted bariatric surgery is more expensive than conventional laparoscopy, but the additional costs associated with the robot are partly offset by a reduction in post-operative complications at 1 year, which should also help to improve patients' quality of life.",[64],[64,427,428],"Bariatric surgery","Robot",{"date":326,"type":39},{"date":431,"type":39},"2025-07-25",{"date":382,"type":23},{"name":45,"class":46},18,{"id":436,"slug":437,"hasResults":12,"nctId":438,"briefTitle":439,"officialTitle":440,"acronym":441,"eligibilityCriteria":442,"healthyVolunteers":12,"sex":18,"minAge":443,"maxAge":84,"enrollmentInfo":444,"targetDuration":4,"studyType":24,"phases":446,"briefSummary":447,"conditions":448,"keywords":450,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":455,"lastUpdatePostDateStruct":456,"startDateStruct":457,"completionDateStruct":459,"leadSponsor":461,"locationsCount":47},"100613932","tongue-muscular-assessment-in-children-with-sleep-disordered-breathing-100613932","NCT07273019","Tongue Muscular Assessment in Children With Sleep Disordered Breathing","Tongue Muscular Assessment in Children Referred for Polysomnography in a Context of Suspected Obstructive Sleep Apnea","TMAC-C","Inclusion Criteria:\n\n* With suspected sleep-disordered breathing\n* Referred for polysomnography\n* Affiliated to a social security scheme\n* With informed consent from both legal representatives\n\nExclusion Criteria:\n\n* Insufficient comprehension of French language\n* Regarding patients with suspected OSA type I or II:\n\n  * Neurological, cardiac, or unstable respiratory conditions other than sleep disorders and their repercussions\n  * Any deficit possibly impacting measurements according to the investigator (e.g., psychiatric condition)\n  * Malformation of the skull, the upper airway or the oral cavity\n* Regarding patients with suspected OSA type III:\n\n  * Any deficit possibly impacting measurements according to the investigator (e.g., psychiatric condition)\n  * Intellectual deficit impeding the understanding of instructions","4 Years",{"count":445,"type":23},78,[26],"Obstructive sleep apnea (OSA) is part of the sleep-disordered breathing spectrum. Its prevalence in children is 1-5%, and it can have negative consequences at the cardiovascular, cognitive as well as behavioral levels. In children, the first-line treatment is adenotonsillectomy. However, residual obstructive events can persist as the success rate of surgery reaches only 49% in non-obese children. Residual OSA may be explained by multiple sites of obstruction, found in 20-85% children concerned by persistent OSA. Indeed, the tongue appears among one possible primary sites of obstruction. Given the tongue's crucial role in upper-airway patency during sleep, its assessment can inform us about the myofunctional deficits involved in sleep-disordered breathing.\n\nThe primary objective of the present study is to assess tongue motor functions in children with sleep-disordered breathing and to compare them to those of healthy children (data collected in a current study (TMAC) conducted at UCLouvain, Belgium; NCT06166680), in order to document possible myofunctional deficits in children with OSA. The hypothesis is that tongue motor functions will be lower in children with sleep-disordered breathing.",[449],"Obstructive Sleep Apnea",[451,452,453,454],"Tongue","Motor functions","Sleep","Sleep apnea","2026-07-29",{"date":378,"type":39},{"date":458,"type":39},"2026-03-26",{"date":460,"type":23},"2028-03-26",{"name":45,"class":46},{"id":463,"slug":464,"hasResults":12,"nctId":465,"briefTitle":466,"officialTitle":466,"acronym":467,"eligibilityCriteria":468,"healthyVolunteers":12,"sex":18,"minAge":84,"maxAge":4,"enrollmentInfo":469,"targetDuration":4,"studyType":24,"phases":471,"briefSummary":472,"conditions":473,"keywords":475,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":455,"lastUpdatePostDateStruct":481,"startDateStruct":482,"completionDateStruct":484,"leadSponsor":486,"locationsCount":47},"100534946","circadian-rhythmicity-during-coma-awakening-100534946","NCT06245434","Circadian Rhythmicity During Coma Awakening","COMARHYTHM","Inclusion Criteria:\n\nGroup 1\n\n* Admission to the Neurological Intensive Care Unit\n* Initial disorder of consciousness (GCS \\\u003C 8) or initial brain lesion (on CT or MRI) requiring intubation and sedation during management (for upper airway protection or due to coma)\n* Intubated patient under mechanical ventilation with no response to simple commands\n* Weaning from sedation : acquired \u002F possible within 7 days of inclusion in the absence of new complications\n* Severity of clinical or morphological impairment leading to risk of persistent disturbance of consciousness\n* Sedation discontinued or able to be discontinued within 3 month of initial management of the disorder of consciousness or brain injury\n* Effective treatment of the cause of admission without risk of short-term recurrence\n* Patient aged 17 or over\n* Urinary catheter in place at the time of inclusion and to remain in place until Visit N°1\n* Presence of relatives able to sign consent or of the minor's legal representative\n\nGroup 2\n\n* Admission to the Neurological Intensive Care Unit or the Neurological Continuing Care Unit\n* Absence of severe disorder of consciousness but possibility of minimal alteration of the initial Glasgow score (GCS between 9 and 15) with no time limit, with a stratification of three consecutive patient populations distinguished by the initial neurological alteration:\n\n  * GCS = 15\n  * GCS \\\u003C 15 by predominance of an initial defect in responses to simple or complex commands obtained by motor or verbal means, without abnormality of arousal (E score = 4 but M score \\\u003C 6 and\u002For V score \\\u003C 5)\n  * GCS \\\u003C 15 with predominant initial somnolence, with or without abnormal motor or verbal responses to simple or complex commands (E score = 2 or 3 but M score = 6 and\u002For V score = 5).\n* Existence of functional communication or functional use of objects at inclusion\n* Mechanism of injury for which the aetiology is no longer active or at risk of recurrence\n* Patient aged 17 or over\n* Urinary catheter in place at the time of inclusion and to remain in place until Visit N°1\n* In the case of impaired judgement despite functional communication or in the case of aphasia with functional use of objects: presence of relatives able to sign consent or of the legal representative of the minor or of the legal representative of the protected adult.\n\nGroup 3\n\n* Admission to the Adult Post-Resuscitation Rehabilitation Department, in the Neurological Multidisciplinary Intensive Care Unit\n* Disturbance of consciousness defined by an absence of communication or an absence of functional use of objects (for patients with aphasia), i.e. the two signs that could indicate emergence from the pauci-relational state, which includes patients presenting :\n\n  * persistent coma\n  * a vegetative state (or unresponsive wakefulness syndrome)\n  * a pauci-relational state (MCS- or MCS+ if responding to simple commands).\n* Persistent within the following timeframe\n\n  * More than 3 months after the initial management of the disorder of consciousness or brain injury\n  * More than 1 month after a post-anoxic coma.\n* Mechanism of injury for which the aetiology is no longer active or at risk of recurrence\n* Patient aged 17 or over\n* Presence of relatives likely to sign the consent or of the legal representative of a minor or of the legal representative of a protected adult\n\nExclusion Criteria:\n\nGroup 1\n\n* Subjects with a contraindication to MRI scans\n* Admission for status epilepticus\n* Existence of status epilepticus during the stay and persisting for \\> 24h or presenting an electrical remission for less than 48h prior to inclusion\n* Post-anoxic coma with bilateral abolition of N20 PES cortical responses\n* Coma related to a potentially recurrent cause of coma (tumours, infectious diseases with risk of relapse and inflammatory diseases)\n* Moribund patient (life expectancy \\\u003C 24h) or in WLST (no assessment possible of the dynamics of ongoing awakening)\n* Haemodynamic or respiratory instability incompatible with a prolonged attempt to stop sedation (except in the case of scheduled surgery outside the visit dates)\n* Patients under guardianship, curatorship or safeguard of justice\n* Patients not affiliated to the French health insurance system\n* Pregnant women or women of childbearing age without proof of the absence of a current pregnancy\n\nGroup 2\n\n* Subjects with a contraindication to MRI scans\n* Epileptic seizures on admission or during the stay\n\n  * Single seizure: if no rapid return to consciousness (GCS \\\u003C 8 for \\> 12 hours)\n  * \\> 2 distinct epileptic seizures regardless of the duration of loss of consciousness\n  * Status epilepticus\n* Post-anoxic coma with bilateral abolition of N20 cortical PES responses.\n* Coma linked to a potentially recurrent cause of coma (tumour, infection with risk of relapse and inflammation).\n* A moribund patient (life expectancy \\\u003C 24 hours) or a patient undergoing WLST with a high risk of death before the end of the study (inclusion possible if no therapeutic escalation is decided in a stabilised patient).\n* Haemodynamic or respiratory instability incompatible with prolonged evaluation of the absence of sedation (risk of general anaesthesia for further failure, except in the case of scheduled surgery outside the visit dates).\n* Patients under guardianship, curatorship or safeguard of justice\n* Patients not affiliated to the French health insurance system\n* Pregnant women or women of childbearing age without proof of the absence of a current pregnancy\n\nGroup 3\n\n* Subjects with a contraindication to MRI scans\n* Epileptic seizures during the week preceding inclusion:\n\n  * Single seizure: if no rapid return to usual state of consciousness for \\> 12 hours\n  * \\> 2 separate comitial seizures regardless of duration of loss of consciousness\n  * Epileptic malaise\n* Post-anoxic coma with bilateral abolition of N20 cortical responses to SEP\n* Coma related to a potentially recurrent cause of coma (tumour, infection with risk of relapse and inflammation)\n* Moribund patients (life expectancy \\\u003C 24 hours) or patients undergoing WSLT with a high risk of death before the end of the study (inclusion possible if no therapeutic escalation is decided in a stabilised patient).\n* Haemodynamic or respiratory instability incompatible with prolonged evaluation of the absence of sedation (risk of general anaesthesia for further failure, except in the case of scheduled surgery outside the visit dates).\n* Patients under guardianship, curatorship or safeguard of justice prior to the event that provoked their state of chronic disturbance of consciousness. Patients under guardianship because of their chronic disorder of consciousness are eligible for the study.\n* Patients not affiliated to the French health insurance system\n* Pregnant women or women of childbearing age without proof of the absence of a current pregnancy",{"count":470,"type":23},90,[26],"Acute brain injury is a major cause of admission to intensive care units, as well as of mortality and morbidity, worldwide and for all age groups. With most patients surviving these injuries thanks to recent medical advances, society is facing not only the growing burden of disability, but above all the ethical issues involved in withdrawal of life-sustaining therapies (WSLT). To resolve this dilemma, effective treatment would be necessary, but this is hampered by our limited knowledge of the pathophysiological mechanisms of the natural history of coma, from onset to recovery. A more systematic description of coma awakening using a multimodal battery in intensive care unit patients would enable us to refine the awakening and re-emergence of consciousness and define appropriate biomarkers for selecting candidates in interventional studies.\n\nThe investigators hypothesize that the current postulate of successive stages (i.e. from one clinical class to the next) of coma recovery is incomplete, as it does not take into account the rhythmic nature of wakefulness. The investigators propose that the best correlate of the natural history of coma recovery is a gradual shift from the loss of physiological cycles to a circadian rhythmicity of arousal indices (behavioural and neurophysiological) and a wide amplitude of metric fluctuations in assessing content richness.",[474],"Acute Brain Injury Coma",[476,477,478,479,480],"Circadian rhythms","Consciousness","Wakefulness","Biomarkers","Monoamines",{"date":378,"type":39},{"date":483,"type":39},"2024-12-02",{"date":485,"type":23},"2029-06-02",{"name":45,"class":46},{"id":488,"slug":489,"hasResults":12,"nctId":490,"briefTitle":491,"officialTitle":492,"acronym":493,"eligibilityCriteria":494,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":495,"targetDuration":4,"studyType":24,"phases":497,"briefSummary":498,"conditions":499,"keywords":501,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":506,"lastUpdatePostDateStruct":507,"startDateStruct":508,"completionDateStruct":510,"leadSponsor":512,"locationsCount":513},"100580233","nephroprotection-in-severe-trauma-patients-with-kidney-stress-100580233","NCT06834633","Nephroprotection in Severe Trauma Patients With Kidney Stress","Impact of a Nephroprotection Bundle-of-care in Severe Trauma Patients at Risk of Acute Kidney Injury: a Multicenter Randomized Controlled Trial","NephroTrauma","Inclusion Criteria:\n\n* Adult patient (≥ 18 years)\n* Severe trauma patients (ISS score \\> 15) admitted to a trauma center\n* Time between trauma and admission to trauma center \\\u003C6h\n* High risk of AKI: at least one NC score greater than 0.3 within 12 hours of admission to critical care (intensive care and continuous monitoring unit)\n* Affiliated with a social security scheme or beneficiary of a similar scheme\n* Consent signed by patient or close relative, or attestation signed by investigator in case of emergency\n\nExclusion Criteria:\n\n* Adult under legal protection (guardianship, curators)\n* Persons deprived of their liberty by judicial or administrative decision\n* Patients taking part in other interventional research which may interfere with the research and which includes an exclusion period still in progress at the time of inclusion.\n* Pregnant or breast-feeding woman (diagnosis of pregnancy by plasma βHCG (Beta-Human Chorionic Gonadotropin) assay routinely performed as part of the blood test on admission to the outpatient department of a woman of childbearing age).\n* Patients with end-stage or severe chronic renal failure with Glomerular Filtration Rate (GFR) \\\u003C 30 milliliters\u002Fmin\u002F1.73m2 or chronic dialysis.\n* Anuric patients\n* Severe heart failure defined as Left Ventricular Ejection Fraction (LVEF) \\\u003C25%.\n* Patient moribund on admission with an estimated length of stay of less than 24 hours\n* Patient with AKI at time of randomization (developed prior to ICU admission or within the first 12 hours of ICU admission, before randomization).",{"count":496,"type":23},523,[26],"Acute Kidney Injury (AKI) occurs in 24% of trauma patients, and is even more common in those with severe trauma. It is a major contributor to morbidity and mortality in trauma. Diagnosis of AKI is based on elevated serum creatinine and decreased urine output, two functional markers already indicating the presence of a significant kidney function impairment. Earlier detection of kidney stress, at a preclinical stage when cellular modifications are still reversible, could reduce the occurrence of AKI episodes if nephroprotective measures are rapidly implemented.\n\nSeveral randomized controlled trials have shown that early implementation of such a nephroprotection bundle-of-care in patients at risk of AKI after major surgery reduces the incidence of severe AKI within 72 hours. Although its use is supported by international guidelines, this nephroprotection bundle-of-care is rarely implemented in its totality, due to the significant financial and human resources required for its full implementation.\n\nThe Nephrocheck® (NC) test is a urine test for which a result \\> 0.3 is predictive of AKI development. It might enable early identification of trauma patients at risk of AKI, so that implementation of the nephroprotection bundle-of-care could be targeted solely at those high-risk patients.\n\nThus, the investigators hypothesize that in a population of severe trauma patients (ISS score\\>15) at risk of AKI (defined by a NC on Intensive Care Unit (ICU) admission \\> 0.3), early implementation of a nephroprotection bundle-of-care would reduce the risk of AKI occurring within 3 days of ICU admission, compared with standard-of-care management. This study will compare the occurrence of AKI in these two groups in a multicenter randomized controlled trial.",[500],"Trauma; Complications",[502,503,504,505],"Severe trauma","Acute Kidney Injury","Nephroprotection bundle-of-care","Biomarker","2026-07-27",{"date":455,"type":39},{"date":509,"type":39},"2025-07-09",{"date":511,"type":23},"2027-09",{"name":45,"class":46},6,{"id":515,"slug":516,"hasResults":12,"nctId":517,"briefTitle":518,"officialTitle":519,"acronym":520,"eligibilityCriteria":521,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":522,"targetDuration":4,"studyType":87,"phases":4,"briefSummary":524,"conditions":525,"keywords":527,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":532,"lastUpdatePostDateStruct":533,"startDateStruct":534,"completionDateStruct":536,"leadSponsor":538,"locationsCount":47},"100577660","single-center-exploratory-study-of-the-intestinal-microbiota-in-patients-treated-for-irritable-bowel-syndrome-with-predominant-constipation-and-methane-production-100577660","NCT06801184","Single-center Exploratory Study of the Intestinal Microbiota in Patients Treated for Irritable Bowel Syndrome With Predominant Constipation and Methane Production","Single-center Exploratory Study of the Intestinal Microbiota in Patients Suffering of Irritable Bowel Syndrome With Predominant Constipation and Methane Production: METHANOBIOTE","METHANOBIOTE","Inclusion Criteria:\n\n* Patient suffering from Irritable Bowel Syndrome (IBS) (abdominal pain for the past 6 months occurring on average at least 1 day per week in the last 3 months, with at least 2 of the following criteria: associated with defecation, associated with a change in stool frequency, associated with a change in stool consistency):\n\n  1. Predominant constipation type (IBS-C): Bristol Stool Scale 1-2 ≥ 25% of the time and Bristol Stool Scale 6-7 ≤ 25% of the time\n  2. Alternating diarrhea-constipation type (IBS-M): Bristol Stool Scale 1-2 25% of the time and Bristol Stool Scale 6-7 25% of the time\n  3. Unspecified type: absence of sufficient criteria to meet criteria for IBS-C, IBS-D, or IBS-M.\n* Patient exhibiting a high methane level (≥ 10 ppm) during a glucose breath test.\n* Aged ≥ 18 years at the time of study entry.\n* Patient not opposing participation in the study.\n\nExclusion Criteria:\n\n* Patient who has been treated with antibiotics or probiotics in the last 3 months prior to inclusion.\n* Patient suffering from diarrhea-predominant IBS (Bristol Stool Scale 6-7 ≥ 25% of the time and Bristol Stool Scale 1-2 ≤ 25% of the time).\n* Patient with a history of abdominal surgery other than appendectomy and cholecystectomy.\n* Patient with a history of celiac disease.\n* Patient with proven inflammatory bowel disease.\n* Patient with a history of colorectal cancer.\n* Patient with uncontrolled hypothyroidism.\n* Patient with uncontrolled diabetes.\n* Pregnant or breastfeeding women.\n* Patient deprived of liberty by a judicial or administrative decision.\n* Adult patient under legal protection (guardianship, curators).\n* Patient unable to discontinue proton pump inhibitor treatment during the study period",{"count":523,"type":23},40,"Irritable Bowel Syndrome (IBS), characterized by the Rome IV criteria, is a functional bowel disorder combining abdominal pain with changes in bowel habits and\u002For stool consistency. This condition is common, affecting 5% to 10% of the population in developed countries.\n\nThe etiology of IBS is multifactorial, involving intestinal motility disorders, visceral hypersensitivity, micro-inflammation of the intestinal mucosa, and dysbiosis. It has been demonstrated that the sub-category of IBS patients with constipation predominantly have increased amounts of Methanobrevibacter smithii, the most common methanogenic archaea found in the intestinal lumen, compared to other IBS patients.\n\nBreath tests can evaluate methane production by the intestinal microbiota, indirectly assessing the presence and quantity of methanogenic archaea. The acronym IMO (intestinal methanogen overgrowth) defines the association of digestive symptoms (notably bloating and constipation) with a high concentration of methane in exhaled gases (≥ 10 ppm).\n\nThe links between constipation, methane production, and fecal microbiota are uncertain, necessitating further studies that could lead to precise diagnostic and treatment recommendations.\n\nMain objective: Describe the initial composition of the fecal microbiota of constipated methano-producing IBS patients.\n\nSecondary objectives:\n\n2\\. Describe the initial composition of blood metabolites linked to the microbiota of constipated methano-producing IBS patients 3. Describe the evolution of the fecal microbiota and blood metabolites linked to the fecal microbiota during conventional therapeutic management (before and after) of constipated methano-producing IBS patients.\n\n4\\. Compare the composition of the fecal microbiota before and after conventional therapeutic management of responding IBS-C patients (-30% on the IBS-SSS symptom severity score) compared to non-responding patients.\n\n5\\. Evaluate the impact of Methanobrevicter smithii in the response to symptomatic treatment.\n\nExploratory observational single-center study (cohort follow-up) descriptive in patients with irritable bowel syndrome with constipation (IBS-C, IBS-m or IBS-U) with excessive methane production detected on a glucose breath test.\n\nPatients will be invited to participate once the results of the breath test are known.\n\nPlease note:\n\nIn the context of this study, only two microbiota samples and 4 additional tubes and one tube of blood will be added to the usual practice. All treatments will be prescribed as part of the care and are not conditioned by the research protocol.\n\nThe primary endpoint is the analysis of the initial composition (16S rRNA gene sequencing) of the fecal microbiota of constipated methano-producing IBS patients.\n\nThe study population consists of constipated IBS patients with excessive methane production seen in the digestive functional exploration department for a breath test prescribed as part of an external procedure or a day hospital session.\n\nA total of 40 patients will be included over 18 months, with a participation duration of 2 months +\u002F- 2months per subject.\n\nPatients with IBS constitute a heterogeneous population for whom only symptomatic treatment is currently offered with variable and unpredictable efficacy. Through this work, we seek to find new therapeutic axes to relieve or even treat their symptoms.",[526],"Irritable Bowel Syndrome",[528,529,526,530,531],"gastroenterology","microbiota","constipation","methano-production","2026-07-24",{"date":506,"type":39},{"date":535,"type":39},"2025-02-10",{"date":537,"type":23},"2028-10-10",{"name":45,"class":46},{"id":540,"slug":541,"hasResults":12,"nctId":542,"briefTitle":543,"officialTitle":544,"acronym":545,"eligibilityCriteria":546,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":547,"enrollmentInfo":548,"targetDuration":4,"studyType":24,"phases":549,"briefSummary":550,"conditions":551,"keywords":555,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":561,"lastUpdatePostDateStruct":562,"startDateStruct":563,"completionDateStruct":565,"leadSponsor":567,"locationsCount":333},"100535429","fluid-removal-guided-by-vexus-score-with-usual-care-in-patients-with-acute-kidney-injury-after-cardiac-surgery-100535429","NCT06251713","Fluid-removal Guided by VeXUS Score With Usual Care in Patients With Acute Kidney Injury After Cardiac Surgery","Feasibility of a Randomised Trial Comparing a Fluid-removal Guided by VeXUS Score With Usual Care in Patients With Acute Kidney Injury After Cardiac Surgery: a Pilot Randomised Trial.","VeXUS","Inclusion Criteria:\n\n* Intensive care unit admission within 72 hours of cardiac surgery with extracorporeal circulation\n* Acute kidney injury defined by KDIGO criteria\n* Vasoactive inotropic score \\\u003C45 and capillary refill time \\\u003C3s\n* Informed written consent\n\nExclusion Criteria:\n\n* Hypokalaemia \\\u003C3.5mmol\u002FL\n* Hyponatremia\\\u003C125mmol\u002FL\n* Hypernatremia \\>145mmol\u002FL\n* Metabolic alkalosis with pH \\>7.50\n* Impossibility to measure capillary refill time\n* Chronic liver disease\n* Cirrhosis with portal hypertension\n* Known thrombus of the inferior vena cava\n* Mechanical circulatory assistance (ECMO or mono left ventricular assistance)\n* Severe pre-operative chronic kidney disease (GFR \\\u003C 30mL\u002Fmin\u002F1.73m2)\n* Need for renal replacement therapy anticipated by the attending physician within 24 hours\n* Known hypersensitivity to Furosemide and\u002For hydrochlorothiazide\n* Severe allergy to wheat\n* Patient already included in another interventional study with an exclusion period still in progress\n* Pregnant, breast-feeding or women of childbearing age without suitable contraception\n* Patients under guardianship, curatorship or safeguard of justice\n* Patients under psychiatric care\n* Patients not affiliated to a social security scheme or beneficiaries of a similar scheme","85 Years",{"count":523,"type":23},[26],"Acute kidney injury affects more than 30% of patients after cardiac surgery, and is associated with an excess in mortality. There is a clinical continuum between acute kidney injury (transient if \\\u003C48h, persistent if \\>48h), the development of acute kidney and chronic renal failure. Each of these entities characterising renal recovery is associated with an increase in long-term morbidity and mortality. Fluid management in patients with acute kidney injury is challenging, as both hypovolaemia and hypervolaemia are detrimental. Venous congestion (reflecting intravascular hypervolaemia), is a well-established haemodynamic factor contributing to acute kidney injury after cardiac surgery. An ultrasound score, based on the venous doppler pattern explored in intra-abdominal organs, has recently been developed and is a better predictor of acute kidney injury than central venous pressure. Whether using the VeXUS score to guide fluid removal in haemodynamically stabilised patients could promote renal recovery after acute kidney injury remains to be investigated.\n\nBefore designing a large randomised trial to test such a strategy, its feasibility in a pilot randomised trial is assessed.",[503,552,553,554],"Cardiac Surgery","Venous Congestion","Hemodynamic Stability",[556,557,553,558,559,560],"Acute kidney injury","Cardiac surgery","VeXUS score","diuretic","fluid removal","2026-07-23",{"date":532,"type":39},{"date":564,"type":39},"2024-07-31",{"date":566,"type":23},"2027-07",{"name":45,"class":46},{"id":569,"slug":570,"hasResults":12,"nctId":571,"briefTitle":572,"officialTitle":573,"acronym":574,"eligibilityCriteria":575,"healthyVolunteers":222,"sex":18,"minAge":576,"maxAge":4,"enrollmentInfo":577,"targetDuration":4,"studyType":24,"phases":579,"briefSummary":580,"conditions":581,"keywords":584,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":590,"lastUpdatePostDateStruct":591,"startDateStruct":592,"completionDateStruct":594,"leadSponsor":595,"locationsCount":333},"100586925","phosphorus-31-spectroscopy-in-phosphate-diabetes-100586925","NCT06921720","Phosphorus-31 Spectroscopy in Phosphate Diabetes","ATP (Adenosine Triphosphate) Concentration Measurement by Phosphorus-31 Spectroscopy in Phosphate Diabetes","Phos-ATP","Inclusion Criteria:\n\n* Inclusion Criteria for Patients:\n* Patient ≥ 10 years old with phosphate diabetes, i.e., genetically confirmed XLH or phosphate diabetes of another origin characterized by hypophosphatemia with a decreased Tm\u002FGFR.\n* Patient has given consent to participate in the study.\n* Signed consent (by both legal representatives for minor patients).\n* Patient regularly followed up within the pediatric nephrology services at the Femme Mère Enfant hospital and the nephrology-functional exploration services at the Edouard Herriot hospital.\n\nInclusion Criteria for Pediatric Controls:\n\n* Patient aged 10 to 17 years, without chronic kidney disease, without hypophosphatemia, without muscular abnormalities, and without growth disorders.\n* Patient has given consent to participate in the study.\n* Signed consent (by both legal representatives for minor patients).\n* Patient regularly followed up within the pediatric nephrology services at the Femme Mère Enfant hospital.\n\nInclusion Criteria for Adult Controls:\n\n* Patient without chronic kidney disease, without hypophosphatemia, without muscular abnormalities, and without malnutrition.\n* Patient has given consent to participate in the study.\n* Signed consent.\n* Patient regularly followed up within the renal functional exploration services at the Edouard Herriot hospital.\n\nExclusion Criteria:\n\n* Pregnant, parturient, or breastfeeding women\n* Individuals deprived of liberty by a judicial or administrative decision\n* Individuals receiving psychiatric care\n* Individuals admitted to a healthcare or social institution for purposes other than research\n* Adults under legal protection (guardianship, curators)\n* Individuals not affiliated with a social security system or benefiting from a similar scheme\n* Subjects participating in another interventional study with an exclusion period still in effect at pre-inclusion\n* General contraindications for MRI: wearing a pacemaker\u002FICD (implantable cardiac device) or mechanical heart valves not MRI-compatible, presence of non-MRI-compatible equipment, presence of metallic objects.","10 Years",{"count":578,"type":23},65,[26],"Phosphate diabetes is defined by urinary phosphate wasting due to impaired tubular reabsorption. It can be classified based on either a genetic or acquired origin. Chronic hypophosphatemia causes rickets in children, leading to growth disorders, bone deformities, and bone pain. In adults, it results in osteomalacia, pseudofractures, as well as muscle fatigue and weakness during exertion.\n\nX-linked hypophosphatemia (XLH) is a common cause of hereditary rickets linked to renal phosphate loss due to elevated FGF23 levels, most often caused by mutations in the PHEX (Phosphate Regulating Endopeptidase X-Linked) gene. Clinical trials have already demonstrated significant improvements in the quality of life of patients with XLH following the approval of the anti-FGF23 antibody, Burosumab.\n\nHowever, there are other causes of phosphate diabetes, such as tumor-induced osteomalacia (TIO), proximal tubulopathies (Dent disease, cystinosis), or mutations in Npt2a\u002FC.\n\nAs described above, patients with phosphate diabetes report bone pain and variable muscle fatigue depending on the underlying cause. These symptoms can significantly impact quality of life by limiting physical activities early on. However, standard quality-of-life questionnaires often lack the specificity to accurately assess these symptom-related impairments. At present, the investigators lack objective biomarkers that can quantitatively assess subclinical metabolic abnormalities at the muscular level in these patients.\n\nVarious data from animal models and preclinical studies suggest direct links between serum phosphate levels, intracellular phosphate (Pi), ATP production, and altered muscle metabolism. Muscle tissue requires energy, primarily derived from ATP hydrolysis. ATP is synthesized via mitochondrial oxidative phosphorylation, which is regulated by intracellular phosphate levels.\n\nIn five XLH patients, older studies compared intracellular Pi levels to those of five healthy controls and showed a decrease in Pi without a change in intracellular ATP. Smith et al. found ATP concentrations within the lower limit of normal at rest, while Pesta et al. reported a decrease in muscle ATP concentration in hypophosphatemic mice, which normalized after correcting serum phosphate levels.\n\nTwo recent studies using 31-phosphorus magnetic resonance spectroscopy (31P-MRS) showed no change in intracellular ATP levels in XLH patients, both before muscle activity and after burosumab treatment. However, these studies were conducted at rest. Yet, the main issue for patients lies in physical activity, as quality-of-life impairments often begin with limitations in daily physical tasks. Moreover, no current data are available on intracellular Pi or ATP levels in other forms of phosphate diabetes.\n\nThese parameters can be measured in vivo, non-invasively, using 31P-MRS. This technique employs a standard 3T MRI scanner equipped with a multinuclear coil to detect phosphorus instead of protons. It allows for ATP, Pi, and phosphocreatine concentrations to be measured every 2 minutes and 45 seconds. The procedure is non-irradiating, requires no contrast injection, and focuses on the patient's leg, meaning the whole body does not need to be inside the MRI scanner.\n\nAdditionally, in FGF23-mediated phosphate diabetes, calcitriol suppression leads to renin-angiotensin-aldosterone system (RAAS) activation and hypertension. In contrast, proximal tubulopathies cause salt wasting. The third sodium compartment (non-osmotically active sodium stored in subcutaneous and muscle tissue) can be assessed non-invasively using 23Na-MRI (sodium-23 MRI), which also uses a 3T (3 tesla) MRI scanner and a multinuclear coil to detect sodium signals under the same conditions as 31P-MRS.\n\nPatients with XLH also exhibit a distinct metabolic profile, with an increased risk of obesity, hypertension, left ventricular hypertrophy, and elevated uric acid levels.\n\nThe goal of the study is to quantitatively measure intramuscular ATP, intracellular phosphate (Pi), intracellular pH, and phosphocreatine both before and during exercise in patients with phosphate diabetes. The study also aims to characterize the mitochondrial and metabolic profile of these patients and assess the non-osmotically active third sodium compartment in these disorders.",[582,583],"Phosphate Diabetes","X-linked Hypophosphatemia",[585,586,587,588,589],"Hypophosphatemia","XLH","phosphate diabetes","muscle","31P-MRS","2026-07-22",{"date":561,"type":39},{"date":593,"type":39},"2025-05-16",{"date":74,"type":23},{"name":45,"class":46},{"id":597,"slug":598,"hasResults":12,"nctId":599,"briefTitle":600,"officialTitle":600,"acronym":601,"eligibilityCriteria":602,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":603,"targetDuration":4,"studyType":87,"phases":4,"briefSummary":605,"conditions":606,"keywords":609,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":614,"lastUpdatePostDateStruct":615,"startDateStruct":616,"completionDateStruct":618,"leadSponsor":620,"locationsCount":47},"100648532","study-of-surgical-practices-in-hemophilia-a-patients-treated-with-efanesoctocog-alfa-altuvoct-100648532","NCT07723560","Study of Surgical Practices in Hemophilia A Patients Treated With Efanesoctocog Alfa (Altuvoct®)","CHALE II","Inclusion Criteria:\n\n* Hemophilia A\n* Surgery performed with Altuvoct®\n* Patient consent to participate after receiving detailed written information.\n\nExclusion Criteria:\n\n* Presence of any blood coagulation disorder other than hemophilia A.\n* Detectable factor VIII inhibitors.\n* Known severe liver disease.\n* Known severe kidney disease.\n* Known hypersensitivity to Altuvoct® or any of its excipients.\n* Participation in another clinical trial (participation in non-interventional studies is not an exclusion criterion).",{"count":604,"type":23},160,"Hemophilia A is an inherited bleeding disorder caused by the absence or deficiency of coagulation factor VIII. The perioperative management of individuals with hemophilia A involves replacement therapies, typically through bolus or continuous infusions of Factor VIII, to ensure effective hemostatic control during surgery.\n\nEfanesoctocog alfa represents a significant advance in treatment. It is a highly engineered, VWF-independent, recombinant FVIII fusion molecule with an ultra-long half-life of 47 hours in adults and 40 hours in children. Efanesoctocog alfa is approved in the U.S. and Germany for adults and children with hemophilia A for multiple purposes: routine prophylaxis to reduce bleeding episodes, on-demand treatment of bleeding episodes, and perioperative management. Despite its approval, the precise optimal use of efanesoctocog alfa in the surgical setting remains underexplored. Further research is essential to define its specific benefits in surgery, thereby enhancing its clinical utility and informing treatment protocols.\n\nThe objective of this cohort study is to collect clinical data on the surgical management of patients with hemophilia A treated with Altuvoct® in a real-world setting. Data collected will include surgical context (outpatient or inpatient), number of FVIII infusions during the perioperative period, length of hospital stay, postoperative date of return to usual prophylaxis, and factor VIII use. The results will be compared with those obtained using efmoroctocog (Elocta) in the ongoing CHALE study in France.\n\nThe multicenter design is critical due to the rarity of hemophilia A, the diversity of surgical procedures, and the need to enroll a sufficient number of patients. The management of patients with hemophilia A during and after surgery is inherently multidisciplinary and requires careful coordination and adherence to numerous requirements. Given the variability in practice among centers, this study aims to support secondary harmonization of protocols and minimize intercenter variability. Such efforts are in line with the missions assigned to the National Reference Center for Hemophilia in France, coordinated by Pr Dargaud, and emphasize the importance of optimizing and standardizing care practices.\n\nA similar study is currently underway in France with efmoroctocog alfa (Elocta), which has already included over 155 procedures under real-world conditions. Using a similar case report form (CRF) for the present study will enable a direct comparison of surgical outcomes between extended half-life and ultra-extended half-life FVIII treatments, providing deeper insight into their respective roles in perioperative care. Additionally, this approach will highlight the added value of efanesoctocog alfa compared to existing therapies.\n\nAnother key advantage of this research is the opportunity to compare outcomes in patients receiving combined therapy with efanesoctocog alfa and emicizumab. Since the ongoing CHALE study has already included patients treated with both efmoroctocog and emicizumab, this comparison will further enhance our understanding of combination treatment strategies.",[607,608],"Haemophilia A","Factor VIII",[610,611,612,613],"Heamophilia A","Surgery","Ultra-prolonged half-life factor VIII","Efanesoctocog alfa","2026-07-20",{"date":561,"type":39},{"date":617,"type":39},"2026-01-03",{"date":619,"type":23},"2028-10-01",{"name":45,"class":46},{"id":622,"slug":623,"hasResults":12,"nctId":624,"briefTitle":625,"officialTitle":625,"acronym":626,"eligibilityCriteria":627,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":628,"targetDuration":4,"studyType":24,"phases":630,"briefSummary":631,"conditions":632,"keywords":634,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":614,"lastUpdatePostDateStruct":654,"startDateStruct":655,"completionDateStruct":657,"leadSponsor":659,"locationsCount":47},"100648484","prospective-evaluation-of-subcutaneous-administration-of-daratumumab-by-the-freedomedge-infusion-system-100648484","NCT07721350","Prospective Evaluation of Subcutaneous Administration of Daratumumab by the FreedomEDGE® Infusion System","ESCAPE","Inclusion Criteria:\n\n* Aged 18 and over\n* Having a diagnosis of multiple myeloma or light chain amyloidosis\n* Whose daratumumab is prescribed SC\n* Whose treatment with daratumumab takes place in a day hospital\n* Whose treatment with daratumumab is in the monthly injection period\n* Whose treatment with daratumumab has been carried out manually until now\n* Having signed consent to participate in the study\n\nExclusion Criteria:\n\n* Having known allergies to the metals of the infusion set (stainless steel)\n* Presenting bleeding disorders\n* Pregnant or breastfeeding women\n* Persons placed under guardianship, curatorship or under judicial protection;\n* Persons deprived of their liberty, persons subject to psychiatric care and persons admitted to a health or social establishment for purposes other than that of clinical investigation;\n* Persons who are not affiliated to a social security scheme or beneficiaries of such a scheme.\n* Subject participating in another interventional research including an exclusion period still in progress at pre-inclusion and which may interfere with the present study according to the judgment of the investigator",{"count":629,"type":23},100,[26],"This study is evaluating a new method for administering daratumumab, a treatment commonly used in the management of multiple myeloma and amyloidosis. For several years, this treatment has been administered by subcutaneous injection in just a few minutes, significantly reducing the amount of time patients spend in hospital. Currently, this injection is performed manually by nurses. Although effective, this method may be demanding in daily practice due to the repetitive nature of the procedure and the physical workload involved for healthcare professionals.\n\nThe aim of this study is to evaluate a medical device called FreedomEDGE®, developed by KORU Medical Systems, which enables mechanical and automated subcutaneous administration of daratumumab. This device operates without electricity: a spring-based system applies constant pressure to a syringe in order to deliver the medication steadily through a subcutaneous needle. This type of equipment is already used for the administration of other subcutaneous treatments, like immunoglobulins.\n\nThe primary objective of the study is to assess whether this device enables safe and effective administration of the treatment. Secondary objectives include evaluating administration time, identifying potential technical malfunctions, describing the occurrence of local or systemic adverse events, and assessing the experience and satisfaction of both patients and nurses using the device.\n\nFor patients, the expected benefits include more consistent and controlled administration, potential improvement in injection comfort, and a smoother care experience. For healthcare professionals, this approach may help to reduce the burden associated with repeated injections, improve working conditions, and support more efficient organisation of care in the day hospital setting.\n\nThis study will be conducted in the daily hospitalisation unit of the Clinical Hematology Department at Lyon Sud Hospital and will include approximately 100 patients with multiple myeloma or amyloidosis receiving subcutaneous daratumumab. Participation is fully integrated into routine care. Patients who agree to participate will sign an informed consent form before any study-specific procedures are carried out.\n\nThe treatment administered will remain exactly the same as that planned as part of routine care; only the method of administration will change, with one injection being delivered using the FreedomEDGE® device. An additional clinical assessment will be performed before administration to confirm that there are no contraindications to injection. After administration, patients will be asked to complete a short questionnaire regarding their experience and satisfaction, and nurses will also complete a questionnaire about their experience using the device.\n\nNo additional blood samples, no additional medication, and no specific restrictions regarding usual treatments are planned as part of this study. Participation will end after the visit corresponding to the injection performed using the device. At any time, the investigator may discontinue participation if considered necessary for patient safety or in the patient's medical interest.",[633],"Multiple Myeloma or Amyloidosis",[635,636,637,638,639,640,641,642,643,644,645,646,647,648,649,650,651,652,653],"Multiple myeloma","amyloidosis","Daratumumab","Subcutaneous administration","Drug delivery device","Mechanical infusion system","FreedomEDGE®","Infusion pump","Clinical research","Medical device evaluation","Patient experience","Patient satisfaction","Nursing practice","Healthcare professionals","Treatment administration","Injection comfort","Device performance","Adverse events","Feasibility study",{"date":561,"type":39},{"date":656,"type":23},"2026-10",{"date":658,"type":23},"2027-05",{"name":45,"class":46},{"id":661,"slug":662,"hasResults":12,"nctId":663,"briefTitle":664,"officialTitle":665,"acronym":666,"eligibilityCriteria":667,"healthyVolunteers":222,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":668,"targetDuration":4,"studyType":24,"phases":670,"briefSummary":671,"conditions":672,"keywords":674,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":676,"lastUpdatePostDateStruct":677,"startDateStruct":679,"completionDateStruct":680,"leadSponsor":682,"locationsCount":4},"100648148","stethotop-study-evaluation-of-the-impact-of-potential-optimization-techniques-on-general-self-efficacy-among-nursing-students-throughout-their-educational-curriculum-100648148","NCT07717047","STETHO'TOP Study: Evaluation of the Impact of Potential Optimization Techniques on General Self-Efficacy Among Nursing Students Throughout Their Educational Curriculum","Evaluation of the Impact of Potential Optimization Techniques on General Self-Efficacy Among Nursing Students Throughout Their Educational Curriculum","STETHO'TOP","Inclusion Criteria:\n\n\\- The participants in this study are nursing students enrolled in the 2025-2028 cohorts at the Esquirol and Clémenceau Nursing Training Institutes (IFSI), affiliated with the Hospices Civils de Lyon.\n\nExclusion Criteria:\n\n* Current history of severe neuropsychiatric conditions (severe depressive disorder, severe anxiety disorder)-self-reported-or uncontrolled acute psychiatric symptoms during the study (severe anxiety, severe behavioral disturbances).\n* This criterion is incompatible with a pedagogical method like TOP, which falls outside the scope of psychology. The teaching skills involved in TOP do not enable the management of psychological disorders. However, they may complement psychological care within the context of these exclusion criteria.",{"count":669,"type":23},340,[26],"In response to the concerning decline in nursing students' mental health, innovative measures were piloted in several nursing schools (IFSI) in 2024. Notably, a pilot program by the \\*Mutuelle Nationale des Hospitaliers\\* (MNH) was launched to address rising dropout rates, the increase in anxiety and depressive disorders, and the finding that nearly 25% of these young people have experienced suicidal thoughts.\n\nIn this context, \"Potential Optimization Techniques\" (TOP) emerge as a promising avenue for intervention. Developed in the 1990s within the French military by Dr. Édith Perreaut-Pierre to meet the demands of operational stress, TOPs comprise a structured set of psycho-cognitive and behavioral strategies designed to optimize physical, mental, and emotional resources according to the requirements of the task at hand. They have proven effective in stress management, fatigue prevention, and the improvement of concentration and recovery, as well as in mobilizing the motivational and emotional resources needed for sustained performance (Perreaut-Pierre, 2024).\n\nTheir pragmatic, adaptable, and self-directed nature makes them a potentially valuable tool for healthcare students, who also face demanding environments.\n\nTOPs could thus address the current concerns of nursing schools and the requirements of the 2026 reform by enabling students to develop emotional agility, autonomy in stress management, and a sense of agency in the face of training challenges. These anticipated benefits align with institutional goals aimed at reducing stress, fatigue, and academic dropout rates, while fostering well-being and performance within the healthcare professions.",[673],"Stress Related Nurse Study",[675],"nurse study","2026-07-16",{"date":678,"type":39},"2026-07-21",{"date":128,"type":23},{"date":681,"type":23},"2028-09-02",{"name":45,"class":46},{"id":684,"slug":685,"hasResults":12,"nctId":686,"briefTitle":687,"officialTitle":688,"acronym":689,"eligibilityCriteria":690,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":691,"targetDuration":4,"studyType":87,"phases":4,"briefSummary":693,"conditions":694,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":696,"lastUpdatePostDateStruct":697,"startDateStruct":699,"completionDateStruct":701,"leadSponsor":703,"locationsCount":47},"100367698","septic-shock-induced-immunosuppression-100367698","NCT04067674","Septic Shock-induced Immunosuppression","Evaluation of Immunosuppression in Septic Shock: Biomarkers and Pharmacological Restoration","IMMUNOSEPSIS 4","Inclusion Criteria:\n\n* Age over 18 years\n* Patient admitted to ICU\n* Diagnosis of septic shock within less than 48h at time of screening defined by :\n* Presence of a microbiologically diagnosed or suspected infection\n* Initiation of a vasopressive treatment to maintain mean arterial blood pressure ≥ 65 mm Hg initiated during the first 48h after ICU admission\n* Presence of an hyperlactatemia \\> 2 mmol\u002FL (18 mg\u002FdL) during the 24h before or after initiation of vasopressive treatment despite adequate volemic reanimation (30 ml\u002Fkg)\n* Blood sample at D3\u002FD4 available (lab working days)\n* Non opposition to study participation obtained from patient or next of kin\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding woman\n* Patient with no social security insurance, with restricted liberty or under legal protection\n* Language barrier\n* Patient taking part in interventional study about medicin that could interfere with biologic results",{"count":692,"type":23},305,"Septic syndromes are a major although largely under-recognized health care problem and represent the first cause of mortality in intensive care units (ICU). While it has long been known that sepsis deeply perturbs immune homeostasis by inducing a tremendous systemic inflammatory response, novel findings indicate that sepsis indeed initiates a more complex immune response that varies over time, with the concomitant occurrence of both pro- and anti-inflammatory mechanisms. As a resultant, after a short pro-inflammatory phase, septic patients enter a stage of protracted immunosuppression. This is illustrated in those patients by reactivation of dormant viruses (cytomegalovirus (CMV) or Herpes Simplex Virus (HSV)) or infections due to pathogens, including fungi, which are normally pathogenic solely in immunocompromised hosts. These alterations might be directly responsible for worsening outcome in patients who survived initial resuscitation as nearly all immune functions are deeply compromised. New promising therapeutic strategies are currently emerging from those recent findings such as adjunctive immunostimulation for the most immunosuppressed patients. The prerequisite for immunostimulation administration (Interferon gama (IFNg), Granulocyte Macrophage Colony Stimulating Factor (GM-CSF), interleukin 7 (IL-7)) however relies on clinicians' capacity to identify patients who could benefit the most from these immunoadjuvant therapies, as there is no clinical sign of immune dysfunctions.\n\nIn this context, the main objectives of IMMUNOSEPSIS 4 study are:\n\n1. to identify the best biomarkers for sepsis-induced immunosuppression\n2. to evaluate ex vivo candidate treatments which could rejuvenate immune functions after septic shock",[695],"Septic Shock","2026-07-10",{"date":698,"type":39},"2026-07-13",{"date":700,"type":39},"2019-10-21",{"date":702,"type":23},"2026-11-21",{"name":45,"class":46},""]