[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Nantes University Hospital\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":633},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,178,0,25,[9,43,68,103,129,156,186,207,233,259,289,314,340,362,386,410,433,459,486,513,531,550,571,594,615],{"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":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100536828","phase-3-dexamethasone-for-treating-severe-hospital-acquired-pneumonia-in-critically-ill-patients-with-a-proinflammatory-phenotype-100536828",false,"NCT06269900","Dexamethasone for Treating Severe Hospital-acquired Pneumonia in Critically Ill Patients With a Proinflammatory Phenotype","Dexamethasone for Treating Severe Hospital-acquired Pneumonia in Critically Ill Patients With a Proinflammatory Phenotype, an International Phase III, Double-blind, Placebo-controlled, Randomized Trial","HAP-DEX","Inclusion Criteria:\n\n* Hospital-acquired pneumonia (HAP) according to European guidelines (Torres et al. Eur Respir J 2017): Association of two criteria among (body temperature \\> 38°C, leukocytosis\\>12000 cells per mL, leucopenia \\\u003C4000 cells per mL and purulent pulmonary secretions), appearance of a new infiltrate or change in an existing infiltrate on chest radiography, and respiratory sample (Sputum, AET, BAL, mini-BAL or blind BAL) collected for bacteriological diagnosis (results can be pending at inclusion). The diagnosis of HAP can have been made outside of ICU. Diagnosis is done at least 48 hours after hospital admission.\n* HAP severity defined as a PaO2\u002FFiO2 ratio \\\u003C 300 under mechanical ventilation.\n* Biological systemic inflammatory response defined as CPR≥ 150 mg\u002FL (15 mg\u002FdL)\\*\n* Receiving curative antimicrobial therapy for the current episode of HAP pneumonia for less than 48 hours.\n* Informed consent from a legal representative, or emergency procedure (when possible, according to national regulation, see below). If it is not possible to obtain the patient consent prior the inclusion (comatose patients), patient consent for the study continuation will be obtained as soon as deemed possible.\n* Person insured under a health insurance scheme.\n* Female of childbearing age who agree and who are able to comply with effective contraception for the 28 first days of the study.\n\nExclusion Criteria:\n\n* Pregnant women (serum or urine test), breastfeeding women.\n* Patient under legal protection (incl. under guardianship or trusteeship).\n* Hypersensitivity to dexamethasone and hypersensitivity to all of its excipients\n* Ongoing administration of glucocorticoid at the time of randomisation, such as for COVID-19 infection requiring supplemental oxygen therapy\n* Severe septic shock (norepinephrine \\> 0.4 microg\u002Fkg\u002Fmin and serum lactate level greater than 2 mmol\u002FL) at the time of randomisation\n* Prolonged use of corticosteroids at a mean minimum dose of 0.3 mg\u002Fkg\u002Fday of prednisone equivalent for \\>3 weeks in the past 60 days\n* Uncontrolled viral (hepatitis,herpes, zona, varicella) or systemic fungal infection\n* Immunosuppression pre-existing to hospitalisation (severe lymphopenia \\\u003C 500 lymphocytes\u002Fmm3, hematologic cancer, aplasia, chemotherapy\u002Fradiotherapy for cancer within 3 months prior to the inclusion, or anti-graft rejection drug).\n* Uncontrolled psychotic disorder (acute or chronical)\n* Patients not expected to survive for more than 48 hours.\n* Participation in another drug clinical trial :\n\n  * testing steroids or anti-graft rejection drug or chemotherapy- radiotherapy for cancer\n  * And \u002F Or testing a drug regimen with a known interaction with dexamethasone,\n  * And \u002F Or whose implementation would alter the HAP-DEX 6-month follow-up, notably the collection of the primary outcome.\n  * Situations that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study","ALL","18 Years","85 Years",{"count":22,"type":23},450,"ESTIMATED","INTERVENTIONAL",[26],"PHASE3","Determine the efficacy of dexamethasone plus standard of care (SOC) as compared to placebo plus SOC for treating severe hospital-acquired pneumonia in critically ill patients with a proinflammatory phenotype; It's an international phase III, double-blind, placebo-controlled, randomized trial.",[29],"Hospital Acquired Pneumonia","RECRUITING","2026-08-16",{"date":33,"type":34},"2026-08-19","ACTUAL",{"date":36,"type":34},"2024-03-26",{"date":38,"type":23},"2027-03-15",{"name":40,"class":41},"Nantes University Hospital","OTHER",34,{"id":44,"slug":45,"hasResults":12,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":67},"100511056","biocollection-on-peripheral-inflammation-100511056","NCT05934474","Biocollection on Peripheral Inflammation","Biocollection on Peripheral Inflammation in Psychiatric Pathologies","IBIS-PSY","Inclusion Criteria:\n\n* Major patient\n* Patient with one of the following diagnoses confirmed by a psychiatrist:\n\n  * Characterized depressive episode with psychotic features,\n  * Bipolar disorder type I\n  * Bipolar disorder type II\n  * Schizoaffective disorder\n  * Schizophrenia\n  * Schizophreniform disorder\n* Patient under psychiatric care at Nantes University Hospital\n* Patients weighing at least 45kg\n* Patient affiliated to a social security scheme or beneficiary of such a scheme\n* Patient who has given informed consent to participate in the study\n\nExclusion Criteria:\n\n* Pregnant,\n* History of cancer in the last 5 years,\n* Vaccination within the last 4 weeks,\n* Acute or chronic infection,\n* Medical history of organ transplant,\n* Medical history of autoimmune disease,\n* Hearing impairment making it impossible to complete study questionnaires,\n* Patient under court protection",{"count":52,"type":23},50,"OBSERVATIONAL","Most psychiatric research is based on the nosographic classifications used in current practice. At present, there is no diagnostic or prognostic biomarker for psychiatric pathologies commonly used in clinical practice. The study hypothesis is that peripheral inflammatory biomarkers could be common to several psychiatric disorders, in particular psychotic disorders (bipolar disorder, schizophreniform disorder, schizophrenia, depressive episode with psychotic features). The aim of this project is to set up a bio-collection of biological samples (peripheral blood samples) with associated phenotypic data (assessment of various symptoms using standardized scales in patients whose blood is sampled). The setting up of this cohort follows on from work carried out on a PsyCourse cohort also using a transdiagnostic approach in psychiatry, in order to be able to collaborate within a European research project.",[56,57,58],"Schizoaffective Disorder, Depressive Type","Bipolar Disorder I","Bipolar Disorder II","2026-07-28",{"date":61,"type":34},"2026-07-29",{"date":63,"type":34},"2024-03-19",{"date":65,"type":23},"2028-03-19",{"name":40,"class":41},1,{"id":69,"slug":70,"hasResults":12,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":12,"sex":76,"minAge":19,"maxAge":77,"enrollmentInfo":78,"targetDuration":4,"studyType":24,"phases":80,"briefSummary":82,"conditions":83,"keywords":87,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":67},"100649193","cost-utility-analysis-of-outpatient-manual-vacuum-aspiration-versus-operating-room-electric-aspiration-for-the-management-of-first-trimester-miscarriage-100649193","NCT07732231","Cost-utility Analysis of Outpatient Manual Vacuum Aspiration Versus Operating Room Electric Aspiration for the Management of First-trimester Miscarriage","Cost-utility Analysis of Outpatient Manual Vacuum Aspiration Versus Operating Room Electric Aspiration for the Management of First-trimester Miscarriage (ASPIR Study)","ASPIR","Inclusion Criteria:\n\n* Female, aged 18-44 years\n* Ultrasound-confirmed first-trimester miscarriage requiring surgical management\n* Gestational age between 5 and 12 weeks of amenorrhea\n* Incomplete spontaneous abortion or ongoing non-viable pregnancy\n* Patient able to provide oral informed consent\n\nExclusion Criteria:\n\n* Complete expulsion of pregnancy (endometrial thickness \\\u003C 15 mm)\n* Choice of medical treatment with misoprostol\n* Elective termination of pregnancy\n* Unwanted pregnancy\n* Pregnancy of unknown location, molar pregnancy\n* Known uterine malformation\n* Prior surgical aspiration for the current pregnancy\n* Intrauterine device in place\n* Contraindicating medications (e.g. anticoagulants)\n* Protected adults (under guardianship)\n* Inability to complete study questionnaires\n* Lack of social security coverage\n* Haemorrhagic miscarriage","FEMALE","44 Years",{"count":79,"type":23},860,[81],"NA","The ASPIR study aims to evaluate the cost-utility of outpatient manual vacuum aspiration compared with operating room electric aspiration for the management of first-trimester miscarriage. It is hypothesized that manual aspiration will demonstrate equivalent clinical efficacy and patient quality of life while reducing healthcare costs.",[84,85,86],"Miscarriage","Pregnancy Loss","First Trimester Pregnancy",[88,89,90,91,92,93,94],"Manual vacuum aspiration","Electric aspiration","Cost-effectiveness","Health economics","Gynecology","Pregnancy loss","miscarriage","NOT_YET_RECRUITING","2026-07-27",{"date":59,"type":34},{"date":99,"type":23},"2026-10-01",{"date":101,"type":23},"2029-10-01",{"name":40,"class":41},{"id":104,"slug":105,"hasResults":12,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":111,"enrollmentInfo":112,"targetDuration":4,"studyType":24,"phases":114,"briefSummary":115,"conditions":116,"keywords":118,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":122,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},"100617483","phase-3-efficacy-of-early-continuous-infusion-of-hss-on-the-neurological-outcome-at-6-months-in-tbi-patients-100617483","NCT07319208","Efficacy of Early Continuous Infusion of HSS on the Neurological Outcome at 6 Months in TBI Patients.","Efficacy of Early Continuous Infusion of Hypertonic Saline Solution on the Neurological Outcome at 6 Months in Traumatic Brain Injured Patients. A Single-blinded, Multicenter, Randomized, Controlled Clinical Trial With Blinded Evaluation of the Primary Outcome.","COSMOS-TBI","Inclusion Criteria:\n\n* Patient admitted to intensive care unit\n* Traumatic brain injury with Glasgow Coma Scale ≤ 12\n* Intracranial pressure (ICP) monitoring based on the attending physician's clinical judgment, in accordance with guidelines or clinical\u002Fradiological signs considered at risk of intracranial hypertension\n* Inclusion during the first 12 hours after Intracranial pressure monitoring placement\n* Informed and signed consent\n* National health insurance\n\nExclusion Criteria:\n\n* Glasgow Coma Scale (score = 3) and persistent abnormal pupillaryreactivity despite urgent therapy\n* Associated cervical spinal cord injury\n* Imminent death and do-not-resuscitate orders\n* Coma secondary to cardiac arrest\n* Pregnancy (serum or urine test performed in routine care)\n* Severe Cardiac insufficiency\n* Severe chronic renal insufficiency\n* Severe hepatic insufficiency: patient presenting with oedemato-ascitic decompensation of liver cirrhosis or patient with Child-Pugh class C cirrhosis\n* High risk of follow-up difficulties after ICU discharge\n* Patients under court protection\n* Patient who does not speak French","75 Years",{"count":113,"type":23},760,[26],"The purpose of this study is to demonstrate the efficacy of early continuous intravenous infusion of hypertonic saline solution (HSS) to improve survival and independence in daily life activities (at 6 months) of patients with traumatic brain injury at high risk of intracranial hypertension.",[117],"TBI Traumatic Brain Injury",[119,120,121],"Traumatic brain injury","Saline Solution","Hypertonic",{"date":61,"type":34},{"date":124,"type":34},"2026-04-21",{"date":126,"type":23},"2029-06-01",{"name":40,"class":41},23,{"id":130,"slug":131,"hasResults":12,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":135,"eligibilityCriteria":136,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":137,"targetDuration":4,"studyType":24,"phases":139,"briefSummary":140,"conditions":141,"keywords":143,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":155},"100619492","phase-3-rifampin-free-regimen-versus-rifampin-containing-regimen-in-the-treatment-of-staphylococcal-prosthetic-valve-endocarditis-100619492","NCT07345325","Rifampin-free Regimen Versus Rifampin-containing Regimen in the Treatment of Staphylococcal Prosthetic Valve Endocarditis","Rifampin-free Regimen Versus Rifampin-containing Regimen in the Treatment of Staphylococcal Prosthetic Valve Endocarditis: a Multicenter Randomized Controlled Non-inferiority Study","RIFREE","Inclusion Criteria:\n\n* Definite infective endocarditis according to the 2023 Duke ISCVID criteria or confirmed by the endocarditis team if the endocarditis was classified as possible\n* Prosthetic valve endocarditis\n* At least one positive blood culture due to Staphylococcus sp (S. aureus or CoNS)\n* After the first positive blood culture, at least one negative blood culture (after a minimum of 72 hours of incubation)\n* Infective endocarditis due to Staphylococcus sp (S. aureus or coagulase negative staphylococci) susceptible to rifampin\n* Antistaphylococcal treatment for endocarditis introduced less than 14 days ago. We do not consider all antibiotic received before the first positive blood culture\n* Age ≥ 18-year-old\n* Informed, written consent obtained from patient or from patient's near in kin\n* Patient insured under a health insurance scheme\n* Patient with adequate contraceptive measure\n\nExclusion Criteria:\n\n* Presence of cardiovascular implanted electronic device with suspected device-related IE without removal of the device\n* Expected duration of follow-up \\\u003C6 months at the time of randomization\n* Patient moribund (expected to die in next 48 hours with or without treatment)\n* Patients already receiving more than 72 hours of rifampin for the endocarditis treatment prior to randomization\n* Positive blood cultures less than 72 hours before randomization\n* Medical history of infective endocarditis in the last 3 months\n* True allergy to rifampin or a severe intolerance to rifampin\n* Contraindication to rifampin\n* Patients requiring treatment contraindicated or not recommended with rifampin or incompatible with the inducer effect of rifampicin according to the marketing authorisation.\n* ALAT increase greater than 3 times the upper laboratory range\n* Extreme weight (\\\u003C 45 kg or \\> 150 kg)\n* Patients with confirmed prosthetic vascular graft infection or orthopedic-device-related infection\n* Patients treated with rifampin for infections other than endocarditis, such as tuberculosis\n* Pregnancy or breastfeeding woman\n* Inclusion in another drug clinical trial\n* Patients who have already been included in the study for a previous episode of endocarditis\n* Patients under court protection, guardianship or trusteeship\n* Patients who do not speak or understand French language\n* Patient unable to collect information in a daily journal\n* Patient unable to understand a follow-up by phone contact",{"count":138,"type":23},422,[26],"The primary objective of this study is to demonstrate that a rifampin-free regimen is non-inferior to the rifampin-containing regimen in terms of all-cause mortality in staphylococcal prosthetic valve endocarditis within 6 months after randomization.",[142],"Infective Endocarditis",[144,145,146,147],"infective endocarditis","prosthetic valve","Rifampin","Staphylococcus aureus","2026-07-25",{"date":59,"type":34},{"date":151,"type":34},"2026-06-11",{"date":153,"type":23},"2031-06-11",{"name":40,"class":41},31,{"id":157,"slug":158,"hasResults":12,"nctId":159,"briefTitle":160,"officialTitle":161,"acronym":162,"eligibilityCriteria":163,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":164,"targetDuration":4,"studyType":24,"phases":166,"briefSummary":168,"conditions":169,"keywords":172,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":185},"100614366","phase-2-preoperative-use-of-romiplostim-in-thrombocytopenic-patients-undergoing-cardiac-surgery-100614366","NCT07278661","Preoperative Use of Romiplostim in Thrombocytopenic Patients Undergoing Cardiac Surgery.","Preoperative Use of Romiplostim in Thrombocytopenic Patients Undergoing Cardiac Surgery. A Phase 3, Multicenter Randomized Double-blinded Controlled Against Placebo Study.","CT-PLATE","Inclusion Criteria:\n\n* Adult patients with no upper age limit,\n* Scheduled cardiac surgery with cardiopulmonary bypass,\n* Patients with preoperative thrombocytopenia strictly \\\u003C150,000\u002Fmm3\n* Surgery performed with a blood recovery system using centrifugation (Cell Saver type) or equivalent,\n* Feasibility of a first injection (Romiplostim or Placebo) between D-14 and D-10 before surgery,\n* Surgery requiring the administration of antiplatelet and\u002For anticoagulant therapy for a minimum of 1 month postoperatively.\n\nExclusion Criteria:\n\n* Inability to administer the first injection of Romiplostim or Placebo within 10 days prior to surgery,\n* Cardiac surgery without cardiopulmonary bypass,\n* Coronary artery bypass graft surgery due to one or more significant coronary stenoses presenting with unstable angina (defined by anginal pain at rest, or with minimal exertion, or pain that has recently worsened),\n* Tangential filtration blood recovery system (i-SEP SAME® type) planned for intraoperative use or absence of intraoperative blood recovery system due to investigator choice or availability issues,\n* Planned use of aprotinin as an antifibrinolytic agent during surgery,\n* Patients treated with clopidogrel (Plavix) or ticagrelor who cannot switch to acetylsalicylic acid (Kardégic) monotherapy at least 5 days before surgery. The study allows for continued use of acetylsalicylic acid (Kardégic) as well as anticoagulants,\n* Hereditary or acquired thrombophilia with or without a history of thrombosis,\n* History of ischemic or hemorrhagic stroke,\n* History of phlebitis, pulmonary embolism, or portal vein thrombosis,\n* History of myocardial infarction with coronary stenting that occurred less than one year ago,\n* Current limb immobilization (e.g., plaster cast for ankle fracture) or inability to walk independently due to limited mobility (e.g., paralysis),\n* Current immobilization of a limb (e.g., plaster cast for ankle fracture) or inability to walk independently due to motor limitation (e.g., complete paralysis of a limb) or medical contraindication (e.g., strict bed rest required),\n* Myelogram indicating malignant hematological disease or blast cells strictly greater than 5%,\n* Malignant diseases with last follow-up indicating disease progression,\n* Severe chronic liver disease with a CHILD-PUGH score \\> 6 or B (measured without decompensation),\n* Treatment with thrombopoietin receptor agonist received within 3 months prior to inclusion,\n* Treatment with JAK2 inhibitor currently underway or within the last month,\n* Treatment with Rituximab within the last 7.5 months or intravenous immunoglobulin within the last 40 days,\n* Ongoing treatment with corticosteroids at doses equal to or greater than 20mg of hydrocortisone, 5mg of prednisone\u002For prednisolone, 4mg of methylprednisone, or 0.75mg of dexamethasone,\n* Known hemophilia,\n* Hypersensitivity to romiplostim or any of its excipients, or to proteins derived from E. coli,\n* Context of hyperchloremia, hypernatremia, or major water and salt retention with anasarca refractory to medical treatment,\n* Pregnant women or women of childbearing age who are not using effective contraception,\n* Currently using combined oral contraceptive pills or oral hormone replacement therapy containing estrogen,\n* Breastfeeding women,\n* Minors,\n* Adults under guardianship, curatorship, or judicial protection,\n* Patients who do not speak French,\n* Patients without Social Security coverage.",{"count":165,"type":23},136,[167],"PHASE2","Romiplostim has demonstrated its efficacy and good tolerance in multiple indications. If the efficacy of Romiplostim is confirmed in this population, thrombocytopenic patients will be able to undergo cardiac surgery, which is generally life-saving, without prior thrombocytopenia.\n\nPatients included in the study will be hospitalized within 15 days of the first administration of the study treatment and will be closely monitored clinically and biologically for at least 10 days after surgery. The occurrence of an adverse event can therefore be quickly detected and managed.\n\nCollectively, \"Patient Blood Management\" strategies are mainly focused on the management of preoperative anemia. If positive, this study will enrich the therapeutic arsenal available for optimizing patients in preparation for major surgery. As no major collective complications are expected, the collective benefit\u002Frisk ratio also appears favorable.",[170,171],"Chirurgical Intervention","Thrombocytopaenia",[173,174,175,176],"Thrombocytopenia","Cardiac Surgery","Growth Factor","Patient Blood Management","2026-07-23",{"date":179,"type":34},"2026-07-24",{"date":181,"type":34},"2026-07-16",{"date":183,"type":23},"2028-12-01",{"name":40,"class":41},8,{"id":187,"slug":188,"hasResults":12,"nctId":189,"briefTitle":190,"officialTitle":191,"acronym":192,"eligibilityCriteria":193,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":194,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":196,"conditions":197,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":200,"lastUpdatePostDateStruct":201,"startDateStruct":202,"completionDateStruct":204,"leadSponsor":206,"locationsCount":67},"100605048","identifying-electrocardiographic-markers-to-determine-eligibility-for-the-implantation-of-a-subcutaneous-defibrillator-100605048","NCT07157449","Identifying Electrocardiographic Markers to Determine Eligibility for the Implantation of a Subcutaneous Defibrillator.","Identifying Electrocardiographic Markers on a Standard 12-lead ECG to Determine Which Patients Are Eligible for the Implantation of a Subcutaneous Defibrillator.","Screen-ICD","Inclusion Criteria :\n\n* Patient undergoing cardiology consultation, whatever the pathology\n* Patient over 18 years of age\n* Patient having been informed and having given their oral non-opposition\n* Patient and relatives affiliated to a social security scheme\n\nExclusion Criteria :\n\n* Patients receiving cardiac stimulation\n* Patient taking part in a therapeutic trial which may interfere with the results of the research\n* Patients under guardianship.",{"count":195,"type":23},1000,"The S-ICD defibrillator developed by Boston Scientific Inc. is a fully subcutaneous automatic defibrillation system that prevents and treats sudden cardiac arrest. The subcutaneous system offers the advantage of avoiding the risks associated with transvenous access, limiting serious infections and lead failures. The detection system is based on the identification of rapid ventricular arrhythmias using one of three bipolar vectors defined by the subcutaneous lead (distal and median electrode) and the generator. However, before implanting the device in a patient, it is essential to carry out a screening procedure to ensure that the patient's QRS signal amplitude is sufficient to be detected by the S-ICD. This screening procedure is carried out by recording a specific three-lead electrocardiogram (ECG), which represents the three bipolar vectors of the S-ICD. The aim of this research is to show that the recording of a standard 12-lead ECG can be sufficient to predict the eligibility of patients for S-ICD implantation. More specifically, it aims to identify electrocardiographic markers on a standard 12D-ECG that can be used to determine which patients may benefit from implantation of a subcutaneous defibrillator, thereby eliminating the need for a 3-lead screening ECG. The developments that will be carried out will be based on the development of signal analysis algorithms and decision support using artificial intelligence.",[198,199],"Defibrillator","ECG","2026-07-22",{"date":179,"type":34},{"date":203,"type":34},"2026-01-27",{"date":205,"type":23},"2027-06-01",{"name":40,"class":41},{"id":208,"slug":209,"hasResults":12,"nctId":210,"briefTitle":211,"officialTitle":211,"acronym":212,"eligibilityCriteria":213,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":214,"targetDuration":4,"studyType":24,"phases":216,"briefSummary":217,"conditions":218,"keywords":220,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":226,"startDateStruct":228,"completionDateStruct":230,"leadSponsor":232,"locationsCount":67},"100533786","patient-safety-incidents-in-coordinated-primary-care-teams-a-multi-method-study-100533786","NCT06230341","Patient Safety Incidents in Coordinated Primary Care Teams: a Multi-method Study","EVIDENS-Prim","Inclusion Criteria:\n\n* Characteristics of the MSPs included in the study:\n* Located in the Pays de la Loire region;\n* Having a contract with a health insurance (specifications and financing defined nationally) for at least 1 year;\n* Agreeing to take part in the project;\n* Having a quality representative or committing to appoint one when they join the project.\n\nCharacteristics of professionals working in MSPs included:\n\n* All independent health professionals involved in the MSP: general practitioners and, depending on the MSP, nurses, pharmacists, podiatrists, physiotherapists, midwives, speech therapists, dentists, occupational therapists, psychomotor therapists, etc,)\n* All professionals involved in MSP outside the health sector: (coordinators, medical assistants, independent psychologists, etc.),\n* agree to take part in the project.\n\nExclusion Criteria:\n\nOther group exercise modalities or other forms of coordinated exercise (other than MSP) do not have a quality representative on their team and will not be considered for inclusion.\n\nCharacteristics of MSPs not included in the research:\n\n\\- Where the members of the research team work.\n\nCharacteristics of professionals working in MSPs included:\n\n\\- Not included.",{"count":215,"type":23},16,[81],"In France, improving the practice of health professionals working in coordinated primary care teams (health centres called Maisons de Santé Pluriprofessionnelles - MSPs) could be facilitated by a learning system consisting of (i) a risk management support programme and (ii) the provision of a comprehensive online system combining training, reporting and support for the analysis and management of patient safety incidents (PSIs).\n\nEVIDENS-Prim is a multi-method, multi-centre, prospective study. It aims to describe the PSIs that occur in MSPs, using an international classification system, and to describe the ways in which professionals have adopted a global approach to PSIs management, from PSI reporting to feedback.",[219],"Adverse Event",[221,222,223,224,225],"Healthcare","Adverse event","Safety culture","Patient safety","Learning",{"date":227,"type":34},"2026-07-20",{"date":229,"type":34},"2024-12-10",{"date":231,"type":23},"2026-12-31",{"name":40,"class":41},{"id":234,"slug":235,"hasResults":12,"nctId":236,"briefTitle":237,"officialTitle":238,"acronym":239,"eligibilityCriteria":240,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":241,"enrollmentInfo":242,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":243,"conditions":244,"keywords":246,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":251,"lastUpdatePostDateStruct":252,"startDateStruct":254,"completionDateStruct":256,"leadSponsor":258,"locationsCount":67},"100647103","follow-up-of-the-cohort-of-newborns-screened-at-birth-using-trec-analysis-100647103","NCT07704281","Follow-up of the Cohort of Newborns Screened at Birth Using TREC Analysis","Follow-up of the Cohort of Infants Screened at Birth Using TREC Analysis : DépisTrec - SUIVI","DépisTrec","Inclusion Criteria:\n\n* Children with a positive Guthrie test result, confirmed by lymphocyte immunophenotyping performed during their first visit with a pediatric specialist.\n\nExclusion Criteria:\n\n* Children whose parents objected to the collection of data after receiving the informational letter","5 Years",{"count":22,"type":23},"Since September 2025, neonatal screening for severe combined immunodeficiency (SCID) has been generalized in France. These genetic disorders, which are asymptomatic at birth, cause severe immunodeficiency, exposing infants to serious infections (viral, bacterial, or fungal) as early as the first year of life. Without early treatment and management, infectious complications can be life-threatening.\n\nStudies show that this screening improves survival and quality of life and reduces treatment costs by enabling intervention before complications arise.\n\nIn France, the Ministry of Health referred this matter to the Haute Autorité de Santé (HAS), which issued a favorable opinion in January 2022 via a ministerial decree (published on April 16, 2025) regarding the combined screening for DICS and spinal muscular atrophy. These authorizations follow the DEPISTREC study (2015-2017), which demonstrated the effectiveness of this screening: 190,517 children were screened, resulting in a reduction in DICS-related deaths.\n\nThe primary objective of the study will be to describe the underlying causes of T-cell lymphopenia identified in newborns through neonatal screening by quantifying TRECs on Guthrie cards. (SCID; variant SCID; syndromic T-cell deficiency; secondary T-cell deficiency; attenuated SCID; Omenn syndrome; immunosuppressive treatment in the mother; not found; isolated prematurity).",[245],"Severe Combined Immunodeficiencies (SCID)",[247,248,249,250],"Severe combined immunodeficiencies (SCID)","neonatal screening","T-cell lymphopenia","Guthrie test","2026-07-09",{"date":253,"type":34},"2026-07-15",{"date":255,"type":23},"2026-11-01",{"date":257,"type":23},"2035-08-31",{"name":40,"class":41},{"id":260,"slug":261,"hasResults":12,"nctId":262,"briefTitle":263,"officialTitle":263,"acronym":264,"eligibilityCriteria":265,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":266,"targetDuration":4,"studyType":24,"phases":268,"briefSummary":269,"conditions":270,"keywords":272,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":251,"lastUpdatePostDateStruct":281,"startDateStruct":283,"completionDateStruct":285,"leadSponsor":287,"locationsCount":288},"100614027","phase-3-lidocaine-for-opioid-sparing-in-vaso-occlusive-crisis-of-sickle-cell-disease-100614027","NCT07274254","Lidocaine for Opioid Sparing in Vaso-occlusive Crisis of Sickle Cell Disease","LidoVOC","Inclusion Criteria:\n\n* Age \\>= 18 years\n* Known sickle cell disease with an SS, SC, Sβ, or Sβ+ genotype\n* Patient admitted to the Intensive Care Unit for Vaso-Occlusive Crisis and\u002For ACS as the main reason for admission:\n\n  * Vaso-Occlusive Crisis defined by acute pain or tenderness, affecting at least one part of the body, including limbs, ribs, sternum, head (skull), spine, and\u002For pelvis, not attributable to other causes\n  * Acute Chest Syndrome defined by the association of clinical respiratory sign(s): dyspnea and\u002For chest pain and\u002For auscultatory abnormality (crepitants and\u002For bronchial breathing) with a new pulmonary infiltrate on chest X-ray, thoracic CT-scan, or lung ultrasound.\n* Treatment with parenteral morphine or oxycodone started less than 72 hours prior to inclusion\n* Patient or next of kin informed about the study and having consented to the participation of the patient in the study. If patient is no competent and no next of kin can be contacted during screening for the study, trial inclusion will be completed as an emergency procedure by the Intensive Care Unit physician, in compliance with French law.\n* French speaking\n* Patient with health care insurance\n\nExclusion Criteria:\n\n* Pregnant women or nursing mothers; Women of child bearing potential will be tested for pregnancy before inclusion\n* Patients under guardianship, curatorship or under legal protection\n* Prisoners or subjects who are involuntarily incarcerated\n* Sickle Cell Disease acute complication other than Vaso-Occlusive Crisis or Acute Chest Syndrome as the main reason for admission:\n\npriapism, stroke, acute splenic sequestration, acute hepatic sequestration, bone marrow necrosis…\n\n* Patients wearing a lidocaine-medicated plaster at the time of screening for inclusion\n* Known or assumed hypersensitivity to lidocaine hydrochloride, other local anaesthetics (e.g., bupivacaine or ropivacaine) or an excipient\n* Patients treated with anti-arhythmic drugs known to induce torsade de pointe.\n* Patients on chronic or occasional treatment with drugs that interact with the 3A cytochrome isoenzymes (CYP3A) and\u002For 1A2 cytochrome isoenzymes (CYP1A2)\n* Patients with recurrent porphyria, porphyria in remission, or known asymptomatic carriage of gene mutations responsible for porphyria\n* Epileptic patients\n* Hypovolemic shock or shock of other cause at screening for inclusion\n* Known atrioventricular block, QT prolongation or other heart conduction disorder or heart failure\n* Chronic respiratory failure with long term non invasive ventilation (excluding Continuous Positive Air way pressure), or long term oxygen therapy at home\n* Acute Respiratory Distress Syndrome according to The 2012 Berlin definition\n* Acute or Chronic liver failure with MELD \\> 19 according to CKD-EPI\n* Acute or Chronic kidney failure with clearance \\\u003C30mL\u002Fmin\u002Fm2\n* Body weight \\\u003C40kg and \\>120kg\n* Prior inclusion in the study in the last 3 months\n* Patient under invasive mechanical ventilation\n* Altered consciousness with Glasgow coma scale \\\u003C13",{"count":267,"type":23},104,[26],"The purpose of the study is to determine whether adding lidocaine to standard of care in pain management during severe vaso-occlusive crisis has an effect on the cumulative opioid consumption expressed as morphine milligram equivalent.",[271],"Vaso-Occlusive Pain Episode in Sickle Cell Disease",[273,274,275,276,277,278,279,280],"Sickle Cell disease","Sickle Cell Syndrome","Vaso-occlusive crisis","Acute Chest Syndrome","Painful crisis","Pain management","Opioid sparing","Lidocaine",{"date":282,"type":34},"2026-07-13",{"date":284,"type":34},"2026-07-03",{"date":286,"type":23},"2028-08-03",{"name":40,"class":41},11,{"id":290,"slug":291,"hasResults":12,"nctId":292,"briefTitle":293,"officialTitle":294,"acronym":295,"eligibilityCriteria":296,"healthyVolunteers":12,"sex":76,"minAge":19,"maxAge":4,"enrollmentInfo":297,"targetDuration":4,"studyType":24,"phases":299,"briefSummary":300,"conditions":301,"keywords":304,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":251,"lastUpdatePostDateStruct":308,"startDateStruct":309,"completionDateStruct":311,"leadSponsor":313,"locationsCount":185},"100592581","phase-3-evaluation-of-the-analgesic-effect-of-intramyometrial-botulinum-toxin-injection-via-hysteroscopy-in-pelvic-pain-suggestive-of-dysmenorrhea-100592581","NCT06995287","Evaluation of the Analgesic Effect of Intramyometrial Botulinum Toxin Injection Via Hysteroscopy in Pelvic Pain Suggestive of Dysmenorrhea","Evaluation of the Analgesic Effect of Intramyometrial Botulinum Toxin Injection Via Hysteroscopy in Pelvic Pain Suggestive of Dysmenorrhea: A Prospective, Multicenter, Double-Blind, Randomized Placebo-Controlled Study.","HYSTEROXINE","Inclusion Criteria:\n\n* Adult women who are not menopausal,\n* Presenting with:\n* Either severe primary dysmenorrhea, defined by an average pain intensity (VAS) ≥ 6\u002F10 over the last 3 months at the inclusion visit,\n* Or, in cases of amenorrhea under hormonal treatment, severe chronic pelvic pain (average VAS ≥ 6\u002F10 over the last 3 months), described as cramp-like, localized in the pelvic region, and similar to the initial dysmenorrhea pain.\n* Having failed optimal first-line medical treatment combining hormonal therapy and appropriate analgesics (Level I and II analgesics, and NSAIDs),\n* Having undergone a pelvic MRI within 1 year prior to the randomization visit that shows no evidence of deep infiltrating endometriosis or endometrioma, following systematic review by radiologists from the expert center managing the patient (if the pelvic MRI is deemed of insufficient quality for interpretation, a new MRI will be performed at the center),\n* Using a highly effective method of contraception (failure rate \\\u003C1%) for the entire duration of the follow-up period. Highly effective contraception methods are defined as one of the following: combined hormonal contraception (containing estrogen and progestin) with ovulation inhibition (oral, vaginal, or transdermal), progestin-only hormonal contraception with ovulation inhibition (oral, injectable, or implantable), intrauterine device (IUD), intrauterine hormonal system (IUS), condoms, bilateral tubal occlusion, vasectomized partner, or sexual abstinence,\n* Having a negative urine pregnancy test on the day of the procedure,\n* Having signed the informed consent form for the study at the M-1 visit.\n\nExclusion Criteria:\n\n* Pregnant or planning a pregnancy during the entire study period,\n* Currently breastfeeding,\n* Refusal to use effective contraception during the study and for 6 months after its completion,\n* Contraindications to botulinum toxin, including:\n* Generalized disorders of muscular activity (e.g., myasthenia gravis, Lambert-Eaton syndrome),\n* Ongoing treatment with aminoglycosides, peripheral muscle relaxants, or amino-4-quinolines,\n* Hypersensitivity to the active substance, human albumin, or sucrose,\n* Bleeding disorders or current treatment with anticoagulants,\n* Ongoing vaginal or upper genital tract infection,\n* Participation in another interventional clinical trial,\n* Inability to cooperate or understand the study requirements in a way that would allow strict adherence to the protocol,\n* Subject to legal protection measures (e.g., guardianship, curatorship, or judicial protection),\n* Not affiliated with the French social security system,\n* Unable to access the internet to complete questionnaires at Month 1 and Month 6.",{"count":298,"type":23},222,[26],"The objective of the study is to evaluate the global impression of improvement at 3 months following intramyometrial botulinum toxin injections via hysteroscopy in women with severe primary dysmenorrhea who have failed first-line medical treatment, compared to intramyometrial placebo injections.",[302,303],"Primary Dysmenorrhea","Chronic Pelvic Pain",[305,306,307],"Primary dysmenorrhea","injection","Botulimum toxin, Type A",{"date":282,"type":34},{"date":310,"type":34},"2026-02-09",{"date":312,"type":23},"2028-09-09",{"name":40,"class":41},{"id":315,"slug":316,"hasResults":12,"nctId":317,"briefTitle":318,"officialTitle":318,"acronym":319,"eligibilityCriteria":320,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":321,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":323,"conditions":324,"keywords":327,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":331,"lastUpdatePostDateStruct":332,"startDateStruct":334,"completionDateStruct":336,"leadSponsor":338,"locationsCount":339},"100600588","determinants-of-the-response-to-btk-degraders-btkd-in-chronic-lymphocytic-leukemia-100600588","NCT07099443","Determinants of the Response to BTK Degraders (BTKd) in Chronic Lymphocytic Leukemia","REBELLE","Inclusion Criteria:\n\n* Patient with CLL candidates ou exposed to BTKd\n* Patient who has provided informed consent to participate in the study.\n* Patient covered by a social security health insurance plan\n\nExclusion Criteria:\n\n* Minor patients.\n* Adults under guardianship.\n* Protected persons.",{"count":322,"type":23},60,"The aim of the REBELLE cohort - bio-collection is to collect samples from patients with Chronic Lymphocytic Leukemia candidates or those exposed to BTK degraders to evaluate the mechanisms of resistance to these new molecules. To do this, an additional blood or bone marrow sample to those planned in the context of patient care or a residual lymph node biopsy sample will be collected after signing consent.",[325,326],"Chronic Lymphocytic Leukemia","BTK Degraders",[325,328,329,330],"Bruton tyrosine kinase inhibitors","BCL-2 inhibitors","BTK degraders","2026-07-07",{"date":333,"type":34},"2026-07-08",{"date":335,"type":34},"2025-10-09",{"date":337,"type":23},"2039-09-15",{"name":40,"class":41},14,{"id":341,"slug":342,"hasResults":12,"nctId":343,"briefTitle":344,"officialTitle":345,"acronym":346,"eligibilityCriteria":347,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":348,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":350,"conditions":351,"keywords":353,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":284,"lastUpdatePostDateStruct":356,"startDateStruct":357,"completionDateStruct":359,"leadSponsor":361,"locationsCount":67},"100643234","immune-monitoring-following-b-cell-depletion-in-anca-associated-vasculitis-100643234","NCT07636655","Immune Monitoring Following B-cell Depletion in ANCA-associated Vasculitis","NALVANCA: Immune Monitoring Following B-cell Depletion in ANCA-associated Vasculitis","NALVANCA","Inclusion criteria :\n\n* Adult patient (age ≥ 18 years).\n* Patient affiliated with the French social security system.\n* Seropositive ANCA-associated vasculitis (AAV) (positive for anti-PR3 or anti-MPO) meeting the Chapel-Hill classification criteria.\n* Patient scheduled to receive rituximab (RTX) maintenance therapy (500 mg every 6 months) following an initial flare or a relapse of the disease.\n\nExclusion Criteria:\n\n* Patient unable to provide informed consent.\n* Patient refusing to participate in the study.\n* End-stage renal disease.\n* Progressive neoplasia (excluding cutaneous carcinomas)",{"count":349,"type":23},120,"ANCA-associated vasculitis is a serious autoimmune disease. The standard treatment is rituximab (RTX), which depletes B-cells to control inflammation. However, identifying patients at high risk of relapse remains a challenge, often leading to unnecessarily long treatments and side effects. Recent research suggests that RTX also impacts CD8+ T-cells, which could serve as valuable markers for better disease monitoring.\n\nThe main goal of the NALVANCA cohort is to identify biomarkers within these CD8+ T-cells. Researchers aim to find biological signals that respond to treatment and can predict a relapse. By studying these markers at the start of therapy and during the immune recovery phase, the study hopes to personalize treatment duration and management for each patient.\n\nRecruitment targets adult patients diagnosed with ANCA-associated vasculitis. Participants must provide written informed consent for the use and storage of their blood samples in a biocollection. The protocol involves long-term monitoring with regular sampling to track changes in immune cells alongside the patient's clinical health.",[352],"Vasculitis Associated With Anti-neutrophil Cytoplasmic Antibodies",[354,355],"ANCA","AAV",{"date":331,"type":34},{"date":358,"type":23},"2026-09-01",{"date":360,"type":23},"2051-09-01",{"name":40,"class":41},{"id":363,"slug":364,"hasResults":12,"nctId":365,"briefTitle":366,"officialTitle":366,"acronym":367,"eligibilityCriteria":368,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":369,"targetDuration":4,"studyType":24,"phases":371,"briefSummary":372,"conditions":373,"keywords":375,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":378,"lastUpdatePostDateStruct":379,"startDateStruct":381,"completionDateStruct":383,"leadSponsor":385,"locationsCount":67},"100635219","phase-2-exploratory-study-evaluating-the-relevance-of-68gaga-fapi-46-for-staging-and-identifying-progressing-patients-with-transthyretin-cardiac-amyloidosis-100635219","NCT07549841","Exploratory Study Evaluating the Relevance of [68Ga]Ga-FAPI-46 for Staging and Identifying Progressing Patients With Transthyretin Cardiac Amyloidosis","FAPICAM","Inclusion Criteria:\n\n* Men or women ≥ 18 years\n* Definite ATTR-CM diagnosis based on the 2021 ESC expert consensus\n* Written and signed informed consent (obtained on the screening day at the latest and before any investigation)\n* Affiliation with French social security system or beneficiary from such system\n* Women must meet one of the following criteria at the time of inclusion:\n\n  * present a negative pregnancy test (blood test) before the injection of \\[68Ga\\]Ga-FAPI-46 and use highly1 effective contraceptive measures for a duration of 6 months after the PET with \\[68Ga\\]Ga-FAPI-46;\n  * or be post-menopausal (aged over 50 with amenorrhea for at least 12 months after stopping all exogenous hormone treatments);\n  * or (if under 50 years of age) have been in amenorrhea for at least 12 months after stopping exogenous hormone treatments and with luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels corresponding to post-menopausal levels;\n  * or have undergone irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy (this operation must be documented);\n* Male patients will be required to use male contraception (condoms) for a duration of 3 months after the PET;\n* Women partners will be required to use an acceptable2 contraceptive measure (as they will not receive the trial drug) for a duration of 3 months after the PET;\n* Male partners will be required to use male contraception (condoms) for a duration of 6 months after the PET.\n\nExclusion Criteria:\n\n* History of Myocardial infarction or myocarditis\n* Severe aortic stenosis\n* Current or prior participation in a clinical trial evaluating a TTR-targeted gene-silencing therapy (TTR= transthyretin) or an amyloid-depleting treatment for cardiac transthyretin amyloidosis (ATTR-CM).\n* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule\n* Women who are pregnant or breastfeeding. A serum pregnancy test will be performed at the start of the study and within 48 hours prior to PET for all female subjects of childbearing potential.\n* Patient under guardianship or trusteeship.\n* Patient under judicial protection.\n* Patient unable to understand spoken or written French\n* Known hypersensitivity to gallium-68, to any excipient or derivative",{"count":370,"type":23},40,[167],"Transthyretin cardiac amyloidosis (ATTR-CM) is an infiltrative cardiomyopathy caused by amyloid fibril deposition, leading to heart failure and arrhythmias. Despite advances in diagnosis, the disease remains commonly unrecognized and presents heterogeneously. Recent therapies targeting transthyretin stabilization and gene silencing have improved outcomes, but current staging systems based on biological and functional markers have limited ability to guide treatment.\n\nImaging techniques such as cardiac magnetic resonance (CMR) provide tissue characterization, but noninvasive molecular imaging of myocardial fibrotic activity remains limited. Positron emission tomography (PET) tracers targeting fibroblast activation protein (FAPI), labeled with gallium-68 (68Ga), offer a promising approach to detect and quantify fibroblast activity associated with myocardial remodeling.\n\nThis study aims to evaluate \\[68Ga\\]Ga-FAPI PET imaging for staging ATTR-CM and distinguishing patients with disease progression under therapy. The investigators hypothesize that \\[68Ga\\]Ga-FAPI uptake reflects fibrotic activity correlating with disease severity and progression. If validated, \\[68Ga\\]Ga-FAPI PET could serve as a novel biomarker for improved staging and personalized strategies in ATTR-CM.",[374],"Transthyretin Cardiac Amyloidosis",[376,377],"FAPI-46","staging and identifying progressing patients","2026-06-30",{"date":380,"type":34},"2026-07-02",{"date":382,"type":23},"2026-09",{"date":384,"type":23},"2027-10",{"name":40,"class":41},{"id":387,"slug":388,"hasResults":12,"nctId":389,"briefTitle":390,"officialTitle":391,"acronym":392,"eligibilityCriteria":393,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":394,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":395,"conditions":396,"keywords":399,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":378,"lastUpdatePostDateStruct":403,"startDateStruct":405,"completionDateStruct":407,"leadSponsor":409,"locationsCount":185},"100569123","characterization-and-support-of-neurodevelopmental-disorders-associated-with-congenital-cardiac-malformations---neonatal-100569123","NCT06690151","Characterization and Support of Neurodevelopmental Disorders Associated With Congenital Cardiac malfoRmations - Neonatal","CATAMARAN - Neonatal Cohort : Characterization and Support of Neurodevelopmental Disorders Associated With Congenital Cardiac malfoRmations - Neonatal","CATAMARAN - NN","The inclusion criteria are as follows:\n\n* Fetus with a congenital heart defect (CHD) detected prenatally (prenatal diagnosis of the heart defect)\n* Fetus with a critical CHD defined as requiring cardiac surgery during the first three months of the infant's life\n* Parents affiliated with or beneficiaries of a social security or equivalent system\n* Parents' good understanding of the French language\n* Voluntary, informed, and written consent from both parents for themselves and the unborn child\n\nCriteria for parents\\*:\n\n\\- Biological parents \\*The inclusion of the father in the project does not limit the participation of the child (patient) in the study.\n\n\\*The father will be encouraged to participate in the project by providing a blood sample to create a trio (mother\u002Ffather\u002Finfant) for future genetic analyses.\n\nHowever, if the father is unavailable or does not consent to the collection and storage of samples for analysis (as part of the CATAMARAN study or future research projects related to biobanking), the child can still be included in the study.\n\nExclusion Criteria:\n\n* Medical termination of pregnancy considered\n* Genetic anomaly or malformative syndrome identified prior to inclusion",{"count":22,"type":23},"Congenital heart defects (CHD), as the leading cause of birth defects, affect 12 million people globally and approximately 41,000 newborns each year in Europe. CHD presents a significant public health concern due to its association with high morbidity and mortality rates across the lifespan. Over 50% of infants born with critical CHD will develop neurodevelopmental disorders (NDD), requiring specialized care and impacting their quality of life. NDDs, involving early and persistent disruptions in cognitive, emotional, and behavioral development due to abnormal brain development, are highly variable. They may impact language, learning, motor skills, intellectual efficiency, social cognition, attention, memory, and executive functions, often accompanied by psychosocial difficulties. These hidden disabilities constitute the primary long-term sequelae of CHD, surpassing even cardiovascular complications in impact, and affect children who often undergo multiple cardiac surgeries during early childhood. NDDs are associated not only with complex CHDs but also with simpler CHDs that are repaired in early childhood and considered 'cured.'\n\nThe origin of CHD-associated NDDs remains largely unknown. While few genetic or environmental causes have been identified, recent research suggests a possible common origin linking heart malformations and neurodevelopmental abnormalities. The CATAMARAN neonatal cohort project aims to detect developmental delays associated with CHD as early as six months of age and to identify both individual susceptibility factors and acquired vulnerabilities contributing to the development of NDDs in infants with CHD.",[397,398],"Heart Disease Congenital","Neurodevelopmental Disorder",[400,401,402],"Congenital heart defects (CHD)","neurodevelopmental disorders (NDD)","genetics",{"date":404,"type":34},"2026-07-01",{"date":406,"type":34},"2025-02-28",{"date":408,"type":23},"2028-08-28",{"name":40,"class":41},{"id":411,"slug":412,"hasResults":12,"nctId":413,"briefTitle":414,"officialTitle":414,"acronym":415,"eligibilityCriteria":416,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":417,"enrollmentInfo":418,"targetDuration":4,"studyType":24,"phases":420,"briefSummary":421,"conditions":422,"keywords":424,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":427,"lastUpdatePostDateStruct":428,"startDateStruct":429,"completionDateStruct":430,"leadSponsor":432,"locationsCount":67},"100645418","phase-2-a-pilot-superiority-study-comparing-the-efficacy-of-a-combination-of-a-glenohumeral-intra-articular-injection-with-a-suprascapular-nerve-block-versus-a-glenohumeral-intra-articular-corticosteroid-injection-in-retractile-capsulitis-100645418","NCT07680504","A Pilot Superiority Study Comparing the Efficacy of a Combination of a Glenohumeral Intra-articular Injection With a Suprascapular Nerve Block Versus a Glenohumeral Intra-articular Corticosteroid Injection in Retractile Capsulitis","EBLOUIR","Inclusion Criteria:\n\n* Patients with shoulder pain and stiffness that has persisted for at least 2 months but less than 12 months, with a loss of passive range of motion in at least 2 planes (lateral rotation, medial rotation, abduction, forward flexion) of at least 30 degrees compared to the contralateral side\n* Patients between the ages of 18 and 65\n* Patients enrolled in a social security program\n\nExclusion Criteria:\n\n* \\- Corticosteroid injection into the affected shoulder \\\u003C 4 months ago\n* History of any surgery on the affected shoulder within the past 12 months\n* Patients with a neuromuscular condition (neurological deficit) or shoulder condition (arthropathy) that could interfere with the assessment of the primary endpoint\n* Signs or risk of infection (bacterial-like infection and\u002For fever and\u002For antibiotic use)\n* Poor skin condition of the affected shoulder\n* Anticoagulation with VKAs or anti-Xa agents, or active bleeding disorder or one in remission for less than 5 years (malignant hematologic disorders, myelodysplasia, autoimmune thrombocytopenia) or chemotherapy (antiplatelet agents permitted except prasugrel and clopidogrel)\\*\n* Uncontrolled hypertension,\n* Decompensated diabetes or diabetes at risk of decompensation,\n* Contraindications to diprosten, Kenacort, or lidocaine\n* Psychiatric conditions that may be exacerbated by corticosteroids\n* Pregnant or breastfeeding women, or women who refuse to use effective contraception\n* Individuals belonging to a vulnerable group as defined by Regulation (EU) No. 536\u002F2014 and French law (See section 4.4 of the protocol) - - Patients unable to comply with the protocol requirements (see Section 4.4 of the protocol)\n* Patients participating in another clinical research protocol involving a drug or medical device\n* Patients who refuse to participate in the study","65 Years",{"count":419,"type":23},38,[167],"Drug Trial\n\n* Single-center\n* Exploratory trial\n* Controlled\n* Randomized\n* Double-blind\n* Prospective\n\nObjective is to compare improvements in shoulder function at 3 months between the group receiving an intra-articular injection combined with a suprascapular nerve block and the group receiving an intra-articular injection combined with a placebo block 19 patients in the Experimental Group (block with corticosteroid and intra-articular injection on Day 0) 19 patients in the Control Group (block with saline and intra-articular injection on Day 0)\n\n* Total duration: 36 months\n* Recruitment period: 24 months\n* Treatment duration per patient: 2 ultrasound-guided procedures on Day 0\n* Follow-up duration per patient: 12 months after the procedure\n\nAt J0 : Under ultrasound guidance, inject 2 mL of lidocaine into the notch, then:\n\n* Experimental Group: 8 mL of 1% lidocaine into the notch with 1 mL of betamethasone,\n* Control Group: 9 mL of saline into the notch.\n\nDuring these consultations, M1, M3, M6 et M12 , the following examinations will be performed:\n\n* Clinical examination of the painful shoulder, including measurement of range of motion\n* Visual Analog Scale (VAS) for pain\n* Quick Dash, OSS, and SPADI self-report questionnaires completed by the patient\n* Recording of complications\n* Questions about returning to work",[423],"Retractile Capsulitis",[425,426],"suprascapular nerve block","intra-articular injection","2026-06-25",{"date":380,"type":34},{"date":427,"type":23},{"date":431,"type":23},"2029-06-25",{"name":40,"class":41},{"id":434,"slug":435,"hasResults":12,"nctId":436,"briefTitle":437,"officialTitle":438,"acronym":4,"eligibilityCriteria":439,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":440,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":441,"conditions":442,"keywords":447,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":427,"lastUpdatePostDateStruct":452,"startDateStruct":454,"completionDateStruct":456,"leadSponsor":458,"locationsCount":67},"100520649","premorbid-personality-profile-of-patients-with-cognitive-and-behavioral-disorders-100520649","NCT06059313","Premorbid Personality Profile of Patients With Cognitive and Behavioral Disorders","Relationship Between Premorbid Personality Traits and Cognitive and Behavioral Disorders","Inclusion Criteria :\n\n* Patients with behavioral variant of frontotemporal disorder (bvFTD) according to Rascovsky criteria (2011) or patients with phénocopy frontotemporal dementia (phFTD) who fulfill criteria for possible bvFTD and have no imaging abnormalities or patients with frontal variant of Alzheimer disease according to Ossenkopele criteria (2022), or patient with bipolar disorder according to CIM 10 criteria\n* Score for Mini-mental state examination ≥ 18\n* Patient with caregiver who has who has known him\u002Fher in the 10 years preceding the disease onset.\n* Patient and caregiver consents (no opposition)\n\nExclusion Criteria :\n\n* Patient with no caregiver\n* Pregnant or breast feeding women",{"count":349,"type":23},"Damages in frontal area present in neurodegenerative disease (frontotemporal degeneration, frontal variant of Alzheimer disease) and in psychiatric disease (bipolar disorder) can affect behavior and cognition including social cognition. Symptoms vary both quantitatively and qualitatively from disease to another and from person to person. It cannot be completely excluded that in some cases, factors of susceptibility such as premorbid personality traits lead to frontal fragility.\n\nThe study will assess the relationship between premorbid profile using NEO-PI 3 inventory and cognitive and behavioral\u002Fpsychobehavioral manifestations in patients with behavioral variant of frontotemporal disorder (bvFTD), phenocopy frontotemporal dementia (phFTD), frontal variant of Alzheimer disease, bipolar disorder characterized with frontal damages.",[443,444,445,446],"Behavioral Variant of Frontotemporal Disorder (bvFTD)","Phenocopy Frontotemporal Dementia (phFTD)","Frontal Variant of Alzheimer Disease","Bipolar Disorder",[448,449,450,451],"bvFTD","fvAD","phFTD","bipolar disorder,personality",{"date":453,"type":34},"2026-06-29",{"date":455,"type":34},"2023-12-14",{"date":457,"type":23},"2026-12-14",{"name":40,"class":41},{"id":460,"slug":461,"hasResults":12,"nctId":462,"briefTitle":463,"officialTitle":464,"acronym":465,"eligibilityCriteria":466,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":417,"enrollmentInfo":467,"targetDuration":4,"studyType":24,"phases":469,"briefSummary":470,"conditions":471,"keywords":473,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":478,"lastUpdatePostDateStruct":479,"startDateStruct":480,"completionDateStruct":482,"leadSponsor":484,"locationsCount":485},"100622011","efficacy-of-12-week-daytime-restricted-eating-on-hepatic-steatosis-of-obesity-100622011","NCT07378072","Efficacy of 12-week Daytime Restricted Eating on Hepatic Steatosis of Obesity","Efficacy of 12-week Daytime Restricted Eating on Hepatic Steatosis of Obesity: Randomized, Open-label, Parallel Group, Controlled Superiority Trial _ CHRONOSTEATOSIS","CHRONOSTEATOSI","Inclusion Criteria:\n\n* Body mass index (BMI) between 30.0 and 49.9 kg\u002Fm2\n* Age between 18 and 65 years (limits included)\n* Sedentary (light-intensity physical activity less than 1 hour per week) or moderately active (moderate exercise 1 to 2 hours per week). Self-declared criteria.\n* Weight stable for at least 3 months prior to the beginning of the study (gain or loss \\\u003C4 kg). Self-declared criteria.\n* Able to give written informed consent\n* Self-reported eating interval \\> 12 hours per day\n* Subject who owns a smartphone with access to the internet, and agrees to use it in the study\n* Affiliation with French social security system or beneficiary from such system\n* Fibroscan® Controlled Attenuation Parameter (CAP) \\> 300 dB\u002Fms\n* Hepatitis B and C serologies negative (or showing past-infection or protective immunization)\n\nExclusion Criteria:\n\n* Alcohol intake \\> 20 g\u002Fday\n* Night-shift workers or rotating shift workers\n* Smoking\n* Patient with diabetes if HbA1c not at target (\\\u003C7%) and\u002For using a non-authorized medication)\n* Chronic liver disease other than MASLD\n* Severe hepatic disease (cirrhosis, hepatocellular carcinoma)\n* Severe cardiac disease (Chronic heart failure classified as being in New York Heart Association (NYHA) Class III or IV)\n* Severe Kidney disease with CKD-EPI\\\u003C30 mL\u002Fmin\u002F1,73m2\n* Initiation of hormonal treatment during the study period\n* Medications affecting weight or energy balance\n* Magnetic Resonance Imaging (MRI) not possible due to patient's anthropometric characteristics. Any of the following:\n\n  * abdominal and\u002For thoracic circumference with arms greater than 200 cm\n  * Sagittal diameter (or abdominal height, i.e. the distance between the dorsum and the apex of the abdomen, which was measured in the supine position at the midpoint between the iliac crest and the last rib) over 70 cm\n  * body weight over 160 kg\n* MRI not possible due to the following (an MRI safety screening form will have to be filled for inclusion): presence of a pacemaker or cardiac defibrillator or cardiovascular catheter or neurostimulator or an implantable electronic pump for automated drug injection or an electronically-controlled implantable chamber. Ocular metallic foreign bodies\n* History of severe eating disorders: Binge Eating Disorder, Bulimia Nervosa; Night eating syndrome\n* Minors\n* Adults under guardianship, trusteeship or under safeguard of justice\n* Other clinical trial participation that could interfere with the study\n* Pregnant women or women trying to be pregnant\n* Nursing mothers\n* Any treatment triggering hepatic steatosis",{"count":468,"type":23},72,[81],"The objective of this study is to demonstrate that an \\\u003C or equal to 8-hour time-restricted eating (i.e., fasting for at least 16 hours every day), not focusing on reducing caloric intake, reduces intra-hepatic fat in patients with obesity and Metabolic dysfunction-Associated Steatotic liver Disease (MASLD).",[472],"MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease)",[474,475,476,477],"Time-restricted eating","Obesity","MASLD","circadian rhythms","2026-06-24",{"date":453,"type":34},{"date":481,"type":34},"2026-06-17",{"date":483,"type":23},"2029-06",{"name":40,"class":41},9,{"id":487,"slug":488,"hasResults":12,"nctId":489,"briefTitle":490,"officialTitle":491,"acronym":4,"eligibilityCriteria":492,"healthyVolunteers":12,"sex":18,"minAge":493,"maxAge":4,"enrollmentInfo":494,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":496,"conditions":497,"keywords":500,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":505,"lastUpdatePostDateStruct":506,"startDateStruct":507,"completionDateStruct":509,"leadSponsor":511,"locationsCount":512},"100640576","the-mai-foie-cohort-100640576","NCT07594990","The MAI-FOIE Cohort","Cohorte Des Maladies Auto-Immunes du Foie","AIH (Auto-Immune Hepatitis) patients :\n\nInclusion Criteria :\n\n1. age≥10 years old\n2. weight≥25kg\n3. AIH (with or without the presence of an overlap) whose diagnosis is validated by at least 2 of the following criteria :\n\n   * ALT\\>2N or IgG\\>1.1N\n   * Presence of autoantibodies : ANA (antinuclear), ML (anti-smooth muscle), SLA (anti-soluble liver antigen), LKM1 (anti-endoplasmic reticulum), LC1 (anti-liver cytosol)\n   * Presence of interface hepatitis on biopsy\n4. signing of a written consent form for participation in the study and for the storage of biological samples research\n\nControl patients :\n\n1. age≥18 years old\n2. weight≥37kg\n3. Patient with one of the following 3 conditions :\n\n   * Primary Biliary Cholangitis\n   * Metabolic steatohepatitis\n   * Drug induced hepatitis\n\nExclusion Criteria :\n\nPositive HIV serology HBV infection Positive HCV serology and PCR Patients under guardianship or curatorship","10 Years",{"count":495,"type":23},800,"The MAI-FOIE cohort will be a French multicenter cohort with the development of a biobank including patients with autoimmune, metabolic and medicated liver diseases",[498,499],"Autoimmune Liver Diseases","Immunological Mechanisms",[501,502,503,504],"Cohort","biocollection","pathophysiology","biomarkers","2026-06-23",{"date":427,"type":34},{"date":508,"type":23},"2026-06-01",{"date":510,"type":23},"2038-05-30",{"name":40,"class":41},13,{"id":514,"slug":515,"hasResults":12,"nctId":516,"briefTitle":517,"officialTitle":518,"acronym":519,"eligibilityCriteria":520,"healthyVolunteers":12,"sex":76,"minAge":19,"maxAge":4,"enrollmentInfo":521,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":522,"conditions":523,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":505,"lastUpdatePostDateStruct":525,"startDateStruct":526,"completionDateStruct":528,"leadSponsor":530,"locationsCount":67},"100635517","effectiveness-of-a-four-session-focal-shock-wave-therapy-protocol-in-women-with-vulvodynia-100635517","NCT07553715","Effectiveness of a Four-Session Focal Shock Wave Therapy Protocol in Women With Vulvodynia","Evaluation of the Effectiveness of a Four-Session Low-Intensity Focal Extracorporeal Shock Wave Therapy (LiSWT) Protocol in Women With Vulvodynia: A Retrospective Observational Cohort Study","Shock-V","Inclusion Criteria:\n\n* Female patients aged 18 years or older\n* Clinical diagnosis of vulvodynia\n* Received at least one session of low-intensity focal extracorporeal shock wave therapy in routine clinical practice\n\nExclusion Criteria:\n\n* Refusal to participate (non-opposition not obtained)\n* Inability to understand French language, preventing completion of study questionnaires",{"count":52,"type":23},"Vulvodynia is a chronic vulvar pain condition that can significantly affect quality of life. Low-intensity focal extracorporeal shock wave therapy has been proposed as a non-invasive therapeutic option, but real-world data remain limited.\n\nThis retrospective observational study aims to evaluate the effectiveness of a four-session focal shock wave therapy protocol in women with vulvodynia treated in routine clinical practice at a university hospital. Clinical data collected during standard care, as well as questionnaire responses, will be analyzed to assess changes in symptoms and functional outcomes following treatment.",[524],"Vulvodynia",{"date":478,"type":34},{"date":527,"type":34},"2026-04-01",{"date":529,"type":23},"2026-12-01",{"name":40,"class":41},{"id":532,"slug":533,"hasResults":12,"nctId":534,"briefTitle":535,"officialTitle":536,"acronym":537,"eligibilityCriteria":538,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":539,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":541,"conditions":542,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":505,"lastUpdatePostDateStruct":545,"startDateStruct":546,"completionDateStruct":547,"leadSponsor":549,"locationsCount":67},"100635389","reproducibility-of-dental-bite-mark-overlay-analysis-using-digital-3d-models-in-adult-participants-100635389","NCT07552051","Reproducibility of Dental Bite Mark Overlay Analysis Using Digital 3D Models in Adult Participants","Reproducibility and Repeatability of Digital Overlay Techniques in Bite Mark Morphological Analysis: An Observational Study Using 3D Dental Models","OVERLAY-REPRO","Inclusion Criteria:\n\n* Age ≥18 years\n* Patients requiring dental care including intraoral optical scan\n* Able to understand the study and provide informed consent\n* Sufficient dentition allowing usable maxillary scan\n\nExclusion Criteria:\n\n* Age \\\u003C18 years\n* Individuals under legal protection (guardianship or curatorship)\n* Oral conditions preventing intraoral scanning\n* Refusal to participate\n* Completely edentulous patients\n* Partially edentulous patients (\\>8 missing maxillary teeth)",{"count":540,"type":23},30,"This study aims to evaluate the reproducibility and repeatability of a standardized digital overlay protocol used in forensic odontology for bite mark analysis. Bite mark analysis methods have been increasingly questioned due to concerns about their scientific reliability. This study focuses on the methodological evaluation of an overlay generation protocol independently of biological trace interpretation.\n\nThirty adult participants requiring routine dental care involving intraoral scanning will be included. A digital impression of the maxillary dentition will be obtained using a standard intraoral scanner, which is a non-invasive and routine clinical procedure.\n\nDigital dental models will be anonymized and processed using dedicated software to generate overlays. Four operators with different levels of expertise will independently perform the overlay procedure at two separate time points.\n\nThe study will assess intra-operator repeatability and inter-operator reproducibility using quantitative 2D and 3D metrics. The objective is to determine the variability of the protocol and to contribute to the standardization and reliability of overlay-based analyses in forensic dentistry.",[543,544],"Forensic Dentistry","Bite Mark Analysis",{"date":478,"type":34},{"date":527,"type":34},{"date":548,"type":23},"2027-06",{"name":40,"class":41},{"id":551,"slug":552,"hasResults":12,"nctId":553,"briefTitle":554,"officialTitle":555,"acronym":556,"eligibilityCriteria":557,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":558,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":560,"conditions":561,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":505,"lastUpdatePostDateStruct":565,"startDateStruct":566,"completionDateStruct":568,"leadSponsor":570,"locationsCount":67},"100635388","dental-management-of-patients-with-hiv-in-pays-de-la-loire-100635388","NCT07552038","Dental Management of Patients With HIV in Pays de la Loire","Dental Management of Patients Living With HIV: A Retrospective Study Using COREVIH Data in Pays de la Loire","VIH-ODONTO","Inclusion Criteria:\n\n* Adult patients aged ≥18 years\n* Confirmed diagnosis of HIV infection\n* Followed at participating hospital centers\n* Available clinical and biological data relevant to dental care management (CD4 count, viral load, blood count)\n\nExclusion Criteria:\n\n* Patients with missing key biological data required for analysis\n* Patients not followed in participating centers\n* Patients with incomplete medical records preventing assessment of outcomes",{"count":559,"type":23},5603,"Dental care for people living with HIV has evolved with the widespread use of antiretroviral therapy, which has improved life expectancy and disease control. However, uncertainty remains about whether specific adaptations are still needed during dental procedures due to potential biological abnormalities that may increase infectious or bleeding risks.\n\nThis study aims to evaluate the proportion of patients living with HIV in the Pays de la Loire region who may require adapted dental management based on biological parameters such as immune status, hematological values, and comorbidities.\n\nA retrospective descriptive study will be conducted using anonymized data from 5,603 patients followed in the COREVIH Pays de la Loire database. The results are expected to provide objective data to better inform dental practice and reduce unnecessary precautions or stigmatization in the management of patients living with HIV.",[562,563,564],"HIV Infection","Acquired Immune Deficiency Syndrome","Oral Health Care",{"date":427,"type":34},{"date":567,"type":34},"2026-05-02",{"date":569,"type":23},"2027-05-30",{"name":40,"class":41},{"id":572,"slug":573,"hasResults":12,"nctId":574,"briefTitle":575,"officialTitle":575,"acronym":576,"eligibilityCriteria":577,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":578,"targetDuration":4,"studyType":24,"phases":579,"briefSummary":580,"conditions":581,"keywords":583,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":505,"lastUpdatePostDateStruct":587,"startDateStruct":588,"completionDateStruct":590,"leadSponsor":592,"locationsCount":593},"100629341","synovial-tissue-as-a-biomarker-in-the-early-management-of-osteoarthritis-100629341","NCT07473414","Synovial Tissue as a Biomarker in the Early Management of Osteoarthritis","SYNPA","Inclusion Criteria:\n\n* Diagnosis of early osteoarthritis defined by the following clinical criteria:\n\n  1. score ≤ 85% in at least two of the four categories of the KOOS questionnaire: pain, symptoms\u002Fsigns, function and quality of life;\n  2. presence of tenderness on palpation of the joint space or crepitus (clinical examination);\n  3. Kellgren and Lawrence (KL) score of 0 or 3 (X-rays).\n* Referred for therapeutic management including an intra-articular injection in the affected knee\n* Patient affiliated with a social security scheme\n* Patient able to understand the protocol and having signed an informed consent form.\n\nExclusion Criteria:\n\n* Minors\n* Adults under guardianship or trusteeship\n* Pregnant women\n* Breastfeeding women\n* Protected patients\n* Curative anticoagulation\n* Thrombocytopenia \\\u003C 50,000 platelets\u002Fmm3\n* Patients who object to participating in the study.",{"count":540,"type":23},[81],"Osteoarthritis is a common disease whose prevalence continues to increase. To date, there is no medical treatment that has proven effective, and only symptomatic treatments exist, mainly to reduce pain.\n\nArthroplasty, a costly and invasive surgical procedure, is often unavoidable in advanced stages of the disease. More than just a degenerative disease of the cartilage, osteoarthritis is now recognised as a heterogeneous disease causing multi-tissue damage of varying intensity. Synovitis plays a particularly important role in the onset and progression of osteoarthritis and has been closely correlated with radiographic severity, pain and loss of joint function. The investigators have identified several synovial histological pathotypes based on the type of synovial cell infiltrate and its distribution in samples from advanced osteoarthritis (surgical waste from prosthesis implantation). The investiogators' studies show that the presence of these pathotypes appears to be related to the clinical phenotype of patients. Analysis of synovial tissue at earlier stages of the disease is now essential to advance the understanding of the role of synovitis in osteoarthritis and its link to the clinical phenotype of patients.\n\nThe objective of this protocol is to describe the different synovial histological pathotypes present in the early stages of osteoarthritis; To this end, the investigators will establish a cohort of osteoarthritis patients with a collection of synovial tissue samples obtained by ultrasound-guided needle biopsy in an outpatient setting, a well-tolerated procedure with simple follow-up, as well as blood sampling.",[582],"Osteoarthritis",[584,585,586],"arthroplasty","synovial tissue","synovial histological pathotypes",{"date":427,"type":34},{"date":589,"type":34},"2026-05-26",{"date":591,"type":23},"2028-05-26",{"name":40,"class":41},2,{"id":595,"slug":596,"hasResults":12,"nctId":597,"briefTitle":598,"officialTitle":599,"acronym":600,"eligibilityCriteria":601,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":602,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":604,"conditions":605,"keywords":4,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":505,"lastUpdatePostDateStruct":609,"startDateStruct":610,"completionDateStruct":612,"leadSponsor":614,"locationsCount":67},"100625500","frequency-and-intensity-of-inflammatory-relapses-in-patients-with-non-infectious-posterior-uveitis-treated-with-a-fluocinolone-acetonide-implant-100625500","NCT07423442","Frequency and Intensity of Inflammatory Relapses in Patients With Non-infectious Posterior Uveitis Treated With a Fluocinolone Acetonide Implant","Frequency and Intensity of REcurrences in Non-infectious Posterior Uveitis Treated With Fluocinolone Acetonide Implant (FACi): a Multicenter Retrospective Real-world Study","FIRE","Inclusion Criteria:\n\n* Adult patients aged 18 years or older\n* Diagnosis of non-infectious uveitis with posterior segment involvement\n* Presence of uveitic macular edema or persistent posterior segment inflammation\n* Treatment with a fluocinolone acetonide intravitreal implant prior to January 2024\n\nExclusion Criteria:\n\n* Infectious uveitis\n* Refusal to participate or documented opposition to the study\n* Follow-up duration shorter than 12 months after implantation",{"count":603,"type":23},100,"Non-infectious posterior uveitis is a chronic inflammatory eye disease that can lead to irreversible retinal damage and visual impairment due to repeated inflammatory relapses.\n\nThe fluocinolone acetonide intravitreal implant is approved for the prevention of inflammatory relapses in this condition, but data from real-world clinical practice remain limited, particularly regarding the intensity of relapses over time.\n\nThis multicenter retrospective observational study aims to evaluate the frequency and intensity of inflammatory recurrences in adult patients with non-infectious posterior uveitis treated with a fluocinolone acetonide implant. Clinical and imaging data routinely collected during follow-up will be analyzed over a three-year period to better characterize long-term outcomes, treatment burden, and safety in real-life conditions.",[606,607,608],"Noninfectious Posterior Uveitis","Uveitis, Posterior","Uveitic Macular Edema",{"date":478,"type":34},{"date":611,"type":23},"2026-06",{"date":613,"type":23},"2027-01",{"name":40,"class":41},{"id":616,"slug":617,"hasResults":12,"nctId":618,"briefTitle":619,"officialTitle":620,"acronym":621,"eligibilityCriteria":622,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":623,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":624,"conditions":625,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":505,"lastUpdatePostDateStruct":627,"startDateStruct":628,"completionDateStruct":630,"leadSponsor":632,"locationsCount":67},"100625499","study-of-switching-to-aflibercept-8-mg-in-patients-with-refractory-or-dependent-exudative-age-related-macular-degeneration-100625499","NCT07423429","Study of Switching to Aflibercept 8 mg in Patients With Refractory or Dependent Exudative Age-related Macular Degeneration","Retrospective Multicenter Real-world Observational Study of Switching to Aflibercept 8 mg in Patients With Refractory or Dependent Exudative Age-related Macular Degeneration","AFLIWEST","Inclusion Criteria:\n\n* Adults (≥18 years) with exudative (neovascular) age-related macular degeneration\n* Treated with intravitreal anti-VEGF therapy for more than 1 year\n* Switched to aflibercept 8 mg before July 31, 2025\n* Injection interval strictly less than 12 weeks prior to switch\n\nExclusion Criteria:\n\n* High myopia (axial length \\> 26 mm or spherical equivalent \\\u003C -6 diopters)\n* Angioid streaks\n* Moderate or severe diabetic retinopathy\n* History of diabetic macular edema\n* History of uveitis\n* History of retinal vein occlusion (branch or central)\n* History of pseudovitelliform macular dystrophy\n* Patient under legal guardianship or curatorship\n* Pregnant or breastfeeding women",{"count":603,"type":23},"Age-related macular degeneration is a leading cause of visual impairment in older adults. In its exudative form, repeated intravitreal injections of anti-VEGF agents are required to control disease activity. A new formulation of aflibercept at a higher dose (8 mg) has been developed with the aim of extending the interval between injections.\n\nThis multicenter retrospective real-world observational study will evaluate the effect of switching to aflibercept 8 mg in patients with refractory or dependent exudative age-related macular degeneration. Clinical data collected during routine care will be analyzed to compare injection intervals, treatment burden, visual outcomes, anatomical outcomes, and safety before and after the switch.",[626],"Exudative Age-Related Macular Degeneration",{"date":427,"type":34},{"date":629,"type":34},"2026-02-20",{"date":631,"type":23},"2026-10-20",{"name":40,"class":41},""]