[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Centre Hospitalier Universitaire de Besancon\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":625},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,68,0,25,[9,41,72,98,120,144,164,186,209,230,256,279,305,325,354,384,405,428,454,480,507,531,554,578,602],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100644357","use-of-extracorporeal-photopheresis-in-kidney-transplantation-effects-on-antibody-mediated-rejection-100644357",false,"NCT07663669","Use of Extracorporeal Photopheresis in Kidney Transplantation: Effects on Antibody-Mediated Rejection","PETRUM","Inclusion Criteria:\n\n* Kidney transplant recipients followed at the University Hospitals of Besançon and Lille between September 1, 2016, and August 31, 2023\n* Patients with antibody-mediated rejection (as confirmed by histological analysis of the renal biopsy)\n* Rejection treated with extracorporeal photopheresis\n* Subjects who do not object to the use of their personal data and\u002For biological samples\n* Subjects affiliated with, or beneficiaries of, the French social security system\n\nExclusion Criteria:\n\n* Patients with acute rejection\n* Pregnant women, women in labor, or breastfeeding mothers\n* Individuals deprived of liberty by judicial or administrative decision; individuals receiving compulsory psychiatric care; or individuals admitted to a healthcare or social institution for reasons other than research participation\n* Minors\n* Adults under legal protection or unable to provide informed consent\n* Subjects without health insurance coverage\n* Subjects currently within an exclusion period from another study, or as listed in the \"national volunteer registry\"","ALL","18 Years",{"count":20,"type":21},31,"ESTIMATED","OBSERVATIONAL","This study aims to describe, over a one-year period, the clinical, biological, and histological evolution of a cohort of kidney transplant recipients who developed antibody-mediated rejection and were treated with extracorporeal photopheresis.",[25],"Antibody-mediated Rejection in Kidney Transplant",[27],"Extracorporeal photopheresis","RECRUITING","2026-06-24",{"date":31,"type":32},"2026-06-29","ACTUAL",{"date":34,"type":21},"2026-06",{"date":36,"type":21},"2026-10",{"name":38,"class":39},"Centre Hospitalier Universitaire de Besancon","OTHER",1,{"id":42,"slug":43,"hasResults":12,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":49,"sex":17,"minAge":18,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":60,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":4},"100643286","clap--compare-the-quality-of-3d-modeling-of-the-wrist-based-on-the-cone-beam-to-the-gold-standard-100643286","NCT07632521","CLAP : Compare the Quality of 3D Modeling of the Wrist Based on the Cone Beam to the Gold Standard","CLAP: Single Center Prospective Study to Compare the Quality of 3D Modeling of the Wrist Based on the Cone Beam to the Gold Standard of CT SCAN in 6 Healthy Volunteers.","CLAP","Inclusion Criteria:\n\n* no clinical symptoms suggestive of a wrist ligament injury (e.g., pain, instability)\n* no contraindications to undergoing a CBCT scan (e.g., pregnancy, history of hypersensitivity to radiation).\n* Enrolled in or eligible for a French social security plan.\n* Signing of an informed consent form indicating that the subject understands the purpose and procedures required by the study and agrees to participate in the study and comply with the requirements and restrictions inherent to this study\n\nExclusion Criteria:\n\n* Pregnant women and breastfeeding mothers\n* Persons deprived of their liberty by a judicial or administrative decision; persons undergoing involuntary psychiatric treatment; persons admitted to a health or social care facility for purposes other than research\n* Adults subject to a legal protection measure (judicial protection, guardianship, or conservatorship) or who are unable to give consent",true,"65 Years",{"count":52,"type":21},6,"INTERVENTIONAL",[55],"NA","Recent advances in personalized 3D modeling make it possible to consider personalized hand modeling based on cone-beam CT. The goal is to develop a personalized 3D modeling tool for use in routine clinical practice that reduces both the radiation dose to which patients are currently exposed during CT scans and the time required to process CT data (segmentation). the main, objective of the study is to compare the quality of 3D hand modeling based on cone-beam CT with the gold standard of computed tomography.\n\nThis prospective, single-center, interventional study will include 6 healthy volunteers.",[58,59],"Wrist Injuries","Ligament Injury",[61,62],"CT scan","cone-beam scan","NOT_YET_RECRUITING","2026-06-02",{"date":66,"type":32},"2026-06-08",{"date":68,"type":21},"2026-06-01",{"date":70,"type":21},"2026-10-30",{"name":38,"class":39},{"id":73,"slug":74,"hasResults":12,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":53,"phases":82,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},"100595740","phase-2-mp0317-in-combination-with-chemoimmunotherapy-in-first-line-treatment-for-patients-with-advanced-biliary-tract-carcinoma-100595740","NCT07036380","MP0317 in Combination With Chemoimmunotherapy in First Line Treatment for Patients With Advanced Biliary Tract Carcinoma","MP0317, a Tumor Targeting FAP Dependent CD40 Agonist DARPin, in Combination With Chemoimmunotherapy in First Line Treatment for Patients With Advanced Biliary Tract Carcinoma: a Radnomized Non-comparative Proof of Concept Phase II Study","TACTIC","Inclusion Criteria:\n\n1. Signed and dated informed consent\n2. Histologically confirmed biliary tract carcinoma: intra\u002Fextrahepatic cholangiocarcinoma (note that gallbladder carcinoma are not eligible)\n3. Locally advanced unresectable or metastatic\n4. Patient who had not previously received systemic anti-cancer treatment (adjuvant treatment with Capecitabine is allowed if the end of the chemotherapy was at least 6 months ago)\n5. Age ≥ 18 years\n6. Measurable disease defined according to RECIST v1.1 (Response Evaluation Criteria In Solid Tumours) guidelines Note: Previously irradiated lesions can be considered as measurable disease only if disease progression has been unequivocally documented at that site since radiation.\n7. Patients who have received previous chemoembolization, radioembolization and\u002For radiotherapy should have recovered from any treatment related toxicity, to a level of ≤ grade 1 according to National Cancer Institute \\[NCI\\] common terminology criteria for adverse events, version 5 (CTCAE v5); with the exception of Grade 2 alopecia\n8. Performance status ECOG-PS \\\u003C 2 (Eastern Cooperative Oncology Group)\n9. Females must be using highly effective contraceptive measures, and have a negative pregnancy test prior to the start of dosing if of childbearing potential, and during treatment and at least 7 months after the end of the treatment with cisplatin, 6 months after the end of the treatment with gemcitabine, 3 months after the end of the treatment with durvalumab, or must have evidence of non-childbearing potential by fulfilling one of the following criteria at screening:\n\n   1. Post-menopausal is defined as aged more than 50 years and amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatments.\n   2. Women under the age of 50 years would be considered postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatments and with luteinizing hormone and follicle stimulating hormone levels in the post-menopausal range for the institution.\n   3. Women with documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation.\n   4. Male patients with a female partner of childbearing potential should be willing to use barrier contraception during the study and at least: 4 months after the end of the treatment with cisplatin and 3 months after the end of the treatment with gemcitabine. Patients should refrain from donating sperm from the start of dosing until 4 months after discontinuing study treatment.\n10. Documented virology status of hepatitis, as confirmed by screening HBV and HCV tests:\n\n    1. For patients with active HBV: HBV DNA \\\u003C500 IU\u002Fml (International unit)during screening, initiation of anti-HBV treatment at least 14 days prior to randomization and willingness to continue anti-HBV treatment during the study (per local standard of care; e.g., entecavir)\n    2. Patients with HCV, either with resolved infection (as evidenced by detectable antibody) or chronic infection (as evidence by detectable HCV RNA), are eligible\n11. Patient affiliated to or beneficiary of French social security system\n12. Ability to comply with the study protocol, in the Investigator's judgment.\n\nExclusion Criteria:\n\nFor patients whose tumors present a genetic alteration of IDH1, FGFR2 or BRAF as well as an amplification of HER2, the investigators of the TACTIC study recommend, if possible, the orientation for preferential inclusion in the SAFIR ABC10 study\".\n\n1. Patients previously exposed to anti-tumor immunotherapy such as anti-PD-1, anti-PD-L1, or anti-CTLA4 (cytotoxic T-lymphocyte-associated protein 4) agent or any immune therapy\n2. Diagnosis of additional malignancy within 3 years prior to the inclusion with the exception of curatively treated basal cell carcinoma of the skin and\u002For curatively resected in situ cervical or breast cancer\n3. Patient with any medical or psychiatric condition or disease, which would make the patient inappropriate for entry into this study\n4. Current participation in a study of an investigational agent or in the period of exclusion\n5. Patient under guardianship, curatorship or under the protection of justice\n6. Other liver malignancy: hepatocellular carcinoma and hepato-cholangiocarcinoma\n7. Uncontrolled pleural effusion, pericardial effusion, ascites or symptomatic fistula\n8. Uncontrolled tumor-related pain: exposing patients to risk of exposure to corticoids or iterative hospitalizations. Symptomatic lesions amenable to palliative radiotherapy should be treated prior to inclusion. Patients should be recovered from the effects of radiation. There is no required minimum recovery period\n9. Known active central nervous system metastases and\u002For carcinomatous meningitis.\n10. History of angiocholitis, liver abscess, or acute pancreatitis within 4 weeks prior to initiation of study treatment\n11. Inadequate organ functions: known cardiac failure of unstable coronaropathy, respiratory failure, or uncontrolled infection or another life-risk condition. Patients requiring oxygen therapy or with LEVF\\\u003C40% (Left ventricular ejection fraction).\n12. HIV (human immunodeficiency virus) positive (HIV 1\u002F2 antibodies patients), or a known history of active Tuberculosis bacillus\n13. Any immunosuppressive therapy (i.e. corticosteroids \\>10 mg of hydrocortisone or equivalent dose) within 14 days before the planned start of study therapy\n14. Active autoimmune disease that has required a systemic treatment in the past 2 years (i.e. corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin) is allowed. Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis, with the following exceptions:\n\n    1. Patients with a history of autoimmune-related hypothyroidism who are on thyroid replacement hormone are eligible for the study\n    2. Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study\n    3. Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:\n\n       * Rash must cover \\\u003C 10% of body surface area,\n       * Disease is well controlled at baseline and requires only low-potency topical corticosteroids,\n       * No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high potency or oral corticosteroids within the previous 12 months,\n15. Prior allogeneic bone marrow transplantation or prior solid organ transplantation\n16. History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins\n17. Known hypersensitivity or allergy to Chinese hamster ovary cell products or any component of durvalumab\n18. Receipt of a live, attenuated vaccine within 30 days prior to inclusion or anticipation that such a live, attenuated vaccine will be required during the study Note: Patients must agree not to receive live, attenuated influenza vaccine within 28 days prior to randomization, during treatment or within 5 months following the last dose of durvalumab\n19. Inadequate hematology function: Lymphocyte count at baseline \\\u003C 700\u002Fmm3; neutrophil count \\\u003C 1 500\u002Fmm3, platelets \\\u003C 10 0000\u002Fmm3 (without transfusion), Hemoglobin \\\u003C 9g\u002FdL (patients may be transfused to meet this criterion).\n20. Inadequate hepatic function: bilirubin \\>2 fold ULN (upper limit of normal), AST\u002FALT \\>3 fold ULN, International normalized thromboplastin time ratio \\>2\n21. Creatinine clearance (CrCl) \\\u003C 60 ml\u002Fmin (by the Modification of Diet in Renal Disease \\[MDRD\\], Cockroft formula, or chronic kidney disease \\[CKD\\] formula\\])\n22. Serum albumin \\\u003C 28 g\u002FL\n23. Surgery within 4 weeks previously the initiation of the study treatment\n24. Radiotherapy within 2 weeks previously the initiation of the study treatment\n25. Patient with weight \\\u003C 36 kg.\n26. Pregnant or breastfeeding woman\n27. Known hypersensitivity to components of MP0317, for exemple, histidine buffer or the Tween diluent, according to section 7.2 \" Contraindications \" of the Investigator's brochure of MP0317\n28. Hypersensitivity to gemcitabine or to cisplatin, or to any of their excipients, according to the SmPCs of these products\n29. According to the SmPC of cisplatin: hearing problem, in case of combination with phenytoin with prophylactic aim, patients with neuropathy caused by cisplatin, in case of cardiorespiratory pathology in particular, which forbids a hyperhydration",{"count":81,"type":21},75,[83],"PHASE2","In the present TACTIC clinical trial, the investigators propose to determine the clinical interest and immunological efficacy of a treatment combining MP0317 the FAP (Fibroblast Activation Protein)-dependent CD40 agonist, with anti-PD-L1(Programmed Death-Ligand 1) therapy (durvalumab) and gemcitabine-cisplatin-based chemotherapy in unresectable cholangiocarcinoma.\n\nThe main objective is to assess the 12-month progression free survival (PFS) rate in the experimental arm. The trial proposed is a non-comparative proof of concept randomized two-stage phase II. The control arm will serve to verify the good calibration of the null hypothesis made in the experimental arm and to provide \"true\" controls for translational investigations. A semi-continuous monitoring of toxicity is planned in the experimental arm during the first stage of the study to warrant the tolerability of the experimental treatment and then to guarantee the security of the patients.\n\n75 patients (50 in the experimental arm) will be included. The investigators will also decipher, as a translational objective, the molecular and immunological parameters determining the clinical outcomes.",[86],"Advanced Biliary Tract Carcinoma",[88,89,86],"immunotherapy","DARPin","2026-05-29",{"date":68,"type":32},{"date":93,"type":32},"2025-12-22",{"date":95,"type":21},"2029-11",{"name":38,"class":39},11,{"id":99,"slug":100,"hasResults":12,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":106,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":108,"conditions":109,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":4},"100630786","high-depth-exome-sequencing-on-dna-from-a-salivary-sample-by-mouth-smear-100630786","NCT07492199","High Depth Exome Sequencing on DNA From a Salivary Sample by Mouth Smear.","Evaluation of the Diagnostic Performance of High-depth Exome Sequencing on DNA From a Salivary Sample by Oral Smear in the Etiological Assessment of Patients With a Syndromic Neurodevelopmental Disorder or an Intellectual Development Disorder and for Which the Sequencing of the Genome on Blood Has Proved Inconclusive.","SEPASA","Inclusion Criteria:\n\n* Patient with syndromic neurodevelopmental disorder (NDD) or intellectual developmental disorder (IDD)\n* Trio genome sequencing on blood inconclusive\n* Men and women\n* All ages\n* No objection to participating in the study\n* Affiliation with a French social security system or beneficiary of such a system\n\nExclusion Criteria:\n\n* Pregnant women and nursing mothers\n* Persons deprived of their liberty by judicial or administrative decision; persons undergoing compulsory psychiatric care; persons admitted to a health or social care facility for purposes other than research\n* Subjects who are in the exclusion period of another study or listed in the \"national volunteer registry\"\n* Genetic cause identified in the preliminary etiological assessment\n* Phenocopy: other likely non-genetic cause of TND (perinatal anoxia, infection, trauma, etc.)\n* Patients without health insurance\n* Patients unlikely to cooperate with the study and\u002For anticipated low cooperation by the investigator",{"count":107,"type":21},50,"Despite technological advances, a genetic etiology has been identified in only about 50% to 60% of patients with Neurodevelopmental disorders (NDDs), with a higher diagnostic yield in the syndromic NDD and IDD subgroups. However, identifying a precise etiological diagnosis is essential to optimize patient care, clarify their prognosis, consider targeted therapies, refer families to appropriate resources and support, and provide genetic counseling to relatives. The tests typically offered as part of the etiological assessment of syndromic NDDs and IDD include DNA microarray analysis, testing for fragile X syndrome and genome sequencing from a blood sample. When this assessment remains negative, the cause usually remains unknown.\n\nMosaic genomic abnormalities (or post-zygotic variations) are a common cause of negative results in current diagnostic genetic tests and represent a field of research that has yet to be fully explored outside of skin disorders. Identifying mosaic genomic abnormalities remains technically complex due to the difficulty of detecting low levels of mosaicism and limited access to the tissue of interest when the variation is absent from blood tissue.\n\nHigh-depth exome sequencing is the technique of choice for detecting low levels of mosaicism. In the case of NNDs, as the affected tissue is not available, the buccal epithelium is an interesting alternative to blood, as it is easily accessible and inexpensive.\n\nThe objective of our study is to evaluate the diagnostic yield of high-depth exome sequencing technology on a DNA extracted from a buccal swab in the etiological assessment of patients with IDD or syndromic NDD whose reference analysis (genome sequencing on blood) proved inconclusive.",[110,111],"Neurodevelopmental Disorders","Intellectual Developmental Disorder","2026-04-09",{"date":114,"type":32},"2026-04-14",{"date":116,"type":21},"2026-04-01",{"date":118,"type":21},"2029-04-01",{"name":38,"class":39},{"id":121,"slug":122,"hasResults":12,"nctId":123,"briefTitle":124,"officialTitle":124,"acronym":125,"eligibilityCriteria":126,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":127,"targetDuration":4,"studyType":53,"phases":129,"briefSummary":130,"conditions":131,"keywords":133,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":143},"100577270","identification-of-innovative-biomarkers-to-predict-outcomes-in-hepatocellular-carcinoma-treated-with-tremelimumab-and-durvalumab-100577270","NCT06796114","Identification of Innovative Biomarkers to Predict Outcomes in Hepatocellular Carcinoma Treated With Tremelimumab and Durvalumab","PREDICT-HCC","Inclusion Criteria:\n\n1. Signed informed consent\n2. Histologically confirmed hepatocellular carcinoma\n3. Locally advanced, metastatic, or unresectable disease\n4. Patient who had not previously received systemic anti-cancer treatment and are eligible to STRIDE therapy according to investigator decision in routine care and who have no contraindications to STRIDE treatment according to approved product label.\n5. Measurable disease defined according to RECIST v1.1 guidelines (Note: Previously irradiated lesions can be considered as measurable disease only if disease progression has been unequivocally documented at that site since radiation.)\n6. Age ≥ 18 years\n7. Patient affiliated to or beneficiary of French social security system\n8. Ability to comply with the study protocol, in the Investigator's judgment.\n\nExclusion Criteria:\n\n1. Patients previously exposed to anti-tumor immunotherapy as anti-PD-1, anti-PD-L1, or anti-CTLA4 agent or any immune therapy.\n2. Patient with any medical or psychiatric condition or disease, which would make the patient inappropriate for entry into this study\n3. Patient under guardianship, curatorship or under the protection of justice",{"count":128,"type":21},120,[55],"Several cancer immunotherapies that target the PD-L1\u002FPD-1 pathway (i.e., checkpoint inhibitors) show promising clinical activity in patients with HCC. In particular, atezolizumab selectively targets PD-L1 to prevent interaction with receptors PD-1 and B7-1, thus reversing T-cell suppression. Moreover, atezolizumab in combination with bevacizumab, a monoclonal antibody that targets VEGF and inhibits angiogenesis, is associated with an objective response rate of 27.3% (Cheng et al. 2021; Finn et al. 2020). This tumor response has led to FDA (Food and Drug Administration) and EMA (European Medicines Agency) approvals, in first-line treatment in unresectable HCC.\n\nCombinations studies evaluating anti-CTLA4 and anti-PD1\u002FPDL1 antibodies displayed greater benefits (Abou-Alfa et al. 2022). In the Phase 3 HIMALAYA study (NCT03298451) in uHCC, a single priming dose of tremelimumab (anti-CTLA-4) plus durvalumab (anti-PD-L1) in the STRIDE (Single Tremelimumab Regular Interval Durvalumab) regimen significantly improved OS versus sorafenib; durvalumab monotherapy was noninferior to sorafenib for OS.\n\nIn the HIMALAYA study, STRIDE regimen induced long term survival (defined as the absence of progression above 36 months following inclusion) in 103 out of the 393 patients exposed to this strategy (26%).\n\nThe identification of biomarkers allowing the prediction of immunotherapy efficacy in HCC is still an unmet medical need.",[132],"Hepatocellular Carcinoma",[134],"biomarker, immunotherapy","2026-03-13",{"date":137,"type":32},"2026-03-16",{"date":139,"type":32},"2025-06-25",{"date":141,"type":21},"2030-01-31",{"name":38,"class":39},10,{"id":145,"slug":146,"hasResults":12,"nctId":147,"briefTitle":148,"officialTitle":148,"acronym":149,"eligibilityCriteria":150,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":151,"targetDuration":4,"studyType":53,"phases":153,"briefSummary":154,"conditions":155,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":157,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":163},"100546661","identification-of-biomarkers-associated-with-the-presence-of-malignant-pancreatic-lesions-compared-to-benign-lesions-100546661","NCT06397846","Identification of Biomarkers Associated With the Presence of Malignant Pancreatic Lesions Compared to Benign Lesions.","PANORAMA","Inclusion Criteria:\n\n* Men and women ≥18 years\n* Patient followed for benign pancreatic lesions:\n\nchronic pancreatitis acute pancreatitis at a distance from the acute episode (\\> 4 weeks) with indication for echo-endoscopy for suspected precancerous pancreatic lesions (PanIN, TIPMP, mucinous cystadenomas) or other cystic lesions (serous cystadenomas)\n\nExclusion Criteria:\n\n* Malignant pancreatic tumor\n* Legal incapacity or limited legal capacity",{"count":152,"type":21},100,[55],"The challenge for medical oncology is to develop plasma biomarkers that can detect the influence of the stroma on diagnosis, prognosis and response to chemotherapy.\n\nToday, there is no validated blood test to help diagnose pancreatic cancer (PDAC). The search for blood biomarkers of the tumor stroma and immunological markers is therefore a major challenge in orienting the diagnosis towards PDAC and optimizing the therapeutic management of pancreatic cancers.\n\nThe aim of the study is to identify biomarkers associated with the presence of malignant pancreatic lesions (patients from the Pancreas-CGE cohort, a cohort already set up by our team) compared with benign lesions (patients followed up for benign pancreatic lesions). Candidate biomarkers from our preliminary work will be considered initially. Other biomarkers may be explored secondarily.\n\nThe ultimate goal is to develop a clinico-biological signature that is as efficient as possible in predicting the presence of malignant pancreatic lesions compared with benign ones.",[156],"Benign Pancreatic Lesion",{"date":137,"type":32},{"date":159,"type":32},"2024-12-11",{"date":161,"type":21},"2027-06",{"name":38,"class":39},2,{"id":165,"slug":166,"hasResults":12,"nctId":167,"briefTitle":168,"officialTitle":169,"acronym":170,"eligibilityCriteria":171,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":172,"targetDuration":4,"studyType":53,"phases":174,"briefSummary":175,"conditions":176,"keywords":177,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":179,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":185},"100479897","phase-2-evaluation-of-the-interest-to-combine-a-cd4-th1-inducer-cancer-vaccine-derived-from-telomerase-and-atezolizumab-plus-bevacizumab-in-unresectable-hepatocellular-carcinoma-100479897","NCT05528952","Evaluation of the Interest to Combine a CD4 Th1-inducer Cancer Vaccine Derived From Telomerase and Atezolizumab Plus Bevacizumab in Unresectable Hepatocellular Carcinoma","Evaluation of the Interest to Combine a CD4 Th1-inducer Cancer Vaccine Derived From Telomerase and Atezolizumab Plus Bevacizumab in Unresectable Hepatocellular Carcinoma: a Proof of Concept Randomized Phase II Study (TERTIO - Prodige 82)","TERTIO","Main inclusion Criteria:\n\n1. Signed informed consent\n2. Histologically confirmed hepatocellular carcinoma\n3. Locally advanced, metastatic, or unresectable disease\n4. Patient who had not previously received systemic anti-cancer treatment\n5. Age ≥ 18 years\n6. Measurable disease defined according to mRECIST guidelines (Note: Previously irradiated lesions can be considered as measurable disease only if disease progression has been unequivocally documented at that site since radiation.)\n7. Patients who have received previous chemoembolization, radioembolization and\u002For radiotherapy should have recovered from any treatment related toxicity, to a level of ≤ grade 1 (according to National Cancer Institute \\[NCI\\] common terminology criteria for adverse events, version 5 (CTCAE v5) with the exception of Grade 2 alopecia\n8. Performance status \\\u003C 2\n9. Child-Pugh Class A status\n10. BCLC C stage or BCLC B stage not eligible to loco-regional therapy according to the Barcelona Clinic Liver Cancer (BCLC) staging system\n\nMain exclusion Criteria:\n\nNon-eligible to a clinical trial:\n\n1. Patients previously exposed to anti-tumor immunotherapy as anti-PD-1, anti-PD-L1, or anti-CTLA4 agent or any immune therapy.\n2. Diagnosis of additional malignancy within 3 years prior to the inclusion with the exception of curatively treated basal cell carcinoma of the skin and\u002For curatively resected in situ cervical or breast cancer\n3. Patient with any medical or psychiatric condition or disease, which would make the patient inappropriate for entry into this study\n4. Current participation in a study of an investigational agent or in the period of exclusion\n5. Patient under guardianship, curatorship or under the protection of justice\n\n   Cancer-specific exclusion criteria:\n6. Know fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC\n7. Uncontrolled pleural effusion, pericardial effusion, ascites or symptomatic fistula\n8. Uncontrolled tumor-related pain: exposing patients to risk of exposure to corticoids or iterative hospitalizations. Symptomatic lesions amenable to palliative radiotherapy should be treated prior to inclusion. Patients should be recovered from the effects of radiation. There is no required minimum recovery period\n9. Known active central nervous system metastases and\u002For carcinomatous meningitis. Subject with previously treated brain metastases and with radiological and clinical stability are allowed\n\n   Non-eligible to treatment:\n10. History of encephalopathy\n11. Prior bleeding event due to untreated or incompletely treated esophageal and\u002For gastric varices within 6 months prior to randomization\n12. Inadequate organ functions: known cardiac failure of unstable coronaropathy, respiratory failure, or uncontrolled infection or another life-risk condition",{"count":173,"type":21},105,[83],"The TERTIO trial will propose to determine the clinical interest and immunological efficacy of a treatment combining the CD4 helper T-inducer cancer anti-telomerase vaccine (UCPVax) with anti-PD-L1 therapy (atezolizumab) and bevacizumab in unresectable HCC by evaluation of the objective response rate at 6 months (randomized phase II, 10 centers, 105 patients)",[132],[178],"CD4 Th1-inducer cancer vaccine",{"date":137,"type":32},{"date":181,"type":32},"2022-09-27",{"date":183,"type":21},"2030-02-27",{"name":38,"class":39},14,{"id":187,"slug":188,"hasResults":12,"nctId":189,"briefTitle":190,"officialTitle":190,"acronym":191,"eligibilityCriteria":192,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":193,"targetDuration":4,"studyType":53,"phases":195,"briefSummary":196,"conditions":197,"keywords":199,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":202,"startDateStruct":203,"completionDateStruct":205,"leadSponsor":207,"locationsCount":208},"100421421","exploratory-study-of-the-relevance-of-a-blood-test-in-the-management-of-patients-in-the-context-of-colorectal-cancer-screening-100421421","NCT04767568","Exploratory Study of the Relevance of a Blood Test in the Management of Patients in the Context of Colorectal Cancer Screening","PREDICT-IRFC","Inclusion Criteria:\n\n* Patients aged more than18 years\n* Cohort A : patients with suspected colorectal cancer following a positive immunological test during screening (presence of blood detected in the stool) or with gross bleeding OR Cohort B : patients who have already performed colonoscopy (on symptoms, or because of family history, or other ...), for whom the diagnosis of adenocarcinoma was identified by pathology prior to surgery, candidates for surgery on their colorectal tumor\n* Signed and dated informed consent\n* Patient affiliated to or beneficiary of French social security system.\n\nExclusion Criteria:\n\n* Vulnerable persons according to the law (minors, adults under protection, persons deprived of liberty ...)\n* Not ability to comply with the study protocol, in the Investigator's judgment\n* pregnant woman\n* Patient in the period of exclusion of another study",{"count":194,"type":21},400,[55],"Colorectal cancer (CRC) is the third most common cancer in men and the second in women with an incidence of 43,350 new cases in 2018. This incidence is increasing every year.\n\nEarly detection is crucial in this pathology. In France, free screening is organized by health insurance for people aged 50 to 74 years. This screening is based on an immunological test (FIT: Fecal Immunological test), which aims to detect the presence of blood in the stool. In fact, some polyps or cancers cause bleeding that is often minimal and therefore difficult or even impossible to detect with the naked eye.\n\nIf this test is positive, a colonoscopy is done to check whether or not abnormalities are present in the colon or rectum. Performed under anesthesia, this examination can detect the possible presence of polyps or cancer.\n\nRecently, with the covid-19 epidemic, the investigators were faced with an extension of the delays for colonoscopies which led to delays in patient care.\n\nTo prevent this, they propose to develop a blood test that would allow rapid identification of patients with colorectal cancer, requiring rapid management.\n\nThis blood test will permit to have a parameter for stratifying the therapeutic care in the event of epidemia or situation that constrains the organisation of the health system.",[198],"Colorectal Cancer",[200,201],"blood test","early detection",{"date":137,"type":32},{"date":204,"type":32},"2021-03-30",{"date":206,"type":21},"2032-08",{"name":38,"class":39},3,{"id":210,"slug":211,"hasResults":12,"nctId":212,"briefTitle":213,"officialTitle":214,"acronym":215,"eligibilityCriteria":216,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":217,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":219,"conditions":220,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":225,"completionDateStruct":227,"leadSponsor":229,"locationsCount":4},"100628887","the-envscore-aorte-diagnostic-study-protocol-for-the-identification-of-acute-aortic-syndrome-100628887","NCT07467486","The EnvScore-Aorte Diagnostic Study Protocol for the Identification of Acute Aortic Syndrome","Diagnostic Performance of a Modified AORTAs Score Integrated With Environmental Exposure Data for Acute Aortic Syndrome Identification : The EnvScore-Aorte Diagnostic Study Protocol","EnvScore Aorte","Inclusion Criteria (Cases - AAS+) :\n\n* Adults (\\>18 years)\n* Diagnosis of AAS (aortic dissection, intramural hematoma, or penetrating atherosclerotic ulcer) identified according to medicalization programs for information systems\n* Diagnosis confirmed by imaging (CTA, TTE, or TOE)\n\nInclusion Criteria (Controls - AAS-):\n\n* Adults (\\>18 years)\n* Presenting in the emergency department for chest, back, or abdominal pain.-\n* Confirmed differential diagnosis by CTA, ruling out AAS\n\nExclusion Criteria:\n\n* Post-traumatic or iatrogenic AAS.\n* Subacute (8-30 days) or chronic symptoms (\\>30 days).\n* Patients under legal protection or unable to provide consent\u002Fnon-opposition.",{"count":218,"type":21},580,"The goal of this retrospective observational study is to evaluate the diagnostic performance of the AORTAs score integrated with environmental exposure data (AORTAs-E) for the identification of Acute Aortic Syndrome (AAS) during initial maangement in the emergency departement.\n\nThe main question it aims to answer is:\n\nCan the integration of real-time meteorological and atmospheric pollution data improve the early identification of AAS in patients presenting in the emergency department for chest, abdominal, or back pain?\n\nResearchers will analyze medical records and environmental data for 580 adult patients (290 cases with confirmed AAS and 290 controls) managed at the University Hospital of Besançon between 2014 and 2026. Environmental exposure, including temperature and pollutant concentrations, will be calculated based on each patient's residential address to determine if adding these factors to clinical data increases diagnostic accuracy.",[221],"Acute Aortic Syndrome","2026-03-09",{"date":224,"type":32},"2026-03-12",{"date":226,"type":21},"2026-04",{"date":228,"type":21},"2028-12",{"name":38,"class":39},{"id":231,"slug":232,"hasResults":12,"nctId":233,"briefTitle":234,"officialTitle":234,"acronym":235,"eligibilityCriteria":236,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":237,"targetDuration":4,"studyType":53,"phases":239,"briefSummary":240,"conditions":241,"keywords":243,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":248,"lastUpdatePostDateStruct":249,"startDateStruct":251,"completionDateStruct":253,"leadSponsor":255,"locationsCount":40},"100626621","vexus-rea--evaluation-of-ultrasound-parameters-of-venous-congestion-in-patients-in-a-medical-intensive-care-unit-100626621","NCT07438015","VEXUS-REA : Evaluation of Ultrasound Parameters of Venous Congestion in Patients in a Medical Intensive Care Unit","VEXUS-REA","Inclusion Criteria:\n\n* Patients admitted to medical intensive care at Besançon Teaching Hospital for any reason.\n* Aged over 18.\n* Affiliated with a French social security scheme or beneficiary of such a scheme.\n* No objection to participating in the study.\n\nNon-inclusion criteria :\n\n* Minors\n* Pregnant women and breastfeeding mothers\n* Persons deprived of their liberty by judicial or administrative decision; persons undergoing compulsory psychiatric treatment; persons admitted to a health or social care institution for purposes other than research\n* Adults subject to legal protection measures or unable to give their consent\n* Subjects who are excluded from another study or listed in the 'national volunteer registry'.\n\nExclusion Criteria:\n\n\\- Portal vein, suprahepatic or femoral vein thrombosis at the time of ultrasound examination.",{"count":238,"type":21},525,[55],"Shock is a common and serious cause of admission to intensive care. Vascular filling is one of the cornerstones of shock treatment, aimed at increasing cardiac output and restoring adequate organ perfusion through rapid intravenous administration of a solution. However, this vascular filling can be accompanied by venous congestion, which can be harmful. Fluid administration must therefore be sparing and carefully considered.\n\nHowever, it is difficult to assess the correct amount of intravenous fluid to inject. Multi-site venous ultrasound (inferior vena cava, suprahepatic vein, portal vein, renal vein), recently published under a score called VExUS, could be a useful bedside tool for documenting venous congestion and avoiding excessive vascular filling. Nevertheless, this tool has been little evaluated in the general intensive care population, particularly in patients with acute respiratory distress syndrome (ARDS). Its link with other venous sites (femoral, popliteal) has also been little studied to date.\n\nThe main objective of our study is to describe the distribution of the VEXUS score among patients in a general intensive care unit.\n\nThe secondary objectives are:\n\n* To study the feasibility of measuring the VEXUS score in patients with ARDS, including during prone positioning, a recommended and frequently used treatment for this condition, which could make it difficult to acquire venous ultrasound data.\n* In this case, other more accessible venous flows could be analysed, namely the femoral venous flow and the popliteal venous flow. We will therefore also study their feasibility during prone positioning sessions.\n* Subsequently, we will study the correspondence between the VEXUS score and these other types of venous flow (femoral, popliteal).\n* Finally, we will evaluate the association between the VEXUS score in our general intensive care population and the long-term prognosis of patients, in this case death on day 28 and the occurrence of acute renal failure requiring renal replacement therapy during the intensive care stay.",[242],"Venous Congestion",[244,245,246,247],"VExUS score","venous congestion","femoral venous flow","popliteal venous flow","2026-02-20",{"date":250,"type":32},"2026-02-27",{"date":252,"type":21},"2026-03-01",{"date":254,"type":21},"2026-10-01",{"name":38,"class":39},{"id":257,"slug":258,"hasResults":12,"nctId":259,"briefTitle":260,"officialTitle":260,"acronym":261,"eligibilityCriteria":262,"healthyVolunteers":49,"sex":17,"minAge":18,"maxAge":263,"enrollmentInfo":264,"targetDuration":4,"studyType":53,"phases":266,"briefSummary":267,"conditions":268,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":271,"lastUpdatePostDateStruct":272,"startDateStruct":274,"completionDateStruct":276,"leadSponsor":278,"locationsCount":40},"100624574","assessment-and-characterization-of-sleep-among-video-game-adult-players-without-video-game-use-disorder--a-feasability-study-100624574","NCT07411404","Assessment and Characterization of Sleep Among Video Game Adult Players Without Video Game Use Disorder : a Feasability Study","SLEEPLAY","Inclusion Criteria:\n\n* Women and men aged 18 to 40\n* Signed informed consent form\n* For regular gamers: playing video games at least 3 times a week in the past 2 years, with IGDT-10 (Ten-Item Internet Gaming Disorder Test) \\> 5\n* For control group: non-player or occasional player (at least once in the previous year, but less than once a month)\n\nExclusion Criteria:\n\n* Night worker\n* WIth treatment for sleep disorder or interfering with melatonin secretion (betablokers, melatonin supplements,some antidepressants)\n* Any pathology leading to circadian rythm disorder, neurological or psychiatric disorder\n* major addiction (any game or gambling disorder) except for coffee and tabacco","40 Years",{"count":265,"type":21},40,[55],"The primary objective of the SLEEPLAY study is to assess the feasibility of a research protocol investigating the impact of video games on sleep in adults. More specifically, this study aims to identify potential barriers, facilitators of participation, and participant adherence to various measurement tools (such as actigraphy and melatonin assays) to validate the protocol for a larger future study. Additionally, it seeks to optimize the recruitment of regular adult gamers and determine the conditions that will enable better collection of objective sleep data. The relevance of this feasibility study lies in its ability to test and refine the methodology, thereby facilitating future research while minimizing costs and implementation time.",[269,270],"Sleep","Video Gamers","2026-02-11",{"date":273,"type":32},"2026-02-13",{"date":275,"type":32},"2025-09-29",{"date":277,"type":21},"2027-04",{"name":38,"class":39},{"id":280,"slug":281,"hasResults":12,"nctId":282,"briefTitle":283,"officialTitle":283,"acronym":284,"eligibilityCriteria":285,"healthyVolunteers":12,"sex":286,"minAge":263,"maxAge":4,"enrollmentInfo":287,"targetDuration":4,"studyType":53,"phases":289,"briefSummary":290,"conditions":291,"keywords":294,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":271,"lastUpdatePostDateStruct":298,"startDateStruct":300,"completionDateStruct":302,"leadSponsor":304,"locationsCount":40},"100625059","interest-of-adaptated-physical-activity-apa-on-the-k-recovery-constant-reflecting-the-rate-of-muscle-oxygenation-recovery-in-menopausal-women-suffering-from-depression-100625059","NCT07417709","Interest of Adaptated Physical Activity (APA) on the K Recovery Constant, Reflecting the Rate of Muscle Oxygenation Recovery in Menopausal Women Suffering From Depression","APhyDeM","Inclusion Criteria:\n\n* Menopaused women aged ≥ 40 years old,\n* Suffering from a major depressive episode according to international Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-V)\n* Presenting a score ≥11 on the 16-item Quick Inventory of Depressive Symptomatology Clinician Rating (QIDS-C16) depression scale\n* With a stabilized teatment by antidepressors since at least 4 weeks\n\nExclusion Criteria:\n\n* Medical contraindication for physical activity (cardio-vascular pathology, and\u002For previous cardiac disease)\n* Asthma or other unstabilized condition impairing the ability to perform physical exertion\n* Adipose tissue thickness measured on the forearm \\> 12 mm causing muscle oxygenation measurement by NIRS to be non contributive","FEMALE",{"count":288,"type":21},52,[55],"APhyDeM is a randomized controlled study investigating the relationship between adapted physical activity and mitochondrial function in postmenopausal women with major depressive disorder.\n\nDepression is associated with metabolic dysfunction, including alterations in mitochondrial activity and inflammatory processes. Physical activity has been shown to influence mitochondrial function, yet individuals with depression frequently experience reduced physical activity levels.\n\nThis study aims to evaluate whether an adapted physical activity program can improve mitochondrial function compared with a control intervention. Mitochondrial function will be indirectly assessed using near-infrared spectroscopy to measure post-exercise muscle oxygen recovery kinetics.\n\nThe study compares adapted physical activity with a non-physical therapeutic intervention in postmenopausal women receiving care in a psychiatric day hospital setting.",[292,293],"Depression - Major Depressive Disorder","Menopausal Depression",[295,296,297],"postmenopausal women","major depressive disorder","adapted physical activity",{"date":299,"type":32},"2026-02-18",{"date":301,"type":21},"2026-02",{"date":303,"type":21},"2028-11",{"name":38,"class":39},{"id":306,"slug":307,"hasResults":12,"nctId":308,"briefTitle":309,"officialTitle":310,"acronym":311,"eligibilityCriteria":312,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":50,"enrollmentInfo":313,"targetDuration":4,"studyType":53,"phases":314,"briefSummary":315,"conditions":316,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":271,"lastUpdatePostDateStruct":318,"startDateStruct":320,"completionDateStruct":322,"leadSponsor":324,"locationsCount":40},"100570369","effect-of-adapted-physical-activity-on-sleep-quality-in-people-with-alcohol-use-disorder-100570369","NCT06706349","Effect of Adapted Physical Activity on Sleep Quality in People With Alcohol Use Disorder","Study of Adapted Physical Activity's Impact on Sleep's Quality in Alcohol-use Disorder","APhysOH","Inclusion Criteria:\n\n* Subjects aged 18 to 65 years inclusive\n* Present an Alcohol Use Disorder (AUD) with at least 2 positive items as defined by the DSM-5\n* Present a sleep complaint with a score on the Pittsburgh Sleep Quality Index (PSQI) ≥ 5\n* Present active alcohol consumption with at least 6 days of excessive alcohol consumption in the last 4 weeks\n* Speak and understand French\n* Live within 30 minutes of the University Hospital of Besançon\n* Treatment allowed if stabilized for at least 4 weeks\n* Signature of informed consent indicating that the subject has understood the purpose and procedures required by the study and agrees to participate and comply with the requirements and restrictions inherent to the study\n* Signed automobile safety contract:\n\n  1. The participant agrees to hand over the keys to their vehicle if necessary.\n  2. The keys will be returned when the blood alcohol level is below 0.25 mg\u002FL\n  3. The participant agrees to name one or more people to contact in case the medical staff deems the participant unfit to return home alone.\n* Affiliation to a French social security system or beneficiary of such a system\n* Postmenopausal women for at least 24 months, surgically sterilized, or, for women of childbearing age, using an effective method of contraception (oral contraceptives, contraceptive injections, intrauterine devices, double-barrier method, contraceptive patches) (self-reported)\n\nExclusion Criteria:\n\n* Decompensated heart failure\n* Complex ventricular arrhythmias\n* Severe uncontrolled hypertension\n* Pulmonary hypertension (\\>60 mmHg)\n* Myocarditis or acute pericardial effusion\n* Severe obstructive cardiomyopathy\n* Severe and\u002For symptomatic aortic stenosis\n* All acute illnesses\n* All decompensated or unstable chronic conditions\n* Significant malnutrition\n* Extreme fatigue and\u002For manifest physical incapacity\n* Severe anemia\n* Severe intoxication (psychoactive substances)\n* Severe withdrawal syndrome (Cushman \\>7)\n* Relative contraindications for high-intensity physical activities:\n* Chronic respiratory insufficiency on long-term oxygen\n* Severe chronic respiratory conditions\n* Complicated diabetes with severe retinopathy\n* Sickle cell disease\n* Mild intoxication (psychoactive substances)\n* Mild withdrawal syndrome (Cushman \\>2)\n* Musculoskeletal and dermatological limitations: Unhealed traumatic injuries.\n* Musculoskeletal and dermatological limitations: Osteoarticular conditions in acute flare (osteoarthritis, arthritis).\n* Musculoskeletal and dermatological limitations: Diabetes with plantar ulcer.\n* Musculoskeletal and dermatological limitations: Pressure ulcers and evolving or chronic wounds.\n* On the day of signing consent: Blood alcohol concentration \\> 0 mg\u002FL of expired air.\n* On the day of signing consent: If blood alcohol concentration is \\\u003C 0.25 mg\u002FL, the participant may join other therapeutic activities and return home autonomously.\n* On the day of signing consent: If blood alcohol concentration is \\> 0.25 mg\u002FL without clinical signs of intoxication, the participant may join other therapeutic activities and return home accompanied.\n* On the day of signing consent: If blood alcohol concentration is \\> 0.25 mg\u002FL with clinical signs of intoxication, the participant will not join other therapeutic activities. A supervised room placement will be offered, and emergency services may be contacted if intoxication is unusually high (\\>2 g\u002FL).\n* Excessive alcohol consumption ≥ 6 days in the 4 weeks prior to inclusion.\n* Average alcohol consumption \\> 20 g\u002Fday or \\> 100 g\u002Fweek.\n* CIWA score ≥ 9, indicating the need for medication-assisted withdrawal.\n* High physical activity levels according to the Global Physical Activity Questionnaire (GPAQ).\n* Concurrent treatment with disulfiram, melatonin, and beta-blockers.\n* Unstable or recently changed treatments (\\\u003C4 weeks).\n* History of pre-delirium tremens or delirium tremens.\n* Substance use disorder (other than alcohol\u002Fnicotine per DSM-5).\n* Acute psychiatric disorders requiring immediate hospitalization or adjustment of psychotropic medications.\n* Advanced somatic disorders contraindicating physical activity.\n* Lack of signed automobile safety contract.\n* Legal incapacity or refusal to sign consent.\n* No health insurance.\n* Anticipated poor cooperation or difficulty completing the study\n* Pregnant or breastfeeding women.\n* Currently in the exclusion period of another study or listed in the national volunteer registry.",{"count":265,"type":21},[55],"This feasibility study aims to assess interest, recruitment, and adherence to a supervised physical activity (APA) program among individuals with Alcohol Use Disorder (AUD). It also investigates the program's impact on sleep quality and efficiency. Key objectives include evaluating recruitment feasibility, assessing randomization acceptance, quantifying adherence rates, and identifying sensitive sleep assessment tools. The study will explore whether APA improves sleep outcomes in AUD patients with sleep complaints, laying groundwork for larger-scale research.\n\nParticipants will engage in APA sessions, complete sleep assessments (including sleep diaries and psychometric scales), and provide sociodemographic data and past activity adherence.",[317],"Alcohol Use Disorder",{"date":319,"type":32},"2026-02-12",{"date":321,"type":32},"2024-10-17",{"date":323,"type":21},"2027-10",{"name":38,"class":39},{"id":326,"slug":327,"hasResults":12,"nctId":328,"briefTitle":329,"officialTitle":330,"acronym":331,"eligibilityCriteria":332,"healthyVolunteers":12,"sex":17,"minAge":333,"maxAge":4,"enrollmentInfo":334,"targetDuration":4,"studyType":53,"phases":336,"briefSummary":337,"conditions":338,"keywords":340,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":347,"lastUpdatePostDateStruct":348,"startDateStruct":350,"completionDateStruct":351,"leadSponsor":353,"locationsCount":4},"100623142","early-gliflozin-for-elderly-patients-with-acute-decompensated-heart-failure-in-the-emergency-department-100623142","NCT07392788","Early Gliflozin for Elderly Patients With Acute Decompensated Heart Failure in the Emergency Department","Early Gliflozin Treatment in Elderly Patient Hospitalized for Decompensated Chronic Heart Failure Admitted in the Emergency Room - a Feasibility Study","GlifloFastER","Inclusion Criteria:\n\n1. Age ≥ 75 years\n2. ED admission for ADCHF with:\n\n   * Worsening CHF symptoms (dyspnea, fatigue, weight gain, edema)\n   * Objective signs of peripheral\u002Fpulmonary congestion\n   * Elevated natriuretic peptides:\n\n     * Sinus rhythm: BNP ≥ 400 pg\u002FmL or NT-proBNP ≥ 1,600 pg\u002FmL\n     * Atrial fibrillation: BNP ≥ 600 pg\u002FmL or NT-proBNP ≥ 2,400 pg\u002FmL\n   * Need for treatment intensification\n3. Expected hospitalization\n4. No prior gliflozin treatment\n5. Signed informed consent\n\nExclusion Criteria:\n\n* Type 1 diabetes\n* Chronic kidney disease (eGFR \\\u003C 25ml\u002Fmin\u002F1.73m²)\n* Cardiogenic shock\n* Acute coronary syndrome (current or within 30 days)\n* Severe valvular disease requiring surgery\n* Recent\u002Fplanned coronary intervention\n* Known intolerance to study medication\n* Legal protection measure or inability to consent\n* Hospitalization in cardiology department\n* Discharge home or to nursing home","75 Years",{"count":335,"type":21},144,[55],"Background: SGLT2 inhibitors reduce CHF morbidity\u002Fmortality but are underutilized in elderly patients with acute decompensated CHF (ADCHF) admitted outside cardiology departments.\n\nObjective: Assess feasibility of early ED-initiated gliflozin therapy in elderly ADCHF patients.\n\nDesign: Multicenter, randomized, open-label pilot study; N=144 patients (72 per arm) across 6 EDs over 30 months.\n\nPopulation: Age ≥75 years, ED admission for ADCHF (symptomatic worsening, congestion, elevated natriuretic peptides), gliflozin-naïve, requiring hospitalization.\n\nKey Exclusions: Type 1 diabetes, eGFR \\\u003C25 mL\u002Fmin\u002F1.73m², cardiogenic shock, recent ACS, cardiology ward admission.\n\nIntervention:\n\nTreatment: Dapagliflozin 10mg daily within 24h + cardiac nurse telephone follow-up at 1 month Control: Standard care only Primary Outcome: Feasibility (organizational implementation, acceptability, protocol adherence, timeline compliance).\n\nFollow-up: 7-day visit (clinical assessment, NT-proBNP, echocardiography) and 3-month cardiology consultation (mortality, rehospitalization, QoL, biomarkers, safety parameters).",[339],"Acute Heart Failure (AHF)",[341,342,343,344,345,346],"acute heart failure","emergency department","elderly","SGLT2 Inhibitors","Feasibility study","Acute Decompensated Chronic Heart Failure","2026-02-05",{"date":349,"type":32},"2026-02-06",{"date":226,"type":21},{"date":352,"type":21},"2028-02",{"name":38,"class":39},{"id":355,"slug":356,"hasResults":12,"nctId":357,"briefTitle":358,"officialTitle":359,"acronym":360,"eligibilityCriteria":361,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":362,"targetDuration":4,"studyType":53,"phases":364,"briefSummary":365,"conditions":366,"keywords":368,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":375,"lastUpdatePostDateStruct":376,"startDateStruct":378,"completionDateStruct":380,"leadSponsor":382,"locationsCount":383},"100619637","phase-2-evaluation-of-ucpvax-vaccine---pembrolizumab-combined-with-standard-treatment-as-adjuvant-therapy-in-patients-with-unmethylated-mgmt-glioblastoma-100619637","NCT07347210","Evaluation of UCPVax Vaccine +\u002F- Pembrolizumab Combined With Standard Treatment as Adjuvant Therapy in Patients With Unmethylated MGMT Glioblastoma","Evaluation of UCPVax Vaccine +\u002F- Pembrolizumab Combined With Standard Treatment as Adjuvant Therapy in Patients With Unmethylated MGMT Glioblastoma: a Randomized Phase II Trial","MATVAC-1","Inclusion Criteria:\n\n1. Male or female, age ≥ 18 with informed consent signed\n2. Patient with a confirmed histological diagnosis of non-mutated IDH primary glioblastoma (surgical resection or biopsy).\n3. Tumor with unmethylated MGMT promoter status\n4. Patients having completed the concomitant phase of radiotherapy + temozolomide regimen (standard radiotherapy with 60 Gy in 30 fractions or hypofractionated radiotherapy with 40 Gy in 15 fractions), and eligible for the 6 monthly cycles of maintenance temozolomide\n5. Karnofsky Perfomance status (KPS) ≥ 70%\n6. Life expectancy ≥ 3 months\n7. If patient is treated by corticosteroïds (CS), patient must be on stable CS dose for 15 days and total daily dose ≤ 10 mg prednisone, or equivalent\n8. Adequate organ function laboratory values\n9. Females must be using highly effective contraceptive measures, and have a negative pregnancy test prior to the start of dosing if of childbearing potential, or must have evidence of non-childbearing potential by fulfilling one of the following criteria at screening :\n\n   * Post-menopausal is defined as aged more than 50 years and amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatments.\n   * Women under the age of 50 years would be considered postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatments and with luteinizing hormone and follicle stimulating hormone levels in the post-menopausal range for the institution.\n   * Women with documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but tubal ligation.\n\n   Female with childbearing potential must use effective contraception during study treatment and after the end of treatment based on the last study drug administrated: 6 months after the last dose of Temozolomide; 4 months after the last dose of pembrolizumab and 1 month after the last injection of UCPVax.\n10. Male patients with a female partner of childbearing potential should be willing to use barrier contraception and to refrain from donating sperm during the study and and post-treatment based on the last study drug administrated: 3 months after the last dose of temozolomide; 4 months after the last pembrolizumab dose; 1 month after the last UCPVax injection.\n11. Patient affiliated to or beneficiary of French social security system\n12. Ability to comply with the study protocol, in the Investigator's judgment.\n13. Signed and dates informed consent\n\nExclusion Criteria:\n\nPatients will not be eligible for this study for any of the following reasons:\n\nCancer specific exclusion criteria:\n\n1. IDH1 or IDH2 mutated tumor\n2. Presence of extracranial metastasis\n3. Leptomeningeal disease on MRI\n4. Contrast enhancement ≥4 cm (largest diameter on axial T1 sequences) on inclusion MRI\n5. Previous treatment with Carmustine impregnated wafers (GliadelR)\n6. Previous treatment with bevacizumab or other Vascular Endothelial Growth Factor (VEGF) antagonists\n7. Patient with any medical or psychiatric condition or disease, which would make the patient inappropriate for entry into this study.\n\n   Non-eligible to treatment by UCPVax:\n8. Prior therapy with an anti-PD-1, anti-PD-L1, or with an agent directed to another immune checkpoint (e.g. CTLA-4, TIGIT, Lag3…).\n9. Immunosuppressive treatment including CS \\> 10 mg prednisone or equivalent within the previous 2 weeks\n10. Concurrent active Hepatitis B (defined as HBsAg positive and\u002For detectable HBV DNA) and Hepatitis C virus (defined as anti-HCV Ab positive and detectable HCV RNA) infection.\n11. Has a known history of Human Immunodeficiency Virus (HIV) infection.\n12. History of tuberculosis infection\n13. History of (non-infectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease.\n14. Active auto-immune disease that has required a systemic treatment in the past 2 years (i.e. corticosteroïds or immunosuppressors). Replacement therapy (e.g. thyroxine, insulin) is allowed.\n15. Active or history of auto-immune disease or immune deficiency\n16. History of solid organ transplant nor allogenic hematopoietic stem cell transplantation\n17. Hypersensitivity to the active substance temozolomide or to any of the excipients listed (anhydrous lactose, colloidal anhydrous silica, sodium carboxymethyl starch type A, tartaric acid, stearic acid),\n18. Hypersensitivity to dacarbazine (DTIC)\n19. Hypersensitivity to the active substance pembrolizumab or to any of the excipients listed (L-histidine, L-histidine hydrochloride monohydrate, sucrose, polysorbate 80 (E433))\n20. Hypersensitivity to the active substance Montanide\n21. Uncontrolled active systemic fungal, bacterial, viral, or other infection within the previous 4 weeks or requirement for intravenous (IV) antibiotics within the last two weeks\n22. Inadequate hematology and organ functions; known cardiac failure or unstable coronaropathy, respiratory failure or another life threatening condition.\n23. Patient with unresolved non-hematologic toxicities \\> Grade 1 (or \\> Grade 2 if deemed acceptable by the investigator and not considered a safety risk)\n24. Major surgery within 1 month prior randomization or planned during the study\n25. Vaccination with alive attenuated vaccine within 4 weeks prior the first dosing. Patient must agree not to receive live attenuated vaccine including influenza vaccine during the treatment and within 6 months following the last dose of pembrolizumab\n\n    Non-eligible to a clinical trial:\n26. Diagnosis of another malignant tumor within 2 years before randomization except treating resected basocellular carcinoma and carcinoma in situ such as breast cancer, endometrial or cervical carcinoma that have undergone curative therapy.\n27. Current or treatment with another investigational drug within the previous 4 weeks.\n28. Breast-feeding or pregnant women, no effective contraception if risk of conception exists (up to 4 months after end of chemotherapy)",{"count":363,"type":21},98,[83],"Glioblastomas (GBM) are the most frequent brain tumors and one of the most lethal adult cancers despite maximal multimodal therapy. Despite maximal safe resection followed by radiotherapy and temozolomide (TMZ) ± tumor-treating fields, median overall survival for newly diagnosed GBM remains around 18 months and long-term survival is rare, and recurrence is nearly universal. So, the development of new therapeutic strategies is a critical unmet need in GBM.\n\nDespite the limited success of anti-PD(L)-1 therapy, immunotherapy remains a promising option in GBM. Current challenge supports to develop combinatorial therapy approaches considering the particular immune tumor microenvironment in GBM. Anticancer vaccines have shown promising signs of efficacy in GBM but critical factors challenge their efficacy. CD4 T help is of major interest for cancer vaccine effectiveness and for immune checkpoint inhibitors success. We previously designed UCPVax a CD4 T helper-targeted cancer vaccine derived from telomerase (TERT), a very attractive GBM-associated antigen (Adotévi O, J Clin Oncol 2023 ; Laheurte C, Cell Report Med 2025). The induction of robust tumor reactive CD4 T cell response with UCPVax together with TMZ-mediated immune effects will promote recruitment of effectors immune cells into tumor bed creating a more suitable microenvironment for anti-PD-1 action.\n\nThis is a proof-of-concept phase II trial to evaluate the efficacy of maintenance therapy evaluating UCPVax +\u002F- pembrolizumab combined to standard treatment in newly diagnosed unmethylated MGMT glioblastoma. A translational research network will be implemented to better understand the therapeutic efficacy of this combination.",[367],"Primary Glioblastoma",[369,370,371,372,373,374],"GBM","UCPVax","pembrolizumab","cancer vaccine","telomerase","CD4 T cell","2026-01-08",{"date":377,"type":32},"2026-01-16",{"date":379,"type":21},"2026-01",{"date":381,"type":21},"2029-07",{"name":38,"class":39},4,{"id":385,"slug":386,"hasResults":12,"nctId":387,"briefTitle":388,"officialTitle":388,"acronym":389,"eligibilityCriteria":390,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":391,"enrollmentInfo":392,"targetDuration":4,"studyType":53,"phases":393,"briefSummary":394,"conditions":395,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":397,"lastUpdatePostDateStruct":398,"startDateStruct":400,"completionDateStruct":402,"leadSponsor":404,"locationsCount":4},"100614105","diagnostic-contribution-of-early-abdominal-ultrasound-in-the-situation-of-acute-abdomen-of-premature-100614105","NCT07275268","DIAGNOSTIC CONTRIBUTION OF EARLY ABDOMINAL ULTRASOUND IN THE SITUATION OF ACUTE ABDOMEN OF PREMATURE","EchoPrémA","Inclusion Criteria:\n\nPremature under 37 weeks of amenorrhea with an adverse event of special interest such as :\n\n* altered abdomen with bloating or presence of previsouly unknow marked collateral circulation,\n* absence of spontaneous transit (\\> 48 hours),\n* episode of rectal bleeding,\n* repeated regurgitation\u002Fvomiting (during more than 50% of feedings),\n* prolonged fasting (\\>12 hours), OR\n* increase in cardiorespiratory events on continuous monitoring associated with one of the elements listed above.\n\nExclusion Criteria:\n\n* organic malformation detected during prenatal monitoring or discovered in the immediate postnatal period,\n* chromosomal abnormality detected during prenatal monitoring or discovered in the immediate postnatal period,- spontaneous perforation occurring during the first week of life.","36 Weeks",{"count":152,"type":21},[55],"This study will assess the diagnostic contribution of early abdominal ultrasound for acute abdomen in premature newborns.\n\nEarly ultrasound assessment would provide diagnostic assistance, in conjunction with clinical examination and biological testing, in the three main clinical situations encountered with an acute abdomen in premature infants: enterocolitis (digestive translocation of a bacterium secondary to inflammation, local fragility of the digestive tract, associated ischemic phenomena), reflex ileus (decrease in intestinal peristalsis secondary to peritoneal reactivity following inflammatory phenomena) and digestive immaturity (expressed by bloating, regurgitation, absence of spontaneous transit, related to the degree of prematurity).",[396],"Acute Abdomen in Children","2025-11-28",{"date":399,"type":32},"2025-12-10",{"date":401,"type":21},"2025-12",{"date":403,"type":21},"2028-06",{"name":38,"class":39},{"id":406,"slug":407,"hasResults":12,"nctId":408,"briefTitle":409,"officialTitle":410,"acronym":411,"eligibilityCriteria":412,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":413,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":415,"conditions":416,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":420,"lastUpdatePostDateStruct":421,"startDateStruct":423,"completionDateStruct":425,"leadSponsor":427,"locationsCount":4},"100602507","desir-evaluation-of-the-pre-therapeutic-activity-of-dihydropyrimidine-deshydrogenase-dpd-in-patients-with-cancer-andor-renal-failure-100602507","NCT07124403","DESIR. Evaluation of the Pre-therapeutic Activity of Dihydropyrimidine dEShydrogenase (DPD) in Patients With Cancer and\u002For Renal Failure","Evaluation of the Pre-therapeutic Activity of Dihydropyrimidine dEShydrogenase (DPD) in Patients With Cancer and\u002For Renal Failure","DESIR","Inclusion Criteria:\n\n* Signed written informed consent\n* Affiliation to the Social Security System\n* Patients with breast or digestive cancer for whom a fluoroptmidine therapy is being considered\n* OR Patients on dialysis (GFR \\\u003C 10 ml\u002Fmin\u002F1.73 m²)\n* OR Nephrology patients with IR\n\nExclusion Criteria:\n\n* Patient with anemia \\\u003C 8.5 g\u002Fdl\n* Patient with LDH \\> 2 x \\> ULN\n* Legal incapacity or limited legal capacity\n* Subject without health insurance\n* Subject in the exclusion period of another study or in the \"national volunteer file\"",{"count":414,"type":21},742,"Fluoropyrimidine drugs (5-Fluorouracil or 5-FU and its prodrug capecitabine) are a widely used in the treatment of numerous solid tumors in adults. Approximately 85% of administered 5-FU is rapidly catabolized in the liver into inactive dihydrofluorouracil (5-FUH2) by dihydro-pyrimidine dehydrogenase (DPD), leaving only a small fraction of the initial drug for an eventual transformation into cytotoxic metabolites. Impeded DPD activity is associated to an increase of cytotoxic metabolites leading to potentially very severe toxicities.\n\nTo prevent these toxicities, a pre-therapeutic measurement of plasma uracil can help assess DPD activity. Indeed, uracil is an endogenous substrate of DPD and an increase in its plasma concentration may be associated with a decrease in DPD activity. In this case, a reduction of the fluoropyrimidine dose is suggested.\n\nHowever, the investigators observed that uracilemia increased concomitantly to the severity of renal impairment. There are two possible explanations for this observation. Either the renal impairment reduces the renal elimination of uracil from blood, or DPD activity is actually impaired. In both cases, this can explain an increase in plasma uracil concentration.\n\nHowever, the impact on fluoropyrimidine dosage is different in the two cases. If the increase in uracilemia is due to renal impairment, DPD activity remains unaffected and there is no need to reduce the fluoropyrimidine dose. If DPD activity is actually impaired, a reduction in the fluoropyrimidine dose is required. In cases of renal impairment, uracilemia may therefore not be as relevant for DPD assessment as in the absence of renal impairment.\n\nTo assess if DPD activity is actually impede during renal impairment, the DPD activity of Peripheral Blood Mononuclear Cells (PBMCs) will be assessed together with uracilemia in patients with or without renal impairment. As uracilemia decreases after dialysis, the DPD activity of Peripheral Blood Mononuclear Cells (PBMCs) will also be assessed in patient before and after dialysis. Four groups of 50 patients will be studied: patients with normal renal function with hyperuracilemia (uracilemia ≥ 16 ng\u002FmL) or normal uracilemia (uracilemia \\\u003C 16 ng\u002FmL) ; and patients with renal impairment with hyperuracilemia (uracilemia ≥ 16 ng\u002FmL) or normal uracilemia (uracilemia \\\u003C 16 ng\u002FmL).\n\nThe main objective of the study is to describe the distribution of DPD activity in these four populations. The secondary objectives are to determine in normorenal patients the optimal threshold for DPD activity in non-deficient patients, allowing differentiation between deficient and non-deficient patients based on uracilemia ; and to describe in patients with impaired renal function the distribution of uracilemia with respect to the threshold previously described with the aim of verifying the relevance of uracilemia as a marker of DPD activity in such patients.",[417,418,419],"Renal Impairment","Digestive Cancers","Breast Cancer","2025-09-11",{"date":422,"type":32},"2025-09-17",{"date":424,"type":21},"2025-09",{"date":426,"type":21},"2028-09",{"name":38,"class":39},{"id":429,"slug":430,"hasResults":12,"nctId":431,"briefTitle":432,"officialTitle":432,"acronym":433,"eligibilityCriteria":434,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":435,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":437,"conditions":438,"keywords":442,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":447,"lastUpdatePostDateStruct":448,"startDateStruct":450,"completionDateStruct":451,"leadSponsor":453,"locationsCount":40},"100588988","prognosis-of-cirrhotic-patients-admitted-to-the-general-intensive-care-unit-between-2014-and-2024-a-regional-retrospective-multicentre-cohort-study-100588988","NCT06948565","Prognosis of Cirrhotic Patients Admitted to the General Intensive Care Unit Between 2014 and 2024: a Regional Retrospective Multicentre Cohort Study","REACIRRHOSE","Inclusion Criteria:\n\nPatients with cirrhosis over 18 years of age (cirrhosis either histologically proven or diagnosed by hepatologists according to clinical, biological and ultrasound criteria) admitted to intensive care between January 2014 and December 2024.\n\nExclusion Criteria:\n\nNone",{"count":436,"type":21},500,"Ten years after our team's publication, practices have changed considerably in the management of severe cirrhotic patients. This study will analyse these practices in primary care hospitals and in a tertiary centre, and assess the impact of these changes on the prognosis of these patients.\n\nThe following hypotheses will be tested:\n\n* Improvement in intensive care and overall prognosis compared with data from the literature prior to 2014\n* Improved access to liver transplantation compared with the literature prior to 2014\n* Improvement in intensive care unit practices (for example: application of recommendations published by learned societies concerning the intensive care unit management of patients with cirrhosis, access to comfort care, degree of clinical severity on admission to the intensive care unit, etc.).\n* Centre' effect: variability in the phenotype of patients admitted to intensive care depending on the technical facilities available and whether or not the hospital centre has access to TH.",[439,440,441],"Cirrhosis","Intensive Care Medicine","Acute on Chronic Liver Failure(ACLF)",[443,444,445,446],"prognosis","cirrhosis","ICU","ACLF","2025-08-08",{"date":449,"type":32},"2025-08-11",{"date":447,"type":32},{"date":452,"type":21},"2026-12",{"name":38,"class":39},{"id":455,"slug":456,"hasResults":12,"nctId":457,"briefTitle":458,"officialTitle":459,"acronym":460,"eligibilityCriteria":461,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":462,"targetDuration":4,"studyType":53,"phases":464,"briefSummary":466,"conditions":467,"keywords":469,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":473,"lastUpdatePostDateStruct":474,"startDateStruct":476,"completionDateStruct":478,"leadSponsor":479,"locationsCount":40},"100598154","phase-3-evaluation-of-oral-corticosteroid-therapy-in-idiopathic-sudden-unilateral-hearing-loss-100598154","NCT07067801","Evaluation of Oral Corticosteroid Therapy in Idiopathic Sudden Unilateral Hearing Loss.","Evaluation of Oral Corticosteroid Therapy in Idiopathic Sudden Unilateral Hearing Loss; a Randomized, Double Blind, Futility (Non-superiority) Trial.","ECOSUB","Inclusion Criteria:\n\n* Men and women at least 18 years of age\n* ISSNH: idiopathic unilateral sensorineural hearing loss occurring in less than 72 hours, with loss of at least 30dB on 3 consecutive frequencies compared with the norm or the contralateral ear, confirmed on audiogram.\n* Hearing loss beginning no more than 10 days ago\n* Signed informed consent indicating that the subject has understood the purpose and procedures of the study, and agrees to participate in the study and to abide by its requirements and restrictions\n* Affiliation with a French social security scheme or beneficiary of such a scheme\n\nExclusion Criteria:\n\n* Otological medical history, illness or treatment affecting hearing\n* Pregnancy\n* Recurrent ISSNH\n* Contraindication to oral corticosteroids or already treated with long-term corticosteroids\n* Neurological symptoms other than vertigo or tinnitus\n* Persons deprived of liberty by judicial or administrative decision; persons under forced psychiatric care; persons admitted to a health or social establishment for purposes other than research.\n* Adults under legal protection or unable to express their consent\n* Subjects who have been excluded from another study or who are on the \"national volunteer list\".\n* Exclusion criteria during the course of the study : discovery of vestibular schwannoma, or other pathology explaining the SUB, on MRI centered on the internal auditory canals and cerebellopontine angles prescribed as part of routine care.",{"count":463,"type":21},430,[465],"PHASE3","Context: Idiopathic Sudden Sensorineural Hearing Loss (ISSHL) is a rapid-onset, sensorineural hearing loss of unknown etiology. It is one of the most common ENT emergencies, with spontaneous recovery occurring in 32% to 65% of cases. Treatment remains controversial, and the need for treatment itself is debated. Oral corticosteroids (OCS) are commonly used as first-line therapy, although they may have short-term side effects. Intratympanic corticosteroid injections (ITCIs) are an option for patients with contraindications to OCS or as a salvage treatment. The most recent Cochrane review includes three placebo-controlled studies on OCS efficacy (totaling 267 patients): two found no superiority of OCS, while one showed improvement in hearing. These studies are inconsistent and present methodological biases. Therefore, a sufficiently powered study is needed to assess OCS efficacy and establish clear treatment recommendations for ISSHL.\n\nObjectives: Primary Objective: To demonstrate the equivalence of OCS as first-line treatment for ISSHL compared to no treatment, in terms of hearing recovery between days 7 and 10. Secondary Objectives: To assess the effect of OCS versus no treatment on tinnitus, and hearing recovery based on initial severity of ISSHL. To evaluate hearing recovery in patients treated with rescue ITCIs. In the absence of equivalence, to investigate the superiority of OCS over no treatment.\n\nMethods: This multicenter, randomized, controlled equivalence trial will include two arms, each with 215 patients: one receiving OCS and the other a no-treatment control. In the absence of early hearing improvement, ITCIs will be administered regardless of study arm.\n\nPerspective: The goal is to clarify the role of OCS in treating ISSHL and guide the development of updated treatment recommendations.",[468],"Sudden Sensorineural Hearing Loss",[468,470,471,472],"Corticosteroids","Randomized clinical trial","Placebo","2025-07-21",{"date":475,"type":32},"2025-07-24",{"date":477,"type":21},"2025-11",{"date":228,"type":21},{"name":38,"class":39},{"id":481,"slug":482,"hasResults":12,"nctId":483,"briefTitle":484,"officialTitle":484,"acronym":485,"eligibilityCriteria":486,"healthyVolunteers":49,"sex":286,"minAge":18,"maxAge":487,"enrollmentInfo":488,"targetDuration":4,"studyType":53,"phases":490,"briefSummary":491,"conditions":492,"keywords":496,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":473,"lastUpdatePostDateStruct":501,"startDateStruct":503,"completionDateStruct":505,"leadSponsor":506,"locationsCount":208},"100582496","study-of-emotional-regulation-and-underlying-prefrontal-activity-in-binge-eating-disorder-100582496","NCT06864065","Study of Emotional Regulation and Underlying Prefrontal Activity in Binge Eating Disorder","EmoBED","Inclusion Criteria:\n\n* Women between 18 and 60 years old (including 60)\n* Right-handed.\n* For patients only : diagnosed with Binge Eating Desordors according to DSM criteria.\n* Membership of a French social security scheme or beneficiary of such a scheme.\n* Non-opposition of the subject to participate in the study.\n\nNon inclusion Criteria:\n\nHealthy volunteers only :\n\n* Suffering from an eating disorder or any other psychiatric disorder.\n* History of bariatric surgery.\n\nAll subjects (healthy volunteers and patients) :\n\n* Rare obesity (genetic or syndromic).\n* Specific addictions (substances or behaviors).\n* Neurological disorders and\u002For history of stroke or head trauma.\n* Presence of lesions, wounds or dermatitis at the sites where the recording devices are applied.\n* Any serious acute or chronic illness other than the pathology under study, or any treatment likely to interfere with the evaluation of the parameter under study.\n* Inability to follow protocol requirements.\n* Subject unlikely to cooperate with the study and\u002For poor cooperation anticipated by the investigator.\n* Subject unable to speak French and\u002For unable to read.\n* Pregnant or breast-feeding women.\n* Persons deprived of their liberty by judicial or administrative decision; persons under compulsory psychiatric care; persons admitted to a health or social institution for purposes other than research.","60 Years",{"count":489,"type":21},80,[55],"The goal of this exploratory, interventional, multicentre study is to compare the prefrontal activity during a negative emotion regulation task in women with Binge-Eating Disorder (BED) and healthy women with and without Emotional Eating (EE).\n\nThe aim of this study is to compare the prefrontal processing of cognitive control of emotions between BED and EE and to compare the emotional processing and emotional experience between BED and EE.\n\nThe study will thus compare four experimental groups: patients with BED, BMI-matched healthy volunteers with EE, BMI-matched healthy volunteers, and healthy volunteers of normal weight without BED.\n\nParticipants will perform a down-regulation task of negative emotions elicited by negative pictures. During this task, their cerebral activity will be recorded using functional near-infrared spectroscopy (fNIRS), as well as their autonomous activity (skin conductance, pulse rate, respiration rate).",[493,494,495],"Binge-Eating Disorder","Emotional Eating","Healthy Volunteers",[493,497,498,499,500,494],"Emotion regulation","fNIRS","Prefrontal cortex","Eating disorder",{"date":502,"type":32},"2025-07-22",{"date":504,"type":32},"2025-06-24",{"date":70,"type":21},{"name":38,"class":39},{"id":508,"slug":509,"hasResults":12,"nctId":510,"briefTitle":511,"officialTitle":511,"acronym":512,"eligibilityCriteria":513,"healthyVolunteers":49,"sex":17,"minAge":18,"maxAge":50,"enrollmentInfo":514,"targetDuration":4,"studyType":53,"phases":516,"briefSummary":517,"conditions":518,"keywords":520,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":524,"lastUpdatePostDateStruct":525,"startDateStruct":527,"completionDateStruct":529,"leadSponsor":530,"locationsCount":40},"100542025","validation-of-a-making-decision-hybrid-ecologic-and-virtual-task-100542025","NCT06337500","Validation of a Making Decision Hybrid (Ecologic and Virtual) Task","LABLife","Inclusion Criteria:\n\n* Men and women aged 18 to 65 inclusive\n* Subjects with no neurological or psychiatric disorders\n* Subjects with no addictive disorder except tobacco\n* Signed informed consent indicating that the subject has understood the purpose and procedures of the study and agrees to participate in the study and to abide by the requirements and restrictions inherent in the study\n* Affiliation with a French social security scheme or beneficiary of such a scheme.\n\nExclusion Criteria:\n\n* Men and women under 18 or over 65 years of age\n* Subjects suffering from a neurological or psychiatric disorder\n* Subjects suffering from an addictive disorder, with the exception of tobacco\n* Legal incapacity or limited legal capacity\n* Subject unlikely to cooperate with the study and\u002For poor cooperation anticipated by the investigator\n* Subject without health insurance\n* Pregnant\n* Subject within the exclusion period of another study or on the \"national volunteer list\".",{"count":515,"type":21},180,[55],"The aim of this study is to validate a new hybrid (ecological + virtual) decision-making tool. The difference in behavior (risky choices) between the \"hybrid\" task and the \"virtual\" task will be evaluated.",[495,519],"Behavior and Behavior Mechanisms",[521,522,523],"decision-making","ecological task","brain activity","2025-07-16",{"date":526,"type":32},"2025-07-18",{"date":528,"type":32},"2024-02-01",{"date":68,"type":21},{"name":38,"class":39},{"id":532,"slug":533,"hasResults":12,"nctId":534,"briefTitle":535,"officialTitle":536,"acronym":537,"eligibilityCriteria":538,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":539,"targetDuration":4,"studyType":53,"phases":540,"briefSummary":542,"conditions":543,"keywords":545,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":548,"lastUpdatePostDateStruct":549,"startDateStruct":550,"completionDateStruct":551,"leadSponsor":553,"locationsCount":40},"100598100","phase-1-neutralizing-interferon-type-1-in-hidradenitis-suppurativa-100598100","NCT07067099","Neutralizing Interferon Type 1 in Hidradenitis Suppurativa","Use of Plasma With Neutralizing Autoantibodies to Type I Interferons in Patients With Severe Refractory Flare-up of Hidradenitis Suppurativa","NIHS-I","Inclusion Criteria:\n\n* Men and women aged over 18\n* Patients with Hidradenitis suppurativa (Hurley stages II-III)\n* Disease affecting at least two distinct anatomical areas,\n* Total count of abscesses (A) and inflammatory nodules (N) ≥ 3\n* IHS4 score ≥ 11\n* Treatment of pain with opioids (≥ 20 mg\u002Fday)\n* Resistance to previous use (for at least 3 months) of systemic antibiotics and TNF inhibitors (infliximab or adalimumab) or anti-IL17 (secukinumab).\n* Vaccinations against SARS-CoV-2 and influenza up to date (or able to be carried out prior to the study procedure)\n* Women using an effective method of contraception\n* Signed informed consent\n\nExclusion Criteria:\n\n* Active viral infection: herpes, VZV, HIV, HBV, HCV\n* Active bacterial infection requiring systemic antibiotics\n* Known allergy to blood components\u002Fplasma proteins\n* Poor myocardial function (increased risk of for transfusion-associated circulatory overload) (symptomatic left ventricular failure and ejection fraction \\\u003C 40%)\n* Pregnant women\n* Subjects with no social security coverage",{"count":52,"type":21},[541],"PHASE1","The purpose of the study is to evaluate the safety and type 1 Interferon (IFN) neutralization in patients with refractory severe Hidradenitis Suppurativa (Hurley stage III) after transfusion of plasma containing high titer anti-IFN-1 autoantibodies.",[544],"Hidradenitis Suppurativa (HS)",[546,547],"Plasma therapy","Neutralizing type-1 interferon autoantibodies","2025-07-04",{"date":524,"type":32},{"date":424,"type":21},{"date":552,"type":21},"2026-09",{"name":38,"class":39},{"id":555,"slug":556,"hasResults":12,"nctId":557,"briefTitle":558,"officialTitle":558,"acronym":559,"eligibilityCriteria":560,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":561,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":563,"conditions":564,"keywords":567,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":548,"lastUpdatePostDateStruct":571,"startDateStruct":573,"completionDateStruct":575,"leadSponsor":577,"locationsCount":40},"100577961","clinical-efficacy-of-platelet-transfusion-100577961","NCT06805097","Clinical Efficacy of Platelet Transfusion","ECLAT","Inclusion Criteria:\n\n* Patients with haematological malignancies or bone marrow aplasia with severe thrombocytopenia due to bone marrow failure related to the disease or treatments received\n* Severe thrombocytopenia requiring transfusion\n* Patient able to self-assess bleeding events\n* Non-opposition of the subject to participate in the study\n* Registered with the French social security system or benefiting from such a system.\n\nExclusion Criteria:\n\n* Acute promyelocytic leukaemia\n* Curative dosage of anticoagulants\n* Treatment with antiplatelet agents\n* Patient with proven thrombocytopenia of immunological origin, or disseminated intravascular coagulation\n* Patients with a clinically significant haemorrhagic event (WHO grade 2) in the 48 hours prior to transfusion\n* Indication for deplasmatised, cryopreserved and reduced-volume PCs\n* Patient refusing transfusion of labile blood products\n* Pregnant women or breast-feeding mothers\n* Adults subject to a legal protection measure or unable to express their consent\n* Persons deprived of their liberty by a judicial or administrative decision; persons under compulsory psychiatric care; persons admitted to a health or social care institution for purposes other than research\n* Subject in the exclusion period of another study",{"count":562,"type":21},343,"The aim of this study is to analyze the effect of the storage time of platelet concentrates on the occurrence of bleeding events during prophylactic platelet transfusions in patients with hematological malignancies.",[565,566],"Thrombocytopaenia","Haematological Malignancies",[568,569,570],"platelet concentrate","transfusion","haemorrhage",{"date":572,"type":32},"2025-07-09",{"date":574,"type":32},"2025-06-17",{"date":576,"type":21},"2028-07",{"name":38,"class":39},{"id":579,"slug":580,"hasResults":12,"nctId":581,"briefTitle":582,"officialTitle":583,"acronym":584,"eligibilityCriteria":585,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":586,"enrollmentInfo":587,"targetDuration":4,"studyType":53,"phases":589,"briefSummary":590,"conditions":591,"keywords":594,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":548,"lastUpdatePostDateStruct":596,"startDateStruct":597,"completionDateStruct":599,"leadSponsor":601,"locationsCount":383},"100536058","influence-of-sodium-intake-in-spondyloarthrites-100536058","NCT06259890","Influence of Sodium Intake in spondyLoarthriTes","Sodium Intake in spondyLoarthriTes: Analysis of the Influence on the Activity of the Disease and the Therapeutic Response to Anti IL-17A Agents.","SALT","Inclusion Criteria:\n\n* patients with axial spondyloarthritis (radiographic or non-radiographic) or psoriatic arthritis\n* women who have been menopausal for at least 24 months, surgically sterilized, or, for women of childbearing potentiale, use an effective method of contraception (oral contraceptives, contraceptive injections, intrauterine devices, double-barrier method, contraceptive patches)\n\nExclusion Criteria:\n\n* patient treated by cyclosporine, diuretics, angiotensin-converting enzyme inhibitors or angiotensin II receptor antagonists.\n* current treatment with an anti-IL-17A agent (secukinumab or ixekizumab or bimekizumab or brodalumab) or with an anti-IL23 agent (ustekinumab, guselkumab, risankizumab or tildrakizumab) or previous treatment less than 6 months old.\n* patients on systemic corticosteroids with corticosteroid therapy \\> 10 mg prednisone equivalent\n* pregnant woman","80 Years",{"count":588,"type":21},250,[55],"The aim of the SALT study is to analyze the relationship between dietary sodium intake and disease activity in patients with axial spondyloarthritis (radiographic or non-radiographic) or psoriatic arthritis.",[592,593],"Spondyloarthritis, Axial","Arthritis, Psoriatic",[595],"Sodium intake",{"date":572,"type":32},{"date":598,"type":32},"2024-01-30",{"date":600,"type":21},"2027-05",{"name":38,"class":39},{"id":603,"slug":604,"hasResults":12,"nctId":605,"briefTitle":606,"officialTitle":607,"acronym":608,"eligibilityCriteria":609,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":586,"enrollmentInfo":610,"targetDuration":4,"studyType":53,"phases":612,"briefSummary":613,"conditions":614,"keywords":617,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":548,"lastUpdatePostDateStruct":619,"startDateStruct":620,"completionDateStruct":622,"leadSponsor":624,"locationsCount":40},"100425218","evaluation-of-mood-disorders-under-biologics-in-chronic-inflammatory-rheumatic-disease-100425218","NCT04817072","Evaluation of Mood Disorders Under Biologics in Chronic Inflammatory Rheumatic Disease","Evaluation of Mood Disorders Under Biologics (Anti-TNF Alpha) in Chronic Inflammatory Rheumatic Disease","EMOTION","Inclusion Criteria:\n\n* Adult patients (≥18 ; ≤ 80)\n* Patient with rheumatoid arthritis (RA) according to the ACR 2010 criteria, axial or peripheral spondyloarthritis (SpA) according to ASAS criteria, ankylosing spondylitis (AS) according to the New York criteria or psoriatic arthritis (PsA) according to CASPAR criteria\n* Signature of informed consent\n* Affiliation to a French social security or receiving such a scheme\n\nExclusion Criteria:\n\n* Patient having previously received anti-TNFα treatment\n* Patient with previously diagnosed depressive or psychiatric pathology and \u002F or receiving anti-depressant treatment\n* Subjects with limited legal capacity.\n* Subjects judged by the investigator to be unlikely to comply with study procedures\n* Subjects with no social security coverage.\n* Pregnant women.\n* Subjects still in the exclusion period of another study, or according to the national registry of clinical trial participants.",{"count":611,"type":21},108,[55],"Chronic inflammatory rheumatic diseases (CIRD) affect many organ systems. Painful sensations within the joints spine, hand and foot deformities, low quality of life and psychosocial status in patients with rheumatoid arthritis, spondyloarthritis and psoriatic arthritis can lead to the development of anxiety and depression. Prevalences of anxiety increase in patients suffering of CIRD, compared with healthy individuals. Another connection has been identified by the links between depression and systemic inflammation. It is proven that higher plasma levels of pro-inflammatory cytokines such as tumor necrosis factor alpha (TNFa) affect neurotransmitter metabolism, with influence on patients mood. The purpose of EMOTION study is therefore to analyze thymic variation under TNFa therapy, as treatment of CIRDs.",[615,616],"Rheumatic Diseases","Mood Disorders",[618],"TNF alpha inhibitor",{"date":572,"type":32},{"date":621,"type":32},"2021-05-19",{"date":623,"type":21},"2026-05",{"name":38,"class":39},""]