[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Assistance Publique Hopitaux De Marseille\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":642},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,118,0,25,[9,44,69,97,123,152,179,206,228,255,277,307,332,364,386,412,441,465,484,507,526,554,581,603,622],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":18,"sex":19,"minAge":20,"maxAge":21,"enrollmentInfo":22,"targetDuration":4,"studyType":25,"phases":26,"briefSummary":28,"conditions":29,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100331862","application-of-ihmt-mri-in-multiple-sclerosis-100331862",false,"NCT03600779","Application of ihMT MRI in Multiple Sclerosis","Application of the Inhomogeneous Magnetisation Transfer MRI (ihMT) Technique, a New Myelin-specific MRI Technique, in Multiple Sclerosis","ihMTMS","Inclusion Criteria:\n\n* For Patients and Controls :\n\n  * Adult patient, male and female, age 18 to 45\n  * Patient affiliated with health insurance coverage,\n  * Patient who signed a free and informed consent after receiving detailed, understandable and honest information,\n* For patients only :\n\n  * Patient with relapsing-remitting multiple sclerosis according to the McDonald 2010 criteria or progressive\n  * Patients treated or not treated with first-line disease modifying therapy\n  * Detection of at least one post-Gadolinium injection active lesion identified on the initial brain MRI (T0) or a chronic active lesion (PRL: Paramagnetic rim lesions)\n\nExclusion Criteria:\n\n* For patients only :\n\n  • Patients with a progressive form of MS other than the early relapsing-remitting form (primary progressive or secondary progressive)\n* For Patients and Controls :\n\n  * Patients with the usual contraindications for MRI (pacemaker, agitation, metal shards, claustrophobia)\n  * Patients at risk of non-compliance to the exam: basic problems with understanding, confusion, involuntary movements, poor tolerance of prolonged supine position\n  * Patients who are unable to give their consent: problems with understanding, lack of vigilance, confusion\n  * Woman who is pregnant and breastfeeding\n  * Patients with a history of neurological or psychiatric condition\n  * Patients under guardianship or trusteeship",true,"ALL","18 Years","45 Years",{"count":23,"type":24},85,"ESTIMATED","INTERVENTIONAL",[27],"NA","The development of in vivo biomarkers sensitive to myelin disruption represents a major clinical need to be able to monitor the demyelination processes as well as the effect of remyelinating therapies in multiple sclerosis. The investigators recently proposed a technique, derived from the conventional magnetisation transfer (MT): inhomogeneous Magnetisation Transfer (ihMT). In preliminary studies, this simple-to-implement and robust technique has shown great sensitivity for evaluating the demyelination processes. The goal of the project is to evaluate the ability of ihMT to measure and describe the spontaneous demyelination and remyelination processes involved in active lesions in a population of patients with MS at the the disease onset.",[30],"Sclerosis, Multiple","RECRUITING","2026-08-04",{"date":34,"type":35},"2026-08-06","ACTUAL",{"date":37,"type":35},"2018-06-14",{"date":39,"type":24},"2028-08-14",{"name":41,"class":42},"Assistance Publique Hopitaux De Marseille","OTHER",1,{"id":45,"slug":46,"hasResults":12,"nctId":47,"briefTitle":48,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":25,"phases":53,"briefSummary":54,"conditions":55,"keywords":58,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":43},"100603297","implementation-of-a-joint-pulmonologist-and-ent-consultation-in-the-care-pathway-of-patients-suffering-from-asthma-and-chronic-rhinosinusitis-with-nasal-polyposis-effectiveness-compared-with-consultations-by-specialty-con-po-study-100603297","NCT07134686","Implementation of a Joint Pulmonologist and ENT Consultation in the Care Pathway of Patients Suffering From Asthma and Chronic Rhinosinusitis With Nasal Polyposis: Effectiveness Compared With Consultations by Specialty (CON-PO Study).","CON-PO","Inclusion Criteria:\n\n* Male or female, 18 years of age or older;\n* With a diagnosis of asthma;\n* With a diagnosis of chronic rhinosinusitis with nasal polyposis;\n* Whose asthma and\u002For chronic rhinosinusitis is\u002Fare not controlled according to SNOT-22 and ACQ-6 scores;\n* Having used systemic corticosteroids in the previous year to treat symptoms related to one of these conditions at least;\n\nExclusion Criteria:\n\n* Patient in a period of exclusion from another research protocol at the time of consent signature;\n* Subjects covered by articles L1121-5 to 1121-8 of the French Public Health Code (adult patients under guardianship or curatorship, patients deprived of their liberty, pregnant or breast-feeding women);\n* Patients who do not read and\u002For understand French",{"count":52,"type":24},195,[27],"Asthma affects the lower respiratory tract (bronchi), whereas chronic rhinosinusitis with nasal polyposis (CRSwNP) involves the upper airways. Despite this anatomical distinction, the upper and lower airways form a continuous respiratory tract and share common pathophysiological mechanisms. Consequently, asthma and CRSwNP frequently coexist, and several therapeutic strategies are effective for both conditions.\n\nGiven these overlaps, we hypothesize that a multidisciplinary consultation involving both a pulmonologist and an ENT specialist could be more effective than separate consultations for patient care. We also believe that this innovative organization that would benefit the healthcare system.\n\nTo test this hypothesis, we are conducting a study whose primary objective is to assess whether joint consultations lead to a reduction in oral corticosteroid need over the year following the initial consultation, by enabling more personalized treatment strategies.\n\nSecondary outcomes will include the frequency of asthma exacerbations, frequency of ENT-related events, respiratory symptoms, quality of life, and healthcare ressources utilization.\n\nWe will compare outcomes between two patient groups: one receiving joint consultation from both specialists, and the other managed through standard, separate consultations as per current clinical practice.",[56,57],"Asthma","Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)",[56,59,60],"Care pathway","Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)","2026-07-31",{"date":63,"type":35},"2026-08-03",{"date":65,"type":35},"2026-07-28",{"date":67,"type":24},"2029-11",{"name":41,"class":42},{"id":70,"slug":71,"hasResults":12,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":12,"sex":19,"minAge":4,"maxAge":20,"enrollmentInfo":77,"targetDuration":4,"studyType":25,"phases":79,"briefSummary":80,"conditions":81,"keywords":84,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":43},"100650029","impact-of-ultra-fast-genetic-diagnosis-of-familial-lymphohistiocytosis-on-the-time-to-bone-marrow-transplantation-and-overall-survival-100650029","NCT07741747","Impact of Ultra-fast Genetic Diagnosis of Familial Lymphohistiocytosis on the Time to Bone Marrow Transplantation and Overall Survival","Impact of Ultra-rapid Genetic Diagnosis of Primary Haemophagocytic Lymphohistiocytosis on the Time to Haematopoietic Stem Cell Transplantation","LongRead-HLH","Inclusion Criteria:\n\n* Children under 18 years old\n* Confirmed or suspected diagnosis of FHL or a related genetic syndrome predisposing to HLH (e.g. Griscelli Syndrome, Chédiak-Higashi Syndrome, XLP1, XLP2) or a family history of lymphohistiocytic activation syndrome\n* Presence of at least 5 of the 8 following criteria (diagnostic criteria according to the definition of the \"Histiocyte Society\" (1)):\n\n  1. Fever\n  2. Splenomegaly\n  3. Hypertriglyceridemia ≥ 3 mmol\u002Fl and\u002For hypofibrinogenemia≤ 1.5g\u002Fl\n  4. Hemophagocytosis found in a histological sample\n  5. Decreased or absent NK function (\\\u003C10% of the laboratory normal)\n  6. Ferritin ≥ 500μg\u002Fl\n  7. Soluble CD25 ≥ 2,400U\u002Fml or presence of activated T cells in phenotyping\n  8. Cytopenia (affecting at least two blood cell lines): Haemoglobin \\\u003C 9.0 g\u002Fdl, Platelets \\\u003C100 G\u002FL, Neutrophils \\\u003C1,0 G\u002FL\n* Patient benefiting from social security coverage\n* The legal guardian(s) who have signed the informed consent form\n\nExclusion Criteria:\n\n* Age ≥ 18 years\n* Solid tumor, leukemia, lymphoma\n* Subjects covered by articles L1121-5 to 1121-8 of the public health code (patients under guardianship or curatorship, patient deprived of liberty, pregnant or breadtfeeding woman)\n* Persons who do not understand the French language\n* Patient in the exclusion period of another research protocol at the time of signing the consent form",{"count":78,"type":24},240,[27],"Familial lymphohistiocytosis (FHL) is a group of rare genetic diseases (around fifteen cases per year in France). The defect in T lymphocyte cytotoxicity resulting from this disease is responsible for hemophagocytic lymphohistiocytosis (HLH). Promptly treatment of HLH is essential for prognosis. These diseases are fatal without a bone marrow transplant, with an overall 5-year survival rate of no more than 80% for FHL. The genetic or acquired nature of HLH is not easy to determine. An infectious trigger can be confounding when it occurs in an FHL. But above all, functional biological tests demonstrating a T lymphocyte cytotoxicity defects are difficult to interpret. Genetic diagnosis is therefore essential for confirming the primary nature of HLH, and for initiating targeted treatments (first stage: putting HLH into remission with chemotherapy or immunotherapy; second stage: bone marrow transplant). Genetic diagnosis of FHL is therefore a matter of emergency, and is currently based on targeted gene panel exploration (fragmentation sequencing) requiring 6 to 8 weeks. Recently, the development of third-generation sequencing (TGS) has revolutionized genomic medicine, enabling unitary sequencing in real time. As a result of this innovation, certain private molecular diagnostic specialties can now access this new emergency genomic medicine.\n\nAim: the main aim of this study is to demonstrate the feasibility of a national circuit for ultra-rapid genetic diagnosis of pediatric HLH revealing familial lymphohistiocytosis. The secondary objective is to evaluate the impact of this early genetic diagnosis on the delay to remission of HLH and the delay to transplantation.\n\nMethods: This prospective, multicenter study measures the time required for genetic diagnosis of FHL in pediatric HLH, using innovative TGS sequencing technology.\n\nPerspectives: Fast genomic diagnosis of FHL will considerably shorten the time to confirm the diagnosis, to obtain HLH remission and, finally, to reach transplantation faster.",[82,83],"Familial Lymphohistiocytosis","Lymphohistiocytosis",[83,85,86,87,88],"Rare disease","Fast-genomic","Precision medecin","Bone marrow transplant","NOT_YET_RECRUITING","2026-07-30",{"date":63,"type":35},{"date":93,"type":24},"2026-10",{"date":95,"type":24},"2030-10",{"name":41,"class":42},{"id":98,"slug":99,"hasResults":12,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":103,"eligibilityCriteria":104,"healthyVolunteers":12,"sex":105,"minAge":20,"maxAge":4,"enrollmentInfo":106,"targetDuration":4,"studyType":25,"phases":108,"briefSummary":110,"conditions":111,"keywords":115,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":117,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":4},"100542919","phase-3-autop-2-screen-and-treat-strategy-for-vaginal-flora-abnormalities-by-molecular-biology-in-pregnant-women-at-high-risk-of-preterm-birth-100542919","NCT06349122","AUTOP 2: Screen-and-treat Strategy for Vaginal Flora Abnormalities by Molecular Biology in Pregnant Women at High Risk of Preterm Birth","Screen-and-treat Strategy for Vaginal Flora Abnormalities by Molecular Biology in Pregnant Women at High Risk of Preterm Birth: A Multicentre, Randomized Study (AUTOP 2)","AUTOP 2","* Pregnant woman over 18 years of age;\n* Single intra uterine pregnancy after 8 weeks and before 18 weeks of gestation (i.e. ≥ 8 weeks and ≤ 18 weeks). Woman can present symptomatic vaginal discharge, or can be asymptomatic or symptomatic with regard to the diagnosis of bacterial vaginosis (BV) with usual technics;\n* With a history of :\n\n  * preterm birth before 37 weeks of gestation (even if the preterm birth was following preterm rupture of membranes);\n  * and \u002F or late miscarriage or fetal loss (i.e. miscarriage or foetal loss between 14 and 22 weeks of gestation), even if one any of her last birth occurred at term.\n* Woman having a reliable connexion by phone\n* Woman who has understood the study process and objectives and agreed to sign an informed consent form;\n* affiliated to a social security regimen or equivalent.\n\nAny eligible woman who will agree to participate in the study after being invited must sign a consent form before being included in the study. Women meeting all of these eligibility criteria will be invited even if they have oral or vaginal progestative treatment, cerclage or pessary, partially septate or arcuate uterus.\n\nExclusion Criteria:\n\n* \\- Woman of legal age under legal protection;\n* Women deprived of their freedom for administrative or legal reasons;\n* Woman who has not signed a consent form\n* Nulliparous;\n* Ectopic pregnancy;\n* Non-evolutive pregnancy or IUFD\n* Multiple pregnancy\n* Serious fetal malformation identified at first trimester screening such as cardiopathy, exencephaly, anasarque, gastroschisis, omphalocele, diaphragmatic hernia, cerebral or spinal major anomaly.\n* Woman participating in any clinical trial or intent to participate in another clinical trial, which may have an impact on flora or on prematurity rate, with or without investigational product at any time during the conduct of this study\n* Woman presenting contraindications to the study treatments: Hypersensitivity to the active substance or to any of the excipients\n* Woman presenting uterine malformation ( unicornuate, bicornuate, full septate)\n* Woman with preterm birth history because of twin pregnancy\n* Woman having received anti-infective treatment in the week preceding inclusion","FEMALE",{"count":107,"type":24},1794,[109],"PHASE3","Preterm birth is a major cause of mortality and long-term disability. Bacterial vaginosis (BV) is a frequent form of dysbiosis that is often asymptomatic and increases the risk of preterm birth. BV is usually diagnosed using conventional tools such as the Nugent score. Molecular diagnosis of BV has now been shown to be more reproducible and to provide a more accurate characterization of dysbiosis.\n\nThe main objective of this study is to evaluate the effectiveness of a self screen and treat strategy for vaginal flora dysbiosis, based on molecular point of care (POC) multiplex technology before 18 weeks' gestation, in reducing the rate of preterm birth among pregnant women at high risk, compared with usual care.\n\nThe hypothesis is that a Screen-and-Treat strategy using molecular biology among women with previous preterm or\u002Fand an history of late abortion could be effective in reducing preterm births by 40%.",[112,113,114],"Bacterial Vaginosis","Vaginal Dysbiosis","Premature Delivery",[116],"screen and treat strategy",{"date":63,"type":35},{"date":119,"type":24},"2026-07",{"date":121,"type":24},"2029-06",{"name":41,"class":42},{"id":124,"slug":125,"hasResults":12,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":129,"eligibilityCriteria":130,"healthyVolunteers":12,"sex":19,"minAge":131,"maxAge":20,"enrollmentInfo":132,"targetDuration":4,"studyType":134,"phases":4,"briefSummary":135,"conditions":136,"keywords":138,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":43},"100649830","patient-reported-outcome-measurement-within-the-secured-access-to-innovative-medicines-for-children-with-cancer-sacha-study-100649830","NCT07738601","Patient Reported Outcome Measurement Within the Secured Access to Innovative Medicines for Children With cAncer (SACHA) Study","PRO-SACHA: Patient Reported Outcome Measurement Within the Secured Access to Innovative Medicines for Children With cAncer (SACHA) Study","PRO-SACHA","Inclusion Criteria:\n\n* Aged 2 to 18 years\n* Patients aged 8 to 18 years who can read French, English, or Spanish fluently OR patients aged 6 to 7 years who can read French, English, or Spanish fluently, OR patients aged 2 to 7 years who cannot read fluently but whose parents can read French, English, or Spanish fluently\n* Patients included in the SACHA study before starting treatment\n* Patients with a pediatric tumor or leukemia who have failed treatment or relapsed and have no standard treatment options available OR patients receiving first-line treatment with no standard treatment options available (e.g., inoperable plexiform neurofibroma and MEK inhibitors, infantile fibrosarcoma and NTRK inhibitors)\n* Not eligible for an open early-phase clinical trial in France, or declining participation\n* Treated with a new innovative medicinal product and discussed at a RCCPI meeting under a granted early access authorization or compassionate use authorization issued by the ANSM, or receiving off-label use of a medicinal product already authorized in adults\n* Treated in one of the SFCE centers authorized to prescribe chemotherapy\n* The holders of parental authority have stated their non-opposition to their child's participation in the study after being informed. Minors will receive age-appropriate information adapted to their level of understanding. If the minor is emancipated, they will provide non-opposition directly\n* A patient who is prescribed another innovative therapy and is re-included in SACHA may be included again in PRO-SACHA\n\nExclusion Criteria:\n\n* Patient who has already started the innovative treatment\n* Patients aged 8 years and older who cannot read\n* Patients whose clinical condition does not allow them to report symptoms themselves (i.e., non-communicative patient; judgment left to the investigator's discretion)\n* Patients currently enrolled in an early-phase trial\n* Refusal of participation by the patient or their legal representatives\n* Patient unable to express consent to participate in the study","2 Years",{"count":133,"type":24},72,"OBSERVATIONAL","Patient-Reported Outcomes (PROs) are patient-centered measures used to assess health status, track changes over time, and evaluate the impact of treatment on the patient's perceived health.\n\nThe SACHA study is a French prospective observational study developed by the Société Française de lutte contre les Cancers de l'Enfant et de l'adolescent (SFCE). It prospectively collects real-world safety and activity data on novel therapies given to patients aged 25 or younger with pediatric malignancies (solid tumors or hematologic malignancies) or related conditions, outside of a clinical trial.\n\nThe Symptom Screening in Pediatrics Tool (SSPedi) is a validated questionnaire for measuring patient-reported symptoms in pediatric oncology. It includes 15 questions covering common symptoms in pediatric cancer patients and one open-ended question allowing patients to report any other bothersome symptoms. Patients complete the questionnaire through an online application.\n\nThe PRO-SACHA study aims to describe the symptoms reported by participants receiving novel therapies in pediatric oncology and to examine the concordance between participant-reported symptoms and symptomatic adverse events (AEs) reported by investigators.\n\nThis prospective observational study evaluates patient-reported symptoms in patients aged 2 to 18 years enrolled in the SACHA study. Participation is voluntary, based on an opt-out consent model (French category 3 interventional research involving the human person).\n\nPlanned enrollment: 72 participants over 18 months, with each participant followed for 7 months (a 6-month follow-up period, with a 7th-month window for questionnaire completion). Participants are enrolled in PRO-SACHA at the same time as their enrollment in SACHA (two separate studies with separate enrollment).\n\nSSPedi responses (a self-report questionnaire capturing symptoms experienced by patients) are collected electronically through an online application. The extracted, anonymized data are then correlated with adverse events reported by investigators. The concordance between participant-reported symptoms and adverse events recorded in SACHA (CTCAE grading) will be analyzed.",[137],"CNS Tumor, Childhood",[139,140,141,142,143,144],"Cancer","Patient Reported Outcomes","Pediatric malignancies","Off-label therapies","Innovative cancer therapies","Real-world evidence","2026-07-27",{"date":61,"type":35},{"date":148,"type":24},"2026-09",{"date":150,"type":24},"2029-07",{"name":41,"class":42},{"id":153,"slug":154,"hasResults":12,"nctId":155,"briefTitle":156,"officialTitle":157,"acronym":158,"eligibilityCriteria":159,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":160,"targetDuration":4,"studyType":25,"phases":162,"briefSummary":164,"conditions":165,"keywords":167,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":177,"locationsCount":178},"100648385","phase-4-safety-and-efficacy-of-a-stopping-strategy-versus-classical-maintenance-dose-of-jak-inhibitors-in-deep-remission-patients-with-ulcerative-colitis-100648385","NCT07718529","Safety and Efficacy of a STOPping Strategy Versus Classical Maintenance Dose of JAK Inhibitors in Deep Remission Patients With Ulcerative Colitis","Safety and Efficacy of a STOPping Strategy Versus Classical Maintenance Dose of JAK Inhibitors in Deep Remission Patients With Ulcerative Colitis: a Randomized Controlled Trial","STOP","Inclusion Criteria:\n\n1. Diagnosis of UC from at least 6 months according to clinical, endoscopic, histological and\u002For radiological criteria.\n2. Male or female age ≥ 18 years\n3. Currently treated by JAK inhibitor (tofacitinib, upadacitinib or filgotinib) for more than 12 months.\n4. Currently at a stable dose of tofacitinib (5mg or 10mg twice a day), upadacitinib (15mg or 30mg per day) or filgotinib (200mg per day) for 6 months.\n5. Clinical steroid free remission for at least 6 months, defined by a partial Mayo Score \\\u003C 2, with no subscore \\> 1 and rectal bleeding (RB) subscore of 0 (annex 1).\n6. Endoscopic steroid free remission for at inclusion, defined by a Mayo endoscopic subscore = 0 (annex 1).\n7. Fecal calprotectin ≤ 150μg\u002Fg.\n8. Without known risk factors for venous thromboembolism (VTE).\n9. Without known risk factors for major adverse cardiovascular events (MACE).\n10. Without known risk factors for malignancy.\n11. For women of child-bearing potential (WOCBP), and for men with partners who are WOCBP, willingness to use appropriate and efficient contraception, as recommended when using JAK inhibitor treatment (notably upadacitinib), during all the experimental treatment and until at least 4 weeks after the end of the experimental treatment, according to SmPC and CTFG (Clinical Trials Facilitation and Coordination Group) recommendations.\n12. Patients able to understand information provide to them and to give written informed consent for study.\n13. Affiliation to a social security scheme.\n14. Good general health according to history and clinical examination.\n\nExclusion Criteria:\n\n1. Steroid use ≤ 6 months prior to enrolment.\n2. Currently treated by steroid, immunosuppressive agents or biologics.\n3. Pregnancy or planned pregnancy during the study.\n4. Breastfeeding.\n5. Non-compliant subject or inability to follow study protocol.\n6. Intolerance of JAK inhibitors (excipients included) or severe adverse event.\n7. Contraindications to using a JAK inhibitor (excipients included).\n8. Known risk factors for VTE.\n9. Known risk factors for MACE.\n10. Active neoplasia or history of malignant tumours less than 5 years old.\n11. Participation to another interventional study protocol (except for RIPH3 studies)\n12. Severe hepatic insufficiency.\n13. Severe to end-stage renal insufficiency.\n14. Active tuberculosis, serious infections such as septicemia or opportunistic infections.\n15. Absence or refusal of informed consent.\n16. People under guardianship, conservatorship, or judicial protection;\n17. People receiving psychiatric care;\n18. People who have been deprived of their liberty by judicial or administrative order\n19. People with difficulty understanding and\u002For cognitive disorder",{"count":161,"type":24},224,[163],"PHASE4","This phase IV, multicenter, open-label randomized controlled trial will evaluate whether a JAK inhibitor discontinuation strategy is superior to standard maintenance therapy in adult patients with ulcerative colitis who are in sustained deep remission. A total of 224 patients treated with tofacitinib, upadacitinib, or filgotinib will be randomized to either treatment withdrawal or continuation of maintenance therapy and followed for 104 weeks. The primary objective is to compare safety, efficacy, and patient satisfaction at Week 52, while secondary objectives include assessment of remission maintenance, quality of life, treatment exposure, endoscopic outcomes, and relapse rates",[166],"Ulcerative Colitis in Remission",[168,169],"ulcerative colitis","treatment removal","2026-07-17",{"date":172,"type":35},"2026-07-22",{"date":174,"type":24},"2027-01",{"date":176,"type":24},"2031-01",{"name":41,"class":42},22,{"id":180,"slug":181,"hasResults":12,"nctId":182,"briefTitle":183,"officialTitle":184,"acronym":185,"eligibilityCriteria":186,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":187,"targetDuration":4,"studyType":134,"phases":4,"briefSummary":189,"conditions":190,"keywords":195,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":201,"startDateStruct":202,"completionDateStruct":203,"leadSponsor":205,"locationsCount":4},"100648341","prognosis-of-epilepsy-with-post-traumatic-stress-disorder-and-surgery-100648341","NCT07718542","Prognosis of Epilepsy With Post-traumatic Stress Disorder and Surgery","Surgical Prognosis for Drug-resistant Focal Epilepsy Associated With Post-traumatic Stress Disorder (PTSD): a Multidimensional Assessment of the Success of Resective Surgery.","PEPSY","Inclusion Criteria:\n\n* Adults aged 18 years or older\n* Individuals informed about the study who do not object to participation\n* Individuals with drug-resistant focal epilepsy (failure of at least two appropriately selected and adequately administered anti-seizure medications)\n* Eligible for resective epilepsy surgery and awaiting surgery\n* Covered by the French health insurance system\n\nExclusion Criteria:\n\n* Concurrent participation in another research study that precludes enrollment\n* Individuals unable to provide informed participation according to French regulations, covered by Articles L1121-5 to L1121-8 of the French Public Health Code\n* Individuals who do not understand French\n* Individuals with generalized epilepsy\n* Individuals whose epilepsy is controlled with anti-seizure medication\n* Contraindication to resective epilepsy surgery",{"count":188,"type":24},42,"Why is this study being conducted? For people with drug-resistant focal epilepsy, surgery, to remove the part of the brain where seizures start, is currently the most effective treatment. In many people, especially those with temporal lobe epilepsy, surgery can stop seizures completely and improve quality of life. However, doctors usually predict the chances of surgical success using brain scans and other neurological tests, while the possible influence of psychological and social factors remains less well understood.\n\nMental health is an important part of overall health. People living with epilepsy are more likely than the general population to experience anxiety, depression, and post-traumatic stress disorder (PTSD). PTSD can develop after experiencing traumatic events and may affect emotional well-being, daily activities, relationships, and physical health.\n\nSome studies suggest that PTSD may affect brain networks involved in epilepsy. This raises an important question: could PTSD influence the success of epilepsy surgery? We hypothesize that PTSD and other psychological or social factors may affect surgical outcomes and recovery after surgery. At present, there is limited evidence available to answer this question.\n\nWhat is the aim of the study? The main objective of this study is to determine whether PTSD affects the success of epilepsy surgery two years after the operation.\n\nThe study also aims to:\n\n* Describe the medical, psychological, and social characteristics of people undergoing epilepsy surgery and estimate how common traumatic experiences and PTSD are in this population;\n* Assess changes in PTSD symptoms, anxiety, depression, quality of life, social vulnerability, and patient satisfaction before and after surgery;\n* Identify biological, psychological, and social factors associated with successful surgical outcomes.\n\nRather than focusing only on seizure control, this study aims to improve understanding of the factors that contribute to recovery, quality of life, and long-term well-being after epilepsy surgery. The findings may help healthcare professionals provide more personalized support before and after surgery.\n\nWho can take part? Between September 2026 and September 2028, the study will recruit 42 adults with drug-resistant focal epilepsy who are being evaluated for resective epilepsy surgery at Timone University Hospital in Marseille, France.\n\nWhat does participation involve? Participants will join the study approximately three months before surgery and will be followed for two years after the operation.\n\nDuring routine pre-operative and post-operative follow-up visits, participants will complete validated self-report questionnaires about:\n\n* Traumatic experiences and PTSD symptoms;\n* Anxiety and depression;\n* Quality of life;\n* Social vulnerability;\n* Satisfaction with surgery. Participants whose questionnaire results suggest possible PTSD will be offered a routine psychiatric assessment to confirm the diagnosis. Based on these assessments, participants will be classified into one of two groups: people with PTSD and people without PTSD.\n\nThe study will also use clinical information routinely collected as part of epilepsy care, including brain imaging, electroencephalography (EEG), and neuropsychological assessments.\n\nWhat are the expected benefits of this research? This study may improve understanding of how psychological and social factors influence epilepsy surgery outcomes. The results may help healthcare professionals better identify patients who could benefit from additional support before and after surgery.\n\nIn the future, the findings could contribute to the development of more personalized care pathways, including advanced practice nursing follow-up, improved mental health screening, and targeted support to enhance seizure outcomes, quality of life, emotional well-being, and patient satisfaction after epilepsy surgery",[191,192,193,194],"Epilepsies, Focal","Drug Restistant Epilepsie","Anxiety Disorders","Post-traumatic Stress Disorder (PTSD)",[196,197,198,199,200],"Epilepsy surgery","Drug-resistant focal epilepsy","Post-traumatic stress disorder","Surgical outcomes","Advanced practice nursing",{"date":172,"type":35},{"date":148,"type":24},{"date":204,"type":24},"2031-05",{"name":41,"class":42},{"id":207,"slug":208,"hasResults":12,"nctId":209,"briefTitle":210,"officialTitle":211,"acronym":212,"eligibilityCriteria":213,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":214,"targetDuration":4,"studyType":25,"phases":216,"briefSummary":217,"conditions":218,"keywords":220,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":223,"startDateStruct":224,"completionDateStruct":225,"leadSponsor":227,"locationsCount":43},"100648318","impact-of-reducing-the-dialysate-flow-rate-in-chronic-hemodialysis-on-dialysis-quality-and-environmental-impact-on-water-consumption-100648318","NCT07718568","Impact of Reducing the Dialysate Flow Rate in Chronic Hemodialysis on Dialysis Quality and Environmental Impact on Water Consumption","Non-inferiority Study on the Efficacy of Hemodialysis With Dialysate Flow Rates of 400 mL\u002FMin Versus 500 mL\u002FMin in a Population of Patients Undergoing Chronic Hemodialysis. Impact of Reducing the Dialysate Flow Rate in Chronic Hemodialysis on Dialysis Quality and Environmental Impact on Water Consumption","ReDeDia","Inclusion Criteria:\n\n* Age \\> 18 years\n* No decompensated psychiatric disorder, acute or decompensated somatic condition\n* Patients on hemodialysis for more than 3 months\n* Dialysis schedule: 3 times per week for 4 hours each session\n* Stable vascular access (arteriovenous fistula or tunneled central catheter)\n* Blood flow \\> 300 mL\u002Fmin\n* Anuric (urine output \\\u003C 500 mL\u002F24 h)\n* Dialysis method: hemodialysis or hemodiafiltration\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years\n* Patient on dialysis for \\\u003C 3 months\n* Unstable vascular access\n* Blood flow rate \\\u003C 300 mL\u002Fmin\n* Urine output \\> 500 mL\u002Fday\n* Dialysis technique: hemofiltration\n* Severe intercurrent condition (somatic or psychiatric)\n* Pregnant or breastfeeding patients.\n* Patients who are legally incapacitated, under guardianship, or under conservatorship",{"count":215,"type":24},250,[27],"In France, 60,000 patients are receiving renal replacement therapy via dialysis in 2022, 90% of whom are on hemodialysis. This technique is based on the principle of exchange across a membrane between the patient's blood and the dialysate. The goal is to purify the patient's blood as effectively as possible by removing all solutes that have accumulated due to kidney failure. The dialysate is produced from municipal water, which is treated through several processes (reverse osmosis, filtration) to produce ultrapure water. Water consumption at the La Conception Hospital center in Marseille, which conducts 37,000 sessions per year (64 hemodialysis stations), is estimated at 120 m³ of water per day, which is discharged into the sewer system after use. In France, this would correspond to an estimated total consumption of nearly one million m³ of drinking water per year. In the context of climate change, which will lead to a reduction in water resources, it is important to rethink all aspects of water consumption. The investigator's reflection is part of a growing awareness of the environmental impact of dialysis within a working group of the Francophone Society of Nephrology, Dialysis, and Transplantation: \"Green Dialysis.\" The quality of clearance depends on blood flow and dialysate flow rate (Qd). The Qd was set at 500 mL\u002Fmin based on earlier studies that showed this flow rate corresponded to maximum clearance of urea and the main toxic solutes. These studies were conducted at a time when dialysis membranes were less efficient. Today, the investigators use membranes with higher exchange efficiency. Despite this, the investigators have not reevaluated the appropriateness of a Qd of 500 mL\u002Fmin. The quality criterion in dialysis is a balanced urea Kt\u002FV measurement \\>1.2 for a 4-hour session (target set at 1.4 with certain \"single-pool\" dialysis machine measurement techniques). At the ivnestigator's center, the average urea Kt\u002FV is 1.55 in \"single-pool\" mode. Reducing the Qd could be done without risk to patients, even if it leads to a decrease in urea Kt\u002FV. A Colombian study with 5 years of follow-up demonstrates patient safety with a Qd of 400 mL\u002Fmin (vs. 500 mL\u002Fmin), with no difference in mortality or dialysis efficacy. The study population was not representative of chronic dialysis patients; 10% regained renal function, and the final analysis included only 25 of the 71 patients enrolled.",[219],"Kidney Disease, Chronic",[221,222],"Efficicency or Quality of Hemodialysis","Green Dialysis",{"date":172,"type":35},{"date":174,"type":24},{"date":226,"type":24},"2029-10",{"name":41,"class":42},{"id":229,"slug":230,"hasResults":12,"nctId":231,"briefTitle":232,"officialTitle":233,"acronym":234,"eligibilityCriteria":235,"healthyVolunteers":12,"sex":19,"minAge":236,"maxAge":4,"enrollmentInfo":237,"targetDuration":4,"studyType":25,"phases":239,"briefSummary":240,"conditions":241,"keywords":243,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":248,"startDateStruct":250,"completionDateStruct":252,"leadSponsor":254,"locationsCount":43},"100623645","biomarkers-of-response-to-seeg-thermocoagulation-100623645","NCT07399327","Biomarkers of Response to SEEG Thermocoagulation","Biomarkers of Response to SEEG Thermocoagulation in Patients With Refractory Focal Epilepsy","THALPO","Inclusion Criteria:\n\n* Patient, parents or legal representative who have given their written informed consent,\n* Adult or pediatric patient ≥ 12 years old suffering from drug-resistant focal epilepsy,\n* Standardized pre-surgical assessment including medical history, scalp video-EEG and 3T MRI,\n* Patients in whom a SEEG exploration for pre-surgical evaluation has been indicated,\n* Patient able to understand, speak and write in French,\n* Patient able to follow study's procedure,\n* Patient beneficiary or affiliated to a health insurance plan.\n\nExclusion Criteria:\n\n* Epilepsy surgery performed without the requirement of SEEG,\n* Contraindication to 3T or 7T brain MRI (patient with a cardiac pacemaker, metallic foreign bodies, non-removable implanted electronic medical devices, claustrophobia, inability to remain in supine position, patient havingwith Vagus Nerve Stimulation (VNS) or Deep Brain Sstimulation (DBS), intrauterine devices or tattoos in the imaging area less than 6 weeks old at the time of the 3T\u002F7T brain MRI),\n* Contraindication to gadolinium-based MRI contrast agent (history of allergic or anaphylactic reaction to gadolinium, hypersensitivity to gadoteric acid, meglumine, or any drug containing gadolinium, severe renal failure (glomerular filtration rate, GFR, below 30 ml\u002Fmin\u002F1.73 m2), patients on dialysis or with a history of kidney disease, such as renal transplantation, a single kidney, or renal malignancy),\n* Person protected by articles L1121-5, L1121-6 and L1121-8 of the Public Health Code (pregnant or breastfeeding woman, deprived of liberty by judicial decision, situations of social fragility, adults unable or unable to express their consent),\n* Patient in exclusion period of another study.","12 Years",{"count":238,"type":24},45,[27],"Drug-resistant focal epilepsy is a severe neurological disease that affects one-third of patients with epilepsy. Surgery is the only potentially curative treatment. Intracerebral exploration by stereo electroencephalography (SEEG) is an important step in the surgical pathway. It aims to establish the precise mapping of the epileptogenic network (EZN), including all the brain regions that generate seizures. At the end of SEEG, SEEG-guided radiofrequency thermocoagulation (SEEG RFTC) represents a therapeutic option that may be efficient as a palliative treatment in patients ineligible for resective surgery, or may lead, in some cases, to a definitive effect, avoiding open surgery. The safety and effectiveness of this approach have been established. However, the odds of remaining seizure-free after one year vary greatly between studies, ranging from 4% to 71%. This disparity in therapeutic responses could be linked to the absence of objective criteria for the selection of targets, but also to the existence of mechanisms of action outside of the direct lesional effect. A decrease in SEEG markers of epileptogenicity may predict thermocoagulation efficiency. However, no data are available regarding changes in alteration of the blood-brain barrier (BBB) connectivity, inflammation, or associated molecular changes and their relationship to prognosis.\n\nThis study aims to elucidate the mechanisms underlying the clinical effect of SEEG RFTC by studying the changes in electrophysiological (SEEG), structural (ultra-high field MRI), and biological (blood biomarkers of neuro-glio-vascular damage and inflammation, molecular adaptations) markers. They will be correlated with clinical outcome in a prospective cohort of patients with drug-resistant focal epilepsy. As advantages for clinical care, this study will allow selection of RFTC targets based on scientifically validated criteria, and elaboration of predictive scores for therapeutic response in each patient.\n\nThe primary objective is to study the predictive factors of response to SEEG RFTC, by correlating changes in BBB permeability with clinical response 3 months after RFTC, in a prospective cohort of patients with drug-resistant focal epilepsy.",[242],"Drug Resistant Epilepsy",[244,245,246],"RFTC","Drug resistant epilepsy","SEEG","2026-06-23",{"date":249,"type":35},"2026-06-26",{"date":251,"type":35},"2026-06-19",{"date":253,"type":24},"2029-06-30",{"name":41,"class":42},{"id":256,"slug":257,"hasResults":12,"nctId":258,"briefTitle":259,"officialTitle":259,"acronym":260,"eligibilityCriteria":261,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":262,"targetDuration":4,"studyType":25,"phases":263,"briefSummary":266,"conditions":267,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":269,"lastUpdatePostDateStruct":270,"startDateStruct":272,"completionDateStruct":274,"leadSponsor":276,"locationsCount":43},"100638889","phase-1-tolerance-of-local-administration-of-cryopreserved-autologous-stromal-vascular-fraction-combined-with-micrograft-for-the-treatment-of-refractory-ano-perineal-fistulas-in-crohns-disease-100638889","NCT07629245","Tolerance of Local Administration of Cryopreserved Autologous Stromal Vascular Fraction Combined With Micrograft for the Treatment of Refractory Ano-perineal Fistulas in Crohn's Disease","ADICROHN3","Inclusion Criteria:\n\n* (1) Signing of a consent form.\n* (2) Patients with Crohn's disease diagnosed at least 6 months prior, in accordance with clinical, endoscopic, histological, and\u002For radiological criteria.\n* (3) Patients previously enrolled in or treated as part of the ADICROHN 2 study.\n* (4) Non-active or mildly active luminal Crohn's disease, defined by a CDAI score ≤ 220.\n* (5) Patients who failed to respond to the ADICROHN-2 protocol, defined by the persistence of anoperineal fistula(s) at the end of the ADICROHN-2 study and their persistence at the time of enrollment.\n* (6) Patients who achieved success (combined remission) at the end of the ADICROHN-2 study but who have a recurrence of anoperineal fistula(s) at the time of enrollment.\n* (7) Sufficient quantity of cryopreserved cells to allow for the innovative treatment, based on the number of fistulas to be treated.\n* (8) Patients over 18 years of age.\n* (9) Good general health based on medical history and clinical examination.\n* (10) Women of childbearing age must have a negative pregnancy test (serum or urine; detection threshold: 25 mIU hCG\u002Fml). Patients of both sexes must use a reliable method of contraception.\n* (11) Enrollment in a social security program.\n\nExclusion Criteria:\n\n* (1) Active, primarily luminal Crohn's disease requiring immediate treatment.\n* (2) Patients who experienced intolerance to the advanced therapy medicinal product during the ADICROHN-2 study.\n* (3) Presence of an abscess or collections \\> 2 cm at the time of enrollment, unless this issue is resolved during the fistula preparation period.\n* (4) Rectal and\u002For anal stenosis and\u002For active proctitis resulting in a limitation of the surgical procedure.\n* (5) Patients currently receiving corticosteroids or who have received them within the four weeks prior to the injection of the investigational product.\n* (6) Malignant tumors or a history of malignant tumors within the past 5 years.\n* (7) Congenital or acquired immunodeficiency.\n* (8) Contraindications to local anesthetics and gadolinium (MRI contrast agent).\n* (9) Contraindications to MRI: metallic foreign bodies (ferromagnetic material) and metallic implants (pacemakers, heart valves, vascular clips, surgical clips or staples, cochlear implants, any implanted electronic medical device or material \\[e.g., insulin pump\\], orthopedic medical prostheses.\n* (10) Treatment with darvadstrocel administered \\\u003C 6 months prior to enrollment)\n* (11) Contraindications to general anesthesia.\n* (12) BMI \\\u003C 18 kg\u002Fm² to ensure an adequate amount of abdominal adipose tissue or other subcutaneous adipose tissue accessible via manual liposuction.\n* (13) Coagulation disorders that contraindicate surgery.\n* (14) Known hypersensitivity to human albumin.\n* (15) Participation in another clinical trial (excluding observational studies).\n* (16) Persons protected under Articles L1121-5, L1121-6, and L1121-8 of the Public Health Code (pregnant or breastfeeding women, persons deprived of liberty by judicial decision, persons in situations of social vulnerability, adults who are legally incapacitated or unable to give informed consent).",{"count":7,"type":24},[264,265],"PHASE1","PHASE2","The ADICROHN-3 study is a prospective, multicenter, open-label cohort study.\n\nIts design is supported by the following elements:\n\n* The results of the ADICROHN pilot study (EudraCT No. 2013-002602-31) and our 3-year study, which demonstrate an excellent safety profile with a promising efficacy signal.\n* Data from the literature confirming that cryopreservation of FVS does not compromise the clonogenic and differentiation potential of mesenchymal progenitors, nor its regenerative effect.\n* The ongoing ADICROHN-2 study (PHRC N 2019; EudraCT No. 2019-001948-21) confirming the feasibility of patient recruitment, mastery of the therapeutic approach, and the absence of adverse events related to the experimental treatment.\n* The opportunity for a second FVS injection for patients initially treated but who did not respond to the treatment.\n* The opportunity for a first FVS injection in patients in the placebo arm, thereby providing access to an innovative therapy available to patients included in this trial who are untreated and remain refractory to standard care.\n\nTo avoid compromising the results of the ongoing ADICROHN-2 study, enrolled patients will remain blinded to the treatment arm to which they belonged in the ADICROHN-2 study.",[268],"Crohn Disease (CD)","2026-06-01",{"date":271,"type":35},"2026-06-05",{"date":273,"type":35},"2025-12-30",{"date":275,"type":24},"2028-06-29",{"name":41,"class":42},{"id":278,"slug":279,"hasResults":12,"nctId":280,"briefTitle":281,"officialTitle":282,"acronym":283,"eligibilityCriteria":284,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":285,"enrollmentInfo":286,"targetDuration":4,"studyType":25,"phases":288,"briefSummary":289,"conditions":290,"keywords":294,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":299,"lastUpdatePostDateStruct":300,"startDateStruct":302,"completionDateStruct":304,"leadSponsor":306,"locationsCount":43},"100637464","efficacy-of-spinal-cord-stimulation-in-chemotherapy-induced-peripheral-neuropathy-100637464","NCT07579611","Efficacy of Spinal Cord Stimulation in Chemotherapy-Induced Peripheral Neuropathy","Efficacy of Posterior Spinal Cord Stimulation in Chemotherapy-Induced Peripheral Neuropathic Pain: A Multicenter Randomized Crossover Trial","CHEMOSTIM","Inclusion Criteria:\n\n1. Adult patient with chemotherapy-induced painful neuropathy (platinum salts, vincristine, taxanes, alkaloids, epothilone, thalidomide, etc.) evolving for at least 1 year\n2. Indication for spinal cord stimulation validated by a multidisciplinary team meeting according to SFETD\u002FSFNM guidelines\n3. Resistance to pharmacological or topical treatment (failure of at least two therapeutic lines or intolerable side effects: anticonvulsants, antidepressants, capsaicin, etc.)\n4. Pain score \\> 5\u002F10 on numerical scale in the lower limbs\n5. Patient able to understand and give informed consent to the protocol\n6. Patient affiliated to the French Social Security system\n7. Patient able to complete follow-up questionnaires\n\nExclusion Criteria:\n\n* 1\\. Contraindication to spinal cord stimulation:\n* Extensive laminectomy\n* Coagulopathy\n* Intercurrent infections\n* Psychiatric disorders\n\n  2\\. Body Mass Index (BMI) \\> 40\n\n  3\\. Life expectancy \\\u003C 1 year\n\n  4\\. Ongoing pregnancy\n\n  5\\. Patient under guardianship or curatorship\n\n  6\\. Patient already implanted with a spinal cord stimulation device","100 Years",{"count":287,"type":24},68,[27],"Chemotherapy-induced peripheral neuropathy (CIPN) is a frequent and debilitating side effect of many cancer treatments. It affects 28 to 48% of patients receiving chemotherapy. Symptoms include tingling, numbness, burning sensations, and pain mainly in the hands and feet. While CIPN often improves after chemotherapy ends, in some patients the pain persists and becomes chronic, severely impairing quality of life, sleep, and daily functioning.\n\nCurrently, no treatment has been shown to prevent CIPN. For patients with chronic pain, duloxetine is the only recommended drug, but its efficacy is limited. When standard medications fail, patients have very few options.\n\nSpinal cord stimulation (SCS) is a well-established neurosurgical technique used to treat various forms of chronic neuropathic pain, including pain after surgery, trauma, or diabetes. In this procedure, thin electrodes are placed in the epidural space near the spinal cord and connected to a small implantable pulse generator. The electrical impulses delivered by the device modulate pain signals in the nervous system.\n\nPreliminary case reports suggest that SCS may be effective in patients with CIPN, but no randomized controlled trial has yet established its value in this specific indication. The CHEMOSTIM study aims to fill this gap.\n\nCHEMOSTIM is a multicenter, prospective, randomized crossover trial. All enrolled patients will undergo SCS implantation. Participants will then be randomized to receive either active stimulation first followed by sham stimulation, or sham stimulation first followed by active stimulation. In the sham phase, the device is implanted but switched off following a simulated programming session, so patients cannot tell which phase they are in.\n\nThe primary outcome is the proportion of patients achieving more than 50% pain reduction on a Visual Analog Scale (VAS) during the active stimulation phase compared to the sham stimulation phase, assessed at 4 months.\n\nSecondary outcomes include changes in quality of life, anxiety and depression, sleep quality, medication use, individualized goal attainment, neurological examination, and nerve conduction studies. The study will also evaluate post-stimulation effects and complications.\n\nEligible patients are adults with chronic CIPN evolving for at least one year, with pain greater than 5\u002F10 in the lower limbs, who have failed at least two lines of pharmacological treatment (antidepressants, anticonvulsants, topical agents, etc.) and whose indication for SCS has been validated by a multidisciplinary team following SFETD\u002FSFNM guidelines.",[291,292,293],"Neuropathic Pain","Chemotherapy-induced Peripheral Neuropathy (CIPN)","Cancer-related Pain",[295,296,297,298],"spinal cord stimulation","posterior cord stimulation","neuropathic pain","Chemotherapy-induced neuropathy","2026-05-06",{"date":301,"type":35},"2026-05-12",{"date":303,"type":24},"2026-09-01",{"date":305,"type":24},"2029-05-01",{"name":41,"class":42},{"id":308,"slug":309,"hasResults":12,"nctId":310,"briefTitle":311,"officialTitle":312,"acronym":313,"eligibilityCriteria":314,"healthyVolunteers":12,"sex":19,"minAge":315,"maxAge":20,"enrollmentInfo":316,"targetDuration":4,"studyType":25,"phases":318,"briefSummary":319,"conditions":320,"keywords":323,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":325,"lastUpdatePostDateStruct":326,"startDateStruct":328,"completionDateStruct":329,"leadSponsor":331,"locationsCount":43},"100639620","phase-3-pediatric-prolonged-release-melatonin-for-sleep-disturbances-in-children-and-adolescents-with-anorexia-nervosa-melsom-anorexia-100639620","NCT07576764","Pediatric Prolonged-Release Melatonin for Sleep Disturbances in Children and Adolescents With Anorexia Nervosa (MELSom-ANOREXIA)","Efficacy of Pediatric Prolonged-Release Melatonin (PedPRM) Treatment in Children and Adolescents With Impaired Sleep and Anorexia Nervosa (AN)","MELSomAnorexia","INCLUSION CRITERIA\n\nParticipants aged 6 to 18 years, inclusive, with a diagnosis of Anorexia Nervosa (AN) according to DSM-5 criteria Presence of a sleep problem for at least 1 month, defined as ≤ 6 hours of continuous sleep and\u002For ≥ 0.5 hours sleep latency from lights-off on 3 out of 5 nights, based on participant report (with or without parental assistance according to age), confirmed at D0 by 2-week sleep diary No response to at least 4 weeks of sleep hygiene Negative pregnancy test at baseline, prior to randomization, for female participants of childbearing potential Women of childbearing potential must agree to use a highly effective method of contraception during the study treatment period and for at least 4 weeks after the last dose of study treatment Written informed consent obtained in accordance with the participant's legal status and applicable regulations Affiliation to a social security system or equivalent\n\nEXCLUSION CRITERIA\n\nKnown diagnosis of another significant sleep disorder (e.g. moderate to severe sleep apnea) Use of prohibited medication (z-drugs, melatonin agonist, benzodiazepine, phenylpiperazine class, clomethiazole) or melatonin within 2 weeks prior to screening Declared allergy to melatonin, lactose, or any excipient included in the therapeutic units Pregnant or breastfeeding female participants Unresponsiveness to previous prolonged-release melatonin within the 2 years prior to the study Start of cognitive behavioural therapy (CBT) targeting sleep disturbances or mood disorders within 6 weeks before study inclusion Trans-meridian travel (\\> 2 time zones) within the month before the start of the study Patient under legal protection regimen","6 Years",{"count":317,"type":24},120,[109],"Sleep disturbances are reported by more than 50% of patients with Anorexia Nervosa (AN) and are associated with increased AN severity, psychiatric comorbidities, and poorer quality of life. To date, no pharmacological treatment has been approved or recommended for sleep disorders in children and adolescents with AN. Many drugs are currently prescribed off-label for their sedative side effects, without proven safety or efficacy in this population.\n\nPediatric prolonged-release melatonin (PedPRM, Slenyto®) is the only melatonin formulation approved by the European Medicines Agency (EMA) for chronic insomnia in children aged 2 to 18 years with neurodevelopmental disorders. Its excellent safety profile, absence of tolerance, and long-acting formulation make it a prime candidate for treating sleep disturbances in children and adolescents with AN.\n\nMELSom-ANOREXIA is a multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase IIIb trial. Its primary objective is to assess the efficacy of PedPRM compared to placebo in improving Total Sleep Time (TST) in children and adolescents aged 6 to 18 years with AN and impaired sleep.\n\nParticipants are randomized into two groups: the experimental group receives PedPRM (2 mg or 5 mg depending on response at Day 22) and the control group receives a matching placebo, both administered 0.5 to 1 hour before habitual bedtime for 13 weeks. Sleep is assessed by Sleep Diary and actigraphy. Secondary outcomes include other sleep parameters, AN severity (BMI, EDI-2, EDE-Q), associated symptoms (anxiety, depression, physical activity, executive function, emotionality), and quality of life. Melatonin secretion profiles and specific subgroups (ASD traits, early-onset AN) are also explored.\n\nThe study includes a 2-week run-in period (D-14 to D0) for baseline sleep assessment, followed by 13 weeks of treatment, with visits at D0, D22, and D93. A total of 120 participants will be enrolled across 7 French pediatric psychiatry centers over 24 months.",[321,322],"Anorexia Nervosa","Sleep Disorders in Children",[324],"anorexia","2026-05-04",{"date":327,"type":35},"2026-05-08",{"date":303,"type":24},{"date":330,"type":24},"2029-01-01",{"name":41,"class":42},{"id":333,"slug":334,"hasResults":12,"nctId":335,"briefTitle":336,"officialTitle":337,"acronym":338,"eligibilityCriteria":339,"healthyVolunteers":12,"sex":19,"minAge":340,"maxAge":341,"enrollmentInfo":342,"targetDuration":4,"studyType":25,"phases":344,"briefSummary":345,"conditions":346,"keywords":348,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":325,"lastUpdatePostDateStruct":358,"startDateStruct":359,"completionDateStruct":361,"leadSponsor":363,"locationsCount":43},"100598716","transcriptomic-analysis-of-fibroblasts-and-blood-in-patients-with-rare-diseases-100598716","NCT07075107","Transcriptomic Analysis of Fibroblasts and Blood in Patients With Rare Diseases","Transcriptomic Analysis (RNAseq) of Blood and Fibroblasts to Establish a Diagnosis in Patients With Rare Diseases","ARNseqFibroSan","Inclusion Criteria:\n\n* Male or female, aged 0-99 years\n* Patient with neonatal intellectual disability and\u002For hypotonia followed at one of three inclusion centers\n* Patient or parent has been informed about the study and has signed an informed consent form\n* Genetic analysis by high-throughput DNA sequencing (gene panel, exome, genome) did not identify any abnormality explaining the patient's phenotype.\n* If the patient's phenotype is suggestive of Prader-Willi syndrome or Angelman syndrome: a methylation anomaly test on chromosome 15 was negative.\n* If the patient's phenotype is suggestive of fragile X syndrome: a repeat expansion analysis of the FMR1 gene was negative.\n* If the patient's phenotype is suggestive of myotonic dystrophy type I, DM1: a repeat expansion analysis of the DMPK gene was negative.\n* Patient entitled to or beneficiary of a social security scheme\n\nExclusion Criteria:\n\n* Patient deprived of liberty\n* Pregnant or breast-feeding woman,\n* The person required to sign the consent form does not understand French\n* Person under guardianship and\u002For curatorship","0 Years","99 Years",{"count":343,"type":24},62,[27],"This study aims to answer a key question in the field of rare genetic diseases by determining the prevalence of deleterious variants at RNA level in undiagnosed patients with intellectual disability and\u002For neonatal hypotonia. This study will put an end to diagnostic erraticism in a number of patients.\n\nFinally, the results of this study will make it possible to compare the two types of tissue used for RNAseq, with a view to facilitating the implementation of this analysis method in the diagnostic setting.",[347],"Rare Genetic Disease",[349,350,351,352,353,354,355,356,357],"genetic analysis by high-throughput DNA sequencing","ARNseq","transcriptomic data","interpretation of sequence variants","Genomic Testing","RNA sequencing data","transcriptome analysis in rare disease","Rare diseases","Intellectual disability",{"date":327,"type":35},{"date":360,"type":35},"2026-03-09",{"date":362,"type":24},"2029-04-30",{"name":41,"class":42},{"id":365,"slug":366,"hasResults":12,"nctId":367,"briefTitle":368,"officialTitle":368,"acronym":369,"eligibilityCriteria":370,"healthyVolunteers":18,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":371,"targetDuration":4,"studyType":25,"phases":372,"briefSummary":373,"conditions":374,"keywords":376,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":379,"lastUpdatePostDateStruct":380,"startDateStruct":382,"completionDateStruct":383,"leadSponsor":385,"locationsCount":43},"100633050","dysbiosis-of-methanogenic-archaea-and-nanoarchaea-in-the-oral-microbiome-100633050","NCT07521644","Dysbiosis of Methanogenic Archaea and Nanoarchaea in the Oral Microbiome","METHAORAL","Inclusion Criteria:\n\nCase selection criteria:\n\nCases are defined as subjects with oral health vulnerability\n\n* Men or women aged 60 years or older\n* and\u002For immunocompromised individuals without periodontal disease (gingivitis, periodontitis, and peri-implantitis) clinically diagnosed by the dentist during the consultation.\n* Patients who have received information about the study and have not expressed objection\n* Patients who are beneficiaries or eligible for a social security program Control group selection criteria Controls are defined as subjects without oral health vulnerability • Men and women under 60 years of age without periodontal disease (gingivitis, periodontitis, and peri-implantitis) clinically diagnosed by the dentist during the consultation.\n\nThe clinical examination allows for the diagnosis of the absence or presence of periodontal disease, with particular attention to: bleeding on probing, the depth of periodontal pocket(s), tooth mobility, bone destruction in furcation areas, and the assessment of radiographic bone level taking age into account.\n\nExclusion Criteria:\n\n* Patients who are currently excluded from another research protocol at the time the informed consent form is collected.\n* Subjects covered by Articles L1121-5 through L1121-8 of the Public Health Code (minors, adults under guardianship or conservatorship, patients deprived of their liberty, pregnant or breastfeeding women),\n* Men and women with periodontal disease (gingivitis, periodontitis, and peri-implantitis)\n* Men and women with any systemic disease\n* Men and women currently undergoing drug treatment",{"count":215,"type":24},[27],"Need to improve understanding of oral dysbiosis in the elderly and\u002For immunocompromised individuals (involvement of nanogenes in these dysbiosis) Comparison of dysbiosis identification between results from dental plaque samples and saliva samples (the saliva sample is non-operator-dependent due to its ease of collection). Comparison of the reliability of results obtained with this type of saliva sample versus results obtained with dental plaque samples, which are considered the reference sample type (Antézack 2023).\n\nPrimary objective To estimate the prevalence of dysbiosis in individuals with oral frailty versus individuals without oral frailty.\n\nIn this project:\n\n* Dysbiosis will be defined by the presence of Archaea (Bringuier 2013). For the primary objective, prevalence will be estimated based on dental plaque samples.\n* The population with oral frailty will be defined as individuals over 60 years of age or those with immunosuppression.\n\nHypothesis: The expected proportion of dysbiosis in the population with oral health vulnerability is 40%, whereas the expected proportion of dysbiosis in the population without oral health vulnerability is 20% (Li CL 2009).\n\nSecondary objectives Estimate the prevalence of dysbiosis in the two populations based on a saliva sample\n\n\\- Compare the results from the sample",[375],"Oral Health",[377,378],"oral health issues","without oral health issues","2026-04-08",{"date":381,"type":35},"2026-04-13",{"date":303,"type":24},{"date":384,"type":24},"2029-12-01",{"name":41,"class":42},{"id":387,"slug":388,"hasResults":12,"nctId":389,"briefTitle":390,"officialTitle":390,"acronym":391,"eligibilityCriteria":392,"healthyVolunteers":12,"sex":105,"minAge":20,"maxAge":4,"enrollmentInfo":393,"targetDuration":4,"studyType":134,"phases":4,"briefSummary":395,"conditions":396,"keywords":4,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":403,"lastUpdatePostDateStruct":404,"startDateStruct":406,"completionDateStruct":408,"leadSponsor":410,"locationsCount":411},"100629641","study-on-the-prevention-of-recidivism-and-the-consequences-of-sexual-violence-suffered-by-female-asylum-seekers-in-france-100629641","NCT07477314","Study on the Prevention of Recidivism and the Consequences of Sexual Violence Suffered by Female Asylum Seekers in France","PREVISEDA","Inclusion Criteria:\n\n* Woman seeking asylum in France\n* Asylum application registered less than 3 months before inclusion.\n* Self-identified female gender.\n* Age ≥ 18 years.\n* Received study information and provided informed consent to participate\n\nExclusion Criteria:\n\n* Re-examination of a previous asylum application.\n* Major cognitive impairment (e.g. dementia or intellectual disability) preventing reliable collection of study outcomes.",{"count":394,"type":24},675,"Women seeking asylum (WSA) are overexposed to sexual violence (SV) in their countries of origin, along migration routes, and within host countries. This overexposure does not cease upon arrival in host countries; on the contrary, the first months following arrival are characterised by heightened vulnerability, with an increased incidence of sexual violence, particularly among women with a prior history of victimisation.\n\nSexual violence has major consequences on physical health, mental health, quality of life, and healthcare utilisation, and generates substantial individual and societal costs. International organisations, including the United Nations High Commissioner for Refugees, have identified the prevention of sexual violence and the improvement of care for survivors as public health priorities.\n\nPrevious work suggests that addressing sexual violence within primary care, when embedded in a comprehensive, culturally informed, and coordinated approach integrating medical, psychological, social, and medico-legal dimensions, may contribute to preventing the occurrence or recurrence of sexual violence in host countries. However, no comparative study has yet evaluated the effectiveness of such a coordinated model of care on the prevention of sexual violence among women seeking asylum, nor assessed its efficiency or transferability.\n\nThe primary objective of this study is to evaluate the effectiveness of a coordinated, transcultural, multidisciplinary outpatient care model on the prevention of sexual violence occurring in host European countries among women seeking asylum.",[397,398,399,400,401,402],"Sexual Violence","Refugee Health","Physical Health","Mental Health","Quality of Life","Access to Recommended Healthcare","2026-03-17",{"date":405,"type":35},"2026-03-19",{"date":407,"type":24},"2026-04",{"date":409,"type":24},"2028-09",{"name":41,"class":42},6,{"id":413,"slug":414,"hasResults":12,"nctId":415,"briefTitle":416,"officialTitle":417,"acronym":418,"eligibilityCriteria":419,"healthyVolunteers":18,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":420,"targetDuration":4,"studyType":134,"phases":4,"briefSummary":422,"conditions":423,"keywords":425,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":432,"lastUpdatePostDateStruct":433,"startDateStruct":435,"completionDateStruct":437,"leadSponsor":439,"locationsCount":440},"100618195","occupational-exposure-to-antineoplastic-drugs-among-physiotherapists-in-healthcare-settings-100618195","NCT07328464","Occupational Exposure to Antineoplastic Drugs Among Physiotherapists in Healthcare Settings","Occupational Exposure to Antineoplastic Drugs Among Physiotherapists in Healthcare Settings: From Assessing Internal Contamination to Implementing Co-constructed Prevention Measures","KINEMAC","Inclusion Criteria:\n\nInclusion criteria for individuals eligible for inclusion in the study:\n\nBeing a state-certified physiotherapist or hold an equivalent qualification, Working in one of the healthcare departments selected for the study, Being a man or woman aged 18 or over, Having received information about the study and not expressed any opposition to participating in it\n\nInclusion criteria for each physiotherapist observation visit as part of the internal contamination study:\n\nPerform at least one physiotherapy treatment during this visit that must meet all of the following five criteria:\n\nThe physiotherapy treatment taken into account for this observation visit must be carried out in one of the healthcare departments selected for the study, This physiotherapy treatment being at least one of the following: massage and\u002For manual\u002Flymphatic drainage and\u002For limb mobilisation and\u002For respiratory physiotherapy, This physiotherapy treatment being performed on a patient who has received intravenously at least one of the seven antineoplastic drugs studied, This physiotherapy treatment being performed within 4 to 72 hours of the start of intravenous administration of the antineoplastic drug(s) studied, This physiotherapy treatment is performed on a patient who is not in septic isolation and\u002For in a protected area.\n\nInclusion criteria for each physiotherapist observation visit as part of the external contamination study:\n\nPerform at least one physiotherapy treatment during this visit that must meet all of the following five criteria:\n\nThe physiotherapy treatment taken into account for this observation visit, must be carried out in one of the healthcare departments selected for the study, This physiotherapy treatment being at least one of the following: massage and\u002For manual\u002Flymphatic drainage and\u002For limb mobilisation and\u002For respiratory physiotherapy, This physiotherapy treatment being performed on a patient who has received intravenously at least one of the twelve antineoplastic drugs studied, This physiotherapy treatment being performed within 4 to 72 hours of the start of intravenous administration of the antineoplastic drug(s) studied, This physiotherapy treatment is performed on a patient who is not in septic isolation and\u002For in a protected area.\n\nExclusion Criteria:\n\nBeing a physiotherapy student, Being treated with one of the 12 antineoplastic drugs studied during the study or having been treated with one of them in the 2 months prior to the start of the study, Having a person and\u002For animal in their household who has been treated with one of the 12 antineoplastic drugs during the study or in the 2 months prior to the start of the study.\n\nPhysiotherapists who meet any of the following exclusion criteria for the observation visit will not be eligible for inclusion in the internal contamination assessment:\n\nBeing assessed for the internal contamination on the same day as the external contamination assessment, Being treated with one of the seven antineoplastic drugs studied during the study or having been treated with one of them during the two months preceding the observation visit, Having a person and\u002For animal in their household who is being treated with one of the seven antineoplastic drugs during the study or in the two months prior to the observation visit.\n\nExclusion criteria for each observation visit as part of the external contamination study\n\nPhysiotherapists who meet any of the following exclusion criteria for the studied physiotherapy treatment cannot be included in the external contamination assessment:\n\nBeing assessed for the external contamination on the same day as the internal contamination assessment, Performing this physiotherapy treatment while wearing a long-sleeved gown and\u002For long-sleeved overgown, Performing this physiotherapy treatment while using a cream and\u002For gel and\u002For oil, Being treated oneself with one of the 12 antineoplastic drugs studied during the study or having been treated with one of them during the 2 months preceding the physiotherapy treatment, Having a person and\u002For animal in their household who is being treated with one of the 12 antineoplastic drugs during the study or in the 2 months prior to the physiotherapy treatment.",{"count":421,"type":24},20,"Many antineoplastic drugs are considered \"hazardous to handle\" for healthcare professionals, notably because of their carcinogenic, mutagenic and\u002For reprotoxic effects. Occupational exposure occurs mainly through the cutaneous route, either by direct contact with the drug and\u002For indirectly through contact with treated patients and their excreta, or through contact with contaminated surfaces or textiles.\n\nTo date, physiotherapists have been little studied in terms of occupational exposure, even though they frequently perform care practices (massage, lymphatic drainage, limb mobilisation, respiratory physiotherapy) involving direct, prolonged and sustained skin contact with patients treated with antineoplastic drugs; these compounds may be eliminated in the sweat of the treated patient for several days after administration.\n\nIn this context, the present study aims to assess the occupational exposure of physiotherapists to antineoplastic drugs in healthcare settings. The primary objective is to estimate the prevalence of internal contamination of physiotherapists by antineoplastic drugs after performing one of the care practices (massage, lymphatic drainage, limb mobilisation, respiratory physiotherapy) selected for the study, in patients receiving intravenous treatment with antineoplastic drugs.\n\nThe secondary objectives are to describe for each antineoplastic drug studied the prevalence, the frequency of internal contamination of physiotherapists, and urinary concentration levels, to characterise the circumstances of exposure and the personal protective equipment worn, to describe the prevalence and the frequency of external cutaneous contamination on the hands and forearms of physiotherapists after performing an exposing care practice, to quantify this external cutaneous contamination, to identify the factors associated with internal and external contamination, and to co-develop preventive measures in collaboration with physiotherapists and stakeholders and to assess their acceptability.\n\nThis study is a non-interventional (RIPH3), cross-sectional and multicenter study conducted at AP-HM (Public Assistance for Marseille hospitals) and Bordeaux University Hospital (CHU de Bordeaux). Twenty physiotherapists will be included in this study. Internal contamination will be assessed over 100 observation visits and external contamination over 70 observation visits (all participants combined). Observation visit include at least one \" an exposing care practice\" (massage, lymphatic drainage, limb mobilisation, respiratory physiotherapy) performed on a patient who received an intravenous antineoplastic drug from a predefined list, within a time window of 4 to 72 hours after the start of injection.\n\n\\- Internal contamination assessment (urine samples collection) For each observation visit, two urine samples of the physiotherapist participant will be collected: one sample within the 3 hours preceding the start of the work shift, and a second sample 6 to 10 hours after the end of the shift (or the next morning after waking up).\n\nData on exposure, activity and preventive practices (personal protective equipments worn) will be collected using an administered questionnaire (CRF). Information on the antineoplastic drugs administered to the patient receiving care by the physiotherapist will also be collected.\n\n\\- Cutaneous external contamination assessment (dermal wipe sampling) For each observation visit, the physiotherapist will apply a standardized hands and forearms washing protocol, observed by the clinical research technician. Then, cutaneous swab samples will be taken immediately after the washing.\n\nThe physiotherapist will then perform an exposing care practice, limiting contact with the environment (e.g., door handles\u002Fsurfaces), and new samples will be taken immediately after the exposing care practice, without prior decontamination of hands and forearms. A total of eight cutaneous swab samples (four before and four after an exposing care practice) will be collected per observation visit, according to a protocol validated by the reference laboratory.\n\nThe assessment of cutaneous external contamination of physiotherapists will be evaluated during visits separate from those used to study internal contamination.\n\nThe expected outcomes of this study are: an individual assessment of exposure and potential internal contamination and\u002For external dermal contamination, for each physiotherapist; traceability of exposure in occupational health medical records, for each physiotherapist; improved knowledge on the proportion of contaminated physiotherapists (prevalence and frequency) and knowledge on urinary and cutaneous concentration levels of antineoplastic drugs in physiotherapists; increased awareness among physiotherapists regarding these exposures; implementation of co-developed preventive actions aiming to reduce exposures to the lowest possible level; and improved professional practices and working conditions.",[424],"Internal and External Contamination of Physiotherapists by Antineoplastic Drugs",[426,427,428,429,430,431],"Internal contamination","external contamination","physiotherapists","antineoplastic drugs","prevention measures","healthcare","2026-03-13",{"date":434,"type":35},"2026-03-16",{"date":436,"type":24},"2026-03",{"date":438,"type":24},"2027-03",{"name":41,"class":42},2,{"id":442,"slug":443,"hasResults":12,"nctId":444,"briefTitle":445,"officialTitle":445,"acronym":446,"eligibilityCriteria":447,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":448,"targetDuration":4,"studyType":25,"phases":450,"briefSummary":451,"conditions":452,"keywords":455,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":459,"lastUpdatePostDateStruct":460,"startDateStruct":461,"completionDateStruct":462,"leadSponsor":464,"locationsCount":43},"100607727","predicting-reactions-and-effects-of-drugs-immunotherapy-and-complications-through-oncosafety-predicto-clinical-study-100607727","NCT07192315","Predicting Reactions and Effects of Drugs Immunotherapy and Complications Through Oncosafety (PREDICTO Clinical Study)","PREDICTO","Inclusion Criteria:\n\n* Adult patient (≥18 years old)\n* Patient presenting an histologically or cytologically confirmed solid tumour malignancy\n* Patient scheduled to receive his\u002Fher first infusion of immunotherapy with anti-PD1, anti-PDL1, anti-CTLA4, anti-LAG3, alone or in combination, as part of standard care, in all validated solid oncology indications.\n* Patient must have at least one measurable lesion according to RECIST 1.1 criteria\n* Patient treated at AP-HM in one of the CEPCM-affiliated departments.\n* Patient able to comply with study procedures and follow-up schedule\n* Patient who has been informed about the study and signed the consent form\n* Patient who is a beneficiary or entitled beneficiary of a social security scheme\n\nExclusion Criteria:\n\n* Patient previously treated with ICIs\n* Patient whose treatment plan includes targeted therapy, chemotherapy or any other systemic treatment in combination with ICI\n* Patient included in a trial with an experimental molecule\n* Patient has an active autoimmune disease or any other pathology requiring systemic corticosteroid therapy at more than 10 mg prednisone equivalent per day or any other immunosuppressive drug\n* Patients with a history of organ transplantation, hematopathy or hematopoietic stem cell transplantation\n* Patient with history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator.\n* Patient in emergency situations, persons deprived of their liberty by judicial or administrative decision, adults subject to legal protection measures, or persons who are unable to give their consent, or pregnant or breastfeeding.",{"count":449,"type":24},160,[27],"Immune Checkpoint Inhibitors (ICI) have revolutionized cancer therapy, providing unprecedented responses in a wide range of malignancies. However, they induced various immune-related adverse events (iRAE) that can be life-threatening. About 20% of patients treated with an ICI monotherapy, and up to 60% of patients treated with a combination of ICIs, experienced a severe iRAE. Most side effects are reversible if managed early, but can affect survival and quality of life, leading to treatment interruptions or hospitalization. Some of these irAEs, particularly those affecting hormonal functions, may be irreversible and persist even after treatment discontinuation.\n\nThe development of predictive biomarkers of such toxicities is an unmet medical need. The variety of mechanisms involved in iRAE, and the lack of effective animal models, could probably explain why the topic remains largely unexplored. To date, some biomarkers predictive of the occurrence of iRAE, irrespective of the type of organ affected, have been identified by state-of-the-art techniques on small cohorts prior to treatment initiation, but none is individually robust enough to be used in daily practice.\n\nWe hypothesize that a signature derived from the integrative analysis of various biological parameters (immunomonitoring, auto-immunity features, viral monitoring, microbiota monitoring, fragmentome analysis, pharmacokinetics, radiomics and genetics), available in routine hospital practice, could answer this question, and thus enable the development of specific prevention strategies\n\nThe objectives are :\n\nPrimary objective:\n\nIdentify a baseline predictive signature for severe iRAE, irrespective of the type of organ affected.\n\nSecondary objectives:\n\n* Identify a predictive signature for severe iRAE including baseline and T1 data, irrespective of the type of organ affected.\n* Identify a baseline predictive signature for organ-specific severe iRAE.\n* Identify a predictive signature for organ-specific severe iRAE including baseline and T1 data.\n* Identify a baseline predictive signature for severe iRAE, irrespective of the type of organ affected, for patient receiving an anti-PD(L)1 in monotherapy.\n* Identify a baseline predictive signature for severe iRAE, irrespective of the type of organ affected, for patient receiving an anti-PD(L)1 in combination.\n* Identify a baseline predictive signature for severe iRAE, irrespective of the type of organ affected, for each specific immunotherapy received.\n* Compare the predictive signatures between responders and non-responders according to RECIST 1.1 in order not to overlook the influence of clinical response on the variability observed.\n* Describe the results obtained for each biological parameter between severe irAEs and non-severe irAEs patients.\n* Describe patient-reported outcomes and quality of life parameters.",[453,454],"Solid Tumor Malignancies","Solid Cancers",[456,457,458],"immuno-induced adverse events","Immune checkpoint inhibitor","baseline predictive signature","2026-03-11",{"date":432,"type":35},{"date":407,"type":24},{"date":463,"type":24},"2028-01",{"name":41,"class":42},{"id":466,"slug":467,"hasResults":12,"nctId":468,"briefTitle":469,"officialTitle":469,"acronym":470,"eligibilityCriteria":471,"healthyVolunteers":18,"sex":19,"minAge":315,"maxAge":472,"enrollmentInfo":473,"targetDuration":4,"studyType":25,"phases":474,"briefSummary":475,"conditions":476,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":459,"lastUpdatePostDateStruct":478,"startDateStruct":479,"completionDateStruct":481,"leadSponsor":483,"locationsCount":43},"100582920","identification-of-anti-hif-1alpha-autoantibodies-in-patients-with-anorexia-nervosa-and-characterization-of-their-pathogenic-potential-in-undernutrition-associated-hepatic-cytolysis-100582920","NCT06869590","Identification of Anti-HIF 1alpha Autoantibodies in Patients With Anorexia Nervosa and Characterization of Their Pathogenic Potential in Undernutrition-associated Hepatic Cytolysis","HIAM","Inclusion Criteria:\n\nExperimental group:\n\n* Male or female, 6 to 65 years of age\n* Anorexia nervosa diagnosed according to DSM-5 criteria\n* Presence of undernutrition according to HAS 2019 criteria\n* Patient having received information about the study and having signed an informed consent form\n* Beneficiary or beneficiary of a social security scheme\n\nControl group:\n\n* Minor patients :\n\n  * Male or female strictly under 18 years of age\n  * Patients undergoing scheduled non-inflammatory surgery (orthopedic, ENT, etc.)\n  * Patients who have been informed about the study and have signed an informed consent form.\n  * Patients who are beneficiaries or entitled beneficiaries of a social security scheme.\n* Patients without anorexia with livers cytolysis :\n\n  * Male or female between 18 and 65 years of age\n  * With hepatic cytolysis determined by an ALT value at least equal to twice the normal value\n  * Patient having received information about the study and having signed an informed consent form\n  * Patient who is a beneficiary or eligible beneficiary of a social security scheme.\n* samples Etablissement Français de don de sang: no specific criteria\n\nExclusion Criteria:\n\n* Patient in a period of exclusion from another research protocol at the time consent is signed.\n* Opposition of patient and parents or legal guardians\n* Psychiatric disorder preventing patient consent to study\n* Person unable to understand the French language\n* Subjects covered by articles L1121-5 to 1121-8 of the French Public Health Code (minors, adults under guardianship or trusteeship, patients deprived of their liberty, pregnant or breast-feeding women).","65 Years",{"count":215,"type":24},[27],"Anorexia nervosa (AN) is a psychiatric disorder belonging to the eating disorders (EDs). It is internationally recognized as a priority for improving health care. Among the markers of severity of undernutrition is hepatic cytolysis. Around 30-50% of patients with AN present with hepatic cytolysis, of variable intensity, and usually associated with severe undernutrition. In a previous study, we demonstrated the presence of autoantibodies against HIF1alpha (Hypoxic inducible Factor 1 alpha) in 22% of cases in a sample of patients with AN. HIF1alpha (HIF1a) is a major transcription factor involved in the regulation of satiety and hunger. These autoantibodies were positive in 80% of AN patients with hepatic cytolysis. Taken together, these data led us to hypothesize an anti-HIF1a autoimmune mechanism in AN, potentially involved in the patients' hepatic cytolysis.\n\nThis pioneering study, demonstrating the existence of anti-HIF1a autoantibodies, was carried out on a population of 18 patients with AN. To extend investigator's hypothesis, these results need to be confirmed on a larger number of patients, thus increasing the number of patients with AN and hepatic cytolysis. To determine the relevance of these autoantibodies in AN, \"healthy\" subjects and patients without AN but with hepatic cytolysis should be tested in parallel. Finally, the in vitro pathogenic potential of autoantibodies can be confirmed on a larger scale and studied in greater detail.\n\nThe main aim of our study is to evaluate the association between the presence of anti-HIF1a autoantibodies (AAHIF) and that of hepatic cytolysis in patients with anorexia nervosa and undernutrition.\n\nThis study is a prospective, cross-sectional, descriptive, multicenter, 2-arm study.\n\n250 patients will be included. Experimental group (n=100)\n\n* Patients with anorexia nervosa and undernutrition with hepatic cytolysis (CH) (n=70)\n* Patients with anorexia nervosa and undernutrition without hepatic cytolysis (n=30) Comparator control groups (n=150)\n* Control patients under 18 years of age, treated at the CHU de la Timone for scheduled non-inflammatory surgery (orthopedic, ENT, etc.) (n=50): Minor patients\n* Patients (children and adults) with hepatic cytolysis without anorexia nervosa (n=50): Patients without AN with CH\n* Samples from French blood donation establishment: control group consisting of biological blood samples from healthy individuals from the Etablissement Français du Sang (n=50)",[477],"Hepatic Cytolysis",{"date":432,"type":35},{"date":480,"type":35},"2026-02-02",{"date":482,"type":24},"2029-05-24",{"name":41,"class":42},{"id":485,"slug":486,"hasResults":12,"nctId":487,"briefTitle":488,"officialTitle":488,"acronym":489,"eligibilityCriteria":490,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":491,"targetDuration":4,"studyType":25,"phases":493,"briefSummary":494,"conditions":495,"keywords":497,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":499,"lastUpdatePostDateStruct":500,"startDateStruct":502,"completionDateStruct":504,"leadSponsor":506,"locationsCount":43},"100576589","involvement-of-archaea-in-carious-disease-100576589","NCT06787261","Involvement of Archaea in Carious Disease","CARIARCHAE","Inclusion Criteria:\n\n* Male or female of legal age.\n* Patient who is a beneficiary or entitled beneficiary of a social security\n* Patient under the care of the Restorative and Preventive Dentistry of the PROMOD - Timone Dentistry Unit.\n* Patients capable of giving written consent.\n\nExclusion Criteria:\n\nPatient in a period of exclusion from another research protocol at the time of signing the consent form, Subjects covered by articles L1121-5 to 1121-8 of the Public Health public health code (minor patients, patients of full age under guardianship, patients deprived of their liberty, pregnant or breast-feeding), A person who does not have a sufficient command of reading and understanding of the French language to be able to consent to take part in the research Presence of periodontitis (gingivitis not being a criterion for a criterion for non-inclusion). Antibiotics taken in the previous month. Use of mouthwash in the previous 7 days.",{"count":492,"type":24},200,[27],"Dental caries is a major public health probleme the result of hard tissue demineralization and oral microbiota changes.\n\nMethanogenic archaea, mainly Methanobrevibacter oralis, are associated with various oral problems, including pathologies periodontal.\n\nPrevious research has not really studied the Archaea in carious lesions, hence the importance of our study.\n\nOur study aims to explore their potential role in the the development of caries by analysing their prevalence and their quantification in relation to the carious risk individual. The aim is to improve understanding of the Cavity microbiology to advance management of this pathology in terms of prevention or of treatment.\n\nOur team is particularly competent in the field of Archaea, especially in the cultivation of Archaea methanogens since we have a dedicated platform. We also discovered the first human Nanoarchaea, opening up a whole new possible search field.",[496],"Dental Caries",[498],"Dental caries","2026-02-20",{"date":501,"type":35},"2026-02-23",{"date":503,"type":35},"2026-02-19",{"date":505,"type":24},"2028-02-01",{"name":41,"class":42},{"id":508,"slug":509,"hasResults":12,"nctId":510,"briefTitle":511,"officialTitle":511,"acronym":512,"eligibilityCriteria":513,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":514,"targetDuration":4,"studyType":134,"phases":4,"briefSummary":516,"conditions":517,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":503,"lastUpdatePostDateStruct":520,"startDateStruct":521,"completionDateStruct":523,"leadSponsor":525,"locationsCount":43},"100503566","association-between-renal-regional-oxygen-saturation-measured-by-near-infrared-spectroscopy-and-postoperative-renal-failure-after-lung-transplantation-surgery-a-pilot-study-100503566","NCT05836922","Association Between Renal Regional Oxygen Saturation Measured by Near-InfraRed Spectroscopy and Postoperative Renal Failure After Lung Transplantation Surgery: A Pilot Study","SO-AKI-TP","Inclusion Criteria:\n\n* patient undergoing a lung transplant (mono or bi-transplantation)\n* Age \\>= 18 years\n* Affiliated to the French social security system\n\nExclusion Criteria:\n\n* Renal anatomical abnormality likely to induce a misleading NIRS signal: single kidney, polycystic kidney disease.\n* Expression of opposition to participation in the research protocol.\n* Hyperbilurbinemia \\> 17mmol\u002Fl\n* Preoperative Extra Corporeal Membran Oxygenation (ECMO).\n* Preoperative mechanical ventilation",{"count":515,"type":24},80,"Complications after lung transplantation are almost ubiquitous, among which postoperative acute renal failure may represent more than 50% of lung transplant patients and require extrarenal purification in 5 to 13% of cases.\n\nMultiple factors are associated with postoperative acute renal failure. These factors can be classified into preoperative, intraoperative, and postoperative factors. While some postoperative complications are explained by donor and recipient factors, the literature suggests that certain intraoperative events represent modifiable or avoidable risk factors that could be targeted by therapeutic interventions to reduce the risk of postoperative acute renal failure. Some of these factors (intraoperative hemodynamic instability, significant bleeding or hypoxemia) can generate renal hypoxic aggression, alone or in combination. However, to date, there is no validated tool available at the patient's bedside during surgery to detect renal hypoxia or guide interventions to restore renal perfusion during surgery. Yet, as recent recommendations suggest, intraoperative renal protection is an important axis for improving the outcome of lung transplant patients, to the extent that the recommendations of Marczin et al. recommend the establishment of a renal prevention protocol for each patient. Without a tool to guide this plan intraoperatively, anesthesia teams can't establish a renal prevention protocol. This research aims to establish whether renal NIRS is a reliable tool for monitoring intraoperative renal hypoxic aggression predictive of postoperative renal failure.\n\nNear-infrared spectroscopy (NIRS) is an optical technology that allows non-invasive measurement of tissue oxygen saturation. This technique is commonly used for intraoperative monitoring of cerebral perfusion in adults and children. Some studies have shown that regional renal oxygen saturation (renal rSO2) measured by NIRS during aortic-coronary bypass surgery under extracorporeal circulation (ECC) is correlated with renal venous oxygen saturation measured by catheterization. It is also associated with the risk of postoperative acute renal failure in patients undergoing cardiac surgery under ECC. However, there are no equivalent data in lung transplant patients, who frequently present with postoperative acute renal failure. In the available literature, no clear threshold of renal desaturation has been established. Because it is assumed that the depth of renal desaturation can be particularly deleterious, in addition to desaturation time, the investigator have chosen to retain in this project the integral of time and magnitude spent under a renal desaturation threshold, aggregated into a renal hypoxia index, during the intraoperative period.\n\nThe primary objective of this research is to demonstrate the usefulness of measuring the intraoperative renal hypoxia index in predicting the risk of early postoperative acute renal failure",[518,519],"Lung Transplant; Complications","Acute Kidney Injury",{"date":501,"type":35},{"date":522,"type":35},"2024-03-23",{"date":524,"type":24},"2026-09-28",{"name":41,"class":42},{"id":527,"slug":528,"hasResults":12,"nctId":529,"briefTitle":530,"officialTitle":530,"acronym":531,"eligibilityCriteria":532,"healthyVolunteers":12,"sex":19,"minAge":533,"maxAge":534,"enrollmentInfo":535,"targetDuration":4,"studyType":134,"phases":4,"briefSummary":537,"conditions":538,"keywords":540,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":546,"lastUpdatePostDateStruct":547,"startDateStruct":549,"completionDateStruct":551,"leadSponsor":553,"locationsCount":7},"100625145","determinants-and-consequences-of-the-transition-to-adulthood-for-adolescents-with-severe-haemophilia-transhemo-2-an-ancillary-study-to-the-transhemo-project-100625145","NCT07418827","Determinants and Consequences of the Transition to Adulthood for Adolescents With Severe Haemophilia: TRANSHEMO 2, an Ancillary Study to the TRANSHEMO Project","TRANSHEMO2","Inclusion Criteria:\n\n* Young adults who participated in the TRANSHEMO project during adolescence and who are currently aged 20-29 years;\n* Young adults with severe haemophilia (haemophilia A or B);\n* Young adults registered in the FranceCoag registry;\n* Young adults who have received the participant information sheet for the TRANSHEMO 2 project;\n* Young adults who did not object to participation in the present study.\n\nExclusion Criteria:\n\n* patients with comprehension difficulties;\n* patients who are unable to read and\u002For write;\n* patients who express opposition to participation in this study.","20 Years","29 Years",{"count":536,"type":24},75,"Haemophilia is a rare genetic disorder which, in its severe form and in the absence of treatment, can be life-threatening. Since the 1960s and the introduction of coagulation factor concentrates, the life expectancy of people with haemophilia has increased rapidly. Today, for most affected individuals, the disease is experienced as a chronic condition.\n\nThe transition process enabling adolescents and young adults (AYA) with a chronic disease to move into adult life can be complex, as they must face all the changes experienced by AYA in general, combined with issues related to their chronic condition and its management.\n\nA successful transition involves a transfer of responsibility from parents to AYA regarding the management of their health condition, as well as the acquisition by AYA of knowledge, skills and autonomy. A difficult transition may lead to decreased adherence to follow-up or treatment, deterioration of overall health status and\u002For quality of life, or difficulties in entering adult life.\n\nIn this context, the national cross-sectional study TRANSHEMO was initiated in 2017. Its objective was to compare adherence to healthcare management between two groups of AYA with severe haemophilia (adolescents \\[for whom the transition is ongoing\\] versus young adults \\[for whom the transition may have been completed\\]), and to identify the determinants of this adherence. The results showed that young adults had a lower adherence rate than adolescents (82.2% vs. 61.2%, p\\\u003C0.001). Among the determinants studied, being a young adult, having repeated at least one school year, and presenting psychological and emotional difficulties were factors that had a negative effect on adherence to healthcare management. However, the cross-sectional nature of the study represents a limitation that restricts causal inference. Complementing this project with a longitudinal study would address this limitation.\n\nThe results obtained from this new study (TRANSHEMO 2) may contribute to the literature by providing insights into both the determinants of sustained adherence to healthcare management among adolescents with severe haemophilia who become young adults, and the associations between these determinants.\n\nThe longitudinal design of the project will allow the establishment of a higher level of causal inference between the maintenance of adherence during the transition to adult life and its determinants, which represents a major epidemiological strength. Moreover, results addressing the issue of transition in the context of chronic diseases and derived from longitudinal studies remain scarce, making the findings of this project particularly original. Finally, haemophilia, a relatively frequent condition among rare diseases, could represent an interesting model for understanding the impact of transition in this type of pathology.\n\nStudy hypothesis The extent of the reduction in adherence to healthcare during the transition process, and\u002For the determinants of the maintenance of adherence identified in the longitudinal TRANSHEMO 2 project, may differ from those highlighted in the original cross-sectional TRANSHEMO project.\n\nSpecific aims\n\nMain objective:\n\nTo compare the rate of adherence to healthcare among adolescents who participated in the TRANSHEMO project, using data collected during the original TRANSHEMO study when they were adolescents (before transition) and data to be collected as part of the TRANSHEMO 2 study when they have become young adults (after transition).\n\nSecondary objective:\n\nTo identify the determinants of the maintenance of this adherence and the associations between these determinants, within the framework of a longitudinal study.",[539],"Haemophilia",[541,542,543,544,545],"haemophilia","young adult","cohort study","genetic disorder","healthcare management","2026-02-11",{"date":548,"type":35},"2026-02-18",{"date":550,"type":24},"2026-02",{"date":552,"type":24},"2027-06",{"name":41,"class":42},{"id":555,"slug":556,"hasResults":12,"nctId":557,"briefTitle":558,"officialTitle":558,"acronym":559,"eligibilityCriteria":560,"healthyVolunteers":12,"sex":561,"minAge":20,"maxAge":562,"enrollmentInfo":563,"targetDuration":4,"studyType":25,"phases":565,"briefSummary":566,"conditions":567,"keywords":569,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":574,"lastUpdatePostDateStruct":575,"startDateStruct":576,"completionDateStruct":578,"leadSponsor":580,"locationsCount":43},"100566645","local-anesthesia-with-schelin-catheter-in-rezum-treatment-a-randomized-controlled-trial-100566645","NCT06657872","Local Anesthesia With Schelin Catheter in Rezum Treatment: a Randomized Controlled Trial","LOCALVAPOR","Inclusion Criteria:\n\n* Patients referred for symptomatic benign prostatic hyperplasia (BPH)\n* Men between 45 and 80 years of age\n* IPSS \\> 13\n* Qmax \\\u003C15 ml\u002Fs\n* Prostate volume between 30 and 80 g on ultrasound\n* Patient able to understand study details, benefits and risks\n* Patient able to give informed consent\n* Beneficiary of or affiliated to the French social security system\n* Patient having signed an informed consent form\n\nExclusion Criteria:\n\n* Patients with a history of prostate cancer\n* Patient with history of BPH surgery\n* Patients with a history of neurological bladder disease\n* Patient with history of urethral stricture\n* Patient with history of penile implants\n* Patient with history of pelvic irradiation\n* Patient with a symptomatic urinary tract infection in the 10 days prior to surgery\n* Presence of bladder stones on ultrasonography\n* Patient allergic to lidocaine 2% or any medication used in the pre-operative protocol (anxiolytics, analgesics and non-steroidal anti-inflammatory drugs)\n* Patient under guardianship or curatorship\n* Protected patient, deprived of liberty\n* Patient with a neurological and\u002For psychiatric disorder making it impossible to understand the terms of the study and to sign an informed consent form","MALE","80 Years",{"count":564,"type":24},24,[27],"In a pilot study, water vapor therapy (RezumTM, Boston Scientific Corporation, Marlborough, MA) was proposed as a minimally invasive procedure for benign prostatic hyperplasia, but often requiring oral ± intravenous sedation or a transrectal prostatic block. Therefore, pain management during Rezum therapy remains a challenge and may lead to the use of pain control protocols and general anesthesia, limiting in some ways the concept of a minimally invasive ambulatory surgical approach. The Schelin® catheter (ProstaLund AB, Lund, Sweden), approved by the European Medicines Agency, is a device for injecting analgesic drugs directly into the prostate via the trans-urethral route, providing more effective local anesthesia and avoiding the need for transrectal route or general anesthesia. This catheter is therefore of crucial importance in offering to our patients an ultra-minimally invasive treatment, associated with a reduction in room occupancy time, outpatient surgery time, a procedure performed independently of the anesthesia team, and for the patient, an accelerated post-operative recovery. Our hypothesis is that the REZUM procedure under local anesthesia could be associated with a \\>20% reduction in operating room occupancy time compared to procedures performed under general anesthesia.",[568],"Benign Prostatic Hyperplasia",[570,571,572,573],"REZUM","MIST","general anesthesia","local anesthesia","2026-02-10",{"date":546,"type":35},{"date":577,"type":35},"2025-03-24",{"date":579,"type":24},"2026-11-24",{"name":41,"class":42},{"id":582,"slug":583,"hasResults":12,"nctId":584,"briefTitle":585,"officialTitle":586,"acronym":587,"eligibilityCriteria":588,"healthyVolunteers":12,"sex":561,"minAge":21,"maxAge":589,"enrollmentInfo":590,"targetDuration":4,"studyType":134,"phases":4,"briefSummary":591,"conditions":592,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":574,"lastUpdatePostDateStruct":596,"startDateStruct":598,"completionDateStruct":600,"leadSponsor":602,"locationsCount":43},"100550428","identification-of-markers-of-poor-clinical-prognosis-in-sepsis-by-epigenetic-analysis-100550428","NCT06446947","Identification of Markers of Poor Clinical Prognosis in Sepsis by Epigenetic Analysis","Identification de Marqueurs de Mauvais Pronostic Clinique du Sepsis Par Analyse épigénétique.","EPISEPSIS","Inclusion Criteria:\n\n* Male patients,\n* Patients between 45 and 75 years of age,\n* Patients undergoing major esophageal or digestive carcinological surgery,\n* Patients with post-operative gram-negative bacterial sepsis (proven or suspected in the context of organ failure).\n\nExclusion Criteria:\n\n* patients under 45 and aged 76 and over,\n* female patients,\n* non-carcinological or minor surgery,\n* non-esophageal or non-digestive surgery,\n* Gram-positive bacterial or fungal infections in the absence of associated BGN,\n* patients with hematological cancer,\n* immunocompromised patients,\n* septic surgery (surgical site infection),\n* patients expressing opposition to data collection and analysis (clinical and\u002For biological) within the regulatory framework of the study,\n* patients under guardianship or curatorship,\n* patients not affiliated to a social security system or equivalent in France,\n* patients deprived of their liberty.","75 Years",{"count":7,"type":24},"Sepsis is a multifactorial syndrome characterized by a dynamic course and a clinical outcome dependent on several factors, and responsible for one in five deaths worldwide. The aim of this trial is to identify new prognostic markers for the progression of sepsis to septic shock, by comparing epigenetic markers between patients who have or have not developed severe forms of sepsis.\n\nThe main objective of this preliminary study is to identify prognostic markers for the progression of sepsis to septic shock, i.e. to compare targeted markers between subjects with sepsis who progress to septic shock versus subjects with sepsis who do not progress to septic shock.",[593,594,595],"Sepsis Syndrome","Septic Shock","Sepsis",{"date":597,"type":35},"2026-02-12",{"date":599,"type":35},"2025-03-20",{"date":601,"type":24},"2026-09-30",{"name":41,"class":42},{"id":604,"slug":605,"hasResults":12,"nctId":606,"briefTitle":607,"officialTitle":608,"acronym":4,"eligibilityCriteria":609,"healthyVolunteers":18,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":610,"targetDuration":4,"studyType":25,"phases":612,"briefSummary":613,"conditions":614,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":574,"lastUpdatePostDateStruct":616,"startDateStruct":617,"completionDateStruct":619,"leadSponsor":621,"locationsCount":43},"100336215","speckle-tracking-echocardiography-for-the-prediction-of-weaning-failure-100336215","NCT03657524","Speckle Tracking Echocardiography for the Prediction of Weaning Failure","Combined Thoracic Ultrasound Using Speckle Tracking for the Prediction of Weaning Failure : a Prospective Multicenter Study","Inclusion Criteria:\n\n\\- Patients hospitalized in intensive care unit under mechanical fulfilling the criteria of ventilation weaning trial.\n\nExclusion Criteria:\n\n* Less than 18 years old.\n* Pregnancy\n* Non sinusal cardiac rhythm\n* Neuro Myopathy\n* Tracheotomy\n* Lack of echogenicity to perform at least a four chamber apical view",{"count":611,"type":24},110,[27],"Deciding the optimal timing for extubation in patients who are mechanically ventilated can be challenging, and traditional weaning predictor tools are not accurate. Recent studies suggest that isolated sonographic assessment of the respiratory and cardiac function (ie diastolic function and filling pressure), in mechanically ventilated patients may assist in identifying patients at risk of weaning failure. Recently, the association of conventional echocardiography and lung ultrasound showed promising results for the prediction of post extubation distress. Speckle Tracking is an emerging tool in intensive care medicine that has never been investiguated for the prediction of weaning failure. It could early detects diastolic dysfunction and and elevated filling pressure. Of more, speckle tracking is known to be less operator dependant. The main objective of our study is to evaluate the diagnosis accuracy of speckle tracking echocardiography performed during a weaning trial to predict weaning failure. The secondary objectives are to assess the diagnosis accuracy of combined heart and lung ultrasound to predict weaning failure.",[615],"Weaning Failure of Mechanical Ventilation",{"date":597,"type":35},{"date":618,"type":35},"2019-05-20",{"date":620,"type":24},"2026-05-21",{"name":41,"class":42},{"id":623,"slug":624,"hasResults":12,"nctId":625,"briefTitle":626,"officialTitle":627,"acronym":628,"eligibilityCriteria":629,"healthyVolunteers":12,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":630,"targetDuration":4,"studyType":25,"phases":632,"briefSummary":633,"conditions":634,"keywords":4,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":636,"lastUpdatePostDateStruct":637,"startDateStruct":638,"completionDateStruct":639,"leadSponsor":641,"locationsCount":43},"100624176","methotrexate-early-toxicity-monitoring-100624176","NCT07406230","Methotrexate Early Toxicity Monitoring","Methotrexate Early Toxicity Monitoring in Primary Central Nervous System Lymphomas (PCNSL)","METoxiM","Inclusion Criteria:\n\n* Adult patient aged 18 years or older,\n* Patient with a primary lymphoma of the central nervous system, histologically or cytologically proven,\n* Patient eligible for high-dose methotrexate treatment (\\> at 500 mg\u002Fm 2), in the first line of treatment,\n* Patient who has received information regarding the study and signed an informed consent,\n* Patient beneficiary or entitled to a social security scheme.\n\nExclusion Criteria:\n\n* Patient treated with a therapy complementary to the standard 1st-line treatment based on high-dose MTX as part of a clinical research protocol,\n* Patient in a period of exclusion from another research protocol at the time of signing consent,\n* Subjects covered by articles L1121-5 to 1121-8 of the Public Health Code (minor patient, adult patient under guardianship or curatorship, patient deprived of liberty, pregnant or breastfeeding woman).",{"count":631,"type":24},50,[27],"High-dose methotrexate (MTX) is the main componement of first line treatment in primary central nervous system lymphoma. Renal toxicity is the main dose limiting toxicity because of major MTX elimination by the kidneys. MTX crystallizes in renal tubules, leading to a renal failure (RF) and further delaying its elimination. When RF occurs, MTX accumulates, prolonging the duration of treatment exposure. MTX prolonging exposure can cause life-threatening complications and delay further treatments in the patient. Preventive measures have been developped, such as alkaline fluid hyperhydration and folic acid administration, to try to reduce the risk of these adverse events.\n\nIn suspected severe RF in link to MTX is suspected, glucarpidase can be administared. However, this is an expensive treatment and not all patients recover normal renal function despite its use.\n\nMTX is an essential treatment for the management of PCNSL which is currently a curable disease especially in patients who are able to receive a consolidation treatment as thiotepa-based intensive consolidation followed by autologous stem cell transplantation (IC-ASCT). IC-ASCT requires a normal renal function, which could be impaired by severe RF secondary to MTX.\n\nThe purpose of the study is to investigate how early dosing MTX could be used to simulate late concentrations. Early monitoring of MTX elimination could be implemented to identify patients at risk of delayed elimination and thus introduce rapid mesures as early administration of glucarpidase.",[635],"Primary Central Nervous System Lymphoma","2026-02-05",{"date":597,"type":35},{"date":407,"type":24},{"date":640,"type":24},"2027-12",{"name":41,"class":42},""]