[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"CHU de Reims\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":642},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,48,0,25,[9,42,73,103,129,158,180,202,228,254,280,304,334,367,387,408,429,458,480,502,521,542,569,590,613],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100641639","effect-of-exercise-order-during-pulmonary-rehabilitation-on-muscle-strength-in-patients-with-copd-100641639",false,"NCT07655011","Effect of Exercise Order During Pulmonary Rehabilitation on Muscle Strength in Patients With COPD","Effect of Intra-Session Training Order of Cardiorespiratory Endurance Work and Muscle Strengthening in COPD Patients","ISTOR-COPD","Inclusion Criteria:\n\n* Age ≥ 18 years\n* COPD GOLD stages 2 to 4\n* Admitted for pulmonary rehabilitation in a participating center\n* Ability to read and speak French\n* Written informed consent\n* Affiliation with a social security system\n\nExclusion Criteria:\n\n* Legal protection (guardianship or trusteeship)\n* Pregnancy beyond the second trimester\n* Musculoskeletal disorders affecting lower limb strength or walking performance\n* Vascular disease limiting walking distance\n* Cardiac contraindication to pulmonary rehabilitation","ALL","18 Years",{"count":21,"type":22},138,"ESTIMATED","INTERVENTIONAL",[25],"NA","Chronic Obstructive Pulmonary Disease (COPD) is a chronic multisystem disease frequently associated with peripheral muscle dysfunction, which is strongly linked to prognosis and survival. Pulmonary rehabilitation is a cornerstone of COPD management and includes both cardiorespiratory endurance training and muscle strengthening exercises. Although these components are routinely combined within rehabilitation programs, the optimal order in which they should be performed during the same training session remains unclear.\n\nIn healthy individuals, performing endurance and strength exercises in different sequences within a single session may influence muscular adaptations, a phenomenon referred to as the intra session interference effect. This effect has never been studied in patients with COPD undergoing pulmonary rehabilitation. Given the high prevalence and clinical importance of muscle weakness in COPD, optimizing exercise prescription may improve functional outcomes and long term benefits.\n\nThis multicenter randomized controlled trial aims to compare two pulmonary rehabilitation strategies that differ only in the order of exercise administration. Participants with moderate to severe COPD will be randomly assigned to perform either muscle strengthening before endurance training or endurance training before muscle strengthening during each rehabilitation session.\n\nThe primary objective is to evaluate the impact of exercise order on lower limb muscle strength, assessed by the Five Times Sit to Stand test at the end of the rehabilitation program. Secondary objectives include assessment of exercise capacity, dyspnea, muscle and inflammatory biomarkers, tolerance, and adherence to the rehabilitation program, as well as follow up evaluations up to 12 months after completion.\n\nThe results of this study are expected to provide evidence to optimize pulmonary rehabilitation programs for patients with COPD and to inform clinical practice regarding exercise sequencing.",[28],"Chronic Obstructive Pulmonary Disease (COPD)","NOT_YET_RECRUITING","2026-06-12",{"date":32,"type":33},"2026-06-17","ACTUAL",{"date":35,"type":22},"2026-08",{"date":37,"type":22},"2030-01",{"name":39,"class":40},"CHU de Reims","OTHER",1,{"id":43,"slug":44,"hasResults":12,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":50,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":23,"phases":53,"briefSummary":54,"conditions":55,"keywords":60,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":41},"100516585","intraoral-scanners-as-periodontal-and-dental-pathologies-diagnosis-tools-100516585","NCT06006429","Intraoral Scanners as Periodontal and Dental Pathologies Diagnosis Tools","Digital Extraction and Scientific Visualization of Clinical Characteristics From 3D Data From Intraoral Scanners for Dental and Periodontal Pathologies Research : Computer Formalization and Feasibility Study","Odonto3D","Inclusion Criteria:\n\n* adultes\n* consulting the Dental Care Service of the university hospital of Reims\n* presenting at least one gingival recession\n* presenting at least 10 pairs of opposing teeth\n* speaking French\n* who signed the informed consent form\n* affiliated to the French Social Security system\n\nExclusion Criteria:\n\nPatients presenting :\n\n* pregnancy or breastfeeding\n* orthodontic treatments\n* patients under legal protection, trusteeship or guardianship\n* unable to understand auto-questionnary",true,{"count":52,"type":22},30,[25],"Periodontal diseases and dental pathologies are highly prevalent oral diseases. Thirty-three to fifty percent of adult population presented at least one untreated caries and more than 50% of French population are affected by severe periodontitis. These diseases affect dental organ or periodontal attached system but could have negative impact on general health, quality of life, word and individual well-being. Association between chronic diseases as diabetes, rheumatoid arthritis, cardiovascular diseases, and oral health have been well investigated. Dental and periodontal diagnosis is dependent of various clinical parameters time consuming and dependent operator. It represents a public health challenge. Informatic analysis detecting diseases could be a time gain and a more precise diagnosis tool. Today, any software or algorithm allow automatized detection, clinical qualitative or quantitative indices recording while these informations are present in numeric models",[56,57,58,59],"Periodontitis","Gingivitis","Dental Caries","Diagnosis",[61,62,63,64],"Periodontal diseases","Dental caries","intra-oral camera","diagnosis","RECRUITING","2026-06-11",{"date":30,"type":33},{"date":69,"type":33},"2022-05-11",{"date":71,"type":22},"2027-12-11",{"name":39,"class":40},{"id":74,"slug":75,"hasResults":12,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":84,"conditions":85,"keywords":89,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":41},"100634279","right-ventriculo-arterial-coupling-during-fluid-loading-in-icu-patients-100634279","NCT07537621","Right Ventriculo-Arterial Coupling During Fluid Loading in ICU Patients","Prospective Observational Study of Right Ventriculo-arterial Coupling Changes During Fluid Loading and Their Relationship With Congestion Parameters in Critically Ill Adults","RVPA-FLICU","Inclusion criteria:\n\n* Critically ill hospitalized patients\n* Age ≥ 18 years\n* Patients undergoing fluid loading at the discretion of the attending physician, following prediction of fluid responsiveness using any recommended maneuver or dynamic parameter, in the setting of acute circulatory failure requiring vasopressor support and\u002For mean arterial pressure \\\u003C 65 mmHg (or a decrease of ≥ 30 mmHg from baseline in patients with chronic hypertension), and\u002For other signs of hemodynamic instability (tachycardia, mottling, oliguria, hyperlactatemia)\n* Affiliated with a national health insurance system\n\nExclusion criteria :\n\n* Formal refusal from the patient or legally representative after information\n* Patients transferred from another intensive care unit\n* Pregnant or postpartum patients\n* Acute respiratory distress (defined as respiratory rate ≥ 35 breaths\u002Fmin and\u002For signs of increased work of breathing)\n* Ongoing acute coronary syndrome\n* Acute or pulmonale (defined by right ventricular dilation associated with paradoxical septal motion related to an abrupt increase in right ventricular afterload)\n* Primary pulmonary arterial hypertension\n* Intra-abdominal hypertension (intravesical pressure \\> 15 mmHg)\n* Poor echogenicity precluding adequate echocardiographic assessment of the right ventricle\n* Severe valvular heart disease or early postoperative period following valvular surgery",{"count":82,"type":22},100,"OBSERVATIONAL","Preload responsiveness and venous congestion have largely been investigated independently in recent literature. However, recent data report a similar incidence of venous congestion regardless of fluid responsiveness status, challenging the concept of a linear continuum between preload independence and fluid intolerance. These findings support the need for a more individualized hemodynamic management strategy that takes venous congestion risk into account.\n\nThe right ventricle plays a central role in this framework. Its function is to maintain an adequate venous return pressure gradient to ensure cardiac output while limiting upstream venous congestion, under strong dependence on its afterload. In physiological conditions, the right ventricle adapts to changes in afterload by increasing contractility to preserve right ventriculo-arterial coupling and optimize its performance.\n\nIn chronic cardiopulmonary diseases, right ventriculo-arterial uncoupling is a well-established prognostic factor, including the presence of occult uncoupling revealed by fluid loading. In critically ill patients, right ventricular systolic dysfunction associated with venous congestion-defining right heart failure-is strongly associated with increased mortality, as is right ventriculo-arterial uncoupling itself.\n\nTo support the concept of fluid tolerance, the investigators hypothesize that impairment of right ventriculo-arterial coupling may exist or occur during fluid loading in critically ill patients, independently of preload responsiveness, and may be associated with worsening upstream venous congestion.",[86,87,88],"Shock","Right Ventricular Dysfunction","Venous Congestion",[90,91,92,93,94],"Right ventriculo-arterial coupling","Fluid loading","Venous congestion","VEXUS score","Critical care echocardiography","2026-06-09",{"date":97,"type":33},"2026-06-10",{"date":99,"type":33},"2026-06-03",{"date":101,"type":22},"2029-06-04",{"name":39,"class":40},{"id":104,"slug":105,"hasResults":12,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":12,"sex":18,"minAge":111,"maxAge":112,"enrollmentInfo":113,"targetDuration":4,"studyType":23,"phases":115,"briefSummary":116,"conditions":117,"keywords":119,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":41},"100643056","sarcopenia-and-juvenile-idiopathic-arthritis-100643056","NCT07634354","Sarcopenia and Juvenile Idiopathic Arthritis","Prevalence Study of Sarcopenia in Juvenile Idiopathic Arthritis","SAJI","inclusion criteria :\n\n* Patients followed in French hospitals participating in the study for juvenile idiopathic arthritis, all forms combined, diagnosed according to the ILAR criteria defined in Edmonton in 2001\n* Patients aged 15 to 40 years\n* Affiliated to social security\n* Agreeing to participate in the study and having given their written consent (signed consent form).\n\nIn the case of a minor patient, the consent of the patient and their legal guardians is required.\n\nexclusion criteria :\n\n* Patient under legal guardianship\n* Patient not covered by social security\n* Pregnant woman\n* Inability to perform a functional test required by the study (grip test or whole-body DEXA scan)\n* Inability to understand the questionnaires","15 Years","40 Years",{"count":114,"type":22},200,[25],"Juvenile idiopathic arthritis (JIA) is a rare chronic inflammatory rheumatic disease that begins during childhood and may persist into adulthood in many patients. In addition to joint pain, swelling, and long-term articular damage, chronic inflammatory diseases may also be associated with early sarcopenia, defined as a loss of muscle strength and muscle mass. While this association has been described in adult inflammatory rheumatic diseases, it has not been well studied in patients with JIA.\n\nThe aim of this study is to screen for sarcopenia in adolescents and adults with JIA in France. Sarcopenia will be assessed using validated questionnaires, hand grip strength measured with a Jamar dynamometer, and body composition measured by dual-energy X-ray absorptiometry (DEXA). Completion of validated questionnaires will assess nutritional status, fatigue, physical activity, and functional impact. Socio-demographic and clinical data will also be collected from medical records.\n\nThis multicenter cross-sectional study will be conducted between June 2026 and October 2027 in 11 French hospitals. Eligible participants are patients aged 15 to 40 years with JIA diagnosed according to ILAR criteria and followed in a French hospital.\n\nThis study will provide the first estimate of sarcopenia prevalence among patients with JIA in France. It will also help identify factors associated with sarcopenia and its impact on daily functioning and quality of life. In the longer term, the findings may help clinicians better identify patients at risk and support earlier management focused on disease control, physical activity, and nutritional care.",[118],"Juvenile Idiopathic Arthritis",[120,121],"Juvenile idiopathic arthritis","Sarcopenia",{"date":123,"type":33},"2026-06-08",{"date":125,"type":22},"2026-06",{"date":127,"type":22},"2027-10",{"name":39,"class":40},{"id":130,"slug":131,"hasResults":12,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":135,"eligibilityCriteria":136,"healthyVolunteers":50,"sex":18,"minAge":19,"maxAge":137,"enrollmentInfo":138,"targetDuration":4,"studyType":23,"phases":140,"briefSummary":141,"conditions":142,"keywords":144,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":41},"100628666","social-cognition-in-severe-alcohol-use-disorder-100628666","NCT07464613","Social Cognition in Severe Alcohol Use Disorder","Social Cognition in Severe Alcohol Use Disorder: Towards a Neuroscientific Model Linking Cognitive Processes, Neurostructural Correlates, and Social Functioning","COSMO","1. AUD patients\n\n   Inclusion criteria:\n   * Patients between 18 and 65 years old, men or women, right-handed, following AUD treatment as inpatients or outpatients and currently abstinent\n   * Having a diagnosis of severe alcohol use disorder according to DSM-5 criteria\n   * Native French speakers\n   * Patients enrolled in the national healthcare insurance program\n   * Patients consenting to participate in the study\n\n   Exclusion criteria:\n   * A diagnosis of schizophrenia, of any other chronic psychotic state, or of bipolar disorder according to DSM-5 criteria\n   * The presence of a current depressive episode as defined by DSM-5 criteria\n   * The presence of another moderate or severe substance use disorder according to DSM-5 criteria, except for tobacco and cannabis if alcohol is the primary substance consumed and the criteria for cannabis dependence are not met\n   * The presence of a neurodevelopmental disorder\n   * The presence of any clinically significant or unstable pathology: organic pathology affecting the central nervous system or disease likely to interfere with assessments, including the neurological complications of alcoholism\n   * Having any uncorrected auditory or visual deficits\n   * Contraindication to the use of MRI\n   * Individuals particularly protected by the law\n   * No smartphone with Apple or Android operating system\n2. Healthy control participants:\n\nInclusion criteria:\n\n* Participants between 18 and 65 years old, men or women, right-handed\n* Native French speakers\n* Participants enrolled in the national healthcare insurance program\n* Participants consenting to participate in the study\n\nExclusion criteria:\n\n* A diagnosis of schizophrenia, of any other chronic psychotic state, or of bipolar disorder according to DSM-5 criteria\n* The presence of a current depressive episode as defined by DSM-5 criteria\n* The presence of substance use disorder as defined by DSM-5 diagnostic criteria, except for tobacco dependence\n* Having any first-degree relative with alcohol use disorder according to DSM-5 diagnostic criteria\n* The presence of a neurodevelopmental disorder\n* The presence of any clinically significant or unstable pathology: organic pathology affecting the central nervous system\n* Having any uncorrected auditory or visual deficits\n* Contraindication to the use of MRI\n* Individuals particularly protected by the law\n* No smartphone with Apple or Android operating system","65 Years",{"count":139,"type":22},60,[25],"With 41,000 deaths per year, alcohol consumption is the second leading cause of preventable mortality in France. Nearly 3.4% of adults engage in excessive and chronic alcohol use, meeting criteria for Severe Alcohol Use Disorder (SAUD).\n\nSAUD is associated with cerebral and cognitive alterations, including deficits in social cognition. These deficits manifest as difficulties in perceiving and interpreting social cues during interactions and encompass, in particular, the recognition of emotional facial expressions and the accurate attribution of others' beliefs, emotions, and intentions (i.e., theory of mind). Such alterations contribute to interpersonal difficulties and psychological distress and are recognized as risk factors for the development and maintenance of SAUD.\n\nTo date, social cognition has primarily been explored through behavioral tests, providing a description of deficits without examining their neuro-structural correlates. Moreover, no neuroscientific study has investigated the impact of sex and concomitant tobacco use on social cognition and associated brain structures in SAUD, although these factors are known to influence both social cognitive abilities and cerebral organization in this disorder. Finally, the everyday consequences of these alterations on social functioning and the trajectory of alcohol consumption remain poorly explored.\n\nIn this context, the present project aims, first, to explore the neuro-structural correlates of social cognition deficits in SAUD using psychometric assessments (i.e., emotion recognition, theory of mind) combined with magnetic resonance imaging (MRI). The impact of sex and tobacco use will be accounted for by including these variables as covariates in statistical analyses. Second, the project seeks to assess the daily-life impact of social cognition deficits on the social functioning of individuals with SAUD (i.e., quantity and quality of social interactions) and on the evolution of alcohol use behaviors six months after hospitalization (i.e., risk of relapse).\n\nThe study will include two participant groups: individuals with SAUD and age-, sex-, and education-matched control participants.\n\nThe expected results will refine our understanding of social cognition alterations in SAUD, thereby contributing to the improvement of current neuroscientific models. These advances will pave the way for the identification of potential targets for prevention programs and therapeutic interventions.",[143],"Alcohol Use Disorder",[145,146,147,148,149],"Alcohol use disorder","MRI exam","social cognition","social functioning","neuropsychology","2026-05-22",{"date":152,"type":33},"2026-05-26",{"date":154,"type":33},"2026-05-11",{"date":156,"type":22},"2028-12",{"name":39,"class":40},{"id":159,"slug":160,"hasResults":12,"nctId":161,"briefTitle":162,"officialTitle":163,"acronym":164,"eligibilityCriteria":165,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":166,"targetDuration":4,"studyType":23,"phases":168,"briefSummary":169,"conditions":170,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":173,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":41},"100529628","evaluation-of-the-efficacy-of-suprascapular-nerve-block-in-adhesive-capsulitis-100529628","NCT06176248","Evaluation of the Efficacy of Suprascapular Nerve Block in Adhesive Capsulitis","Evaluation of the Efficacy of Suprascapular Nerve Block in Adhesive Capsulitis: a Randomized Controlled Superiority Trial","BAC-Reims","Inclusion Criteria:\n\n* Patient treated for adhesive capsulitis corresponding to a loss of passive amplitude of more than 20° in external rotation elbow to body and\u002For abduction in relation to the contralateral shoulder.\n* Patient over 18 years of age\n* Patient covered by a social security scheme\n* Presence of an accompanying person on the day of the procedure for the return trip\n* Patient having signed the consent form to participate in the study\n\nExclusion Criteria:\n\n* Patient protected by law\n* Pregnant women\n* Patient who has had shoulder surgery less than six months old\n* Patient unable to undergo rehabilitation within one month of surgery\n* Allergy to one of the products used (anesthetic, iodinated contrast medium)\n* Neuro-orthopedic disorder hampering clinical recovery\n* Hemostasis disorder contraindicating block (no discontinuation of anticoagulants according to SFAR recommendations, congenital hemostasis disorder)",{"count":167,"type":22},62,[25],"This is a double-blind interventional superiority study evaluating the efficacy of suprascapular nerve block in addition to conventional therapies for adhesive capsulitis.\n\nAdhesive capsulitis is a pathology that results in reduced shoulder mobility due to retraction of the periarticular capsule. It may be primary or secondary to traumatic or neurological events, or associated with diabetes in particular.\n\nThe usual treatment includes re-education sessions to improve joint amplitude and restore shoulder mobility. In persistent forms, intra-articular injection of cortisone is combined with distension of the capsule with a local anaesthetic under radiographic control.\n\nIn some countries, subscapular nerve block (reversible anaesthesia) is used to improve pain. The combination of arthrodistension and subscapular nerve block has never been performed to accelerate the healing process.\n\nThe aim of this study is to compare the performance of these two procedures together against the reference technique alone on time to improvement with the number of patients improved at one month according to the Constant score.\n\nThis score is used to assess shoulder pain and function, with a significant improvement above eight points.",[171],"Adhesive Capsulitis","2026-05-05",{"date":174,"type":33},"2026-05-06",{"date":176,"type":33},"2024-10-11",{"date":178,"type":22},"2027-03",{"name":39,"class":40},{"id":181,"slug":182,"hasResults":12,"nctId":183,"briefTitle":184,"officialTitle":185,"acronym":4,"eligibilityCriteria":186,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":187,"targetDuration":4,"studyType":23,"phases":189,"briefSummary":190,"conditions":191,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":197,"completionDateStruct":199,"leadSponsor":201,"locationsCount":41},"100338003","soluble-cluster-of-differentiation-160-scd160-in-sera-and-intra-ocular-fluids-association-with-ischaemic-retinopathies-100338003","NCT03680794","Soluble Cluster of Differentiation 160 (sCD160) in Sera and Intra-ocular Fluids: Association With Ischaemic Retinopathies","sCD160 in Sera and Intra-ocular Fluids: Association With Ischaemic Retinopathies","inclusion criteria :\n\n* over 18 years old\n* with social security affiliation\n* willing to participate this study non-inclusion criteria :\n* any prior (3 months) or concomitant treatment with anti-VEGF therapy, corticosteroids, or immunosuppressive agents\n* any history of previous vitreoretinal surgery, ocular tumor, severe ocular trauma, severe intraocular, periocular infection, inflammation, or radiation\n* any serious allergy to the fluorescein sodium for injection in angiography\n* any history of previous systemic anti-VEGF treatment\n* any history of inflammatory or auto-immune disease\n* any active extraocular inflammation or infection in the last 4 weeks before surgery exclusion criteria :\n* Patients with C-reactive protein CRP \\> 10mg\u002FmL (serum sampling during surgery)",{"count":188,"type":22},120,[25],"CD160 represents a new angiogenic factor as its specific engagement by an agonist monoclonal antibody directed against human CD160 reduced angiogenesis of endothelial cells with a distinct mechanism from current angiogenic therapies that target the VEGF\u002FVEGF-R pathway. A soluble form of CD160, sCD160, has been found to be highly expressed in the vitreous and the sera of patients with severe diabetic retinopathies, and can now be dosed with help of an ELISA test.\n\nThe investigators aim to evaluate the association between ischaemic retinopathies (patients with or without) and sCD160 concentrations in the vitreous, the aqueous humour and the serum.",[192,193],"Diabetic Retinopathy","Retinal Vein Occlusion","2026-04-27",{"date":196,"type":33},"2026-04-30",{"date":198,"type":33},"2018-06-27",{"date":200,"type":22},"2028-02-27",{"name":39,"class":40},{"id":203,"slug":204,"hasResults":12,"nctId":205,"briefTitle":206,"officialTitle":207,"acronym":208,"eligibilityCriteria":209,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":210,"targetDuration":4,"studyType":23,"phases":212,"briefSummary":213,"conditions":214,"keywords":216,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":220,"lastUpdatePostDateStruct":221,"startDateStruct":223,"completionDateStruct":225,"leadSponsor":227,"locationsCount":41},"100589542","measurement-of-mmp-14-protein-a-potential-new-marker-for-colorectal-cancer-detection-in-plasma-vesicles-named-exosomes-100589542","NCT06955767","Measurement of MMP-14 Protein, a Potential New Marker for Colorectal Cancer Detection, in Plasma Vesicles Named Exosomes","Performance of Serum Matrix Metalloproteinase (MMP14) Assay as a Novel Biomarker for Colorectal Cancer Screening in Subjects From 50 to 74 Years Old Referred for Colonoscopy After Positive FIT","EXOSCOL02","Inclusion criteria:\n\n* Individuals presenting for colonoscopy with a positive FIT result.\n* Positive fecal immunoassay requiring total colonoscopy under general anesthesia.\n* Persons having agreed to participate in the study (signed consent form)\n* Adults affiliated to a health insurance scheme.\n\nExclusion criteria:\n\n* History of other cancer not in remission or in remission for less than five years (with the exception of cervical cancer or basal cell skin cancer treated with curative intent)\n* Patients undergoing chemotherapy\n* Legally protected individuals",{"count":211,"type":22},650,[25],"Colorectal cancer is the third most common cancer in men, and the second most common in women. Screening for colorectal cancer is based on the search for blood in the stool using fecal immunochemical test (FIT). Occult bleeding is an indication for colonoscopy. In a FIT positive population, 60% of colonoscopies are negative, 34% diagnose an adenomatous lesion, and 6% a cancer. The identification of new biological markers could reduce the number of colonoscopies performed. Cancer cells release extracellular vesicles that contain proteins, mRNAs, DNA, which they can transfer to neighbouring or distant cells. The use of exosomal proteins as novel tumor markers looks very promising. We performed a pilot study comparing the levels of different exosomal proteins in 74 subjects which was recently accepted for publication in Journal of Clinical Laboratory Analysis. Comparison of results showed that only matrix metalloproteinase 14 (MMP14) was significantly higher in patients with colorectal cancer or adenoma than in people with normal colonoscopy.\n\nThe primary objective of the current study is to determine the best cut-off value of MMP-14 for colorectal cancer screening and to evaluate the performance (Sensitivity, Specificity…) associated to this cut-off value. The secondary objective will be to determine the best cut-off value of MMP-14 for colorectal adenomas screening and to evaluate its performance.\n\nFor this purpose, 650 patients, seen for diagnostic colonoscopy following a positive FIT test, will be included in the study. After blood collection and exosome isolation, MMP-14 will be measured using a quantitative test (enzyme-linked immunosorbent assay) and the results will be associated with colonoscopy results to determine the sensitivity, specificity, positive predictive value (PPV) and net present value (NPV).",[215],"Colorectal Adenocarcinoma",[215,217,218,219],"Exosomes","Matrix Metalloproteinase 14","MMP-14","2026-04-08",{"date":222,"type":33},"2026-04-09",{"date":224,"type":33},"2026-04-02",{"date":226,"type":22},"2028-04-02",{"name":39,"class":40},{"id":229,"slug":230,"hasResults":12,"nctId":231,"briefTitle":232,"officialTitle":233,"acronym":234,"eligibilityCriteria":235,"healthyVolunteers":50,"sex":18,"minAge":19,"maxAge":137,"enrollmentInfo":236,"targetDuration":4,"studyType":23,"phases":237,"briefSummary":238,"conditions":239,"keywords":242,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":248,"startDateStruct":250,"completionDateStruct":251,"leadSponsor":253,"locationsCount":41},"100631637","functional-magnetic-resonance-imaging-study-of-inhibitory-control-in-bipolar-disorder-and-major-depressive-disorder-100631637","NCT07503275","Functional Magnetic Resonance Imaging Study of Inhibitory Control in Bipolar Disorder and Major Depressive Disorder","Neurofunctional Characterization of Inhibitory Control in Bipolar Disorder and Major Depressive Disorder","COLIBRI","Group 1 and 2: Bipolar patients, Depressive patients\n\nInclusion criteria:\n\n* Patients between 18 and 65 years old, men or women, right-handed\n* Having a diagnosis of bipolar disorder or depressive disorder\n* No substantial change in treatment for 2 weeks preceding study enrollment\n* Being a native French speaker\n* Patients enrolled in the national healthcare insurance program\n* Consenting to participate to the study\n\nExclusion criteria:\n\n* The presence of any alcohol use disorder or any other substance use disorder in the last six months, except for tobacco dependence\n* A significant general medical illness, including neurological disorders or head trauma\n* Contraindication to the use of MRI\n* A sensorial impairment uncorrected (visual and\u002For hearing)\n\nGroup 3 and 4: Healthy control participants\n\nInclusion criteria:\n\n* Participants between 18 and 65 years old, men or women, right-handed\n* Being a native French speaker\n* Patients enrolled in the national healthcare insurance program\n* Consenting to participate to the study\n\nExclusion criteria:\n\n* A diagnosis of schizophrenia or of bipolar disorder or of major depressive disorder according to DSM-5 criteria\n* The presence of any alcohol use disorder or any other substance use disorder in the last six months, except for tobacco dependence\n* Participants having one first-degree relative presenting an bipolar disorder or depressive disorder or schizophrenia according to DSM-5 criteria\n* A significant general medical illness, including neurological disorders or head trauma\n* Contraindication to the use of MRI\n* A sensorial impairment uncorrected (visual and\u002For hearing)",{"count":188,"type":22},[25],"Bipolar disorder and unipolar depressive disorder are two chronic mood disorders associated with a significant social impact, even during euthymic phases. Their differential diagnosis remains complex, particularly when bipolar disorder begins with a depressive episode. Identifying distinctive markers between these pathologies therefore represents a major clinical and economic challenge, as appropriate mood-stabilizing treatment can reduce healthcare costs and improve patients' functional outcomes.\n\nAmong potential biomarkers, executive functions-and more specifically inhibition-have received particular attention. Inhibitory deficits are observed in both disorders, including during euthymic states, and also among first-degree relatives, suggesting their potential as cognitive and cerebral endophenotypes. These deficits may help explain the difficulties in emotion regulation and impulsivity frequently observed in mood disorders.\n\nTwo components of inhibition are distinguished:\n\n1. Behavioral inhibition, which refers to the ability to stop an ongoing response.\n2. Interference control, which refers to the ability to resist distraction. These processes rely on partially distinct neural networks and operate at different stages of information processing. The few studies comparing these two components in bipolar disorder have shown contradictory results, and neuroimaging investigations have only partially explored these mechanisms, particularly their emotional dimension. It is, however, well established that patients with bipolar or depressive disorders show greater difficulties in executive tasks involving emotional stimuli than in purely cognitive tasks.\n\nThe study is expected to reveal:\n\n* Differences in brain activation between euthymic bipolar and unipolar depressive patients in regions involved in inhibitory control, modulated by the emotional content of the task.\n* Distinct cognitive performance profiles according to pathology, reflecting specific alterations in inhibitory and interference processes.\n\nThese findings should provide a better understanding of the differential neurocognitive bases of mood disorders. Identifying specific cognitive and neural profiles could contribute to more accurate differential diagnosis and to the personalization of therapeutic interventions, particularly through cognitive remediation strategies targeting executive and emotional deficits.",[240,241],"Bipolar Disorder","Major Depressive Disorder",[243,244,245,246],"fMRI","bipolar disorder","major depressive disorder","inhibitory control","2026-03-25",{"date":249,"type":33},"2026-03-31",{"date":125,"type":22},{"date":252,"type":22},"2029-12",{"name":39,"class":40},{"id":255,"slug":256,"hasResults":12,"nctId":257,"briefTitle":258,"officialTitle":259,"acronym":260,"eligibilityCriteria":261,"healthyVolunteers":12,"sex":18,"minAge":262,"maxAge":4,"enrollmentInfo":263,"targetDuration":4,"studyType":23,"phases":264,"briefSummary":265,"conditions":266,"keywords":267,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":272,"lastUpdatePostDateStruct":273,"startDateStruct":275,"completionDateStruct":277,"leadSponsor":279,"locationsCount":41},"100591861","self-concept-and-autobiographical-memory-in-alcohol-use-disorder-100591861","NCT06985927","Self-Concept and Autobiographical Memory in Alcohol Use Disorder","Self-Concept and Autobiographical Memory in the Care of Patients With Alcohol Use Disorder","CoSMA","Inclusion Criteria:\n\n* Patients over 24 years old, men or women\n* Having a diagnosis of alcohol use disorder according to DSM-5 criteria\n* Being a native French speaker\n* Patients enrolled in the national healthcare insurance program\n* Consenting to participate to the study\n\nExclusion Criteria:\n\n* A diagnosis of current non-stabilized psychiatric disorders according to DSM-5 criteria\n* The presence of another substance use disorder, except for tobacco dependence\n* The presence of any intellectual disability, of pervasive developmental disorders\n* The presence of any neurological disorder or any other disorder affecting the central nervous system including neurological complications of alcoholism\n* A sensorial impairment uncorrected (visual and\u002For hearing)","24 Years",{"count":139,"type":22},[25],"This study has two objectives. First, to evaluate the effectiveness of psychotherapy sessions based on self-concept and autobiographical memory in patients suffering from alcohol use disorders (AUD). Second, investigate the relationship between drinking identity and AUD. These objectives will be investigated according to a longitudinal design.\n\nIn this study, the drinking identity is evaluated on its implicit dimension and on its explicit dimension. Levels of alcohol use and dependence are assessed by the amount and frequency of drinking, the duration of abstinence, and the intensity of AUD symptoms. These assessments consist three visits: on the day of inclusion, then at three months and six months after the first visit. The psychotherapy sessions consist of four individual sessions. They are inspired by the Social Identity Mapping in Addiction Recovery (SIM-AR) by Beckwith et al. (2019), combined with autobiographical reasoning exercises.\n\nPatients with an AUD, participants in the study, are recruited from the addiction department of the Etablissement Public de Santé Mentale de la Marne. To investigate the effects of individual psychotherapy sessions, two groups of patients are constituted randomly. The first group will have four psychotherapy sessions between the first visit and the second vist. The second group will not follow psychotherapy sessions but will benefit from the usual addiction treatments.\n\nThe first hypothesis is that patients who have completed the psychotherapy sessions will have lower alcohol consumption (frequency, quantities, peaks) and symptoms of AUD (cravings, drinking refusal self-efficacy and feeling of recovery) than those who have not benefited from the program.\n\nThe second hypothesis is that implicit and explicit levels of drinking identity will predict alcohol consumption (frequencies, quantities, peaks) and symptoms of dependence (cravings, drinking refusal self-efficacy and feeling of recovery) for all participants.",[143],[268,269,270,271],"Alcohol Use Disorders","Self-Concept","Autobiographical Memory","Psychotherapeutic Care","2026-03-11",{"date":274,"type":33},"2026-03-13",{"date":276,"type":33},"2025-05-28",{"date":278,"type":22},"2027-12",{"name":39,"class":40},{"id":281,"slug":282,"hasResults":12,"nctId":283,"briefTitle":284,"officialTitle":284,"acronym":285,"eligibilityCriteria":286,"healthyVolunteers":50,"sex":18,"minAge":19,"maxAge":137,"enrollmentInfo":287,"targetDuration":4,"studyType":23,"phases":289,"briefSummary":290,"conditions":291,"keywords":293,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":272,"lastUpdatePostDateStruct":298,"startDateStruct":299,"completionDateStruct":301,"leadSponsor":303,"locationsCount":41},"100572981","social-cognition-memory-and-executive-functions-in-bipolar-disorder-and-major-depressive-disorder-100572981","NCT06740331","Social Cognition, Memory, and Executive Functions in Bipolar Disorder and Major Depressive Disorder","COMET","Inclusion criteria:\n\n* Patients between 18 and 65 years old, men or women\n* Having a diagnosis of bipolar disorder or depressive disorder\n* No substantial change in treatment for 2 weeks preceding study enrollment\n* Being a native French speaker\n* Patients enrolled in the national healthcare insurance program\n* Consenting to participate to the study\n\nExclusion criteria:\n\n* The presence of any alcohol use disorder or any other substance use disorder in the last six months, except for tobacco dependence\n* A significant general medical illness, including neurological disorders or head trauma\n* A sensorial impairment uncorrected (visual and\u002For hearing)\n\nGroup 3: First-degree relatives of bipolar patients\n\nInclusion criteria:\n\n* Participants between 18 and 65 years old, men or women\n* Participants having at least one first-degree relative presenting an bipolar disorder (parents, children, siblings)\n* Being a native French speaker\n* Patients enrolled in the national healthcare insurance program\n* Consenting to participate to the study\n\nExclusion criteria:\n\n* A diagnosis of schizophrenia or of bipolar disorder or of depressive disorder according to DSM-5 criteria\n* The presence of any alcohol use disorder or any other substance use disorder in the last six months, except for tobacco dependence\n* A significant general medical illness, including neurological disorders or head trauma\n* A sensorial impairment uncorrected (visual and\u002For hearing)\n\nGroup 4, 5, 6: Healthy control participants\n\nInclusion criteria:\n\n* Participants between 18 and 65 years old, men or women\n* Being a native French speaker\n* Patients enrolled in the national healthcare insurance program\n* Consenting to participate to the study\n\nExclusion criteria:\n\n* A diagnosis of schizophrenia or of bipolar disorder or of major depressive disorder according to DSM-5 criteria\n* The presence of any alcohol use disorder or any other substance use disorder in the last six months, except for tobacco dependence\n* Participants having one first-degree relative presenting an bipolar disorder or depressive disorder or schizophrenia according to DSM-5 criteria\n* A significant general medical illness, including neurological disorders or head trauma\n* A sensorial impairment uncorrected (visual and\u002For hearing)",{"count":288,"type":22},180,[25],"Bipolar disorder (BD) are common psychiatric disorders often misdiagnosed, leading to delayed treatment. Even during stable phases, individuals with bipolar disorder experience residual cognitive impairments that affect their social functioning and quality of life.\n\nThis study aims to explore social cognition deficits (e.g., emotional processing, theory of mind, attribution bias) and their relationship with executive functions (e.g., flexibility, inhibition, working memory) and memory in bipolar disorder and major depressive disorder, ultimately seeking to improve understanding of their functional outcomes.\n\nSocial cognition and executive functions in BD are both state- and trait-related. One recent meta-analysis demonstrated impairment in social cognitive domains for manic, depressive, and euthymic bipolar disorders' patients but it remains unclear whether these social cognitive deficits in BD are due to executive functions and\u002For other confounding effects.\n\nFew studies have investigated the interdependency between these cognitive impairments in these two affective disorders while a better understanding of the link between executive functions and social cognition seems crucial in order to better characterize the nature of patients' deficits and thus their caring.",[292],"Bipolar Disorder and Major Depressive Disorder",[294,245,295,147,296,297],"Bipolar disorder","high-risk individuals","executive functions","memory functions",{"date":274,"type":33},{"date":300,"type":33},"2025-01-07",{"date":302,"type":22},"2028-02-07",{"name":39,"class":40},{"id":305,"slug":306,"hasResults":12,"nctId":307,"briefTitle":308,"officialTitle":309,"acronym":310,"eligibilityCriteria":311,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":312,"targetDuration":4,"studyType":23,"phases":313,"briefSummary":314,"conditions":315,"keywords":318,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":326,"lastUpdatePostDateStruct":327,"startDateStruct":329,"completionDateStruct":331,"leadSponsor":333,"locationsCount":41},"100628034","sensory-stimulation-program-delivered-by-family-members-of-brain-injured-patients-in-critical-care-effect-on-relatives-post-traumatic-stress-100628034","NCT07456384","Sensory Stimulation Program Delivered by Family Members of Brain-injured Patients in Critical Care: Effect on Relatives' Post-traumatic Stress","Evaluation of the Impact of a Standardized Neurosensory Stimulation Protocol Delivered by Relatives of Brain-injured Patients Hospitalized in Critical Care on Post-traumatic Stress in Those Relatives","StimulSensRea","inclusion criteria :\n\n* Age ≥ 18 years\n* Relative (family member or close person) of an eligible brain-injured patient hospitalized in critical care\n* Able and willing to provide informed consent to participate.\n* Available to attend at least three visits during the patient's critical care hospitalization.\n* French-speaking (sufficient proficiency to understand study information and complete questionnaires).\n\nexclusion criteria :\n\n* Non-French-speaking or insufficient French proficiency to complete study procedures\u002Fquestionnaires.\n* Insufficient understanding\u002Fcomprehension of the study procedures, as assessed during the initial interview after explanations by the study nurse.",{"count":114,"type":22},[25],"Severe traumatic brain injuries are common and can lead to major long-term disability. Patients with severe brain injury often require admission to critical care. For relatives, this period is highly distressing: during and after an ICU stay, family members frequently experience anxiety, depression, and post-traumatic stress symptoms.\n\nIn recent years, family involvement in critical care has been associated with better communication with the healthcare team and fewer psychological difficulties among relatives. In parallel, findings from neuroscience suggest that early multisensory stimulation (engaging the five senses) may help support brain recovery by promoting neuronal connections during the awakening phase.\n\nThis study evaluates whether a standardized neurosensory stimulation program, delivered by trained relatives of brain-injured patients hospitalized in critical care, can reduce post-traumatic stress symptoms in those relatives. We hypothesize that involving relatives in a structured, supervised multisensory stimulation protocol during the patient's awakening phase (before transfer to rehabilitation) will decrease relatives' post-traumatic stress symptoms at 3 months after critical care discharge (or after the patient's death). We also expect potential secondary benefits on patients' awakening and recovery trajectory.",[316,317],"Stress Disorder","Post-traumatic",[319,320,321,322,323,324,325],"craniocerebral trauma","stress disorders","post-traumatic","anxiety","critical care","sensory stimulation","caregivers","2026-03-04",{"date":328,"type":33},"2026-03-06",{"date":330,"type":22},"2026-05",{"date":332,"type":22},"2029-05",{"name":39,"class":40},{"id":335,"slug":336,"hasResults":12,"nctId":337,"briefTitle":338,"officialTitle":338,"acronym":339,"eligibilityCriteria":340,"healthyVolunteers":50,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":341,"targetDuration":343,"studyType":83,"phases":4,"briefSummary":344,"conditions":345,"keywords":351,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":359,"lastUpdatePostDateStruct":360,"startDateStruct":362,"completionDateStruct":364,"leadSponsor":366,"locationsCount":41},"100614056","a-cohort-for-inflammatory-respiratory-diseases-from-phenotyping-to-personalised-medicine-100614056","NCT07274631","A Cohort for Inflammatory Respiratory Diseases: From Phenotyping to Personalised Medicine","PALMIRE","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Follow-up for one of the following conditions: asthma, COPD, bronchiectasis (DDB), cystic fibrosis (CF), primary ciliary dyskinesia (PCD), or interstitial lung diseases (ILD)\n* Healthy volunteers (controls)\n\nExclusion Criteria:\n\n* Subjects protected by law (e.g., legal incapacity)\n* Any condition preventing informed consent or participation",{"count":342,"type":22},470,"10 Years","Chronic inflammatory pulmonary diseases, including asthma, chronic obstructive pulmonary disease (COPD), bronchiectasis, cystic fibrosis (CF), primary ciliary dyskinesia (PCD) and interstitial lung diseases (ILD) are characterised by lung inflammation and remodelling. Clinical, functional, microbiological, biological, pathological and prognostic features are highly variable and heterogeneous. Several phenotypes have been described within the same pathology, as similar phenotypic traits between different pathologies, or the coexistence of components of several diagnoses in the same patient, suggesting shared underlying mechanisms that could represent new therapeutic targets, beyond the initial medical diagnosis.\n\nThe objectives of this prospective study are to analyze the phenotypic characteristics (clinical, demographic, biological, morphological, pathological, and microbiological characteristics) together with respiratory exposures and underlying mechanisms involving airway epithelium and inflammation processes in a cohort of patients diagnosed with asthma, COPD, bronchiectasis, CF, PCD and ILD.",[346,347,348,349,350],"Chronic Obstructive Pulmonary Disease","Asthma","Bronchiectasis","Cystic Fibrosis","Primary Ciliary Dyskinesia",[352,347,348,353,354,355,356,357,358],"Chronic obstructive pulmonary disease","Cystic fibrosis","Primary ciliary dyskinesia","Airway microbiota","Airway epithelium","Remodeling","Exposome","2026-02-18",{"date":361,"type":33},"2026-02-20",{"date":363,"type":33},"2025-09-15",{"date":365,"type":22},"2040-09-15",{"name":39,"class":40},{"id":368,"slug":369,"hasResults":12,"nctId":370,"briefTitle":371,"officialTitle":372,"acronym":373,"eligibilityCriteria":374,"healthyVolunteers":12,"sex":18,"minAge":375,"maxAge":19,"enrollmentInfo":376,"targetDuration":4,"studyType":23,"phases":377,"briefSummary":378,"conditions":379,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":359,"lastUpdatePostDateStruct":381,"startDateStruct":382,"completionDateStruct":384,"leadSponsor":386,"locationsCount":41},"100551825","difficult-intravenous-access-in-pediatric-patients-paramedical-care-using-ultrasound-guidance-100551825","NCT06465121","Difficult Intravenous Access in Pediatric Patients: Paramedical Care Using Ultrasound Guidance","Difficult Venous Access in Pediatric Patients: Paramedical Care Using Ultrasound Guidance","VVParamECHO","Inclusion Criteria :\n\n* age ≥ 1 month and \\\u003C 18 years\n* intravenous catheter insertion indicated for hospital care\n* DIVA (Difficult Intravenous Access Scale) score ≥ 4\n* hospitalized in one of the pediatric departments of the Reims University Hospital\n* who agree to participate in the study (if old enough to understand) and for whom the consent of the holder(s) of parental authority has been obtained\n* affiliated to a social security scheme\n\nExclusion Criteria:\n\n* Newborns (\\\u003C 1 month) and premature babies hospitalized in neonatal intensive care, neonatology and maternity units\n* Known vascular pathology\n* Hemodialysis with arteriovenous fistula\n* Unstable hemodynamic and\u002For respiratory clinical state according to the judgment of the medical team","1 Month",{"count":188,"type":22},[25],"Obtaining intravenous access is difficult in the pediatric population. Ultrasound-guidance allows real-time visualization of target veins which are invisible and impalpable. We hypothesize that the use of ultrasound by a trained nurse team would improve the success rate of peripheral intravenous catheter insertion in pediatric patients with difficult intravenous access, compared to palpation of the vein alone.\n\nFor this study, when peripheral intravenous catheterization will be indicated in one of the participating pediatric services for an eligible patient, state-certified nurse investigators, trained in ultrasound guidance, will be contacted. After verification of eligibility criteria and all informed consents obtained, one of the investigators will randomize the patient in one of the 2 treatment groups under study: peripheral intravenous catheterization by visualization and palpation of the vein alone (standard of care) or by ultrasound guidance performed by a trained nurse.\n\nSeveral outcomes will be measured and compared between the 2 groups (e.g. successful insertion of intravenous catheter, pain, adverse events).",[380],"Catheter Related Complication",{"date":361,"type":33},{"date":383,"type":33},"2026-02-17",{"date":385,"type":22},"2027-09",{"name":39,"class":40},{"id":388,"slug":389,"hasResults":12,"nctId":390,"briefTitle":391,"officialTitle":392,"acronym":393,"eligibilityCriteria":394,"healthyVolunteers":12,"sex":395,"minAge":19,"maxAge":396,"enrollmentInfo":397,"targetDuration":4,"studyType":23,"phases":399,"briefSummary":400,"conditions":401,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":359,"lastUpdatePostDateStruct":403,"startDateStruct":404,"completionDateStruct":406,"leadSponsor":407,"locationsCount":41},"100535558","new-cognitive-treatment-for-peripartum-depression-100535558","NCT06253390","New Cognitive Treatment for Peripartum Depression","Effect of the Metacognitive Training Programme (D-MCT) in Patients With Peripartum Depression","MCT-DPP","Inclusion Criteria:\n\n* Women over 18 years\n* Meets the diagnostic criteria for depressive disorder with peripartum onset (PPD) (APA, 2013) and has already given birth\n* EPDS score over 10\n* Have given their consent to take part in the study\n* Be affiliated to a social security system\n* Have an adequate knowledge of written, understood and spoken French (French mother tongue or primary education in the French education system) All women with PPD, whether breastfeeding or not, can be included in the study. Baby care can be organised if mothers are unable to have their babies looked after. This service is provided by nurses from the UPPE in the unit's reception room, which has all the equipment needed to care for infants. Mothers meet the nurses before the group and tell them what they expect, and the nurses give them feedback when they come to collect their baby.\n\nExclusion Criteria:\n\n* \\- Be the subject of a protection measure\n* Being a minor\n* Meets the diagnostic criteria for schizophrenia spectrum disorders (brief psychotic disorder; schizophrenic disorder; schizoaffective disorder; delusional disorder; brief psychotic disorder with peripartum onset)\n* Meet the criteria for substance abuse or dependence (alcohol, drugs)\n* With insufficient command of the French language\n* People with a deceased child\n* People who do not meet the diagnostic criteria for depressive disorder with peripartum onset (APA, 2013)\n* People who do not agree to take part in the study","FEMALE","45 Years",{"count":398,"type":22},96,[25],"The peripartum period is the period between the last month of pregnancy and up to a year after childbirth. It can be considered a difficult time for women, as it is a period of transition during which vulnerability to psychiatric disorders and in particular to major depressive disorder (MDD) (Vesga-Lopez, Blanco, Olfson, Grant \\& Hasin, 2008). Depression with peripartum onset (PPD) is characterised by the fact that the onset of symptoms may occur during pregnancy or within four weeks of delivery, but may also persist for up to 12 months after delivery (American Psychiatric Association, 2013). PPD affects 10 to 20% of women who have given birth (Tebeka et al. 2021). In addition, the psychological distress experienced by the mother during the peripartum period can disrupt interactions with her newborn (Lefkovics et al. 2014). Depression during this period can therefore have long-term consequences, not only for the women who suffer it, but also for their children (Gavin et al. 2005).\n\nThe investigators now know that women with PPD have deficits in metacognition. Metacognition is the body of knowledge, processes and practices that enable individuals to control and evaluate their own cognitive activities, thereby enabling them to regulate them (Flavell, 1976). Patients with PPD therefore have difficulty identifying, controlling and evaluating their own cognitive activities. These deficits may also represent a risk factor for the development of PPD if they are present at an early stage (Diop et al. 2022).\n\nIn patients with PPD, metacognitive therapies appear to be effective in reducing symptoms. In 2013, Bevan, Wittkowski and Wells conducted a pilot study to test the effects associated with metacognitive therapy in depression. This was the first published study to evaluate the effects of metacognitive therapy on patients with depression in the peripartum period. It shows promising results which it would be interesting to replicate, as this is a pilot study. A metacognitive training program for depression (D-MCT) was developed by Jelinek, Hauschildt, Moritz and Dubreucq in 2016, it is a brief group intervention that is easy to manage to participants. To date, no study has yet tested this specific program in patients with PPD, but it has been able to show its effectiveness in reducing the metacognitive deficits.\n\nIn the light of the scientific literature, the aims of this study are, firstly, to demonstrate the efficacy of D-MCT therapy in subjects with post-partum depression. Secondly, to examine the effects of this therapy on mother-child interactions.\n\nThe investigators make the following assumptions:\n\n* Women in the experimental group showed a greater reduction in depressive symptoms and an improvement in metacognitive functioning than those in the control group.\n* Women in the experimental group showed a reduction in depressive symptoms after therapy (v2) and maintenance of this improvement (v3).\n* Improvement in the quality of mother-child bonding for women who took part in the program compared with those in the control group.\n* Improvement in the quality of mother-child bonding after the program (v2 and v3) for women in the experimental group compared with when they entered the program.",[402],"Postnatal Depression",{"date":361,"type":33},{"date":405,"type":33},"2024-01-10",{"date":156,"type":22},{"name":39,"class":40},{"id":409,"slug":410,"hasResults":12,"nctId":411,"briefTitle":412,"officialTitle":413,"acronym":414,"eligibilityCriteria":415,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":416,"enrollmentInfo":417,"targetDuration":4,"studyType":23,"phases":418,"briefSummary":419,"conditions":420,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":359,"lastUpdatePostDateStruct":422,"startDateStruct":424,"completionDateStruct":426,"leadSponsor":428,"locationsCount":41},"100391674","evaluation-of-a-sensory-tonic-stimulation-on-development-of-parent-infant-interactions-and-social-cognition-in-very-premature-children-100391674","NCT04380051","Evaluation of a Sensory-tonic Stimulation on Development of Parent-infant Interactions and Social Cognition in Very Premature Children","Evaluation of a Sensory-tonic Stimulation on Development of Parent-infant Interaction and Social Cognition in Very Premature Children","CALIN","inclusion criteria :\n\n* very preterm child (born before 32 weeks of amenorrhoea)\n* parents agreeing to participate to the study\n\nexclusion criteria :\n\n* child born before 25 weeks of amenorrhoea\n* child with a birth weight less than 600 grams\n* child with congenital malformation\n* child with hemodynamic instability","1 Day",{"count":188,"type":22},[25],"Attachment is built primarily on the first interactions of the first 9 months of a baby's life. These first interactions and their effects of stress, pleasure and displeasure are retained to establish some of the baby's attachment behaviours and future relationships with others.\n\nExtreme prematurity strongly modify these first interactions between parents and child. Very preterm child is separated from his parents and is placed in a stressful, technical and potentially painful environment.\n\nEarly interventions stimulate neuroplasticity and can positively affect the neurological development of very preterm infant. Tactile stimuli such as skin-to-skin contact and massages carried out by parents can be pleasant experiences that can support early interactions between parents and child.",[421],"Very Preterm Birth",{"date":423,"type":33},"2026-02-19",{"date":425,"type":33},"2023-01-19",{"date":427,"type":22},"2033-01-19",{"name":39,"class":40},{"id":430,"slug":431,"hasResults":12,"nctId":432,"briefTitle":433,"officialTitle":434,"acronym":435,"eligibilityCriteria":436,"healthyVolunteers":12,"sex":395,"minAge":19,"maxAge":4,"enrollmentInfo":437,"targetDuration":4,"studyType":23,"phases":439,"briefSummary":440,"conditions":441,"keywords":445,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":452,"lastUpdatePostDateStruct":453,"startDateStruct":454,"completionDateStruct":456,"leadSponsor":457,"locationsCount":41},"100624615","kynurenine-concentrations-during-pregnancy-in-women-with-or-without-chronic-kidney-disease---a-prospective-multicenter-study-100624615","NCT07411937","Kynurenine Concentrations During Pregnancy in Women With or Without Chronic Kidney Disease - A Prospective Multicenter Study","Concentrations of Kynurenine During Pregnancy in Women With or Without Chronic Kidney Disease: A Prospective Multicenter Study","KIDNEY-MOM","Inclusion Criteria:\n\n* Adult pregnant women \\\u003C14 weeks of amenorrhea\n* With or without CKD stage 2-4 (eGFR 15-89 mL\u002Fmin\u002F1.73m², diagnosed before pregnancy)\n* Written informed consent\n* Affiliation to a social security system\n\nExclusion Criteria:\n\n* Multiple pregnancy\n* Kidney transplantation\n* Persons under guardianship or legal protection",{"count":438,"type":22},204,[25],"Chronic kidney disease (CKD) affects more than 10% of the population worldwide and represents the second most important risk factor for preeclampsia, a life-threatening complication of pregnancy responsible for approximately 80,000 maternal and 500,000 perinatal deaths each year. Experimental studies have suggested a causal link between CKD, relative kynurenine deficiency during pregnancy, and preeclampsia development. Kynurenine, a tryptophan metabolite, plays a central role at the materno-fetal interface, supporting placental energy production, maternal-fetal immune tolerance, and placental perfusion. This study will prospectively assess and compare longitudinal kynurenine concentrations in pregnant women with and without CKD, and evaluate their associations with maternal and fetal outcomes.",[442,443,444],"Chronic Kidney Diseases","Pregnancy","Preeclampsia",[446,447,448,449,450,451],"kidney disease","pregnancy","preeclampsia","kynurenine","maternal outcomes","fetal outcomes","2026-02-09",{"date":383,"type":33},{"date":455,"type":22},"2026-03",{"date":332,"type":22},{"name":39,"class":40},{"id":459,"slug":460,"hasResults":12,"nctId":461,"briefTitle":462,"officialTitle":463,"acronym":464,"eligibilityCriteria":465,"healthyVolunteers":12,"sex":395,"minAge":19,"maxAge":4,"enrollmentInfo":466,"targetDuration":4,"studyType":23,"phases":468,"briefSummary":470,"conditions":471,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":473,"lastUpdatePostDateStruct":474,"startDateStruct":476,"completionDateStruct":478,"leadSponsor":479,"locationsCount":41},"100550124","phase-4-evaluation-of-the-efficacy-of-the-addition-of-magnesium-sulfate-to-morphine-on-the-occurrence-of-acute-urinary-retention-following-epidural-anesthesia-for-cesarean-section-100550124","NCT06442995","Evaluation of the Efficacy of the Addition of Magnesium Sulfate to Morphine on the Occurrence of Acute Urinary Retention Following Epidural Anesthesia for Cesarean Section.","Superiority Randomized Double-blind Controlled Trial of Epidural Magnesium Sulfate Addition Versus Placebo on the Occurrence of Acute Post-caesarean Urinary Retention","EPIMAG","Inclusion Criteria:\n\n* Patients who have undergone scheduled or emergency Caesarean section surgery under extended epidural anesthesia or combined epidural and spinal anesthesia at the Reims University Hospital.\n* Patients who have just undergone caesarean section and have the epidural catheter in place in the post-interventional monitoring room (SSPI).\n* Patients who agree to take part in the research and have signed the informed consent form\n* Patients of legal age\n* Patients affiliated to a social security scheme\n\nExclusion Criteria:\n\n* Minor patients\n* Patients protected by law\n* Patients allergic to local anesthetics, morphine or magnesium sulfate\n* Patients with severe renal insufficiency (GFR \\\u003C 30 ml\u002Fmin)\n* Patients with pre-pregnancy mictional disorders\n* Patients with an American Society of Anesthesiologists (ASA) score of 4\n* Patients undergoing caesarean section under general anaesthesia, after failure of perimedullary anaesthesia\n* Patients with accidental intraoperative injury to the urinary tract\n* Patients who have received intravenous magnesium sulfate in the 24 hours preceding cesarean section",{"count":467,"type":22},290,[469],"PHASE4","Peri-medullary anesthesia is the preferred anesthetic technique for Caesarean surgery. Compared with general anesthesia, it reduces maternal and fetal morbidity and mortality, as well as postoperative pain. However, this technique exposes the patient to the adverse effects of peri-medullary morphine, particularly the risk of postoperative urinary retention. Urinary retention during the first 72 hours after Caesarean section affects around 33% of parturients.\n\nThis is a particularly debilitating event for parturients, exposing them to the risk of further urinary catheterization, increased theoretical risk of urinary tract infection, traumatic urethral injury, hindered accelerated rehabilitation and altered maternal satisfaction.\n\nSeveral studies have demonstrated the benefits of adding magnesium sulfate to epidural anesthesia for Caesarean sections, notably by reducing postoperative pain.\n\nMagnesium sulfate may also have a facilitating effect on postoperative micturition, thanks to its sympathicolytic effect.\n\nThis hypothesis is supported by a retrospective study carried out in our maternity hospital, which showed a 15% reduction in post-Caesarean urinary retention when women were given magnesium sulfate in addition to the drugs traditionally used for epidurals.\n\nThis little-known property needs to be clarified",[472],"Urinary Retention","2025-12-22",{"date":475,"type":33},"2025-12-30",{"date":477,"type":33},"2025-01-16",{"date":278,"type":22},{"name":39,"class":40},{"id":481,"slug":482,"hasResults":12,"nctId":483,"briefTitle":484,"officialTitle":485,"acronym":486,"eligibilityCriteria":487,"healthyVolunteers":12,"sex":18,"minAge":488,"maxAge":19,"enrollmentInfo":489,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":491,"conditions":492,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":494,"lastUpdatePostDateStruct":495,"startDateStruct":497,"completionDateStruct":499,"leadSponsor":501,"locationsCount":41},"100560803","study-of-vitamin-b12-metabolism-in-children-with-sickle-cell-disease-exposed-to-meopa-100560803","NCT06581900","Study of Vitamin B12 Metabolism in Children With Sickle Cell Disease Exposed to MEOPA","Study of Vitamin B12 Metabolism in Children With Sickle Cell Disease Exposed to MEOPA , a Prospective Study at Reims University Hospital","DREPAM","Inclusion Criteria:\n\n* Sickle cells patient\n* Age between 2 and 18 years old\n* Being affiliated with social security\n\nExclusion Criteria:\n\n* Having a neurological defect prior to the study\n* Being against the collection of blood or data","2 Years",{"count":490,"type":22},29,"Short description of the protocol intended for the lay public. Include a brief statement of the study hypothesis (Limit : 5000 characters) The sickle cells anemia is a monogenic disease linked to the presence of Hemoglobin S due to a mutation in the Hemoglobin Beta chain. The lack of circulating oxygen induces a polymerization of the Hemoglobin S which change the red cell conformation into sickle. Those cells interact and causes vaso-occlusive crisis (CVO).\n\nThe MEOPA is a medical gas used as an antalgic and a sedative especially in sickle cells disease patients. The nitrous oxide, oxide the cobalt ion in the vitamin B12 which inactivate it irreversibly creating a functional deficiency.\n\nDuring the metabolism of vitamin B12, homocysteine is transformed in methionine which is used in to form the myelin sheath and helped in producing DNA. Numerous studies already shown that the longer the exposition to MEOPA is the greater the functional deficiency of vitamin B12 occur.\n\nA few studies shown a symptomatic deficiency of vitamin B12 due to the exposition of MEOPA in sickle cells patient but there is no explanation on the necessary amount of exposure or if some patients are more at risk. When there is a deficiency of vitamin B12 the symptoms can go from a simple orthostatic hypotension to a combined spinal sclerosis.\n\nThe participation to the study will be proposed to every patient hospitalized for a CVO in the follow up of the emergency room visit or directly in pediatric reanimation. During a usual blood test, a small amount of blood (4mL) will be collected in addition to dose the Vitamin B12, the vitamin B9, the homocysteine, and the methionine. A small amount of urine will also be collected to dose the methylmalonic acid, all those elements are a part of the metabolism of B12 vitamin.\n\nThe same sample will be taken on the day of departure of the hospital. During the hospitalization the pain management, a daily neurological exam, and the exposition to the MEOPA will be assessed meticulously.\n\nAn appointment will take place at 7 days and at one month after the hospital departure to evaluate the possible neurological defect.\n\nEach patient can only be included once.",[493],"Sickle Cells Patients","2025-12-09",{"date":496,"type":33},"2025-12-10",{"date":498,"type":33},"2024-11-27",{"date":500,"type":22},"2026-12",{"name":39,"class":40},{"id":503,"slug":504,"hasResults":12,"nctId":505,"briefTitle":506,"officialTitle":506,"acronym":507,"eligibilityCriteria":508,"healthyVolunteers":50,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":509,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":510,"conditions":511,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":513,"lastUpdatePostDateStruct":514,"startDateStruct":516,"completionDateStruct":518,"leadSponsor":520,"locationsCount":41},"100495712","impact-of-preterm-birth-on-symptoms-of-anxiety-and-depression-in-parents-and-on-the-precursors-of-cognition-including-social-cognition-in-their-child-100495712","NCT05734768","Impact of Preterm Birth on Symptoms of Anxiety and Depression in Parents, and on the Precursors of Cognition, Including Social Cognition in Their Child","PréDANPa","Inclusion Criteria:\n\nChildren and their parents will be included in the study in the exposed group if:\n\n* the infant is born preterm, i.e., between 32 weeks of amenorrhea (SA) and 36 SA + 6 days.\n* at the maternity ward of the University Hospital of Reims\n* the parents are older than 18 years.\n* parents are affiliated to a social insurance.\n* parents agreed to participate in the study, within 72 hours after birth\n\nWill be included in the study, in the non-exposed group, children and their parents, if:\n\n* the children is born at term, i.e., from 37 SA + 0 Days\n* at the maternity ward of the Reims University Hospital\n* parents are older than 18 years.\n* parents are affiliated to a social insurance.\n* parents agreed to participate in the study, within 72 hours after birth\n\nExclusion Criteria:\n\nWill not be included in the study, children and their parents, if:\n\n* the infant is born from multiple pregnancy\n* the infant is hemodynamically unstable\n* the birth occured more than 72 hours ago\n* the infant is affected by congenital malformations\n* the infant is affected by severe brain lesion detected by transfontanellar ultrasound scan performed before inclusion (cystic leukomalacia, and stages III and IV of the Papille classification i.e. severe ventricular dilatation or intra-parenchymal hemorrhage)\n* separation from the parents and placement of the child is intended\n* child is born anounymously\n* parents with psychiatric disorders\n* if the mother is suffering from hemodynamic compromise\n* parents under guardianship\n* parents non-native speaking",{"count":139,"type":22},"In 2018, the World Health Organization (WHO) counted no less than 15 million preterm births each year worldwide, or more than one in ten children. In recent years, the number of newborns surviving preterm birth has gradually increased due to advances in neonatal medicine. However, these rescues are not without consequences.\n\nIndeed, to do so, the child is separated from his parents, placed in a stressful, technical and potentially painful environment. This early separation is compounded by medical co-morbidities and sedations that compromise the child's physiology and availability to interact. Extreme prematurity also disrupts the early interactions between the child and his parents, and eventually the relationships with others. Thus, more than 35% of children born prematurely show insecure attachment behavior in their relationships with others.\n\nMoreover, premature births are accompanied by numerous somatic, cognitive and social cognitive difficulties. At school age, these children present more learning, social-emotional and behavioral problems. The greater the degree of prematurity, the more marked these difficulties are. They would be associated with an executive and social cognition deficit, inherent to a globally altered cerebral development, in particular the frontal subcortical cerebral regions.\n\nOn the parents' side, premature birth is also fraught with consequences. Indeed, the idea of an idealized post-natal period gives way to an anxious, even traumatic experience. Notions of guilt are often expressed, as well as major anxiety about the child's survival and \"parenting skills\". A higher prevalence of signs of parental anxiety, postnatal depression and post-traumatic stress disorder is observed in mothers of premature infants, even up to 18 months after birth. These psychological states influence the parents' ability to interact with their newborn, as well as the content of these interactions.\n\nFinally, both parents and newborns see, for different reasons, their ability to interact and to reassure themselves profoundly disrupted by premature birth.\n\nEven if since 2010, prematurity has been identified as a \"public health problem\" by the WHO, studies on the subject still have limitations. Indeed, if we estimate that the prevalence of anxiety and\u002For depression signs in mothers of premature babies is on average three times higher than in mothers of full-term babies; what about fathers? It seems fundamental to improve our knowledge of the anxious and depressive symptoms that fathers and mothers of premature babies may display, with the aim of providing comprehensive and multidisciplinary care for families in neonatal intensive care units.\n\nSimilarly, the exact impact of an increase in parental anxious depressive symptomatology on the precursors of cognitive and social cognitive development is not known. Since the environment and stimulation are fundamental to the child's development, what happens when one or both parents have their interaction modified by anxious-depressive symptomatology? Indeed, the rare studies publishing data on the subject are carried out on populations of parents of non-premature children, often non-French-speaking and above all with tools that are not available to French-speaking practitioners in charge of the early detection of developmental difficulties in premature children. Today, it seems necessary to provide data concerning the development of precursors to cognitive and social cognitive development in preterm infants, and to better understand the extent of its interaction with the anxious depressive symptomatology of the mother and father.\n\nThe investigators therefore formulate the following hypotheses:\n\n* Anxious depressive symptomatology, such as signs of parental anxiety, postnatal depression, and posttraumatic stress disorder, would be higher in mothers and fathers of preterm infants than in mothers and fathers of full-term infants at 7 ± 1 weeks after birth.\n* The level of development of the precursors to cognitive and social cognitive development would be lower in children whose parents present an exacerbated anxious depressive symptomatology.",[512],"Parental Anxiety Following Premature Birth","2025-11-28",{"date":515,"type":33},"2025-12-02",{"date":517,"type":33},"2023-11-28",{"date":519,"type":22},"2028-05-28",{"name":39,"class":40},{"id":522,"slug":523,"hasResults":12,"nctId":524,"briefTitle":525,"officialTitle":526,"acronym":527,"eligibilityCriteria":528,"healthyVolunteers":50,"sex":18,"minAge":19,"maxAge":529,"enrollmentInfo":530,"targetDuration":4,"studyType":23,"phases":532,"briefSummary":533,"conditions":534,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":513,"lastUpdatePostDateStruct":536,"startDateStruct":537,"completionDateStruct":539,"leadSponsor":541,"locationsCount":41},"100450604","functional-magnetic-resonance-imaging-in-patients-with-obstructive-sleep-apnea-syndrome-100450604","NCT05147649","Functional Magnetic Resonance Imaging in Patients With Obstructive Sleep Apnea Syndrome","Functional Magnetic Resonance Imaging in Patients With Obstructive Sleep Apnea Syndrome, With and Without CPAP, During Wakefulness - Impact on Cognitive Functions","IRM SAOS","Inclusion criteria :\n\n1. OSAS patients\n\n   * severe OSAS with an Apnea-Hypopnea Index (AHI) \\> 30\u002Fh\n   * without CPAP treatment\n2. Non-OSAS patients\n\n   * absence of OSAS (AHI \\\u003C 15\u002Fh and absence of excessive daytime sleepiness with Epworth score \\\u003C11)\n\nNon-inclusion criteria :\n\n* \\\u003C 18 years old\n* \\>75 years old\n* left-handed\n* BMI\\> 40 kg\u002Fm²\n* another sleep disorder\n* central component of sleep apnea syndrome (central apnea index\\> 5 \u002F h)\n* current or past neurological pathology\n* respiratory pathology (obstructive ventilatory disorder, restrictive ventilatory disorder, hypercapnia)\n* MRI contraindication (metallic foreign body, claustrophobia, pregnant woman, etc.)\n* taking drugs that can modify the BOLD signal on MRI (psychotropic drugs, vasodilators, vasoconstrictors, etc.),\n* uncorrected sensory impairment (vision or hearing)\n* protected by law.\n\nExclusion criteria :\n\n* pregnant woman according to the positive beta-hCG test result\n* left-handed following the laterality questionnaire\n* MINI results showing:\n\n  * a current mood episode\n  * a current disorder of the use of psychoactive substances or in the last 6 months (excluding tobacco)\n  * an eating disorder\n  * a diagnosis of bipolar disorder, current or past schizophrenia","75 Years",{"count":531,"type":22},70,[25],"The obstructive sleep apnea syndrome (OSAS) involves recurrent sleep-related upper airways (UA) collapse. UA mechanical properties and neural control are altered, imposing a mechanical load on inspiration. UA collapse does not occur during wakefulness, hence arousal-dependent compensation. Experimental inspiratory loading in normal subjects elicits respiratory-related cortical activity during wakefulness. The objective of this study is to test whether awake OSAS patients would exhibit a similar cortical activity. Whether or not such cortical compensatory mechanisms have cognitive consequences would be also analyze.",[535],"Obstructive Sleep Apnea Syndrome",{"date":515,"type":33},{"date":538,"type":33},"2023-03-02",{"date":540,"type":22},"2027-07-02",{"name":39,"class":40},{"id":543,"slug":544,"hasResults":12,"nctId":545,"briefTitle":546,"officialTitle":547,"acronym":548,"eligibilityCriteria":549,"healthyVolunteers":12,"sex":18,"minAge":137,"maxAge":4,"enrollmentInfo":550,"targetDuration":4,"studyType":23,"phases":552,"briefSummary":553,"conditions":554,"keywords":556,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":561,"lastUpdatePostDateStruct":562,"startDateStruct":564,"completionDateStruct":566,"leadSponsor":568,"locationsCount":41},"100605501","prevalence-and-consequences-of-antiphospholipid-syndrome-in-patients-aged-65-and-over-with-ischemic-strokes-is-100605501","NCT07163338","Prevalence and Consequences of Antiphospholipid Syndrome in Patients Aged 65 and Over With Ischemic Strokes (IS)","A Prospective, Single-center Cohort Study to Determine the Prevalence and Consequences of Antiphospholipid Syndrome in Patients Aged 65 and Over With Ischemic Strokes (IS)","SAPLAGE","inclusion criteria :\n\n* patients aged 65 and over during the inclusion phase\n* hospitalized for a TIA\u002Fischemic stroke in neurology or internal medicine department during the inclusion phase\n* affiliated with social security system exclusion criteria :\n* patients under 65 years old\n* under legal guardianship, curatorship, or tutorship\n* incarcerated\n* under psychiatric care\n* admitted to a healthcare or social institution",{"count":551,"type":22},400,[25],"Stroke represents a major cause of morbidity and mortality despite significant progress in recent decades. In individuals under the age of 65, the etiologies of ischemic stroke (IS) are diverse, and management is well-established. Antiphospholipid syndrome (APS) accounts for 10 to 20% of the causes of stroke in this population. In elderly individuals, APS is not systematically investigated due to the predominance of embolic, atherosclerotic, and small vessel disease causes. However, delayed discovery of APS is not uncommon and is more frequently associated with the occurrence of arterial thrombosis. Moreover, the management of APS involves several challenges given the risk of recurrence of thrombosis and the potential association with conventional cardiovascular risk factors. The antithrombotic treatment consists of lifelong anticoagulation, excluding direct oral anticoagulants (DOACs) due to the risk of thrombotic recurrence. The main objective of the study will be to assess the prevalence of antibodies useful for the diagnosis of APS (Sapporo criteria) in individuals aged 65 or older hospitalized for an ischemic stroke (IS) or transient ischemic attack (TIA).\n\nFurthermore, the classification of APS is likely to evolve in the coming years with the inclusion of new clinically relevant antibodies (anti-phosphatidylserine and anti-phosphatidylethanolamine) because of their strong association with the occurrence of thrombosis. Even though they are often associated with circulating anticoagulants, they are also found in 10% of APS cases negative for other antibodies.\n\nPatient inclusion in the study should occur during the acute phase of the stroke, before the initiation of anticoagulant treatment.\n\nThus, after verifying the inclusion and exclusion criteria, patients will be informed and must sign the informed consent form if they agree to participate.\n\nAfter inclusion, the research procedure will be as follows:\n\n* Conduct a unique immunological biological assessment with:\n\n  * Part performed as part of standard care: circulating anticoagulants, anti-cardiolipin antibodies, and anti-β2-glycoprotein type 1.\n  * Part performed specifically for the study (3.5 mL of additional blood): anti-phosphatidylserine and anti-phosphatidylethanolamine antibodies. The search for these antibodies will be performed using the 7mL dry tube collected for anti-cardiolipin and anti-β2-glycoprotein type 1 antibody testing.\n  * If the diagnostic sample is positive for any of these antibodies, a follow-up at 3 months is recommended and will be performed as part of standard care to confirm the APS diagnosis.\n* Data collection will include patient details, stroke\u002FTIA details, biological data, and follow-up. As part of routine follow-up, patients will be seen in a neurological consultation at 6 months.\n\nClinical and biological data will be reviewed at the end of the study by two doctors (a neurologist and an internist) to confirm or exclude the APS diagnosis and its contribution to the neurological condition.\n\nAn internal medicine follow-up will be initiated for patients with confirmed APS, and an appropriate treatment will be proposed.",[555],"Antiphospholipid Syndrome",[557,558,559,560],"Antiphospholipid syndrome","antiphospholipid antibody syndrome","stroke","ischemic stroke","2025-11-24",{"date":563,"type":33},"2025-11-25",{"date":565,"type":33},"2025-09-16",{"date":567,"type":22},"2028-03-16",{"name":39,"class":40},{"id":570,"slug":571,"hasResults":12,"nctId":572,"briefTitle":573,"officialTitle":573,"acronym":574,"eligibilityCriteria":575,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":576,"targetDuration":4,"studyType":23,"phases":578,"briefSummary":579,"conditions":580,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":582,"lastUpdatePostDateStruct":583,"startDateStruct":585,"completionDateStruct":587,"leadSponsor":589,"locationsCount":41},"100448284","comparison-of-hydrolink-and-hepran-membranes-in-a-per-dialytic-heparin-weaning-strategy-in-chronic-hemodialysis-patients-100448284","NCT05117450","Comparison of HYDROLINK™ and HeprAN™ mEmbranes in a Per Dialytic Heparin Weaning Strategy in Chronic Hemodialysis Patients","RESTIT","inclusion criteria :\n\n* Patients with Age \\> 18 years\n* Chronic hemodialysis for at least 3 months\n* Hemodialysis three times a week\n* On per dialytic heparin therapy (UFH or LMWH)\n* Affiliated to the French Social Security\n* Having given their consent for this study\n\nexclusion criteria :\n\n* Patients undergoing Hemodiafiltration (HDF)\n* Pregnant or lactating woman\n* Patient participating in another interventional study\n* Persons deprived of liberty by judicial or administrative decision\n* Adults under legal protection (under guardianship or curators)\n* Persons under a legal protection measure\n* Patients with a history of HIT\n* Patients with acquired or congenital coagulation disorders\n* Pathology with active neoplasia (Myeloma, Waldenström disease, solid cancers)\n* Patient on an ACE inhibitor (ACE inhibitor)\n* Patient requiring transfusion during the study period\n* Patient not hemoglobin-stabilized (mean Hb \\\u003C 10g\u002FdL or \\>12 g\u002FdL in the previous month)\n* Patient septic or with significant inflammation (defined as C-reactive protein \\> 25mg\u002FL) at the time of inclusion\n* Patient requiring per-dialytic parenteral nutrition\n* Patient requiring hospitalization or scheduled surgery during the study period\n* Vascular access (Arteriovenous Fistula or Arteriovenous graft with the possibility of 2 needles) not allowing a sufficient blood pump flow (\\\u003C 300 mL\u002Fmin determined during the screening phase = blood flow prescribed by the nephrologist)\n* Patient dialyzing on catheter (\"single line\" or \"double line\") or in unipuncture on Arteriovenous fistula on the day of the screening session\n* Net ultrafiltration on the day of the screening session \\> 4000 mL",{"count":577,"type":22},302,[25],"Chronic kidney disease (CKD) results from the progressive and irreversible destruction of the kidneys. As of December 31, 2018, there were 89,692 people in France undergoing replacement therapy, including 49,271 (55%) on dialysis and 40,421 (45%) with a functioning kidney transplant. The primary treatment modality is currently hemodialysis. It is known to activate the coagulation cascade and blood platelets, leading to thrombus formation and premature termination of the hemodialysis session. This loss of circuitry results in a decrease in session time leading to an insufficient dialysis dose and blood loss in patients who are already often anemic due to their chronic renal failure.\n\nTo avoid this complication, current recommendations recommend the use of unfractionated heparin (UFH) or low molecular weight heparin (LMWH) during the hemodialysis session at the cost of an obligatory hemorrhagic risk due to the systemic administration of heparin. However, this risk of bleeding is already very high, due to platelet dysfunction, a direct consequence of uremic toxin impregnation in these patients. In addition, this hemodialysis population is frequently exposed to antiplatelet agents and anticoagulants (heparin or VKA), which aggravate the hemorrhagic risk inherent to renal pathology.\n\nIn this context, bioactive membranes such as the HeprAN™ membrane, coated in heparin, have been developed to minimize or even eliminate the need for anticoagulation during sessions in chronic hemodialysis patients. Several studies with this membrane have demonstrated the absence of the need for additional heparin in populations with no particular bleeding risk and in populations at risk of bleeding: post-operative (HepZero study), patients on VKA.\n\nThe HYDROLINK™ membrane offers the same anticoagulant prospects as the HeprAN™ membrane, but its mode of action involves the use of a copolymer with hydrophilic properties, making it possible to avoid the presence of heparin. This membrane would have an influence on platelet aggregation. It would also make it possible to avoid the risk of heparin-induced thrombocytopenia (HIT) by completely excluding heparin from the dialysis session",[581],"Renal Insufficiency","2025-11-20",{"date":584,"type":33},"2025-11-21",{"date":586,"type":33},"2021-11-17",{"date":588,"type":22},"2026-12-17",{"name":39,"class":40},{"id":591,"slug":592,"hasResults":12,"nctId":593,"briefTitle":594,"officialTitle":595,"acronym":596,"eligibilityCriteria":597,"healthyVolunteers":50,"sex":18,"minAge":598,"maxAge":599,"enrollmentInfo":600,"targetDuration":4,"studyType":23,"phases":601,"briefSummary":602,"conditions":603,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":605,"lastUpdatePostDateStruct":606,"startDateStruct":608,"completionDateStruct":610,"leadSponsor":612,"locationsCount":41},"100381958","social-cognition-in-pediatric-epilepsy-100381958","NCT04253379","Social Cognition in Pediatric Epilepsy","Impact of Executive Functions and Language on Social Cognition in Pediatric Epilepsy","TOMEPI","Inclusion Criteria:\n\n* exposed children : children aged 6-12 with a diagnosis of epilepsy French native speaker\n* A control group of age-matched children who meet patient selection criteria with the exception of the epilepsy will also be sought\n\nExclusion Criteria:\n\n* neurological or psychiatric disease in control group\n* Raven's Matrices score \\\u003C percentile 10","6 Years","12 Years",{"count":398,"type":22},[25],"The purpose of this study is to investigate the development of social cognition skills in pediatric epilepsy compared to healthy children. There are evidences indicating that children with epilepsy have executive dysfunctions and language problems. Executive functions refer to multiple cognitive processes that contribute to human higher order abilities, such as purposeful and future-orientated behavior. Moreover, the literature regarding development of non epileptic children, with ordinary development indicates that executive functions and language are linked to the emergence of social cognition. Then, the investigators asked if children with epilepsy, as they commonly present executive dysfunctions, would show an atypical development of social cognition. Children with epilepsy and a control group of healthy volunteers will be compared to identify relationships between executive functions, language and social cognition.",[604],"Pediatric Epilepsy","2025-09-19",{"date":607,"type":33},"2025-09-22",{"date":609,"type":33},"2020-02-02",{"date":611,"type":22},"2027-01-19",{"name":39,"class":40},{"id":614,"slug":615,"hasResults":12,"nctId":616,"briefTitle":617,"officialTitle":618,"acronym":4,"eligibilityCriteria":619,"healthyVolunteers":12,"sex":395,"minAge":19,"maxAge":396,"enrollmentInfo":620,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":622,"conditions":623,"keywords":625,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":634,"lastUpdatePostDateStruct":635,"startDateStruct":637,"completionDateStruct":639,"leadSponsor":641,"locationsCount":41},"100594176","translation-and-validation-of-the-french-mpcosq-mpcosq-f-100594176","NCT07016035","Translation and Validation of the French mPCOSQ (mPCOSQ-F).","Translation and Validation of the French Version of the Health-related Quality of Life Questionnaire for the Polycystic Ovary Syndrome: the mPCOSQ-F.","Inclusion criteria:\n\n* Women aged 18 to 45\n* Fluent in french\n* Having a diagnosis of PCOS according to the international recommendations published in 2023\n* Willing to participate in the study\n* Affiliated to the french social security system\n\nExclusion criteria:\n\n* Diagnosis of adrenal hyperplasia, androgen-producing tumor, Cushing's syndrome, or thyroid disorder\n* Pregnancy or breast-feeding\n* Under legal protection",{"count":621,"type":22},350,"This study is a prospective, observational, bicentric study, evaluating the validity and reliability of a French version of the mPCOSQ questionnaire (mPCOSQ-F), used to assess health-related quality of life (HRQOL) in women with polycystic ovary syndrome.\n\nThe first stage of the study consisted in translating the questionnaire from English to French.\n\nPatients agreeing to take part in the study will complete the mPCOSQ-F and the SF-36 (generic HRQOL questionnaire). After 1 to 2 weeks, patients will receive the mPCOSQ-F and complete it again.",[624],"Polycystic Ovary Syndrome Health-related Quality of Life",[626,627,628,629,630,631,632,633],"polycystic ovary syndrome","PCOS","quality of life","health-related quality of life","mPCOSQ","questionnaire","SF-36","French","2025-08-06",{"date":636,"type":33},"2025-08-07",{"date":638,"type":33},"2025-05-12",{"date":640,"type":22},"2027-05-12",{"name":39,"class":40},""]