[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Versailles Hospital\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":251},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,44,70,92,109,134,157,180,208,231],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100621332","techniques-for-activating-consciousness-tac-for-outpatients-with-moderate-to-severe-alcohol-addiction-100621332",false,"NCT07369245","Techniques for Activating Consciousness (TAC) for Outpatients With Moderate to Severe Alcohol Addiction","Randomized Controlled Trial to Evaluate the Efficacy of Hypnosis and Learning Self-exercises for Outpatients With Moderate to Severe Alcohol Addiction","TAC-ADDICT","Inclusion Criteria:\n\n* Adult patients consulting for an alcohol-related addiction problem at the CSAPA of Versailles (sites in Versailles, Trappes, Rambouillet) or at the Centre Hospitalier des 4 Villes (day hospital or CSAPA in Sèvres)\n* Patients must meet at least 4 of the 11 DSM-5 criteria (Annex 2), corresponding to moderate to severe addiction\n* Patients must be affiliated with the French social security system\n\nExclusion Criteria:\n\n* Refusal to participate\n* Decompensated psychiatric pathology contraindicating therapy:\n\n  * Presence at inclusion of delusional, dissociative, and\u002For persecutory symptoms\n  * Presence at inclusion of hypomanic or manic decompensation\n* Severe cognitive impairment, evidenced by inability to perform the clock-drawing test (draw the clock face, place the numbers, and set the hands to 11:10)\n* Adults legally protected under French law (deprivation of liberty, legal safeguard, guardianship, curatorship)\n* Inability to understand French","ALL","18 Years",{"count":20,"type":21},98,"ESTIMATED","INTERVENTIONAL",[24],"NA","Many patients are considering the use of so-called \"hypnosis\" treatments in the field of addictions. However, these techniques lack sufficient levels of evidence with regard to the standards required by Evidence-Based Medicine.\n\nIn other domains, however, hypnosis has demonstrated an interesting level of evidence, particularly in pain management.\n\nThe investigators will focus on the \"Techniques for Activating Consciousness\" (TAC), which represent an optimized therapeutic approach derived from hypnotic therapy.",[27],"Alcohol Addiction",[29,30,31],"Hypnotic therapy","Techniques for Activating Consciousness (TAC)","Alcohol addiction","NOT_YET_RECRUITING","2026-04-15",{"date":35,"type":36},"2026-04-16","ACTUAL",{"date":33,"type":21},{"date":39,"type":21},"2028-01-15",{"name":41,"class":42},"Versailles Hospital","OTHER",2,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":69},"100630135","phase-3-efficacy-of-an-empirical-treatment-with-amoxicillin-clavulanate-ac-compared-to-the-combination-amoxicillin-clavulanate-and-ciprofloxacin-acc-in-the-outpatient-care-of-chemotherapy-induced-fever-in-adult-haematology-patients-100630135","NCT07483736","Efficacy of an Empirical Treatment With Amoxicillin-clavulanate (AC) Compared to the Combination Amoxicillin-clavulanate and Ciprofloxacin (AC+C) in the Outpatient Care of Chemotherapy-induced Fever in Adult Haematology Patients.","Efficacy of an Empirical Treatment With Amoxicillin-clavulanate (AC) Compared to the Combination Amoxicillin-clavulanate and Ciprofloxacin (AC+C) in the Outpatient Care of Chemotherapy-induced Fever in Adult Haematology Patients. AC-CIF Protocol","AC-CIF","Inclusion Criteria:\n\n1. Adult patients (≥ 18 years) with one of the following haematological disorders (in whom chemotherapy regimens are expected to provoke neutropenia lasting \\\u003C7 days) (1) lymphoma of all histological types treated with the goal of remission; (2) myelodysplasia treated with azacytidine; (3) acute myeloblastic leukaemia, treated with a non-intensive scheme (azacytidine, azacytidine+venetoclax, other oral treatment against molecular targets)\n2. Written informed consent\n3. Patient able to understand all information related to the study and able to follow the protocol procedures (phone call and completion of the patient follow-up form (electronic or paper))\n4. Affiliated to or beneficiary of the welfare care\n\nExclusion Criteria:\n\n* 1\\. Patient under legal protection 2. Patient deprived of liberty by judicial or administrative decision 3. Patient who is the investigator, any member of the study team, or a relative directly involved in the trial, including assistant physicians, pharmacists, study coordinators, etc… 4. Participation in another interventional clinical trial 5. Impossible collection of informed consent (including non-francophone patient, or cognitive disorders) 6. Body mass index (BMI) \\> 30 7. Basal neutrophils count \\\u003C 1000\u002Fmm3 (on the latest available blood test performed \\\u003C 1 month before inclusion) 8. Aminotransferase serum levels \\> 5 X normal values (on the latest available blood test performed \\\u003C 1 month before inclusion) 9. Creatinine clearance \\\u003C 30 mL\u002Fmin (on the latest available blood test performed \\\u003C 1 month before inclusion) 10. Previous treatment with CAR-T cells 11. Previous allogeneic or autogeneic bone-marrow transplantation 12. Chronic obstructive pulmonary disease (COPD) 13. Previous invasive fungal infection 14. Allergy to one of the study medications 15. Contraindication to fluoroquinolones:\n\n  1. hypersensitivity to ciprofloxacin, to other quinolones, or to any of the following excipients (microcrystalline cellulose, crospovidone, anhydrous colloidal silica, magnesium stearate, hypromellose, macrogol, titanium dioxide),\n  2. treatment with tizanidine,\n  3. previous hypersensitivity to any quinolone,\n  4. previous tendonitis attributed to any fluoroquinolone,\n  5. epilepsy 16. Contraindication to amoxicillin-clavulanate 17. QT prolongation (defined as a QT interval \\> 0.45 seconds for males and \\> 0.47 seconds for females) 18. Antibiotic prophylaxis (with the exception of the combination sulfamethoxazole and trimethoprim) 19. Pregnant or breastfeeding women, 20. Women not using contraception 21. Patient treated with anti-psychotic drug",{"count":53,"type":21},1526,[55],"PHASE3","The combination of amoxicillin-clavulanate (AC) and a fluoroquinolone (FQ) is currently recommended for the treatment for outpatients with hematologic malignancies presenting with chemotherapy-induced fever (CIF), if the expected duration of neutropenia is \\\u003C 7 days. However, infections due to Pseudomonas aeruginosa (naturally resistant to AC) are rare in this population. Furthermore, FQ might result in severe adverse events, and to the selection of bacterial resistance.\n\nThe investigators hypothesize that monotherapy with AC is non-inferior to the reference treatment AC + FQ in the outpatient treatment of CIF in adult hematology patients.\n\nMethod: Pragmatic, multicentre, randomized clinical trial, controlled in two parallel groups, with stratified randomization according to the type of haematological disorder. The study will include 1,526 adult patients with one of the following haematological disorders: (1) lymphoma of all histology types treated with the goal of remission; (2) myelodysplasia treated with azacytidine; (3) acute myeloblastic leukemia receiving non-intensive care, with a basal neutrophils count \\> 1000\u002Fmm3. The participants will be randomized prior to chemotherapy to receive either Amoxicillin-clavulanate 1g\u002F152 mg tid. (AC) or Amoxicillin-clavulanate 1g\u002F152 mg tid. and Ciprofloxacin 500 mg bid. (AC+C) orally for 7 days, to be taken in case of CIF. Only the first episode of CIF of each patient will be included in the analysis. The main evaluation criterion will be clinical success, defined as apyrexia 4 days after the first antibiotic dose, without modification of antibiotic treatment. The main secondary evaluation criteria (recorded at Day 14) will be fever recurrence, hospital admission, modification of antibiotic treatment, treatment with a beta-lactamine antibiotic efficient against P. aeruginosa, duration of antibiotic treatment, bacteraemia, inefficiency of the study treatment against the identified bacteria, and adverse events of FQ.",[58],"C15.378",[60],"Febrile neutropenia","2026-03-17",{"date":63,"type":36},"2026-03-19",{"date":65,"type":21},"2026-03",{"date":67,"type":21},"2028-09",{"name":41,"class":42},16,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":22,"phases":79,"briefSummary":80,"conditions":81,"keywords":4,"overallStatus":83,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},"100357346","descriptive-study-of-multiligamentary-reconstruction-of-the-knee-100357346","NCT03932838","Descriptive Study of Multiligamentary Reconstruction of the Knee","Descriptive Study of Multiligamentary Reconstruction of the Knee: Clinical Results and Postoperative Laxity by Dynamic Radiography.","Inclusion Criteria:\n\n* Patients operated for one-time allograft or autograft reconstruction of multiligamentous knee injury\n* \\>18 years old\n\nExclusion Criteria:\n\n* Neurological or vascular injury during trauma.\n* Fracture of the femur or both bones of the leg.\n* Ligamentous lesion on the contralateral knee.\n* History of surgery on the affected knee.",{"count":78,"type":21},80,[24],"Evaluation of clinical results and postoperative laxity after single-stage reconstruction of multiligamentous lesions of the knee. Comparison of two types of transplant: allograft versus autograft.\n\nThere is currently little data in the clinical outcome literature after allograft reconstruction. There is one study reporting postoperative laxity assessed by dynamic radiography in the four planes (anterior, posterior, varus, valgus). No study compares postoperative laxity after allograft versus autograft reconstruction.",[82],"Injury, Knee","RECRUITING","2026-03-16",{"date":61,"type":36},{"date":87,"type":36},"2017-12-01",{"date":89,"type":21},"2035-06-01",{"name":41,"class":42},1,{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":96,"acronym":4,"eligibilityCriteria":97,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":98,"targetDuration":4,"studyType":22,"phases":100,"briefSummary":101,"conditions":102,"keywords":4,"overallStatus":83,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":104,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":108,"locationsCount":91},"100355514","descriptive-study-of-the-reconstruction-of-osteochondral-lesions-of-the-knee-clinical-and-imaging-results-100355514","NCT03908931","Descriptive Study of the Reconstruction of Osteochondral Lesions of the Knee: Clinical and Imaging Results","Inclusion Criteria:\n\n* cartilaginous reconstruction by autologous transplant or collagenous chondro-inducing knee matrix\n* \\> 18 years\n\nExclusion Criteria:\n\n* Other cartilaginous reconstruction techniques,\n* other than knee joint",{"count":99,"type":21},130,[24],"The purpose of this study is to evaluate the clinical results and MRI imaging of autologous cartilage reconstructions or collagen matrix of the knee.\n\nThere is currently little data in the literature on clinical outcomes and imaging of this type of lesion.",[103],"Osteochondral Defect",{"date":61,"type":36},{"date":106,"type":36},"2019-04-01",{"date":89,"type":21},{"name":41,"class":42},{"id":110,"slug":111,"hasResults":11,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":115,"eligibilityCriteria":116,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":117,"enrollmentInfo":118,"targetDuration":4,"studyType":22,"phases":120,"briefSummary":121,"conditions":122,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":133},"100622450","phase-3-targeted-hypothermia-versus-targeted-normothermia-after-convulsive-refractory-status-epilepticus-100622450","NCT07383779","Targeted Hypothermia Versus Targeted Normothermia After Convulsive Refractory Status Epilepticus","Targeted Hypothermia Versus Targeted Normothermia After Convulsive Refractory Status Epilepticus: a Multicenter Randomized Controlled Trial","HYBERNATUS II","Inclusion Criteria:\n\n* Age between 18 and 65 years \\[18-65 years\\]\n* Continued motor seizure activity lasting more than 5 minutes, or two or more motor seizures without a return to baseline level of consciousness in the interval at least 5 minutes after the first seizure\n* Refractory to two recommended antiseizure medications (benzodiazepine and \"classic\" antiseizure drug)\n* Receiving mechanical ventilation\n* Time from seizure onset no longer than 3.5 hours (210 min)\n* Consent to participate (patient's relative or emergent consent)\n\nExclusion Criteria:\n\n* Estimated pre-morbid GOS-E score \\\u003C 5\n* Preexisting ultimately fatal comorbidity \\\u003C 1 year\n* Patients unlikely to survive for the next 24 hours\n* Full recovery at time of inclusion\n* Need for emergent surgery or interventional neuroradiology for bleeding embolization (neurosurgery or other precluding therapeutic hypothermia)\n* Postanoxic status epilepticus\n* Traumatic Brain Injury with an acute bleeding on Computed Tomographic (CT) scan or Magnetic Resonance Imaging (MRI) of the brain\n* Bacterial meningitis as a cause of convulsive SE\n* Cryoglobulinemia, sickle cell disease, serum cold agglutinins comorbidities\n* Pregnancy\n* Absence of coverage by the French\u002FEuropean statutory healthcare insurance system","65 Years",{"count":119,"type":21},466,[55],"The HYBERNATUS-II study is a phase-III, open-label, randomized controlled trial in patients with convulsive refractory SE receiving mechanical ventilation. Patients are allocated at random to either early targeted hypothermia for 24 hours or targeted normothermia at the acute phase of ICU management. This trial is a superiority multicentric trial and patients will be randomized in a 1:1 ratio using an electronic Cas Report Form.\n\nBefore any examination or intervention related to the study may be carried out, the investigator must obtain the freely given, informed and written consent of the participant, or of his\u002Fher substitute decision maker (family member, close relative or legal representative) where applicable. However, eligible subjects are unconscious and inherently not able to consent.\n\nTwo situations of inclusion are therefore envisaged:\n\n\\- In case a substitute decision maker is present or contactable: a freely given, informed and written consent of the substitute decision maker will be performed.\n\n\\- In case a substitute decision maker is not present or contactable in the inclusion time frame, the patient may be included through a process of differed consent. Substitute decision maker will be informed as soon as possible and a freely given, informed and written pursuit consent will be performed.\n\nIn all cases, the patient will have to confirm his participation to the study through a freely given, informed and written pursuit consent as soon as their condition allows it. If the patient is under curatorship, the pursuit consent may be given based on his or her own decision. If the patient is under guardianship, the written guardian's consent will also be required.\n\nIndividuals liable to participate in studies stipulated in line 1° of article L. 1121-1 of the Code de la Santé Publique (French Public Health Code) benefit from a preliminary medical examination adapted to the study.\n\nPatients will be included after informed consent as soon as possible once they satisfied all eligibility criteria. The inclusion window is until 3.5 hours (210 minutes) after convulsive SE onset. Consecutive eligible patients will be included and randomly allocated in a 1:1 ratio to one of the two procedure groups.\n\nRandomization and concealment will be ensured by using a secure, computer-generated, interactive, response system accessible via the Internet available at each study centre 24H\u002F24. Randomization list will be prepared by an independent statistician who will not be in charge of the analysis. Randomization lists will be generated by a dedicated computer program, with randomly varying sized blocks, and stratified as follows: according to sites, previous history of epilepsy \\[yes or not\\], and results of brain imaging \\[Abnormal Brain Imaging or not\\].\n\nEach investigator will be able to access the randomization site using a personal password.\n\nRandomization will be carried out after checking of the inclusion criteria and the absence of exclusion criteria and after obtaining a written and informed consent or according to the emergency procedure by the principal investigator or a physician representing the investigator before the person is enrolled in the study of each centre involved in the study. Each patient will be assigned a unique identification number. An inclusion confirmation will be sent by email to the investigator specifying the allocated procedure arm.\n\nPatients will be randomly allocated to one of the two study procedure groups.\n\nThe two groups will differ only in the administration of early targeted hypothermia for 24 hours or targeted normothermia at the acute phase of ICU management. All other treatment will be standardized in the two groups.\n\nTargeted Hypothermia group : Implementation of allocation arm is started within 30 min after randomization.The objective is to lower the core body temperature to 33°C \\[32-34°C\\] rapidly after randomization then to maintain this temperature for 24 hours. The management in the targeted hypothermia group will include the following.\n\nTargeted normothermia group. Implementation of allocation arm is started within 30 min after randomization. The objective of the control group is to ensure normothermia 37° \\[36.5-37.5°C\\] for 72 hours after randomization. Antipyretic treatments will be given in case of a core temperature higher than 37.8°C. In case of failure, cooling with a surface non-invasive loop-feedback TTM device associating pads directly adhering to the patient's skin (Artic Sun TM provided by the study, similar in all participating centers) will be initiated with a target temperature of 37° \\[36.5-37.5°C\\]. No active warming will be provided for patients in the normothermia group who had a spontaneous body temperature below 36.5°C.\n\nPatients included in the study will be followed until the 90th day after inclusion. The duration of the participation will therefore be 3 months for each patient.",[123,124],"Convulsive Refractory Status Epilepticus","Status Epilepticus","2026-02-06",{"date":127,"type":36},"2026-02-10",{"date":129,"type":21},"2026-03-01",{"date":131,"type":21},"2029-06-01",{"name":41,"class":42},20,{"id":135,"slug":136,"hasResults":11,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":140,"eligibilityCriteria":141,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":142,"targetDuration":4,"studyType":22,"phases":144,"briefSummary":145,"conditions":146,"keywords":4,"overallStatus":83,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":156},"100580299","phase-3-prophylactic-anti-arrhythmic-therapy-with-amiodarone-in-critically-ill-patients-admitted-for-an-out-of-hospital-cardiac-arrest-with-initial-shockable-rhythm-100580299","NCT06835491","Prophylactic Anti-aRrhythmic Therapy With Amiodarone in Critically Ill Patients Admitted for an Out-of-hospital Cardiac Arrest With Initial Shockable Rhythm","Prophylactic Anti-aRrhythmic Therapy With Amiodarone in Critically Ill Patients Admitted for an Out-of-hospital Cardiac Arrest With Initial Shockable Rhythm.","PARACA","Inclusion Criteria:\n\n1. Patient aged ≥ 18 years\n2. Admitted in intensive care unit\n3. Out-of-hospital cardiac arrest with initial shockable rhythm\n4. Presumed cardiac or unknown cause\n5. Delay between ROSC and screening for randomisation \\\u003C 6 hours\n6. Informed consent from the patient or a surrogate or deferred consent\n7. Affiliated to or benefiting from a social insurance\n\nExclusion Criteria:\n\n1. Cardiac arrest secondary to an extra-cardiac cause (suspected or confirmed)\n2. Indication for amiodarone decided by the physician at ICU admission\n3. No central venous catheter available for continuous infusion of amidoarone\n4. Thyroid disease under treatment\n5. History of cardiac conduction disorders, not treated by permanent pacemaker\n6. Any contra indication to amiodarone treatment\n7. Refractory ventricular arrhythmia or electrical storm\n8. Need for veno-arterial extracorporeal membrane oxygenation (VA-ECMO) at admission\n9. Known limitations in therapy and Do Not Resuscitate-order\n10. Moribund patient due to pre-arrest history (estimated life expectancy \\\u003C 3 months)\n11. Pregnant or breastfeeding women\n12. Patient needing a nadolol treatment due to QT long syndrome or catecholaminergic polymorphic ventricular tachycardia\n13. Patient with known pulmonary fibrosis\n14. Patient with known interstitial lung disease",{"count":143,"type":21},674,[55],"To determine if prophylactic administration of amiodarone for 72 hours in critically ill patients admitted after an OHCA with shockable rhythm, with a confirmed or a presumed cardiac cause, decreases the incidence of a composite endpoint of 30-day (starting from inclusion) all-cause mortality and\u002For severe in-hospital ventricular arrhythmia recurrence (ventricular fibrillation and\u002For ventricular tachycardia requiring intervention including re-arrest)",[147],"Ventricular Arrhythmias and Cardiac Arrest","2025-12-17",{"date":150,"type":36},"2025-12-23",{"date":152,"type":36},"2025-11-06",{"date":154,"type":21},"2027-03-15",{"name":41,"class":42},29,{"id":158,"slug":159,"hasResults":11,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":163,"eligibilityCriteria":164,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":165,"targetDuration":4,"studyType":22,"phases":167,"briefSummary":168,"conditions":169,"keywords":4,"overallStatus":83,"whyStopped":4,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":173,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":43},"100566102","adapting-the-facets-program-to-sickle-cell-disease-100566102","NCT06650813","Adapting the FACETS Program to Sickle Cell Disease","Adapting the FACETS Fatigue Management Program to Sickle Cell Disease","Drépa-FACETS","Inclusion Criteria:\n\n* Participant having freely given his oral agreement.\n* Participant with a major sickle cell syndrome, regardless of genotype (e.g. SS, SC, Sbeta).\n* Participant with a sufficient command of spoken and written French to take the assessments, complete the questionnaires, follow the program sessions and carry out the home exercises.\n\nExclusion Criteria:\n\n* Participant with one or more severe psychiatric pathologies (e.g. severe depression, psychosis) that could interfere with the conduct of the study, in particular the primary and secondary endpoints.\n* Participants with another chronic pathology causing fatigue.\n* Participants in vaso-occlusive crisis (VOC) or hospitalization.\n* Participant under legal protection (guardianship, curatorship, safeguard of justice, deprived of liberty).",{"count":166,"type":21},24,[24],"Adaptation of a fatigue management program combining the principles of cognitive-behavioral therapy and energy conservation strategies (FACETS program) for a population of adult patients with sickle cell disease (Drépa-FACETS program).",[170,171],"Fatigue Symptom","Sickle Cell Disease","2025-08-14",{"date":174,"type":36},"2025-08-19",{"date":176,"type":36},"2025-01-10",{"date":178,"type":21},"2026-05-02",{"name":41,"class":42},{"id":181,"slug":182,"hasResults":11,"nctId":183,"briefTitle":184,"officialTitle":185,"acronym":186,"eligibilityCriteria":187,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":188,"targetDuration":4,"studyType":190,"phases":4,"briefSummary":191,"conditions":192,"keywords":4,"overallStatus":83,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":200,"startDateStruct":202,"completionDateStruct":204,"leadSponsor":206,"locationsCount":207},"100523843","patient-reported-outcome-and-patient-reported-experience-after-status-epilepticus-100523843","NCT06100978","Patient-reported Outcome and Patient-reported Experience After Status Epilepticus","Patient-reported Outcomes in Status Epilepticus Requiring Intensive Care Unit Management. A Multicenter Longitudinal Cohort Study","POSEIDON2","Inclusion Criteria:\n\n* Adults 18 years old or older\n* Patients previously included in the ICTAL registry (Status Epilepticus cohort NCT03457831)\n* Survivors after ICU management for Status Epilepticus More than 3 months and less than 5 years after ICU discharge\n\nExclusion Criteria:\n\n* Legal guardianship\n* Opposition to participate\n* Unread and unwritten French language\n* Patient not affiliated to a Social Security system",{"count":189,"type":21},145,"OBSERVATIONAL","Status epilepticus (SE) is a common life-threatening neurological emergency in which prolonged or multiple closely spaced seizures can result in long-term impairments. SE remains associated with considerable mortality and morbidity, with little progress over the last three decades. The proportion of patients who die in the hospital is about 20% overall and 40% in patients with refractory SE. Morbidity is more difficult to evaluate, as adverse effects of SE are often difficult to differentiate from those attributed to the cause of SE. Our experience suggests that nearly 50% of patients may experience long-term functional impairments. The precise description of the consequences of these functional impairments and their impact on quality of life after SE requiring intensive care management has been little studied. Indeed, if cognitive, physical and mental impairments are now identified in the populations of patients who required intensive care under the term postresuscitation syndrome (PICS), neuronal lesions consecutive to the SE itselfor to its cause could be responsible for these different functional alterations.\n\nThus, the following have been described: (i) cognitive disorders in the areas of attention, executive functions and verbal fluency, visual and working memory disorders, but also spatio-temporal disorders; (ii) physical disorders such as the so-called post-resuscitation polyneuromyopathy; and (iii) mental disorders such as anxiety disorders, depressive states or those related to post-traumatic stress.\n\nAssessment and characterization of patient-reported outcomes is essential to complement the holistic assessment of clinically relevant outcomes from the patient's perspective. The POSEIDON study was a cross-sectional collection of PROs and HR-QOL components, and associated with patient functional outcomes, in those who required ICU management for status epilepticus. We propose here to continue the description of potential alterations after a subsequent ME, namely a longitudinal study (POSEIDON 2) which will also include the evaluation of patient-reported experience (PREMS) and the measurement of family burden.",[193,194,195,124,196,197,198],"Patient Reported Outcomes","Patient Satisfaction","Long Term Outcomes","Intensive Care Unit","Burden","Relatives","2024-11-04",{"date":201,"type":36},"2024-11-05",{"date":203,"type":36},"2024-05-25",{"date":205,"type":21},"2026-07",{"name":41,"class":42},13,{"id":209,"slug":210,"hasResults":11,"nctId":211,"briefTitle":212,"officialTitle":213,"acronym":214,"eligibilityCriteria":215,"healthyVolunteers":11,"sex":17,"minAge":216,"maxAge":4,"enrollmentInfo":217,"targetDuration":219,"studyType":190,"phases":4,"briefSummary":220,"conditions":221,"keywords":4,"overallStatus":83,"whyStopped":4,"lastUpdateSubmitDate":223,"lastUpdatePostDateStruct":224,"startDateStruct":226,"completionDateStruct":228,"leadSponsor":230,"locationsCount":91},"100495681","copd-icu-multicentre-prospective-observational-register-100495681","NCT05734365","COPD-ICU Multicentre Prospective Observational Register","Epidemiological, Clinical and Biological Characteristics and Therapeutic Management of ICU Patients With Severe Acute Exacerbation of COPD. Evaluation of the Prognosis and the Factors Associated With Survival Multicentre Prospective Observational Register","COPD-ICU","Inclusion Criteria:\n\n1. Age ≥ 40 years old\n2. COPD documented or strongly suspected\n\n   * Chronic respiratory symptoms (dyspnoea, cough and\u002For sputum)\n   * Exposure to a known risk factor for COPD (such as tobacco smoke)\n   * If available, respiratory function tests showing non- or partially reversible obstructive syndrome (post-bronchodilator ratio FEV1\u002FCV \\\u003C 0.7)\n3. Severe acute exacerbation, defined as a worsening of the patient's usual respiratory symptoms with signs of acute respiratory distress (polypnoea ≥ 30 cycles.min-1 or use of accessory respiratory muscles) and\u002For hypercapnic acidosis (with PaCO2 ≥ 45 mmHg and pH ≤ 7.35)\n4. Admission to an ICU, or a dedicated respiratory intensive care unit\n\nExclusion Criteria:\n\n1. Known asthma (according to the criteria of the international \"Global Initiative for Asthma\" guidelines)\n2. Patient refusal to participate (information note, application for non-opposition)","40 Years",{"count":218,"type":21},500,"1 Year","COPD is one of the leading causes of morbidity, mortality and health care utilisation worldwide. Currently, COPD is the third leading cause of death worldwide and is therefore a major public health problem. Projections show an increase in the prevalence and burden of COPD in the coming decades due to ageing populations and continued exposure to risk factors.\n\nIn patients with COPD, mortality due to exacerbations is about 35%. Exacerbations represent the most important respiratory event in the history of this chronic disease and are of major socio-economic interest (about 50-75% of healthcare expenditure in this disease).\n\nIn the most severe cases, COPD exacerbations lead to respiratory distress with hypercapnic ventilatory acidosis requiring ventilatory support. These most severe episodes are common, accounting for 20% of exacerbations and are a signal of advanced disease, with a high risk of future hospitalisations and a limited long-term prognosis.\n\nDespite progress in management, the mortality of these severe acute exacerbations is around 15% in the ICU and 20% in hospital. The long-term prognosis following hospitalisation for an acute exacerbation of COPD is poor with a 5-year mortality of around 50%. On the one hand, the means and treatments likely to improve the prognosis of these patients are of great medical and socio-economic interest, on the other hand, it seems important to identify the elements that may be associated with management failure and to treat them where appropriate.\n\nThus, improving scientific knowledge thanks to prospective data, evaluating the different characteristics and prognosis of patients hospitalised for a severe acute exacerbation of COPD seems, in the 21st century, a major axis in order to continue to optimise the individual management of these patients but also collectively, given the COPD public health burden.",[222],"COPD Exacerbation Acute","2023-02-16",{"date":225,"type":36},"2023-02-17",{"date":227,"type":36},"2022-11-01",{"date":229,"type":21},"2027-12",{"name":41,"class":42},{"id":232,"slug":233,"hasResults":11,"nctId":234,"briefTitle":235,"officialTitle":235,"acronym":4,"eligibilityCriteria":236,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":237,"targetDuration":239,"studyType":190,"phases":4,"briefSummary":240,"conditions":241,"keywords":4,"overallStatus":83,"whyStopped":4,"lastUpdateSubmitDate":243,"lastUpdatePostDateStruct":244,"startDateStruct":246,"completionDateStruct":248,"leadSponsor":250,"locationsCount":91},"100331366","versailles-hospital-cardiac-arrest-registry-100331366","NCT03594318","Versailles Hospital Cardiac Arrest Registry","Inclusion Criteria:\n\n* Cardiac arrest requiring Intensive Care Unit management\n* Age \\>= 18 years\n\nExclusion Criteria:\n\n\\- Refusal to participate",{"count":238,"type":21},1000,"24 Years","Out-of-hospital and in-hospital cardiac arrest (CA) requiring intensive care unit management.\n\nData collection using a standardized form : demographic data and data related to the CA according to the Utstein guidelines.. Circumstances of onset, dates and times of onset and control of abnormal movements (myoclonus and.or seizures).\n\nOn-scene clinical findings, pre-hospital and hospital care providers, timing of various treatments and supportive care, results of etiological investigations, cause of CA. Dates and times of EEG monitoring, EEG results. Outcomes including vital status and Cerebral Performance Category scale score at ICU and hospital discharge, day-90 and 1-year after CA and determined based on data in the ICU and\u002For hospital\u002Fneurologist charts and\u002For general practitionner phone interview.",[242],"Cardiac Arrest","2018-07-18",{"date":245,"type":36},"2018-07-20",{"date":247,"type":36},"2006-01",{"date":249,"type":21},"2030-12",{"name":41,"class":42},""]