[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Erasme University Hospital\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":571},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,20,0,[8,50,78,104,132,165,197,228,263,292,317,339,364,388,413,440,466,493,522,543],{"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":31,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100640910","phase-2-feasibility-and-safety-of-targeting-neutral-vs-liberal-fluid-balance-in-traumatic-brain-injured-patients--limit-tbi-trial-100640910",false,"NCT07625995","Feasibility and Safety of Targeting Neutral vs Liberal Fluid Balance in Traumatic Brain Injured Patients- LIMIT-TBI Trial","Feasibility and Safety of Targeting Neutral vs Liberal Fluid Balance in Traumatic Brain Injured Patients: a Phase II Randomized Controlled Trial - LIMIT-TBI Trial","LIMIT-TBI","Inclusion Criteria:\n\n* Adult patients with traumatic brain injury (isolated or associated with extracranial injuries), with or without intracranial pressure monitoring\n* Admission to the intensive care unit\n* Age \\>18 years\n* Enrollment within 48 hours after ICU admission\n\nExclusion Criteria:\n\n* Enrollment in another clinical trial not approved for co-enrollment\n* Pregnancy or suspected pregnancy\n* Concomitant hemorrhagic shock expected to require surgical treatment within 24 hours from inclusion or requiring massive transfusion protocol\n* Hemodynamic instability at ICU admission, defined as heart rate \\>120 beats\u002Fmin and systolic arterial pressure \\\u003C100 mmHg despite at least 1 L of fluid resuscitation, or requirement for high-dose norepinephrine (\\>0.5 mcg\u002Fkg\u002Fmin) or any inotropic support\n* Need for continuous venovenous hemodiafiltration (CVVHDF) at admission\n* Expected survival \\\u003C48 hours","ALL","18 Years",{"count":20,"type":21},88,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The LIMIT-TBI trial is a multicenter, international, randomized, phase II clinical trial designed to evaluate the feasibility and safety of targeting a neutral fluid balance compared to standard care in critically ill adult patients with traumatic brain injury (TBI).\n\nFluid therapy is a cornerstone of TBI management, but optimal fluid balance remains uncertain, with both fluid overload and restriction potentially leading to adverse outcomes. This study aims to determine whether maintaining a daily fluid balance close to zero (±500 mL) during the first 5 days of ICU admission is achievable and safe.\n\nParticipants will be randomized within 48 hours of ICU admission to either a protocolized neutral fluid balance strategy or standard care. Outcomes include feasibility of achieving the target balance, organ complications, hemodynamic parameters, ICU resource utilization, and mortality and neurological outcomes up to 6 months.",[27,28,29,30],"Traumatic Brain Injury","Severe Traumatic Brain Injury","Acute Brain Injury","Neurocritical Care",[32,33,34,35,36],"Fluid Balance","Fluid Therapy","Hemodynamic Management","Feasibility Study","Intracranial Pressure","RECRUITING","2026-05-30",{"date":40,"type":41},"2026-06-04","ACTUAL",{"date":43,"type":41},"2025-07-01",{"date":45,"type":21},"2029-02",{"name":47,"class":48},"Erasme University Hospital","OTHER",3,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":57,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":60,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},"100633903","respiratory-and-haemodynamic-effects-of-conscious-sedation-with-dexmedetomidine-for-a-tavi-procedure-100633903","NCT07532733","Respiratory and Haemodynamic Effects of Conscious Sedation With Dexmedetomidine for a TAVI Procedure","Respiratory and Haemodynamic Effects Comparison of Conscious Sedation With Dexmedetomidine Versus Sedation With Remifentanil-propofol for a TAVI Procedure: a Prospective, Randomised, Single-blind Study","Inclusion Criteria:\n\n* -aged 60 or over,\n* undergoing transfemoral TAVI,\n* treated under sedation without general anaesthesia,\n* having given their written informed consent,\n* with sufficient command of French to undertake cognitive tests.\n\nExclusion Criteria:\n\n* whose first language is not English,\n* who have a contraindication to dexmedetomidine,\n* who require conversion to general anaesthesia during the procedure,\n* or who present with major haemodynamic instability (shock, uncontrolled arrhythmia).","60 Years",{"count":59,"type":21},80,[61],"NA","Transcatheter aortic valve implantation (TAVI) is now the standard procedure for elderly patients with severe aortic stenosis. This patient group is characterised by increased frailty, multiple comorbidities and limited physiological reserve, exposing them to an increased risk of intraoperative complications.\n\nThe majority of TAVI procedures are now performed under conscious sedation, in order to limit the risks associated with general anaesthesia and to promote a faster recovery. However, this strategy carries a risk of intraoperative respiratory events, notably bradypnoea, oxygen desaturation and airway obstruction, particularly in elderly patients with comorbidities.\n\nThe anaesthetic strategy, and in particular the type of sedation used, is likely to influence intraoperative respiratory and haemodynamic tolerance. Traditionally used agents, such as propofol combined with opioids, can induce dose-dependent respiratory depression. Conversely, dexmedetomidine, an α2-adrenergic receptor agonist, has a distinct pharmacological profile, characterised by sedation with a theoretically limited respiratory impact.\n\nHowever, comparative data regarding the impact of different sedation strategies on intraoperative respiratory tolerance during TAVI remain limited, justifying the conduct of this study.\n\nDexmedetomidine is a selective α2-adrenergic receptor agonist, used in anaesthesia and intensive care for its sedative and anxiolytic properties. It induces what is known as 'cooperative' sedation, characterised by the maintenance of relative alertness, the possibility of interacting with the patient and, above all, a limited impact on spontaneous breathing.\n\nPhysiologically, dexmedetomidine differs from conventional sedatives, such as propofol and opioids, in causing less respiratory depression, making it a particularly attractive option for conscious sedation. This property is essential in elderly and comorbid patients, particularly during procedures such as TAVI, where maintaining spontaneous ventilation is a major concern.\n\nSeveral clinical studies, particularly in procedural sedation and interventional cardiology, suggest that the use of dexmedetomidine is associated with better respiratory tolerance, with a reduction in episodes of desaturation, bradypnoea and the need for airway interventions, compared with strategies based on propofol and opioids.\n\nHowever, data specific to the context of TAVI under conscious sedation remain limited, particularly regarding the prospective and standardised assessment of intraoperative respiratory events.\n\nThis study therefore aims to address this knowledge gap by assessing the effect of dexmedetomidine, compared with standard sedation using propofol-remifentanil, on intraoperative respiratory tolerance in patients undergoing TAVI under conscious sedation.",[64],"TAVI(Transcatheter Aortic Valve Implantation)",[66,67,68],"TAVI","sedation","dexmedetomidine","2026-04-27",{"date":71,"type":41},"2026-04-30",{"date":73,"type":41},"2026-04-22",{"date":75,"type":21},"2027-06-30",{"name":47,"class":48},1,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":22,"phases":87,"briefSummary":88,"conditions":89,"keywords":92,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":77},"100633899","effect-of-early-versus-late-surgical-intercostal-block-on-postoperative-pain-relief-following-video-assisted-thoracic-surgery-vats-100633899","NCT07532681","Effect of Early Versus Late Surgical Intercostal Block on Postoperative Pain Relief Following Video-Assisted Thoracic Surgery (VATS)","Effect of Early Versus Late Surgical Intercostal Block on Postoperative Pain Relief Following Video-Assisted Thoracic Surgery (VATS): a Randomised, Double-blind Study","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Scheduled for single-port or two-port video-assisted thoracoscopic surgery (VATS).\n* ASA classification 1 to 3\n* Able to understand the study, describe their pain and provide valid informed consent\n\nExclusion Criteria:\n\n* Neurological or psychiatric conditions that compromise the reliable assessment of pain(dementia, cognitive impairment, severe communication disorders)\n* Chronic opioid use or regular use (\\> 3 months) of strong analgesics for chronic pain\n* History of allergy or known hypersensitivity to local anaesthetics\n* Coagulopathy or anticoagulant therapy precluding the safe performance of an intercostal block\n* Local infection at the injection site or active systemic infection\n* Bilateral thoracic surgery or intraoperative conversion to thoracotomy\n* Second surgery at the same site.\n* Current pregnancy or breastfeeding\n* Inability to understand postoperative instructions or a language barrier preventing a validated assessment of pain\n* Simultaneous participation in another clinical trial involving analgesia or thoracic surgery\n* Refusal to participate or withdrawal of consent at any time",{"count":86,"type":21},140,[61],"Video-assisted thoracoscopic surgery (VATS) is associated with significant postoperative pain despite lower morbidity compared with thoracotomy. Adequate pain management is essential within Enhanced Recovery After Surgery (ERAS) pathways to preserve respiratory function and facilitate postoperative recovery. Surgical intercostal block performed under direct vision is a simple and effective regional analgesic technique commonly used following VATS. However, the optimal timing of intercostal block administration during surgery remains uncertain.\n\nThis prospective randomized double-blind study will compare surgical intercostal block performed at the beginning versus the end of the surgical procedure. The study aims to evaluate the effect of block timing on postoperative pain intensity and postoperative opioid consumption. The results may help optimize multimodal analgesic strategies in patients undergoing thoracic surgery.",[90,91],"Video Assisted Thoracic Surgery (VATS)","Intercostal Nerve Block",[93,91,94],"VATS","Pain","NOT_YET_RECRUITING","2026-04-09",{"date":98,"type":41},"2026-04-16",{"date":100,"type":21},"2026-04-01",{"date":102,"type":21},"2027-09-30",{"name":47,"class":48},{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":4,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":111,"targetDuration":4,"studyType":113,"phases":4,"briefSummary":114,"conditions":115,"keywords":117,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":77},"100628149","impact-of-the-reimbursement-of-fibrinogen-in-cardiac-surgery-100628149","NCT07457879","Impact of the Reimbursement of Fibrinogen in Cardiac Surgery","Impact of the Reimbursement of Fibrinogen on Transfusion, Mortality and Morbidity in Cardiac Surgery","Inclusion Criteria:\n\n* Patients aged ≥ 18 years\n* Complex cardiac surgery under cardiopulmonary bypass (CPB), defined as:\n\n  1. Coronary artery bypass grafting combined with valve replacement\n  2. Replacement of two or more valves\n  3. Cardiac reoperation\n  4. Surgery for infective endocarditis\n  5. Ascending aorta surgery\n* Scheduled or emergency procedures\n* Complete clinical and biological data available (transfusions, hospital stay, complications, tests)\n* Surgery performed between Jan 1st, 2016 and Dec 31st, 2024\n\nExclusion Criteria:\n\n* Surgery without cardiopulmonary bypass (CPB)\n* Patients aged \\\u003C 18 years\n* Pregnancy\n* Patients requiring postoperative extracorporeal membrane oxygenation (ECMO)",{"count":112,"type":21},450,"OBSERVATIONAL","This retrospective, single-center observational study aims to evaluate the impact of fibrinogen concentrate reimbursement introduced in Belgium in April 1st, 2020, on transfusion practices in complex cardiac surgery. Adult patients undergoing complex cardiac surgery with cardiopulmonary bypass between Jan 1st 2016 and Dec 31st 2024 at Erasme Hospital will be included. Transfusion strategies and clinical outcomes will be compared between the pre-reimbursement and post-reimbursement periods.",[116],"Cardiac Surgery",[118,119,120,121,122,123],"Cardiac surgery","Fibrinogen","Blood transfusion","Hemostasis","Transfusion practice","Perioperative bleeding","2026-03-03",{"date":126,"type":41},"2026-03-09",{"date":128,"type":21},"2026-03-20",{"date":130,"type":21},"2026-06-10",{"name":47,"class":48},{"id":133,"slug":134,"hasResults":11,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":138,"eligibilityCriteria":139,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":140,"targetDuration":4,"studyType":22,"phases":141,"briefSummary":142,"conditions":143,"keywords":149,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":77},"100621941","hyper-mind---hyperoxia-effects-on-cerebral-hemodynamics-100621941","NCT07377162","HYPER MIND - Hyperoxia Effects on Cerebral Hemodynamics","HYPERMIND - Hyperoxia Effects on Cerebral Hemodynamics","HYPER-MIND","Inclusion Criteria\n\n* Adult patients aged ≥18 years\n* Admitted to the intensive care unit (ICU)\n* Intubated and mechanically ventilated for ≤72 hours\n* Receiving volume-controlled mechanical ventilation\n* Arterial partial pressure of carbon dioxide (PaCO₂) between 35 and 45 mmHg\n* Invasive arterial blood pressure monitoring in place\n* Adequate transcranial Doppler (TCD) acoustic window\n* Clinically judged to be suitable for a brief normobaric hyperoxic stimulus\n* Expected to receive one or two hyperoxic steps based on baseline FiO₂ requirements: a) Baseline FiO₂ \\\u003C 0.5: two-step hyperoxic stimulus (FiO₂ 0.5 followed by FiO₂ 1.0); b) Baseline FiO₂ ≥ 0.5: one-step hyperoxic stimulus (FiO₂ 1.0)\n\nExclusion Criteria:\n\n* Age \\\u003C18 years\n* Pregnancy\n* Extracorporeal membrane oxygenation (ECMO)\n* Continuous renal replacement therapy (CRRT)\n* Contraindications to hyperoxia, as judged by the treating physician\n* Severe hemodynamic instability requiring changes in vasopressor dose during the recording period\n* Inability to obtain a reliable transcranial Doppler signal through the temporal acoustic windows\n* Any clinical condition deemed by the treating physician to pose unacceptable risk during hyperoxic exposure",{"count":59,"type":21},[61],"This study aims to better understand how short periods of exposure to high oxygen levels affect blood flow in the brain of patients who are intubated and mechanically ventilated in the Intensive Care Unit (ICU). Many ICU patients receive more oxygen than strictly necessary, and high blood oxygen levels (hyperoxemia) are very common. However, the immediate effects of short hyperoxic exposures on cerebral circulation and autoregulation remain poorly understood.\n\nIn this study, patients who already require mechanical ventilation for medical reasons will undergo a brief and controlled increase in the oxygen delivered through the ventilator (FiO₂). During this time, we will continuously monitor blood flow in one of the main brain arteries using a non-invasive ultrasound technique called transcranial Doppler (TCD). The goal is to evaluate how cerebral blood flow, pulsatility, and autoregulatory capacity change during and after a short hyperoxic stimulus.\n\nNo additional invasive procedures are required beyond standard ICU monitoring, except for the temporary adjustment of the ventilator's oxygen settings and arterial blood gas sampling, which are part of usual care in critically ill patients. Participation does not provide direct clinical benefit but may help improve future oxygen management in ICU patients. The study involves minimal risk, as short hyperoxic exposures are already common in routine care and will be interrupted immediately in case of any adverse event.",[144,145,146,147,148],"Hyperoxemia","Cerebrovascular Circulation","Cerebral Autoregulation","Critical Illness","Mechanical Ventilation",[150,151,152,153,147,154,155,156],"hyperoxemia","brain hemodynamics","tcd","cerebral autoregulation","intensive care unit","hyperoxia","oxygen","2026-01-22",{"date":159,"type":41},"2026-01-29",{"date":161,"type":41},"2024-01-01",{"date":163,"type":21},"2028-12-31",{"name":47,"class":48},{"id":166,"slug":167,"hasResults":11,"nctId":168,"briefTitle":169,"officialTitle":170,"acronym":171,"eligibilityCriteria":172,"healthyVolunteers":11,"sex":17,"minAge":173,"maxAge":4,"enrollmentInfo":174,"targetDuration":176,"studyType":113,"phases":4,"briefSummary":177,"conditions":178,"keywords":183,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":190,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":4},"100607132","electrical-impendance-tomography-usage-in-icu-100607132","NCT07184580","Electrical Impendance Tomography Usage in ICU","Electrical Impendance Tomography Usage in ICU : Registry Creation","EITICU","Inclusion Criteria for ICU Patients:\n\n* Patient aged more than 12 years old (no pediatric EIT belt)\n* Patient monitored by an EIT belt\n\nExclusion criteria Patient who expressed opposition to participate.","12 Years",{"count":175,"type":21},1000,"2 Months","Electrical Impedance Tomography (EIT) is a non-invasive, radiation-free, bedside imaging technique that has been in clinical use for over three decades (1).\n\nIt is primarily utilized to monitor regional lung ventilation in mechanically ventilated patients. In recent years, EIT has become a routine tool in critical care settings due to its capacity to provide real-time, bedside insights into pulmonary function. Its applications are diverse, ranging from support during non-invasive ventilation and endotracheal intubation (2) to the management of complex cases of mechanical ventilation. One of its key advantages lies in guiding the optimization of Positive End-Expiratory Pressure (PEEP) titration, which may help tailor ventilatory support to individual patients and potentially reduce the mechanical power delivered to the lungs(3,4).\n\nDespite these benefits, current evidence does not conclusively demonstrate a reduction in mortality associated with the use of EIT in critical care (5,6). Nevertheless, EIT shows promise in several emerging areas, such as monitoring ventilation distribution during prone positioning - even in awake, non-intubated patients (7) - and in the early detection of atelectasis under various clinical conditions (8).\n\nRecently, advancements in EIT technology have led to the development of new models capable of assessing pulmonary \"pulsatility,\" thereby expanding the potential clinical applications of EIT beyond traditional ventilation monitoring. This feature may facilitate the bedside detection of conditions such as atelectasis, pneumonia, pleural effusion, and even pulmonary embolism (9,10).\n\nIn this context, the Intensive Care Unit at Erasme Hospital is acquiring two EIT devices to enhance diagnostic capabilities and improve the care of patients requiring either non-invasive or invasive ventilation during their ICU stay. To support the systematic implementation of these devices and enable future research, it is necessary to establish a registry documenting their clinical use within the ICU. This registry will serve as a foundation for tracking usage patterns, evaluating outcomes, and potentially contributing to future scientific studies.\n\nStandard ICU data such as SOFA scores and SAPS II will be recorded, as is already routinely done in some registries like Epimed.\n\nThis registry will be specific to the Erasme ICU and will collect detailed data on ventilation parameters, EIT measurements, and recruitment maneuvers in patients undergoing mechanical ventilation-whether invasive or non-invasive-when the clinical team determines that a recruitment maneuver is indicated and chooses to use an EIT device for monitoring.\n\nData will be entered into RedCap by the attending physicians or physiotherapists responsible for the patient.\n\nData collection will be prospective, as it is not technically possible to automatically synchronize the recording of ventilation parameters and EIT measurements using the existing software systems.\n\nThere are no expected risks for the patients, as the procedures involved are considered standard practice in intensive care settings.\n\nPatients may benefit from the collection of these data, as it allows for closer monitoring of ventilation parameters during their ICU stay.\n\nAs this is a registry-based study, there will be no predefined duration or fixed number of patients. However, we estimate data will be recorded over a five-year period, with an inclusion of at least 300 patients per year.\n\nInclusion Criteria for ICU Patients:\n\n* Patient aged more than 12 years old (no pediatric EIT belt)\n* Patient monitored by an EIT belt OR Patient undergoing a recruitment maneuver OR Patient undergoing prone position.",[179,180,181,182],"ARDS","Alveolar Recruitment Manoeuvres","Prone Position","Electrical Impedance Tomography (EIT)",[179,184,185,186,187,188],"Recruitment manoeuvres","Prone positioning","PEEP optimization","EIT","Electrical impedance tomography","2025-09-17",{"date":191,"type":41},"2025-09-22",{"date":193,"type":21},"2025-10-15",{"date":195,"type":21},"2031-04",{"name":47,"class":48},{"id":198,"slug":199,"hasResults":11,"nctId":200,"briefTitle":201,"officialTitle":202,"acronym":203,"eligibilityCriteria":204,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":205,"targetDuration":4,"studyType":113,"phases":4,"briefSummary":207,"conditions":208,"keywords":215,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":223,"startDateStruct":224,"completionDateStruct":226,"leadSponsor":227,"locationsCount":4},"100607133","nucleosome-monitoring-relevance-for-outcome-prediction-in-critically-ill-patients-100607133","NCT07184593","Nucleosome Monitoring Relevance for Outcome Prediction in Critically Ill Patients","Validation of a Point-of-care Device for Rapid Bedside Measurement of Circulating Nucleosome Levels in Critically Ill Patients and Study of Its Relevance to Prognostication","NuROPI","Inclusion Criteria:\n\n* Admission to the intensive care unit (ICU) within the past 24 hours.\n* Patient must meet one of the following conditions:\n\nSepsis, defined according to SEPSIS-3 criteria.\n\nSeptic shock, defined according to SEPSIS-3 criteria.\n\nCardiogenic shock, classified as Stage C according to the Society for Cardiovascular Angiography and Interventions (SCAI).\n\nSevere trauma requiring transfusion of four or more units of red blood cells within six hours.\n\nAcute brain injury requiring invasive neuromonitoring.\n\nPost-cardiac arrest with at least 15 minutes of no or low perfusion.\n\nSevere acute pancreatitis requiring ICU-level care.\n\n\\- Presence of an arterial or central venous catheter to allow blood sampling.\n\nExclusion Criteria\n\n* Patient who has expressed opposition to participate.\n* Age younger than 18 years.\n* Imminent death with an expected survival of less than 24 hours.\n* Presence of therapeutic limitations (e.g., no indication for intubation).\n* Active cancer.\n* Absence of the required vascular access.\n* ICU admission longer than 24 hours prior to screening.\n* Readmission of a previously enrolled patient.",{"count":206,"type":21},130,"The goal of this observational study is to evaluate whether whole blood H3.1 nucleosome levels can predict 30-day mortality in adult critically ill patients admitted to the ICU with conditions such as sepsis, septic shock, cardiogenic shock, severe trauma, post-cardiac arrest, acute brain injury, or severe acute pancreatitis.\n\nThe main questions it aims to answer are:\n\nDo initial whole blood H3.1 nucleosome levels predict 30-day mortality in critically ill patients?\n\nAre whole blood nucleosome measurements using a novel point-of-care device correlated with traditional plasma chemiluminescence immunoassays (ChLIA)?\n\nIf there is a comparison group: Researchers will compare point-of-care whole blood nucleosome results with plasma ChLIA assays to see if the device provides reliable and feasible bedside measurements.\n\nParticipants will:\n\nProvide blood samples at admission, 6h, Day 1, Day 3, and Day 7 for nucleosome analysis.\n\nUndergo point-of-care H3.1 nucleosome measurement and parallel plasma storage for ChLIA testing.\n\n(If applicable, in acute brain injury patients with external ventricular drains) provide daily cerebrospinal fluid samples until Day 5, only if otherwise discarded.\n\nHave standard ICU data (SOFA, SAPS II, etc.) collected as part of routine care.",[209,210,211,212,29,213,214],"Sepsis","Septic Shock","Cardiac Arrest (CA)","Pancreatitis","Trauma Blunt","Cardiogenic Shock",[216,217,218,219,220,221,222],"nucleosome","septic shock","Histones","Cardiac Arrest","Cardiogenic shock","Trauma","Acute brain injury",{"date":191,"type":41},{"date":225,"type":21},"2025-10-01",{"date":102,"type":21},{"name":47,"class":48},{"id":229,"slug":230,"hasResults":11,"nctId":231,"briefTitle":232,"officialTitle":233,"acronym":234,"eligibilityCriteria":235,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":236,"targetDuration":238,"studyType":113,"phases":4,"briefSummary":239,"conditions":240,"keywords":249,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":255,"lastUpdatePostDateStruct":256,"startDateStruct":258,"completionDateStruct":260,"leadSponsor":262,"locationsCount":77},"100547068","transfusion-surveillance-in-anaesthesia-100547068","NCT06403163","Transfusion Surveillance in Anaesthesia","Biological Transfusion Efficiency Registry Transfusion Surveillance in Anaesthesia","STAR","Inclusion Criteria:\n\n* all patients who have received an hemostasis product\n\nExclusion Criteria:\n\n* patient who refused to consent to data analysis and study participation",{"count":237,"type":21},50000,"2 Weeks","the aim of this register is to collect exhaustively the different data available surrounding a transfusion act in the context of an active haemorrhage. The aim is to allow different modelling and analysis related to emergency transfusion.",[241,242,243,244,245,246,247,248],"Transfusion Reaction","Transfusion Related Complication","Anesthesia","Anesthesia; Shock","Side Effect","Fresh Blood Stool","Blood Coagulation Disorder","Blood Loss",[250,251,252,253,254],"transfusion","monitoring","emergency situation","shock","fresh frozen plasma","2025-08-25",{"date":257,"type":41},"2025-09-02",{"date":259,"type":41},"2022-09-01",{"date":261,"type":21},"2030-12-31",{"name":47,"class":48},{"id":264,"slug":265,"hasResults":11,"nctId":266,"briefTitle":267,"officialTitle":268,"acronym":269,"eligibilityCriteria":270,"healthyVolunteers":271,"sex":17,"minAge":272,"maxAge":4,"enrollmentInfo":273,"targetDuration":4,"studyType":22,"phases":275,"briefSummary":276,"conditions":277,"keywords":279,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":283,"lastUpdatePostDateStruct":284,"startDateStruct":286,"completionDateStruct":288,"leadSponsor":290,"locationsCount":291},"100550587","efficacy-of-mini-implant-assisted-maxillary-expansion-in-adolescents-and-adults-100550587","NCT06449014","Efficacy of Mini-implant Assisted Maxillary Expansion in Adolescents and Adults","Efficacy of Mini-Implant-Assisted Maxillary Expansion on Late Adolescents and Adults and Its Effects on Nasal Permeability and Airway Volume Using Three Different Activation Protocols: A Randomized Controlled Trial (MARPE_1)","MARPE_1","Inclusion Criteria:\n\n* from the age of 16 onwards\n* who presented with transverse maxillary discrepancy (unilateral, bilateral, anticipated, or constriction without crossbite).\n\nExclusion Criteria:\n\n* history or presence of maxillofacial surgery, cleft lip and palate, craniofacial anomalies or syndromes, congenital tooth anomalies, and periodontal disease.\n* Patients who had previously palatal expansion were excluded also.\n* Presence of anatomic or pathological obstacle of the palatal mini-screw insertion (impacted tooth, tumor.)\n* refusal of study participation",true,"16 Years",{"count":274,"type":21},60,[61],"Transverse maxillary deficiency is a common orthodontic issue, affecting around 10% of adults. Late adolescents and adults often require more force to expand the midpalatal suture due to its increased interdigitation. This study aims to assess the effectiveness of MARPE in this demographic and determine the best activation protocol for non-surgical maxillary expansion using mini-screw-supported appliances. Additionally, the study will evaluate the effectiveness of MARPE on nasal permeability and airway volume.",[278],"Narrow Maxilla",[280,281,282],"MARPE","Endognathia","rhinomanometry","2025-08-08",{"date":285,"type":41},"2025-08-11",{"date":287,"type":41},"2024-10-02",{"date":289,"type":21},"2027-09",{"name":47,"class":48},2,{"id":293,"slug":294,"hasResults":11,"nctId":295,"briefTitle":296,"officialTitle":297,"acronym":4,"eligibilityCriteria":298,"healthyVolunteers":271,"sex":17,"minAge":18,"maxAge":299,"enrollmentInfo":300,"targetDuration":4,"studyType":22,"phases":302,"briefSummary":303,"conditions":304,"keywords":4,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":309,"lastUpdatePostDateStruct":310,"startDateStruct":312,"completionDateStruct":314,"leadSponsor":316,"locationsCount":77},"100596881","sleep-stimulation-to-enhance-waste-clearance-in-the-brain-100596881","NCT07051239","Sleep Stimulation to Enhance Waste Clearance in the Brain","Enhancing Waste Clearance Through Sleep Stimulation","For the positive amyloid load group:\n\n-Participants who meet the criteria of subjective cognitive decline or mild cognitive impairment (Clinical Dementia Rating \\\u003C 2; Mini-Mental State Examination ≥ 21) and brain amyloid-beta (Aβ) accumulation confirmed by CSF or amyloid-PET, the inclusion age range is 55-80 years.\n\nFor healthy groups:\n\n-Inclusion age range is 18-80 years.\n\nInclusion criteria:\n\n* Proficiency in the French language (close to native level) to complete the neuropsychological evaluation and cognitive tests.\n* MRI compatibility: absence of metallic materials in the body (implants, vascular clips, certain types of orthopedic material, etc.), a pacemaker or other types of stimulators, cochlear implants, or any other electronic devices.\n\nExclusion criteria:\n\n* Current or past psychiatric or neurological conditions (except for those directly associated with the patient group).\n* The presence of severe untreated sleep disorders.\n* The presence of irregular sleep-wake cycles (due to shiftwork or extreme chronotype).\n* The presence of moderate depression or high levels of anxiety.\n* Ongoing treatment with psychotropic medications (benzodiazepines, antidepressants).\n* Regular or excessive consumption of alcohol or caffeinated drinks.\n* Consumption of other psychoactive substances known to have an impact on the central nervous system.\n* Insufficient visual or auditory acuity to complete the assessments if uncorrected. Normal hearing is required for sound stimulation to be effective.\n* Claustrophobia that prevents undergoing brain imaging (MRI).\n* Pregnancy or currently breastfeeding","80 Years",{"count":301,"type":21},105,[61],"This study aims to examine whether multi-night closed-loop auditory stimulation (CLAS) during sleep can enhance waste clearance and memory consolidation in healthy adults and older adults with subjective cognitive decline or mild cognitive impairment who exhibit elevated brain amyloid levels identified through prior clinical screening. Specifically, the study investigates whether sleep stimulation increases the clearance of plasma biomarkers related to neurodegeneration, improves the brain's waste clearance system, and supports memory consolidation. Participants will undergo five nights each of CLAS and sham (no stimulation) interventions, with a washout period in between. They will also complete clinical assessments, including MRI scans, blood sample collection, and cognitive testing, and will keep track of subjective sleep quality, sleepiness, mood, and fatigue throughout the interventions.",[305,306,307,308],"Healthy","Subjective Cognitive Decline (SCD)","Mild Cognitive Impairment (MCI)","Alzheimer Disease (AD)","2025-07-03",{"date":311,"type":41},"2025-07-09",{"date":313,"type":21},"2025-09",{"date":315,"type":21},"2028-09",{"name":47,"class":48},{"id":318,"slug":319,"hasResults":11,"nctId":320,"briefTitle":321,"officialTitle":321,"acronym":322,"eligibilityCriteria":323,"healthyVolunteers":11,"sex":324,"minAge":18,"maxAge":325,"enrollmentInfo":326,"targetDuration":4,"studyType":113,"phases":4,"briefSummary":328,"conditions":329,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":331,"lastUpdatePostDateStruct":332,"startDateStruct":334,"completionDateStruct":336,"leadSponsor":338,"locationsCount":77},"100582179","prospective-randomized-non-inferiority-study-comparing-natural-cycle-frozen-embryo-transfer-nc-fet-to-a-new-type-of-endometrial-preparation-for-fet-natural-proliferative-phase-npp-fet-100582179","NCT06859944","Prospective Randomized Non-Inferiority Study Comparing Natural Cycle Frozen Embryo Transfer (NC-FET) to a New Type of Endometrial Preparation for FET: Natural Proliferative Phase (NPP-FET)","NPP","Inclusion Criteria:\n\n* Single transfer Blastocyste\n\nExclusion Criteria:\n\n* PGT (Preimplantation genetic diagnosis)\n* Testicular Sperm\n* Donor oocytes","FEMALE","45 Years",{"count":327,"type":21},272,"Frozen embryo replacement cycle :Two methods traditionally used: the spontaneous cycle and the artificial cycle.Now, Emergence of new protocols: NPP-FET or \"Natural proliferative phase - frozen embryo transfer\" Demonstrate non-inferiority between the NPP-FET and the spontaneous cycle, and superiority in terms of planning.",[330],"Comparison of Pregnancy Rate (HCG+ Level) Obtained After a Replacement Embryonic in Spontaneous Cycle and Following Protocol \"NPP\". Comparison","2025-03-05",{"date":333,"type":41},"2025-03-10",{"date":335,"type":41},"2024-08-05",{"date":337,"type":21},"2026-06-30",{"name":47,"class":48},{"id":340,"slug":341,"hasResults":11,"nctId":342,"briefTitle":343,"officialTitle":343,"acronym":344,"eligibilityCriteria":345,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":346,"targetDuration":4,"studyType":22,"phases":348,"briefSummary":349,"conditions":350,"keywords":353,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":356,"lastUpdatePostDateStruct":357,"startDateStruct":359,"completionDateStruct":361,"leadSponsor":363,"locationsCount":77},"100439616","phase-2-hypertonic-lactate-after-cardiac-arrest-100439616","NCT05004610","Hypertonic Lactate After Cardiac Arrest","LATTE","Inclusion Criteria:\n\n* Age \\> 18 years old\n* Sustained (\\> 20 minutes) return of spontaneous circulation (ROSC)\n* Comatose (GCS \\\u003C 9)\n* Time to ROSC \\> 15'\n\nExclusion Criteria:\n\n* Protected categories (Pregnant women)\n* Anticipated withdrawal of support within 24 hours\n* Traumatic cause of cardiac arrest\n* Body weight at admission \\> 120Kg",{"count":347,"type":21},125,[24],"The study is intended to test the hypothesis that sodium lactate infusion after resuscitation from a cardiac arrest will decrease the magnitude of brain damage, as measured by the serum biomarker concentration of NSE.",[219,351,352],"Ischemia Reperfusion Injury","Anoxic Brain Injury",[354,355],"sodium lactate","cerebral metabolism","2025-02-20",{"date":358,"type":41},"2025-02-21",{"date":360,"type":41},"2025-02-19",{"date":362,"type":21},"2028-05-15",{"name":47,"class":48},{"id":365,"slug":366,"hasResults":11,"nctId":367,"briefTitle":368,"officialTitle":368,"acronym":369,"eligibilityCriteria":370,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":371,"enrollmentInfo":372,"targetDuration":4,"studyType":22,"phases":374,"briefSummary":375,"conditions":376,"keywords":380,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":382,"lastUpdatePostDateStruct":383,"startDateStruct":384,"completionDateStruct":385,"leadSponsor":387,"locationsCount":77},"100577389","insights-into-the-pathophysiology-of-neurovascular-uncoupling-in-patients-with-brain-lesions-100577389","NCT06797661","Insights Into the Pathophysiology of Neurovascular Uncoupling in Patients with Brain Lesions.","NVUCVR","Inclusion Criteria:\n\n* patients in the study include prior imaging showing a potentially resectable intra-cerebral mass lesion. Patient has to be included before surgery, chemotherapy and radiation\n\nExclusion Criteria:\n\n* previous brain surgery\n* respiratory failure\n* Asthma\n* Claustrophobia\n* Previous adverse reaction to gadovist (contrast agent)\n* Pregnancy and Breath feeding\n* Diabetes (type I and II)","90 Years",{"count":373,"type":21},40,[61],"Neurovascular uncoupling (NVU) represents a major source of potential bias for the identification of eloquent brain regions through activation procedures in blood oxygen level dependent (BOLD) functional magnetic resonance imaging (fMRI).\n\nSame region shows proper pattern in glucose metabolism in victiny of brain lesions, investigated with positron emitted tomography with radiolabeled glucose (PET-FDG) This research project aims at investigating the mechanisms of NVU by using a multimodal noninvasive imaging approach in neurosurgical patients.",[377,378,379],"Glioblastoma","Glioma","Astrocytoma",[381],"Primary brain tumor","2025-02-17",{"date":360,"type":41},{"date":382,"type":41},{"date":386,"type":21},"2026-12-31",{"name":47,"class":48},{"id":389,"slug":390,"hasResults":11,"nctId":391,"briefTitle":392,"officialTitle":393,"acronym":394,"eligibilityCriteria":395,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":396,"targetDuration":4,"studyType":22,"phases":398,"briefSummary":399,"conditions":400,"keywords":4,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":405,"lastUpdatePostDateStruct":406,"startDateStruct":408,"completionDateStruct":410,"leadSponsor":412,"locationsCount":4},"100559394","erasme-randomized-controlled-trial-surveys-hemodynamic-excursions-during-esophagectomy-100559394","NCT06563557","Erasme Randomized Controlled Trial Surveys Hemodynamic Excursions During Esophagectomy","ERASME ULB: Erasme Randomized Controlled Trial Surveys Hemodynamic Excursions During Esophagectomy - a Double Blind Study","ERASME ULB","Inclusion Criteria:\n\n* Adult, Capable of giving consent, two or three incisions esophagectomy (thoracoscopic\u002F thoracotomy) no laparotomy\n\nExclusion Criteria:\n\n* patient refusal, total language barrier, coagulation disorders, thrombocytopenia \\\u003C75 000, contraindications to locoregional anesthesia (infection local site, allergy to local anesthesic), scoliosis Cobb \\> 45%, atrial fibrillation, end stage renal disease),",{"count":397,"type":21},75,[61],"In our high volume center, the majority of esophagectomy procedures are performed with minimally invasive techniques. The thoracic epidural technique remains the gold standard and homolateral paravertebral catheter is strongly recommended. The vasoplegia and sympathetic blockade due to the epidural can cause significant hypotension especially as reverse Trendelenburg position is required during surgery. The aim is to study hemodynamic changes caused by two different techniques. Previous studies found a similar pain management between both locoregional techniques, however few studies suggested less side effects in the paravertebral group during major abdominal surgeries.",[401,402,403,404],"Esophagectomy","Epidural; Anesthesia","Paravertebral Anesthesia","Hemodynamic Instability","2024-08-19",{"date":407,"type":41},"2024-08-21",{"date":409,"type":21},"2024-08",{"date":411,"type":21},"2026-12-12",{"name":47,"class":48},{"id":414,"slug":415,"hasResults":11,"nctId":416,"briefTitle":417,"officialTitle":418,"acronym":4,"eligibilityCriteria":419,"healthyVolunteers":11,"sex":324,"minAge":4,"maxAge":4,"enrollmentInfo":420,"targetDuration":4,"studyType":113,"phases":4,"briefSummary":422,"conditions":423,"keywords":426,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":432,"lastUpdatePostDateStruct":433,"startDateStruct":435,"completionDateStruct":437,"leadSponsor":439,"locationsCount":77},"100531129","effect-of-epidural-analgesia-on-regional-lung-ventilation-in-parturient-women-as-assessed-by-thoracic-impedance-100531129","NCT06195774","Effect of Epidural Analgesia on Regional Lung Ventilation in Parturient Women as Assessed by Thoracic Impedance","Impact on Respiratory Function Associated to Epidural Analgesia in Parturient Women as Assessed by Electrical Impedance Tomography: a Monocentric Prospective Study","Inclusion Criteria:\n\n* At-term pregnancy (at least 36 weeks)\n* ASA class I-II\n\nExclusion Criteria:\n\n* American Society of Anesthesiologists (ASA) Class III or more\n* BMI\\>35 before pregnancy\n* Contraindication to routinely administrated drugs (levobupivacaine, lidocaine, sufentanil)\n* Contraindication to epidural analgesia\n* Pregnancy-related complications (including pre-eclampsia)\n* Respiratory system diseases\n* Severe psychiatric disorders\n* Twin pregnancy\n* Skin lesions in correspondence to the position of the Electric impedance tomography belt\n* Pacemaker or Implantable Cardioverter Defibrillator (ICD)\n* Language barrier",{"count":421,"type":21},100,"The goal of this observational study is to learn more about the effect of obstetric epidural anesthesia on regional lung ventilation in healthy parturient women. The main question it aims to answer is whether the initiation or epidural analgesia improves or not regional lung ventilation in healthy women at term during labor.\n\nParticipants will be subject to measurements of pulmonary impedance by electric impedance tomography before and after the start of epidural analgesia. No change will be applied to clinical care as a result of this measurement.",[424,425],"Pregnancy Complications","Atelectasis",[427,428,429,430,431],"pregnancy","labor","at term","electric impedance tomography","pulmonary impedance","2023-12-23",{"date":434,"type":41},"2024-01-08",{"date":436,"type":21},"2024-01",{"date":438,"type":21},"2026-12",{"name":47,"class":48},{"id":441,"slug":442,"hasResults":11,"nctId":443,"briefTitle":444,"officialTitle":444,"acronym":445,"eligibilityCriteria":446,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":447,"targetDuration":4,"studyType":22,"phases":449,"briefSummary":450,"conditions":451,"keywords":456,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":458,"lastUpdatePostDateStruct":459,"startDateStruct":461,"completionDateStruct":463,"leadSponsor":465,"locationsCount":77},"100530671","phase-2-role-of-the-fibroblast-activation-protein-fap-as-biomarker-of-fibrotic-lung-diseases-100530671","NCT06189820","Role of the Fibroblast Activation Protein (FAP) as Biomarker of Fibrotic Lung Diseases","FAPIPET","Inclusion Criteria:\n\n* Adults patients with a fibrotic lung disease (idiopathic pulmonary fibrosis (IPF) or non-IPF fibrotic ILD) as defined according to the 2022 ATS\u002FERS\u002FJRS\u002FALAT Clinical Practice Guidelines\n\nExclusion Criteria:\n\n* Pregnant or nursing patients\n* Patients with another significant medical condition which, in the investigator's opinion, may interfere with the completion of the study.\n* Patients with an active lung neoplasm or any active neoplasm for blood samples",{"count":448,"type":21},70,[24],"To evaluate the effect of an anti-fibrotic treatment initiation on the fibrotic activity as assessed by FAPI PET\u002FCT.",[452,453,454,455],"Pulmonary Fibrosis","Lung Fibrosis","Idiopathic Pulmonary Fibrosis","FAP",[457,455],"Pulmonary fibrosis","2023-12-18",{"date":460,"type":41},"2024-01-05",{"date":462,"type":41},"2023-03-09",{"date":464,"type":21},"2027-03-09",{"name":47,"class":48},{"id":467,"slug":468,"hasResults":11,"nctId":469,"briefTitle":470,"officialTitle":470,"acronym":471,"eligibilityCriteria":472,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":473,"enrollmentInfo":474,"targetDuration":4,"studyType":22,"phases":476,"briefSummary":477,"conditions":478,"keywords":481,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":485,"lastUpdatePostDateStruct":486,"startDateStruct":488,"completionDateStruct":490,"leadSponsor":492,"locationsCount":77},"100511361","evaluation-of-the-performance-of-magnetic-gastrointestinal-universal-septotome-for-treatment-of-candy-cane-syndrome-100511361","NCT05938439","Evaluation of the Performance of MAgnetic Gastrointestinal Universal Septotome for Treatment of Candy Cane Syndrome","MAGUS-CCS","Inclusion Criteria:\n\n* Patient is diagnosed with candy cane syndrome based on clinical and endoscopic and\u002For radiologic assessment\n* Patient has at least one of this 3 symptoms associated to CCS: pain, nausea, vomiting, regurgitation\n* Patient agrees and is able to comply with the study procedures and provide written informed consent to participate in the study\n\nExclusion Criteria:\n\n* Refractory stenosis of the UGI proximal to the septum\n* Septum height smaller than 2 cm or higher than 8 cm\n* Coagulation disorders.\n\n  • Previous implantation of a magnetic-sensitive medical device (including active electronic implant, metallic stent, …).\n* Dysphagia related to motility disorder\n* Planned MRI in the following month (30 days) of intervention\n* Condition that could compromise patient safety\n* Patient who went through an abdominal surgery less than 8 weeks before implantation of the magnets\n* Patient pregnant, breastfeeding or incapacitated\n* Patient currently enrolled in another clinical trial","85 Years",{"count":475,"type":21},51,[61],"Candy cane syndrome (CCS) is an adverse event (AE) from gastrectomy or gastric bypass and end-to-side anastomosis to a jejunal loop. It seems to be predominantly mechanical, the afferent blind loop enlarge and becomes preferential passage of food. This food accumulated in the blind loop increase luminal pressure, causing dilatation, early satiety, fullness, pain, reflux, regurgitation, postprandial vomiting, weight loss, and, ultimately, inability to eat, leading to cachexia.Up to now, main treatment is laparoscopic revision which is invasive. Adverse events related this surgical procedure occurred in 13,3% of cases and substantial improvement only in 73.9%.\n\nA first clinical study with MAGUS including oesophageal diverticulum (n=2) and CCS (n=14) has been performed to assess safety and feasibility of this new device. MAGUS is an implantable device which is placed endoscopically and which, by using pressure necrosis, entailed the marsupialization of the blind loop in less than 30 days. Substantial improvement was observed in all patient and only 7,1% of patients experience an adverse event possibly related to the device. This study aim therefore to assess the safety and performance of the endoscopic treatment of CCS using a new medical device: MAGUS.\n\nThis will be a single-center, open-label prospective, safety and performance study on 51 patients with Candy Cane Syndrome (CCS). Patients will be followed for 12 months after the procedure, with an enrolment period of 3 years.\n\nAfter the screening, the following data will be collected and examinations and tests performed : physical Exam, medical history including CCS cause and treatment(s) history, weight, Eckart and dysphagia score, Quality of Life questionnaire (SF 12 and GERD HRQL), Main symptom selection (Nausea, Vomiting\u002Fregurgitation or pain), nausea VAS, vomiting, regurgitation VAS, pain VAS, barium swallow X-ray or endoscopic assessment of Candy Cane. Follow-up visits will be performed at 14 days, 28 days, 3 months and 12 months post-procedure.",[479,480],"Blind Loop Syndrome Postoperative","Candy Cane Syndrome",[482,483,484],"candy cane syndrome","therapeutic endoscopy","steptotomy","2023-11-16",{"date":487,"type":41},"2023-11-18",{"date":489,"type":41},"2023-08-01",{"date":491,"type":21},"2027-08-31",{"name":47,"class":48},{"id":494,"slug":495,"hasResults":11,"nctId":496,"briefTitle":497,"officialTitle":498,"acronym":499,"eligibilityCriteria":500,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":501,"targetDuration":4,"studyType":22,"phases":503,"briefSummary":504,"conditions":505,"keywords":509,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":514,"lastUpdatePostDateStruct":515,"startDateStruct":517,"completionDateStruct":519,"leadSponsor":520,"locationsCount":521},"100445654","phase-2-preoperative-mfolfirinox-or-gem-nab-p---isotoxic-high-dose-sbrt-for-borderline-resectable-pancreatic-adenocarcinoma-100445654","NCT05083247","Preoperative mFOLFIRINOX (or Gem-Nab-P) +\u002F- Isotoxic High-dose SBRT for Borderline Resectable Pancreatic Adenocarcinoma","Preoperative Treatment With mFOLFIRINOX (or Gem-Nab-P) +\u002F- Isotoxic High-dose Stereotactic Body Radiation Therapy (iHD-SBRT) for Borderline Resectable Pancreatic Adenocarcinoma: a Randomised Phase II Study (STEREOPAC)","STEREOPAC","Inclusion criteria:\n\n* Cytologic or histologic proof of adenocarcinoma of the pancreatic head or uncinated process or body or tail. Diagnosis should be verified by local pathologist\n* cTNM stage: T1-4N0-2M0\n* Confirmation of clinical and radiographic stage as borderline resectable (CT scan and\u002For MRI scan with contrast according to the NCCN criteria) by a multidisciplinary board, composed by a dedicated oncological surgeon, radiologist and GI oncologist)\n* Age \\> 18 years old\n* No prior chemotherapy or radiation for pancreatic cancer\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n* No grade ≥ 2 neuropathy\n* Laboratory parameters as follows:\n* Absolute neutrophil count (ANC) ≥ 1,500\u002Fmm³\n* Platelet count ≥ 100,000\u002Fmm³\n* Hemoglobin ≥ 9 g\u002FdL\n* Creatinine ≤ 1.5 x upper limit of normal (ULN) or estimated GFR \\>45 mL\u002Fmin\n* Bilirubin ≤ 1.5 x ULN, including after adequate biliary stenting with metal stent (ideally 4 cm length)\n* Aspartate aminotransferase (AST) \u002F alanine aminotransferase (ALT) ≤ 2.5x ULN\n* CA 19.9 \\\u003C 2500 kU\u002Fl (baseline, prior to any therapy and absence of cholestasis)\n\nExclusion Criteria:\n\n* Evidence of extrapancreatic disease on diagnostic imaging (CT, MRI or PET scan), histologically proven or at laparoscopy, including distal nodal involvement beyond the peripancreatic tissues (including non-regional lymph node involvement, ie: proven involvement of precaval lumbar lymphadenopathy(ies) and\u002For distant metastases\n* Locally advanced disease as defined by the NCCN criteria (version 2.2021) ie \\> 180° arterial encasement (SMA and CA) unreconstructible venous encasement (SMV\u002FPV) due to tumor involvement or occlusion of a long segment.\n* CA 19.9 \\> 2500 kU\u002Fl (baseline and absence of cholestasis)\n* Contraindication of surgery (general)\n* Contraindications to receive FFX or gemcitabine-nab-Paclitaxel\n* History of radiotherapy of the upper abdomen\n* Prior treatment with oxaliplatin, irinotecan, fluoruouracil or capecitabin\n* Patient \\\u003C 18 years old\n* Major surgery within 4 weeks of study entry\n* Uncontrolled pre-existing disease including, but not limited to: active infection, symptomatic congestive heart failure, unstable angina, social \u002F psychiatric disorder that would limit compliance to treatment and good understanding of the informed consent form\n* Other concurrent anticancer therapies\n* Existence of another active neoplasia other than basal cell carcinoma of the skin, cervical carcinoma in situ or non-metastatic prostate cancer. Patients who have a history of neoplasia must have been in remission for more than 5 years to be included in the protocol\n* Pregnant or breastfeeding women; for women of childbearing potential only, a negative pregnancy test done \\\u003C 7 days prior to registration is required. Using of reliable contraception for at least 1 month before treatment is mandatory\n* Chronic concomitant treatment with strong inhibitors of cytochrome p450, family 3, subfamily a, polypeptide 4 gene (CYP3A4) is not allowed on this study; patients on strong CYP3A4 inhibitors must discontinue the drug for 14 days prior to registration on the study\n\nAdditional exclusion criteria before randomisation:\n\n* Progressive disease (RECIST or PETCT, including non locoregional nodal involvement and increase of CA 19.9 by 20%) after receiving 4 cycles of FFX (or G\u002FNP), including shift chemotherapy in case of early progression.\n* CA 19.9 \\> 1000 kU\u002Fl after neoadjuvant therapy.\n* Presence of unmanageable toxicity during the first part of neoadjuvant chemotherapy (first 4 cycles or 6 doses of FFX or G\u002FNP, respectively.\n* Pancreatic tumour \\> 7.0 cm in greatest axial dimension at the time of randomization\n* Massive invasion of the stomach or intestines and\u002For direct intestinal invasion of the mucosae visible at ultrasoundendoscopy\n* Active gastric or duodenal ulcer disease at the time of randomization. Tolerated in case of antecedent without active ulcer (confirmation by endoscopy before iHD-SBRT)",{"count":502,"type":21},256,[24],"Surgical resection is the only potentially curative treatment for patients with pancreatic cancer with the aim of curative R0 resection and related improvement of survival. As a standard, surgery is usually followed by adjuvant therapy that improves survival but neoadjuvant therapy (NAT) is a rapidly emerging concept that needs to be explored and validated in terms of therapeutic options in borderline resectable pancreatic tumors. In this setting, preoperative FFX seems to be feasible and can be prolonged by radiation therapy. However, the exact and best therapeutic sequence is not yet known and the additional role of adding isotoxic high-dose stereotactic body radiotherapy (iHD-SBRT) to chemotherapy requires validation in randomised trials. We propose to evaluate the impact and efficacy of adding iHD-SBRT to preoperative neoadjuvant mFFX or Gem-NabP in patients with borderline resectable pancreatic adenocarcinoma.",[506,507,508],"Pancreatic Neoplasm","Pancreatic Adenocarcinoma","Borderline Resectable Pancreatic Adenocarcinoma",[510,511,512,513],"borderline resectable pancreatic cancer","neoadjuvant therapy","stereotactic body radiation therapy","chemotherapy","2023-05-22",{"date":516,"type":41},"2023-05-23",{"date":518,"type":41},"2023-03-24",{"date":261,"type":21},{"name":47,"class":48},10,{"id":523,"slug":524,"hasResults":11,"nctId":525,"briefTitle":526,"officialTitle":526,"acronym":527,"eligibilityCriteria":528,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":529,"targetDuration":531,"studyType":113,"phases":4,"briefSummary":532,"conditions":533,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":535,"lastUpdatePostDateStruct":536,"startDateStruct":538,"completionDateStruct":540,"leadSponsor":541,"locationsCount":542},"100503758","sustained-effort-network-for-treatment-of-status-epilepticuseuropean-academy-of-neurology-registry-on-refractory-status-epilepticus-sense-iiarouse-100503758","NCT05839418","Sustained Effort Network for Treatment of Status Epilepticus\u002FEuropean Academy of Neurology Registry on Refractory Status Epilepticus (SENSE-II\u002FAROUSE)","SENSEII\u002FAROUSE","Inclusion Criteria:\n\n* Patients aged 18 years or above\n* Patients admitted for management of Status Epilepticus as their primary diagnosis\n* Patients admitted for another primary diagnosis but identified with Status Epilepticus during their acute hospital stay\n\nExclusion Criteria:\n\n\\- Patients with post-cardiac arrest SE",{"count":530,"type":21},3000,"3 Months","SENSE-II\u002FAROUSE is a prospective, multicenter registry for patients treated for SE. The primary objective is to document patients and SE characteristics, treatment modalities, EEG features, and outcome of consecutive adults admitted fir SE treatment in each of the participating centers and to identify predictors of outcome and refractoriness.",[534],"Status Epilepticus","2023-04-20",{"date":537,"type":41},"2023-05-03",{"date":539,"type":41},"2023-03-01",{"date":163,"type":21},{"name":47,"class":48},11,{"id":544,"slug":545,"hasResults":11,"nctId":546,"briefTitle":547,"officialTitle":548,"acronym":549,"eligibilityCriteria":550,"healthyVolunteers":11,"sex":324,"minAge":551,"maxAge":552,"enrollmentInfo":553,"targetDuration":4,"studyType":113,"phases":4,"briefSummary":555,"conditions":556,"keywords":561,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":563,"lastUpdatePostDateStruct":564,"startDateStruct":566,"completionDateStruct":568,"leadSponsor":570,"locationsCount":521},"100254767","amh-as-a-predictor-of-infertility-risk-in-children-with-cancer-chance-100254767","NCT02595255","AMH as a Predictor of Infertility Risk in Children With Cancer (CHANCE)","Antimüllerian Hormone as a Predictor of Future Infertility Risk in Prepubertal\u002FPubertal Cancer Patients","CHANCE","Inclusion Criteria:\n\n* Patients from 3 to 14 year old included - Belong to one of these 3 groups (modified from Wallace et al, 2005):\n\n  * High risk : Conditioning therapy for bone marrow transplantation or pelvic irradiation\n  * Moderate\u002FLow risk : Pathologies treated with chemotherapy regimen with moderate or low risk of inducing ovarian function insufficiency: AML, osteosarcoma, Ewing sarcoma, neuroblastoma, non-Hodgkin lymphoma, Hodgkin lymphoma, soft tissue sarcoma, ALL, Wilms tumour, retinoblastoma.\n  * No risk (control group) : patients with chronic benign diseases or malignancies who don't receive any chemotherapy or other gonadotoxic treatment.\n\nExclusion Criteria:\n\n* CNS (central nervous system) irradiation, cerebral tumour\n* Current or previous ovarian disease\u002Fsurgery\n* Familial history of premature ovarian failure (no iatrogenic or surgical origins)\n* Previous known severe chronic disease potentially affecting normal growth or puberty (diseases inducing malnutrition, anorexia, genetic\u002Fcongenital disorders as Turner, Kallman, BPES(Blepharophimosis, ptosis, and epicanthus inversus syndrome) syndromes, uncontrolled severe diabetes, Cushing Syndrome, auto-immune diseases, cystic fibrosis, severe renal dysfunction)\n* Genetic\u002Fcongenital disorders inducing mental retardation","3 Years","14 Years",{"count":554,"type":21},275,"While most of the children spontaneously recover menstruation or experienced normal puberty after chemotherapy, their ovarian reserve may be impaired by treatment inducing future infertility. Fertility preservation is currently proposed for selected prepubertal patients with a high risk of premature ovarian failure after treatment (mostly conditioning regimen for bone marrow transplantation). For patients with low or moderate risks, counselling is very difficult and no fertility preservation procedure is usually proposed for these patients as no marker of the ovarian reserve has been validated in this young population to assess the individual risk.\n\nThe primary objective of the study is to prevent long-term treatment-related infertility by detecting the young patients who normally progressed to menarche but have a reduced ovarian reserve. These patients may benefit from particular follow-up and fertility preservation procedure.",[557,558,559,560],"Fertility Preservation","Lymphoma","Pediatrics Cancer","Gonadotropin-releasing Hormone Agonist",[562],"chemotherapy\u002FGnRH (gonadotropin-releasing hormone) analogues\u002Flymphoma\u002Fchildren\u002Ffertility","2020-04-30",{"date":565,"type":41},"2020-05-04",{"date":567,"type":41},"2014-04",{"date":569,"type":21},"2036-12",{"name":47,"class":48},""]