[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100590923":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":10,"centralContacts":24,"locations":10,"responsibleParty":30,"collaborators":10,"id":34,"slug":35,"hasResults":36,"nctId":37,"briefTitle":38,"officialTitle":39,"acronym":10,"eligibilityCriteria":40,"healthyVolunteers":36,"sex":41,"minAge":42,"maxAge":10,"enrollmentInfo":43,"targetDuration":10,"studyType":46,"phases":10,"briefSummary":47,"conditions":48,"keywords":51,"overallStatus":53,"whyStopped":10,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":58,"completionDateStruct":59,"leadSponsor":61,"locationsCount":10},{"fullName":5,"class":6},"China-Japan Friendship Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"ARDS",null,"Patients meeting the 2024 global new definition of ARDS.",[13],"Behavioral: Clinical data and biospecimen collection",{"label":15,"type":10,"description":16,"interventionNames":17},"High-risk ARDS patients","Patients admitted to the ICU who do not meet ARDS diagnostic criteria but present with established ARDS risk factors, including: SCAP,, sepsis, high-risk trauma, post high-risk surgery, acute pancreatitis, shock, and aspiration.The primary etiology in this cohort is SCAP.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":10},"BEHAVIORAL","Clinical data and biospecimen collection","Clinical Data Collection: Case report forms were utilized to systematically capture multimodal clinical data, including: demographic characteristics, clinical symptoms and physical signs, laboratory test results, chest imaging data, organ support parameters, pharmacological interventions , complications and clinical outcomes.\n\nBiospecimen Collection: ARDS patients underwent biospecimen collection at days 1, 4, and 7 post-diagnosis. High-risk ARDS cohorts provided specimens within 24 hours of ICU admission. Specimens included: peripheral blood, Sputum\u002FBALF, stool and urine.",[9,15],[25],{"name":26,"role":27,"phone":28,"phoneExt":10,"email":29},"Hangyong He","CONTACT","86+13693585722","yonghang2004@sina.com",{"type":31,"investigatorFullName":32,"investigatorTitle":33,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Qingyuan Zhan","Director, Department of Respiratory and Critical Care Medicine","100590923","multimodal-database-and-large-language-model-for-ards-100590923",false,"NCT06973733","Multimodal Database and Large Language Model for ARDS","Construction of ARDS Clinical Multimodal Database and ARDS-Specific Large Language Model","Inclusion Criteria:\n\n1\\. ARDS Group: ( 1 ) Admitted to the ICU; ( 2 ) Age ≥18 years; ( 3 ) Meets the 2024 Global New Definition of ARDS (diagnosis confirmed by at least two experienced physicians; in case of disagreement, a third physician will adjudicate):Diagnostic Criteria:\n\n1. Risk Factors \\& Origin of Pulmonary Edema:Acute risk factors (e.g., pneumonia, non-pulmonary infection, trauma, transfusion, aspiration, shock).\n\n   Pulmonary edema not fully or primarily attributable to cardiogenic pulmonary edema\u002Ffluid overload.Hypoxemia\u002Fgas exchange abnormalities not primarily due to atelectasis.Exception: ARDS can still be diagnosed if predisposing risk factors exist, even with concurrent conditions.\n2. Timing:Acute onset or worsening of hypoxemic respiratory failure within 7 days of risk factor exposure or new\u002Fworsening respiratory symptoms.\n3. Chest Imaging (X-ray\u002FCT\u002FUS):Bilateral opacities (not fully explained by effusions, atelectasis, or nodules\u002Fmasses)；Ultrasound findings: Bilateral B-lines and\u002For consolidations.\n4. Oxygenation Status:\n\n   1. Non-intubated ARDS:PaO₂\u002FFiO₂ ≤300 mmHg OR SpO₂\u002FFiO₂ ≤315 (if SpO₂ ≤97%). High-flow nasal oxygen (HFNO) ≥30 L\u002Fmin or NIV\u002FCPAP ≥5 cm H₂O.\n   2. Intubated ARDS (all enrolled patients assessed via PaO₂\u002FFiO₂):\n\n      Mild: 200 \\\u003C PaO₂\u002FFiO₂ ≤300 OR 235 ≤ SpO₂\u002FFiO₂ ≤315 (if SpO₂ ≤97%). Moderate: 100 \\\u003C PaO₂\u002FFiO₂ ≤200 OR 148 \\\u003C SpO₂\u002FFiO₂ ≤235 (if SpO₂ ≤97%). Severe: PaO₂\u002FFiO₂ ≤100 OR SpO₂\u002FFiO₂ ≤148 (if SpO₂ ≤97%).\n   3. Resource-limited settings:No PEEP\u002Fminimum oxygen flow required; SpO₂\u002FFiO₂ ≤315 (if SpO₂ ≤97%).\n\n( 4 ) Signed informed consent.\n\n2\\. ARDS High-Risk Group: ( 1 ) Admitted to the ICU; ( 2 ) Age ≥18 years; ( 3 ) Does not meet ARDS criteria at ICU admission but has high-risk factors for ARDS development, including: SCAP, sepsis, high-risk trauma, post high-risk surgery, acute pancreatitis, shock, aspiration.The primary etiology in this cohort is SCAP.\n\nSCAP Diagnostic Criteria (≥1 major or ≥3 minor criteria):\n\n1. Major Criteria:\n\n   1. Requires mechanical ventilation (intubation).\n   2. Septic shock requiring vasopressors after fluid resuscitation.\n2. Minor Criteria:\n\n   1. Respiratory rate ≥30 breaths\u002Fmin.\n   2. PaO₂\u002FFiO₂ ≤250 mmHg.\n   3. Multilobar infiltrates.\n   4. Altered mental status\u002Fdisorientation.\n   5. BUN ≥20 mg\u002FdL (7.12 mmol\u002FL).\n   6. Leukopenia (WBC \\\u003C4×10⁹\u002FL).\n   7. Thrombocytopenia (platelets \\\u003C100×10⁹\u002FL).\n   8. Hypothermia (core temp \\\u003C36°C).\n   9. SBP \\\u003C90 mmHg requiring aggressive fluid resuscitation.\n\n( 4 ) Signed informed consent.\n\nExclusion Criteria:\n\n1. Patients without ARDS or ARDS high-risk factors.\n2. Age \\\u003C18 years.\n3. Incomplete clinical data.\n4. Refusal to sign informed consent.\n5. Long-term nursing home residents.\n6. Tracheostomy patients.\n7. Currently enrolled in another clinical trial.","ALL","18 Years",{"count":44,"type":45},6500,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to integrate existing clinical cohorts from the research team to establish dedicated cohorts for ARDS and high-risk ARDS patients (primarily SCAP patients), then systematically collect comprehensive clinical data and multi-omics biological samples to construct a high-quality multimodal ARDS database. Building upon this foundation, the research will develop an ARDS-specific large-scale disease model to assist clinical decision-making in early warning, diagnosis, and prognosis prediction. The main question it seeks to address is: Can the establishment of specialized ARDS cohorts and multimodal databases, combined with the development of an ARDS-specific large-scale disease model, effectively improve ARDS prediction rates, diagnostic accuracy, and reduce mortality rates, thereby enhancing overall clinical management standards?",[49,50],"Respiratory Distress Syndrome, Acute","Severe Community-Acquired Pneumonia",[52],"Acute Respiratory Distress Syndrome","NOT_YET_RECRUITING","2025-05-07",{"date":56,"type":57},"2025-05-15","ACTUAL",{"date":54,"type":45},{"date":60,"type":45},"2028-03-31",{"name":5,"class":6}]