[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"respiratory-distress-syndrome-acute\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:respiratory-distress-syndrome-acute":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,41,71],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100500377","phase-2-a-study-of-gen-1124-in-subjects-with-acute-respiratory-distress-syndrome-ards-100500377",false,"NCT05795465","A Study of GEn-1124 in Subjects With Acute Respiratory Distress Syndrome (ARDS)","A Phase 2, Two-Part Study to Evaluate the Safety and Tolerability of GEn-1124 in Subjects With Acute Respiratory Distress Syndrome (ARDS)","Inclusion Criteria:\n\n1. Male or female subject between the ages of 18 and 85 years old, inclusive.\n2. Written informed consent .\n3. Dosing as early as possible after first meeting ARDS 2023 Global definition.\n4. Acceptable method of birth control.\n\nExclusion Criteria:\n\n1. Subject, surrogate, or physician not committed, or eligible, to receive full supportive care measures.\n2. Pregnant or breastfeeding\n3. Currently incarcerated in a correctional institution or involuntarily committed to an inpatient mental health facility.\n4. Active malignancy (other than non-melanoma skin cancer) requiring treatment with immunosuppressant drugs within the last 3 months or within the last 6 months if an anti-B cell antibody was received.\n5. Any other irreversible disease or condition for which 6-month mortality is estimated to be \\>50%.\n6. Moderate to severe liver failure.\n7. Estimated glomerular filtration rate (eGFR) \\\u003C10 mL\u002Fmin\u002F1.73 m2 or requiring dialysis at screening.\n8. Subjects with known:\n\n   1. New York Heart Association Class IV heart disease; or\n   2. Acute Coronary Syndrome within the past 30 days (e.g., myocardial infarction, unstable angina) or dosing; or\n   3. Cardiac arrest within 30 days of dosing with sequelae likely to increase mortality.\n9. Severe chronic respiratory disease with continuous home oxygen \\>2 liters per minute (LPM) or \\>28% (adjusted for altitude); and\u002For home noninvasive ventilation (except for the treatment of obstructive sleep apnea).\n10. Poly-traumatic injury resulting in significant blood loss and\u002For likely to require major surgery within the study period, or subject condition that would interfere with study procedures.\n11. History of any type of solid organ or cellular transplant.\n12. Receiving immunosuppressive therapy for solid organ or hematopoietic cancer, transplant anti-rejection medication, and\u002For other chronic conditions.\n13. Moribund subject not expected to survive 24 hours.\n14. Do not resuscitate (DNR) status.\n15. World Health Organization (WHO) functional class III or IV pulmonary hypertension.\n16. Subject has been on mechanical ventilation for more than 7 days at time of dosing.\n17. Burn victims currently undergoing treatment for \\>40% total body surface area (TBSA) involvement or for known airway inhalation injury.\n18. Neuromuscular disease that could impact ability to wean from mechanical ventilation.\n19. History of tuberculosis (TB); undergoing treatment for latent TB infection (LTBI); untreated LTBI (as determined by documented results within 3 months of Screening of a positive TB test).\n20. Active Hepatitis B, positive Hepatitis C (and has not completed antiviral treatment), or positive human immunodeficiency (HIV) screen.\n21. Use of any investigational drug or device within last 30 days of dosing or 5 half-lives, whichever is longer.\n22. Any other medical, psychiatric, or social condition that, in the opinion of the investigator, is likely to unfavorably alter the risk-benefit of subject participation, to interfere with protocol compliance, or to confound safety.","ALL","18 Years","85 Years",{"count":20,"type":21},52,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","GEn1E-1124-002 is a two-part Phase 2 study to evaluate the safety and tolerability of GEn-1124 in subjects with ARDS. Treatment with IV infusion dosing as early as possible after ARDS diagnosis. Subjects will be given a second dose approximately 8 hours after the first dose and will continue with twice daily dosing (BID regimen) for 5 days.",[27],"Respiratory Distress Syndrome, Acute","RECRUITING","2026-06-18",{"date":31,"type":32},"2026-06-23","ACTUAL",{"date":34,"type":32},"2023-04-04",{"date":36,"type":21},"2026-12",{"name":38,"class":39},"GEn1E Lifesciences","INDUSTRY",11,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":48,"minAge":4,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":53,"conditions":54,"keywords":56,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":70},"100530547","establishment-and-evaluation-of-prenatal-prevention-and-treatment-strategy-for-nards-100530547","NCT06188195","Establishment and Evaluation of Prenatal Prevention and Treatment Strategy for NARDS","Establishment and Evaluation of Prenatal Prevention and Treatment Strategy for Neonatal Acute Respiratory Distress Syndrome","A predictive model for neonatal acute respiratory distress syndrome was established based on perinatal risk factors.\n\nInclusion Criteria:\n\n1. The pregnant women with a probability greater than 80% in the prediction model of neonatal acute respiratory distress syndrome and agreed to ACS intervention.\n2. Obtaining patient consent.\n\nExclusion Criteria:\n\n1. the pregnant women with a probability of less than 80% in the neonatal acute respiratory distress syndrome prediction model.\n2. The patient refuses.","FEMALE",{"count":50,"type":21},500,[52],"NA","1. A predictive model for NARDS was established based on perinatal risk factors. Multivariate Logistic regression analysis was used to screen the independent prenatal risk factors for NARDS. A Logistic regression model was constructed using the above independent risk factors and quantified in a nomogram to construct a visualization model for prenatal prediction of NARDS.\n2. The role of ACS in the prevention and treatment of ARDS in near-term\u002Ffull-term infants.\n\nFor neonates with a probability greater than 80% in the prediction model of ARDS, at least one ACS was given before the termination of pregnancy. The GC level of cord blood (taken at birth) and the mRNA levels of α-ENaC, Na-K-atpase and SGK1 in nasal epithelium were measured within 2 hours and 1 day after birth in the ACS intervention group and the control group. The occurrence and severity of pulmonary edema, the occurrence and severity of ARDS, and the mortality rate of NARDS were evaluated by lung ultrasound. The indexes of the two groups were compared horizontally and longitudinally.",[55,27],"Acute Respiratory Distress Syndrome",[57,58,59],"Neonatal Acute Respiratory Distress Syndrome","Prediction nomogram","antenatal corticosteroids","2025-06-02",{"date":62,"type":32},"2025-06-04",{"date":64,"type":32},"2024-02-01",{"date":66,"type":21},"2025-12-31",{"name":68,"class":69},"The Second Affiliated Hospital of Chongqing Medical University","OTHER",1,{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":80,"phases":4,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":90,"leadSponsor":92,"locationsCount":4},"100590923","multimodal-database-and-large-language-model-for-ards-100590923","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.",{"count":79,"type":21},6500,"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?",[27,83],"Severe Community-Acquired Pneumonia",[55],"NOT_YET_RECRUITING","2025-05-07",{"date":88,"type":32},"2025-05-15",{"date":86,"type":21},{"date":91,"type":21},"2028-03-31",{"name":93,"class":69},"China-Japan Friendship Hospital"]