[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"adult-respiratory-distress-syndrome\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:adult-respiratory-distress-syndrome":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":39,"leadSponsor":41,"locationsCount":5},"100555581","phase-2-anti-cd14-treatment-with-ic14-in-hospitalized-ards-patients-100555581",false,"NCT06513949","Anti-CD14 Treatment With IC14 in Hospitalized ARDS Patients","Phase 2, Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Study of Anti-CD14 Treatment With a Recombinant Chimeric Monoclonal Antibody (IC14) in Hospitalized Patients With Acute Respiratory Distress Syndrome","Inclusion Criteria:\n\nPatients may be included in the study only if they meet all the following criteria:\n\n1. Adult patients (18+) on mechanical ventilations with acute respiratory distress syndrome (ARDS) by Berlin Criteria (≤48 hours)\n\n   1. P:F ratio \\\u003C 300\n   2. Positive end-expiratory pressure (PEEP) ≥5 cm H2O\n   3. Bilateral opacities on chest x-ray or chest computerized tomography (CT)-- not fully explained by effusions, lobar\u002Flung collapse, or nodules\n   4. Respiratory failure not fully explained by cardiac failure or fluid overload\n   5. Within 1 week of known clinical insult or new or worsening respiratory symptoms\n\n   i. Common Risk Factors for ARDS: Pneumonia, aspiration, inhalation injury, pulmonary contusion, pulmonary vasculitis, drowning, non-pulmonary sepsis, major trauma, pancreatitis, severe burns, non-cardiogenic shock, drug overdose, multiple transfusions\n2. Patient or Legal authorized representative able to understand and give written informed consent\n\nExclusion Criteria:\n\nAn individual fulfilling any of the following criteria should be excluded from enrollment in the study:\n\n1. Significant pre-existing organ dysfunction prior to hospitalization\n\n   1. Lung: Currently receiving home oxygen therapy as documented in medical record\n   2. Heart: Pre-existing congestive heart failure defined as an ejection fraction \\\u003C20% as documented in the medical record\n   3. Renal: End-stage renal disease requiring renal replacement therapy or estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin.\n   4. Liver: Severe chronic liver disease defined as Child-Pugh Class C or hepatic transaminases \\>5 times upper limit of normal\n   5. Hematologic: Baseline platelet count \\\u003C50,000\u002Fmm3\n2. Presence of co-existing infection, including, but not limited to:\n\n   1. HIV infection not virally suppressed and with pre-hospitalization CD4 counts ≤ 500 cell\u002Fmm3\n   2. Active tuberculosis or a history of inadequately treated tuberculosis\n   3. Active hepatitis B or hepatitis C viral infection\n3. Current treatment, or treatment within 30 days or five half-lives (whichever is longer) with etanercept (Enbrel®), infliximab (Remicade®), adalimumab (Humira®), certolizumab (Cimzia®), golimumab (Simponi®), anakinra (Kineret®), rilonacept (Arcalyst®), tocilizumab (Actemra®), sarilumab (Kevzara®), siltuximab (Sylvant®), or other potent immunosuppressant or immunomodulatory drugs or treatments\n4. Receiving comfort measures only\n5. Requiring \\>2 vasopressors\n6. Pregnant\n7. Prisoners\n8. History of hypersensitivity or idiosyncratic reaction to IC14\n9. Women who are currently breastfeeding\n10. Bronchoscopy safety exclusions\n\n    1. P:F \\\u003C100 on 100% FiO2\n    2. Mean pulmonary artery pressure \\> 55 mmHg\n    3. Marked cardiovascular instability (Mean arterial pressure \\\u003C55 mmHg with vasopressor support)\n    4. Intracranial pressure ≥20 mmHg\n    5. Acute ischemic heart disease (unstable angina or ST-elevation myocardial infarction or Type 1 non-ST-elevation myocardial infarction)\n    6. Supported on extracorporeal membrane oxygenation\n    7. Endotracheal tube \\\u003C6.5 mm","ALL","18 Years",{"count":19,"type":20},56,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","Hospitalized patients with ARDS will be randomized to intravenous treatment with a monoclonal antibody against CD14, called IC14, or placebo. They will be followed for 28 days.\n\nThe primary outcome is the day 4 oxygenation index assessed as a continuous measure.",[26,27,28,29],"Acute Respiratory Distress Syndrome","Adult Respiratory Distress Syndrome","Acute Lung Injury","Acute Lung Injury\u002FAcute Respiratory Distress Syndrome (ARDS)",[31,32],"ARDS","IC14","RECRUITING","2025-08-15",{"date":36,"type":37},"2025-08-20","ACTUAL",{"date":34,"type":37},{"date":40,"type":20},"2027-12",{"name":42,"class":43},"Implicit Bioscience","INDUSTRY",{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":55,"conditions":56,"keywords":57,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":73},"100580329","prevention-of-lung-injury-induced-by-mechanical-ventilation-in-acute-respiratory-distress-syndrome-ards-patients-100580329","NCT06835881","Prevention of Lung Injury Induced by Mechanical Ventilation in Acute Respiratory Distress Syndrome ARDS Patients","Exploratory Study on the Value of Advanced Respiratory Monitoring Data During Mechanical Ventilation in Patients With Acute Respiratory Distress Syndrome (ARDS) in Terms of (1) Estimating the Risk of Ventilator Induced Lung Injury (VILI) and (2) the Relationship Between Aeration Benefit and Gas Exchange","PULMODEL","Inclusion Criteria:\n\n* Adults ≥ 18 years requiring intensive care hospitalization for moderate-to-severe ARDS defined by a PaO2\u002FFiO2 ratio \\\u003C 200 mmHg and benefiting from respiratory monitoring including esophageal pressure (EPP) and EIT.\n* Patient having been individually informed and not objecting to the re-use of his\u002Fher data for research purposes or, where applicable, trusted support person \u002F close relative \u002F parent of patient unable to express his\u002Fher wishes.\n\nExclusion Criteria:\n\n* Patient, or where applicable, trusted support person \u002F close relative \u002F parent of patient unable to express his\u002Fher wishes, opposed to the re-use of his\u002Fher data for research purposes.",{"count":53,"type":20},30,"OBSERVATIONAL","Given the huge volume of mechanically ventilated patients at risk of ARDS, optimizing hematosis by limiting pulmonary and systemic aggression associated with artificial ventilation techniques is a key objective if we are to further improve the prognosis of ARDS.\n\nWith a view to improving cardiopulmonary monitoring in ARDS, modeling using digital twins individualized by nature should ultimately enrich the diagnostic approach by simplifying the technical set-up. Advances in modeling in terms of speed, rendering and results could be applied to personalized monitoring to find the right artificial ventilation setting for the right patient, at the right time.",[27],[58,59,60,61],"Ventilator optimization","Ventilator induced lung injury","Digital twin","Smart data","NOT_YET_RECRUITING","2025-04-22",{"date":65,"type":37},"2025-04-24",{"date":67,"type":20},"2025-06",{"date":69,"type":20},"2027-07",{"name":71,"class":72},"Assistance Publique - Hôpitaux de Paris","OTHER",1]