[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"acute-lung-injury\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:acute-lung-injury":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,49,63,91,123,151,176,203],{"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":33,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100053350","phase-3-fibrotic-disease-activity-in-cardiopulmonary-disorders-using-18f-fibroblast-activation-protein-inhibitor-18f-fapi-74-petct-imaging-100053350",false,"NCT07613099","Fibrotic Disease Activity in Cardiopulmonary Disorders Using 18F-Fibroblast Activation Protein Inhibitor (18F-FAPI-74) PET\u002FCT Imaging","Evaluation of Fibrotic Disease Activity in Cardiopulmonary Disorders Using 18F-Fibroblast Activation Protein Inhibitor (18F-FAPI-74 PET\u002FCT Imaging)","* INCLUSION CRITERIA\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Provision of signed and dated informed consent form\n2. Stated willingness to comply with all study procedures and availability for the duration of the study\n3. Participant \\>=18 years old\n4. Has a specific diagnosis of a cardiopulmonary and\u002For vascular disease that puts them at risk of developing or having developed tissue fibrosis.\n5. Has undergone prior imaging of lungs, heart, and\u002For vasculature with chest CT\n6. Able to lie on the PET\u002FCT scanner for imaging up to 45 minutes.\n7. For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 4 weeks after the end of FAPI-PET\u002FCT or the FDG PET\u002FCT scan.\n8. For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner during study participation and for an additional 4 weeks after the end of FAPI-PET\u002FCT or the FDG PET\u002FCT scan.\n9. Ability of subject to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. History of allergic reactions attributed to compounds of similar chemical or biologic composition to 18F-FAPI-74 or other agents used in the study.\n2. Uncontrolled intercurrent illness, factors, or social situations that would limit compliance with study requirements\n3. Pregnancy or lactation\n4. Women able to become pregnant or men actively trying to father a child and are unwilling to use an effective form of birth control during the study and 4 weeks after the last 18F-FAPI-74 PET\u002FCT scan or the FDG PET\u002FCT scan.\n5. Subjects with severe claustrophobia unresponsive to oral anxiolytics.\n6. Subjects weighing \\> 350 lbs (weight limit for PET scanner table), or unable to fit within the imaging gantry","ALL","18 Years","100 Years",{"count":20,"type":21},210,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","Background:\n\nInjury or diseases of the heart and lung can sometimes cause scar tissue (fibrosis) to build up in those organs. Current imaging scans can see this scar tissue once it has formed, but researchers want to find a way to detect the fibrosis in its earliest stages, while there might still be time to prevent serious damage. A new tracer (a radioactive substance injected during imaging scans) may be able to help.\n\nObjective:\n\nTo test a new tracer (18F-FAPI-74) during imaging scans in people with heart or lung disease.\n\nEligibility:\n\nPeople aged 18 years and older with lung or heart disease that may cause scarring in those organs.\n\nDesign:\n\nParticipants will have 6 clinic visits over 2 years.\n\nParticipants will be screened: They will have blood tests and tests of their heart and lung function. Those with heart disease will have a magnetic resonance imaging (MRI) scan of the heart.\n\nThe study tracer will be used with positron emission tomography (PET)\u002Fcomputed tomography (CT) scans. The study tracer will be injected into a vein in the arm. Participants will lie on a padded bed that slides through a donut-shaped machine.\n\nParticipants will have scans with the study tracer 2 times, 8 to 12 months apart. They will also have standard CT scans and blood tests during these visits. They will also have blood tests at 3 and 6 months between these visits.\n\nParticipants will have a follow-up visit after 18 to 24 months. The study scans, MRI and standard CT scans, and lung function tests may be repeated....",[27,28,29,30,31,32],"Allogeneic Stem Cell Transplantation","Lung Allograft Transplantation","Interstitial Lung Disease","Acute Lung Injury","Pulmonary Arterial Hypertension","Cardiovascular Diseases",[34,35],"Fibroblast activation protein (FAP) FAPI\u002FPET","Fibrotic Disease Activity","NOT_YET_RECRUITING","2026-07-10",{"date":39,"type":40},"2026-07-13","ACTUAL",{"date":42,"type":21},"2026-07-16",{"date":44,"type":21},"2033-05-26",{"name":46,"class":47},"National Heart, Lung, and Blood Institute (NHLBI)","NIH",1,{"id":50,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":53,"conditions":54,"keywords":55,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":62,"locationsCount":48},"100641631",{"count":20,"type":21},[24],"Background:\n\nInjury or diseases of the heart and lung can sometimes cause scar tissue (fibrosis) to build up in those organs. Current imaging scans can see this scar tissue once it has formed, but researchers want to find a way to detect the fibrosis in its earliest stages, while there might still be time to prevent serious damage. A new tracer (a radioactive substance injected during imaging scans) may be able to help.\n\nObjective:\n\nTo test a new tracer (18F-FAPI-74) during imaging scans in people with heart or lung disease.\n\nEligibility:\n\nPeople aged 18 years and older with lung or heart disease that may cause scarring in those organs.\n\nDesign:\n\nParticipants will have 6 clinic visits over 2 years.\n\nParticipants will be screened: They will have blood tests and tests of their heart and lung function. Those with heart disease will have a magnetic resonance imaging (MRI) scan of the heart.\n\nThe study tracer will be used with positron emission tomography (PET)\u002Fcomputed tomography (CT) scans. The study tracer will be injected into a vein in the arm. Participants will lie on a padded bed that slides through a donut-shaped machine.\n\nParticipants will have scans with the study tracer 2 times, 8 to 12 months apart. They will also have standard CT scans and blood tests during these visits. They will also have blood tests at 3 and 6 months between these visits.\n\nParticipants will have a follow-up visit after 18 to 24 months. The study scans, MRI and standard CT scans, and lung function tests may be repeated.",[27,28,29,30,31,32],[34,35],"2026-07-01",{"date":58,"type":40},"2026-07-02",{"date":60,"type":21},"2026-07-07",{"date":44,"type":21},{"name":46,"class":47},{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":70,"targetDuration":4,"studyType":72,"phases":4,"briefSummary":73,"conditions":74,"keywords":77,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":90},"100604988","safety-and-performance-of-the-novalung-ultimate-kit-and-xenios-20-during-stationary-use-in-hospital-and-ground-based-transport-of-patients-on-extracorporeal-life-support-ecls-100604988","NCT07156669","Safety and Performance of the Novalung Ultimate Kit and Xenios 2.0 During Stationary Use in Hospital and Ground-based Transport of Patients on Extracorporeal Life Support (ECLS)","Transport+","Inclusion Criteria:\n\n* Adult patients receiving an ECMO treatment with the Novalung ultimate kit in combination with the Xenios 2.0 (and the MultiSupport Ground during inter- and intra-hospital transport, if applicable) according to the intended use\n* Informed consent signed and dated by the attending physician; and\n\n  1. If patient is able to give consent: by the study patient\n  2. If patient is unable to give consent: by the legal representative or\n  3. If an emergency situation is determined: by a consultant physician\n\nExclusion Criteria:\n\n* Participation in any interventional clinical study that could impact the results of this prospective, observational PMCF study\n* Previous participation in the same study\n* ECMO cannulation outside the referring or trial site hospital",{"count":71,"type":21},20,"OBSERVATIONAL","This prospective observational study will evaluate the safety and performance of the Novalung ultimate kit in combination with the Xenios 2.0 and the MultiSupport Ground during stationary use in hospital and ground-based transport of patients treated on extracorporeal membrane oxygenation (ECMO). The primary objective is to assess whether the use of the medical devices improves and maintains the gas exchange (blood oxygenation) in these patients. Medical Devices will be used according to their intended purpose and local standards\u002F requirements.",[75,76,30],"Cardio-Respiratory Failure","Extracorporeal Membrane Oxygenation Complication",[78,79],"Extracorporeal Life Support","Extracorporeal Membrane Oxygenation","2026-04-08",{"date":82,"type":40},"2026-04-13",{"date":84,"type":21},"2026-04",{"date":86,"type":21},"2027-07",{"name":88,"class":89},"Xenios AG","INDUSTRY",2,{"id":92,"slug":93,"hasResults":11,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":97,"eligibilityCriteria":98,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":99,"enrollmentInfo":100,"targetDuration":4,"studyType":22,"phases":102,"briefSummary":104,"conditions":105,"keywords":108,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":48},"100631321","phase-4-perioperative-lidocaine-for-lung-protection-in-infants-undergoing-cardiac-surgery-100631321","NCT07499154","Perioperative Lidocaine for Lung Protection in Infants Undergoing Cardiac Surgery","Evaluation of the Effect of Perioperative Lidocaine Administration on Reducing Pulmonary Injury in Infants Following Cardiac Surgery: A Randomized, Placebo-Controlled, Double-Blind, Multi-center Superiority Trial.","PLICS","Inclusion Criteria:\n\n1. Infants aged 0 to 12 months.\n2. Congenital heart disease requiring corrective, non-palliative cardiac surgery with cardiopulmonary bypass.\n3. American Society of Anesthesiologists (ASA) physical status I to III.\n4. Written informed consent provided by parent(s) or legal guardian(s).\n\nExclusion Criteria:\n\n1. Multiple malformations, chromosomal abnormalities, or immunodeficiency.\n2. Known or suspected allergy to lidocaine.\n3. Concomitant continuous infusion of another local anesthetic.\n4. Conditions associated with increased risk of lidocaine accumulation or toxicity, including severe conduction block or severe bradycardia.\n5. ASA physical status IV or higher.\n6. Severe malnutrition expected to substantially impair postoperative recovery.\n7. Severe hepatic or renal dysfunction.\n8. Significant pre-existing pulmonary disease or markedly impaired preoperative pulmonary function.\n9. Central nervous system disorders that may increase susceptibility to lidocaine neurotoxicity, including epilepsy or prior central nervous system infection.\n10. Use of medications that may interact with lidocaine or constitute an exclusion, including class I or class III antiarrhythmic agents, cimetidine, or antiviral drugs, as determined by the clinical team.\n11. Current or recent participation in another interventional clinical trial in its active intervention phase.","12 Months",{"count":101,"type":21},320,[103],"PHASE4","Cardiopulmonary bypass-associated pulmonary injury is a common complication after infant cardiac surgery and may contribute to impaired oxygenation, prolonged mechanical ventilation, and longer intensive care stay. Lidocaine has anti-inflammatory and membrane-stabilizing properties and may attenuate perioperative lung injury. This investigator-initiated, randomized, placebo-controlled, double-blind trial will evaluate whether perioperative intravenous lidocaine reduces postoperative pulmonary injury in infants undergoing corrective non-palliative congenital cardiac surgery with cardiopulmonary bypass.",[106,107,30],"Congenital Heart Disease","Postoperative Pulmonary Complications",[109,110,111,112],"Lidocaine","Lung injury","Infant cardiac surgery","Cardiopulmonary bypass","2026-03-23",{"date":115,"type":40},"2026-03-30",{"date":117,"type":21},"2026-04-01",{"date":119,"type":21},"2027-12-31",{"name":121,"class":122},"The Children's Hospital of Zhejiang University School of Medicine","OTHER",{"id":124,"slug":125,"hasResults":11,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":129,"eligibilityCriteria":130,"healthyVolunteers":11,"sex":16,"minAge":131,"maxAge":4,"enrollmentInfo":132,"targetDuration":4,"studyType":22,"phases":134,"briefSummary":136,"conditions":137,"keywords":138,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":146,"completionDateStruct":147,"leadSponsor":149,"locationsCount":48},"100629690","the-impact-of-automatic-lung-recruitment-postoperative-pulmonary-complications-100629690","NCT07477951","The Impact of Automatic Lung Recruitment Postoperative Pulmonary Complications","The Effect of Automatic Lung Re-expansion on Postoperative Pulmonary Function in Elderly Patients Undergoing Laparoscopic Surgery Under Total Intravenous Anesthesia: A Prospective, Single-center, Randomized Controlled Trial","lung","Inclusion Criteria:\n\n* aged≥65 years\n* American Society of Anesthesiologists (ASA) grades I-III;\n* Body mass index (BMI) between 18-30kg\u002Fm²\n* No history of drug allergy or abnormal anesthesia;\n* Patients undergoing laparoscopic gastrointestinal surgery, and operative time\\> 2 hours;\n* Participants with a preoperative oxygen saturation not \\\u003C 94%\n* Participants for whom extubation is planned in the operating room.\n* The assess respiratory risk in surgical patients in Catalonia (ARISCAT) score is 26-44 or \\> 44.\n\nExclusion Criteria:\n\n* ALI or ARDS patient within 3 months; severe pulmonary dysfunction; severe COPD (FEV1 \\\u003C50% of predicted value) or pulmonary hypertension;\n* New York Heart Association classification: Class IV;\n* Chronic renal failure(GFR\\\u003C30ml min-11.73m-2);\n* Severe liver disease;\n* Patients with confusion and cognitive dysfunction;\n* Severe coagulation disorders;\n* Patients with tracheal tubes transported to the ICU;\n* Other reasons;","65 Years",{"count":133,"type":21},58,[135],"NA","Study Background and Purpose As society ages, an increasing number of elderly patients undergo surgery. Following surgery, particularly abdominal procedures, patients are susceptible to lung-related issues such as atelectasis (lung collapse) and infection, collectively known as Postoperative Pulmonary Complications (PPCs). These complications are a major factor affecting the recovery of elderly patients.\n\nOne method of general anesthesia is called Total Intravenous Anesthesia (TIVA). This study aims to investigate whether using an automated lung recruitment function, a smart feature available on modern anesthesia machines, can help protect lung function and reduce complications in elderly patients undergoing laparoscopic surgery under TIVA. The goal is to identify safer and more effective methods for anesthesia care.\n\nStudy Design\n\nThis is a clinical research study. Eligible elderly patients who provide consent will be randomly assigned to one of two groups:\n\nStudy Group: The automated lung recruitment function on the anesthesia machine will be used to manage breathing during surgery.\n\nControl Group: Current standard methods for breathing management will be used during surgery.\n\nThe primary goal is to observe and compare the blood oxygenation level 30 minutes after surgery (a key indicator of lung function) between the two groups. The investigators will also record the occurrence of any lung-related complications within the first 3 days after surgery.\n\nWhat Will Participants Do?\n\nIf participants agree to participate, they will be asked to:\n\nSign an informed consent form.\n\nUndergo some pre-operative assessments arranged by the research team.\n\nReceive the corresponding breathing management method during surgery, as determined by random assignment.\n\nAllow the research team to collect relevant medical data after surgery (e.g., blood gas analysis results, medical records). All data will be kept strictly confidential.\n\nParticipation does not involve any additional invasive procedures. All medical care and monitoring will adhere to the standard safety protocols required for the surgery, and may even be more meticulous.\n\nPotential Benefits and Risks of the Study\n\nPotential Benefits:\n\nDirect Benefit: Participants will receive more precise monitoring and care for their respiratory function during and after surgery.\n\nSocietal Value: Data from their participation will contribute to developing better anesthesia strategies for future elderly patients, potentially improving their recovery outcomes.\n\nPotential Risks and Protections:\n\nThe study intervention is integrated into standard anesthesia. The main risks are associated with routine anesthesia and surgery itself (e.g., temporary blood pressure fluctuations, low oxygen levels). These risks are possible in any similar surgical procedure.\n\nThe study will be conducted by experienced anesthesiologists with continuous, close monitoring. Comprehensive emergency plans are in place to ensure participant safety.\n\nParticipants have the right to withdraw from the study at any time, for any reason, without affecting their eligibility for any future standard medical care.\n\nAll personal information and study data will be kept strictly confidential. Data will be analyzed using coded identifiers only. Any published results will not contain information that could reveal the identity of participants.",[30],[139,140,141,142],"Automated recruitment maneuver (Auto-RM)","Total Intravenous Anesthesia (TIVA)","postoperative pulmonary complications (PPCs)","acute lung injury (ALI)","2026-03-13",{"date":145,"type":40},"2026-03-17",{"date":117,"type":21},{"date":148,"type":21},"2027-06-30",{"name":150,"class":122},"Yongtao Sun",{"id":152,"slug":153,"hasResults":11,"nctId":154,"briefTitle":155,"officialTitle":155,"acronym":156,"eligibilityCriteria":157,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":158,"enrollmentInfo":159,"targetDuration":4,"studyType":72,"phases":4,"briefSummary":160,"conditions":161,"keywords":164,"overallStatus":167,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":90},"100573765","evaluating-the-safety-and-performance-of-the-minilung-petite-kit-in-neonatal-and-pediatric-patients-with-acute-respiratory-and-cardiac-failure-100573765","NCT06750536","Evaluating the Safety and Performance of the MiniLung Petite Kit in Neonatal and Pediatric Patients With Acute Respiratory and Cardiac Failure","PETIT","Inclusion criteria\n\n* Informed consent signed and dated by parents or legal representative and investigator\u002Fauthorized physician\n* Patients ≥2- ≤8 kg bodyweight to be treated with the MiniLung petite kit\n* Acute severe respiratory and\u002For cardiopulmonary failure with an ECMO indication\n\nExclusion criteria:\n\n* Participation in an interventional clinical study during the preceding 30 days that could interfere with the ECLS therapy\n* Previous participation in the same study\n* Prematurity (\\\u003C34 weeks gestational age)\n* Hypersensitivity to heparin or known history of heparin induced thrombocytopenia (HIT)\n* Impossibility of systemic anticoagulation","8 Months",{"count":71,"type":21},"This prospective observational study will evaluate the safety and performance of the MiniLung petite kit in neonatal and pediatric patients with acute respiratory and cardiac failure.\n\nThe main question it aims to answer is (study hypotheses):\n\nVeno-venous (VV) and veno-arterial (VA) Extracorporeal Membrane Oxygenation (ECMO) using the MiniLung petite kit is safe and improves gas exchange (oxygenation and CO2 removal) and hemodynamic stabilization in neonatal and pediatric patients with severe acute respiratory and\u002For cardiopulmonary failure within 24 hours compared to the treatment before VV or VA ECMO initiation and maintain a life-sustaining condition.",[76,162,163,30],"Neonatal Aspiration Pneumonia","Acute Respiratory Failure",[79,165,166],"Neonatal and pediatric patients","MiniLung petite kit","RECRUITING","2025-12-18",{"date":170,"type":40},"2025-12-24",{"date":172,"type":40},"2025-10-12",{"date":174,"type":21},"2026-12",{"name":88,"class":89},{"id":177,"slug":178,"hasResults":11,"nctId":179,"briefTitle":180,"officialTitle":181,"acronym":4,"eligibilityCriteria":182,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":183,"targetDuration":4,"studyType":22,"phases":185,"briefSummary":187,"conditions":188,"keywords":192,"overallStatus":167,"whyStopped":4,"lastUpdateSubmitDate":195,"lastUpdatePostDateStruct":196,"startDateStruct":198,"completionDateStruct":199,"leadSponsor":201,"locationsCount":90},"100555581","phase-2-anti-cd14-treatment-with-ic14-in-hospitalized-ards-patients-100555581","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",{"count":184,"type":21},56,[186],"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.",[189,190,30,191],"Acute Respiratory Distress Syndrome","Adult Respiratory Distress Syndrome","Acute Lung Injury\u002FAcute Respiratory Distress Syndrome (ARDS)",[193,194],"ARDS","IC14","2025-08-15",{"date":197,"type":40},"2025-08-20",{"date":195,"type":40},{"date":200,"type":21},"2027-12",{"name":202,"class":89},"Implicit Bioscience",{"id":204,"slug":205,"hasResults":11,"nctId":206,"briefTitle":207,"officialTitle":208,"acronym":4,"eligibilityCriteria":209,"healthyVolunteers":11,"sex":210,"minAge":17,"maxAge":211,"enrollmentInfo":212,"targetDuration":4,"studyType":22,"phases":214,"briefSummary":215,"conditions":216,"keywords":218,"overallStatus":167,"whyStopped":4,"lastUpdateSubmitDate":223,"lastUpdatePostDateStruct":224,"startDateStruct":226,"completionDateStruct":228,"leadSponsor":230,"locationsCount":48},"100493362","phase-2-pirfenidonevsplacebo-as-prophylaxis-against-acute-radiation-induced-lung-injury-following-hfrt-in-breast-cancer-patients-100493362","NCT05704166","PirfenidoneVsPlacebo as Prophylaxis Against Acute Radiation-induced Lung Injury Following HFRT in Breast Cancer Patients","Pirfenidone Versus Placebo as Prophylaxis Against Acute Radiation-induced Lung Injury Following Hypofractionated Radiotherapy in Breast Cancer Patients (PRILI): A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study Evaluating","Inclusion Criteria:\n\n* To be enrolled in this study, patients must meet all of the following inclusion criteria:\n\n  1. Breast invasive carcinoma or ductal carcinoma in situ or lobular carcinoma in situ confirmed by histology;\n  2. Age 18-75, female;\n  3. The physical state score of the Eastern Tumor Cooperative Group (ECOG) was 0-2;\n  4. Patients meeting the indications of postoperative radiotherapy and neoadjuvant chemotherapy: clinical stage 3 or above or postoperative ypT3-T4 or N+; Non-neoadjuvant chemotherapy patients: postoperative pathological staging of pT3-T4 or pN2 or above, or positive for upper and lower clavicle and lymph nodes in the internal milk region, or positive for clinical consideration; For patients with pT1-2N1, postoperative adjuvant radiotherapy should be determined based on the patient's age, tumor grade, incisal margin, number of positive lymph nodes, molecular typing, past complications, and patient's intention.\n  5. Radiotherapy regimen was chest wall + supraclavicular 40Gy\u002F15f after root modification, or whole milk ± upper and lower clavicular 40Gy\u002F15f after breast preservation, tumor bed simultaneous supplement 50Gy\u002F15f;\n  6. All screening period laboratory tests should be performed in accordance with protocol requirements and within 28 days prior to enrollment. The values of laboratory tests performed by screening must meet the following criteria:\n\n     blood routine check all meet the following criteria: A. Hb≥90g\u002FL; B. ANC≥1.5×109\u002FL; C. PLT≥70×109\u002FL; biochemical examination all meet the following criteria: TBIL \\\u003C 1.5× upper limit of normal range (ULN); ALT and AST≤2.5 x ULN; Serum Cr≤1.25×ULN or endogenous creatinine clearance ≥45 mL\u002Fmin (Cockcroft-Gault formula)\n  7. Women who are at risk of becoming pregnant must undergo a negative serum pregnancy test within 7 days before the first dose and be willing to use a highly effective method of contraception during the trial period and 120 days after the last dose of the test drug. Male subjects with a partner of a woman of reproductive age should be surgically sterilized or consent to a highly effective method of contraception during the trial period and 120 days after the last test drug administration;\n  8. The subjects voluntarily joined the study, signed the informed consent, had good compliance, and cooperated with follow-up.\n\nExclusion Criteria:\n\n* Patients with any of the following criteria were not enrolled in this study\n\n  1. History and complications A. male breast cancer patients; B. Did not meet the conditions of large segmentation radiotherapy (upper and lower clavicular lymph node metastasis, internal milk lymph node metastasis, the patient refused large segmentation radiotherapy); C. The subject has any active, known, or suspected autoimmune disease. To admit subjects who are in a stable state and do not require systemic immunosuppressive therapy; D. The patient is participating in another clinical study or less than 4 weeks after the end of the previous clinical study; E. Patients with a known or highly suspected history of interstitial pneumonia; Or may interfere with the detection or management of suspected drug-related pulmonary toxicity; F. A history of other malignant tumors; Except in patients who have had potentially curable therapy and have not had disease recurrence for 5 years since treatment began; G. Pregnant women and patients with mental illness; H. Prior treatment with radiotherapy, chemotherapy, etc.; I. Patients with active tuberculosis should be excluded; J. Severe acute or chronic lung infections requiring systemic treatment; K. Patients with obvious blood coughing or daily hemoptysis of half a teaspoon (2.5ml) or more in the 2 months before randomization; L. Patients with heart failure (New York Heart Association standard Class III or IV), poor coronary artery disease control or arrhythmia, or a history of myocardial infarction in the 6 months prior to screening despite receiving appropriate medication.\n  2. Physical examination and laboratory examination A. A known history of testing positive for human immunodeficiency virus (HIV) or a known history of acquired immunodeficiency syndrome (AIDS); B. untreated active hepatitis (hepatitis B: HBsAg positive with HBV DNA≥ 500 IU\u002FmL; Hepatitis C: HCV RNA positive and abnormal liver function); Combined with hepatitis B and hepatitis C co-infection.\n  3. As determined by the investigator, the patient may have other factors that may lead to the termination of the study, such as other serious diseases or serious abnormalities in laboratory tests or other factors that may affect the safety of the subjects, or family or social factors such as the collection of test data and samples.","FEMALE","75 Years",{"count":213,"type":21},214,[186],"The incidence of chest CT manifestations of lung injury after radiotherapy for breast cancer is more than 50%. Although the prognosis and quality of life of patients are rarely affected, it is still necessary to prevent the occurrence of minor radiation lung injury with the use of more novel drugs and subsequent salvage treatment may aggravate the radiation injury. This study intends to conduct a randomized, double-blind, single-center clinical study of pirfenidone versus placebo in the prevention of acute radiation induced lung injury after breast cancer surgery",[30,217],"Prevention",[219,220,221,222],"Pirfenidone","Prophylaxis","Acute Radiation-induced Lung Injury","Breast Cancer","2025-08-04",{"date":225,"type":40},"2025-08-08",{"date":227,"type":40},"2023-03-16",{"date":229,"type":21},"2026-05-31",{"name":231,"class":122},"Fujian Medical University Union Hospital"]