[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"lung-transplantation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:lung-transplantation":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,17,0,[8,46,59,83,111,140,166,208,230,249,277,305,328,359,380,408,442],{"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":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100053930","phase-1-syk-inhibition-in-mitigating-lung-allograft-rejection-similar-a-trial-to-evaluate-the-safety-and-tolerability-of-fostamatinib-in-lung-transplant-patients-with-donor-specific-antibodies-100053930",false,"NCT06948097","Syk Inhibition in MItigating Lung Allograft Rejection (SIMILAR): A Trial to Evaluate the Safety and Tolerability of Fostamatinib in Lung Transplant Patients With Donor-Specific Antibodies","Syk Inhibition in MItigating Lung Allograft Rejection (SIMILAR): A Phase 1, Double-Blind, Randomized, Placebo-Controlled, Dose Escalation Trial to Evaluate the Safety and Tolerability of Fostamatinib in Lung Transplant Patients With Donor-Specific Antibodies.","* INCLUSION CRITERIA:\n\nSubjects who do not meet any of the following criteria during screening will not be randomized but will be counted toward study accrual. Screen failures may be rescreened at a later time if the reason for screening failure is revised. In order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n* First time LT recipients\n* Have provided signed written informed consent, prior to performing any study procedure, including screening procedures.\n* Age greater than or equal to 18 years\n* Patients who are positive for de novo DSA that is first reported on or after day 21 post-transplantation in a recipient with no prior history of the same DSA specificity, and who sign informed consent within 30 days of positive test results.\n* No prior demonstration of DSA specificity at any time point preceding the qualifying positive test (including pre-transplant and post-transplant testing).\n* Demonstrate no clinical or spirometry signs of allograft dysfunction at the time of enrollment.\n* Have adequate liver function, as defined by:\n\n  * Serum aspartate aminotransferase (AST) \\\u003C=1.5 x Upper Limit of Normal (ULN) (unless the increased AST is assessed by the Investigator as due to hemolysis) and alanine aminotransferase (ALT) \\\u003C=1.5 x ULN.\n  * Absolute neutrophil count \\>=1.0 x 10\\^9\u002FL.\n  * Hemoglobin \\>= 9 g\u002FdL\n* For women of reproductive potential, have a negative serum pregnancy test during the screening period. Women of reproductive potential are defined as sexually mature women who have not undergone a hysterectomy, bilateral oophorectomy, or tubal occlusion; or who have not been naturally postmenopausal (i.e., who have not menstruated at all for at least the preceding 1 year prior to signing informed consent unrelated to hormonal contraception).\n* For women of reproductive potential, be abstinent as part of their usual lifestyle, or agree to use 2 effective forms of contraception from the time of giving informed consent, during the study, and for 28 days following the last dose of study treatment. An effective form of contraception is defined as hormonal oral contraceptives, injectables, patches, intrauterine or subdermal contraceptive implants, and barrier methods.\n* Be willing to comply with all study procedures for the duration of the study.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n* Have a significant medical condition that confers an unacceptable risk to participating in the study, and\u002For that could confound the interpretation of the study data. Such significant medical conditions include, but are not limited to the following:\n\n  * History of neutropenia (benign ethnic neutropenia and\u002For acquired neutropenia) within 90 days of screening.\n  * History of posterior reversible encephalopathy syndrome (PRES)\n  * History of poorly controlled hypertension or hypertensive crises (defined as systolic blood pressure \\>=180 mmHg or average diastolic blood pressure \\>=120 mmHg based on an average of 3 blood pressure readings despite adequate antihypertensive therapy) unless controlled for \\>90 days prior to enrollment\n  * History of positive post-transplant active hepatitis C and\u002For hepatitis B viral infection.\n  * History of drug-induced cholestatic hepatitis within 90 days of screening.\n  * History of any primary malignancy within the last 5 years, with the exception of: curatively treated non-melanomatous skin cancer; curatively treated cervical or breast carcinoma in situ; or other primary tumor treated with curative intent, no known active disease present, and no treatment administered during the last 5 years.\n  * Testing positive for human immunodeficiency virus 1 or 2 Ab with evidence for ongoing active infection (i.e., CD 4 count \\\u003C400\u002Fmicroliter and viral load \\>100,000 copies\u002Fml) on antiretroviral therapy.\n  * Current or recent history of psychiatric disorder within the last 90 days that, in the opinion of the Investigator or Medical Monitor, could compromise the ability of the subject to cooperate with study visits and procedures.\n  * Are currently enrolled in another therapeutic clinical trial involving ongoing therapy with any investigational or marketed product or placebo.\n  * Having had a prior lung or any organ transplant.\n  * Currently pregnant or lactating.\n  * Estimated glomerular filtration (eGFR) rate less than 30 mL\u002Fmin.\n  * Any grade 3 diarrhea within 90 days of screening.\n* Subjects on strong CYP3A4 inducers. Glucocorticoids are standard transplant therapies and are not excluded. Relevant strong inducers include apalutamide, carbamazepine, encorafenib, enzalutamide, fosphenytoin, lumacaftor, lumacaftor-ivacaftor, mitotane,\n\nphenytoin, rifampin (rifampicin) - (https:\u002F\u002Fwww.uptodate.com\u002Fcontents\u002Fimage?imageKey=CARD%2F76992)\n\n-Subjects who have received prior treatment for DSA within 6 months of screening. Patients on an on-going therapy for first-time DSA are eligible, if screening is performed within 30 days of positive DSA results.","ALL","18 Years","99 Years",{"count":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","Background:\n\nPeople who have lung transplants often survive 6 or 7 years. But some people develop donor-specific antibodies (DSA) after their transplants; antibodies are proteins that attack foreign invaders in the body. Antibodies typically kill viruses and other agents that can cause disease. But when the antibodies attack a transplanted organ, they can cause the body to reject the new tissues. People who develop DSA after a transplant have a higher risk of death within 1 year.\n\nObjective:\n\nTo test a drug called fostamatinib in people who develop DSA after a lung transplant.\n\nEligibility:\n\nAdults aged 18 and older who developed DSA after a lung transplant.\n\nDesign:\n\nParticipants will continue with their standard care after a transplant.\n\nFostamatinib is a pill taken by mouth. Some participants will take the study drug along with their standard care; others will take a placebo. A placebo is a pill that looks just like the real drug but contains no medicine. All participants will take 1 pill per day for 2 weeks. Then they will take 2 pills per day for the next 6 weeks.\n\nParticipants will have clinic visits every 2 weeks while taking their pills. They will have a physical exam, with blood and urine tests, during each visit.\n\nIf participants have fluid samples collected from their airways during their standard treatment, some extra fluid may be collected for this study.\n\nParticipants will have a follow-up visit 4 weeks after they stop taking their pills.",[27],"Lung Transplantation",[29,30,31,32],"Fostamatinib","Lung Transplant","Donor-specific antibodies","Antibody-mediated rejection","NOT_YET_RECRUITING","2026-07-10",{"date":36,"type":37},"2026-07-13","ACTUAL",{"date":39,"type":21},"2026-07-16",{"date":41,"type":21},"2028-07-14",{"name":43,"class":44},"National Heart, Lung, and Blood Institute (NHLBI)","NIH",5,{"id":47,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":48,"targetDuration":4,"studyType":22,"phases":49,"briefSummary":25,"conditions":50,"keywords":51,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":52,"lastUpdatePostDateStruct":53,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":58,"locationsCount":45},"100588952",{"count":20,"type":21},[24],[27],[29,30,31,32],"2026-07-01",{"date":54,"type":37},"2026-07-02",{"date":56,"type":21},"2026-07-07",{"date":41,"type":21},{"name":43,"class":44},{"id":60,"slug":61,"hasResults":11,"nctId":62,"briefTitle":63,"officialTitle":63,"acronym":4,"eligibilityCriteria":64,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":65,"targetDuration":4,"studyType":22,"phases":67,"briefSummary":69,"conditions":70,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":77,"leadSponsor":79,"locationsCount":82},"100643213","phase-4-the-effect-of-bupivacaine-liposomes-on-postoperative-pain-in-lung-transplant-patients-after-intercostal-nerve-block-a-randomized-controlled-study-100643213","NCT07641647","The Effect of Bupivacaine Liposomes on Postoperative Pain in Lung Transplant Patients After Intercostal Nerve Block: a Randomized Controlled Study","Inclusion Criteria:\n\n* Patients with end-stage lung disease undergoing bilateral lung transplantation; Age \\>18 years; Expected discontinuation of mechanical ventilation within 48 hours after surgery; The patient or legally authorized representative signs the informed consent form and agrees to participate in the study and follow-up.\n\nExclusion Criteria:\n\n* Body mass index ≤18 kg\u002Fm² or ≥35 kg\u002Fm²; Allergy or contraindication to local anesthetics; Preoperative tracheal intubation or requirement for extracorporeal life support; Expected use of other types of nerve block; Active systemic infection or infection at the planned block site; Severe hepatic insufficiency; Severe renal impairment; Chronic pain, neuropathic pain, long-term use of analgesics, or use of other psychotropic medications; Preoperative cognitive impairment, cerebrovascular disease, or history of psychiatric disorders; Severe coagulation dysfunction; Concomitant surgery during the same operative session; Pregnant or breastfeeding women.",{"count":66,"type":21},88,[68],"PHASE4","The goal of this clinical trial is to evaluate the efficacy and safety of liposomal bupivacaine for postoperative analgesia in adult patients undergoing lung transplantation. The main questions it aims to answer are:\n\nDoes liposomal bupivacaine reduce postoperative opioid consumption after lung transplantation? Does liposomal bupivacaine relieve postoperative pain without increasing adverse events?\n\nResearchers will compare patients receiving liposomal bupivacaine combined with bupivacaine hydrochloride with patients receiving bupivacaine hydrochloride alone to see whether liposomal bupivacaine provides better postoperative analgesia and reduces opioid requirements after lung transplantation.\n\nParticipants will:\n\nReceive lung transplantation under standard perioperative care. Receive intercostal nerve block with either liposomal bupivacaine combined with bupivacaine hydrochloride or bupivacaine hydrochloride alone.\n\nBe assessed for postoperative opioid consumption, pain scores, recovery-related outcomes, and adverse events after surgery.",[27,71,72],"Pain Management","Liposomal Bupivacaine","2026-06-07",{"date":75,"type":37},"2026-06-11",{"date":52,"type":21},{"date":78,"type":21},"2028-07-01",{"name":80,"class":81},"Second Affiliated Hospital, School of Medicine, Zhejiang University","OTHER",1,{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":4,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":90,"targetDuration":4,"studyType":92,"phases":4,"briefSummary":93,"conditions":94,"keywords":95,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":110},"100503623","trifecta-lung-cfdna-mmdx-study-100503623","NCT05837663","Trifecta-Lung cfDNA-MMDx Study","Trifecta-Lung cfDNA-MMDx Study: Comparing the Dd-cfDNA Test to MMDx Microarray Test and Central HLA Antibody Test","Inclusion Criteria:\n\nAdult, Older adult\n\nExclusion Criteria:\n\nPatients will be excluded from the study if they decline participation Are unable to give informed consent. Recipients of multiple organs, cancer patients and pregnant women",{"count":91,"type":21},600,"OBSERVATIONAL","Demonstrate the relationship between dd-cfDNA levels and HLA antibodies in blood transplant recipient and Demonstrate the Molecular Microscope® (MMDx) Diagnostic System results in indication and protocol biopsies from lung transplants.",[27],[96,97,98,99],"Donor derived cfDNA","Gene expression","Lung transplant biopsy","Blood","RECRUITING","2026-06-01",{"date":103,"type":37},"2026-06-02",{"date":105,"type":37},"2023-11-01",{"date":107,"type":21},"2028-12",{"name":109,"class":81},"University of Alberta",19,{"id":112,"slug":113,"hasResults":11,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":117,"eligibilityCriteria":118,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":119,"targetDuration":4,"studyType":22,"phases":120,"briefSummary":122,"conditions":123,"keywords":126,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":82},"100517532","phase-2-lam-001-in-lung-transplant-recipients-with-bronchiolitis-obliterans-syndrome-100517532","NCT06018766","LAM-001 in Lung Transplant Recipients With Bronchiolitis Obliterans Syndrome.","A Randomized, Placebo-controlled Phase 2 Study to Demonstrate the Safety and Efficacy of the Addition of LAM-001 to Standard Immunosuppression Therapy for Chronic Lung Allograft Dysfunction (BOS).","INSPO-BOS","Inclusion Criteria:\n\n* Age \\> 18 years old\n* Recipient of a double pulmonary allograft at least 12 months before study entry\n* Subjects with clinically diagnosed CLAD-BOS phenotype (all 3 required)\n\n  * BOS defined as screening FEV1 between 85-51% of the baseline as defined by the 2 highest FEV1 measures at least 3 weeks apart.\n  * Diagnosis within 12 months of screening visit.\n  * FEV1 decline is persistent as defined by decline sustained for \\> 30 days.\n* Currently receiving Standard Immunosuppression. This is defined as a combination of 3 medications including Prednisone, Mycophenolate or Azathioprine, and Tacrolimus or Cyclosporine. The dosing should be stable for 4 weeks prior to screening.\n* Absence of oral sirolimus or everolimus treatment for at least 4 weeks prior to screening based on the half-life and resolution of the tissue effects\n* Stable enough to enable routine post-transplant bronchoscopy with BAL and biopsy when indicated\n* Capable of understanding the purposes and risks of the study\n* Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.\n* Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to study entry\n* Women of childbearing potential if sexually active must agree to using highly effective contraception during study and for 90 days after discontinuation of study treatment\n* Women of childbearing potential must refrain from breast feeding or donating eggs for the duration of the study and for 90 days after the last dose of study treatment\n* Male participants must agree to use a condom during sexual contact with a female of childbearing potential while participating in the study and for 90 days following discontinuation of investigational product use\n* Male participants must refrain from donating sperm for the duration of the study and for 90 days after the last dose of study treatment\n\nExclusion Criteria:\n\n* Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.\n* Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.\n* Patients with re-transplantation or currently listed for re-transplantation\n* Patients with confirmed other causes for loss of lung function, such as acute infection, acute rejection, restrictive allograft syndrome (CLAD - RAS phenotype, see Protocol Specific Definition), etc.\n* Patients with acute antibody-mediated rejection at Screening. In this context, clinically stable patients (as judged by the Investigator) with detectable donor-specific antibodies (DSA) levels at the Screening Visit are eligible for the study\n* Active acute bacterial, viral, or fungal infection that has not successfully resolved in at least 4 weeks prior to the Screening Visit. Patients with chronic infection or colonization who are clinically stable as per judgement of the investigator are eligible.\n* Mechanical ventilation within 12 weeks prior to the randomization\n* Patient has baseline resting oxygen saturation of \\\u003C 89% on room air or use of supplemental oxygen at rest at screening\n* Evidence of functional airway stenosis (i.e., bronchomalacia\u002F tracheomalacia, airway stents, or airways requiring balloon dilatations to maintain patency) with onset after the initial diagnosis of BOS and ongoing at Screening and\u002For Baseline Visit\n* Known hypersensitivity to sirolimus or everolimus\n* Currently enrolled in another investigational trial for obstructive chronic lung allograft dysfunction (BOS)\n* Patients with chronic renal failure, defined as serum creatinine \\> 2.5 mg\u002FdL at screening, or requiring chronic dialysis\n* Patients with liver disease and serum bilirubin \\> 3-fold upper limit of normal range or transaminases \\> 2.5 upper limit of normal range\n* Patients with active malignancy within the previous 2 years, including post-transplant lymphoproliferative disorder, except for treated, localized basal and squamous cell carcinomas\n* Any history of malignancy likely to result in significant disability or likely to require significant medical or surgical intervention within the next 6 months. This does not include minor surgical procedures for localized skin cancer.\n* History of severe allergic reaction to lactose (patients with lactose intolerance are eligible)\n* Patients with uncontrolled hypertension",{"count":20,"type":21},[121],"PHASE2","The goal of this clinical trial is to learn about the safety and effectiveness of LAM-001 in patients who have developed bronchiolitis obliterans syndrome (BOS), a form of chronic rejection, after lung transplantation.\n\nThe main questions it aims to answer are:\n\n* Is LAM-001 safe in these patients?\n* Is LAM-001 effective in slowing BOS progression?\n\nParticipants will:\n\n* Be randomly assigned to inhale either LAM-001 or placebo (a look-alike substance that contains no active drug) daily for 48 weeks\n* Attend 10 study visits (mixture of in-person and telehealth) over the 48 week period\n* Undergo pulmonary function testing, bronchoscopy, lab testing, and physical examination\n* Submit weekly home spirometry monitoring\n\nResearchers will compare participants assigned to LAM-001 versus placebo to see if LAM-001 is safely tolerated and to assess the effectiveness of LAM-001 on slowing BOS progression.",[124,125,27],"Bronchiolitis Obliterans Syndrome","Chronic Lung Allograft Dysfunction",[124,125,127,128,129,130],"Lung Transplant Rejection","Sirolimus","mTOR inhibitor","CLAD","2026-05-13",{"date":133,"type":37},"2026-05-18",{"date":135,"type":37},"2023-08-17",{"date":137,"type":21},"2026-12",{"name":139,"class":81},"Steven Hays, MD",{"id":141,"slug":142,"hasResults":11,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":146,"eligibilityCriteria":147,"healthyVolunteers":148,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":149,"targetDuration":4,"studyType":22,"phases":151,"briefSummary":152,"conditions":153,"keywords":4,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":82},"100581662","phase-2-this-study-is-assessing-the-safety-and-efficacy-of-immune-inhibition-as-a-treatment-to-prevent-primary-graft-dysfunction-100581662","NCT06853223","This Study is Assessing the Safety and Efficacy of Immune Inhibition as a Treatment to Prevent Primary Graft Dysfunction","A Randomized Trial of CCR5 Inhibition as a Complement to Lung Transplant Induction Immunosuppression","MARAVIROC","Inclusion Criteria:\n\n1. Male or female ≥18 years of age at the time of lung transplant waitlisting.\n2. Listed for a bilateral lung transplantation.\n3. Written informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.\n4. PGD risk score \\> 50% at the time of donor organ offer\n5. Planned induction with basiliximab, mycophenolatge, and prednisone and routine maintenance immunosuppression of tacrolimus, mycophenolate and prednisone.\n\nExclusion Criteria:\n\n1. Recipient scheduled to receive alternate induction regimen that is cell depleting such as anti-thymocyte globulin or alemtuzumab.\n2. Active chronic pulmonary infection in the recipient that are considered relative contraindications to lung transplantation such as Burkholderia or Mycobacterium abscessus.\n3. Recipients receiving HIV, HCV or HBV positive donor organs. Only documented infections are considered exclusion criteria. Recipients receiving increased risk organs will not be excluded.\n4. Recipient listed for concurrent heart or other solid organ transplantation.\n5. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.",true,{"count":150,"type":21},120,[121],"Lung transplant recipient survival lags other solid organ recipients, with the main early cause of death being primary graft dysfunction (PGD). PGD occurs in up to 1\u002F3 of all recipients, is driven by the body's innate immune response, and has no known medical therapies for treatment or prevention. Investigators have recently shown that Natural Killer (NK) cells, a key innate immune cell, are critical in causing PGD. Importantly, the investigators found that Maraviroc, an FDA-approved drug that works to inhibit these immune cells, prevented lung injury in mouse models of PGD.\n\nThe goal of this clinical trial is to learn if Maraviroc works to treat PGD in Lung Transplant patients who are above the age of 18 and have a PGD risk score greater than 50%. The objectives the study hopes to address are:\n\nTo address the safety and tolerability of Maraviroc. To test a strategy for PGD enrichment in a lung transplant population. To measure the efficacy and biological efficacy of using Maraviroc. To study the biochemical, physiologic, and molecular effects of the drug on the body.\n\nThis will be a double blind study where patients will either get the Maraviroc drug or a placebo. Researchers will then compare the two groups to address the above objectives.\n\nParticipants will:\n\nTake drug Maraviroc or a placebo every 12 hours for 3 days post surgery. Follow up will occur during the entire length of stay at UCSF, about 16 days, with a single 12 month follow up once released.",[154,27,155,156],"Primary Graft Dysfunction","Acute Lung Injury(ALI)","Natural Killer Cell Mediated Immunity","2026-01-15",{"date":159,"type":37},"2026-01-20",{"date":161,"type":37},"2025-12-07",{"date":163,"type":21},"2028-08-14",{"name":165,"class":81},"University of California, San Francisco",{"id":167,"slug":168,"hasResults":11,"nctId":169,"briefTitle":170,"officialTitle":171,"acronym":4,"eligibilityCriteria":172,"healthyVolunteers":148,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":173,"targetDuration":4,"studyType":92,"phases":4,"briefSummary":175,"conditions":176,"keywords":189,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":200,"startDateStruct":202,"completionDateStruct":204,"leadSponsor":206,"locationsCount":82},"100615334","long-term-follow-up-of-the-offspring-born-to-mothers-with-a-solid-organ-transplant-transplantlines-next-generation-100615334","NCT07291258","Long-term Follow-up of the Offspring Born to Mothers With a Solid Organ Transplant, Transplantlines Next Generation","Long-term Follow-up of the Offspring Born to Mothers With a Solid Organ Transplant","Inclusion Criteria:\n\n* Mother with a KTx, LiTx, PTx (including pancreas islet transplantation), HTx or LuTx before pregnancy (including mothers with multiple transplantation types)\n* Age ≥16 years for offspring born to mother with a KTx or LiTx\n\nExclusion Criteria:\n\n* No informed consent\n* Non Dutch or English speaking",{"count":174,"type":21},200,"Background Pregnancy after all types of solid organ transplantation (SOT) is possible, although these have higher risk of pregnancy complications for mother and child, such as preeclampsia and preterm birth. Thus, the development of the unborn child seems to be affected by the transplant and its consequences such as the immunosuppressive medication use. Worldwide data regarding follow-up after birth is scarce. The very limited existing data existing only in young children are reassuring. However, the investigators hypothesize that there are health risks for the children. Given the side effects of the immunosuppressive medication on patients and limited knowledge from animal studies, the investigators particularly expect cardiovascular effects such as hypertension and kidney damage. These develop over a long time-period and lead late to symptoms.\n\nAims Aim of this study is to gain more insight into the overall health of offspring born after SOT. Primary aim is to assess the cardiovascular health and the presence of kidney disease, and compare these with reference values from the general population or birth cohorts. Secondary aims are the immunological status including the microbiome of the child given the maternal immunosuppressive medication use, and the overall development of the offspring, including qualitative research regarding the quality of life. Third aim is to assess if there are differences in health between offspring born to mothers with a kidney, liver, pancreas (including pancreas islet), heart and lung transplantation (KTx, LiTx, PTx, HTx, LuTx resp.). The investigators also want to establish a biobank for later follow-up research.\n\nStudy design This will be a cross-sectional monocenter cohort study. All offspring ≥16 years of age born after KTx or LiTx and all offspring born at any age after PTx, HTx and LuTx in the Netherlands will be eligible for inclusion. The investigators estimate that there will be about 150(-220) participants. Before the study visit, participants will be asked to complete a questionnaire. Participants will be invited for a one-time study visit consisting of physical tests (including ultrasound of the kidneys and a 24-hour ambulatory blood pressure measurement) and biological sample (urine, blood and feces) collection, including sample collection for biobanking. Information about the growth and development of the offspring and, if present, diseases and medication use will be collected from the medical files of the general practitioner and pharmacy (LSP) and from data from the youth healthcare check-ups. As a control group pseudoanonymized data from the Lifelines cohort will be used.\n\nDeliverables To the best of our knowledge, this will be the first study worldwide that will gather and analyze detailed information about the cardiovascular, kidney and immunological health at a later age (≥16 years) in the offspring born to mothers after KTx, LiTx, PTx, HTx and LuTx. This information will be important for the preconceptional counseling of families with a pregnancy wish after transplantation and thereby contribute to the health of women with a SOT. Next to that, find adverse effects of the pregnancy after transplantation on the offspring are found, the investigators expect there will be modifiable factors and\u002For early screening\u002Finterventions that can reduce these risks and thereby contribute to the health of the offspring.",[177,178,179,180,181,182,183,27,184,185,186,187,188],"Solid Organ Transplantation","Pregnancy","Long-term Follow-up","Kidney Transplant","Liver Transplant","Pancreas Transplant","Heart Transplantation","Offspring, Adult","Children","Cardiovascular Abnormalities","Kidney Disease","Quality of Life",[190,178,191,192,193,194,195,196,197,198],"Solid organ transplantation","Offspring","Long-term follow-up","kidney transplantation","liver transplantation","pancreas transplantation","pancreas islet transplantation","Heart transplantation","lung transplantation","2025-12-04",{"date":201,"type":37},"2025-12-18",{"date":203,"type":37},"2025-10-15",{"date":205,"type":21},"2028-06",{"name":207,"class":81},"University Medical Center Groningen",{"id":209,"slug":210,"hasResults":11,"nctId":211,"briefTitle":212,"officialTitle":213,"acronym":4,"eligibilityCriteria":214,"healthyVolunteers":11,"sex":16,"minAge":215,"maxAge":216,"enrollmentInfo":217,"targetDuration":4,"studyType":92,"phases":4,"briefSummary":219,"conditions":220,"keywords":4,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":221,"lastUpdatePostDateStruct":222,"startDateStruct":224,"completionDateStruct":226,"leadSponsor":228,"locationsCount":82},"100099147","risk-factors-that-increase-the-chance-of-developing-primary-graft-dysfunction-after-lung-transplantation-100099147","NCT00552357","Risk Factors That Increase the Chance of Developing Primary Graft Dysfunction After Lung Transplantation","Clinical Risk Factors for Primary Graft Dysfunction","Inclusion Criteria:\n\n* Undergoing lung or combined heart and lung transplantation\n\nExclusion Criteria:\n\n* Undergoing combined organ transplantation other than heart and lung transplantation","13 Years","68 Years",{"count":218,"type":21},1150,"Primary graft dysfunction (PGD) is a severe lung complication that can occur in the days after lung transplant surgery. This study will analyze blood samples to determine if high levels of certain chemicals may increase the risk of developing PGD after a lung transplant.",[154,27],"2025-07-11",{"date":223,"type":37},"2025-07-16",{"date":225,"type":4},"2007-12",{"date":227,"type":21},"2026-06",{"name":229,"class":81},"University of Pennsylvania",{"id":231,"slug":232,"hasResults":11,"nctId":233,"briefTitle":234,"officialTitle":235,"acronym":4,"eligibilityCriteria":236,"healthyVolunteers":11,"sex":16,"minAge":237,"maxAge":238,"enrollmentInfo":239,"targetDuration":4,"studyType":92,"phases":4,"briefSummary":240,"conditions":241,"keywords":242,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":221,"lastUpdatePostDateStruct":244,"startDateStruct":245,"completionDateStruct":247,"leadSponsor":248,"locationsCount":82},"100092034","identifying-genetic-characteristics-that-increase-risk-of-primary-graft-dysfunction-following-lung-transplantation-100092034","NCT00457847","Identifying Genetic Characteristics That Increase Risk of Primary Graft Dysfunction Following Lung Transplantation","Genetics of Primary Graft Dysfunction","Inclusion Criteria:\n\n* Undergoing lung transplant surgery\n\nExclusion Criteria:\n\n\\- Individuals undergoing multi-organ transplantation except heart\u002Flung transplants","15 Years","65 Years",{"count":218,"type":21},"Primary graft dysfunction (PGD) is a severe lung injury that can occur in the days following lung transplant surgery. The purpose of this study is to identify genetic factors that may put someone at risk for developing PGD.",[154,27],[243],"PGD",{"date":223,"type":37},{"date":246,"type":4},"2007-02",{"date":227,"type":21},{"name":229,"class":81},{"id":250,"slug":251,"hasResults":11,"nctId":252,"briefTitle":253,"officialTitle":254,"acronym":4,"eligibilityCriteria":255,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":256,"enrollmentInfo":257,"targetDuration":4,"studyType":22,"phases":259,"briefSummary":261,"conditions":262,"keywords":263,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":268,"lastUpdatePostDateStruct":269,"startDateStruct":271,"completionDateStruct":273,"leadSponsor":275,"locationsCount":82},"100597963","lung-transplant-candidates-effects-of-aerobic-vs-hiit-training-on-icf-assessments-100597963","NCT07065318","Lung Transplant Candidates: Effects of Aerobic vs. HIIT Training on ICF Assessments","Comparison of the Effects of Continuous Aerobic Exercise Training and High-Intensity Interval Exercise Training on ICF-Based Assessments in Lung Transplant Candidates","Inclusion Criteria:\n\n* Being diagnosed with interstitial lung disease and being followed up at the Ankara City Hospital Chest Diseases Clinic,\n* Being 18 years of age or older,\n* Patients who are being followed up with a diagnosis of ILD according to the ATS\u002FERS 2022 international ILD guideline,\n* Being on the lung transplant waiting list according to the International Society for Heart and Lung Transplantation and are being evaluated for listing and are being followed up by the chest diseases department (25-28),\n* Being willing to participate in the exercise program regularly and volunteering to participate in the study,\n* Patients who have dyspnea levels of 2 and above according to the Modified Medical Research Council dyspnea scale and are able to ambulate,\n* Patients who receive long-term oxygen support will be included.\n\nExclusion Criteria:\n\n* Patients with a history of exertional syncope,\n* Patients in acute exacerbation,\n* Patients with sarcoidosis,\n* Patients with serious comorbidities that may limit exercise (e.g. musculoskeletal, neurological or cardiovascular problems) will not be included.\n* Patients with an aortic aneurysm greater than 5.5 cm,\n* Patients with cardiovascular impediments to exercise during cardiological evaluations prior to pulmonary rehabilitation","64 Years",{"count":258,"type":21},34,[260],"NA","Lung transplantation is a crucial surgical intervention aimed at increasing survival rates in patients with end-stage lung diseases such as chronic obstructive pulmonary disease (COPD), cystic fibrosis, idiopathic pulmonary fibrosis, and pulmonary hypertension. One of the most important determinants of health outcomes before and after lung transplantation is exercise capacity. An increase in the 6-minute walking distance (6MWD), which serves as a measure of functional exercise capacity, is associated with lower mortality rates in both pre- and post-transplantation settings. Therefore, effective rehabilitation programs are needed to enhance the exercise capacities of lung transplant candidates.\n\nPulmonary rehabilitation (PR) is a comprehensive program designed specifically for individuals with chronic respiratory diseases. PR aims to improve patients\\' physical and psychological conditions through detailed assessments and personalized treatment plans. It can play a role in enhancing the preoperative exercise capacities of lung transplant candidates and improving their chances of successful health outcomes. However, lung transplant candidates often have more advanced lung disease and face greater challenges compared to typical patients undergoing PR, making the expected benefits more complex to achieve.\n\nThe primary aim of this study is to investigate the effects of high-intensity interval training (HIIT) in lung transplant candidates with interstitial lung disease (ILD). The first objective is to compare the physiological responses and effectiveness of HIIT and moderate-intensity continuous training (MICT) within the same exercise volume. The secondary aim is to evaluate the impact of HIIT on body structure and function, activity, and participation levels using ICF-based assessments.",[27],[264,265,266,267],"lung transplant candidates","exercise training","high intensity interval training","aerobic exercise","2025-07-03",{"date":270,"type":37},"2025-07-15",{"date":272,"type":37},"2024-11-01",{"date":274,"type":21},"2026-01",{"name":276,"class":81},"Ankara City Hospital Bilkent",{"id":278,"slug":279,"hasResults":11,"nctId":280,"briefTitle":281,"officialTitle":282,"acronym":283,"eligibilityCriteria":284,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":285,"targetDuration":4,"studyType":22,"phases":287,"briefSummary":288,"conditions":289,"keywords":294,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":296,"lastUpdatePostDateStruct":297,"startDateStruct":299,"completionDateStruct":301,"leadSponsor":303,"locationsCount":82},"100492233","electrical-activity-of-the-diaphragm-and-respiratory-mechanics-during-nava-100492233","NCT05689476","Electrical Activity of the Diaphragm and Respiratory Mechanics During NAVA","Evaluation of the Relationship Between Electrical Activity of the Diaphragm and Respiratory Mechanics During Neurally Adjusted Ventilatory Assist in Lung Transplant Patients and in Patients Affected by Acute Respiratory Failure.","NAVAMECH","Inclusion Criteria:\n\n* Age \\> 18 y.o.\n* Admission to ICU for post-operative monitoring after LTx or acute respiratory failure needing invasive mechanical ventilation\n* Presence of spontaneous breathing activity\n* Sedation titrated to a target RASS between 0 and -2\n* Written informed consent obtained\n\nExclusion Criteria:\n\n* Contraindication to nasogastric tube insertion (gastroesophageal surgery in the previous 3 months, gastroesophageal bleeding in the previous 30 days, history of esophageal varices, facial trauma)\n* Increased risk of bleeding with nasogastric tube insertion, due to severe coagulation disorders and severe thrombocytopenia ( i.e., INR \\> 2 and platelets count \\\u003C 70.000\u002Fmm3)\n* Severe hemodynamic instability (noradenaline \\> 0.3 μg\u002Fkg\u002Fmin and\u002For use of vasopressin)\n* Postoperative extracorporeal respiratory support (ECMO)\n* Pre-operative reconditioning of the transplanted lungs by means of ex-vivo lung perfusion (EVLP)\n* Lung retransplantation\n* Failure to obtain a stable EAdi signal",{"count":286,"type":21},40,[260],"Protective ventilatory strategy should be applied to reduce ventilator-induced lung injury (VILI) after Lung Transplantation (LTx) or in case of acute respiratory failure requiring invasive mechanical ventilation. Neurally Adjusted Ventilatory Assist (NAVA) is an assisted ventilation mode in which respiratory support is coordinated by the electrical activity of the diaphragm (EAdi). Aim of the study is to assess the physiological relationship between neural respiratory drive, as assessed by EAdi, and tidal volume, driving pressure, and mechanical power, at different levels of ventilatory assist, in the absence of pulmonary vagal afferent feedback or during acute respiratory failure. Additional parameters will be collected: Pmus, Pocc, transpulmonary pressure etc.",[290,27,291,292,293],"Work of Breathing","Neurally Adjusted Ventilatory Assist","Ventilator-Induced Lung Injury","Acute Respiratory Failure (ARF)",[295,292,291],"Lung Injury","2025-07-01",{"date":298,"type":37},"2025-07-08",{"date":300,"type":37},"2022-12-27",{"date":302,"type":21},"2025-12-27",{"name":304,"class":81},"University of Padova",{"id":306,"slug":307,"hasResults":11,"nctId":308,"briefTitle":309,"officialTitle":310,"acronym":311,"eligibilityCriteria":312,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":313,"targetDuration":4,"studyType":92,"phases":4,"briefSummary":315,"conditions":316,"keywords":4,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":318,"lastUpdatePostDateStruct":319,"startDateStruct":321,"completionDateStruct":323,"leadSponsor":325,"locationsCount":327},"100596175","study-of-tacrolimus-melt-dose-for-lung-transplant-patients-100596175","NCT07042035","Study of Tacrolimus Melt-Dose® for Lung Transplant Patients","Pharmacokinetic Study, Effectiveness, and Safety of the Tacrolimus Formulation Based on Melt-Dose® Technology (LCPT) as an Immunosuppressive Treatment for Lung Transplant Patients, Under Usual Clinical Practice Conditions.","ESENCIAL","Inclusion Criteria:\n\n* Patients ≥18 years old.\n* Patients who have received a first unilateral or bilateral lung transplant.\n* Patients who have started oral treatment with tacrolimus using the LCPT formulation, with a once-daily dosage within the first 3 months post-transplant.\n* Patients with a treatment duration expected to be ≥12 months.\n* The patient (or their representative) can sign the informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Patients who have received a multi-organ transplant or have a history of any organ transplant, including lung.\n* Patients with an estimated survival of \\\u003C12 months\n* Patients diagnosed with cystic fibrosis\n* Patients diagnosed with scleroderma.\n* Patients diagnosed with a systemic disease affecting the digestive system.\n* Patients in any situation or condition that, in the investigator's opinion, makes participation inadvisable, such as any treatment that may interfere with the study.\n* Patients who are participating or have participated in an interventional research study within 30 days prior to inclusion.\n* Pregnant women, those planning to become pregnant, or those who are breastfeeding.\n* Patients who are unable to complete the study.\n* Patients who have not signed the informed consent.",{"count":314,"type":21},240,"To evaluate, under usual clinical practice conditions and with a 12-month follow-up , the most relevant pharmacokinetic parameters of tacrolimus metabolism and safety, in patients with recent lung transplant (unilateral or bilateral) treated with LCPT.",[317,27],"Lung Trasplant","2025-06-25",{"date":320,"type":37},"2025-06-27",{"date":322,"type":37},"2024-10-29",{"date":324,"type":21},"2026-12-31",{"name":326,"class":81},"Chiesi España, S.A.U.",2,{"id":329,"slug":330,"hasResults":11,"nctId":331,"briefTitle":332,"officialTitle":333,"acronym":334,"eligibilityCriteria":335,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":336,"targetDuration":4,"studyType":92,"phases":4,"briefSummary":337,"conditions":338,"keywords":341,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":350,"lastUpdatePostDateStruct":351,"startDateStruct":353,"completionDateStruct":355,"leadSponsor":357,"locationsCount":82},"100582862","prospective-observational-pilot-study-of-lmwh-versus-ufh-as-ecmo-anticoagulation-in-lung-transplantation-100582862","NCT06868823","Prospective Observational Pilot Study of LMWH Versus UFH as ECMO Anticoagulation in Lung Transplantation","LMWH Versus UFH as ECMO Anticoagulation in Lung Transplantation: A Prospective, Observational, and Pilot Study","LUX-ET-LT","Inclusion Criteria:\n\n1. ⃣ Adults (≥18 years old).\n2. ⃣ Patients undergoing bilateral lung transplantation with perioperative veno-arterial (V-A) ECMO support.\n3. ⃣ Planned perioperative anticoagulation with either UFH or LMWH, as determined by the attending anesthesiologist.\n4. ⃣ Ability to provide informed consent or consent provided by a legally authorized representative.\n\nExclusion Criteria:\n\n1. ⃣ Patients receiving ECMO as a bridge to lung transplantation.\n2. ⃣ Patients requiring postoperative continuation of ECMO.\n3. ⃣ Patients with perioperative blood loss ≥3,000 mL.\n4. ⃣ Patients undergoing lung re-transplantation.\n5. ⃣ History of severe coagulopathy or bleeding disorder.\n6. ⃣ Active use of antiplatelet or anticoagulant therapy (excluding study anticoagulants).\n7. ⃣ Known heparin-induced thrombocytopenia (HIT).\n8. ⃣ Severe liver dysfunction (Child-Pugh C) or end-stage renal disease requiring dialysis.\n9. ⃣ Pregnant or breastfeeding women.",{"count":286,"type":21},"The aim of this observational pilot study is to evaluate the effectiveness and safety of low-molecular-weight heparin (LMWH) compared to unfractionated heparin (UFH) as anticoagulation in perioperative ECMO during bilateral lung transplantation.\n\nThe main question this study seeks to answer is:\n\nDoes LMWH provide a safe and effective alternative to UFH for ECMO anticoagulation in lung transplantation, with reduced bleeding and thrombotic complications?\n\nPatients undergoing bilateral lung transplantation with perioperative veno-arterial (V-A) ECMO support will be assigned to one of two anticoagulation strategies:\n\nUFH group: Standard UFH anticoagulation monitored using ROTEM. LMWH group: Enoxaparin-based anticoagulation monitored using ROTEM. The study will assess perioperative blood loss, hemoglobin levels, transfusion needs, and thrombotic events. Additional analyses will include coagulation profile assessments using point-of-care (POC) tests, thrombin generation test (TGT), and laboratory coagulation parameters.",[27,339,340],"Extracorporeal Membrane Oxygenation (ECMO)","Anticoagulants and Bleeding Disorders",[27,339,342,343,344,345,346,347,348,349],"Anticoagulation","Low-Molecular-Weight Heparin (LMWH)","Unfractionated Heparin (UFH)","Thrombosis Prevention","Bleeding Complications","Coagulation Management in Surgery","Hemorrhagic and Thrombotic Events","Perioperative Hemostasis","2025-06-09",{"date":352,"type":37},"2025-06-10",{"date":354,"type":37},"2025-05-01",{"date":356,"type":21},"2025-12-31",{"name":358,"class":81},"University Hospital, Motol",{"id":360,"slug":361,"hasResults":11,"nctId":362,"briefTitle":363,"officialTitle":364,"acronym":4,"eligibilityCriteria":365,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":366,"targetDuration":4,"studyType":22,"phases":368,"briefSummary":369,"conditions":370,"keywords":4,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":371,"lastUpdatePostDateStruct":372,"startDateStruct":374,"completionDateStruct":376,"leadSponsor":378,"locationsCount":82},"100541291","transplanting-lungs-from-uncontrolled-donation-after-circulatory-death-100541291","NCT06327945","Transplanting Lungs From Uncontrolled Donation After Circulatory Death","Transplanting Lungs From Uncontrolled Donation After Circulatory Death: An Early Phase Clinical Trial","Inclusion Criteria:\n\n* Patients waiting for lung transplants\n* Willing to participate in the research study\n\nExclusion Criteria:\n\n* Unable to be followed for 1 year after transplantation\n* Unable to provide written informed consent to participate in the research (or designate a surrogate)",{"count":367,"type":21},24,[260],"The study team developed an uncontrolled donation after circulatory death (uDCD) protocol that preserves lungs for just over 3 hours after death using positive end expiratory pressure (PEEP) and supplemental oxygen. The study will assess lung uDCD program safety by continuous review of operations\u002Fclinical records from each case activation and transplantation. Attrition outcomes include rates of initial and continued lung preservation, donation authorization, lung recovery, passing ex-vivo lung perfusion (EVLP) performance testing, and lung transplantation. Planned viability assessments also include macroscopic determination, radiology (X-ray), and fiber optic bronchoscopy before initiating EVLP. We expect \\~50% of lungs assessed with EVLP will be transplanted to meet sustainability targets. Safety outcomes include the primary outcome, primary graft dysfunction (PGD) grade III at 72 hours, and secondarily survival one year after transplantation.",[27],"2025-02-25",{"date":373,"type":37},"2025-02-28",{"date":375,"type":37},"2025-01-24",{"date":377,"type":21},"2028-06-30",{"name":379,"class":81},"NYU Langone Health",{"id":381,"slug":382,"hasResults":11,"nctId":383,"briefTitle":384,"officialTitle":385,"acronym":4,"eligibilityCriteria":386,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":387,"targetDuration":4,"studyType":92,"phases":4,"briefSummary":389,"conditions":390,"keywords":393,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":399,"lastUpdatePostDateStruct":400,"startDateStruct":402,"completionDateStruct":404,"leadSponsor":406,"locationsCount":82},"100562477","microplastics-in-the-human-respiratory-system-100562477","NCT06603675","Microplastics in the Human Respiratory System","Detection and Analysis of Microplastic Subtypes in the Human Respiratory System.","Inclusion Criteria:\n\n* patients undergoing surgery for lung cancer, emphysema, interstitial lung diseases, or other respiratory conditions,\n* patients undergoing lung transplantation (lungs removed from transplant recipients),\n* age 18 years or older,\n* ability to provide informed consent.\n\nExclusion Criteria:\n\n* patients with a history of recent or ongoing chemotherapy, immunotherapy, or radiation therapy,\n* inability or unwillingness to provide informed consent,\n* previous lung surgeries,\n* insufficient tissue or blood samples available for analysis due to technical or procedural reasons.",{"count":388,"type":21},100,"Environmental pollution from plastics has become a significant global issue, with microplastics-tiny particles resulting from plastic degradation-being increasingly detected in various environments, including aquatic ecosystems, soil, and air. These particles can enter the human body through ingestion or inhalation. Despite growing concerns, little is known about the prevalence and types of microplastics in human lungs. Some studies suggest that microplastics may negatively impact respiratory function and lead to lung diseases. Hypothetically, they could cause inflammation, metabolic disorders, and contribute to lung cancer development. However, research is still in its early stages, and conclusive evidence about the mechanisms linking microplastics to negative health effects is lacking. This study aims to quantify and characterize microplastics in the lung parenchyma and lymph nodes of patients with lung cancer and other respiratory diseases. Tissue samples will be collected during surgeries, and microplastic particles will be detected using FTIR microspectroscopy. The research may contribute to a better understanding of the role of microplastics in the development of respiratory diseases.",[391,392,27],"Microplastics","Lung Cancer (NSCLC)",[394,395,396,397,398],"microplastics","lung","respiratory system","lung cancer","transplantation","2024-10-01",{"date":401,"type":37},"2024-10-03",{"date":403,"type":21},"2024-09-30",{"date":405,"type":21},"2026-07-31",{"name":407,"class":81},"Wielkopolskie Centrum Pulmonologii i Torakochirurgii",{"id":409,"slug":410,"hasResults":11,"nctId":411,"briefTitle":412,"officialTitle":413,"acronym":414,"eligibilityCriteria":415,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":416,"targetDuration":4,"studyType":22,"phases":418,"briefSummary":419,"conditions":420,"keywords":424,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":434,"lastUpdatePostDateStruct":435,"startDateStruct":436,"completionDateStruct":438,"leadSponsor":440,"locationsCount":82},"100542336","quantiferon-cmv-to-identify-treatment-need-for-asymptomatic-cmv-infection-after-solid-organ-transplant-quantifot-100542336","NCT06341543","Quantiferon CMV to Identify Treatment Need for Asymptomatic CMV Infection After Solid Organ Transplant (QUANTIFOT)","Use of QuantiFERON® CMV in the Therapeutic Decision in Asymptomatic CMV Infection in Solid Organ Transplant Recipients","QUANTIFOT","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Solid organ transplant recipient (heart, kidney, liver and lung)\n* Detectable CMV viral load between 1,000 and 15,000 IU\u002FmL (including 2 borderline values):\n\n  * Asymptomatic (no fever or organ dysfunction) ;\n  * Occurrence within 2 years of transplantation in the absence of primary post-transplant anti-CMV prophylaxis;\n  * Or within 2 years of discontinuation of primary post-transplant anti-CMV prophylaxis if such prophylaxis was used.\n* Having signed an informed consent form.\n* Affiliated to a social security scheme.\n\nExclusion Criteria:\n\n* Presence of anti-Herpesviridae treatment when CMV replication is detected (\\[val\\]aciclovir, \\[val\\]ganciclovir, foscarnet, cidofovir, letermovir, maribavir, anti-CMV immunoglobulins, cidofovir, brincidofovir).\n* Pregnant or breast-feeding women.\n* Persons under guardianship or trusteeship.\n* Subjects under administrative or judicial supervision.\n* Subject unable to be contacted in case of emergency.",{"count":417,"type":21},288,[260],"Context\n\nCytomegalovirus (CMV) infection is a frequent and potentially severe event in solid organ transplant (SOT) recipients.\n\nMost of available treatment display adverse effects that limit their use. Therefore, in case of an infection, it is of primary importance to identify the patients at high risk of severe infection and\u002For disease, and who ill benefit the most from antiviral therapy.\n\nAs CMV infection is mainly controlled by cellular immunity, measuring specific anti-CMV T lymphocyte immunity could be an interesting tool for identifying these at-risk individuals. One of these tests is the QuantiFERON-CMV (QF-CMV) assay (QuiagenTM, Courtabœuf, France).\n\nAim of the study\n\nThe aim of the study is to determine the extent to which the QF-CMV can be use to identify, among SOT recipients with a CMV viremia, those that may not need antiviral therapy.\n\nMethods\n\nParticipation to the study will be proposed to SOT recipients with an asymptomatic CMV infection with a blood viral load between 1,000 and 15,000 IU\u002FmL.\n\nThe QF-CMV will be performed in included participants, and the result will be given or not to the clinician in charge (according to the attributed group through randomisation).\n\n* In the group without result communication, the clinician in charge will determine whether a treatment is needed according to the guidelines and the local practices.\n* in the group with result communication, the clinician in charge will be advised not to introduce antiviral therapy if the result is positive, and to determine whether a treatment is needed according to the guidelines and the local practices if the result is positive.\n\nIn the following weeks, the viral load will be monitored, along with creatininemia, cell blood count, and kalemia (to detect antiviral adverse effect).\n\nThe participants will be sampled:\n\n* 5 to 12 days after QF-CMV sampling (V2) ;\n* 7 to 14 days days after V2 (V3 - between D12 and D26) ;\n* 7 to 14 days days after V3 (V4 - between D19 and D40) .\n\nEndpoints\n\nThe primary endpoint is the rate of uncontrolled infection 5 to 12 days after QF-CMV sampling, defined as follows:\n\n* Blood CMV viral load \\>10,000 IU\u002FmL \\[4 log\\];\n* And\u002For increase in blood viral load ≥0.5 log IU\u002FmL with CV otherwise \\>5000 IU\u002FmL;\n* And\u002For the onset of CMV disease.\n\nThe secondary endpoint is the is the occurrence antiviral adverse effects (hematoxicity or nephrotoxicity).",[421,183,422,27,423],"Cytomegalovirus Infections","Kidney Transplantation","Liver Transplantation",[425,426,427,428,429,430,431,432,433],"solid organ transplantation","cytomegalovirus","CMV","quantiferon","IGRA","interferon gamma release assay","antiviral","adverse effect","viremia","2024-09-27",{"date":399,"type":37},{"date":437,"type":37},"2024-09-24",{"date":439,"type":21},"2026-10",{"name":441,"class":81},"University Hospital, Grenoble",{"id":443,"slug":444,"hasResults":11,"nctId":445,"briefTitle":446,"officialTitle":4,"acronym":4,"eligibilityCriteria":447,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":448,"targetDuration":4,"studyType":92,"phases":4,"briefSummary":450,"conditions":451,"keywords":4,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":453,"lastUpdatePostDateStruct":454,"startDateStruct":456,"completionDateStruct":458,"leadSponsor":460,"locationsCount":82},"100296671","sleep-disordered-breathing-after-solid-organ-transplantation-100296671","NCT03142022","Sleep-disordered Breathing After Solid Organ Transplantation","Inclusion Criteria:\n\n* Patients 1 year after lung transplantation\n\nExclusion Criteria:\n\n* Refusal of PSG\n* Medical contra-indication to perform PSG",{"count":449,"type":21},300,"Sleep-disordered breathing (SDB) describes a group of disorders in which partial or complete cessation of breathing occurs many times throughout the night, resulting in daytime sleepiness or fatigue that interferes with a person's ability to function and reduces quality of life. Transplantation has become an important treatment modality for end-stage organ failure. Transplant recipients are now living longer and, hence, develop chronic adverse medical conditions. Furthermore, transplantation is associated with weight gain. Despite the high prevalence of poor sleep and cardiovascular conditions among transplant patients, SDB is not well studied in these patients.",[27,452],"Sleep-disordered Breathing","2024-07-02",{"date":455,"type":37},"2024-07-03",{"date":457,"type":4},"2014-11",{"date":459,"type":21},"2025-12",{"name":461,"class":81},"Universitaire Ziekenhuizen KU Leuven"]