[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"immunosuppression\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:immunosuppression":29},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,26,0,25,[9,46,81,117,142,163,189,219,247,271,293,322,346,373,396,426,449,483,529,554,576,602,628,653,677],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":4},"100645274","metabolic-and-functional-study-of--t-cells-in-critically-ill-patients-100645274",false,"NCT07680816","Metabolic and Functional Study of γδ T Cells in Critically Ill Patients","Subset-specific Metabolic Adaptation and Functional Remodeling of Gamma Delta T (γδ T) Cells in Critically Ill ICU Patients: A Single-center, Prospective, Observational Cohort Study.","Inclusion Criteria:\n\n1. Healthy Control Group (NHC):\n\n   * Age ≥ 18 years.\n   * No acute or chronic major diseases.\n   * Provide written informed consent.\n2. Non-septic Critical Illness Group (CI-NS):\n\n   * Age ≥ 18 years.\n   * Admitted to the ICU and meeting the definition of critical illness.\n   * Excluded from sepsis according to the Sepsis-3 criteria (infection + ΔSOFA ≥ 2 points).\n   * Written informed consent provided by the participant or legally authorized representative.\n3. Septic Critical Illness Group (CI-Sep):\n\n   * Age ≥ 18 years.\n   * Admitted to the ICU and meeting the Sepsis-3 criteria (infection + ΔSOFA ≥ 2 points).\n   * Written informed consent provided by the participant or legally authorized representative.\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years.\n* Known immunodeficiency, HIV infection, active hematologic malignancy, or history of hematopoietic stem cell or solid organ transplantation within the past 3 months.\n* Receipt of T-cell-targeted immunosuppressive therapy (e.g., antithymocyte globulin, calcineurin inhibitors, mycophenolate mofetil, methotrexate, or high-dose corticosteroids \\>1 mg\u002Fkg\u002Fday prednisone equivalent) before ICU admission or within 24 hours after ICU admission.\n* Use of immune checkpoint inhibitors (e.g., anti-PD-1\u002FPD-L1\u002FCTLA-4 antibodies) within the past 6 weeks.\n* Expected ICU stay \\\u003C 24 hours or imminent risk of death (moribund state).\n* Pregnancy or breastfeeding.\n* Active major bleeding.\n* Inability to obtain informed consent.",true,"ALL","18 Years","80 Years",{"count":22,"type":23},105,"ESTIMATED","OBSERVATIONAL","This prospective observational cohort study investigates the subset-specific metabolic adaptation and functional remodeling of cytotoxic γδT cells in critically ill patients with and without sepsis. Emerging evidence indicates that γδT cells, as a bridge between innate and adaptive immunity, play a critical role in early anti-infection defense during sepsis. However, the functional status and underlying regulatory mechanisms of cytotoxic γδT cells in septic patients remain incompletely understood. Our preliminary single-cell transcriptomic analysis revealed that cytotoxic γδT cells from septic patients exhibit significant alterations in cytotoxicity-associated molecules (GZMB, PRF1, GNLY) and mitochondrial oxidative phosphorylation (OXPHOS) pathway genes, particularly COX6C, which correlates with cytotoxic effector molecule expression. This study aims to systematically characterize the proportion, cytotoxicity, and mitochondrial metabolic function of circulating cytotoxic γδT cells across three cohorts: healthy controls, critically ill non-septic patients, and critically ill septic patients. By integrating flow cytometry, mitochondrial function assays, and functional validation experiments, we seek to elucidate the role of COX6C-mediated mitochondrial metabolic abnormalities in cytotoxic γδT cell dysfunction, providing theoretical basis for understanding immune dysregulation in sepsis and identifying novel therapeutic targets.",[27,28,29,30,31,32,33],"Sepsis","Critical Illness","Immunosuppression","MODS","Mitochondrial Diseases","Dysbiosis","γδ T Cells","NOT_YET_RECRUITING","2026-07-01",{"date":37,"type":38},"2026-07-02","ACTUAL",{"date":40,"type":23},"2026-07-15",{"date":42,"type":23},"2027-07-15",{"name":44,"class":45},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology","OTHER",{"id":47,"slug":48,"hasResults":12,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":17,"sex":18,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":57,"conditions":58,"keywords":62,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":4,"leadSponsor":77,"locationsCount":80},"100176270","oral-bacteria-and-immune-system-problems-involved-in-gum-disease-periodontitis-100176270","NCT01568697","Oral Bacteria and Immune System Problems Involved in Gum Disease (Periodontitis)","Oral Microbial and Immunological Characterization of Patients With Immune Dysfunction","* INCLUSION CRITERIA:\n\nSubjects with Genetic Immune Defects:\n\nPatients with a known genetic immune defect will be eligible for screening inclusion under this protocol.\n\n* Diagnosed with a genetic immune defect\n* Willing to allow genetic testing\n\n  * 7 years old\n\nSubjects with Severe Periodontitis of Suspected Genetic Etiology:\n\n* History of severe periodontitis prior to age \\\u003C30\n* Willing to allow genetic testing\n\n  -\\>=7 years old\n* In good general health\n\nFamily members of Subjects with Severe Periodontitis of Suspected Genetic Etiology:\n\n-Willing to allow genetic testing\n\n-\\>=7 years old\n\nHealthy Volunteer Subjects (with\u002Fwithout periodontitis):\n\n* In good general health\n\n  -\\>=18 years old\n* Willing to allow genetic testing\n* Have a minimum of 20 natural teeth\n\nInclusion Criteria for Natural History phase, all subjects:\n\n* Diagnosis of genetic immune defect\n* Presence of oral manifestation (primarily periodontitis)\n\nCriteria for standard of care treatment:\n\n* Active untreated disease (visible signs of tissue inflammation including erythema\u002Fedema, generalized bleeding upon probing)\n* Periodontal disease defined as bone loss of \\>=5mm as measured on periodontal exam.\n\nEXCLUSION CRITERIA:\n\nAll Subjects:\n\n* History of Hepatitis B or C\n* History of HIV\n* Prior radiation therapy to the head or neck\n* Have an active malignancy except localized basal or squamous cell carcinoma of the skin\n* Have been treated with systemic chemotherapeutics or radiation therapy within 5 years of screening\n* Pregnant or lactating\n* If participation in the protocol would not be safe or in the subject s best interest in the opinion of either the PI or the primary medical team.\n\nAdditional Exclusions for Healthy Volunteers:\n\n* Diagnosis of diabetes and\u002For HbA1C level \\>6%\n* More than 3 hospitalizations in the last 3years\n* Have an autoimmune disorder such as Lupus, Rheumatoid arthritis, etc.\n* In the 3 months before study enrollment, have used any of the following:\n\n  * Systemic (intravenous, intramuscular, or oral) antibiotics\n  * Oral, intravenous, intramuscular, intranasal, or inhaled corticosteroids or other immunosuppressants (e.g., cyclosporine)\n  * Cytokine therapy\n  * Methotrexate or immunosuppressive chemotherapeutic agents\n  * Large doses of commercial probiotics (\\>=10\\^8 colony-forming units or organisms per day); includes tablets, capsules, lozenges, chewing gum, or powders in which a probiotic is a primary component; ordinary dietary components such as fermented beverages\u002Fmilks, yogurts, and foods do not apply\n* Have used tobacco products (including e-cigarettes) within 1 year of screening\n* Unwillingness to consent to oral biopsy\n* NIH employees working in the Oral Immunity and Inflammation Unit and members of the Clinical Research Core Team will not be eligible for enrollment.\n\nAdditional Exclusions for Standard of Care Treatment at NIH:\n\n* Mild\u002Fmoderate non-active disease (absence of active inflammatory lesions)\n* Subjects with urgent\u002Fcomplex restorative needs (ex. severe active carious lesions\u002Ffractured dentition)\n* Subjects in need for advanced prosthetic needs (including implants and restorations)","7 Years","100 Years",{"count":56,"type":23},700,"Background:\n\n\\- Gum disease is a condition in which the tissue around the tooth root becomes swollen and infected. This condition can cause tooth loss if it is not treated. Who gets gum disease and how bad it will be depends on (1) the different bacteria in the mouth and (2) how the immune system of an individual handles these bacteria. Researchers want to look at the oral bacteria and genetic immune problems of different people to learn how these affect gum disease and other conditions of the mouth.\n\nObjectives:\n\n\\- To study how immune system problems may lead to problems in the mouth, including gum disease.\n\nEligibility:\n\n* Children and adults at least 7 years of age who have genetic problems with their immune system.\n* Healthy adults that have periodontal disease\n* Health adults that do not have periodontal disease\n\nDesign:\n\n* This study will involve a screening visit and a study visit.\n* Participants will be screened with a medical history, blood work and a full oral and dental exam, including dental x-rays and photos.\n* The study visit will involve collection of blood, urine, and other samples, including saliva, plaque, and gum swabs. Any abnormal tissue will sampled for a biopsy. Additional oral and dental exams will be performed. Participants will also answer questions about any current medical or dental problems.",[29,59,60,61],"Periodontal Disease","Healthy Subjects","Healthy Volunteer",[63,64,65,66,67,68,59,69,61,70],"Microbiome","Periodontitis","Oral Mucosal Immunity","Oral Infection","Natural History","Immune Disorder","Gum Disease","HV","RECRUITING","2026-06-27",{"date":74,"type":38},"2026-06-30",{"date":76,"type":38},"2012-10-05",{"name":78,"class":79},"National Institute of Dental and Craniofacial Research (NIDCR)","NIH",1,{"id":82,"slug":83,"hasResults":12,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":4,"eligibilityCriteria":87,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":88,"targetDuration":4,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":97,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":4},"100639367","phase-2-nai-for-sepsis-with-persistent-lymphopenia-100639367","NCT07578558","NAI for Sepsis With Persistent Lymphopenia","Phase 2, Randomized, Open-Label Clinical Trial Evaluating Nogapendekin Alfa Inbakicept in Combination With Standard of Care Versus Standard of Care Alone in Critically Ill Adults With Sepsis and Persistent Lymphopenia","Inclusion Criteria:\n\n1. Age 18 years or older at the time of informed consent\n2. Admitted to the ICU with a diagnosis of sepsis as defined by Sepsis-3 criteria: life-threatening organ dysfunction caused by a dysregulated host response to infection, operationalized as a Sequential Organ Failure Assessment (SOFA) score increase of 2 or more points\n3. Documented persistent lymphopenia defined as ALC \\\u003C1,000 cells\u002FµL on at least two consecutive measurements within 72 hours of sepsis diagnosis (measurements must be separated by at least 12 hours)\n4. Prior initiation of appropriate antimicrobial therapy per institutional guidelines\n5. Ability to obtain written informed consent from the participant or legally authorized representative\n6. Agreement to practice effective contraception for female participants of child-bearing potential and non-sterile males (for up to 7 months after completion of therapy)\n\nExclusion Criteria:\n\n1. Hematologic malignancies including leukemia, lymphoma, and myelodysplastic syndromes\n2. Prior CAR-T cell therapy or hematopoietic stem cell transplant (HSCT) within 3 months of screening\n3. Active cytokine release syndrome (CRS) at screening\n4. Current or recent (within 7 days) use of colony stimulating factors (G-CSF, GM-CSF)\n5. Lymphopenia attributable to chemotherapy, radiation therapy, or immunosuppressive medications administered within 30 days prior to screening\n6. High-dose immunosuppressive therapy (\\>0.5 mg\u002Fkg prednisone equivalent daily), excluding physiologic replacement and stress-dose hydrocortisone for septic shock\n7. Life expectancy less than 24 hours as assessed by the treating physician\n8. Active uncontrolled bleeding requiring \\>2 units of packed red blood cells in the preceding 24 hours\n9. Known HIV infection with CD4 count \\\u003C350 cells\u002FµL and detectable viral load\n10. Known active viral hepatitis (hepatitis B or C with detectable viral load)\n11. Advanced dementia or other conditions precluding meaningful participation\n12. Known hypersensitivity to any component of the investigational products\n13. Participation in another interventional trial with an investigational immunomodulatory agent within 30 days prior to screening\n14. Pregnant or breastfeeding",{"count":89,"type":23},50,"INTERVENTIONAL",[92],"PHASE2","This is a Phase 2, randomized, open-label study evaluating the safety and efficacy of nogapendekin alfa inbakicept (NAI, ANKTIVA®) in combination with standard of care versus standard of care alone in critically ill adults with sepsis and persistent lymphopenia. The study aims to determine whether NAI can improve 28-day mortality by addressing the immunosuppressive phase of sepsis characterized by persistent lymphopenia (absolute lymphocyte count \\\u003C1,000 cells\u002FµL). Participants will be randomized 1:1 to receive either NAI 1.2 mg subcutaneous injection on Days 3 (or earlier if ALC \\\u003C700 cells\u002FµL), Day 14, and potentially Day 21 if ALC remains \\\u003C1,000 cells\u002FµL, plus standard of care, or standard of care alone. The study will enroll approximately 50 participants (25 per arm) with persistent lymphopenia.",[27,95,96,29,28],"Septic Shock","Lymphopenia",[27,98,99,29,100,101,102,103,104,105,106],"Septic shock","Persistent lymphopenia","IL-15 receptor agonist","Nogapendekin alfa inbakicept","N-803","ANKTIVA","Immune reconstitution","Critical care","ICU","2026-05-05",{"date":109,"type":38},"2026-05-11",{"date":111,"type":23},"2026-07-06",{"date":113,"type":23},"2027-10-04",{"name":115,"class":116},"ImmunityBio, Inc.","INDUSTRY",{"id":118,"slug":119,"hasResults":12,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":123,"eligibilityCriteria":124,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":125,"targetDuration":4,"studyType":90,"phases":127,"briefSummary":129,"conditions":130,"keywords":4,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":80},"100536280","safety-and-immunogenicity-of-recombinant-zoster-vaccine-for-transplant-recipients-100536280","NCT06262776","Safety and Immunogenicity of Recombinant Zoster Vaccine for Transplant Recipients","Safety and Immunogenicity of Recombinant Zoster Vaccine for Transplant Recipients (SIR ZOSTER)","SIR ZOSTER","1. Population - Group 1. Healthy co-habitants (n = 30)\n\n   Inclusion criteria:\n   * Household co-habitant of transplant recipient in trial\n   * Aged \\>50 years\n   * Previous documented infection with VZV (known infection history or positive VZV IgG result)\n\n   Exclusion criteria:\n   * Aged \\\u003C50 years\n   * Unable or unwilling to provide informed consent to participate in the trial\n   * Known allergy to or intolerance of the contents of the RZV vaccine\n   * No previous infection with VZV (chickenpox)\n   * History of primary immunodeficiency, documented vaccine hypo-responsiveness, or active immunosuppressive therapy\n2. Population - Groups 2-4. Transplant recipients (n = 90)\n\n   Inclusion criteria:\n   * Organ transplant recipients\n\n     \\-- Specific immunosuppression regimen\n     * Tacrolimus, mycophenolate, prednisolone (n = 30, Group 2)\n     * Tacrolimus, mTORi, prednisolone (n = 30, Group 3)\n     * mTORi, mycophenolate, prednisolone (n = 30, Group 4)\n   * Aged \\>18 years\n   * estimated GFR \\> 15 mL\u002Fmin\u002F1.73m2\n   * Previous documented infection with VZV (known infection history or positive VZV IgG result)\n\n   Exclusion criteria:\n   * Aged \\\u003C18 years\n   * Unable or unwilling to provide informed consent to participate in the trial\n   * No previous infection with VZV (chickenpox)\n   * Known allergy to or intolerance of the contents of the RZV vaccine\n   * Current pregnancy\n3. Population - Group 5. Other (n = 10)\n\n   Inclusion criteria:\n   * Immunosuppressed patient receiving single-agent rapamycin immunosuppression\n   * Aged \\>18 years\n   * Previous documented infection with VZV (known infection history or positive VZV IgG result)\n\n   Exclusion criteria:\n   * Aged \\\u003C18 years\n   * Unable or unwilling to provide informed consent to participate in the trial\n   * Known allergy to or intolerance of the contents of the RZV vaccine\n   * No previous infection with VZV (chickenpox)\n   * Known allergy to or intolerance of the contents of the RZV vaccine\n   * Current pregnancy\n   * History of primary immunodeficiency, documented vaccine hypo-responsiveness, or active immunosuppressive therapy\n4. Population - Group 6. Dialysis group (n = 30)\n\nInclusion criteria:\n\n* Kidney failure receiving haemodialysis as kidney replacement therapy\n* Aged \\>18 years\n* Previous documented infection with VZV (known infection history or positive VZV IgG result)\n\nExclusion criteria:\n\n* Aged \\\u003C18 years\n* Unable or unwilling to provide informed consent to participate in the trial\n* Known allergy to or intolerance of the contents of the RZV vaccine\n* No previous infection with VZV (chickenpox)\n* Known allergy to or intolerance of the contents of the RZV vaccine\n* Current pregnancy\n* History of primary immunodeficiency or active immunosuppressive therapy",{"count":126,"type":23},160,[128],"NA","The goal of this clinical trial is to compare responses to Varicella Zoster vaccination between transplant patients on different medication regimens, and their healthy co-habitants. The main questions it aims to answer are:\n\n1. Are there differences in vaccination immunological responses in transplant patients on different immunosuppression regimens?\n2. Are there differences in vaccination immunological responses between transplant patients and their healthy co-habitants? Participants will all receive a 2-dose course of SHINGRIX recombinant Zoster vaccination, and have immunological responses measured and compared at 5 timepoints between 1 week to 1 year post-vaccination.",[29,131],"Vaccine Response Impaired","2026-04-06",{"date":134,"type":38},"2026-04-09",{"date":136,"type":38},"2024-03-20",{"date":138,"type":23},"2027-12",{"name":140,"class":141},"Central Adelaide Local Health Network Incorporated","OTHER_GOV",{"id":143,"slug":144,"hasResults":12,"nctId":145,"briefTitle":146,"officialTitle":146,"acronym":4,"eligibilityCriteria":147,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":148,"enrollmentInfo":149,"targetDuration":4,"studyType":90,"phases":150,"briefSummary":151,"conditions":152,"keywords":153,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":80},"100232990","phase-2-immunomodulation-to-optimize-vascularized-composite-allograft-integration-for-limb-loss-therapy-100232990","NCT02310867","Immunomodulation to Optimize Vascularized Composite Allograft Integration for Limb Loss Therapy","Inclusion Criteria:\n\n1. Patients from 18-65 years old with loss of limb\n2. Willingness and legal ability to give informed consent\n3. Willingness to travel to study site for protocol specific samples to be taken, or in some cases, the ability to send samples via overnight mail\n\nExclusion Criteria:\n\n* Any condition that precludes serial follow-up\n* Any condition that would likely increase the risk of protocol participation or confound the interpretation of the data\n* Any active malignancy or any history of a malignancy or lymphoma\n* Inability or unwillingness to comply with protocol monitoring and therapy and immunodeficiency syndrome(s)","65 Years",{"count":89,"type":23},[92],"The purpose of this study is to determine the safety and efficacy of hand transplantation as a treatment for patients with loss of limb below the elbow, The study will focus on patients who have had loss of limb. The primary endpoint is the ability to use the tranplanted limb in activities of daily living at 18 months following transplantation measured by a quantitative functional test.\n\nStudy activities include several study visits over 18 months and include; demographics, medical history, vital signs, psychosocial evaluation, urine, blood test, chest x-ray, bone density scans, and biopsies. Subjects who are 18-65 and willing to travel to site and have loss of limb will be included in study evaluation.\n\nRisks of the study include risk of rejection and infection after being transplanted. Additional risk are associated with procedures that include blood draws, biopsies, x-rays, and potential loss of confidentiality. All patient data will be kept electronically and in accordance with the requirements of Duke University. In addition to the experimental data, this database includes recipient and donor demographics and transplant relevant medical history, range of motion, sensation, and immunosuppressive medications. Data will be recorded and reported in accordance with the standards required by the United Network for Organ Sharing (UNOS).",[29],[154],"hand transplantation, amputation","2026-04-04",{"date":134,"type":38},{"date":158,"type":38},"2015-03",{"date":160,"type":23},"2028-06",{"name":162,"class":45},"Linda Cendales",{"id":164,"slug":165,"hasResults":12,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":4,"eligibilityCriteria":169,"healthyVolunteers":12,"sex":18,"minAge":170,"maxAge":19,"enrollmentInfo":171,"targetDuration":4,"studyType":90,"phases":173,"briefSummary":175,"conditions":176,"keywords":4,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":80},"100442629","phase-4-combined-immunosuppression-for-pediatric-crohns-disease-100442629","NCT05043870","Combined Immunosuppression for Pediatric Crohn's Disease","Combination Therapy of Infliximab and Immunosuppressives for Pediatric Crohn's Disease","Inclusion Criteria:\n\n1. 6-18 years old\n2. diagnosis of Crohn's Disease\n3. Pediatric Crohn's disease Activity Index (PCDAI)\\>30 or The Simple Endoscopic Score for Crohn Disease (SES-CD) \\>10 before treatment\n4. receiving exclusive enteral nutrition or corticosteroids as first-line treatment, Pediatric Crohn's disease Activity Index (PCDAI)\\>10 or The Simple Endoscopic Score for Crohn Disease (SES-CD)≥3 after exclusive enteral nutrition or corticosteroids\n5. The patient or legal guardian sign the informed consent documents\n\nExclusion Criteria:\n\n1. history of biological agents targeting at tumor necrosis factor (TNF)\n2. Crohn's Disease-related surgery\n3. infections\n4. tumors","6 Years",{"count":172,"type":23},128,[174],"PHASE4","This is a randomized controlled trial to compare the efficacy and safety of infliximab and immunosuppressives therapy alone or in combination for pediatric Crohn's disease.",[177,178,29,179],"Crohn Disease","Infliximab","Children, Only","2026-03-17",{"date":182,"type":38},"2026-03-19",{"date":184,"type":38},"2022-10-10",{"date":186,"type":23},"2026-12-31",{"name":188,"class":45},"Children's Hospital of Fudan University",{"id":190,"slug":191,"hasResults":12,"nctId":192,"briefTitle":193,"officialTitle":194,"acronym":195,"eligibilityCriteria":196,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":197,"targetDuration":4,"studyType":90,"phases":199,"briefSummary":200,"conditions":201,"keywords":203,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":211,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":218},"100543308","phase-4-evaluation-of-the-benefits-of-administering-immunosuppressive-drugs-as-single-daily-doses-over-the-first-year-after-liver-transplantation-easy-100543308","NCT06354179","Evaluation of the Benefits of Administering Immunosuppressive Drugs as Single Daily Doses Over the First Year After Liver Transplantation (EASY)","Evaluation of the Benefits of Administering Immunosuppressive Drugs as Single Daily Doses Over the First Year After Liver Transplantation","EASY","Inclusion Criteria:\n\n* Recipients of a first liver allograft from a deceased donor\n* Transplanted for less than four weeks at enrolment.\n* Without inter-current progressive life-threatening or graft-threatening disease.\n* Having signed a written informed consent for their participation in the study.\n* Affiliated to, or beneficiary of, a social security regimen\n\nExclusion Criteria:\n\n* Recipients of a split-liver transplantation.\n* Recipients of any transplanted organ other than the liver\n* Patient who has undergone colon resection\n* Patients under legal protection (guardianship, curatorship).\n* Patient presenting any contra-indication to tacrolimus or to MMF according to the summary of product characteristics (SmPC) of ENVARSUS®, ADVAGRAF® and CELLCEPT®.\n* Patients in whom everolimus-based calcineurin inhibitors (CNI) minimization is anticipated\n* Patients treated with HIV or HCV protease inhibitors.\n* Pregnant or lactating women.\n* Women of childbearing potential without any effective contraceptive method (according to the guidelines of CTFG, Clinical Trial Facilitation Group, related to contraception and pregnancy test in clinical trials) or not practicing sexual abstinence.\n* Sexually active men having a female partner, without any effective contraception.\n* Patients incapable of understanding the purposes and risks of the study, who cannot give written informed consent, or who are unwilling to comply with the study protocol.\n* Patients enrolled in another clinical study evaluating drugs or therapeutic strategies potentially interfering with the objectives of the EASY study.",{"count":198,"type":23},162,[174],"World Health Organization considers non-adherence has a strong negative impact on the health of patients with chronic diseases. In transplantation, adherence to immunosuppressive drug regimens associates with late rejection and graft loss making it a critical determinant of patient outcome. The prevalence of non-adherence in transplant patients, including liver transplant patients, can be as high as 40%. Among others, life-long intake and complexity of immunosuppressive regimen make patients prone to non-adherence. For instance, non-adherence is more prevalent among patients with higher numbers of immunosuppressive drugs. One of the most commonly cited causes of non-adherence is forgetfulness and disruptions in routine, with the evening dose of twice daily regimens being the most likely to be affected6. Besides non-adherence, the constraints generated in everyday life by immunosuppression (including timely and regular drug intake) and the complexity of the immunosuppressive regimens represent a burden for the patients and are probably associated with a health-related quality of life deterioration. Therefore, long-term adherence and quality of life after liver transplantation might be improved by using a well-tolerated and easy-to-handle immunosuppressive regimen.\n\nThe immunosuppressive regimen after liver transplantation is in most cases based on different combinations of tacrolimus, mycophenolate mofetil and corticosteroids. While corticosteroids are administered once daily, tacrolimus can be administered either twice-daily (BID) as an immediate-release, or once-daily (QD) as an extended-release formulation. Among once-daily tacrolimus formulations, LCP-tacrolimus (ENVARSUS XR®) is approved for the prevention of transplant rejection in adult liver allograft recipients. It has demonstrated similar outcomes compared to immediate-release tacrolimus BID, in both kidney and liver transplantation. Mycophenolate has only been approved for BID administration, preventing from taking all immunosuppressive drugs once daily. Yet, single daily dosing would probably contribute to better adherence and quality of life in patients receiving a life-long treatment.\n\nAlthough the half-life of mycophenolic acid (MPA), the active moiety of mycophenolate mofetil (MMF) is compatible with once-daily administration, no published randomized clinical study has ever evaluated the efficacy and safety of MMF administered QD.\n\nThe narrow therapeutic index and wide pharmacokinetic variability of tacrolimus and mycophenolate justify individual dose adjustment by means of therapeutic drug monitoring (TDM), in order to minimize the risk of acute rejection and the occurrence of adverse events. For tacrolimus, TDM is generally based on the trough concentration (C0) and sometimes on the area under the concentration-time curve (AUC), while for mycophenolate it should be based on the AUC of MPA. However, the dose adjustment of MMF in liver transplant patients is most of the time performed a posteriori, based on clinical signs of inefficacy of toxicity.\n\nLimited sampling strategies with maximum a posteriori Bayesian estimation have been developed by our team for both molecules in adult liver transplant patients to estimate their AUC, which is considered the best marker of exposure for both. Therefore, tacrolimus AUC0-24h can be estimated by Bayesian estimation using samples collected before administration (C0), 8 (C8h) and 12 (C12h) hours after the administration of ENVARSUS XR®, or 1 and 3 hours after the administration of PROGRAF® and ADVAGRAF®. For mycophenolate, the MPA AUC can be estimated using samples collected 20 min, 1 and 3 hours after MMF administration, by Bayesian estimation.\n\nEven if limited to 2 or 3 blood samples, tacrolimus TDM for ENVARSUS® requires late sampling (12h post-dose). To overcome the necessity of a longer hospital stay, microsampling devices (MSD) such as the Volumetric absorptive microsampling (VAMS®) device (Mitra®) can be used by the patients to take samples themselves, at home. Moreover, they are less invasive than venipuncture and collect low but accurate volumes of blood for analysis.\n\nIn this context, we propose a randomized controlled non-inferiority study to demonstrate that in liver transplant recipients, an immunosuppressive strategy based on single daily doses of LCP-tacrolimus (ENVARSUS XR®) and mycophenolate mofetil (CELLCEPT®) started at M6 post-transplantation is not inferior to XR-tacrolimus (ADVAGRAF®) and MMF administered BID, in terms of incidence of treatment failure (see below) at the end of the first year after transplantation, and to obtain adherence, quality of life and safety data. In order to compare solely MMF QD to MMF BID, patients on ENVARSUS XR® and MMF QD will be compared to a third group of patients receiving ENVARSUS XR® and MMF BID. A direct comparison of efficacy and safety, quality of life, adherence and exposure indices will be performed between ENVARSUS XR® and ADVAGRAF®.",[202,29],"Liver Transplantation",[204,205,206,207,208,209],"liver transplantation","immunosuppression","tacrolimus","mycophenolate","adherence","once-daily intake","2026-03-16",{"date":182,"type":38},{"date":213,"type":38},"2025-04-15",{"date":215,"type":23},"2028-04-15",{"name":217,"class":45},"University Hospital, Limoges",18,{"id":220,"slug":221,"hasResults":12,"nctId":222,"briefTitle":223,"officialTitle":224,"acronym":225,"eligibilityCriteria":226,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":227,"enrollmentInfo":228,"targetDuration":4,"studyType":90,"phases":230,"briefSummary":231,"conditions":232,"keywords":236,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":239,"startDateStruct":241,"completionDateStruct":242,"leadSponsor":244,"locationsCount":246},"100608632","phase-2-tnx-1500-in-kidney-transplant-recipients-100608632","NCT07204080","(TNX-1500) in Kidney Transplant Recipients","Phase II Clinical Trial Evaluating the Safety and Efficacy of Fc-Modified Anti-CD154 mAB (TNX-1500) in Kidney Transplant Recipients","TONIX-1500","Inclusion Criteria:\n\n1. Male or female subjects ≥18 to 75 years of age.\n2. Kidney transplant candidates with chronic kidney disease (stage IV or V) or end-stage kidney disease evaluated and listed for transplantation at Massachusetts General Hospital.\n3. Recipient of an ABO-compatible, non-human leukocyte antigen (HLA) identical living or deceased donor kidney (de novo or second transplant)\n4. Ability to understand the study requirements and provide written informed consent.\n5. Epstein-Barr virus (EBV) seropositive\n\nExclusion Criteria:\n\n1. Recipient seropositive for human immunodeficiency virus (HIV-1), or hepatitis B surface antigen (HBsAg) or core antibody (Anti-HBc); subjects who are seropositive for hepatitis C virus (HCV) are excluded without proof of sustained viral response (SVR) after anti-HCV treatment or spontaneous clearance.\n2. Recipient of a kidney from a donor who tests positive for HIV, HBsAg, Anti-HBc, or HCV NAT.\n3. Subjects with a severe systemic infection, current or within the 2 weeks prior to screening.\n4. Left ventricular ejection fraction \\\u003C 40% as determined by TTE or clinical evidence of heart failure.\n5. Pregnant or nursing (lactating) women confirmed by human chorionic gonadotropin (hCG) laboratory test.\n6. Women of childbearing potential (women capable of becoming pregnant) unless using a highly effective method of contraception during dosing and for 24 weeks after study treatment. Highly effective contraception methods include:\n\n   1. Female sterilization (surgical, bilateral oophorectomy with or without hysterectomy), or tubal ligation at least 6 weeks before taking study treatment.\n   2. Male sterilization (at least 6 months prior to screening); for female subjects on the study, the vasectomized male partners should be the sole partners for that subject.\n   3. Use of injected or implanted hormonal methods of contraception or other hormonal contraception that have comparable efficacy (\\\u003C1% for example, hormone vaginal ring or placement of a long-acting reversible contraceptives, an intrauterine device, or intrauterine system.\n   4. Total abstinence\n7. Use of other investigational products or enrollment in another investigational drug study within 30 days prior to screening or 5 half-lives, whichever is longer.\n8. Subjects with clinically significant lab abnormalities (\\>2.5 x the upper limit of normal (ULN) of the following liver function chemistries unless due to, as judged by the investigator, a benign underlying condition:\n\n   1. Alanine aminotransferase (ALT)\n   2. Aspartate aminotransferase (AST)\n   3. Alkaline phosphatase (ALP)\n   4. Bilirubin\n   5. Coagulation studies (international normalization ratio (INR), prothrombin time (PT), and partial thromboplastin time (PTT))\n9. Any other clinically significant medical condition, active infection, laboratory abnormality, or psychosocial condition (e.g. history of substance use disorder) that would, in the judgement of the investigator, impact the subject's ability to participate in the trial.\n10. Subject receives an organ at high risk for delayed graft function, including from a deceased donor after cardiac death (DCD) or a high Kidney Donor Profile Index ≥85%.\n11. Presence of pre-existing donor-specific antibodies (DSA) or calculated panel reactive antibodies (cPRA) \\>20% based upon results within 6 months prior to transplant.\n12. Virtual crossmatch (VXM) positive transplant with an MFI \\>1000 as assessed by routine methodology (Luminex)\n13. Cytomegalovirus (CMV) high risk combination: donor positive to recipient negative\n14. Multi-organ transplant or tissue recipient.\n15. History of malignancy of any organ system, except for localized excised non-melanomatous skin or carcinoma in situ of the cervix\n16. Subjects with any of the following: hemoglobin \\\u003C8 mg\u002FdL, white blood cell ≤2,000\u002Fmm3, or platelet count ≤75,000\u002Fmm3.","75 Years",{"count":229,"type":23},5,[92],"The primary objective is to investigate the safety and efficacy of TNX-1500, an FC-modified anti-CD154 mAb, in five kidney transplant recipients at 12 months.",[233,234,29,235],"Kidney Transplant","Kidney Transplant Failure and Rejection","Immunosuppression After Kidney Transplantation",[233,237],"New Immunosuppression","2026-02-24",{"date":240,"type":38},"2026-02-25",{"date":35,"type":23},{"date":243,"type":23},"2029-06-30",{"name":245,"class":45},"Ayman Al Jurdi, MD",2,{"id":248,"slug":249,"hasResults":12,"nctId":250,"briefTitle":251,"officialTitle":252,"acronym":4,"eligibilityCriteria":253,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":254,"targetDuration":4,"studyType":90,"phases":255,"briefSummary":256,"conditions":257,"keywords":258,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":262,"lastUpdatePostDateStruct":263,"startDateStruct":265,"completionDateStruct":267,"leadSponsor":269,"locationsCount":80},"100608801","fibroscan-to-guide-post-transplant-immunosuppression-minimization-100608801","NCT07206277","Fibroscan to Guide Post Transplant Immunosuppression Minimization","Use of Transient Elastography to Guide Immunosuppression Minimization Post Liver Transplantation","Inclusion Criteria:\n\n* 2 years or more post-liver transplant\n* 18 years or older\n\nExclusion Criteria:\n\n* diagnosis of either acute or chronic rejection in the past 12 months\n* abnormal liver enzymes (ALT \\> 50; bilirubin \\> 19 umol\u002FL)\n* transplant for autoimmune liver disease (autoimmune hepatitis, primary sclerosing cholangitis, and primary biliary cholangitis)\n* presence of HCV RNA\n* presence of HBV DNA\n* presence of class II donor specific antibodies (DSA; pre-existing or de novo)\n* beyond 6 years of transplantation\n* presence of ascites, decompensated heart failure, biliary obstruction, CKD (bl eGFR 30 ml\u002Fmin\u002F1.73m2 or less), re-transplantation, or multi-visceral transplant.",{"count":89,"type":23},[128],"Following Liver transplantation, recipients remain on life long immunosuppression. Prolonged exposure to immunosuppression is associated with side effects and complications including kidney dysfunction, diabetes, heart disease and cancer risk.\n\nTherefore studies are looking at safe ways to reduce or stop immunosuppression. An individual without autoimmune liver disease (these patients are at higher risk of rejection), without history of rejection, with normal blood tests (liver biochemistry, liver function, etc.) can be eligible for minimization of immunosuppression. A recent study showed use of fibroscan (an Ultrasound, which provides information on liver stiffness (diseased liver is hard while a normal liver is soft) and fat content) provides more objective information to help investigators select individuals who will tolerate immunosuppression minimization.\n\nOur goal is to see if use of fibroscan allows the investigators to safely minimize immunosuppression in eligible individuals. The secondary aims are to assess benefit on kidney function, heart disease and risk factors for heart disease.",[29],[259,260,261],"Liver transplantation","minimization","rejection","2026-01-06",{"date":264,"type":38},"2026-01-08",{"date":266,"type":38},"2025-12-01",{"date":268,"type":23},"2028-12-31",{"name":270,"class":45},"University of Alberta",{"id":272,"slug":273,"hasResults":12,"nctId":274,"briefTitle":275,"officialTitle":276,"acronym":4,"eligibilityCriteria":277,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":54,"enrollmentInfo":278,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":280,"conditions":281,"keywords":4,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":284,"lastUpdatePostDateStruct":285,"startDateStruct":287,"completionDateStruct":289,"leadSponsor":291,"locationsCount":80},"100486596","pathological-myeloid-activation-after-sepsis-and-trauma-100486596","NCT05616130","Pathological Myeloid Activation After Sepsis and Trauma","Pathological Myeloid Activation After Sepsis and Trauma Subtitle: Dysfunctional Myelopoiesis and Myeloid-Derived Suppressor Cells in Sepsis Pathobiology","Trauma population\n\nInclusion Criteria:\n\n1. All adults age ≥ 18 years\n2. Blunt and\u002For penetrating trauma resulting in long bone or pelvic fractures requiring open reduction internal fixation or closed reduction percutaneous pinning\n3. Blunt and\u002For penetrating trauma patient with a. Injury Severity Score (ISS) greater than or equal to 25 b. ISS \\> 15 and one of the following: i. \\> 4 units of packed red blood cell or \\>3 units of whole blood or \\>1500 ml of autogenous blood product in the first 24 hours of admission ii. AIS (acute injury score) \\> 2 spine iii. Shock on arrival (SBP \\\u003C 90)\n\nOR\n\nc. ISS \\> 15 and two of the following: i. Age \\> 55 ii. AIS \\> 2 chest iii. +ethyl alcohol on arrival iv. Any red blood cell transfusion in first 24 hours\n\nExclusion Criteria:\n\n1. Patients not expected to survive greater than 48 hours.\n2. Prisoners.\n3. Pregnancy.\n4. Patients receiving chronic corticosteroids or immunosuppression therapies.\n5. Previous bone marrow transplantation.\n6. Patients with End Stage Renal Disease.\n7. Patients with any pre-existing hematological disease.\n8. Patients deemed to be futile care or have advanced directives limiting resuscitative efforts.\n9. Patients with severe congestive heart failure (NY Heart Association Class IV).\n10. Known HIV infection with CD4+ (clusters of differentiation) count \\\u003C200 cells\u002Fmm3\n11. Chronic liver disease with MELD (Model for End-Stage Liver Disease) score ≥15\n\nElective Hip population\n\nInclusion Criteria:\n\n1. All adults (age ≥18)\n2. Patient undergoing elective hip repair for non-infectious reasons.\n3. Ability to obtain Informed Consent prior to operation.\n\nExclusion Criteria:\n\n1. Pregnancy.\n2. Prisoners.\n3. Patients receiving chronic corticosteroids or immunosuppression therapies.\n4. Pre-existing conditions such as pathological fractures, cancer, history of HIV, or history of connective tissue disease.\n5. Previous bone marrow transplantation.\n6. Patients with End Stage Renal Disease.\n7. Patients with any pre-existing hematological disease.\n8. Patients with known active\u002Fsymptomatic COVID-19 (Coronavirus disease).",{"count":279,"type":23},255,"The goal of this observational study is to better understand what happens to circulating blood after a patient experiences severe trauma injury. The main questions it aims to answer are: Is severe human trauma associated with specific patterns of development in the hematopoietic stem cells of these patients? and Does the initial severe trauma injury create immunosuppression and increase risk of in-hospital sepsis? Participants in study will give blood samples and a waste sample of bone marrow at time of operative repair of traumatic orthopedic injuries, supply medical information and participate in surveys and assessments during recovery from their injury(ies). Researchers will compare severe trauma injury patients to elective hip repair patients to see if immunosuppression and specific development patterns occur in the trauma patient versus the otherwise healthy hip surgery patient.",[282,27,29,283],"Trauma Injury","Chronic Critical Illness","2025-12-23",{"date":286,"type":38},"2025-12-26",{"date":288,"type":38},"2022-09-01",{"date":290,"type":23},"2028-09-30",{"name":292,"class":45},"University of Florida",{"id":294,"slug":295,"hasResults":12,"nctId":296,"briefTitle":297,"officialTitle":298,"acronym":299,"eligibilityCriteria":300,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":301,"targetDuration":4,"studyType":90,"phases":303,"briefSummary":304,"conditions":305,"keywords":308,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":314,"lastUpdatePostDateStruct":315,"startDateStruct":317,"completionDateStruct":319,"leadSponsor":320,"locationsCount":80},"100570021","phase-4-effectiveness-and-cost-effectiveness-of-a-pre-emptive-genotyping-strategy-in-patients-receiving-tacrolimus-100570021","NCT06701825","Effectiveness and Cost-effectiveness of a Pre-emptive Genotyping Strategy in Patients Receiving Tacrolimus","A Multicentre, Controlled, Randomised and Single-blind, Adaptive Phase IV Protocol to Evaluate Effectiveness and Cost-effectiveness of Pre-emptive Genotyping Strategy to Optimise Tacrolimus Dosage in a Pretransplant Chronic Kidney Disease Population Cohort","TRANSPGx","Inclusion Criteria:\n\n1. Participants must be willing and able to provide written informed consent prior the initiation of any study procedures.\n2. Subject or their legally authorized representative has voluntarily signed the informed consent document.\n3. Participant is on the waiting list for a kidney transplant.\n4. Subject is able and willing to take part and be followed-up for the majority of the study duration, and adhere to the procedures specified in this protocol.\n5. Subjects must be naïve to any genotyping test of the following genes: CYP3A5.\n\nExclusion Criteria:\n\n1. Known hypersensitivity\u002Fallergy reaction to tacrolimus or any of the excipients.\n2. History of renal, heart, and\u002For liver transplant.\n3. History or clinical evidence of any disease and\u002For existence of any surgical or medical condition, which might interfere in a relevant manner with the absorption, distribution, metabolism, or excretion of the study treatment, except for renal disease.\n4. Any condition or situation precluding or interfering the compliance with the protocol.\n5. Any condition at medical discretion for which renal transplantation and\u002For study treatment should not be received.",{"count":302,"type":23},114,[174],"This is a phase IV multicentre adaptive single-blinded randomized clinical trial to evaluate if preemptively genotyping populations at pretransplant chronic kidney disease susceptible of receiving tacrolimus therapy is effective, cost-effective, and feasible within the Spanish National Health System when compared to the current standard of care. This trial is nested within the iPHARMGx master protocol.",[306,307,29],"Kidney Disease, Chronic","Transplant Recipient (Kidney)",[309,310,311,312,313],"Tacrolimus","Kidney transplant","Cost-effectiveness","Pharmacogenetic","Phase IV Clinical Trial","2025-09-04",{"date":316,"type":38},"2025-09-11",{"date":318,"type":38},"2025-06-02",{"date":186,"type":23},{"name":321,"class":45},"Instituto de Investigación Hospital Universitario La Paz",{"id":323,"slug":324,"hasResults":12,"nctId":325,"briefTitle":326,"officialTitle":326,"acronym":4,"eligibilityCriteria":327,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":328,"targetDuration":4,"studyType":90,"phases":330,"briefSummary":331,"conditions":332,"keywords":334,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":336,"lastUpdatePostDateStruct":337,"startDateStruct":339,"completionDateStruct":341,"leadSponsor":343,"locationsCount":4},"100536965","phase-4-evaluation-of-pcv21-vaccination-among-ppsv23-experienced-immunocompromised-elderly-veterans-100536965","NCT06271681","Evaluation of PCV21 Vaccination Among PPSV23-experienced, Immunocompromised Elderly Veterans","Inclusion Criteria:\n\n* Subject meets the CDC definition of an immunocompromising condition\n\n  o chronic renal failure, congenital or acquired asplenia, generalized malignancy, HIV infection, Hodgkin disease, iatrogenic immunosuppression, leukemia, lymphoma, multiple myeloma, nephrotic syndrome, sickle cell disease or other hemoglobinopathies, and solid organ transplant.\n* Have received at least 1 dose of PPSV23\n\nExclusion Criteria:\n\n* Less than 5 years since last receipt of PPSV23 validated to patient medical record and Immunize Nevada Website\n* Previous administration of PCV20\n* Previous administration of PCV13\n* Previous administration of PCV15\n* Less than 14 days since administration of any COVID19 vaccination\n* Previous history of Invasive Pneumococcal Disease (IPD)\n* Antibiotic treatment within the previous 90 days",{"count":329,"type":23},45,[174],"The investigators will evaluate the immune response of immunocompromised adults, who have previously received at least 1 dose of 23-valent pneumococcal polysaccharide vaccine, to the booster with of 21-valent pneumococcal conjugate vaccine . Immune response will be assessed by opsonophagocytic assay reactivity.",[333,29],"Pneumococcal Vaccines",[205,335],"pneumococcal vaccines","2025-08-08",{"date":338,"type":38},"2025-08-14",{"date":340,"type":23},"2026-01-01",{"date":342,"type":23},"2027-06-01",{"name":344,"class":345},"VA Sierra Nevada Health Care System","FED",{"id":347,"slug":348,"hasResults":12,"nctId":349,"briefTitle":350,"officialTitle":351,"acronym":352,"eligibilityCriteria":353,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":354,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":356,"conditions":357,"keywords":360,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":365,"lastUpdatePostDateStruct":366,"startDateStruct":368,"completionDateStruct":370,"leadSponsor":371,"locationsCount":80},"100517952","role-of-mdscs-and-cancer-stem-cells-and-their-cross-talks-in-nsclc-100517952","NCT06024226","Role of MDSCs and Cancer Stem Cells and Their Cross Talks in NSCLC","Role of Myeloid Derived Suppressive Cells (MDSCs) and Cancer Stem Cells and Their Cross Talks in Non-Small Cell Lung Cancer (NSCLC)","MyéloLungSC","Inclusion Criteria:\n\n* consecutive patients\n* lung carcinoma surgically treated by surgery only\n\nExclusion Criteria:\n\n* patient receiving chemotherapy, radiotherapy or immunotherapy in the neoadjuvant setting (all objectives)\n* patient with concomitant or previous cancer (in the 2 years)",{"count":355,"type":23},10,"Immunotherapy have revolutionized the field of oncology, but response rates are low and all patients relapse, due to cellular and soluble immunosuppressive mechanisms. MDSC are one of the most important immunosuppressive cells, that also harbour non immunologic functions, favouring cancer invasion. These non immunologic functions of MDSC in lung cancer will be better characterized. Indeed, cellular mechanisms will be analysed by in vitro studies, assessing the effect of immunosuppressive cells, provided by fresh tumor samples, on phenotype and functions of lung cancer cell lines. The aim of this study is to better characterize immunosuppressive landscape of NSCLC and mechanisms involved in their protumor functions.",[358,359,29],"Lung Neoplasms","Myeloid-Derived Suppressor Cells",[361,29,362,363,364],"Lung cancer","Immuno-oncology","Antitumor immune escape","Invasion","2025-07-29",{"date":367,"type":38},"2025-07-30",{"date":369,"type":23},"2025-12",{"date":138,"type":23},{"name":372,"class":45},"University Hospital, Bordeaux",{"id":374,"slug":375,"hasResults":12,"nctId":376,"briefTitle":377,"officialTitle":378,"acronym":4,"eligibilityCriteria":379,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":380,"targetDuration":4,"studyType":90,"phases":382,"briefSummary":383,"conditions":384,"keywords":387,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":388,"lastUpdatePostDateStruct":389,"startDateStruct":391,"completionDateStruct":393,"leadSponsor":395,"locationsCount":246},"100427282","phase-4-immunoinflammatory-regulation-of-esketamine-in-septic-patients-100427282","NCT04843982","Immunoinflammatory Regulation of Esketamine in Septic Patients","Effects of Esketamine Combined With Propofol for Sedation on Systemic Inflammation and Immune Function in Septic Patients in the ICU: a Single-center, Non-blind, Prospective Randomized Controlled Trial","Inclusion Criteria:\n\n* 18 years old ≤ age ≤60 years old;\n* SOFA score ≥2;\n* Mechanical ventilation should be required for at least 24 hours when included in the study;\n* Informed consent is obtained.\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years old or ≥ 60 years old;\n* Previous solid organ or bone marrow transplantation;\n* Autoimmune diseases (rheumatoid arthritis, systemic lupus erythematosus, etc.), or hematologic malignancies (leukemia and lymphoma, etc.);\n* Received radiotherapy or chemotherapy within the past 30 days, or received immunosuppressant drugs (tripterygium wilfordii, mycophenolate mofetil, cyclophosphamide, FK506, etc.), or continuous treatment with prednisolone more than 10 mg\u002Fday (or equivalent doses of the other hormones);\n* Unstable angina pectoris or myocardial infarction in the past six months;\n* Acute brain injury (traumatic brain injury, subarachnoid hemorrhage, acute ischemic stroke, acute intracranial hemorrhage, acute intracranial infection, etc.);\n* Poorly controlled hypertension and congestive heart failure;\n* Increased intraocular or intracranial pressure;\n* Chronic kidney disease, received continuous renal replacement therapy in the past 30 days, or acute renal failure requiring CRRT;\n* Severe chronic liver disease (Child-Pugh class B or C);\n* Alcohol dependence, mental illness or severe cognitive impairment;\n* Pregnancy or lactation;\n* Informed consent is not obtained.",{"count":381,"type":23},100,[174],"Studies have shown that excessive systemic inflammatory response and concomitant immunosuppression are the main cause of early death in patients with sepsis. Therefore, it is very important to reduce excessive inflammation and improve immunosuppression in the acute phase of sepsis. Clinical studies have shown that esketamine combined with propofol for sedation has been proven to be safe and effective for septic patients in the ICU due to its cardiovascular stability. Previous studies have demonstrated that esketamine has anti-inflammatory effects against depression and surgical stress. Our preliminary experimental studies have found that esketamine had strong anti-inflammatory effects in the acute phase of sepsis. However, it is not clear whether esketamine could reduce excessive inflammation and improve immunosuppression in septic patients primarily sedated with a continuous infusion of propofol.\n\nThis intervention study is to investigate whether three consecutive days of intravenous esketamine infusions via infusion pump (0.07 mg\u002Fkg\u002Fh) could reduce excessive inflammation and improve immunosuppression in septic patients requiring mechanical ventilation in the ICU under sedation primarily with propofol.",[385,27,386,29],"Esketamine","Inflammatory Response",[385,27,386,29],"2025-07-17",{"date":390,"type":38},"2025-07-18",{"date":392,"type":38},"2021-07-28",{"date":394,"type":23},"2026-10-30",{"name":44,"class":45},{"id":397,"slug":398,"hasResults":12,"nctId":399,"briefTitle":400,"officialTitle":401,"acronym":4,"eligibilityCriteria":402,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":403,"targetDuration":4,"studyType":90,"phases":405,"briefSummary":407,"conditions":408,"keywords":412,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":417,"lastUpdatePostDateStruct":418,"startDateStruct":420,"completionDateStruct":422,"leadSponsor":424,"locationsCount":229},"100501836","phase-3-efficacy-and-safety-of-high-dose-liposomal-amphotericin-b-for-disseminated-histoplasmosis-in-aids-100501836","NCT05814432","Efficacy and Safety of High-dose Liposomal Amphotericin B for Disseminated Histoplasmosis in AIDS","Efficacy and Safety of High-dose Liposomal Amphotericin B (10 Mg\u002Fkg) for Disseminated Histoplasmosis in AIDS: a Randomized Phase III Trial (INDUCTION Trial)","Inclusion Criteria:\n\n* Adult patients admitted to the centers that will be part of the study\n* Infected by the HIV, regardless of the use of antiretroviral therapy\n* Patients diagnosed with disseminated histoplasmosis, confirmed by classical mycological methods (microscopy, culture or histopathology) or urinary Histoplasma antigen detection\n* Patients with central nervous system (CNS) infection may be included if they have an alternative diagnosis suggestive of another CNS infection\n* Patients using fluconazole for oroesophageal candidiasis may be included\n\nExclusion criteria:\n\n* Refusal to participate in the trial\n* Previous diagnosis of histoplasmosis\n* Pregnant or lactating women\n* Patients with renal failure at any given time (serum creatinine \\> 2x or upper limit of normality (KDIGO, 2012)\n* Previous severe reaction to a polyene antifungal\n* Receipt of more than one dose of a polyene antifungal in the last 48 h\n* Suspected histoplasmosis involving the central nervous system\n* Patients who, in the judgment of the attending physician, have the prospect of death within the next 48 hours after selection, will also be excluded\n* Patients with suspected histoplasmosis involving the central nervous system (CNS), as this condition requires high doses of amphotericin B\n* Patients with the prospect of death in the next 48 hours after selection\n* Patients with a concomitant diagnosis of cryptococcus will be excluded, as will patients with leishmaniasis in treatment or in secondary prophylaxis with amphotericin\n* Patients without the capacity to administer enteral medication-at the discretion of the principal investigator of each center-considering that these patients will not be able to use itraconazole orally or through a feeding tube",{"count":404,"type":23},279,[406],"PHASE3","Phase III trial evaluating the safety and efficacy of a single high dose (10 mg\u002Fkg) of liposomal amphotericin B for disseminated histoplasmosis in AIDS patients, in comparison to standard therapy (3 mg\u002Fkg of liposomal amphotericin B for two weeks) (INDUCTION trial).",[409,410,29,411],"Disseminated Histoplasma Capsulatum Infection","AIDS and Infections","Fungal Infection",[413,414,415,416],"Disseminated Histoplasmosis","AIDS","Liposomal amphotericin B","Fungal infection","2025-01-31",{"date":419,"type":38},"2025-02-04",{"date":421,"type":38},"2025-01-16",{"date":423,"type":23},"2026-11-28",{"name":425,"class":45},"Federal University of Health Science of Porto Alegre",{"id":427,"slug":428,"hasResults":12,"nctId":429,"briefTitle":430,"officialTitle":430,"acronym":431,"eligibilityCriteria":432,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":433,"targetDuration":435,"studyType":24,"phases":4,"briefSummary":436,"conditions":437,"keywords":438,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":440,"lastUpdatePostDateStruct":441,"startDateStruct":443,"completionDateStruct":445,"leadSponsor":447,"locationsCount":80},"100551671","registry-of-vaccine-responses-in-immune-compromised-patients-100551671","NCT06463119","Registry of Vaccine Responses in Immune Compromised Patients","REVAPI","Inclusion Criteria:\n\n1. Immune compromised patient or patient who will soon be immunocompromised\n2. Informed consent as documented by signature\n\nExclusion Criteria:\n\n1. Individual\u002Fparental inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, known\u002Fsuspected non-compliance, substance abuse, etc.\n2. Plan to move out of the country or have prolong absence in the next 2 months",{"count":434,"type":23},300,"5 Years","The aim of this project is to monitor, guide and document vaccination, vaccine responses, persistence of protection, vaccine efficacy and safety in immune compromised patients at various moment of their disease: right after the diagnosis, before the introduction of the immunosuppressive treatment, once the individual is under immunosuppressive treatment, or once immunosuppression is over.",[29],[439],"Vaccine","2024-11-06",{"date":442,"type":38},"2024-11-07",{"date":444,"type":38},"2024-09-24",{"date":446,"type":23},"2029-04",{"name":448,"class":45},"Laure Pittet, MD-PhD",{"id":450,"slug":451,"hasResults":12,"nctId":452,"briefTitle":453,"officialTitle":454,"acronym":455,"eligibilityCriteria":456,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":457,"targetDuration":4,"studyType":90,"phases":459,"briefSummary":460,"conditions":461,"keywords":464,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":475,"lastUpdatePostDateStruct":476,"startDateStruct":478,"completionDateStruct":479,"leadSponsor":481,"locationsCount":4},"100474536","heartcare-immuno-optimization-in-cardiac-allografts-mosaic-100474536","NCT05459181","HeartCare Immuno-optimization in Cardiac Allografts (MOSAIC)","Molecular Outcome Surveillance Using AlloSure and AlloMap Guided Immunomodulation in Cardiac Transplant","MOSAIC","Inclusion Criteria:\n\n1. Heart transplant recipients \\\u003C2 weeks post-transplant\n2. Patients aged 18 years or older\n3. Planned post-transplant maintenance immunosuppression regimen consisting of prednisolone, tacrolimus and mycophenolate\n4. Female participants of childbearing potential must be willing to ensure that they or their partner use effective contraception during the trial and for 3 months thereafter\n5. Participant is willing and able to give informed consent for participation in the trial\n6. In the Investigator's opinion, is able and willing to comply with all trial requirements\n\nExclusion Criteria:\n\nThe participant may not enter the trial if ANY of the following apply:\n\n1. Multi-visceral transplant recipients\n2. Female participant who is pregnant, lactating or planning pregnancy during the trial\n3. Heart transplant recipients undergoing desensitization protocols prior to transplant based off high immunological risk profiles (determined by treating clinician)\n4. Chronic oral steroid use for any reason that cannot be tapered off and discontinued\n5. Planned post-transplant immunosuppression regimen utilizing cyclosporine, azathioprine, mTOR inhibitors, and\u002For co-stimulatory blockers\n6. Contraindication to having AlloSure or AlloMap testing\n7. Participant with life expectancy of less than 6 months or is inappropriate for immuno-optimization (including those patients at increased risk of primary disease recurrence w\u002F reduction in post-transplant immunosuppression)\n8. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial. This includes clinical events that would significantly impact post-transplant immunosuppression such as major infectious complications or significant rejection episodes within the first month post-transplant.\n9. Participants who are currently or have previously participated in another research trial involving an investigational immunological drug in the past 12 weeks\n10. Any condition that would preclude protocol biopsies\n\nRandomization Criteria (assessed at Week 4)\n\nThe participant may not proceed with randomization if ANY of the following apply at Week 4 post-transplant:\n\n1. Maintenance immunosuppression that includes cyclosporine, azathioprine, mTOR inhibitors, and\u002For co-stimulatory blockers\n2. Any episodes of biopsy-proven acute rejection (ACR ≥2R or AMR\\*)\n3. Abnormal molecular profile defined as AlloSure \\>0.2%\n4. Allograft dysfunction defined as LVEF \\\u003C45%\n5. eGFR \\\u003C30mL\u002Fmin\n6. Presence of DSA (persistence of any pre-transplant DSA or dnDSA) \\*AMR 1 (H+) with DSA\u002Fgraft dysfunction or AMR \\> 2",{"count":458,"type":23},930,[128],"This is an unblinded, randomized, controlled, two-arm interventional research study enrolling patients who are undergoing heart transplantation. The aim of the study is to determine whether patients at low risk of rejection can safely reduce the doses of their post-transplant immunosuppression medications using a combination of tests that include donor-specific antibodies (DSA), histology (looking at tissue from the donor heart), donor-derived cell-free DNA (AlloSure), and gene expression profiling (AlloMap). Eligible participants will be randomized in a 1:1 ratio into the HeartCare immune-optimization (intervention) arm or the corresponding observational (control) arm. AlloSure and AlloMap are the components of the HeartCare panel developed by CareDx.",[462,29,463],"Heart Transplant","Allograft",[465,466,467,468,469,470,471,472,473,474],"HeartCare","Allograft loss and survival","Calcineurin inhibitors","Chronic immunosuppression","Steroid avoidance","Donor-specific antibodies","Donor-derived cell-free DNA","AlloSure","AlloMap","Gene expression profiling","2024-10-21",{"date":477,"type":38},"2024-10-23",{"date":369,"type":23},{"date":480,"type":23},"2026-09",{"name":482,"class":116},"CareDx",{"id":484,"slug":485,"hasResults":12,"nctId":486,"briefTitle":487,"officialTitle":487,"acronym":488,"eligibilityCriteria":489,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":490,"targetDuration":492,"studyType":24,"phases":4,"briefSummary":493,"conditions":494,"keywords":503,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":520,"lastUpdatePostDateStruct":521,"startDateStruct":523,"completionDateStruct":525,"leadSponsor":527,"locationsCount":80},"100402555","role-of-endomyocardial-biopsy-and-aetiology-based-treatment-in-patients-with-inflammatory-heart-disease-in-arrhythmic-and-non-arrhythmic-clinical-presentations-an-integrated-approach-for-the-optimal-diagnostic-and-therapeutic-management-100402555","NCT04521790","Role of Endomyocardial Biopsy and Aetiology-based Treatment in Patients With Inflammatory Heart Disease in Arrhythmic and Non-arrhythmic Clinical Presentations: an Integrated Approach for the Optimal Diagnostic and Therapeutic Management","MYOCAR","Inclusion Criteria:\n\n* Written informed consent.\n* Age ≥ 18 years.\n* Clinically suspected myocarditis.\n* Enrollment performed by one of the participating Centers.\n\nExclusion Criteria:\n\n* Absence of written informed consent.\n* Age \\\u003C 18 years (paediatric population).",{"count":491,"type":23},1000,"10 Years","Myocarditis is a complex inflammatory disease, usually occurring secondary to viral infections, autoimmune processes or toxic agents. Clinical presentations are multiple, including chest-pain, heart failure and a broad spectrum of arrhythmias. In turn, outcome is largely unpredictable, ranging from mild self-limiting disease, to chronic stage and progressive evolution towards dilated cardiomyopathy, to rapid adverse outcome in fulminant forms. Subsequently, myocarditis is often underdiagnosed and undertreated, and optimal diagnostic and therapeutic strategies are still to be defined. This study, both retrospective and prospective, originally single-center and subsequently upgraded to multicenter, aims at answering multiple questions about myocarditis, with special attention to its arrhythmic manifestations.\n\n1. Optimal diagnostic workflow is still to be defined. In fact, although endomyocardial biopsy (EMB) is still the diagnostic gold standard, especially for aetiology identification, it is an invasive technique. Furthermore, it may lack sensitivity because of sampling errors. By converse, modern imaging techniques - cardiac magnetic resonance (CMR) in particular - have been proposed as alternative or complementary diagnostic tool in inflammatory heart disease. Other noninvasive diagnostic techniques, like delayed-enhanced CT (DECT) scan or position emission tomography (PET) scan, are under investigation.\n2. Biomarkers to identify myocarditis aetiology, predisposition, prognosis and response to treatment are still to be defined.\n3. Arrhythmic myocarditis is largely underdiagnosed and uninvestigated. Importantly, myocarditis presenting with arrhythmias requires specific diagnostic, prognostic and therapeutic considerations. At the group leader hospital, which is an international referral center for ventricular arrhythmias management and ablation, a relevant number of patients with unexplained arrhythmias had myocarditis as underlying aetiology. The experience of a dedicated third-level center is going to be shared with other centers, to considerably improve knowledge and management of arrhythmic myocarditis.\n4. The role of CMR, as well as alternative noninvasive imaging techniques, in defining myocarditis healing is a relevant issue. In particular, optimal timing for follow-up diagnostic reassessment is still to be defined, in patients with myocarditis at different inflammatory stages, either with or without aetiology-dependent treatment.\n5. Uniformly-designed studies are lacking, to compare myocarditis among different patient subgroups, differing by variables like: clinical presentations, myocarditis stage, associated cardiac or extra-cardiac diseases, aetiology-based treatment, associated arrhythmic manifestations, diagnostic workup, and devices or ablation treatment.",[495,496,497,498,499,500,501,29,502],"Myocarditis","Ventricular Arrythmia","Inflammatory Cardiomyopathy","Genetic Predisposition","Autoimmunity","Arrhythmia","Cardiomyopathies","Catheter Ablation",[495,504,505,506,507,508,509,510,511,512,513,514,515,516,517,518,519],"Ventricular arrhythmias","Arrhythmias","Arrhythmogenic inflammatory cardiomyopathy","Endomyocardial biopsy","Cardiac magnetic resonance","Ablation","Positron emission tomography","Cardiac imaging","Electroanatomical mapping","Immunosuppressive therapy","Arrhythmic risk stratification","Genetic predisposition","Environment","Implantable cardioverter defibrillator","Implantable loop recorder","Multicenter","2024-09-07",{"date":522,"type":38},"2024-09-19",{"date":524,"type":38},"2018-01-30",{"date":526,"type":23},"2035-12-31",{"name":528,"class":45},"Scientific Institute San Raffaele",{"id":530,"slug":531,"hasResults":12,"nctId":532,"briefTitle":533,"officialTitle":534,"acronym":535,"eligibilityCriteria":536,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":537,"targetDuration":4,"studyType":90,"phases":538,"briefSummary":539,"conditions":540,"keywords":541,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":544,"lastUpdatePostDateStruct":545,"startDateStruct":547,"completionDateStruct":549,"leadSponsor":551,"locationsCount":553},"100536741","phase-4-tacrolimus-cd-ratio-measured-in-renal-transplant-recipients-treated-with-once-daily-prolonged-release-drugs-100536741","NCT06268769","Tacrolimus C:D Ratio Measured in Renal Transplant Recipients Treated With Once-daily Prolonged-release Drugs","Multicentre, Open-label, Randomised, Two-arm, Parallel-group, Superiority Trial to Assess Bioavailability and Practicability of Two Once-daily Tacrolimus Formulations, Envarsus® Compared With Advagraf™, Administered in Kidney Transplant Recipients","TaC:Drop","Inclusion Criteria:\n\n1. Signed and dated written informed consent\n2. Adult (≥18 years old) male or female\n3. Renal insufficiency necessitating kidney transplantation and approved to receive a first or second kidney allograft from a living or deceased organ donor\n4. ABO blood type compatible with the donor kidney\n5. Able to swallow an oral formulation of tacrolimus in tablet or capsule form\n\nExclusion Criteria:\n\n1. Multi-organ transplantation\n2. Any previous solid organ transplantation (other than a first kidney allograft)\n3. For recipients of a second kidney transplant: loss of first kidney transplant within 2 years after transplantation owing to immunological reasons or recurrence of the underlying renal disease\n4. Patient and\u002For donor is positive for HCV, HBV or HIV\n5. History of any malignancy that could not be curatively treated\n6. Ongoing abuse of drugs or alcohol\n7. Signs of advanced liver disease or any signs of liver decompensation\n8. Ongoing uncontrolled systemic infection\n9. Severe diarrhoea, vomiting, active peptic ulcer, previous bariatric surgery, or any other gastrointestinal disorder that may affect absorption of tacrolimus\n10. Planned or foreseeable use of cyclosporine, belatacept or any tacrolimus preparation other than Envarsus® or Advagraf™\n11. Known contraindication or hypersensitivity to tacrolimus, and\u002For to any of the excipients listed in section 6.1 of the Summary of Product Characteristics (SmPC) of both Envarsus® and Advagraf™, and\u002For to any other macrolides\n12. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test\n13. Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, unless using a highly-effective method of contraception\n14. Participation in another interventional clinical trial in the time period starting from 4 weeks prior to randomisation and throughout the entire trial period\n15. Any condition or factor which, in the judgement of the investigator, would place the subject at undue risk, invalidate communication with the investigator or study team, or hamper compliance with the trial protocol or follow-up schedule\n16. Inability to freely give informed consent (e.g. individuals under legal guardianship)",{"count":434,"type":23},[174],"The goal of this clinical trial is to compare the bioavailability and practicability of two different formulations of tacrolimus in kidney transplant recipients. The main objective is to demonstrate that Envarsus® (test drug) has superior (higher) oral bioavailability compared with Advagraf™ (comparator drug) at 12 weeks after kidney transplantation. The trial also aims to compare the practicability (handling) of the two drugs using a series of pharmacokinetic parameters and to explore the relationship between drug bioavailability and long-term clinical outcomes, with a special focus on dose-dependent adverse reactions, measured until 3 years post-transplantation. The trial incorporates a pharmacokinetic sub-study designed to profile the peak tacrolimus blood concentration up to 6 hours after drug intake on the day of the 12-week study visit.",[29],[542,309,543],"Kidney transplantation","Concentration\u002Fdose ratio","2024-05-14",{"date":546,"type":38},"2024-05-16",{"date":548,"type":38},"2024-03-09",{"date":550,"type":23},"2029-09",{"name":552,"class":45},"Edward Geissler",9,{"id":555,"slug":556,"hasResults":12,"nctId":557,"briefTitle":558,"officialTitle":558,"acronym":4,"eligibilityCriteria":559,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":560,"targetDuration":492,"studyType":24,"phases":4,"briefSummary":562,"conditions":563,"keywords":4,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":567,"lastUpdatePostDateStruct":568,"startDateStruct":570,"completionDateStruct":572,"leadSponsor":574,"locationsCount":80},"100542730","the-transplant-cohort-of-the-german-center-for-infection-research-100542730","NCT06346665","The Transplant Cohort of the German Center for Infection Research","Inclusion Criteria:\n\n* Consent\n* undergone transplantation of kidney, pancreas, liver, heart or stem cells\n\nExclusion Criteria:\n\n* No consent",{"count":561,"type":23},3000,"Medical data and biological samples obtained from transplant patients are collected and managed across Germany with the help of the DZIF Transplant Cohort. The data and samples form the basis of scientific studies which investigate the connections between numerous factors influencing an organ's susceptibility to infection and organ function.",[564,565,566,29],"Infections","Transplant Complication","Transplant Failure","2024-04-22",{"date":569,"type":38},"2024-04-23",{"date":571,"type":38},"2016-01",{"date":573,"type":23},"2030-12",{"name":575,"class":45},"Technical University of Munich",{"id":577,"slug":578,"hasResults":12,"nctId":579,"briefTitle":580,"officialTitle":581,"acronym":582,"eligibilityCriteria":583,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":148,"enrollmentInfo":584,"targetDuration":4,"studyType":90,"phases":585,"briefSummary":586,"conditions":587,"keywords":591,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":593,"lastUpdatePostDateStruct":594,"startDateStruct":596,"completionDateStruct":598,"leadSponsor":600,"locationsCount":80},"100412779","phase-4-study-to-evaluate-the-efficacy-of-immunosuppression-in-myocarditis-or-inflammatory-cardiomyopathy-100412779","NCT04654988","Study to Evaluate the Efficacy of Immunosuppression in Myocarditis or Inflammatory Cardiomyopathy.","A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy of Immunosuppression in Biopsy-proven Virus Negative Myocarditis or Inflammatory Cardiomyopathy","IMPROVE-MC","Inclusion Criteria:\n\nTo be eligible for inclusion in this study, patient must fulfill all of the following inclusion criteria:\n\n1. Written informed consent to participate in the IMPROVE-MC study (including two EMBs and two cardiac CMRs) prior to any evaluation or procedure related to the study.\n2. Patient with clinically suspected myocarditis or inflammatory cardiomyopathy (according to the criteria of the ESC Working Group on Myocardial \\& Pericardial Diseases 2013 and ESC Heart Failure Guidelines 2021); OR\u002F AND, Patients with already diagnosed active myocarditis (lymphocytic or eosinophilic) or inflammatory cardiomyopathy who will undergo diagnostic right ventricular (or\u002Fand left ventricular) EMB during the screening; OR \u002F AND, Patients with already diagnosed active myocarditis (lymphocytic or eosinophilic) or inflammatory cardiomyopathy confirmed by right ventricular (or\u002Fand left ventricular) EMB that was performed according to the IMPROVE-MC study protocol within 3 months from screening.\n3. Men or women aged 18-65. Women of childbearing age must have a negative pregnancy test result. Female patients must be 1 year post-menopausal, surgically sterile, or using an acceptable method of contraception (with a failure rate of \\\u003C 1% per year) for the duration of the study (from the time they sign consent) and for 8 weeks after the last dose of study treatment to prevent pregnancy. Patients agreeing to total sexual abstinence can also be included, assuming it is their usual lifestyle. Women are considered postmenopausal and without the potential to have a child if they have 12 months of natural (spontaneous) amenorrhea with an appropriate clinical picture (e.g. appropriate age, history of vasomotor symptoms) or have undergone bilateral surgical ovariectomy (with or without hysterectomy) or tubal ligation at least six weeks ago. In the case of ovariectomy alone, only if the reproductive status of the woman has been confirmed by assessing hormone levels.\n4. No significant improvement in clinical condition or worsening course of the disease despite the standard treatment in the investigator's opinion, in the last ≥ 3 months prior to the screening period.\n5. LVEF 10 - 45% measured by echocardiogram taken during the screening period\n\n   1. No significant LVEF improvement in the last ≥3 months prior to the screening period in the investigator's opinion.\n   2. LVEF should be measured under stable conditions as assessed by the investigator.\n   3. LVEF should be verified in the CORE-LAB.\n6. Histological and immunohistochemical evidence of active myocarditis (lymphocytic or eosinophilic) OR inflammatory cardiomyopathy during the screening period (EMB during the screening or within last 3 months).\n7. Absence of cardiotropic viruses in cardiac tissue at PCR analysis during the screening period (EMB during the screening or within last 3 months).\n\nExclusion Criteria:\n\nPatients fulfilling any of the following exclusion criteria are not eligible for inclusion in this study. No additional exclusions may be applied by the investigator, in order to ensure that the study population will be representative of all eligible patients.\n\n1. Presence of contraindications to immunosuppressive therapy with steroids and\u002F or azathioprine (including hypersensitivity to azathioprine\u002F 6-mercaptopurine or prednisone, mainly untreated systemic infection, uncontrolled diabetes, poorly controlled endocrine diseases, osteoporosis, active gastric or duodenal ulcer, uncontrolled hypertension, leukocytopenia (leukocyte counts \\\u003C4 x 109\u002Fl), neutropenia (neutrophils \\\u003C1.5 x 109\u002Fl), thrombocytopenia (platelet levels \\\u003C130 x 109\u002Fl), anemia (hemoglobin levels \\\u003C11 g\u002Fdl).\n2. Positive clinical screening for active infections, including HIV, HBV, HCV. Assessment of tuberculosis infection should be considered before screening, according to the local epidemiologic status and according to investigator's opinion. After careful evaluation of the activity of the infection (or cure of the infection), the patient may continue participation in the study according to investigator's opinion.\n3. Another specific cause of heart failure (including severe congenital, valvular, hypertensive, and\u002For coronary artery disease) that could justify the severity of cardiac dysfunction.\n4. Cardiomyopathy based on infiltrative diseases (e.g. amyloidosis), storage diseases (e.g. haemochromatosis, Fabry disease), muscular dystrophies, genetic hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy or known pericardial constriction.\n5. Diagnosed or suspected cardiac sarcoidosis or giant cell myocarditis, autoimmune\u002F systemic immune-mediated disease (i.e. granulomatosis with polyangiitis, lupus erythematosus) that might require specific immunosuppressive therapy. Recent, current or expected future need for long-term use of immunosuppressive therapy with steroids and\u002F or azathioprine and\u002F or other immunosuppressive agent (caution - short-term course of steroids \\[i.e. for asthma attack, occasional topical applications\\] is not an exclusion).\n6. NYHA class I and IV.\n7. Subjects with body mass index \\>40 kg\u002Fm2 or body weight \\\u003C50 kg.\n8. Pregnancy, lactation or women who plan to become pregnant during the trial. Lack of consent to the use of effective forms of contraception.\n9. Any documented or suspected active malignant neoplasm or history of malignant neoplasm within the 5 years prior to the screening period.\n10. History of cytostatic therapy or radiotherapy.\n11. Liver disease defined as any of the following: AST or ALT or ALP above 3x ULN; bilirubin \\>1.5 mg\u002FdL.\n12. Impaired renal function, defined as eGFR \\\u003C45 mL \u002F min \u002F 1.73 m2 (CKD-EPI) measured under stable condition or requiring dialysis. Conditionally, according to the investigator's decision, patients with eGFR 40-45 ml \u002F min \u002F 1.73 m2 may be included.\n13. The need or refusal to stop taking any drug considered to interfere with the safe course of the study (e.g., allopurinol).\n14. Currently implanted or planned VAD, CRT or heart transplant.\n15. Patients with pacemaker or ICD requiring a high percentage of ventricular pacing (\\>30%) which could influence the result of LVEF measurement in the investigator's opinion.\n16. Gastrointestinal surgery or gastrointestinal disorder that could interfere with trial drug(s) absorption in the investigator's opinion.\n17. History or presence of any other disease with a life expectancy \\\u003C3 years.\n18. Any contraindications or intolerance to CMR\\*, including but not limited to:\n\n    1. the presence of cardiac implantable electronic device implanted \\\u003C6 weeks ago;\n    2. pacing capture threshold out of the normal range;\n    3. additional cardiac leads (particularly abandoned pacemaker leads), epicardial leads, fractured leads, additional components such as lead adapters or lead extension;\n    4. aneurysm clips, artificial heart valves, ear implants, or foreign metal objects in the eyes, skin, or body that could be contraindication to CMR;\n    5. presence of claustrophobia making impossible to perform CMR;\n    6. or any other clinical history or study that determines that, in the investigator's judgment, the performance of an CMR may pose a potential risk to the patient.\n19. Immunization with live organism vaccines in the last 3 months prior to randomization.\n20. Chronic alcohol or drug abuse or non-compliance with medical recommendations or any condition that, in the investigator's opinion, makes patient an unreliable trial subject or unlikely to complete the trial.\n21. Use of other investigational drugs at the time of enrollment, or within 30 days, or within 5 half-lives of enrollment, whichever is longer.\n22. Subjects directly involved in the execution of this protocol.\n\n    * CMR in non-conditional CIED proved to be safe. CMR in CIED patients will be performed according to HRS 2017 and ESC Pacing 2021 guidelines",{"count":381,"type":23},[174],"Myocarditis can result in numerous complications, but there is paucity of data regarding optimal therapy, short- and long-term effects of possibly effective immunosuppressive therapy. The IMPROVE-MC study will provide high-quality scientific data about efficacy and safety of immunosuppressive therapy, non-invasive (MRI, biomarkers) and invasive diagnostics tests (endomyocardial biopsy), and prognosis in myocarditis. The objective of this multicenter, prospective, randomized, double-blind placebo-controlled trial is to assess the efficacy and safety of 12 - month treatment with prednisone and azathioprine comparing to placebo on top of guideline-recommended medical therapy in patients with biopsy-proven virus negative myocarditis or inflammatory cardiomyopathy and reduced ejection fraction (LVEF ≤ 45%). The study will also assess persistence of the treatment effects after 12 months.",[495,588,589,590,29],"Heart Failure","Endomyocardial Biopsy","Cardiomyopathies, Secondary",[592],"myocarditis, cardiomyopathy, immunosuppression, biopsy","2024-03-25",{"date":595,"type":38},"2024-03-28",{"date":597,"type":38},"2022-12-01",{"date":599,"type":23},"2028-03-30",{"name":601,"class":45},"Medical University of Warsaw",{"id":603,"slug":604,"hasResults":12,"nctId":605,"briefTitle":606,"officialTitle":607,"acronym":608,"eligibilityCriteria":609,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":610,"targetDuration":4,"studyType":90,"phases":612,"briefSummary":613,"conditions":614,"keywords":617,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":620,"lastUpdatePostDateStruct":621,"startDateStruct":623,"completionDateStruct":625,"leadSponsor":626,"locationsCount":80},"100446143","phase-4-tacrolimus-associated-tremors-in-liver-transplantation-immediate-release-versus-extended-release-formulations-100446143","NCT05089604","Tacrolimus Associated Tremors in Liver Transplantation: Immediate-Release Versus Extended-Release Formulations","Tacrolimus Associated Tremors in Liver Transplant Recipients: a Randomized Open Label Trial Comparing De Novo Extended-release Once Daily (LCP-TAC) and Twice Daily Immediate-release (IR-TAC) Tacrolimus Formulations","LCP-TAC","Inclusion Criteria:\n\n1. Adults aged 18 years or older\n2. Recipients of a first-time liver transplant\n3. eGFR more than 30 ml\u002Fmin on the day of tacrolimus initiation\n4. All patients who are eligible to initiate Tacrolimus within 7 days post-liver transplant\n5. Informed consent\n\nExclusion Criteria:\n\n1. Recipients of prior organ transplant\n2. Need for hemodialysis either prior or following liver transplantation\n3. Recipients of living donor liver or split deceased donor liver allografts\n4. Recipients of combined liver\u002Fkidney transplants\n5. Recipients receiving liver allografts from donors with HCV viremia (detected through nucleic acid testing or other means)\n6. Patients with a history of tremor prior to transplantation including essential tremors, Parkinson's or Parkinsonian syndromes\n7. Patients receiving concomitant medications known to induce tremors such as dopamine blocking agents\n8. Baseline TSH, T3, T4 indicating hyperthyroidism",{"count":611,"type":23},124,[174],"This is a randomized open label study in de novo liver transplant recipients that aims to compare the risk of tacrolimus induced tremors with once daily extended-release formulation, Envarsus, versus the twice daily immediate-release formulation. Both formulations of tacrolimus are currently approved for the prevention of rejection in liver transplant patients.",[202,29,615,616,309],"Neurotoxicity","Tremor",[618,309,29,616,619,608,615],"Liver Transplant","Envarsus","2023-12-27",{"date":622,"type":38},"2024-01-02",{"date":624,"type":38},"2023-01-09",{"date":186,"type":23},{"name":627,"class":45},"University of British Columbia",{"id":629,"slug":630,"hasResults":12,"nctId":631,"briefTitle":632,"officialTitle":632,"acronym":4,"eligibilityCriteria":633,"healthyVolunteers":12,"sex":18,"minAge":634,"maxAge":4,"enrollmentInfo":635,"targetDuration":4,"studyType":90,"phases":637,"briefSummary":638,"conditions":639,"keywords":642,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":644,"lastUpdatePostDateStruct":645,"startDateStruct":647,"completionDateStruct":649,"leadSponsor":651,"locationsCount":80},"100527408","efficacy-and-safety-of-immunosuppressive-withdrawal-after-pediatric-liver-transplantation-100527408","NCT06147375","Efficacy and Safety of Immunosuppressive Withdrawal After Pediatric Liver Transplantation","Inclusion Criteria:\n\n* Age at liver transplantation: under 6 years\n* Follow-up time after liver transplantation: more than 4 years\n* Liver function maintains normal before enrollment\n* Monotherapy of IS (Tacrolimus or Cyclosporine A)\n* Liver biopsy: No signs of acute rejection or chronic rejection, and no obvious fibrosis (Ishak\\\u003C2) 2 years before enrollment\n* Female recipients of fertility treatment must have a negative pregnancy test before enrollment\n* No Hepatitis virus infection 1 year before enrollment\n* Written consents are required\n\nExclusion Criteria:\n\n* Original disease before liver transplantation: Tumor, secondary liver transplantation, hepatitis virus infection, autoimmune hepatitis\n* Type of liver transplantation: ABO incompatible liver transplantation or multiple organ transplantation\n* Liver biopsy: obvious fibrosis(Ishak≥2；LAFSc moderate or severe)\n* Recipients taking IS for other diseases besides their liver transplantation","4 Years",{"count":636,"type":23},47,[128],"The goal of this clinical trial is to learn about the efficacy and safety of immunosuppressive withdrawal in pediatric liver transplant recipients. The main question it aims to answer is:exploring the landscape of immune tolerance after pediatric liver transplantation. Moreover,this clinical trial aims to provide important foundation and clinical data for inducing immune tolerance, as well as to clarify the mechanism of immune tolerance development in pediatric liver transplantation, identify biomarkers that can be used to predict immune tolerance, and build a prediction model of immune tolerance after pediatric liver transplantation.\n\nThe study planned to enroll 47 recipients after pediatric liver transplantation which would gradually withdrawal immunosuppressive after enrollment, divided the participants into immune tolerance and immune intolerance groups based on the outcome of immunosuppressive withdrawal.In this study, we collect the peripheral blood and liver biopsy samples from the two groups, find biomarkers with predictive value for immune tolerance in recipients after pediatric liver transplantation, and build a predictive model of immune tolerance by machine learning.",[640,29,641],"Immune Tolerance","Liver Transplant; Complications",[640,643,29],"Pediatric liver transplant","2023-11-23",{"date":646,"type":38},"2023-11-27",{"date":648,"type":23},"2023-12-01",{"date":650,"type":23},"2028-12",{"name":652,"class":45},"Wei Gao",{"id":654,"slug":655,"hasResults":12,"nctId":656,"briefTitle":657,"officialTitle":658,"acronym":659,"eligibilityCriteria":660,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":661,"targetDuration":4,"studyType":90,"phases":662,"briefSummary":663,"conditions":664,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":668,"lastUpdatePostDateStruct":669,"startDateStruct":671,"completionDateStruct":673,"leadSponsor":675,"locationsCount":4},"100501556","phase-2-histamine-dihydrochloride-and-interleukin-2-in-primary-resectable-pancreatic-cancer-100501556","NCT05810792","Histamine Dihydrochloride and Interleukin-2 in Primary Resectable Pancreatic Cancer","A Phase I\u002FII Trial of Peri- and Postoperative Treatment With Histamine Dihydrochloride and Low-dose Interleukin-2 in Patients With Primary Resectable Pancreatic Cancer","PANCEP-1","Inclusion Criteria:\n\n1. Subjects must give written informed consent prior to initiation of therapy, in keeping with the policies of the institution.\n2. Subject is a male or female age \\>18\n3. By the surgeon´s evaluation fit for pancreatic surgery\n4. Subjects must have radiologic, and or cytologic confirmation of primary pancreatic cancer\n\nExclusion Criteria (any of the following):\n\n1. Class III or IV cardiac disease, hypotension or severe hypertension, vasomotor instability, serious or uncontrolled cardiac dysrhythmias (including ventricular arrhythmias) at any time, acute myocardial infarction within the past 6 months, active uncontrolled angina pectoris or symptomatic arteriosclerotic peripheral blood vessel disease.\n2. History of uncontrolled seizures, severe central nervous system disorders, or psychiatric disability thought to be clinically significant in the opinion of the Investigator and adversely affecting compliance to protocol.\n3. Any other condition or symptoms preventing the patient from entering the study, according to the PI's judgement.\n4. A woman of childbearing potential (WOCBP) must agree to comply with using an effective contraceptive method for the duration of the treatment (a WOCBP is a sexually mature woman who is not surgically sterile or has not been naturally postmenopausal for at least 12 consecutive months). Investigators shall counsel WOCBP and male subjects who are sexually active with WOCBP on the importance of pregnancy prevention and the implications of an unexpected pregnancy. Investigators shall advise WOCBP and male subjects who are sexually active with WOCBP on the use of highly effective methods of contraception. Highly effective methods of contraception have a failure rate of \\\u003C 1% when used consistently and correctly. Local laws and regulations may require use of alternative and\u002For additional contraception methods. One of the highly effective methods of contraception listed below is required during study duration and until the end of relevant systemic exposure, defined as 5 months after the end of study treatment.",{"count":89,"type":23},[92],"A key aspect of the trial is that functions of anti-neoplastic T cells and natural killer (NK) cells, may be inhibited by immunosuppressive signals from myeloid cells, in particular reactive oxygen species (ROS) produced by several subsets of myeloid cells. In cancer, such immunosuppressive cells are commonly denoted myeloid-derived suppressor cells (MDSCs), which are immature monocytes and granulocytes that impede immune-mediated clearance of malignant cells by multiple mechanisms, including the formation of immunosuppressive ROS via myeloid cell NADPH oxidase (NOX2). The presence of MDSCs within or adjacent to tumor tissue is assumed to facilitate the growth and spread of tumors and may also dampen the efficacy of cancer immunotherapies. The underlying hypothesis for this clinical trial is the administration of HDC\u002FIL-2 will reduce surgery-induced inflammation and reduce metastasis. A phase I\u002FII open label, single-center study of the safety, tolerability, and efficacy of peri- and postoperative therapy with histamine dihydrochloride and low-dose interleukin-2 treatment in subjects with primary pancreatic cancer.To assess the frequency and extent of adverse events associated with low dose interleukin-2 and histamine dihydrochloride when used as perioperative therapy.To determine progression free survival and overall survival following surgery, and compare with matched historical controls from the Swedish Cancer Registry.",[665,666,667,29],"Pancreatic Cancer","Surgery","Metastasis","2023-11-20",{"date":670,"type":38},"2023-11-22",{"date":672,"type":23},"2024-04-01",{"date":674,"type":23},"2028-04-01",{"name":676,"class":45},"Sahlgrenska University Hospital",{"id":678,"slug":679,"hasResults":12,"nctId":680,"briefTitle":681,"officialTitle":682,"acronym":4,"eligibilityCriteria":683,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":227,"enrollmentInfo":684,"targetDuration":4,"studyType":90,"phases":686,"briefSummary":687,"conditions":688,"keywords":691,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":695,"lastUpdatePostDateStruct":696,"startDateStruct":698,"completionDateStruct":700,"leadSponsor":702,"locationsCount":80},"100374075","phase-2-rfa-plus-carrizumab-vs-carrizumab-alone-for-hcc-100374075","NCT04150744","RFA Plus Carrizumab vs Carrizumab Alone for HCC","Radiofrequency Ablation Plus Carrizumab vs Carrizumab Alone for Moderate or Advanced Hepatocellular Carcinoma: A Real World Study","Inclusion Criteria:\n\n1. Age from 18-75 years\n2. Diagnosis as hepatocellular carcinoma from histology and cytology\n3. BCLC B-C degree\n4. Score of ECOG PS: 0-2\n5. Child-Pugh Score: A or B\n6. Not suitable for resection or liver transplantation\n7. Have not received systemic therapy\n8. Have at least one evaluable target mass from CT or MRI according to mRECIST\n9. The estimated survival time ≥ 12 weeks\n10. Patients with HBV infection having HBV-DNA \\\u003C500IU\u002FmL and standard anti-virus treatment. Patients with HCV infection must receive standard anti-virus treatment.\n11. The function of main organs normal\n12. Sign informed consent\n\nExclusion Criteria:\n\n1. Have cholangiocarcinoma, mixed type of hepatocarcinoma and fibrolamellar hepatocellular carcinoma. Have incurable malignant tumor in five years.\n2. Have local ablation, TACE or radiotherapy in 3 months before enrolled.\n3. Prepared to or have received organic or bone marrow transplantation.\n4. Uncontrollable ascites, hepatic encephalopathy or esophageal and gastric varices.\n5. Have hypertension and can't lower down to the normal level using blood pressure medication.\n6. Have type II myocardial ischemia or myocardial infarction, uncontrollable arrhythmia.\n7. Have diseases to influent the effect of oral drugs, for example, unable to swallow, chronic diarrhea and intestinal obstruction.\n8. Have gastrointestinal bleeding in 6 months\n9. Have abdominal fistula, gastrointestinal perforation or abdominal abscess\n10. Patients with lung fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug related pneumonia or severe dysfunction of lung.\n11. Routine urine test showed urinary protein ≥++ or the 24 hours amount of urinary protein ≥1.0 g\n12. Patients have autoimmune disease\n13. Patients need corticosteroid or other immunosuppressant therapy\n14. Patients have anti-tumor vaccine and other immunostimulate anti-tumor drugs in 3 months\n15. Allergy to monocloning antibody\n16. Pregnant or breastfeeding female Other patients not suitable to be enrolled in the study.",{"count":685,"type":23},120,[92],"The study aims to find whether patients with advanced HCC can get more benefits from RFA +PD-1 immunosuppressant (carrizumab) compared with carrizumab alone, considering with the result of PFS.",[689,29,690],"Tumor Immunity","Radiofrequency Ablation",[692,693,694],"RFA","immunosuppressant","hepatocellular carcinoma","2020-07-06",{"date":697,"type":38},"2020-07-08",{"date":699,"type":23},"2020-08-01",{"date":701,"type":23},"2026-12-30",{"name":703,"class":45},"Second Affiliated Hospital, School of Medicine, Zhejiang University"]