[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hemorrhagic-cystitis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hemorrhagic-cystitis":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,49,78,113],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100641393","phase-1-evaluation-of-the-safety-and-efficacy-of-lb-dtk-bkv-in-patients-with-bk-virus-associated-hemorrhagic-cystitis-following-allogeneic-hematopoietic-stem-cell-transplantation-100641393",false,"NCT07638332","Evaluation of the Safety and Efficacy of LB-DTK-BKV in Patients With BK Virus-Associated Hemorrhagic Cystitis Following Allogeneic Hematopoietic Stem Cell Transplantation.","A Single-Center, Open-Label, Phase 1\u002F2 Clinical Trial to Evaluate the Safety and Efficacy of LB-DTK-BKV in Patients With BK Virus-Associated Hemorrhagic Cystitis Following Allogeneic Hematopoietic Stem Cell Transplantation in Children, Adolescents, and Adults.","Inclusion Criteria:\n\n1. Patients who have undergone allogeneic hematopoietic stem cell transplantation, including pediatric and adolescent patients as well as adults who were 12 years of age or older at the time of transplantation. However, only adults aged 19 years or older are eligible for enrollment in Phase 1.\n2. Patients diagnosed with BK virus-associated hemorrhagic cystitis who meet all three of the following criteria.\n\n   * Clinical symptoms and signs of cystitis, such as lower abdominal pain and dysuria\n   * Hematuria of grade 2 or higher according to the Bedi criteria\n   * Detection of BKV \\>7log10 copies\u002FmL in urine\n3. Subjects confirmed by the investigator to be unresponsive to treatment despite at least 7 days of standard inpatient therapy.\n4. Patients with evidence of neutrophil engraftment, defined as an absolute neutrophil count (ANC) maintained at 0.5 × 10³\u002FμL or higher for 3 consecutive days following allogeneic hematopoietic stem cell transplantation.\n5. Patients for whom at least 21 days (D+21) have elapsed since allogeneic hematopoietic stem cell transplantation as of the screening date.\n6. Patients who are able to reduce their steroid dosage to 0.5 mg\u002Fkg\u002Fday of prednisolone (or an equivalent dose) or less.\n7. For women of childbearing potential, those who tested negative on a pregnancy test (blood test) performed on the screening visit.\n8. Female subjects or male subjects with female partners who agree to use the following contraceptive methods during the duration of this clinical trial and who meet the following criteria:\n\n   * Female participants or male participants with female partners who are postmenopausal (diagnosed with non-therapy-induced amenorrhea for 12 months or more or menopause)\n   * Female subjects or the female partners of male subjects who are surgically sterile (i.e., lacking ovaries and\u002For a uterus)\n   * Individuals who have agreed to strict abstinence during the clinical trial period \\[For female participants, intermittent abstinence (e.g., withdrawal during ovulation, the basal body temperature method, or withdrawal after ovulation) does not constitute agreement to abstinence\\]\n   * If the female subject or the female partner of a male subject is a woman of childbearing potential (WOCBP) who has not undergone sterilization, those who meet the following criteria:\n\n     * Hormonal contraceptives (implant, patch, oral)\n     * Intrauterine devices\n     * Dual barrier method (simultaneous use of the following two contraceptive methods: male condoms, female condoms, cervical caps, contraceptive diaphragms, contraceptive sponges)\n9. Individuals who have voluntarily decided to participate in this clinical trial and have provided written consent to comply with the restrictions.\n10. Individuals deemed suitable as trial subjects through screening tests (vital signs, physical examination, medical and surgical history, electrocardiogram, laboratory tests, etc.).\n\nExclusion Criteria:\n\n1. Individuals who have received treatment with ATG (Antithymocyte Globulin), Campath (Alemtuzumab), or other T-cell immunosuppressive monoclonal antibodies within 28 days prior to the first dose.\n2. Patients with hemorrhagic cystitis caused by adenovirus (excluded via urine PCR)\n3. Patients with bacterial growth in urine culture (excluded via bacterial culture)\n4. Individuals who meet any of the following criteria at the time of screening:\n\n   * Uncontrolled hypertension\n\n     * Systolic BP ≥ 160 mmHg or diastolic BP ≥ 100 mmHg despite taking antihypertensive medication.\n   * Uncontrolled diabetes: Severe diabetes is defined as follows.\n\n     * Severe hyperglycemia with HbA1C ≥ 10.0%\n     * Individuals who have been hospitalized for diabetic ketoacidosis within the past 12 weeks.\n     * Individuals who have received emergency treatment or been hospitalized within the past 12 weeks for severe hypoglycemia (glucose \\\u003C54 mg\u002FdL) accompanied by seizures and loss of consciousness.\n   * Human Immunodeficiency Virus (HIV) infection\n   * Hepatitis B Virus (HBV) infection. However, individuals who are HBsAg-negative and Anti-HBcAb-positive are not subject to this exclusion criterion.\n   * Hepatitis C Virus (HCV) infection\n   * Tuberculosis\n   * Syphilis\n   * Moderate or severe liver damage \\[Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) \\> 5 times the upper limit of normal (ULN)\\]\n   * Patients with other uncontrolled infections. However, the following cases are considered controlled infections and do not meet the exclusion criteria.\n\n     * Bacterial infection Patients must be undergoing definitive antibiotic treatment for the infection and must have shown no signs of progression of the infection for 72 hours prior to enrollment in this clinical trial.\n     * Fungal infection The patient must be receiving systemic antifungal therapy and must have shown no signs of infection progression for 1 week prior to enrollment in this clinical trial.\n5. Patients who have undergone allogeneic hematopoietic stem cell transplantation within 28 days prior to the scheduled first dose, or who have received donor lymphocyte infusion (DLI) within 28 days prior to enrollment in this clinical trial.\n6. Active acute graft-versus-host disease (GvHD) of grade 3 or higher.\n7. Patients requiring urgent anticancer therapy due to rapid tumor progression.\n8. Patients with a history of substance abuse within 24 weeks prior to administration of the investigational drug, or patients suspected of taking drugs of concern based on medical history and physical examination.\n9. Patients requiring vasopressors.\n10. Patients who have previously shown hypersensitivity to T-cell therapy.\n11. Patients with a history of autoimmune disease.\n12. Patients with hemophilia who are at risk of severe bleeding during administration, or patients receiving anticoagulants.\n13. Patients who have received another investigational drug within 24 weeks prior to administration of the investigational drug.\n14. Patients with a life expectancy of less than 24 hours at the time of the screening visit.\n15. Patients deemed ineligible for participation in this clinical trial by the investigator.","ALL","12 Years",{"count":19,"type":20},42,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","The goal of this clinical trial is to assess efficacy of BK virus specific T cells (LB-DTK-BKV) to treat pediatric, adolescent, and adult patients with BK virus-associated hemorrhagic cystitis after allogenic hematopoietic stem cell transplantation (allo-HSCT). It will also evaluate the safety of LB-DTK-BKV using treatment-emergent adverse events (TEAEs). The main questions it aims to answer are:\n\n* Does LB-DTK-BKV reduce the number of BKV virus viral load in allo-HSCT patients with hemorrhagic cystitis?\n* Do adverse events occur after the second dose? Researchers will compare LB-DTK-BKV to a placebo to see if LB-DTK-BKV works to treat hemorrhagic cystitis in allo-HSCT patients.\n\nParticipants will:\n\n* Receive a single intravenous infusion of LB-DTK-BKV at the baseline visit (low dose: 1x10\\^7\u002Fm\\^2; high dose: 2x10\\^7\u002Fm\\^2).\n* Receive the second dose of LB-DTK-BKV intravenously at the same dose 14 days after the first dose.\n* Visit the clinic every week for follow-up for 6 months after the first dose.",[27],"Hemorrhagic Cystitis",[29,27,30,31,32,33,34,35],"BK-Virus","Virus-specific T cells","Allogeneic Hematopoietic Stem Cell Transplantation","Stem Cell Transplant","Virus Diseases","Infections","Cystitis","NOT_YET_RECRUITING","2026-06-15",{"date":39,"type":40},"2026-06-17","ACTUAL",{"date":42,"type":20},"2026-09-01",{"date":44,"type":20},"2028-03-01",{"name":46,"class":47},"LucasBio","INDUSTRY",9,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":21,"phases":60,"briefSummary":62,"conditions":63,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":5},"100531339","moxibustion-for-the-prevention-of-hemorrhagic-cystitis-after-allo-hsct-100531339","NCT06198517","Moxibustion for the Prevention of Hemorrhagic Cystitis After Allo-HSCT","Clinical Study of Moxibustion for the Prevention of Hemorrhagic Cystitis After Allogeneic Hematopoietic Stem Cell Transplantation","Inclusion Criteria:\n\n1. Patients are fully aware of the study, participate voluntarily and sign the informed consent form (ICF);\n2. Age: 14-60 years;\n3. Patients with pernicious blood diseases undergoing allo-HSCT using the MAC protocol or patients with severe aplastic anemia (Severe aplastic anemia; severeaplasticanimin, SAA) undergoing allo-HSCT;\n\nExclusion Criteria:\n\n1. refuse to participate in this clinical study;\n2. The corresponding skin at the moxibustion site is broken or sensitive;\n3. allo-HSCT pretreated with the RIC program;","14 Years","60 Years",{"count":59,"type":20},266,[61],"NA","This study was a prospective, multicenter, randomized controlled clinical study planned to recruit 266 hematological patients with allogeneic hematopoietic stem cell transplantation (allo-HSCT), who were randomly divided into two groups according to gender, type of transplantation, and type of primary disease. The control group was treated conventionally, and the experimental group increased moxibustion of Zhongji, Guanyuan and Qihai for 30 min qd starting on the first day after HSCT was performed until the 14th day after transplantation. Urine routine tests were performed at the time of admission, +1d, and +14d, and urine BK virus, JC virus, and adenovirus were tested at four time points, namely, +1d, +14 days, onset of hematuria symptoms, and remission of HC, respectively; routine urine tests were performed once every 7 days for all patients within 100days. For patients with Hemorrhagic cystitis (HC), daily severity grading, pain scoring, cystitis symptom scoring, use of antispasmodic and analgesic medications, and major TCM evidence were recorded with the aim of evaluating the efficacy of moxibustion in the prevention of HC in this patient population.",[64,65,27,66],"Moxibustion","Hematopoietic Stem Cell Transplantation","Prevention","RECRUITING","2026-03-09",{"date":70,"type":40},"2026-03-12",{"date":72,"type":40},"2024-03-21",{"date":74,"type":20},"2026-09-30",{"name":76,"class":77},"Yi Zhang","OTHER",{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":16,"minAge":86,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":21,"phases":89,"briefSummary":91,"conditions":92,"keywords":99,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":5},"100495100","phase-3-the-role-of-preoperative-immunonutrition-on-morbidity-and-immune-response-after-cystectomy-incyst-trial-100495100","NCT05726786","The Role of Preoperative Immunonutrition on Morbidity and Immune Response After Cystectomy (INCyst Trial)","The Role of Preoperative Immunonutrition on Morbidity and Immune Response After Cystectomy - A Multicenter Randomized Controlled Trial (INCyst Trial)","INCyst","Inclusion Criteria:\n\n* Patient undergoing open cystectomy (for all reasons)\n* Age ≥18 years\n* Ability and willingness to provide informed consent documented by signature\n\nExclusion Criteria:\n\n* Contraindications to IN, e.g. known hypersensitivity or allergy to lactose, fish oil or soy lecithin\n* Severe diarrhoea requiring medical attention\n* Current treatment with any immunosuppressive drug\n* In standard practice, pregnant or lactating women are systematically rejected by the surgeon for this surgical procedure. Furthermore, during the pre-surgical anaesthesia consultation, the eligibility of each patient for anaesthesia will be assessed according to the usual criteria and recommendations of the anaesthesia service of the CHUV\n* Other clinically significant concomitant disease affecting immunity (e.g., severe renal failure, HIV, SLE, transplant recipient, ...)\n* Inability to follow the procedures of the study, e.g. due psychological disorders, dementia, etc.\n* Participation in another study with investigational drug within the 30 days preceding and during the present study\n* Previous enrolment into the current study\n* Use of IN independently of the study\n* Enrolment of the investigator, his\u002Fher family members, employees and other dependent persons\n* Emergency procedure (less than 7 days between screening and surgery)","18 Years",{"count":88,"type":20},232,[90],"PHASE3","The goal of this clinical trial research study is to evaluate the impact of preoperative oral immunonutrition (IN) on post-operative complications in patients undergoing a cystectomy.\n\nAs a secondary focus, this study will aim to develop a signature that would identify patients that would benefit the most from IN.\n\nThis is a multicentric (Swiss: N=3), prospective, controlled, pragmatic, parallel-group comparative study with block randomization stratified by centers.",[93,94,95,96,27,97,98],"Bladder Cancer","Interstitial Cystitis","Painful Bladder Syndrome","Neurogenic Bladder","Endometriosis","Bladder Disease",[100,101,102,103],"Cystectomy","Immunonutrition","Complication","Malnutrition","2025-12-02",{"date":106,"type":40},"2025-12-09",{"date":108,"type":40},"2023-04-10",{"date":110,"type":20},"2026-10",{"name":112,"class":77},"Centre Hospitalier Universitaire Vaudois",{"id":114,"slug":115,"hasResults":11,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":4,"eligibilityCriteria":119,"healthyVolunteers":11,"sex":16,"minAge":86,"maxAge":120,"enrollmentInfo":121,"targetDuration":4,"studyType":21,"phases":123,"briefSummary":124,"conditions":125,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":136},"100534626","moxibustion-in-the-treatment-of-hemorrhagic-cystitis-after-allo-hsct-100534626","NCT06241274","Moxibustion in the Treatment of Hemorrhagic Cystitis After Allo-HSCT","Clinical Study of Moxibustion in the Treatment of Hemorrhagic Cystitis After Allogeneic Hematopoietic Stem Cell Transplantation","Inclusion Criteria:\n\n1. patients were fully aware of the study, participated voluntarily, and signed the informed consent form;\n2. Age: 18-55 years old;\n3. patients with hemorrhagic cystitis after allogeneic hematopoietic stem cell transplantation;\n\nExclusion Criteria:\n\n1. refusal to participate in this clinical study;\n2. broken or sensitized skin corresponding to the moxibustion site;\n3. allogeneic hematopoietic stem cell transplantationpatients pretreated with the Reduced-intensity conditioning.","55 Years",{"count":122,"type":20},60,[61],"This study was a prospective, multicenter, single-arm clinical study planned to enroll 60 patients who developed hemorrhagic cystitis after sexually allogeneic hematopoietic stem cell transplantation Patients with hemorrhagic cystitis after allogeneic hematopoietic stem cell transplantation were given symptomatic supportive treatment combined with moxibustion covering Shenque, Zhongguo, Guanyuan, and Qihai for 30 minutes every day for 14 days and urine routine was collected every day for 14 days to assess the severity of hemorrhagic cystitis and pain scores to evaluate the effectiveness of moxibustion in treating hemorrhagic cystitis after allogeneic hematopoietic stem cell transplantation.",[64,65,27,126],"Treatment","2024-07-23",{"date":129,"type":40},"2024-07-24",{"date":131,"type":20},"2024-08-15",{"date":133,"type":20},"2025-12-31",{"name":135,"class":77},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology",1]