[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"TCM Biotech International Corp.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":102},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,55,79],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"100607151","phase-3-evaluate-the-efficacy-and-safety-of-u101-oral-capsules-in-the-prevention-of-uncomplicated-rutis-in-women-100607151",false,"NCT07184827","Evaluate the Efficacy and Safety of U101 Oral Capsules in the Prevention of Uncomplicated rUTIs in Women","A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of U101 Oral Capsules in the Prevention of Uncomplicated Recurrent Urinary Tract Infections (rUTIs) in Women","U101","Inclusion Criteria:\n\n1. Provide a signed informed consent form.\n2. Non-pregnant, non-nursing females ≥ 20 and \\\u003C 76 years old.\n3. Having a history of ≥ 2 UTI events during the preceding 6 months or ≥ 3 UTI events during the preceding 12 months (including any UTI event that occurs on the date of ICF signing). At least one of the previous UTI events must have microbiologic evidence (e.g., per the investigator's judgment based on urine culture results).\n4. The last urine culture (including those conducted for suspected UTI event or retest) before the randomization has to be negative.\n5. Having a negative urinalysis result and no symptoms suggestive of a UTI on the day of randomization.\n\nExclusion Criteria:\n\n1. Females who are pregnant, nursing, have a desire for pregnancy or have a positive pregnancy test at screening.\n2. Women of childbearing potential who are unwilling or unable to use an acceptable contraceptive method to avoid pregnancy for the entire study period (use of spermicide is prohibited). Women of childbearing potential are defined as premenopausal females capable of becoming pregnant.\n3. Serum aspartate transaminase (AST), serum alanine transaminase (ALT) and serum total bilirubin \\> 1.5 x upper limit of normal (ULN).\n4. Serum creatinine \\> 1.5 x ULN.\n5. Prothrombin time (PT) or INR \\> 1.2 x ULN.\n6. Platelet counts \\\u003C 100,000\u002FμL.\n7. Serum vitamin D level \\\u003C 11 ng\u002FmL.\n8. HbA1c \\> 8.0%.\n9. Positive test for hepatitis B (both HBsAg and HBeAg), hepatitis C (anti-HCV antibody) or HIV (anti-HIV antibody).\n10. Symptoms suggestive of a systemic inflammatory response (fever \\> 38℃ or WBC count \\> 12,000) at the screening.\n11. A major functional or anatomical abnormality of the urogenital tract (e.g., renal cell carcinoma, outlet obstruction, etc.).\n12. Diagnosis of pelvic organ prolapse ≥ grade 2 (according to pelvic organ prolapse quantification POP-Q classification) without any treatment within 6 months of the screening visit.\n13. Diagnosis of complicated UTIs within 6 months of the screening visit.\n14. Residual urine volume \\> 100 mL within a month of the screening visit.\n15. History of interstitial cystitis, pelvic inflammatory disease, or chronic pelvic pain syndrome.\n16. Having any of the following procedures within a week of the screening: urinary catheterization (e.g., Foley catheter), ureteral stent, percutaneous nephrostomy, or cystostomy.\n17. Intravesical instillation of hyaluronic acid within 6 months of the screening visit.\n18. Treatment with pentosan polysulfate sodium (PPS) within 6 months of the screening visit.\n19. Use of antibiotic prophylaxis for rUTI within a month of the screening visit.\n20. Use of local hormone therapy (cream, gel, insert, ring, or tablets) in urogenital areas within a month of the screening.\n21. Any history of thrombocytopenia, hemophilia, or bladder cancer; history of endoscopy-confirmed gastrointestinal ulcers within 3 years prior to randomization.\n22. Active malignancy (under intensive cancer treatment or considered in progression) or a history of any malignancy involving the pelvic cavity within 5 years prior to randomization, with the exception of adequately treated basal cell carcinoma and cervical cancer in-situ. Subjects in stable condition will be evaluated and discussed individually with the investigator.\n23. Immunocompromised or history of organ transplant.\n24. History of allergies to pentosan polysulfate sodium.\n25. Having planned major surgery within 24 weeks after the study.\n26. Participation in any interventional clinical trial within 30 days of the screening visit.\n27. Other significant medical problem(s) or intercurrent acute illness(es) that in the opinion of the Investigators, would make participation in the study unsafe, complicate the interpretation of study outcome data, or otherwise interfere with achieving the study objective.\n28. Subjects who are illiterate.\n29. Subjects having a family history of macular degeneration or having been diagnosed with macular degeneration (except for those with asymptomatic age-related macular degeneration) .","FEMALE","20 Years","75 Years",{"count":21,"type":22},348,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","The goal of this clinical trial is to learn if drug U101 works to prevent recurrent urinary tract infection (rUTI) in women (≥ 20 and \\\u003C 76 years old) with a medical history. It will also investigate the safety and the impact on the Quality of Life improvement of drug U101. The main questions it aims to answer are:\n\n* Does the drug prevent or decrease the recurrence of urinary tract infection (UTI) during the 24-week treatment?\n* Will the Quality of Life be improved during the 24-week treatment?\n* What medical problems do participants have when taking drug U101?\n\nResearchers will compare drug U101 to a placebo (a look-alike substance that contains no drug) to see if drug U101 works to prevent rUTI.\n\nParticipants will:\n\n* Orally take drug U101 or placebo every day for 24 weeks in the main study, three times per day (TID) for 8 weeks and twice per day (BID) for 16 weeks.\n* Visit the site once every 4 weeks for checkups and tests during the main study.\n* be asked to enroll in extensional study (the open-label extension (OLE) with drug U101 treatment or the Safety Follow-Up Visits with no investigational product treatment) for 24 weeks after they complete the 24-week main study.\n* Visit the site when the suspected UTI occurred during the main study or the extension study.",[28],"Recurrent Urinary Tract Infections in Women",[30,31,32,33,34,35,36,37,38,39,40,41],"recurrent urinary tract infections","recurrent urinary tract infections in women","rUTI","UTI","rUTIs","UTIs","pentosan polysulfate sodium","PPS","Glycosaminoglycan","Glycosaminoglycans","GAG","GAGs","RECRUITING","2025-09-14",{"date":45,"type":46},"2025-09-22","ACTUAL",{"date":48,"type":46},"2020-10-14",{"date":50,"type":22},"2028-07-31",{"name":52,"class":53},"TCM Biotech International Corp.","INDUSTRY",13,{"id":56,"slug":57,"hasResults":11,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":4,"eligibilityCriteria":61,"healthyVolunteers":11,"sex":62,"minAge":18,"maxAge":19,"enrollmentInfo":63,"targetDuration":4,"studyType":23,"phases":65,"briefSummary":67,"conditions":68,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},"100510719","evaluate-the-efficacy-and-safety-of-livphcd-capsules-in-the-nafld-subjects-100510719","NCT05930093","Evaluate the Efficacy and Safety of LivPhcD Capsules in the NAFLD Subjects","Multi-center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of LivPhcD Capsules in the NAFLD Subjects","Inclusion Criteria:\n\n1. Male or female between 20 and 75 years of age.\n2. Capable of giving written informed consent and able to effectively communicate with the investigator and study personnel.\n3. Has a body mass index (BMI) ≥20 kg\u002Fm\\^2 and ≤50 kg\u002Fm\\^2 and stable weight for the past 3 months\n4. CAP ≥ 238 db\u002Fm\n5. Fibro scan (transient elastography) F0\\~F3\n\nExclusion Criteria:\n\n1. Pregnant or breastfeeding or planning to become pregnant or unwilling to use an acceptable contraceptive method to avoid pregnancy during the study period\n2. Type 1 diabetes mellitus.\n3. History of other causes of chronic liver disease \\[autoimmune, primary biliary cirrhosis, HBV (HBsAg positive) and HCV, Wilson disease, alpha-1-antitrypsin deficiency, hemochromatosis etc.\n4. Use of medications that could induce steatosis, such as estrogen or other hormonal replacement therapy, amiodarone, methotrexate, tamoxifen, raloxifene, pharmacological doses of oral glucocorticoids (≥10 mg per day of prednisone or equivalent), or chloroquine.\n5. Use of vitamin E (doses ≥800 IU\u002Fdy) or pioglitazone or SGLT2 inhibitor or GLP-1 agonists any FDA-approved drug for NASH to be approved during the study.\n6. Has significant systemic or major illnesses other than liver disease, ex: recent events (≤6 months before study entry) of congestive heart failure, unstable coronary artery disease, serious COPD, renal failure and need hemodialysis, stroke, transient ischemic attack, or organ transplantation\n7. Known alcohol abuse or alcohol use disorder (\\>20 g\u002Fday for women; \\>30 g\u002Fday for men)\n8. Has the abnormal data including: fasting TG \\>400 mg\u002FdL ; ALT or GGT\\>5.0 x ULN；Bilirubin \\>2 x ULN，unless due to an alternative etiology such as Gilbert's syndrome; INR ≥1.3; Albumin \\\u003C LLN; Platelet \\\u003C0.95x LLN\n9. Subjects with hemoglobin A1c (HbA1c) \\>8.5% within 3 months before study entry\n10. Plan to have major surgery during the study period (bariatric surgery, biliary diversion surgery)\n11. Participation in any other investigational clinical trial within 30 days of entry to this protocol(including drugs, medical devices, novel medical technologies, food, and lifestyle interventions affecting diet, exercise, and circadian rhythm investigational clinical trial.);\n12. History of HIV","ALL",{"count":64,"type":22},108,[66],"NA","Non-alcoholic fatty liver disease (also called NAFLD) is a disease in which excessive fat accumulates in the liver of a patient without a history of alcohol abuse. Early-stage NAFLD does not usually cause any harm but nonalcoholic steatohepatitis (NASH) can lead to serious liver damage, including fibrosis or cirrhosis. Nearly 25% of the world's population is affected by NAFLD.\n\nThere are no FDA-approved medications for the treatment of NAFLD currently and although lifestyle modifications with appropriate diet and exercise have been shown to be beneficial, this has been difficult to achieve and sustain for the majority of patients.\n\nLivPhcD™ capsule have shown hepatoprotective effects in both animal and human data. This study aims to investigate the effects of LivPhcD™ capsule in hepatocellular lipid content using Fibroscan.",[69],"NAFLD","2025-04-07",{"date":72,"type":46},"2025-04-10",{"date":74,"type":46},"2023-12-07",{"date":76,"type":22},"2026-05-01",{"name":52,"class":53},1,{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":62,"minAge":18,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":23,"phases":88,"briefSummary":91,"conditions":92,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":78},"100348138","phase-1-a-study-of-ptx-9908-injection-for-non-resectable-hcc-with-tace-100348138","NCT03812874","A Study of PTX-9908 Injection for Non-resectable HCC with TACE","Phase I\u002FII Study of PTX-9908 Injection As an Inhibitor of Cancer Progression in Patients with Non-resectable Hepatocellular Carcinoma Following Transarterial Chemoembolization Treatment","Inclusion Criteria:\n\n1. Unresectable hepatocellular carcinoma and at intermediate-stage HCC (BCLC stage B or Child-Pugh class A\u002FB with large or multifocal HCC, no vascular invasion, or extrahepatic spread) with completed TACE procedure in 4 weeks before day 1 of study intervention infusion.\n2. Recovered from TACE treatment and procedure related toxicities including ALT\u002FAST and bilirubin within normal limit or reference numeric value (reference value is defined as the test value before TACE procedure).\n3. ECOG (Eastern Cooperative Oncology Group) performance status \\\u003C 2.\n4. Have adequate organ and marrow function as defined below:\n\n   1. Absolute neutrophil count \\> 1,200\u002FµL\n   2. Hemoglobin \\> 9 g\u002FdL\n   3. Platelets \\> 100,000\u002FµL\n   4. Total bilirubin \\\u003C 2 X ULN\n5. Have adequate kidney function as estimated glomerular filtration rate (eGFR) \\> 60 mL\u002Fmin\u002F1.73m2\n6. A negative pregnancy test at screening. This applies to any female patient with childbearing potential.\n7. Agree to use adequate contraception after signing informed consent form, during the duration of study participation and for at least 4-weeks after completion or withdrawal from the study. This applies to any female patient with childbearing potential and any male patient whose female partner has childbearing potential.\n\n   Acceptable contraceptive methods include:\n   1. Established use of oral, injected or implanted hormonal methods of contraception\n   2. Placement of an intrauterine device (IUD) or intrauterine system (IUS)\n   3. Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical\u002Fvault caps) \\>=20 years of age. (Note: In Taiwan, age of majority recognized in law is 20 years of age)\n8. \\>=20 years of age. (Note: In Taiwan, age of majority recognized in law is 20 years of age)\n9. Anticipated life expectancy of \\>= 6 months at assessment during screening.\n10. Ability to understand and have signed a written informed consent document.\n\nExclusion Criteria:\n\n1. 1\\. Patient with Child-Pugh B8-9.\n2. Patient who has had anti-cancer therapy including surgery, radiotherapy, immunotherapy, or chemotherapy (except in TACE regimen) within 4 weeks prior to the screening visit.\n3. Patient who has received any other investigational agents within 4 weeks prior to the screening visit.\n4. Patient who has not recovered from the side effects of the earlier investigational agent or had anti-cancer therapy including surgery, radiotherapy, immunotherapy, or chemotherapy.\n5. Patient with known brain metastases, leptomeningeal or epidural metastases (unless treated and well controlled for \\>= 3 months).\n6. Patient with prior history of co-malignancies, except for adequately treated carcinoma in situ of the cervix, ductal carcinoma in situ (DCIS) of the breast, and basal cell\u002Fsquamous cell skin cancer.\n7. Patient with history of myocardial infarction or uncontrolled cardiac dysfunction, or unstable arrhythmia or symptomatic peripheral arterial vascular disease.\n8. Patient with history of positive serology for human immunodeficiency virus (HIV).\n9. Patient with active, uncontrolled bacterial, viral, or fungal infections, which require systemic therapy.\n10. Patient with poor liver function as indicated by serum bilirubin \\> 2 mg\u002FdL, Child-Pugh Class C, severe coagulopathy (INR \\> 2) not correctable with vitamin K, or active hepatic encephalopathy.\n11. Patient with known allergic reactions to biological agent or polypeptides similar to PTX-9908 Injection.\n12. Woman who is pregnant or nursing.\n13. Patient with concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the patient in this study.\n14. Patient with unwillingness or inability to comply with the study protocol for any reason.\n15. A marked baseline prolongation of QT\u002FQTc interval (e.g., repeated demonstration of a QTc interval \\>480 milliseconds (ms) (CTCAE grade 1) using Frederica's QT correction formula\n16. A history of additional risk factors for torsades de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)\n17. The use of concomitant medications that prolong the QT\u002FQTc interval",{"count":87,"type":22},50,[89,90],"PHASE1","PHASE2","This is a multicenter, Phase I\u002FII study in patients with non-resectable hepatocellular carcinoma following TACE treatment.\n\nPhase I (Open-label dose escalation)\n\nThis study will be an open-label study with an Accelerated Phase and a Standard Phase. For the Accelerated Phase of the study, one patient per dose level (1 mg\u002Fkg, and 2 mg\u002Fkg) is planned. For the dose levels in the standard phase (4 mg\u002Fkg, 8 mg\u002Fkg and 16 mg\u002Fkg), it will follow the Fibonacci's rule of 3 + 3 design. All eligible patients who have received TACE treatment and recovered well, will be administrated PTX-9908 Injection intravenously one dose per day for 5 days on Week 1 (excludes weekends and public holidays), and one dose per week (on Day 8, Day 15, and Day 22) for 3 consecutive weeks. The 4-week treatment period, will be followed by a 2-week follow-up period.\n\nPhase II (Randomized placebo controlled dose expansion)\n\nThe objective of phase II is to further evaluate the safety, tolerability and antitumor activity of PTX-9908 Injection for patients with non-resectable hepatocellular carcinoma following TACE treatment. Approximately 24 eligible patients who have received TACE treatment and recovered, will be randomized to PTX-9908 Injection using the predetermined dose in phase I or the vehicle placebo in a 2:1 ratio. PTX-9908 Injection or placebo will be administered intravenously one dose per day for 5 days in Week 1 (excludes weekends and public holidays), and one dose per week till Week 12 (Day 78). The 12-week treatment period, will be followed by a 2-week follow-up period.",[93],"Carcinoma, Hepatocellular","2024-11-18",{"date":96,"type":46},"2024-11-21",{"date":98,"type":46},"2020-10-06",{"date":100,"type":22},"2026-12-30",{"name":52,"class":53},""]