[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"randomized\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:randomized":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,45,80,106],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100644443","phase-1-a-randomized-multicenter-open-label-active-controlled-phase-ib-study-to-evaluate-the-safety-tolerability-pharmacokinetics-and-preliminary-efficacy-of-multiple-intravaginal-doses-of-gensci142-in-patients-with-bacterial-vaginosis-bv-100644443",false,"NCT07663838","A Randomized, Multicenter, Open-label, Active-controlled Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Multiple Intravaginal Doses of GenSci142 in Patients With Bacterial Vaginosis (BV)","Inclusion Criteria:\n\n1. Women of childbearing age aged 18-50 years (inclusive of the cut-off values, as of the date of signing the informed consent form), with a history of sexual activity and a regular menstrual cycle (21-35 days, inclusive of the cut-off values);\n2. Screening visits were conducted for women clinically diagnosed with bacterial vaginosis who had not received any treatment for bacterial vaginosis since the onset of their current symptoms. The clinical diagnostic criteria for bacterial vaginosis are as follows:\n\n   1. At least one clinical symptom (itching, odour, abnormal vaginal discharge),\n   2. and at least three positive findings on the Amsel clinical assessment (with clue cells constituting more than 20% of the total vaginal epithelial cells being a mandatory criterion),\n   3. and a Nugent score of ≥7;\n3. Trial participants must agree to abstain from sexual intercourse for 48 hours prior to the first administration of the investigational medicinal product, throughout the treatment period, and for 48 hours prior to each return visit;\n4. be willing to use vaginal administration and agree to avoid the use of any vaginal products not specified in the trial protocol (such as contraceptive creams, gels, foams, sponges, lubricants, douches, tampons, etc.) throughout the trial period;\n5. Trial participants must voluntarily sign a written informed consent form prior to the trial;\n6. Trial participants must be able to understand the procedures and methods of this trial and be willing to strictly adhere to the clinical trial protocol to complete the trial.\n\nExclusion Criteria:\n\nMedical History\n\n1. Those currently suffering from any acute infection of the urinary or reproductive system, including but not limited to pelvic inflammatory disease, cervicitis, endometritis, and adnexitis;\n2. Those currently suffering from vulvovaginitis caused by other pathogens, including but not limited to Aerobic vaginitis, vulvovaginal candidiasis, trichomoniasis, gonorrhoea, genital herpes, and genital warts;\n3. Current presence of other vaginal or vulvar conditions, or being in the recovery phase following reproductive system surgery, where the investigator considers this to affect the trial evaluation;\n4. Patients currently receiving, or who will require during the trial, medications that reduce or antagonise oestrogen levels, such as gonadotropin-releasing hormoneagonists, high-potency progestogens and combined oral contraceptives;\n5. Patients with a history of or currently suffering from major diseases such as cardiovascular, hepatic, renal, pulmonary, gastrointestinal, neurological, metabolic, urogenital, endocrine or psychiatric disorders, where the investigator considers inclusion inappropriate;\n6. Women who are pregnant, breastfeeding, or have tested positive for pregnancy; or those planning to become pregnant during the trial; or those unable to use reliable contraception during the study;\n7. Individuals with impaired immunity or immune dysfunction, including but not limited to those currently undergoing treatment for malignant tumours, those with autoimmune diseases, or those currently using immunosuppressants;\n8. Participants with abnormal uterine bleeding, including prolonged menstrual periods (\\>7 days);\n9. Those who are menstruating at the time of the screening visit or who are expected to commence menstruation within 14 days;\n10. Participants who have received treatment with inhalational anaesthetics, antispasmodic anti-diarrhoeal agents, kaolin-containing anti-diarrhoeal agents, muscle relaxants, chloramphenicol or erythromycin, or opioid analgesics within 7 days prior to screening;\n11. Participants who had received treatment with topical or systemic broad-spectrum antibiotics (excluding nitroimidazole antibiotics that do not affect Lactobacillus) within 1 month prior to screening;\n12. Those who have undergone vaginal douching or other vaginal procedures involving antiseptic treatment within 1 month prior to screening;\n13. A history of severe allergy to the investigational medicinal product, any of its excipients, or vaginal effervescent preparations; or a predisposition to allergies (e.g. allergy to two or more medicines or foods); Diet and lifestyle\n14. Those with an average daily cigarette consumption of ≥5 cigarettes in the 30 days prior to screening;\n15. Those who have consumed more than 5 litres of beer, 600 ml of spirits with an alcohol content of 40%, or 2 litres of wine per week within the 6 months prior to screening; History of substance abuse or dependence\n16. History of substance abuse within the past year (e.g. cannabis, benzodiazepines, ketamine, morphine, cocaine, methamphetamine); Screening examinations\n17. Participants with clinically significant abnormalities or vaginal mucosal lesions (e.g. mucosal oedema, congestion, ulcers, erosions) identified during the screening colposcopy, as judged by the investigator, which may affect drug administration;\n18. During the screening period, based on an assessment of medical history, vital signs, physical examination, clinical laboratory tests and ancillary investigations, the investigator considers the subject's general health status unsuitable for inclusion;\n19. Participants with positive results in infectious disease screening \\[Hepatitis B surface antigen, Hepatitis C antibody, Human Immunodeficiency Virus antibody, or positive syphilis serology\\]; Other\n20. Participants who have participated in other clinical trials of medicinal products or medical devices within the 3 months prior to screening and have used the investigational medicinal product or device; or who participated in a clinical study 3 months prior but are still within the follow-up period of that study or within 5 half-lives of the investigational medicinal product (whichever is longer) at the time of screening;\n21. The investigator considers that the trial participant has any other condition rendering them unsuitable for participation in the trial, or any other medical condition that may impair the participant's ability to tolerate the investigational medicinal product or to continue with the procedures specified in this study.","FEMALE","18 Years","50 Years",{"count":19,"type":20},30,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","A randomized, multicenter, open-label, active-controlled Phase Ib study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of multiple intravaginal doses of GenSci142 in patients with bacterial vaginosis (BV).",[26,27,28,29,30,31],"Randomized","Open-label","Safety","Tolerability","Pharmacokinetics","Bacterial Vaginosis","NOT_YET_RECRUITING","2026-06-17",{"date":35,"type":36},"2026-06-23","ACTUAL",{"date":38,"type":20},"2026-06-15",{"date":40,"type":20},"2027-05-05",{"name":42,"class":43},"Changchun GeneScience Pharmaceutical Co., Ltd.","INDUSTRY",7,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":53,"minAge":16,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":56,"briefSummary":58,"conditions":59,"keywords":65,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":79},"100628199","phase-2-neoadjuvant-chemoradiotherapy-plus-tislelizumab-with-or-without-probio-m9-in-pmmrmss-locally-advanced-rectal-cancer-100628199","NCT07458529","Neoadjuvant Chemoradiotherapy Plus Tislelizumab With or Without Probio-M9 in pMMR\u002FMSS Locally Advanced Rectal Cancer","Neoadjuvant Chemoradiotherapy Combined With Tislelizumab With or Without Probio-M9 in pMMR\u002FMSS Locally Advanced Middle and Low Rectal Cancer: A Single-Center, Prospective, Randomized Controlled Trial (NCRIT-PM9 Trial)","NCRIT-PM9","Inclusion Criteria:\n\n* Age ≥ 18 years\n* ECOG performance status 0-2\n* Biopsy-proven rectal adenocarcinoma\n* Distal tumor margin within 10 cm of the anal verge\n* No distant metastasis\n* Clinical stage II or III based on MRI (T4b excluded)\n* Maximum diameter of rectal tumor ≥ 10 mm on baseline CT or MRI (measurable lesion according to RECIST 1.1)\n* Willing and able to comply with the study protocol\n* Willing to provide blood and tissue specimens for research purposes\n* No prior anti-tumor treatment (e.g., radiotherapy, chemotherapy, immunotherapy, biological therapy, or herbal therapy)\n* No history of immune system disorders (e.g., systemic lupus erythematosus, rheumatoid arthritis, systemic vasculitis, scleroderma, pemphigus, dermatomyositis, mixed connective tissue disease, autoimmune hemolytic anemia, thyroid autoimmune disease, ulcerative colitis, HIV infection, etc.)\n* No significant dysfunction of major organs (heart, lung, liver, kidney)\n* No jaundice or gastrointestinal obstruction\n* No acute or ongoing infection\n* Adequate hematologic and biochemical function including:\n\n  * Neutrophils ≥ 1.5 × 10\\^9\u002FL\n  * Hemoglobin ≥ 80 g\u002FL\n  * Platelets ≥ 100 × 10\\^9\u002FL\n  * Serum creatinine ≤ 1.5 × ULN\n  * Total bilirubin ≤ 1.5 × ULN\n  * ALT and AST ≤ 2.5 × ULN\n* No social or psychiatric disorders that may interfere with study participation\n* Women of childbearing potential must have a negative pregnancy test before enrollment and must use effective contraception from study entry until 60 days after the last dose of study drug\n\nExclusion Criteria:\n\n* History of multiple primary cancers or concomitant malignant tumors other than rectal cancer\n* Receipt of any anti-cancer treatment (e.g., surgery, chemotherapy, radiotherapy, or other systemic therapies) within the past 5 years\n* History of recent major surgery\n* Conditions that may affect the gastrointestinal absorption of capecitabine (e.g., inability to swallow, persistent nausea or vomiting, chronic diarrhea)\n* Uncontrolled or severe concomitant diseases of any kind\n* Known allergy or hypersensitivity to any components of the study drugs\n* Estimated life expectancy ≤ 5 years due to any cause\n* Planned or prior organ or bone marrow transplantation\n* Use of immunosuppressive therapy or systemic corticosteroids for immunosuppressive purposes within 1 month prior to enrollment\n* History of central nervous system disorders that may impair the ability to provide informed consent or affect compliance with oral medication (investigator discretion)\n* Other conditions that may interfere with study results or lead to premature discontinuation of study treatment (e.g., alcoholism or drug abuse)\n* Pregnant or breastfeeding women, or women planning to become pregnant during the treatment period","ALL",{"count":55,"type":20},50,[57],"PHASE2","This prospective, single-center, randomized controlled trial aims to assessing the efficacy and safety of neoadjuvant chemoradiation plus Tislelizumab (PD-1 inhibitor) with or without Probio-M9 and subsequent TME surgery, by comparing assorted endpoints between two experiment groups (Experiment group 1: chemoradiation+PD-1 inhibitor+Probio-M9; Experiment group 2: chemoradiation+PD-1 inhibitor+placebo) with a control group (chemoradiation only).",[60,61,62,63,64,26],"Rectal Cancer, Adenocarcinoma","Neoadjuvant Therapy","Immunotherapy","Probio-M9","Tislelizumab",[63,66,67],"tislelizumab","locally advanced rectal cancer","RECRUITING","2026-03-08",{"date":71,"type":36},"2026-03-10",{"date":73,"type":36},"2026-02-10",{"date":75,"type":20},"2030-12-01",{"name":77,"class":78},"Seventh Medical Center of PLA General Hospital","OTHER",1,{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":86,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":4,"studyType":21,"phases":91,"briefSummary":93,"conditions":94,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":105},"100615179","randomized-clinical-trial-comparing-transurethral-prostate-resection-turp-and-echolaser-soractelite-tpla-transperineal-laser-ablation-in-patients-with-lower-urinary-tract-symptoms-due-to-benign-prostatic-obstruction-100615179","NCT07289243","RANDOMIZED CLINICAL TRIAL COMPARING TRANSURETHRAL PROSTATE RESECTION (TURP) AND ECHOLASER SORACTELITE-TPLA (TRANSPERINEAL LASER ABLATION) IN PATIENTS WITH LOWER URINARY TRACT SYMPTOMS DUE TO BENIGN PROSTATIC OBSTRUCTION","Inclusion Criteria:\n\n* age, Lower urinary tract simptoms (IPSS \\>= 8), uncompliance or no achived drugs treatment for IPB, prostate volume 40ml-80ml , ability to express informed consent.\n\nExclusion Criteria:\n\n* previous surgical tretment for IPB, bladder catheter, bladder stones, urinary or seminal infections, hypo-\u002Fa-contractilitis of bladder, bladder tuomrs, urethral stricture, neurological bladder, refuse to sign informed consent","MALE","40 Years","85 Years",{"count":90,"type":20},80,[92],"NA","THIS STUDY IS A RANDOMIZED CLINICAL TRIAL COMPARING TRANSURETHRAL PROSTATE RESECTION (TURP) AND ECHOLASER SORACTELITE-TPLA (TRANSPERINEAL LASER ABLATION) IN PATIENTS WITH LOWER URINARY TRACT SYMPTOMS DUE TO BENIGN PROSTATIC OBSTRUCTION. THE PRIMARY GOAL IS TO SHOW THE NON-INFERIORITY OF TPLA VERSUS TURP BY IPSS-SCORE.",[95],"RANDOMIZED","2025-12-04",{"date":98,"type":36},"2025-12-17",{"date":100,"type":36},"2024-07-14",{"date":102,"type":20},"2026-12-25",{"name":104,"class":78},"Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari",2,{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":53,"minAge":16,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":21,"phases":116,"briefSummary":117,"conditions":118,"keywords":121,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":79},"100558893","the-analgesic-efficacy-of-pericapsular-nerve-group-peng-block-in-patients-undergoing-primary-total-hip-arthoplasty-100558893","NCT06557044","The Analgesic Efficacy of Pericapsular Nerve Group (PENG) Block in Patients Undergoing Primary Total Hip Arthoplasty:","The Analgesic Efficacy of Pericapsular Nerve Group (PENG) Block in Patients Undergoing Primary Total Hip Arthoplasty: a Prospective, Double-blinded, Randomized Controlled Trial","PENG","Inclusion Criteria:\n\n* planned cementless hip TEP operation for primary coxarthrosis via minimally invasive anterolateral approach using the identical implant system (Taperloc stem, Plamafit cup)\n* Patient capable of giving consent\n* Informed consent has been obtained\n* age \\> 18 years\n\nExclusion Criteria:\n\n* Refusal to participate in the study\n* Regular use of opioids\n* Known chronic pain symptoms\n* Infections in the area of the puncture site\n* Presence of a contraindication to ropivacaine\n* Presence of a contraindication to metamizole\n* Presence of a contraindication to postoperative analgesia with diclofenac\n* Secondary forms of osteoarthritis with deformities (i.e. high-grade dysplasia, secondary conditions after trauma, secondary conditions after childtrauma, secondary conditions after childhood hip joint diseases\n* Spinopelvic dysbalance, spinal canal stenosis\n* Previous operations on the hip\u002Fpelvis",{"count":115,"type":20},110,[92],"The aim of this study is to investigate the analgesic efficacy of the pericapsular nerve group (PENG) block during the implantation of hip endoprostheses. The study is designed as a prospective randomized double-blind study and the study participants were randomized into 2 arms and either 20 ml ropivacaine 0.5% (verum group) or 20 ml physiological saline solution (placebo group) will be applied.",[119,26,120],"Prospective","Double-blind",[122,123],"Pericapsular Nerve Group Block","hip endoprostheses","2024-08-13",{"date":126,"type":36},"2024-08-16",{"date":128,"type":36},"2024-03-07",{"date":130,"type":20},"2025-03",{"name":132,"class":78},"Diakonie-Klinikum Stuttgart"]