[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Shandong University\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":592},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,29,0,25,[9,48,75,99,120,145,167,188,210,234,257,286,307,335,358,379,400,422,442,466,485,499,525,544,570],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100644201","one-click-autofocus-versus-segmented-focus-in-gastric-endoscopy-100644201",false,"NCT07664813","One-Click Autofocus Versus Segmented Focus in Gastric Endoscopy","A Comparative Study of One-Click Autofocus Versus Segmented Focus Techniques Under Magnifying Endoscopy for Gastric Diseases: A Tandem Randomized Controlled Trial","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Patients with gastric diseases (e.g., suspicious lesions, known gastric disorders) requiring further magnifying endoscopy examination\n* Ability to understand and provide written informed consent voluntarily\n\nExclusion Criteria:\n\n* Absolute contraindications to upper gastrointestinal endoscopy (e.g., severe cardiopulmonary insufficiency, coagulopathy)\n* Pregnant or lactating women\n* History of gastric surgery (e.g., gastrectomy) that may affect endoscopic manipulation or anatomy","ALL","18 Years",{"count":20,"type":21},93,"ESTIMATED","INTERVENTIONAL",[24],"NA","Magnifying endoscopy provides high-resolution images that enhance the detection of early gastrointestinal lesions. However, conventional manual zoom techniques require frequent focal adjustments, which can be technically demanding and may compromise image stability, especially in complex anatomical settings.\n\nThis study evaluates a novel one-click autofocus system based on image recognition and computer vision algorithms. The system automatically adjusts focal distance within seconds, eliminating the need for manual operation. This trial aims to compare the efficiency and image quality of one-click autofocus versus segmented manual focus in patients undergoing magnifying endoscopy for gastric diseases.\n\nA tandem randomized controlled trial will be conducted to assess procedure time, image clarity score, and operator satisfaction between the two techniques.",[27,28],"Stomach Neoplasms","Stomach Diseases",[30,31,32,33,34],"Magnifying Endoscopy","Gastroscopy","One-Click Autofocus","Segmented Focus","Image Quality","NOT_YET_RECRUITING","2026-06-23",{"date":38,"type":39},"2026-06-24","ACTUAL",{"date":41,"type":21},"2026-06-18",{"date":43,"type":21},"2026-08-15",{"name":45,"class":46},"Shandong University","OTHER",1,{"id":49,"slug":50,"hasResults":12,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":12,"sex":55,"minAge":18,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":4},"100642681","phase-2-fluzoparib--bevacizumab-vs-olaparib--bevacizumab-for-maintenance-therapy-in-hrd-positive-advanced-ovarian-cancer-100642681","NCT07647653","Fluzoparib + Bevacizumab vs Olaparib + Bevacizumab for Maintenance Therapy in HRD-Positive Advanced Ovarian Cancer","A Multicenter, Randomized, Open-Label Exploratory Study of Fluzoparib Plus Bevacizumab Versus Olaparib Plus Bevacizumab for Maintenance Therapy After First-Line Platinum-Based Chemotherapy in Patients With HRD-Positive Advanced Ovarian Cancer","Inclusion Criteria:\n\n1. The participant voluntarily agrees to take part in the study, signs the informed consent form, demonstrates good treatment compliance, and is willing to complete scheduled follow-up.\n2. Female participants aged ≥ 18 years (age calculated on the date of signing the informed consent form).\n3. Newly pathologically diagnosed high-grade (or moderately\u002Fpoorly differentiated) serous ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma; or grade II and higher ovarian endometrioid adenocarcinoma.\n\n   For mixed tumors: The proportion of high-grade serous component or grade II+ endometrioid component must exceed 50%.\n4. Disease staged as Stage III or Stage IV per the 2018 FIGO staging system.\n5. Confirmed HRD (Homologous Recombination Deficiency)-positive status via laboratory testing.\n6. The participant has received 6 to 9 cycles of platinum-based chemotherapy. For participants who cannot tolerate chemotherapy for documented reasons, a minimum of 4 cycles of platinum-based chemotherapy is required.Prior to randomization, participants must have received bevacizumab combined with platinum-based chemotherapy for at least the final 3 cycles, with a minimum of 3 cycles of bevacizumab administration.For participants undergoing interval debulking surgery (IDS), a minimum of 2 cycles of bevacizumab combined with the final 3 cycles of platinum-based chemotherapy is acceptable.\n7. Prior to randomization, participants must have No Evidence of Disease (NED), or be assessed as having achieved Complete Response (CR) or Partial Response (PR) after first-line platinum-based chemotherapy, and maintain this status until initiation of study treatment. Randomization and study drug administration must be completed within 8 weeks after the last dose of chemotherapy.\n8. ECOG Performance Status (ECOG-PS) score: 0 or 1.\n9. Major organ function meets the following requirements. Use of any blood products or hematopoietic growth factors is prohibited within 14 days prior to randomization:\n\nAbsolute Neutrophil Count (ANC) ≥ 1.5 × 10⁹\u002FL Platelet count ≥ 90 × 10⁹\u002FL Hemoglobin ≥ 9 g\u002FdL Serum albumin ≥ 3 g\u002FdL Total bilirubin ≤ 1.5 × ULN Alanine Transaminase (ALT) and Aspartate Transaminase (AST) ≤ 2.5 × ULN Serum creatinine ≤ 1.5 × ULN 10、For women of childbearing potential: A negative serum pregnancy test result must be obtained within 72 hours prior to randomization. Participants must agree to use one medically approved contraceptive method throughout the study treatment period and for 6 months after the last dose of study drug. Participants must not be breastfeeding.\n\nExclusion Criteria:\n\n1. History of other untreated malignant tumors within the past 5 years, or concurrent untreated malignant tumors.\n\n   Exceptions: cured thyroid carcinoma, cutaneous basal cell carcinoma, cervical carcinoma in situ, and breast cancer with no recurrence for more than 3 years after radical resection.\n2. Presence of untreated central nervous system (CNS) metastases. Exception: Participants who have received definitive systemic or radical treatment (radiotherapy or surgery) for brain or meningeal metastases, with radiologically confirmed stable disease for at least 1 month, who have discontinued systemic glucocorticoid therapy (prednisone \\> 10 mg\u002Fday or equivalent glucocorticoids) for more than 2 weeks and have no associated clinical symptoms are eligible.\n3. Prior exposure to any PARP inhibitors, including but not limited to olaparib, niraparib, rucaparib, pamiparib and fluzoparib.\n4. Inability to swallow oral tablets normally, or presence of gastrointestinal dysfunction that may interfere with drug absorption, as judged by the investigator.\n5. History of intestinal obstruction or gastrointestinal perforation within the past 3 months.\n6. Symptomatic malignant ascites or pleural effusion requiring paracentesis or drainage; or history of ascites\u002Fpleural effusion drainage within 3 months prior to randomization.\n7. Uncontrolled cardiac symptoms or diseases, including:\n\n(1) Heart failure with NYHA Functional Class ≥ 2; (2) Unstable angina pectoris; (3) Myocardial infarction within the past 1 year; (4) Clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention; (5) QTc interval \\> 470 ms. 8、Coagulopathy defined as International Normalized Ratio (INR) \\> 1.5 or Prothrombin Time (PT) \\> ULN + 4 seconds; presence of bleeding diathesis, or receipt of thrombolytic or systemic anticoagulant therapy.\n\nException: Prophylactic anticoagulation with low-dose low-molecular-weight heparin or oral aspirin is allowed during the study.\n\n9、Clinically significant bleeding events or definite bleeding diathesis within 3 months prior to randomization (e.g., gastrointestinal hemorrhage, hemorrhagic gastric ulcer, vasculitis).\n\n10、If the baseline fecal occult blood test is positive, repeat testing is permitted. If the repeat test remains positive, clinical evaluation is required, and gastroscopy shall be performed if necessary.\n\n11、Presence of active ulcers, unhealed wounds or fractures. Uncontrolled hypertension despite standard antihypertensive therapy (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg).\n\n12、Any bleeding event graded ≥ Grade 2 per CTCAE v6.0 within 4 weeks prior to randomization.\n\n13、Active infection, or unexplained fever \\> 38.5 °C during the screening period or prior to randomization.\n\n14、Congenital or acquired immunodeficiency (e.g., HIV infection), or active viral hepatitis.\n\n15、Prior radiotherapy, chemotherapy, hormonal therapy or molecular targeted therapy completed less than 4 weeks before study drug administration (less than 5 drug half-lives for oral molecular targeted agents). Adverse events from previous anti-tumor therapies have not recovered to Grade ≤ 1 per CTCAE v6.0 (alopecia is excluded).\n\n16、History of arterial or venous thromboembolic events within 6 months prior to randomization, including cerebrovascular accident (transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, pulmonary embolism, etc.\n\n17、Hereditary or acquired bleeding disorders or coagulation dysfunction (e.g., hemophilia, thrombocytopenia).\n\n18、Plan to receive other systemic anti-tumor therapy during the study period. 19、Any other medical conditions or circumstances that may lead to premature termination of the study, as judged by the investigator.","FEMALE",{"count":57,"type":21},120,[59],"PHASE2","The PAOLA-1 trial demonstrated that for HRD-positive patients who received first-line chemotherapy combined with bevacizumab, sequential maintenance therapy with olaparib plus bevacizumab yielded a progression-free survival (PFS) of up to 46.8 months, with an olaparib-related treatment discontinuation rate of approximately 20%.\n\nThe combination of olaparib and bevacizumab has been recommended by multiple clinical guidelines as the first-line maintenance regimen for HRD-positive patients treated with first-line chemotherapy plus bevacizumab. This regimen has obtained approved indications and been covered by national medical insurance. In clinical practice, around 30% of patients receiving chemotherapy plus bevacizumab adopt olaparib combined with bevacizumab for first-line maintenance treatment.\n\nFluzoparib has been approved in China for first-line maintenance therapy in the overall patient population. The treatment discontinuation rate of fluzoparib plus apatinib is merely about 2%. However, there is currently no available data regarding fluzoparib combined with bevacizumab in the HRD-positive population, and the clinical value of this regimen remains to be further explored.\n\nThis study aims to generate efficacy and safety data for olaparib plus bevacizumab versus fluzoparib plus bevacizumab in HRD-positive patients who have undergone first-line chemotherapy combined with bevacizumab, so as to provide objective evidence for clinical medication decisions.",[62],"Ovarian Cancer",[62,64,65,66],"first-line maintenance","PARPi","bevacizumab","2026-06-10",{"date":69,"type":39},"2026-06-15",{"date":71,"type":21},"2026-06-30",{"date":73,"type":21},"2031-02-28",{"name":45,"class":46},{"id":76,"slug":77,"hasResults":12,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":82,"enrollmentInfo":83,"targetDuration":4,"studyType":22,"phases":85,"briefSummary":87,"conditions":88,"keywords":4,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":47},"100635949","phase-3-high-dose-dexamethasone-combined-with-orelabrutinib-versus-high-dose-dexamethasone-combined-with-placebo-in-adult-patients-with-newly-diagnosed-primary-immune-thrombocytopenia-100635949","NCT07559331","High-Dose Dexamethasone Combined With Orelabrutinib Versus High-Dose Dexamethasone Combined With Placebo in Adult Patients With Newly Diagnosed Primary Immune Thrombocytopenia","A Randomized Controlled Study of High-Dose Dexamethasone Combined With Orelabrutinib Versus High-Dose Dexamethasone Combined With Placebo in Adult Patients With Newly Diagnosed Primary Immune Thrombocytopenia","Inclusion Criteria:\n\n1. Subjects must thoroughly understand the nature, significance, potential benefits, possible inconveniences, and potential risks of the trial prior to enrollment. They must understand the study procedures and voluntarily sign the informed consent form.\n2. Male or female subjects aged 18-80 years (inclusive).\n3. Body weight ≥35 kg at screening.\n4. Adult patients with newly diagnosed, untreated primary ITP, with platelet count (PLT) \\\u003C30×10⁹\u002FL and no active bleeding in vital organs.\n5. Subjects who responded to prior treatment with oral dexamethasone 40 mg\u002Fday for 4 days, defined as meeting all three of the following criteria on any day between Day 5 and Day 7 post-treatment: ① PLT ≥30×10⁹\u002FL; ② ≥2-fold increase from baseline; and ③ no active bleeding. Between Week 2 and Week 12, any abnormal PLT result meeting any of the following criteria must be confirmed by repeat testing at Qilu Hospital within 24-48 hours: ① PLT \\\u003C30×10⁹\u002FL; ② \\\u003C2-fold increase from baseline; or ③ active bleeding.\n6. Women of childbearing potential must use an effective method of contraception during the screening period, throughout the entire trial, and for 90 days following the last dose of study medication.\n\nExclusion Criteria:\n\n1. Subjects with severe ITP at screening (e.g., life-threatening thrombocytopenia, major bleeding events, or requiring urgent treatment including intravenous immunoglobulin, high-dose glucocorticoids, or plasma exchange), whom the investigator anticipates will require rescue treatment within 2 weeks after enrollment.\n2. Subjects with autoimmune systemic diseases other than ITP, unless the investigator determines that such conditions will not affect the evaluation of study outcomes.\n3. Subjects who failed to respond to prior treatment with oral dexamethasone 40 mg\u002Fday for 4 days, defined as meeting any of the following criteria on any day between Day 5 and Day 7 post-treatment: ① PLT \\\u003C30×10⁹\u002FL; ② \\\u003C2-fold increase from baseline; or ③ active bleeding.\n4. History of intracranial hemorrhage within 6 months prior to screening.\n5. Subjects with a history of coagulation disorders other than ITP, such as disseminated intravascular coagulation, hemolytic uremic syndrome, or thrombotic thrombocytopenic purpura.\n6. Subjects with a known hypersensitivity to any component of the study drugs described in this protocol.\n7. Known human immunodeficiency virus (HIV) infection, or positive serologic test results.\n8. Subjects with positive tuberculosis screening test (based on interferon-gamma release assay, including T-SPOT®, etc.), or active, latent, or incompletely appropriately treated tuberculosis at screening.\n9. Activated partial thromboplastin time (aPTT) ≥1.5× upper limit of normal (ULN) or international normalized ratio (INR) ≥1.5 at screening.\n10. Organ dysfunction, with the following laboratory findings at screening: Absolute neutrophil count (ANC) \\\u003C1.5×10⁹\u002FL; hemoglobin \\\u003C90 g\u002FL; lymphocyte count \\\u003C0.8×10⁹\u002FL. Total bilirubin \\>1.2×ULN; aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\>ULN. Amylase or lipase \\>2×ULN. Estimated glomerular filtration rate (eGFR) \\\u003C40 mL\u002Fmin\u002F1.73 m² calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula. Immunoglobulin IgG \\\u003C6 g\u002FL.\n11. Pregnant or lactating women.\n12. Subjects unable to undergo blood collection, or with contraindications to phlebotomy.\n13. Any other condition that the investigator considers unsuitable for participation in this trial.","80 Years",{"count":84,"type":21},86,[86],"PHASE3","This is a randomized controlled study of high-dose Dexamethasone combined with Orelabrutinib versus high-dose Dexamethasone combined with placebo in adult patients with newly diagnosed Primary Immune Thrombocytopenia.",[89],"Primary Immune Thrombocytopenia (ITP)","RECRUITING","2026-04-23",{"date":93,"type":39},"2026-04-30",{"date":95,"type":39},"2026-04-08",{"date":97,"type":21},"2028-12-31",{"name":45,"class":46},{"id":100,"slug":101,"hasResults":12,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":4,"eligibilityCriteria":105,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":82,"enrollmentInfo":106,"targetDuration":4,"studyType":22,"phases":108,"briefSummary":109,"conditions":110,"keywords":4,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":115,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},"100615110","effect-of-predictive-model-on-double-balloon-enteroscopy-100615110","NCT07288346","Effect of Predictive Model on Double-Balloon Enteroscopy","Effect of Predictive Model on Total Double-Balloon Enteroscopy Rate: a Randomized Controlled Trial","Inclusion Criteria:\n\n1. patients aged between 18 and 80 years who were planned to undergo an attempt at total enteroscopy for suspected small-bowel disease\n2. CT scan of the abdomen was performed within two weeks before enteroscopy\n\nExclusion Criteria:\n\n1. cases terminated upon the target lesion (strictures, masses, hemorrhagic or other lesions) and not the maximal insertion\n2. poor quality of bowel preparation\n3. high risk esophageal varices\n4. the insertion route is not oral or anal because of changes in anatomical structure\n5. unsuitable for general anesthesia\n6. pregnant women\n7. unable to provide informed consent",{"count":107,"type":21},338,[24],"The aim of this study is to assess the effect of predictive model on total enteroscopy rate in double-balloon enteroscopy.",[111],"Double-balloon Enteroscopy","2026-01-12",{"date":114,"type":39},"2026-01-13",{"date":112,"type":39},{"date":117,"type":21},"2027-08-31",{"name":45,"class":46},5,{"id":121,"slug":122,"hasResults":12,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":4,"eligibilityCriteria":126,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":127,"targetDuration":4,"studyType":22,"phases":129,"briefSummary":130,"conditions":131,"keywords":133,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":47},"100617955","active-locomotion-of-magnetically-controlled-capsule-endoscopy-in-the-small-bowel-a-feasibility-study-100617955","NCT07325344","Active Locomotion of Magnetically Controlled Capsule Endoscopy in the Small Bowel: A Feasibility Study","Active Locomotion of Magnetically Controlled Capsule Endoscopy With Small Bowel Insufflation or Water Infusion: A Feasibility Study","Inclusion Criteria:\n\n* Patients scheduled to undergo enteroscopy.\n\nExclusion Criteria:\n\n* Patients with severe dysfunction of vital organs (e.g., heart, lungs). Patients with small bowel obstruction precluding adequate bowel preparation. Patients with a history of multiple abdominal surgeries. Patients with implanted devices such as cardiac pacemakers or metal implants. Patients with other high-risk conditions or lesions (e.g., moderate-to-severe esophagogastric varices, massive ascites).\n\nPatients who are pregnant or lactating. Patients unable or unwilling to provide informed consent.",{"count":128,"type":21},15,[24],"The aim of this study is to evaluate the responsiveness of the capsule endoscope to the attitude controller and to investigate its active locomotion performance within the small bowel.",[132],"Capsule Endoscopy",[134,135,136],"capsule endoscopy","small bowel disease","locomotion","2026-01-07",{"date":139,"type":39},"2026-01-08",{"date":141,"type":39},"2025-12-01",{"date":143,"type":21},"2026-12-31",{"name":45,"class":46},{"id":146,"slug":147,"hasResults":12,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":4,"eligibilityCriteria":151,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":152,"targetDuration":4,"studyType":154,"phases":4,"briefSummary":155,"conditions":156,"keywords":4,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":47},"100617491","evaluating-the-effect-of-nurse-led-stroke-transitional-care-in-tanzania-100617491","NCT07319312","Evaluating the Effect of Nurse-Led Stroke Transitional Care in Tanzania","Evaluating the Clinical Effectiveness and Implementation Outcomes of Nurse-Led Stroke Transitional Care Model in Tanzania","Inclusion criteria\n\n* Clinical nurses and physicians with six months of working experience in stroke care\n* Clinical nurses and physicians with a minimum of diploma in their professions.\n* Stroke survivors with 18 years old and above\n* Stroke survivors admitted in the stroke units\n* Stroke survivors with primary diagnosis of stroke confirmed by brain CT\u002FMRI\n* Stroke survivors who undergo usual discharge process\n* Stroke survivors who live with their family caregivers\n* Stroke survivors who have mobile phones\n* Stroke survivors who can read and write\n* Stroke survivors who are able to communicate\n* Stroke survivors with National Institutes of Health Stroke Scale (NIHSS) \\\u003C 6\n* Stroke survivors with Modified Barthel Index (MBI) \\> 9\n* Stroke survivors with Modified Rankin Scale (mRS) \\\u003C 5\n* Stroke survivors with Montreal Cognitive Assessment Test (MoCA) \\> 14\n* Stroke survivors who are expected to stay in the ward for 3-5 days,\n* Stroke survivors who are expected to survive for 3 months\n* Family caregivers with mobile phones\n* Family caregivers who can read and write\n* Family caregivers who are able to communicate\n* Family caregivers who live with the patient after stroke\n\nExclusion criteria\n\n* Healthcare providers who will be on leave during the study period.\n* Stroke survivors with previous stroke who are not admitted in stroke units\n* Stroke survivors who are discharged against medical advice\n* Stroke survivors who have end-stage organ failure\n* Stroke survivors who have family caregivers\n* Stroke survivors who can't read\u002Fwrite\n* Stroke survivors who have no mobile phones.\n* Family caregivers without mobile phone that is accessible",{"count":153,"type":21},130,"OBSERVATIONAL","The goal of this observational study is to assess the effects of nurse-led stroke transitional care in stroke survivors, caregivers and healthcare providers who participate in nurse-led stroke transitional care program to improve discharge preparedness, disease self-management and quality of life among stroke survivors. The main question it aims to answer is: does nurse-led stroke transitional care program improve discharge preparedness, disease self-management and quality of life among stroke survivors? Participants are currently participating in nurse-led stroke transitional care program as part of their medical care. Stroke survivors and their caregivers will be followed for six months period to assess their transitional care quality and clinical outcome measures.",[157,158],"Stroke Acute","Stroke (CVA) or Transient Ischemic Attack","2025-12-21",{"date":161,"type":39},"2026-01-06",{"date":163,"type":39},"2025-08-01",{"date":165,"type":21},"2026-03-30",{"name":45,"class":46},{"id":168,"slug":169,"hasResults":12,"nctId":170,"briefTitle":171,"officialTitle":171,"acronym":4,"eligibilityCriteria":172,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":173,"enrollmentInfo":174,"targetDuration":4,"studyType":22,"phases":176,"briefSummary":178,"conditions":179,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":182,"startDateStruct":184,"completionDateStruct":185,"leadSponsor":187,"locationsCount":47},"100598020","early-phase-1-study-on-the-efficacy-and-safety-of-shouhui-tongbian-capsules-in-protecting-intestine-during-the-perioperative-period-100598020","NCT07066059","Study on the Efficacy and Safety of Shouhui Tongbian Capsules in Protecting Intestine During the Perioperative Period","Inclusion Criteria:\n\n1. Aged 18-70 years, regardless of gender;\n2. ASA class I-III, elective surgery patients;\n3. Signed the informed consent form.\n\nExclusion Criteria:\n\n1. Disease-related exclusions:\n\n   Digestive system diseases: intestinal obstruction, intestinal perforation, acute peritonitis; inflammatory bowel disease (ulcerative colitis, Crohn's disease); gastrointestinal tumors (primary or metastatic); severe hemorrhoids or anal fissures (grade Ⅲ-Ⅳ); severe liver disease (Child-Pugh class ≥ B); Other systemic diseases: severe cardiovascular diseases (cardiac function grade Ⅲ or above, severe arrhythmia); uncontrolled diabetes (fasting blood glucose \\> 11.1 mmol\u002FL); autoimmune diseases (such as active systemic lupus erythematosus, rheumatoid arthritis); advanced malignant tumors or during radiotherapy\u002Fchemotherapy.\n2. Liver and kidney function abnormalities:\n\n   Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\> 2 times the upper limit of normal (ULN); serum creatinine (Cr) \\> 1.5 times ULN; estimated glomerular filtration rate (eGFR) \\\u003C 60 mL\u002Fmin\u002F1.73 m².\n3. Medication-related exclusions:\n\n   Use of the following drugs within the past 2 weeks:\n\n   Laxatives (e.g., lactulose, polyethylene glycol), gastrointestinal motility agents (e.g., domperidone, mosapride), antibiotics (systemic use), opioid analgesics, anticholinergic drugs, long-term laxative use (continuous use ≥ 2 weeks), preoperative use of enteral nutrition preparations or intravenous nutritional support.\n4. Exclusions for special populations:\n\n   Pregnant or lactating women; those allergic to components of Shouhui Tongbian Capsules (including Chinese herbal ingredients such as ginseng, atractylodes, polygonum multiflorum); patients with mental disorders or cognitive impairment; emergency or urgent surgery patients; those with an expected postoperative hospital stay \\\u003C 3 days.\n5. Other exclusions:\n\nParticipation in other clinical trials without passing the washout period; other situations where the investigator deems the subject unsuitable for the study.","70 Years",{"count":175,"type":21},80,[177],"EARLY_PHASE1","The goal of this clinical trial is to investigate if Shouhui Tongbian Capsules can shorten intestinal function recovery time (exhaust\u002Fdefecation time) and improve defecation quality in perioperative patients, and to evaluate its safety and comfort advantages during the perioperative period. The study involves participants aged 18-70 years, both male and female, with ASA grade I-III scheduled for elective surgery. The main questions it aims to answer are:\n\nCan Shouhui Tongbian Capsules shorten the intestinal function recovery time (first flatus and defecation time) in perioperative patients? Can Shouhui Tongbian Capsules improve defecation quality (assessed by Bristol Stool Scale) and reduce inflammatory factor levels (e.g., IL-6, TNF-α)? Researchers will compare the experimental group (receiving Shouhui Tongbian Capsules 2 pills twice daily from admission to the night before surgery, then resuming after bowel sound recovery and oral intake postoperatively, with a 3-day post-discharge regimen) to the control group (receiving routine perioperative care including diet control and standard bowel-cleansing drugs) to see if the capsules show superior efficacy in intestinal function recovery and safety.\n\nParticipants will:\n\nTake Shouhui Tongbian Capsules according to the specified regimen (experimental group) or receive routine care (control group).\n\nHave their exhaust\u002Fdefecation status recorded every 6 hours postoperatively. Undergo blood tests for liver\u002Fkidney function and inflammatory factors on the day before surgery and day 3 postoperatively.\n\nComplete questionnaires on bowel preparation comfort and postoperative defecation satisfaction.",[180],"Perioperative Period","2025-07-03",{"date":183,"type":39},"2025-07-15",{"date":163,"type":21},{"date":186,"type":21},"2027-07-31",{"name":45,"class":46},{"id":189,"slug":190,"hasResults":12,"nctId":191,"briefTitle":192,"officialTitle":192,"acronym":4,"eligibilityCriteria":193,"healthyVolunteers":12,"sex":17,"minAge":194,"maxAge":18,"enrollmentInfo":195,"targetDuration":197,"studyType":154,"phases":4,"briefSummary":198,"conditions":199,"keywords":201,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":203,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":47},"100596555","population-pharmacokinetics-of-terbinafine-in-children-with-tinea-capitis-100596555","NCT07046988","Population Pharmacokinetics of Terbinafine in Children With Tinea Capitis","Inclusion Criteria:\n\n1. Aged 2 to 18 years;\n2. Diagnosis of tinea capitis:\n\n   * Typical clinical manifestations, dermatoscopic findings combined with Wood's lamp examination; ② Positive mycological examination, including positive fungal microscopy and\u002For isolation of dermatophytes by fungal culture; ③ Exclusion of scalp seborrheic dermatitis, psoriasis, alopecia areata, lupus erythematosus, lichen planopilaris, trichotillomania, suppurative perifolliculitis of scalp, syphilitic alopecia, etc.\n\nExclusion Criteria:\n\n1. Concomitant topical treatment with terbinafine;\n2. Conditions interfering with gastrointestinal absorption of terbinafine;\n3. Documented hepatic\u002Frenal impairment or hematological disorders;\n4. Receipt of radiotherapy, systemic cytostatic\u002Fimmunosuppressive therapy, or antibacterial\u002Fantiviral\u002Fantiparasitic therapy currently or within 2 weeks prior to study initiation;\n5. Participation in other clinical trials, or other circumstances deemed inappropriate by the investigator.","2 Years",{"count":196,"type":21},60,"4 Weeks","The goal of this observational study is to characterize the population pharmacokinetics (PPK) of terbinafine in pediatric patients with tinea capitis, evaluate its efficacy and safety, and identify covariates affecting drug disposition in Chinese children aged 2-18 years diagnosed with tinea capitis and treated with oral terbinafine. The main questions it aims to answer are:\n\nWhat are the terbinafine pharmacokinetic parameters (e.g., AUC, CL, V) in children with tinea capitis, and how do they differ from adult values? Which covariates (e.g., age, body weight, CYP enzyme activity, renal function) significantly influence inter-individual variability in terbinafine PK parameters? What is the clinical efficacy (based on TSSS reduction and mycological cure rate) and safety profile of terbinafine in this pediatric population?\n\nParticipants will:\n\nUndergo oral terbinafine treatment according to weight-based dosing (62.5-250 mg daily).\n\nConcentration determination is carried out using the opportunistic sampling method.\n\nComplete clinical assessments (TSSS scoring) and mycological examinations (microscopy\u002Fculture) at baseline and follow-up visits.\n\nUndergo routine laboratory tests (liver\u002Fkidney function, hematology) to monitor safety.",[200],"Tinea Capitis",[200],"2025-06-30",{"date":204,"type":39},"2025-07-02",{"date":206,"type":39},"2021-06-15",{"date":208,"type":21},"2026-06-01",{"name":45,"class":46},{"id":211,"slug":212,"hasResults":12,"nctId":213,"briefTitle":214,"officialTitle":215,"acronym":4,"eligibilityCriteria":216,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":217,"enrollmentInfo":218,"targetDuration":4,"studyType":22,"phases":220,"briefSummary":221,"conditions":222,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":227,"startDateStruct":229,"completionDateStruct":231,"leadSponsor":233,"locationsCount":47},"100590873","efficacy-and-safety-of-robot-assisted-endoscopic-submucosal-dissection-for-colorectal-neoplasm-100590873","NCT06973083","Efficacy and Safety of Robot-assisted Endoscopic Submucosal Dissection for Colorectal Neoplasm","Efficacy and Safety of Robot-assisted Endoscopic Submucosal Dissection for Colorectal Neoplasm: A Randomized Controlled Trial.","Inclusion Criteria:\n\n* Patients aged 18-85.\n* Patients with pathologically verified colorectal neoplasms scheduled to undergo ESD.\n\nExclusion Criteria:\n\n* Patients have lesions with confirmed or potential deep submucosal invasion or lymph node metastasis or other conditions that are not suitable for endoscopic therapy.\n* Patients with severe underlying diseases precluding endotracheal intubation, general anesthesia, or surgery.\n* Patients have a history of colorectal malignancy with previous radiotherapy or operative treatment leading to changes in colorectal structure.\n* Patients have lesions with local recurrence after endoscopic resection.\n* Patients unable to obtain informed consent.","85 Years",{"count":219,"type":21},104,[24],"The objective of this study is to investigate the role of the flexible auxiliary single-arm transluminal endoscopic robot (FASTER) system in colorectal endoscopic submucosal dissection (ESD) and to validate its superiority over conventional ESD in terms of reducing procedural difficulty, shortening procedure time, and enhancing procedural safety.\n\nThe main questions it aims to answer are:\n\nDoes the use of the FASTER system improve the dissection speed of the ESD procedure? Does the use of the FASTER system reduce the procedure and dissection time, improving the efficacy of the ESD procedure? Does the use of the FASTER system reduce the rate of perforation and hemorrhage, improving the safety of the ESD procedure? Researchers will compare FASTER-assisted ESD and conventional ESD to evaluate the safety and efficacy of the FASTER system.\n\nParticipants will:\n\nBe randomly assigned to the group with ESD using the traditional procedure or to the group with ESD assisted by the FASTER system.\n\nKeep a diary of their symptoms after the procedure. ESD has gained widespread acceptance as the standard method for treating early-stage gastrointestinal cancers. However, ESD is a technically demanding and intricate procedure that requires advanced proficiency of operators, with a heightened risk of complications such as hemorrhage and perforation. The inherent challenges of the colorectal ESD are further amplified by the thin mucosa, highly tortuous and flexible lumen, and occasional obstruction of lesions by mucosal folds, all of which collectively elevate both the procedural difficulty and the probability of postoperative complications. Adequate exposure of the submucosa layer through effective tissue traction is vital for the safe and effective performance of ESD. The FASTER system is designed to overcome this technical difficulty.",[223,224,225],"Robot Surgery","Endoscopic Submucosal Dissection (ESD)","Colorectal Neoplasms","2025-05-16",{"date":228,"type":39},"2025-05-21",{"date":230,"type":21},"2025-06-01",{"date":232,"type":21},"2026-12-30",{"name":45,"class":46},{"id":235,"slug":236,"hasResults":12,"nctId":237,"briefTitle":238,"officialTitle":239,"acronym":4,"eligibilityCriteria":240,"healthyVolunteers":12,"sex":17,"minAge":241,"maxAge":242,"enrollmentInfo":243,"targetDuration":4,"studyType":22,"phases":245,"briefSummary":246,"conditions":247,"keywords":4,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":250,"startDateStruct":252,"completionDateStruct":254,"leadSponsor":256,"locationsCount":47},"100590831","a-study-on-the-infusion-regimen-of-piperacillin-tazobactam-in-patients-aged-65-and-older-with-pneumonia-100590831","NCT06972537","A Study on the Infusion Regimen of Piperacillin-Tazobactam in Patients Aged 65 and Older With Pneumonia","Model-Guided Dose Optimization vs. Empirical Dosing of Piperacillin-Tazobactam in the Treatment of Pneumonia in Elderly Patients: A Study on Superiority","Inclusion Criteria:\n\nAge must be greater than 65 years Clinical diagnosis of Pneumonia Receiving intravenous piperacillin-tazobactam treatment\n\nExclusion Criteria:\n\nHistory of allergy to β-lactam antibiotics Continuous renal replacement therapy, severe organ dysfunction Malignant tumor disease","65 Years","100 Years",{"count":244,"type":21},42,[24],"Pneumonia is characterized by high incidence and mortality rates in elderly patients (≥65 years old). Piperacillin-tazobactam, as a broad-spectrum antibiotic, has its therapeutic efficacy and safety potentially influenced by the infusion regimen. However, research on infusion regimens specifically targeting the elderly population is currently limited. In our preliminary dose simulation, under the pharmacokinetic\u002Fpharmacodynamic (PK\u002FPD) target of achieving a free drug concentration time percentage above 100% of the minimum inhibitory concentration (fT%\\>100% MIC), the regimen of administering the drug every 6 hours (q6h) achieved a concentration compliance rate of 90% within 4 hours. This study aims to explore the differences between two infusion modes (q6h for 4 hours vs. q8h for 3 hours) and to provide preliminary evidence for clinical practice.",[248],"Pneumonia","2025-05-14",{"date":251,"type":39},"2025-05-15",{"date":253,"type":39},"2024-07-24",{"date":255,"type":21},"2026-09-30",{"name":45,"class":46},{"id":258,"slug":259,"hasResults":12,"nctId":260,"briefTitle":261,"officialTitle":262,"acronym":4,"eligibilityCriteria":263,"healthyVolunteers":12,"sex":17,"minAge":264,"maxAge":217,"enrollmentInfo":265,"targetDuration":4,"studyType":22,"phases":267,"briefSummary":268,"conditions":269,"keywords":274,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":278,"lastUpdatePostDateStruct":279,"startDateStruct":281,"completionDateStruct":283,"leadSponsor":285,"locationsCount":47},"100589956","linked-color-imaging-versus-indigo-carmine-pump-spraying-on-the-colorectal-adenoma-detection-rate-100589956","NCT06961149","Linked-Color Imaging Versus Indigo Carmine Pump Spraying on the Colorectal Adenoma Detection Rate","Linked-Color Imaging Versus Indigo Carmine Pump Spraying on the Colorectal Adenoma Detection Rate: a Prospective , Randomized Controlled, Non-inferiority Study","Inclusion Criteria:\n\n1. Age between 45 and 85 years\n2. Patients with a history of colorectal adenoma\n3. Patients whose first-degree relatives have a history of colorectal cancer or colorectal adenoma\n4. Patients with gastrointestinal symptoms (abdominal pain, bloody stool, chronic diarrhea or constipation, Unexplained anemia or weight loss;\n5. Patients with positive Fecal Immunochemical Test\n\nExclusion Criteria:\n\n1. Patients with pregnancy, inflammatory bowel disease, familial adenomatosis polyposis, suspected CRC; intestinal obstruction, coagulopathy\n2. Patients with aspirin, clopidogrel or other anticoagulants\u002F antiplatelet drugs intake within 7 days\n3. Patents previous colorectal resection\n4. Patients with failed cecal intubation\n5. Patients with inadequate bowel preparation quality (BBPS≤5)\n6. Patients who refuse to participate or to provide informed consent","45 Years",{"count":266,"type":21},352,[24],"Detection and removal of polyps during colonoscopy is crucial for the prevention of colorectal cancer. Indigo carmine spraying up to the colonic mucosa could probably increase the adenoma detection rate, but considering the long withdrawal time of the endoscope and the resulting increase in time and cost. Linked-color imaging (LCI) is a newly developed image-enhanced endoscopy technology. It relies on wave length optimization of three colors (red, green, and blue) to make the lesions appear fuller. LCI improves the visibility of colorectal adenomas and polyps and may increase the detection rate of lesions. In order to explore the clinical application value of Linked-color imaging endoscopy, we performed a prospective, randomized controlled trial to compare adenoma detection rate of Linked-color imaging endoscopy and indigo carmine chromoendoscopy.",[270,271,272,273,225],"Colonic Polyps","Adenomatous Polyps","Adenoma Detection Rate","Chromoendoscopy",[272,275,273,276,277],"Linked-color imaging","Colonoscopy","Indigo Carmine","2025-05-05",{"date":280,"type":39},"2025-05-07",{"date":282,"type":39},"2025-04-08",{"date":284,"type":21},"2026-04-01",{"name":45,"class":46},{"id":287,"slug":288,"hasResults":12,"nctId":289,"briefTitle":290,"officialTitle":291,"acronym":4,"eligibilityCriteria":292,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":82,"enrollmentInfo":293,"targetDuration":4,"studyType":22,"phases":295,"briefSummary":296,"conditions":297,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":299,"lastUpdatePostDateStruct":300,"startDateStruct":302,"completionDateStruct":304,"leadSponsor":306,"locationsCount":47},"100588104","efficacy-and-safety-of-cold-versus-hot-snare-polypectomy-for-removal-of-4-10-mm-pedunculated-colorectal-polyps-100588104","NCT06937047","Efficacy and Safety of Cold Versus Hot Snare Polypectomy for Removal of 4-10 mm Pedunculated Colorectal Polyps","Efficacy and Safety of Cold Versus Hot Snare Polypectomy for Removal of 4-10 mm Pedunculated Colorectal Polyps: a Randomized Controlled Trial","Inclusion Criteria:\n\n1. 18-80 years old, male and female\n2. Proposed colonoscopy and colonoscopy detection of at least one 4-10 mm pedunculated colorectal polyp\n\nExclusion Criteria:\n\n1. Contraindication to colonoscopy or polypectomy\n2. Use of antiplatelet or anticoagulant drugs within 1 week before polypectomy\n3. Alarming signs and symptoms of colorectal cancer (blood in stool, black stool, unexplained anaemia and weight loss, abdominal mass, positive rectal examination; or imaging and laboratory tests highly suspicious for colorectal cancer) or endoscopic manifestations of polyps highly suspicious for high-grade intraepithelial neoplasia or carcinoma\n4. Comorbidity with inflammatory bowel disease, colonic polyposis, or active gastrointestinal bleeding\n5. Inadequate bowel preparation\n6. Pregnant or lactating women\n7. Failure to sign the informed consent form\n8. Patients deemed ineligible by investigators to enrol in the trial",{"count":294,"type":21},196,[24],"This was a non-inferiority randomized controlled trial designed to compare the efficacy and safety of cold versus hot snare polypectomy for the removal of 4-10 mm pedunculated colorectal polyps. The primary outcome was delayed postpolypectomy bleeding. The secondary outcomes included immediate postpolypectomy bleeding, procedure time, en bloc resection, complete histologic resection, use of haemostatic clips and perforation rate.",[298],"Colorectal Polyps","2025-04-27",{"date":301,"type":39},"2025-04-29",{"date":303,"type":21},"2025-05-06",{"date":305,"type":21},"2027-02-28",{"name":45,"class":46},{"id":308,"slug":309,"hasResults":12,"nctId":310,"briefTitle":311,"officialTitle":312,"acronym":4,"eligibilityCriteria":313,"healthyVolunteers":314,"sex":55,"minAge":18,"maxAge":4,"enrollmentInfo":315,"targetDuration":317,"studyType":154,"phases":4,"briefSummary":318,"conditions":319,"keywords":323,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":328,"lastUpdatePostDateStruct":329,"startDateStruct":331,"completionDateStruct":333,"leadSponsor":334,"locationsCount":119},"100587379","corona-virus-disease-2019-cohort-study-100587379","NCT06927622","Corona Virus Disease 2019 Cohort Study","Study on the Influence of Corona Virus Disease 2019 on Obstetric Outcome and Offspring Development","Inclusion Criteria:\n\n* Conduct regular prenatal examinations in the hospital and establish a pregnancy and childbirth health manual, planning for pregnant women who are hospitalized for delivery;\n* Conduct regular physical examinations in the hospital and establish a children's health manual for infants.\n* Age ≥ 18 years old\n\nExclusion Criteria:\n\n* Concomitant tumor related diseases;\n* Individuals with severe mental disorders.",true,{"count":316,"type":21},1000,"1 Year","The goal of this observational study is to learn about the influence of Corona Virus Disease 2019 on obstetric outcome and offspring development.",[320,321,322],"COVID-19 Pneumonia","COVID-19 Pandemic","COVID-19",[324,325,326,327],"pregnant woman","birth cohort","infant","nervous system development","2025-04-14",{"date":330,"type":39},"2025-04-15",{"date":332,"type":39},"2023-04-01",{"date":208,"type":21},{"name":45,"class":46},{"id":336,"slug":337,"hasResults":12,"nctId":338,"briefTitle":339,"officialTitle":340,"acronym":4,"eligibilityCriteria":341,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":342,"targetDuration":4,"studyType":22,"phases":344,"briefSummary":345,"conditions":346,"keywords":348,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":351,"lastUpdatePostDateStruct":352,"startDateStruct":353,"completionDateStruct":355,"leadSponsor":357,"locationsCount":47},"100586284","phase-2-the-study-of-different-cycles-of-high-dose-dexamethasone-in-the-treatment-of-itp-100586284","NCT06913374","The Study of Different Cycles of High-dose Dexamethasone in the Treatment of ITP","Dicycle Versus Tri-cycle High-dose Dexamethasone in Adult ITP: a Multicenter Randomized Controlled Trial","Inclusion Criteria:\n\n* Participant must be at least 18 years of age at the time of the screening.\n* Participant may be male or female.\n* Participant has a confirmed diagnosis of newly diagnosed ITP according to the 2019 International Working Group assessment at screening, and has a baseline platelet count of less than 30 × 10\\^9 cells per L or had bleeding manifestations, or both.\n\nExclusion Criteria:\n\n* Participant has evidence of a secondary cause of immune thrombocytopenia (e.g. leukemia, lymphoma, common variable immune- deficiency, systemic lupus erythematosus, autoimmune thyroid disease, past medical history of untreated H. pylori infection) or to drug treatments (e.g. heparin, quinine, antimicrobials, anticonvulsants) or participant has a multiple immune cytopenia, e.g. Evan's syndrome.\n* Participant has clinically life-threatening bleeding (e.g. central nervous system bleeding, menorrhagia with significant drop in hemoglobin).\n* Participant has a history of coagulopathy disorders other than ITP.\n* Participant has a history of arterial or venous thromboembolism (e.g. stroke, transient ischemic attach, myocardial infarction, deep vein thrombosis or pulmonary embolism) within the 6 months prior to randomization or requires anticoagulant treatment.\n* Participant has 12-lead ECG with changes considered to be clinically significant upon medical review at baseline.\n* Participant has severe renal impairment (glomerular filtration rate less than 45ml\u002Fmin\u002F1.73 m2).\n* Participant has 3 × upper limit of normal of any of the following: alanine aminotransferase, aspartate aminotransferase, or alkaline phosphatase.\n* Participant with any of the following conditions: severe immunodeficiency, active or previous malignancy, human immunodeficiency virus (HIV), hepatitis B or C virus infection, pregnancy or lactation.",{"count":343,"type":21},118,[59,86],"Primary immune thrombocytopenia is an autoimmune disorder characterised by decreased platelet counts and increased bleeding risk. Corticosteroids have been the standard initial treatment of primary immune thrombocytopenia for more than 30 years. The aim of this randomized controlled trial is to compare the efficacy and safety of high-dose dexamethasone in treating new-diagnosed primary immune thrombocytopenia (ITP) in di-cycle and tri-cycle.",[347],"Thrombocytopenia",[349,350],"ITP","Dexamethasone","2025-04-06",{"date":282,"type":39},{"date":354,"type":21},"2025-05-01",{"date":356,"type":21},"2027-05-30",{"name":45,"class":46},{"id":359,"slug":360,"hasResults":12,"nctId":361,"briefTitle":362,"officialTitle":363,"acronym":4,"eligibilityCriteria":364,"healthyVolunteers":12,"sex":17,"minAge":365,"maxAge":4,"enrollmentInfo":366,"targetDuration":4,"studyType":22,"phases":368,"briefSummary":369,"conditions":370,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":372,"lastUpdatePostDateStruct":373,"startDateStruct":374,"completionDateStruct":376,"leadSponsor":378,"locationsCount":47},"100586601","phase-2-short-course-anti-tuberculosis-regimens-for-mild-spinal-tuberculosis-100586601","NCT06917495","Short-Course Anti-tuberculosis Regimens for Mild Spinal Tuberculosis","Rifapentine- And Moxifloxacin-Containing Short-Course Regimens for Mild Spinal Tuberculosis: A Multicenter, Randomized, Non-inferiority Clinical Trial","Inclusion Criteria:\n\n1. Age ≥ 12 years.\n2. Based on the medical history, clinical manifestations, radiological, laboratory tests and possible histological samples, the diagnostic criteria are met and judged to be mild spinal tuberculosis.\n3. Laboratory test values are completed within 14 days prior to screening.\n4. Women of child-bearing potential who are not surgically sterilized must agree to practice a barrier method of contraception or abstain from heterosexual intercourse during study drug treatment.\n5. For women of childbearing potential, a negative pregnancy test at or within seven (7) days prior to screening.\n6. Karnofsky score greater than or equal to 60.\n7. A verifiable address or residence location that is readily accessible for visiting, and willingness to inform the study team of any change of address during the treatment and follow-up period.\n8. Written informed consent.\n\nExclusion Criteria:\n\n\\- Exclusions Before Randomization:\n\n1. Pregnant or breast-feeding.\n2. Unable to take oral medications.\n3. Previously enrolled in similar studies.\n4. With spinal tumors or metastatic tumors.\n5. Patients with mental disorders and cognitive dysfunction.\n6. Received any investigational drug in the past 3 months.\n7. More than five (5) days of treatment directed against active tuberculosis within 6 months preceding initiation of study drugs.\n8. More than five (5) days of systemic treatment with any one or more of the following drugs within 30 days preceding initiation of study drugs: Isoniazid, rifampin, rifambutin, rifabentine, ethambutol, pyrazinamide, kanamycin, amikacin, streptomycin, capreomycin, moxifloxacin, levofloxacin, gatifloxacin, ofloxacin, ciprofloxacin, other fluoroquinolones, ethionamide, prothionamide, cycloserine, terizidone, para-aminosalicylic acid, linezolid, clofazimine, delamanid or bedaquiline.\n9. Known history of prolonged QT syndrome.\n10. Weight less than 40.0 kg.\n11. Known allergy or intolerance to any of the study medications.\n12. Individuals will be excluded from enrollment if, at the time of enrollment, their M. tuberculosis isolate is already known to be resistant to any one or more of the following: rifampin, isoniazid, pyrazinamide, ethambutol, or fluoroquinolones.\n13. Other medical conditions, that, in the investigator's judgment, make study participation not in the individual's best interest.\n\n    * Exclusions After Randomization:\n14. No M. tuberculosis is identified in the screening, baseline, and week 2 samples.\n15. Mycobacterium tuberculosis grown from or tested by molecular assays (Xpert MTB \u002F RIF) in samples obtained before or after the study are determined to be resistant to isoniazid, rifampicin, or fluoroquinolones.","12 Years",{"count":367,"type":21},300,[59],"To evaluate the non-inferiority in efficacy between the rifapentine- and moxifloxacin-containing short-course regimens (with rifampicin replaced by rifapentine and ethambutol replaced by moxifloxacin, while isoniazid and pyrazinamide remaining the same as the empirical regimen) and the empirical long-course regimen, so as to determine whether it is possible to shorten the treatment duration to 26 weeks for patients with mild spinal tuberculosis.",[371],"Mild Spinal Tuberculosis","2025-03-31",{"date":282,"type":39},{"date":375,"type":21},"2025-04-05",{"date":377,"type":21},"2029-12-31",{"name":45,"class":46},{"id":380,"slug":381,"hasResults":12,"nctId":382,"briefTitle":383,"officialTitle":383,"acronym":4,"eligibilityCriteria":384,"healthyVolunteers":12,"sex":55,"minAge":18,"maxAge":385,"enrollmentInfo":386,"targetDuration":4,"studyType":22,"phases":388,"briefSummary":390,"conditions":391,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":393,"lastUpdatePostDateStruct":394,"startDateStruct":396,"completionDateStruct":397,"leadSponsor":399,"locationsCount":4},"100575842","phase-4-neoadjuvant-chemotherapy-with-or-without-talniflumate-for-the-treatment-of-breast-cancer-100575842","NCT06777537","Neoadjuvant Chemotherapy with or Without Talniflumate for the Treatment of Breast Cancer","Inclusion Criteria:\n\n* Age: ≥ 18 and ≤ 75 years, female;\n* The breast cancer has been confirmed by pathological examination and Immunohistochemistry (IHC);\n* Not receiving any preoperative anticancer drugs;\n* The liver and kidney function satisfies the following conditions within 3 days after surgery (excluding day 3): aspartate aminotransferase (AST), glutamic-oxalacetic transaminase (ALT) \\\u003C 2 upper limit of normal (ULN), total bilirubin ≤ 1.5 ULN, serum creatinine \\\u003C 1.5 ULN;\n* Other laboratory tests meet the following requirements within 3 days after surgery (excluding day 3): Hb ≥ 90g\u002Fl, platelet count ≥ 100×109\u002FL, absolute neutrophil count \\> 1.5×109\u002FL;\n* The expected survival time ≥ 6 months;\n* The subjects volunteer to sign the informed consent.\n\nExclusion Criteria:\n\n* Patients with stage IV breast cancer;\n* Pregnant or lactating women;\n* Those with active bleeding due to various reasons;\n* Those with HIV infection or AIDS-associated diseases;\n* Those with severe acute and chronic diseases;\n* Those with severe diabetes;\n* Those with serious infectious diseases;\n* Those who can not take drugs by oral route;\n* Drug abusers or those with psychological or mental diseases that may interfere with study compliance;\n* Conditions that are considered not suitable for this study investigators","75 Years",{"count":387,"type":21},200,[389],"PHASE4","RATIONALE:\n\nTalniflumate, a prodrug of niflumic acid with significant anti-inflammatory properties, has emerged as a promising candidate in breast cancer therapy due to its ability to modulate key oncogenic pathways. Its mechanisms of action include the inhibition of cyclooxygenase (COX) enzymes, which mitigates tumor-promoting inflammation and fosters a less permissive microenvironment for cancer progression. Additionally, talniflumate disrupts ionic homeostasis by targeting calcium-activated chloride channels (CaCCs), leading to impaired cellular proliferation and potential induction of apoptosis. The agent also exhibits anti-angiogenic activity by downregulating vascular endothelial growth factor (VEGF), thereby restricting tumor vascularization and growth. Furthermore, talniflumate shows potential as a chemosensitizer, enhancing the cytotoxic effects of standard chemotherapy and improving therapeutic outcomes while reducing chemoresistance. These multifaceted mechanisms highlight the therapeutic promise of talniflumate in breast cancer, warranting further preclinical and clinical studies to validate its efficacy, refine dosing strategies, and define its role in combination therapies.\n\nPURPOSE:\n\nTo assess the therapeutic efficacy of Talniflumate in the management of breast cancer, with a focus on its synergistic interactions with neoadjuvant chemotherapy.",[392],"Breast Cancer","2025-01-14",{"date":395,"type":39},"2025-01-16",{"date":230,"type":21},{"date":398,"type":21},"2030-12-01",{"name":45,"class":46},{"id":401,"slug":402,"hasResults":12,"nctId":403,"briefTitle":404,"officialTitle":405,"acronym":4,"eligibilityCriteria":406,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":82,"enrollmentInfo":407,"targetDuration":4,"studyType":22,"phases":409,"briefSummary":410,"conditions":411,"keywords":4,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":414,"lastUpdatePostDateStruct":415,"startDateStruct":417,"completionDateStruct":419,"leadSponsor":421,"locationsCount":47},"100573597","safety-and-efficacy-of-traction-robot-assisted-endoscopic-submucosal-dissection-for-early-gastric-cancer-100573597","NCT06748352","Safety and Efficacy of Traction Robot-assisted Endoscopic Submucosal Dissection for Early Gastric Cancer","Safety and Efficacy of Traction Robot-assisted Endoscopic Submucosal Dissection for Early Gastric Cancer: a Pilot Randomized Controlled Study","Inclusion Criteria:\n\n* Patients aged 18-80.\n* Patients with pathologically verified high-grade intraepithelial neoplasia (HGIN) or intramucosal carcinoma of the stomach.\n\nExclusion Criteria:\n\n* Patients have lesions with confirmed or potential deep submucosal invasion or lymph node metastasis.\n* Patients with severe underlying diseases precluding endotracheal intubation, general anesthesia, or surgery.\n* Patients have a history of gastric malignancy with previous radiotherapy or operative treatment leading to changes in gastric structure.\n* Patients have lesions with local recurrence after endoscopic resection.\n* Patients unable to obtain informed consent.",{"count":408,"type":21},50,[24],"The goal of this clinical trial is to investigate whether the flexible auxiliary single-arm transluminal endoscopic robot (FASTER) system can improve the safety of the endoscopic submucosal dissection (ESD). It will also evaluate the efficacy of the system, such as whether it could reduce the procedure time and so on. The main questions it aims to answer are:\n\nDoes the use of the FASTER system reduce the number of muscular injuries, improving the safety of the ESD procedure? Does the use of the FASTER system reduce the procedure and dissection time, improving the efficacy of the ESD procedure? Researchers will compare FASTER-assisted ESD and conventional ESD to evaluate the safety and efficacy of the FASTER system.\n\nParticipants will:\n\nBe randomly assigned to the group with ESD using the traditional procedure or to the group with ESD assisted by the FASTER system.\n\nKeep a diary of their symptoms after the procedure. ESD has gained widespread acceptance as the standard method for treating early-stage gastrointestinal cancers. Adequate exposure of the submucosa layer through effective tissue traction is vital for the safe and effective performance of ESD. The FASTER system is designed to overcome this technical difficulty.",[412,413,223],"Early Gastric Cancer","Endoscopic Submucosal Dissection","2024-12-21",{"date":416,"type":39},"2024-12-27",{"date":418,"type":21},"2024-12-30",{"date":420,"type":21},"2025-03-01",{"name":45,"class":46},{"id":423,"slug":424,"hasResults":12,"nctId":425,"briefTitle":426,"officialTitle":427,"acronym":4,"eligibilityCriteria":428,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":173,"enrollmentInfo":429,"targetDuration":4,"studyType":22,"phases":431,"briefSummary":432,"conditions":433,"keywords":4,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":435,"lastUpdatePostDateStruct":436,"startDateStruct":438,"completionDateStruct":439,"leadSponsor":441,"locationsCount":47},"100571664","phase-4-efficacy-of-different-durations-of-dual-and-quadruple-regimens-for-helicobacter-pylori-eradication-100571664","NCT06723197","Efficacy of Different Durations of Dual and Quadruple Regimens for Helicobacter Pylori Eradication","Efficacy of Different Durations of Dual and Quadruple Regimens for Helicobacter Pylori Eradication: a Multicentre, Randomised, Controlled Trial","Inclusion Criteria:\n\n1. Patients aged 18-70 years old\n2. Patients with H.pylori infection (13C\u002F14C-urea breath test)\n3. Patients without previous treatment for H. pylori eradication\n\nExclusion Criteria:\n\n1. Patients with serious underlying diseases, such as liver insufficiency (Aspartate aminotransferase or alanine aminotransferase greater than the normal value), renal insufficiency (Cr≥2.0mg\u002FdL or glomerular filtration rate \\\u003C50 ml\u002Fmin), immunosuppression, malignant tumors, Coronary heart disease or coronary artery stenosis ≥75%\n2. Patients with active gastrointestinal bleeding\n3. Patients with a history of upper gastrointestinal surgery\n4. Patients allergic to treatment drugs\n5. Patients with medication history of bismuth, antibiotics within 4 weeks, or proton pump inhibitor within 2 weeks\n6. Patients who are pregnant or lactating or unwilling to take contraceptive measures during the trial\n7. Patients with other behaviors that may increase the risk of illness, such as alcohol and drug abuse\n8. Patients who are unwilling or incapable to provide informed consents",{"count":430,"type":21},330,[389],"The study aimed to compare the efficacy and safety of dual and quadruple regimens with different durations (7-day, 10-day, 14-day) for the eradication of Helicobacter pylori. Subjects were randomized to receive the intervention and were reviewed by 13C-urea breath test after 6 weeks. The eradication rates, adverse reaction rates and patient adherence were calculated.",[434],"HELICOBACTER PYLORI INFECTIONS","2024-12-10",{"date":437,"type":39},"2024-12-11",{"date":435,"type":39},{"date":440,"type":21},"2025-11-30",{"name":45,"class":46},{"id":443,"slug":444,"hasResults":12,"nctId":445,"briefTitle":446,"officialTitle":446,"acronym":4,"eligibilityCriteria":447,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":448,"enrollmentInfo":449,"targetDuration":4,"studyType":154,"phases":4,"briefSummary":451,"conditions":452,"keywords":454,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":459,"lastUpdatePostDateStruct":460,"startDateStruct":462,"completionDateStruct":464,"leadSponsor":465,"locationsCount":47},"100538046","clinical-characteristics-of-small-intestinal-bacterial-overgrowth-in-individuals-with-abdominal-distention-100538046","NCT06285734","Clinical Characteristics of Small Intestinal Bacterial Overgrowth in Individuals with Abdominal Distention","Inclusion Criteria:\n\n1. Patients aged 18 to 70 years.\n2. Patients presenting with the primary complaint of abdominal bloating and\u002For abdominal distension, or those exhibiting abdominal distension with prominence over other symptoms.\n\nExclusion Criteria:\n\n1. Patients who are pregnant or lactating.\n2. Patients have history of gastrointestinal malignancy or gastrointestinal surgery.\n3. Patients manifesting food intolerance or presenting with a confirmed diagnosis or suspicion of lactose intolerance.\n4. Patients with urinary system (chronic kidney disease, etc.), immune system (scleroderma, etc.), nervous system (Parkinson's disease, etc.), mental system (depression, etc.), or other diseases outside the digestive system.\n5. Patients who used antibiotics or microecological agents or underwent endoscopic examination within two weeks.\n6. Patients with a medication history encompassing motility enhancers, secretory enhancers, antifoaming agents, spasmolytics, opioids, and antidepressants within the past week.\n7. Patients who are unwilling or incapable to provide informed consents.","60 Years",{"count":450,"type":21},402,"Abdominal distention represents a prevalent clinical manifestation characterized by an unclear etiology and pathogenesis. This symptomatology is frequently observed in various conditions, including small intestinal bacterial overgrowth (SIBO) and abnormal orocecal transit time (OCTT). The utilization of the breath test as a non-invasive diagnostic approach has become widespread in recent years for identifying SIBO and abnormalities in OCTT. In this study, the prevalence of SIBO and OCTT irregularities in individuals presenting with abdominal distention was ascertained through the implementation of the breath test. Furthermore, the correlation between abdominal distention and SIBO\u002FOCTT was analysed to enhance the elucidation of the underlying etiology of abdominal distention. These findings aim to offer valuable insights for refining clinical comprehension and strategies related to the diagnosis and treatment of abdominal distention.",[453],"Abdominal Distention",[455,456,457,458],"abdominal distention","small intestinal bacterial overgrowth","orocecal transit time","cross-sectional survey","2024-12-07",{"date":461,"type":39},"2024-12-12",{"date":463,"type":39},"2024-03-01",{"date":163,"type":21},{"name":45,"class":46},{"id":467,"slug":468,"hasResults":12,"nctId":469,"briefTitle":470,"officialTitle":471,"acronym":4,"eligibilityCriteria":472,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":473,"targetDuration":4,"studyType":154,"phases":4,"briefSummary":474,"conditions":475,"keywords":4,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":477,"lastUpdatePostDateStruct":478,"startDateStruct":480,"completionDateStruct":482,"leadSponsor":484,"locationsCount":47},"100570770","model-informed-individualized-treatment-of-anti-infective-drugs-100570770","NCT06711562","Model-informed Individualized Treatment of Anti-infective Drugs","Model-informed Individualized Treatment of Anti-infective Drugs in Patients With Osteoarticular Infections","Inclusion Criteria:\n\n* Patients with suspected\u002Fconfirmed osteoarticular infections who are undergoing anti-infective drug therapy.\n\nExclusion Criteria:\n\n* Pregnant\u002Flactating women.\n* There are other factors that the researchers think are not suitable for inclusion.",{"count":367,"type":21},"The study aims to optimize individualized treatment of anti-infective drugs in osteoarticular infections by analyzing drug exposure in patients blood and\u002For tissues using population pharmacokinetics.",[476],"Osteoarticular Infections","2024-11-29",{"date":479,"type":39},"2024-12-02",{"date":481,"type":39},"2024-10-12",{"date":483,"type":21},"2026-10-01",{"name":45,"class":46},{"id":486,"slug":487,"hasResults":12,"nctId":488,"briefTitle":489,"officialTitle":489,"acronym":4,"eligibilityCriteria":490,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":491,"targetDuration":4,"studyType":154,"phases":4,"briefSummary":492,"conditions":493,"keywords":4,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":477,"lastUpdatePostDateStruct":495,"startDateStruct":496,"completionDateStruct":497,"leadSponsor":498,"locationsCount":47},"100570771","model-informed-individualized-treatment-of-anti-infective-drugs-in-patients-with-spinal-infections-100570771","NCT06711575","Model-informed Individualized Treatment of Anti-Infective Drugs in Patients With Spinal Infections","Inclusion Criteria:\n\n* Patients with suspected\u002Fconfirmed spinal infections who are undergoing anti-infective drug therapy.\n\nExclusion Criteria:\n\n* Pregnant\u002Flactating women.\n* There are other factors that the researchers think are not suitable for inclusion",{"count":367,"type":21},"The purpose of this study is to describe the population pharmacokinetic characteristics in patients with suspected\u002Fconfirmed spinal infections who are undergoing anti-infective drug therapy, and to evaluate effectiveness and safety of these drugs.",[494],"Infectious Diseases of Spine",{"date":479,"type":39},{"date":481,"type":39},{"date":483,"type":21},{"name":45,"class":46},{"id":500,"slug":501,"hasResults":12,"nctId":502,"briefTitle":503,"officialTitle":504,"acronym":4,"eligibilityCriteria":505,"healthyVolunteers":12,"sex":17,"minAge":506,"maxAge":241,"enrollmentInfo":507,"targetDuration":4,"studyType":154,"phases":4,"briefSummary":509,"conditions":510,"keywords":512,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":517,"lastUpdatePostDateStruct":518,"startDateStruct":520,"completionDateStruct":522,"leadSponsor":524,"locationsCount":4},"100565995","reduced-dose-chemo-followed-by-14-days-of-blinatumomab-for-newly-diagnosed-adult-b-all-patients-a-multicenter-study-100565995","NCT06649422","Reduced-Dose Chemo Followed by 14 Days of Blinatumomab for Newly Diagnosed Adult B-ALL Patients: a Multicenter Study","Clinical Study on the Efficacy and Safety of Reduced-Dose Chemotherapy Followed by 14 Days of Blinatumomab in Adult Patients with Newly Diagnosed Ph-Negative B-ALL: a Prospective, Multicenter, Observational Study.","Inclusion Criteria:\n\n* Age 15-65 years, both male and female are eligible;\n* Untreated newly diagnosed Ph-negative B-ALL patients; Diagnosis is defined by using morphological, immunological, cytogenetic, and molecular (MICM) diagnostic models, with immunotyping showing \\>20% primitive lymphoid cells in the bone marrow; bone marrow cytogenetics showing Philadelphia chromosome (Ph) negative (after observing at least 20 metaphases) and\u002For fluorescence in situ hybridization (FISH) BCR\u002FABL negative and\u002For molecular BCR\u002FABL fusion gene negative;\n* Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-2;\n* Organ function tests must meet all the following criteria: Total bilirubin \\\u003C1.5×upper limit of normal (ULN); Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) \\\u003C2.5×ULN (if liver is involved, then ALT and AST \\\u003C5×ULN are allowed); Creatinine \\\u003C1.5×ULN; Serum amylase and lipase ≤1.5×ULN; Alkaline phosphatase ≤2.5× ULN; Serum electrolytes potassium, magnesium, phosphorus within normal limits.\n* Cardiac color Doppler echocardiography ejection fraction ≥45%;\n* Female patients of childbearing potential must have a negative pregnancy test (within 7 days prior to enrollment).\n\nExclusion Criteria:\n\n* Previous or ongoing systemic anti-acute lymphoblastic leukemia (ALL) treatment (including but not limited to radiotherapy), except for appropriate pretreatment;\n* Clinical manifestations of central nervous system or extramedullary involvement at the time of diagnosis;\n* Patients participating in other clinical studies simultaneously;\n* Accompanying diseases that, in the judgment of the investigator, pose a serious risk to patient safety or affect the patient's ability to complete the study;\n* A history of definite neurological or psychiatric disorders, including epilepsy or dementia;\n* Major surgery within the last 4 weeks or not recovered from previous surgery;\n* Having other malignant tumors, unless the other primary malignant tumor is currently stable or does not require active intervention;\n* Women of childbearing age or men who cannot use sufficient methods for contraception, including pregnant or lactating women;\n* Clinically significant severe uncontrollable heart disease (including but not limited to a history of myocardial infarction, stroke, or revascularization; unstable angina or transient ischemic attack within 6 months before enrollment; congestive heart failure or left ventricular ejection fraction (LVEF) below the local institutional standard lower limit within 6 months before enrollment; a history of clinically significant (determined by the attending physician) atrial arrhythmia; a history of ventricular arrhythmia; a history of venous thromboembolism, including deep vein thrombosis or pulmonary embolism, uncontrollable hypertension, etc.);\n* Confirmed positive status for human immunodeficiency;\n* Active severe infections that cannot be controlled by oral or intravenous antibiotics;\n* Patients known to be allergic or contraindicated to the study drug (active pharmaceutical ingredient and\u002For excipients);\n* Existence of bleeding disorders unrelated to ALL.","15 Years",{"count":508,"type":21},36,"This is a prospective, multicenter, observational study aimed at exploring the efficacy and safety of reduced-dose chemotherapy followed by frontline therapy with blinatumomab in patients aged 15-65 with newly diagnosed Ph-negative B-ALL.",[511],"Leukemia, Lymphocytic, Acute, Adult",[513,514,515,516],"blinatumomab","newly diagnosed Ph-chromosome negative acute B-lymphoblastic leukemia","induction treatment","reduced-dose chemotherapy","2024-10-17",{"date":519,"type":39},"2024-10-18",{"date":521,"type":21},"2024-11-01",{"date":523,"type":21},"2027-12",{"name":45,"class":46},{"id":526,"slug":527,"hasResults":12,"nctId":528,"briefTitle":529,"officialTitle":529,"acronym":4,"eligibilityCriteria":530,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":385,"enrollmentInfo":531,"targetDuration":4,"studyType":22,"phases":532,"briefSummary":529,"conditions":533,"keywords":535,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":537,"lastUpdatePostDateStruct":538,"startDateStruct":540,"completionDateStruct":542,"leadSponsor":543,"locationsCount":4},"100549958","phase-3-a-multicenter-randomized-controlled-study-on-the-treatment-of-refractory-ctit-with-romiplostim-n01-compared-to-recombinant-human-thrombopoietin-100549958","NCT06440824","A Multicenter Randomized Controlled Study on the Treatment of Refractory CTIT With Romiplostim N01 Compared to Recombinant Human Thrombopoietin","Inclusion Criteria:\n\n1. Sign a written informed consent form before enrollment;\n2. Age range from 18 to 75 years old;\n3. Solid tumors or hematological tumors confirmed by tissue or pathology;\n4. CTIT patients caused by anti-tumor therapy;\n5. At least 2 weeks of treatment with two types of platelet growth factors and no response (including rhTPO or TPO-RA)\n6. Have not received treatment with Roptistine\u002FRoptistine N01;\n7. ECOG PS score: 0-2;\n8. Platelet value\\\u003C30 × 109\u002FL;\n9. Estimated survival time during screening is ≥ 12 weeks;\n10. Subjects of childbearing age agree to take reliable contraceptive measures (including male or female condoms, contraceptive foam, contraceptive gel, contraceptive film, contraceptive cream, contraceptive suppository, abstinence and the placement of intrauterine devices, etc.) throughout the study period; Excluding female participants who have undergone hysterectomy, bilateral salpingectomy, bilateral tubal ligation, or more than 1 year after menopause, as well as male participants who have undergone bilateral salpingectomy or ligation;\n11. Voluntarily participate in this study, sign an informed consent form, and have good compliance.\n\nExclusion Criteria:\n\n\\-\n\nPatients with any of the following conditions are not eligible for inclusion in this study:\n\n1. Suffering from hematopoietic system diseases other than thrombocytopenia (CIT) caused by tumor chemotherapy drugs, including but not limited to leukemia, primary immune thrombocytopenia, myeloproliferative diseases, multiple myeloma, and myelodysplastic syndrome;\n2. Screening for thrombocytopenia caused by causes other than CIT within the first 6 months, including but not limited to chronic liver disease, splenic hyperfunction, infection, and bleeding;\n3. Bone marrow invasion or metastasis;\n4. Have received pelvic and spinal radiation therapy, as well as bone field radiation therapy, or are currently\u002Fexpected to receive radiation therapy within the three months prior to screening;\n5. Screening for a history of severe cardiovascular disease within the first 6 months, such as congestive heart failure (NYHA heart function score III-IV), known arrhythmias that increase the risk of thromboembolism, such as atrial fibrillation, after coronary stent implantation, angioplasty, and coronary artery bypass grafting;\n6. Any history of arterial or venous thrombosis occurring within the first 6 months of screening;\n7. Screening for clinical manifestations of severe bleeding within the first two weeks, such as gastrointestinal or central nervous system bleeding;\n8. Brain tumors or brain metastases;\n9. Urgent treatment is required, such as vena cava syndrome and spinal cord compression syndrome;\n10. Neutrophil absolute value \\\u003C 1.0 × 109\u002FL, hemoglobin \\\u003C 80g\u002FL, allowing the use of granulocyte colony-stimulating factors and red blood cells that comply with clinical norms EPO infusion therapy;\n11. Significant abnormalities in liver function: patients without liver metastasis, ALT\u002FAST\\>3ULN (upper limit of normal value), TBIL\\>3ULN； Patients with liver metastasis are present, ALT\u002FAST≥5ULN，TBIL≥5ULN；\n12. Renal dysfunction: blood creatinine ≥ 1.5ULN or eGFR ≤ 60 ml\u002Fmin (Cockcroft Gault formula);\n13. Within the first month prior to screening, patients who have received treatment with loperstine\u002Floperstine N01 or recombinant human thrombopoietin (rhTPO);\n14. Received platelet transfusion within the first 3 days of randomization;\n15. Patients who are known or expected to be allergic or intolerant to Roxetine N01 or rhTPO excipients\n16. HIV infected individuals;\n17. Pregnant or lactating women;\n18. Participated in any clinical study of any other investigational drug or device three months prior to screening;\n19. The researchers believe that participating in the trial poses a significant risk to the health or safety of the subjects, or other circumstances that may affect the efficacy evaluation.",{"count":196,"type":21},[86],[534],"CTIT-Chemotherapy Induced Thrombocytopenia",[536],"Romiplostim N01，Recombinant Human Thrombopoietin，CTIT","2024-06-03",{"date":539,"type":39},"2024-06-04",{"date":541,"type":21},"2024-06-01",{"date":440,"type":21},{"name":45,"class":46},{"id":545,"slug":546,"hasResults":12,"nctId":547,"briefTitle":548,"officialTitle":549,"acronym":550,"eligibilityCriteria":551,"healthyVolunteers":314,"sex":55,"minAge":552,"maxAge":553,"enrollmentInfo":554,"targetDuration":4,"studyType":22,"phases":556,"briefSummary":557,"conditions":558,"keywords":4,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":562,"lastUpdatePostDateStruct":563,"startDateStruct":565,"completionDateStruct":567,"leadSponsor":569,"locationsCount":47},"100521059","effect-of-metformin-on-healthy-live-birth-in-women-with-prediabetes-100521059","NCT06064669","Effect of Metformin on Healthy Live Birth in Women With Prediabetes","Effect of Metformin on Healthy Live Birth After In-vitro Fertilization in Women With Prediabetes Mellitus: a Multicenter Double-blind Placebo Controlled Randomized Trial","MELT-PreDM","Inclusion Criteria:\n\n1. Women who are diagnosed with prediabetes by ADA criteria, including either IFG, IGT, or HbA1C 5.7-6.4%.\n2. Women aged 20-40 years.\n3. Women who plan to undergo a new cycle of IVF, ICSI, or PGT-A.\n\nExclusion Criteria:\n\n1. Women who are diagnosed with diabetes according to the ADA criteria11,12, which is meeting one of the following criteria: fasting plasma glucose ≥7.0mmol\u002FL, 2-h plasma glucose during 75-g OGTT ≥11.1mmol\u002FL, HbA1c≥6.5%, or a random plasma glucose≥11.1mmol\u002FL.\n2. Women who are taking medicine that interfere with glucose metabolism, such as metformin, oral anti-diabetic agents (sulfonylureas, glinides, thiazolidinediones, α-glycosidase inhibitors, GLP-1 receptor agonist, etc.), weight loss drugs (i.e.orlistat, etc.), glucocorticoids, and growth hormones within 2 months before enrollment.\n3. Women with un-corrected hyperthyroidism or hypothyroidism.\n4. Women with congenital or acquired abnormal uterine cavity including septate uterus, unicornous uterus, uterus duplex, and intrauterine adhesions.\n5. Women with a diagnosis of adenomyosis.\n6. Women with untreated hydrosalpinx.\n7. Women who plan to undergo PGT-SR or PGT-M.\n8. Women with major medical comorbidities, such as known liver disease, known renal disease, or known significant anemia.","20 Years","40 Years",{"count":555,"type":21},988,[24],"To evaluate the efficacy and safety of metformin pretreatment on reproductive outcomes in infertile women with prediabetes.",[559,560,561],"Metformin","Prediabetes","In-Vitro Fertilization","2024-05-27",{"date":564,"type":39},"2024-05-29",{"date":566,"type":39},"2024-02-22",{"date":568,"type":21},"2027-12-31",{"name":45,"class":46},{"id":571,"slug":572,"hasResults":12,"nctId":573,"briefTitle":574,"officialTitle":575,"acronym":4,"eligibilityCriteria":576,"healthyVolunteers":12,"sex":55,"minAge":18,"maxAge":173,"enrollmentInfo":577,"targetDuration":4,"studyType":22,"phases":579,"briefSummary":580,"conditions":581,"keywords":4,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":583,"lastUpdatePostDateStruct":584,"startDateStruct":586,"completionDateStruct":588,"leadSponsor":590,"locationsCount":591},"100535447","phase-2-efbemalenograstim-alfa-injection-for-ovarian-or-cervical-cancer-receiving-chemotherapy-regimen-100535447","NCT06251947","Efbemalenograstim Alfa Injection for Ovarian or Cervical Cancer Receiving Chemotherapy Regimen","A Study of Efbemalenograstim Alfa Injection for Ovarian or Cervical Cancer Receiving Chemotherapy Regimen With Risk Factors:A Single-Arm, Multicenter Clinical Trial","Inclusion Criteria:\n\n1. ≥ 18 years old and ≤ 70 years old.\n2. First-line epithelial ovarian cancer (including fallopian tube cancer and primary peritoneal cancer) and first-line treatment or recurrent\u002Fmetastatic cervical cancer.\n3. Planned to receive 3-6 cycles of paclitaxel + carboplatin\u002Fcisplatin ± bevacizumab therapy.\n4. Eastern Cooperative Oncology Group (ECOG) score \\\u003C 2.\n5. Expected survival time \\> 3 months.\n6. Before enrollment, neutrophil count (ANC) ≥ 2.0 × 10\\^9\u002FL, hemoglobin (Hb) ≥ 90.0 g\u002FL, and platelet (PLT) ≥ 80 × 10\\^9\u002FL.\n7. Associated with ≥ 1 self-factors increasing the risk of febrile neutropenia (FN): ① age \\> 65 years, receiving full-dose intensity chemotherapy; ② history of previous chemotherapy or radiotherapy; ③ persistent neutropenia; ④ tumor involvement of the bone marrow; ⑤ recent surgery and\u002For open wounds; ⑥ hepatic dysfunction (bilirubin \\> 2.0 mg•dL-1); ⑦ renal dysfunction (creatinine clearance rate \\\u003C 50 mL•min-1); ⑧ history of previous FN occurrence; ⑨ concomitant malignant hematological or lymphatic system diseases; ⑩ chronic immunosuppression; ⑪ poor nutritional\u002Fphysical status. Individualized judgment and decision-making based on the patient's specific condition are required in clinical practice.\n8. Left ventricular ejection fraction (LVEF) \\> 50%.\n9. Women who are not capable of reproduction, i.e., postmenopausal for at least 1 year or have undergone sterilization procedures (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy). Fertile patients agree to use appropriate contraceptive measures within 1 month before the start of the trial and up to 30 days after the end of the study, such as condoms, spermicidal condoms, foam, gel, diaphragm, intrauterine device (IUD), contraceptive pills (oral or injectable), etc.\n10. Willing to provide written informed consent and to compliant study procedure.\n11. The investigator determines that the patient can tolerate treatment with Efgbemalenograstim alfa.\n\nExclusion Criteria:\n\n1. Uncontrolled infection or systemic antibiotic therapy within 72 hours prior to chemotherapy.\n2. Pregnant or lactating women.\n3. History of bone marrow or stem cell transplantation.\n4. Concurrent malignancies other than primary ovarian or cervical cancer.\n5. Treatment with recombinant human granulocyte colony-stimulating factor within 6 weeks prior to enrollment.\n6. Psychiatric illness or brain metastases.\n7. Clinical, electrocardiographic, or other diagnostic evidence of acute congestive heart failure, cardiomyopathy, or myocardial infarction.\n8. Diseases associated with splenomegaly.\n9. Diagnosis of acute infection, chronic active hepatitis B within 1 year (unless known negative for hepatitis B virus antigen prior to enrollment), or hepatitis C.\n10. Allergy to recombinant human granulocyte colony-stimulating factor or excipients of the study drug, or allergy to rubber.\n11. Known positive serum reaction for human immunodeficiency virus (HIV) or AIDS.\n12. Active tuberculosis or recent history of contact with a tuberculosis patient unless negative on tuberculin skin test, or receiving treatment for tuberculosis, or suspected case on chest X-ray examination.\n13. Sickle cell anemia patients.\n14. Use of other investigational drugs within 1 month prior to enrollment.\n15. Patients who abuse alcohol or drugs, affecting their compliance with the study.\n16. The investigator believes that the patient has a disease or symptom that makes them unsuitable for participation in this study, or that the study drug may harm the patient's health or affect the assessment of adverse events.",{"count":578,"type":21},83,[59],"The aim of this study was to observe the efficacy and safety of Efbemalenograstim Alfa in the prevention of absolute neutrophil count (ANC) reduction after chemotherapy in Ovarian and Cervical cancer patients at risk of platinum-containing chemotherapy with risk factors in febrile neutropenia (FN).",[62,582],"Cervical Cancer","2024-05-05",{"date":585,"type":39},"2024-05-07",{"date":587,"type":39},"2024-04-15",{"date":589,"type":21},"2026-12",{"name":45,"class":46},6,""]