[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Sir Run Run Shaw Hospital\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":594},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,43,0,25,[9,38,64,86,110,129,148,175,198,221,243,270,290,309,338,361,390,410,429,458,480,502,525,546,569],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":4},"100053562","end-expiratory-diaphragmatic-residual-contraction-index-for-identifying-intrinsic-peep-and-assisting-peep-titration-a-prospective-physiological-study-100053562",false,"NCT07697703","End-Expiratory Diaphragmatic Residual Contraction Index for Identifying Intrinsic PEEP and Assisting PEEP Titration: A Prospective Physiological Study","Inclusion Criteria:\n\n* Age ≥ 18 years. Patients receiving invasive mechanical ventilation in Pressure Support Ventilation (PSV) mode.\n\nClinically assessed as having a risk of dynamic intrinsic PEEP (PEEPi,dyn) or experiencing difficult weaning from mechanical ventilation.\n\nPresence of an indwelling esophageal balloon catheter (for reference standard measurements).\n\nProvision of written informed consent from the patient or legally authorized representative.\n\nExclusion Criteria:\n\n* Pregnancy or lactation. Known esophageal diseases (e.g., esophageal varices, strictures, recent esophageal surgery) or contraindications to esophageal catheter placement.\n\nSevere hemodynamic instability (e.g., requiring high-dose vasoactive support, uncontrolled arrhythmias).\n\nSevere hypoxemia (PaO2\u002FFiO2 \\\u003C 100 mmHg) or severe hypercapnia with hemodynamic compromise at baseline.\n\nConditions precluding ultrasound assessment of the diaphragm (e.g., extensive chest wall trauma, large pleural effusion, severe subcutaneous emphysema).\n\nActive spontaneous breathing with severe patient-ventilator asynchrony that cannot be stabilized during the trial.\n\nAnticipated extubation or withdrawal of life-sustaining treatment within the next 24 hours.\n\nParticipation in another interventional clinical trial within the last 30 days.","ALL","18 Years",{"count":19,"type":20},100,"ESTIMATED","OBSERVATIONAL","This study proposes the End-expiratory Diaphragmatic Residual Contraction (EDRC) index to quantify residual diaphragmatic activity at end-expiration during Pressure Support Ventilation (PSV) mode. The study aims to validate the relationship between EDRC and dynamic intrinsic PEEP (PEEPi), triggering load, patient-ventilator asynchrony, and PEEP responsiveness through a brief, standardized PEEP titration trial conducted within a clinically safe range. This will provide a basis for subsequent individualized PEEP setting guided by EDRC.",[24,25],"Speckle Tracking","Diaphragm","NOT_YET_RECRUITING","2026-07-05",{"date":29,"type":30},"2026-07-13","ACTUAL",{"date":32,"type":20},"2026-08-21",{"date":34,"type":20},"2027-09-03",{"name":36,"class":37},"Sir Run Run Shaw Hospital","OTHER",{"id":39,"slug":40,"hasResults":12,"nctId":41,"briefTitle":42,"officialTitle":43,"acronym":4,"eligibilityCriteria":44,"healthyVolunteers":12,"sex":45,"minAge":17,"maxAge":46,"enrollmentInfo":47,"targetDuration":4,"studyType":49,"phases":50,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":63},"100643201","application-of-multimodal-intervention-in-the-prevention-of-postoperative-nausea-and-vomiting-after-gynecological-laparoscopic-surgery-100643201","NCT07631910","Application of Multimodal Intervention in the Prevention of Postoperative Nausea and Vomiting After Gynecological Laparoscopic Surgery","Transcutaneous Electrical Acupoint Stimulation Versus Sham Stimulation Combined With Dexamethasone Versus Amisulpride for Preventing Postoperative Nausea and Vomiting After Laparoscopic Gynecological Surgery: A Randomized Controlled Factorial Trial","Inclusion Criteria:\n\n* Age 18-65 years;\n* ASA physical status I-II;\n* Scheduled for elective gynecological laparoscopic surgery (e.g., ovarian cystectomy, myomectomy) under general anesthesia;\n* Willing to provide informed consent.\n\nExclusion Criteria:\n\n* Severe cardiac, hepatic, renal, or pulmonary disease;\n* Allergy or skin disease at TEAS application site;\n* Use of antiemetics within 24 hours before surgery; pregnancy or lactation;\n* Vulnerable populations (e.g., critically ill, psychiatric disorders, cognitive impairment, illiteracy);\n* Any condition deemed unsuitable by the investigator.","FEMALE","65 Years",{"count":48,"type":20},212,"INTERVENTIONAL",[51],"NA","1. Background Postoperative nausea and vomiting (PONV) is a common complication after general anesthesia, with an incidence as high as 80% in gynecological laparoscopic surgery. Transcutaneous electrical acupoint stimulation (TEAS) has shown potential as a non-invasive, side-effect-free intervention. Combining pharmacological agents (dexamethasone or amisulpride) with TEAS may provide a synergistic preventive effect, aligning with enhanced recovery after surgery (ERAS) principles.\n2. Study Objectives To evaluate the preventive effect of TEAS on PONV in patients undergoing gynecological laparoscopic surgery, compared with sham stimulation.\n\n   To explore the synergistic effect of dexamethasone or amisulpride when combined with TEAS, and to optimize PONV prevention strategies.\n\n   To assess the impact of multimodal intervention on postoperative recovery quality, length of hospital stay, and patient satisfaction.\n\n   To evaluate the safety of the combined interventions and record any adverse events.\n3. Study Design Design type: 2×2 factorial, randomized, double-blind (participants, outcome assessors, and data analysts blinded to group assignment).\n\n   Randomization: 1:1:1:1 allocation using an online randomization tool.\n\n   3.1 Study Groups Group Intervention A TEAS + Dexamethasone B TEAS + Amisulpride C Sham stimulation + Dexamethasone D Sham stimulation + Amisulpride 3.2 Participants Inclusion criteria: Age 18-65 years; ASA physical status I-II; scheduled for elective gynecological laparoscopic surgery (e.g., ovarian cystectomy, myomectomy) under general anesthesia; willing to provide informed consent.\n\n   Exclusion criteria: Severe cardiac, hepatic, renal, or pulmonary disease; allergy or skin disease at TEAS application site; Receipt of antiemetics within 24 h before surgery; Implanted cardiac pacemaker, cardioverter-;pregnancy or lactation; vulnerable populations (e.g., critically ill, psychiatric disorders, cognitive impairment, illiteracy); any condition deemed unsuitable by the investigator.\n\n   3.3 Interventions A wearable transcutaneous electrical acupoint stimulation (TEAS) wristband will be applied to the P6 (Neiguan) acupoint on the dominant upper extremity. The P6 acupoint is located approximately 3-5 cm proximal to the distal wrist crease, between the tendons of the flexor carpi radialis and palmaris longus. The device integrates the stimulating electrodes within the wristband and does not require external adhesive electrodes.\n\n   TEAS or sham stimulation will be administered at three time points: 30 minutes before surgery and 24 and 48 hours after surgery, with each session lasting 30 minutes.\n\n   Dexamethasone 5 mg (off-label for PONV; approved for inflammatory\u002Fallergic conditions).\n\n   Amisulpride 5 mg.\n\n   3.4 Outcome Measures\n\n   Primary outcomes (0-48 h postoperatively):\n\n   PONV incidence (proportion of patients with nausea, vomiting, or retching). PONV severity (0 = none, 1 = nausea only, 2 = vomiting\u002Fretching, 3 = refractory nausea\u002Fvomiting).\n\n   Secondary outcomes:\n\n   Recovery quality: time to first flatus, first ambulation, hospital stay, bowel function recovery.\n\n   Patient satisfaction: Visual Analogue Scale (VAS, 0-10) and QoR-15 score (0-150).\n\n   Rescue antiemetic use. Management needs for severe PONV. Postoperative pain (VAS at rest and on movement) and opioid consumption. Device-related adverse events (skin irritation, burning, allergy). Drug-related adverse events (e.g., hyperglycemia, hypotension, headache, dizziness, QT prolongation).\n\n   Intraoperative hemodynamics and postoperative complications (e.g., infection, shivering, urinary retention).\n\n   3.5 Follow-up Schedule Postoperative day 1 (24 h): PONV assessment, time to first flatus and ambulation.\n\n   Postoperative day 2 (48 h): PONV incidence\u002Fseverity, rescue medication. At discharge: Satisfaction, hospital stay (via in-person or telephone follow-up).\n4. Sample Size Calculation Assumptions: PONV incidence 50% in control groups, 30% in TEAS groups; two-sided α = 0.05; power = 80%.\n\n   Each main effect level requires \\~93 patients. For a 2×2 factorial design with 1:1:1:1 allocation, this translates to 47 patients per group (total 188). Accounting for a 10% dropout rate, final sample size = 212 patients (53 per group).\n5. Data Management and Confidentiality Electronic Data Capture (EDC) system with unique coding (no direct identifiers).\n\n   Access restricted to authorized research team members.\n6. Informed Consent Written informed consent will be obtained from each participant after full explanation of the study purpose, procedures, risks, and benefits. Participants are informed of their right to withdraw at any time.\n7. Adverse Event Management Dexamethasone-related AEs (transient hyperglycemia, blood pressure fluctuation, gastrointestinal discomfort, rare allergic reactions).\n\nAmisulpride-related AEs (headache, dizziness, constipation\u002Fdiarrhea, QT prolongation, allergic reactions).\n\nTEA-related AEs (local skin discomfort, redness, itching, rare blisters or mild burns).",[54],"Nausea and Vomiting, Postoperative","2026-06-01",{"date":57,"type":30},"2026-06-08",{"date":59,"type":20},"2026-07-01",{"date":61,"type":20},"2026-10-31",{"name":36,"class":37},1,{"id":65,"slug":66,"hasResults":12,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":4,"eligibilityCriteria":70,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":71,"targetDuration":4,"studyType":49,"phases":73,"briefSummary":76,"conditions":77,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":83,"leadSponsor":85,"locationsCount":4},"100637737","phase-2-study-of-becotatug-vedotin-added-to-standard-treatment-for-advanced-bile-duct-cancer-with-egfr-mutations-100637737","NCT07598318","Study of Becotatug Vedotin Added to Standard Treatment for Advanced Bile Duct Cancer With EGFR Mutations","A Randomized, Controlled, Open-Label, Multi-center Study of Becotatug Vedotin (EGFR-ADC) Combined With Chemo and Immunotherapy vs. Chemo and Immunotherapy as First-Line Treatment in Advanced\u002FMetastatic EGFR-Mutated Biliary Tract Cancer","Inclusion Criteria:\n\n* Age ≥ 18 years old, both genders are eligible.\n* Histologically confirmed unresectable or metastatic cholangiocarcinoma (including: gallbladder cancer, intrahepatic cholangiocarcinoma and extrahepatic cholangiocarcinoma), histologically confirmed unresectable or metastatic cholangiocarcinoma (including: gallbladder cancer, intrahepatic cholangiocarcinoma and extrahepatic cholangiocarcinoma, after previous chemotherapy failure), and at least one assessable lesion.\n* IHC test is positive for EGFR.\n* ECOG PS score 0-1, normal major organ functions, no severe abnormalities in blood, heart, lungs, liver, kidneys, bone marrow and immune deficiency diseases.\n* For female participants of childbearing age, a pregnancy test (serum\u002Furine) result must be negative within 14 days before enrollment, and they must voluntarily use appropriate methods of contraception during the observation period and 8 weeks after the last administration of the study drug; for male participants, they should be surgically sterilized or agree to use appropriate methods of contraception during the observation period and 8 weeks after the last administration of the study drug.\n* Expected good compliance, able to follow up on efficacy and adverse reactions as per the protocol requirements.\n* Voluntary participation in this study and signing the informed consent form. If the participant is unable to read and sign the informed consent form due to lack of capacity, their guardian should act on their behalf in the informed process and sign the informed consent form. If the participant is unable to read the informed consent form (such as illiterate participants), a witness should witness the informed process and sign the informed consent form.\n\nExclusion Criteria:\n\n* Within the 3 months prior to enrollment, the participant has not participated in any other clinical studies.\n* Has any active autoimmune disease or history of autoimmune disease (such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (after hormone replacement therapy can be included)); Has completely recovered from childhood asthma and does not require any intervention after adulthood or vitiligo can be included, but patients requiring bronchodilators for medical intervention are not included.\n* Has congenital or acquired immune dysfunction, such as human immunodeficiency virus (HIV) infected individuals.\n* Has uncontrolled clinical symptoms or diseases of the heart, such as NYHA II or above heart failure, unstable angina pectoris, myocardial infarction within 1 year, clinical significance of supraventricular or ventricular arrhythmias requiring clinical intervention.\n* Had severe infection within 4 weeks before the first medication (such as requiring intravenous infusion of antibiotics, antifungal or antiviral drugs), or had unexplained fever \\> 38.5℃ during screening or before the first administration.\n* Has a history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.\n* Had vaccination with attenuated live vaccines within 4 weeks before the first administration or planned during the study period.\n* Has had or is currently suffering from other systemic malignant tumors within the last 5 years (excluding cured skin basal cell carcinoma, cervical carcinoma in situ and ovarian cancer).\n* Has known allergies to any study drug.\n* Pregnant or lactating women, or subjects with reproductive capacity who are unwilling to take effective contraceptive measures.\n* Vulnerable groups other than the elderly or illiterate, including those with mental illness, cognitive impairment, critically ill patients, etc.\n* Other situations that the investigator deems unsuitable for inclusion in this study. Such as: the patient has central nervous system metastasis, has severe laboratory test abnormalities, is accompanied by family or social factors, which may affect the safety of the subject or the collection of data\u002Fsamples.",{"count":72,"type":20},164,[74,75],"PHASE2","PHASE3","This study tests whether adding becotatug vedotin (EGFR-ADC) to standard chemotherapy plus immunotherapy improves outcomes compared to chemotherapy plus immunotherapy alone as first-line treatment for patients with advanced or metastatic biliary tract cancer whose tumors carry EGFR mutations. Participants will be randomly assigned to receive either the experimental combination (becotatug vedotin + pucotenlimab + gemcitabine + cisplatin) or the control combination (pucotenlimab + gemcitabine + cisplatin). The main goal is to see if the experimental group has a higher objective response rate (tumor shrinkage rate). This is a randomized, controlled, open-label, multicenter study led by Sir Run Run Shaw Hospital, Zhejiang University, with Dr. Chen Mingyu as the principal investigator.",[78],"Cholangiocarcinoma","2026-05-17",{"date":81,"type":30},"2026-05-20",{"date":81,"type":20},{"date":84,"type":20},"2028-12-31",{"name":36,"class":37},{"id":87,"slug":88,"hasResults":12,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":92,"eligibilityCriteria":93,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":94,"enrollmentInfo":95,"targetDuration":4,"studyType":49,"phases":97,"briefSummary":98,"conditions":99,"keywords":101,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":104,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":4},"100640897","phase-2-gemcitabine-cisplatin-plus-envafolimab-in-resectable-biliary-tract-malignancies-100640897","NCT07599995","Gemcitabine-Cisplatin Plus Envafolimab in Resectable Biliary Tract Malignancies","The Efficacy and Safety of Gemcitabine-Cisplatin Plus Envafolimab as Neoadjuvant Therapy in Resectable Biliary Tract Malignancies at High Risk of Recurrence","GENE","Inclusion Criteria:\n\n* Participants who have signed a written Informed Consent Form (ICF);\n* Male or female participants aged 18-80 years;\n* Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0\u002F1;\n* Biliary Tract Cancer (BTC) diagnosed by puncture pathology prior to enrollment;\n* Participants must meet the following requirements for major vital organ function: a. Absolute neutrophil count (ANC) ≥ 1.5×10⁹\u002FL; platelet count ≥ 90×10⁹\u002FL; hemoglobin ≥ 9 g\u002FdL; b. Coagulation function: international normalized ratio (INR) ≤ 1.2; c. Alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 3 times the upper limit of normal (ULN); d. Serum albumin ≥ 3.5 g\u002FdL; total bilirubin ≤ 1.5 times the ULN. Patients with obstructive jaundice who meet the eligibility criteria after percutaneous transhepatic cholangial drainage or endoscopic retrograde cholangiopancreatography treatment are also eligible for enrollment; e. Child-Pugh class A or B; f. Serum creatinine ≤ 1.5 times the ULN;\n* Patients with high-risk factors for recurrence. The criteria are defined as meeting at least one of the following: a. Preoperative CA19-9 ≥ 200 U\u002FmL; b. Tumor diameter ≥ 5 cm or multiple tumor nodules on imaging; c. Regional lymph node metastasis with a short-axis diameter ≥ 1.0 cm on imaging; d. Vascular invasion (portal vein or hepatic artery) on imaging; e. Low or undifferentiated histologic grade;\n* Participants who have at least 1 measurable lesion (RECIST v1.1);\n* Be able to provide fresh stool samples and liver samples if undergoing surgery.\n\nExclusion Criteria\n\n* Pathological diagnosis of hepatocellular carcinoma, mixed hepatocellular carcinoma, and other non-cholangiocarcinoma malignant tumor components;\n* Prior systemic therapy for BTC, including immunotherapy, targeted therapy, or chemotherapy;\n* History of other prior or concurrent malignancies, except those with complete treatment and disease-free survival for more than 5 years;\n* Presence of an active, known or suspected autoimmune disease, or requirement for long-term systemic corticosteroid therapy (equivalent to ≥ 10 mg prednisone daily) or other immunosuppressive agents. Participants using inhaled or topical corticosteroids will not be excluded;\n* Presence of ascites, hepatic encephalopathy, sclerosing cholangitis, or other concurrent organ dysfunctions that would preclude tolerance of general anesthesia or hepatectomy;\n* Women who are breastfeeding or pregnant;\n* Any other factors that, in the investigator's judgment, may compromise participant safety or trial compliance, including serious comorbidities requiring ongoing treatment, clinically significant laboratory abnormalities, or relevant social or family-related issues.","80 Years",{"count":96,"type":20},34,[74],"This trial is to evaluate the efficacy of Gemcitabine-Cisplatin (GC) plus Envafolimab neoadjuvant therapy in the patients at high risk of recurrence. Primary endpoint: Major Pathologic Response (MPR). It will also learn about the safety of drug including Gemcitabine-Cisplatin (GC) plus Envafolimab as a neoadjuvant therapy in this trial.",[100],"Biliary Tract Cancer",[102,103],"Resectable Biliary Tract Cancer","High Risk of Recurrence",{"date":81,"type":30},{"date":106,"type":20},"2026-05-30",{"date":108,"type":20},"2030-03-30",{"name":36,"class":37},{"id":111,"slug":112,"hasResults":12,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":4,"eligibilityCriteria":116,"healthyVolunteers":12,"sex":16,"minAge":46,"maxAge":4,"enrollmentInfo":117,"targetDuration":4,"studyType":49,"phases":119,"briefSummary":120,"conditions":121,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":127,"leadSponsor":128,"locationsCount":63},"100637158","transcutaneous-electrical-acustimulation-on-postoperative-bowel-function-recovery-in-elderly-patients-100637158","NCT07574502","Transcutaneous Electrical Acustimulation on Postoperative Bowel Function Recovery in Elderly Patients","Efficacy of Transcutaneous Electrical Acustimulation on Postoperative Bowel Function Recovery in Elderly Patients With Colorectal Cancer: A Multicenter Randomized Controlled Trial Study Protocol","Inclusion Criteria:\n\n* Age ≥ 65 years old.\n* Elective minimally invasive (laparoscopic or robotic) resection of colorectal cancer.\n* American Society of Anesthesiologists classification (ASA) 1-4.\n* Able to understand the research process and the use of various assessment scales, and able to communicate effectively with the researchers.\n* The patient voluntarily participates in this study and signs the informed consent form.\n\nExclusion Criteria:\n\n* Previous history of abdominal gastrointestinal surgery.\n* Planned for palliative or emergency surgery.\n* Planned for open abdominal surgery or creation of a new stoma.\n* Transfer to ICU.\n* Diagnosed with severe heart, liver, kidney or mental system diseases.\n* Patients with implanted cardiac pacemakers.\n* Patients currently using or having used in the past month glucagon-like peptide-1 (GLP-1) receptor agonists, dual glucose-dependent insulinotropic polypeptide (GIP) receptor agonists, and sodium-glucose cotransporter-2 (SGLT-2) inhibitors.\n* Planned to use epidural anesthesia or epidural analgesia.\n* Presence of local skin lesions, infection at the stimulation site, or obvious skin allergy or severe skin sensitivity to electrodes\u002Fadhesive materials.\n* Participated in other clinical studies within the past 3 months or received acupuncture treatment within the past month.\n* Other conditions that the investigator considers make the patient unsuitable for participation in this study.",{"count":118,"type":20},190,[51],"The goal of this clinical trial is to clarify the efficacy and safety of transcutaneous electrical acustimulation (TEA) in elderly patients with colorectal cancer, and to evaluate its clinical value in promoting postoperative intestinal function recovery and reducing the incidence of intestinal complications. The main questions it aims to answer are:\n\nCan TEA promote the recovery of intestinal function in elderly patients with colon cancer after surgery? What medical problems might occur to the participants when using TEA? The researchers will compare TEA with the control group (non-acupoint sham stimulation) to see if TEA is effective in promoting the recovery of intestinal function after surgery.\n\nParticipants will:\n\nStarting from the first day after the surgery, they received TEA or sham stimulation twice a day for a total of 3 days.\n\nRecord the time of the first defecation, defecation, and eating. Record their symptoms and adverse events.",[122],"Colorectal Cancer (CRC)","2026-05-14",{"date":125,"type":30},"2026-05-15",{"date":55,"type":20},{"date":84,"type":20},{"name":36,"class":37},{"id":130,"slug":131,"hasResults":12,"nctId":132,"briefTitle":133,"officialTitle":133,"acronym":4,"eligibilityCriteria":134,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":135,"targetDuration":4,"studyType":49,"phases":137,"briefSummary":138,"conditions":139,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":4},"100632503","phase-2-the-efficacy-and-safety-of-pucotenlimab-pd-1-combined-with-becotatugvedotin-egfr-adc-in-advanced-cholangiocarcinoma-100632503","NCT07514533","The Efficacy and Safety of Pucotenlimab (PD-1) Combined With Becotatugvedotin (EGFR-ADC) in Advanced Cholangiocarcinoma","Inclusion Criteria:\n\n* 1\\) Age ≥ 18 years old, both male and female are acceptable. 2) Histologically confirmed unresectable or metastatic cholangiocarcinoma (including: gallbladder cancer, intrahepatic cholangiocarcinoma and extrahepatic cholangiocarcinoma), or (including: gallbladder cancer, intrahepatic cholangiocarcinoma and extrahepatic cholangiocarcinoma, after previous chemotherapy failure); 3) ECOG PS score 0-1. 4) Normal major organ functions, without severe blood, heart, lung, liver, kidney, bone marrow, or immune deficiency diseases.\n\n  5\\) For female subjects of childbearing age, a pregnancy test (serum\u002Furine) result must be negative within 14 days before enrollment, and they must voluntarily use appropriate methods of contraception during the observation period and 8 weeks after the last administration of the study drug; for male subjects, surgical sterilization or consent to use appropriate methods of contraception during the observation period and 8 weeks after the last administration of the study drug is required.\n\n  6\\) IHC test is positive for EGFR. 7) Expected good compliance and able to follow up on efficacy and adverse reactions as per the protocol.\n\n  8\\) Voluntary participation in this study and signing the informed consent form. If the subject is unable to read and sign the informed consent form due to lack of capacity, the guardian should act on behalf of the informed process and sign the informed consent form. If the subject is unable to read the informed consent form (such as illiterate subjects), a witness should witness the informed process and sign the informed consent form.\n\nExclusion Criteria:\n\n* 1\\) Received PD1, PDL1, PDL2, CTLA4 treatment before enrollment, or directly received another stimulating or co-inhibitory T cell receptor (such as CTLA-4, OX40, CD137) treatment.\n\n  2\\) Used any other study drug within 4 weeks before enrollment. 3) Has any active autoimmune disease or autoimmune disease history (such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitaryitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (after hormone replacement therapy can be included)); has completely resolved childhood asthma and no need for any intervention after adulthood, and can be included, but patients requiring medical intervention with bronchodilators are not included.\n\n  4\\) Has congenital or acquired immune dysfunction, such as human immunodeficiency virus (HIV) infection.\n\n  5\\) Has uncontrolled clinical symptoms or diseases of the heart, such as NYHA II or above heart failure, unstable angina pectoris, heart attack within 1 year, patients with clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention.\n\n  6\\) Had severe infection within 4 weeks before the first administration (such as requiring intravenous infusion of antibiotics, antifungal or antiviral drugs), or had unexplained fever \\> 38.5℃ during screening or before the first administration.\n\n  7\\) Has a history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.\n\n  8\\) Had a live attenuated vaccine administered within 4 weeks before the first administration or is planned to be administered during the study period.\n\n  9\\) Had other systemic malignant tumors within the last 5 years (excluding cured skin basal cell carcinoma and cervical carcinoma in situ and ovarian cancer).\n\n  10\\) Has known allergies to any study drug. 11) Pregnant or lactating women, subjects with reproductive capacity who are unwilling to take effective contraceptive measures.\n\n  12\\) Vulnerable groups other than the elderly or illiterate, including those with mental illness, cognitive impairment, critically ill patients, etc.\n\n  13\\) Other situations considered by the investigator as not suitable for inclusion in this study. Such as: the patient already has central nervous system metastasis. There are serious laboratory test abnormalities, accompanied by factors related to family or society, which may affect the safety of the subjects or the collection of data\u002Fsamples.",{"count":136,"type":20},60,[74],"(1) Primary efficacy endpoint: Objective Response Rate (ORR) after 2 treatment cycles. ORR is defined as the proportion of subjects with complete response (CR) and partial response (PR) among all subjects. (2) Secondary efficacy endpoints include Progression-Free Survival (PFS), 2-year Relapse-Free Survival Rate, Disease Control Rate (DCR), Duration of Response (DOR), Adverse Reaction Incidence, 1-year Overall Survival Rate, 2-year Overall Survival Rate. Safety assessment includes physical examination, physical condition assessment (based on ECOG score), clinical laboratory tests and concomitant medication status. All observed drug toxicities and side effects need to be classified according to NCICTCAE and evaluated for their correlation with the drug. Patient Quality of Life (QoL) assessment uses the EORTC QLQC30 questionnaire and the BIL21 questionnaire. Recurrence patterns are classified as local recurrence and distant recurrence. Local control status is defined as the local failure rate (occurrence of local recurrence or local lymph node metastasis).",[78],"2026-03-31",{"date":142,"type":30},"2026-04-07",{"date":144,"type":20},"2026-03-11",{"date":146,"type":20},"2027-12-31",{"name":36,"class":37},{"id":149,"slug":150,"hasResults":12,"nctId":151,"briefTitle":152,"officialTitle":153,"acronym":154,"eligibilityCriteria":155,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":94,"enrollmentInfo":156,"targetDuration":4,"studyType":49,"phases":158,"briefSummary":160,"conditions":161,"keywords":163,"overallStatus":165,"whyStopped":4,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":174},"100632048","phase-4-study-on-the-prevention-of-atrial-fibrillation-recurrence-after-ablation-by-qidong-yixin-granule-100632048","NCT07508618","Study on the Prevention of Atrial Fibrillation Recurrence After Ablation by Qidong Yixin Granule","Study on the Prevention of Atrial Fibrillation Recurrence After Ablation by Qidong Yixin Granule Based on Multicenter Clinical Trials and Omics Mechanisms","QDYX-AF","Inclusion Criteria:\n\n* Age 18-80 years (inclusive);\n* Diagnosed with non-valvular persistent atrial fibrillation, having failed at least one antiarrhythmic drug treatment, and scheduled to undergo initial ablation;\n* Voluntarily participate in this study and sign an informed consent form. If the subject is unable to read or sign the informed consent form due to reasons such as lack of capacity, the informed consent process must be completed and signed by their legal guardian. If the subject is unable to read the informed consent form (e.g., illiterate subjects), the informed consent process must be witnessed and signed by a witness.\n\nExclusion Criteria:\n\n* Valvular atrial fibrillation or paroxysmal atrial fibrillation\n* NYHA functional class IV or LVEF \\\u003C40%, LA diameter \\>55mm;\n* Moderate to severe left ventricular hypertrophy (wall thickness \\>1.5cm);\n* Patients with acute coronary syndrome or requiring stent implantation\n* Patients with a history of cardiac surgery within the past 6 months or previous catheter ablation\n* Duration of atrial fibrillation ≥5 years;\n* Hyperthyroidism;\n* Patients with atrial fibrillation and cardiomyopathy;\n* Patients with bradyarrhythmia requiring pacemaker implantation\n* Known bleeding diathesis, presence of left atrial\u002Fleft atrial appendage thrombus, or severe hemostasis and coagulation dysfunction\n* Severe hepatic or renal insufficiency ALT ≥3 × ULN or eGFR \\\u003C45 ml\u002Fmin\u002F1.73 m²;\n* Patients allergic to the components of the study drug;\n* Patients who are currently participating or have participated in other interventional clinical studies within the past 3 months.\n* Pregnant or lactating women, or those with an expected lifespan of \\\u003C12 months;\n* Other vulnerable groups, excluding the elderly\u002Filliterate individuals, including those with mental illnesses, cognitive impairments, critically ill patients, etc\n* Any other reasons deemed by the investigator as unsuitable for the patient's participation in this study",{"count":157,"type":20},846,[159],"PHASE4","The goal of this clinical trial is to investigate the efficacy and safety of Qidong Yixin Granules in preventing recurrence in patients after radiofrequency catheter ablation for atrial fibrillation. The main question it aims to answer is:\n\nCan Qidong Yixin Granules reduce the recurrence rate of atrial fibrillation within 1 year in patients undergoing radiofrequency catheter ablation for atrial fibrillation?\n\nParticipants will be randomly assigned, with a 50% chance of being allocated to either the study group or the control group. Regardless of which group a participant is assigned to, researchers will administer Qidong Yixin Granules or placebo within 48 hours after catheter ablation for atrial fibrillation. Group assignment is determined by computer-generated randomization, and no individual has the authority to interfere with the allocation result.\n\nIf a participant is assigned to the study group, they will receive oral Qidong Yixin Granules after atrial fibrillation ablation: one sachet each time, three times daily, for a 12-month treatment course.\n\nIf a participant is assigned to the control group, they will receive oral placebo matching Qidong Yixin Granules after atrial fibrillation ablation: one sachet each time, three times daily, for a 12-month treatment course.\n\nRegardless of the group assignment, all participants will attend outpatient follow-up at 1, 3, 6, 9, and 12 months postoperatively. Electrocardiography (ECG) and ambulatory electrocardiography (Holter monitoring) will be performed at 1, 3, 6, and 12 months after surgery. Transthoracic echocardiography will be conducted at 3 and 12 months postoperatively. Anticoagulation will be administered for at least 3 months after surgery, and subsequent anticoagulation strategies will be determined based on the CHA₂DS₂-VASc score.",[162],"Persistent Atrial Fibrillation",[162,164],"QiDongYiXin","RECRUITING","2026-03-27",{"date":168,"type":30},"2026-04-02",{"date":170,"type":30},"2026-02-09",{"date":172,"type":20},"2027-08-30",{"name":36,"class":37},5,{"id":176,"slug":177,"hasResults":12,"nctId":178,"briefTitle":179,"officialTitle":179,"acronym":180,"eligibilityCriteria":181,"healthyVolunteers":12,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":182,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":184,"conditions":185,"keywords":187,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":192,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"locationsCount":63},"100632073","decision-making-and-optimization-of-ventilatory-support-for-aecopd-patients-100632073","NCT07508943","Decision-making and Optimization of Ventilatory Support for AECOPD Patients","OPTIVENT-COPD","Inclusion Criteria:\n\n* Hospitalized patients with a documented diagnosis of acute exacerbation of chronic obstructive pulmonary disease.\n* Patients identified retrospectively from hospital records during the predefined study period.\n* Patients who received at least one form of respiratory support during the index hospitalization, including conventional oxygen therapy, high-flow nasal cannula oxygen therapy, noninvasive ventilation, or invasive mechanical ventilation.\n* Patients with available clinical records containing sufficient dynamic physiological, laboratory, and treatment-related data for retrospective analysis.\n\nExclusion Criteria:\n\n• Patients whose hospitalization was not primarily due to acute exacerbation of COPD, even if COPD was documented as a comorbidity.\n\nPatients with stable COPD and no evidence of acute exacerbation during the index hospitalization.\n\n* Patients admitted primarily for other acute conditions, including but not limited to pneumonia without documented AECOPD, acute heart failure, pulmonary embolism, pneumothorax, asthma exacerbation, trauma, or postoperative care.\n* Patients with insufficient documentation to confirm AECOPD as the primary reason for admission.\n* Patients with incomplete clinical records preventing retrospective analysis.\n* Repeated hospitalizations of the same patient during the study period, with only the first eligible admission included.",{"count":183,"type":20},1000,"The goal of this retrospective observational study is to learn about how respiratory support is selected and adjusted in hospitalized patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD). The main questions it aims to answer are:\n\n1. How are different respiratory support modalities selected for patients with AECOPD in real-world practice?\n2. What clinical patterns are associated with escalation, de-escalation, switching, or discontinuation of respiratory support during hospitalization? Researchers will review de-identified hospital records of patients admitted with AECOPD and analyze the dynamic use of respiratory support during hospitalization, including conventional oxygen therapy, high-flow nasal cannula oxygen therapy, non-invasive ventilation, and invasive mechanical ventilation.\n\nParticipants will not receive any study-assigned intervention. The study will use existing clinical data collected during routine inpatient care and will not change diagnosis, treatment, or follow-up.",[186],"Acute Exacerbation of Chronic Obstructive Pulmonary Disease",[186,188,189,190,191],"Decision-Making","Real-World Data","Dynamic Programming","Respiratory Support",{"date":168,"type":30},{"date":194,"type":20},"2026-03-18",{"date":196,"type":20},"2029-03-18",{"name":36,"class":37},{"id":199,"slug":200,"hasResults":12,"nctId":201,"briefTitle":202,"officialTitle":202,"acronym":4,"eligibilityCriteria":203,"healthyVolunteers":204,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":205,"targetDuration":4,"studyType":49,"phases":206,"briefSummary":207,"conditions":208,"keywords":210,"overallStatus":165,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":220},"100592687","diaphragmatic-physiology-similarity-index-may-titrate-hfnc-flow-setting-a-prospective-observational-study-100592687","NCT06996665","Diaphragmatic Physiology Similarity Index May Titrate HFNC Flow Setting: A Prospective Observational Study","Feasibility and reproducibility：adult ICU patients\n\nMethodology for diaphragmatic motion synchrony:healthy adults and adult ICU patients Between-group comparisons and flow-titration study\n\nInclusion Criteria:\n\n1. Age ≥18 years old.\n2. Clear diagnosis of respiratory failure requiring respiratory support.\n3. Expected duration of respiratory support ≥24 hours or (high-flow\u002Fnon-invasive ventilation) ≥48 hours.\n4. Voluntary participation in this study and signed informed consent. If the participant is unable to read or sign the informed consent form due to incapacity (e.g., unconsciousness), the legal guardian must act as a proxy in the informed consent process and sign the form. If the participant cannot read the consent form (e.g., illiterate participants), a witness must observe the informed consent process and sign the form.\n\nExclusion Criteria:\n\n1. Severe chest wall deformities or diaphragmatic paralysis.\n2. End-stage disease with a predicted life expectancy of less than 24 hours.\n3. Inability to acquire STE (strains and echoes) images (e.g., severe subcutaneous emphysema, position limitations).\n4. Vulnerable groups other than critically ill patients\u002Felderly\u002Filliterate individuals, including those with mental disorders, cognitive impairments, pregnant women, etc.",true,{"count":19,"type":20},[51],"Study Objective This prospective observational study aims to investigate the role of the Diaphragmatic Physiology Similarity Index (DPSI) derived from speckle tracking ultrasound in titrating high-flow nasal cannula (HFNC) flow settings, and to evaluate its application in patients with acute respiratory failure.\n\nPrimary Research Questions\n\nTo characterize the features of the DPSI in healthy individuals and in patients with acute respiratory failure.\n\nTo assess the behavior of the DPSI under different HFNC flow settings in patients with acute respiratory failure.\n\nSecondary Research Questions\n\nFeasibility and inter-operator reproducibility of diaphragmatic speckle tracking.\n\nAssessment of the Diaphragmatic Contraction Synchrony Index.\n\nEvaluation of End-Diaphragmatic Residual Contraction (EDRC).\n\nAdditional fundamental parameters, including diaphragmatic displacement velocity and maximum displacement.",[209],"Respiratory Failure",[25,24,211],"PEEP","2026-03-22",{"date":214,"type":30},"2026-03-25",{"date":216,"type":30},"2025-06-01",{"date":218,"type":20},"2026-12-02",{"name":36,"class":37},2,{"id":222,"slug":223,"hasResults":12,"nctId":224,"briefTitle":225,"officialTitle":226,"acronym":227,"eligibilityCriteria":228,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":229,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":230,"conditions":231,"keywords":4,"overallStatus":165,"whyStopped":4,"lastUpdateSubmitDate":235,"lastUpdatePostDateStruct":236,"startDateStruct":238,"completionDateStruct":240,"leadSponsor":242,"locationsCount":220},"100613589","real-world-effectiveness-of-aztreonam-avibactam-against-mbl-producing-cre-100613589","NCT07268560","Real-World Effectiveness of Aztreonam-Avibactam Against MBL-Producing CRE","Aztreonam-Avibactam Real World Study Against Metallo-β-lactamase-Producing Carbapenem-Resistant Enterobacterales","AWARE","Inclusion Criteria:\n\n* 1\\. Age 18 years or older 2. Hospitalized with a diagnosis of confirmed cIAI or HAP\u002FVAP 3. Confirmed infection with MBL-producing CRE 4. Received on label use of ATM-AVI treatment for ≥24 hours 5. Informed consent will be obtained or waived.\n\nExclusion Criteria:\n\n* 1\\. Confirmed or suspected infection caused by Gram-negative species not expected to respond to ATM-AVI 2. Currently enrolled in an interventional clinical tria",{"count":19,"type":20},"Why This Study is Needed Some bacterial infections have become resistant to common antibiotics, making them very difficult to treat. This is a growing and serious health problem. A new combination drug, Aztreonam-Avibactam (we'll call it ATM-AVI), has been developed to fight these tough bacteria.\n\nThis new drug was recently approved for use in Europe (April 2024), the United States (February 2025), and China (June 2025). Because it is so new, there is very little information available, especially in China, on how well it works for real patients outside of initial testing.\n\nThis lack of real-world experience means we don't know enough about:\n\n* How effective it is for typical patients in China.\n* The types of patients and infections it is used for.\n* How it affects a patient's time in the hospital. This study aims to fill these gaps by looking at how ATM-AVI performs in Chinese hospitals, which will help doctors better treat these dangerous infections and improve patient recovery.\n\nWhat the Study Aims to Find Out\n\nMain Goal:\n\nTo see how well ATM-AVI works for adult patients in China with these specific antibiotic-resistant infections.\n\nOther Goals:\n\nTo gather more details about:\n\n* How patients are responding to the treatment at different points (e.g., after 5 days, at the end of treatment, and at a follow-up check).\n* Whether the bacteria causing the infection are cleared.\n* How the treatment affects the patient's hospital stay and use of resources.\n* The number of patients who, unfortunately, pass away during or after treatment.\n* The characteristics of the patients (like age) and their infections.\n* How doctors are using this new drug and if it's used alongside other antibiotics.\n\nHow the Study Will Work This is an observational study that will be conducted in about 30 hospitals across China. We plan to include around 100 adult patients who were hospitalized with these tough infections and received the new drug, ATM-AVI, for at least one full day.\n\nThe study will run from October 2025 to June 2027. We will look at both past (retrospective) and future (prospective) patients. For past patients, we will review their existing medical records. For future patients, we will ask for their permission (informed consent) before collecting any information.\n\nWe will collect information from patient records, such as:\n\n* Basic patient details and the nature of their infection.\n* How and when the ATM-AVI drug was used.\n* Details about their hospital stay.\n* The results of their lab tests. A doctor will assess and record how each patient is doing at key points: 5 days after starting the drug, at the end of the treatment, and at a follow-up check to see if the infection is cured.",[232,233,234],"Complicated Intra-Abdominal Infections, cIAIs","Hospital-acquired Pneumonia (HAP)","Ventilator-Associated Pneumonia (VAP)","2026-03-19",{"date":237,"type":30},"2026-03-23",{"date":239,"type":30},"2025-12-25",{"date":241,"type":20},"2027-07-31",{"name":36,"class":37},{"id":244,"slug":245,"hasResults":12,"nctId":246,"briefTitle":247,"officialTitle":248,"acronym":249,"eligibilityCriteria":250,"healthyVolunteers":12,"sex":16,"minAge":251,"maxAge":4,"enrollmentInfo":252,"targetDuration":4,"studyType":49,"phases":254,"briefSummary":255,"conditions":256,"keywords":258,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":262,"lastUpdatePostDateStruct":263,"startDateStruct":265,"completionDateStruct":267,"leadSponsor":269,"locationsCount":63},"100628132","cognitive-behavioral-therapy-for-mobile-phone-addiction-in-hospitalized-patients-100628132","NCT07457658","Cognitive Behavioral Therapy for Mobile Phone Addiction in Hospitalized Patients","The Efficacy of Cognitive Behavioral Therapy for Mobile Phone Addiction and Emotional Improvement in Hospitalized Patients: A Randomized Controlled Trial","CBT","Inclusion Criteria:\n\n* Age ≥ 14 years old.\n* Willingness to treat problematic mobile phone usage behavior.\n* Voluntarily participate in this study and sign an informed consent form. If the subject is unable to read and sign the informed consent form due to reasons such as lack of legal capacity, or if the subject is a minor, their guardian must act as a proxy for the informed process and sign the informed consent form. If the subject lacks the ability to read the informed consent form (such as illiterate subjects), a witness must witness the informed process and sign the informed consent form.\n\nExclusion Criteria:\n\n* Having serious physical or mental illnesses (such as ongoing psychotic symptoms, manic episodes, or severely disabling neurological and psychiatric disorders), unable to cooperate with intervention.\n* Previously received or currently undergoing CBT intervention for mobile phone addiction.\n* Cognitive impairment patients, critically ill patients, pregnant women, etc.\n* There are other situations that researchers consider unsuitable to participate in this study.","14 Years",{"count":253,"type":20},140,[51],"Problematic mobile phone use is excessive dependence and use of electronic products and their functions, which affects the daily life of users. Previous studies have shown that mobile phone addiction is related to depression, anxiety severity, and stress, and it is negatively correlated with sleep quality. For hospitalized patients in the mental health department, symptoms such as anxiety, depression, and poor sleep are very common. Cognitive behavioral therapy has been widely applied in online gaming addiction and is also effective in intervening in mobile phone addiction. Therefore, Hospitalized patients in the mental health department will be randomized to either the CBT interventions or an control group. The main outcome measure is the Simplified Smartphone Addiction Scale (SAS-SV), measured before intervention and after the completion of the last brief intervention.",[257],"Problematic Use of Mobile Phones",[259,260,261],"Problematic use of mobile phones","cognitive behavioral therapy","psychotherapy","2026-03-03",{"date":264,"type":30},"2026-03-09",{"date":266,"type":20},"2026-03",{"date":268,"type":20},"2027-06",{"name":36,"class":37},{"id":271,"slug":272,"hasResults":12,"nctId":273,"briefTitle":274,"officialTitle":275,"acronym":4,"eligibilityCriteria":276,"healthyVolunteers":204,"sex":16,"minAge":17,"maxAge":94,"enrollmentInfo":277,"targetDuration":4,"studyType":49,"phases":279,"briefSummary":280,"conditions":281,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":283,"lastUpdatePostDateStruct":284,"startDateStruct":285,"completionDateStruct":286,"leadSponsor":288,"locationsCount":289},"100627191","comparison-of-radiofrequency-ablation-with-concomitant-or-staged-treatment-for-tributary-varicose-veins-100627191","NCT07445425","Comparison of Radiofrequency Ablation With Concomitant or Staged Treatment for Tributary Varicose Veins","Comparison of Concomitant or Staged Treatment of Tributary Veins for Lower Extremity Varicose Veins: A Multicenter Randomized Controlled Study","Inclusion Criteria:\n\naged between 18 and 80 years; primary unilateral lower limb GSV varicose; hemodynamic classification I and III involvement in tributary veins, tributary veins originating within 15 cm inferior to the knee joint; clinical grade C2-C4; primary trunk diameter of GSV in thigh segment≥3mm to ≤ 15 mm; agree to participate in this study and voluntarily sign an informed consent form.\n\nExclusion Criteria:\n\nBody Mass Index (BMI) ≥35kg\u002Fm2; severe tortuosity or tight adherence of the trunk of the GSV to the skin in the thigh; history of previous varicose vein surgery on the ipsilateral lower limb (investigator allows to be controlled); previous deep vein thrombosis and\u002For calf muscle venous thrombosis; uncorrectable coagulation disorders or significant blood abnormalities (platelets≤30×109\u002FL); allergy to lidocaine or sclerosing agents; ankle-brachial index (ABI) \\\u003C0.6 and\u002For absolute ankle pressure \\\u003C60mmHg; pregnancy or lactation, or intend to have a child in the next year; participation in other clinical trials; anterior saphenous vein start diameter\\>3.5mm; any other patients investigator considers improper to participate in this study.",{"count":278,"type":20},206,[51],"The purpose of this clinical trial is to know which is better to treat the branch vein at the same time or in stages during radiofrequency ablation. The main questions it aims to answer are:\n\nDoes the patient who did not treat the branch vein in the first stage of operation need to intervene again? Are there any differences in patients' indexes between the two surgical strategies?\n\nParticipants will:\n\nRadiofrequency ablation with or without foam sclerosing agent therapy One week, three months and six months after operation, go to the clinic for a reexamination.\n\nRecord their symptoms",[282],"Varicose Veins of Lower Limb","2026-02-26",{"date":262,"type":30},{"date":266,"type":20},{"date":287,"type":20},"2026-12",{"name":36,"class":37},21,{"id":291,"slug":292,"hasResults":12,"nctId":293,"briefTitle":294,"officialTitle":295,"acronym":4,"eligibilityCriteria":296,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":297,"targetDuration":4,"studyType":49,"phases":298,"briefSummary":299,"conditions":300,"keywords":4,"overallStatus":165,"whyStopped":4,"lastUpdateSubmitDate":283,"lastUpdatePostDateStruct":302,"startDateStruct":304,"completionDateStruct":306,"leadSponsor":308,"locationsCount":220},"100552240","the-hi-tacs-on-cognitive-function-in-patients-with-schizophrenia-100552240","NCT06470516","The Hi-tACS on Cognitive Function in Patients With Schizophrenia","The Impact of High-frequency Transcranial Alternating Current Stimulation (Hi-tACS) on Cognitive Function in Patients With Schizophrenia","Inclusion Criteria:\n\n1. Meets the diagnostic criteria for schizophrenia according to DSM-5.\n2. Age ≥ 18 years old.\n3. Right-handed.\n4. Willing to participate in this study and sign an informed consent form. If the participant is unable to read and sign the informed consent form due to lack of capacity, a legal guardian must act as a proxy during the informed consent process and sign the form.\n5. Clinically stable, receiving antipsychotic medication treatment with a stable dose for 4 weeks without any changes.\n6. Montreal Cognitive Assessment score ≥ 10 points.\n\nExclusion Criteria:\n\n1. Psychotic disorders caused by split affective disorder, bipolar disorder, intellectual disability, anxiety spectrum disorders, drugs, alcohol, and other psychoactive substances according to DSM-V diagnostic criteria.\n2. Those with severe or unstable organic diseases, with a history of brain tumors or epilepsy.\n3. Those who have received MECT or TMS treatment within 1 month before enrollment.\n4. Skin integrity at the electrode placement site is compromised. Allergy to electrode gel or adhesive.\n5. Implants of metal or electronic devices (such as pacemakers, cochlear implants, deep brain stimulators, aneurysm clips, internal fixation devices after ventriculoperitoneal shunt surgery, etc.).\n6. Participation in any other clinical trials within 1 month prior to baseline.\n7. Pregnant and lactating women.\n8. The investigator believes that there are inappropriate conditions for participating in this study.",{"count":19,"type":20},[51],"This study is a double-blind, randomized, controlled intervention study aimed at exploring whether high-frequency transcranial alternating current stimulation (Hi-tACS) can improve cognitive impairment in patients with schizophrenia.",[301],"Schizophrenia",{"date":303,"type":30},"2026-03-02",{"date":305,"type":30},"2024-04-01",{"date":307,"type":20},"2026-04-01",{"name":36,"class":37},{"id":310,"slug":311,"hasResults":12,"nctId":312,"briefTitle":313,"officialTitle":314,"acronym":315,"eligibilityCriteria":316,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":317,"enrollmentInfo":318,"targetDuration":4,"studyType":49,"phases":320,"briefSummary":321,"conditions":322,"keywords":324,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":331,"lastUpdatePostDateStruct":332,"startDateStruct":334,"completionDateStruct":335,"leadSponsor":337,"locationsCount":63},"100626372","group-based-improve-therapy-for-problematic-internet-use-in-university-students-100626372","NCT07434778","Group-based IMPROVE Therapy for Problematic Internet Use in University Students","Effectiveness and Psychological Mechanisms of Group-based IMPROVE Therapy for Problematic Internet Use in University Students: A Single-blind Randomized Controlled Trial","IMPROVE-PIU","Inclusion Criteria:\n\n* University students aged between 18 and 30 years.\n* Score 50 or above on the Internet Addiction Test (IAT), indicating moderate to severe PIU.\n* Report subjective suffering regarding internet use.\n* Own a personal smartphone or other electronic communication device.\n* Provide written informed consent\n\nExclusion Criteria:\n\n* Self-reported history of substance use (excluding tobacco and alcohol) within the past 12 months.\n* Current or previous participation in any form of psychotherapy for PIU.\n* Presence of severe physical or neurological conditions (e.g., organic brain diseases, TBI).\n* Self-reported history of diagnosed psychiatric disorders (e.g., schizophrenia, bipolar disorder).","30 Years",{"count":319,"type":20},600,[51],"Problematic internet use (PIU) is a growing behavioral health concern among university students. This study aims to evaluate the effectiveness and psychological mechanisms of \"IMPROVE,\" a manualized, multimodal group-based psychotherapy. The IMPROVE program integrates cognitive-behavioral strategies with motivational elements, mindfulness training, and socially interactive exercise. In this randomized controlled trial, 600 university students with moderate to severe PIU will be randomized to either the 8-week IMPROVE intervention or an enhanced waitlist control group. The primary outcome is the change in PIU severity, assessed by the Internet Addiction Test (IAT) score, from baseline to the post-intervention endpoint (8 weeks).",[323],"Problematic Internet Use",[325,326,327,328,329,330],"problematic internet use","digital addiction","group psychotherapy","mindfulness","cognitive-behavioral therapy","exercise","2026-02-19",{"date":333,"type":30},"2026-02-27",{"date":266,"type":20},{"date":336,"type":20},"2028-06",{"name":36,"class":37},{"id":339,"slug":340,"hasResults":12,"nctId":341,"briefTitle":342,"officialTitle":343,"acronym":4,"eligibilityCriteria":344,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":345,"enrollmentInfo":346,"targetDuration":4,"studyType":49,"phases":348,"briefSummary":349,"conditions":350,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":353,"lastUpdatePostDateStruct":354,"startDateStruct":356,"completionDateStruct":358,"leadSponsor":360,"locationsCount":63},"100623195","phase-2-neoadjuvant-becotatug-vedotin-plus-pucotenlimab-and-cisplatin-for-locally-advanced-head-and-neck-squamous-cell-carcinoma-100623195","NCT07393477","Neoadjuvant Becotatug Vedotin Plus Pucotenlimab and Cisplatin for Locally Advanced Head and Neck Squamous Cell Carcinoma","Efficacy and Safety Profile of Becotatug Vedotin(EGFR-Targeting ADC) in Combination With Pucotenlimab and Cisplatin as Neoadjuvant Therapy for Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma (LA-HNSCC)","Inclusion Criteria:\n\n1. Aged 18-70 years (inclusive).\n2. Histopathologically confirmed Stage III\u002FIVA head and neck squamous cell carcinoma (HNSCC) of the oropharynx, oral cavity, hypopharynx, or larynx (per 8th edition AJCC Cancer Staging Manual).\n3. Measurable primary lesions per RECIST v1.1.\n4. Treatment-naive (no prior anti-tumor therapy for current disease).\n5. ECOG performance status 0-1.\n6. Eligible for elective standard surgery plus adjuvant chemoradiotherapy\u002Fradiotherapy (investigator-assessed).\n7. No active autoimmune diseases.\n8. No concurrent malignant tumors.\n9. Estimated life expectancy \\>= 6 months.\n10. Available tumor tissue for PD-L1 IHC testing (22C3 DAKO assay).\n11. Adequate hematological function (screening): ANC \\>= 1.5×10⁹\u002FL, platelets \\>= 100×10⁹\u002FL, Hb \\>= 100 g\u002FL, WBC \\>= 3.5×10⁹\u002FL; no blood transfusion or bleeding tendency within 7 days.\n12. Normal liver function: ALT, AST, ALP, serum bilirubin \\\u003C= 1.5×ULN.\n13. Normal renal function: Serum Cr \\\u003C= 1.5×ULN or creatinine clearance \\> 60 mL\u002Fmin.\n14. HPV status confirmed by p16 IHC and in situ hybridization (ISH).\n15. Voluntary participation with signed informed consent; legal guardian-signed consent for incompetent subjects, and witness-supervised consent for illiterate subjects.\n\nExclusion Criteria:\n\n1. Cachexia or multiple organ failure.\n2. Active autoimmune disease of any type.\n3. Concomitant second primary malignancy (e.g., esophageal cancer).\n4. Severe active infection requiring systemic therapy.\n5. Uncontrolled serious medical conditions interfering with study treatment (e.g., severe heart\u002Fcerebrovascular disease, uncontrolled diabetes\u002Fhypertension, active peptic ulcer).\n6. Dementia, altered mental status, or other conditions impairing informed consent or questionnaire completion.\n7. Peripheral neuropathy \\>= Grade 2 per CTCAE v5.0.\n8. Hearing impairment \\>= Grade 2 per CTCAE v5.0.\n9. History of malignancy within 5 years prior to screening.\n10. Known HIV-positive status or diagnosed AIDS.\n11. Nasopharyngeal carcinoma or HNSCC at sites other than oral cavity, oropharynx, larynx, hypopharynx (e.g., paranasal sinuses, unknown primary).\n12. Receipt of investigational drugs or participation in other interventional trials within 30 days prior to screening.\n13. Systemic glucocorticoids (\\>10 mg prednisone equivalent\u002Fday) or other immunosuppressants within 14 days prior to randomization (inhaled\u002Ftopical steroids and adrenal hormone replacement are permitted without active autoimmune disease).\n14. Pregnant\u002Flactating women; subjects of childbearing potential refusing contraception.\n15. Active infection requiring treatment or systemic anti-infective use within 1 week prior to first dose.\n16. Live vaccine administration within 30 days prior to first dose.\n17. Vulnerable populations (e.g., mental illness, cognitive impairment, critically ill status).\n18. Other conditions deemed unsuitable for enrollment by the investigator.","70 Years",{"count":347,"type":20},30,[74],"This clinical trial aims to evaluate the efficacy and safety of Becotatug Vedotin (EGFR-Targeting ADC) in combination with Pucotenlimab and Cisplatin as neoadjuvant therapy for patients with locally advanced head and neck squamous cell carcinoma (LA-HNSCC).\n\nThe primary objective is to assess whether this combination therapy improves the pathological complete response (pCR) rate and to evaluate its safety and tolerability. The secondary objective includes evaluating 1-year disease-free survival (DFS) rates and major pathological response (MPR) rates in patients treated with this combination therapy.\n\nMain Questions This Trial Aims to Answer:\n\n1. Does the combination of Becotatug Vedotin, Pucotenlimab, and Cisplatin lead to higher rates of pathological complete response (pCR) and major pathological response (MPR) in patients with locally advanced head and neck squamous cell carcinoma (LA-HNSCC)?\n2. What are the safety and tolerability profiles of the combination therapy?\n3. Does the treatment improve disease-free survival at 1 year after treatment?\n\nWhat Participants Will Do:\n\nTreatment: Participants will receive Becotatug Vedotin (EGFR-Targeting ADC), Pucotenlimab, and Cisplatin as a combination therapy in the neoadjuvant setting.\n\nTreatment Duration: Treatment will last approximately 6-12 weeks, depending on the patient's individual regimen.\n\nFollow-up Visits: Participants will attend routine check-ups for safety evaluations and pathological assessments approximately 7 weeks after completing neoadjuvant therapy.\n\nOutcomes: Researchers will assess pathological complete response (pCR), major pathological response (MPR), and 1-year disease-free survival (DFS) following treatment.",[351,352],"Head and Neck Squamous Cell Carcinoma","Head and Neck Squamous Cell Carcinoma HNSCC","2026-01-30",{"date":355,"type":30},"2026-02-06",{"date":357,"type":20},"2026-02",{"date":359,"type":20},"2029-05",{"name":36,"class":37},{"id":362,"slug":363,"hasResults":12,"nctId":364,"briefTitle":365,"officialTitle":366,"acronym":367,"eligibilityCriteria":368,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":94,"enrollmentInfo":369,"targetDuration":4,"studyType":49,"phases":371,"briefSummary":372,"conditions":373,"keywords":375,"overallStatus":165,"whyStopped":4,"lastUpdateSubmitDate":382,"lastUpdatePostDateStruct":383,"startDateStruct":385,"completionDateStruct":387,"leadSponsor":389,"locationsCount":63},"100598228","phase-2-node-sparing-short-course-radiation-combined-with-capecitabine-and-pd-1ctla-4-for-mss-early-rectal-cancer-100598228","NCT07068763","Node-Sparing Short-Course Radiation Combined With Capecitabine and PD-1\u002FCTLA-4 for MSS Early Rectal Cancer","Node-Sparing Short-Course Radiation Combined With Capecitabine and PD-1\u002FCTLA-4 for MSS Early Middle and Low Rectal Cancer (mRCAT-E): An Open-label, Single-arm, Prospective Multicenter Clinical Trial","mRCAT-E","Inclusion Criteria:\n\n1. Patients who have a strong willingness to preserve the anus and are willing to receive neoadjuvant therapy.\n2. Male or Female aged 18-80.\n3. Patients diagnosed with low rectal cancer within 7 cm from the lower edge of the tumor to the anal verge by pelvic MRI and rectal ultrasound, the clinical stage is cT2-3N0M0.\n4. Histologically confirmed rectal adenocarcinoma; Genetic testing suggests MSI-L or MSS, or tumor biopsy immunohistochemistry reveals pMMR, that is, MSH1, MSH2, MSH6, and PMS2 are all positive.\n5. Eastern Cooperative Oncology Group (ECOG) score 0-1.\n6. No previous treatment (including anti-tumor therapy, immunotherapy or pelvic radiation).\n7. Informed consent form signed.\n\nExclusion Criteria:\n\n1. Patients with a previous history of malignant tumors besides rectal cancer.\n2. Patients with distant metastases before enrollment.\n3. Patients with metastatic regional or non-regional lymph nodes are assessed by MRI or CT.\n4. Patients with obstruction, perforation, or bleeding that require emergency surgery.\n5. Patients with severe concomitant diseases and estimated survival time ≤ 5 years.\n6. Allergic to any component of the therapy.\n7. Patients who received immunosuppressive or systemic hormone therapy for immunosuppressive purposes within 1 month prior to the initiation of therapy.\n8. Contraindications to radiotherapy and chemotherapy.\n9. Patients who have received any other experimental drug (including immunotherapy) or participated in another interventional clinical trial within 30 days before screening.\n10. Factors leading to study termination, such as alcoholism, drug abuse, other serious illnesses (including psychiatric disorders) requiring combination therapy, and patients with severe laboratory abnormalities. Patients with congenital or acquired immune deficiency (such as HIV infection).\n11. Vulnerable groups, including mentally ill, cognitively impaired, critically ill patients, minors, pregnant or lactating women, illiterate, etc.\n\n    Other conditions that investigators consider not suitable for this study.\n12. Patient not suitable for participating by other concerns of researchers.",{"count":370,"type":20},52,[74],"This is a single-arm, prospective, multicenter study evaluating a novel neoadjuvant treatment strategy for patients with early, mid-low rectal adenocarcinoma that is microsatellite stable (MSS). Instead of irradiating regional lymph nodes, we deliver short-course radiotherapy (25 Gy in 5 fractions) exclusively to the primary tumor (\"lymph-node-sparing\" approach), immediately followed by four 3-week cycles of capecitabine plus combined PD-1\u002FCTLA-4 immune checkpoint inhibitors. Two weeks after completing chemo-immunotherapy, tumor response is assessed. Patients who achieve a clinical complete response may enter a \"watch-and-wait\" program; others will undergo local excision or total mesorectal excision (TME) as appropriate. The primary endpoint is the rate of complete response (clinical and pathological). Secondary endpoints include organ-preservation rate, 3-year local recurrence, 3-year disease-free and overall survival, toxicity, and quality-of-life measures. Results from a pilot study suggest that this regimen may substantially improve complete response rates while reducing radiation-related toxicity, potentially allowing more patients to avoid radical surgery and permanent stoma.",[374],"Rectal Cancer",[376,377,378,379,380,381],"lymph-node-sparing short-course radiotherapy","capecitabine","PD-1 inhibitor","CTLA-4 inhibitor","organ preservation","clinical complete response","2026-01-03",{"date":384,"type":30},"2026-01-06",{"date":386,"type":30},"2025-10-09",{"date":388,"type":20},"2029-12-31",{"name":36,"class":37},{"id":391,"slug":392,"hasResults":12,"nctId":393,"briefTitle":394,"officialTitle":394,"acronym":4,"eligibilityCriteria":395,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":396,"targetDuration":4,"studyType":49,"phases":398,"briefSummary":399,"conditions":400,"keywords":4,"overallStatus":165,"whyStopped":4,"lastUpdateSubmitDate":402,"lastUpdatePostDateStruct":403,"startDateStruct":405,"completionDateStruct":407,"leadSponsor":409,"locationsCount":63},"100611677","study-on-the-therapeutic-effect-of-different-infusion-times-of-tislelizumab-on-postoperative-high-risk-hepatocellular-carcinoma-100611677","NCT07243691","Study on the Therapeutic Effect of Different Infusion Times of Tislelizumab on Postoperative High-risk Hepatocellular Carcinoma","Inclusion Criteria:\n\n1. (1) 18\\~75 years old (including boundary values).\n2. (2) The first diagnosis confirmed by histology or cytology is HCC.\n3. (3) Barcelona Clinical Liver Cancer (BCLC) stage A-B has undergone curative resection of the tumor, with no extrahepatic metastasis or adjacent organ invasion before surgery.\n4. (4) Must meet at least one of the high-risk recurrence risk criteria (as follows): Characteristics of high-risk recurrent liver cancer after surgery: preoperative single lesion\\>5cm; MVI positive; Preoperative presence of sub lesions; Intraoperative margin\\\u003C1cm.\n5. (5) After one month of postoperative follow-up, there was no recurrence and no systemic treatment for HCC (systemic chemotherapy, immunotherapy, targeted therapy, or other treatments for HCC) was received.\n6. (6) The Child Pugh score for liver function is 5-6 points, and the liver function is grade A.\n7. (7) The physical fitness status score of the Eastern Cancer Collaboration Group (ECOG) is ≤ 1.\n8. (8) Research on organ function levels that meet the requirements before the first use of medication; The functional indicators of important organs meet the following requirements: serum total bilirubin ≤ 51.3 μ mol\u002FL or 3 mg\u002FdL; Hemoglobin ≥ 90g\u002FL, neutrophil count ≥ 1.5 × 10\u002FL, platelet count ≥ 100 × 10\u002FL; aspartate or alanine aminotransferase ≤ 5 times the upper limit of normal (ULN), alkaline phosphatase ≤ 2.5 ULN, serum albumin ≥ 30g\u002FL; Serum creatinine\\\u003C1.5 ULN; International normalized ratio (INR) ≤ 2 or prothrombin time (PT) exceeding the upper limit of the normal range ≤ 6 seconds; Serum creatinine ≤ 1.5 ULN, creatinine clearance rate ≥ 60 mL\u002Fmin.\n9. (9) Women who have the ability to conceive (i.e. physically capable of pregnancy) must agree to take effective contraceptive measures during the study period and within 120 days after the last dose of Trastuzumab treatment, and test negative for pregnancy within 7 days before the first dose of the study drug; Men who are capable of reproduction must agree to take effective contraceptive measures during the study period and within 120 days after the last administration of Trastuzumab.\n10. (10) If the subject is infected with HBV or HCV The following conditions must be met: for inactive\u002Fasymptomatic HBV carriers, in the chronic phase; Active HBV (HBV deoxyribonucleic acid (DNA)\\\u003C500 IU\u002FmL (or 2500 copies\u002FmL) during screening) should be treated according to treatment guidelines. Patients receiving antiviral therapy during screening should receive treatment\\>2 weeks prior to screening and continue treatment during the study period. For subjects infected with HCV: Confirmation of infection is based on detectable HCV ribonucleic acid RNA, and antiviral treatment must be completed before enrollment.\n11. (11) The expected lifespan is ≥ 6 months.\n12. (12) Voluntarily participate in this study and sign an informed consent form. If the subject does not have the ability to read the informed consent form (such as illiterate subjects), a witness must witness the informed process and sign the informed consent form.\n\nExclusion Criteria:\n\n1. (1) The pathological diagnosis is non hepatocellular carcinoma.\n2. (2) Within one month after surgery, there may be intrahepatic or extrahepatic recurrence.\n3. (3) Previously received anti-tumor treatment plans such as chemotherapy, radiotherapy, radiofrequency ablation, interventional therapy, targeted therapy, and immunotherapy for liver cancer (excluding previous non tumor related surgeries and diagnostic biopsies).\n4. (4) The viral load is limited to hepatitis B virus (HBV) DNA\\>2500 copies\u002Fml, hepatitis C virus (HCV) RNA\\>1000, and no treatment has been received.\n5. (5) Long term hormone users require long-term systemic hormone therapy (equivalent to\\>10 mg prednisone\u002Fday) or any other form of immunosuppressive therapy.\n6. (6) Within the first 3 months of enrollment, there has been clinically significant bleeding or bleeding tendency, or ongoing thrombolytic or anticoagulant therapy.\n7. (7) Patients with complete intestinal obstruction and those with incomplete intestinal obstruction in need of treatment (but those who relieve obstruction through fistula or stent placement can be included).\n8. (8) Active severe clinical infections (\\>grade 2, NCI-CTCAE V5.0), including: active tuberculosis; Having a history of active tuberculosis infection for more than 1 year prior to enrollment; Has not received formal anti tuberculosis treatment or tuberculosis is still active.\n9. (9) History of active immunodeficiency or autoimmune disease and\u002For possible recurrence of immunodeficiency or autoimmune disease in the past or long-term use of steroids.\n10. (10) Uncontrolled diabetes (fasting blood glucose ≥ 10 mmol\u002FL), severe lung disease (such as acute lung disease, pulmonary fibrosis affecting lung function, interstitial lung disease, but the recovered radiation pneumonia is excluded).\n11. (11) Clinically significant cardiovascular diseases; Suffering from hypertension, antihypertensive drugs cannot effectively control (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg).\n12. (12) Renal replacement therapy providers.\n13. (13) Individuals who have allergic reactions to any component of the investigational drug.\n14. (14) Within the past 5 years or currently suffering from other malignant tumors (excluding cured cervical carcinoma in situ, uterine carcinoma in situ, and non melanoma skin cancer).\n15. (15) Pregnant or lactating female patients, and patients of childbearing age who refuse to receive contraceptive measures.\n16. (16) Vulnerable groups, including individuals with mental illness, cognitive impairment, critically ill patients, etc.\n17. (17) The researchers believe that patients who are not suitable to participate in this study.",{"count":397,"type":20},33,[51],"Study on the therapeutic effect of different infusion times on tislelizumab in high-risk postoperative hepatocellular carcinoma",[401],"Hepatocellular Carcinoma","2025-11-19",{"date":404,"type":30},"2025-11-24",{"date":406,"type":20},"2025-12-01",{"date":408,"type":20},"2027-12-15",{"name":36,"class":37},{"id":411,"slug":412,"hasResults":12,"nctId":413,"briefTitle":414,"officialTitle":414,"acronym":4,"eligibilityCriteria":415,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":416,"targetDuration":4,"studyType":49,"phases":418,"briefSummary":419,"conditions":420,"keywords":4,"overallStatus":165,"whyStopped":4,"lastUpdateSubmitDate":421,"lastUpdatePostDateStruct":422,"startDateStruct":424,"completionDateStruct":426,"leadSponsor":428,"locationsCount":63},"100601081","phase-2-exploring-the-safety-and-efficacy-of-sacituzumab-tirumotecan-combined-with-pucotenlimab-in-the-treatment-of-advanced-cholangiocarcinoma-100601081","NCT07105852","Exploring the Safety and Efficacy of Sacituzumab Tirumotecan Combined With Pucotenlimab in the Treatment of Advanced Cholangiocarcinoma","Inclusion Criteria:\n\n* 1\\. Age \\>= 18 years old; 2. Histologically confirmed unresectable or metastatic cholangiocarcinoma (including gallbladder cancer, intrahepatic cholangiocarcinoma, and extrahepatic cholangiocarcinoma)\n\n  (1) First line treatment cohort:\n  1. Patients who explicitly refuse chemotherapy;\n  2. Patients who fail adjuvant therapy with chemotherapy;\n  3. Patients who have not received systemic therapy; (2) Second line treatment cohort:\n\n  \u003C!-- -->\n\n  1. First line chemotherapy is effective, but toxicity is not tolerated;\n  2. Disease progression after first-line chemotherapy regimen\\]; 3. Patients with positive TROP2 protein; 4. The patient is a patient with distant metastasis or locally advanced stage who cannot undergo surgery or radiotherapy and has not received systemic treatment; 5. According to RECIST 1.1 tumor evaluation criteria, there is a measurable primary lesion; 6. No active autoimmune diseases; 7. No concurrent malignant tumors; 8. ECOG physical fitness score 0-1; 9. Expected survival period \\>= 3 months; 10. Having sufficient organ and bone marrow function (not receiving blood transfusions, recombinant human thrombopoietin or colony-stimulating factor therapy within 2 weeks prior to the first administration), defined as follows:\n\n  \u003C!-- -->\n\n  1. Blood routine: neutrophil count (NEUT) \\>= 1.2 × 10\\^9\u002FL; platelet count (PLT) \\>= 75 × 10\\^9\u002FL; hemoglobin \\>= 9 g\u002FdL;\n  2. Liver function: Aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP) \\\u003C= 2.5 x upper limit of normal (ULN); Total bilirubin (TBIL) \\\u003C= 1.5 × ULN; If there is liver metastasis, ALT and AST should be \\\u003C= 5ULN;\n  3. Renal function: plasma Cr \\\u003C= 1.5ULN or creatinine clearance rate (Ccr) \\>= 60 ml\u002Fmin (for males: GFR (ml\u002Fmin)=(140 age) x body weight (kg) x 0.85\u002Fblood creatinine (mg\u002Fdl); For women: GFR (ml\u002Fmin)=(140 age) x body weight (kg) x 0.85 x 0.85\u002Fblood creatinine (mg\u002Fdl);\n  4. Coagulation function: International normalized ratio (INR), activated partial thromboplastin time (APTT), and prothrombin time (PT) \\\u003C= 1.5 × ULN; 11. For female subjects with fertility and male subjects with reproductive potential partners, they must agree to take effective medical contraceptive measures within 6 months from the signing of the informed consent form until the last administration; 12. Voluntarily join this study and sign an informed consent form. If the subject is unable to read and sign the informed consent form due to reasons such as lack of capacity, their guardian needs to act as a proxy for the informed process and sign the informed consent form. If the subject lacks the ability to read the informed consent form (such as illiterate subjects), a witness is required to witness the informed process and sign the informed consent form.\n\n     Exclusion Criteria:\n* 1\\. Previously received any of the following treatments (including in the context of adjuvant or neoadjuvant therapy): targeted TROP2 therapy; Any drug therapy containing targeted topoisomerase I, including antibody conjugated drug (ADC) therapy; Immune checkpoint inhibitors (such as anti-PD-1\u002FL1 antibodies, anti-CTLA-4 antibodies, etc.), immune checkpoint agonists (such as ICOS, CD40, CD137, GITR, OX40 antibodies, etc.), immune cell therapy, and any other treatment targeting the tumor immune mechanism; 2. Suffering from other malignant tumors within 3 years before administration (excluding tumors that have been cured through local treatment, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, cervical carcinoma in situ, etc.); 3. Ampullary cancer; 4. Previously received ADC targeting TROP2 or any drug treatment containing topoisomerase I inhibitors; 5. Allergies to any components of the investigational drugs (sacituzumab tirumotecan and pucotenlimab); 6. There is a history of (non infectious) interstitial lung disease (ILD) or non infectious pneumonia that requires steroid treatment, current ILD or non infectious pneumonia, or suspected ILD or non infectious pneumonia that cannot be excluded by imaging examination during screening; 7. Suffering from active autoimmune diseases that require systematic treatment within the past two years (including but not limited to: autoimmune hepatitis, uveitis, enteritis, pituitary inflammation, vasculitis, nephritis, etc.). Hormone replacement therapy, such as thyroid hormone, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency, is not considered systemic therapy; 8. Any disease requiring systemic corticosteroid treatment (dose\\>10 mg\u002Fd of prednisolone or equivalent dose of similar drugs) or other immunosuppressive therapy within 10 days prior to the first study treatment. However, subjects who receive intranasal, inhaled, topical, or local corticosteroid injections (such as intra-articular injections), or corticosteroids as a preventive medication for hypersensitivity reactions, may be included; 9. Known active pulmonary tuberculosis. Subjects suspected of having active pulmonary tuberculosis need to undergo clinical examination for exclusion; 10. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation; 11. Diagnosed as active hepatitis B or C; 12. Human immunodeficiency virus (HIV) test is positive or there is a history of acquired immunodeficiency syndrome (AIDS); Known active syphilis infection; 13. Suffering from local or systemic diseases caused by non malignant tumors, or diseases or symptoms secondary to tumors, which can lead to higher medical risks and\u002For uncertainty in survival evaluation, such as tumor like leukemia reactions, cachexia manifestations, etc.; 14. There is a recorded history of severe dry eye syndrome, severe meibomian gland disease and\u002For blepharitis, or corneal diseases that hinder\u002Fdelay corneal healing; 15. Unable to comply with the visit and related procedures stipulated in the plan; 16. Pregnant or lactating women; 17. Vulnerable groups other than the elderly\u002Filliterate, including critically ill patients, individuals with mental illnesses, and those with cognitive impairments; 18. The researcher believes that the patient is not suitable to participate in any other circumstances of this study.",{"count":417,"type":20},59,[74],"1. Primary Objectives (1) To evaluate the safety and tolerability of sacituzumab tirumotecan in combination with pucotenlimab in patients with advanced cholangiocarcinoma; (2) To assess the objective response rate (ORR) of sacituzumab tirumotecan combined with pucotenlimab in patients with unresectable or metastatic cholangiocarcinoma, as evaluated by investigators per RECIST v1.1;\n2. Secondary Objectives (1) To evaluate the overall survival (OS) of sacituzumab tirumotecan combined with pucotenlimab in advanced cholangiocarcinoma; (2) To assess progression-free survival (PFS), disease control rate (DCR), duration of response (DOR), and time to response (TTR) in patients treated with sacituzumab tirumotecan combined with pucotenlimab, as determined by investigators based on RECIST v1.1; (3) To further evaluate PFS (as a standalone secondary endpoint);\n3. Exploratory Objectives (1) To investigate the correlation between TROP2 expression, systemic immune biomarkers, and treatment efficacy.",[78],"2025-07-30",{"date":423,"type":30},"2025-08-06",{"date":425,"type":30},"2025-07-03",{"date":427,"type":20},"2027-07-01",{"name":36,"class":37},{"id":430,"slug":431,"hasResults":12,"nctId":432,"briefTitle":433,"officialTitle":434,"acronym":4,"eligibilityCriteria":435,"healthyVolunteers":12,"sex":16,"minAge":436,"maxAge":4,"enrollmentInfo":437,"targetDuration":4,"studyType":49,"phases":439,"briefSummary":440,"conditions":441,"keywords":443,"overallStatus":165,"whyStopped":4,"lastUpdateSubmitDate":450,"lastUpdatePostDateStruct":451,"startDateStruct":453,"completionDateStruct":455,"leadSponsor":457,"locationsCount":63},"100589765","effectiveness-of-ditm-versus-imt-in-copd-patients-100589765","NCT06958666","Effectiveness of DITM Versus IMT in COPD Patients","Effectiveness of DITM Versus IMT in COPD Patients With High Symptom Burden and High Risk of Acute Exacerbation: A Randomized Controlled Study","Inclusion Criteria:\n\n* Diagnosed as COPD according to \"GOLD2024\"\n* Lung function results FEV1\u002FFVC\\\u003C60%\n* Patients with stable COPD who meet one of the following criteria: (A)with CAT score ≥10 or mMRC≥2; (B) ≥2 moderate acute exacerbation or ≥1 hospitalization in the past 12 months\n* Uses Budesonide MDI (Breztri Aerosphere) or Fluticasone, umeclidinium, and vilanterol (Trelegy Ellipta) or umeclidinium and vilanterol (Anoro Ellipta) as maintenance drug for COPD management\n* Volunteer to participate in this study and sign the informed consent form. If the subject is unable to read and sign the informed consent form due to incapacity, his\u002Fher guardian shall act on his\u002Fher behalf to read and sign the informed consent form.\n\nExclusion Criteria:\n\n* Unstable angina or severe arrhythmia\n* Severe weakness-related fatigue, such as in advanced congestive heart failure or chemotherapy-related fatigue\n* Unstable mental illness with a risk of self-harm or harm to others\n* Severe cognitive impairment, progressive neuromuscular disease\n* Pregnant and breastfeeding women\n* Life expectancy of less than 6 months\n* Pregnant and breastfeeding women\n* Inability to cooperate with pulmonary function tests\n* Inability to complete the entire follow-up period\n* Vulnerable populations other than the elderly, including individuals with mental illness, cognitive impairment, critically ill patients, illiterate individuals, etc.","40 Years",{"count":438,"type":20},410,[51],"The goal of this clinical trial is to learn if digital inhaled therapy management (DITM) and inspiratory muscle training (IMT), alone or in combination, can improve outcomes in adults aged 40 years and older with symptomatic, high-risk chronic obstructive pulmonary disease (COPD) with moderate to severe airflow limitation (FEV1\u002FFVC \\\u003C 60%). The main questions it aims to answer are:\n\nDoes DITM reduce the rate of moderate to severe COPD exacerbations and hospitalizations compared to usual care? Does IMT reduce the rate of moderate to severe COPD exacerbations and hospitalizations compared to usual care? Does the combination of DITM and IMT reduce the rate of moderate to severe COPD exacerbations and hospitalizations compared to usual care? What are the effects of DITM, IMT, and their combination on the time to first moderate to severe exacerbation, COPD Assessment Test (CAT) score, modified Medical Research Council (mMRC) score, and St. George's Respiratory Questionnaire for chronic obstructive pulmonary disease (SGRQ-C) score? Researchers will compare four groups: a DITM group, an IMT group, a DITM+IMT group, and a control group receiving usual care, to see if these interventions improve outcomes related to COPD exacerbations, symptoms, quality of life, and inspiratory muscle strength.\n\nParticipants will:\n\nDITM Group: Receive training on inhaler technique using a digital device and use a digital sensor with a mobile app for home-based inhalation management, including reminders and feedback.\n\nIMT Group: Receive verbal inhaler technique training and use a breathing trainer with accompanying software for inspiratory muscle training.\n\nDITM+IMT Group: Receive both the digital inhalation management and inspiratory muscle training interventions.\n\nControl Group: Receive verbal inhaler technique training only. All participants will undergo baseline assessments and follow-up assessments at 3, 6, and 12 months, including questionnaires, lung function tests, respiratory muscle strength measurements, and a 6-minute walk test. They will also report on any COPD exacerbations experienced during the study period.",[442],"COPD (Chronic Obstructive Pulmonary Disease)",[444,445,446,447,448,449],"Pulmonary Rehabilitation","COPD","GOLD2024","Global Initiative for Chronic Obstructive Lung Disease","Digital Inhaled Therapy Management","Inspiratory Muscle Training","2025-07-15",{"date":452,"type":30},"2025-07-17",{"date":454,"type":30},"2025-06-30",{"date":456,"type":20},"2028-05",{"name":36,"class":37},{"id":459,"slug":460,"hasResults":12,"nctId":461,"briefTitle":462,"officialTitle":463,"acronym":4,"eligibilityCriteria":464,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":94,"enrollmentInfo":465,"targetDuration":4,"studyType":49,"phases":467,"briefSummary":468,"conditions":469,"keywords":4,"overallStatus":165,"whyStopped":4,"lastUpdateSubmitDate":471,"lastUpdatePostDateStruct":472,"startDateStruct":474,"completionDateStruct":476,"leadSponsor":478,"locationsCount":479},"100579534","phase-2-icaritin-in-combination-with-ag-in-patients-with-previously-untreated-advanced-pancreatic-ductal-adenocarcinoma-100579534","NCT06825546","Icaritin in Combination With AG in Patients With Previously Untreated Advanced Pancreatic Ductal Adenocarcinoma","A Multicenter Study Assessing the Efficacy and Safety of Icaritin in Combination With AG Chemotherapy Versus AG Chemotherapy Alone in Patients With Previously Untreated Advanced Pancreatic Ductal Adenocarcinoma","Inclusion Criteria:\n\n1. 18-80 years old (including the cutoff value).\n2. patients with histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC) disease from multiple centers including Sir Run Run Shaw Hospital, Zhejiang University School of Medicine (group lead unit).\n3. locally advanced or metastatic PDAC according to the 2024 CSCO Guidelines for the Management of Pancreatic Cancer.\n4. no prior systemic therapy.\n5. presence of measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1).\n6. Eastern Cooperative Oncology Group PS 0 or 1.\n7. have a life expectancy of at least 3 months.\n8. adequate organ function (absolute neutrophil count ≥1.5×109\u002FL; Platelet count ≥100×109\u002FL; Creatinine \\\u003C1.5×ULN (upper limit of normal) or creatinine clearance (CRCI) ≥60 ml\u002Fmin; Albumin ≥30g\u002FL; Total bilirubin \\\u003C5×ULN; Aspartate aminotransferase (AST) \\\u003C2.5×ULN; Alanine aminotransferase (ALT) \\\u003C2.5×ULN (≤5×ULN is acceptable if liver metastasis is present); INR or PT \\\u003C 1.5×ULN, APTT \\\u003C 1.5×ULN.\n9. in a fertile woman, a negative serum pregnancy test within 7 days before the first trial treatment;\n10. willingness to use a highly effective contraceptive method (failure rate \\\u003C 1.0% per year) from the first study treatment until 24 weeks after completion of the trial treatment, if the woman is fertile or the male participant's partner is fertile.\n11. no other serious underlying medical conditions.\n12. voluntarily participated in this study and signed informed consent. If the subjects were unable to read and sign the informed consent form due to incapacity or other reasons, their guardians were required to act for them during the informed consent process and sign the informed consent form. If the subjects were unable to read the informed consent form (e.g., illiterate subjects), witnesses were required to witness the informed consent process and sign the informed consent.\n\nExclusion Criteria:\n\n1. neuroendocrine (carcinoid, islet cell) or pancreatic acinar carcinoma.\n2. Patients had moderate to severe ascites (ascites was defined by B-ultrasound).\n3. untreated active central nervous system or meningeal metastases.\n4. Previous systemic therapies such as targeted therapy, immunotherapy, chemotherapy, and modern Chinese medicine with anti-tumor indications or other treatments such as surgery and particle implantation have been used to treat pancreatic cancer.\n5. surgery for any reason (other than diagnostic biopsy), within 4 weeks after the first trial treatment, and\u002For the subject did not fully recover from surgery within 4 weeks after the first trial treatment.\n6. history of RT within 3 months of the first dose of trial treatment. No more than 30% bone marrow irradiation or large field irradiation should be used in the 4 weeks before the first trial treatment.\n7. patients with a history of other cancers within the past 2 years.\n8. major cardiovascular impairment in the 12 months before the first dose of study drug: such as a history of congestive heart failure higher than NYHA class II, unstable angina, myocardial infarction, or stroke due to cerebrovascular accident, or arrhythmia associated with hemodynamic instability; The corrected QT (QTc) interval was prolonged \\>480ms.\n9. with bleeding or thrombotic diseases or receiving thrombolytic therapy, and coagulopathy; Patients who were deemed by the investigator to be ineligible for participation in the study.\n10. clinically significant hemoptysis or tumor bleeding of any cause within 2 weeks before the first dose of study intervention.\n11. patients with a history of uncontrolled epilepsy, central nervous system disease, or psychiatric illness, or hypertension The investigator will determine whether clinical severity prevents informed consent from being signed or affects patient adherence to oral medication.\n12. had active autoimmune disease requiring systemic therapy within the previous 2 years.\n13. may have other comorbidities that are relatively contraindicated in this trial.\n14. had a severe allergic reaction to the active ingredient of the trial drug.\n15. were pregnant or lactating, or were unwilling to plan pregnancy during the trial.\n16. any other medical condition that the investigator considered to interfere with the requirements of the trial in terms of safety or efficacy assessment or adherence to treatment.\n17. vulnerable groups except the elderly\u002Filliterate, including people with mental illness, cognitive impairment, critically ill patients, pregnant women, etc.",{"count":466,"type":20},70,[74],"Icaritin is a drug that has been approved by the National Medical Products Administration (NMPA) based on a multicenter, randomized, double-blind, parallel-controlled Phase III clinical trial - SNG1705 ICR-1. It is used for patients with unresectable hepatocellular carcinoma who are not suitable for or refuse standard treatment and have not previously received systemic therapy. According to numerous studies, in tumor cells, Icaritin can downregulate the expression of TNF-α, IL-6, PD-L1 and exert anti-tumor effects. At the same time, it regulates the tumor immune microenvironment by reducing the secretion of TNFa and IL-6 as well as inhibiting PD-L1 expression through decreasing MDSC cell proportion. Importantly, Icaritin has excellent safety profile and greatly ensure patients' quality of life clinically. Rare grade 3-4 TRAEs were observed in clinical trials which is uncommon among existing standard drugs. Good safety is a prerequisite for combination therapy; therefore, further exploration of optimal drug combinations is worth considering. Thus,we investigated the efficacy and safety of Icaritin administered in conjunction with AG in patients newly diagnosed with advanced pancreatic ductal adenocarcinoma, compare with AG only.",[470],"Advanced Pancreatic Ductal Adenocarcinoma","2025-06-25",{"date":473,"type":30},"2025-06-27",{"date":475,"type":30},"2025-04-01",{"date":477,"type":20},"2027-10-01",{"name":36,"class":37},6,{"id":481,"slug":482,"hasResults":12,"nctId":483,"briefTitle":484,"officialTitle":485,"acronym":4,"eligibilityCriteria":486,"healthyVolunteers":12,"sex":16,"minAge":317,"maxAge":94,"enrollmentInfo":487,"targetDuration":4,"studyType":49,"phases":489,"briefSummary":491,"conditions":492,"keywords":4,"overallStatus":165,"whyStopped":4,"lastUpdateSubmitDate":494,"lastUpdatePostDateStruct":495,"startDateStruct":497,"completionDateStruct":499,"leadSponsor":501,"locationsCount":63},"100441955","early-phase-1-the-treatment-of-bioartificial-liver-with-hihep-cells-after-extensive-hepatectomy-100441955","NCT05035108","The Treatment of Bioartificial Liver With hiHep Cells After Extensive Hepatectomy","A Clinical Study of hiHep Cells for Bioartificial Liver After Extensive Hepatectomy","Inclusion Criteria:\n\n1. Diagnosed as liver cancer, hepatolithiasis, benign liver tumor, with clear indications for liver resection;\n2. Liver function Child A-B;\n3. There is no contraindication to surgery for cardiopulmonary function;\n4. The expected remaining liver volume\u002Fstandard liver volume is less than 50%;\n\nExclusion Criteria:\n\n1. In the late stage of the disease, patients with frequent symptoms such as cerebral edema accompanied by cerebral herniation and clinical evidence indicating intracranial hemorrhage;\n2. PaO2\u002FFiO2 is less than 200 and cannot be corrected;\n3. Patients with diffuse intravascular coagulation;\n4. Those with active bleeding;\n5. Uncontrolled infection;\n6. The platelet count is less than 50,000\u002FμL and cannot be corrected;\n7. There is no blood vessel available for dialysis treatment;\n8. HIV, HDV or HCV positive;\n9. Drug abuse within 1 year;\n10. Those with severe systemic circulatory failure;\n11. Those who are highly allergic to the drugs used in the treatment process, such as plasma, heparin, protamine, etc.;\n12. Combined pregnancy;\n13. Patients with hepatorenal syndrome;\n14. Patients with autoimmune liver disease;\n15. Patients with non-alcoholic fatty liver and hereditary liver diseases (Wilson syndrome and a-antitrypsin deficiency);\n16. Other conditions that the clinician believes cannot tolerate the treatment.",{"count":488,"type":20},10,[490],"EARLY_PHASE1","It is a prospective, non-randomized, single-arm cohort study. A total of 10 patients will be included in this study. Based on standardized treatment, the treatment of bioartificial liver device will be applied 48-72 hours after extensive hepatectomy. The bioartificial liver device consists of clinical-grade human-induced hepatocytes (hiHep) generated from human fibroblasts via transdifferentiation. In order to evaluate the security and effectiveness of the device, liver function, liver volume, the incidence of liver failure and other results will be analyzed.",[493],"Hepatoma Resectable","2025-06-23",{"date":496,"type":30},"2025-06-26",{"date":498,"type":30},"2021-09-05",{"date":500,"type":20},"2030-11-30",{"name":36,"class":37},{"id":503,"slug":504,"hasResults":12,"nctId":505,"briefTitle":506,"officialTitle":507,"acronym":508,"eligibilityCriteria":509,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":510,"targetDuration":4,"studyType":49,"phases":511,"briefSummary":512,"conditions":513,"keywords":515,"overallStatus":165,"whyStopped":4,"lastUpdateSubmitDate":518,"lastUpdatePostDateStruct":519,"startDateStruct":521,"completionDateStruct":523,"leadSponsor":524,"locationsCount":63},"100594239","early-endovascular-treatment-in-isolated-internal-carotid-artery-occlusion-100594239","NCT07016854","Early Endovascular Treatment in Isolated Internal Carotid Artery Occlusion","Evaluation of Early Endovascular Treatment in Acute Ischemic Stroke With Isolated Internal Carotid Artery Occlusion (EVT-iICAO)","EVT-iICAO","Inclusion Criteria:\n\n1. Age ≥18.\n2. Clinical signs consistent with an acute ischemic stroke and randomization no later than 23 hours after the time last known to be well.\n3. CTP, CTA or enhanced MRA within 1 hour before randomization showed that the offending vessel was isolated internal carotid artery occlusion, namely occlusion of C1-C6 segments (according to Bouthillier's segmentation) at any location. There was no ipsilateral intracranial branch occlusion (T or L shape of internal carotid artery, M1 or M2 segment of middle cerebral artery, A1 or A2 segment of anterior cerebral artery, P1 or P2 segment of posterior cerebral artery).\n4. Neurological deficit with a NIHSS of \\>5, or ≤5 points with disabling symptoms (complete hemianopsia, severe aphasia, neglect, any limb weakness that cannot sustain resistance to gravity, and functional loss that is considered by doctors and patients to be potentially disabling by clinical evaluation).\n5. Mismatch: target Mismatch Profile on CT perfusion or MRI (ischemic core volume is \\\u003C 70 ml, mismatch ratio is ≥1.8 and mismatch volume is ≥15 ml); clinical-imaging mismatch defined as an ASPECTS score of more than 5, was present if perfusion data were not available or imaging quality was poor enough to be interpreted.\n6. mRS Score before stroke ≤2.\n7. Patient\u002FLegally Authorized Representative has signed the Informed Consent form.\n\nExclusion Criteria:\n\n1. The patient underwent carotid endarterectomy within 1 month.\n2. Severe comorbid condition with life expectancy less than 6 months at baseline.\n3. Other suspected cerebrovascular diseases (vasculitis, untreated cerebrovascular malformation, intracranial aneurysm, etc.) based on history and CTA\u002FMRA.\n4. Women who are pregnant or planning to become pregnant at the time of the study and who are known to be pregnant or breastfeeding at the time of admission.\n5. Known life-threatening allergic reactions to contrast media or intravascular products.\n6. Chronic internal carotid artery occlusion, defined as known carotid artery occlusion (imaging examination) ≥30 days before randomization or highly suspected chronic internal carotid artery occlusion based on medical history and CT\u002FMRI.\n7. Tandem occlusion, which was defined as internal carotid artery occlusion combined with large intracranial vessel occlusion (T or L shape of internal carotid artery, M1 or M2 segment of middle cerebral artery, A1 or A2 segment of anterior cerebral artery, P1 or P2 segment of posterior cerebral artery).\n8. No known vascular access.\n9. Suspected aortic dissection based on medical history, clinical evaluation or\u002Fand imaging.\n10. Evidence of intracranial hemorrhage on CT\u002FMRI.\n11. Patient unable to come or unavailable for follow-up.\n12. Pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations.\n13. Seizures at stroke onset if they make the diagnosis of stroke doubtful and preclude obtaining an accurate baseline NIHSS assessment.\n14. Patients have contraindications to the use of heparin and antiplatelet drugs.",{"count":253,"type":20},[51],"The primary hypothesis being tested in this trial is that acute ischemic stroke with isolated internal carotid artery occlusion will have improved clinical outcomes when given early endovascular treatment compared with that of given best medical treatment.",[514],"Stroke, Acute Ischemic",[516,517],"endovascular treatment","isolated internal carotid artery occlusion","2025-06-10",{"date":520,"type":30},"2025-06-12",{"date":522,"type":20},"2025-06",{"date":146,"type":20},{"name":36,"class":37},{"id":526,"slug":527,"hasResults":12,"nctId":528,"briefTitle":529,"officialTitle":530,"acronym":4,"eligibilityCriteria":531,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":46,"enrollmentInfo":532,"targetDuration":4,"studyType":49,"phases":534,"briefSummary":535,"conditions":536,"keywords":4,"overallStatus":165,"whyStopped":4,"lastUpdateSubmitDate":538,"lastUpdatePostDateStruct":539,"startDateStruct":541,"completionDateStruct":543,"leadSponsor":545,"locationsCount":63},"100585388","smoking-cessation-program-with-cbt-and-mindfulness-audio-support-a-randomized-controlled-trial-100585388","NCT06901713","Smoking Cessation Program With CBT and Mindfulness Audio Support: A Randomized Controlled Trial","Protocol for a Smoking Cessation Program With CBT Text and Mindfulness Audio Support: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Who smoke at least 5 cigarettes per day.\n* Express a desire to quit or reduce smoking.\n* Who has the ability to access and use the provided digital materials.\n\nExclusion Criteria:\n\n* Those currently enrolled in other smoking cessation programs.\n* Individuals with severe psychiatric disorders that may interfere with participation.\n* Those without access to the necessary digital devices.",{"count":533,"type":20},2000,[51],"This protocol describes a randomized controlled trial evaluating the effectiveness of a smoking cessation program with two intervention methods. One method provides only CBT text messages (Group A), while the other combines CBT text with mindfulness audio (Group B). The study aims to compare the two approaches in reducing smoking frequency, managing cravings, and improving emotional regulation.\n\nThis study investigates the effects of two different smoking cessation interventions: (1) CBT text-based program alone (Group A), and (2) CBT text combined with mindfulness audio (Group B). The primary outcomes include reductions in smoking frequency and cravings, as well as improvements in emotional regulation and quality of life.",[537],"Smoking Cessation; Tobacco Dependence","2025-04-21",{"date":540,"type":30},"2025-04-24",{"date":542,"type":30},"2024-10-09",{"date":544,"type":20},"2026-11-01",{"name":36,"class":37},{"id":547,"slug":548,"hasResults":12,"nctId":549,"briefTitle":550,"officialTitle":551,"acronym":4,"eligibilityCriteria":552,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":345,"enrollmentInfo":553,"targetDuration":4,"studyType":49,"phases":554,"briefSummary":555,"conditions":556,"keywords":558,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":561,"lastUpdatePostDateStruct":562,"startDateStruct":564,"completionDateStruct":566,"leadSponsor":568,"locationsCount":63},"100584900","phase-2-the-efficacy-and-safety-of-pucotenlimab-combined-with-tp-chemotherapy-as-neoadjuvant-therapy-for-locally-advanced-hnscc-100584900","NCT06895369","The Efficacy and Safety of Pucotenlimab Combined With TP Chemotherapy as Neoadjuvant Therapy for Locally Advanced HNSCC","The Efficacy and Safety of Pucotenlimab Combined With TP Chemotherapy Regimen (Cisplatin and Docetaxel) as Neoadjuvant Therapy for Locally Advanced Squamous Cell Carcinoma of the Head and Neck","Inclusion Criteria:\n\n1. Age: 18 to 70 years old.\n2. Diagnosis: Histopathologically confirmed head and neck squamous cell carcinoma (HNSCC) of the oropharynx, oral cavity, hypopharynx, or larynx, classified as Stage III or IV A according to the AJCC Cancer Staging Manual (8th Edition).\n3. Measurable Disease: At least one measurable primary lesion per RECIST 1.1 criteria.\n4. Treatment Status: Treatment-naïve patients with no prior therapy for the disease.\n5. Performance Status: ECOG performance status of 0-1.\n6. Surgical Eligibility: Deemed eligible for elective standard surgery followed by standard adjuvant chemoradiotherapy\u002Fradiotherapy, as assessed by the investigator.\n7. Autoimmune Disease: No active autoimmune diseases.\n8. Concurrent Malignancy: No concurrent malignancies.\n9. Life Expectancy: ≥6 months.\n10. Biomarker Testing: Available tumor tissue samples for PD-L1 testing via Combined Positive Score (CPS) using 22C3 pharmDx assay (DAKO).\n11. Hematologic Parameters:\n\n    * ANC ≥1.5×10⁹\u002FL, platelet count ≥100×10⁹\u002FL, hemoglobin ≥100 g\u002FL, WBC ≥3.5×10⁹\u002FL.\n    * No transfusion within 7 days or bleeding tendency.\n12. Liver Function: ALT, AST, ALP, and total bilirubin ≤1.5× upper limit of normal (ULN).\n13. Renal Function: Serum creatinine ≤1.5× ULN or creatinine clearance \\>60 mL\u002Fmin.\n14. HPV Status: HPV status confirmed via p16 immunohistochemistry (IHC) and\u002For in situ hybridization (ISH).\n15. Informed Consent: Voluntarily participates and signs informed consent. For participants unable to consent due to incapacity, consent must be provided by a legally authorized representative. For illiterate participants, an impartial witness must attest to the informed consent process.\n\nExclusion Criteria:\n\n1. Cachexia or multiple organ failure.\n2. Active autoimmune disease(s) requiring systemic treatment (excluding vitiligo, resolved childhood asthma\u002Fatopy, or controlled hypothyroidism on hormone replacement).\n3. Concurrent second primary malignancy (e.g., esophageal cancer).\n4. Severe active infection requiring systemic therapy.\n5. Uncontrolled comorbid medical conditions that may compromise protocol compliance, per investigator judgment, including:\n\n   * Severe cardiovascular\u002Fcerebrovascular diseases,\n   * Uncontrolled diabetes\u002Fhypertension,\n   * Active peptic ulcer,\n   * Uncontrolled infections.\n6. Dementia, altered mental status, or cognitive impairment affecting informed consent or questionnaire completion.\n7. Grade ≥2 peripheral neuropathy (per CTCAE v5.0).\n8. Grade ≥2 hearing impairment (per CTCAE v5.0).\n9. History of malignancy within the past 5 years (excluding cured non-melanoma skin cancer or carcinoma in situ).\n10. Known HIV-positive status or AIDS.\n11. Nasopharyngeal carcinoma or squamous cell carcinoma originating outside oral cavity, oropharynx, hypopharynx, or larynx (e.g., sinonasal tract, paranasal sinuses, or unknown primary).\n12. Participation in another interventional clinical trial or use of investigational drugs within 30 days prior to screening.\n13. Systemic glucocorticoids (\\>10 mg\u002Fday prednisone equivalent) or immunosuppressive agents within 14 days prior to randomization.\n\n    • Exceptions: Inhaled\u002Ftopical steroids or physiologic replacement doses for adrenal insufficiency.\n14. Pregnancy, breastfeeding, or refusal of contraception by subjects of childbearing potential.\n15. Active infection requiring treatment or systemic antimicrobial use within 1 week prior to first dose.\n16. Live vaccines administered within 30 days before first dose or during the study.\n17. Vulnerable populations (e.g., severe psychiatric disorders, cognitive impairment, critically ill patients, prisoners, pregnant individuals).\n18. Other conditions deemed by the investigator to preclude safe study participation.",{"count":347,"type":20},[74],"Study Objective: To evaluate the efficacy and safety of pucotenlimab combined with TP (cisplatin + docetaxel) as neoadjuvant therapy for locally advanced head and neck squamous cell carcinoma (HNSCC).\n\nStudy Design: This is a single-arm interventional study. Intervention: Patients will receive 3 cycles of pucotenlimab combined with TP (cisplatin + docetaxel) as neoadjuvant therapy, followed by standard surgical treatment and postoperative histopathological examination.\n\nEndpoints: Pathological complete response rate (pCR) after surgery, major pathological response rate (MPR) of the treatment regimen, disease-free survival (DFS), and overall survival (OS).\n\nHypothesis: The combination of pucotenlimab and TP (cisplatin + docetaxel) as neoadjuvant therapy for locally advanced HNSCC is expected to improve pathological response rates and enhance patient prognosis.",[557],"Squamous Cell Carcinoma of Head and Neck",[559,557,560],"Pucotenlimab","Neoadjuvant Therapy","2025-03-25",{"date":563,"type":30},"2025-03-26",{"date":565,"type":20},"2025-05-01",{"date":567,"type":20},"2033-12-31",{"name":36,"class":37},{"id":570,"slug":571,"hasResults":12,"nctId":572,"briefTitle":573,"officialTitle":574,"acronym":575,"eligibilityCriteria":576,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":577,"targetDuration":4,"studyType":49,"phases":578,"briefSummary":579,"conditions":580,"keywords":582,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":587,"lastUpdatePostDateStruct":588,"startDateStruct":590,"completionDateStruct":591,"leadSponsor":593,"locationsCount":63},"100583152","phase-2-short-course-radiotherapy-combined-with-intracavitary-brachytherapy-followed-by-pucotenlimab-bevacizumab-oxaliplatin-and-trifluridinetipiracil-tas-102-for-total-neoadjuvant-therapy-of-microsatellite-stable-mss-locally-advanced-low-rectal-cancer-100583152","NCT06872606","Short-Course Radiotherapy Combined with Intracavitary Brachytherapy Followed by Pucotenlimab, Bevacizumab, Oxaliplatin, and Trifluridine\u002FTipiracil (TAS-102) for Total Neoadjuvant Therapy of Microsatellite Stable (MSS) Locally Advanced Low Rectal Cancer","The Efficacy and Safety of Short-Course Radiotherapy Combined with Intracavitary Brachytherapy Followed by Pucotenlimab, Bevacizumab, Oxaliplatin, and Trifluridine\u002FTipiracil (TAS-102) for Total Neoadjuvant Therapy of Microsatellite Stable (MSS) Locally Advanced Low Rectal Adenocarcinoma: an Prospective, Single Arm Clinical Trial （SCRIPBOT Trial）","SCRIPBOT","Inclusion Criteria:\n\n1. Patients who are willing to receive neoadjuvant therapy.\n2. ≧18 years old.\n3. Diagnosed by digital rectal examination, colonoscopy, and high-resolution MRI of the pelvis, the tumor is less than or equal to 5 cm from the anus.\n4. Histologically diagnosed as rectal adenocarcinoma.\n5. Clinical stage: cT2-4a N+ or cT3\u002FT4a N0 (MRI\u002FCT-confirmed).\n6. MSS\u002FpMMR status confirmed by immunohistochemistry or PCR before treatment .\n7. ECOG Scale of Performance Status score 0-1 point.\n8. Adequate organ function (hematologic, hepatic, renal).\n9. Have not received anti-tumor and immunotherapy before enrollment.\n10. Laboratory inspections must meet the following standards:\n\n1\\) White blood cell count\\>3.5×109\u002FL, absolute value of neutrophils\\>1.8×109\u002FL, platelet count ≥75×109\u002FL, hemoglobin ≥100g\u002FL; 2) INR≤1.5, and APTT≤1.5 times the upper limit of normal or partial prothrombin time (PT) ≤1.5 times the upper limit of normal; 3) Total bilirubin ≤ 1.25 times the upper limit of normal; ALT and AST \\\u003C 5 times the upper limit of normal; 4) 24h creatinine clearance \\>50mL\u002Fmin or serum creatinine \\\u003C1.5 times the upper limit of normal.\n\n11\\. Voluntarily participate in this study and sign the informed consent.\n\nExclusion Criteria:\n\n1. History of other malignant diseases in the past 5 years.\n2. Patients with metastases from other sites (stage IV patients).\n3. Patients withT4b or positive lateral lymph nodes by pelvic contrast-enhanced CT and pelvic high-resolution MRI.\n4. Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, etc. requiring emergency surgery.\n5. Known allergic to oxaliplatin, PD-1 monoclonal antibody and other intervention drugs.\n6. Pathologically suggested signet ring cell carcinoma and mucinous adenocarcinoma.\n7. dMMR or MSI-H patients.\n8. The patient is accompanied by any unstable systemic disease, including but not limited to: severe infection, uncontrolled diabetes, hypertension uncontrolled by medication, unstable angina, cerebrovascular accident or transient cerebral ischemia, myocardial Infarction, congestive heart failure, severe cardiac arrhythmia requiring medication, hepatic, renal or metabolic disease; disease affecting the patient's life.\n9. The disease (such as mental illness, etc.) or condition (such as alcoholism or drug abuse, etc.) associated with the patient will increase the risk of the patient receiving the trial drug treatment or affect the patient's compliance with the trial requirements, or may confuse the research results.\n10. Active autoimmune disease that may worsen while receiving immunostimulants.\n11. Known history of positive HIV test or known acquired immunodeficiency syndrome.\n12. Patients who are using immunosuppressive agents, except for the following conditions:\n\n1\\) Intranasal, inhaled, topical steroids, or topical steroid injections (eg, intra-articular injections); 2) Physiological doses of systemic corticosteroids ≤10 mg\u002Fday prednisone or equivalent; 3) Steroids used to prevent allergic reactions (eg, before CT scan). 13. Received any other experimental drug treatment or participated in another interventional clinical trial within 30 days before screening 14. Women who are pregnant or breastfeeding or who plan to become pregnant or breastfeeding during the study period; men or women who are unwilling to take effective contraceptive measures.\n\n15\\. Vulnerable groups, including mentally ill, cognitively impaired, critically ill patients, minors, etc.\n\n16\\. Other conditions that the investigator judges that the patient is not suitable to participate in the clinical study, etc.",{"count":397,"type":20},[74],"A Prospective Single-Arm Study of Short-Course Radiotherapy Followed by PD-1 Monoclonal Antibody, Bevacizumab, Oxaliplatin, and Trifluridine\u002FTipiracil for Total Neoadjuvant Therapy in MSS Locally Advanced Low Rectal Cancer. This is a Non-Randomized, Single Group Assignment, Open Label, Phase: Phase II study. The Primary Objective is to assess the organ preservation rate (clinical complete response, cCR) after total neoadjuvant therapy. Secondary Objectives are Tumor regression grade (TRG), 3-year overall survival (OS) and disease-free survival (DFS), and Safety and quality of life (QoL). In this study, the investigators will perform the multi-dimensional omics study to explore the tumors microenvironments, explore the characteristics of the treatment benefit population, and try to construct an efficacy prediction model to screen the treatment benefit population early and implement precise treatment.",[581],"Rectal Adenocarcinoma",[583,559,584,585,586],"Short-Course Radiotherapy","Oxaliplatin","Bevacizumab","Trifluridine\u002FTipiracil（TAS-102）","2025-03-10",{"date":589,"type":30},"2025-03-12",{"date":475,"type":20},{"date":592,"type":20},"2028-04-01",{"name":36,"class":37},""]