[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Xijing Hospital\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":595},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,128,0,25,[9,44,70,91,112,135,168,187,215,236,254,274,292,321,348,379,402,422,448,467,490,513,536,554,576],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100586366","phase-2-neoadjuvant-sbrt-followed-by-nab-paclitaxel-combined-with-toripalimab-in-hrher2--breast-cancer-100586366",false,"NCT06914440","Neoadjuvant SBRT Followed by Nab-Paclitaxel Combined With Toripalimab in HR+\u002FHER2- Breast Cancer","Neoadjuvant SBRT Followed by Nab-Paclitaxel Combined With Toripalimab in HR+\u002FHER2- Breast Cancer: A Single-arm, Prospective Clinical Trial","Inclusion Criteria:\n\n1. Female patients aged ≥18 and ≤75 years at the time of signing informed consent.\n2. ECOG PS status of 0-1.\n3. Breast cancer assessed as non-metastatic (M0), meeting all of the following:\n\n   1. Clinical stage: Stage IIB, IIIA, IIIB, or IIIC\n   2. Required imaging assessments (within 28 days): Abdominal CT, ECT Bone scan, Chest CT and Brain MRI\n4. Histologically or pathologically confirmed invasive carcinoma of no special type, with all of the following:\n\n   1. Grade 2 or 3 (confirmed by central laboratory);\n   2. ER-positive (\\>1% staining) and\u002For PR-positive (\\>1% staining) by IHC;\n   3. HER2-negative (IHC 0\u002F1+ or HER2\u002Fneu FISH ratio ≤1.8);\n   4. Ki-67 ≥15%.\n5. Patient deemed eligible for radiotherapy after MDT evaluation.\n6. No prior antitumor therapy within 1 month before enrollment.\n7. Organ Function Requirements (within 7 days prior to enrollment):\n\n   1. Complete blood count (no transfusion or hematopoietic growth factors within 7 days): ANC ≥1.5×10⁹\u002FL; ALC ≥0.5×10⁹\u002FL; Platelets ≥100×10⁹\u002FL; Hemoglobin ≥90 g\u002FL; WBC ≥3.0×10⁹\u002FL and ≤15×10⁹\u002FL;\n   2. Blood biochemistry (no transfusion\u002Falbumin within 7 days): ALT\u002FAST ≤2.5×ULN; ALP ≤2.5×ULN；BUN\u002FCr ≤1.5×ULN; Cr≥60 mL\u002Fmin (Cockcroft-Gault formula);\n   3. Coagulation: PT\u002FAPTT ≤1.5×ULN; INR ≤1.5×ULN (if no anticoagulant therapy);\n   4. Urinalysis: Urine protein \\\u003C2+; if ≥2+, 24-hour urine protein must be ≤1g;\n   5. Thyroid function:TSH ≤1×ULN; if abnormal, normal T3\u002FT4 levels required for eligibility.\n8. Women of childbearing potential must:\n\n   1. Have a negative serum pregnancy test within 7 days before treatment;\n   2. Use highly effective contraception during the study and for 180 days after the last dose.\n9. Voluntarily sign informed consent, demonstrate good compliance, and commit to follow-up.\n\nExclusion Criteria:\n\n1. Inflammatory Breast Cancer.\n2. Comorbidities\u002FMedical History:\n\n   1. Autoimmune disease: patients with any known or suspected autoimmune disease, except: hypothyroidism due to autoimmune thyroiditis managed with hormone replacement therapy only, stable type-1 diabetes with well-controlled blood glucose.\n   2. Cardiovascular Diseases: poorly controlled hypertension despite medication (SBP \\>140 mmHg or DBP\\>90 mmHg). And with the history (within 6 months prior to enrollment) of myocardial infarction, severe\u002Funstable angina, NYHA Class ≥2 heart failure, clinically significant arrhythmias as well as symptomatic congestive heart failure.\n   3. Interstitial lung disease, non-infectious pneumonitis, or other uncontrolled systemic diseases (e.g., diabetes, pulmonary fibrosis, acute pneumonia);\n   4. Vaccination: receipt of live attenuated vaccines within 28 days prior to enrollment or planned during the study;\n   5. Infections: HIV\u002FAIDS, active hepatitis(HBV-DNA ≥500 IU\u002FmL; HCV-RNA above detection limit), or co-infection with HBV and HCV, severe infections within 4 weeks prior to enrollment (e.g., bacteremia, severe pneumonia requiring hospitalization), active infection requiring systemic antibiotics (CTCAE≥Grade 2) within 2 weeks prior to treatment, active tuberculosis within 1 year prior to enrollment;\n   6. Unexplained fever \\>38.5°C during screening (unless deemed tumor-related by the investigator);\n   7. Malignancy History: other malignancies diagnosed within 5 years prior to enrollment (except adequately treated basal cell carcinoma, squamous cell skin cancer, or cervical carcinoma in situ);\n   8. Surgery:Major surgery within 28 days prior to enrollment (diagnostic biopsies or PICC line placement are allowed);\n   9. Transplant: Prior or planned allogeneic bone marrow or solid organ transplant;\n   10. Neurological: peripheral neuropathy ≥Grade 2;\n   11. Gastrointestinal: clinically significant bowel obstruction;\n   12. Thrombotic Events: arterial\u002Fvenous thrombosis within 6 months prior to enrollment (e.g., stroke, transient ischemic attack, DVT, pulmonary embolism);\n   13. Bleeding Risk: hemoptysis (≥2.5 mL\u002Fday) within 2 months prior to enrollment, clinically significant bleeding within 3 months prior to enrollment (e.g. gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occult blood≥++), and the known bleeding\u002Fthrombotic disorders (e.g., hemophilia, coagulopathy, thrombocytopenia, hypersplenism);\n   14. Coagulation abnormalities (INR \\>1.5×ULN or APTT \\>1.5×ULN), or requiring long-term anticoagulation (warfarin\u002Fheparin) or antiplatelet therapy (aspirin≥300 mg\u002Fday or clopidogrel ≥75 mg\u002Fday).\n3. Treatment-Related Exclusions:\n\n   1. Prior systemic targeted therapy or immunostimulants (e.g., interferon, IL-2) within 4 weeks before treatment;\n   2. Known allergy to the investigational drug (recombinant humanized anti-PD-1 mAb) or its excipients.\n4. Clinical Trial Participation: participation in another drug trial within 4 weeks prior to enrollment, or within 5 half-lives of the last investigational drug dose.\n5. Substance Abuse: history of drug\u002Falcohol abuse or dependency.\n6. Pregnancy\u002FLactation: pregnant, breastfeeding, or planning pregnancy during the study.\n7. Investigator' s Discretion: other conditions that may compromise subject safety or study integrity (e.g., severe lab abnormalities, social factors).","FEMALE","18 Years","75 Years",{"count":21,"type":22},27,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","The goal of this clinical trial is to evaluate the efficacy and safety of neoadjuvant radiotherapy followed by chemotherapy combined with immunotherapy in patients with previously untreated stage IIB-IIIC (cT3N0 or cT2-4N1-3) HR-positive and HER2-negative breast cancer. 27 enrolled patients will be assigned to receive stereotactic body radiotherapy followed by Nab-Paclitaxel combined with Toripalimab. The main question it aims th answer is that whether the combination therapy of radiotherapy, de-escalated chemotherapy, and immunotherapy could improve the pCR rate of HR-positive and HER2-negative breast cancer.",[28],"Breast Cancer",[28,30],"Neoadjuvant therapy","RECRUITING","2026-06-21",{"date":34,"type":35},"2026-06-23","ACTUAL",{"date":37,"type":35},"2025-06-05",{"date":39,"type":22},"2030-12",{"name":41,"class":42},"Xijing Hospital","OTHER",2,{"id":45,"slug":46,"hasResults":12,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":12,"sex":51,"minAge":52,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":23,"phases":55,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":69},"100644210","the-effect-of-esketamine-on-postoperative-cognitive-function-in-elderly-patients-undergoing-oral-and-maxillofacial-surgery-100644210","NCT07665099","The Effect of Esketamine on Postoperative Cognitive Function in Elderly Patients Undergoing Oral and Maxillofacial Surgery","Effect of Esketamine on Postoperative Cognitive Function in Elderly Patients Undergoing Oral and Maxillofacial Surgery: A Prospective, Randomized, Double-Blind, Placebo-Controlled Parallel Clinical Trial","Inclusion Criteria:\n\nAge ≥ 60 years, either sex; Scheduled for elective oral and maxillofacial surgery under general anesthesia (including oral and maxillofacial tumor surgery, orthognathic surgery, and maxillofacial trauma repair surgery); American Society of Anesthesiologists (ASA) physical status I-III; Expected duration of anesthesia ≥ 2 hours; Willing and able to provide written informed consent.\n\nExclusion Criteria:\n\nPre-existing behavioral disorders or psychiatric diseases (e.g., Alzheimer's disease, Parkinson's disease), or current use of antipsychotic medications (e.g., clozapine, risperidone, olanzapine, haloperidol, chlorpromazine); Pre-existing severe organ dysfunction including: severe cardiovascular disease (life-threatening arrhythmias, severe uncontrolled hypertension, coronary artery disease, heart failure), severe respiratory disease (respiratory failure, severe chronic obstructive pulmonary disease), severe hepatic insufficiency (Child-Pugh Class C), or severe renal insufficiency (glomerular filtration rate \\\u003C 30 mL\u002Fmin or creatinine \\> 2.5 mg\u002FdL); Known contraindications to esketamine including: hypersensitivity to the active substance or any excipients; severe risk of elevated blood pressure or intracranial pressure; uncontrolled or untreated hypertension (resting systolic\u002Fdiastolic blood pressure \\> 180\u002F100 mmHg); preeclampsia or eclampsia; untreated or inadequately treated hyperthyroidism; conditions requiring uterine relaxation (e.g., uterine rupture, umbilical cord prolapse); use as the sole anesthetic in patients with significant ischemic heart disease; Surgical approach that would interfere with postoperative MoCA assessment; Concurrent participation in another clinical trial; Pre-existing cognitive impairment or Mini-Mental State Examination (MMSE) score \\\u003C 24, unable to complete questionnaire-based assessments.","ALL","60 Years",{"count":54,"type":22},98,[56],"NA","Esketamine is a common anesthetic adjuvant. Previous studies have shown that it may have protective effects on the brain. This study aims to investigate whether esketamine can improve cognitive function recovery in elderly patients (aged 60 years and older) undergoing oral and maxillofacial surgery.\n\nParticipants will be randomly assigned to receive either esketamine or a placebo (normal saline) during anesthesia. Neither the participants nor the researchers will know which treatment is given.\n\nCognitive function will be assessed using standardized tests before surgery and at 1, 3, 7, and 15 days after surgery. Sleep quality, pain scores, emotional status, and adverse events will also be recorded. Blood samples will be collected to explore potential mechanisms.\n\nThe study is expected to enroll approximately 98 participants at the Third Affiliated Hospital of Air Force Medical University in Xi'an, China. Participation will last about 16 days from the day before surgery to the final follow-up on day 15 after surgery.",[59],"Perioperative Neurocognitive Disorders","NOT_YET_RECRUITING","2026-06-18",{"date":63,"type":35},"2026-06-24",{"date":65,"type":22},"2026-07-01",{"date":67,"type":22},"2027-01-31",{"name":41,"class":42},1,{"id":71,"slug":72,"hasResults":12,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":12,"sex":51,"minAge":18,"maxAge":77,"enrollmentInfo":78,"targetDuration":4,"studyType":80,"phases":4,"briefSummary":81,"conditions":82,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":88,"leadSponsor":90,"locationsCount":4},"100641382","clinical-study-on-the-efficacy-of-laparoscopic-assisted-open-surgery-through-subclavian-approach-for-unilateral-thyroid-cancer-100641382","NCT07654322","Clinical Study on the Efficacy of Laparoscopic Assisted Open Surgery Through Subclavian Approach for Unilateral Thyroid Cancer","Multicenter Prospective Cohort Clinical Study on the Efficacy of Pneumoperitoneum-Free, Subclavian Transaxillary Laparoscopic-Assisted Versus Open Surgery for Unilateral Thyroid Cancer","Inclusion Criteria:\n\n1. Patients with newly diagnosed thyroid cancer aged ≥ 18 years and ≤ 70 years old;\n2. According to the latest ATA guidelines for the diagnosis and treatment of thyroid nodules and thyroid cancer in China, papillary thyroid carcinoma confirmed by histopathology has a clinical staging of cN0 in cervical lymph nodes.\n3. The patient has unilateral thyroid cancer with T1-T2 stage tumors, no lymph node metastasis, no extraglandular invasion, and no distant metastasis. They are willing to undergo surgical treatment for thyroid cancer;\n4. The surgical method is determined through joint consultation between the patient and the doctor;\n5. Participants voluntarily join this study and sign an informed consent form.\n\nExclusion Criteria:\n\n1. Age\\>70 years old;\n2. Initial diagnosis of stage III-IV thyroid cancer;\n3. Thyroid cancer accompanied by abnormal thyroid function;\n4. The heart, lung, liver, kidney and other important organs have abnormal functions, and diabetes with poor control cannot tolerate surgery;\n5. The researcher believes that the patient is not suitable to participate in any other circumstances of this study.","70 Years",{"count":79,"type":22},400,"OBSERVATIONAL","This study compares the clinical efficacy of non inflatable subclavian endoscopic surgery and open surgery for unilateral thyroid cancer, aiming to compare the differences in lymph node dissection rate, complication rate, surgical time, hospitalization time, drainage tube placement time and other indicators between the two surgical procedures, and provide guidance for surgical selection and safety in the later stage.\n\nThis study is a clinical controlled trial that plans to include 400 consecutive patients with thyroid cancer. After being fully informed and signing the informed consent form, the subjects will enter the trial period after being screened and qualified. The subjects will undergo non inflatable subclavian endoscopic thyroidectomy or open subclavian thyroidectomy according to their own wishes. The enrollment period is from March 2026-2028. The follow-up period should be at least 5 years.\n\nAfter the start of the experiment, a recruitment notice and corresponding recruitment manual will be issued, with a planned recruitment of 100 patients. The preparation stage for clinical research should include the preparation, distribution, and confirmation of research documents, as well as personnel training; Sign the informed consent form and screen the subjects. The surgical method for thyroid cancer is determined by the surgeon based on the patient's condition and after communication with the patient Evaluate the number of lymph nodes and metastatic lymph nodes in the central area by the pathology department, organize the operation time according to the surgical records, calculate the patient's drainage volume and hospitalization time according to the nursing records, and conduct telephone follow-up on patient satisfaction in the later stage.\n\nEstablish individual patient information using the existing thyroid cancer database in the department, recording general information, diagnosis and treatment history, and other relevant data.",[83],"Thyroid Cancer","2026-06-12",{"date":86,"type":35},"2026-06-17",{"date":65,"type":22},{"date":89,"type":22},"2031-02-28",{"name":41,"class":42},{"id":92,"slug":93,"hasResults":12,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":4,"eligibilityCriteria":97,"healthyVolunteers":12,"sex":51,"minAge":4,"maxAge":4,"enrollmentInfo":98,"targetDuration":100,"studyType":80,"phases":4,"briefSummary":101,"conditions":102,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":69},"100642432","a-real-world-hcm-cohort-trial-100642432","NCT07638033","A Real-world HCM-cohort Trial","A Multicenter, Prospective, Real-world Study on Hypertrophic Cardiomyopathy","Inclusion Criteria:\n\n1. Meet the clinical diagnostic criteria for HCM\\*;\n2. Patients who understand the purpose of this study, voluntarily participate in the trial and sign the informed consent form, have good compliance, and are willing to undergo clinical follow-up.\n\n   * Clinical diagnosis of HCM is defined as left ventricular wall thickness ≥15mm at any position during diastole by.echocardiography or CMR (≥13mm if there is a family history of HCM or positive cardiac genetic testing), and other secondary factors (such as severe hepertension, aortic stenosis) causing myocardial hypertrophy are excluded.\n\nExclusion Criteria:\n\n1. Metabolic syndrome or hypertrophic cardiomyopathy-like syndromes associated with left ventricular hypertrophy, such as amyloid cardiomyopathy, sarcoidosis, Fabry disease, Danon disease or Noonan syndrome;\n2. Severe systemic hypertension and\u002For severe aortic stenosis (\\\u003C1cm²);\n3. Comorbid malignant tumors;\n4. Comorbid with other end-stage diseases with an expected lifespan of less than 3 years;\n5. Comorbid with mental disorders;\n6. Currently participating in other clinical trials and not reaching the primary endpoint.",{"count":99,"type":22},3000,"3 Years","Hypertrophic cardiomyopathy (HCM) is a genetically mediated myocardial disease predominantly caused by pathogenic mutations in sarcomeric protein genes and characterized by asymmetric left ventricular hypertrophy. Patients with HCM commonly present with dyspnea, chest pain, and exercise intolerance. Sudden cardiac death, progressive heart failure, and thromboembolic events remain the leading causes of mortality and morbidity, substantially impairing quality of life and increasing healthcare burden.\n\nDespite advances in understanding the pathophysiology, diagnosis, and management of HCM, significant challenges persist, including etiological heterogeneity and underdiagnosis. At present, dedicated and systematic HCM databases remain lacking in China. Establishing a nationally HCM cohort and disease-specific database is therefore of considerable importance. In alignment with the goals of the \"Healthy China 2030\" initiative and supported by advances in medical big data technologies.\n\nThis study aims to construct a comprehensive HCM cohort, evaluate contemporary diagnostic and therapeutic practices and patient prognosis, identify relevant risk factors, and ultimately improve the overall management of patients with HCM.",[103],"Hypertrophic Cardiomyopathy (HCM)","2026-06-04",{"date":106,"type":35},"2026-06-10",{"date":108,"type":22},"2026-06-30",{"date":110,"type":22},"2030-12-31",{"name":41,"class":42},{"id":113,"slug":114,"hasResults":12,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":118,"eligibilityCriteria":119,"healthyVolunteers":12,"sex":51,"minAge":18,"maxAge":120,"enrollmentInfo":121,"targetDuration":123,"studyType":80,"phases":4,"briefSummary":124,"conditions":125,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":69},"100638730","pulsed-field-ablation-versus-radiofrequency-ablation-effects-of-pulmonary-vein-isolation-combined-with-left-atrial-posterior-wall-isolation-on-postoperative-gastric-motility-in-patients-with-persistent-atrial-fibrillation-100638730","NCT07612241","Pulsed Field Ablation Versus Radiofrequency Ablation: Effects of Pulmonary Vein Isolation Combined With Left Atrial Posterior Wall Isolation on Postoperative Gastric Motility in Patients With Persistent Atrial Fibrillation","A Comparative Study on the Effects of Pulmonary Vein Isolation Combined With Left Atrial Posterior Wall Isolation Via Pulsed Field Ablation Versus Radiofrequency Ablation on Postoperative Gastric Motility in Patients With Persistent Atrial Fibrillation","PFA-GM","Inclusion Criteria:\n\n* Age 18-80 years\n* Diagnosed with persistent atrial fibrillation (AF) according to current guidelines\n* Undergoing first-time catheter ablation (PFA or RF) with planned pulmonary vein isolation plus left atrial posterior wall isolation\n* Able to understand and sign informed consent\n* Able to complete radionuclide gastric emptying scintigraphy and symptom questionnaires\n\nExclusion Criteria:\n\n* Previous AF ablation or cardiac surgery\n* History of gastroparesis or severe gastrointestinal disease\n* Prior upper gastrointestinal surgery\n* Use of prokinetic or antisecretory medications within 4 weeks before enrollment\n* Severe renal\u002Fhepatic dysfunction or active malignancy\n* Pregnant or breastfeeding women\n* Inability to comply with study procedures or follow-up","80 Years",{"count":122,"type":22},20,"7 Days","This is a single-center, prospective, matched cohort study comparing the effect of Pulsed Field Ablation (PFA) versus Radiofrequency Ablation (RF) on postoperative gastric motility in patients with persistent atrial fibrillation (AF). A total of 20 patients will be enrolled in a 1:1 matched design (10 PFA, 10 RF), matched by age, gender, left atrial diameter, AF duration, and diabetes history. All patients will undergo pulmonary vein isolation (PVI) plus left atrial posterior wall isolation (LAPWI).\n\nThe primary outcome is gastric emptying assessed by radionuclide imaging preoperatively and at 48 hours post-ablation. Secondary outcomes include gastrointestinal symptom scores: PAGI-SYM, GSRS, and GerdQ measured before ablation and at 7 days post-procedure.\n\nPatients with prior AF ablation, upper gastrointestinal surgery, gastroparesis, or recent use of gastrointestinal medications are excluded. The study period is from January 30, 2026 to July 30, 2026.\n\nThis study aims to evaluate whether PFA is associated with better gastric motility preservation compared with conventional RF ablation in persistent AF patients undergoing extended PVI plus posterior wall isolation.",[126],"Persistent Atrial Fibrillation","2026-05-28",{"date":129,"type":35},"2026-06-02",{"date":131,"type":22},"2026-05-31",{"date":133,"type":22},"2026-12-31",{"name":41,"class":42},{"id":136,"slug":137,"hasResults":12,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":141,"eligibilityCriteria":142,"healthyVolunteers":12,"sex":51,"minAge":18,"maxAge":4,"enrollmentInfo":143,"targetDuration":4,"studyType":23,"phases":145,"briefSummary":147,"conditions":148,"keywords":153,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":167},"100570077","phase-3-nitric-oxide-for-reduced-intensive-support-in-cardiac-surgery-with-cardiopulmonary-bypass-100570077","NCT06702553","Nitric Oxide for Reduced Intensive Support in Cardiac Surgery With Cardiopulmonary Bypass","Effect of Inhaled Nitric Oxide on Major Adverse Events Requiring Intensive Life Support in Adults Undergoing Cardiac Surgery With Cardiopulmonary Bypass: A Phase III, Double-Blind, Multicenter, Randomized Controlled Trial (Nitric Oxide for Reduced Intensive Support in Cardiac Surgery With Cardiopulmonary Bypass, the NORISC Trial)","NORISC","Inclusion Criteria:\n\n1. Age ≥18 years.\n2. Elective cardiac or aortic surgery requiring CPB\n3. Without history of previous open heart surgery.\n\nExclusion Criteria:\n\n1. Immediate emergency cardiac surgery;\n2. Cardiac surgery that requires deep hypothermic circulatory arrest;\n3. Planned cardiac surgery for congenital heart disease repair;\n4. Planned for heart transplatation\n5. Ongoing heart failure or low output syndrome already on intensive support (IABP, ECMO, left ventricular assist device such as impella, mechanical ventilation), left ventricular ejection fraction of \\\u003C 30% or comparable, equivalent preoperative conditions\n6. Already accepted or currently on inhaled NO therapy or inhaled\u002Faerosolized prostacyclin in the week prior to the enrollment;\n7. Endstage kidney disease with estimated glomerular filtration rate (eGFR) \\\u003C 15 ml\u002Fmin or already on renal replacement surgery.\n8. Hemophilia A or B\n9. Other terminal stage of chronic disease with life expectancy less than 1 year per evaluation and adjudication of the attending physicians.",{"count":144,"type":22},3650,[146],"PHASE3","Cardiac surgery is a procedure that is commonly performed worldwide. Despite these technological advances, cardiac surgery remains a high-risk surgery. Among post-operative complications, acute kidney injury, respiratory failure, myocardial infarction, and stroke as well as cognitive dysfunction are significant causes of mortality in patients undergoing and following cardiac surgery. Inhaled nitric oxide (NO) therapy as a selective pulmonary vasodilator in cardiac surgery has been one of the most significant pharmacological advances in managing pulmonary hemodynamics and life threatening right ventricular dysfunction and failure. In addition, newer applications show greater promise of inhaled NO as a therapy in the area of cardiac surgery associated acute kidney injury and ischemia reperfusion. However, this remarkable expectation to inhaled NO has experienced a roller-coaster ride with high hopes and nearly universal demonstration of physiological benefits but disappointing translation of these benefits to harder clinical outcomes, like mortality. Most of our understanding on the iNO field in cardiac surgery stems from small observational or single center randomized trials, which failed to ascertain strong evidence base. As a consequence, there are only week clinical practice guidelines on the field and only European expert opinion for the use of iNO in routine and more specialized cardiac surgery. There is need for a large multicenter randomized controlled study to confirm the administration of iNO as an effective weapon for the battle against life threatening complication in high risk cardiac surgical patients.\n\nIn a previous meta analysis with 27 studies included, we demonstrated that inhaled nitric oxide (NO) could reduce the duration of mechanical ventilation and reducing biomarkers of organ injury and clinical signs of organ dysfunction in cardiac surgery under cardiopulmonary bypass (CPB) , but had no significance in the ICU stay, hospital stay, and mortality. This may be attributed to the small sample size of the most included studies (of the 27 studies included, 20 studies with sample size less than 100) and heterogeneity in timing, dosage and duration of iNO administration. Well-designed, large-scale, multicenter clinical trials are needed to further explore the effect of iNO in improving postoperative prognosis in cardiovascular surgical patients.\n\nWe are planning a large multicenter controlled randomized trial to demonstrate that inhaled nitric oxide can reduce composite outcome of death and Major Adverse Events (MAEs), including need for intensive supports due to heart failure, low cardiac output sydrome, or renal failure, respiratory failure, etc., and myocardial infarction, stroke, and sepsis at 30 days after surgery from 20% to 16% in patient undergoing cardiac surgery with cardiopulmonary bypass.\n\nIf the hypothesis had been proved and validated, the results of this study can provide strong evidence for guidelines to facilitate the routine use of iNO in all cardiopulmonary bypass assisted cardiac procedures with 31,800 postoperative outcomes improved per year in US and in China.",[149,150,151,152],"Nitric Oxide","Cardiac Surgery","Cardiopulmonary Bypass","Adult Patients Undergoing Cardiovascular Surgery With Cardiopulmonary Bypass",[149,154,155,156,157,158],"cardiopulmonary bypass","major adverse events","cardiac surgery","complications","Organ protection","2026-05-26",{"date":161,"type":35},"2026-05-29",{"date":163,"type":35},"2025-05-19",{"date":165,"type":22},"2029-03-31",{"name":41,"class":42},3,{"id":169,"slug":170,"hasResults":12,"nctId":171,"briefTitle":172,"officialTitle":173,"acronym":4,"eligibilityCriteria":174,"healthyVolunteers":12,"sex":51,"minAge":18,"maxAge":4,"enrollmentInfo":175,"targetDuration":4,"studyType":80,"phases":4,"briefSummary":177,"conditions":178,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":4},"100637592","observational-study-of-electrical-impedance-tomography-for-non-invasive-assessment-of-cerebral-autoregulation-in-neurocritical-patients-100637592","NCT07602114","Observational Study of Electrical Impedance Tomography for Non-Invasive Assessment of Cerebral Autoregulation in Neurocritical Patients","A Clinical Study of Non-Invasive Assessment of Cerebral Autoregulation Using Electrical Impedance Tomography","Inclusion Criteria:\n\n* Aged ≥18 years old\n* Diagnosed with acute intracerebral hemorrhage, subarachnoid hemorrhage or ischemic stroke, admitted to the Neurosurgical Intensive Care Unit\n* Receiving routine invasive monitoring of intracranial pressure (ICP) and mean arterial pressure (MAP)\n* Written informed consent obtained from the legally authorized representative\n\nExclusion Criteria:\n\n* Severe scalp damage, infection or skull defect affecting electrode placement\n* Craniotomy history with metal implants interfering with EIT signal acquisition Pregnancy\n* Terminal critical illness with estimated survival \\\u003C24 hours\n* Severe coagulation dysfunction or confirmed allergy to electrode materials\n* Unavailable for ≥2-hour continuous valid monitoring data collection",{"count":176,"type":22},100,"This is a single-center, prospective, observational, self-controlled clinical study conducted at the Neurosurgical Intensive Care Unit of Xijing Hospital, The First Affiliated Hospital of Air Force Military Medical University. The study aims to evaluate whether non-invasive Electrical Impedance Tomography (EIT) can reliably assess cerebral blood flow autoregulation in neurocritically ill participants, by comparing EIT-derived parameters with the current gold-standard invasive index PRx.\n\nCerebral blood flow autoregulation helps maintain stable brain perfusion in critically ill neurological patients. Impaired autoregulation raises the risk of secondary brain injury. The current standard evaluation requires invasive intracranial pressure monitoring, which carries risks of infection, bleeding, and tissue damage. EIT is a non-invasive, radiation-free bedside monitoring technique that uses scalp electrodes to measure real-time changes related to cerebral blood flow, with no additional harm to participants.\n\nAdult participants admitted to the neurosurgical intensive care unit who require routine invasive intracranial pressure monitoring will be enrolled, with informed consent provided by legal guardians. All participants receive standard clinical care as prescribed by current medical guidelines; no extra experimental treatments, drugs, or invasive procedures are applied for this study.\n\nDuring the study, invasive monitoring data and non-invasive EIT brain monitoring data will be collected simultaneously. Researchers will analyze the correlation and consistency between EIT-derived parameters and the gold-standard index.\n\nThis study has received ethical approval from the Medical Ethics Committee of The First Affiliated Hospital, Air Force Military Medical University. All participant information is anonymized to protect privacy, and adverse events will be recorded and reported in accordance with regulatory requirements. The results are expected to support a safe, non-invasive monitoring method for cerebral blood flow autoregulation in neurocritical care.",[179],"Homeostasis","2026-05-24",{"date":127,"type":35},{"date":183,"type":22},"2026-05-30",{"date":185,"type":22},"2028-05-30",{"name":41,"class":42},{"id":188,"slug":189,"hasResults":12,"nctId":190,"briefTitle":191,"officialTitle":192,"acronym":4,"eligibilityCriteria":193,"healthyVolunteers":12,"sex":51,"minAge":194,"maxAge":77,"enrollmentInfo":195,"targetDuration":4,"studyType":80,"phases":4,"briefSummary":197,"conditions":198,"keywords":201,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":206,"lastUpdatePostDateStruct":207,"startDateStruct":209,"completionDateStruct":211,"leadSponsor":213,"locationsCount":214},"100579915","sapien-3-transcatheter-aortic-valve-replacement-in-young-aortic-valve-stenosis-patients-from-china-100579915","NCT06830499","Sapien 3 Transcatheter Aortic Valve Replacement in Young Aortic Valve Stenosis Patients From China","Safety, Effectiveness and Durability of Sapien 3 Transcatheter Aortic Valve Replacement in Young Aortic Valve Stenosis Patients From China","Inclusion Criteria:\n\nSubjects must meet ALL of the following inclusion criteria to be eligible for participation:\n\n* 50 years of age or older but ≤70 years old at time of consent.\n* Severe AS, defined as follows:\n\n  a) For symptomatic patients: i) Aortic valve area ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2\u002Fm2), OR mean gradient ≥40 mm Hg, OR Maximal aortic valve velocity ≥4.0 m\u002Fsec by transthoracic echocardiography at rest b) For asymptomatic patients: i) Very severe AS with an aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2\u002Fm2), AND maximal aortic velocity ≥5.0 m\u002Fsec, or mean gradient ≥60 mm Hg by transthoracic echocardiography at rest, OR ii) Aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2\u002Fm2), AND a mean gradient ≥40 mm Hg or maximal aortic valve velocity ≥4.0 m\u002Fsec by transthoracic echocardiography at rest, AND an exercise tolerance test that demonstrates a limited exercise capacity, abnormal BP response, or arrhythmia OR iii) Aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2\u002Fm2), AND mean gradient ≥40 mmHg, or maximal aortic valve velocity ≥4.0 m\u002Fsec by transthoracic echocardiography at rest, AND a left ventricular ejection fraction \\\u003C50%.\n* Tricuspid aortic valve stenosis and type-1 bicuspid aortic valve anatomy confirmed by MDCT.\n* The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits.\n* Adequate iliofemoral access and acceptable level of vessel calcification and tortuosity for safe device implant.\n* The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site.\n\nExclusion Criteria:\n\nSubjects are NOT eligible for participation if they meet ANY of the following exclusion criteria:\n\n* Any of the following: a. no calcification; b. challenging calcification based on physician's experience and discretion (Case Review Board would decide whether to exclude challenging calcification cases).\n* Aortic valve is a congenital unicuspid valve, congenital Type-0 or Type-2 bicuspid valve, or quadricuspid valve.\n* Severe femoral, iliac or aortic atherosclerosis, calcification, coarctation, aneurysm or tortuosity, which prevents transfemoral TAVR.\n* Evidence of an acute myocardial infarction ≤ 1 month (30 days), with evidence of myocardial necrosis in a clinical setting consistent with acute myocardial ischemia.\n* Need for open heart surgery (including severe aortic regurgitation, mitral regurgitation or stenosis, or tricuspid regurgitation, congenital heart disease, AF, complex coronary artery disease).\n* Aortic disease: a. bicuspid aortic valve with an ascending aorta diameter ≥ 45mm b. tricuspid aortic valve with an ascending aorta diameter ≥ 50mm.\n* Pre-existing mechanical or bioprosthetic valve in any position.\n* Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance within 30 days of the screening visit.\n* Emergency interventional\u002Fsurgical procedures within 30 days of the valve implant procedure.\n* Hypertrophic cardiomyopathy with or without obstruction.\n* Ventricular dysfunction with LVEF \\\u003C 30%.\n* Cardiac imaging (echo, CT, and\u002For MRI) evidence of ventricular mass, thrombus or vegetation.\n* Inability (including allergy) to heparin, iodine contrast agent, warfarin or NOAC, aspirin or clopidogrel.\n* Stroke or transient ischemic attack (TIA) within 180 days of the valve implant procedure.\n* Renal replacement therapy at the time of screening.\n* Severe lung disease (FEV1 \\\u003C 50% predicted) or currently on home oxygen.\n* Estimated life expectancy \\\u003C 24 months.\n* Currently participating in an investigational drug or another device study. Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials. Observational studies are not considered exclusionary.","50 Years",{"count":196,"type":22},450,"Safety, effectiveness and durability of Sapien 3 transcatheter aortic valve replacement in young aortic valve stenosis patients from China：A multi-center, retrospective and prospective, single arm, observational study",[199,200],"AORTIC VALVE DISEASES","Bicuspid Aortic Valve (BAV)",[202,203,204,205],"TAVR","real-world","aortic valve stenosis","Sapien 3","2026-05-21",{"date":208,"type":35},"2026-05-27",{"date":210,"type":35},"2025-04-24",{"date":212,"type":22},"2031-06-30",{"name":41,"class":42},4,{"id":216,"slug":217,"hasResults":12,"nctId":218,"briefTitle":219,"officialTitle":220,"acronym":4,"eligibilityCriteria":221,"healthyVolunteers":222,"sex":51,"minAge":18,"maxAge":4,"enrollmentInfo":223,"targetDuration":4,"studyType":80,"phases":4,"briefSummary":225,"conditions":226,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":228,"lastUpdatePostDateStruct":229,"startDateStruct":231,"completionDateStruct":233,"leadSponsor":235,"locationsCount":69},"100638058","evaluation-of-fecal-multi-target-biomarkers-in-the-screening-of-digestive-tract-cancers-100638058","NCT07600125","Evaluation of Fecal Multi-target Biomarkers in the Screening of Digestive Tract Cancers","Evaluation of Fecal Multi-target Biomarkers in the Screening of Digestive Tract Cancers: a Multi-center Prospective Observational Cohort Study","Inclusion Criteria:\n\n1. Participants must be at least 18 years of age at the time of enrollment;\n2. Participants must be scheduled to undergo gastroscopy and colonoscopy;\n3. Participants must agree to undergo a two-year follow-up as outlined in the protocol;\n4. Participants must be willing to participate and sign an informed consent form.\n\nExclusion Criteria:\n\n1. Have undergone gastrointestinal endoscopy screening within the past year;\n2. History of any type of gastrointestinal malignancy;\n3. Concurrent severe medical conditions that reduce the benefits of screening, such as severe pulmonary disease, kidney disease, liver disease, cardiovascular and cerebrovascular diseases, and hematological disorders;\n4. Other situations where a physician determines that endoscopic screening poses excessive risk (e.g., hemodynamic instability) or offers no benefit (e.g., short life expectancy);\n5. Pregnant or breastfeeding women.",true,{"count":224,"type":22},5000,"This study is a multi-center, observational study. Participants scheduled for gastroscopy and colonoscopy will undergo an epidemiological assessment and provide a stool sample prior to endoscopy for qualitative FIT, quantitative FIT, and novel biomarker testing, followed by the endoscopic examination. After completion of the baseline endoscopic screening, all enrolled participants will undergo a 2-year follow-up. The primary endpoints of the study are sensitivity and specificity for the screening of gastrointestinal cancers.The aim of this study is to develop and evaluate the sensitivity and specificity of fecal multi-marker panels for the screening of gastrointestinal cancers.",[227],"Gastric Cancer, Colorectal Cancer","2026-05-13",{"date":230,"type":35},"2026-05-20",{"date":232,"type":22},"2026-06",{"date":234,"type":22},"2027-12",{"name":41,"class":42},{"id":237,"slug":238,"hasResults":12,"nctId":239,"briefTitle":240,"officialTitle":241,"acronym":4,"eligibilityCriteria":242,"healthyVolunteers":12,"sex":51,"minAge":18,"maxAge":120,"enrollmentInfo":243,"targetDuration":4,"studyType":80,"phases":4,"briefSummary":245,"conditions":246,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":248,"lastUpdatePostDateStruct":249,"startDateStruct":250,"completionDateStruct":252,"leadSponsor":253,"locationsCount":69},"100640574","liquid-biopsy-multi-omics-and-biomarker-development-in-melanoma-100640574","NCT07584291","Liquid Biopsy Multi-Omics and Biomarker Development in Melanoma","Multi-Omics Analysis of Liquid Biopsy and Development of Clinical Biomarkers in Melanoma: A Prospective Cohort Study","Inclusion Criteria:\n\n* Diagnosed with acral or cutaneous melanoma according to the \"Melanoma Diagnosis and Treatment Guidelines.\"\n* Underwent sentinel lymph node biopsy with complete information available.\n* Archived melanoma tissue samples available with complete information.\n* Complete basic demographic and clinical information.\n* Age 18-80 years, any sex.\n\nExclusion Criteria:\n\n* Patients with severe organic diseases, immunodeficiency disorders, organ absence, or organ transplantation.\n* Patients diagnosed with mucosal melanoma according to the \"Melanoma Diagnosis and Treatment Guidelines.\"\n* Patients with other concurrent malignant tumors (e.g., basal cell carcinoma, lung cancer).\n* Incomplete patient information or pathological sample data.",{"count":244,"type":22},200,"This prospective, observational cohort study aims to explore the multi-omics profiles of liquid biopsies and develop clinical biomarkers in melanoma. Two hundred participants with pathologically confirmed acral or cutaneous melanoma who are scheduled to receive standard first-line immunotherapy will be enrolled. Blood samples will be collected at baseline and every 3 weeks during treatment, along with radiological assessments every 12 weeks. Tumor tissue will be obtained at surgery after approximately 3 months of therapy. Using microfluidic-based circulating tumor cell isolation, exosome enrichment, ctDNA analysis, and integrative multi-omics approaches, the study will compare molecular features across primary tumors, metastases, and liquid biopsy components. The primary outcomes are progression-free survival and overall survival, assessed up to 36 months. Secondary outcomes include changes in circulating tumor cell counts, ctDNA concentrations, exosomal biomarker levels, pathological response rate at surgery, and the predictive accuracy of a multi-omics model for treatment response. The findings are expected to provide a basis for personalized monitoring and treatment strategies in melanoma.",[247],"Melanoma (Skin Cancer)","2026-05-12",{"date":228,"type":35},{"date":251,"type":35},"2025-07-01",{"date":185,"type":22},{"name":41,"class":42},{"id":255,"slug":256,"hasResults":12,"nctId":257,"briefTitle":258,"officialTitle":259,"acronym":4,"eligibilityCriteria":260,"healthyVolunteers":12,"sex":51,"minAge":18,"maxAge":19,"enrollmentInfo":261,"targetDuration":4,"studyType":23,"phases":263,"briefSummary":264,"conditions":265,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":266,"lastUpdatePostDateStruct":267,"startDateStruct":269,"completionDateStruct":271,"leadSponsor":273,"locationsCount":69},"100640582","exploratory-study-with-parallel-controls-on-the-safety-and-efficacy-of-neoadjuvant-low-branched-chain-amino-acid-diet-in-combination-with-anti-pd-1-monoclonal-antibody-for-stage-iii-melanoma-100640582","NCT07586891","Exploratory Study With Parallel Controls on the Safety and Efficacy of Neoadjuvant Low Branched-Chain Amino Acid Diet in Combination With Anti-PD-1 Monoclonal Antibody for Stage III Melanoma","A Randomized, Double-Blind, Single-Center, Exploratory Study With Parallel Controls on the Safety and Efficacy of Neoadjuvant Low Branched-Chain Amino Acid Diet in Combination With Anti-PD-1 Monoclonal Antibody for Stage III Melanoma","Inclusion Criteria:\n\n* Patients with histopathologically or cytologically confirmed Stage III malignant melanoma. Stage III is defined as the presence of at least one clinically accessible lymph node metastasis or in-transit metastasis. Patients with mucosal or ocular melanoma are excluded; those with melanoma of unknown primary are also excluded.\n* No prior radiotherapy or systemic chemotherapy. No treatment with anti-PD-1, anti-PD-L1, anti-PD-L2 monoclonal antibodies, anti-CTLA-4 monoclonal antibody, interferon (IFN), or targeted agents within the last month.\n* Life expectancy ≥ 6 months.\n* At least one measurable lesion as defined by RECIST version 1.1.\n* Patients must have provided written informed consent to participate voluntarily in this trial and must be between 18 and 75 years of age on the day of signing the consent form.\n* ECOG (Eastern Cooperative Oncology Group) performance status score of 0 or 1.\n* Adequate organ function as assessed by the following laboratory values (within 4 weeks prior to the start of study drug treatment):\n\n  1. Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL\n  2. Platelets ≥ 100 × 10⁹\u002FL\n  3. Hemoglobin ≥ 90 g\u002FL (no transfusion within 14 days prior to enrollment)\n  4. Serum creatinine ≤ 1.5 × upper limit of normal (ULN)\n  5. Serum total bilirubin ≤ 1.5 × ULN\n  6. AST (SGOT) and ALT (SGPT) ≤ 2.5 × ULN or ≤ 5 × ULN (for patients with liver metastases)\n  7. Prothrombin time (PT)\u002FInternational Normalized Ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN (unless the patient is on anticoagulant therapy, in which case PT or aPTT must be within the therapeutic range intended for the anticoagulant).\n* For women of childbearing potential, a negative urine or serum pregnancy test within 7 days prior to receiving the first dose of the study drug.\n* Female patients of childbearing potential who enroll in the study must be willing to use adequate contraception for up to 12 months after the last dose of the study drug.\n\nExclusion Criteria:\n\n* The patient is currently participating, or has participated in a clinical trial of an investigational drug or medical device within 4 weeks prior to the first dose of the study drug.\n* The patient has received any anti-tumor therapy within the past month, including but not limited to chemotherapy, radiotherapy, immunotherapy (such as anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies, or any other antibody targeting T-cell co-regulatory pathways), etc.\n* The patient has received systemic corticosteroid therapy (\\>10 mg\u002Fkg prednisone or equivalent) within two weeks prior to the first dose, or any other form of immunosuppressive therapy.\n* The patient has a known history of hematologic malignancies, primary brain tumors, sarcoma, or other primary solid tumors, unless the patient has been cured and has had no evidence of recurrence for 5 years. Exceptions include cured basal cell carcinoma of the skin and carcinoma in situ of the cervix.\n* The patient has known central nervous system (CNS) metastases and\u002For carcinomatous meningitis.\n* The patient has a history of severe hypersensitivity reaction to another monoclonal antibody (mAb) therapy.\n* The patient has an active autoimmune disease that has required systemic treatment in the past 2 years (e.g., with corticosteroids or immunosuppressive drugs). Replacement therapies (such as thyroxine, insulin, or physiologic corticosteroid replacement for adrenal or pituitary insufficiency) are not considered systemic treatments and are allowed. Exceptions include patients with vitiligo, type I diabetes mellitus, or childhood asthma\u002Fatopy.\n* Any other severe, uncontrolled co-morbid condition that may compromise protocol compliance or interfere with the interpretation of results, including metabolic diseases, active opportunistic or advanced (severe) infections, cardiovascular disease (e.g., Class III or IV heart failure as defined by the New York Heart Association classification, second-degree or greater heart block, myocardial infarction within the past 6 months, unstable arrhythmias or unstable angina, cerebral infarction within 3 months), or pulmonary disease (interstitial lung disease, obstructive pulmonary disease, history of symptomatic bronchospasm). Also included are HIV positivity; HCV positivity; HBsAg or HBcAb positivity with detectable HBV DNA (quantitation limit: 500 IU\u002FmL); or a known history of tuberculosis.\n* The patient has received a live vaccine within 4 weeks prior to the first dose. The patient has received hematopoietic growth factors (e.g., colony-stimulating factors, erythropoietin) within 2 weeks prior to treatment initiation. The patient has undergone major surgical procedures (excluding diagnostic surgery) within 2 weeks prior to treatment initiation.\n* The patient has a known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the trial.\n* The patient is pregnant or breastfeeding, or plans to conceive or father children during the study period.\n* Any other severe, acute, or chronic medical or psychiatric condition, or laboratory abnormality that, in the investigator's judgment, may increase the risk associated with study participation or may interfere with the interpretation of study results.",{"count":262,"type":22},80,[56],"1. Primary Objective:\n\n   To evaluate the safety of a low branched-chain amino acid diet (60% of the normal dietary BCAA content) combined with anti-PD-1 monoclonal antibody as neoadjuvant therapy in patients with stage III melanoma, by documenting the incidence of all adverse events (AEs) and serious adverse events (SAEs), and analyzing changes from baseline in physical examinations, vital signs, and laboratory test results.\n2. Secondary Objectives:\n\n   To assess the pathological response rates (including pCR, near-pCR, pPR, and pNR) of the combination therapy in stage III melanoma; to evaluate the objective response rate (ORR) according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1) and the immune-related RECIST (irRECIST) criteria; and to estimate event-free survival (EFS) and overall survival (OS) through long-term follow-up.\n3. Exploratory Objectives:\n\nTo investigate the quality of life (QoL) in patients receiving the low BCAA diet combined with anti-PD-1 therapy; and to identify predictive biomarkers for treatment outcome differences, such as immune-related gene signatures (e.g., PD-L1 expression) and driver gene mutations in somatic variants.",[247],"2026-05-07",{"date":268,"type":35},"2026-05-14",{"date":270,"type":35},"2024-07-01",{"date":272,"type":22},"2027-06",{"name":41,"class":42},{"id":275,"slug":276,"hasResults":12,"nctId":277,"briefTitle":278,"officialTitle":279,"acronym":4,"eligibilityCriteria":280,"healthyVolunteers":12,"sex":51,"minAge":18,"maxAge":19,"enrollmentInfo":281,"targetDuration":4,"studyType":23,"phases":283,"briefSummary":285,"conditions":286,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":266,"lastUpdatePostDateStruct":287,"startDateStruct":288,"completionDateStruct":290,"leadSponsor":291,"locationsCount":69},"100637911","early-phase-1-efficacy-and-safety-of-neoadjuvant-cadonilimab-plus-high-dose-recombinant-human-interferon-1b-in-stage-iiiiv-melanoma-100637911","NCT07586904","Efficacy and Safety of Neoadjuvant Cadonilimab Plus High-Dose Recombinant Human Interferon α1b in Stage III\u002FIV Melanoma.","Efficacy and Safety of Neoadjuvant Cadonilimab Plus High-Dose Recombinant Human Interferon α1b in Stage III\u002FIV Melanoma: A Single-Center, Open-Label, Phase Ib Trial","Inclusion Criteria:\n\n* Voluntarily participate in this trial, sign the informed consent form, and be between 18 and 75 years of age, regardless of gender.\n* Patients with histopathologically or cytologically confirmed stage III or resectable stage IV malignant melanoma.\n\n  * Stage III is defined as the presence of at least one clinically accessible lymph node metastasis or in-transit metastasis.\n  * Resectable stage IV is defined as a single distant metastasis, excluding brain metastases or any other metastases that cannot be completely surgically resected.\n  * Mucosal or ocular melanomas are excluded.\n  * Melanomas of unknown primary origin are excluded.\n* Have not received treatment with PD-1, PD-L1, or PD-L2 antibodies, anti-CTLA4 antibodies, interferon (IFN), targeted therapy, radiotherapy, or systemic chemotherapy within the past month.\n* Have an expected survival period of ≥ 6 months.\n* Have at least one measurable lesion according to RECIST version 1.1.\n* Have an ECOG performance status score of 0 or 1.\n* Have adequate organ function, as indicated by the following laboratory values (within 4 weeks prior to the start of study treatment):\n\n  1. Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL\n  2. Platelets ≥ 100 × 10⁹\u002FL\n  3. Hemoglobin ≥ 90 g\u002FL (no blood transfusion within 14 days prior to enrollment)\n  4. Serum creatinine ≤ 1.5 × upper limit of normal (ULN)\n  5. Serum total bilirubin ≤ 1.5 × ULN\n  6. AST (SGOT) and ALT (SGPT) ≤ 2.5 × ULN or ≤ 5 × ULN (for patients with liver metastases)\n  7. Prothrombin time (PT)\u002FInternational Normalized Ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN (unless the subject is receiving anticoagulant therapy, in which case PT or aPTT must be within the therapeutic range intended for the anticoagulant used).\n\n     8.Female patients of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to receiving the first dose of the study drug.\n\n     9.Female patients enrolled in the study must be willing to use appropriate contraception methods until 12 months after the last dose of the study drug.\n\n     Exclusion Criteria:\n* The patient is currently participating, or has participated within 4 weeks prior to the first dose of the study drug, in another interventional clinical trial of drugs or medical devices.\n* The patient has received any anti-tumor therapy within the past month, including but not limited to chemotherapy, radiotherapy, immunotherapy (e.g., anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies, or any other antibody targeting T-cell co-regulatory pathways), etc.\n* The patient has received systemic steroid therapy (\\>10 mg\u002Fkg prednisone or equivalent) within two weeks prior to the first dose, or any other form of immunosuppressive medication.\n* The patient has a known history of hematologic malignancy, primary brain tumor, sarcoma, or another primary solid tumor, unless the patient has been cured and has had no evidence of recurrence for 5 years. Exceptions include cured basal cell carcinoma of the skin and carcinoma in situ of the cervix.\n* The patient has known central nervous system metastases and\u002For carcinomatous meningitis.\n* The patient has a history of severe hypersensitivity to another monoclonal antibody (mAb) therapy.\n* The patient has had an active autoimmune disease requiring systemic treatment (e.g., with corticosteroids or immunosuppressive drugs) within the past 2 years, and related replacement therapies (e.g., thyroxine, insulin, or physiologic corticosteroid replacement for renal or pituitary insufficiency). Exceptions include patients with vitiligo, type I diabetes, childhood asthma\u002Fatopy.\n* Other severe, uncontrolled concomitant diseases that may affect protocol compliance or interpretation of results, including active opportunistic or advanced (severe) infections; uncontrolled diabetes; cardiovascular disease (e.g., Class III or IV heart failure as defined by the New York Heart Association classification, second-degree or greater heart block, myocardial infarction within the past 6 months, unstable arrhythmias or unstable angina, cerebral infarction within 3 months); pulmonary disease (interstitial lung disease, obstructive pulmonary disease, history of symptomatic bronchospasm); HIV positivity; HCV positivity; HBsAg or HBcAb positivity with detectable HBV DNA (quantitative limit ≥500 IU\u002FmL); or a documented history of tuberculosis.\n* The patient has received a live vaccine within 4 weeks prior to the first dose; hematopoietic growth factors (e.g., colony-stimulating factors, erythropoietin) within 2 weeks prior to treatment initiation; or major surgical procedures (excluding diagnostic surgery) within 2 weeks prior to treatment initiation.\n* The patient has a known psychiatric or substance use disorder that would interfere with cooperation with trial requirements.\n* The patient is pregnant or breastfeeding, or plans to become pregnant or father a child during the study period.\n* Any other severe, acute, or chronic medical or laboratory abnormality that, in the investigator's judgment, could increase the risk associated with study participation or could interfere with the interpretation of study results.",{"count":282,"type":22},10,[284],"EARLY_PHASE1","1. Primary Objective\n\n   To evaluate the efficacy and safety of cadonilimab in combination with high-dose recombinant human interferon α1b injection as neoadjuvant therapy in patients with stage III\u002FIV melanoma. Assessments include:\n\n   Target lesion response (complete response \\[CR\\], partial response \\[PR\\], stable disease \\[SD\\], progressive disease \\[PD\\]) Objective response rate (ORR) Pathological response rate (pathological complete response \\[pCR\\], near pCR, pathological partial response \\[pPR\\], pathological non-response \\[pNR\\]) Incidence of all adverse events (AEs) and serious adverse events (SAEs) Changes from baseline in physical examinations, vital signs, and laboratory test results.\n2. Exploratory Objectives To investigate the correlation between treatment efficacy\u002Fpatient outcomes and:PD-L1 expression in tumor tissue CD8+ T-cell infiltration Tumor mutational burden (TMB).\n3. Study Significance To conduct a preliminary exploration in support of future multicenter clinical studies.",[247],{"date":268,"type":35},{"date":289,"type":35},"2025-05-01",{"date":272,"type":22},{"name":41,"class":42},{"id":293,"slug":294,"hasResults":12,"nctId":295,"briefTitle":296,"officialTitle":297,"acronym":298,"eligibilityCriteria":299,"healthyVolunteers":12,"sex":51,"minAge":18,"maxAge":19,"enrollmentInfo":300,"targetDuration":4,"studyType":23,"phases":302,"briefSummary":304,"conditions":305,"keywords":310,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":266,"lastUpdatePostDateStruct":315,"startDateStruct":316,"completionDateStruct":318,"leadSponsor":320,"locationsCount":69},"100638093","phase-1-safety-and-efficacy-of-s103-cells-in-progressiverefractory-multiple-sclerosis-100638093","NCT07587125","Safety and Efficacy of S103 Cells in Progressive\u002FRefractory Multiple Sclerosis","Safety and Efficacy of S103 Cells in Patients With Progressive or Refractory Multiple Sclerosis：An Open-Label, Single-Arm, Exploratory Clinical Study","RESET-MS","Inclusion Criteria:\n\n1. Age ≥18 years and ≤75 years;\n2. The subject signs the informed consent form, is willing and able to comply with the protocol, complete the research assessments and return for follow-up;\n3. To be diagnosed with Multiple Sclerosis (MS) according to the 2017 McDonald criteria, specifically including Progressive MS (Primary Progressive MS \\[PPMS\\] or Secondary Progressive MS \\[SPMS\\]) or Relapsing-Remitting MS (RRMS);\n4. The subject must be assessed by the investigator as having progressive or refractory MS for which no effective standard therapy is available. For subjects with Relapsing MS (RMS), refractory\u002Fprogressive disease is defined as having experienced at least 2 clinical relapses within the past 2 years, or at least 1 clinical relapse within the past 1 year accompanied by at least one gadolinium-enhancing lesion on MRI within the past year, despite treatment with standard disease-modifying therapies (DMTs). In addition, the subject must have an Expanded Disability Status Scale (EDSS) score between 2.0 and 7.0, inclusive, at both screening and baseline;\n5. Male study participants must agree to take contraceptive measures during the treatment period and within 1 year after receiving study treatment, and are prohibited from donating sperm throughout the study period;\n6. Women of childbearing potential (WOCBP) must agree to take contraceptive measures during treatment and for at least 1 year after receiving study treatment. Participants must have a negative serum pregnancy test result during screening; a negative urine pregnancy test result must be confirmed before receiving CAR-T for the first time.\n\nExclusion Criteria:\n\nSubjects will be ineligible for inclusion in the study if they meet any of the following criteria prior to screening or at the baseline visit:\n\n1. The subject has any medical, psychological, or social condition that, in the investigator's opinion, may harm the subject, interfere with their ability to participate in the study, or result in poor protocol compliance;\n2. Female subjects who are pregnant or lactating, plans to become pregnant at any time within 12 months after receiving CAR-T cell treatment, or has a history of spontaneous or induced abortion within 4 weeks prior to screening;\n3. The subject has a clinically relevant active infection, such as sepsis, pneumonia, or a severe local abscess, or a serious infection requiring hospitalization or intravenous antibiotic treatment within 4 weeks prior to screening. Subjects are also excluded if they have a known immunodeficiency disorder including Human Immunodeficiency Virus (HIV), test positive for Hepatitis B surface antigen (HBsAg) or detectable Hepatitis B virus (HBV) DNA, test positive for Hepatitis C virus (HCV) antibody with detectable HCV RNA, test positive for syphilis during the screening period, or have an active or high-risk history of tuberculosis infection;\n4. The subject has previously received any Chimeric Antigen Receptor (CAR) T-cell therapy or other genetically modified cell therapies, or has a history of allogeneic hematopoietic stem cell transplantation (HSCT) or solid organ transplantation. Furthermore, subjects are excluded if they have received intravenous immunoglobulin (IVIG) or plasma exchange (PE) within 4 weeks prior to screening, or have received tocilizumab or eculizumab treatment within 3 months prior to screening;\n5. The subject is diagnosed with an active, severe autoimmune disease other than Multiple Sclerosis, such as Systemic Lupus Erythematosus or Rheumatoid Arthritis. This also includes the presence of other severe progressive neurodegenerative or central nervous system (CNS) disorders, such as Parkinson's disease, Alzheimer's disease, stroke, or active CNS tumors, that the investigator believes would confound the clinical assessment of Multiple Sclerosis. Additionally, a history of active malignancy within the past 5 years excludes the subject, with the exception of adequately treated basal cell or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix;\n6. The subject exhibits specific laboratory abnormalities or organ dysfunction during the screening period, including elevated liver enzymes with AST or ALT greater than 1.5 times the upper limit of normal (ULN), total bilirubin greater than 1.5 times the ULN, or a Creatinine Clearance (CrCl) of less than 60 mL\u002Fmin. Exclusions also apply for an absolute neutrophil count (ANC) of less than 2.0 × 10\\^9\u002FL, a platelet count of less than 100 × 10\\^9\u002FL, hemoglobin levels below 100 g\u002FL, or severe cardiovascular or pulmonary diseases, which include a Left Ventricular Ejection Fraction (LVEF) below 50%, unstable angina or myocardial infarction within the past 6 months, or a resting peripheral blood oxygen saturation (SpO2) of 91% or less;\n7. The subject has a known severe allergy, hypersensitivity, or intolerance to fludarabine, cyclophosphamide, or any excipients contained in the S103 CAR-T cell product, such as human serum albumin. Subjects are also excluded if they have received any live attenuated vaccine within 6 weeks prior to screening, or plan to receive a live vaccine during the study period.",{"count":301,"type":22},9,[303],"PHASE1","This study is a single-center, open-label, single-arm, exploratory clinical study to evaluate the safety, tolerability, and preliminary efficacy of S103（BCMA-CAR T ）cells in the treatment of progressive or refractory multiple sclerosis. The study is a dose escalation trial in adult progressive and refractory MS patients. A standard \"3+3\" design will be used to perform dose escalation to explore the safety profile and dose-limiting toxicities (DLTs). A total of 9 MS patients who meet the inclusion criteria are expected to be recruited.",[306,307,308,309],"Multiple Sclerosis (MS) Primary Progressive","Multiple Sclerosis","Multiple Sclerosis (MS) Secondary Progressive","Refractory Multiple Sclerosis",[307,311,309,312,313,314],"Progressive Multiple Sclerosis","BCMA-CAR T Cells","Chimeric Antigen Receptor T-Cell Therapy","Safety and Efficacy",{"date":268,"type":35},{"date":317,"type":22},"2026-05",{"date":319,"type":22},"2029-11",{"name":41,"class":42},{"id":322,"slug":323,"hasResults":12,"nctId":324,"briefTitle":325,"officialTitle":326,"acronym":4,"eligibilityCriteria":327,"healthyVolunteers":12,"sex":51,"minAge":18,"maxAge":19,"enrollmentInfo":328,"targetDuration":4,"studyType":23,"phases":330,"briefSummary":331,"conditions":332,"keywords":335,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":339,"lastUpdatePostDateStruct":340,"startDateStruct":342,"completionDateStruct":344,"leadSponsor":346,"locationsCount":347},"100560421","phase-2-efficacy-and-safety-of-serplulimab-combined-with-chemotherapy-as-neoadjuvant-treatment-for-locally-advanced-gastric-cancer-or-adenocarcinoma-of-esophagogastric-junction-100560421","NCT06576921","Efficacy and Safety of Serplulimab Combined With Chemotherapy as Neoadjuvant Treatment for Locally Advanced Gastric Cancer or Adenocarcinoma of Esophagogastric Junction","Efficacy and Safety of Serplulimab Combined With Nab-paclitaxel and SOX as Neoadjuvant Treatment for Locally Advanced Gastric Cancer or Adenocarcinoma of Esophagogastric Junction: A Multicenter Randomized Controlled Trial","Inclusion Criteria:\n\n* Age older than 18 and younger than 75 years\n* Primary GC or AEG (Siewert II\u002FIII)confirmed pathologically by endoscopic biopsy\n* Clinical stage T3\u002FT4N+M0 disease as assessed by CT\u002FMRI, PET-CT, and laparoscopy, if feasible\n* At least one measurable lesion according to the RECIST, version 1.1\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Surgical treatment after neoadjuvant chemotherapy is planned according to clinical staging criteria.\n* Life expectancy of at least 3 months\n* Acceptable bone marrow, hepatic, and renal function, including: a)Blood routine examination(No blood transfusion within 14 days; No granulocyte colony-stimulating factor (G-CSF) or other hematopoietic stimulating factors were used): white blood cell count ≥3.5 ×109\u002FL, neutrophils ≥1.5 × 109\u002FL, platelet count \\>100 × 109\u002FL, and hemoglobin ≥90 g\u002FL; b)Hepatic function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST), ALT and AST≤2.5×ULN; total bilirubin (TBIL) ≤1.5×ULN (Gilbert syndrome patients, ≤3×ULN); c)Renal function: serum creatinine (Cr) ≤1.5×ULN or creatinine clearance (Ccr) ≥60mL\u002F min; d)Coagulation function: activated partial thromboplastin time (APTT), international standardized ratio (INR), prothrombin time (PT) ≤1.5×ULN;\n* Written informed consent\n\nExclusion Criteria:\n\n* Squamous cell carcinoma, adenosquamous cell carcinoma, small cell carcinoma, and undifferentiated gastric cancer were confirmed by pathology\n* Positive Her-2 detection (IHC3+ or IHC2+ amplified by FISH detection)\n* Prior chemotherapy, radiotherapy, hormone therapy, targeted therapy, or immunotherapy\n* Contraindications for surgical treatment or chemotherapy\n* Presence of distant metastasis\n* History of other malignant disease within the past 5 years, except: basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that have been treated radically and have shown no signs of disease for at least 5 years\n* Any active or history of autoimmune disease, or history of syndrome that required systemic steroids or immunosuppressive medications, except for subjects with vitiligo or resolved childhood asthma\u002Fatopy\n* History of immunodeficiency diseases, including human immunodeficiency virus (HIV), or other acquired or congenital immune-deficient disease, or transplantation\n* Severe mental disorder\n* Presence of digestive tract obstruction, jaundice, acute infectious diseases, inflammatory bowel disease, Crohn's disease, ulcerative colitis, chronic diarrhea, active tuberculosis\n* Immunosuppressive drugs are required for 2 weeks or within 2 weeks or during the study period, excluding the following: a) intranasal, inhaled, topical or topical steroid injections (e.g. intra-articular injections); b) Physiological dose of systemic corticosteroids (≤10mg\u002F day prednisone or equivalent dose); c) Short-term (≤7 days) use of steroids for the prevention or treatment of non-autoimmune allergic diseases;\n* Patients who have undergone major surgery or received live virus vaccine within 4 weeks\n* Pregnant or breast-feeding women, subjects who are unwilling to receive effective contraception during treatment and within 6 months after the end of treatment (including male subjects who have the ability to impregnate women and female subjects and their male partners)\n* Evidence of bleeding tendency or receiving thrombolytics or anticoagulants\n* According to the criteria of the term Common Adverse Events (NCI-CTCAE V5.0), the corresponding symptoms have been diagnosed;\n* Hepatitis B or hepatitis C virology tests at the time of screening meet any of the following: a) HBsAg positive and HBV-DNA titer ≥104 copy number \u002FmL or ≥2000IU\u002FmL (hepatitis B carriers should ask researchers for appropriate antiviral treatment); b) Active hepatitis C: HCV antibody positive and HCV-RNA higher than the lower detection limit of the assay;\n* Allergic to study drugs\n* The investigator believes that the subjects have other conditions that may affect their adherence to the protocol and evaluation of the study indicators, and the subjects are not suitable to participate in the study.",{"count":329,"type":22},116,[25],"This is a multicenter, double-blind, randomized, phase 2 trial to investigate the efficacy and safety of serlulimab combined with nab-paclitaxel plus SOX versus nab-paclitaxel plus SOX alone as neoadjuvant treatment for locally advanced GC or AEG.\n\nThe goal of this clinical trial is to learn if serlulimab combined with nab-paclitaxel plus SOX as neoadjuvant treatment for locally advanced AEG\u002FGC. It will also learn about the safety of serlulimab combined with nab-paclitaxel plus SOX. The main questions it aims to answer are:\n\nDoes serlulimab increase the pCR of participants with locally advanced AEG\u002FGC ? What medical problems do participants have when taking serlulimab? Researchers will compare to a placebo (a look-alike substance that contains no drug) to see if serlulimab combined with nab-paclitaxel plus SOX as neoadjuvant treatment for locally advanced AEG\u002FGC.\n\nParticipants will:\n\nEligible patients were randomly assigned to receive serlulimab (4.5 mg intravenously on day 1) combined with chemotherapy (nap-paclitaxel 260 mg\u002Fm2 intravenously on days 1, OXA 130mg\u002F \u002Fm2, intravenously on days 1, and S-1 40 to 60 mg orally twice daily depending on BSA on days 1 to 14) or chemotherapy alone every 3 weeks for 3 preoperative cycles followed by 3 postoperative cycles. All patients will be followed for survival.",[333,334],"Stomach Neoplasms","Immune Checkpoint Inhibitors",[336,337,338],"Gastric cancer","Adenocarcinoma of Esophagogastric junction cancer","PD-1 antibody","2026-04-21",{"date":341,"type":35},"2026-04-23",{"date":343,"type":35},"2024-11-15",{"date":345,"type":22},"2026-09-30",{"name":41,"class":42},5,{"id":349,"slug":350,"hasResults":12,"nctId":351,"briefTitle":352,"officialTitle":353,"acronym":354,"eligibilityCriteria":355,"healthyVolunteers":12,"sex":356,"minAge":18,"maxAge":4,"enrollmentInfo":357,"targetDuration":4,"studyType":80,"phases":4,"briefSummary":359,"conditions":360,"keywords":368,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":371,"lastUpdatePostDateStruct":372,"startDateStruct":374,"completionDateStruct":376,"leadSponsor":378,"locationsCount":301},"100635520","plasma-exosomal-rna-signature-for-prostate-cancer-bone-metastasis-100635520","NCT07553754","Plasma Exosomal RNA Signature for Prostate Cancer Bone Metastasis","Plasma Exosomal RNA Signature for Predicting PSMA PET-Defined Bone Metastasis in Prostate Cancer: A Prospective, Multicenter Discovery, Development, and Validation Study","EXO-MET","Inclusion Criteria\n\n1. Patients with histologically confirmed prostate cancer who are scheduled to undergo baseline PSMA PET imaging.\n2. Patients who undergo PSMA PET imaging prior to any prostate cancer-related treatment (including androgen deprivation therapy, radiotherapy, or surgery).\n3. Patients who provide blood samples for plasma exosomal RNA analysis collected prior to any treatment AND prior to prostate biopsy (if applicable).\n\n   Whole blood samples (approximately 10 mL) will be collected in EDTA tubes at this specified time point. Samples will be processed within 2 hours to obtain plasma and stored at -80°C until analysis.This timing ensures circulating exosomal RNA profiles reflect tumor biology without biopsy-induced contamination.\n4. Patients who are willing to undergo prostate biopsy if clinically indicated (biopsy performed after blood collection).\n5. Patients who provide written informed consent to participate in the study.\n6. Age ≥18 years.\n\nExclusion Criteria\n\n1. Patients who have received any prior prostate cancer-related treatment before the baseline PSMA PET scan (including hormonal therapy, radiotherapy, chemotherapy, or surgery).\n2. Patients whose blood samples were collected after prostate biopsy.\n3. Patients with a history of other active malignancies within the past two years (excluding non-melanoma skin cancer).\n4. Patients with inadequate blood sample quality or quantity for exosomal RNA extraction and analysis (e.g., hemolysis, insufficient volume \\\u003C8 mL).\n5. Patients with severe comorbidities or conditions that, in the judgment of the investigator, could interfere with study compliance or pose significant risk.","MALE",{"count":358,"type":22},1000,"Brief Summary:\n\nThis prospective, multicenter study aims to discover, develop, and validate a plasma exosomal RNA-based signature as a rule-out test for predicting bone metastasis in prostate cancer, using baseline treatment-naïve PSMA PET as the gold standard. The study is designed in four sequential phases:\n\nPhase 1 (Discovery, n=250): High-throughput sequencing of plasma exosomal RNAs to identify differentially expressed candidate RNAs.\n\nPhase 2 (Model Development, n=300): Digital droplet PCR (ddPCR) analysis of candidates in an independent cohort to construct and lock the final multi-RNA predictive signature using appropriate machine learning methods.\n\nPhase 3 (Internal Validation, n=300): Independent validation of the locked signature in a consecutive cohort reflecting natural disease prevalence.\n\nPhase 4 (External Validation, n=150): Final independent validation in a multi-center cohort enriched for bone metastasis.\n\nPrimary Outcome:\n\nTo evaluate the diagnostic performance of the signature as a rule-out test for PSMA PET-defined bone metastasis. The primary performance metrics are:\n\nSensitivity, with a prespecified target of ≥95% (to ensure minimal false negatives).\n\nSpecificity at the threshold that achieves the ≥95% sensitivity. A specificity of ≥30% will be considered supportive of clinical utility. A specificity of ≥30% (or a lower bound of the 95% confidence interval exceeding 20%) will be considered supportive of clinical utility.\n\nNeed:\n\nCurrent biomarkers lack sensitivity and specificity for early detection of bone metastasis. More importantly, existing tools lack adequate negative predictive value to safely rule out bone metastasis in low-risk patients, leading to over-imaging or delayed detection. There is an urgent need for a non-invasive rule-out test to safely defer PSMA PET\u002FCT in very-low-risk patients. Plasma exosomal RNAs offer a promising liquid biopsy approach, but prospective multicenter studies with rigorous validation are lacking.\n\nSecondary Outcomes:\n\n1. Secondary metrics include negative predictive value (NPV), positive predictive value (PPV), area under the ROC curve (AUC), calibration, and decision curve analysis.\n2. Correlation between exosomal RNA levels and number of bone metastatic lesions (PSMA PET).\n3. Association with PSA, PSMA PET SUVmax, and MRI findings.\n4. Tissue-plasma correlation to confirm tumor origin (exploratory).\n5. Mechanistic exploration of key candidates via in vitro\u002Fin vivo assays (exploratory).\n6. Subgroup analyses by hormone sensitivity, metastatic pattern, Gleason grade (exploratory).\n\nInclusion Criteria:\n\n1. Histologically confirmed prostate cancer scheduled for baseline PSMA PET.\n2. PSMA PET performed prior to any prostate cancer-related treatment.\n3. Blood samples collected prior to any treatment AND prior to prostate biopsy.\n4. Willing to undergo prostate biopsy if clinically indicated (after blood collection).\n5. Written informed consent.\n6. Age ≥18 years.\n\nExclusion Criteria:\n\n1. Any prior prostate cancer treatment before baseline PSMA PET.\n2. Blood samples collected after prostate biopsy.\n3. Other active malignancy within past two years (excluding non-melanoma skin cancer).\n4. Inadequate blood sample quality or quantity.\n5. Severe comorbidities interfering with study conduct.",[361,362,363,364,365,366,367],"Prostate Cancer (Diagnosis)","Bone Metastasis","PSMA PET","Liquid Biopsy","Exosomal RNA","Biomarker Discovery and Validation","Treament-naive",[369,362,363,364,365,370],"Prostate Cancer","Predictive Signature","2026-04-20",{"date":373,"type":35},"2026-04-28",{"date":375,"type":35},"2026-03-12",{"date":377,"type":22},"2027-12-31",{"name":41,"class":42},{"id":380,"slug":381,"hasResults":12,"nctId":382,"briefTitle":383,"officialTitle":384,"acronym":385,"eligibilityCriteria":386,"healthyVolunteers":12,"sex":356,"minAge":18,"maxAge":4,"enrollmentInfo":387,"targetDuration":4,"studyType":80,"phases":4,"briefSummary":389,"conditions":390,"keywords":394,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":371,"lastUpdatePostDateStruct":396,"startDateStruct":397,"completionDateStruct":399,"leadSponsor":401,"locationsCount":301},"100635522","serial-psma-pet-for-therapy-monitoring-in-clinically-significant-prostate-cancer-100635522","NCT07553780","Serial PSMA PET for Therapy Monitoring in Clinically Significant Prostate Cancer","Serial PSMA PET for Treatment Response Monitoring in Newly Diagnosed Clinically Significant, Treatment-Naïve Prostate Cancer - A Prospective, Multicenter Study","PSMA-TM","Inclusion Criteria\n\n1. Newly diagnosed, histologically confirmed prostate cancer with Gleason score ≥7 (clinically significant prostate cancer).\n2. Planned to receive curative-intent therapy (radical prostatectomy or radiotherapy) or systemic therapy (androgen deprivation therapy, chemotherapy, or combination).\n3. Undergo baseline PSMA PET\u002FCT imaging prior to any prostate cancer-related treatment.\n4. Age ≥18 years.\n5. Willing and able to comply with the follow-up schedule, including the second PSMA PET\u002FCT scan.\n6. Provide written informed consent.\n\nExclusion Criteria\n\n1. Any prior prostate cancer treatment (including hormonal therapy, radiotherapy, chemotherapy, or surgery) before baseline PSMA PET\u002FCT.\n2. Contraindications to PSMA PET\u002FCT imaging (e.g., known severe allergic reaction to radiotracer components, inability to lie flat for the duration of the scan).\n3. Other active malignancy within the past two years, excluding non-melanoma skin cancer.\n4. Severe comorbidities or conditions that, in the opinion of the investigator, could interfere with study compliance or pose a significant risk to the patient.\n5. Unable or unwilling to provide informed consent.",{"count":388,"type":22},110,"This prospective, multicenter study aims to evaluate the clinical utility of serial PSMA PET for therapy monitoring in patients with newly diagnosed clinically significant prostate cancer.\n\nClinically significant prostate cancer is defined as Gleason score ≥7.Patients will undergo baseline PSMA PET\u002FCT prior to any treatment. A second PSMA PET\u002FCT will be performed either at PSA recurrence (PSA rise ≥2 ng\u002FmL above nadir after radiotherapy or biochemical progression per PCWG3 criteria) or at a fixed time window of 12-24 months after treatment completion for those without biochemical recurrence.\n\nPrimary Outcome:\n\n1\\. Absolute and relative change in SUVmax from baseline to follow-up PSMA PET, correlated with treatment response categories (complete response, partial response, stable disease, progressive disease) defined by a composite reference standard (PSA kinetics, conventional imaging, clinical outcomes).\n\n\\[Time Frame: Baseline and follow-up (up to 24 months)\\]\n\nSecondary Outcomes:\n\n1. Absolute and relative change in the number of PSMA-avid lesions (primary tumor, nodal, bone metastases) as a supportive exploratory endpoint.\n2. Proportion of patients with treatment strategy change following serial PSMA PET.\n3. Agreement between PSMA PET response (≥30% decrease in SUVmax) and PSA50 response (≥50% PSA decline) using Cohen's kappa.\n4. Agreement between PSMA PET response and PSA90 response (≥90% PSA decline).\n5. Prognostic value of baseline and follow-up PSMA PET parameters for progression-free survival (PFS).\n6. Prognostic value of baseline and follow-up PSMA PET parameters for time to castration resistance (ADT-treated patients only).\n7. Subgroup analyses by treatment type (radiotherapy, ADT, chemotherapy), baseline disease burden (oligometastatic vs. polymetastatic), and Gleason grade group (≤7 vs. ≥8).\n8. Inter-reader agreement for PSMA-avid lesion counts. \\[Time Frame: Up to 2 years, except inter-reader agreement at baseline\\]\n\nNeed:\n\nCurrent treatment response evaluation relies on PSA changes and conventional imaging, which lack sensitivity and accuracy for early assessment. PSMA PET has demonstrated superior sensitivity for detecting prostate cancer lesions, but its role in longitudinal therapy monitoring remains undefined, with no specific regulatory approval for this indication. Prospective data on serial PSMA PET to guide treatment decisions in patients with clinically significant prostate cancer (Gleason score ≥7) are urgently needed.\n\nInclusion Criteria:\n\n1. Newly diagnosed, histologically confirmed clinically significant prostate cancer with Gleason score ≥7.\n2. Planned curative-intent or systemic therapy.\n3. Baseline PSMA PET performed prior to any treatment.\n4. Age ≥18 years.\n5. Written informed consent.\n\nExclusion Criteria:\n\n1. Prior prostate cancer treatment before baseline PSMA PET.\n2. Contraindication to PSMA PET imaging.\n3. Other active malignancy within past two years (excluding non-melanoma skin cancer).\n4. Unable to comply with follow-up schedule.",[391,363,392,393],"High-risk Prostate Cancer","Treatment Response","Therapy Monitoring",[369,363,392,393,395],"High-Risk",{"date":373,"type":35},{"date":398,"type":35},"2021-03-07",{"date":400,"type":22},"2028-12-31",{"name":41,"class":42},{"id":403,"slug":404,"hasResults":12,"nctId":405,"briefTitle":406,"officialTitle":407,"acronym":4,"eligibilityCriteria":408,"healthyVolunteers":12,"sex":51,"minAge":18,"maxAge":409,"enrollmentInfo":410,"targetDuration":4,"studyType":23,"phases":412,"briefSummary":413,"conditions":414,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":371,"lastUpdatePostDateStruct":416,"startDateStruct":418,"completionDateStruct":420,"leadSponsor":421,"locationsCount":69},"100635420","picankibart-in-palmoplantar-pustulosis-100635420","NCT07552454","Picankibart in Palmoplantar Pustulosis","Efficacy and Safety of Picankibart in the Treatment of Moderate-to-Severe Palmoplantar Pustulosis: A Prospective, Single-Arm, Open-Label Clinical Study","Inclusion Criteria:\n\n* Aged 18-65 years, regardless of gender. Patients with a confirmed diagnosis of palmoplantar pustulosis based on clinical manifestations and\u002For skin histopathology.\n\nFailed treatment with at least one conventional systemic agent (regular administration at standard dosage for 12-24 weeks), or intolerant to adverse reactions.\n\nConsidered suitable for treatment with picankibart as assessed by the clinician.\n\nVoluntarily participate in the study and provide written informed consent.\n\nExclusion Criteria:\n\n* Patients with active hepatitis B, hepatitis C, or tuberculosis. Pregnant patients or those planning pregnancy within 6 months. Subjects unable to comply with follow-up as required by the study protocol. Other conditions deemed unsuitable for this study.","65 Years",{"count":411,"type":22},60,[56],"1. Study Design This study is designed as a prospective, single-arm, open-label clinical study. It will be conducted by the Department of Dermatology, the First Affiliated Hospital of Air Force Medical University, and plans to enroll 60 eligible subjects.\n2. Study Subjects\n\nInclusion Criteria\n\n1. Aged 18-65 years, regardless of gender.\n2. Patients with a confirmed diagnosis of palmoplantar pustulosis based on clinical manifestations and\u002For skin histopathology.\n3. Failed treatment with at least one conventional systemic agent (regular administration at standard dosage for 12-24 weeks), or intolerant to adverse reactions.\n4. Considered suitable for treatment with Picankibart as assessed by the clinician.\n5. Voluntarily participate in the study and provide written informed consent.\n\nExclusion Criteria\n\n1. Patients with active hepatitis B, hepatitis C, or tuberculosis.\n2. Pregnant patients or those planning pregnancy within 6 months.\n3. Subjects unable to comply with follow-up as required by the study protocol.\n4. Other conditions deemed unsuitable for this study.\n\nWithdrawal Criteria\n\n1. Subjects may withdraw from the study at any time for any reason.\n2. Occurrence of a serious adverse event or intolerable adverse event.\n3. Development of any item listed in the exclusion criteria during the study.\n4. The investigator may decide subject withdrawal for medical reasons.",[415],"Palmoplantar Pustulosis",{"date":417,"type":35},"2026-04-27",{"date":419,"type":22},"2026-04-15",{"date":377,"type":22},{"name":41,"class":42},{"id":423,"slug":424,"hasResults":12,"nctId":425,"briefTitle":426,"officialTitle":427,"acronym":428,"eligibilityCriteria":429,"healthyVolunteers":12,"sex":51,"minAge":18,"maxAge":120,"enrollmentInfo":430,"targetDuration":4,"studyType":23,"phases":432,"briefSummary":433,"conditions":434,"keywords":436,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":440,"lastUpdatePostDateStruct":441,"startDateStruct":443,"completionDateStruct":445,"leadSponsor":447,"locationsCount":69},"100634123","phase-2-transcutaneous-electrical-acupoint-stimulation-at-jing-well-points-for-disorders-of-consciousness-100634123","NCT07535593","Transcutaneous Electrical Acupoint Stimulation at Jing-Well Points for Disorders of Consciousness","Efficacy and Safety of Transcutaneous Electrical Acupoint Stimulation at Hand Jing-Well Points in Patients With Disorders of Consciousness：A Multicenter Randomized Controlled Trial","Wells-DoC II","Inclusion Criteria:\n\n* Age: 18-80 years old;\n* From 7 to 90 days since brain injury;\n* Diagnosed in VS\u002FUWS or MCS as defined by at least two CRS-R assessments performed during the screening period\n* Acquired cerebral damage of known etiology\n* Intact hand skin\n* Informed consent given by the legal surrogate\n\nExclusion Criteria:\n\n* Patients who continuously receive sedative drugs and Na+ or Ca2+ channel blockers (e.g., carbamazepine) or NMDA receptor antagonists (e.g., dextromethorphan)\n* History of previous serious、progressive neurological disorder prior to the brain injury;\n* Epilepsy and seizure\n* Unstable vital signs or life-threatening comorbidities\n* Implanted devices: including cardiac pacemakers or implantable cardioverter-defibrillators (ICDs), deep brain stimulators, ventriculoperitoneal (VP) shunts, and other indwelling electronic or neurosurgical implants.\n* Documented pregnancy",{"count":431,"type":22},160,[25,146],"Effective treatment options for disorders of consciousness (DoC) remain limited, and available interventions show heterogeneous efficacy. To date, limited evidences support the use of amantadine and transcranial direct current stimulation in this population.\n\nBloodletting puncture (BP) at the hand twelve Jing-Well points (HTWPs) has been traditionally used in China as an empirical therapy for DoC; however, its efficacy has not been established by robust clinical evidence. Transcutaneous electrical acupoint stimulation (TEAS) provides a modern, noninvasive alternative for acupoint stimulation. The Wells-DoC trial, a multicenter, randomized, controlled, open-label study with blinded endpoint assessment, provided preliminary evidence that TEAS applied at the hand twelve Jing-Well points was associated with a numerically higher proportion of consciousness improvement in patients with DoC, although the difference did not reach statistical significance. These findings support the need for further evaluation in an adequately powered randomized controlled trial.\n\nThe Wells-DoC II trial is a multicenter, randomized, controlled, double-blind clinical trial designed to evaluate the efficacy and safety of TEAS at the twelve Jing-Well points of the hand in patients with DoC. The primary objective of the Wells-DoC II trial is to determine whether TEAS applied at the twelve Jing-Well points of the hand improves consciousness in adults with DoC. The primary endpoint is the proportion of patients achieving consciousness improvement after 14 consecutive days of treatment, compared between the TEAS group and the sham stimulation (placebo control) group.\n\nThe secondary objectives are to assess the effects of TEAS versus sham stimulation on: (1) changes in Coma Recovery Scale-Revised (CRS-R) scores at 7 and 14 days; (2) change in ABCD model classification at day 14; and (3) functional outcomes measured by the Glasgow Outcome Scale-Extended (GOSE) at 3 and 6 months after enrollment.\n\nA total of 160 patients will be recruited over a 28-month period.",[435],"Disorders of Consciousness Due to Severe Brain Injury",[437,438,439],"Transcutaneous Electrical Acupoint Stimulation","Hand Jing-Well Points","Disorders of Consciousness","2026-04-14",{"date":442,"type":35},"2026-04-17",{"date":444,"type":22},"2026-04",{"date":446,"type":22},"2028-12",{"name":41,"class":42},{"id":449,"slug":450,"hasResults":12,"nctId":451,"briefTitle":452,"officialTitle":452,"acronym":4,"eligibilityCriteria":453,"healthyVolunteers":12,"sex":51,"minAge":52,"maxAge":4,"enrollmentInfo":454,"targetDuration":4,"studyType":23,"phases":455,"briefSummary":456,"conditions":457,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":460,"lastUpdatePostDateStruct":461,"startDateStruct":463,"completionDateStruct":465,"leadSponsor":466,"locationsCount":69},"100576703","impact-of-sevoflurane-versus-propofol-on-postoperative-delirium-in-elderly-diabetic-patients-undergoing-non-cardiac-surgery-a-multicenter-randomized-controlled-trial-100576703","NCT06788743","Impact of Sevoflurane Versus Propofol on Postoperative Delirium in Elderly Diabetic Patients Undergoing Non-Cardiac Surgery: a Multicenter, Randomized Controlled Trial","Inclusion Criteria:\n\n* Age ≥60 years\n* Elective surgery (with an expected duration of 2 hours or more)\n* ASA grade Ⅰ-Ⅲ\n* Voluntary participation and informed consent obtained\n* Diabetes mellitus\n\nExclusion Criteria:\n\n* Pre-operative BMI≥35 kg\u002Fm² (Class II obesity or above)\n* Severe hepatic dysfunction (Child-Pugh class C) or pre-operative dialysis-dependent renal dysfunction\n* Known neurological or psychiatric diseases (Parkinson's disease, depression, schizophrenia), or cognitive impairment (dementia)\n* Severe visual or auditory impairments, language barriers, or patients who cannot cooperate\n* Long-term use of sedatives, antipsychotic drugs, or long-term alcohol abuse\n* Neurosurgical patients\n* Patients with a known allergy to the drugs used in this study or those suspected of having propofol infusion syndrome",{"count":196,"type":22},[56],"The present study is a multicenter， randomized controlled clinical trial, which plans to enroll 450 diabetic patients aged more than 60 years. The participants will be randomly assigned in a 1:1 ratio and will receive either propofol or sevoflurane for intraoperative anesthesia maintenance to evaluate the impact of these two anesthetic drugs on postoperative delirium. The aim of our study is to explore whether the use of propofol for anesthesia maintenance in elderly diabetic patients undergoing elective non-cardiac major surgery can reduce the incidence of postoperative delirium. This study will provide new perspectives for improving perioperative management in elderly diabetic patients and optimizing anesthesia management strategies to reduce the risk of postoperative delirium.",[458,459],"Postoperative Delirium (POD)","Diabetes","2026-04-13",{"date":462,"type":35},"2026-04-16",{"date":464,"type":35},"2025-06-01",{"date":131,"type":22},{"name":41,"class":42},{"id":468,"slug":469,"hasResults":12,"nctId":470,"briefTitle":471,"officialTitle":472,"acronym":473,"eligibilityCriteria":474,"healthyVolunteers":12,"sex":51,"minAge":18,"maxAge":409,"enrollmentInfo":475,"targetDuration":4,"studyType":23,"phases":477,"briefSummary":478,"conditions":479,"keywords":481,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":484,"lastUpdatePostDateStruct":485,"startDateStruct":486,"completionDateStruct":487,"leadSponsor":489,"locationsCount":4},"100632848","tis-for-drug-resistant-tle-100632848","NCT07519018","TIS for Drug Resistant TLE","Study on the Effect of Temporal Interference Stimulation in the Therapy of Drug Resistant Temporal Lobe Epilepsy","TITE-Effect","Inclusion Criteria:\n\n1. 18 to 65 years old;\n2. According to the 2010 International League Against Epilepsy (ILAE) diagnostic criteria for drug-resistant epilepsy;\n3. Temporal lobe epilepsy assessed by semiology, video electroencephalogram, and imaging;\n4. The duration of epilepsy was ≥2 years, and the average seizure frequency was ≥2 times per month in the 3 months before enrollment;\n5. Taking two or more antiepileptic drugs and continuing the same drug regimen for the duration of the trial;\n6. Could cooperate with the completion of treatment and related examinations;\n7. Patients and their family members fully understood and voluntarily signed the informed consent.\n\nExclusion Criteria:\n\n1. The anti-seizure medication therapy was adjusted during the treatment and follow-up period;\n2. Patient in status epilepticus;\n3. Patient with other systemic diseases leading to nervous system involvement and seizures;\n4. Patients with severe infection, cerebrovascular disease, malignant tumor and other diseases, accompanied by severe dysfunction of heart, liver, kidney and other organs, or accompanied by severe mental or cognitive impairment, or intractable hyperglycemia, or long-term use of corticosteroids;\n5. Patient with pregnant or lactating;\n6. Patients with contraindications to TI stimulation, fMRI examination or EEG examination, metal implants (pacemakers, metal dentures, metal IUD rings, etc.), or claustrophobia;\n7. Participating in other clinical trials;\n8. Patients or their family members withdrew informed consent.",{"count":476,"type":22},30,[56],"Temporal interference (TI) stimulation is a new neuromodulation method. Compared with traditional neuromodulation therapy, TI has deep targeting and focusing, and it has been confirmed to modulate sleep, cognition, and movement disorders. Recent study shown that TI stimulation targeting the hippocampus could significantly reduce epileptiform discharges, but its efficacy on seizures was still unclear. Therefore, the aim of this study is to observe the therapeutic effect of TI stimulation targeting the hippocampus in patients with refractory temporal lobe epilepsy (TLE) for 5 days, and to provide support for clinical trials of non-invasive treatment of refractory TLE.",[480],"Epilepsy",[482,483],"TIS","TLE","2026-04-09",{"date":440,"type":35},{"date":419,"type":22},{"date":488,"type":22},"2028-04-30",{"name":41,"class":42},{"id":491,"slug":492,"hasResults":12,"nctId":493,"briefTitle":494,"officialTitle":495,"acronym":4,"eligibilityCriteria":496,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":77,"enrollmentInfo":497,"targetDuration":4,"studyType":23,"phases":499,"briefSummary":500,"conditions":501,"keywords":502,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":506,"lastUpdatePostDateStruct":507,"startDateStruct":508,"completionDateStruct":510,"leadSponsor":512,"locationsCount":69},"100633854","extended-sentinel-lymph-node-biopsy-with-methylene-blue-single-tracer-post-neoadjuvant-therapy-for-node-positive-breast-cancer-100633854","NCT07532096","Extended Sentinel Lymph Node Biopsy With Methylene Blue Single Tracer Post-Neoadjuvant Therapy for Node-Positive Breast Cancer","A Multicenter, Single-Arm, Open-Label Study of Extended Sentinel Lymph Node Biopsy Using Methylene Blue as a Single Tracer After Neoadjuvant Therapy in Patients With Axillary Node-Positive Breast Cancer","Inclusion Criteria:\n\n* Female treatment-naive breast cancer patients aged 18 to 70 years old.\n* Histopathologically confirmed invasive breast cancer, either early-stage (T1-2N0-1M0, Stage Ⅰ-Ⅱ) or locally advanced (T3N0-1M0\u002FT1-3N1M0, Stage ⅢA) as defined by the latest ASCO\u002FCAP guidelines; initial clinical axillary stage cN0-1 with pathologically confirmed axillary lymph node positivity via needle biopsy.\n* Voluntarily accept a complete course of standard neoadjuvant therapy for 6 or 8 cycles, and achieve clinical axillary node negativity (cN0) in axillary lymph node re-evaluation by ultrasound after completion of neoadjuvant therapy.\n* Willing to undergo neoadjuvant therapy plus methylene blue single tracer-guided extensive sentinel lymph node biopsy combined with axillary lymph node dissection.\n* Voluntarily participate in the study and sign the informed consent form.\n\nExclusion Criteria:\n\n* Patients over 70 years old.\n* Newly diagnosed metastatic breast cancer (Stage Ⅳ).\n* Gestational breast cancer patients.\n* Patients with abnormal function of vital organs (heart, lung, liver, kidney) or poorly controlled diabetes, who are unable to tolerate surgery.\n* Other conditions that the investigator deems unsuitable for study participation.",{"count":498,"type":22},240,[56],"The goal of this clinical trial is to evaluate the safety and feasibility of methylene blue single tracer-based extensive sentinel lymph node biopsy (ESLNB) and provide evidence for simplifying surgical procedures on the basis of ensuring axillary safety, as well as clarify the incidence of postoperative upper limb lymphedema in female patients with axillary node-positive breast cancer who achieve clinical axillary node negativity after neoadjuvant therapy. The main questions it aims to answer are:\n\n* What is the false negative rate of methylene blue single tracer-based extensive sentinel lymph node biopsy in the above-mentioned breast cancer patients?\n* What are the false negative rate and detection rate of methylene blue single tracer-based conventional sentinel lymph node biopsy\n* What is the incidence of upper limb lymphedema within 2 years after surgery in these patients?\n\nParticipants will:\n\n* Undergo strict screening to confirm eligibility for the trial and sign an informed consent form\n* Receive a complete standard neoadjuvant therapy for 6 or 8 cycles as required\n* Undergo personalized breast surgery combined with methylene blue single tracer-based ESLNB plus axillary lymph node dissection\n* Accept pathological evaluation of the number of lymph nodes and metastatic lymph nodes in each resected part after surgery\n* Receive adjuvant therapies such as targeted therapy, endocrine therapy or local radiotherapy in accordance with clinical guidelines\n* Complete regular follow-up for 2 years after surgery (once every 6 months), including physical sign checks, surgical site evaluations, and upper limb circumference measurements to assess lymphedema",[28],[503,504,505],"Breast cancer","Extensive sentinel lymph node biopsy","Methylene blue","2026-04-08",{"date":419,"type":35},{"date":509,"type":22},"2026-04-25",{"date":511,"type":22},"2028-05-15",{"name":41,"class":42},{"id":514,"slug":515,"hasResults":12,"nctId":516,"briefTitle":517,"officialTitle":517,"acronym":518,"eligibilityCriteria":519,"healthyVolunteers":12,"sex":356,"minAge":18,"maxAge":4,"enrollmentInfo":520,"targetDuration":4,"studyType":80,"phases":4,"briefSummary":521,"conditions":522,"keywords":526,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":506,"lastUpdatePostDateStruct":530,"startDateStruct":531,"completionDateStruct":533,"leadSponsor":535,"locationsCount":301},"100633795","delayed-psma-petct-imaging-for-diagnosing-clinically-significant-prostate-cancer-in-biopsy-nave-men-with-suspected-prostate-cancer-100633795","NCT07531329","Delayed PSMA PET\u002FCT Imaging for Diagnosing Clinically Significant Prostate Cancer in Biopsy-Naïve Men With Suspected Prostate Cancer","DEPICT","Inclusion Criteria:\n\n1. Patients with suspected prostate cancer and a PSA level ≥4.0 ng\u002FmL\n2. Patients who undergo PSMA PET imaging (including delayed phase imaging) prior to prostate biopsy\n3. Patients who are willing to undergo prostate biopsy\n4. Patients who provide written informed consent to participate in the study\n\nExclusion Criteria:\n\n1. Patients who have received any prior prostate cancer-related treatment before the initial PSMA PET scan\n2. Patients with a history of other malignancies within the past two years\n3. Patients judged by the study investigator to be at risk for serious complications that could interfere with the normal conduct of the study",{"count":358,"type":22},"Brief Summary This prospective, multicenter study evaluates whether delayed PSMA PET imaging improves diagnostic efficacy for detecting clinically significant prostate cancer (Gleason score ≥7) compared with standard imaging in patients with suspected newly diagnosed prostate cancer. Each patient serves as their own control, with diagnostic performance compared between standard (60-minute) and delayed (2-3 hour) acquisitions.\n\nBackground PSMA PET has transformed prostate cancer imaging, with emerging evidence suggesting delayed acquisition may further improve diagnostic accuracy by increasing tumor-to-background ratio. Recent studies demonstrate that delayed imaging significantly reduces equivocal findings and enhances detection of clinically significant prostate cancer.\n\nNeed While standard PSMA PET is well-validated, prospective multicenter data specifically evaluating the incremental diagnostic value of delayed imaging for clinically significant prostate cancer in treatment-naïve patients are lacking. This study addresses this gap by systematically comparing standard and delayed imaging in a large, well-defined cohort.\n\nPrimary Outcome The primary outcome is to compare the area under the curve (AUC) of delayed SUVmax versus standard SUVmax for detecting clinically significant prostate cancer (csPCa), and to determine whether delayed imaging is superior to standard imaging.\n\nSecondary Outcomes\n\n1. Optimal diagnostic thresholds for delayed imaging\n\n   1. Determine the optimal threshold for delayed SUVmax using ROC analysis with the Youden index;\n   2. Determine the optimal threshold for ΔSUVmax (delayed minus standard SUVmax);\n   3. Validate the sensitivity, specificity, and AUC of these thresholds in an independent validation set.\n2. Biopsy avoidance potential In patients with PI RADS 4-5 lesions, calculate the negative predictive value (NPV) using a predefined high threshold to estimate the proportion who could safely avoid biopsy.\n3. Diagnostic performance in key subgroups Compare the AUC of delayed SUVmax versus standard SUVmax for csPCa detection in patients with PI RADS 2-3 and in those with PI RADS 4-5.\n4. Additional lesion detection Proportion of patients with additional csPCa lesions detected only on delayed imaging, and the proportion whose PI RADS category would be upgraded based on these findings.\n5. Clinical decision impact Proportion of patients in whom management recommendations would change after incorporating delayed imaging results, compared with standard imaging alone.\n6. Exploratory subgroup analyses Stratify by PSA level (\\\u003C4, 4 10, \\>10 ng\u002FmL) and PSA density (\\\u003C0.10, 0.10-0.20, \\>0.20 ng\u002FmL\u002Fcc) to identify subgroups that derive the greatest benefit from delayed imaging; additionally, explore combined subgroups such as PI RADS 3 with PSA 4-10 or PSAD 0.10-0.20.\n\nInclusion Criteria\n\n1. Suspected prostate cancer based on elevated PSA (≥4.0 ng\u002FmL) or clinical symptoms\n2. Undergo PSMA PET (standard + delayed) prior to prostate biopsy\n3. Willing to undergo prostate biopsy\n4. Provide written informed consent Exclusion Criteria\n\n1\\. Prior prostate cancer treatment before PSMA PET imaging 2. Other malignancy within past two years 3. Investigator-judged risk of serious complications interfering with study conduct",[523,524,525],"Treatment-naive Prostate Cancer","Suspected Prostate Cancer","Molecular Imaging",[369,363,527,528,529],"Delayed imaging","Diagnostic","Efficacy",{"date":419,"type":35},{"date":532,"type":35},"2021-03-05",{"date":534,"type":22},"2028-03-05",{"name":41,"class":42},{"id":537,"slug":538,"hasResults":12,"nctId":539,"briefTitle":540,"officialTitle":541,"acronym":4,"eligibilityCriteria":542,"healthyVolunteers":12,"sex":51,"minAge":18,"maxAge":4,"enrollmentInfo":543,"targetDuration":4,"studyType":80,"phases":4,"briefSummary":545,"conditions":546,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":506,"lastUpdatePostDateStruct":549,"startDateStruct":550,"completionDateStruct":552,"leadSponsor":553,"locationsCount":4},"100632846","correlation-between-preoperative-sleep-and-postoperative-brain-and-renal-dysfunction-100632846","NCT07518992","Correlation Between Preoperative Sleep and Postoperative Brain and Renal Dysfunction","Correlation Between Preoperative Sleep Parameters Clustering and Postoperative Brain and Renal Dysfunction","Inclusion Criteria:\n\nAged 18 years or above who were scheduled for elective cardiac surgery with cardiopulmonary bypass\n\nExclusion Criteria:\n\nPatients undergoing congenital heart disease repair surgery or surgeries necessitating deep hypothermic circulatory arrest were excluded.\n\nPatients with a history of schizophrenia, epilepsy, Parkinson's disease, myasthenia gravis, or neurosurgery were also excluded.\n\nPatients with a preoperative Mini - Mental State Examination (MMSE) score less than 24 , or those unable to communicate due to coma, severe dementia, or language barriers were excluded.",{"count":544,"type":22},549,"To explore the correlation between preoperative sleep parameter clustering and postoperative brain and renal dysfunction.",[547,548],"Postoperative Delirium","Acute Kidney Injury",{"date":484,"type":35},{"date":551,"type":22},"2026-04-10",{"date":419,"type":22},{"name":41,"class":42},{"id":555,"slug":556,"hasResults":12,"nctId":557,"briefTitle":558,"officialTitle":559,"acronym":560,"eligibilityCriteria":561,"healthyVolunteers":12,"sex":51,"minAge":18,"maxAge":409,"enrollmentInfo":562,"targetDuration":4,"studyType":23,"phases":564,"briefSummary":565,"conditions":566,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":570,"lastUpdatePostDateStruct":571,"startDateStruct":572,"completionDateStruct":573,"leadSponsor":575,"locationsCount":69},"100632849","phase-1-study-of-umbilical-cord-mesenchymal-stem-cell-derived-exosomes-in-vitiligo-100632849","NCT07519031","Study of Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes in Vitiligo","A Single-Center, Randomized, Controlled Trial of Human Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes for the Treatment of Vitiligo","hUMSCs-Exo-VIT","Inclusion Criteria:\n\n* Clinically diagnosed non-segmental vitiligo\n* Progressive vitiligo: new lesions or enlargement of existing lesions within the past 3 months (VIDA score ≥ 3); Stable vitiligo: no new lesions or enlargement of existing lesions within the past 1 year (VIDA score = 0)\n* Total body surface area (BSA) of vitiligo lesions between 1% and 30%\n* Age 18 to 65 years, male or female\n* Willing to participate and provide written informed consent\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding\n* Known allergy to mesenchymal stem cells or exosome components\n* Severe cardiac, hepatic, or renal dysfunction, or severe immunocompromised status\n* For progressive vitiligo: use of systemic immunosuppressants, corticosteroids, phototherapy, or photochemotherapy within the past 3 months\n* For stable vitiligo: use of phototherapy, topical immunosuppressants, or corticosteroids within the past 1 month\n* Concurrent autoimmune diseases (e.g., systemic lupus erythematosus, rheumatoid arthritis, psoriasis) or severe infectious diseases\n* History of malignancy or hematologic disorders\n* History of psychiatric disorders or inability to comply with study procedures\n* Any other condition that, in the investigator's judgment, may increase the risk to the participant or interfere with the conduct of the trial",{"count":563,"type":22},96,[303,25],"This study evaluates whether exosomes derived from human umbilical cord mesenchymal stem cells (hUMSCs-Exo) are safe and effective for treating vitiligo in adults.\n\nVitiligo is a skin condition that causes white patches due to loss of pigment-producing cells. Current treatments have limitations, especially for patients with active disease who require oral steroids with significant side effects.\n\nThis study is a single-center, randomized, controlled trial enrolling 96 adults aged 18 to 65 years with non-segmental vitiligo. Participants are divided into two groups based on disease activity: progressive vitiligo (new patches appearing or existing patches expanding in the past 3 months) and stable vitiligo (no changes in the past year).\n\nFor progressive vitiligo, participants are randomly assigned to either:\n\nExperimental group: hUMSCs-Exo given by intravenous infusion every 2 weeks for 5 sessions, plus tacrolimus ointment and narrowband UVB light therapy, or Control group: oral prednisone (a standard steroid treatment) plus tacrolimus ointment and narrowband UVB light therapy\n\nFor stable vitiligo, participants are randomly assigned to either:\n\nExperimental group: hUMSCs-Exo given by local injection into the white patches every 2 weeks for 5 sessions, plus tacrolimus ointment and narrowband UVB light therapy, or Control group: tacrolimus ointment plus narrowband UVB light therapy alone The treatment period lasts 12 weeks, with follow-up visits continuing to 24 weeks. The main outcome measures include improvement in skin repigmentation measured by the Vitiligo Area Scoring Index (VASI), changes in quality of life, and safety monitoring throughout the study.\n\nThis study aims to establish a standardized approach for using hUMSCs-Exo in vitiligo treatment and to explore how exosomes may work by reducing oxidative stress and regulating immune responses.",[567,568,569],"Vitiligo","Mesenchymal Stem Cells","Exosomes","2026-04-01",{"date":484,"type":35},{"date":444,"type":22},{"date":574,"type":22},"2028-03",{"name":41,"class":42},{"id":577,"slug":578,"hasResults":12,"nctId":579,"briefTitle":580,"officialTitle":580,"acronym":4,"eligibilityCriteria":581,"healthyVolunteers":12,"sex":356,"minAge":18,"maxAge":4,"enrollmentInfo":582,"targetDuration":4,"studyType":80,"phases":4,"briefSummary":584,"conditions":585,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":587,"lastUpdatePostDateStruct":588,"startDateStruct":590,"completionDateStruct":592,"leadSponsor":594,"locationsCount":282},"100630842","plasma-exorna-based-liquid-biopsy-to-diagnose-clinically-significant-prostate-cancer-100630842","NCT07492927","Plasma exoRNA-Based Liquid Biopsy to Diagnose Clinically Significant Prostate Cancer","Inclusion Criteria:\n\n1. Blood prostate-specific antigen PSA\\>4ng\u002Fdl;\n2. Patients suspected of having prostate cancer through clinical symptoms, digital rectal examination, ultrasound examination, magnetic resonance imaging.\n3. The patient is willing to undergo prostate biopsy.\n\nExclusion Criteria:\n\n1. Previous diagnosis of prostate cancer through prostate biopsy;\n2. History of other malignant tumors in the past two years;\n3. According to the research physician''s judgment, serious complications may occur and affect the normal conduct of the experiment",{"count":583,"type":22},1700,"The aim of the present study is to investigate a plasma exosome RNA signature to diagnose clinically significant prostate cancer.",[586],"Clinically Significant Prostate Cancer","2026-03-19",{"date":589,"type":35},"2026-03-25",{"date":591,"type":35},"2021-03-12",{"date":593,"type":22},"2027-06-30",{"name":41,"class":42},""]