[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Peking University First Hospital\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":679},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,147,0,25,[9,49,80,115,143,171,199,218,249,274,298,326,354,382,402,435,457,477,498,530,558,577,598,626,654],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100571617","phase-4-sirolimus-monotherapy-in-the-treatment-of-antiphospholipid-antibody-related-thrombocytopenia-100571617",false,"NCT06722586","Sirolimus Monotherapy in the Treatment of Antiphospholipid Antibody Related Thrombocytopenia","Sirolimus Monotherapy in the Treatment of Antiphospholipid Antibody Related Thrombocytopenia: a Multicenter Randomized, Double Blind, Placebo Controlled, Clinical Trial","SMART","Inclusion Criteria:\n\n* persistent positive of antiphospholipid antibody (either lupus anticoagulant, anti-cardiolipin antibody, or anti-b2GP1 antibody, at least two times with 12 weeks apart)\n* persistent thrombocytopenia (30-100×10\\^9\u002FL, at least for 2 weeks)\n\nEligible concomitant treatment:\n\n* prednisone or equivalent dose less than 10mg per day is allowed, and dose should be stable for more than 2 weeks\n* hydroxychloroquine less than 400mg per day is allowed, and dose should be stable for more than 1 month\n* anti-platelet and\u002For anti-coagulant therapy is allowed, and strength should be the stable for 1 week\n* these following therapies should be discontinued for more than 5 half-lives before the enrollment, including thrombopoietin or thrombopoietin receptor antagonist, intravenous immunoglobulin, immunosuppressants, B cell inhibitors (Belimumab or Talitacicept) and B cell depletion therapy (Rituximab or Obinutuzumab).\n\nExclusion Criteria:\n\n* fulling the criteria of other connective tissue disease other than antiphospholipid syndrome\n* received oral\u002Fintravenous antibiotics within 2 weeks before the enrollment.\n* new onset of thrombosis within 4 weeks before the enrollment.\n* apparent bleeding tendency.\n* life or organ threatening manifestations, includes but not limit to catastrophic antiphospholipid syndrome and thrombotic microangiopathy.\n* liver and renal dysfunction: ALT or AST more than three times of upper limit of normal range; eGFR\\\u003C40mL\u002Fmin\u002F1.73m\\^2\n* hematocytopenia: WBC\\\u003C3.0×10\\^9\u002FL, Hb\\\u003C100g\u002FL.\n* uncontrollable hyperlipidemia: low density lipoprotein cholesterol\\>3.1 mmol\u002FL, triglycerides\\>2.3 mmol\u002FL after lipid lowering therapy.\n* current active infection\n* women in pregnancy and postpartum period","ALL","18 Years",{"count":21,"type":22},84,"ESTIMATED","INTERVENTIONAL",[25],"PHASE4","The goal of this clinical trial is to evaluate the efficacy and safety of sirolimus in patients with anti-phospholipid antibody-associated thrombocytopenia.\n\nIn the 6-month randomized, double-blind, placebo-controlled phase, participants will receive either sirolimus 1 mg once daily or matching placebo. Participants will be followed at 2 weeks, 1 month, 3 months, and 6 months after enrollment.\n\nParticipants who do not achieve the primary endpoint at 6 months may enter a 3-month open-label extension and receive sirolimus 1.5 mg once daily, with follow-up through month 9.\n\nThe main question is whether sirolimus improves the overall response rate at 6 months compared with placebo.\n\nPrimary outcome:\n\n\\- Overall response rate at 6 months\n\nSecondary outcomes:\n\n* Overall response rate at 1 month and 3 months\n* Complete response rate at 6 months\n* Partial response rate at 6 months\n* Change in anti-phospholipid antibody titers at 6 months\n* Change in oral glucocorticoid dosage at 6 months\n\nExploratory outcomes:\n\n* Proportion and reasons for early discontinuation during the double-blind phase\n* Among participants who do not achieve the primary endpoint at 6 months and enter the open-label extension, overall response rate, complete response rate, partial response rate, and safety outcomes after 3 months of open-label treatment",[28,29],"Antiphospholipid (aPL)-Positive","Thrombocytopaenia",[31,32,33,34,35],"antiphospholipid","thrombocytopaenia","sirolimus","rapamycin","mTOR inhibitor","RECRUITING","2026-06-25",{"date":39,"type":40},"2026-06-30","ACTUAL",{"date":42,"type":40},"2025-01-07",{"date":44,"type":22},"2027-12",{"name":46,"class":47},"Peking University First Hospital","OTHER",10,{"id":50,"slug":51,"hasResults":12,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":12,"sex":18,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":23,"phases":60,"briefSummary":62,"conditions":63,"keywords":67,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},"100636786","individualized-transcranial-magnetic-stimulation-in-parkinsonian-disorders-100636786","NCT07570212","Individualized Transcranial Magnetic Stimulation in Parkinsonian Disorders","Exploration of the Efficacy of Individualized Transcranial Magnetic Stimulation in the Treatment of Parkinsonian Disorders","Inclusion Criteria:\n\n1. Diagnostic Criteria Clinically established or clinically probable Parkinson's Disease (PD) according to the 2015 International Parkinson and Movement Disorder Society (MDS) diagnostic criteria; Clinically established or clinically probable Multiple System Atrophy (MSA) according to the 2022 MDS diagnostic criteria; Clinically probable or clinically possible Progressive Supranuclear Palsy (PSP) according to the 2017 MDS diagnostic criteria.\n2. Demographics Aged 30 to 80 years, inclusive; no gender restrictions.\n3. Disease Severity and Staging PD: Modified Hoehn and Yahr (H-Y) stage 2-4; MSA: Unified Multiple System Atrophy Rating Scale (UMSARS) Part IV stage 1-4; PSP: Modified Rankin Scale (mRS) grade 2-4.\n4. Informed Consent and Compliance Ability to understand and comply with the study requirements and provide written informed consent.\n\nExclusion Criteria:\n\n1. Contraindications to TMS Presence of intracranial metallic implants or other foreign bodies, including but not limited to cochlear implants, cardiac pacemakers, or internal metallic\u002Fmagnetic fragments.\n2. Contraindications to EEG and MRI EEG: Known allergy to conductive paste or other EEG-related contraindications. MRI: History of claustrophobia, presence of MRI-incompatible implants, or extensive tattoos.\n3. Concurrent Physical Therapies Currently receiving Transcranial Magnetic Stimulation (TMS) or other therapeutic physical modalities, such as Transcranial Direct Current Stimulation (tDCS).\n4. Unstable Medical Conditions Presence of unstable systemic diseases requiring urgent pharmacological or surgical intervention.\n5. Neurological and Psychiatric History Personal or family history of epilepsy; History of moderate-to-severe psychiatric or psychological disorders; Chronic insomnia or regular use of sedative-hypnotics; Current use of medications that significantly alter central nervous system excitability.","30 Years","80 Years",{"count":59,"type":22},50,[61],"NA","This clinical trial aims to evaluate whether individualized targeted repetitive transcranial magnetic stimulation (rTMS) can improve motor and non-motor symptoms in patients with parkinsonian disorders. The main question it aims to answer is:\n\n* Does individualized targeted rTMS alleviate symptoms of parkinsonian disorders?\n* Which clinical manifestations of parkinsonian syndromes are responsive to individualized targeted rTMS, and to what degree?\n\nProcedures:\n\n* Preparation (Screening) Participants will undergo clinical assessments, MRI, and EEG before the treatment.\n* Treatment (2 Weeks) Participants will receive a 10-day TMS treatment (once daily, Monday-Friday). Each treatment day takes approximately 3-4 hours. Participants need to keep stable medications and rehabilitation routines during this time.\n* Follow-up (10 Weeks) Participants will undergo follow-up assessments at the end of treatment and 10 weeks after treatment. Assessments include clinical scales, MRI, and EEG.",[64,65,66],"Parkinson's Disease","Multiple System Atrophy","Progressive Supranuclear Palsy",[68,69,70],"parkinsonian disorders","transcranial magnetic stimulation","somato-cognitive action network","2026-06-24",{"date":73,"type":40},"2026-06-29",{"date":75,"type":40},"2025-12-22",{"date":77,"type":22},"2027-12-22",{"name":46,"class":47},1,{"id":81,"slug":82,"hasResults":12,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":87,"sex":18,"minAge":88,"maxAge":4,"enrollmentInfo":89,"targetDuration":4,"studyType":23,"phases":91,"briefSummary":92,"conditions":93,"keywords":99,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},"100641106","targeted-temperature-management-on-delayed-neurocognitive-recovery-in-older-patients-after-major-cancer-surgery-100641106","NCT07655687","Targeted Temperature Management on Delayed Neurocognitive Recovery in Older Patients After Major Cancer Surgery","Intraoperative Targeted Temperature Management on Delayed Neurocognitive Recovery in Older Patients After Major Cancer Surgery: a Multicenter Randomized Trial","Inclusion Criteria:\n\n1. Age ≥ 65 years.\n2. Planned potentially curative initial cancer surgery with an expected duration of 2 hours or longer under general anesthesia.\n\nExclusion Criteria:\n\n1. Preoperative fever (tympanic temperature ≥ 38℃).\n2. Known or suspected preoperative infection.\n3. Previous schizophrenia, epilepsy, Parkinson's disease, myasthenia gravis, or preexisting delirium.\n4. Inability to communicate due to coma, severe dementia, or hearing or speech impairment.\n5. Critically ill patients, defined as NYHA functional class \\> III or LVEF \\\u003C 30%, Child-Pugh class C, preoperative dialysis dependence, ASA physical status \\> IV, or expected survival \\\u003C 24 hours.\n6. Surgery for breast cancer, intracranial tumors, or rare cancers.\n7. Planned to undergo therapeutic hypothermia.\n8. Body mass index \\> 30 kg\u002Fm² (to facilitate temperature management).\n9. Previous enrollment in this study.\n10. Other conditions deemed unsuitable for study participation.",true,"65 Years",{"count":90,"type":22},1512,[61],"With aging population, more older patients will receive major surgery for cancer. Older patients are at increased risk of postoperative neurocognitive complications including delayed neurocognitive recovery (dNCR), which is associated with prolonged hospital stay, raised complications, and impaired quality of life. Intraoperative hypothermia occurs in 57.1%-78.6% of patients undergoing major cancer surgery, especially in the elderly. Studies show that intraoperative hypothermia suppresses immune function, interferes with anesthetic metabolism, and delays anesthesia emergence. All these may be correlated with the occurrence of early postoperative dNCR. This study aims to verify whether intraoperative targeted temperature management (target core temperature: 36.8°C) compared with conventional temperature management (core temperature: 35.5°C) can reduce the incidence of dNCR in older patients undergoing major cancer surgery.",[94,95,96,97,98],"Elderly Patients","Cancer Surgery","Hypothermia, Accidental","Targeted Temperature Management","Delayed Neurocognitive Recovery",[100,101,102,103,104],"elderly patient","major cancer surgery","intraoperativ hypothermia","targeted temperature management","delayed neurocognitive recovery","NOT_YET_RECRUITING","2026-06-18",{"date":108,"type":40},"2026-06-23",{"date":110,"type":22},"2026-06",{"date":112,"type":22},"2028-11",{"name":46,"class":47},2,{"id":116,"slug":117,"hasResults":12,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":4,"eligibilityCriteria":121,"healthyVolunteers":12,"sex":18,"minAge":88,"maxAge":4,"enrollmentInfo":122,"targetDuration":4,"studyType":23,"phases":124,"briefSummary":125,"conditions":126,"keywords":130,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":136,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":142},"100535786","effects-of-intraoperative-targeted-temperature-management-on-incidence-of-postoperative-delirium-and-long-term-survival-100535786","NCT06256354","Effects of Intraoperative Targeted Temperature Management on Incidence of Postoperative Delirium and Long-term Survival","Effects of Intraoperative Targeted Temperature Management on Incidence of Postoperative Delirium and Long-term Survival in Older Patients Having Major Cancer Surgery: A Multicenter Randomized Trial","Inclusion Criteria:\n\n1. Age ≥65 years.\n2. Planned potentially curative initial cancer surgery with an expected duration of 2 hours or longer under general anesthesia.\n\nExclusion Criteria:\n\n1. Preoperative fever (tympanic temperature ≥38℃).\n2. Known or suspected preoperative infection.\n3. Previous history of schizophrenia, epilepsy, Parkinson disease, myasthenia gravis, or delirium.\n4. Unable to communicate due to severe dementia, language barrier, or coma.\n5. Critically ill (Left ventricular ejection fraction \\\u003C30%, Child-Pugh grades C, requirement of renal replacement therapy, American Society of Anesthesiologists physical status\\>IV, or expected survival \\\u003C24 hours).\n6. Scheduled surgery for breast cancer, intracranial tumors, or rare cancers.\n7. Planned to undergo therapeutic hypothermia.\n8. Body mass index \\>30 kg\u002Fm2 (to facilitate thermal management).\n9. Have participated in this study previously.\n10. Any other conditions that are considered unsuitable for study participation.",{"count":123,"type":22},3992,[61],"Intraoperative hypothermia is common in patients having major surgery and the compliance with intraoperative temperature monitoring and management remains poor. Studies suggest that intraoperative hypothermia is an important risk factor of postoperative delirium, which is associated with worse early and long-term outcomes. Furthermore, perioperative hypothermia increases stress responses and provokes immune suppression, which might promote cancer recurrence and metastasis. In a recent trial, targeted temperature management reduced intraoperative hypothermia and emergence delirium. There was also a trend of reduced postoperative delirium, although not statistically significant. This trial is designed to test the hypothesis that intraoperative targeted temperature management may reduce postoperative delirium and improves progression-free survival in older patients recovering from major cancer surgery.",[95,127,97,128,129],"Intraoperative Hypothermia","Postoperative Delirium","Long-term Survivors",[131,132,133,134,135],"Cancer surgery","Intraoperative hypothermia","Targeted temperature management","Postoperative delirium","Long-term survival",{"date":108,"type":40},{"date":138,"type":40},"2024-05-29",{"date":140,"type":22},"2032-06",{"name":46,"class":47},36,{"id":144,"slug":145,"hasResults":12,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":149,"eligibilityCriteria":150,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":151,"targetDuration":4,"studyType":23,"phases":153,"briefSummary":155,"conditions":156,"keywords":159,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":4},"100642007","phase-2-efficacy-and-safety-of-benvitimod-cream-in-cutaneous-t-cell-lymphoma-100642007","NCT07658924","Efficacy and Safety of Benvitimod Cream in Cutaneous T-Cell Lymphoma","Evaluation of the Efficacy and Safety of Benvitimod Cream in Cutaneous T-Cell Lymphoma","BEST-CTCL","Inclusion Criteria:\n\n* Patients diagnosed with cutaneous T-cell lymphoma (CTCL) \u002F mycosis fungoides (MF) by skin biopsy.\n* Aged 18 years or older.\n* Possess complete baseline clinical data.\n* Good compliance with treatment and willing to attend follow-up visits.\n* Conscious, with no cognitive impairment or communication barriers.\n* Voluntarily participate in this study and sign the informed consent form.\n\nExclusion Criteria:\n\n* Pregnant or lactating women, or those planning pregnancy within the next 6 months.\n* Known allergy or hypersensitivity to benvitimod cream or its excipients.\n* Severe ulceration or active infection at the target application sites.\n* Unwilling or unable to sign the informed consent form.",{"count":152,"type":22},35,[154],"PHASE2","Background:\n\nCTCL is a rare type of non-Hodgkin lymphoma that primarily affects the skin, causing red patches, plaques, and severe itching. Currently, topical corticosteroids are commonly used for early-stage disease, but long-term application can cause significant skin side effects such as atrophy. Benvitimod is a novel, non-steroidal aryl hydrocarbon receptor (AhR) agonist. Previous studies suggest it has the potential to inhibit tumor cell proliferation and reduce skin inflammation, providing a promising new targeted therapy for CTCL patients.\n\nStudy Design:\n\nThis is a prospective, single-center, double-blind, placebo-controlled study. To ensure a highly accurate comparison and eliminate individual differences, the study uses an intra-patient (left-right) control design. Approximately 35 patients will be enrolled.\n\nParticipants will have two comparable target lesions selected on opposite sides of their body (e.g., left and right trunk or limbs). They will be randomly assigned to apply benvitimod cream to the lesion on one side and a placebo cream to the matching lesion on the other side. The creams will be applied once daily for up to 24 weeks.\n\nResearchers will evaluate the improvement in skin lesions (using the mSWAT score), reduction in itching (using the VAS score), and closely monitor any adverse events at weeks 2, 4, 8, 16, and 24 to assess both the effectiveness and safety of the treatment.",[157,158],"Cutaneous T-Cell Lymphoma","Mycosis Fungoides (MF)",[160,161,162],"Benvitimod","Tapinarof","Topical Therapy","2026-06-16",{"date":165,"type":40},"2026-06-22",{"date":167,"type":22},"2026-07-01",{"date":169,"type":22},"2027-10-01",{"name":46,"class":47},{"id":172,"slug":173,"hasResults":12,"nctId":174,"briefTitle":175,"officialTitle":176,"acronym":4,"eligibilityCriteria":177,"healthyVolunteers":87,"sex":18,"minAge":19,"maxAge":57,"enrollmentInfo":178,"targetDuration":4,"studyType":23,"phases":179,"briefSummary":181,"conditions":182,"keywords":185,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":194,"startDateStruct":195,"completionDateStruct":196,"leadSponsor":198,"locationsCount":79},"100642057","phase-1-gprc5d-targeted-petct-imaging-in-plasma-cell-disorders-100642057","NCT07660939","GPRC5D Targeted PET\u002FCT Imaging in Plasma Cell Disorders","A Single-Center, Phase I, Single-Arm Prospective Interventional Study of GPRC5D-Targeted PET\u002FCT Imaging in Patients With Multiple Myeloma and Other Plasma Cell Disorders","Inclusion Criteria:\n\n* Adults with confirmed or suspected plasma cell disorders, including multiple myeloma.\n* Healthy volunteers eligible for PET\u002FCT imaging may also be enrolled.\n* Availability of recent clinical laboratory results within 1 week prior to imaging, when applicable.\n* Ability to undergo PET\u002FCT imaging procedures.\n* Ability to understand the study requirements and provide written informed consent.\n\nExclusion Criteria:\n\n* History of other active malignant tumors, unless considered clinically insignificant by the investigator.\n* Pregnant or breastfeeding women.\n* Inability to understand study procedures or comply with imaging examinations.\n* Any medical or psychiatric condition that, in the investigator's judgment, may interfere with study participation or image interpretation.",{"count":59,"type":22},[180],"PHASE1","This is a prospective, single-center, single-arm Phase I study evaluating GPRC5D-targeted PET\u002FCT imaging in patients with plasma cell disorders, including multiple myeloma.\n\nParticipants will undergo GPRC5D-targeted PET\u002FCT, 18F-FDG PET\u002FCT, and 68Ga-BCMA PET\u002FCT within 5 days whenever feasible for head-to-head comparison of lesion detection and disease assessment.\n\nThe study aims to evaluate the safety, feasibility, biodistribution, and diagnostic performance of GPRC5D-targeted PET\u002FCT and to compare its imaging characteristics with currently available molecular imaging modalities in plasma cell disorders.",[183,184],"Plasma Cell Disorders","Multiple Myeloma (MM)",[186,187,188,189,190,191,192,193],"targeted imaging","molecular imaging","GPRC5D","precise oncology","multiple myeloma","PET\u002FCT","nuclear medicine","precise diagnosis",{"date":165,"type":40},{"date":37,"type":22},{"date":197,"type":22},"2027-05-25",{"name":46,"class":47},{"id":200,"slug":201,"hasResults":12,"nctId":202,"briefTitle":203,"officialTitle":204,"acronym":4,"eligibilityCriteria":205,"healthyVolunteers":12,"sex":18,"minAge":206,"maxAge":4,"enrollmentInfo":207,"targetDuration":4,"studyType":209,"phases":4,"briefSummary":210,"conditions":211,"keywords":4,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":213,"startDateStruct":214,"completionDateStruct":215,"leadSponsor":217,"locationsCount":4},"100641837","predicting-peritoneal-ktvurea-based-on-single-exchange-dialysate-effluent-100641837","NCT07659067","Predicting Peritoneal Kt\u002FVurea Based on Single-Exchange Dialysate Effluent","Development and Validation of a Prediction Model for Peritoneal Kt\u002FVurea Using Single-Exchange Dialysate Effluent in Patients Undergoing Peritoneal Dialysis","Inclusion Criteria:\n\nPatients aged ≥14 years who have been receiving PD for at least one month.\n\nExclusion Criteria:\n\n(1) peritonitis or other acute complications (e.g., severe infection or acute heart failure) within 1 month prior to enrollment; (2) spontaneous ascites; (3) inability to complete full collection of all dialysate effluent during the study dialysis day; (4) refusal or inability to provide written informed consent.","14 Years",{"count":208,"type":22},300,"OBSERVATIONAL","Background:\n\nPeritoneal dialysis (PD) adequacy is routinely evaluated using the urea clearance index (Kt\u002FVurea), a key indicator of small-solute clearance and treatment adequacy. The standard method for calculating peritoneal Kt\u002FVurea requires complete collection of 24-hour dialysate effluent, which is labor-intensive, time-consuming, and prone to errors arising from incomplete collection, inadequate mixing, and inaccurate sampling. Although proportional sampling from each exchange has been shown to yield results comparable to those obtained from complete 24-hour effluent collection, this approach still requires collection of all exchanges throughout the day. Previous studies have suggested that Kt\u002FVurea estimated from a single dialysate exchange may correlate with the standard measurement; however, these investigations were limited by small sample sizes and did not establish predictive equations. Therefore, a practical and accurate alternative for assessing peritoneal Kt\u002FVurea is still lacking.\n\nObjective:\n\nTo develop and validate a prediction model for peritoneal Kt\u002FVurea based on single-exchange dialysate effluent in patients undergoing PD.\n\nMethods:\n\nThis multicenter cross-sectional study will be conducted between 2026 and 2027 across four PD centers in China. Consecutive prevalent patients receiving manual PD will be screened for eligibility. Patients aged ≥14 years who have been receiving PD for at least one month will be included. Exclusion criteria comprise peritonitis or other acute complications within the preceding month, spontaneous ascites, inability to complete full dialysate collection during the study day, and refusal to provide informed consent. Demographic characteristics, primary kidney disease, comorbidities, and PD prescription parameters will be collected. On a designated study day, effluent from each dialysis exchange, 24-hour urine samples, and fasting blood samples will be obtained. The correlations between peritoneal Kt\u002FVurea calculated from individual exchanges and the reference peritoneal Kt\u002FVurea derived from complete 24-hour dialysate collection will be evaluated. Multivariable prediction models incorporating single-exchange effluent measurements and relevant clinical parameters will subsequently be developed and validated. Model performance will be assessed using measures of discrimination, calibration, and agreement with reference Kt\u002FVurea values.\n\nConclusions:\n\nThis study aims to establish and validate a simplified method for estimating peritoneal Kt\u002FVurea using single-exchange dialysate effluent. If validated, the proposed model may substantially reduce the burden associated with 24-hour dialysate collection while maintaining adequate accuracy for routine assessment of PD adequacy.",[212],"Peritoneal Dialysis",{"date":165,"type":40},{"date":110,"type":22},{"date":216,"type":22},"2027-06",{"name":46,"class":47},{"id":219,"slug":220,"hasResults":12,"nctId":221,"briefTitle":222,"officialTitle":223,"acronym":4,"eligibilityCriteria":224,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":225,"targetDuration":4,"studyType":23,"phases":227,"briefSummary":228,"conditions":229,"keywords":235,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":243,"startDateStruct":244,"completionDateStruct":246,"leadSponsor":248,"locationsCount":79},"100632066","phase-1-68ga-pfd3-pet-imaging-for-the-diagnosis-and-evaluation-of-small-cell-lung-cancer-100632066","NCT07508852","68Ga-PFD3 PET Imaging for the Diagnosis and Evaluation of Small Cell Lung Cancer","Targeting Delta-like Ligand 3 (DLL3) With 68Ga-PFD3 PET\u002FCT for the Diagnosis and Assessment of Small Cell Lung Cancer (SCLC)","Inclusion Criteria:\n\n* Adults.\n* Histologically confirmed small cell lung cancer (SCLC).\n* At least one measurable lesion ≥1 cm in diameter (primary tumor, metastatic lesion, or involved lymph node) confirmed by standard imaging modalities.\n* Laboratory tests (complete blood count and biochemical analysis) completed within 4 weeks prior to enrollment.\n\nExclusion Criteria:\n\n* Pregnancy.\n* Breastfeeding.\n* Acute psychiatric disorders.\n* Inability to undergo PET scanning (e.g., due to claustrophobia, weight limits, or other medical contraindications).\n* Inability to complete the study procedures as anticipated.\n* Prior therapy targeting DLL3.",{"count":226,"type":22},30,[180,154],"This study aims to investigate and evaluate the safety and performance of a novel probe, PFD3, for the diagnosis and assessment of patients with small cell lung cancer (SCLC).",[230,231,232,233,234],"SCLC","SCLC, Extensive Stage","SCLC, Limited Stage","Small Cell Lung Cancer","Small Cell Lung Cancer ( SCLC )",[230,236,191,237,238,239,240,241,242],"small cell lung cancer","PET","DLL3","Delta-like ligand 3","imaging","diagnosis","evaluation",{"date":106,"type":40},{"date":245,"type":40},"2025-10-22",{"date":247,"type":22},"2027-12-31",{"name":46,"class":47},{"id":250,"slug":251,"hasResults":12,"nctId":252,"briefTitle":253,"officialTitle":254,"acronym":4,"eligibilityCriteria":255,"healthyVolunteers":87,"sex":18,"minAge":19,"maxAge":57,"enrollmentInfo":256,"targetDuration":4,"studyType":23,"phases":257,"briefSummary":259,"conditions":260,"keywords":264,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":267,"startDateStruct":268,"completionDateStruct":270,"leadSponsor":272,"locationsCount":273},"100617536","phase-2-68ga-bcma-petct-in-multiple-myeloma-100617536","NCT07319897","68Ga-BCMA PET\u002FCT in Multiple Myeloma","A Prospective, Multicenter, Diagnostic Study Evaluating 68Ga-BCMA PET\u002FCT for Targeting BCMA Expression in Multiple Myeloma.","Inclusion Criteria:\n\n* patients with suspected or previously diagnosed multiple myeloma (MM) who were scheduled for bone marrow aspiration or tissue biopsy within two weeks, including those undergoing initial diagnostic evaluation or follow-up\u002Fre-evaluation for disease monitoring or relapse;\n* patients with confirmed symptomatic MM;\n* ability to understand and voluntarily sign written informed consent;\n* ability to comply with study procedures;\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤2.\n\nExclusion Criteria:\n\n* pregnancy or lactation;\n* inability to comprehend study procedures or cooperate with protocol requirements;\n* any other condition judged by the investigator to potentially interfere with study participation.",{"count":208,"type":22},[154,258],"PHASE3","This is a prospective, multicenter diagnostic imaging study designed to evaluate the diagnostic accuracy and clinical utility of BCMA-targeted positron emission tomography\u002Fcomputed tomography (PET\u002FCT) in patients with multiple myeloma and related plasma cell disorders. The study aims to non-invasively visualize and quantify whole-body BCMA expression and to assess its role in the detection of active disease and disease heterogeneity.",[261,262,263],"Multiple Myeloma","Multiple Myeloma and Malignant Plasma Cell Neoplasms","Multiple Myeloma and Plasma Cell Neoplasm",[190,265,191,241,266],"bcma","multicenter",{"date":165,"type":40},{"date":269,"type":40},"2025-12-25",{"date":271,"type":22},"2027-12-30",{"name":46,"class":47},5,{"id":275,"slug":276,"hasResults":12,"nctId":277,"briefTitle":278,"officialTitle":279,"acronym":4,"eligibilityCriteria":280,"healthyVolunteers":12,"sex":18,"minAge":281,"maxAge":4,"enrollmentInfo":282,"targetDuration":4,"studyType":209,"phases":4,"briefSummary":284,"conditions":285,"keywords":291,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":292,"startDateStruct":293,"completionDateStruct":295,"leadSponsor":296,"locationsCount":297},"100577043","diagnosis-and-allergen-identification-of-perioperative-anaphylaxis-100577043","NCT06793163","Diagnosis and Allergen Identification of Perioperative Anaphylaxis","Diagnosis and Allergen Identification of Perioperative Anaphylaxis: a Multicenter Prospective Cohort Study","Inclusion Criteria:\n\n* Aged 2 years or over;\n* Suspected anaphylaxis in the operating rooms, or history of suspected anaphylaxis in the operating room.\n\nExclusion Criteria:\n\n* Refuse to participate;\n* Other conditions that are considered unsuitable for study participation.","2 Years",{"count":283,"type":22},115,"Perioperative anaphylaxis may lead to fatal respiratory and\u002For circulatory events, yet both clinical diagnosis and management are challenging. Serum tryptase is an indicator that can provide important retrospective diagnostic value for anaphylaxis. Another key point in perioperative anaphylaxis management is to identify the allergens, and thus avoid re-exposure during later perioperative management. Skin testing is an important way to identify allergens.",[286,287,288,289,290],"Perioperative\u002FPostoperative Complications","Anaphylaxis","Tryptase","Allergens","Skin Testing",[286,287,288,289,290],{"date":106,"type":40},{"date":294,"type":40},"2025-01-25",{"date":44,"type":22},{"name":46,"class":47},6,{"id":299,"slug":300,"hasResults":12,"nctId":301,"briefTitle":302,"officialTitle":303,"acronym":4,"eligibilityCriteria":304,"healthyVolunteers":12,"sex":18,"minAge":305,"maxAge":4,"enrollmentInfo":306,"targetDuration":4,"studyType":23,"phases":308,"briefSummary":309,"conditions":310,"keywords":316,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":318,"lastUpdatePostDateStruct":319,"startDateStruct":321,"completionDateStruct":323,"leadSponsor":325,"locationsCount":79},"100642566","phase-4-fascia-iliaca-block-using-liposomal-bupivacaine-for-analgesia-after-hip-fracture-surgery-100642566","NCT07643792","Fascia Iliaca Block Using Liposomal Bupivacaine for Analgesia After Hip Fracture Surgery","Fascia Iliaca Block Using Liposomal Bupivacaine for Analgesia After Hip Fracture Surgery: a Randomized Trial","Inclusion Criteria:\n\n* Aged ≥ 55 years.\n* Diagnosed as hip fracture and scheduled to undergo hip replacement surgery.\n* Agree to receive regional nerve block and postoperative patient-controlled intravenous analgesia (PCIA).\n\nExclusion Criteria:\n\n* Inability to communicate due to visual, auditory, language, or other reasons before surgery.\n* Chronic opioid dependence and long-term use of various types of analgesics (for more than 3 months).\n* Severe coagulation abnormalities (International Normalized Ratio \\> 1.7, activated partial thromboplastin time exceeding the normal value by more than 4 seconds, platelet count \\\u003C 80 × 10⁹\u002FL), trauma or infection at the intended puncture site, or severe low back pain.\n* Preoperative severe renal insufficiency (serum creatinine \\> 442 μmol\u002FL or requiring renal replacement therapy), hepatic insufficiency (Child-Pugh class C), or ASA physical status \\> IV.\n* Known allergy to local anesthetics.\n* Any other condition that the investigator or attending physician deems unsuitable for participation in the study.","55 Years",{"count":307,"type":22},148,[25],"Older patients with hip fractures often suffer from severe pain. Inadequate analgesia increases the risk of postoperative delirium, myocardial injury, and other complications. Peripheral nerve block is an important component of multimodal analgesia, but conventional local anesthetics (such as plain bupivacaine) provide only approximately 12 hours of analgesic duration, which is far from covering the most painful 72 hours after surgery. Liposomal bupivacaine has a slow-release property, prolonging the analgesic duration up to 72 hours after a single injection. However, its clinical advantages in hip fracture surgery remain controversial. The investigators suppose that, compared with plain bupivacaine alone, preoperative supra-inguinal fascia iliaca block using liposomal bupivacaine combined with plain bupivacaine can further improve analgesia, decrease opioid consumption, and improve postoperative recovery quality within 72 hours in older patients after hip fracture surgery.",[311,312,313,314,315],"Older Adults","Hip Fracture Surgery","Fascia Iliaca Block","Liposomal Bupivacaine","Postoperative Pain",[311,317,313,314,315],"Hip fracture surgery","2026-06-11",{"date":320,"type":40},"2026-06-15",{"date":322,"type":22},"2026-07",{"date":324,"type":22},"2028-08",{"name":46,"class":47},{"id":327,"slug":328,"hasResults":12,"nctId":329,"briefTitle":330,"officialTitle":331,"acronym":4,"eligibilityCriteria":332,"healthyVolunteers":12,"sex":333,"minAge":19,"maxAge":4,"enrollmentInfo":334,"targetDuration":4,"studyType":23,"phases":336,"briefSummary":337,"conditions":338,"keywords":345,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":318,"lastUpdatePostDateStruct":349,"startDateStruct":350,"completionDateStruct":351,"leadSponsor":353,"locationsCount":79},"100642691","phase-4-intranasal-esketamine-dexmedetomidine-combination-and-postpartum-depression-100642691","NCT07639099","Intranasal Esketamine-dexmedetomidine Combination and Postpartum Depression","Impact of Intranasal Esketamine-dexmedetomidine Combination on Postpartum Depression in Parturients With Prenatal Depressive Symptoms: a Randomized, Double-blind, and Placebo-controlled Trial","Inclusion Criteria:\n\n* Pregnant women aged ≥18 years who are preparing for childbirth;\n* Positive prenatal depression screening, defined as a Patient Health Questionnaire-9 (PHQ-9) score ≥5.\n\nExclusion Criteria:\n\n* History of schizophrenia or existence of communication barriers;\n* Severe obstetric complications, including severe preeclampsia, placenta accreta, HELLP syndrome, placenta previa, placental abruption, or ASA physical status classification \\>III;\n* Contraindications to ketamine\u002Fesketamine, including refractory hypertension, severe cardiovascular disease (NYHA class ≥III), or hyperthyroidism;\n* Contraindications to dexmedetomidine, including severe bradycardia (heart rate \\\u003C50 bpm), or second-degree or higher atrioventricular block;\n* Unsuitable for intranasal administration due to nasal cavity diseases (e.g., rhinitis, nasal polyps, or nasal congestion of any cause);\n* Refusal to participate in this study or concurrent participation in another clinical trial.","FEMALE",{"count":335,"type":22},164,[25],"Esketamine has rapid-onset antidepressant effects and may reduce postpartum depression in parturients with prenatal depressive symptoms. However, its adverse neuropsychiatric symptoms limits clinical application. Dexmedetomidine can alleviate these adverse symptoms and has independent antidepressant effect. This randomized, double-blind, placebo-controlled trial is designed to evaluate whether intranasal esketamine combined with dexmedetomidine can reduce the prevalence of postpartum depression in women with prenatal depressive symptoms.",[339,340,341,342,343,344],"Parturients","Depressive Symptoms","Esketamine","Dexmedetomidine","Intranasal Administration","Postpartum Depression",[339,346,341,342,347,348],"Prenatal depressive symptoms","Intranasal administration","Postpartum depression",{"date":320,"type":40},{"date":110,"type":22},{"date":352,"type":22},"2029-12",{"name":46,"class":47},{"id":355,"slug":356,"hasResults":12,"nctId":357,"briefTitle":358,"officialTitle":359,"acronym":4,"eligibilityCriteria":360,"healthyVolunteers":12,"sex":361,"minAge":19,"maxAge":362,"enrollmentInfo":363,"targetDuration":4,"studyType":23,"phases":365,"briefSummary":366,"conditions":367,"keywords":369,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":375,"lastUpdatePostDateStruct":376,"startDateStruct":377,"completionDateStruct":379,"leadSponsor":381,"locationsCount":79},"100580738","optimizing-prostate-biopsy-schemes-in-men-with-multiple-mri-visible-lesions-100580738","NCT06841211","Optimizing Prostate Biopsy Schemes in Men With Multiple MRI Visible Lesions","Optimizing Prostate Biopsy Schemes in Men With Multiple MRI Visible Lesions: a Randomized Controlled Trial Evaluating the Efficacy of Perilesional Biopsy in Prostate Cancer Diagnosis","Inclusion Criteria:\n\n* the age of the patient is between 18 and 85;\n* no previous biopsy;\n* presence of multiple MRI visible lesions;\n* every MRI visible lesion is in accordance with the EAU guidelines for performing perilesional biopsy (PB) (PI-RADS ≥4 or PI-RADS =3, clinical suspicion of PCa);\n* a verified prostate-specific antigen (PSA) less than 50 ng\u002Fml;\n* complete MRI data, and high MRI quality (Prostate Imaging Quality \\[PI-QUAL\\] V1.0 score ≥3);\n* the time interval between prostate biopsy and prostate MRI examination should not exceed one month;\n* patients with complete prostate biopsy pathological results;\n* patients with complete clinical information.\n\nExclusion Criteria:\n\n* contraindication for MRI examination (i.e., in acute attack period such as high fever, coma, epilepsy, prone to cardiac arrest, claustrophobia, presence of ferrous metallic implants, or claustrophobia);\n* contraindication for prostate biopsy ((a) in the period of acute infection or fever; (b) hypertensive crisis; (c) in the decompensated stage of heart failure; (d) diseases with severe bleeding tendency; (e) poorly controlled complications of hypertension or diabetes; (f) patients with severe internal or external hemorrhoids, perianal or rectal lesions should not undergo transrectal biopsy);\n* a history of radiotherapy, chemotherapy, androgen deprivation therapy, or surgery for PCa;\n* patients with previous biopsy;\n* the absence of MRI-visible prostate lesions or presence of single suspicious lesions;\n* PI-RADS V2.1 \\\u003C3;\n* unqualified or incomplete MRI data;\n* the patient could not cooperate to complete the prostate biopsy;\n* the patients or their family members refused to participate in this study;\n* patients with incomplete clinical information.","MALE","85 Years",{"count":364,"type":22},572,[61],"The goal of this randomized controlled trial (RCT) is to evaluate the efficacy of different prostate biopsy schemes in prostate cancer diagnosis among men with multiple MRI visible lesions, including combination of targeted and perilesional (PB) (TPLBx) and combination of systematic biopsy and targeted biopsy (CTSBx).\n\nThe main questions it aims to answer are:\n\nDoes TPLBx promote the accurate diagnosis of clinically significant prostate cancer (csPCa) among men with multiple MRI visible lesions? What's the value of TPLBx in improving the evaluation of prostate cancer when developing the treatment plan for patients with multiple MRI visible lesions? What's the value of TPLBx in avoiding the adverse pathological outcomes after the radical prostatectomy such as upgrade, upstage, and capsule invasion among patients with multiple MRI visible lesions? Researchers will compare the cancer detection rates of TPLBx and CTSBx to explore the efficacy of different prostate biopsy schemes.\n\nParticipants will:\n\nReceive TPLBx or CTSBx.",[368],"Prostate Cancer",[370,371,372,373,374],"Prostate cancer","Randomized controlled trial","Targeted biopsy","Perilesional biopsy","Diagnosis","2026-06-09",{"date":318,"type":40},{"date":378,"type":40},"2025-02-01",{"date":380,"type":22},"2026-12-31",{"name":46,"class":47},{"id":383,"slug":384,"hasResults":12,"nctId":385,"briefTitle":386,"officialTitle":387,"acronym":4,"eligibilityCriteria":388,"healthyVolunteers":12,"sex":361,"minAge":389,"maxAge":362,"enrollmentInfo":390,"targetDuration":4,"studyType":23,"phases":392,"briefSummary":393,"conditions":394,"keywords":395,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":375,"lastUpdatePostDateStruct":397,"startDateStruct":398,"completionDateStruct":400,"leadSponsor":401,"locationsCount":79},"100553173","evaluation-of-perilesional-biopsy-in-diagnosis-of-prostate-cancer-100553173","NCT06482645","Evaluation of Perilesional Biopsy in Diagnosis of Prostate Cancer","Evaluation of Perilesional Biopsy in Diagnosis of Prostate Cancer: a Multicenter Randomized Controlled Trial","Inclusion Criteria:\n\n* The age of the patient is between 45 and 85.\n* No previous biopsy.\n* Patients with single suspicious lesion, complete MRI data, qualified image quality control, suspicious lesions, and Prostate Imaging Reporting and Data System version 2.1 (PI-RADS V2.1) of \\> 3.\n* Patients were in accordance with the indication of prostate biopsy, including patients with suspicious prostate nodes found by digital rectal examination (DRE), the suspicious lesions found by transrectal ultrasound (TRUS) or MRI, total prostate-specific antigen (tPSA) \\>10ng\u002FmL, tPSA 4-10ng\u002FmL with free-to-total PSA ratio (f\u002FtPSA) \\\u003C0.16 or PSA density (PSAD) \\>0.15.\n* The prostate biopsy pathological results were complete. The time interval between prostate biopsy and prostate MRI examination should not exceed one month.\n* Patients with complete clinical information.\n\nExclusion Criteria:\n\n* The MRI data was unqualified or incomplete.\n* Patients had received radiotherapy, chemotherapy, androgen deprivation therapy, or surgery treatment before prostate MRI examination or prostate biopsy.\n* Patients with previous biopsy.\n* Patients with PI-RADS V2.1 of \\\u003C 4.\n* Patients were not in accordance with the indication of prostate biopsy.\n* The patient could not cooperate to complete the prostate biopsy.\n* The patients or their family members refused to participate in this study.\n* Patients with incomplete clinical information.","45 Years",{"count":391,"type":22},640,[61],"The goal of this multicenter randomized controlled trial (RCT) is to evaluate the efficacy of different prostate biopsy schemes, including perilesional biopsy (PB) and combination of systematic biopsy and targeted biopsy (TB+SB).\n\nThe main questions it aims to answer are:\n\nDoes PB promote the accurate diagnosis of clinically significant prostate cancer? What's the value of PB in improving the safety of prostate biopsy? Researchers will compare the cancer detection rates of PB and TB+SB to explore the efficacy of different prostate biopsy schemes.\n\nParticipants will:\n\nReceive TB+PB or TB+SB.",[368],[370,396,373],"Multicenter randomized controlled trial",{"date":318,"type":40},{"date":399,"type":40},"2024-07-01",{"date":380,"type":22},{"name":46,"class":47},{"id":403,"slug":404,"hasResults":12,"nctId":405,"briefTitle":406,"officialTitle":407,"acronym":408,"eligibilityCriteria":409,"healthyVolunteers":87,"sex":18,"minAge":410,"maxAge":411,"enrollmentInfo":412,"targetDuration":414,"studyType":209,"phases":4,"briefSummary":415,"conditions":416,"keywords":418,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":427,"lastUpdatePostDateStruct":428,"startDateStruct":430,"completionDateStruct":432,"leadSponsor":434,"locationsCount":79},"100642000","prospective-multicenter-registry-study-of-multiple-system-atrophy-in-china-100642000","NCT07644013","Prospective Multicenter Registry Study of Multiple System Atrophy in China","Clinical Features and Natural History of Multiple System Atrophy: A Prospective Multicenter Registry Study in China","MSA Registry S","Inclusion Criteria\n\n1. Patients with clinically established or clinically probable multiple system atrophy according to the 2022 Movement Disorder Society diagnostic criteria; or\n2. Patients with clinically established or clinically probable Parkinson disease according to the Movement Disorder Society diagnostic criteria; or\n3. Healthy controls or controls without hereditary or neurodegenerative diseases who voluntarily agree to participate.\n4. Age between 40 and 75 years.\n5. Ability to provide informed consent or availability of a legally authorized representative when applicable.\n\nExclusion Criteria\n\n1. Parkinsonism that cannot be classified as Parkinson disease or multiple system atrophy at the time of evaluation.\n2. Clinical suspicion or diagnosis of other atypical parkinsonian syndromes, including progressive supranuclear palsy, dementia with Lewy bodies, or corticobasal syndrome.\n3. Secondary parkinsonism due to intracranial space-occupying lesions, normal pressure hydrocephalus, drug-induced parkinsonism, or other identifiable causes.\n4. Comorbid diseases that may substantially affect autonomic function, such as diabetic peripheral neuropathy or amyloidosis.\n5. Refusal to participate in the study or refusal to undergo routine clinical evaluations for parkinsonian syndromes.\n6. Psychiatric or behavioral abnormalities that preclude reliable clinical data collection or scale-based assessment.","40 Years","75 Years",{"count":413,"type":22},214,"6 Months","Multiple system atrophy is a rare, rapidly progressive neurodegenerative disease characterized by variable combinations of parkinsonism, cerebellar ataxia, and autonomic dysfunction. Existing natural history studies from North America, Europe, and Japan suggest that clinical phenotypes and disease progression may differ across populations. However, comprehensive multicenter prospective data from Chinese patients with multiple system atrophy remain limited.\n\nThis prospective multicenter registry study aims to describe the clinical characteristics, longitudinal progression, and outcomes of Chinese patients with multiple system atrophy, to identify factors associated with disease progression and prognosis, and to establish a longitudinal cohort for future biomarker validation and clinical trial design.",[65,64,417],"Atypical Parkinsonism",[419,420,421,422,423,424,425,426],"Multiple system atrophy","natural history","prospective cohort","multicenter registry","disease progression","neuroimaging","biomarkers","alpha-synuclein","2026-06-08",{"date":429,"type":40},"2026-06-12",{"date":431,"type":40},"2025-06-01",{"date":433,"type":22},"2030-06-30",{"name":46,"class":47},{"id":436,"slug":437,"hasResults":12,"nctId":438,"briefTitle":439,"officialTitle":440,"acronym":4,"eligibilityCriteria":441,"healthyVolunteers":12,"sex":18,"minAge":442,"maxAge":4,"enrollmentInfo":443,"targetDuration":4,"studyType":23,"phases":445,"briefSummary":446,"conditions":447,"keywords":450,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":451,"lastUpdatePostDateStruct":452,"startDateStruct":454,"completionDateStruct":455,"leadSponsor":456,"locationsCount":79},"100638812","phase-4-intranasal-dexmedetomidine-esketamine-on-sleep-and-cognition-in-older-adults-with-mild-to-moderate-cognitive-impairment-100638812","NCT07610343","Intranasal Dexmedetomidine-esketamine on Sleep and Cognition in Older Adults With Mild-to-moderate Cognitive Impairment","Impact of Intranasal Dexmedetomidine-esketamine on Sleep Quality and Cognitive Function in Older Adults With Mild-to-moderate Cognitive Impairment: a Randomized, Double-blind, and Placebo-controlled Trial","Inclusion Criteria:\n\n1. Aged ≥ 60 years.\n2. Meeting the clinical diagnostic criteria for Alzheimer's disease, with mild cognitive impairment (MoCA score 18-25) or moderate cognitive impairment (MoCA score 10-17) due to Alzheimer's disease.\n3. Comorbid with sleep disorders (Pittsburgh Sleep Quality Index \\[PSQI\\] score ≥ 7).\n4. Signed informed consent.\n\nExclusion Criteria:\n\n1. Cognitive impairment\u002Fdementia due to other causes (e.g., vascular dementia, frontotemporal dementia, Parkinson's disease dementia).\n2. Unsuitable for intranasal administration due to nasal cavity diseases (e.g., rhinitis, nasal polyps, or nasal congestion of any cause).\n3. Inability to communicate due to visual, auditory, language, or other reasons, or Mini-Mental State Examination (MMSE) score ≤ 9 or MoCA score ≤ 9.\n4. History of schizophrenia, epilepsy, or Parkinson's disease, or confirmed diagnosis of glaucoma, hyperthyroidism, pheochromocytoma, or myasthenia gravis.\n5. Confirmed diagnosis of restless legs syndrome or sleep apnea, or judged to be at high risk of moderate-to-severe sleep apnea according to STOP-Bang score, or Body Mass Index (BMI) \\> 30 kg\u002Fm2.\n6. History of stroke or transient ischemic attack within 12 months prior to enrollment, confirmed intracranial aneurysm, or elevated intracranial pressure from any cause.\n7. Uncontrolled hypertension (e.g., hypertensive crisis or systolic blood pressure \\> 160 mmHg and\u002For diastolic blood pressure \\> 100 mmHg prior to enrollment), myocardial infarction, unstable angina, revascularization surgery within 12 months prior to enrollment, or NYHA class III.\n8. Sick sinus syndrome, severe sinus bradycardia (heart rate \\\u003C 50 beats\u002Fmin), atrioventricular block above degree II without a pacemaker, corrected QT interval (Fridericia-corrected QTcF) ≥ 450 ms, or other severe arrhythmias (e.g., frequent premature ventricular contractions).\n9. Uncontrolled diabetes (e.g., HbA1c \\> 9%, diabetic ketosis, hyperglycemic coma, or hypoglycemia).\n10. Severe hepatic dysfunction (Child-Pugh Class C), renal dysfunction (eGFR ≤ 30 ml\u002Fmin\u002F1.73m2), respiratory insufficiency (SpO2 \\\u003C 93% on room air), or other severe diseases (e.g., frailty with inability to walk independently, advanced-stage tumors).\n11. Alcohol or drug dependence (manifested as strong cravings, uncontrolled use, and withdrawal symptoms upon cessation), or use of contraindicated medications.\n12. Major surgery under general anesthesia within 12 weeks prior to enrollment, or planned surgery within 12 weeks.\n13. Allergy to dexmedetomidine and\u002For esketamine.\n14. Participation in other interventional clinical studies.\n15. Any other conditions deemed unsuitable for study inclusion by the investigator.","60 Years",{"count":444,"type":22},60,[25],"Patients with cognitive decline are frequently comorbid with sleep disorders which may in turn aggravate cognitive decline. Sedative dose dexmedetomidine improved sleep quality but incresed bradycardia and hypotension; low dose dexmedetomidine produce less side effects, but the sleep promoting effects are relatively weak. Low dose esketamine also has sleep-promoting effects but may produce neuropsychiatric side effects. Both dexmedetomidine and esketamine are approved for intranasal administration. We suppose that intranasal administration of dexmedetomidine-esketamine combination may improve sleep quality and therefore cognitive function in older ptients with Alzheimer's disease cognitive impairment and sleep disorders.",[311,448,449,342,341],"Cognitive Impairment","Sleep Disorders",[311,448,449,342,341],"2026-05-28",{"date":453,"type":40},"2026-06-01",{"date":110,"type":22},{"date":44,"type":22},{"name":46,"class":47},{"id":458,"slug":459,"hasResults":12,"nctId":460,"briefTitle":461,"officialTitle":461,"acronym":4,"eligibilityCriteria":462,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":57,"enrollmentInfo":463,"targetDuration":465,"studyType":209,"phases":4,"briefSummary":466,"conditions":467,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":469,"lastUpdatePostDateStruct":470,"startDateStruct":472,"completionDateStruct":474,"leadSponsor":476,"locationsCount":79},"100640739","diagnostic-value-of-68ga-pentixafor-petct-in-adrenal-tumors-with-aldosterone-and-cortisol-cosecretion-100640739","NCT07605156","Diagnostic Value of 68Ga-Pentixafor PET\u002FCT in Adrenal Tumors With Aldosterone and Cortisol Cosecretion","Inclusion Criteria:\n\n* Age 18-80 years.\n\nConfirmed diagnosis of PA+MACS according to guideline-directed algorithms: elevated aldosterone-to-renin ratio (ARR) and at least one positive confirmatory test for primary aldosteronism, together with serum cortisol \\>1.8 µg\u002FdL (\\>50 nmol\u002FL) after a 1 mg overnight dexamethasone suppression test (1 mg-ONDST).\n\nScheduled to undergo \\[⁶⁸Ga\\]Pentixafor-CXCR4 PET\u002FCT imaging.\n\nMeeting surgical indications, scheduled for adrenalectomy or adrenal ablation, having provided written informed consent, and agreeing to a follow-up of at least 12 months.\n\nExclusion Criteria:\n\n* Previous adrenal surgery or confirmed adrenal malignancy.\n\nPregnancy or lactation.\n\nSevere renal impairment (eGFR \\\u003C30 mL·min-¹·1.73 m-²) or contraindication to contrast agents\u002Fradiopharmaceuticals.\n\nInability to discontinue medications that interfere with diagnostic testing according to protocol, or presence of severe infection\u002Funstable comorbidities that preclude relevant examinations.\n\nDefinite overt Cushing's syndrome (CS).\n\nCritical missing data, inability to complete the required examinations, or anticipated inability to attend follow-up.",{"count":464,"type":22},130,"12 Months","The goal of this observational study is to evaluate the diagnostic accuracy of 68 68\n\nGa-Pentixafor-CXCR4 PET\u002FCT in identifying the dominant side of hormone excess in adult patients (aged 18-80 years) with primary aldosteronism and concomitant mild autonomous cortisol secretion (PA+MACS) who are candidates for unilateral adrenalectomy or ablation. The main questions it aims to answer are:\n\nWhat is the overall diagnostic performance of 68 68 Ga-Pentixafor-CXCR4 PET\u002FCT for lateralizing the dominant source of aldosterone and cortisol co-secretion, as measured by the area under the receiver operating characteristic curve (AUC)?\n\nHow do the PET\u002FCT-based lateralization results compare with adrenal venous sampling (AVS) and metanephrine-corrected AVS, and are there clinical or biochemical factors that predict discordance between these methods?\n\nResearchers will compare the dominant side determined by PET\u002FCT with the reference standard derived from postoperative PASO outcomes and cortisol-related hormonal outcomes (supplemented by histopathology) to assess sensitivity, specificity, accuracy, and agreement. They will further compare PET\u002FCT results to conventional AVS and metanephrine-corrected AVS to determine concordance and identify potential predictors of discordant cases.\n\nParticipants will:\n\nProvide written informed consent and undergo baseline clinical, biochemical, and imaging assessments as part of routine PA+MACS work-up.\n\nUndergo a single 68 68 Ga-Pentixafor-CXCR4 PET\u002FCT scan, along with AVS and metanephrine-corrected AVS, typically within a 4-week window.\n\nBe discussed by a multidisciplinary team that integrates all diagnostic information to formulate an individualized surgical plan.\n\nIf surgery proceeds, be followed at 1, 3, 6, and 12 months postoperatively to assess blood pressure, antihypertensive medication use, serum potassium, aldosterone\u002Frenin\u002Fcortisol levels, and 1-mg overnight dexamethasone suppression test results.",[468],"Primary Aldosteronism Concurrent With Autonomous Cortisol Secretion","2026-05-17",{"date":471,"type":40},"2026-05-22",{"date":473,"type":40},"2025-12-01",{"date":475,"type":22},"2027-09-30",{"name":46,"class":47},{"id":478,"slug":479,"hasResults":12,"nctId":480,"briefTitle":481,"officialTitle":482,"acronym":4,"eligibilityCriteria":483,"healthyVolunteers":87,"sex":18,"minAge":19,"maxAge":484,"enrollmentInfo":485,"targetDuration":486,"studyType":209,"phases":4,"briefSummary":487,"conditions":488,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":490,"lastUpdatePostDateStruct":491,"startDateStruct":493,"completionDateStruct":495,"leadSponsor":497,"locationsCount":79},"100621744","the-value-of-super-resolution-ultrasound-imaging-for-peripheral-artery-disease-100621744","NCT07374601","The Value of Super-resolution Ultrasound Imaging for Peripheral Artery Disease","The Predictive Value of Super-resolution Ultrasound Microvascular Imaging for the Prognosis of Peripheral Artery Disease","\\*Inclusion Criteria:\\*\n\n1. Adults aged ≥18 years and ≤100 years;\n2. Diagnosis of peripheral artery disease (PAD) confirmed by comprehensive clinical assessment-including characteristic symptoms (e.g., intermittent claudication, rest pain), physical findings (e.g., diminished or absent distal pulses, bruits), ankle-brachial index (ABI) \\\u003C 0.9, and corroborating vascular imaging (e.g., duplex ultrasonography, CTA, or MRA);\n3. Alternatively, healthy adults without PAD (i.e., ABI ≥ 0.9, absence of suggestive symptoms or signs, and no history of atherosclerotic cardiovascular disease) who meet all other eligibility requirements;\n4. Willing and able to provide written informed consent.\n\n\\*Exclusion Criteria:\\*\n\n1. Inability to complete study procedures due to:\n\n   1. Severe involuntary movement disorders (e.g., advanced Parkinson's disease or cerebellar ataxia) interfering with image acquisition;\n   2. Contraindication to contrast-enhanced ultrasound (e.g., documented hypersensitivity to sulfur hexafluoride microbubble contrast agent \\[SonoVue®\\]);\n   3. Active lower-limb infection (e.g., diabetic foot infection with systemic signs or osteomyelitis), which precludes safe or interpretable data collection;\n2. Cognitive impairment or legal incapacity precluding autonomous informed consent;\n3. Refusal-by the participant or their legally authorized representative-to provide informed consent.","100 Years",{"count":208,"type":22},"300 Months","Peripheral artery disease (PAD) is a chronic atherosclerotic disorder characterized by stenosis or occlusion of the extracranial arteries distal to the aortic arch, most commonly affecting the lower extremities. This vascular compromise leads to tissue hypoperfusion, resulting in a spectrum of clinical manifestations ranging from asymptomatic disease to intermittent claudication, critical limb ischemia, and limb loss.\n\nThe microvascular system comprises arterioles, capillaries, and post-capillary venules with diameters less than or equal to 100 micrometers. Emerging evidence underscores that microvascular dysfunction (MVD)-defined as structural and functional impairment of this microcirculatory network-plays a pivotal pathophysiological role in PAD progression, contributing to impaired perfusion reserve, endothelial dysfunction, inflammation, and tissue fibrosis, independent of macrovascular stenosis severity.\n\nSuper-resolution ultrasound microvascular imaging (SRUMI) is an advanced contrast-enhanced ultrasound technique that leverages the nonlinear acoustic signatures of intravascular microbubble contrast agents (e.g., SonoVue) under ultra-low mechanical index (MI) pulsing schemes. Implemented on the Verasonics Vantage 256 research platform (Verasonics, Inc., Kirkland, WA, USA), SRUMI achieves in vivo visualization of microvascular architecture at sub-diffraction resolution (approximately 10-20 micrometers), surpassing conventional Doppler and contrast-enhanced ultrasound. Key advantages include absence of ionizing radiation, negligible thermal and mechanical bioeffects, real-time capability, portability, and cost-effectiveness. As such, SRUMI represents a promising noninvasive tool to probe microvascular integrity in PAD, enabling mechanistic investigation of MVD's contribution to disease initiation, progression, and therapeutic response.\n\nThis study aims to evaluate the diagnostic and prognostic utility of SRUMI for assessing microvascular dysfunction in patients with PAD. The investigators prospectively enrolled patients diagnosed with PAD and admitted to the Department of Interventional Vascular Surgery at Peking University First Hospital. Primary objectives include:\n\nCharacterizing lower-limb microvascular density, morphology, and perfusion patterns via SRUMI across PAD subgroups stratified by comorbidities-including diabetes mellitus, current or former smoking, hypertension, and chronic kidney disease;\n\nAssessing the concordance between SRUMI-derived microvascular parameters and established clinical and paraclinical markers, including symptom severity (Rutherford classification), ankle-brachial index (ABI), urinary albumin-to-creatinine ratio (UACR), and retinal microvascular findings on fundoscopy;\n\nDetermining the sensitivity, specificity, and predictive value of baseline SRUMI metrics for major adverse limb events (MALE) and cardiovascular outcomes during longitudinal follow-up; and\n\nComparing the incremental prognostic value of SRUMI against conventional modalities-including ABI, duplex ultrasonography, and clinical risk scores-using multivariable Cox regression and time-dependent receiver operating characteristic (ROC) analyses.\n\nCollectively, this research seeks to establish SRUMI as a quantitative, translatable biomarker of microvascular health in PAD, thereby advancing precision phenotyping, risk stratification, and monitoring of therapeutic efficacy in this high-morbidity population.",[489],"Peripheral Artery Disease","2026-05-14",{"date":492,"type":40},"2026-05-18",{"date":494,"type":40},"2026-02-08",{"date":496,"type":22},"2028-12-31",{"name":46,"class":47},{"id":499,"slug":500,"hasResults":12,"nctId":501,"briefTitle":502,"officialTitle":503,"acronym":4,"eligibilityCriteria":504,"healthyVolunteers":87,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":505,"targetDuration":4,"studyType":23,"phases":507,"briefSummary":508,"conditions":509,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":523,"lastUpdatePostDateStruct":524,"startDateStruct":525,"completionDateStruct":527,"leadSponsor":529,"locationsCount":79},"100635787","18f-t2-petct-imaging-for-caix-positive-solid-tumors-100635787","NCT07557225","18F-T2 PET\u002FCT Imaging for CAIX Positive Solid Tumors","Evaluation of Diagnostic Value of 18F-T2 PET\u002F CT Imaging for Tumors Likely to Express High Levels of CAIX","Inclusion Criteria:\n\nAll participants must meet the following criteria:\n\n1. Written and voluntarily given Informed Consent.\n2. Male or female ≥18 years of age at time of consent.\n3. Have the capacity to understand the study and be willing and able to comply with all protocol requirements.\n4. Participants with histologically confirmed or suspected tumors of the following types, but not limited to:\n\nClear Cell Renal Cell Cancer; Urothelial Carcinoma; Colorectal Cancer; Cervical Cancer; Ovarian Cancer; Head and Neck Cancer; Hepatocellular Carcinoma; Cholangiocarcinoma; Non Small Cell Lung Cancer; Small Cell Lung Cancer; Breast Cancer; Pancreatic Cancer; Endometrial Cancer; Von Hippel Lindau Disease.\n\nExclusion Criteria:\n\nParticipants will be excluded from participation in the study if one or more of the following criteria are met:\n\n1. Have any serious non-malignant disease (e.g., psychiatric, infectious, autoimmune or metabolic) that may interfere with the objectives of the study or with the safety or compliance of the participant, as judged by the Investigator.\n2. Have a mental impairment that may compromise the ability to give Informed Consent and comply with the requirements of the study.\n3. Be a female who is pregnant or breastfeeding.",{"count":506,"type":22},200,[61],"The goal of this clinical trial is to evaluate the diagnostic value of CAIX protein specific probe 18F-T2 in PET\u002FCT imaging in participants with solid tumors. It will also assess the safety, tolerability and radiation dosimetry of 18F-T2.",[510,511,512,513,514,515,516,517,518,233,519,520,521,522],"Clear Cell Renal Cell Cancer (ccRCC)","Urothelial Carcinoma (UC)","Colorectal Cancer","Cervical Cancer","Ovarian Cancer","Head and Neck Cancer","Hepatocellular Carcinoma (HCC)","Cholangiocarcinoma","Non Small Cell Lung Cancer","Breast Cancer","Pancreatic Cancer","Endometrial Cancer","Von Hippel Lindau Disease","2026-05-12",{"date":490,"type":40},{"date":526,"type":40},"2026-04-27",{"date":528,"type":22},"2029-03",{"name":46,"class":47},{"id":531,"slug":532,"hasResults":12,"nctId":533,"briefTitle":534,"officialTitle":535,"acronym":4,"eligibilityCriteria":536,"healthyVolunteers":87,"sex":18,"minAge":88,"maxAge":537,"enrollmentInfo":538,"targetDuration":4,"studyType":23,"phases":540,"briefSummary":541,"conditions":542,"keywords":548,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":552,"lastUpdatePostDateStruct":553,"startDateStruct":554,"completionDateStruct":555,"leadSponsor":557,"locationsCount":297},"100638808","phase-4-long-term-follow-up-of-dexmedetomidine-esketamine-and-tdcs-for-neurocognitive-complications-after-surgery-100638808","NCT07576543","Long-term Follow-up of Dexmedetomidine-esketamine and tDCS for Neurocognitive Complications After Surgery","Long-term Follow-up of Perioperative Dexmedetomidine-esketamine Combination and Transcranial Direct Current Stimulation for Prevention of Neurocognitive Complications in Older Patients After Non-cardiac Surgery","Inclusion Criteria:\n\n* Aged 65 to 90 years;\n* Preoperative Mini-Mental State Examination (MMSE) score \\\u003C 27 points, indicating possible cognitive impairment ranging from mild to moderate;\n* Scheduled to undergo elective non-cardiac, non-neurosurgical surgery under general anesthesia, with an expected surgical duration \\> 1 hour;\n* Required patient-controlled intravenous analgesia (PCIA) after surgery.\n\nExclusion Criteria:\n\n* Preoperative inability to communicate due to coma, severe dementia, endstage disease, or language impairment;\n* History of schizophrenia, epilepsy, Parkinson's disease, brain trauma\u002Fsurgery, or myasthenia gravis;\n* Presence of metal implants in the intracranial or cervical region (such as cochlear implants, aneurysm clips, deep brain stimulation electrodes), or skin damage or severe skin disease on the head;\n* Severe cardiac dysfunction (left ventricular ejection fraction \\\u003C 30%), comorbid with sick sinus syndrome, severe bradycardia (heart rate \\\u003C 50 bpm), or second-degree or higher atrioventricular block, or implantation of a cardiac pacemaker;\n* Uncontrolled hyperthyroidism or pheochromocytoma;\n* Severe liver dysfunction (Child-Pugh class C), severe renal dysfunction (requiring dialysis), or ASA classification ≥ IV;\n* Allergy to dexmedetomidine or esketamine;\n* Participation in other clinical studies within the past 3 months;\n* Other conditions that are deemed unsuitable for study participation.","90 Years",{"count":539,"type":22},1160,[25],"Neurocognitive complications, mainly delirium and neurocognitive disorders, are common cerebral complications in older patients after surgery and associated with worse long-term outcomes. An ongoing 2×2 factorial trial conducted by the investigators plan to test the effects of perioperative dexmedetomidine-esketamine combination and transcranial direct current stimulation (tDCS) on postoperative neurocognitive complications in older patients. This long-term follow-up of the ongoing trial aims to investigate the effects of perioperative dexmedetomidine-esketamine combination and tDCS on long-term outcomes in older patients after noncardiac surgery.",[543,544,342,341,545,546,547],"Older Patients","Surgery","Transcranial Direct Current Stimulation","Cognitive Function","Survival",[549,544,342,341,550,551,547],"Older patients","Transcranial direct current stimulation","Cognitive function","2026-05-07",{"date":523,"type":40},{"date":110,"type":22},{"date":556,"type":22},"2031-06",{"name":46,"class":47},{"id":559,"slug":560,"hasResults":12,"nctId":561,"briefTitle":562,"officialTitle":563,"acronym":4,"eligibilityCriteria":564,"healthyVolunteers":87,"sex":18,"minAge":88,"maxAge":537,"enrollmentInfo":565,"targetDuration":4,"studyType":23,"phases":566,"briefSummary":567,"conditions":568,"keywords":570,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":552,"lastUpdatePostDateStruct":572,"startDateStruct":573,"completionDateStruct":574,"leadSponsor":576,"locationsCount":297},"100637701","phase-4-dexmedetomidine-esketamine-and-tdcs-for-prevention-of-neurocognitive-complications-after-surgery-100637701","NCT07576517","Dexmedetomidine-esketamine and tDCS for Prevention of Neurocognitive Complications After Surgery","Perioperative Use of Dexmedetomidine-esketamine Combination and Transcranial Direct Current Stimulation for Prevention of Neurocognitive Complications in Older Patients After Non-cardiac Surgery: a 2×2 Factorial Trial","Inclusion Criteria:\n\n* Aged 65 to 90 years;\n* Preoperative Mini-Mental State Examination (MMSE) score \\\u003C 27 points, indicating possible cognitive impairment ranging from mild to moderate;\n* Scheduled to undergo elective non-cardiac, non-neurosurgical surgery under general anesthesia, with an expected surgical duration \\> 1 hour;\n* Required patient-controlled intravenous analgesia (PCIA) after surgery.\n\nExclusion Criteria:\n\n* Preoperative inability to communicate due to coma, severe dementia, end-stage disease, or language impairment;\n* History of schizophrenia, epilepsy, Parkinson's disease, brain trauma\u002Fsurgery, or myasthenia gravis;\n* Presence of metal implants in the intracranial or cervical region (such as cochlear implants, aneurysm clips, deep brain stimulation electrodes), or skin damage or severe skin disease on the head;\n* Severe cardiac dysfunction (left ventricular ejection fraction \\\u003C 30%), comorbid with sick sinus syndrome, severe bradycardia (heart rate \\\u003C 50 bpm), or second-degree or higher atrioventricular block, or implantation of a cardiac pacemaker;\n* Uncontrolled hyperthyroidism or pheochromocytoma;\n* Severe liver dysfunction (Child-Pugh class C), severe renal dysfunction (requiring dialysis), or ASA classification ≥ IV;\n* Allergy to dexmedetomidine or esketamine;\n* Participation in other clinical studies within the past 3 months;\n* Other conditions that are deemed unsuitable for study participation.",{"count":539,"type":22},[25],"Neurocognitive complications, mainly delirium and neurocognitive disorders, are common cerebral complications in older patients after surgery and associated with worse outcomes. In previous studies, perioperative use of dexmedetomidine-esketamine combination improved analgesia and sleep quality after surgery. Perioperative use of transcranial direct current stimulation (tDCS) also improved sleep quality and reduced delirium occurrence early after surgery. This 2×2 factorial trial is designed to investigate the effects of perioperative dexmedetomidine-esketamine combination and tDCS on early postoperative neurocognitive recovery and delirium occurrence in older patients.",[543,544,342,341,545,569],"Perioperative Neurocognitive Disorders",[549,544,342,341,550,571],"Perioperative neurocognitive disorders",{"date":523,"type":40},{"date":110,"type":22},{"date":575,"type":22},"2030-06",{"name":46,"class":47},{"id":578,"slug":579,"hasResults":12,"nctId":580,"briefTitle":581,"officialTitle":582,"acronym":4,"eligibilityCriteria":583,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":584,"enrollmentInfo":585,"targetDuration":4,"studyType":23,"phases":587,"briefSummary":588,"conditions":589,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":591,"lastUpdatePostDateStruct":592,"startDateStruct":594,"completionDateStruct":595,"leadSponsor":597,"locationsCount":79},"100626731","simplified-dual-regimen-guided-by-fecal-clarithromycin-resistance-gene-detection-for-first-line-h-pylori-eradication-100626731","NCT07439445","Simplified Dual Regimen Guided by Fecal Clarithromycin Resistance Gene Detection for First-line H. Pylori Eradication","Efficacy and Safety of Simplified Regimen Guided by Fecal Clarithromycin Resistance Gene Detection for First-line Helicobacter Pylori Eradication","Inclusion Criteria:\n\n1. Aged 18-70 years;\n2. Positive results for both ¹³C-urea breath test (¹³C-UBT) and fecal polymerase chain reaction (PCR), confirming Helicobacter pylori infection, with a clinical indication for H. pylori eradication as judged by the physician;\n3. Treatment-naïve individuals with no prior history of H. pylori eradication therapy.\n\nExclusion Criteria:\n\n1. Pregnant or lactating women\n2. Patients with a history of allergy to any drugs used in the eradication regimen\n3. Patients with severe systemic diseases or malignant tumors\n4. History of gastric resection surgery\n5. Recent use of antibiotics or bismuth salts (within 4 weeks), H₂-receptor antagonists, proton pump inhibitors (PPIs), or Potassium-competitive acid blockers(P-CABs) (within 2 weeks).","70 Years",{"count":586,"type":22},70,[61],"To investigate the efficacy, safety, and compliance of a simplified strategy using vonoprazan plus clarithromycin for first-line treatment in patients with Helicobacter pylori infection, among those infected with strains without clarithromycin resistance gene mutations based on fecal clarithromycin resistance gene detection.",[590],"Helicobacter Pylori Infection","2026-04-25",{"date":593,"type":40},"2026-04-30",{"date":591,"type":40},{"date":596,"type":22},"2027-02-13",{"name":46,"class":47},{"id":599,"slug":600,"hasResults":12,"nctId":601,"briefTitle":602,"officialTitle":603,"acronym":4,"eligibilityCriteria":604,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":411,"enrollmentInfo":605,"targetDuration":4,"studyType":23,"phases":607,"briefSummary":608,"conditions":609,"keywords":614,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":618,"lastUpdatePostDateStruct":619,"startDateStruct":621,"completionDateStruct":623,"leadSponsor":625,"locationsCount":79},"100633384","phase-4-anrikefon-based-patient-controlled-intravenous-analgesia-following-laparoscopic-surgery-100633384","NCT07525986","Anrikefon-based Patient-controlled Intravenous Analgesia Following Laparoscopic Surgery","Efficacy of Anrikefon-based Patient-controlled Intravenous Analgesia for Pain Management After Laparoscopic Surgery: a Randomized, Double-blind, Active-controlled Pilot Tria","Inclusion Criteria:\n\n1. Aged \\>= 18 years but \\\u003C 75 years;\n2. Scheduled to undergo elective laparoscopic colorectal surgery with an expected duration of \\>=1 hour;\n3. The incisional pain can be covered by the transversus abdominis plane block or rectus sheath block; yet patients still require postoperative patient-controlled intravenous analgesia.\n\nExclusion Criteria:\n\n1. Presence of preoperative cognitive impairment (Mini-Mental State Examination \\[MMSE\\] score \\\u003C 27), or inability to communicate due to language barrier;\n2. Body mass index (BMI) \\> 30 kg\u002Fm² or \\\u003C 18 kg\u002Fm²;\n3. Presence of poorly controlled or untreated comorbidities, including but not limited to the following: hypertension characterized by a resting systolic blood pressure (SBP) \\> 180 mmHg and\u002For diastolic blood pressure (DBP) \\> 110 mmHg, coronary artery disease with unstable angina or myocardial infarction within 6 months, heart failure rated as New York Heart Association classification \\>= III, severe chronic obstructive pulmonary disease (or in a state of acute exacerbation), severe hepatic insufficiency (Child-Pugh grade C), severe renal insufficiency (estimated glomerular filtration rate \\\u003C 30 ml\u002Fmin\u002F1.73m²), or American Society of Anesthesiologists (ASA) physical status classification \\>= IV;\n4. Continuous use of opioid analgesics for more than 10 days for any reason, or alcohol abuse (average daily intake of pure alcohol \\> 36 g) within 3 months before screening;\n5. Preoperative use of opioid or non-opioid analgesics with the interval between the last administration and randomization shorter than five half-lives of the drug or the duration of drug action (whichever is longer);\n6. Known allergies or contraindications to opiates or other medications that may be used in this study, such as anesthetics, antiemetics, and nonsteroidal anti-inflammatory drugs (NSAIDs);\n7. Anticipated need for postoperative mechanical ventilation；\n8. Other conditions that are considered unsuitable for study participation.",{"count":606,"type":22},140,[25],"Visceral pain following laparoscopic surgery is frequently underestimated, yet it is associated with a range of adverse outcomes. Effective visceral pain management should constitute an essential component of postoperative analgesic strategies following laparoscopic procedures. However, conventional analgesic agents, including μ-opioid receptor agonists, lack specificity for visceral pain. Anrikefon, a novel selective peripheral κ-opioid receptor agonist, demonstrates unique efficacy in alleviating visceral pain with a favorable safety profile. Preliminary studies showed that a single intravenous dose of anrikefon effectively alleviates postoperative pain after abdominal surgery with a low risk of adverse effects. The investigators hypothesize that an appropriate dosing regimen of anrikefon administered via patient-controlled intravenous analgesia (PCIA) pump, as part of a multimodal analgesic strategy, can specifically target and alleviate visceral pain after laparoscopic surgery, thereby achieving comprehensive postoperative analgesia.",[610,611,612,613],"Laparoscopic Surgery","Visceral Pain, Postoperative","Anrikefon","Patient-controlled Intravenous Analgesia",[615,616,612,617],"Laparoscopic surgery","Visceral pain, Postoperative","Patient-controlled intravenous analgesia","2026-04-22",{"date":620,"type":40},"2026-04-24",{"date":622,"type":40},"2026-04-14",{"date":624,"type":22},"2027-04",{"name":46,"class":47},{"id":627,"slug":628,"hasResults":12,"nctId":629,"briefTitle":630,"officialTitle":631,"acronym":4,"eligibilityCriteria":632,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":633,"targetDuration":4,"studyType":209,"phases":4,"briefSummary":634,"conditions":635,"keywords":638,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":647,"lastUpdatePostDateStruct":648,"startDateStruct":649,"completionDateStruct":651,"leadSponsor":653,"locationsCount":79},"100631765","multimodal-kidney-sparing-strategy-for-high-risk-upper-tract-urothelial-carcinoma-100631765","NCT07504939","Multimodal Kidney-Sparing Strategy for High-Risk Upper Tract Urothelial Carcinoma","Evaluating a Kidney-sparing Strategy Combining Endoscopic Surgery, Adjuvant Radiotherapy, and HER2-targeted Antibody-Drug Conjugate in High-risk Upper Tract Urothelial Carcinoma: Study Protocol for a Prospective, Multicenter, Non-randomized Comparative Clinical Trial","Inclusion Criteria\n\nParticipants must meet all of the following criteria:\n\nAge 18 years or older Voluntary participation with written informed consent Pathology indicating upper tract urothelial carcinoma with HER2 at least 1+ expression Clinical stage cT1-T2N0M0 based on imaging evaluation Classified as high-risk upper tract urothelial carcinoma according to European Association of Urology (EAU) criteria Eastern Cooperative Oncology Group (ECOG) performance status 0-1 Adequate renal function with split renal function of the affected kidney ≥10 mL\u002Fmin on renal dynamic scintigraphy Expected life expectancy greater than 24 months Ability and willingness to comply with study procedures and follow-up schedule Exclusion Criteria\n\nParticipants will be excluded if any of the following conditions are present:\n\nInability to tolerate or refusal of kidney-sparing treatment Evidence of advanced disease (≥T3), lymph node metastasis, or distant metastasis Synchronous bladder urothelial carcinoma or other urological malignancies Previous systemic anticancer therapy, including chemotherapy, targeted therapy, immunotherapy, or antibody-drug conjugates Prior radiotherapy involving the urinary tract or retroperitoneal region Severe uncontrolled comorbidities such as cardiovascular, pulmonary, neurological, psychiatric, or systemic diseases Active severe infections requiring systemic antimicrobial therapy Known immune-related disorders requiring long-term immunosuppressive treatment Pregnancy or breastfeeding Known allergy to investigational drugs used in this study Concurrent participation in another therapeutic clinical trial Indeterminate postoperative pathological diagnosis",{"count":142,"type":22},"UTUC is a cancer that develops in the lining of the kidney or ureter. The standard treatment is radical nephroureterectomy, which removes the kidney and ureter. Although this surgery can control the cancer, it permanently reduces kidney function.\n\nEndoscopic treatment can serve as a kidney-sparing approach for low-risk UTUC; however, in high-risk patients, the high rate of upper tract local recurrence after endoscopic treatment remains the primary failure pattern. This study aims to evaluate the efficacy and safety of radiotherapy-involved kidney-sparing treatment for UTUC.\n\nThe main questions this study aims to answer are: Can this multimodal kidney-sparing strategy reduce local recurrence of UTUC compared with endoscopic treatment alone? Participants in the kidney-sparing group will: Undergo endoscopic surgery to remove the tumor; Receive systemic therapy with disitamab vedotin and toripalimab; Receive targeted radiotherapy after surgery.\n\nParticipants will undergo regular follow-up visits, including imaging examinations and endoscopic evaluations, to monitor for recurrence or disease progression.\n\nThe results of this study may help determine whether a multimodal kidney-sparing treatment strategy could become a safe and effective option for selected patients with high-risk UTUC.",[636,637],"Upper Tract Urothelial Carcinoma Receiving Kidney-sparing Therapy","Upper Tract Urothelial Carcinoma",[639,640,641,642,643,644,645,646],"UTUC","Kidney-Sparing Surgery","Endoscopic Treatment","Disitamab Vedotin","Toripalimab","HER2-Targeted Therapy","Radiotherapy","Multimodal Therapy","2026-04-21",{"date":620,"type":40},{"date":650,"type":22},"2026-04-01",{"date":652,"type":22},"2030-04-01",{"name":46,"class":47},{"id":655,"slug":656,"hasResults":12,"nctId":657,"briefTitle":658,"officialTitle":659,"acronym":660,"eligibilityCriteria":661,"healthyVolunteers":12,"sex":18,"minAge":442,"maxAge":4,"enrollmentInfo":662,"targetDuration":664,"studyType":209,"phases":4,"briefSummary":665,"conditions":666,"keywords":670,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":622,"lastUpdatePostDateStruct":674,"startDateStruct":675,"completionDateStruct":677,"leadSponsor":678,"locationsCount":79},"100634682","aspirin-50-mg-vs-100-mg-in-elderly-cardiovascular-disease-patients-100634682","NCT07542860","Aspirin 50 mg vs. 100 mg in Elderly Cardiovascular Disease Patients","Risk Assessment and Application of Antithrombotic Therapy in Elderly Patients With Cardiovascular Disease: A Multicenter, Prospective Cohort Study","LAPIS","Inclusion Criteria:\n\n1. Age ≥ 60 years.\n2. Diagnosis of established atherosclerotic cardiovascular disease (ASCVD), including acute coronary syndrome, stable coronary artery disease, post-revascularization (percutaneous coronary intervention or coronary artery bypass grafting), ischemic cardiomyopathy, ischemic stroke, transient ischemic attack, or peripheral artery disease.\n3. Long-term use of aspirin (≥1 year) for secondary prevention of ASCVD.\n4. Available laboratory tests (within the past 3 months): complete blood count, urinalysis, routine stool examination and occult blood test, liver and kidney function, electrolytes, glucose, lipids, uric acid, coagulation function, etc.\n5. Willing to provide written informed consent.\n\nExclusion Criteria:\n\n1. Hypersensitivity to aspirin or other salicylates, or any other component of the drug product; history of asthma induced by salicylates or nonsteroidal anti-inflammatory drugs (NSAIDs), or any other condition that, in the clinical judgment, makes the patient unsuitable for study participation.\n2. Life expectancy ≤ 2 years due to non-cardiovascular causes.\n3. Poor compliance (unable to adhere to prescribed medication or follow scheduled follow-up visits as judged by the investigator).",{"count":663,"type":22},5448,"3 Years","Elderly patients with cardiovascular disease face a high risk of both thrombotic and bleeding events when receiving antithrombotic therapy. The optimal dose of aspirin for secondary prevention in this population remains uncertain, particularly in Chinese elderly individuals. This multicenter, prospective cohort study aims to evaluate the effectiveness and safety of a lower dose of aspirin (50 mg daily) compared with the standard dose (100 mg daily) for secondary prevention of atherosclerotic cardiovascular disease (ASCVD) in Chinese patients aged 60 years and older. The study is an extension of the existing LAPIS cohort (ChiCTR1900021980), which has enrolled 5,448 participants receiving long-term aspirin for secondary prevention. Participants will be followed for an additional 2 years (total follow-up up to approximately 6 years) through telephone, clinic visits, and electronic medical records. The primary effectiveness outcome is the first occurrence of major adverse cardiovascular events (MACE), including non-fatal myocardial infarction, unstable angina, need for revascularization, non-fatal stroke, transient ischemic attack, and cardiovascular death (excluding intracranial bleeding). The primary safety outcome is the first occurrence of bleeding events (classified by BARC criteria). A secondary aim is to develop and validate a risk prediction model (nomogram) for thrombotic and bleeding events specifically for elderly Chinese patients receiving antithrombotic therapy, using LASSO regression and Cox proportional hazards models. The study will provide real-world evidence to guide individualized antithrombotic management in the aging Chinese population.",[667,668,669],"Atherosclerotic Cardiovascular Disease (ASCVD)","Secondary Prevention","Cardiovascular Diseases",[671,668,669,672,673],"Aspirin","Aged","Risk Assessment",{"date":647,"type":40},{"date":676,"type":40},"2019-04-10",{"date":247,"type":22},{"name":46,"class":47},""]