[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"efficacy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:efficacy":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,16,0,[8,49,75,96,123,156,179,202,229,251,276,296,320,342,364,384],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":33,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100407991","early-phase-1-human-amniotic-derived-mesenchymal-stem-cell-therapy-for-calciphylaxis-100407991",false,"NCT04592640","Human Amniotic-Derived Mesenchymal Stem Cell Therapy for Calciphylaxis","Effects of Human Amniotic-derived Mesenchymal Stem Cells (hAMSCs) on Calciphylaxis Patients: An Open-Label Single-Arm Study","Inclusion Criteria:\n\n1. 18-75 years old.\n2. Clinical diagnosis of calciphylaxis, including patients with chronic kidney disease who did not or had regular dialysis (hemodialysis or peritoneal dialysis).\n3. All subjects signed informed consent.\n\nExclusion criteria:\n\n1. Patients who refuse to sign informed consent.\n2. Patients with malignant tumors or severe psychiatric disorders, or an expected survival time of less than 6 months.\n3. Pregnant or lactating women of childbearing age.\n4. Participation in another clinical trial with an experimental drug within 90 days prior the inclusion.","ALL","18 Years","75 Years",{"count":20,"type":21},9,"ESTIMATED","INTERVENTIONAL",[24],"EARLY_PHASE1","Treatment for Calciphylaxis Patients with Human Amniotic-derived Mesenchymal Stem Cells",[27,28,29,30,31,32],"Chronic Kidney Diseases","Calciphylaxis","Calcific Uremic Arteriolopathy","Treatment","Safety","Efficacy",[27,28,29,34,35,31,32],"Human Amniotic-derived Mesenchymal Stem Cells","Rare disease (ORPHA280062)","RECRUITING","2026-03-02",{"date":39,"type":40},"2026-03-04","ACTUAL",{"date":42,"type":40},"2018-09-17",{"date":44,"type":21},"2028-09-17",{"name":46,"class":47},"The First Affiliated Hospital with Nanjing Medical University","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":61,"conditions":62,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":74},"100534786","phase-1-phase-12-study-of-hyp-2090ptsa-in-patients-with-advanced-solid-tumors-harboring-kras-mutation-100534786","NCT06243354","Phase 1\u002F2 Study of HYP-2090PTSA in Patients With Advanced Solid Tumors Harboring KRAS Mutation","An Open-label, Multi-center, Multi-cohort, Phase 1\u002F2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HYP-2090PTSA in Patients With Advanced Solidt Tumors Harboring KRAS Mutation","Inclusion Criteria:\n\n* A written informed consent should be signed by a subject or his\u002Fher legal representative before any study-related procedures are performed;\n* 18 Years and older;\n* Subjects with histologically or cytologically confirmed locally advanced or metastatic advanced solid tumors;\n* Subjects must have at least one measurable lesion as defined by RECIST v1.1;\n* Eastern Cooperative Oncology Group(ECOG) performance status 0-1;\n* Expected survival ≥ 3 months;\n* Patients are willing to use a highly effective method of birth control during the study, and for at least 180 days after the last dose of study medication.\n\nExclusion Criteria:\n\n* Patients who have received major surgical or interventional treatment within 4 weeks prior to the first dose, with the exception of tumor biopsy, puncture, etc. Patients who have received anti-tumor therapy (radiotherapy, immunologic therapy or biological therapy) within 4 weeks, prior to the first dose, or received small molecular targeted therapy, chemotherapy within 2 weeks, or received palliative radiotherapy for bone metastases within 2 weeks, or received nitrosoureas or mitomycin C within 6 weeks;\n* Patients who have received live vaccines within 4 weeks prior to the first dose;\n* Patients who have previously participated in clinical trials of other drugs within 4 weeks before the first dose;\n* Patients with a history of central nervous system disease within 12 months prior to enrollment, such as seizures, cerebral vascular embolism\u002Fhemorrhage, paralysis, aphasia, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, psychiatric disease, or any autoimmune disease with involvement of the central nervous system;\n* Presence of severe pulmonary diseases such as pulmonary embolism, interstitial lung disease at screening;\n* Patients who have previously received allogeneic tissue\u002Fsolid organ transplantation;\n* Patients with active infection;\n* Patients who are positive for human immunodeficiency virus (HIV) (HIV1\u002F2 antibody), positive treponema pallidum antibody (positive treponema pallidum antibody is required to undergo a confirmatory test, and those with negative confirmatory test can be enrolled), active chronic hepatitis B (HBsAg positive and HBV DNA \\> 500 IU\u002FmL) or active hepatitis C (HCV antibody positive and HCV-RNA \\> lower limit of detection by the research center);\n* Female subjects who are lactating or have a positive blood\u002Furine pregnancy result during the screening period;\n* Any other condition of the subject (e.g., mental, geographical, or medical condition) that does not allow him or her to comply with the study and follow-up procedures, or other conditions that, in the judgment of the investigator, the subject is not suitable for inclusion in this study.",{"count":57,"type":21},257,[59,60],"PHASE1","PHASE2","This is a multicenter, open-label phase 1\u002F2 study consisting of two parts: dose escalation phase and dose expansion phase. The objective of the dose escalation phase is to evaluate the safety, tolerability and pharmacokinetics of HYP-2090PTSA in patients with advanced solid tumors harboring KRAS mutation and to determine the RP2D. In the dose expansion phase, preliminary efficacy and safety at the RP2D will be further explored in patients with specific cancer harboring KRAS p.G12C mutation.",[31,63,32],"Tolerability","2026-01-27",{"date":66,"type":40},"2026-01-29",{"date":68,"type":40},"2024-02-04",{"date":70,"type":21},"2026-12",{"name":72,"class":73},"Sichuan Huiyu Pharmaceutical Co., Ltd","INDUSTRY",6,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":82,"enrollmentInfo":83,"targetDuration":4,"studyType":22,"phases":85,"briefSummary":86,"conditions":87,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":48},"100565213","phase-1-phase-12-clinical-study-of-hy07121-powder-for-solution-for-infusion-in-patients-with-advanced-solid-tumors-100565213","NCT06639256","Phase 1\u002F2 Clinical Study of HY07121 Powder for Solution for Infusion in Patients With Advanced Solid Tumors","An Open-label, Multiple-center, Phase 1\u002F2 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of HY07121 Powder for Solution for Infusion in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n* Written informed consent;\n* ≥18 years old and ≤80 years old, gender: male or female;\n* Histologically or cytologically confirmed unresectable advanced\u002Fmetastatic solid tumor that has relapsed or progressed on or after standard systemic treatments, or refused the standard treatment, or for which no standard treatment is available;\n* Presence of at least one measurable lesion according to Response Evaluation Criteria in Solid Tumours (RECIST) Version 1.1;\n* Eastern Cooperative Oncology Group (ECOG) performance status score is 0 or 1;\n* Life expectancy ≥3 months;\n* Participant must have adequate main organ function;\n* Fertile female patients must have a negative serological pregnancy test within 7 days before the first dosing and be willing to use effective birth control\u002Fcontraception to prevent pregnancy during the study period up to 6 months after the last dosing of the study. Male patients must agree to have no sperm donation plans and to use effective contraceptive methods during the study period until 6 months after the last dose of the study. Postmenopausal women must have amenorrhea for at least 12 months before they are considered infertile.\n\nExclusion Criteria:\n\n* Within the defined washout periods for prior anti-cancer treatments;\n* Participant is currently participating or has participated in a study of an investigational agent or using an investigational device within 4 weeks of first dose of HY07121.\n* Any other malignancy within 2 years prior to the first dose of the study treatment except for localized cancers that are considered to have been cured and in the opinion of the Investigator present a low risk for recurrence.\n* Participant has not recovered (i.e., to Grade 1 or to baseline) from previous anticancer therapy-induced Adverse Events (AEs).\n* Participants with a history of recently (within previous 2 years of the first dose of the study treatment) active diverticulitis or symptomatic peptic ulcer disease;\n* Major surgery within 4 weeks of receiving the first dose of study treatment;\n* Participant has Symptomatic Central Nervous System (CNS) metastases, or CNS metastases requiring CNS-directed local therapy (such as radiotherapy or surgery) or corticosteroids therapy within 4 weeks of first dose of study treatment;\n* Participants with untreated or under treatment for tuberculosis, including but not limited to tuberculosis; Patients who have received standardized anti-tuberculosis treatment and have been confirmed cured by the researchers can be included;\n* Participants with clinically significant cardiovascular diseases, in the past 6 months prior to the first dose of the study treatment; symptomatic coronary heart disease requiring drug treatment; arrhythmia requiring drug treatment; or uncontrolled hypertension;\n* Known Human Immunodeficiency Virus (HIV) infection or known Acquired Immunodeficiency Syndrome (AIDS);\n* Active or chronic hepatitis B or hepatitis C infection; treponema pallidum antibody positive, and confirmed positive test;\n* Active known or suspected autoimmune disease.\n* History of non-infectious pneumonitis that has required a course of oral or intravenous steroids to assist with recovery, or interstitial lung disease or severe obstructive pulmonary disease;\n* History of severe allergy;\n* History of allogeneic organ transplantation or graft-versus-host disease;\n* Have received live\u002Fattenuated vaccines and mRNA vaccines within 4 weeks prior to screening or plan to receive live\u002Fattenuated vaccines and mRNA vaccines during the study period;\n* Any active infection requires systemic treatment via intravenous infusion within 4 weeks prior to the first dose of study treatment;\n* Known psychiatric disorder or drug abuse that would interfere the trial requirements;\n* Participant with uncontrolled pleural effusion, pericardial effusion or peritoneal effusion or need drainage;\n* In addition to the tumors present at the time of entry into the study, other active malignancies were present within 3 years prior to the first dose (not excluding locally cured tumors, such as skin basal cell carcinoma, superficial bladder cancer or carcinoma in situ of the breast, etc.);\n* Participants considered unsuitable for participation in this study by the investigators.","80 Years",{"count":84,"type":21},258,[59,60],"This is a multi-center, open-label, phase 1\u002F2 study to evaluate the safety, efficacy, and pharmacokinetic (PK)\u002Fpharmacodynamic (PD) characteristics of HY07121 in participants with advanced solid tumors.",[31,63,32],"2026-01-26",{"date":90,"type":40},"2026-01-28",{"date":92,"type":40},"2024-10-24",{"date":94,"type":21},"2026-10",{"name":72,"class":73},{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":100,"acronym":4,"eligibilityCriteria":101,"healthyVolunteers":102,"sex":16,"minAge":103,"maxAge":104,"enrollmentInfo":105,"targetDuration":4,"studyType":22,"phases":107,"briefSummary":109,"conditions":110,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":48},"100617794","clinical-study-on-the-effectiveness-of-diverse-segments-defocus-optimization-in-spectacle-lenses-for-slowing-myopia-progression-100617794","NCT07323251","Clinical Study on the Effectiveness of Diverse Segments Defocus Optimization in Spectacle Lenses for Slowing Myopia Progression","Inclusion Criteria:\n\n* Age 6-14 years\n* Myopic spherical equivalent refraction between -0.75D and -4.00D (inclusive of -0.75D and -4.00D, based on cycloplegic refraction)\n* Astigmatism ≤1.50D\n* Anisometropia ≤1.50D\n* Best-corrected visual acuity (BCVA) reaching 5.0 (0.00 LogMAR) or better in both eyes; monocular BCVA reaching 5.0 (0.00 LogMAR) or better after wearing myopic defocus spectacles\n* Absence of organic ocular diseases\n* No history of myopia control treatment within the past three months, including orthokeratology, progressive multifocal lenses, peripheral defocus spectacle lenses, bifocal spectacle lenses, defocus-designed soft hydrophilic contact lenses, other myopia control medications, or light-therapy devices\n* Voluntary participation in this clinical study and provision of signed informed consent\n\nExclusion Criteria:\n\n* History of ocular trauma or surgery\n* Systemic diseases affecting visual function\n* Inability to cooperate with examinations\n* Poor compliance\n* Inability to adhere to wearing requirements and follow-up visits during the trial period",true,"6 Years","14 Years",{"count":106,"type":21},120,[108],"NA","Clinical Trial\n\nThe goal of this clinical trial is to evaluate the effectiveness of two types of Diverse Segments Defocus Optimization (D.S.D.O.) spectacle lenses in slowing myopia progression in children. It will also assess the safety of these lenses. The main questions it aims to answer are:\n\nDo D.S.D.O. lenses reduce the progression of myopia as measured by changes in cycloplegic refraction and axial length? What adverse events do participants experience when wearing D.S.D.O. lenses? Researchers will compare two optical designs of D.S.D.O. lenses (Intervention Group1: Design 1; Intervention Group2: Design 2) to determine their relative efficacy in controlling myopia progression.\n\nParticipants will:\n\nWear assigned D.S.D.O. lenses daily for 12 months (except during sleep or unavoidable situations).\n\nAttend clinic visits at baseline, 3, 6, 9, and 12 months for comprehensive eye examinations.\n\nMaintain a diary recording daily wear time, visual symptoms, and any adverse events.",[111,30,112,113,32],"Children With Myopia","Multizone Lens Design for Myopic Defocus","Visual Quality","2025-12-23",{"date":116,"type":40},"2026-01-07",{"date":118,"type":40},"2024-08-02",{"date":120,"type":21},"2026-09-30",{"name":122,"class":47},"Beijing Tongren Hospital",{"id":124,"slug":125,"hasResults":11,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":4,"eligibilityCriteria":129,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":130,"enrollmentInfo":131,"targetDuration":4,"studyType":22,"phases":133,"briefSummary":134,"conditions":135,"keywords":141,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":48},"100591115","phase-1-safety-and-early-efficacy-of-ipsc-derived-motor-neuron-progenitor-cells-xs228-in-subacute-spinal-cord-injury-a-phase-i-trial-100591115","NCT06976229","Safety and Early Efficacy of iPSC-Derived Motor Neuron Progenitor Cells (XS228) in Subacute Spinal Cord Injury: A Phase I Trial","A Phase I Clinical Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of Human Allogeneic Induced Pluripotent Stem Cell (iPSC)-Derived Motor Neuron Progenitor Cells (XS228 Cell Injection) in Patients With Subacute Spinal Cord Injury","Inclusion Criteria:\n\nAge: 18 to 65 years (inclusive), regardless of gender.\n\nEtiology: Cervical (C4) to lumbar (L2) spinal cord injury (SCI) caused by traumatic injury or surgery-related factors.\n\nSeverity:\n\nClassified as ASIA Impairment Scale (AIS) Grades A, B, or C. MRI-confirmed evidence of spinal cord injury.\n\nDisease Stage:\n\nPrimary SCI occurring 14 to 60 days prior to screening (subacute phase).\n\nContraception:\n\nParticipants of childbearing potential (male and female) must agree to use effective non-hormonal contraceptive methods during the trial and for 6 months after trial completion.\n\nCompliance:\n\nVoluntarily participate in the clinical study. Ability to understand and comply with study procedures. Participant or legal guardian can provide written informed consent.\n\nExclusion Criteria:\n\n* Neurological Inability\n\nPrimary spinal cord injury (SCI) during screening with concomitant severe traumatic brain injury precluding neurological function assessment.\n\nRespiratory\u002FCirculatory Instability\n\nHigh cervical SCI (C1-C3) causing respiratory\u002Fcirculatory compromise requiring endotracheal intubation or tracheostomy.\n\nLife-Threatening Multiorgan Dysfunction\n\nConcurrent severe injuries to other organ systems with life-threatening dysfunction.\n\nUnstable Thoracoabdominal Injuries\n\nInjuries to lungs, liver, kidneys, spleen, etc., deemed unstable by the investigator.\n\nPrior Spinal Pathology\n\nHistory of SCI or coexisting spinal disorders (e.g., ankylosing spondylitis, spinal deformities, primary\u002Fmetastatic spinal tumors, spinal vascular malformations, syringomyelia).\n\nLocal Infection\u002FIncreased ICP\n\nActive infection at the lumbar puncture site or intracranial hypertension during screening.\n\nSevere Infections\n\nSepsis, septic shock, or severe pneumonia (per IDSA\u002FATS 2007 diagnostic criteria).\n\nConfounding Neurological\u002FPsychiatric Conditions\n\nParkinson's disease, severe dementia, myasthenia gravis, stroke, Guillain-Barré syndrome, diabetic neuropathy, or other conditions interfering with study assessments.\n\nCardiac Abnormalities (any of the following):\n\nCongestive heart failure (NYHA Class III\u002FIV). Severe uncontrolled arrhythmias (e.g., sick sinus syndrome, third-degree AV block).\n\nUnstable angina or acute myocardial infarction within 3 months prior. Pulmonary Complications\n\nPulmonary hypertension, pulmonary embolism, or suspected embolism during screening.\n\nUncontrolled Hypertension\u002FHypotension\n\nSystolic BP \\>160 mmHg or diastolic BP \\>100 mmHg; or systolic BP \\\u003C90 mmHg or diastolic BP \\\u003C60 mmHg.\n\nActive Autoimmune Diseases\n\nRequiring immunosuppressants (e.g., uncontrolled hyperthyroidism, systemic lupus erythematosus).\n\nImmunosuppressant Non-Compliance\n\nUnwillingness or inability to use immunosuppressants per protocol.\n\nLaboratory Abnormalities (any of the following):\n\nALT\u002FAST \\>2×ULN or total bilirubin \\>2×ULN. eGFR \\\u003C60 mL\u002Fmin\u002F1.73m² (CKD-EPI 2021 formula). APTT\u002FPT \\>2.5×ULN (without anticoagulants). Platelets \\\u003C100×10⁹\u002FL or hemoglobin \\\u003C90 g\u002FL. Allergy\n\nHistory of severe allergies or hypersensitivity to trial drug\u002Fexcipients (human albumin, lactated Ringer's solution).\n\nInfectious Diseases\n\nHBsAg+ with HBV DNA \\>1000 IU\u002FmL; HCV-Ab+; HIV-Ab+; or TP-Ab+. Lumbar Puncture Refusal\n\nUnwillingness to undergo intrathecal administration procedures. Pregnancy\u002FLactation\n\nFemales who are pregnant or breastfeeding. Malignancy\n\nActive malignancy or anticancer therapy within 5 years prior. Recent Clinical Trial Participation\n\nEnrollment in another drug trial within 3 months prior. Investigator Discretion\n\nAny condition deemed unsuitable for participation by the investigator.","65 Years",{"count":132,"type":21},12,[59],"This Phase I clinical trial is designed to evaluate the safety, tolerability of XS228 ( iPSC-Derived Motor Neuron Progenitor Cells) in patients with Subacute Spinal Cord Injury",[136,31,137,32,138,139,140],"Spinal Cord Injury","Clinical Trials","Induced Pluripotent Stem Cells","Human Motor Neuron Progenitor","Transplantation",[142,143,144,145,138,146,140],"spinal cord injury","safety","efficacy","clinical trials","Human motor neuron progenitor","2025-11-19",{"date":149,"type":40},"2025-11-25",{"date":151,"type":40},"2025-07-02",{"date":153,"type":21},"2028-05-30",{"name":155,"class":73},"XellSmart Bio-Pharmaceutical (Suzhou) Co., Ltd.",{"id":157,"slug":158,"hasResults":11,"nctId":159,"briefTitle":160,"officialTitle":161,"acronym":4,"eligibilityCriteria":162,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":130,"enrollmentInfo":163,"targetDuration":4,"studyType":22,"phases":165,"briefSummary":166,"conditions":167,"keywords":170,"overallStatus":172,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":173,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":48},"100591018","phase-2-efficacy-of-ipsc-derived-motor-neuron-cells-xs228-in-subacute-spinal-cord-injury-a-phase-ii-randomized-controlled-trial-100591018","NCT06974968","Efficacy of iPSC-Derived Motor Neuron Cells (XS228) in Subacute Spinal Cord Injury: A Phase II Randomized Controlled Trial","A Phase II Clinical Study Evaluating the Preliminary Efficacy of Human Allogeneic Induced Pluripotent Stem Cell (iPSC)-Derived Motor Neuron Progenitor Cells (XS228 Cell Injection) in Patients With Subacute Spinal Cord Injury","Inclusion Criteria:\n\n* Age: 18 to 65 years (inclusive), regardless of gender.\n\nEtiology: Cervical (C4) to lumbar (L2) spinal cord injury (SCI) caused by traumatic injury or surgery-related factors.\n\nSeverity:\n\nClassified as ASIA Impairment Scale (AIS) Grades A, B, or C. MRI-confirmed evidence of spinal cord injury.\n\nDisease Stage:\n\nPrimary SCI occurring 14 to 60 days prior to screening (subacute phase).\n\nContraception:\n\nParticipants of childbearing potential (male and female) must agree to use effective non-hormonal contraceptive methods during the trial and for 6 months after trial completion.\n\nCompliance:\n\nVoluntarily participate in the clinical study. Ability to understand and comply with study procedures. Participant or legal guardian can provide written informed consent.\n\nExclusion Criteria:\n\n* Neurological Inability\n\nPrimary spinal cord injury (SCI) during screening with concomitant severe traumatic brain injury precluding neurological function assessment.\n\nRespiratory\u002FCirculatory Instability\n\nHigh cervical SCI (C1-C3) causing respiratory\u002Fcirculatory compromise requiring endotracheal intubation or tracheostomy.\n\nLife-Threatening Multiorgan Dysfunction\n\nConcurrent severe injuries to other organ systems with life-threatening dysfunction.\n\nUnstable Thoracoabdominal Injuries\n\nInjuries to lungs, liver, kidneys, spleen, etc., deemed unstable by the investigator.\n\nPrior Spinal Pathology\n\nHistory of SCI or coexisting spinal disorders (e.g., ankylosing spondylitis, spinal deformities, primary\u002Fmetastatic spinal tumors, spinal vascular malformations, syringomyelia).\n\nLocal Infection\u002FIncreased ICP\n\nActive infection at the lumbar puncture site or intracranial hypertension during screening.\n\nSevere Infections\n\nSepsis, septic shock, or severe pneumonia (per IDSA\u002FATS 2007 diagnostic criteria).\n\nConfounding Neurological\u002FPsychiatric Conditions\n\nParkinson's disease, severe dementia, myasthenia gravis, stroke, Guillain-Barré syndrome, diabetic neuropathy, or other conditions interfering with study assessments.\n\nCardiac Abnormalities (any of the following):\n\nCongestive heart failure (NYHA Class III\u002FIV). Severe uncontrolled arrhythmias (e.g., sick sinus syndrome, third-degree AV block).\n\nUnstable angina or acute myocardial infarction within 3 months prior. Pulmonary Complications\n\nPulmonary hypertension, pulmonary embolism, or suspected embolism during screening.\n\nUncontrolled Hypertension\u002FHypotension\n\nSystolic BP \\>160 mmHg or diastolic BP \\>100 mmHg; or systolic BP \\\u003C90 mmHg or diastolic BP \\\u003C60 mmHg.\n\nActive Autoimmune Diseases\n\nRequiring immunosuppressants (e.g., uncontrolled hyperthyroidism, systemic lupus erythematosus).\n\nImmunosuppressant Non-Compliance\n\nUnwillingness or inability to use immunosuppressants per protocol.\n\nLaboratory Abnormalities (any of the following):\n\nALT\u002FAST \\>2×ULN or total bilirubin \\>2×ULN. eGFR \\\u003C60 mL\u002Fmin\u002F1.73m² (CKD-EPI 2021 formula). APTT\u002FPT \\>2.5×ULN (without anticoagulants). Platelets \\\u003C100×10⁹\u002FL or hemoglobin \\\u003C90 g\u002FL. Allergy\n\nHistory of severe allergies or hypersensitivity to trial drug\u002Fexcipients (human albumin, lactated Ringer's solution).\n\nInfectious Diseases\n\nHBsAg+ with HBV DNA \\>1000 IU\u002FmL; HCV-Ab+; HIV-Ab+; or TP-Ab+. Lumbar Puncture Refusal\n\nUnwillingness to undergo intrathecal administration procedures. Pregnancy\u002FLactation\n\nFemales who are pregnant or breastfeeding. Malignancy\n\nActive malignancy or anticancer therapy within 5 years prior. Recent Clinical Trial Participation\n\nEnrollment in another drug trial within 3 months prior. Investigator Discretion\n\nAny condition deemed unsuitable for participation by the investigator",{"count":164,"type":21},60,[60],"Purpose: This clinical trial is studying an investigational cell therapy called XS228-a lab-made stem cell product designed to help repair damaged nerves in the spinal cord. The goal is to see if XS228 is safe and can improve movement, sensation, and function in people with recent spinal cord injuries.\n\nStudy Treatment: XS228 contains specialized nerve-supporting cells derived from human stem cells. These cells are injected into the spinal fluid (intrathecal administration) in a single dose.\n\nWho Can Join? Adults aged 18-65 with a spinal cord injury (thoracic or lumbar level) that occurred 2-12 weeks before enrollment. Participants must have severe but incomplete paralysis (ASIA Impairment Scale Grade A , B or C).\n\nStudy Plan:\n\nPhase II (Main Study): About 60 participants will be randomly assigned to receive either XS228 or a placebo (inactive solution) in a 2:1 ratio.\n\nFollow-up: Patients will be monitored for 1 year, with regular check-ups to assess safety, nerve function, and recovery progress.\n\nWhat Researchers Are Looking For:\n\nPrimary Goal: Measure changes in leg and arm function using the ASIA Motor Score at 6 months.\n\nSecondary Goals:\n\nImprovement in ASIA Impairment Scale (AIS) grade (e.g., from \"complete\" to \"incomplete\" paralysis).\n\nRecovery of sensation and bladder\u002Fbowel control. Safety (monitoring for side effects like infections or immune reactions). Exploratory Tests: MRI scans and biomarker tests in spinal fluid to see if the treatment helps nerve regrowth.\n\nWhy This Study Matters: If successful, XS228 could become the first stem cell therapy to promote meaningful recovery in spinal cord injury patients. Currently, no treatments exist to repair nerve damage-this trial aims to change that.",[136,31,32,168,138,139,140,169],"Clinical Trial","RCT",[136,31,144,171,138,146,140,169],"clinical trial","NOT_YET_RECRUITING",{"date":149,"type":40},{"date":175,"type":21},"2028-05-25",{"date":177,"type":21},"2031-05-26",{"name":155,"class":73},{"id":180,"slug":181,"hasResults":11,"nctId":182,"briefTitle":183,"officialTitle":184,"acronym":4,"eligibilityCriteria":185,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":186,"targetDuration":4,"studyType":22,"phases":188,"briefSummary":189,"conditions":190,"keywords":4,"overallStatus":172,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":48},"100602984","phase-1-evaluation-of-the-efficacy-and-safety-of-megestrol-acetate-in-preventing-nausea-and-vomiting-induced-by-highly-emetogenic-chemotherapy-100602984","NCT07130617","Evaluation of the Efficacy and Safety of Megestrol Acetate in Preventing Nausea and Vomiting Induced by Highly Emetogenic Chemotherapy","A Phase Ib, Multicenter, Randomized, Double-blind, Placebo-controlled Parallel Group Clinical Study Evaluating the Efficacy and Safety of Megestrol Acetate Oral Suspension in Preventing Nausea and Vomiting Induced by Highly Emetogenic Chemotherapy","Inclusion Criteria:\n\n1. Age ≥ 18 years, regardless of sex\n2. Histologically or cytologically confirmed lung cancer\n3. Expected survival ≥ 3 months\n4. Female subjects of childbearing potential must have negative serum pregnancy test within 72 hours prior to randomization and must be non-lactating\n5. Capable of comprehending and willingly providing signed informed consent form (ICF), and adhering to study requirements\u002Frestrictions Exclusion Criteria\n\n1\\. Received or scheduled to receive concurrent radiotherapy within 7 days prior to enrollment through Day 1-8 of treatment 2. Systemic corticosteroid therapy or sedating antihistamines within 7 days prior to enrollment 3. Poorly controlled serous cavity effusions (pleural\u002Fperitoneal\u002Fpericardial) 4. Severe cardiovascular diseases within 3 months prior to enrollment 5. Participation in other clinical trials within 30 days prior to enrollment",{"count":187,"type":21},132,[59],"To evaluate the efficacy of Megestrol Acetate Oral Suspension in Preventing Nausea and Vomiting Induced by Highly Emetogenic Chemotherapy in Malignant Solid Tumor Patients",[32,31,191,192],"Megestrol Acetate","Adult Subject","2025-08-12",{"date":195,"type":40},"2025-08-19",{"date":197,"type":21},"2025-09-29",{"date":199,"type":21},"2026-07-31",{"name":201,"class":73},"Changchun GeneScience Pharmaceutical Co., Ltd.",{"id":203,"slug":204,"hasResults":11,"nctId":205,"briefTitle":206,"officialTitle":206,"acronym":4,"eligibilityCriteria":207,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":82,"enrollmentInfo":208,"targetDuration":4,"studyType":22,"phases":210,"briefSummary":211,"conditions":212,"keywords":218,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":219,"lastUpdatePostDateStruct":220,"startDateStruct":222,"completionDateStruct":224,"leadSponsor":226,"locationsCount":228},"100565457","effect-of-vitamin-d-supplementation-on-the-efficacy-and-adverse-effects-of-neoadjuvant-therapy-in-patients-with-breast-cancer-100565457","NCT06642428","Effect of Vitamin D Supplementation on the Efficacy and Adverse Effects of Neoadjuvant Therapy in Patients with Breast Cancer","Inclusion Criteria:\n\n1. Age between 18 and 80 years, with an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.\n2. Primary diagnosis of breast cancer confirmed by preoperative pathological examination.\n3. Serum 25(OH)D levels less than 20 ng\u002Fml (50 nmol\u002FL).\n4. Patients who have not previously received chemotherapy and who plan to undergo at least 4 cycles of 5.neoadjuvant chemotherapy or combined targeted therapy.\n\n6.Life expectancy of at least 6 months. 7.No other uncontrolled benign diseases at the time of recruitment. 8.All patients must have complete clinical medical records. 9.Willingness to voluntarily sign an informed consent form.\n\nExclusion Criteria:\n\n1. History of invasive breast cancer.\n2. Prior systemic treatment for the treatment or prevention of breast cancer.\n3. Known allergic reactions to vitamin D or calcium compounds.\n4. Comorbidities that may affect vitamin D or calcium balance or bone health.\n5. Vitamin D or calcium supplementation in the past 3 months.\n6. Presence of other tumors.\n7. Pregnant or lactating women.\n8. Individuals who do not wish to participate in the study.",{"count":209,"type":21},140,[108],"This randomized controlled Phase III trial was designed to evaluate the impact of supplemental vitamin D (VD) on the efficacy and side effects of neoadjuvant therapy in patients with breast cancer.",[213,214,215,216,32,217],"Vitamin D","Neoadjuvant Therapy","Breast Cancer","Adverse Reaction","Chemotherapy",[213,215,216,32],"2025-01-16",{"date":221,"type":40},"2025-01-17",{"date":223,"type":40},"2024-10-18",{"date":225,"type":21},"2026-04-30",{"name":227,"class":47},"Jiuda Zhao",2,{"id":230,"slug":231,"hasResults":11,"nctId":232,"briefTitle":233,"officialTitle":234,"acronym":235,"eligibilityCriteria":236,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":237,"targetDuration":4,"studyType":22,"phases":239,"briefSummary":240,"conditions":241,"keywords":4,"overallStatus":172,"whyStopped":4,"lastUpdateSubmitDate":242,"lastUpdatePostDateStruct":243,"startDateStruct":245,"completionDateStruct":247,"leadSponsor":249,"locationsCount":4},"100531209","phase-1-ak112-plus-platinum-based-chemotherapy-for-egfralkros1-positve-nsclc-100531209","NCT06196814","AK112 Plus Platinum-based Chemotherapy for EGFR\u002FALK\u002FROS1 Positve NSCLC","Efficay and Satety of PD-1\u002FVEGR Bispecific Antibodies (AK112) Plus Platinum-based Chemotherapy for EGFR\u002FALK\u002FROS1 Positve NSCLC: A Multiple Centers, Multiple Cohorts, Dose Escalation Phase II Apple Study","Apple","Inclusion Criteria:\n\n* Eligible subjects selected for this study must meet all of the following criteria:\n\n  1. Sign written informed consent before implementing any trial-related procedures;\n  2. Age ≥18 years old and ≤75 years old;\n  3. No limit on the gender;\n  4. The ECOG score is 0 or 1.\n* The investigators want to evaluated the Efficay and Satety of PD-1\u002FVEGR bispecific antibodies (AK112) plus Platinum-based Chemotherapy for EGFR\u002FALK\u002FROS1 Positve NSCLC who Failed from First-Line Standard Treatment.\n\nThis study will be devided into three cohorts.\n\n* Cohort A for EGFR mutation NSCLC, Patient with NGS idenfied EGFR sensitive mutation NSCLC who failed from first line Osimertinib will be included. The 3+3 stud will conducted for dose escalation for AK112 （from 20mg to 30mg), and than the fix dose will be set up for cohort A, B and C.\n* Cohort B for ALK fusion NSCLC, Patient with NGS idenfied ALK fusion NSCLC who failed from first line Alectinib will be included. All the patients will be devided two group,3'ALK and 3'ALK with reteintion of 5'ALK. All the patients will be treated with PD-1\u002FVEGR bispecific antibodies (AK112) plus Platinum-based Chemotherapy.\n* Cohort C for ROS1 fusion NSCLC, Patient with NGS idenfied ROS1 fusion NSCLC who failed from first line crizotinib or Entrectinib will be included. All the patients will be treated with PD-1\u002FVEGR bispecific antibodies (AK112) plus Platinum-based Chemotherapy.\n\nThe investigators will collect the satety and efficacy data for all the patients.\n\nExclusion Criteria:\n\n* Histological or cytological pathology confirmed the presence of a small cell carcinoma component, or a squamous cell carcinoma as a major component\n* Patients who have received immunotherapy previously, including immune checkpoint inhibitors (such as anti-PD-1\u002FL1, anti-CTLA-4 , anti-LAG-3, etc.), immune checkpoint activators (such as ICOS, CD40, CD137, GITR, OX40 antibodies, etc.), immune cell therapy and any other treatment targeting the immunity mechanism.\n* Previously received other anti-tumor therapy for advanced stages of NSCLC (stages IIIB to IV) (including cytotoxic chemotherapy used with radiotherapy, systemic chemotherapy, and anti-VEGFR therapy) .\n\nPatients who have previously undergone adjuvant\u002Fneoadjuvant chemotherapy with the aim of curing non-metastatic diseases are eligible for inclusion in this study if disease progression occurs at least 6 months after the completion of the last chemotherapy cycle.\n\n* Concurrent enrollment in another clinical trial is allowed, unless it involves a non-interventional clinical study or the follow-up period of an interventional study (defined as the time elapsed from the initiation of the first drug to at least 4 weeks after the last drug administration in the previous clinical study or beyond 5 half-lives of the investigational drug in that study, whichever is shorter).\n* Received TKI treatment within the 2 weeks preceding the first dose; underwent palliative local therapy for non-target lesions within the 2 weeks preceding the first dose; received non-specific immunomodulatory therapy within the 2 weeks preceding the first dose, such as interleukins, interferons, thymosin alpha-1, tumor necrosis factor, etc. (excluding IL-11 used for treating thrombocytopenia); received herbal medicine or traditional Chinese medicine with anti-tumor indications within the 1 week preceding the first dose.",{"count":238,"type":21},150,[59,60],"The investigators want to evaluated the Efficay and Satety of PD-1\u002FVEGR bispecific antibodies (AK112) plus Platinum-based Chemotherapy for EGFR\u002FALK\u002FROS1 Positve NSCLC who Failed from First-Line Standard Treatment.",[32],"2024-10-06",{"date":244,"type":40},"2024-10-09",{"date":246,"type":21},"2024-10-01",{"date":248,"type":21},"2027-02-01",{"name":250,"class":47},"Hunan Province Tumor Hospital",{"id":252,"slug":253,"hasResults":11,"nctId":254,"briefTitle":255,"officialTitle":256,"acronym":4,"eligibilityCriteria":257,"healthyVolunteers":11,"sex":258,"minAge":17,"maxAge":18,"enrollmentInfo":259,"targetDuration":4,"studyType":22,"phases":261,"briefSummary":263,"conditions":264,"keywords":4,"overallStatus":172,"whyStopped":4,"lastUpdateSubmitDate":267,"lastUpdatePostDateStruct":268,"startDateStruct":270,"completionDateStruct":271,"leadSponsor":273,"locationsCount":4},"100557513","phase-3-fluzoparib-in-combination-with-apatinib-mesylate-for-maintenance-therapy-in-stage-iii-iv-ovarian-cancer-100557513","NCT06539091","Fluzoparib in Combination With Apatinib Mesylate for Maintenance Therapy in Stage III-IV Ovarian Cancer","A Single-Arm, Open, Multicenter, Exploratory Clinical Study of Fluzoparib in Combination With Apatinib Mesylate for Maintenance Therapy in Stage III-IV Ovarian Cancer (FAT-1)","Inclusion Criteria:\n\n* ECOG PS: 0-1;\n\n  * Initially treated patients with histologically or cytologically confirmed high-grade plasma ovarian cancer (HGSOC), fallopian tube cancer, primary peritoneal cancer, or endometrioid carcinoma of the ovary with FIGO stage III-IV;\n\n    * No prior maintenance therapy with PARP inhibitors; ④Final use of a combination chemotherapy regimen of bevacizumab, paclitaxel and carboplatin; ⑤Good function of major organs; ⑥Subjects voluntarily enrolled in this study, signed an informed consent form, had good compliance, and cooperated with follow-up visits; ⑦The modeled CA-125 ELIMination rate constant K (KELIM) ≥ 1.\n\nExclusion Criteria:\n\n* Patients concurrently enrolled in other clinical trials;\n\n  * Previous maintenance therapy with PARP inhibitors combined with anti-angiogenic drugs;\n\n    * Previous history of allergic reaction, hypersensitivity reaction, intolerance to antibody-based drugs;\n\n      * Previous significant allergy to drugs or food or other substances;\n\n        * Subjects with untreated CNS metastases, previously treated with systemic, radical brain or meningeal metastases (radiotherapy or surgery), may be included if imaging confirms that stabilization has been maintained for at least 1 month and systemic hormone therapy (dose \\>10mg\u002Fday prednisone or other isotonic hormones) has been discontinued for \\>2 weeks without clinical evidence;\n\n          * Those who are unable to swallow tablets normally, or have abnormal gastrointestinal function that, in the judgment of the investigator, may interfere with drug absorption;\n\n            * Have experienced clinically significant bleeding symptoms or have a clear bleeding tendency within 3 months prior to randomization, such as peptic bleeding, bleeding gastric ulcer or suffering from vasculitis, etc. If the fecal occult blood is positive at the baseline period, it can be reviewed, and if it is still positive after review, combined with the clinical judgment, and if necessary, gastroscopy can be performed; ⑧The presence of currently uncontrolled malignant pleural fluid, ascites or pericardial effusion (defined as not effectively controlled by diuretics or puncture, as judged by the investigator);\n\n              * Presence of uncontrolled comorbidities including, but not limited to: active HBV or HCV infection, known HIV infection or history of AIDS, active syphilis, active tuberculosis, active infections, uncontrolled hypertension, symptomatic cardiac insufficiency, and active bleeding;\n\n                * Previous (within 5 years) or concurrent other untreated malignant tumors, except for cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, and breast cancer without recurrence \\> 3 years after completion of radical surgery; ⑪Women during pregnancy or lactation; ⑫Having taken a drug that clearly affects the study drug within 30 days or 5 half-lives (whichever is longer) prior to enrollment; ⑬In the judgment of the investigator, the subject has other factors that may cause this study to be forcibly terminated midway, such as other serious illnesses (including psychiatric illnesses) that require comorbid treatment, serious laboratory test abnormalities, accompanied by family or social factors that would affect the subject's safety, or the collection of data and samples.","FEMALE",{"count":260,"type":21},51,[262],"PHASE3","This study is a single-arm, open, multicenter, exploratory clinical study to observe and evaluate the efficacy and safety of fluazoparib combined with apatinib mesylate in the treatment of patients with ovarian cancer.\n\nPatients with epithelial ovarian, fallopian tube, and primary peritoneal cancers will be selected as the study population with Progression-Free Survival (PFS) as the primary study endpoint, and Overall Survival (OS), Duration Of Response (DOR), Quality of Life Score QoL, Chemotherapy-Free Interval (CFI), Progression-Free Survival 2 (PFS-2), CA125 response criteria by GCGI, to access the safety、Bone Mineral Density (BMD) changes and the tolerability of fluazoparib in combination with apatinib mesylate.\n\nThe study is planned to enroll 51 subjects, all of whom will receive study treatment after being signed informed and screened.",[265,32,31,266,63],"Epithelial Ovarian Cancer","Bone Mineral Density","2024-08-03",{"date":269,"type":40},"2024-08-06",{"date":246,"type":21},{"date":272,"type":21},"2026-10-01",{"name":274,"class":275},"Anhui Provincial Hospital","OTHER_GOV",{"id":277,"slug":278,"hasResults":11,"nctId":279,"briefTitle":280,"officialTitle":281,"acronym":4,"eligibilityCriteria":282,"healthyVolunteers":11,"sex":258,"minAge":17,"maxAge":18,"enrollmentInfo":283,"targetDuration":4,"studyType":22,"phases":285,"briefSummary":286,"conditions":287,"keywords":4,"overallStatus":172,"whyStopped":4,"lastUpdateSubmitDate":267,"lastUpdatePostDateStruct":290,"startDateStruct":292,"completionDateStruct":293,"leadSponsor":295,"locationsCount":4},"100557779","phase-3-efficacy-and-safety-of-ak104-pd-1ctla-4-bispecial-antibody-combined-with-chemotherapy-for-neoadjuvant-treatment-of-advanced-ovarian-cancer-100557779","NCT06542549","Efficacy and Safety of AK104 (PD-1\u002FCTLA-4 Bispecial Antibody) Combined With Chemotherapy for Neoadjuvant Treatment of Advanced Ovarian Cancer","Efficacy and Safety of AK104 (PD-1\u002FCTLA-4 Bi-specific Antibody) Combined With Chemotherapy for Neoadjuvant Treatment of Advanced Ovarian Cancer: a Randomized Controlled, Single-center Clinical Study","Inclusion Criteria:\n\n1. Agree to sign the informed consent form.\n2. 18 years ≤ age \\\u003C75 years, female.\n3. Patients with epithelial ovarian cancer (high-grade serous adenocarcinoma, ovarian endometrial carcinoid adenocarcinoma), peritoneal or fallopian tube carcinoma, or clear cell carcinoma confirmed by histopathology, FIGO 2018 stage III-IV.\n4. Evidence of compliance with neoadjuvant chemotherapy for ovarian cancer: (a) Preoperative evaluation by gynecologic oncologists (multidisciplinary if necessary) indicates that R0 resection is less likely to be achieved after primary tumor reduction; (b) Patients whose physical state cannot tolerate PDS and are not suitable for immediate surgery (such as perioperative high risk, old age, medical complications, etc.); (c) Without any systematic anti-tumor therapy for ovarian cancer (including but not limited to radiotherapy, chemotherapy, surgery, targeted therapy and immunotherapy); Note: Histopathology is obtained by puncture biopsy, laparoscopic exploration, etc. Lymph node resection or biopsy for clinical staging purposes is permitted.\n5. Those with at least one measurable lesion (RECIST version 1.1).\n6. ECOG Physical status score 0-2.\n7. Estimated survival time \\> 12 weeks.\n8. Good organ function.\n9. Participants of reproductive age must agree to use effective contraception during the trial; Serum or urine pregnancy tests for women of childbearing age must be negative.\n10. Non-lactating patients.\n\nExclusion Criteria:\n\n1. Ovarian cancer, fallopian tube cancer, primary peritoneal cancer (such as germ cell tumor) of non-epithelial origin; Ovarian tumors with low malignant potential (e.g., borderline tumors).\n2. Patients with other malignant tumors in the past (within 5 years) or at the same time, with the exception of cured local tumors (such as basal cell skin cancer, squamous cell skin cancer, superficial bladder cancer, cervical carcinoma in situ, breast carcinoma in situ, etc.) and breast cancer with no recurrence \\>3 years after radical surgery.\n3. Subjects with active viral hepatitis B, inactive or asymptomatic hepatitis B virus (HBV) carriers (HBV surface antigen \\[HBsAg\\] positive) with HBV DNA \\> 1000 IU\u002FmL, and subjects with active viral hepatitis C. Note: Inactive or asymptomatic carriers, treated and stable hepatitis B subjects with HBV DNA ≤ 1000 IU\u002FmL were admitted. Subjects with cured viral hepatitis C, HCVAb positive and HCV RNA negative were admitted.\n4. A history of testing positive for known human immunodeficiency virus or known acquired immunodeficiency syndrome.\n5. Have an active or possibly recurring autoimmune disease; The following are excluded: vitiligo, alopecia, psoriasis or eczema that do not require systematic treatment; Hypothyroidism due to autoimmune thyroiditis requires only stable dose hormone replacement therapy; Only a steady dose of insulin replacement is required for type 1 diabetes.\n6. A history of severe allergic reactions to any monoclonal antibody and\u002For investigational drug ingredient.\n7. Subjects with known active TB and suspected active TB should undergo clinical examination to rule out known active syphilis infection.\n8. There is a history or current presence of noninfectious pneumonia\u002Finterstitial lung disease requiring systemic glucocorticoid therapy.\n9. Severe infections occurring within 4 weeks prior to first dosing, including but not limited to active infections with comorbidification requiring hospitalization, sepsis, or severe pneumonia that received systemic anti-infective therapy within 2 weeks prior to first dosing (excluding antiviral therapy for hepatitis B or C).\n10. Serious medical conditions or concomitant non-oncological conditions, such as neurological disorders, psychosis, infectious diseases, or laboratory abnormalities, may increase the risk of participating in the study or taking the investigational drug, which the investigator believes would make the patient unfit for entry into the study.\n11. Patients with clinically significant cardiovascular disease.\n12. Patients who were judged by the investigator to be unsuitable for this study.",{"count":284,"type":21},100,[262],"This is a randomized, controlled, single-center clinical study to evaluate AK104 in FIGO 2018 stage III-IV ovarian cancer subjects who were assessed to be at high perioperative risk and\u002For unable to achieve R0 resection prior to initial treatment. The efficacy and safety of neoadjuvant therapy with intravenous infusion combined with chemotherapy compared with chemotherapy alone.",[288,289,217,32,31],"Advanced Ovarian Cancer","AK104(PD-1\u002FCTLA-4 Bispecial Antibody)",{"date":291,"type":40},"2024-08-07",{"date":246,"type":21},{"date":294,"type":21},"2030-10-31",{"name":274,"class":275},{"id":297,"slug":298,"hasResults":11,"nctId":299,"briefTitle":300,"officialTitle":300,"acronym":4,"eligibilityCriteria":301,"healthyVolunteers":11,"sex":16,"minAge":302,"maxAge":17,"enrollmentInfo":303,"targetDuration":4,"studyType":305,"phases":4,"briefSummary":306,"conditions":307,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":311,"lastUpdatePostDateStruct":312,"startDateStruct":314,"completionDateStruct":316,"leadSponsor":318,"locationsCount":48},"100556814","clinical-follow-up-study-of-rituximab-in-the-treatment-of-nephrotic-syndrome-in-children-100556814","NCT06530004","Clinical Follow-up Study of Rituximab in the Treatment of Nephrotic Syndrome in Children","Inclusion Criteria:\n\n* Children clinically diagnosed with FRNS\u002FSDNS\u002FSRNS with complete clinical data;\n* age \\\u003C 18 years old;\n* For the first time using RTX treatment, and used in nephrotic syndrome ease;\n* The follow-up for 1 year or more.\n\nExclusion Criteria:\n\n* Congenital or infantile nephrotic syndrome, secondary nephrotic syndrome (such as lupus nephritis, IgA nephropathy, purpura nephritis, hepatitis B nephritis, etc.);\n* Active stage of hepatitis, complicated with severe infection, severe deficiency of immune response, malignant diseases;\n* Estimated glomerular filtration rate (GFR) \\\u003C60mL\u002Fmin\u002F1.73m2.","1 Year",{"count":304,"type":21},50,"OBSERVATIONAL","This was a retrospective study. Children who were diagnosed with refractory nephrotic syndrome and treated with rituximab (RTX) and followed up for ≥1 year in the Department of Pediatrics, the First Affiliated Hospital of Xiamen University from March 2020 to March 2026 were enrolled. Personal information, past medical history, clinical examination data and follow-up data before and after the use of RTX were extracted from the medical record system. (1) The median relapse-free survival, the number of relapses and the adverse reactions of RTX were compared before and after RTX treatment, and the clinical efficacy and safety of RTX were evaluated. (2) By comparing the annual relapse frequency, reduction and withdrawal of steroids and immunosuppressive agents, B cell reconstitution and adverse drug reactions between prophylactic RTX and post-relapse RTX maintenance regimens; (3) Multivariate analysis of risk factors for recurrence of nephropathy after RTX treatment. (4) growth indicators monitoring patient evaluation and RTX medical economic benefit analysis.",[308,309,310,32],"Nephrotic Syndrome","Rituximab","Children","2024-07-29",{"date":313,"type":40},"2024-07-31",{"date":315,"type":40},"2020-03-01",{"date":317,"type":21},"2028-03-01",{"name":319,"class":47},"The First Affiliated Hospital of Xiamen University",{"id":321,"slug":322,"hasResults":11,"nctId":323,"briefTitle":324,"officialTitle":325,"acronym":4,"eligibilityCriteria":326,"healthyVolunteers":11,"sex":16,"minAge":327,"maxAge":4,"enrollmentInfo":328,"targetDuration":4,"studyType":22,"phases":330,"briefSummary":331,"conditions":332,"keywords":4,"overallStatus":172,"whyStopped":4,"lastUpdateSubmitDate":333,"lastUpdatePostDateStruct":334,"startDateStruct":336,"completionDateStruct":338,"leadSponsor":340,"locationsCount":4},"100534313","phase-2-genome-based-assessment-of-niraparib-zejula-efficacy-in-advanced-solid-tumors-with-homologous-recombination-deficiency-100534313","NCT06237205","Genome-Based Assessment of Niraparib (ZEJULA®) Efficacy in Advanced Solid TumorS With Homologous Recombination Deficiency","Genome-Based Assessment of Niraparib (ZEJULA®) Efficacy in Advanced Solid TumorS With Homologous Recombination Deficiency (GAUSS)","Inclusion Criteria:\n\n1. Patient who agreed to participate in the KOSMOS-II master observation study.\n2. 19 years of age or older on the day of signing informed consent.\n3. Has a histologically- or cytologically-confirmed advanced (metastatic and\u002For unresectable) solid tumor.\n4. Has either known or suspected deleterious mutations in at least 1 of the genes involved in HRR or centrally confirmed HRD based on whole-genome sequencing (WGS).\n5. Has Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.\n6. Has measurable disease per RECIST v1.1 as assessed by the local site investigator.\n7. Female participants of reproductive potential must agree to use contraception during the treatment period and for at least 6 months after the last dose. Male participants must agree to use contraception during the treatment period and for 90 days plus 5 X half-life after last dose.\n8. Has adequate organ function.\n9. Willing to provide biopsies from the tumor at screening to the central laboratory\n\nExclusion Criteria:\n\n1. Any previous exposure to PARP inhibitor\n2. Any other active malignancy or diagnosis of another malignancy within 2 years before study enrollment\n3. Has leptomeningeal metastases.\n4. Active central nervous system (CNS) lesions.\n5. Were resistant to prior platinum therapy (cisplatin, carboplatin, or oxaliplatin either as monotherapy or in combination) for advanced (metastatic and\u002For unresectable) solid tumor.\n6. Any cytotoxic chemotherapy from a previous treatment regimen within 14 days.\n7. Has received prior endocrine therapy as cancer treatment within 2 weeks prior to administration of study intervention.\n8. Has received palliative radiotherapy encompassing \\>20% of the bone marrow within 1 week of the first dose of study treatment.\n9. Has an active infection requiring systemic therapy.\n10. Has hypertension that cannot be adequately controlled with medication.\n11. Has active tuberculosis.\n12. Has active infection such as hepatitis B, hepatitis C\n13. Has a known history of Human Immunodeficiency Virus (HIV) infection.\n\n15\\) Impairment of gastrointestinal function or gastrointestinal disorders 16) Is pregnant or breastfeeding or expecting to conceive children within the projected duration of the study, starting with the screening visit through 6 months after the last dose of the Investigational product.\n\n17\\) Patients who do not consent to adequate contraception throughout the study period.\n\n18\\) Has a known hypersensitivity to the components of the investigational product or its analogs.\n\n19\\) Since this drug contains lactose, patients with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.\n\n20\\) Since this drug contains Yellow No. 4 (Tartrazine), patients with a history of hypersensitivity or allergy to this ingredient.\n\n21\\) Medical, psychiatric, cognitive, or other conditions that may interfere with the ability of the subject to understand the subject information, provide the informed consent, follow the protocol process, or complete the clinical trial.\n\n22\\) The investigator judges that it is not appropriate to participate in this study for else reasons.","19 Years",{"count":329,"type":21},33,[60],"Investigational Products: Niraparib Period: 3 years after IRB\u002FEC approval Indication: Adult patients with histologically confirmed and locally advanced, unresectable, or metastatic solid tumors having known or suspected deleterious mutations in genes involved in homologous recombination repair (HRR) or homologous recombination deficiency identified by whole genome sequencing",[32],"2024-01-23",{"date":335,"type":40},"2024-02-01",{"date":337,"type":21},"2024-02-27",{"date":339,"type":21},"2027-06-30",{"name":341,"class":47},"Korea University Anam Hospital",{"id":343,"slug":344,"hasResults":11,"nctId":345,"briefTitle":346,"officialTitle":346,"acronym":4,"eligibilityCriteria":347,"healthyVolunteers":102,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":348,"targetDuration":4,"studyType":22,"phases":350,"briefSummary":351,"conditions":352,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":355,"lastUpdatePostDateStruct":356,"startDateStruct":358,"completionDateStruct":360,"leadSponsor":362,"locationsCount":228},"100491635","phase-3-pyloplus-urea-breath-test-system-post-therapy-efficacy-confirmation-study-100491635","NCT05681689","PyloPlus Urea Breath Test System Post Therapy Efficacy Confirmation Study","Inclusion Criteria:\n\n* Male or Female at least 18 years of age\n* Patients who have been diagnosed with H. pylori and have been treated within the past 6 months\n* Naive to H. pylori treatment in the past 4 weeks (including PPIs)\n\nExclusion Criteria:\n\n* Pregnant and\u002For lactating women.\n* Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.\n* Participation in other interventional trials.\n* Allergy to test substrates.\n* Antibiotics taken within 4 weeks of the testing.\n* Study subjects shall not consume the following items at least 1 hour prior to the PPUBT test: Mouthwash, Chewing Gum, Carbonated Beverages, Cigarette Smoke, Acetone (to simulate the effect of ketone production that may result from some diets), Alcohol, Food",{"count":349,"type":21},77,[262],"This is a multi-center, non-randomized, open label study. Subjects will be enrolled if they are deemed eligible given the inclusion criteria. Subjects who meet all inclusion criteria and none of the exclusion criteria will be entered into the study. Subjects will be exposed to non-radioactive 13C-Urea with citric acid, and may submit a stool sample or undergo endoscopy for Rapid Urease Test and Histology samples.\n\nCenter(s) will house a PyloPlus UBT Analyzer to document results. PyloPlus Analyzer results shall remain blinded to the investigator and treating physician. No patient management decisions should be made based on the investigational PyloPlus UBT System.\n\nTreating physician will either prescribe a H. pylori Stool Antigen Test through P4 Diagnostics, along with another Urea Breath Test using Breath ID, or patient will undergo Endoscopy to provide a composite reference method consisting of Rapid Urease Test and Histology. These will act as the comparators to the PyloPlus Urea Breath Test System.",[353,354,32],"Helicobacter Pylori Infection","Post-Treatment","2023-05-03",{"date":357,"type":40},"2023-05-06",{"date":359,"type":40},"2022-12-21",{"date":361,"type":21},"2023-06",{"name":363,"class":73},"ARJ Medical, Inc.",{"id":365,"slug":366,"hasResults":11,"nctId":367,"briefTitle":368,"officialTitle":368,"acronym":4,"eligibilityCriteria":369,"healthyVolunteers":102,"sex":16,"minAge":370,"maxAge":371,"enrollmentInfo":372,"targetDuration":4,"studyType":22,"phases":374,"briefSummary":375,"conditions":376,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":355,"lastUpdatePostDateStruct":378,"startDateStruct":379,"completionDateStruct":381,"leadSponsor":382,"locationsCount":383},"100460509","phase-3-pyloplus-urea-breath-test-system-pediatric-safety-and-efficacy-study-100460509","NCT05276557","PyloPlus Urea Breath Test System Pediatric Safety and Efficacy Study","Inclusion Criteria:\n\n* Male or female age 3-17 at the time of visit\n* Subject\u002FLegal guardian (and subject when relevant) is willing to sing the Informed Consent\u002FAssent Form\n* Naive to H. pylori treatment in the past 4 weeks\n\nExclusion Criteria:\n\n* Pregnant and\u002For lactating women\n* Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient of the quality of data\n* Participation in other interventional trials\n* Allergy to test substrates\n* Antibiotics taken within 4 weeks of the testing\n* Study subjects shall not consume the following items at least 1 hour prior to the PPUBT test: Mouthwash, Chewing Gum, Carbonated Beverages, Cigarette Smoke, Acetone (to simulate the effect of ketone production that may result from some diets), Alcohol, Food\n* Children 12 years and older - to be excluded after a written notification from the sponsor is received at the site that the limit of (approx.) 1\u002F3 of the sample size was achieved for this group","3 Years","17 Years",{"count":373,"type":21},40,[262],"This is a multi-center, non-randomized, open label study. Subjects will be enrolled on a walk-in basis. Screening data will be reviewed to determine subject eligibility. Subjects who meet all inclusion criteria and none of the exclusion criteria will be entered into the study. All children will be exposed to non-radioactive 13C-Urea with citric acid, and shall submit a stool sample.\n\nCenters will house a PyloPlus UBT Analyzer to document results. PyloPlus Analyzer results shall remain blinded to the investigator and treating physician. No patient management decisions should be made based on the investigational PyloPlus® UBT System.\n\nTreating physician will prescribe a H. Pylori Stool Antigen Test to Stool test at either LabCorp or Quest Diagnostic, for the patient, which will be used for diagnostic purposes by the ordering physician.\n\nTotal duration of study is anticipated to be approximately 6 months.",[377,31,32],"Helicobacter Pylori",{"date":357,"type":40},{"date":380,"type":40},"2022-11-17",{"date":361,"type":21},{"name":363,"class":73},3,{"id":385,"slug":386,"hasResults":11,"nctId":387,"briefTitle":388,"officialTitle":389,"acronym":4,"eligibilityCriteria":390,"healthyVolunteers":11,"sex":258,"minAge":17,"maxAge":18,"enrollmentInfo":391,"targetDuration":4,"studyType":305,"phases":4,"briefSummary":392,"conditions":393,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":396,"lastUpdatePostDateStruct":397,"startDateStruct":399,"completionDateStruct":401,"leadSponsor":403,"locationsCount":48},"100495443","observational-of-adjuvant-treatment-of-breast-cancer-with-liposomal-doxorubicin-regimen-100495443","NCT05731258","Observational of Adjuvant Treatment of Breast Cancer With Liposomal Doxorubicin Regimen","Clinical Observational Study of Postoperative Adjuvant Treatment of Breast Cancer With Liposomal Doxorubicin Regimen","Inclusion Criteria:\n\n1. Female, aged 18-75 years;\n2. Primary breast cancer diagnosed histopathologically;\n3. Adjuvant chemotherapy regimens include liposomal doxorubicin;\n4. ECoG PS score: 0-1 points;\n5. Left ventricular ejection fraction (LVEF) ≥ 55%;\n6. Estimated survival ≥ 6 months;\n7. Major organ function is normal, i.e. meets the following criteria:\n\n   ① And white blood cells ≥ 4.0 × 10 9 \u002F L, neutrophil count (ANC) ≥ 1.5 × 10 9 \u002FL；② Platelets ≥ 100 × 10 9 \u002FL；③ And hemoglobin ≥ 10 g \u002F dl; ④ Serum creatinine ≤ 1.5 × ⑤ the upper limit of normal (ULN) Mmol \u002F L and aspartate transaminase (AST) ≤ 2.5\n\n   × ULN；⑥ Alanine transaminase (ALT) ≤ 2.5 × ULN；⑦ Total bilirubin ≤ 1.5 × ULN；⑧ Serum creatinine ≤ 1.5 × ULN；\n8. Subjects voluntarily join this study, sign the informed consent form, have good compliance and cooperate with follow-up.\n\nExclusion Criteria:\n\n1. Pregnant, lactating patients;\n2. Breast cancer has been found to have distant metastasis;\n3. Those with peripheral nervous system disorders caused by the disease or with a history of significant mental disorders and central nervous system disorders;\n4. Those with severe infection or active peptic ulcer requiring treatment;\n5. Allergic to chemotherapy drugs;\n6. Cancer free period less than 5 years except for cured basal cell carcinoma of the skin and cured carcinoma in situ of the cervix;\n7. Severe liver disease (e.g., cirrhosis, etc.), renal disease, respiratory disease, or uncontrolled diabetes;\n8. Patients who are participating in other clinical trials or within a month.",{"count":238,"type":21},"The goal of this observational study aims to observe and evaluate the efficacy and safety of a liposomal doxorubicin containing regimen in the postoperative adjuvant treatment of breast cancer patients.",[215,394,32,31,395],"Liposomal Doxorubicin","Postoperative Adjuvant Treatment","2023-02-07",{"date":398,"type":40},"2023-02-16",{"date":400,"type":40},"2022-05-01",{"date":402,"type":21},"2032-10",{"name":404,"class":47},"Second Affiliated Hospital, School of Medicine, Zhejiang University"]