[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"high-risk\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:high-risk":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,47,82,110,137,166,198,220,244],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":31,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100625680","phase-2-venetoclax-combined-with-azacitidine-for-consolidation-therapy-in-aml-100625680",false,"NCT07425782","Venetoclax Combined With Azacitidine for Consolidation Therapy in AML","A Prospective, Randomized, Open-Label Study of Venetoclax Combined With Azacitidine for Consolidation Therapy in Adult Acute Myeloid Leukemia","Inclusion Criteria:\n\n* Diagnosis of AML confirmed by bone marrow morphology, flow cytometry, and molecular genetics, meeting WHO 2022 classification criteria;\n* Age ≥ 18 years;\n* Classified as high-risk according to the European LeukemiaNet (ELN) prognostic risk stratification for AML, including AML with myelodysplasia-related changes (AML-MRC) and therapy-related acute myeloid leukemia (t-AML);\n* Achieved CR or CRi after ≤ 2 cycles of VA induction chemotherapy;\n* Availability of a suitable donor, with plans to undergo allogeneic hematopoietic stem cell transplantation (allo-HSCT);\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2;\n* Creatinine clearance ≥ 50 mL\u002Fmin (calculated using the Cockcroft-Gault formula); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 times the upper limit of normal (ULN), total bilirubin ≤ 2 times ULN; left ventricular ejection fraction (LVEF) ≥ 50% as shown by echocardiography (ECHO); expected survival \\> 8 weeks;\n* Voluntarily signed the informed consent form and can understand and comply with study requirements.\n\nExclusion Criteria:\n\n* Presence of clinically active cardiovascular disease, such as uncontrolled ventricular arrhythmia, uncontrolled hypertension, congestive heart failure, cardiac disease classified as Class 3 or 4 according to the New York Heart Association (NYHA) Functional Classification, or a history of myocardial infarction within 3 months prior to screening;\n* Active central nervous system leukemia (CNSL) or extramedullary infiltration of leukemia;\n* Other serious diseases that may limit the patient's participation in this trial (e.g., severe infection, renal failure);\n* Known human immunodeficiency virus (HIV) infection or uncontrolled severe viral hepatitis;\n* Pregnant or breastfeeding women;\n* Inability to understand, comply with the study protocol, or sign the informed consent form;\n* Any other conditions deemed by the investigator as unsuitable for participation in this study.","ALL","18 Years",{"count":19,"type":20},216,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","The goal of this clinical trial is to compare the efficacy and safety of a venetoclax-based consolidation therapy versus conventional consolidation chemotherapy in newly diagnosed adult patients with high-risk acute myeloid leukemia (AML) who have achieved complete remission (CR) or CR with incomplete hematologic recovery (CRi) after induction therapy with venetoclax and azacitidine and are planned for transplantation.\n\nThe main questions it aims to answer are:\n\nDoes consolidation therapy with a venetoclax-containing regimen lead to superior clinical outcomes compared to conventional chemotherapy in this specific patient population? What is the comparative safety profile of the venetoclax-containing consolidation regimen versus conventional chemotherapy in these patients? Participants will be randomly assigned to receive either the venetoclax-based consolidation therapy or the conventional consolidation chemotherapy before undergoing transplantation.",[26,27,28,29,30],"Acute Myeloid Leukemia","Consolidation Therapy","Venentoclax","High Risk","Hematopoietic Stem Cell Transplant (HSCT)",[26,27,28,32,33],"Allogenice Hematopoietic Stem Cell Transplantation","High risk","RECRUITING","2026-06-19",{"date":37,"type":38},"2026-06-23","ACTUAL",{"date":40,"type":38},"2026-02-01",{"date":42,"type":20},"2028-11-26",{"name":44,"class":45},"The First Affiliated Hospital of Soochow University","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":21,"phases":59,"briefSummary":61,"conditions":62,"keywords":67,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":81},"100564094","phase-4-inhaling-penehyclidine-to-prevent-perioperative-respiratory-adverse-events-in-children-at-risk-undergoing-sevoflurane-anesthesia-100564094","NCT06624696","Inhaling Penehyclidine to Prevent Perioperative Respiratory Adverse Events in Children at Risk Undergoing Sevoflurane Anesthesia","Inhaling Penehyclidine to Prevent Perioperative Respiratory Adverse Events in Children at Risk Undergoing Sevoflurane Anesthesia: a Double-blind, Randomized, Placebo-controlled Trial","PEPSI","Inclusion Criteria:\n\n1. Pediatric patients aged 3 to 7 years.\n2. Scheduled to undergo ophthalmic surgery.\n3. Judged to be at risk of PRAEs (with at least one parentally reported risk factor for the PRAEs, including history of a recent cold, wheezing during exercise, wheezing more than three times in the past 12 months, nocturnal dry cough, eczema, or a family history of asthma, rhinitis, eczema, or exposure to passive smoke).\n\nExclusion Criteria:\n\n1. American Society of Anesthesiologists (ASA) physical classification ≥ IV.\n2. Known cardiopulmonary diseases (eg. uncorrected congenital heart disease, primary or secondary pulmonary hypertension, tumors, or structural lung diseases).\n3. Severe renal dysfunction (requirement of renal replacement therapy) or severe hepatic dysfunction (Child-Pugh grade C);\n4. Neurological disorders.\n5. Neuromuscular diseases.\n6. Contraindication for PHC.\n7. Inhalation of β2-receptor activator, M-receptor blockers and\u002For glucocorticoids within 1 month before surgery.\n8. Allergy to anticholinergic drugs.\n9. Use of endotracheal tube (ETT) for ventilation.\n10. Known difficult airway.\n11. Severe upper respiratory tract infections (URTIs) and the anesthesiologist recommended delaying surgery.\n12. Participation in other clinical trial during the last month or within the six half-life periods of the study drug used in the last trial.\n13. Parents refusing to allow their children to participate.\n14. Obesity, with a body mass index (BMI) over 95th percentile according to the WHO guideline.","3 Years","7 Years",{"count":58,"type":20},204,[60],"PHASE4","This randomized controlled study is to evaluate the effectiveness of inhaling penehyclidine hydrochloride in reducing perioperative respiratory adverse events in children at risk undergoing minor elective surgery.",[63,64,65,66,29],"Respiratory Hypersensitivity","Perioperative Respiratory Adverse Events","Anticholinergics","Inhalation Therapy; Complications",[68,69,70,71],"perioperative respiratory adverse events","pediatric anesthesia","penehyclidine","sevoflurane","2026-04-09",{"date":74,"type":38},"2026-04-14",{"date":76,"type":38},"2024-11-12",{"date":78,"type":20},"2026-09-30",{"name":80,"class":45},"Sun Yat-sen University",2,{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":4,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":16,"minAge":89,"maxAge":90,"enrollmentInfo":91,"targetDuration":4,"studyType":21,"phases":93,"briefSummary":95,"conditions":96,"keywords":4,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":46},"100602898","shenbai-granules-for-preventing-malignant-transformation-of-high-risk-colorectal-adenomas-100602898","NCT07129499","Shenbai Granules for Preventing Malignant Transformation of High-risk Colorectal Adenomas","A Multicenter, Randomized, Double-blind, Placebo-Controlled Clinical Trial of Shenbai Granules for Preventing Malignant Transformation of High-Risk Colorectal Adenomas","Inclusion Criteria:\n\nAll of the following criteria must be met for enrolment:\n\n1. Aged 40-75 years, regardless of gender;\n2. High-quality colonoscopy performed within 14 days before randomisation, with initial endoscopic resection of all polyps and histological confirmation of at least one HR-CRA criteria;\n3. Complete endoscopic resection of every detected lesion;\n4. TCM syndrome differentiation of \"spleen deficiency with dampness-heat\";\n5. Signed informed consent and willingness to comply with long-term follow-up. a: High-quality colonoscopy criteria: Boston Bowel Preparation Scale score ≥ 6, cecal intubation confirmed by visualization of the ileocecal valve, and withdrawal time (excluding biopsy and polypectomy) ≥ 6 minutes.\n\nExclusion Criteria:\n\nParticipants who meet any of the following criteria will be excluded from the trial:\n\n1. Concomitant malignancy or history of malignancy in the digestive system;\n2. Personal or family history of familial adenomatous polyposis or hereditary non-polyposis colorectal cancer (Lynch syndrome);\n3. History of inflammatory bowel disease;\n4. Malignancy in any other organ system within 5 years before screening, except for adequately treated thyroid carcinoma, cervical carcinoma in situ, basal or squamous cell skin carcinoma, or ductal carcinoma in situ of the breast cured by radical surgery;\n5. Clinically significant organic disorders or neuro-psychiatric conditions that may affect treatment or prognosis, including but not limited to severe cardiovascular or cerebrovascular disease, autoimmune disease, motor, haematological, gastrointestinal, respiratory, immune, circulatory, reproductive, genitourinary, or endocrine disorders; coagulation abnormalities; or serious post-procedural complications (e.g., gastrointestinal bleeding, perforation, cholangitis, intra-abdominal infection, cardiorespiratory depression, mesenteric tear, or pneumoperitoneum), serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\>2.5 × the upper limit of normal (ULN), or alkaline phosphatase (ALP) \\>2 × ULN;\n6. Active gastrointestinal disease, conditions predisposing to perforation, or disorders that could substantially interfere with the absorption, distribution, metabolism, or excretion of the investigational drug, such as inability to take oral medication, uncontrolled nausea or vomiting, intestinal obstruction, or chronic diarrhoea;\n7. Within 3 months before screening, continuous use for ≥3 months of ≥2 doses per week (with \\\u003C2-week interruption) of agents potentially protective against colorectal adenoma: NSAIDs (e.g., aspirin, ibuprofen, celecoxib), metformin, berberine hydrochloride, folic acid, vitamin D, selenium, calcium, systemic immunotherapy, or Chinese patent medicines or decoctions labelled for \"tonifying spleen and augmenting qi, clearing heat and eliminating dampness\". Subjects may be enrolled after a washout of 1 month or ≥5 drug half-lives, whichever is longer;\n8. Cold-pattern manifestations such as aversion to cold, cold pain in the waist\u002Fabdomen, cold extremities, or preference for hot drinks;\n9. Pregnant or lactating women, or men and women of child-bearing potential with plans to conceive during the trial or within 7 months after trial completion;\n10. Participation in another drug or device trial within 1 month or \\\u003C 5 half-lives of the investigational agent (whichever is longer) before screening, concurrent participation in another trial, or intention to participate in any other clinical trial during this trial;\n11. Known allergy or hypersensitivity to ≥ 2 drugs or foods, or hypersensitivity to any component of the trial medication;\n12. Any other condition that, in the opinion of the investigator, makes the subject unsuitable for enrolment (e.g., poor expected compliance, cognitive impairment).","40 Years","75 Years",{"count":92,"type":20},450,[94],"NA","This multicenter, randomized, double-blind, placebo-controlled trial will enroll 450 patients with completely resected high-risk colorectal adenoma (HR-CRA), randomly assigned (1:1) to 6 months of Shenbai Granules (SBG) or placebo, followed for 3 years post-polypectomy. Primary endpoint: 3-year cumulative incidence of metachronous HR-CRA. Secondary endpoints: incidence, number, size, distribution, histology of low-risk adenomas and serrated lesions, and colorectal cancer occurrence.",[97,29,98],"Colorectal Adenoma","TCM","NOT_YET_RECRUITING","2025-08-11",{"date":102,"type":38},"2025-08-19",{"date":104,"type":20},"2025-08-15",{"date":106,"type":20},"2028-11-30",{"name":108,"class":109},"Jiangsu Famous Medical Technology Co., Ltd.","INDUSTRY",{"id":111,"slug":112,"hasResults":11,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":4,"eligibilityCriteria":116,"healthyVolunteers":117,"sex":118,"minAge":17,"maxAge":4,"enrollmentInfo":119,"targetDuration":4,"studyType":21,"phases":121,"briefSummary":122,"conditions":123,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":46},"100602501","remote-cardiotocography-telemonitoring-within-high-risk-pregnancy-care-100602501","NCT07124325","Remote Cardiotocography Telemonitoring Within High-risk Pregnancy Care","The Use of Remote Cardiotocography Telemonitoring Within High-risk Pregnancy Care.","Inclusion Criteria:\n\n* Women aged ≥18 years\n* Gestational age 32+0 weeks onwards.\n* Singleton pregnancy.\n* Able to speak English\n* Receiving antenatal care which includes routine antenatal fetal monitoring for one of the 6 index conditions (hypertensive disease in pregnancy, reduced fetal growth (small for gestational age and fetal growth restriction) obstetric cholestasis, PPROM, previous history of stillbirth and recurrent reduced fetal movements )\n* Able to give written informed consent.\n* Willing to attend hospital immediately in the event of an unexpected finding whilst using the home devices.\n\nExclusion Criteria:\n\n* Multiple pregnancy.\n* Fetal abnormalities or a non-viable fetus.\n* Body mass index (BMI) ≥35\n* Women with internal cardiac devices such as pacemaker and implantable cardioverter defibrillator.\n* History of allergic reaction to skin adhesives and\u002For latex.\n* Acute or chronic skin lesions and wounds in areas in contact with the device.",true,"FEMALE",{"count":120,"type":20},50,[94],"The overall aim of this research proposal is to explore the feasibility and acceptability of home antenatal maternal-fetal monitoring technology within a high-risk pregnancy group. The investigators hypothesise that home monitoring is feasible and acceptable to both pregnant women and HCPs.\n\n50 women from a single site will be recruited to use a home cardiotocography (CTG) device alongside routine antenatal care. Participants will use this device once a week, for an hour at a time, for up to 6 weeks or until delivery. The primary outcome is 20 minutes of continuous monitoring. Additional outcomes assess acceptability, adherence and safety.",[124,29,125,126,127],"Pregnancy","Telemonitoring","Telemedicine","Cardiotocography","2025-08-08",{"date":104,"type":38},{"date":131,"type":38},"2025-06-11",{"date":133,"type":20},"2026-04-01",{"name":135,"class":136},"Birmingham Women's NHS Foundation Trust","OTHER_GOV",{"id":138,"slug":139,"hasResults":11,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":4,"eligibilityCriteria":143,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":90,"enrollmentInfo":144,"targetDuration":4,"studyType":21,"phases":146,"briefSummary":147,"conditions":148,"keywords":152,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":81},"100598704","tonsillectomy-and-immunosuppression-in-caucasian-patients-with-high-risk-iga-nephropathy-100598704","NCT07074951","Tonsillectomy and Immunosuppression in Caucasian Patients With High-risk IgA-nephropathy","Effectiveness of Immunosuppression Combined With Tonsillectomy in Caucasian Patients With High-risk IgA-nephropathy (the Pragmatic Study)","Inclusion Criteria:\n\nPrimary IgA-nephropathy (IgAN) patients with:\n\n1. DP \\>1 g with haematuria (\\>5 RBC\u002FHPF)\n2. DP \\\u003C1 g with haematuria AND probability of starting dialysis within 5 years \\>11% (estimated by the International risk-prediction tool in IgAN) AND at least one of the following histologic changes: at least one of the following histologic changes: mesangial proliferation, endocapillary hypercellularity, cellular crescents\n\nExclusion Criteria:\n\n1. Age \\\u003C18 or \\>75 years;\n2. eGFR ≤20 ml\u002Fmin\u002F1.73m2\n3. Patients with mild renal lesions (M0, E0, S0, T0, C0), minor urinary findings, DP \\\u003C1.0 g\n4. Contraindications to IST or TE\n5. Patients with any co-existing kidney disease\n6. Patients with secondary IgAN (Schoenlein-Henoch purpura, liver cirrhosis, etc.)\n7. Patients with diabetes mellitus\n8. Any clinically significant acute illness within 60 days prior to kidney biopsy (including infection, aseptic necrosis of any bone, patients with myocardial infarction or cerebrovascular stroke, other conditions that can be exacerbated by corticosteroids\n9. Incomplete empiric IST administered prior to kidney biopsy\n10. Pregnancy",{"count":145,"type":20},240,[94],"The open-label prospective non-randomised controlled aims to assess the efficacy of the combination of immunosupression (IST) and tonsillectomy (TE) in Caucasian patients at high risk of the IgA-nephropathy.",[149,150,151],"Primary IgA-nephropathy","High-risk","Caucasians",[149,153,154,150,151,155,156],"Corticosteroids","Tonsillectomy","Progression","Remission","2025-07-10",{"date":159,"type":38},"2025-07-20",{"date":161,"type":38},"2013-03-10",{"date":163,"type":20},"2027-12-10",{"name":165,"class":45},"St. Petersburg State Pavlov Medical University",{"id":167,"slug":168,"hasResults":11,"nctId":169,"briefTitle":170,"officialTitle":171,"acronym":172,"eligibilityCriteria":173,"healthyVolunteers":117,"sex":16,"minAge":174,"maxAge":17,"enrollmentInfo":175,"targetDuration":4,"studyType":177,"phases":4,"briefSummary":178,"conditions":179,"keywords":182,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":190,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":46},"100595377","a-cohort-study-of-disease-prediction-model-for-high-risk-population-with-bipolar-disorder-100595377","NCT07031661","A Cohort Study of Disease Prediction Model for High-risk Population With Bipolar Disorder","The Establishment of Disease Prediction Model for High-risk Population With Bipolar Disorder Based on Multimodal Data: A Multicenter, Large Sample, Prospective Cohort Study","DPM-rBD","Inclusion Criteria:\n\n* High-risk offsprings of parents with BD: Aged 6-18 yrs, both male and female. Offsprings and parents can sign the writtened informed consent form. At least one of parents was diagnosed with bipolar disorder by two or more senior psychiatric doctor.\n* Atypical depression: Aged 6-18 yrs, both male and female. Patients and parents can sign the writtened informed consent form. Patients was diagnosed with atypical depression by two or more senior psychiatric doctor according to DSM-5. The disease phase and treatment regime are unrestricted.\n* Health control: health individuals with age and gender matched with high-risk offsprings, no psychiatric family history.\n\nExclusion Criteria:\n\n* High-risk offsprings of parents with BD: HCL-32 total score \\> 12. Individuals was diagnosed with BD or have symptoms of Axis I psychiatric disorder screened by K-SADS-PL . Individuals with severe physical disease, including kidney diseases, liver diseases or nervous system diseases etc.\n* Atypical depression: HCL-32 total score \\> 12. Individuals was diagnosed with BD or have symptoms of Axis I psychiatric disorder screened by K-SADS-PL . Individuals with severe physical disease, including kidney diseases, liver diseases or nervous system diseases etc. Patients cormobid substance abuse or treated with MECT in recent half a year.\n* Health control: Individuals with psychiatric family history, severe physical disease, including kidney diseases, liver diseases or nervous system diseases etc.","6 Years",{"count":176,"type":20},1200,"OBSERVATIONAL","Bipolar disorder (BD) is a serious, complicated, familial aggregation onset of mental illness, which has the characteristics of five-low and one-high, namely high prevalence, high recurrence rate, high morbidity and mortality, high comorbidity rate and younger age characteristics. This situation will seriously influence one's behaviour or thinking, cognitive, emotional, social and occupational function, causing the heavy burden of disease. But, early recognition and early diagnosis are difficult to achieve at present.\n\nBased on the preliminary research results of the project team, it is found that BD can be identified early through specific dimensions, and early recognition is crucial for the prognosis of patients. The earlier the intervention for BD is implemented, the better the prognosis, especially the functional prognosis, but the difficulty lies in how to implement it. Establishing a high-quality clinical cohort of BD high-risk population is a necessary prerequisite. This study intends to establish a high-quality, large-sample cohort through multi-center, long-term and prospective cohort design and enroll 100 BD high-risk patients every year, a total of 400 cases in 4 years. The electronic mental health service platform will be used for ten years of intensive follow-up. Multi-modal data including clinical characteristics, genetic, cognitive, neuroimaging, sleep monitoring, eeg, eye movement, speech, facial expression and movement were collected to construct the database. On this basis, the interaction of biological factors, clinical risk factors, and environmental risk factors in the onset of BD is discussed to establish a big data prediction model for BD onset in high-risk populations. The effective subgroups of early intervention were analyzed and screened. An ethical and individualized prediction model of the effectiveness and safety of early intervention for the BD high-risk population was constructed.\n\nIt is hoped that the smooth implementation of this project can provide empirical evidence for the early identification, prevention and intervention of BD. To provide clinicians with real data-driven decision-making guidance to assist in selecting personalized and precise treatment; Ultimately promote the prognosis and functional recovery of BD patients.",[150,180,181],"Bipolar Disorder","Atypical Depression",[183,184,185,186,187,188],"bipolar disorder","high-risk","offspring","atypical depression","cohort study","prediction model","2025-06-12",{"date":191,"type":38},"2025-06-22",{"date":193,"type":38},"2024-10-15",{"date":195,"type":20},"2025-12",{"name":197,"class":45},"Shanghai Mental Health Center",{"id":199,"slug":200,"hasResults":11,"nctId":201,"briefTitle":202,"officialTitle":203,"acronym":4,"eligibilityCriteria":204,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":205,"targetDuration":4,"studyType":21,"phases":207,"briefSummary":208,"conditions":209,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":213,"lastUpdatePostDateStruct":214,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":46},"100547571","phase-4-treatment-of-high-risk-newly-diagnosed-multiple-myeloma-with-minimal-residual-disease-detection-100547571","NCT06409702","Treatment of High-risk Newly Diagnosed Multiple Myeloma With Minimal Residual Disease Detection","A Single-arm Prospective Study of the Treatment in High-risk Newly Diagnosed Multiple Myeloma With Minimal Residual Disease Detection","Inclusion Criteria:\n\n1. patients with newly diagnosed multiple myeloma（may receive up to one course of a bortezomib-containing regimen for the urgent relief of bone pain, renal insufficiency, and hypercalcemia）;\n2. age ≥ 18 years;\n3. have an evaluable lesion; serum M protein ≥ 10 g\u002FL, or urinary light chain ≥ 200 mg\u002F24h, or involved serum free light chain (FLC) ≥ 100 mg\u002FL, and an extramedullary measurable tumor SPD: The diameter of cutaneous nodules can be measured with a manual tape, and extramedullary tumor SPD of extramedullary tumors is measured on a CT scan as the product of the largest dimension of the largest pendulous diameter of the lesion (minimum diameter of 5mm or more), parosteal lesions need to be in soft tissue outside the bone cavity to meet the above criteria. MRI measures the size of an extramedullary tumor as the product of the maximum pendulous diameter at the level of the largest area of the tumor (minimum diameter of 5mm or more)\n4. ECOG physical status score ≤ 2\n5. or have a high-risk karyotype abnormality recognized in mSMART or NCCN guidelines: t(4;14), t(14;16), t(14;20), Del(17p) or -17 and\u002For TP53 mutation, Del(1p32), 1q21 gain(amp), the coexistence of two adverse karyotypes as a double hit,and triple hit similarly defined\n6. or R-ISS stage 3\n7. or combined plasma cell leukemia (defined as peripheral blood sorted clonal plasma cells ≥ 5%)\n8. bone marrow function: neutrophils ≥ 1.0 x 109 \u002FL, platelets ≥ 70 x 109 \u002FL (if bone marrow plasma cells ≥ 50%, platelets ≥ 50 x 109 \u002FL)\n9. AST, ALT, ALP ≤ 3 × upper limit of normal value, serum bilirubin ≤ 2 times upper limit of normal value;\n10. serum creatinine clearance ≥ 40mL\u002Fmin\n11. negative pregnancy test for women of childbearing age; patients and their spouses must agree to use effective contraception during the treatment period and the following one-year period;\n12. Signed informed consent for chemotherapy. A legal representative will sign the informed consent form if the subject is unable to sign it due to impaired consciousness, paralysis of the subject's upper limbs, or inability to write.\n\nExclusion Criteria:\n\n1. monoclonal gammopathy of undetermined significance (MGUS), smoldering myeloma, primary light chain amyloidosis with organ involvement.\n2. diagnosed or treated for another malignancy prior to pre-registration ≤ 1 year or previously diagnosed with another malignancy with evidence of any residual disease being treated.\n3. other co-morbidities that would interfere with the subject's ability to participate in the trial, e.g., uncontrolled infections, uncompensated cardiac or pulmonary disease, other synchronized chemotherapy or any adjuvant therapy considered investigational.\n4. peripheral neuropathy ≥ grade 1-2 with pain on clinical examination within 30 days prior to pre-registration\n5. major surgery within 14 days prior to pre-registration\n6. evidence of current uncontrolled cardiovascular disease, including uncontrolled hypertension (hypertension defined as SBP ≥ 140 mmHg and\u002For DBP ≥ 90 mmHg on 3 non-same day office measurements without antihypertensive medication), arrhythmias (prolonged QT interval, ventricular tachycardia, ventricular flutter, ventricular fibrillation, frequent ventricular premature beats (24 h ventricular premature load ≥ 15% of the total number of heart beats, atrioventricular block, heart rate \\\u003C30-40 bpm), congestive heart failure, unstable angina or myocardial infarction. New York Heart Association (NYHA) Class III, IV heart failure.\n7. Participants with known chronic obstructive pulmonary disease (COPD) (defined as exertional expiratory volume in 1 second \\[FEV1\\] \\\u003C50% of predicted normal volume), persistent asthma, or a history of asthma within the past 2 years (controlled intermittent asthma or mild persistent asthma is permitted). Participants with known or suspected COPD must have FEV1 testing during screening.\n8. moderate\u002Fsevere renal insufficiency: creatinine clearance \\\u003C 40mL\u002Fmin.\n9. known human immunodeficiency virus (HIV) positivity.\n10. Hepatitis B seropositivity (defined as a positive Hepatitis B surface antigen \\[HBsAg\\] test). Subjects whose infection has resolved (i.e., subjects who are HBsAg negative but positive for Hepatitis B Core Antigen Antibody \\[anti-HBc\\] and\u002For Hepatitis B Surface Antigen Antibody \\[anti-HBs\\]) must be screened for Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) levels using real-time Polymerase Chain Reaction (PCR). PCR-positive subjects will be excluded. Exception:Subjects with serologic results suggestive of HBV vaccination (anti-HBs positivity as the only serologic marker) and a known history of prior HBV vaccination do not need to be tested for HBV DNA by PCR.\n11. known or suspected active hepatitis C infection.\n12. any medical or psychiatric condition that, in the opinion of the investigator, may interfere with the completion of treatment under this protocol.\n13. known allergy or intolerance to the test drug.\n14. inability to comply with the protocol\u002Fprocedure.\n15. Subjects will be ineligible to participate in the trial because the genotoxic, mutagenic, and teratogenic effects of the investigational drug(s) involved in this trial on the developing fetus and neonate are unknown if any of the following conditions are present at the time of screening: Pregnant women, lactating mothers, males or females of childbearing potential who refuse adequate contraception (as per protocol).",{"count":206,"type":20},59,[60],"The goal of this study is to evaluate sustained MRD negativity for one year in DKRD induction \\& consolidation therapy +\u002F- ASCT in newly diagnosed high-risk multiple myeloma patients. It aims to evaluate the efficacy and safety of the combination regimen of Daratumumab in combination with carfilzomib, lenalidomide, and dexamethasone (DKRD) +\u002F- ASCT for the treatment of patients with newly diagnosed high-risk multiple myeloma. Participants will receive bortezomib based induction therapy for one cycle, and then DKRD induction for 3 cycles(+ASCT), DKRD consolidation for 2-4 cycles, and DKR maintenance treatment(adjusted according to MRD negativity after consolidation therapy)",[210,29,211,212],"Newly Diagnosed","MRD","Multiple Myeloma","2025-06-10",{"date":189,"type":38},{"date":216,"type":38},"2024-06-12",{"date":218,"type":20},"2027-12-31",{"name":44,"class":45},{"id":221,"slug":222,"hasResults":11,"nctId":223,"briefTitle":224,"officialTitle":224,"acronym":4,"eligibilityCriteria":225,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":90,"enrollmentInfo":226,"targetDuration":4,"studyType":21,"phases":228,"briefSummary":229,"conditions":230,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":235,"lastUpdatePostDateStruct":236,"startDateStruct":238,"completionDateStruct":240,"leadSponsor":242,"locationsCount":46},"100506683","toripalimab-combined-with-neoadjuvant-chemoradiotherapy-as-first-line-treatment-for-locally-advancedhigh-riskmss-rectal-cancer-100506683","NCT05877573","Toripalimab Combined With Neoadjuvant Chemoradiotherapy as First-line Treatment for Locally Advanced，High-Risk，MSS Rectal Cancer","Inclusion Criteria:\n\n* Age 18-75 years old, female and male;\n* Pathological confirmed MSS or pMMR rectal adenocarcinoma;\n* Clinical stage T3-4 (AJCC 8th) and at least with one high risk factor（CRM+ or EMVI+ or lateral lymph nodes+）;\n* No previous chemotherapy, radiotherapy, immunotherapy or other anti-tumor treatment;\n* Adequate organ function defined at baseline as:\n\nANC ≥1.5××109\u002FL，PLt ≥100×109 \u002FL，Hb ≥90 g\u002FL，15×109 \u002FL≥WBC≥4×109 \u002FL; TBIL ≤1.5×ULN, ALT ≤1.5ULN, AST ≤1.5ULN, BUN and Cr ≤1.5×ULN or Ccr\n\n* 60ml\u002Fmin (Cockcroft-Gault formula);INR ≤1.5×ULN or PT ≤1.5×ULN (when patient didn't accept anticoagulant therapy);\n\n  * Women of childbearing age must have taken reliable contraceptive measures or have a pregnancy test (serum or urine) within 7 days prior to enrollment and the results are negative;\n\nExclusion Criteria:\n\n* Pathological confirmed rectal squamous cell carcinoma;\n* History of other uncured malignancies within 5 years;\n* Allergic to any component of chemotherapy or immunotherapy;\n* History of any active, known, or suspected autoimmune disease, including but not limited to myasthenia gravis,Myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis,Inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener granulation Swollen disease, Sjogren's syndrome, Guillain-Barre syndrome, multiple sclerosis, vasculitis or Glomerulonephritis.\n* With congenital or acquired immunodeficiency (such as those with HIV infection), active hepatitis B or hepatitis C;",{"count":227,"type":20},53,[94],"This is a single arm, open-label, prospective clinical trial to evaluate the combination of neoadjuvant short-course radiotherapy and toripalimab (PD-1 antibody) for locally advanced rectal cancer (LARC) patients with high risk factors. A total of 53patients will be enrolled in this trial to receive 5\\*5Gy short-course radiotherapy, followed by 4 cycles of CAPOX chemotherapy and PD-1 antibody. Then they will receive the TME surgery and another 2 cycles of CAPOX chemotherapy. The primary end point is the rate of pathological complete response (pCR). The long-term prognosis and adverse effects will also be evaluated and analyzed.",[231,232,233,234],"Locally Advanced","High-Risk","Rectal Cancer","MSS","2023-07-02",{"date":237,"type":38},"2023-07-05",{"date":239,"type":20},"2023-07-01",{"date":241,"type":20},"2026-08-01",{"name":243,"class":45},"Nanfang Hospital, Southern Medical University",{"id":245,"slug":246,"hasResults":11,"nctId":247,"briefTitle":248,"officialTitle":249,"acronym":250,"eligibilityCriteria":251,"healthyVolunteers":11,"sex":252,"minAge":17,"maxAge":90,"enrollmentInfo":253,"targetDuration":4,"studyType":21,"phases":255,"briefSummary":256,"conditions":257,"keywords":260,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":265,"lastUpdatePostDateStruct":266,"startDateStruct":268,"completionDateStruct":270,"leadSponsor":272,"locationsCount":274},"100499041","phase-2-adjutant-apalutamide-plus-adt-in-post-rp-patients-with-high-risk-of-recurrence-ares-study-100499041","NCT05778097","Adjutant Apalutamide Plus ADT in Post-RP Patients With High Risk of Recurrence (ARES Study)","Adjuvant Androgen Deprivation Therapy Combined With Apalutamide for Prostate Cancer Patients Post Radical-prostatectomy With High-risk of Reoccurrence: a Prospective, Single-arm, Multicenter Trial (ARES Study)","ARES","Key Inclusion Criteria:\n\n1. Prostate cancer diagnosed histologically or cytologically in males ≥18 years and ≤75 years of age;\n2. Localized prostate cancer (assessed by conventional imaging tools such as CT and bone scan) within 12 weeks after radical prostatectomy;\n3. PSA \\\u003C 0.1 ng\u002Fml within 8 weeks after surgery;\n4. Postoperative CAPRA-S score ≥ 6, suggesting a higher risk of recurrence;\n5. ECOG score at 0-1 according to the Eastern Cooperative Oncology Group (ECOG) Performance Status Scale;\n6. Adequate organ functions:\n\n   Hematology (within 14 days before treatment: no blood transfusion, no use of granulocyte colony-stimulating factor, no use of other drugs for correction)：\n   1. Neutrophil count (NE) ≥1.5×109\u002FL;\n   2. Hemoglobin (HGB) ≥ 90 g\u002FL;\n   3. Platelet count (PLT) ≥100×109\u002FL; Coagulation function (no blood product transfusion within 14 days before treatment): international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5× upper limit of normal (ULN); Blood biochemistry (liver and kidney function)：\n\n   \u003C!-- -->\n\n   1. Creatinine clearance ≥ 30 mL\u002Fmin;\n   2. Total bilirubin (TBIL) ≤ 1.5× ULN;\n   3. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5× ULN;\n7. Ability to provide written informed consent form (ICF) and ability to understand and agree to adhere to study requirements and schedule of assessments;\n8. Patients of childbearing potential must be willing to use highly effective contraception during the study and for 12 weeks after the last dose of treatment.\n\nKey Exclusion Criteria:\n\n1. Patients with neuroendocrine, small cell, or sarcomatoid features in prostate histopathology;\n2. Pelvic lymph node metastasis (cN1) or distant metastasis (cM1) indicated preoperatively by traditional imaging procedures such as CT or bone scan;\n3. Prior treatment by androgen deprivation therapy (including medication or surgical castration), focal therapy for prostate cancer, or radiotherapy and chemotherapy for prostate cancer;\n4. Prior treatment with second-generation antiandrogen (e.g., abiraterone, apalutamide, enzalutamide, darolutamide, etc.);\n5. Any major surgery (other than radical resection) requiring general anesthesia within 28 days prior to the first dose of the study;\n6. Other malignancies present or occurred in the past 2 years, except cured non-melanoma skin cancers and superficial bladder tumors (Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor infiltrating of basement membrane);\n7. Arterial\u002Fvenous thrombotic events (such as cerebrovascular accident, deep vein thrombosis and pulmonary embolism) or anticoagulant therapy with warfarin or heparin within 6 months before the study;\n8. Corrected QT interval (QTc) of heart rate \\> 500 ms; patients with QTc prolonged but \\\u003C 500 ms should be assessed by a cardiologist for eligibility;\n9. Severe cardiovascular diseases: myocardial ischemia or myocardial infarction above grade II, poorly controlled arrhythmia; Classes III-IV cardiac insufficiency according to the New York Heart Association (NYHA) Classification, or left ventricular ejection fraction (LVEF) \\\u003C 50% indicated in cardiac Doppler ultrasound;\n10. Allergy to any study drug or excipients;\n11. Active viral hepatitis requiring treatment as determined by the Investigators:\n\n    1. Chronic hepatitis B, with hepatitis B virus (HBV) deoxyribonucleic acid (DNA) ≥ 500 IU\u002FmL (2500 copies\u002FmL) (HBV DNA testing only for patients with positive test for Hepatitis B surface antigen or core antibody);\n    2. Positive for Hepatitis C virus (HCV) ribonucleic acid (RNA) test (HCV RNA test only for patients with positive HCV antibodies);\n12. Any present active autoimmune disease or history of autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism), or known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation, or long-term heavy use of hormones or other immunomodulators, or other conditions assessed by the Investigator as having an impact on study treatment;\n13. Active infection;\n14. History of interstitial lung disease or uncontrolled systemic disease, including diabetes, hypertension, acute lung disease, etc.;\n15. Known to have human immunodeficiency virus (HIV) infection;\n16. History of epilepsy or conditions that may induce epilepsy\n17. The presence of an underlying medical condition alcohol\u002Fdrug abuse or dependence that is detrimental to the administration of the study drugs, or that may affect the interpretation of the results, or that places the patient at high risk of developing treatment complications;\n18. Men who have sexual activity with women of childbearing potential, unless they:\n\n    Agree to use condom or spermicidal foam\u002Fgel\u002Fdiaphragm\u002Fcream\u002Fsuppository Agree not to donate sperm during the study and for at least 3 months after receiving the last dose of study drug No birth plan during the study or within 3 months after the last dose of study drug\n19. Concurrent participation in another therapeutic clinical study.","MALE",{"count":254,"type":20},103,[23],"ARES is a multicenter, single-arm, phase 2 trial to evaluate the efficacy and safety of ADT in combination with apalutamide as an adjuvant regimen for patients with high risk of recurrence after radical prostatectomy.",[258,259,29],"Prostate Cancer","Biochemical Recurrence",[261,262,263,264],"prostate cancer biochemical recurrence","apalutamide","adjuvant treatment","post-radical prostatectomy","2023-03-17",{"date":267,"type":38},"2023-03-21",{"date":269,"type":20},"2023-04-01",{"date":271,"type":20},"2026-12-31",{"name":273,"class":45},"The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School",3]