[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Peking University Shenzhen Hospital\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":259},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,42,74,96,119,139,159,185,209,232],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100631727","early-phase-1-clinical-study-on-the-efficacy-and-safety-of-car-dc-in-the-treatment-of-advanced-solid-tumors-100631727",false,"NCT07504445","Clinical Study on the Efficacy and Safety of CAR-DC in the Treatment of Advanced Solid Tumors","Inclusion Criteria:\n\n1. Aged 18-70, regardless of gender;\n2. Diagnosed as EphA2or Claudin18.2, TROP2, HER2, GCC, GPC-3, CEA positive advanced solid tumors, such as lung cancer, liver cancer, colorectal cancer, gastric cancer, etc; Note: Advanced solid tumors refer to locally advanced (stage III patients) and metastatic advanced (stage IV patients) TNM staging by the American Cancer Society (AJCC).\n3. Immunohistochemical analysis of pathological tissue approves positive expression for one of the following antigens, including EphA2, Claudin18.2, TROP2, HER2, GCC, GPC-3 and CEA, with expression intensity ≥ 2+;\n4. Failed response to standard treatment or unwilling\u002Fintolerant to all standard treatment regimens;\n5. Imaging indicates measurable tumor lesions;\n6. ECOG PS score: 0-2;\n7. Expected survival time is greater than 3 months;\n8. Maintaining good organ function and bone marrow reserve capacity:\n\n   1. Bone marrow: Absolute neutrophil count (ANC) ≥ 1.0 × 10\\^9\u002FL, platelet count ≥ 50 × 10\\^9\u002FL, hemoglobin ≥ 80 g\u002FL, and no blood transfusion or biological regulator treatments (such as granulocyte colony-stimulating factor, red blood cell growth factor, etc.) within 14 days prior to screening;\n   2. Kidney: creatinine (Cr) ≤ 1.5 × ULN, or creatinine clearance rate (Ccr) ≥ 50 mL\u002Fmin (according to the Cockcroft-Gault formula); Urine output\\>10 mL\u002Fh within 16-24 hours;\n   3. Coagulation: International Normalized Ratio (INR) ≤ 1.5 × ULN, and Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN (excluding those receiving therapeutic anticoagulants);\n   4. Other: Blood oxygen saturation ≥ 90%, negative fecal occult blood test, etc.\n9. The patient is willing to enroll and signs a written informed consent form, and is able to undergo diagnosis, treatment, and visits according to the protocol.\n\nExclusion Criteria:\n\n1. Pregnant and lactating women; (The pregnancy test results are included in the CRF)\n2. The patient can not guarantee effective contraceptive measures (such as condoms or birth control pills) within one year after enrollment;\n3. Patients with brain metastases exhibiting significant psychiatric and neurological symptoms;\n4. Serious heart diseases such as arrhythmia;\n5. Autoimmune diseases;\n6. Active bacterial, fungal, and other infections;\n7. Infectious diseases: such as HIV, syphilis, tuberculosis, viral hepatitis and other diseases;\n8. Patients are receiving medications such as glucocorticoids, thrombolytic drugs, and antipsychotic drugs;\n9. Patients are believed not suitable for this clinical trial for other reasons by investigators.","ALL","18 Years","70 Years",{"count":5,"type":19},"ESTIMATED","INTERVENTIONAL",[22],"EARLY_PHASE1","This is a prospective, open label, single arm clinical trial to evaluate the safety and the preliminary efficacy of chimeric antigen receptor-dendritic cell (CAR-DC) in the treatment of advanced solid tumors positive for one of the following antigens: ephrin type-A receptor 2 (EphA2), claudin-18 isoform 2 (CLDN18.2) , trophoblast cell surface antigen 2 (Trop2), human epidermal growth factor receptor 2 (HER2), guanylyl cyclase-C (GCC), glypican-3 (GPC3) and carcinoembryonic antigen (CEA).",[25],"Advanced Solid Tumors",[27,28],"CAR-DC","Advanced solid tumor","NOT_YET_RECRUITING","2026-06-01",{"date":32,"type":33},"2026-06-03","ACTUAL",{"date":35,"type":19},"2026-06-10",{"date":37,"type":19},"2028-04-03",{"name":39,"class":40},"Peking University Shenzhen Hospital","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":53,"conditions":54,"keywords":61,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":41},"100621745","iruplinalkib-in-alk-positive-advanced-lung-adenocarcinoma-after-lorlatinib-100621745","NCT07374614","Iruplinalkib in ALK-Positive Advanced Lung Adenocarcinoma After Lorlatinib","An Observational Study of the Efficacy and Safety of Iruplinalkib(WX-0593) in ALK-positive Advanced Lung Adenocarcinoma Following Lorlatinib Treatment","SAILOR","Inclusion Criteria:\n\n1. Population: Male or female patients aged ≥18 years.\n2. Diagnosis: Histologically or cytologically confirmed advanced lung adenocarcinoma.\n3. Molecular Status: Documentation of ALK rearrangement confirmed by a validated test (e.g., NGS, IHC, FISH).\n4. Prior Therapy: Prior treatment with lorlatinib (in any line of therapy), with documented disease progression or intolerance.\n5. Current Therapy: Initiated treatment with iruplinalkib in the real-world setting.\n6. Measurability: Presence of at least one evaluable lesion (measurable or non-measurable) for response assessment.\n7. Data Availability: availability of key clinical data (baseline characteristics, treatment history, and follow-up outcomes).\n\nExclusion Criteria:\n\n1. Lack of Exposure: Patients who never actually received iruplinalkib or took only a trivial amount (e.g., \\\u003C 1 week\u002Fcycle) before withdrawal for non-medical reasons.\n2. Wrong Diagnosis: Active malignancy of other histological types (excluding treated basal cell carcinoma, etc.).\n3. Confounding: Participation in another interventional clinical trial involving an investigational anti-tumor drug concurrently.\n4. Pregnancy: Pregnant or breastfeeding women.\n5. Data Quality: Missing critical medical records that preclude assessment of primary endpoints (e.g., unknown start date, unknown prior therapy).",{"count":51,"type":19},20,"OBSERVATIONAL","This observational study aims to evaluate the real-world effectiveness and safety of iruplinalkib in patients with advanced ALK-positive lung adenocarcinoma who have progressed on or are intolerant to prior lorlatinib therapy. The results are expected to provide real-world evidence to inform clinical decision-making for this heavily pretreated patient population.",[55,56,57,58,59,60],"Non-Small Cell Lung Cancer","ALK","Iruplinalkib","Lorlatinib","Real-world Study","Observational Study",[57,62,63,64],"ALK-postive","Post-Lorlatinib","Advanced Lung Adenocarcinoma","RECRUITING","2026-01-24",{"date":68,"type":33},"2026-01-29",{"date":70,"type":19},"2026-01-31",{"date":72,"type":19},"2028-12-31",{"name":39,"class":40},{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":81,"enrollmentInfo":82,"targetDuration":84,"studyType":52,"phases":4,"briefSummary":85,"conditions":86,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":41},"100615621","the-effective-blood-concentration-of-ciprofol-100615621","NCT07294989","The Effective Blood Concentration of Ciprofol","Median Effective Concentration of Ciprofol and Its Correlation With Bispectral Index: A Prospective Observational Study","Inclusion Criteria:\n\n* Patients aged 18-65 years\n* Scheduled for elective thyroidectomy\n* ASA physical status classification I-II\n* Willing to participate and providing written informed consent\n\nExclusion Criteria:\n\n* Recent use of sedatives or opioid analgesics\n* Severe hepatic or renal dysfunction defined as:Child-Pugh class C (score ≥10), Creatinine clearance \\\u003C35 mL\u002Fmin ,Requiring preoperative dialysis\n* Significant cardiovascular comorbidities\n* Body mass index ≥35 kg\u002Fm² or \\\u003C18.5 kg\u002Fm²\n* Known hypersensitivity or adverse reactions to propofol\u002Fciprofol\n* Neuropsychiatric disorders including:Alzheimer's disease,History of cerebrovascular events,Traumatic brain injury,Space-occupying brain lesions,Other significant neurological deficits","65 Years",{"count":83,"type":19},101,"1 Day","1. Eligible patients were selected and enrolled in the study.\n2. General anesthesia was induced using ciprofol in all participants, with standardized evaluation of consciousness levels during induction.\n3. The patients' pain and cognition are followed up after surgery.",[87],"Thyroid Disease","2026-01-05",{"date":90,"type":33},"2026-01-06",{"date":92,"type":33},"2025-07-01",{"date":94,"type":19},"2026-06-30",{"name":39,"class":40},{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":4,"eligibilityCriteria":102,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":103,"enrollmentInfo":104,"targetDuration":4,"studyType":20,"phases":106,"briefSummary":108,"conditions":109,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":41},"100593303","effect-of-mgrnox-guided-general-anesthesia-on-opioid-consumption-in-patients-100593303","NCT07004686","Effect of MGRNOX-Guided General Anesthesia on Opioid Consumption in Patients","Effect of MGRNOX-Guided General Anesthesia on Opioid Consumption in Patients:A Randomized Controlled Trial","Inclusion Criteria:\n\n* Age ≥18 years old and \\\u003C 65 years old；\n* American Society of Anesthesiologists (ASA) class I-II；\n* Scheduled to undergo elective laparoscopic cholecystectomy undergeneral anesthesia （without epidural anesthesia, local blocks, or infiltration）\n\nExclusion Criteria:\n\n* Pregnancy or lactation period；\n* BMI ≥35 kg\u002Fm² or \\\u003C18.5 kg\u002Fm²；\n* Anticipated difficult airway；\n* Previous diagnosis of hypertension；\n* History of drug or alcohol abuse within the past 6 months；\n* Preoperative acute or chronic pain history (routine preoperative use of opioid or non-opioid analgesics), peripheral or central nervous system-related disorders；\n* Definitively diagnosed psychiatric disorders or other neuropsychiatric conditions severely affecting cognitive judgment, history of psychotropic medication use；\n* Allergy or intolerance to anesthetic agents；\n* Baseline mean arterial pressure (MAP) \\\u003C60 mmHg or \\>120 mmHg; baseline heart rate (HR) \\\u003C45 bpm or \\>90 bpm (Baseline values defined as first measurement taken in the ward after admission)；\n* History of severe underlying diseases (untreated or ongoing peripheral\u002Fcentral cardiovascular diseases, severe hepatic disorders with elevated bilirubin\u002FINR or hypoalbuminemia, severe renal diseases with elevated creatinine, severe pulmonary diseases potentially causing acute respiratory failure or persistent dyspnea)；\n* Implanted pacemaker, chronic arrhythmia, preoperative use of prescribed anticholinergics, α2-adrenergic agonists, beta-1 adrenergic antagonists, or antiarrhythmic medications.","64 Years",{"count":105,"type":19},112,[107],"NA","1. Pain management is a crucial part of general anesthesia surgery. Nociception monitoring can help anesthesiologists better titrate the use of intraoperative analgesic drugs, especially the opioid.\n2. Although a variety of nociception monitoring devices have been developed to date, there is not a specific monitoring indicator that serves as the \"gold standard\" to objectively guide analgesic management in general anesthesia.\n3. The MGRNOX index, which is derived from electroencephalogram (EEG), is used to reflect the correlation between noxious stimuli and opioid analgesics in a state of general anesthesia by converting and quantifying the EEG signals collected by the instrument. However, no studies have so far verified the effect of the MGRNOX index-guided analgesic management of general anesthesia on the consumption of opioids in patients.\n4. This study aims to explore the effect of MGRNOX index-guided general anesthesia on opioid consumption in patients undergoing laparoscopic cholecystectomy and the primary hypothesis of our study is that using the MGRNOX index to guide intraoperative pain management during general anesthesia can significantly reduce the consumption of remifentanil during the surgery.",[110],"Opioid Use","2025-12-10",{"date":113,"type":33},"2025-12-18",{"date":115,"type":33},"2025-06-28",{"date":117,"type":19},"2026-05-30",{"name":39,"class":40},{"id":120,"slug":121,"hasResults":11,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":4,"eligibilityCriteria":125,"healthyVolunteers":11,"sex":15,"minAge":81,"maxAge":4,"enrollmentInfo":126,"targetDuration":4,"studyType":20,"phases":128,"briefSummary":129,"conditions":130,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":138,"locationsCount":41},"100593152","effects-of-esketamine-combined-with-dexmedetomidine-on-postoperative-sleep-quality-100593152","NCT07002723","Effects of Esketamine Combined With Dexmedetomidine on Postoperative Sleep Quality","Effects of Esketamine Combined With Dexmedetomidine on Postoperative Sleep Quality in Elderly Patients Undergoing Hip Surgery:A Superiority Randomized Controlled Trail","Inclusion Criteria:\n\n* Age≥ 65 years old;\n* Hip fracture surgery under neuraxial anesthesia;\n* Signed informed consent.\n\nExclusion Criteria:\n\n* ASA classification≥ Class V;\n* Presence of neuraxial anesthesia contraindications: coagulation dysfunction, thrombocytopenia, neuraxial mass, puncture site infection, etc.;\n* Patients with contraindications to esketamine (such as allergies, intracranial aneurysms, hyperthyroidism and glaucoma);\n* Patients with contraindications to dexmedetomidine (allergies);\n* Patients with severe cardiovascular diseases such as sick sinus syndrome, severe sinus bradycardia (heart rate \\\u003C 50 beats\u002Fmin), atrioventricular block grade II or above without pacemaker, unstable angina, severe valvular heart disease, severe arrhythmia, severe macrovascular disease with New York Heart Association class III patients, etc.;\n* Obstructive sleep apnea syndrome (STOP-BANG score \\> 3 points);\n* Patients with severe hepatic and renal insufficiency (such as Child-Pugh score III, creatinine clearance \\\u003C 35 mL\u002Fmin, preoperative dialysis);\n* Those who have delirium, dementia, moderate to severe cognitive dysfunction and psychiatric disorders before the start of the trial and are unable to communicate and cooperate with the investigator.",{"count":127,"type":19},96,[107],"1. Eligible patients are randomly divided into experimental and control groups；\n2. The experimental group is given esketamine combined with dexmedetomidine，while the control group is given normal saline；\n3. The patients' sleep, pain, and cognition are followed up after surgery.",[131],"Hip Fractures","2025-11-30",{"date":134,"type":33},"2025-12-05",{"date":136,"type":33},"2025-06-20",{"date":94,"type":19},{"name":39,"class":40},{"id":140,"slug":141,"hasResults":11,"nctId":142,"briefTitle":143,"officialTitle":143,"acronym":4,"eligibilityCriteria":144,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":81,"enrollmentInfo":145,"targetDuration":4,"studyType":20,"phases":147,"briefSummary":148,"conditions":149,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":41},"100599798","the-effect-site-concentration-of-remifentanil-blunting-endotracheal-intubation-responses-during-anesthesia-induction-with-lidocaine-or-sufentanil-combined-with-etomidate-a-randomized-controlled-study-100599798","NCT07089173","The Effect-site Concentration of Remifentanil Blunting Endotracheal Intubation Responses During Anesthesia Induction With Lidocaine or Sufentanil Combined With Etomidate: A Randomized Controlled Study","Inclusion Criteria:\n\n* Patients scheduled for elective surgery under general anesthesia with endotracheal intubation;\n* Classified as ASA physical status I-II.\n\nExclusion Criteria:\n\n* Age \\\u003C18 years or \\>65 years;\n* Body mass index (BMI) \\>30 kg\u002Fm² or \\\u003C18.5 kg\u002Fm²;\n* Diagnosis of hypertension or severe cardiovascular diseases (including myocardial infarction, heart failure, atrial fibrillation, atrioventricular block, moderate-to-severe valvular diseases) or respiratory diseases (including acute exacerbation of chronic obstructive pulmonary disease, acute respiratory distress syndrome, acute asthma attack, moderate-to-severe pulmonary hypertension, severe pneumonia);\n* Diagnosis of obstructive sleep apnea syndrome or history of difficult intubation or preoperatively anticipated difficult airway;\n* Renal, hepatic or hematologic diseases;\n* High risk of aspiration or reflux;\n* Current use of analgesics for chronic pain or β-blockers for cardiovascular diseases;\n* Current use of psychotropic medications;\n* Contraindications to remifentanil or sufentanil, including: known hypersensitivity to any component of these drugs or other fentanyl analogues, current use of monoamine oxidase inhibitors, myasthenia gravis or conditions predisposing to respiratory depression, bronchial asthma or related disorders;\n* Contraindications to lidocaine, including: known allergy to local anesthetics, concurrent Adams-Stokes syndrome, Wolff-Parkinson-White syndrome, or severe cardiac conduction block.",{"count":146,"type":19},99,[107],"The aim of this study was to compare the effect-site target concentration (including EC₅₀ and EC₉₀) of remifentanil required to suppress cardiovascular responses to tracheal intubation during anesthesia induction with etomidate combined with either lidocaine or sufentanil.",[150],"Hemodynamics","2025-09-17",{"date":153,"type":33},"2025-09-22",{"date":155,"type":33},"2025-08-01",{"date":157,"type":19},"2026-07-30",{"name":39,"class":40},{"id":160,"slug":161,"hasResults":11,"nctId":162,"briefTitle":163,"officialTitle":164,"acronym":4,"eligibilityCriteria":165,"healthyVolunteers":166,"sex":15,"minAge":167,"maxAge":4,"enrollmentInfo":168,"targetDuration":170,"studyType":52,"phases":4,"briefSummary":171,"conditions":172,"keywords":174,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":41},"100603347","incidence-of-postoperative-cognitive-decline-in-patients-with-preexisting-cognitive-impairment-100603347","NCT07135336","Incidence of Postoperative Cognitive Decline in Patients With Preexisting Cognitive Impairment","Incidence of Postoperative Cognitive Decline in Surgical Patients With Preexisting Cognitive Impairment: A Prospective Cohort Study","1. Preexisting Cognitive Impairment (PreCI) Surgical Group\n\n   Inclusion Criteria:\n   * Age ≥ 60 years\n   * Preoperative screening with MMSE and MoCA-B indicating mild cognitive impairment (MCI) or mild dementia\n   * Undergoing elective non-cardiac surgery under general anesthesia\n\n   Exclusion Criteria:\n   * Expected difficulty in completing neuropsychological assessments (e.g., inability to communicate in Mandarin, blindness, or deafness)\n   * Usual residence outside Shenzhen\n2. Normative Reference Group\n\nInclusion Criteria:\n\n* Age ≥ 60 years\n* No history of general anesthesia surgery within the past 12 months\n* Mini-Cog score \\> 1\n\nExclusion Criteria:\n\n* Planned elective surgery under general anesthesia within the next 12 months\n* History of suspected or diagnosed cognitive impairment, or screening indicating cognitive impairment using MMSE and MoCA-B\n* Expected difficulty in completing neuropsychological assessments (e.g., inability to communicate in Mandarin, blindness, or deafness)\n* Usual residence outside Shenzhen",true,"60 Years",{"count":169,"type":19},340,"1 Year","This study aims to find out how often memory and thinking problems happen after surgery in people who already have memory issues before their operation. These memory problems are called postoperative cognitive decline (POCD). Older adults with memory problems before surgery may be more likely to have trouble with thinking, memory, and daily activities after their operation. This study will follow patients who already have memory problems before surgery and see how their thinking and memory change after surgery. The results will help doctors better understand how to care for these patients before, during, and after surgery.",[173],"Cognitive and Behavioral Impairment",[175,176],"postoperative cognitive decline","preexisting cognitive impairment","2025-08-18",{"date":179,"type":33},"2025-08-22",{"date":181,"type":33},"2025-07-15",{"date":183,"type":19},"2027-07-01",{"name":39,"class":40},{"id":186,"slug":187,"hasResults":11,"nctId":188,"briefTitle":189,"officialTitle":190,"acronym":4,"eligibilityCriteria":191,"healthyVolunteers":166,"sex":192,"minAge":16,"maxAge":193,"enrollmentInfo":194,"targetDuration":4,"studyType":20,"phases":196,"briefSummary":198,"conditions":199,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":201,"lastUpdatePostDateStruct":202,"startDateStruct":204,"completionDateStruct":206,"leadSponsor":208,"locationsCount":41},"100421740","phase-4-a-prospective-randomized-controlled-study-of-the-probiotics-as-adjuvant-treatment-for-bacterial-vaginosis-100421740","NCT04771728","A Prospective, Randomized Controlled Study of the Probiotics as Adjuvant Treatment for Bacterial Vaginosis","Department of Obstetrics and Gynecology, Peking University Shenzhen Hospital","Inclusion Criteria:\n\n1. Aged 18 to 55 years old, with history of sexual activity,\n2. Amsel criterion for diagnosing BV\n3. Sign informed consent\n\nExclusion Criteria:\n\n1. History of systemic organic diseases or psychiatric diseases\n2. Planning for or during pregnancy, lactation, menstruation\n3. within 5 days of onset of the disease, any antibiotics has been used\n4. Long-term use of contraceptives or immunosuppressant\n5. Anaphylactic constitution or allergic to known ingredients of research drugs\n6. No same fixed partner (RSP) before and after treatment","FEMALE","55 Years",{"count":195,"type":19},140,[197],"PHASE4","The investigators are trying to determine if oral Probiotics(Umeta-mimi,30 days) with Metronidazole vaginal suppositories (7 days) is better than using Metronidazole vaginal suppositories(7 days) only in preventing the recurrence of bacterial vaginosis",[200],"Bacterial Vaginosis","2025-06-09",{"date":203,"type":33},"2025-06-12",{"date":205,"type":33},"2020-02-01",{"date":207,"type":19},"2026-12-01",{"name":39,"class":40},{"id":210,"slug":211,"hasResults":11,"nctId":212,"briefTitle":213,"officialTitle":214,"acronym":4,"eligibilityCriteria":215,"healthyVolunteers":11,"sex":192,"minAge":16,"maxAge":193,"enrollmentInfo":216,"targetDuration":4,"studyType":20,"phases":218,"briefSummary":220,"conditions":221,"keywords":223,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":201,"lastUpdatePostDateStruct":226,"startDateStruct":227,"completionDateStruct":229,"leadSponsor":231,"locationsCount":41},"100406566","phase-3-treatment-for-aerobic-vaginitis-by-using-bofukang-vaginal-suppository-100406566","NCT04574089","Treatment for Aerobic Vaginitis by Using Bofukang Vaginal Suppository","Medical Ethics Committee of Peking University Shenzhen Hospital","Inclusion Criteria:\n\nAerobic vaginitis diagnosed based on present ：\n\n1. Vaginal dischareg ;\n2. pH \\> 4.5;\n3. Donders score≥3;\n\nExclusion Criteria:\n\n1. Patients with other vaginitis, cervical erosion, or suspected gonorrhea, herpes simplex virus infection and other vulvar diseases;\n2. Patients received systemic or vaginal antifungal or antibiotic treatment within two weeks before admission.\n3. Pregnancy, lactation and intentional pregnancy;\n4. Women with liver and kidney dysfunction, low immune function, diabetes, psychosis or other serious diseases;\n5. Allergic constitution and patients allergic to drug ingredients in this study;\n6. Those with poor compliance.",{"count":217,"type":19},50,[219],"PHASE3","Aerobic vaginitis was treated by using Baofukang Suppository 7 days group or Baofukang Suppository 14 days group.To evaluate the efficacy and safety after treatment.",[222],"Vaginitis",[224,225],"Aerobic vaginitis","Treatment",{"date":203,"type":33},{"date":228,"type":33},"2020-05-01",{"date":230,"type":19},"2026-12-30",{"name":39,"class":40},{"id":233,"slug":234,"hasResults":11,"nctId":235,"briefTitle":236,"officialTitle":237,"acronym":238,"eligibilityCriteria":239,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":240,"targetDuration":4,"studyType":20,"phases":242,"briefSummary":244,"conditions":245,"keywords":247,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":251,"lastUpdatePostDateStruct":252,"startDateStruct":254,"completionDateStruct":256,"leadSponsor":258,"locationsCount":4},"100569303","phase-2-study-of-precision-treatment-for-rare-tumours-in-china-guided-by-pdo-and-ngs-100569303","NCT06692491","Study of Precision Treatment for Rare Tumours in China Guided by PDO and NGS","A Phase II Clinical Study on Precision Treatment of Rare Tumours in China Guided by Patient-Derived Tumor Organoids (PDO) and Next-Generation Sequencing (NGS)","SPRING","Inclusion Criteria:\n\n1. Male or female, the age at the time of signing the informed consent is no less than 18 years old;\n2. Patients with advanced or metastatic rare solid tumor confirmed by histological confirmed;\n3. ECOG score is 0 or 1;\n4. Expected survival ≥12 weeks;\n5. According to Response Evaluation Criteria in Solid Tumor (RECIST 1.1), there is at least one imaging measurable lesions, which has not previously undergone radiotherapy or with obvious disease progress after radiotherapy;\n6. Surgical specimens of paired tumor tissue and adjacent normal tissue, or fresh biopsy tissue samples or ≥500ml serous cavity effusion with positive pathological cytological examination must be provided. These specimens must be obtained without prior exposure to any other anti-tumor treatment, systemic anti-infection treatment, vaccination, et al. and are intended for organoid culture;\n7. Must have a primary or metastatic paraffin-embedded tissue (without radiotherapy) other than bone metastatic lesions before enrollment (within 2 years, 15-20 sheets, 4-6μm thick white slices, of which 5 need to be glued and baked ) and peripheral blood samples for NGS gene testing. If NGS results are already available but sufficient paraffin-embedded tissue cannot be provided, investigator are allowed the decision to enroll subjects according to the specific situation;\n8. In the condition that the primary lesions biopsy specimen has been provided, if the metastatic lesion is able to be biopsied(determined by investigator), it is suggested to keep the specimen for pathological testing and provide fresh tissue specimen;\n9. After the progression of the subject\\'s disease, if conditions permit(determined by investigator), fresh tissue samples shall be obtained from the same biopsy lesions and the metastasis lesions of the previously obtained samples;\n10. Toxic and side effects caused by previous treatment need to be restored to ≤ Grade 1 or returned to the baseline value (NCI-CTCAE version 5.0, except for hair loss);\n11. Negative pregnancy test (only applicable for women with childbearing potential). No childbearing potential is defined as being postmenopausal for longer than one year or having undergone surgical sterilization or hysterectomy;\n12. All patients (male and female) agree to use an effective form of contraceptive measures during the treatment and within 8 weeks after the end of treatment;\n13. Signed, written informed consent of volunteers that join the group shall follow the trial treatment plan, follow-up plan and cooperate to observe the adverse events and efficacy.\n\nExclusion Criteria:\n\n1. No patient lesions available for organoid model construction;\n2. History of interstitial lung disease or radiation pneumonitis of any type;\n3. Central Nervous System (CNS) metastases with brain metastases-related symptoms, which is not stable in neurology, or need to increase steroid dosage to control CNS disease. (Note: Patients with controlled CNS metastasis are eligible to participate in this study);\n4. Current uncontrollable third cavity effusion, such as a large amount of pleural effusion，ascites , or pericardial effusion;\n5. Major surgical operations or incomplete healing of injury within 4 weeks prior to study treatment\\'s first administration and chest radiotherapy of \\> 30 Gy within 6 months;\n6. History of receiving other investigational drugs within 14 days or 5 half-lives (whichever is longer) prior to the first administration;\n7. History of receiving live vaccine within 30 days prior to the first administration. Seasonal influenza vaccines that do not contain live viruses are allowed;\n8. Current active infection requiring systemic treatment (antibiotics); or any of the following:\n\n   1. HIV positive or known history of acquired immunodeficiency syndrome;\n   2. Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection is defined as HBsAg positive and the number of HBV DNA copies exceeds the upper limit of normal value, or HCV AB positive;\n   3. Active tuberculosis (with exposure history or positive tuberculosis test; with clinical and \u002F or imaging manifestations);\n   4. Positive antibody of Treponema Pallidum\n9. Current evidenced uncontrollable systemic diseases (such as severe mental, neurological, epilepsy or dementia, unstable or uncompensated respiratory, cardiovascular, liver or kidney diseases, uncontrolled hypertension \\[still greater than or equal to CTCAE Grade 3 hypertension after drug treatment\\]);\n10. History of myocardial infarction, coronary artery \u002F peripheral artery bypass or cerebrovascular accident within 3 months;\n11. Diagnosed with a second type of malignant tumor within 5 years before the first diagnosis of a rare solid tumor (excluding completely resected basal cell carcinoma, bladder carcinoma in situ, cervical carcinoma in situ);\n12. History of receiving of any organ transplantation, including allogeneic stem cell transplantation. Transplantation without immunosuppression (corneal transplantation, hair transplantation) is excluded;\n13. Cardiovascular disease or symptom includes any of the following:\n\n    1. History of Congestive Heart Failure requiring treatment and of New York Heart Association class III \u002F IV CHF (see Appendix 3) ;\n    2. Current ventricular arrhythmia requiring antiarrhythmic drugs treatment, or uncontrollable or unstable arrhythmia;\n    3. Severe conduction disorder (such as grade II or III AV block);\n    4. Angina requiring treatment;\n    5. QT interval (QTC) of 12 lead ECG is ≥ 450 ms in male and ≥ 470 MS in female;\n    6. History of congenital long QT syndrome, congenital short QT syndrome, torsade de pointe or pre-excitation syndrome;\n    7. History of LVEF decline to below 50% determined by echocardiography or MUGA scan;\n    8. History of myocardial infarction in the past 6 months.\n14. Inadequate bone marrow reserve or organ function;\n15. Pregnant or lactating women;\n16. History of swallowing dysfunction, active gastrointestinal disease or other diseases that significantly affect the absorption, distribution, metabolism and excretion of oral drugs. The patients with history of subtotal gastrectomy. (Note: this standard is not applicable to the sub schemes with the investigational drug as injection).",{"count":241,"type":19},200,[243],"PHASE2","The objective of this Phase II, open-label, multicenter, non-randomised controlled clinical trial is to guide precision treatment for patients with rare tumours based on Patient-Derived Organoids\u002FNext-Generation Sequencing drug screening.",[246],"Rare Tumour",[246,248,249,250],"Patient-Derived Organoids (PDO)","Next-Gneration Sequencing (NGS)","Precision Treatment","2024-11-14",{"date":253,"type":33},"2024-11-18",{"date":255,"type":19},"2025-01-01",{"date":257,"type":19},"2029-12-31",{"name":39,"class":40},""]