[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Affiliated Hospital of Nantong University\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":619},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,34,0,25,[9,46,70,92,113,140,166,189,213,239,264,291,313,332,359,383,408,433,460,485,510,536,559,577,597],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":4},"100636753","tdcs-for-reducing-the-incidence-of-oei-after-cesarean-section-100636753",false,"NCT07569783","tDCS for Reducing the Incidence of OEI After Cesarean Section","Study on the Preventive and Therapeutic Effects and Mechanism of Transcranial Direct Current Stimulation on Morphine-Induced Itching After Cesarean Section: A Randomized Clinical Controlled Trial","Inclusion Criteria:\n\n* Age 18-40 years, gestational age 37-41 weeks, singleton full-term pregnancy;\n* Planned elective or emergency cesarean section, using epidural anesthesia (0.1\\~0.2 mg\u002Fkg of morphine administered intrathecally during surgery);\n* American Society of Anesthesiologists (ASA) classification I-III;\n* Conscious and able to cooperate to complete scale assessments, serum sample collection, and postoperative follow-up;\n* Voluntarily participate in the study and sign the informed consent form.\n\nExclusion Criteria:\n\n* Presence of contraindications for tDCS (such as skull defects, intracranial metal implants, history of epilepsy, coagulation disorders);\n* Allergy to opioids or a history of severe OEI;\n* Presence of skin diseases (such as eczema, urticaria), liver diseases (cholestasis), mental disorders, or cognitive impairments;\n* Coexisting pregnancy complications (preeclampsia, gestational diabetes, autoimmune diseases);\n* Use of medications within the past week that may affect itch assessment, such as antihistamines, 5-HT3 receptor antagonists, or anti-inflammatory drugs.","ALL","18 Years","40 Years",{"count":21,"type":22},104,"ESTIMATED","INTERVENTIONAL",[25],"NA","Cesarean section is the most common obstetric surgery worldwide. Epidural anesthesia has become the preferred anesthesia method for cesarean sections due to its definite analgesic effect and minimal impact on mother and baby. To ensure postoperative analgesia, intrathecal administration of morphine (the preferred opioid for obstetric intrathecal analgesia) is a routine clinical protocol, but morphine-induced postoperative pruritus is a common adverse reaction. A study targeting the cesarean section population confirmed that the incidence of pruritus after epidural morphine administration is as high as 40%-75%.Transcranial direct current stimulation (tDCS) can enhance the activity of GABAergic inhibitory interneurons in the spinal dorsal horn through the cortical-spinal descending pathway, reverse the inhibitory effect of morphine on them, and restore negative feedback regulation of itch-specific GRPR⁺ neurons; at the same time, it downregulates the phosphorylation level and membrane expression of μ-opioid receptors in the spinal dorsal horn, weakening the receptor activation efficiency of morphine. On the other hand, tDCS can reduce peripheral nerve excitability, decrease mast cell degranulation in the skin, and reduce the release of histamine and tryptase; simultaneously, it inhibits the activation of glial cells in the spinal cord\u002Fcortex, decreases the secretion of pro-inflammatory factors such as TNF-α and IL-6, and blocks the vicious cycle of 'inflammation-receptor upregulation-itch exacerbation,' thereby reducing the occurrence of itch.This study aims to explore the effect of transcranial direct current stimulation (tDCS) on the incidence of morphine-induced itching after cesarean section by inhibiting the central itch perception circuits in cesarean section patients and antagonizing the disinhibitory effects mediated by μ-opioid receptors in the spinal dorsal horn.",[28,29],"Itching Symptoms","Itching Caused by Epidural Use of Opioids",[31,32,33],"Transcranial direct current stimulation","Opioid-induced Pruritus after Epidural Administration","Cesarean section","NOT_YET_RECRUITING","2026-06-30",{"date":37,"type":38},"2026-07-02","ACTUAL",{"date":40,"type":22},"2026-06-15",{"date":42,"type":22},"2027-02-20",{"name":44,"class":45},"Affiliated Hospital of Nantong University","OTHER",{"id":47,"slug":48,"hasResults":12,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":56,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":4},"100631898","phase-1-rn1701-injection-in-the-treatment-of-relapsedrefractory-b-cell-lymphomas-100631898","NCT07506668","RN1701 Injection in the Treatment of Relapsed\u002FRefractory B-Cell Lymphomas","An Exploratory Clinical Study of the Safety and Efficacy of RN1701 Injection in the Treatment of Relapsed\u002FRefractory B-Cell Lymphomas","Inclusion Criteria:\n\n1. Voluntary participation; full understanding of the study and provision of written informed consent obtained before any study-related procedure not part of standard care; willingness to comply with follow-up.\n2. Age 18-75 years; either sex.\n3. ECOG performance status 0-1.\n4. Histologically confirmed large B-cell lymphoma, follicular lymphoma, mantle-cell lymphoma, or indolent lymphoma transformed to DLBCL; CD19 and\u002For CD20 positive.\n5. At least one measurable lesion per Lugano criteria: nodal lesion longest diameter \\>1.5 cm, extranodal lesion \\>1.0 cm.\n6. Prior treatment response must meet one of the following:\n\n   • Large B-cell lymphoma, grade 3B follicular lymphoma, transformed indolent lymphoma: i. Primary refractory and ineligible\u002Funable to receive autologous CAR-T: best response PD after ≥2 cycles of first-line therapy, or SD after ≥4 cycles.\n\n   ii. Relapse ≤12 months after achieving CR with first-line chemo-immunotherapy. iii. Relapse\u002Fprogression ≤12 months after autologous HSCT. iv. Refractory to, relapsed after, or progressed on ≥2 prior lines (including autologous CAR-T): best response PD or SD after ≥2 cycles of the most recent regimen.\n\n   v. Transformed indolent lymphoma: prior chemotherapy for iNHL and ≥1 systemic regimen after transformation, fulfilling the above refractory\u002Frelapse criteria.\n\n   • Grade 1, 2, or 3A follicular lymphoma: i. Primary refractory and ineligible\u002Funable to receive autologous CAR-T: best response PD after ≥2 cycles of first-line therapy.\n\n   ii. Refractory to, relapsed after, or progressed on ≥2 prior lines (including autologous CAR-T): best response PD or SD after ≥2 cycles of the most recent regimen.\n\n   • Mantle-cell lymphoma: i. Primary refractory and ineligible\u002Funable to receive autologous CAR-T: best response PD after ≥2 cycles of first-line therapy, or SD after ≥4 cycles.\n\n   ii. Refractory to, relapsed after, or progressed on ≥2 prior lines (including autologous CAR-T): best response PD or SD after ≥2 cycles of the most recent regimen.\n7. Estimated life expectancy ≥3 months.\n8. Screening laboratory values (may be repeated once):\n\n   * Hemoglobin ≥8.0 g\u002FdL (no transfusion within 7 days).\n   * Platelets ≥50×10⁹\u002FL (no transfusion within 7 days).\n   * ANC ≥1.0×10⁹\u002FL (growth-factor support allowed if none within 7 days of test).\n   * AST\u002FALT ≤3×ULN (≤5×ULN if liver involvement).\n   * Serum creatinine ≤1.5×ULN or CrCl ≥60 mL\u002Fmin (Cockcroft-Gault).\n   * Total bilirubin ≤2×ULN (≤3×ULN if liver involvement); except congenital bilirubin disorders (e.g., Gilbert's syndrome: direct bilirubin ≤1.5×ULN).\n   * INR, PT, APTT \\\u003C1.5×ULN.\n9. Toxicities from prior anti-cancer therapy (except alopecia, nausea, and the above lab values) must have stabilized at baseline or resolved to ≤Grade 1.\n10. WOCBP must have a negative high-sensitivity serum β-hCG pregnancy test at screening and again before the first dose of cyclophosphamide\u002Ffludarabine.\n11. Subjects of reproductive potential must use effective contraception for ≥12 months after completing study therapy.\n\nExclusion Criteria:\n\n* Subjects with any of the following conditions are ineligible for this trial:\n\n  1. Any malignancy other than B-cell non-Hodgkin lymphoma ever diagnosed or treated, except:\n\n     * Malignancy that received curative therapy and has shown no evidence of active disease for ≥2 years before enrolment; or\n     * Adequately treated non-melanoma skin cancer with no current evidence of disease.\n  2. Prior anti-cancer therapy within the stated windows (before lymphodepletion):\n\n     * CNS prophylaxis (e.g., intrathecal methotrexate and\u002For cytarabine) within 7 days;\n     * Cytotoxic chemotherapy or radiotherapy within 14 days;\n     * Small-molecule targeted or epigenetic therapy within 14 days or 5 half-lives, whichever is longer;\n     * Monoclonal antibody, bispecific antibody, or antibody-drug conjugate within 21 days or 5 half-lives, whichever is shorter;\n     * Investigational drug or invasive investigational device within 28 days (if the therapy is also investigational, the 28-day wash-out applies);\n     * Autologous haematopoietic stem-cell transplant or CD19-directed autologous CAR-T therapy within 100 days.\n  3. Any autologous cellular or gene therapy other than CD19-directed autologous CAR-T.\n  4. Any allogeneic cellular (including CAR-T) or gene therapy.\n  5. Prior allogeneic haematopoietic stem-cell transplantation.\n  6. Positive donor-specific antibody (DSA).\n  7. At least one of the following high-risk features:\n\n     * Sum of the product of perpendicular diameters (SPD) of all measurable lesions ≥100 cm²;\n     * Bulky disease: single mass ≥7.5 cm; mediastinal mass with maximum diameter \\>1\u002F3 of thoracic diameter;\n     * Obstructive\u002Fcompressive emergency (e.g., bowel obstruction, vascular compression) requiring urgent intervention at screening.\n  8. Active CNS involvement (symptomatic or positive CSF\u002Fimaging); subjects with prior CNS disease now in remission (asymptomatic with negative CSF and imaging) are eligible.\n  9. Significant bleeding diathesis: gastrointestinal bleeding, haemorrhagic cystitis, coagulopathy, hypersplenism (splenomegaly on exam\u002FUS, cytopenias, hyperplastic marrow) or ongoing anticoagulation.\n  10. Chronic concomitant systemic corticosteroids or other immunosuppressants, except: topical, ocular, intra-articular, nasal or inhaled corticosteroids; short-course steroids for prophylaxis (e.g., contrast allergy).\n  11. Severe underlying medical conditions:\n\n      * Active serious viral, bacterial or uncontrolled systemic fungal infection;\n      * Active systemic autoimmune disease requiring therapy.\n  12. Significant cardiac disease:\n\n      * NYHA class III or IV congestive heart failure;\n      * Myocardial infarction or CABG within 6 months before enrolment;\n      * Clinically relevant ventricular arrhythmia or unexplained syncope not vasovagal or dehydration-related;\n      * Severe non-ischaemic cardiomyopathy;\n      * Left ventricular ejection fraction (LVEF) \\\u003C45% by echo or MUGA within 4 weeks before lymphodepletion.\n  13. Resting oxygen saturation \\\u003C92%.\n  14. Clinically relevant prior or current CNS disorder: epilepsy, seizure-like episodes, paralysis, aphasia, stroke, severe head trauma, dementia, Parkinson's disease, cerebellar disorder, organic brain syndrome or major psychiatric illness.\n  15. Live-attenuated vaccine within 4 weeks before screening.\n  16. Major surgery within 2 weeks before screening or planned within 2 weeks after study treatment (local anaesthesia allowed).\n  17. Positive screen for HBsAg, HBeAg, HBV DNA, HCV antibody, HCV RNA, or HIV antibody.\n  18. Life-threatening allergy, hypersensitivity or intolerance to study-drug excipients including, but not limited to, DMSO.\n  19. Lactating women.\n  20. Any condition that, in the investigator's opinion, renders the subject unsuitable for the study.","75 Years",{"count":55,"type":22},10,[57,58],"PHASE1","PHASE2","This single-arm, open-label pilot study will assess the safety and efficacy of RN1701, a bispecific CD19\u002FCD20-targeted allogeneic CAR-T-cell product, in patients with relapsed or refractory B-cell lymphoma. Up to 19 participants will be enrolled in a conventional 3 + 3 dose-escalation scheme. The primary objective of the study is to evaluate the safety and feasibility of RN1701 for the treatment of relapsed\u002Frefractory B-cell lymphoma. The secondary objective is to evaluate the efficacy of RN1701 for the treatment of relapsed\u002Frefractory B-cell lymphoma. The exploratory objective is to evaluate the expansion, persistence, and ability of RN1701 to deplete CD19- and\u002For CD20-positive cells in patients with relapsed\u002Frefractory B-cell lymphoma.",[61],"Relapsed\u002FRefractory B-cell Lymphoma","2026-03-28",{"date":64,"type":38},"2026-04-02",{"date":66,"type":22},"2026-03-23",{"date":68,"type":22},"2028-05-30",{"name":44,"class":45},{"id":71,"slug":72,"hasResults":12,"nctId":73,"briefTitle":74,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":23,"phases":78,"briefSummary":79,"conditions":80,"keywords":4,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},"100619258","phase-2-ql1706-plus-chemotherapy-as-neoadjuvant-therapy-in-triple-negative-breast-cancer-100619258","NCT07342283","QL1706 Plus Chemotherapy as Neoadjuvant Therapy in Triple-Negative Breast Cancer","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed newly diagnosed ER-\u002FHER2- breast cancer. ER and PR with Allred score \\\u003C3 or \\\u003C1% positively stained cells in tumor infiltrating components. HER2 negativity defined as 0 or 1+ by FISH or IHC staining per NCCN guidelines;\n2. Clinical stage II or III breast cancer eligible for neoadjuvant chemotherapy (per AJCC 8th edition: at least T2 any N M0, or any T if N+), with treatment goal of complete surgical resection following neoadjuvant therapy;\n3. Tumor size ≥2 cm by clinical or imaging assessment per WHO criteria. Patients with histologically confirmed or clinically palpable lymph nodes are eligible regardless of tumor size;\n4. Treatment-naïve subjects;\n5. Age ≥18 years, both genders eligible;\n6. ECOG performance status 0-1;\n7. Adequate bone marrow, cardiac, and organ function;\n8. Women of childbearing potential must have a negative pregnancy test (serum or urine HCG) within 30 days prior to study enrollment and must practice effective contraception during the study;\n9. Ability to comprehend and provide written informed consent.\n\nExclusion Criteria:\n\n1. History of invasive malignancies within 5 years prior to signing the informed consent form, except for adequately treated basal cell carcinoma, squamous cell skin cancer, or carcinoma in situ of the cervix;\n2. Subjects who have received chemotherapy, immunotherapy, targeted therapy, or radiotherapy within the past 12 months;\n3. Stage IV metastatic breast cancer;\n4. Administration of a vaccine within 30 days before the first dose of the study treatment;\n5. Subjects with severe systemic diseases;\n6. Subjects with active infections (including but not limited to HIV, hepatitis B or C, tuberculosis);\n7. Severe cardiovascular diseases, such as: history of myocardial infarction, acute coronary syndrome, or coronary angioplasty\u002Fstenting\u002Fbypass grafting within the past 6 months; or congestive heart failure (CHF) of New York Heart Association (NYHA) class II-IV, or history of CHF NYHA class III or IV;\n8. Lactating women should discontinue breastfeeding during the study;\n9. Subjects with known allergies to the study drug or any of its excipients;\n10. Any other condition deemed inappropriate for participation in the study by the investigator.\n\n    \\-",{"count":77,"type":22},30,[58],"This is a single-center, single-arm, prospective study enrolling 30 patients with stage II-III triple-negative breast cancer. The neoadjuvant regimen consists of QL1706 combined with carboplatin plus albumin-bound paclitaxel (21-day cycles for 4 cycles) followed by QL1706 combined with doxorubicin\u002Fepirubicin plus cyclophosphamide (21-day cycles for 4 cycles). The treatment observation period is 1 year, and the primary endpoint is the pathological complete response rate.",[81],"Triple Negative Breast Cancer (TNBC)","RECRUITING","2026-02-26",{"date":85,"type":38},"2026-03-02",{"date":87,"type":38},"2026-02-25",{"date":89,"type":22},"2028-12-25",{"name":44,"class":45},1,{"id":93,"slug":94,"hasResults":12,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":4,"eligibilityCriteria":98,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":99,"enrollmentInfo":100,"targetDuration":4,"studyType":23,"phases":101,"briefSummary":102,"conditions":103,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":4},"100622348","phase-2-effect-of-pae-hydrogel-loaded-with-trf-aso-exo-on-patients-with-diabetic-ocular-surface-diseases-100622348","NCT07382453","Effect of PAE Hydrogel Loaded With tRF-ASO-Exo on Patients With Diabetic Ocular Surface Diseases","Effect of Poly（β-amino Ester）Hydrogel Loaded With tRNA-derived Fragments-antisense Oligonucleotides-exosomes on Patients With Diabetic Ocular Surface Diseases","Inclusion Criteria:\n\n* 1\\. Patients with fasting blood glucose ≥ 7.0 mmol\u002FL or 2-hour postprandial blood glucose ≥ 11.1 mmol\u002FL.\n\n  2\\. Those who clearly understand and voluntarily participate in this study, and sign the written informed consent form themselves, and are able and willing to follow the instructions to participate in all trial evaluations and visits.\n\n  3\\. Male subjects and female subjects of childbearing age must agree to use medically approved contraceptive measures during the trial and for 90 days after the trial. For female subjects who have not reached menopause or have been menopausal for less than two years, the pregnancy test must be negative.\n\n  4\\. A history of severe dry eye symptoms (including one or more of the following subjective symptoms: dryness, foreign body sensation, burning sensation, fatigue, discomfort, redness, sudden eye pain, photophobia, tearing, blurred vision, and decreased corneal sensation) in both eyes for at least 180 days before the screening visit (Visit 0).\n\n  5\\. Currently (within 30 days before Visit 0) using artificial tears to relieve dry eye-related symptoms, and artificial tears must be discontinued 72 hours before Visit 0.\n\n  6\\. At Visit 0, the Chinese Dry Eye Questionnaire score is \\> 7 points or the total score of the Ocular Surface Disease Index is \\> 13 points.\n\n  7\\. At Visit 0 and Visit 1, the dryness score is \\> 40 points. 8. At Visit 0, the best corrected visual acuity of both eyes is ≥ 4.3 (5-meter reading on the international standard logarithmic visual acuity chart, 5-point recording method).\n\n  9\\. At Visit 0 and Visit 1, the corneal fluorescein staining score of at least one area of at least one eye is ≥ 2 points.\n\n  10\\. At Visit 0 and Visit 1, the conjunctival redness score of at least one eye is ≥ 1 point.\n\n  11\\. At the screening visit and baseline visit (Visit 0 and Visit 1), at least one eye of the same subject meets the following criteria: a. The corneal lower zone fluorescein staining score is ≥ 0.5 points; b. The Schirmer's test without anesthesia is ≥ 1 and ≤ 10 mm\u002F5 min.\n\nExclusion Criteria:\n\n1. Any past or current malignancy in or around the eye.\n2. Dry eye traced to scarring (radiation, alkali burn, Stevens-Johnson, cicatricial pemphigoid) or goblet-cell loss (vitamin-A deficiency).\n3. Active ocular allergy now or expected during the study.\n4. Ocular or systemic infection at screening\u002Fbaseline-fever, herpetic keratitis, or on antibiotics.\n5. Prior immunodeficiency, HIV, hep B\u002FC, active hep A, organ or bone-marrow transplant.\n6. Any serious chronic illness the PI thinks could mess with endpoints-severe heart\u002Flung disease, uncontrolled hypertension or diabetes.\n7. Blood donation or major blood loss within 8 weeks of screening.\n8. Active ocular rosacea, periorbital acne, or pterygium.\n9. Lid problems-lagophthalmos, entropion, ectropion, or abnormal blink.\n10. Clinically relevant slit-lamp findings needing treatment (conjunctivitis, trichiasis, conjunctivochalasis) that could skew results.\n11. Eye surgery or laser (including YAG, meibomian thermopulsation, IPL) within 6 months of screening, or any such plan during the trial.\n12. Punctal plugs (non-dissolvable within 90 days; dissolvable within 180 days) or planned plug procedures during the study.\n13. Systemic steroids, immunomodulators, oral doxy\u002Ftetracycline within 90 days, or on-and-off use planned.\n14. Topical glaucoma meds within 90 days.\n15. Cyclosporine-A or lifitegrast drops within 42 days.\n16. Drugs well known to dry the eye-diuretics, antidepressants, decongestants, antispasmodics, antihistamines, etc.-within 30 days or irregular use expected.\n17. Active blepharitis\u002FMGD therapy (lid scrubs, meibomian massage, warm compresses, systemic antibiotics) within 30 days or sporadic use planned.\n18. Topical steroid or mast-cell stabilizer on the eye\u002Fface within 2 weeks.\n19. Contact-lens wear within 7 days or intent to keep wearing them during the study.","70 Years",{"count":77,"type":22},[58],"The purpose of this study is to determine whether poly（β-amino ester）(PAE)hydrogel loaded with tRNA-derived fragments-antisense oligonucleotides-exosomes(tRF-ASO-Exo) could alleviate symptoms in patients with diabetic ocular surface diseases(DOSD).",[104],"Diabetic Keratopathy","2026-02-02",{"date":107,"type":38},"2026-02-04",{"date":109,"type":22},"2026-02-15",{"date":111,"type":22},"2029-06-30",{"name":44,"class":45},{"id":114,"slug":115,"hasResults":12,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":4,"eligibilityCriteria":119,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":120,"enrollmentInfo":121,"targetDuration":4,"studyType":23,"phases":123,"briefSummary":124,"conditions":125,"keywords":129,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":139},"100621826","dynamic-airway-resistance--ml-guide-sputum-suction-in-ventilated-patients-100621826","NCT07375667","Dynamic Airway Resistance & ML: Guide Sputum Suction in Ventilated Patients","Mechanisms of Dynamic Airway Resistance Monitoring and Machine Learning for Assessing Pulmonary Inflammation and Guiding Sputum Suction in Mechanically Ventilated Patients","Inclusion Criteria:\n\n* Clinical diagnosis of Acute Respiratory Distress Syndrome (ARDS)\n* Clinical diagnosis of Acute Exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD)\n* Clinical diagnosis of Severe pneumonia\n\nExclusion Criteria:\n\n* Clinical diagnosis of multiple organ failure;\n* Clinical diagnosis of multiple organ bleeding;","90 Years",{"count":122,"type":22},258,[25],"Research has shown that timely suctioning not only improves survival rates but also enhances the quality of life in ventilator-dependent patients. However, clinical judgment on the optimal timing for suctioning currently relies primarily on physician experience, lacking scientific evidence \\[10\\]. Airway viscous resistance reflects the frictional resistance encountered by gas flow within the airways and is closely associated with airway patency. When airway secretions increase, viscous resistance undergoes dynamic changes. Therefore, analyzing these dynamic variations in viscous resistance derived from ventilator waveforms to determine the optimal suctioning timing and assess its clinical impact on the progression of pulmonary inflammation holds significant scientific value and offers new insights and methodologies for clinical practice.",[126,127,128],"Mechanical Ventilation Pressure High","Ventilator-Associated Pneumonia (VAP)","Respiratory Depression Neonatal",[130],"Airway resistance","2026-01-26",{"date":133,"type":38},"2026-01-29",{"date":135,"type":38},"2025-10-30",{"date":137,"type":22},"2029-12-30",{"name":44,"class":45},3,{"id":141,"slug":142,"hasResults":12,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":146,"eligibilityCriteria":147,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":53,"enrollmentInfo":148,"targetDuration":4,"studyType":23,"phases":149,"briefSummary":150,"conditions":151,"keywords":155,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":91},"100608744","phase-2-clinical-study-of-thiopegfilgrastim-for-preventing-bone-marrow-suppression-in-thoracic-tumor-chemoradiotherapy-100608744","NCT07205536","Clinical Study of Thiopegfilgrastim for Preventing Bone Marrow Suppression in Thoracic Tumor Chemoradiotherapy","A Clinical Study on the Safety and Efficacy of Mecapegfilgrastim in Preventing Myelosuppression Induced by Concurrent Chemoradiotherapy for Thoracic Malignancies","ANC-IIT-004","Inclusion Criteria:\n\n* Aged 18-75 years at the time of giving informed consent， both sexes eligible\n* Histologically or cytologically confirmed thoracic tumor (esophageal or lung cancer)\n* Investigator judges the patient suitable for treatment with mecapegfilgrastim injection or leucogen tablets\n* Expected survival \\> 3 months\n* Signed informed consent; willing and able to comply with protocol-mandated visits\n* The patient is indicated for concurrent chemoradiotherapy and is currently\u002Freceiving or will receive a high-risk chemotherapy regimen for febrile neutropenia (FN risk ≥20%), or is currently\u002Freceiving or will receive an intermediate-risk chemotherapy regimen for FN (FN risk 10%\\~20%) with additional FN risk factors.\n\nExclusion Criteria:\n\n* Pregnant or lactating women\n* Known hypersensitivity to mecapegfilgrastim, pegylated or non-pegylated rhG-CSF, or any E. coli-derived product\n* Any severe comorbidity that, in the investigator's opinion, compromises patient safety or ability to complete the study\n* Any other condition that, in the investigator's judgment, could interfere with study conduct or interpretation of results",{"count":77,"type":22},[58],"This is a prospective observational study designed to observe and evaluate the safety and efficacy of mecapegfilgrastim in the treatment of moderate-to-severe myelosuppression associated with concurrent chemoradiotherapy. The project will provide more robust evidence-based medical support for the use of long-acting granulocyte-stimulating agents in patients undergoing concurrent chemoradiotherapy.",[152,153,154],"Myelosuppression","Thoracic Neoplasms","Chemoradiotherapy",[156,157],"Neutropenia","Febrile neutropenia","2025-12-10",{"date":160,"type":38},"2025-12-11",{"date":162,"type":38},"2025-08-01",{"date":164,"type":22},"2027-12",{"name":44,"class":45},{"id":167,"slug":168,"hasResults":12,"nctId":169,"briefTitle":170,"officialTitle":171,"acronym":4,"eligibilityCriteria":172,"healthyVolunteers":12,"sex":173,"minAge":18,"maxAge":174,"enrollmentInfo":175,"targetDuration":4,"studyType":23,"phases":177,"briefSummary":178,"conditions":179,"keywords":4,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":182,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":91},"100613788","effects-of-tavns-combined-with-dexmedetomidine-on-povn-100613788","NCT07271147","Effects of taVNS Combined With Dexmedetomidine on POVN","The Effect of Dexmedetomidine Combined With Percutaneous Auricular Vagus Nerve Stimulation on Postoperative Nausea and Vomiting in Female Laparoscopic Patients: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Women aged 18 to 65;\n* Elective laparoscopic surgery under general anesthesia;\n* Classified as American Society of Anesthesiologists (ASA) physical status I to II;\n* Capable of understanding the study procedures and various assessment scales and able to effectively communicate with the researchers;\n* Willing to participate in the study and provide written informed consent.\n\nExclusion Criteria:\n\n* Patients with ASA anesthesia classification ≥ III;\n* Poorly controlled hypertension, atrioventricular block ≥ second degree, obesity (BMI \\> 30 kg\u002Fm²);\n* Pregnant or breastfeeding;\n* Known allergy to drugs used in the study protocol, history of traumatic brain injury, history of gastrointestinal surgery;\n* Liver or kidney dysfunction (liver enzymes or creatinine ≥ 1.5 times the normal value), alcoholism or drug abuse, mental illness, use of antiemetics, opioids, psychoactive drugs, or corticosteroids within 24 hours before surgery;\n* Patients with implanted stimulators (such as pacemakers, implantable vagus nerve stimulators, deep brain stimulators, spinal cord stimulators, etc.), cochlear implants, or metal implants (except in dental cases);\n* Skin lesions or dermatological diseases at the site of electrical stimulation;\n* Preoperative heart rate \\\u003C 50 bpm or the presence of sinoatrial node disease or second-degree or higher atrioventricular block;\n* Patients unable to cooperate with assessments;\n* Patients participating in other clinical trials.","FEMALE","65 Years",{"count":176,"type":22},176,[25],"To explore the effects and possible mechanisms of dexmedetomidine combined with taVNS on the incidence of postoperative nausea and vomiting in female patients undergoing laparoscopic surgery",[180],"Postoperative Nausea and Vomiting","2025-12-07",{"date":183,"type":38},"2025-12-09",{"date":185,"type":38},"2025-11-07",{"date":187,"type":22},"2026-12-01",{"name":44,"class":45},{"id":190,"slug":191,"hasResults":12,"nctId":192,"briefTitle":193,"officialTitle":194,"acronym":4,"eligibilityCriteria":195,"healthyVolunteers":196,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":197,"targetDuration":199,"studyType":200,"phases":4,"briefSummary":201,"conditions":202,"keywords":204,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":206,"lastUpdatePostDateStruct":207,"startDateStruct":208,"completionDateStruct":210,"leadSponsor":212,"locationsCount":91},"100611996","prospective-cohort-control-study-on-changes-in-gut-microbiota-in-ischemic-stroke-100611996","NCT07247838","Prospective Cohort Control Study on Changes in Gut Microbiota in Ischemic Stroke","Investigation Into the Gut Microbiota-Immune-Inflammatory Interaction Network and Its Mechanisms in Patients With Ischemic Stroke","Inclusion Criteria:\n\n(1) First-time acute ischemic stroke patients must have completed initial sample collection within 48 hours of symptom onset and hospital admission; (2) Participants must be aged 18 or older, with no gender restrictions; (3) Stroke patients must have a National Institutes of Health Stroke Scale (NIHSS) score of 4 or higher; (4) Participants must fully understand the study protocol and provide informed consent.\n\nExclusion Criteria:\n\n(1) Patients who have taken antibiotics or probiotics within one month prior to hospitalization or during follow-up; (2) Patients with infectious diseases such as pneumonia or urinary tract infections; (3) Patients who cannot obtain stool samples within three days after hospitalization or during three-month follow-up; (4) Patients with severe dysfunction of major organs including heart, lungs, liver, or kidneys; (5) Patients who have not provided or are unable to provide informed consent; (6) Patients with a history of major gastrointestinal diseases; (7) Patients with other severe neurological disorders; (8) Patients deemed unsuitable by investigators to participate in this clinical study.",true,{"count":198,"type":22},200,"6 Months","OBSERVATIONAL","1. Stroke stands as one of the leading causes of death and long-term disability worldwide, imposing a substantial socioeconomic burden. Annual new stroke cases are estimated between 9.5 million and 10.6 million. Stroke survivors commonly face challenges of poor long-term functional outcomes and compromised immunity, which not only drive quality-of-life deterioration but also fuel the persistent escalation of socioeconomic burdens. However, current clinical treatments for stroke prognosis improvement remain limited. In recent years, with the emergence of the \"microbiota-gut-brain axis\" concept and advancing research, the role of gut microbiota in stroke onset, progression, and prognosis regulation has garnered increasing attention.\n\n   The gut-brain axis is a complex bidirectional communication network connecting the central nervous system with the gut and its microbiota, centered on the integration of the microbiota-gut-brain axis concept. Its signaling mechanisms primarily involve multiple pathways including neural (e.g., vagus nerve), endocrine (e.g., HPA axis and gut hormones), immune (e.g., cytokines), and microbial metabolic pathways (e.g., short-chain fatty acids (SCFAs) and neuroactive substances). Dysregulation of the gut-brain axis has been proven closely associated with various diseases, including irritable bowel syndrome (IBS) characterized by visceral hypersensitivity and motility abnormalities, inflammatory bowel disease (IBD) often accompanied by emotional comorbidities, autism spectrum disorder (ASD) with gastrointestinal symptoms and behavioral core symptoms, depression and anxiety related to microbiota dysbiosis and inflammation, as well as Parkinson's disease (PD) with pathological origins potentially originating in the gut. Recent studies support that gut microbiota interact with ischemic stroke through the gut-brain axis, thereby modulating stroke pathogenesis. Gut microbiota can regulate innate and adaptive immune responses and their derived metabolites through neural pathways, influencing host brain function and behavior. Gut microbiota metabolites-short-chain fatty acids (SCFAs) such as butyrate-reduce neuroinflammation and brain injury by promoting regulatory T cell differentiation and secretion of anti-inflammatory factors IL-10 and TGF-β, suppressing pro-inflammatory Th1\u002FTh17 responses, and enhancing expression of blood-brain barrier tight junction proteins Occludin and ZO-1.\n\n   Compared to traditional stroke treatments, gut microbiota therapy breaks the time window limitation. Even days after stroke, restoring a youthful gut microbiome can reduce neuroinflammation and promote recovery in stroke patients. This effect is largely mediated by metabolites produced by bacteria, particularly short-chain fatty acids.\n\n   Although existing studies have demonstrated the crucial role of gut microbiota in stroke treatment, the mechanisms underlying its effects on improving physiological and behavioral functions in stroke patients, as well as the underlying mechanisms, remain insufficiently explored.\n2. Purpose of this study To investigate the mechanisms by which gut microbiota and their metabolites improve the physiological and neurological functions of stroke patients, and to provide new therapeutic approaches for improving the prognosis of stroke patients.\n3. Research Design 3.1 Research Methodology This is a single-center, non-interventional, cohort-controlled clinical study that randomly enrolled 100 stroke patients and 100 healthy individuals. The participants were divided into a stroke group (case group, CS group) and a healthy control group (CON group), with 100 cases in each group. The primary objectives were to investigate the gut microbiota composition, intestinal barrier function, and inflammatory cytokine levels in stroke patients versus healthy controls, while exploring the mechanisms of beneficial gut microbiota in stroke recovery. This research may provide new therapeutic approaches to address current treatment limitations.",[203],"Ischemic Stroke",[205],"Gut Microbiota","2025-12-02",{"date":183,"type":38},{"date":209,"type":38},"2025-11-19",{"date":211,"type":22},"2028-12-31",{"name":44,"class":45},{"id":214,"slug":215,"hasResults":12,"nctId":216,"briefTitle":217,"officialTitle":218,"acronym":4,"eligibilityCriteria":219,"healthyVolunteers":12,"sex":17,"minAge":220,"maxAge":174,"enrollmentInfo":221,"targetDuration":4,"studyType":23,"phases":223,"briefSummary":224,"conditions":225,"keywords":227,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":230,"lastUpdatePostDateStruct":231,"startDateStruct":233,"completionDateStruct":235,"leadSponsor":237,"locationsCount":238},"100572373","clinical-study-of-fospropofol-disodium-for-injection-in-the-painless-endoscopic-diagnosis-and-treatment-100572373","NCT06732427","Clinical Study of Fospropofol Disodium for Injection in the Painless Endoscopic Diagnosis and Treatment","Efficacy and Safety of Fospropofol Disodium for Injection in the Painless Endoscopic Diagnosis and Treatment: a Multicenter-prospective, Randomized, Controlled Trial","Inclusion Criteria:\n\n1. Age 50-65 years, weight 40-65kg, male or female;\n2. Patients undergoing painless gastrointestinal endoscopy or painless colonoscopy;\n3. American Society of Anesthesia (ASA) grades I-II;\n4. Patients and their families can understand and fill in various rating scales, and voluntarily sign the informed consent form; -\n\nExclusion Criteria:\n\n1. Patients with simple and painless gastroscopy\n2. Allergy to this study drug and any ingredients;\n3. Patients with pathological obesity \u002F obstructive sleep apnea, patients with difficult respiratory tract management;\n4. Acute upper respiratory tract infection and asthma attacks;\n5. Liver and kidney insufficiency, abnormal heart function;\n6. History of mental disorders, long-term use of analgesics; history of drug addiction and drug use;\n7. Do not voluntarily cooperate with the patient or be unsuitable by the investigator to participate in the trial.-","50 Years",{"count":222,"type":22},426,[25],"This is a study on the efficacy and safety of fospropofol disodium for injection in painless endoscopic diagnosis and treatment, project No.2024-YCRF-M1021, which will take more than 2 years to complete.\n\nThis is a multicenter, randomized, double-blind, controlled clinical study. Using a computer-generated randomized number table, the patients were divided into two groups: the group L (fospropofol disodium group) and the group B (propofol group). After determining the group of enrolled patients, the drug was administered by two fixed anesthesiologists By participating in this study, it is possible to make your anesthesia induction stable, stable intraoperative circulation, awake and safe and comfortable, to reduce the incidence of intraoperative hypoxemia, intraoperative awareness, cardiovascular and cerebrovascular malignant events (malignant arrhythmia, cardiac arrest), which is conducive to your rapid postoperative recovery and reduce hospitalization costs.",[226],"Efficacy and Safety",[228,229],"Painless gastrointestinal endoscopy","fospropofol disodium for injection","2025-09-25",{"date":232,"type":38},"2025-09-30",{"date":234,"type":38},"2025-08-12",{"date":236,"type":22},"2026-12-31",{"name":44,"class":45},5,{"id":240,"slug":241,"hasResults":12,"nctId":242,"briefTitle":243,"officialTitle":243,"acronym":4,"eligibilityCriteria":244,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":245,"targetDuration":4,"studyType":23,"phases":247,"briefSummary":248,"conditions":249,"keywords":251,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":257,"startDateStruct":259,"completionDateStruct":261,"leadSponsor":263,"locationsCount":91},"100604231","clinical-application-research-of-5-degree-005-d-precision-optometry-in-corneal-refractive-surgery-100604231","NCT07146828","Clinical Application Research of 5-Degree (0.05 D) Precision Optometry in Corneal Refractive Surgery","Inclusion Criteria:\n\n1. The diopter is relatively stable (the diopter increases within -0.50D per year for 2 consecutive years);\n2. Age: 18 to 40 years old;\n3. Optimal preoperative corrected visual acuity \\>= 4.8;\n4. More than 2 weeks for soft contact lenses and more than 3 months for hard contact lenses before surgery\n5. Patients who are willing to perform SMILE surgery\n\nExclusion Criteria:\n\n1. Patients with history of eye surgery and trauma;\n2. Patients with keratoconus tendency;\n3. systemic connective tissue diseases and autoimmune diseases;\n4. Patients with high blood pressure, diabetes and heart disease history;\n5. Other eye disease history such as uveitis, scleritis and other eye inflammation patients;\n6. Patients with scar constitution.",{"count":246,"type":22},600,[25],"In recent years, the incidence of myopia has been high globally and is exhibiting a rapid upward trend, with projections estimating it will reach 49.8% by 2050. Corneal refractive surgery has become a primary method for correcting myopia, demonstrating significant efficacy and favorable safety. However, studies indicate that overcorrection or undercorrection can occur following refractive surgery. Reports have shown that three months post-SMILE surgery, 20% of eyes had residual refractive errors ≥ 0.50 D, and 6% had errors ≥ 1.00 D. We hypothesize that this may be related to imprecise preoperative refraction, subsequently affecting postoperative visual quality.\n\nDue to limitations in lens manufacturing precision, the widely used increment for sphere correction remains 0.25 D. However, this may prevent some patients from achieving their optimal corrected state. Studies have reported that 95% of individuals are sensitive to diopter changes below 0.25 D, and 44% can distinguish changes smaller than 0.125 D. Other research suggests that adjusting spherical power in 0.05 D increments yields better corrected visual acuity. Furthermore, scholars have reported that 0.05 D precision refraction can significantly improve the red-green balance test rate, enabling myopic patients to achieve better visual quality. Therefore, improving refraction precision could provide patients with superior visual outcomes.\n\nCurrently, the Binocular Wavefront Optometry Machine (BWFOM, Ai-Zhitong Medical Technology Co., Ltd., Zhejiang, China) can perform objective and subjective refraction with 0.05 D increments for both sphere and cylinder correction, while also separately measuring higher-order aberrations (HOAs) and lower-order aberrations (LOAs). Given the scarcity of research on the outcomes of 0.05 D refraction for SMILE and FS-LASIK procedures, this study aims to evaluate visual acuity, aberrations, and refractive status in patients following SMILE and FS-LASIK surgery. The primary objective is to investigate whether preoperative 0.05 D precision refraction using the BWFOM can enhance postoperative visual quality for SMILE and FS-LASIK patients.",[250],"Refractive Surgery",[252,253,254,255],"Corneal refractive surgery","SMILE","FS-LASIK","0.05 D precision refraction","2025-08-26",{"date":258,"type":38},"2025-08-28",{"date":260,"type":38},"2025-01-01",{"date":262,"type":22},"2026-10-01",{"name":44,"class":45},{"id":265,"slug":266,"hasResults":12,"nctId":267,"briefTitle":268,"officialTitle":269,"acronym":4,"eligibilityCriteria":270,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":53,"enrollmentInfo":271,"targetDuration":4,"studyType":23,"phases":273,"briefSummary":274,"conditions":275,"keywords":279,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":285,"lastUpdatePostDateStruct":286,"startDateStruct":287,"completionDateStruct":288,"leadSponsor":290,"locationsCount":91},"100602086","phase-2-study-of-sivelestat-sodium-in-opcabg-100602086","NCT07118930","Study of Sivelestat Sodium in OPCABG","Prospective Double-Blind Controlled Study of Sivelestat Sodium in the Perioperative Management of Off-Pump Coronary Artery Bypass Grafting","Inclusion Criteria:\n\n* Undergoing elective OPCABG (≥2 bridged vessels). LVEF≥35%, no severe liver or kidney function abnormalities (ALT\u002FAST≤3 times the upper limit, eGFR≥60 mL\u002Fmin). Sign the informed consent form.\n\nExclusion Criteria:\n\n* Emergency operation, combined valve surgery or aortic surgery. Usage of immunosuppressants or potent anti-inflammatory drugs within 30 days before the operation.\n* Active infections, autoimmune diseases, and allergy history.\n* Preoperative liver and kidney dysfunction\n* Severe cardiopulmonary insufficiency before the operation.",{"count":272,"type":22},62,[58],"The goal of this clinical trial is to learn if drug Sivelestat Sodium works to improve the prognosis of off-pump coronary artery bypass grafting (OPCABG) in adults. It will also learn about the safety of drug Sivelestat Sodium. The main questions it aims to answer are:\n\n* Does drug Sivelestat Sodium have a protective effect on myocardial injury after OPCABG?\n* Does Sivelestat Sodium exert a protective effect on myocardial inflammatory stress after OPCABG? Researchers will compare drug Sivelestat Sodium to a placebo (a look-alike substance that contains no drug) to see if drug Sivelestat Sodium works to protect myocardium following OPCABG.\n\nParticipants will:\n\n* Accept drug Sivelestat Sodium injection or a placebo 2 h after OPCABG for 72 h.\n* Undergo a series of blood tests and echocardiography examinations after the OPCABG.",[276,277,278],"Coronary Heart Disease","Coronary Artery Disease","Coronary Arterial Disease (CAD)",[280,281,282,283,284],"coronary heart disease","coronary artery bypass grafting","Sivelestat Sodium","prognosis","myocardial injury","2025-08-11",{"date":234,"type":38},{"date":162,"type":38},{"date":289,"type":22},"2027-07-31",{"name":44,"class":45},{"id":292,"slug":293,"hasResults":12,"nctId":294,"briefTitle":295,"officialTitle":296,"acronym":4,"eligibilityCriteria":297,"healthyVolunteers":12,"sex":17,"minAge":298,"maxAge":4,"enrollmentInfo":299,"targetDuration":4,"studyType":23,"phases":301,"briefSummary":302,"conditions":303,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":306,"lastUpdatePostDateStruct":307,"startDateStruct":309,"completionDateStruct":310,"leadSponsor":312,"locationsCount":4},"100599847","effect-of-digital-intervention-on-self-management-of-hypertensive-patients-at-high-risk-of-stroke-100599847","NCT07089810","Effect of Digital Intervention on Self-management of Hypertensive Patients at High Risk of Stroke","Digital Intervention Based on BCW Theory Has a High Blood Pressure in High-risk Population of Stroke Study on the Effect of Stress on Self-management Behavior of Patients","Inclusion criteria:\n\n(1) hypertensive patients at high risk of stroke screened in the National Screening and Intervention Project for High-risk Population of Stroke (2) willing to participate Cooperate and sign the informed consent form\n\nExclusion criteria:\n\n(1) TIA and stroke patients (2) severe cognitive impairment (MMSE≤9) and (3) inability to use smartphones (4) Refusal to participate","45 Years",{"count":300,"type":22},120,[25],"Stroke is the second leading cause of death in the world, and the number of stroke patients in China ranks the first in the world. Hypertension is the most important risk factor. Studies have shown that 80% of stroke can be prevented by controlling risk factors. However, the management level of hypertension patients in China is still low, and their self-management ability is insufficient.\n\nDigital health management, such as remote monitoring, AI and mobile health platforms, provides a new way for hypertension prevention and control. Foreign studies have shown that digital interventions can effectively improve patients' self-management behaviors, such as diet, exercise and blood pressure control. Interventions based on wechat, APP and other tools in China have also achieved positive results, but face challenges such as patient acceptance, system adaptation and data continuity.\n\nBased on behavior change wheel (BCW) theory \\*\\* and digital platform, this study formulated personalized intervention programs for hypertension patients in high-risk groups of stroke, and promoted health behavior change from three aspects of \\*\\* ability, motivation and opportunity \\*\\*. By improving disease cognition and strengthening self-management, the incidence of stroke can be ultimately reduced, and a new strategy for hypertension prevention and control in the community can be provided.",[304,305],"Hypertension","Mhealth","2025-07-22",{"date":308,"type":38},"2025-07-28",{"date":162,"type":22},{"date":311,"type":22},"2026-01-10",{"name":44,"class":45},{"id":314,"slug":315,"hasResults":12,"nctId":316,"briefTitle":317,"officialTitle":317,"acronym":4,"eligibilityCriteria":318,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":319,"targetDuration":4,"studyType":23,"phases":320,"briefSummary":321,"conditions":322,"keywords":4,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":324,"lastUpdatePostDateStruct":325,"startDateStruct":327,"completionDateStruct":329,"leadSponsor":330,"locationsCount":331},"100591621","clinical-study-of-smile-40-visulyze-in-correcting-refractive-errors-100591621","NCT06982807","Clinical Study of SMILE 4.0-VISULYZE in Correcting Refractive Errors","Inclusion Criteria:\n\n1. The diopter is relatively stable (the diopter increases within -0.50D per year for 2 consecutive years);\n2. Age: 18 to 40 years old;\n3. Optimal preoperative corrected visual acuity ≥4.8;\n4. More than 2 weeks for soft contact lenses and more than 3 months for hard contact lenses before surgery\n5. Patients who are willing to perform SMILE surgery\n\nExclusion Criteria:\n\n1. Patients with history of eye surgery and trauma;\n2. Patients with keratoconus tendency;\n3. systemic connective tissue diseases and autoimmune diseases;\n4. Patients with high blood pressure, diabetes and heart disease history;\n5. Other eye disease history such as uveitis, scleritis and other eye inflammation patients;\n6. Patients with scar constitution.",{"count":246,"type":22},[25],"The aim of this study is to further optimize the surgical input parameters for patients undergoing Small Incision Lenticule Extraction (SMILE) using the regression model established by the SMILE 4.0-VISULYZE system, thereby achieving satisfactory postoperative refractive outcomes.\n\nIn this study, patients scheduled for SMILE surgery at the investigators' hospital will be divided into two groups: a conventional group, where the input parameters are adjusted based on historical experience according to the patient's refractive error, and a 4.0-VISULYZE group, where the input parameters are optimized using the SMILE 4.0-VISULYZE system.\n\nThe investigators will compare the postoperative outcomes between the two groups, including uncorrected visual acuity (UCVA), best-corrected visual acuity (BCVA), spherical power, cylindrical power, spherical equivalent (SE), and the proportions of patients achieving postoperative visual acuity ≥0.8, ≥1.0, and ≥1.2 at 1 day, 10 days, 1 month, 3 months, 6 months, and 1 year post-surgery. Additionally, the investigators will evaluate the proportions of patients with postoperative SE within ±0.50D and ±1.0D, as well as postoperative cylindrical power within ±0.50D and ±1.0D, to assess the efficacy and safety of the SMILE 4.0-VISULYZE system in treating refractive errors.",[250,323],"Myopia; Refractive Error","2025-05-22",{"date":326,"type":38},"2025-05-28",{"date":328,"type":38},"2024-11-01",{"date":236,"type":22},{"name":44,"class":45},2,{"id":333,"slug":334,"hasResults":12,"nctId":335,"briefTitle":336,"officialTitle":337,"acronym":338,"eligibilityCriteria":339,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":174,"enrollmentInfo":340,"targetDuration":4,"studyType":23,"phases":342,"briefSummary":343,"conditions":344,"keywords":345,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":324,"lastUpdatePostDateStruct":352,"startDateStruct":354,"completionDateStruct":356,"leadSponsor":358,"locationsCount":91},"100592784","phase-1-autologous-bone-marrow-mesenchymal-stem-cell-therapy-for-ischemic-stroke-100592784","NCT06997939","Autologous Bone Marrow Mesenchymal Stem Cell Therapy for Ischemic Stroke","A Clinical Trial of Autologous Bone Marrow-Derived Mesenchymal Stem Cell Transplantation for Precision Therapy in Ischemic Stroke","ABMSC-IS","Inclusion Criteria:\n\n* Age 18-65 years, both male and female\n* Confirmed diagnosis of ischemic stroke within 3-12 months before enrollment.\n* Moderate stroke with NIHSS score 5-12 at screening\n* Modified Rankin Scale (mRS) score 3-5 (moderate to severe disability)\n* Patient or legal guardian willing to provide written informed consent for treatment and study participation\n* Able to comply with medical history collection, data storage, and follow-up procedures\n\nExclusion Criteria:\n\n* Patients with needle phobia or lumbar spine disease affecting bone marrow aspiration\n* Any acute illness at the time of screening\n* Severe disability or end-stage disease\n* Severe heart, liver, or kidney dysfunction\n* Pulmonary infection or severe systemic infection\n* History of severe allergic reactions\n* Use of immunosuppressive drugs (e.g., steroids) within 3 months or vaccination within 6 months\n* Any organic lesions causing increased intracranial pressure\n* Current or past malignancy\n* Seropositive for HIV, syphilis, hepatitis B, hepatitis C, or other severe infectious diseases\n* Severe mental illness or impaired consciousness\n* Coagulopathy or ongoing anticoagulant therapy\n* Blood pressure ≥180\u002F110 mmHg despite treatment\n* Poorly controlled diabetes with advanced complications and Pre-existing conditions affecting limb mobility (e.g., claudication, osteoarthritis, rheumatoid arthritis, gouty arthritis)\n* Participation in another clinical trial within 3 months\n* Major surgery or trauma (including fractures) within 1 month\n* Any other condition deemed unsuitable for study participation by the investigator",{"count":341,"type":22},12,[57,58],"Stroke is a group of diseases mainly characterized by cerebral ischemia or hemorrhage, with a high fatality rate and disability rate. It has now become a major obstacle to social and economic development. Stem cells are a type of primitive cells with self-renewal, proliferation and differentiation potential. Under certain conditions, they can differentiate into cells of various tissues and organs. They have now become one of the key research directions for the repair of functional disorders after ischemic stroke. Compared with other types of stem cells, bone marrow mesenchymal stem cells (BMSCs) have the advantages of being relatively easy to obtain with less tissue damage, convenient and rapid in vitro expansion and culture, and the ability to actively migrate to the lesion area after injection without the risk of canceration.\n\nThis study plans to recruit and screen 12 subjects with ischemic stroke, divided into three groups (Ommaya drug reservoir group, low-dose internal carotid artery transplantation group, and high-dose internal carotid artery transplantation group), with 4 subjects in each group, for a clinical study of ABMSCs treatment for functional disorders after ischemic stroke. In accordance with the established treatment protocol, bone marrow will be collected from subjects during the stable phase of their condition, and ABMSCs will be infused three times via Ommaya drug reservoir\u002Finternal carotid artery within 1-6 months after collection. The study will assess the improvement of motor function in patients and analyze the feasibility and effectiveness of this therapy, laying a solid foundation for future clinical applications.",[203],[346,347,348,349,350,351],"autologous","bone marrow mesenchymal stem cell","mRS","functional recovery","Carotid artery intervention","NIHSS",{"date":353,"type":38},"2025-05-31",{"date":355,"type":22},"2025-06-01",{"date":357,"type":22},"2027-05-31",{"name":44,"class":45},{"id":360,"slug":361,"hasResults":12,"nctId":362,"briefTitle":363,"officialTitle":364,"acronym":365,"eligibilityCriteria":366,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":174,"enrollmentInfo":367,"targetDuration":369,"studyType":200,"phases":4,"briefSummary":370,"conditions":371,"keywords":373,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":324,"lastUpdatePostDateStruct":377,"startDateStruct":378,"completionDateStruct":380,"leadSponsor":382,"locationsCount":91},"100591362","study-on-the-molecular-mechanism-of-berberine-to-improve-type-2-diabetes-mellitus-complicated-with-depression-100591362","NCT06979440","Study on the Molecular Mechanism of Berberine to Improve Type 2 Diabetes Mellitus Complicated With Depression","Study on the Molecular Mechanism of Berberine Regulating the Gut Microbiota-derived Metabolites 5-AVAB to Improve Type 2 Diabetes Mellitus Complicated With Depression.","SBDD","Inclusion Criteria:\n\n1. Aged 18-65 years (including the critical value), regardless of gender;\n2. The Con group was diagnosed with type 2 diabetes and had no history of mental disorders such as depression;\n3. The T2DD patient group was diagnosed with type 2 diabetes and depression, where depression met the DSM-5 diagnostic criteria for recurrent depression without psychotic symptoms or single-episode MDD, and the total score of the HAMD-17 scale was ≥22 points;\n4. The subjects read and fully understood the patient instructions and signed the informed consent form.\n\nExclusion Criteria:\n\n1. Those who do not meet the inclusion criteria;\n2. Those who have not used antibiotics, prebiotics, probiotics, enteral nutrition drugs, etc. within 3 months before diagnosis, and those who do not use antibiotics, prebiotics, probiotics, enteral nutrition drugs, etc. during treatment;\n3. Those with progressive serious diseases (such as cancer);\n4. Those with severe aphasia, agnosia, and apraxia;\n5. Those who have used psychotropic drugs for a long time within 1 month before the study or have received new drug research in the past 3 months;\n6. Pregnant or breastfeeding women;\n7. Alcoholics or drug addicts;\n8. Those with poor mental condition and unable to cooperate;\n9. Those who are considered unsuitable for inclusion in the study.",{"count":368,"type":22},40,"3 Years","The incidence of type 2 diabetes with comorbid depression (T2DD) is notably high, characterized by prolonged disease duration and susceptibility to recurrence. The preliminary experiments identified 5-AVAB, a gut microbiota-derived metabolite, as a potential novel biomarker for T2DD progression. Given the absence of existing research in this area, it warrants in-depth investigation.\n\nThe investigators plan to collect fecal and serum samples from participants with type 2 diabetes and those with T2DD to quantify 5-AVAB levels, as well as conduct in vitro gut microbiota culturing and sequencing studies.",[372],"Diabetes-Related Complications",[374,375,376],"Type 2 diabetes mellitus","depression","Diabetes Complications",{"date":326,"type":38},{"date":379,"type":38},"2024-11-09",{"date":381,"type":22},"2027-12-31",{"name":44,"class":45},{"id":384,"slug":385,"hasResults":12,"nctId":386,"briefTitle":387,"officialTitle":388,"acronym":4,"eligibilityCriteria":389,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":390,"enrollmentInfo":391,"targetDuration":4,"studyType":200,"phases":4,"briefSummary":393,"conditions":394,"keywords":397,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":401,"lastUpdatePostDateStruct":402,"startDateStruct":403,"completionDateStruct":405,"leadSponsor":407,"locationsCount":91},"100591769","the-safety-and-efficacy-of-radiofrequency-ablation-after-left-atrial-appendage-occlusion-100591769","NCT06984731","The Safety and Efficacy of Radiofrequency Ablation After Left Atrial Appendage Occlusion.","Clinical Trial Protocol for Safety and Efficacy of Transcatheter Ablation After Left Atrial Appendicular Occlusion With WATCHMAN FLX","Inclusion Criteria:\n\n1. ≥18 years of age, diagnosed with nonvalvular atrial fibrillation;\n2. Meet the indications for receiving WATCHMAN FLX left atrial appendicular closure and transcatheter atrial fibrillation ablation;\n3. Preoperative imaging evaluation showed that the anatomical structure of the left atrial appendage was suitable for implantation with the WATCHMAN FLX device;\n4. The patient agrees to participate in the study and signs the informed consent.\n\nExclusion Criteria:\n\n1. valvular heart disease or other structural heart disease that causes atrial fibrillation;\n2. left auricular thrombus or acute thrombotic event was found before surgery;\n3. Patients with severe bleeding tendency or recent major bleeding events (such as massive gastrointestinal bleeding, cerebral hemorrhage, etc.);\n4. Patients who are unable to complete postoperative follow-up (such as life expectancy of less than 1 year or poor compliance);\n5. Other serious diseases (such as liver and kidney failure, active infection, etc.) were found in preoperative examination;\n6. Pregnant or lactating women.","80 Years",{"count":392,"type":22},210,"Objective: To evaluate the safety and efficacy of transcatheter atrial fibrillation ablation 1 month after WATCHMAN FLX left atrial appendage closure in patients with nonvalvular atrial fibrillation.",[395,396],"Cardiovascular Diseases","Arrhythmia",[398,399,400],"Atrial Fibrillation (AF)","Left Atrial Appendage closure with WATCHMAN device","Radiofrequency ablation","2025-05-18",{"date":324,"type":38},{"date":404,"type":38},"2025-04-21",{"date":406,"type":22},"2028-06-01",{"name":44,"class":45},{"id":409,"slug":410,"hasResults":12,"nctId":411,"briefTitle":412,"officialTitle":413,"acronym":4,"eligibilityCriteria":414,"healthyVolunteers":196,"sex":17,"minAge":415,"maxAge":416,"enrollmentInfo":417,"targetDuration":4,"studyType":23,"phases":418,"briefSummary":420,"conditions":421,"keywords":424,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":426,"lastUpdatePostDateStruct":427,"startDateStruct":429,"completionDateStruct":431,"leadSponsor":432,"locationsCount":91},"100590407","phase-4-a-clinical-study-on-the-efficacy-and-safety-of-zonisamide-as-a-first-add-on-treatment-in-epileptic-seizures-100590407","NCT06967012","A Clinical Study on the Efficacy and Safety of Zonisamide as a First Add-On Treatment in Epileptic Seizures","Efficacy and Safety of Zonisamide as a First Add-On Treatment in Focal Epileptic Seizures or Secondary Generalized Tonic-Clonic Seizures: A Clinical Study","Inclusion Criteria:\n\n1. Consent to participate in the clinical trial, and the trial subject and\u002For legal guardian has signed the informed consent form.\n2. Age 1-14 years, no gender restrictions.\n3. Compliant with the diagnostic criteria for focal seizures and focal-to-bilateral tonic-clonic seizures as outlined by the International League Against Epilepsy (ILAE) in 2017.\n4. Stable on one antiepileptic drug for ≥4 weeks, and deemed to be appropriate for the addition of zonisamide therapy by the investigator.\n5. ≥ 2 episodes of generalized tonic-clonic seizures （secondary to focal epileptic seizures) per 28-day interval during the 8-week retrospective baseline period.\n\nExclusion Criteria:\n\n1. History of zonisamide treatment.\n2. History of allergy to sulfonamide drugs, zonisamide or any excipients.\n3. History of drug\u002Falcohol abuse.\n4. History of suicide attempt or suicidal ideation within the past 6 months.\n5. Current use of antidepressants, anxiolytics, or antipsychotics.\n6. Diagnosed with progressive diseases affecting the brain and its functions.\n7. Psychogenic non-epileptic seizures.\n8. Diagnosed with severe pulmonary\u002Fhematologic diseases, malignant tumors, immunodeficiency, or psychiatric illnesses.\n9. Have undergone epilepsy brain surgery or plan to undergo epilepsy surgery within the next 4 months.\n10. Deemed to be unsuitable for participation in the trial by the investigator.","1 Year","14 Years",{"count":77,"type":22},[419],"PHASE4","This study primarily aims to assess the efficacy and safety of zonisamide when used as an adjunctive therapy for focal epilepsy. The main questions it aims to answer are:\n\n1. Does the frequency of epileptic seizures decrease after oral zonisamide， and does it improve cognitive function?\n2. Are there any treatment-emergent adverse events associated with oral administration of zonisamide?",[422,423],"Epilepsies, Partial","Epilepsy, Tonic-Clonic",[425,422,423],"Zonisamide","2025-05-08",{"date":428,"type":38},"2025-05-13",{"date":430,"type":38},"2024-08-01",{"date":289,"type":22},{"name":44,"class":45},{"id":434,"slug":435,"hasResults":12,"nctId":436,"briefTitle":437,"officialTitle":437,"acronym":438,"eligibilityCriteria":439,"healthyVolunteers":12,"sex":17,"minAge":440,"maxAge":4,"enrollmentInfo":441,"targetDuration":4,"studyType":23,"phases":443,"briefSummary":444,"conditions":445,"keywords":4,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":452,"lastUpdatePostDateStruct":453,"startDateStruct":455,"completionDateStruct":457,"leadSponsor":459,"locationsCount":91},"100587986","wearable-devices-empowering-active-health-initiatives-for-high-risk-stroke-populations-100587986","NCT06935513","Wearable Devices Empowering Active Health Initiatives for High-Risk Stroke Populations","AISP","Inclusion Criteria:\n\n1. Diagnosed with hypertension;\n2. Diagnosed with diabetes;\n3. Diagnosed with atrial fibrillation;\n4. Smoking subjects;\n5. Physical inactive subjects；\n6. Obesity and overweight subjects;\n7. Must be able to use smart wearable devices.\n\nExclusion Criteria:\n\n1. Diagnosed with malignancies;\n2. Diagnosed with psychiatric disorders;\n3. Diagnosed with cognitive impairment;\n4. Unable to operate smart wearable devices.","30 Years",{"count":442,"type":22},300,[25],"The purpose of this study is to evaluate the control effect of smart wearable devices on key risk factors in the high-risk populations for stroke",[304,446,447,448,449,450,451],"Diabetes","Atrial Fibrillation","Dyslipidemia","Smoking","Physical Inactivity","Obesity and Overweight","2025-04-27",{"date":454,"type":38},"2025-04-30",{"date":456,"type":38},"2025-04-20",{"date":458,"type":22},"2026-04-20",{"name":44,"class":45},{"id":461,"slug":462,"hasResults":12,"nctId":463,"briefTitle":464,"officialTitle":464,"acronym":4,"eligibilityCriteria":465,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":53,"enrollmentInfo":466,"targetDuration":4,"studyType":200,"phases":4,"briefSummary":467,"conditions":468,"keywords":471,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":478,"lastUpdatePostDateStruct":479,"startDateStruct":481,"completionDateStruct":483,"leadSponsor":484,"locationsCount":91},"100581295","clinical-study-on-the-efficacy-and-safety-of-hydromorphone-for-icu-analgesia-100581295","NCT06848452","Clinical Study on the Efficacy and Safety of Hydromorphone for ICU Analgesia","Inclusion Criteria:\n\n* Age ≥18 years and ≤75 years;\n* For patients requiring sedation and analgesia in ICU, invasive mechanical ventilation time is expected to be ≥24 hours;\n* Obtain informed consent from patients or family members.\n\nExclusion Criteria:\n\n* Under 18 years of age, or over 75 years of age;\n* pregnancy or breastfeeding;\n* Known or suspected allergy to opioids (e.g., fentanyl, remifentanil, hydromorphone), butorphanol, midazolam.\n* General anesthesia surgery within 48 hours;\n* Acute bronchial asthma.\n* Acute intestinal obstruction.\n* General anesthesia surgery within 48 hours;\n* ECG QT interval: male \\>450 mm seconds, female \\>470 ms.\n* Failure to obtain informed consent or authorization;\n* Participate in other exploratory clinical trials within 6 months prior to screening;\n* Severe hemodynamic instability (requires epinephrine greater than 0.5ug\u002Fkg\u002Fmin to maintain MAP\\>65mmHg, or malignant arrhythmias frequently occur)\n* Use of monoamine oxidase inhibitors.\n* Chronic pain requires long-term analgesics (\\>3 months).\n* Severe, pre-existing substantial liver disease with clinically significant portal hypertension, Child-Pugh grade C cirrhosis, or acute liver failure;\n* Patients with acute and chronic renal insufficiency requiring dialysis treatment;\n* Severe craniocerebral injury, brain tumor, increased intracranial pressure, cerebrovascular accident, coma, epileptic status, etc.\n* Patients with a history of alcohol or drug abuse;\n* Any condition that prevents the correct assessment of cognitive function, such as speech and sensory disorders or mental disorders (language difficulties or organic mental dysfunction);\n* any other conditions which the investigator considers inappropriate for registration.",{"count":442,"type":22},"This study is a prospective, single-center clinical study to evaluate the advantages, extensibility and safety of hydromorphone as an analgesic drug in ICU, and to compare it with remifentanil, a traditional sedative drug. These conclusions can guide us to understand the characteristics of analgesic drugs, carry out appropriate pain management, improve the status of ICU patients, and improve the quality of life of patients.",[469,470],"Analgesia","ICU Patients Requiring Invasive Mechanical Ventilation",[472,473,474,475,476,477],"ICU","hydromorphone","analgesia","remifentanil","sedation","respirator support","2025-03-12",{"date":480,"type":38},"2025-03-14",{"date":482,"type":22},"2025-03",{"date":381,"type":22},{"name":44,"class":45},{"id":486,"slug":487,"hasResults":12,"nctId":488,"briefTitle":489,"officialTitle":489,"acronym":4,"eligibilityCriteria":490,"healthyVolunteers":12,"sex":17,"minAge":491,"maxAge":99,"enrollmentInfo":492,"targetDuration":4,"studyType":23,"phases":493,"briefSummary":494,"conditions":495,"keywords":497,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":503,"lastUpdatePostDateStruct":504,"startDateStruct":506,"completionDateStruct":507,"leadSponsor":509,"locationsCount":91},"100545997","pretreatment-with-hcq-before-radiotherapy-and-chemotherapy-in-advanced-npc-patients-100545997","NCT06389201","Pretreatment With HCQ Before Radiotherapy and Chemotherapy in Advanced NPC Patients","Inclusion Criteria:\n\n* Clinical diagnosis of NPC.\n* Have not received any cancer therapies\n* Must provide informed consent\n\nExclusion Criteria:\n\n* With metastasis before the first treatment.","20 Years",{"count":77,"type":22},[25],"Dormant cancer cells that survive anti-cancer therapy can lead to cancer recurrence and disseminated metastases that prove fatal in most cases. Recently, specific dormant polyploid giant cancer cells (PGCC) have drawn the investigators' attention because of their association with the clinical risk of nasopharyngeal carcinoma (NPC) recurrence, as demonstrated by previous clinical data. In study, the investigators report the biological properties of PGCC, and reveal that autophagy is a critical mechanism of PGCC induction. Moreover, pharmacological inhibition of autophagy greatly impaired PGCC formation, significantly suppressing metastasis and improving survival in a mouse model. Mechanistically, chemotherapeutic drugs partly damaged mitochondria, and activated autophagy to promote PGCC formation. High numbers of PGCCs correlated with shorter recurrence time and worse survival outcomes in NPC patients. Collectively, these findings suggest a therapeutic approach of targeting dormant PGCCs in cancer.\n\nPretreatment with an autophagy inhibitor (HCQ) before chemotherapy and radiotherapy could prevent formation of therapy-induced dormant polyploid giant cancer cells, thereby reducing recurrence and metastasis of nasopharyngeal carcinoma.",[496],"Nasopharyngeal Carcinoma",[498,499,500,501,502],"autophagy","tumor dormancy","nasopharyngeal carcinoma","recurrence","metastasis","2025-02-14",{"date":505,"type":38},"2025-02-18",{"date":430,"type":38},{"date":508,"type":22},"2034-08-01",{"name":44,"class":45},{"id":511,"slug":512,"hasResults":12,"nctId":513,"briefTitle":514,"officialTitle":515,"acronym":4,"eligibilityCriteria":516,"healthyVolunteers":12,"sex":17,"minAge":517,"maxAge":4,"enrollmentInfo":518,"targetDuration":4,"studyType":23,"phases":519,"briefSummary":520,"conditions":521,"keywords":523,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":529,"lastUpdatePostDateStruct":530,"startDateStruct":532,"completionDateStruct":533,"leadSponsor":535,"locationsCount":331},"100556853","phase-2-polatuzumab-rituximab-and-orelabrutinib-combination-regimen-pro-in-the-treatment-of-elderly-frail-patients-with-treatment-naive-non-gcb-dlbcl-100556853","NCT06530511","Polatuzumab, Rituximab and Orelabrutinib Combination Regimen (PRO) in the Treatment of Elderly Frail Patients with Treatment-naive Non-GCB DLBCL","A Prospective, Single-arm, Multicenter Clinical Study of Polatuzumab, Rituximab and Orelabrutinib Combination Regimen (PRO) in the Treatment of Elderly Patients with Frail Treatment-naive Non-germinal Center Subtype Diffuse Large B-cell Lymphoma","Inclusion Criteria:\n\n* Patients with histopathologically confirmed DLBCL;\n\n  * The sGA evaluation result of octogenarians or 60-79 years old is unfit or f RA il;\n\n    * Non-germinal center (Non-GCB) type;\n\n      * ECOG performance status score of 0-3 points; ⑤ No previous treatment for Lymphoma (unless glucocorticoid); 6 Radiographic Investigation to measurable disease, defined as the longest diameter with at least one Lymph node disorder \\> 1.5 cm, or at least one extranodal lesion \\> 1.0 cm in the longest diameter; ⑦ Adequate organ function;\n\n        * Life expectancy ≥ 12 weeks; ⑨ Signed written informed consent.\n\nExclusion Criteria:\n\n* Accompanied by uncontrolled cardiovascular and cerebrovascular diseases, Coagulopathy diseases, autoimmune diseases and severe Immunization diseases, etc.;\n\n  * Laboratory abnormalities at screening (unless caused by Lymphoma) A) ANC \\\u003C 1.5 x 109\u002FL, PLT \\\u003C 80 x 109\u002FL b） Coagulation: INR greater than 1.5 x upper limit of normal; PT and APTT greater than 1.5 x upper limit of normal c） Liver function: ALT or AST 2 times higher than upper limit of normal, AKP and Bilirubin 1.5 times higher than upper limit of normal d） Renal function: Creatinine high 1.5 times the upper limit of normal, Creatinine clearance \\\u003C 60 mL\u002Fmin (estimated by C OC kcroft-Gault formula); ③ HIV Infection;\n\n    * HbsAg positive patients should be HBV DNA negative before enrollment; in addition, if the patients are HBsAg negative but HBcAb positive (regardless of HBsAb status), HBV DNA detection is still required; if the results are positive, antiviral therapy is required, and HBV DNA negative before enrollment;\n\n      * Requires continuous treatment with strong and moderate CYP3A inhibitors or CYP3A Induction agents. Patients who have taken strong and moderate CYP3A inhibitors or CYP3A Induction agents (or have taken these agents within 5 half-lives) within 7 days prior to the first dose of study drug should not be enrolled; ⑥ Inability to swallow capsules or suffering from diseases that seriously affect gastrointestinal function, such as Syndrome malabsorption, gastric or Small intestinal resection, symptomatic Inflammatory bowel disease or partial or complete Intestinal obstruction; ⑦ Other concurrent and uncontrolled medical conditions that, in the opinion of the investigators, would affect the patients' participation in the study, including patients with Psychosis or other patients known or suspected to be unable to fully comply with the study protocol.","60 Years",{"count":77,"type":22},[58],"This prospective, single-arm, multicenter clinical study aims to enroll 30 frail elderly patients with Non-GCB DLBCL. This study is to evaluate the preliminary efficacy and safety of the combination of Polatuzumab, Rituximab, and orelabrutinib in this population. The primary endpoint is CR rate after induction therapy.",[522],"Diffuse Large B Cell Lymphoma",[524,525,526,527,528],"elderly","frail","PRO","Non-GCB","DLBCL","2025-01-31",{"date":531,"type":38},"2025-02-04",{"date":430,"type":38},{"date":534,"type":22},"2026-08-01",{"name":44,"class":45},{"id":537,"slug":538,"hasResults":12,"nctId":539,"briefTitle":540,"officialTitle":541,"acronym":4,"eligibilityCriteria":542,"healthyVolunteers":12,"sex":173,"minAge":18,"maxAge":390,"enrollmentInfo":543,"targetDuration":4,"studyType":23,"phases":544,"briefSummary":545,"conditions":546,"keywords":548,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":552,"lastUpdatePostDateStruct":553,"startDateStruct":555,"completionDateStruct":556,"leadSponsor":558,"locationsCount":91},"100568057","laparoscopic-surgical-systems-for-gynecological-and-remote-surgical-treatment-100568057","NCT06676267","Laparoscopic Surgical Systems for Gynecological and Remote Surgical Treatment.","Exploratory Study on the Application of Laparoscopic Surgical Systems for Gynecological and Remote Surgical Treatment.","Inclusion Criteria:\n\n* Patients who require endoscopic surgery\n* Voluntarily participate in this study and sign informed consent in writing\n\nExclusion Criteria:\n\n* Patients with malignant tumors with clinical stage IV\n* Those who require emergency surgery\n* Presence of active bleeding, severe abnormal coagulopathy (prothrombin time (PT) or international normalized ratio (INR) greater than 1.5 times the upper limit of normal), or platelet count \\< 80×10\\^9\u002FL\n* Patient has severe cardiovascular or circulatory disease and cannot tolerate surgery\n* Participated in other clinical trials in the past 1 month\n* Inability to understand trial requirements, or inability to complete the study follow-up plan\n* Other conditions that are considered by the investigator to be inappropriate for enrollment",{"count":238,"type":22},[25],"Remote robot-assisted laparoscopic surgery will be performed for gynecological surgical treatment through 5G network, while the safety and effectiveness will be studied.",[547],"Gynecological Cancer",[549,550,551],"Laparoscopic Surgical","gynecological","Telesurgery","2025-01-27",{"date":554,"type":38},"2025-01-28",{"date":430,"type":38},{"date":557,"type":22},"2026-10-31",{"name":44,"class":45},{"id":560,"slug":561,"hasResults":12,"nctId":562,"briefTitle":563,"officialTitle":564,"acronym":4,"eligibilityCriteria":565,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":53,"enrollmentInfo":566,"targetDuration":4,"studyType":23,"phases":567,"briefSummary":568,"conditions":569,"keywords":4,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":571,"lastUpdatePostDateStruct":572,"startDateStruct":573,"completionDateStruct":575,"leadSponsor":576,"locationsCount":91},"100565562","phase-2-evaluation-of-irinotecan-liposome-ii-combined-with-5-fu-lv-and-bevacizumab-for-mcrc-100565562","NCT06643793","Evaluation of Irinotecan Liposome (II) Combined With 5-FU, LV, and Bevacizumab for mCRC","Evaluation of Irinotecan Liposome (II) Combined With 5-fluorouracil, Leucovorin, and Bevacizumab for Second-line\u002FThird-line Treatment of Metastatic Colorectal Cancer (mCRC): a Prospective and Exploratory Clinical Study","Inclusion Criteria:\n\n1. Age ≥ 18 years old and ≤ 75 years old, gender is not limited;\n2. Diagnosis of colorectal cancer by histopathology and\u002For cytology, clinical Records showing inoperable advanced metastatic colon or rectal cancer (ie, stage IV according to the UICC AJCC TNM staging system \\[8th edition 2017\\]) ;\n3. At least 1 measurable target lesion according to RECIST v1.1 criteria (ie, non-nodal lesions with a CT scan length ≥10 mm and nodal lesions with a CT scan short diameter ≥15 mm) ;\n4. Prior first- or second-line oxaliplatin-based therapy with treatment failure or intolerance\\*; Note: \\*Treatment failure or intolerance is defined as (1) disease progression during treatment or disease progression within 6 months of final treatment, both with clear evidence of imaging or clinical progression, and (2) patients who withdrew from treatment because of intolerance of an adverse event of the treatment, as per NCI-CTCAE v5.0 criteria, intolerance is defined as: a. Hematological toxicity: grade III neutropenia accompanied by fever \\>38.5°C, grade III thrombocytopenia with bleeding symptoms, and other grade IV or higher hematologic toxic reactions; b. Non-hematological toxicity: grade III or higher non-hematological toxic reactions; and c. Achievement of the above toxic reactions, which in the judgment of the investigator make continuation of the original regimen of Treatment.\n5. ECOG physical status score 0-1;\n6. Expected survival time ≥ 3 months;\n7. No major organ dysfunction, that is, the subject's organ function level and related laboratory indicators must meet the following requirements within 14 days before the first medication: (1) Blood routine (no blood transfusion, platelet transfusion, growth factors and other supportive treatments): white blood cells (WBC) ≥ 3.0 × 109\u002FL; Absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL; Platelet count (PLT) ≥ 100 × 109\u002FL; Hemoglobin (Hb) ≥ 90 g\u002FL; (2) Blood biochemistry: serum albumin (ALB) ≥ 30 g\u002FL; Alanine aminotransferase (ALT)\u002Faspartate aminotransferase (AST) ≤ 2.5 times the upper normal value (ULN), and if there is liver metastasis, ALT\u002FAST ≤ 5 × ULN; Total bilirubin (TBIL) ≤ 1.5 × ULN; Serum creatinine (Cr) ≤ 1.5 × ULN, or endogenous creatinine clearance ≥ 60 mL\u002Fmin according to the Cockcroft-Gault formula; (3) Urine routine: urine routine indicates urine protein \\\u003C + +; If the urinary protein at baseline is ≥ + +, it is necessary to confirm that the 24-hour urinary protein quantification is ≤ 1.0 g; (4) Coagulation function (within 14 days before the first dose): prothrombin time (PT) or activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN, international normalized ratio (INR) ≤ 1.5 × ULN (no anticoagulant therapy); If the subject is treated with a stable dose of anticoagulant or vitamin K antagonist (such as warfarin, heparin or their analogues), on the premise that the international normalized ratio (INR) of prothrombin time is ≤ 1.5, it is allowed to use low-dose warfarin (1 mg orally once a day) or low-dose aspirin (not exceeding 100 mg a day) for preventive purposes; (5) Cardiac function: normal 12-lead electrocardiogram or abnormal 12-lead electrocardiogram without clinical significance judged by the investigator (i.e., QTcF \\\u003C 450 ms in men, QTcF \\\u003C 470 ms in women); Left ventricular ejection fraction (LVEF) ≥ lower limit of normal value (i.e., LVEF ≥ 50%).\n8. Other previous antineoplastic therapy should be terminated for 4 weeks or more, and the general physical condition or associated adverse effects have recovered (toxicity ≤1 grade) or reached a stable state;\n9. Serum pregnancy test must be negative and non-lactation period in women of childbearing age within 7 days before receiving the test Women of child-bearing age or men whose partners are women of child-bearing age must agree to use medically approved contraception (e.g. , Intrauterine device, male surgical sterilization, birth control pills or condoms) for the duration of the trial;\n10. Voluntarily participate and sign an informed consent form; Ability to comply with research visit plans and other program requirements.\n\nExclusion Criteria:\n\n1. Have had a malignant tumor other than colorectal cancer within 5 years before the screening (cured skin basal cell or squamous cell carcinoma, cervical carcinoma in situ, and malignant tumors assessed by researchers as having a low risk of metastasis and death except);\n2. Tumor tissue is known to have a mismatch repair defect (DMMR) status confirmed by immunohistochemistry, or a microsatellite high instability (MSI-H) status confirmed by second-generation sequencing (NGS) polymerase chain reaction (PCR) methods, they were evaluated by the investigators as being suitable for treatment with immune checkpoint inhibitors (PD-1\u002FPD-L1 inhibitors)\n3. The second generation sequencing (NGS)\u002Fpolymerase chain reaction (PCR) method confirmed that it is a BRAF V600E mutation, which is unfavorable for patients with chemotherapy prognosis;\n4. For those who are known to have central nervous system metastases, for patients with clinically suspected central nervous system metastases, enhanced computed tomography (CT) or enhanced nuclear magnetic resonance (MRI) must be performed within 28 days before the first medication to rule out central nervous system metastases;\n5. Previous treatment with irinotecan\u002Firinotecan liposome-based chemotherapy;\n6. Use of CYP3A4, CYP2C8 and UGT1A1 strong inhibitors\u002Fstrong inducers within 14 days before starting the study. 7. Participated in other drug clinical trials within 4 weeks before the first dose;\n7. Participated in clinical trials of other drugs within 4 weeks before the first medication;\n8. Clinical records showed severe gastrointestinal dysfunction (including bleeding and obstruction; NCI-CTCAE v5.0 \\> Grade 2 inflammation; NCI-CTCAE v5.0 \\> Grade 1 diarrhea)\n9. Presence of severe comorbidities, active infections, or uncontrolled diabetes that interfere with the treatment of the trial drug: (1) uncontrolled severe medical disease that the investigators believe will affect the ability of the subject to receive treatment with the study regimen; For example, complicated with severe medical conditions, including severe heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, uncontrolled infection, active peptic ulcer, etc. (2) the occurrence of A\u002FV thrombotic event within one year before screening, such as cerebrovascular accident (including transient ischemic attack) , thrombosis disease (except venous thrombosis caused by venous catheterization during pre-chemotherapy, which is judged to be cured by researchers) , pulmonary embolism, etc. (3) imaging showed that the tumor had invaded around the important blood vessels or the patients had a high possibility of invading the important blood vessels and causing fatal massive hemorrhage (4) the subjects had active, known or suspected autoimmune diseases including systemic lupus erythematosus, Hashimoto's thyroiditis, scleroderma, Polyarteritis nodosa or autoimmune hepatitis; Participants with type 1 diabetes, hypothyroidism requiring hormone replacement only, skin conditions that do not require systemic treatment (such as leukoplakia, psoriasis, or hair loss) , or conditions that are not expected to recur without an external trigger were allowed to participate; (5) active pulmonary tuberculosis infection. Patients with active tuberculosis infection within 1 year of treatment should be excluded, even if they have been treated, and patients with a history of active tuberculosis infection more than 1 year before should be excluded, (6) previous Interstitial lung disease, or has (non-infectious) pneumonia requiring oral or intravenous steroid hormone therapy; (7) long-term treatment with systemic sex hormones (at a dose equivalent to \\> 10 mg prednisone\u002Fday) or any other form of immunosuppressive therapy is required. Subjects who used inhaled or topical corticosteroid were selected, and those who had poorly controlled cardiac clinical symptoms or conditions, such as heart failure of NYHA Class 2 or above, unstable angina, and heart failure were selected Myocardial infarction within 6 months, clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention, positive Hepatitis C virus antibodies to HCV or HIV; Severe infection (NCI-CTCAE v5.0 \\> 2) occurred within 4 weeks before screening, such as severe pneumonia, bacteremia, infection complications, etc. The presence of symptoms and signs of infection within 2 weeks before study initiation required intravenous antibiotic therapy (except for prophylactic antibiotic use) ; (10) subjects with grade ≥2 peripheral neuropathy according to NCI-CTCAE v5.0.\n10. Known to be allergic or intolerant to any test drug (irinotecan hydrochloride liposome injection (Ⅱ), 5-FU\u002FLV, bevacizumab) or an excipient thereof;\n11. There are known contraindications to any experimental drug (irinotecan hydrochloride liposome injection (Ⅱ), 5-FU\u002FLV, bevacizumab);\n12. Women who are pregnant, breastfeeding or have given birth but refuse to use contraception;\n13. The researcher believes that it should be excluded from this study. For example, if the researcher judges that the subject has other factors that may lead to the forced termination of this study, such as the existence of other serious diseases (including mental illness) that require combined treatment, There are serious abnormalities in laboratory tests, accompanied by family or social factors, which will affect the safety of the subject or the collection of data and samples.",{"count":77,"type":22},[58],"To observe and evaluate the efficacy and safety of irinotecan liposome (II) combined with 5-fluorouracil(5-FU), calcium leucovorin(LV), and bevacizumab in the treatment of metastatic colorectal cancer.",[570],"Colorectal Neoplasms Malignant","2025-01-26",{"date":554,"type":38},{"date":574,"type":38},"2024-11-04",{"date":236,"type":22},{"name":44,"class":45},{"id":578,"slug":579,"hasResults":12,"nctId":580,"briefTitle":581,"officialTitle":582,"acronym":4,"eligibilityCriteria":583,"healthyVolunteers":12,"sex":17,"minAge":517,"maxAge":390,"enrollmentInfo":584,"targetDuration":4,"studyType":200,"phases":4,"briefSummary":586,"conditions":587,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":589,"lastUpdatePostDateStruct":590,"startDateStruct":592,"completionDateStruct":594,"leadSponsor":596,"locationsCount":91},"100546236","the-impact-of-smoking-on-the-prognosis-of-elderly-surgical-patients-100546236","NCT06392308","The Impact of Smoking on the Prognosis of Elderly Surgical Patients","The Impact of Smoking on Postoperative Delirium and Recovery Quality in Elderly Surgical Patients","Inclusion Criteria:\n\n* Age \\>60 years;\n* American Society of Anesthesiologists (ASA) preoperative anesthesia classification ASA Grades I and II;\n* Undergoing elective surgery;\n* Patients and their families are able to understand and complete various scoring scales and voluntarily sign informed consent.\n\nExclusion Criteria:\n\n* Mini-Mental State Examination (MMSE) score \\\u003C23;\n* Preoperative biochemical tests indicate renal dysfunction or active liver disease;\n* History of definite neurological or psychiatric disorders or history of taking corresponding medications before surgery;\n* History of alcohol abuse or drug dependency;\n* Taking antidepressant medications;\n* American Society of Anesthesiologists (ASA) preoperative anesthesia classification \\> Grade II.",{"count":585,"type":22},121,"Postoperative delirium is a common complication that frequently occurs in elderly patients after surgery. It not only increases the length of hospital stays and healthcare costs but also raises the incidence of postoperative cognitive dysfunction and even mortality. However, the underlying mechanisms of its onset are not yet fully understood. Evidence suggests that smoking can lead to gut microbiota dysbiosis and metabolic dysfunction, and the gut microbiota and its metabolites play a crucial role in cognitive function through the gut-brain axis. Yet, no studies have reported whether smoking could affect the occurrence of postoperative delirium and the quality of postoperative recovery through the gut microbiota. This study aims to observe the incidence of postoperative delirium and the postoperative recovery quality scores between smokers and non-smokers.",[588],"Delirium, Postoperative","2025-01-15",{"date":591,"type":38},"2025-01-16",{"date":593,"type":22},"2025-09-01",{"date":595,"type":22},"2025-12-31",{"name":44,"class":45},{"id":598,"slug":599,"hasResults":12,"nctId":600,"briefTitle":601,"officialTitle":602,"acronym":4,"eligibilityCriteria":603,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":99,"enrollmentInfo":604,"targetDuration":4,"studyType":23,"phases":606,"briefSummary":608,"conditions":609,"keywords":4,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":260,"lastUpdatePostDateStruct":612,"startDateStruct":614,"completionDateStruct":616,"leadSponsor":618,"locationsCount":91},"100574210","early-phase-1-a-study-of-car-t-cells-in-relapsedrefractory-hematologic-malignancy-100574210","NCT06756321","A Study of CAR T-Cells in Relapsed\u002FRefractory Hematologic Malignancy","An Exploratory Clinical Study of the Safety and Efficacy of Chimeric Antigen Receptor T-Cells (CAR T-Cells) in Subjects with Relapsed\u002FRefractory Hematologic Malignancy","Inclusion Criteria:\n\n* Patients must meet all of the following criteria to be eligible for the study:\n\n  1. Voluntarily participate in the clinical study. The individual or the legal guardian fully understands the study, sign the informed consent form (ICF), and is willing and able to follow and complete all trial procedures.\n  2. Age ≥ 18 years and \\\u003C 70 years.\n  3. Subjects with refractory or relapsed disease after current standard treatments (including allogeneic or autologous hematopoietic stem cell transplantation) who are not suitable for other treatment options, such as a second stem cell transplant. The definitions of relapsed\u002Frefractory lymphoma include one of the following situations:\n\n     a. Relapsed\u002Frefractory B-cell acute lymphoblastic leukemia (ALL) is defined as one of the following:\n\n     i) Primary refractory disease.\n\n     ii) First relapse if the initial remission is ≤ 12 months.\n\n     iii) Relapse or refractory disease after two or more lines of systemic therapy.\n\n     iv) Relapse or refractory disease after allogeneic transplantation, provided that at the time of enrollment, the subject is at least 100 days post-stem cell transplantation and has not received immunosuppressive drugs for at least 4 weeks prior to enrollment, except for low-dose steroids (≤ 5 mg of prednisone or equivalent).\n\n     b. Subjects with Ph+ B-cell ALL, who are intolerant to or ineligible for tyrosine kinase inhibitor (TKI) treatment, or who have relapsed\u002Frefractory disease after receiving at least two different TKI treatments, are eligible.\n\n     c. Relapsed\u002Frefractory B-cell-derived non-Hodgkin lymphoma (NHL) and Hodgkin lymphoma (HL) defined as one of the following:\n\n     i) No response to first-line treatment (primary refractory disease, excluding subjects intolerant to first-line treatment);\n     * Disease progression (PD) as assessed after first-line treatment.\n     * Best response of SD after at least 4 cycles of first-line treatment (e.g., 4 cycles of RCHOP), with SD duration not exceeding 6 months after the last dose.\n\n     ii) No response to second-line or more treatments.\n     * PD as the best response to the most recent treatment regimen.\n     * Best efficacy of the last line of treatment as SD after at least 2 cycles, with the duration of SD not exceeding 6 months after the last dose.\n\n     iii) Refractory after autologous stem cell transplant (ASCT).\n     * Disease progression or relapse ≤ 12 months post-ASCT (relapsed patients must have biopsy-proven relapse).\n     * If salvage treatment is performed after ASCT, the subjects must have no response to or relapsed after the last line of treatment.\n     * Relapsed or refractory disease after two or more lines of systemic therapy.\n  4. Indications included for enrollment in the cohort of anti-CD19-CAR T-cells:\n\n     1. CD19+ ALL patients, with bone marrow smear reports showing tumor cells ≥ 5%.\n     2. CD19+ NHL patients meeting one of the following subtypes:\n\n        * Diffuse large B-cell Lymphoma, not otherwise specified (DLBCL-NOS)\n        * Primary mediastinal B-cell lymphoma (PMBCL)\n        * Transformed follicular lymphoma (TFL), previously treated for follicular lymphoma and then transformed to refractory DLBCL\n        * Mantle cell lymphoma\n        * High-grade B-cell lymphoma\n        * Chronic lymphocytic leukemia\u002Fsmall lymphocytic lymphoma (CLL\u002FSLL)\n  5. Subtypes of lymphoma included for enrollment in the cohort of anti-CD20\u002F30-CAR T-cells:\n\n     * Previously received anti-CD20\u002F30-CAR T-cell therapy, with CD20 expression positive at enrollment.\n     * Lymphoma with dual positive expression of CD20\u002FCD30.\n  6. Indications included for enrollment in the cohort of anti-CD30-CAR T-cell:\n\n     * CD30 positive HL\n     * CD30 positive T-cell lymphoma\n  7. ECOG performance status ≤ 2.\n  8. Expected survival of at least 12 weeks.\n  9. Adequate venous access (for apheresis) and no other contraindications for blood cell separation.\n  10. Laboratory tests during screening must meet the following requirements, and the subject must not have received cell growth factors (long-acting colony-stimulating factors (G-CSF\u002FPEG-CSF) require a 2-week interval) and platelet transfusions within 7 days prior to hematological assessment:\n\n      1. Absolute neutrophil count ≥ 1.0×10\\^9\u002FL (the condition of ALL patients is determined by the investigator).\n      2. Hemoglobin ≥ 60 g\u002FL (without red blood cell transfusion in the last 14 days).\n      3. Platelets ≥ 50×10\\^9\u002FL (the condition of ALL patients is determined by the investigator).\n      4. Absolute lymphocyte count (ALC) ≥ 0.5×10\\^9\u002FL.\n      5. Total serum bilirubin ≤ 1.5× the upper limit of normal (ULN).\n      6. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5×ULN.\n      7. Creatinine \\\u003C1.5×ULN and estimated creatinine clearance ≥60 mL\u002Fmin.\n  11. Ejection fraction ≥ 45%, with echocardiogram (ECHO) confirming no pericardial effusion (excluding small or physiological amounts), and electrocardiogram results with no clinical significance.\n  12. Baseline oxygen saturation \\> 92% without supplemental oxygen.\n  13. Women of childbearing potential must have a negative serum or urine pregnancy test result (women who have undergone surgical sterilization or have been postmenopausal for at least 2 years are not considered of childbearing potential).\n\nExclusion Criteria:\n\n* Subjects are not eligible to participate in this study if they meet any of the following criteria:\n\n  1. ALL patients with central nervous system (CNS) abnormalities, including CNS-2 and CNS-3 that are of clinically significant neurological changes:\n\n     1. CNS-3 disease is defined as detectable tumor cells in the cerebrospinal fluid (CSF) sample with ≥ 5 WBCs\u002Fmm\\^3, with or without neurological changes.\n     2. CNS-2 disease is defined as detectable tumor cells in the CSF sample with \\\u003C 5 WBCs\u002Fmm\\^3 and with neurological changes.\n\n     Note: Subjects classified as CNS-1 (no detectable tumor cells in CSF) and those with no clinically significant neurological changes classified as CNS-2 are eligible to participate in this study.\n  2. Brain MRI evidence shows central nervous system lymphoma. Active primary central nervous system DLBL, unless CNS involvement has been effectively treated (i.e., participants are asymptomatic) and there has been a local treatment interval of \\>4 weeks prior to enrollment.\n  3. Presence of active central nervous system diseases, such as epilepsy, cerebrovascular ischemia\u002Fhemorrhage, dementia, cerebellar diseases, or any autoimmune diseases with CNS involvement.\n  4. A history of or concurrent presence of other malignancies.\n  5. Clinically significant cardiac disease or arrhythmias that cannot be controlled with medication.\n  6. Presence or suspicion of fungal, bacterial, viral, or other infections that are uncontrolled or require intravenous antibiotics for treatment. Uncomplicated urinary tract infections and uncomplicated bacterial pharyngitis are allowed.\n  7. Positive for hepatitis B (positive for HBsAg, and\u002For positive for Hepatitis B core antibody and HBV DNA \\>1000 copies\u002FmL) and hepatitis C (positive for HCV antibodies), syphilis or human immunodeficiency virus (HIV) infection.\n  8. Presence of any indwelling or drainage catheters (such as percutaneous nephrostomy tubes, indwelling Foley catheters, bile drainage tubes, or pleural\u002Fperitoneal\u002Fpericardial catheters). The use of specialized central venous access devices, such as Port-A-Cath® or Hickman® catheters, is allowed.\n  9. Prior medication:\n\n     1. Use of clofarabine or cladribine within 3 months prior to enrollment, or use of PEG-asparaginase within 3 weeks prior to enrollment.\n     2. Injection of live vaccines within 4 weeks prior to enrollment.\n     3. Donor lymphocyte infusion (DLI) within 28 days prior to enrollment.\n     4. Any medications used for the treatment of GVHD (such as calcineurin inhibitors, methotrexate, mycophenolate, rapamycin, thalidomide) within 4 weeks prior to enrollment, or immunosuppressive antibodies (such as anti-CD20, anti-tumor necrosis factor, anti-interleukin-6, or anti-interleukin-6 receptor) used within 4 weeks prior to enrollment.\n     5. Immune stimulation or immunosuppressive therapy (such as interferon-α, interferon-β, IL-2, etanercept, infliximab, tacrolimus, cyclosporine, or mycophenolic acid) within 4 weeks prior to enrollment.\n     6. Any systemic immunosuppressive\u002Fstimulatory checkpoint molecule therapy within 4 weeks prior to enrollment (such as ipilimumab, nivolumab, pembrolizumab, atezolizumab, OX40 agonists, 4-1BB agonists, etc.).\n     7. Use of systemic cytotoxic drugs within 2 weeks prior to enrollment, including daily or weekly low-dose maintenance chemotherapy (such as cyclophosphamide, ifosfamide, bendamustine, chlorambucil, methotrexate, vincristine, etc.).\n     8. Long-acting growth factors (e.g., pegylated filgrastim) within 14 days prior to leukapheresis, or short-acting growth factors or mobilizing agents (e.g., granulocyte colony-stimulating factor\u002Ffilgrastim, plerixafor) within 5 days prior to leukapheresis.\n     9. Radiation therapy within 2 weeks prior to enrollment.\n     10. Use of pharmacological doses of corticosteroids (\\>5 mg\u002Fday of prednisone or equivalent doses of other corticosteroids) and other immunosuppressive medications must be avoided within 7 days prior to enrollment.\n     11. Use of venetoclax (BCL-2 inhibitor) within 4 days prior to leukapheresis.\n     12. Short-acting targeted therapy (e.g., tyrosine kinase inhibitors) within 72 hours prior to leukapheresis.\n     13. Idelalisib (oral PI3Kδ inhibitor) within 2 days prior to leukapheresis.\n     14. Lenalidomide within 1 day prior to leukapheresis.\n  10. Active graft-versus-host disease (GVHD) ≥ grade 2 on the CIBMTR acute GVHD grading system or requires systemic steroids at doses greater than physiological levels.\n  11. A history of autoimmune diseases (such as Crohn's disease, rheumatoid arthritis, or systemic lupus) resulting in end-organ injury or requiring systemic immunosuppression\u002Fsystemic disease-modifying agents within the last 2 years.\n  12. A history of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac diseases within 12 months prior to enrollment.\n  13. A history of a concomitant genetic syndrome associated with bone marrow failure such as Fanconi anemia, Kostmann syndrome, and Shwachman-Diamond syndrome.\n  14. A history of symptomatic deep vein thrombosis or pulmonary embolism requiring systemic anticoagulation within 6 months prior to enrollment. Subjects need to be on preventive anticoagulant medication.\n  15. A history of other malignancies (except for non-melanoma skin cancer, in situ breast\u002Fcervical cancer, and other malignant tumors that have been effectively controlled without treatment in the past five years).\n  16. Use of other investigational products within 30 days prior to screening.\n  17. Pregnant or breastfeeding women of childbearing age. Chemotherapy poses potential risks to the fetus or infant. Women who have undergone surgical sterilization or are postmenopausal for at least 2 years are not considered of childbearing potential.\n  18. Male and female subjects unwilling to practice birth control from the time of consent through 12 months after the completion of lymphodepleting chemotherapy or CAR T cells infusion (whichever is longer).\n  19. Any medical activities that may interfere with the safety or efficacy assessment of the study treatment.\n  20. In the investigator's judgment, the subject is unlikely to complete all protocol-required procedures and follow-up visits, or to comply with the requirements for participating in the study.",{"count":605,"type":22},9,[607],"EARLY_PHASE1","This study is a single-center, open-label clinical trial of single-dose of CAR T-cells in subjects with relapsed\u002Frefractory hematologic malignancy.",[610,611],"Relapsed\u002Frefractory Lymphoma","Relapsed\u002FRefractory Leukemia",{"date":613,"type":38},"2025-01-03",{"date":615,"type":38},"2023-09-18",{"date":617,"type":22},"2026-03-18",{"name":44,"class":45},""]