[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Nanjing Children's Hospital\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":109},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,53,83],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100636782","phase-4-intranasal-dexmedetomidine-or-esketamine-for-negative-postoperative-behavioral-changes-in-children-100636782",false,"NCT07570160","Intranasal Dexmedetomidine or Esketamine for Negative Postoperative Behavioral Changes in Children","Exploring the Association of Perioperative Electroencephalographic Changes Following Preoperative Intranasal Dexmedetomidine or Esketamine With Negative Postoperative Behavioral Changes in Children Undergoing Day Surgery","PEDI-NPOBCs","Inclusion Criteria:\n\n1. Children aged 2 to 12 years.\n2. Scheduled to undergo elective day surgery under general anesthesia.\n3. ASA (American Society of Anesthesiologists) physical status I to III.\n\nExclusion Criteria:\n\n1. Congenital diseases or severe liver or kidney dysfunction.\n2. History of allergic reactions to study drugs.\n3. Neuromuscular diseases, cerebral palsy, epilepsy.\n4. Other psychiatric or neurological disorders.\n5. Body mass index (BMI) ≥ 30 kg\u002Fm².\n6. Severe upper respiratory tract infections prior to surgery.\n7. Use of sedatives or analgesics within 48 hours before surgery.\n8. Exposure to major life stressors within 1 month before surgery (e.g., family separation, death of a parent).\n9. Refusal to participate or failure to obtain consent from the child's legal guardian.","ALL","2 Years","12 Years",{"count":21,"type":22},342,"ESTIMATED","INTERVENTIONAL",[25],"PHASE4","The goal of this clinical trial is to learn whether intranasal dexmedetomidine or esketamine given before anesthesia can reduce negative postoperative behavioral changes in children undergoing day surgery. Negative postoperative behavioral changes may include anxiety, sleep problems, nightmares, irritability, or other unusual behaviors after surgery. This study will also examine whether changes in brain wave patterns during the perioperative period are related to these behavioral changes.\n\nThe main questions this study aims to answer are:\n\nDoes intranasal dexmedetomidine reduce negative postoperative behavioral changes in children after day surgery? Does intranasal esketamine reduce negative postoperative behavioral changes in children after day surgery? Are perioperative electroencephalographic (EEG) features associated with negative postoperative behavioral changes? Researchers will compare intranasal dexmedetomidine, intranasal esketamine, and normal saline to see whether these treatments differ in their effects on postoperative behavior and perioperative EEG features.\n\nParticipants will be randomly assigned to receive intranasal dexmedetomidine, intranasal esketamine, or intranasal normal saline about 30 minutes before anesthesia. They will receive routine perioperative monitoring, including EEG monitoring during surgery and recovery. They will also be assessed for sedation, pain, and emergence delirium. Follow-up assessments of postoperative behavioral changes will be completed on postoperative days 3, 7, and 28.",[28],"Behavior Problem",[30,31,32,33,34,35,36,37,38,39],"Dexmedetomidine","Esketamine","Intranasal Premedication","Pediatric Day Surgery","Negative Postoperative Behavioral Changes","Emergence Delirium","Perioperative Electroencephalography","General Anesthesia","Children","Randomized Controlled Trial","NOT_YET_RECRUITING","2026-04-29",{"date":43,"type":44},"2026-05-06","ACTUAL",{"date":46,"type":22},"2026-06-01",{"date":48,"type":22},"2027-11-30",{"name":50,"class":51},"Nanjing Children's Hospital","OTHER",1,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":4,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":17,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":4,"studyType":23,"phases":64,"briefSummary":66,"conditions":67,"keywords":69,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":52},"100537222","a-prospective-study-on-the-treatment-of-clm-based-on-icg-imaging-100537222","NCT06275022","A Prospective Study on the Treatment of cLM Based on ICG Imaging","A Prospective Randomized Controlled Study on the Treatment of Cystic Lymphatic Malformation Based on Indocyanine Green-fluorescence Imaging","Inclusion Criteria:\n\n(1) no previous intervention; (2) cLM diagnosed by pretreatment magnetic resonance imaging (MRI); (3)3 to 6 months post-treatment follow-up; (4) Superfacial cLM\n\nExclusion Criteria:\n\n(1) history of iodine allergy; (2) syndromic cLM ; (3) severe liver and kidney dysfunction; (4) intralesional hemorrhage; (5) intralesional infection","30 Days","16 Years",{"count":63,"type":22},110,[65],"NA","The goal of this prospective randomized controlled study is to explore the role of indocyanine green-fluorescence imaging in management of cystic lymphatic malformation.. To clarify the application value of indocyanine green-fluorescence imaging in both diagnosis and treatment of cystic lymphatic malformation (cLM) in children, is helpful for exploring pathogenesis of cLM, and providing a clearer scientific basis for subsequent surgical intervention. It also provides alternative for the future diagnosis and treatment of cLM.\n\nParticipants will receive indocyanine green-fluorescence imaging before operation, while the patients in control group will receive traditional operation.\n\nResearchers will compare difference in curative effect between two groups.",[68],"Lymphatic Malformation",[70,71,72,73],"indocyanine green","children","inflow","lymphography","RECRUITING","2026-02-15",{"date":77,"type":44},"2026-02-18",{"date":79,"type":44},"2023-01-01",{"date":81,"type":22},"2026-03-30",{"name":50,"class":51},{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":4,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":17,"minAge":90,"maxAge":19,"enrollmentInfo":91,"targetDuration":4,"studyType":23,"phases":93,"briefSummary":95,"conditions":96,"keywords":98,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},"100573811","phase-1-chimeric-natural-killer-receptor-universal-t-cells-for-relapsed-or-refractory-neuroblastoma-100573811","NCT06751134","Chimeric Natural Killer Receptor-Universal T Cells for Relapsed or Refractory Neuroblastoma","A Study to Evaluate the Safety, Preliminary Efficacy, Pharmacokinetics of CNK-UT Cells to Treat the Patients with Relapsed\u002Frefractory Neuroblastoma","Inclusion Criteria:\n\n1. Aged 1-12 years with weight≥10kg, male or female;\n2. The child and\u002For guardian has signed the informed consent form (ICF) and has the ability to comply with the study requirements.\n3. Diagnosed with relapsed\u002Frefractory neuroblastoma. Clinical diagnostic criteria and first-line standard treatment can refer to the NCCN guidelines:\n\n   1. Relapsed neuroblastoma: New lesions appear at the primary site or other locations 4 weeks after achieving complete remission through first-line standard treatment.\n   2. Refractory neuroblastoma: Failure to achieve complete remission after standard treatment protocols, which include induction chemotherapy, surgery, and radiotherapy targeting the primary tumor and residual metastatic sites;\n4. Prior to enrollment, appropriate measures can be implemented to ensure that the subject's disease status is either partial remission (PR) or stable disease (SD).\n5. According to the INRC efficacy criteria, there must be at least one lesion whose efficacy can be assessed through functional imaging (123I-MIBG) and\u002For bone marrow examination (bone marrow aspiration or biopsy). If soft tissue lesions are present, the longest diameter of the target lesion should be ≤2 cm.\n6. Tumor tissue sections or paraffin blocks can be provided, and it has been confirmed through immunohistochemistry (IHC) that the tumor tissue expresses B7-H3.\n7. Lansky score\\>60；\n8. Estimated life expectancy \\> 12 weeks;\n9. Adequate organ and bone marrow function, and the laboratory test value meets the following requirements within 7 days before enrollment, as follows:\n\n(1)Blood Routine Test: Absolute neutrophil count(ANC)≥1.5×10\\^9\u002FL;Absolute lymphocyte count (ALC)≥0.2×10\\^9\u002FL；Platelet count ≥75×10\\^9\u002FL; Haemoglobin≥90g\u002FL; (2)Heart: Left ventricular ejection fraction (LVEF)≥50%;Cardiac function Grade I-II; (3)Pulmonary function: indoor oxygen saturation≥92%. (4)Hepatic function：Total bilirubin≤3×ULN; Aspartate aminotransferase (AST) or alanine aminotransferase (ALT)≤5×ULN; (5)Renal function: Serum creatinine≤2×ULN, or Creatinine clearance rate (CCR)≥60 mL\u002Fmin (Cockroft-Gault formula); 10.All toxic responses originating from previous radiotherapy, chemotherapy, or other treatments (occurring within 4 weeks or 5 half-lives of anti-tumor drugs therapy \\[including but not limited to chemotherapy, targeted therapy, immunotherapy, Chinese herbal medicine\\]) have returned to NCI CTCAEV5.0 Grade≤1 (except for hair loss).\n\nExclusion Criteria:\n\n1. Suffering from malignant tumors or diagnosed within 5 years before enrollment, excluding radical skin basal cell carcinoma, skin squamous cell carcinoma, thyroid cancer, breast cancer (ductal carcinoma in situ) and \u002F or radical resection of carcinoma in situ.\n2. Participants with symptomatic central nervous system (CNS) metastasis confirmed by imaging or pathological examination.\n3. Participants with MIBG non-avid disease.\n4. Participants with a history of organ transplantation（excluding stem cell transplantation）;\n5. Participants with active autoimmune diseases requiring systemic treatment (such as the use of disease-modifying drugs, corticosteroids, or immunosuppressants) are considered. The use of replacement therapies (such as thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) is permitted. A known history of primary immunodeficiency is also noted. For patients who only test positive for autoimmune antibodies, the presence of autoimmune disease must be confirmed based on the investigator's judgment.\n6. Uncontrolled or irreparable systemic diseases, metabolic disorders, or other non-malignant organ diseases or cancer sequelae, which may lead to higher medical risks and\u002For uncertainties in survival assessment.\n7. Active pulmonary tuberculosis (TB), who is receiving anti-tuberculosis treatment or has received anti-tuberculosis treatment within 1 year before enrollment; human immunodeficiency virus (HIV) infection, known syphilis infection.\n8. Severe infections that are either active or poorly controlled clinically within 4 weeks prior to enrollment, including but not limited to hospitalization due to infections, bacteremia, or severe pneumonia complications (excluding mild urinary tract infections and upper respiratory tract infections).\n9. Received radiotherapy, chemotherapy (excluding lymphodepletion), molecular targeted therapy, immune checkpoint inhibitors, or other anti-tumor treatments within 4 weeks or 5 half-lives (whichever is shorter) before cell infusion..\n10. Participants who have undergone major surgery (craniotomy, thoracotomy, or laparotomy) within 4 weeks prior to the initiation of the study, or have severe unhealed wounds, ulcers, or fractures.\n11. Participants who have received treatment from other clinical trials within 4 weeks prior to the initiation of the study.\n12. Participants who receive attenuated live vaccines within 4 weeks prior to the initiation of the study.\n13. Participants who have used any gene therapy products prior to cell infusion.\n14. Allergic to components of CNK-UT injection.\n15. Participants suffer from known mental or substance abuse disorders, which may interfere with their ability to comply with research requirements.\n16. Participants considered by the investigator to have other potentially life-threatening serious complications that may interfere with the evaluation of this study..\n17. Other situations that the participant is identified by the investigator as unsuitable to participate in the study.","1 Year",{"count":92,"type":22},12,[94],"PHASE1","This is a single arm, open-label, multi-center, pilot studies (Investigator Initiated Trial, IIT) to evaluate the safety, preliminary efficacy, pharmacokinetics of universal T-cells engineered with chimeric natural killer receptor (CNK-UT) to treat the patients with relapsed\u002Frefractory Neuroblastoma.",[97],"Neuroblastoma, Recurrent, Refractory",[99],"Chimeric natural killer receptor universal T-cells, relapsed\u002Frefractory Neuroblastoma","2025-02-06",{"date":102,"type":44},"2025-02-07",{"date":104,"type":44},"2024-12-28",{"date":106,"type":22},"2026-12-01",{"name":50,"class":51},2,""]