[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Shantou University Medical College\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":124},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,48,79,101],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":27,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100620439","longitudinal-cohort-study-of-immune-related-adverse-events-in-solid-tumor-patients-treated-with-immune-checkpoint-inhibitors-100620439",false,"NCT07357636","Longitudinal Cohort Study of Immune-Related Adverse Events in Solid Tumor Patients Treated With Immune Checkpoint Inhibitors","Longitudinal Cohort Study of Immune-Related Adverse Events in Solid Tumor Patients Receiving Immune Checkpoint Inhibitors, With Deep Phenotyping and Multi-Omics Biomarker Discovery","Inclusion Criteria:\n\n* Age ≥18 years\n* Histologically confirmed solid malignancy\n* Planned initiation of a new immune checkpoint inhibitor regimen (monotherapy or combination) as standard of care or on an approved clinical trial\n* Ability to provide informed consent\n* Baseline study assessments and biospecimen collection completed prior to first ICI dose\n* Life expectancy of at least 6 months as determined by treating oncologist\n* Availability of archival tumor tissue or willingness to undergo biopsy if archival tissue is unavailable\n\nExclusion Criteria:\n\n* Uncontrolled medical, psychiatric, or social conditions that would interfere with study participation or data interpretation\n* Chronic systemic immunosuppression exceeding 10 mg\u002Fday prednisone equivalent within 14 days prior to enrollment (excluding inhaled, topical, or physiologic replacement doses)\n* Prior solid organ transplantation or allogeneic hematopoietic stem cell transplantation\n* Untreated, symptomatic, or progressing brain metastases (treated and stable brain metastases allowed if off systemic steroids for at least 7 days)\n* Inability or unwillingness to provide required baseline biospecimens","ALL","18 Years",{"count":19,"type":20},940,"ESTIMATED","OBSERVATIONAL","Immune checkpoint inhibitors (ICIs) have transformed the treatment of solid tumors but are associated with immune-related adverse events (irAEs) that can affect virtually any organ system. While many irAEs are well recognized, neurological, neurocognitive, and psychiatric toxicities remain diagnostically challenging, potentially severe, and poorly understood, with limited predictive biomarkers.\n\nThis prospective longitudinal observational cohort study enrolls adult patients with solid tumors initiating a new course of ICI therapy. Participants undergo standardized baseline clinical assessments and biospecimen collection prior to ICI initiation, followed by longitudinal follow-up and event-driven sampling. Patients are dynamically assigned to organ-specific irAE cohorts based on the first clinically significant irAE that dictates management. Patients without grade ≥2 irAEs during follow-up serve as a comparator control cohort.\n\nThe primary objective is to characterize longitudinal immune and inflammatory biomarker trajectories associated with the development of irAEs and to identify predictive and prognostic biomarkers, with particular emphasis on neurological, neurocognitive, and psychiatric toxicities. Integrated clinical, imaging, and multi-omics data will be used to elucidate mechanisms of toxicity and inform future risk stratification and personalized management strategies.",[24,25,26],"Solid Tumor","Immune-Related Adverse Events","Immunotherapy Toxicity",[28,29,30,31,32,33,34],"Immune checkpoint inhibitors","Immunotherapy","Biomarkers","Neurotoxicity","Neuroimmune adverse events","immune related adverse events","PD-1 blocker","RECRUITING","2026-01-26",{"date":38,"type":39},"2026-01-28","ACTUAL",{"date":41,"type":39},"2019-01-10",{"date":43,"type":20},"2029-09-10",{"name":45,"class":46},"Shantou University Medical College","OTHER",6,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":66,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},"100567197","evaluating-the-analgesic-efficacy-of-oxycodone-hydrochloride-in-pediatric-laparoscopic-cryptorchidism-surgery-100567197","NCT06665048","Evaluating the Analgesic Efficacy of Oxycodone Hydrochloride in Pediatric Laparoscopic Cryptorchidism Surgery","Anesthesia","Inclusion Criteria:\n\n* Age range: patients between 1 and 6 years old who are scheduled to undergo cryptorchid surgery.\n* No severe cardiopulmonary dysfunction, able to tolerate endotracheal intubation and general anesthesia.\n* Children who have not received long-term analgesic medication before surgery.\n* Children with a BMI range of 18.5-24 kg\u002Fm2.\n\nExclusion Criteria:\n\n* History of allergy to oxycodone hydrochloride, fentanyl or other research-related drugs.\n* Children who have severe pain or need long-term analgesic treatment.\n* Combined with other serious diseases, such as malignant tumors, nervous system diseases, severe infections, coagulation disorders, congenital heart disease or other congenital malformations, and any other diseases that may interfere with the results of the study.\n* Children who have received medication that may affect the evaluation of analgesic effects (such as other analgesics, sedatives, antidepressants, etc.) within two weeks before surgery.\n* There are other situations that are not suitable for participation in this study, such as the child or family members cannot cooperate to complete the research requirements and may not be able to keep in touch during the study.","1 Year","6 Years",{"count":58,"type":20},162,"INTERVENTIONAL",[61],"NA","Cryptorchidism surgery is a common pediatric procedure, often performed laparoscopically to reposition undescended testes into the scrotum. This technique involves manipulation and traction of the spermatic cord, which can lead to emergence agitation and short-term postoperative pain. Managing these symptoms effectively is essential for enhancing perioperative comfort and supporting faster recovery in children.\n\nOxycodone hydrochloride, a newer opioid with established analgesic effects in adult surgery, has been less studied in pediatric contexts. This randomized controlled trial aims to evaluate the effects of administering 0.1 mg\u002Fkg oxycodone hydrochloride 30 minutes before the end of laparoscopic cryptorchidism surgery in children aged 1 to 6. The study will assess outcomes such as anesthesia emergence time, extubation time, incidence of emergence agitation, postoperative analgesia, and nausea and vomiting. The goal is to determine if oxycodone hydrochloride could be an effective choice for pain relief in pediatric laparoscopic surgery, potentially reducing pain and complications, and providing clinical evidence to optimize anesthesia management for safer and more satisfactory pediatric surgical care.\n\nThis research aspires to contribute to the guidelines for pediatric anesthesia, offering a scientific basis for the clinical application of oxycodone hydrochloride in children.",[53,64,65],"Oxycodone","Analgesia, Postoperative",[67,64,68],"anesthesia","Analgesia, postoperative","NOT_YET_RECRUITING","2024-10-28",{"date":72,"type":39},"2024-10-30",{"date":74,"type":20},"2024-12-01",{"date":76,"type":20},"2026-06-01",{"name":45,"class":46},1,{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":86,"enrollmentInfo":87,"targetDuration":4,"studyType":59,"phases":89,"briefSummary":90,"conditions":91,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":4},"100564922","effect-of-intelligent-intervention-strategies-on-self-efficacy-and-hospital-readiness-of-parents-of-preterm-infants-100564922","NCT06635473","Effect of Intelligent Intervention Strategies on Self-efficacy and Hospital Readiness of Parents of Preterm Infants","Effect of Intelligent Intervention Strategies on Self-efficacy and Hospital Readiness of Parents of Preterm Infants: a Randomized Controlled Trial","Inclusion Criteria:\n\n1. Inclusion criteria for premature infants ① gestational age \\< 37 weeks；② Premature infants admitted to NICU；③ The duration of hospitalization is more than 5 days.\n2. Inclusion and exclusion criteria of primary caregivers of preterm infants ① Preterm infants admitted to neonatology and family caregivers of preterm infants with gestational age \\< 37 weeks. ② Family members who volunteer to undertake primary care tasks. ③ No mental disorders and can carry out normal language communication； ④ ≥18 years old, proficient in WeChat use；⑤ Informed consent has been signed.\n\nExclusion Criteria:\n\n1. Exclusion criteria for preterm infants ① intrauterine developmental retardation of preterm infants. ② Preterm infants with a history of major surgery. ③ Unplanned discharge, transfer, transfer or death of premature infants.\n2. Exclusion criteria for primary caregivers of preterm infants ① There are recent major mental trauma injuries caused by non-hospitalization factors. ② the caregiver suffers from serious diseases of the heart, brain, lung, kidney and other organs. 3. Shedding criteria: Caregivers who voluntarily asked to withdraw for various reasons during the study.","100 Years",{"count":88,"type":20},84,[61],"1. Construct intelligent management intervention plan for parents of preterm infants from hospital to family based on the medical and health system suitable for China's national conditions.\n2. Clinical randomized controlled trials were conducted to verify and evaluate the feasibility and application effect of the intervention program.",[92],"Premature Delivery","2024-10-08",{"date":95,"type":39},"2024-10-10",{"date":97,"type":20},"2024-11-01",{"date":99,"type":20},"2025-10-31",{"name":45,"class":46},{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":4,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":108,"minAge":17,"maxAge":109,"enrollmentInfo":110,"targetDuration":4,"studyType":59,"phases":112,"briefSummary":114,"conditions":115,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":121,"leadSponsor":123,"locationsCount":78},"100505077","early-phase-1-single-arm-open-label-clinical-study-of-sz011-in-the-treatment-of-ovarian-epithelial-carcinoma-100505077","NCT05856643","Single-arm, Open-label Clinical Study of SZ011 in the Treatment of Ovarian Epithelial Carcinoma","Single-arm, Open-label Clinical Study of SZ011 in the Treatment of Ovarian Epithelial","Inclusion Criteria:\n\n1. Females aged 18-80;\n2. Histologically confirmed ovarian epithelial carcinoma;\n3. Ovarian cancer patients who have failed or relapsed after first-line treatment, with or without other treatments;\n4. At least one measurable lesion according to RECIST 1.1 ;\n5. Positive expression of mesothelin in ovarian cancer tumors;\n6. Functional status score (KPS) ≥80;\n7. Expected survival ≥28 weeks;\n8. The function of important organs meets the following requirements: absolute neutrophil count ≥1.5×109\u002FL; platelets count ≥50×109\u002FL; hemoglobin ≥80g\u002FL; serum albumin ≥2.5g\u002FdL; bilirubin ≤1.5 times ULN; ALT and AST ≤3 times ULN; serum creatinine ≤1.5 times ULN;\n9. Able to understand the informed consent form, voluntarily participate, and sign the informed consent form;\n10. The subject or their partner agrees to take the contraceptive measures recognized by the trial within 1 month after signing the informed consent form until the end of the study.\n\nExclusion Criteria:\n\n1. Exclusion criteria include those who have had other malignant tumors within the past 5 years, except for those who have been cured of basal cell carcinoma, cervical carcinoma in situ, and breast cancer that has not recurred for \\>3 years after radical surgery.\n2. Patients known to have central nervous system metastasis or leptomeningeal disease are excluded.\n3. Patients who have experienced arterial thromboembolic events (including myocardial infarction, cardiac arrest, cerebrovascular accident, ischemic stroke, deep venous thrombosis of CTCAE 5.0 grade ≥3) or a history of pulmonary embolism within 6 months prior to enrollment are excluded.\n4. Patients with a history of serious bleeding disorder within 6 months prior to screening, or those with a clear tendency to bleed (such as esophageal varices at risk of bleeding, active ulcer lesions, fecal occult blood \\>2+) as judged by the investigator, are excluded.\n5. Patients with congenital or acquired immunodeficiency (such as HIV infection), active hepatitis B or C virus infection, or other severe infectious diseases are excluded.\n6. Patients with clinically significant cardiovascular disease:\n\n   1. Uncontrolled hypertension (systolic blood pressure ≥160mmHg and\u002For diastolic blood pressure ≥110mmHg) despite treatment;\n   2. History of myocardial infarction or unstable angina pectoris within 6 months prior to enrollment;\n   3. Congestive heart failure or NYHA class II heart failure;\n   4. Severe symptomatic arrhythmia requiring medication, excluding asymptomatic atrial fibrillation that is controllable.\n7. Pregnant or lactating women are excluded.\n8. Those who have participated in or are currently participating in other clinical trials within the past three months are excluded.\n9. Patients considered unsuitable for this clinical trial by the investigator are excluded.","FEMALE","80 Years",{"count":111,"type":20},12,[113],"EARLY_PHASE1","This study was a single-center, open-label, investigator-initiated clinical trial (IIT) to observe and investigate the clinical safety and efficacy of SZ011 in the treatment of ovarian epithelial carcinoma",[116],"Ovarian Epithelial Carcinoma","2024-08-12",{"date":119,"type":39},"2024-08-13",{"date":119,"type":20},{"date":122,"type":20},"2025-12-30",{"name":45,"class":46},""]