[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"observational-study\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:observational-study":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,69,104,123,146,176,210,241,264,289],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":41,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":68},"100585203","health-surveillance-at-constructor-university-bremen-cub-and-among-haw-hamburg-employees-100585203",false,"NCT06899308","Health Surveillance at Constructor University Bremen (CUB) and Among HAW-Hamburg Employees","Health Surveillance at Constructor University Bremen (CUB) to Assess Students' and HAW-Hamburg Employees' Health and Wellbeing - Explanatory Sequential Mixed-Methods Approach","CUB-HS2025","Inclusion Criteria:\n\n* English language skills\n* Reading and writing skills\n* Internet access\n* Student status\n* Consent to participate in the study\n\nExclusion Criteria:\n\n* Illiteracy\n* Massively limited cognitive abilities ( i.e. linguistic components of the digital offerings must be able to be used, and questionnaires completed, or interviews participated in) and severe psychiatric disorders (e.g., severe depression)",true,"ALL","18 Years",{"count":21,"type":22},363,"ESTIMATED","OBSERVATIONAL","The aim of Health Surveillance is to analyze and describe the state of health of students at Constructor University, key influencing factors and individual resources by using mixed-method design.",[26,27,28,29,30,31,32,33,34,35,36,37,38,39,40],"Social Isolation or Loneliness","Anxiety","Anxiety Depression (Mild or Not Persistent)","Health Behavior","Observational Study","Stress, Psychological","Emotional Stress","Life Stress","Psychological Stress","Stress, Emotional","Stress (Psychology)","Substance Abuse","Substance Addiction","Substance Dependence","Substance Use",[42,43,44,45,46,47,48,49,50,51,52,53,54,55],"Healthy students","Health literacy","Disability","Age","Gender","Study characteristics","PHQ-4","Self-efficacy","Satisfaction with Life Scale (SWLS)","Subjective health status","Student satisfaction","UCLA-LS","HEI-Stress","Mixed Method","RECRUITING","2026-04-25",{"date":59,"type":60},"2026-05-01","ACTUAL",{"date":62,"type":60},"2025-03-17",{"date":64,"type":22},"2026-12-31",{"name":66,"class":67},"Jacobs University Bremen gGmbH","OTHER",2,{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":77,"enrollmentInfo":78,"targetDuration":80,"studyType":23,"phases":4,"briefSummary":81,"conditions":82,"keywords":89,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":103},"100601955","validation-of-rcc-predicting-model-with-emulated-target-trial-100601955","NCT07117227","Validation of RCC Predicting Model With Emulated-target Trial","Emulated-target Trial for Guiding Stratified Treatment for Renal Cell Carcinoma With Venous Tumor Thrombus","RCCETT","Inclusion Criteria:\n\n* Adults ≥18 years of age;\n* Diagnosis of primary renal cell carcinoma before and during the surgery;\n* Received radical nephrectomy\u002Fnephron-sparing surgery.\n\nExclusion Criteria:\n\n* Subjects with severely missing clinical information;\n* History of other malignant tumors.\n* Recurrence observed before first postoperative follow-up.\n* Discontinue the adjuvant treatment within in the first two course because of severe adverse react.","80 Years",{"count":79,"type":22},4700,"2 Years","This single-center study utilizes real-world data (2012-2024) from 4700 renal cell carcinoma (RCC) patients at Peking University Third Hospital to: (1) Develop and validate a prognostic prediction model specifically for RCC patients, including those with venous tumor thrombus (VTT); (2) Compare the performance of this new model against existing RCC prediction models in both the overall RCC cohort and the VTT subgroup; (3) Employ an emulated target trial (ETT) methodology to evaluate whether risk-stratified treatment based on the prediction model (grouping patients as high\u002Fmedium\u002Flow risk) improves survival outcomes .",[83,84,85,86,87,88,30],"Renal Cell Carcinoma (Kidney Cancer)","Renal Cell Carcinoma (RCC)","Tumor Thrombus","Prognosis","Prognostic Cancer Model","Real World Study",[90,91,92,93],"renal cell carcinoma","tumor thrombus","prognostic model","emulated-target trial","2026-04-08",{"date":96,"type":60},"2026-04-14",{"date":98,"type":60},"2025-09-01",{"date":100,"type":22},"2027-08-01",{"name":102,"class":67},"Peking University Third Hospital",1,{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":108,"acronym":4,"eligibilityCriteria":109,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":110,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":112,"conditions":113,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":103},"100625610","project-veranda-requirement-analysis-survey-100625610","NCT07424872","Project VERANDA: Requirement Analysis Survey","Inclusion Criteria:\n\n* Belonging to one of the target groups.\n* Otherwise, for general members of the public, none.\n\nExclusion Criteria:\n\n* Younger than 18",{"count":111,"type":22},100,"Between 0.6% and 22.2% of the global adult male population has a sexual interest in children (SIIC), depending on evaluation methods \\[1\\]. SIIC constitutes a major risk factor for child sexual abuse (CSA) and viewing of child sexual abuse material (CSAM). The true rates of CSA offences cannot be estimated, but self-report studies find 30 times higher rates of child-reported CSA compared to reports from child protection services or police.\n\nEngagement in therapy is a protective factor against the risk of child sexual abuse and can lead to reductions in CSAM consumption and severity. Anticipated negative therapist behaviour is associated with less willingness to seek treatment. The fear of being reported by the therapist discourages participation in therapy, a concern complicated by mandatory reporting laws in some countries. Negative attitudes towards ISIC are high, and SIIC may be the most stigmatised trait globally.\n\nIdentifying barriers to treatment for ISIC, and of measures to overcome them, is important to increase therapy engagement, with the goal to improve wellbeing, reduce CSAM consumption, and reduce the risk of CSA offences. Patient anonymity during therapy may play an important role in increasing disclosure of stigmatised traits. It remains unclear whether anonymous therapy addresses patient treatment anxieties and therefore increases the comfort or willingness to engage in therapy. To address this research gap, we conduct an anonymous online survey with ISIC to answer the following questions:\n\nRQ1. Can online therapy preferences be identified for minor-attacted individuals and for their therapists?\n\nRQ2. Are there individual factors that predict stigmatized individuals' online therapy preferences? (E.g. Trust, Self-Stigma)\n\nRQ3. Are there differences between the different stigmatized groups', therapists, and general populations' online therapy preferences?",[30],"2026-03-12",{"date":116,"type":60},"2026-03-13",{"date":118,"type":60},"2025-05-13",{"date":120,"type":22},"2026-05-14",{"name":122,"class":67},"Berlin Institute of Health @ Charité",{"id":124,"slug":125,"hasResults":11,"nctId":126,"briefTitle":127,"officialTitle":127,"acronym":4,"eligibilityCriteria":128,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":129,"targetDuration":131,"studyType":23,"phases":4,"briefSummary":132,"conditions":133,"keywords":4,"overallStatus":135,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":103},"100623394","bridging-the-gap-enhancing-cancer-care-for-underserved-populations-with-the-veris-health-cancer-care-platform-100623394","NCT07396064","Bridging the Gap: Enhancing Cancer Care for Underserved Populations With the Veris Health Cancer Care Platform","Inclusion Criteria:\n\n* Adults \\> 18 years old\n* Diagnosis of cancer\n* ECOG Performance Status of 0-2\n* Undergoing or initiating systemic anticancer therapy\n* Able to utilize and interact with a mobile application and in-home devices for physiological monitoring. Have at least one of the following barriers to healthcare access: Spanish as primary language, uninsured, insured with Medicaid, dual eligible for Medicare and Medicaid\n\nExclusion Criteria:\n\n-N\u002FA",{"count":130,"type":22},50,"5 Weeks","The proposed study aims to optimize and validate the Veris Cancer Care Platform for the needs of medically underserved cancer patients receiving outpatient cancer therapy. The Veris Health platform is a remote patient monitoring and communication system designed to bridge the gap between clinical visits and provide oncology care teams with objective data during high-risk periods.\n\nThis study will specifically focus on optimizing the Veris Health platform for patients with language barriers, limited access to technology, and socioeconomic disparities. By incorporating user-centered design and working closely with community health centers, the research team will ensure that the platform is culturally and linguistically appropriate, easy to use, and accessible for all patients.\n\nThe study will use a mixed-methods approach to validate the effectiveness of the optimized platform, including quantitative data analysis and qualitative interviews with patients and healthcare providers. The goal is to demonstrate the potential for the Veris Health platform to improve outcomes for vulnerable populations by reducing hospitalizations, emergency department visits, and the economic burden of cancer care.",[134,30],"Cancer Care Recipient","NOT_YET_RECRUITING","2026-02-03",{"date":138,"type":60},"2026-02-09",{"date":140,"type":22},"2026-02-16",{"date":142,"type":22},"2026-06-30",{"name":144,"class":145},"VERIS HEALTH INC","INDUSTRY",{"id":147,"slug":148,"hasResults":11,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":152,"eligibilityCriteria":153,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":154,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":156,"conditions":157,"keywords":163,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":103},"100621745","iruplinalkib-in-alk-positive-advanced-lung-adenocarcinoma-after-lorlatinib-100621745","NCT07374614","Iruplinalkib in ALK-Positive Advanced Lung Adenocarcinoma After Lorlatinib","An Observational Study of the Efficacy and Safety of Iruplinalkib(WX-0593) in ALK-positive Advanced Lung Adenocarcinoma Following Lorlatinib Treatment","SAILOR","Inclusion Criteria:\n\n1. Population: Male or female patients aged ≥18 years.\n2. Diagnosis: Histologically or cytologically confirmed advanced lung adenocarcinoma.\n3. Molecular Status: Documentation of ALK rearrangement confirmed by a validated test (e.g., NGS, IHC, FISH).\n4. Prior Therapy: Prior treatment with lorlatinib (in any line of therapy), with documented disease progression or intolerance.\n5. Current Therapy: Initiated treatment with iruplinalkib in the real-world setting.\n6. Measurability: Presence of at least one evaluable lesion (measurable or non-measurable) for response assessment.\n7. Data Availability: availability of key clinical data (baseline characteristics, treatment history, and follow-up outcomes).\n\nExclusion Criteria:\n\n1. Lack of Exposure: Patients who never actually received iruplinalkib or took only a trivial amount (e.g., \\\u003C 1 week\u002Fcycle) before withdrawal for non-medical reasons.\n2. Wrong Diagnosis: Active malignancy of other histological types (excluding treated basal cell carcinoma, etc.).\n3. Confounding: Participation in another interventional clinical trial involving an investigational anti-tumor drug concurrently.\n4. Pregnancy: Pregnant or breastfeeding women.\n5. Data Quality: Missing critical medical records that preclude assessment of primary endpoints (e.g., unknown start date, unknown prior therapy).",{"count":155,"type":22},20,"This observational study aims to evaluate the real-world effectiveness and safety of iruplinalkib in patients with advanced ALK-positive lung adenocarcinoma who have progressed on or are intolerant to prior lorlatinib therapy. The results are expected to provide real-world evidence to inform clinical decision-making for this heavily pretreated patient population.",[158,159,160,161,162,30],"Non-Small Cell Lung Cancer","ALK","Iruplinalkib","Lorlatinib","Real-world Study",[160,164,165,166],"ALK-postive","Post-Lorlatinib","Advanced Lung Adenocarcinoma","2026-01-24",{"date":169,"type":60},"2026-01-29",{"date":171,"type":22},"2026-01-31",{"date":173,"type":22},"2028-12-31",{"name":175,"class":67},"Peking University Shenzhen Hospital",{"id":177,"slug":178,"hasResults":11,"nctId":179,"briefTitle":180,"officialTitle":181,"acronym":182,"eligibilityCriteria":183,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":184,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":186,"conditions":187,"keywords":195,"overallStatus":135,"whyStopped":4,"lastUpdateSubmitDate":201,"lastUpdatePostDateStruct":202,"startDateStruct":204,"completionDateStruct":206,"leadSponsor":208,"locationsCount":4},"100613748","french-military-firefighters-to-assess-relationships-between-exposome-and-health-100613748","NCT07270627","French Military Firefighters to Assess Relationships Between Exposome and Health.","Cohorte Militaire et Son Exposome : étude Pilote rétrospective au Sein de la Population Des Sapeurs-pompiers (Actuellement en Exercice et Anciens Sapeurs-pompiers) de la Brigade Des Sapeurs Pompiers de Paris","COMITEX-BSPP","Inclusion Criteria:\n\n* Active-duty or veteran military personnel from French Paris firefighter brigade.\n* Aged at least 18.\n* Not opposed to participate to the study\n\nExclusion Criteria:\n\n* Opposition to participate\n* veterans under legal protection",{"count":185,"type":22},15000,"The aim of the study is to describe professional exposures and health events among French military firefighters (both active-duty personnel and veterans) and identify potential relationships between the exposome (the total history of occupational and personal exposures) and health status in these populations. The study is based on a self-administered questionnaire that collects retrospective and present information about exposures and health conditions.",[188,189,190,191,192,193,194,30],"Health Adult Subjects","Exposure Occupational","Health Behavior, Risky","Occupational Health","Exposure","Firefighters","Military Personnel",[196,197,198,199,200],"Occupational exposure","health","military","exposome","occupational","2025-11-26",{"date":203,"type":60},"2025-12-08",{"date":205,"type":22},"2026-01-01",{"date":207,"type":22},"2026-12",{"name":209,"class":67},"Direction Centrale du Service de Santé des Armées",{"id":211,"slug":212,"hasResults":11,"nctId":213,"briefTitle":214,"officialTitle":214,"acronym":4,"eligibilityCriteria":215,"healthyVolunteers":17,"sex":18,"minAge":216,"maxAge":217,"enrollmentInfo":218,"targetDuration":4,"studyType":220,"phases":221,"briefSummary":223,"conditions":224,"keywords":225,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":233,"startDateStruct":235,"completionDateStruct":237,"leadSponsor":239,"locationsCount":68},"100598534","assessing-the-feasibility-and-acceptability-of-watching-queen-of-katwe-as-a-role-model-intervention-among-adolescents-in-high-schools-in-kenya-100598534","NCT07072741","Assessing the Feasibility and Acceptability of Watching Queen of Katwe as a Role Model Intervention Among Adolescents in High Schools in Kenya","Inclusion Criteria:\n\n* Participants must be high school students in the selected school.\n* Participants must be between the ages of 13 to 19.\n\nExclusion Criteria:\n\n* There will be no other exclusion criteria.","13 Years","19 Years",{"count":219,"type":22},250,"INTERVENTIONAL",[222],"NA","This study will test whether using the film Queen of Katwe as a role model story can help motivate and engage high school students in Kenya. The film is based on the true story of Phiona Mutesi, a Ugandan girl who becomes a chess champion despite growing up in poverty. The study will take place in a mixed secondary school in Ngong town, Kajiado County, with about 250 students aged 13 to 19. Students will watch the film at school. To see if the approach works well, researchers will collect data before and after the film showing.\n\nThey will check:\n\n1. Feasibility (how easy it is to carry out, including costs and logistics)\n2. Acceptability (how students and teachers feel about it)\n3. Engagement (how involved students are) Surveys and focus groups will be used to gather feedback. The goal is to see if this low-cost method could be used more widely to support learning and motivation in schools.",[30],[226,227,228,229,230,231],"Queen of Katwe","Media-based intervention","Role model intervention","Film-based learning","Low-cost intervention","Adolescent motivation","2025-07-17",{"date":234,"type":60},"2025-07-18",{"date":236,"type":60},"2025-07-03",{"date":238,"type":22},"2025-08-30",{"name":240,"class":67},"Shamiri Institute",{"id":242,"slug":243,"hasResults":11,"nctId":244,"briefTitle":245,"officialTitle":245,"acronym":4,"eligibilityCriteria":246,"healthyVolunteers":11,"sex":18,"minAge":247,"maxAge":77,"enrollmentInfo":248,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":250,"conditions":251,"keywords":252,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":257,"startDateStruct":259,"completionDateStruct":261,"leadSponsor":262,"locationsCount":103},"100540431","the-natural-history-of-sialidosis-type-i-100540431","NCT06316752","The Natural History of Sialidosis Type I","Inclusion Criteria:\n\n* Subjects must:\n\n  * Genetic diagnosis of sialidosis type I\n  * Able to tolerate a general exam and neurological exam\n  * Able to tolerate a modest amount of blood drawing\n  * Able to tolerate the complete electrophysiological studies\n  * Able to tolerate the performance of electroencephalogram and brain MRI\n  * Able to tolerate a neuropsychological testing and opathalmology evaluation\n\nExclusion Criteria:\n\n* Patients who cannot tolerate the scheduled examinations and blood drawing","12 Years",{"count":249,"type":22},30,"Sialidosis type 1 is an autosomal recessive disorder caused by bialleic NEU1 gene mutations. Patients with sialidosis type I present variable neurological and eye dysfunction and the progression rate is variable. The goal of this protocol is to assess the neurological and ophthalmological status of these patients and characterize the clinical and laboratory abnormalities in order to determine the natural history of the disease. Patients will be followed every 6 month with comprehensive clinical, neurological and ophthalmological examinations combined with neuropsychological, blood, radiological and electrophysiological tests.",[30],[253,254,255],"sialidosis","NEU1 gene","Natural history","2025-05-15",{"date":258,"type":60},"2025-05-20",{"date":260,"type":60},"2022-03-15",{"date":64,"type":22},{"name":263,"class":67},"National Taiwan University Hospital",{"id":265,"slug":266,"hasResults":11,"nctId":267,"briefTitle":268,"officialTitle":269,"acronym":4,"eligibilityCriteria":270,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":271,"targetDuration":273,"studyType":23,"phases":4,"briefSummary":274,"conditions":275,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":280,"lastUpdatePostDateStruct":281,"startDateStruct":283,"completionDateStruct":285,"leadSponsor":287,"locationsCount":103},"100557757","clinical-study-on-the-effect-of-cpap-on-af-recurrence-after-catheter-ablation-in-patients-with-af-and-osa-100557757","NCT06542263","Clinical Study on the Effect of CPAP on AF Recurrence After Catheter Ablation in Patients with AF and OSA","Clinical Study on the Effect of Continuous Positive Airway Pressure Ventilation on Atrial Fibrillation Recurrence After Catheter Ablation in Patients with Atrial Fibrillation and Obstructive Sleep Apnea","Inclusion Criteria:\n\n1. Clinical diagnosis of AF combined with moderate to severe OSA (OSA diagnostic criteria: apnea hypopnea index (AHI) greater than 15\u002Fhour, and at least 80% of all events are respiratory sleep obstructive events; AF includes persistent atrial fibrillation and paroxysmal atrial fibrillation)\n2. Age ≥ 18 years old\n3. The patient voluntarily participates in the project and signs informed consent\n4. All patients undergo overnight sleep pressure titration at the sleep center to determine the minimum pressure value for continuous positive airway pressure ventilation at home. All patients are required to undergo CPAP treatment at home at least 5 days a week, with each session lasting at least 4 hours\n\nExclusion Criteria:\n\n1. Patients with neuromuscular disorders, pulmonary hypopnea, and severe lung diseases\n2. Preoperative confirmation of thrombus in the left atrium\n3. The patient has no desire for conversion\n4. Secondary atrial fibrillation (hyperthyroidism, tumors, etc.)\n5. Individuals with contraindications to anticoagulants\n6. Left atrial diameter (LAD) exceeding 60mm (2D echocardiography long axis section data)\n7. Pregnant women\n8. History of myocardial infarction, percutaneous coronary intervention, and cardiac surgery in the past three months\n9. Stroke or transient ischemic attack in the past six months\n10. After artificial valve implantation surgery\n11. Severe renal insufficiency (creatinine Cr\\>2.5mg\u002Fdl or\\>221umol\u002FL, or glomerular filtration rate eGFR\\\u003C30ml\u002Fmin\u002F1.73m2)\n12. Acute diseases or active infections that occur before surgery, recorded as pain, fever, positive blood culture, and\u002For leukocytosis, or have been treated with antibiotics.\n13. Expected survival period\\\u003C1 year",{"count":272,"type":22},224,"1 Year","Atrial fibrillation (AF) is the most common sustained arrhythmia in clinical practice, significantly increasing the risks of death, stroke, heart failure, cognitive impairment, and dementia, thus severely impacting patients' quality of life. However, for AF patients with concomitant cardiovascular risk factors, particularly those with obstructive sleep apnea (OSA), the success rate of catheter ablation is significantly reduced. Continuous positive airway pressure (CPAP) is currently an effective treatment for OSA, effectively correcting nocturnal intermittent hypoxia and fragmented sleep caused by OSA. However, the effect of CPAP therapy on AF recurrence in patients with OSA undergoing catheter ablation remains controversial. Faced with conflicting research findings, our team recently conducted a meta-analysis (registration number CRD42023398588) to assess the impact of CPAP on AF recurrence post catheter ablation in patients with AF and OSA, suggesting that CPAP significantly reduces AF recurrence post catheter ablation (RR = 0.58, P \\\u003C 0.01). However, considering the limited number of included studies, potential bias risks, and confounding factors, our meta-analysis results await further confirmation through real-world studies by our team. Therefore, our team plans to conduct further research on the impact of CPAP on AF recurrence post catheter ablation in patients with moderate to severe OSA, aiming to provide clinical guidance for the treatment of AF in patients with moderate to severe OSA.",[276,277,278,279,30],"Atrial Fibrillation","Continuous Positive Airway Pressure","Obstructive Sleep Apnea","Recurrence","2025-01-20",{"date":282,"type":60},"2025-01-23",{"date":284,"type":60},"2024-08-09",{"date":286,"type":22},"2026-08-01",{"name":288,"class":67},"Second Affiliated Hospital of Soochow University",{"id":290,"slug":291,"hasResults":11,"nctId":292,"briefTitle":293,"officialTitle":293,"acronym":294,"eligibilityCriteria":295,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":296,"enrollmentInfo":297,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":299,"conditions":300,"keywords":4,"overallStatus":135,"whyStopped":4,"lastUpdateSubmitDate":301,"lastUpdatePostDateStruct":302,"startDateStruct":304,"completionDateStruct":306,"leadSponsor":308,"locationsCount":4},"100543879","exploring-the-effectiveness-and-factors-affecting-the-collection-of-single-nucleated-cells-from-different-volunteers-100543879","NCT06361602","Exploring the Effectiveness and Factors Affecting the Collection of Single Nucleated Cells From Different Volunteers","SYX-AN-01","Inclusion Criteria.\n\n1. No restriction on nationality, age 18-55 years old (including borderline value), no restriction on gender;\n2. Body weight: Male ≥50kg, female ≥45kg and 18.5kg\u002Fm2≤BMI≤30kg\u002Fm2 (BMI=Body Mass Index (BMI) = Weight (kg)÷Height (m)2);\n3. Blood pressure:\n\n   12.0Kpa (90mmHg)≤systolic blood pressure≤18.7Kpa (140mmHg) 8.0Kpa (60mmHg) ≤ diastolic blood pressure ≤ 12.0Kpa (90mmHg);\n4. Pulse: 60 beats\u002Fmin ≤ pulse ≤ 100 beats\u002Fmin, ≥ 50 beats\u002Fmin for high endurance athletes, or rhythmic abnormalities without clinical significance;\n5. Ear temperature: 35.7 ≤ body temperature ≤ 37.5 ℃;\n6. Good general condition of the body: no damage to vital organs such as heart, lungs, liver, kidneys, etc., no serious or uncontrolled infections, no history of serious mental disorders;\n7. Clinical examination should fulfill the following criteria:\n\n7.1 Hemoglobin (Hb) measurement is normal or abnormal without clinical significance; 7.2 White blood cell (WBC) measurement: (3.5-10) × 109\u002FL; 7.3 Platelet count (PLT) determination normal or abnormal without clinical significance; 7.4 Neutrophil count (NEU) determination normal or abnormal without clinical significance; 7.5 Normal or abnormal liver and kidney function test indexes without clinical significance; 7.6 Normal or abnormal coagulation function without clinical significance; 7.7 Hepatitis B virus surface antigen (HBsAg) negative; 7.8 Hepatitis C virus antibody (HCV antibody) negative; 7.9 human immunodeficiency virus antibody (HIV-1 and HIV-2 antibody) negative; 7.10 Syphilis negative;\n\nExclusion Criteria.\n\n1. the following diseases considered clinically significant by the investigator: 1.1 Have respiratory, circulatory, gastrointestinal, urinary, hematologic, immunologic, endocrine system diseases or metabolic disorders; neurological disorders, psychiatric disorders, Creutzfeldt-Jakob disease, and those with a family history of the disease, or those who are receiving treatment with tissues or tissue derivatives that may have originated from infection with Creutzfeldt-Jakob pathogens; 1.2 Persons with chronic skin diseases, especially infectious, allergic or inflammatory systemic skin diseases; persons with allergic diseases or recurrent allergic attacks; 1.3 persons with malignant tumors or benign tumors affecting health;\n2. those who have not completed 3 months of minor surgery, such as appendectomy, ophthalmic surgery after healing, etc.; those who have not completed 1 year of major surgery, such as: benign gynecological tumors, gastrointestinal malignant tumors after surgery, etc;\n3. Women during pregnancy, less than 6 months after abortion, and less than 1 year after delivery and breastfeeding;\n4. Less than 1 week after recovering from upper respiratory tract infection or less than 3 months after recovering from pneumonia;\n5. less than 3 months after recovery from acute pyelonephritis, or during the period of urinary stone attack;\n6. Injury caused by equipment contaminated by blood or tissue fluid or contaminated wounds, or less than 1 year after tattooing;\n7. Those who have received whole blood and blood component transfusion within 1 year;\n8. within 2 weeks after the last vaccination with live attenuated measles, mumps, or polio vaccine, or within 4 weeks after the last immunization with live rubella vaccine or live attenuated encephalitis B vaccine;\n9. Within 1 year after the last immunization with rabies vaccine after being bitten by an animal;\n10. within 4 weeks of the last immunization with antitoxin or immune serum injection or within 1 year of the last immunization with hepatitis B human immunoglobulin injection\n11. those who have a documented clinical trial with leukocyte, plasma, platelet, or whole blood donation within 3 months\n12. who, in the opinion of the investigator, are not suitable for participation in this study.","55 Years",{"count":298,"type":22},80,"1. 80 cases of healthy donors were subjected to peripheral blood single nucleated cells (PBMC) collection and analyzed the effects of age, body mass index (BMI), blood routine indexes before collection, collection of circulating blood volume, volume of processed blood and the number of circulations, etc., on the PBMC obtained from both men and women, and explored the effects of PBMC collection in different volunteers and the factors affecting the collection. and the influencing factors.\n2. The data obtained will provide a reference for the MNC threshold for the subsequent clinical trials of immunocell therapy in hospitals.\n3. From the screening of volunteers, PBMC collection and transportation conditions and other specific details of the operation, risk assessment and the establishment of a safe operation standard process, for the hospital to carry out subsequent clinical trials of immune cell therapy to provide an effective reference.",[30],"2024-04-09",{"date":303,"type":60},"2024-04-12",{"date":305,"type":22},"2024-05-01",{"date":307,"type":22},"2027-05-01",{"name":309,"class":67},"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University"]