hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06364384, orgStudyIdInfo id: E2024074, briefTitle: Radical Synchronous Chemoradiotherapy With DDP/5-FU and PD-1 for Non-metastatic Rectal Squamous Cell Carcinoma, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-20, primaryCompletionDateStruct date: 2024-04-20, completionDateStruct date: 2027-02-28, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Sixth Affiliated Hospital, Sun Yat-sen University, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to learn if PD-1 monoclonal antibody combined with radical chemoradiotherapy works to treat rectal squamous cell carcinoma (rSCC). lt will also learn about the safety of the regime. The main questions it aims to answer are:Does PD-1 monoclonal antibody combined with radical chemoradiotherapy improve survival prognosis? What is the complete response rate (CCR) of the regime？ Researchers will compare PD-1 monoclonal antibody combined with radical chemoradiotherapy to previous study to see if this regime works to treat rSCCs.Participants will receive chemotherapy with DDP and 5-FU, immunotherapy with PD-1 monoclonal antibody and radiotherapy with a total dose of 50-54GY., conditionsModule conditions: Rectal Squamous Cell Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: PD-1 and CRT, outcomesModule primaryOutcomes measure: 1-year tumor-free survival(DFS), secondaryOutcomes measure: 1-year overall survival (OS), secondaryOutcomes measure: 1-year relapse-free survival (RFS), secondaryOutcomes measure: 1-year metastasis free survival (DMFS), secondaryOutcomes measure: Incidence of chemotherapy and immunotherapy-related adverse reactions, secondaryOutcomes measure: Complete response rate (CRR), secondaryOutcomes measure: 1-year stoma-free survival, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sixth Affiliated Hospital, Sun Yat-sen University, status: RECRUITING, city: Guangzhou, state: Guangdong, country: China, contacts name: Jun Huang, MD, role: CONTACT, phone: +86-13926451242, email: huangj97@mail.sysu.edu.cn, geoPoint lat: 23.11667, lon: 113.25, hasResults: False
protocolSection identificationModule nctId: NCT06364371, orgStudyIdInfo id: E2023210, briefTitle: Dynamic Multi-omics Integration Model to Predict Neoadjuvant Therapy Response in Locally Advanced Rectal Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-06-01, completionDateStruct date: 2026-06-01, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Sixth Affiliated Hospital, Sun Yat-sen University, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to establish a dynamic multi-omics integration model for predicting pathological complete response (pCR) after neoadjuvant treatment in locally advanced (T3-4NxM0) rectal cancer, providing support for subsequent patient selection for the watch-and-wait strategy. The main question it aims to answer is:What is the predictive value of this model to assess individual achievement of pathological complete response (pCR) after neoadjuvant treatment? Eligible patients will be prospectively enrolled, and the clinical features of their pre-neoadjuvant treatment, during-treatment, and post-treatment preoperative will be collected and annotated., conditionsModule conditions: Predictive Cancer Model, conditions: Pathologic Complete Response, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 106, type: ESTIMATED, armsInterventionsModule interventions name: Medical examination, outcomesModule primaryOutcomes measure: Area under curve(AUC), secondaryOutcomes measure: Sensitivity, secondaryOutcomes measure: Specificity, secondaryOutcomes measure: Negative predictive value(NPV), secondaryOutcomes measure: Positive predictive value(PPV), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Sixth Affiliated Hospital, Sun Yatsen University, status: RECRUITING, city: Guangzhou, state: Guangdong, country: China, contacts name: Jun Huang, role: CONTACT, phone: 13926451242, email: huangj97@mail.sysu.edu.cn, geoPoint lat: 23.11667, lon: 113.25, hasResults: False
protocolSection identificationModule nctId: NCT06364358, orgStudyIdInfo id: IRB23-0385, secondaryIdInfos id: 5R21DK121262, type: NIH, link: https://reporter.nih.gov/quickSearch/5R21DK121262, briefTitle: Interactive Computer-adaptive Chronic Kidney Disease Education Program, acronym: ICCKD, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: University of Chicago, class: OTHER, collaborators name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), descriptionModule briefSummary: The goal of this pilot clinical trial is to evaluate a culturally tailored computerized education program in hospitalized African-American patients with advanced chronic kidney disease (CKD). The main question it aims to answer are: does computerized adaptive education (CAE) increase patients' knowledge about CKD self-care and renal replacement therapy (RRT) options compared to usual care (UC) and will CAE will be increase patients' intent to participate in CKD self-care and RRT preparation compared to UC, conditionsModule conditions: Chronic Kidney Diseases, conditions: Hypertension, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Computerized CKD Education, interventions name: Usual Hospital Care, outcomesModule primaryOutcomes measure: Change in CKD Knowledge baseline to post patient education intervention, primaryOutcomes measure: Change in Knowledge about end stage kidney disease (ESKD) treatments from baseline to 1 day post patient education intervention, primaryOutcomes measure: Change in ESKD Treatment Preferences from baseline to 1 day post-intervention, secondaryOutcomes measure: Change in Patient Activation Measure from Baseline to 30 days Post-intervention, secondaryOutcomes measure: Increase in Health Intent baseline to post intervention (at 1 day and 30 day follow-up), secondaryOutcomes measure: CKD Self-Management from baseline to 30 day post-intervention, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Chicago Medical Center, city: Chicago, state: Illinois, zip: 60637, country: United States, geoPoint lat: 41.85003, lon: -87.65005, hasResults: False
protocolSection identificationModule nctId: NCT06364345, orgStudyIdInfo id: INOVA_POCAD_1, briefTitle: [Trial of device that is not approved or cleared by the U.S. FDA], statusModule overallStatus: WITHHELD, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: [Redacted], hasResults: False
protocolSection identificationModule nctId: NCT06364319, orgStudyIdInfo id: 2024PHD002-001, briefTitle: Efficacy and Safety of Anti-CD25 rhMAb in the Treatment of Steroid-Refractory cGVHD, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2027-12-31, completionDateStruct date: 2028-06-30, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Peking University People's Hospital, class: OTHER, descriptionModule briefSummary: The study plan aims to include patients who have been diagnosed with steroid-refractory chronic GVHD in the liver following allogeneic hematopoietic stem cell transplantation. After obtaining informed consent, the patients will be randomly assigned to either the Anti-CD25 rhMAb treatment group or the traditional treatment group. The objective is to assess the effectiveness and safety of Anti-CD25 rhMAb in the treatment of severe chronic GVHD affecting the liver., conditionsModule conditions: cGVHD, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 118, type: ESTIMATED, armsInterventionsModule interventions name: anti-CD25 rhMAb, interventions name: Prednisone, interventions name: Ruxolitinib, interventions name: Cyclosporine, outcomesModule primaryOutcomes measure: overall response rate (ORR), secondaryOutcomes measure: duration of response（DOR）, secondaryOutcomes measure: patient-reported outcomes (PRO), secondaryOutcomes measure: disease-free survival (DFS), secondaryOutcomes measure: failure-free survival (FFS), secondaryOutcomes measure: non-relapse mortality (NRM), secondaryOutcomes measure: overall survival （OS）, secondaryOutcomes measure: adverse drug reactions (ADR), eligibilityModule sex: ALL, minimumAge: 16 Years, maximumAge: 65 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
protocolSection identificationModule nctId: NCT06364293, orgStudyIdInfo id: KY2023-261-01, briefTitle: An Early Warning Model of Unfavorable Outcomes Following Endovascular Interventional Treatment of Intracranial Aneurysm, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Beijing Tiantan Hospital, class: OTHER, collaborators name: National Natural Science Foundation of China, descriptionModule briefSummary: Endovascular treatment has become one of the primary treatment methods for intracranial aneurysms. The unfavorable outcomes during follow-up included aneurysm recurrence and long-term incomplete-occlusion, which would bring a high risk of rebleeding and retreatment. Previous studies have tried to predict the outcomes of aneurysms following endovascular treatment based on aneurysm characteristics including morphology, embolization packing degree, etc, but the conclusion was inconsistent. Hemodynamics of aneurysms and parent artery played a greater role in predicting outcomes following endovascular treatments. Investigators also found that the outcomes were determined by many factors, in which the demography, clinical indicators, treatment methods, and material selection can not be ignored, and the mechanism of unfavorable imaging outcomes should be explored using large samples of clinical cases and numerous variable parameters. The pre-experiment of investigators confirmed that artificial intelligence technology can meet the calculation requirements for deep mining and analysis of large sample data. This study aims to use the deep learning model to identify relevant risk factors and weights, establish a stable and accurate prediction model, then incorporate the prospective study to verify the model. The results will be very helpful in accurately predicting the adverse outcomes such as recurrence and long-term non-occlusion after endovascular treatment and help to improve the therapeutic strategy and avoid risk factors. Besides, the occurrence of ischemic or hemorrhagic complications during follow-up may affect the final follow-up outcome, so the analysis was included as one of the outcome events to evaluate the prognosis after intervention., conditionsModule conditions: Intracranial Aneurysm, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 750, type: ESTIMATED, armsInterventionsModule interventions name: Observational design does not include interventional behavior., outcomesModule primaryOutcomes measure: Unfavorable imaging outcome, secondaryOutcomes measure: Hemorrhagic or ischemic complication occurred during the follow-up, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Beijing Tiantan hospital, city: Beijing, country: China, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
protocolSection identificationModule nctId: NCT06364267, orgStudyIdInfo id: BabyTears, briefTitle: Babytam vs Babyexe in Post-menopausal Women at High Risk for Breast Cancer., acronym: BabyTears, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09-01, primaryCompletionDateStruct date: 2026-09-01, completionDateStruct date: 2026-09-01, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Andrea DeCensi, class: OTHER, collaborators name: Dana-Farber/Brigham and Women's Cancer Center, collaborators name: Herbert Irving Comprehensive Cancer Center, collaborators name: Istituto Europeo di Oncologia, collaborators name: Breast Cancer Research Foundation, descriptionModule briefSummary: The purpose of the study is to determine if 6 and 12 months of treatment with Tamoxifen at lower dose is superior to Exemestane at lower dose on quality of life., conditionsModule conditions: Breast Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 160, type: ESTIMATED, armsInterventionsModule interventions name: Tamoxifen 10 MG, interventions name: Exemestane 25 MG, outcomesModule primaryOutcomes measure: Quality of life MEnQol, secondaryOutcomes measure: Other domains, secondaryOutcomes measure: PMAS questionnaire, secondaryOutcomes measure: Customer Satisfaction questionnaire, secondaryOutcomes measure: BPI, secondaryOutcomes measure: Sex hormones biomarkers, secondaryOutcomes measure: Insulin biomarker, secondaryOutcomes measure: Bone biomarker, eligibilityModule sex: FEMALE, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: E.O. Ospedali Galliera, city: Genova, zip: 16128, country: Italy, geoPoint lat: 44.40478, lon: 8.94438, hasResults: False
protocolSection identificationModule nctId: NCT06364254, orgStudyIdInfo id: 2311054791, briefTitle: Effects of CBD on 2 Mile Run Time Trial Performance, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-11, primaryCompletionDateStruct date: 2024-05-30, completionDateStruct date: 2024-05-30, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: University of Northern Colorado, class: OTHER, descriptionModule briefSummary: Individuals who engage in endurance events tend to experience higher levels of stress within the body, mind, and gut, that often lead to impairment of performance. Based on previous studies, CBD has the potential relieve gut distress, and reduce pre-race anxiety thus resulting in an improvement in sport performance. Given the current research on the use of CBD in active individuals, the aim of this pilot study is to explore the effects of CBD compared to a placebo on anxiety, GI distress and a 2-mile running performance in a moderately active population identifying as female., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: OTHER, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Cannabidiol Capsules, outcomesModule primaryOutcomes measure: Difference in Time Trial Times, primaryOutcomes measure: Difference in Anxiety Measured with the State Trait Anxiety Inventory, primaryOutcomes measure: Difference in Blood Lactate Concentrations, primaryOutcomes measure: Difference in Gastrointestinal Distress, primaryOutcomes measure: Different in Heart Rate Variability, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: University Of Northern Colorado, status: RECRUITING, city: Greeley, state: Colorado, zip: 80639, country: United States, contacts name: Laura K Stewart, PhD, role: CONTACT, phone: 970-351-1891, email: laura.stewart@unco.edu, geoPoint lat: 40.42331, lon: -104.70913, hasResults: False
protocolSection identificationModule nctId: NCT06364241, orgStudyIdInfo id: 331760, secondaryIdInfos id: 226706/Z/22/Z, type: OTHER_GRANT, domain: Wellcome Trust, briefTitle: Focus Groups on Cognitive Function in Psychosis, acronym: PRECOGNITION, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2024-07, completionDateStruct date: 2026-09, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: King's College London, class: OTHER, collaborators name: South London and Maudsley NHS Foundation Trust, descriptionModule briefSummary: Cognitive deficits are commonly observed in people with mental disorders. In psychosis, these impairments are frequently present early in the course of the disorder and have a substantial impact on functional outcomes. This project will gain insight into the cognitive deficits that people with lived experience of psychosis and their carers perceive to be the most troublesome. To achieve this, the investigators will conduct two sets of focus groups. During the first set of focus groups, the investigators will aim to identify the cognitive deficits that individuals with psychosis and their carers consider to be the most impairing.The findings of these focus groups will provide important information about what areas of cognition and functioning should be considered in future analyses of large fully anonymised datasets collected in the past from individuals with psychosis. The focus groups will not form part of those analyses, but will provide input from people with lived experience of psychosis on what problems with thinking skills are the most important for them and that should be considered by further research.The second set of focus groups will enable the investigators to determine the participants' perception of potential risks and benefits associated with the dissemination of findings on cognitive function in psychosis, to ensure this is done in a manner that is sensitive to the wishes and needs of people with lived experience of psychosis.Each participant will be asked to attend one focus group, which will last approximately one hour. Focus groups will take place at the South London and Maudsley (SLaM) Trust or at the Institute of Psychiatry, Psychology and Neuroscience (IoPPN), King's College London, although provision will be made for participants to also participate online., conditionsModule conditions: Psychosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 32, type: ESTIMATED, armsInterventionsModule interventions name: Focus group, outcomesModule primaryOutcomes measure: Individual perception of impairments due to cognitive deficits associated with psychosis, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06364228, orgStudyIdInfo id: 0133-24-FB, briefTitle: Intranasal Oxytocin Intervention for Caregivers to Persons With Dementia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07, primaryCompletionDateStruct date: 2026-04, completionDateStruct date: 2026-04, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: University of Nebraska, class: OTHER, descriptionModule briefSummary: The proposed study is a double-blind, randomized, placebo-controlled study of intranasal oxytocin (OXT) to determine its efficacy in improving quality of life and reducing stress in caregivers to persons with dementia. Planned enrollment is 32 subjects over 2 years., conditionsModule conditions: Stress, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 32, type: ESTIMATED, armsInterventionsModule interventions name: Placebo, interventions name: Oxytocin Intranasal Spray 12 International Unit (12IU), interventions name: Oxytocin Intranasal Spray 24 International Unit (24IU), interventions name: Functional MRI, outcomesModule primaryOutcomes measure: Participants' chronic stress levels in the past thirty days., secondaryOutcomes measure: Participant Quality of Life survey, secondaryOutcomes measure: Blood Oxygen Level Dependent (BOLD) responses in neural areas during the Affective Stroop task (AS) and EmpaTom task., eligibilityModule sex: FEMALE, minimumAge: 50 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Nebraska Medical Center, Department of Psychiatry, city: Omaha, state: Nebraska, zip: 61898-5581, country: United States, contacts name: Minjoo Kang, MEd, role: CONTACT, phone: 402-552-6239, email: mkang@unmc.edu, contacts name: Soonjo Hwang, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Janelle N Beadle, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 41.25626, lon: -95.94043, hasResults: False