hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06279520, orgStudyIdInfo id: 2023-08-003, briefTitle: Driving Ability Evaluation System to Improve the Conditional Driving License System: Safety and Feasibility Study., statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-19, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Seoul National University Hospital, class: OTHER, descriptionModule briefSummary: The primary objective of this study is to verify the safety and validity of a VR driving simulator developed for evaluating the driving abilities in healthy adults.This study also aims to establish indicators in VR driving simulator to evaluate high-risk group for driving, such as cognitive and physical abilities. Therefore, this study aims to measure the physical driving function and cognitive function of healthy drivers. to identify the correlation between their outcomes and the VR driving simulator's result, conditionsModule conditions: Automobile Driving, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SCREENING, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: VR Driving Simulator, interventions name: Computerized Neurocognitive Function Test, interventions name: Driver Test Station, interventions name: On-road field driving Test, outcomesModule primaryOutcomes measure: Feasibility of VR driving simulator, primaryOutcomes measure: Driving performance in simulator, measured by driving errors, eligibilityModule sex: ALL, minimumAge: 19 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Seoul National University Hospital, status: RECRUITING, city: Seoul, country: Korea, Republic of, contacts name: Ja-Ho Leigh, M.D. Msc., role: CONTACT, email: mazican@gmail.com, geoPoint lat: 37.566, lon: 126.9784, hasResults: False
protocolSection identificationModule nctId: NCT06279494, orgStudyIdInfo id: Sirolimus for GVHD prophylaxis, briefTitle: Sirolimus+Abatacept+Mycophenolate Mofetil for Prophylaxis of aGVHD in Patients Receiving Haplo-HSCT Who Are Intolerant to Calcineurin Inhibitors, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Peking University People's Hospital, class: OTHER, descriptionModule briefSummary: Graft-versus-host disease (GVHD) is an important complication after transplantation, with an incidence of 40-60%, which can increase non-relapse mortality if poorly controlled. At present, the standard prophylaxis for GVHD is cyclosporine combined with methotrexate. However, calcineurin inhibitors (CNI) can cause some vital side effects, which are not tolerated by some patients. Therefore, this study aims to explore the safety and efficacy of Sirolimus in combination with Abatacept and Mycophenolate Mofetil for the prophylaxis of GVHD in patients with haplo-HSCT who are intolerant to calcineurin inhibitors., conditionsModule conditions: Acute Leukemia, conditions: Myelodysplastic Syndromes, conditions: Severe Aplastic Anemia, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 6, type: ESTIMATED, armsInterventionsModule interventions name: Sirolimus, interventions name: Abatacept, interventions name: MMF, interventions name: ATG, outcomesModule primaryOutcomes measure: Incidence of Grade 2-4 aGVHD within 100 days post transplantation, secondaryOutcomes measure: Incidence of chronic GVHD (cGVHD) within 1 year post transplantation, secondaryOutcomes measure: Incidence of thrombotic microangiopathy within 1 year post transplantation, otherOutcomes measure: Cumulative incidence of relapse, otherOutcomes measure: Transplant-related mortality, otherOutcomes measure: Overall survival, otherOutcomes measure: Incidence of cytomegalovirus (CMV) and Epstein-Barr virus (EBV), eligibilityModule sex: ALL, minimumAge: 14 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06279481, orgStudyIdInfo id: PUMCH-K2458, briefTitle: Effect of Virtual Reality (VR) on Pain Relieve During Colonoscopy, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Peking Union Medical College Hospital, class: OTHER, descriptionModule briefSummary: Purpose: To evaluate the effectiveness and safety of virtual reality (VR) technology in alleviating pain during colonoscopy.Design and Methods: In the context of a single-centered, prospective, randomized controlled study, the pain levels experienced during colonoscopy are compared between the VR group and the control group., conditionsModule conditions: Pain, conditions: Colonoscopy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: a single-centered, prospective, randomized controlled study, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 98, type: ESTIMATED, armsInterventionsModule interventions name: Nonpharmacological method, outcomesModule primaryOutcomes measure: Comparison of Visual Analogue Scale Mean Scores by Groups, secondaryOutcomes measure: Comparison of State Trait Anxiety Inventory Mean Scores by Groups, secondaryOutcomes measure: Comparison of Vital Signs between Groups: Pulse Rate, secondaryOutcomes measure: Comparison of Vital Signs between Groups: Blood Pressure, secondaryOutcomes measure: Comparison of Vital Signs between Groups: Respiration Rate, secondaryOutcomes measure: Comparison of Vital Signs between Groups: Oxygen Saturation, secondaryOutcomes measure: Comparison of Patient Satisfaction of Colonoscopy between Groups, secondaryOutcomes measure: Comparison of Patient Willingness of Future Colonoscopy between Groups, secondaryOutcomes measure: Comparison of Adverse Effects in both groups, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, status: RECRUITING, city: Beijing, state: Beijing, zip: 100010, country: China, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
protocolSection identificationModule nctId: NCT06279442, orgStudyIdInfo id: LACOG 0723, briefTitle: Adrenal Project: Clinical and Epidemiological Characterization of Adrenocortical Carcinoma in a Brazilian Cohort, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2025-08, completionDateStruct date: 2025-08, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Latin American Cooperative Oncology Group, class: OTHER, descriptionModule briefSummary: This is a retrospective observational cohort study. The clinical, pathological and treatment data of participants identified with adrenocortical carcinoma from the year 2000 onwards will be evaluated. Participants recruited for this study will be identified at the participating sites., conditionsModule conditions: Carcinoma Adrenal, conditions: Carcinoma, Adrenocortical Recurrent, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: OTHER, enrollmentInfo count: 150, type: ESTIMATED, outcomesModule primaryOutcomes measure: Demographic and Clinical Characterization of Adrenocortical Carcinoma in Brazil, secondaryOutcomes measure: Assessment of the Association Between Clinical, Pathological, Epidemiological Factors, and Therapeutic Modalities with Prognosis and Outcomes such as Overall Survival or Recurrence-Free Survival, secondaryOutcomes measure: Evaluating the Impact of Adjuvant Mitotane Use on Progression-Free Survival and Overall Survival, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: A.C. Camargo Cancer Center, city: São Paulo, zip: 01.509-001, country: Brazil, contacts name: Milena Shizue Tariki, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -23.5475, lon: -46.63611, hasResults: False
protocolSection identificationModule nctId: NCT06279429, orgStudyIdInfo id: KTGH11137, briefTitle: Sucrosomial Iron on Insomnia in Non-dialysis Chronic Kidney Disease Patients With Iron Deficiency Anemia, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-05-31, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-29, sponsorCollaboratorsModule leadSponsor name: Kuang Tien General Hospital, class: OTHER, descriptionModule briefSummary: Insomnia or sleep disturbance is a common disorder in patients with chronic kidney disease (CKD), but is often unrecognized and undertreated. It is known that sleep disorders may indirectly cause a variety of diseases and affect quality of life. The most common sleep disorders that occur in CKD are insomnia, excessive daytime sleepiness, obstructive or central sleep apnea (SA), and sleep disorders. This study evaluates the effectiveness and safety of Sideral® Sucrosomial Iron and iron chewable tablets 100mg commonly used in health insurance on sleep disorders in patients with CKD and iron deficiency anemia., conditionsModule conditions: CKD, conditions: Sleep Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Sideral® Sucrosomial Iron, interventions name: Iron chewable tablet, outcomesModule primaryOutcomes measure: Insomnia Severity Index (ISI), primaryOutcomes measure: Pittsburgh Sleep Quality Index (PSQI), primaryOutcomes measure: Epworth sleepiness Scale (ESS), primaryOutcomes measure: Hemoglobin, primaryOutcomes measure: Ferritin, primaryOutcomes measure: Serum Iron, primaryOutcomes measure: Transferrin Saturation, primaryOutcomes measure: Erythrocyte sedimentation rate, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Kuang Tien General Hospital, status: RECRUITING, city: Taichung, zip: 433, country: Taiwan, contacts name: Nai-Hwei Wang, MD, role: CONTACT, phone: 886426885599, email: fengcheese@gmail.com, contacts name: Chun-Pai Yang, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 24.1469, lon: 120.6839, hasResults: False
protocolSection identificationModule nctId: NCT06279416, orgStudyIdInfo id: 2023-31, briefTitle: Expected Difficult Airway Management, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-30, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Kocaeli City Hospital, class: OTHER_GOV, descriptionModule briefSummary: In this study, the investigators will evaluate the advanced airway methods applied in the anesthesiology and reanimation clinic of the hospital to patients who met the criteria for awake intubation specified in the ASA 2022 difficult airway management guideline or who could not be intubated after induction of anesthesia in another center. The advanced airway method applied to the difficult airway patient expected in the operating room, the duration, success and complications of the method will be observed and recorded., conditionsModule conditions: Awake Intubation, conditions: Advanced Airway Techniques, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 108, type: ESTIMATED, armsInterventionsModule interventions name: fiberoptic intubation, interventions name: laryngeal mask airway-mediated aintree catheter, interventions name: videolaryngoscopy, outcomesModule primaryOutcomes measure: Comparison of advanced airway methods in the awake patient with difficult airway., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Kocaeli City Hospital, status: RECRUITING, city: Kocaeli, country: Turkey, geoPoint lat: 39.62497, lon: 27.51145, hasResults: False
protocolSection identificationModule nctId: NCT06279403, orgStudyIdInfo id: IIT-2023-0277, briefTitle: Upfront Immune Checkpoint Inhibitors With Deferred Cytoreductive Nephrectomy for Metastatic Renal Cell Carcinoma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2026-03-01, completionDateStruct date: 2029-03-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: RenJi Hospital, class: OTHER, descriptionModule briefSummary: Study Objective: To determine the efficacy of upfront immune checkpoint inhibitors combined with deferred cytoreductive nephrectomy in treating metastatic renal cell carcinoma.Primary Endpoint: Pathological Major Response (MPR), defined as the percentage of residual tumor cells \<10% in the primary tumor after nephrectomy.Study Design:Population: Participants meeting the diagnostic criteria with biopsy-proven clear cell renal cell carcinoma, IMDC score ≤3, or ≤5 metastatic lesions involving ≤3 organs.Sample Size: 20 participants.Patient Grouping: Non-randomized.Interventions: Eligible participants will receive upfront treatment with a combination of Axitinib and Toripalimab for 4 cycles. After 2 cycles of treatment, radiological assessment will be conducted using RECIST 1.1 criteria. If disease progression is observed, the clinical trial will be terminated, and second-line treatment will be initiated according to guidelines. If disease progression is not observed, treatment will continue for 2 additional cycles followed by repeat radiological assessment before undergoing surgery., conditionsModule conditions: Clear-cell Metastatic Renal Cell Carcinoma, conditions: Immune Checkpoint Inhibitors, conditions: Cytoreductive Nephrectomy, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Toripalimab, interventions name: Cytoreductive Nephrectomy, interventions name: Axitinib, outcomesModule primaryOutcomes measure: Pathological Major Response (MPR), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
protocolSection identificationModule nctId: NCT06279390, orgStudyIdInfo id: 202305126RINC, briefTitle: PRE-DELIRIC Prediction Model Plus SMART Care to Reduce the Incidence of Delirium in ICU Patients, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-06-08, primaryCompletionDateStruct date: 2023-10-30, completionDateStruct date: 2023-10-30, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: National Taiwan University Hospital, class: OTHER, descriptionModule briefSummary: Delirium is a severe acute brain dysfunction characterised by sudden confusion, inattention and fluctuating level of consciousness, which mainly affects intubated intensive care patients. It increases the risk of self-extubation, prolongs ICU stay and increases mortality. The incidence of delirium in ICUs varies, with approximately 33.3% of patients affected, and rates of new-onset and pre-existing delirium range from 4% to 89%. Accurate diagnosis is challenging, with 60-80% of patients remaining undiagnosed. Early detection is critical for intervention and improved outcomes.To address these issues, the PREdiction of DELIRium (PRE-DELIRIC) model incorporates 10 risk factors and predicts delirium within 24 hours of ICU admission, allowing risk stratification into low to very high risk categories. It recalibrates predictive values with a sensitivity of 91.3% and specificity of 64.4% using a cut-off score of 27%. However, its integration into delirium management is underexplored. Delirium risk stratification supports efficient resource allocation, cost control, workload reduction and ethical care, while promptly identifying high-risk patients.In this study, Investigators evaluate the integration of the PRE-DELIRIC model into a comprehensive delirium management approach called PRE-DELIRIC-guided SMART/SmART care. SMART care includes improving familiarity, assessing pain and anxiety, reducing equipment discomfort and cognitive stimulation. Patients with PRE-DELIRIC scores \>30% receive SMART care and multidisciplinary involvement, based on the American Delirium Society., conditionsModule conditions: Intensive Care Unit Delirium, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 381, type: ACTUAL, outcomesModule primaryOutcomes measure: the incidence of delirium, secondaryOutcomes measure: duration of ventilator use, secondaryOutcomes measure: rate of unplanned self-extubation, secondaryOutcomes measure: day of physical restraint, secondaryOutcomes measure: level of mobility, secondaryOutcomes measure: cumulative dose of sedatives, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: National Taiwan University Hospital, city: Taipei, zip: 100, country: Taiwan, geoPoint lat: 25.04776, lon: 121.53185, hasResults: False
protocolSection identificationModule nctId: NCT06279364, orgStudyIdInfo id: SKB264-Ⅲ-11, briefTitle: A Study of SKB264 Versus Investigator's Choice Chemotherapy in Patients With Unresectable Recurrent or Metastatic Triple-Negative Breast Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02, primaryCompletionDateStruct date: 2026-07, completionDateStruct date: 2026-07, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: The aim of the study is to evaluate the efficacy and safety of SKB264 as first-line treatment for patients with unresectable recurrent or metastatic triple-negative breast cancer (TNBC) whose tumors do not express programmed cell death ligand 1 (PD-L1) or in patients with PD-L1 positive tumors who received prior anti-programmed cell death 1 (PD-1)/PD-L1 inhibitor in early setting, conditionsModule conditions: Triple Negative Breast Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants will be randomised in a 1:1 ratio to one of two intervention groups., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 524, type: ESTIMATED, armsInterventionsModule interventions name: SKB264, interventions name: Paclitaxel, interventions name: Nab-paclitaxel, interventions name: Capecitabine, interventions name: Eribulin, interventions name: Carboplatin, outcomesModule primaryOutcomes measure: Overall Survival (OS), primaryOutcomes measure: Progression Free Survival (PFS) assessed by Blinded Independent Central Review (BICR), secondaryOutcomes measure: Objective Response Rate (ORR), secondaryOutcomes measure: Duration of Response (DoR), secondaryOutcomes measure: Progression-Free Survival (PFS) assessed by Investigator, secondaryOutcomes measure: Disease control rate (DCR), secondaryOutcomes measure: Time to Response (TTR), secondaryOutcomes measure: Adverse events(AEs) and severe adverse events (SAEs), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fudan University Shanghai Cancer Center, city: Shanghai, state: Shanghai, country: China, contacts name: Zhimin Shao, role: CONTACT, email: szm@163.com, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
protocolSection identificationModule nctId: NCT06279351, orgStudyIdInfo id: Thalicolorectal, briefTitle: Thalidomide Enhances Clinical Efficacy of Cetuximab Combined With Standard Chemotherapy for Left Colorectal Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Xinqiao Hospital of Chongqing, class: OTHER, collaborators name: Chongqing Medical University, descriptionModule briefSummary: 1. To verify that thalidomide can increase the efficacy of cetuximab plus chemotherapy in the treatment of stage IV RAS and BRAF wild-type unresectable left colorectal cancer, which has important clinical significance and provides a basis for subsequent large-scale research and clinical application.2. To evaluate the changes of cytokines and verify the effect of some cytokines on the efficacy of cetuximab +FOLFIRI, so as to provide a scientific basis for the subsequent precise therapy using cytokines antibodies., conditionsModule conditions: Thalidomide Enhances Clinical Efficacy of Cetuximab Combined With Standard Chemotherapy for Left Colorectal Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 96, type: ESTIMATED, armsInterventionsModule interventions name: Thalidomide+cetuximab+FOLFOX/FOLFIRI, outcomesModule primaryOutcomes measure: ETS, secondaryOutcomes measure: ORR, secondaryOutcomes measure: DCR, secondaryOutcomes measure: PFS, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False