hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06326489, orgStudyIdInfo id: 105122023-1/05.12.2023, secondaryIdInfos id: ERP-2023-13520, type: OTHER_GRANT, domain: Medtronic, briefTitle: Evaluating the Efficacy and Quality of Life Impact of Transitioning to Advanced Hybrid Closed-Loop Insulin Pump Therapy in Romanian Children With Type 1 Diabetes Mellitus, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-11, primaryCompletionDateStruct date: 2024-08-30, completionDateStruct date: 2024-11-30, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: ELIAS Emergency University Hospital, class: OTHER, descriptionModule briefSummary: The proposed study aims to demonstrate the potential benefits of transitioning T1DM children from predictive low glucose suspend insulin pump therapy to advanced hybrid closed-loop insulin pump therapy in Romania. Primary Outcome: Variations in HbA1c between baseline visit (V1 - 740G) and assessment visit following three months of 780G insulin pump therapy (V2 - 780G).Secondary Outcomes: changes in insulin requirements, time in range (TIR) levels, time below range (TBR), coefficient of variation (CV), frequency of severe hypoglycemic and hyperglycemic events requiring hospitalization, and PedsQL SF15 questionnaire scores., conditionsModule conditions: Diabetes Mellitus, Type 1, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: The study will include 30 children with type 1 diabetes aged seven years and older who use a predictive low glucose suspend insulin pump (740G). Patients eligible for the study will receive a 780G insulin pump for three months., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Switching to the Medtronic 780G insulin pump, outcomesModule primaryOutcomes measure: Variations in HbA1c, secondaryOutcomes measure: changes in insulin requirements, secondaryOutcomes measure: changes in time in range (TIR) levels, secondaryOutcomes measure: changes in time below range (TBR), secondaryOutcomes measure: changes in coefficient of variation (CV), secondaryOutcomes measure: changes in frequency of severe hypoglycemic and hyperglycemic events requiring hospitalization, secondaryOutcomes measure: changes in The Pediatric Quality of Life Inventory™ 4.0 Short Form 15 Generic Core Scales questionnaire scores, eligibilityModule sex: ALL, minimumAge: 7 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: Elias University Emergency Hospital, status: RECRUITING, city: Bucharest, state: Sector 1, zip: 011461, country: Romania, contacts name: Sorin Ioacara, MD, PhD, role: CONTACT, phone: 0040213161600, email: drsorin@yahoo.com, geoPoint lat: 44.43225, lon: 26.10626, hasResults: False
protocolSection identificationModule nctId: NCT06326476, orgStudyIdInfo id: IRB-300012699, secondaryIdInfos id: 000544067, type: OTHER, domain: University of Alabama at Birmingham, briefTitle: A Study to Demonstrate the Safety and Efficacy of Siplizumab in the Treatment of Hidradenitis Suppurativa, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2025-01, primaryCompletionDateStruct date: 2025-09-30, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: University of Alabama at Birmingham, class: OTHER, collaborators name: ITB-Med LLC, descriptionModule briefSummary: This study is to investigate the efficacy of siplizumab in the treatment of Hidradenitis Suppurativa., conditionsModule conditions: Hidradenitis Suppurativa, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: Siplizumab, outcomesModule primaryOutcomes measure: Change in inflammatory lesion counts, secondaryOutcomes measure: Change in Hidradenitis Suppurativa Clinical Response (HiSCR), secondaryOutcomes measure: Change in Hurley Stage, secondaryOutcomes measure: Change in Dermatology Life Quality Index (DLQI) scores, secondaryOutcomes measure: Improvement in Visual Analogue Scale (VAS) pain scores, secondaryOutcomes measure: Change in Lesion Counts, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06326463, orgStudyIdInfo id: DIRECT70, secondaryIdInfos id: NCI-2024-03240, type: OTHER, domain: NCI Clinical Trial Registration Program, briefTitle: CAR T-cell Therapy Directed to CD70 for Pediatric Patients With Hematological Malignancies, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2030-07-01, completionDateStruct date: 2031-07-01, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: St. Jude Children's Research Hospital, class: OTHER, descriptionModule briefSummary: The study participant has one of the following blood cancers: acute myelogenous leukemia (AML)/myelodysplastic syndrome (MDS), acute lymphoblastic leukemia (B-ALL, T-ALL) or Lymphoma. Your cancer has been difficult to treat (refractory) or has come back after treatment (relapse).Primary ObjectiveTo determine the safety and maximum tolerated dose of intravenous infusions of escalating doses of CD70-CAR T cells in patients (≤21 years) with recurrent/refractory CD70+ hematological malignancies after lymphodepleting chemotherapy.Secondary ObjectivesTo evaluate the antileukemic activity of CD70-CAR T cells. We will determine the anti- leukemic activity of the CD70-CAR T cells in the bone marrow and in the treatment of extramedullary disease., conditionsModule conditions: Hematologic Malignancy, conditions: ALL, Childhood, conditions: AML, Childhood, conditions: Lymphoma, conditions: MDS, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Fludarabine, interventions name: Cyclophosphamide, interventions name: CD70-CAR T cell infusion (Autologous), interventions name: Mesna, outcomesModule primaryOutcomes measure: Maximum tolerated dose of CD70-CAR T cells, eligibilityModule sex: ALL, maximumAge: 21 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: St. Jude Children's Research Hospital, city: Memphis, state: Tennessee, zip: 38105, country: United States, contacts name: Swati Naik, MD, role: CONTACT, phone: 866-278-5833, email: referralinfo@stjude.org, geoPoint lat: 35.14953, lon: -90.04898, hasResults: False
protocolSection identificationModule nctId: NCT06326450, orgStudyIdInfo id: 74626, briefTitle: Traditional In-Person Vs. Remote AR Clinical Simulation, acronym: AR Brazil, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2025-05-31, completionDateStruct date: 2025-05-31, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Stanford University, class: OTHER, descriptionModule briefSummary: This is a non-inferiority, international, controlled trial that aims to evaluate the progression of physicians and residents through an Advanced Cardiac Life Support (ACLS) clinical simulated scenario. The study's primary objective is to compare the performance outcomes between two groups: participants in the traditional in-person simulation and those immersed in the Augmented Reality (AR) scenario, conditionsModule conditions: Educational Problems, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Augmented Reality Headset, outcomesModule primaryOutcomes measure: Progression through the ACLS clinical simulation demonstrated by NTS and TS, secondaryOutcomes measure: Demonstration of NTS during ACLS scenario, secondaryOutcomes measure: Evaluation of the AR system's usability, secondaryOutcomes measure: Exploration of perceptions, attitudes, and opinions of the AR simulation participants, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
protocolSection identificationModule nctId: NCT06326437, orgStudyIdInfo id: 1223, briefTitle: Dyadic Intervention for Psychological Distress of Patients With Colorectal Cancer and Their Spouses, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-06-01, completionDateStruct date: 2024-07-01, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Sun Yat-sen University, class: OTHER, descriptionModule briefSummary: The overall aim of the study is to evaluate the preliminary effect and feasibility of a dyadic intervention on mutuality, psychological strengths (i.e., illness cognition and dyadic coping), psychological distress, and QoL outcomes of patients with colorectal cancer and spouses. The colorectal cancer couples will be randomly allocated to the intervention group to receive a 6-week dyadic intervention, or to the control group to receive the usual care provided by the clinical team in the hospital., conditionsModule conditions: Colorectal Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: 6-week dyadic intervention, outcomesModule primaryOutcomes measure: the Kessler psychological distress scale-10, secondaryOutcomes measure: The Illness Cognition Questionnaire, secondaryOutcomes measure: Dyadic Coping Inventory, secondaryOutcomes measure: European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire-Core 30, secondaryOutcomes measure: Locke-Wallace Marital Adjustment Scale, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 59 Years, stdAges: ADULT, contactsLocationsModule locations facility: The Sixth Affiliated Hospital of Sun Yat-sen University, city: Guangzhou, state: Guangdong, zip: 510000, country: China, contacts name: Qian Sun, role: CONTACT, phone: +86 15616167998, email: sunq68@mail2.sysu.edu.cn, geoPoint lat: 23.11667, lon: 113.25, hasResults: False
protocolSection identificationModule nctId: NCT06326424, orgStudyIdInfo id: 2023H0085, briefTitle: Delirium Identification in Older Patients With Alzheimer's and Other Related Dementias In the Emergency Department, acronym: DELIRIUM, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-10, primaryCompletionDateStruct date: 2025-03-01, completionDateStruct date: 2025-03-01, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Ohio State University, class: OTHER, descriptionModule briefSummary: Delirium is highly prevalent and very bad for patients with dementia. Delirium is a dangerous medical condition that occurs in 6-38% of older Emergency Department patients and 70% of ICU patients. A person who develops delirium in the ED or hospital has a 12 times higher odds of being newly diagnosed with dementia in the next year compared to a similar patient who does not become delirious. Delirium is especially dangerous for persons living with Alzheimer Disease and Related Dementias (AD/ADRD). Persons living with ADRD have an almost 50% chance of developing delirium in the hospital.Clinicians are bad at recognizing delirium. A recent systematic review led by the Geriatric Emergency Care Applied Research network (NIH funded) found that current delirium screening tools are at most 64% sensitive, meaning that physicians can identify some phenotypes of delirium well, but cannot easily rule out delirium in acutely ill older patients.The investigators propose integrating wrist biosensors into the emergency management of older adults with dementia. The investigators will monitor heart rate variability, movement, and electrodermal activity (electrical activity of at the level of the skin) to determine if an array of biosensors more sensitive to delirium than current verbal screening tools., conditionsModule conditions: Delirium, conditions: Dementia, conditions: Hospital Acquired Condition, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Empatica EmbracePlus, outcomesModule primaryOutcomes measure: Proportion of participants who develop delirium, secondaryOutcomes measure: Intervention Acceptability, secondaryOutcomes measure: Biosensor data usability, secondaryOutcomes measure: Correlation of biosensor array data with clinical delirium, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Ohio State University Wexner Medical Center, city: Columbus, state: Ohio, zip: 43210, country: United States, geoPoint lat: 39.96118, lon: -82.99879, hasResults: False
protocolSection identificationModule nctId: NCT06326411, orgStudyIdInfo id: NST-628-001, briefTitle: A Study to Investigate the Safety and Efficacy of NST-628 Oral Tablets in Subjects With Solid Tumors, acronym: NST-628, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2028-11, completionDateStruct date: 2029-11, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Nested Therapeutics, Inc, class: INDUSTRY, descriptionModule briefSummary: This is a two-part Phase 1, open label, multi-center, single arm, non-randomized, multiple dose, safety, pharmacokinetic (PK) and preliminary efficacy study of single agent NST-628 in adult patients with MAPK pathway mutated/dependent advanced solid tumors who have exhausted standard treatment options., conditionsModule conditions: Oncology, conditions: MEK Mutation, conditions: RAF Gene Mutation, conditions: Ras (KRAS or NRAS) Gene Mutation, conditions: Melanoma, conditions: NSCLC, conditions: Glioma, conditions: Solid Tumor, Adult, conditions: MAPK Pathway Gene Mutation, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 230, type: ESTIMATED, armsInterventionsModule interventions name: NST-628, outcomesModule primaryOutcomes measure: Part A and B: Evaluate the safety of NST-628 in patients with advanced solid tumors, primaryOutcomes measure: Part A: Determine the recommended dose for expansion of NST-628, primaryOutcomes measure: Part B: Evaluate objective tumor response rate, secondaryOutcomes measure: Part A: Evaluate objective tumor response rate, secondaryOutcomes measure: Part A and B: Evaluate progression free survival (PFS), secondaryOutcomes measure: Part A and B: Evaluate overall survival (OS), secondaryOutcomes measure: Part A and B: Characterize the pharmacokinetics of NST-628, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Scientia Clinical Research, Ltd, status: RECRUITING, city: Rand, state: New South Wales, zip: 2031, country: Australia, contacts name: Shiena Lemin, role: CONTACT, phone: +61 2 9382 5800, email: ethics@scientiaclinicalresearch.com.au, contacts name: Charlotte Lemech, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -35.60079, lon: 146.62354, locations facility: Southern Oncology Research Unit, status: NOT_YET_RECRUITING, city: Adelaide, zip: 5042, country: Australia, contacts name: Meggan O'Riley, role: CONTACT, email: Meggan.ORiley@socru.org.au, contacts name: Ganessan Kichenadasse, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -34.92866, lon: 138.59863, hasResults: False
protocolSection identificationModule nctId: NCT06326398, orgStudyIdInfo id: 3D moulage, briefTitle: The Effect of Using 3D Printers and Moulage on Improving Stoma Care, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-05-01, completionDateStruct date: 2024-10-01, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Namik Kemal University, class: OTHER, collaborators name: TÜBİTAK, descriptionModule briefSummary: When studies in the literature are examined, there are studies in which various methods are applied to students' stoma care knowledge and skills. Additionally, it is seen that there are studies using moulage or 3D printers as simulation applications in nursing education. However, there is no study on high-reality simulation application using 3D printer and moulage technique together.nIn this research, the effect of the stoma created with a 3D printer in a high-reality simulation on the stoma care knowledge and skills, satisfaction and self-confidence of nursing students will be examined by using the moulage technique. In addition, this application will be compared with nursing students' stoma care practices in the stoma model, which is classified as low-reality simulation. We think that our project will be unique in this field, as it uses current technological methods together in this planned research and is different from similar studies., conditionsModule conditions: Stoma Colostomy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 76, type: ESTIMATED, armsInterventionsModule interventions name: Stoma Care, outcomesModule primaryOutcomes measure: Knowledge Level Evaluation Form Regarding Stoma Care, primaryOutcomes measure: Stoma Care Skill Grading Key, primaryOutcomes measure: Student Satisfaction and Self-Confidence Scale in Learning, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 22 Years, stdAges: ADULT, hasResults: False
protocolSection identificationModule nctId: NCT06326385, orgStudyIdInfo id: 53244021, briefTitle: Machine Learning Predictive Models for Sepsis Risk in ICU Patients With Intracerebral Hemorrhage, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-30, primaryCompletionDateStruct date: 2024-05-01, completionDateStruct date: 2024-05-30, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Xiangya Hospital of Central South University, class: OTHER, descriptionModule briefSummary: Patients with intracerebral hemorrhage (ICH) in the intensive care unit (ICU) are at heightened risk of developing sepsis, significantly increasing mortality and healthcare burden. Currently, there is a lack of effective tools for the early prediction of sepsis in ICH patients within the ICU. This study aims to develop a reliable predictive model using machine learning techniques to assist clinicians in the early identification of patients at high risk and to facilitate timely intervention.The Medical Information Mart for Intensive Care (MIMIC) IV database (version 2.2) is an international online repository for critical care expertise. This database contains patient-related information collected from the ICUs of Beth Israel Deaconess Medical Center between 2008 and 2019. It includes a vast dataset of 299,712 hospital admissions and 73,181 intensive care unit patients.The eICU Collaborative Research Database (eICU-CRD) comprises data from over 200,000 ICU admissions for 139,367 unique patients across 208 US hospitals between 2014 and 2015, providing a valuable resource for critical care research.This study aims to establish and validate multiple machine learning models to predict the onset of sepsis in ICU patients with ICH and to identify the model with the optimal predictive performance., conditionsModule conditions: Intracerebral Hemorrhage, conditions: Sepsis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 1800, type: ESTIMATED, armsInterventionsModule interventions name: no intervention, outcomesModule primaryOutcomes measure: Occurrence of sepsis, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 89 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Le Zhang, city: Changsha, state: Hunan, zip: 410008, country: China, contacts name: Le Zhang, role: CONTACT, phone: 13973187150, email: zlzdzlzd@csu.edu.cn, contacts name: Ye Li, role: CONTACT, phone: 19967131289, email: 17670516318@163.com, geoPoint lat: 28.19874, lon: 112.97087, hasResults: False
protocolSection identificationModule nctId: NCT06326372, orgStudyIdInfo id: Delirium, briefTitle: The Effect of Intraoperative Hyperoxemia on Postoperative Delirium in Geriatric Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2024-06-20, completionDateStruct date: 2024-07-01, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Tepecik Training and Research Hospital, class: OTHER, descriptionModule briefSummary: Oxygen therapy is the most common treatment modality for patients with hypoxemia, but target values for normoxemia are not clearly defined. Therefore, iatrogenic hyperoxemia is a very common situation. Even though there are many side effects reported related to hyperoxemia and hyperoxemia is shown to be related to worse outcome than expected; clinicians still observe hyperoxemia frequently.Oxygen reserve index (ORi™) (Masimo Corp., Irvine, USA) can guide clinicians in detection of hyperoxia. ORi is a parameter which can evaluate partial pressure of oxygen (PaO2) rating from 0 to 1. There are growing evidences in ORi that it might be helpful to reduce hyperoxia in general anesthesia. Continuous ORi monitoring can be used for detecting and preventing hyperoxia. The ability to perform FiO2 titration with ORi may be an appropriate monitoring management to prevent the harmful effects of hyperoxia.In this study, in patients who underwent major abdominal surgery; It was aimed to investigate the effectiveness of ORi-guided FiO2 titration in preventing hyperoxia., conditionsModule conditions: Hyperoxia, conditions: Delirium in Old Age, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: control, interventions name: ORi+SpO2, outcomesModule primaryOutcomes measure: Correlation of FiO2 and ORi value, primaryOutcomes measure: Correlation of ORi and Delirium, secondaryOutcomes measure: Correlation of FiO2 and delirium, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Aykut Saritaş, city: İ̇zmi̇r, zip: 35640, country: Turkey, geoPoint lat: 38.41273, lon: 27.13838, hasResults: False