hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06351098, orgStudyIdInfo id: 2024579, briefTitle: Longitudinal Investigation of Sleep, Memory, and Brain Development Across the Nap Transition, acronym: HSR, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-05, primaryCompletionDateStruct date: 2028-06, completionDateStruct date: 2028-06, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: University of Maryland, College Park, class: OTHER, collaborators name: University of Massachusetts, Amherst, descriptionModule briefSummary: To examine the relations between sleep (nap transitions, sleep physiology), memory, and brain development longitudinally, the researchers will assess n=180 children (in order to acquire n=152 usable data sets) who are 36-54 months of age and habitual nappers at enrollment. In each wave, the researchers will assess memory, memory change over a nap and equivalent waking interval, sleep physiology of the nap, and brain structure and function (using Magnetic Resonance Imagining or MRI). Additionally, overnight sleep physiology will be assessed in all participants. Waves will take place approximately every 6 months. For all children, three waves will be collected. With these data, the researchers will address the following aims:* Examine neural markers that predict the sleep transition (Aim 1);* Examine changes in sleep-dependent memory processing (mnemonic discrimination) over both nap and overnight sleep intervals, across the sleep transition (Aim 2);* Examine changes in sleep microstructure in both nap and overnight sleep across the sleep transition (Aim 3)* Examine interrelations among brain, memory and sleep microstructure across the sleep transition (Aim 4), conditionsModule conditions: Memory, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 180, type: ESTIMATED, armsInterventionsModule interventions name: nap, outcomesModule primaryOutcomes measure: Memory, eligibilityModule sex: ALL, minimumAge: 36 Months, maximumAge: 60 Months, stdAges: CHILD, contactsLocationsModule locations facility: University of Maryland, status: RECRUITING, city: College Park, state: Maryland, zip: 20742, country: United States, contacts name: Tracy Riggins, Ph.D., role: CONTACT, phone: 301-405-5905, email: riggins@umd.edu, contacts name: Postdoctoral Fellow, role: CONTACT, phone: 301-405-5922, email: napstudy@umd.edu, geoPoint lat: 38.98067, lon: -76.93692, locations facility: University of Massachusetts, status: RECRUITING, city: Amherst, state: Massachusetts, zip: 01003, country: United States, contacts name: Rebecca MC Spencer, PhD, role: CONTACT, phone: 413-577-6128, email: rspencer@umass.edu, contacts name: Postdoctoral Fellow, role: CONTACT, phone: 413-545-4831, email: preschoolnapstudy@gmail.com, geoPoint lat: 42.36723, lon: -72.51852, hasResults: False
protocolSection identificationModule nctId: NCT06351085, orgStudyIdInfo id: 1937769-1, briefTitle: Enhancing Lung Cancer Screening Through Human-Centered Intervention, acronym: ELFE, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-11-10, primaryCompletionDateStruct date: 2025-04-14, completionDateStruct date: 2025-04-14, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: University of California, Davis, class: OTHER, descriptionModule briefSummary: The purpose of this study is to further understand the factors involved in increasing lung cancer screening., conditionsModule conditions: Lung Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Patients of the intervention clinics will be assigned one of two interventions: 1) Pre Visit Planner (PVP) or 2) PVP + patient education delivered via the MyUCDHealth patient web portal., primaryPurpose: SCREENING, maskingInfo masking: SINGLE, maskingDescription: Biostatistician created a randomized table to allocate patient in either intervention 1 or 2., whoMasked: PARTICIPANT, enrollmentInfo count: 2869, type: ESTIMATED, armsInterventionsModule interventions name: Pre-Visit Planner, interventions name: Pre-Visit Planner + MyChart, outcomesModule primaryOutcomes measure: Lung Cancer Screening, secondaryOutcomes measure: Completion of Interviews with Staff and Patients, eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of California, Davis, status: RECRUITING, city: Sacramento, state: California, zip: 95817, country: United States, contacts name: Moon Chen, M.P.H, Ph.D, role: CONTACT, phone: 916-548-3928, email: mschenjr@ucdavis.edu, contacts name: Moon Chen, M.P.H, Ph.D, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.58157, lon: -121.4944, hasResults: False
protocolSection identificationModule nctId: NCT06351072, orgStudyIdInfo id: NOXANI, briefTitle: Correlation Between qNOX and Analgesia Nociception Index (ANI) Values During General Anesthesia, acronym: ANI, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-02, primaryCompletionDateStruct date: 2024-09-01, completionDateStruct date: 2024-10-01, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: University of Padova, class: OTHER, descriptionModule briefSummary: qNOX and ANI are two indexes evaluting the analgesia conduction during general anesthesia.No trials have compared them, so with this trial authors want to explore the correlations between them., conditionsModule conditions: Analgesia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 40, type: ESTIMATED, outcomesModule primaryOutcomes measure: Correlation between qNOX and ANI values, secondaryOutcomes measure: Correlation between qNOX from CONOX and Analgesia nocicpetion index (ANI) values and postoperative pain, secondaryOutcomes measure: Correlation between qNOX from CONOX and analgesia nocicpetion index (ANI) values and postoperative delirium, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Treviso Regional Hospital, status: RECRUITING, city: Treviso, state: TV, zip: 31100, country: Italy, contacts name: Federico Linassi, role: CONTACT, email: federico.linassi@gmail.com, geoPoint lat: 45.66673, lon: 12.2416, hasResults: False
protocolSection identificationModule nctId: NCT06351059, orgStudyIdInfo id: UE-0083, briefTitle: Acoustic Emission Biomarkers for the Detection and Monitoring of Early Knee Osteoarthritis, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2024-07-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Schulthess Klinik, class: OTHER, collaborators name: Ecole Polytechnique Fédérale de Lausanne, descriptionModule briefSummary: The aim of this exploratory study is to further investigate the potential of acoustic emission biomarkers, assessed by the inmodi knee brace, to diagnose osteoarthritis (OA) at earlier stages. Therefore, 20 healthy participants and 100 patients with increased risk of knee OA will be recruited from the Schulthess Klinik in Zurich and examined twice with 9 ± 3 months' time interval. Anthropometric data, EOS radiographs and MR images of both knees, PROMs and acoustic emission data will be collected and evaluated. Artificial Intelligence algorithm will then be used to identify and validate the most promising acoustic emission biomarkers with a prognosis value in the prediction of knee osteoarthritis progress., conditionsModule conditions: Osteoarthritis, Knee, conditions: Diagnosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 120, type: ACTUAL, armsInterventionsModule interventions name: InModi acoustic emission analysis, outcomesModule primaryOutcomes measure: acoustic emissions, primaryOutcomes measure: kinematic data, primaryOutcomes measure: MRI / MOAKS, primaryOutcomes measure: EOS / leg alignment, primaryOutcomes measure: PROMS, eligibilityModule sex: ALL, minimumAge: 35 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Schulthess Klinik, city: Zürich, state: ZH, zip: 8008, country: Switzerland, geoPoint lat: 47.36667, lon: 8.54999, hasResults: False
protocolSection identificationModule nctId: NCT06351046, orgStudyIdInfo id: NCT05178082_WP3, briefTitle: Preventive Interventions for Chronic Pain Worsening, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08-01, primaryCompletionDateStruct date: 2026-07-30, completionDateStruct date: 2027-01-30, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Rigshospitalet, Denmark, class: OTHER, collaborators name: The Novo Nordic Foundation, descriptionModule briefSummary: This is an open label randomized controlled trial (RCT), which will be conducted with patients of the Copenhagen Wound Healing Center at Bispebjerg Hospital in Copenhagen (DK). The trial has three arms (1:1:1): Mindfulness Based Stress Reduction (MBSR) group, Virtual Reality based Pain Self-management (VRPS) program group, and a control group (usual care). Included will be 78 patients at least 18 years old; fluent in the Danish language; complaint of pain lasting 3 months or more; in average pain intensity score ≥ 3 (numerical rating scale 0 to 10); access to internet; and willing and available to participate in the study. Excluded will be specialized or multidisciplinary pain treatment at baseline; history of epilepsy, seizure disorder, nausea or dizziness, hypersensitivity to flashing light or motion or other diseases that may prevent use of virtual reality equipment; injury to eyes, face or neck., conditionsModule conditions: Chronic Non-Cancer Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: FACTORIAL, interventionModelDescription: This is an open label randomized controlled trial (RCT), which will be conducted with patients of the Copenhagen Wound Healing Center at Bispebjerg Hospital in Copenhagen (DK). The trial has three arms (1:1:1): MBSR group, VRPS group, and a control group (usual care). Participants will be randomly assigned to one of the groups. Assessments will occur at baseline and 2, 6, 9, and 12 months after intervention., primaryPurpose: PREVENTION, maskingInfo masking: NONE, maskingDescription: The statistical analysis of the data will be blinded, enrollmentInfo count: 78, type: ESTIMATED, armsInterventionsModule interventions name: Online Mindfullness Based Stress Reduction Program, interventions name: Virtual Reality-based Pain Self-management program, outcomesModule primaryOutcomes measure: Pain intensity, secondaryOutcomes measure: Pain intensity and interference in daily activities, secondaryOutcomes measure: Pain catastrophizing, secondaryOutcomes measure: Pain acceptance, secondaryOutcomes measure: Health status, secondaryOutcomes measure: Health related quality of life, secondaryOutcomes measure: Anxiety, secondaryOutcomes measure: Depression, secondaryOutcomes measure: Use of medication, secondaryOutcomes measure: Use of healthcare system, secondaryOutcomes measure: Number of absent days at work, otherOutcomes measure: Satisfaction with the intervention, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06351020, orgStudyIdInfo id: LM302-03-101, briefTitle: LM-302 for the Treatment of Subjects With Claudin18.2-Positive Gastric and Gastroesophageal Junction Adenocarcinoma., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-08-10, completionDateStruct date: 2026-12-15, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: LaNova Medicines Zhejiang Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: This study will assess the efficacy and safety of LM-302 Versus Treatment of Physician's Choice (TPC) in Subjects With locally advanced or metastatic, Claudin (CLDN) 18.2-positive, Gastric or Gastroesophageal Junction Adenocarcinoma who have progressed on or after 2 lines of systemic therapy, conditionsModule conditions: Locally Advanced or Metastatic GC and GCJ Adenocarcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: experimental arm:LM-302 control arm:Apatinib or Irinotecan, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 375, type: ESTIMATED, armsInterventionsModule interventions name: LM-302, interventions name: Apatinib, interventions name: Irinotecan, outcomesModule primaryOutcomes measure: Overall Survival (OS), primaryOutcomes measure: Progression Free Survival (PFS), secondaryOutcomes measure: Objective response rate (ORR), secondaryOutcomes measure: Duration of response (DoR), secondaryOutcomes measure: Disease control rate (DCR), secondaryOutcomes measure: AE and SAE, secondaryOutcomes measure: Evaluate the immunogenicity of LM-302, secondaryOutcomes measure: Evaluation of pharmacokinetic characteristics of LM-302, secondaryOutcomes measure: Evaluation of pharmacokinetic characteristics of LM-302, secondaryOutcomes measure: Evaluation of pharmacokinetic characteristics of LM-302, secondaryOutcomes measure: Evaluation of pharmacokinetic characteristics of total antibody, secondaryOutcomes measure: Evaluation of pharmacokinetic characteristics of total antibody, secondaryOutcomes measure: Evaluation of pharmacokinetic characteristics of total antibody, secondaryOutcomes measure: Evaluation of pharmacokinetic characteristics of MMAE, secondaryOutcomes measure: Evaluation of pharmacokinetic characteristics of MMAE, secondaryOutcomes measure: Evaluation of pharmacokinetic characteristics of MMAE, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06350994, orgStudyIdInfo id: APHP230625, secondaryIdInfos id: IDRCB 2023-A01957-38, type: OTHER, domain: ANSM, briefTitle: Early Assessment of Cardiac Function After Treatment With CAR-T Cells, acronym: Cardio CAR-T, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09, primaryCompletionDateStruct date: 2026-10, completionDateStruct date: 2027-01, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Assistance Publique - Hôpitaux de Paris, class: OTHER, descriptionModule briefSummary: CAR-T cells (Chimeric Antigen Receptor) are a new immunotherapy, based on the genetic modification of autologous T lymphocytes. CAR-T cell therapy is not devoid of complications.Among the most frequent complications are the risk of infection, cytokine release syndrome (CRS) and neurotoxicity. Nevertheless, some authors have reported serious acute cardiac events in a limited number of patients, often contemporaneous with CRS or sepsis, questioning the imputability of CAR-T cells in this heart disease.This study aims to estimate the incidence of a possible early cardiotoxicity associated with CAR-T cells.The main endpoint will be the change in cardiac function (LVEF: left ventricular ejection fraction) assessed by ultrasound between the pre CAR-T assessment and the early post CAR-T ultrasound (D3-D5)., conditionsModule conditions: Car T- Cell, conditions: Hematologic Malignancy, conditions: Acute Lymphoblastic Leukemia, conditions: Lymphoma, B-Cell, conditions: Multiple Myeloma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Estimation of the incidence of possible early CAR-T cells infusion-induced cardiotoxicity, secondaryOutcomes measure: Characterization of the putative CAR-T cells infusion-induced cardiotoxicity: incidence, phenotype, clinical, rhythmic and biological manifestations, secondaryOutcomes measure: Determination of its possible association with a cytokine release syndrome and the levels of inflammatory biomarkers from the analysis of the serum library of these patients, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Critical care medicine department, city: Paris, zip: 75012, country: France, contacts name: Jérémie JOFFRE, MD, PhD, role: CONTACT, phone: +33 1 49 28 21 45, email: Jeremie.joffre@aphp.fr, contacts name: Hafid AIT-OUFELLA, Professor, role: CONTACT, phone: +33 1 49 28 21 45, email: hafid.ait-oufella@aphp.fr, geoPoint lat: 48.85341, lon: 2.3488, hasResults: False
protocolSection identificationModule nctId: NCT06350981, orgStudyIdInfo id: FORE813, briefTitle: Analgesic Requirement for Post-Operative Pain Control in TLIP Interbody Fusion, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-01-01, completionDateStruct date: 2025-03-01, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Foundation for Orthopaedic Research and Education, class: OTHER, collaborators name: Pacira Pharmaceuticals, Inc, descriptionModule briefSummary: The goal of this clinical trail is to to compare the efficacy of thoracolumbar interfascial plane block with Exparel vs with standard of care 0.25% Bupivacaine HCl in patients undergoing 1-3 level elective transforaminal lumbar interbody fusion. The investigators hypothesize that thoracolumbar interfascial plane block with Exparel will outperform standard of care (supplemented with interfascial plane block of 0.25% Bupivacaine HCl) with regards to pain reduction, narcotic use, length of hospital stay, time to mobilization with physical therapy, narcotic usage in the hospital, and post operative pain scores., conditionsModule conditions: Back Pain, conditions: Surgery-Complications, conditions: Narcotic Use, conditions: Physical Stress, conditions: Post Operative Pain, designModule studyType: INTERVENTIONAL, phases: PHASE2, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Study subjects will be randomized to either Group 1 or Group 2 in a 1:1 ratio based on the randomization scheme in sealed envelopes maintained by the study coordinator., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 76, type: ESTIMATED, armsInterventionsModule interventions name: Exparel, interventions name: Bupivacain, outcomesModule primaryOutcomes measure: Compare efficacy of thoracolumbar interfacial plane block with Exparel vs. standard of care (0.25% Bupivacaine HCL) is surgical subjects undergoing 1-3 level elective transforaminal lumbar interbody fusion., secondaryOutcomes measure: Total Postsurgical opioid consumption, secondaryOutcomes measure: Time to discharge, secondaryOutcomes measure: Time to ambulation, secondaryOutcomes measure: Maximum ambulated distance, secondaryOutcomes measure: Numeric Rating Pain Scale (Physical Therapy), secondaryOutcomes measure: Numeric Rating Pain Scale, secondaryOutcomes measure: Oswestry Disability Index (ODI), secondaryOutcomes measure: Pain Catastrophizing Scale (PCS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Foundation for Orthopaedic Research and Education, city: Tampa, state: Florida, zip: 33607, country: United States, contacts name: Deborah H Warren, role: CONTACT, phone: 813-910-3688, email: dwarren@foreonline.org, geoPoint lat: 27.94752, lon: -82.45843, hasResults: False
protocolSection identificationModule nctId: NCT06350968, orgStudyIdInfo id: MEC-2023-0151, secondaryIdInfos id: 10200012110003, type: OTHER_GRANT, domain: ZonMw, briefTitle: Implementation of Online Advance Care Planning Tool for (Hemato-)Oncological Patients Within the Cancer Network Concord, acronym: INDEED, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-01, primaryCompletionDateStruct date: 2026-06-30, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Erasmus Medical Center, class: OTHER, collaborators name: Maasstad Hospital, collaborators name: Spijkenisse Medical Center, collaborators name: Franciscus &Vlietland, collaborators name: IJsselland, collaborators name: Ikazia Hospital, Rotterdam, collaborators name: Van Weel-Bethesda hospital, collaborators name: Albert Schweitzer Hospital, collaborators name: Beatrix hospital, descriptionModule briefSummary: The aim of this mixed-methods study is to describe both the implementation process and outcomes of the online module Advance Care Plan for (hemato-)oncology patients within the oncology-network CONCORD.The main question is: How is implementation and assurance of the advance care plan in daily care for (hemato-)oncological patients within CONCORD achieved, so that early integration of advance care planning in oncological care takes place and patient preferences are discussed?Healthcare providers and patients are asked to use the module and share their experiences with it., conditionsModule conditions: Oncology, conditions: Advance Care Planning, conditions: Implementation, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 30, type: ESTIMATED, outcomesModule primaryOutcomes measure: Implementation outcome, secondaryOutcomes measure: Intervention outcome, secondaryOutcomes measure: Implementation outcome, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Joica Benschop, status: RECRUITING, city: Rotterdam, zip: 3023TB, country: Netherlands, contacts name: Joica Benschop, MSc, role: CONTACT, phone: +31622586583, email: j.benschop@erasmusmc.nl, contacts name: Wendy Oldenmenger, PhD, role: CONTACT, phone: +31651072608, email: w.h.oldenmenger@erasmusmc.nl, geoPoint lat: 51.9225, lon: 4.47917, hasResults: False