hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06301581, orgStudyIdInfo id: ABIntl-23-42, briefTitle: Retrospective Analysis of Speech Performance Using the HiRes Ultra and HiRes Ultra 3D Cochlear Implant, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-22, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Advanced Bionics AG, class: INDUSTRY, descriptionModule briefSummary: This is a retrospective study designed to collect speech perception results for HiRes Ultra CI and HiRes Ultra 3D CI users as measured in the clinical routine and to confirm the performance of these devices., conditionsModule conditions: Cochlear Hearing Loss, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Freiburger monosyllabic word recognition score in quiet in the implanted ear, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Medizinische Hochschule Hannover, status: RECRUITING, city: Hannover, zip: D-30625, country: Germany, contacts name: Andreas Büchner, role: CONTACT, contacts name: Andreas Büchner, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 52.37052, lon: 9.73322, hasResults: False
protocolSection identificationModule nctId: NCT06301568, orgStudyIdInfo id: ABIntl-23-12, briefTitle: Retrospective Analysis of Long-term Speech Performance in Cochlear Implant Recipients Using Electro-acoustic Stimulation, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-22, primaryCompletionDateStruct date: 2024-04, completionDateStruct date: 2024-05, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Advanced Bionics AG, class: INDUSTRY, descriptionModule briefSummary: This is a retrospective study designed to collect long-term speech perception results for cochlear implants recipients using electro-acoustic-stimulation as measured in the clinical routine and to confirm the performance of sound processors associated with acoustic earhooks., conditionsModule conditions: Cochlear Hearing Loss, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, outcomesModule primaryOutcomes measure: Freiburger monosyllabic word recognition score in quiet, secondaryOutcomes measure: HSM sentence score or OlSa recognition score in quiet, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Medizinische Hochschule Hannover, status: RECRUITING, city: Hannover, zip: D-30625, country: Germany, contacts name: Andreas Büchner, role: CONTACT, geoPoint lat: 52.37052, lon: 9.73322, hasResults: False
protocolSection identificationModule nctId: NCT06301555, orgStudyIdInfo id: db2023, briefTitle: Game-Based Digital Intervention for Relieving Depression and Anxiety Symptoms, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-11-01, primaryCompletionDateStruct date: 2024-01-01, completionDateStruct date: 2024-02-01, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Adai Technology (Beijing) Co., Ltd., class: OTHER, descriptionModule briefSummary: Objective: To collect preliminary data and assess the preliminary effectiveness of a game-based digital therapeutics (DTx) intervention for individuals with symptoms of anxiety and depression, and to investigate whether reinforcement learning (RL) can personalize the intervention and enhance effectiveness. Design: Randomized controlled trial with three arms. Setting: Internet-based recruitment and delivery of the intervention. Participants: 223 individuals with symptoms of anxiety and depression, aged between 18 and 50 years. Interventions: Participants were randomly assigned to one of three groups: game-based DTx with RL algorithm (RL algorithm group), game-based DTx without RL algorithm (no algorithm group), and a blank control group. Main Outcomes and Measures: The primary outcomes were reductions in symptoms of anxiety and depression, measured using the Patient Health Questionnaire-9 and Generalized Anxiety Disorder 7-item scales. Response rates and rates of recovery, as well as the impact of demographic variables, were also examined., conditionsModule conditions: Depression, conditions: Anxiety, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 223, type: ACTUAL, armsInterventionsModule interventions name: Reinforcement learning algorithm powered cognitive and behavioral intervention, interventions name: cognitive and behavioral intervention, outcomesModule primaryOutcomes measure: PHQ9 Response, primaryOutcomes measure: GAD7 Response, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: the First Hospital of China Medical University, city: Shenyang, state: Liaoning, country: China, geoPoint lat: 41.79222, lon: 123.43278, hasResults: False
protocolSection identificationModule nctId: NCT06301542, orgStudyIdInfo id: 2020P003474, briefTitle: Multimodal, Task-Aware Movement Assessment and Control Using Functional Electrical Stimulation, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-07, primaryCompletionDateStruct date: 2024-05-01, completionDateStruct date: 2024-05-01, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Brigham and Women's Hospital, class: OTHER, collaborators name: Boston University, descriptionModule briefSummary: The study aims to investigate the relationship between post-stroke adults' movement patterns and disability levels. Utilizing the functional electrical stimulation (FES) system for individualized dorsiflexor and plantar flexor assistance during gait cycles. The investigators will analyze the cycles with and without the FES system. Initially, the context-aware motion assessment and neuroprosthetic control in a clinic will transition to in-home settings as the study progresses, broadening its application for safe and effective use at home., conditionsModule conditions: Post-stroke, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Functional electrical stimulation, outcomesModule primaryOutcomes measure: Apply functional electrical stimulation to the paretic limb of muscles of poststroke patients, secondaryOutcomes measure: Accurate motion assistance while using the functional electrical stimulation in the laboratory., secondaryOutcomes measure: Accurate motion assistance while using the functional electrical stimulation in the home., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Brigham and Women's Hospital, status: RECRUITING, city: Boston, state: Massachusetts, zip: 02115, country: United States, contacts name: David M Levine, MD MPH MA, role: CONTACT, phone: 617-732-7063, email: dmlevine@partners.org, contacts name: David M Levine, MD MPH MA, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.35843, lon: -71.05977, hasResults: False
protocolSection identificationModule nctId: NCT06301529, orgStudyIdInfo id: ALRx008, briefTitle: The Efficacy and Tolerability of Canagliflozin in Healthy Individual, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-02-12, primaryCompletionDateStruct date: 2024-04-29, completionDateStruct date: 2024-04-29, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: AgelessRx, class: INDUSTRY, descriptionModule briefSummary: The primary objective is to measure the effects that canagliflozin intervention has on reducing average glucose in healthy individuals.The secondary objective is to assess the tolerability and side effects and urinary glucose excretion following the pulsatile dosing protocol., conditionsModule conditions: Healthy Aging, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Invokana Pill, outcomesModule primaryOutcomes measure: Change in blood glucose values after taking Canagliflozin, secondaryOutcomes measure: Number of participants with treatment-related side effects through collected survey responses, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: AgelessRx, city: Ann Arbor, state: Michigan, zip: 48104, country: United States, geoPoint lat: 42.27756, lon: -83.74088, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP_ICF, hasProtocol: True, hasSap: True, hasIcf: True, label: Study Protocol, Statistical Analysis Plan, and Informed Consent Form, date: 2024-01-24, uploadDate: 2024-02-21T09:47, filename: Prot_SAP_ICF_000.pdf, size: 1174837, hasResults: False
protocolSection identificationModule nctId: NCT06301516, orgStudyIdInfo id: HM20027823, secondaryIdInfos id: R41MH133540, type: NIH, link: https://reporter.nih.gov/quickSearch/R41MH133540, briefTitle: Impact VR: An Emotion Recognition and Regulation Training Program for Youth With CD, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-16, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Virginia Commonwealth University, class: OTHER, collaborators name: National Institute of Mental Health (NIMH), descriptionModule briefSummary: Conduct disorder (CD) is one of the most prevalent childhood psychiatric disorders. Unfortunately, there are limited treatments available for CD. The present study aims to test an innovative virtual reality intervention called Impact VR for symptom reduction in a sample of 60 youth with CD., conditionsModule conditions: Conduct Disorder, conditions: Conduct Disorders in Children, conditions: Conduct Disorders in Adolescence, conditions: Callous-Unemotional Traits, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized clinical trial of psychological intervention. Once all assessments are completed, the treatment group allocation will be disclosed to the administrating researcher, youth, and caregiver. This blinded approach to block randomization prevents any bias from occurring during the assessment phase by the researcher., primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Virtual Reality, interventions name: Comparative Control, outcomesModule primaryOutcomes measure: Assess the preliminary efficacy of Impact Virtual Reality (VR) in reducing Callous-Unemotional traits, primaryOutcomes measure: Assess the preliminary efficacy of Impact Virtual Reality (VR) in reducing Conduct disorder, primaryOutcomes measure: Assess the preliminary efficacy of Impact Virtual Reality (VR) in reducing Conduct Problems, primaryOutcomes measure: Assess the preliminary efficacy of Impact Virtual Reality (VR) in reducing Emotion regulation, primaryOutcomes measure: Assess the preliminary efficacy of Impact Virtual Reality (VR) in reducing Emotion recognition, eligibilityModule sex: ALL, minimumAge: 10 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: Virginia Commonwealth University, status: RECRUITING, city: Richmond, state: Virginia, zip: 23298, country: United States, contacts name: Nicholas Johnson, role: CONTACT, phone: 804-828-6386, email: Nicholas.Thomson@VCUHealth.org, geoPoint lat: 37.55376, lon: -77.46026, hasResults: False
protocolSection identificationModule nctId: NCT06301464, orgStudyIdInfo id: B-2003-603-103, briefTitle: Pepsinogen II and Helicobacter Pylori Test in Gastric Cancer, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2003-03-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Seoul National University Bundang Hospital, class: OTHER, descriptionModule briefSummary: The aim of this study to validate the role of pepsinogens in gastric cancer screening., conditionsModule conditions: Gastric Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 24000, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: The level of serum pepsinogens, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Seoul National University Bundang Hospital, city: Seongnam-si, state: Gyeonggi-do, zip: 463-707, country: Korea, Republic of, geoPoint lat: 37.43861, lon: 127.13778, hasResults: False
protocolSection identificationModule nctId: NCT06301438, orgStudyIdInfo id: LY2024-022-A, briefTitle: Dalpiciclib in HR+/HER2- ABC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-25, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2028-12, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: RenJi Hospital, class: OTHER, descriptionModule briefSummary: To evaluate the efficacy and safety of dalpiciclib in patients with HR-positive/HER2-positive advanced breast cancer., conditionsModule conditions: Advanced Breast Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 103, type: ESTIMATED, armsInterventionsModule interventions name: dalpiciclib, outcomesModule primaryOutcomes measure: Progression-Free Survival, secondaryOutcomes measure: Adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Renji Hospital, School of Medicine, Shanghai Jiaotong University, city: Shanghai, zip: 200127, country: China, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
protocolSection identificationModule nctId: NCT06301425, orgStudyIdInfo id: TROPHY-AML01, briefTitle: MRD Response-adapted Allo-HSCT for Adverse-risk AML, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2027-05-01, completionDateStruct date: 2028-05-01, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Peking University People's Hospital, class: OTHER, collaborators name: Ruijin Hospital, collaborators name: Wuhan TongJi Hospital, collaborators name: Anhui Provincial Hospital, descriptionModule briefSummary: This TROPHY-AML01 regimen aims to identify the effectiveness and safety of MRD response-adapted allo-HSCT for adverse-risk acute myeloid leukemia in an open-label, randomized, controlled trial., conditionsModule conditions: Acute Myeloid Leukemia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 178, type: ESTIMATED, armsInterventionsModule interventions name: Intervention group, interventions name: Control group, outcomesModule primaryOutcomes measure: Event-free survival (EFS), secondaryOutcomes measure: Relapse, secondaryOutcomes measure: Leukemia-free survival (LFS), secondaryOutcomes measure: Non-relapse mortality (NRM), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Acute graft-versus-host disease (aGvHD), secondaryOutcomes measure: Chronic graft-versus-host disease (cGvHD), eligibilityModule sex: ALL, minimumAge: 16 Years, maximumAge: 65 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06301412, orgStudyIdInfo id: COTTIS-2_Version4.0-13Nov23, briefTitle: Combination of Hypothermia and Thrombectomy in Acute Stroke, acronym: COTTIS-2, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-18, primaryCompletionDateStruct date: 2026-03-18, completionDateStruct date: 2026-06-18, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: University of Freiburg, class: OTHER, collaborators name: European Union, collaborators name: E+E CRO consulting, Vienna, Austria, collaborators name: Center for Medical data science, University of Vienna, Austria, descriptionModule briefSummary: The goal of this clinical trial is to test the combination of hypothermia and endovascular treatment in acute stroke patients with large vessel occlusion.The main question it aims to answer is: does an additional cooling to 35°C result in a benefit on clinical outcome ? Participants receive immediate cooling using a noninvasive transnasal cooling technique (RhonoChill) and are maintained at 35°C for 6 hours after reopening of the vessel using surface cooling, and then slowly rewarmed.Researchers will compare the intervention group (hypothermia and endovascular treatment and best medical treatment including iv thrombolysis) and control group (only endovascular treatment and best medical treatment including iv thrombolysis) to see if additional hypothermia leads to a better outcome after 3 months without relevant complications., conditionsModule conditions: Ischemic Stroke, conditions: Large Vessel Occlusion, conditions: Endovascular Treatment, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule interventions name: hypothermia, outcomesModule primaryOutcomes measure: functional outcome, secondaryOutcomes measure: infarction volume, secondaryOutcomes measure: increase in infarction, secondaryOutcomes measure: recanalization result, secondaryOutcomes measure: neurological improvement, secondaryOutcomes measure: outcome at discharge, secondaryOutcomes measure: shift in functional outcome, secondaryOutcomes measure: very good clinical outcome, secondaryOutcomes measure: mortality, secondaryOutcomes measure: Length of ventilation, secondaryOutcomes measure: Length of stay, secondaryOutcomes measure: body temperature, secondaryOutcomes measure: time to groin puncture, secondaryOutcomes measure: time to recanalization, otherOutcomes measure: Occurrence of intracerebral haemorrhage (ICH), otherOutcomes measure: Complications associated with hypothermia, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06301399, orgStudyIdInfo id: Rituximab01, briefTitle: Rituximab Combined With Prior Therapy in Advanced Hepatocellular Carcinoma: Efficacy & Safety Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Tianjin Medical University Cancer Institute and Hospital, class: OTHER, descriptionModule briefSummary: Evaluation of the efficacy and safety of adding rituximab after failure of target immunotherapy in the Posterior treatment of advanced hepatocellular carcinoma, conditionsModule conditions: Advanced Hepatocellular 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: Rituximab+PD-1 or PD-L1 inhibitors+targeted therapy, outcomesModule primaryOutcomes measure: ORR, secondaryOutcomes measure: PFS, secondaryOutcomes measure: OS, secondaryOutcomes measure: DoR, secondaryOutcomes measure: DCR, eligibilityModule sex: ALL, minimumAge: 17 Years, maximumAge: 79 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Tianjin Medical University Cancer Institute & Hospital, city: Tianjin, state: Tianjin, zip: 300060, country: China, geoPoint lat: 39.14222, lon: 117.17667, hasResults: False
protocolSection identificationModule nctId: NCT06301386, orgStudyIdInfo id: EVOLUTION, briefTitle: Everolimus Combined With PD-1 in Advanced Colorectal Cancer Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-05-01, completionDateStruct date: 2026-12-01, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Fudan University, class: OTHER, collaborators name: Anyang Tumor Hospital, descriptionModule briefSummary: The goal of this clinical trial is to learn about efficacy of Everolimus in combination with PD-1 in patients with locally advanced and advanced colorectal cancer that cannot be R0 resected. The main question is to explore the survival time, safety and tolerability of the treatment. At the same time, the correlation between biomarkers (including PD-L1 expression, tumor mutation load, lymphocyte subpopulation, cytokines, TCR, intestinal microbes, and others) and the efficacy and drug resistance mechanism will be analyzed, so as to provide reference for the subsequent guidance of the screening of benefit groups., conditionsModule conditions: Colon Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 25, type: ESTIMATED, armsInterventionsModule interventions name: Everolimus, interventions name: PD-1, outcomesModule primaryOutcomes measure: objective response rate (ORR), secondaryOutcomes measure: progression-free survival (PFS）, secondaryOutcomes measure: overall survival (OS), secondaryOutcomes measure: disease control rate (DCRs), secondaryOutcomes measure: advert events, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Anyang Tumor Hospital, city: Anyang, state: Henan, country: China, contacts name: Yanjun Wang, PhD, role: CONTACT, phone: +8613837266702, email: m13837266702@163.com, geoPoint lat: 36.096, lon: 114.38278, locations facility: Fudan University Shanghai Cancer Center, city: Shanghai, state: Shanghai, country: China, contacts name: Dawei Li, PhD, role: CONTACT, phone: +8613774201693, email: li_dawei@fudan.edu.cn, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False