hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06314074, orgStudyIdInfo id: 2023-101143-BO-ff, briefTitle: 2.5 Versus 5 Minutes Trial, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-12, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Universitätsklinikum Hamburg-Eppendorf, class: OTHER, descriptionModule briefSummary: This is a randomized trial investigating the effect of oscillometric blood pressure monitoring at 2.5-minute intervals - compared to 5-minute intervals - on intraoperative hypotension. Specifically, the investigators will test the primary hypothesis that oscillometric blood pressure monitoring at 2.5-minute intervals - compared to 5-minute intervals - reduces the time-weighted average mean arterial pressure below 65 mmHg in patients having non-cardiac surgery., conditionsModule conditions: Hypotension, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 264, type: ESTIMATED, armsInterventionsModule interventions name: Oscillometric blood pressure monitoring at 2.5-minute intervals, interventions name: Oscillometric blood pressure monitoring at 5-minute intervals, outcomesModule primaryOutcomes measure: Time-weighted average mean arterial pressure <65 mmHg, secondaryOutcomes measure: Episodes of a mean arterial pressure <50 mmHg, secondaryOutcomes measure: Norepinephrine dose, eligibilityModule sex: ALL, minimumAge: 45 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf, status: RECRUITING, city: Hamburg, zip: 20246, country: Germany, contacts name: Karim Kouz, Dr, role: CONTACT, phone: +49 40 7410 52415, email: k.kouz@uke.de, geoPoint lat: 53.57532, lon: 10.01534, hasResults: False
protocolSection identificationModule nctId: NCT06314048, orgStudyIdInfo id: 74212, briefTitle: 4T Sustainability Program, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-01, completionDateStruct date: 2026-01, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Stanford University, class: OTHER, descriptionModule briefSummary: The goal of the 4T program is to implement proven methods and emerging diabetes technology into clinical practice to sustain tight glucose control from the onset of type 1 diabetes (T1D) and optimize patient-reported and psychosocial outcomes. The investigators will expand the 4T (Teamwork, Targets, Technology, and Tight Control) program to all patients seen at Stanford Pediatric Diabetes Endocrinology as the standard of care. Disseminating the 4T program as the standard of care will optimize the benefits of diabetes technology by lowering HbA1c, improving PROs, and reducing disparities., conditionsModule conditions: Type1diabetes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: 1. Implement the 4T program as standard of care at Stanford Diabetes clinics, including Continuous Glucose Monitoring (CGM) and Remote Patient Monitoring (RPM) within the first 30 days after T1D diagnosis to reduce the rise in HbA1c trajectory observed 4-12 months post-diagnosis.2. Continue refining automated decision-support tools that use CGM data to support setting personalized goals and identify the need for insulin dose adjustments between quarterly endocrinology standard of care visits. Continue to evaluate the use of the Timely Interventions for Diabetes Excellence (TIDE) tool to analyze and prioritize the CGM data of participants requiring review.3. Continue the systematic screening for patient-reported outcomes, both assessment of PROs and delivery of care linked to screening as a core component of the 4T program., primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 5000, type: ESTIMATED, armsInterventionsModule interventions name: CGM and RPM, outcomesModule primaryOutcomes measure: HbA1c trajectory observed 4-12 months post-diagnosis, primaryOutcomes measure: Diabetes distress measured at baseline and 12 months post-diagnosis., eligibilityModule sex: ALL, minimumAge: 6 Months, maximumAge: 21 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06314009, orgStudyIdInfo id: EH23-302, briefTitle: Beyond MARS: Magnetic Resonance Study: A Novel Assessment of Placental Perfusion During Pregnancy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2026-12, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: NorthShore University HealthSystem, class: OTHER, descriptionModule briefSummary: The purpose of this study is to evaluate the flow of oxygen and blood necessary for nutrient transfer across the placenta during the second and third trimesters in pregnancy in women who are obese before pregnancy compared to women who have an average weight before pregnancy. This study will evaluate blood flow across the placenta by functional Magnetic Resonance Imaging (fMRI) using arterial spin labeling (ASL). The investigators hypothesize that there will be differences in placental oxygenation and blood flow among women with obesity as compared to those with normal weight. Participants will be asked to complete Magnetic Resonance Imaging scans (MRIs), the first in the second trimester at 20-24 weeks and the second in the third trimester at 30-34 weeks., conditionsModule conditions: Placenta Diseases, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: functional Magnetic Resonance Imaging (fMRI), outcomesModule primaryOutcomes measure: Inter - rater reliability of assessing placental blood flow by arterial spin labeling (ASL), primaryOutcomes measure: Mean placental perfusion in second and third trimester, primaryOutcomes measure: Mean R2* relaxation rates in second and third trimester, secondaryOutcomes measure: Perinatal outcomes including hypertensive disorders of pregnancy, gestational diabetes, preterm birth, small for gestational age, NICU admission, and stillbirth., eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06313996, orgStudyIdInfo id: CA082-011, secondaryIdInfos id: 2023-507477-18, type: EUDRACT_NUMBER, briefTitle: A Study to Evaluate the Efficacy and Safety of Liso-cel Compared to Standard of Care in Adults With Relapsed or Refractory Follicular Lymphoma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-29, primaryCompletionDateStruct date: 2031-10-16, completionDateStruct date: 2031-10-16, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company, class: INDUSTRY, collaborators name: Celgene Corporation, descriptionModule briefSummary: The purpose of this study is to evaluate the efficacy and safety of Liso-cel compared to standard of care in adults with Relapsed or Refractory Follicular Lymphoma., conditionsModule conditions: Relapsed or Refractory Follicular Lymphoma, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Cyclophosphamide, interventions name: Doxorubicin, interventions name: Vincristine, interventions name: Rituximab, interventions name: Prednisone, interventions name: Bendamustine, interventions name: Lenalidomide, interventions name: Fludarabine, interventions name: Liso-cel, outcomesModule primaryOutcomes measure: Progression-free survival (PFS), secondaryOutcomes measure: Complete response (CR), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Overall response (OR), secondaryOutcomes measure: Duration of response (DOR), secondaryOutcomes measure: Event-free survival (EFS), secondaryOutcomes measure: Time to next anti-cancer therapy (TTNLT), secondaryOutcomes measure: PFS rate, secondaryOutcomes measure: EFS rate, secondaryOutcomes measure: OS rate, secondaryOutcomes measure: Progression-free survival on the next line of treatment (PFS-2), secondaryOutcomes measure: Number of participants with adverse events (AEs), secondaryOutcomes measure: Number of participants with adverse event of special interest (AESIs), secondaryOutcomes measure: Number of participants with serious adverse events (SAEs), secondaryOutcomes measure: Number of participants with laboratory abnormalities, secondaryOutcomes measure: Frequency and length of hospitalizations, secondaryOutcomes measure: Number of participants with intensive care unit (ICU) inpatient days, secondaryOutcomes measure: Number of participants with non-ICU inpatient days, secondaryOutcomes measure: Mean change from baseline in key health-related quality of life (HRQoL) domains., secondaryOutcomes measure: Time to meaningful improvement/deterioration in key HRQoL domains., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06313983, orgStudyIdInfo id: HM022BC3C01, briefTitle: A Phase Ⅲ Study of Hemay022 in Combination With AI In Advanced Breast Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-01-08, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2026-06, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Tianjin Hemay Pharmaceutical Co., Ltd, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to evaluate the effectiveness of Hemay022 combined with AI (exemestane or letrozole) in the treatment of ER+/HER2+ advanced breast cancer patients based on the progression-free survival (PFS) assessed by the independent review committee (IRC). The second purpose of this study is to evaluate the pharmacokinetics and efficacy of Hemay022 in combination with AI, and the safety of Hemay022 in combination with AI.The trial plans to recruit 339 subjects, who will be randomly divided into two cohorts (the experimental group is hemay022 combined with AI, and the control group is lapatinib combined with capecitabine). During the treatment period, imaging examinations and anti-tumor efficacy evaluations will be performed regularly until the subject develop disease progression or starts receiving other treatments or dies or refuses to come to the hospital for follow-up or the trial is terminated, etc., conditionsModule conditions: Breast Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 339, type: ESTIMATED, armsInterventionsModule interventions name: Hemay022+AI, interventions name: Lapatinib+Capecitabine, outcomesModule primaryOutcomes measure: Median progression-free survival（mPFS）based on IRC assessment according to RECIST v1.1, secondaryOutcomes measure: Overall Survival (OS) of the two group according to RECIST v1.1, secondaryOutcomes measure: Objective response rate ( ORR, partial response rate+ complete response rate) according to RECIST v1.1, secondaryOutcomes measure: Clinical benefit rate (CBR) according to RECIST v1.1, secondaryOutcomes measure: Duration of Response (DOR) according to RECIST v1.1, secondaryOutcomes measure: Time to Response (TTR), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Beijing Cancer Hospital, status: RECRUITING, city: Beijing, country: China, contacts name: Huiping Li, role: CONTACT, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
protocolSection identificationModule nctId: NCT06313970, orgStudyIdInfo id: QLMA-PC-IIT-001, briefTitle: First-line Regimen With QL1706 Plus Chemo ± Bev in PDAC Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2025-04-15, completionDateStruct date: 2026-04-15, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Fudan University, class: OTHER, descriptionModule briefSummary: This is a multicenter, open-label, exploratory study to evaluate the efficacy and safety of QL1706 plus nab-paclitaxel and gemcitabine with or without bevacizumab as first-line treatment in patients with unresectable locally advanced or metastatic pancreatic cancer, conditionsModule conditions: Pancreatic Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: QL1706, interventions name: Nab-paclitaxel, interventions name: Gemcitabine, interventions name: Bevacizumab, outcomesModule primaryOutcomes measure: Objective response rate (ORR), secondaryOutcomes measure: Disease control rate (DCR), secondaryOutcomes measure: Duration of Response (DoR), secondaryOutcomes measure: Time to response(TTR), secondaryOutcomes measure: Progression-free survival (PFS), secondaryOutcomes measure: Overall survival（OS）, secondaryOutcomes measure: Adverse Events, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06313957, orgStudyIdInfo id: LB2302-0001, briefTitle: A Study of LUCAR-20SP in Subjects With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2026-09, completionDateStruct date: 2028-09, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Peking University Cancer Hospital & Institute, class: OTHER, descriptionModule briefSummary: This is a prospective, single-arm, open-label, exploratory clinical study of LUCAR-20SP in adult subjects with relapsed/refractory B-cell non-Hodgkin lymphoma., conditionsModule conditions: Relapsed/Refractory B-cell Non-Hodgkin Lymphoma, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 42, type: ESTIMATED, armsInterventionsModule interventions name: LUCAR-20SP cells, outcomesModule primaryOutcomes measure: Dose-limiting toxicity (DLT) rate, primaryOutcomes measure: Incidence, severity, and type of treatment-emergent adverse events (TEAEs), primaryOutcomes measure: Recommended Phase 2 Dose (RP2D) regimen finding, primaryOutcomes measure: Pharmacokinetics in peripheral blood, primaryOutcomes measure: Pharmacokinetics in bone marrow, secondaryOutcomes measure: Objective Response Rate (ORR) after administration, secondaryOutcomes measure: Time to Response (TTR) after administration, secondaryOutcomes measure: Duration of Remission (DoR) after administration, secondaryOutcomes measure: Progression-free Survival (PFS) after administration, secondaryOutcomes measure: Overall Survival (OS) after administration, secondaryOutcomes measure: Incidence of anti-LUCAR-20SP antibody, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Peking University Cancer Hospital & Institute, status: RECRUITING, city: Beijing, state: Beijing, zip: 100142, country: China, contacts name: Yuqin Song, role: CONTACT, phone: 13683398726, email: songyq22622@163.com, contacts name: Yan Xie, role: CONTACT, phone: 13671376201, email: xieyan9@263.net, contacts name: Yuqin Song, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
protocolSection identificationModule nctId: NCT06313944, orgStudyIdInfo id: GE-R-A-TPS, briefTitle: German Registry of Alzheimer's Disease Treated With Transcranial Pulse Stimulation, acronym: GE-R-A-TPS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-10-01, completionDateStruct date: 2026-10-01, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Heinrich-Heine University, Duesseldorf, class: OTHER, collaborators name: Storz Medical AG, descriptionModule briefSummary: This study will primarily investigate the safety and secondarily the effect and applicability of Transcranial Pulse Wave Stimulation (TPS) for the treatment of Alzheimer's disease in the context of a PMCF study (Post-Market Clinical Follow-up). The multicenter, prospective data collection should help to optimize the stimulation protocol, as well as to record frequent to occasional adverse effects of the product and cognitive, affective and subjective scores., conditionsModule conditions: Alzheimer Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Registry, outcomesModule primaryOutcomes measure: Number of (Serious) Adverse Events, primaryOutcomes measure: Number of adverse device effects, secondaryOutcomes measure: ADAS, secondaryOutcomes measure: Mini Mental State Examination (MMSE) baseline and follow- up, secondaryOutcomes measure: BDI-II, secondaryOutcomes measure: Clinical Dementia Rating Sum of Boxes Score (CDR-SB), secondaryOutcomes measure: Alzheimer's Disease Cooperative Study/ Activities of Daily Living Scale (ADCS-ADL), otherOutcomes measure: Numeric Rating Scale (NRS) for the main symptom, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06313931, orgStudyIdInfo id: UTI-IIDI-074-2023, briefTitle: Effects of Cognitive-motor Training on Cognition, Depression and Daily Functioning in Patients With Mild Cognitive Impairment (MCI), statusModule overallStatus: COMPLETED, startDateStruct date: 2023-07-03, primaryCompletionDateStruct date: 2023-09-14, completionDateStruct date: 2023-09-14, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Universidad de Zaragoza, class: OTHER, descriptionModule briefSummary: This randomized controlled trial evaluated the effectiveness of an immersive virtual reality (IVR) application (focused on a daily activity) to train cognitive functions and its impact on depression and the ability to perform activities of daily living (ADL) in patients with mild cognitive impairment (MCI). With a dose of two sessions per week during six weeks, the study showed significant improvements in cognitive functions and reduction in depression, with notable effects in the experimental group. This underscores the potential of IVR as a valuable tool in the management of MCI., conditionsModule conditions: Mild Cognitive Impairment, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 26, type: ACTUAL, armsInterventionsModule interventions name: cognitive training via immersive virtual reality, interventions name: cognitive training via paper and pencil, interventions name: motor stimulation, outcomesModule primaryOutcomes measure: Spanish version of the Montreal Cognitive Assessment (MoCA-S), primaryOutcomes measure: Short Geriatric Depression Scale (SGDS-S), primaryOutcomes measure: Instrumental Activities of Daily Living Scale (IADL-S), eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Zaragoza, city: Teruel, zip: 44003, country: Spain, geoPoint lat: 40.3456, lon: -1.10646, hasResults: False
protocolSection identificationModule nctId: NCT06313905, orgStudyIdInfo id: DRYLESS1, secondaryIdInfos id: CHU La Rabta, type: OTHER, domain: La Rabta hospital, briefTitle: EVADRY® in the Treatment of Xerostomia in Sjögren's Syndrome, acronym: DRYLESS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: University Tunis El Manar, class: OTHER, descriptionModule briefSummary: Xerostomia is a common and very bothersome manifestation that impairs the quality of life in Sjogren's syndrome. Symptomatic therapeutic alternatives for this syndrome are limited in Tunisia. We resort to bromhexine off-label with low efficacy. The aim of this work is to demonstrate the superiority of a treatment based on dietary supplements (EVADRY) vs placebo in the treatment of xerostomia. This is a double-blind randomized clinical trial with 2 arms: an EVADRY arm (n=90) and a placebo arm (n=90). The primary outcome measure is a 35% increase in salivary flow after 3 months. Secondary outcome measures were based on the Oral Health Impact Profile questionnaire, Xerostomia Inventory, the HAD depression scale, and the buccal Schirmer test., conditionsModule conditions: Sjogren's Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: double-blind randomized study, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 180, type: ESTIMATED, armsInterventionsModule interventions name: EVADRY, interventions name: Placebo, outcomesModule primaryOutcomes measure: salivary flow rate (SFR), secondaryOutcomes measure: Xerostomia Inventory in French version, secondaryOutcomes measure: Oral Health-related quality of life (OHIP-14) questionnaire, secondaryOutcomes measure: Hospital anxiety and depression (HAD) scale, secondaryOutcomes measure: Buccal Schirmer test, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False