hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06358469, orgStudyIdInfo id: VU2, briefTitle: STRatIfication of Vulvar SCC by HPV and p53 Status to Guide Excision, acronym: STRIVE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-30, primaryCompletionDateStruct date: 2030-06-30, completionDateStruct date: 2031-11-30, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Canadian Cancer Trials Group, class: NETWORK, collaborators name: Australia New Zealand Gynaecological Oncology Group, descriptionModule briefSummary: This study is being done to answer the following question: Are there types of early-stage vulvar cancer that require either less or more treatment than the usual approach?, conditionsModule conditions: Vulvar Squamous Cell Carcinoma, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 249, type: ESTIMATED, armsInterventionsModule interventions name: Surgery, interventions name: Active Surveillance, outcomesModule primaryOutcomes measure: Estimate the 3-year local recurrence rates in patients with HPV-Independent (HPV-I) and HPV-Associated (HPV-A) vulvar squamous cell carcinoma (VSCC) surgically managed based on dVIN/p53 status and tumour margin clearance, secondaryOutcomes measure: HPV-I and HPV-A VSCC cohorts: Recurrence-free survival, secondaryOutcomes measure: HPV-I and HPV-A VSCC cohorts: Disease-specific survival, secondaryOutcomes measure: HPV-I and HPV-A VSCC cohorts: Overall-survival, secondaryOutcomes measure: HPV-I and HPV-A VSCC cohorts: Estimate health economic impact of surgical management based on molecular biomarker stratification and margin status assessment utilizing EQ-5D-5L, secondaryOutcomes measure: HPV-I and HPV-A VSCC cohorts: Describe patient-reported outcomes utilizing EORTC QLQ-C30, secondaryOutcomes measure: HPV-I and HPV-A VSCC cohorts: Describe patient-reported outcomes utilizing EORTC QLQ-VU34, secondaryOutcomes measure: HPV-I and HPV-A VSCC cohorts: Describe patient-reported outcomes utilizing Fear of Recurrence Scale, secondaryOutcomes measure: HPV-I cohort: Estimate recurrence rates of vulvar dVIN and/or p53abn, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06358456, orgStudyIdInfo id: 20-928, briefTitle: Influence of Artificial Tears on Keratometry and Biometry Measurements With Different Devices, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-11-20, primaryCompletionDateStruct date: 2022-04-22, completionDateStruct date: 2022-04-22, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: University Clinic Frankfurt, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to learn about the influence of artificial tears on measurements of healthy eyes with three different devices. The main questions it aims to answer are:* Do artificial tears alter the measurements of the corneal surface* Is there a difference between the devices used in this studyThis is relevant because high quality measurements improve the postoperative outcome after cataract surgery., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: one arm for each diagnostic device (three in total), primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, maskingDescription: The investigator and patient knew which device they were tested on, enrollmentInfo count: 145, type: ACTUAL, armsInterventionsModule interventions name: Artificial tear, interventions name: No artificial tears, outcomesModule primaryOutcomes measure: Does the application of artificial tears (Artelac EDO) alter the measurement of the anterior surface of the cornea (K mean in Diopters) using devices that either use keratometry or Scheimpflug-technology (IOL Master 700, Pentacam AXL or Galilei G6), secondaryOutcomes measure: Is there any difference in anterior corneal refractive power measurements (K mean in Diopters) between the three different devices (IOL Master 700, Pentacam AXL, Galilei G6) after artificial tear (Artelac EDO) application?, secondaryOutcomes measure: Does the application of artificial tears (Artelac EDO) alter the anterior astigmatism measurements (in diopters) using devices that either use keratometry or Scheimpflug-technology (IOL Master 700, Pentacam AXL or Galilei G6), secondaryOutcomes measure: If there is an influence of artificial tears (Artelac EDO) on the measurement of the anterior surface of the cornea (K mean in Diopters) using the devices (IOL Master 700, Pentacam AXL or Galilei G6), how long does it last (in minutes)?, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Goethe University Hospital, city: Frankfurt, state: Hesse, zip: 60590, country: Germany, geoPoint lat: 50.11552, lon: 8.68417, hasResults: False
protocolSection identificationModule nctId: NCT06358443, orgStudyIdInfo id: PF-Jarlsberg/IIIB, briefTitle: The Long-term Effect of Daily Jarlsberg Cheese Intake in Patient With Osteopenia, acronym: PF-JB3, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-02, primaryCompletionDateStruct date: 2024-10-18, completionDateStruct date: 2025-02-23, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Meddoc, class: OTHER, collaborators name: Tine, descriptionModule briefSummary: Aim: To estimate the effect of daily optimal efficacy dose (OED) of Jarlsberg cheese in patients with Osteopeni (OP).Study population: Post-menopausal women and men above 55 years of age in risk of Osteoporosis Treatment: Daily OED Jarlsberg cheese + vitamin D and Calcium tablets. Design: An open and one-armed observational study. Main variables: Bone Mineral Density (BMD), Bone turnover markers (BTMs), Osteocalcin and K2 vitameres.Study Procedure: Prior to inclusion in this study, all the patients have undergone 32 days of daily OED intake of Jarlsberg cheese + vitamin D and caicium tablets. Thid is the baseline of this observational study. The duration of this study is 12 months with clinical examination and bloodsampling after 6 and 12 months.Sample size: At least 16 patients will be included, conditionsModule conditions: Osteoporosis, conditions: Osteopenia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: One armed observational study, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Jarlsberg cheese, outcomesModule primaryOutcomes measure: Bone Mineral Density, primaryOutcomes measure: Bone Turnover Markers, primaryOutcomes measure: Osteocalcin, secondaryOutcomes measure: Vitamin K2, eligibilityModule sex: ALL, maximumAge: 80 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06358430, orgStudyIdInfo id: 2023-1017, secondaryIdInfos id: NCI-2024-03107, type: OTHER, domain: NCI-CTRP Clinical Registry, briefTitle: Phase 1 Dose Escalation and Expansion Study of TROP2 CAR Engineered IL-15- Transduced Cord Blood-derived NK Cells in Combination With Cetuximab in Patient With Colorectal Cancer (CRC) With Minimal Residual Disease (MRD), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-10-31, primaryCompletionDateStruct date: 2027-01-18, completionDateStruct date: 2029-01-18, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: M.D. Anderson Cancer Center, class: OTHER, collaborators name: Bellicum Pharmaceuticals, Inc., descriptionModule briefSummary: To find the highest and/or recommended dose of TROP2-CAR-NK cells combined with cetuximab in participants with MRD CRC., conditionsModule conditions: Colorectal Cancer, conditions: Minimal Residual Disease, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 42, type: ESTIMATED, armsInterventionsModule interventions name: Fludarabine Phosphate, interventions name: Cyclophosphamide, interventions name: Cetuximab, interventions name: TROP2-CAR-NK Cells, interventions name: Rimiducid (AP1903), interventions name: Lymphodepleting Chemotherapy, outcomesModule primaryOutcomes measure: Safety and adverse events (AEs), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: MD Anderson Cancer Center, city: Houston, state: Texas, zip: 77030, country: United States, contacts name: Maria Pia Morelli, MD, PhD, role: CONTACT, phone: 713-745-1297, contacts name: Maria Pia Morelli, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.76328, lon: -95.36327, hasResults: False
protocolSection identificationModule nctId: NCT06358417, orgStudyIdInfo id: 2024P000873, briefTitle: CHW Intervention to Improve Nutrition Security of Patients With Hypertension, acronym: HeartWell, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08-01, primaryCompletionDateStruct date: 2027-01-31, completionDateStruct date: 2027-05-01, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Massachusetts General Hospital, class: OTHER, descriptionModule briefSummary: The goal of this study is to implement and evaluate a randomized pilot study of a 4-month Nutrition-enhanced community health worker (CHW) intervention for primary care patients with nutrition insecurity and poorly controlled hypertension. The nutrition intervention will be added to the pre-existing Massachusetts General Hospital CHW hypertension (Basic CHW) program that provides hypertension education, coaching about adherence to medications and primary care visits, and home BP cuffs and promotion of BP self-monitoring over the course of approximately 4 months., conditionsModule conditions: Hypertension, conditions: Nutrition, Healthy, conditions: Food Insecurity, conditions: Community Health Worker, designModule studyType: INTERVENTIONAL, phases: PHASE2, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Nutrition-enhanced CHW, interventions name: Basic CHW, outcomesModule primaryOutcomes measure: Feasiblity, primaryOutcomes measure: Feasibility of CHW nutrition intervention (intervention arm only), primaryOutcomes measure: Acceptability (intervention arm only), secondaryOutcomes measure: Diet quality, secondaryOutcomes measure: Blood pressure, eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06358404, orgStudyIdInfo id: 2024P000615, briefTitle: Developing a Peer Support Intervention for Depression in SCD, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-04-30, completionDateStruct date: 2026-04-30, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Massachusetts General Hospital, class: OTHER, collaborators name: National Institutes of Health (NIH), descriptionModule briefSummary: The purpose of this study is to assess the feasibility, acceptability, and fidelity of an 8-week intervention where peer coaches will deliver depression care to adults 60 years of age or older who have depression and subjective cognitive decline., conditionsModule conditions: Subjective Cognitive Decline, conditions: Depression in Old Age, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: PeersCOG, outcomesModule primaryOutcomes measure: Feasibility of Intervention, primaryOutcomes measure: Acceptability of Intervention, primaryOutcomes measure: Fidelity of Intervention, eligibilityModule sex: ALL, minimumAge: 60 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
protocolSection identificationModule nctId: NCT06358391, orgStudyIdInfo id: TS-RF system, briefTitle: To Compare and Evaluate the Efficacy and Safety Between TS-RF System and BRK Transseptal Needles Used for Transseptal Puncture for Left Atrial Access., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-03-31, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Starmed, class: INDUSTRY, collaborators name: Helptrial, descriptionModule briefSummary: The purpose of this study is to compare and assess efficacy and safety between the study device "TS-RF system consisting of a electrosurgical system, general-purpose (TS-RF Generator) and a electrosurgical system electrode, hand-controlled, general-purpose, single-use (TS-RF Needle)" and the control device "needle, puncture, single-use (BRK Transseptal needle)", both of which are used for the transseptal puncture performed to enable left atrial access for the treatment of symptomatic arrhythmia and mitral stenosis and then to demonstrate that the study device is non-inferior to the control device., conditionsModule conditions: Arrhythmias, Cardiac, conditions: Atrial Fibrillation, conditions: Heart Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule interventions name: TS-RF Transseptal Needle, interventions name: BRK Transseptal Needle, outcomesModule primaryOutcomes measure: First-pass TSP Success Rate (percent), secondaryOutcomes measure: TSP Time (Second), secondaryOutcomes measure: Fluoroscopy Time (Second) for TSP, secondaryOutcomes measure: Needle cross-over between the study and control groups, secondaryOutcomes measure: Intra-TSP procedural device-associated complications, secondaryOutcomes measure: Changes in patient's quality of life, secondaryOutcomes measure: Complications, otherOutcomes measure: Intra-TSP procedural Adverse Events, otherOutcomes measure: Overall Adverse Events, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06358365, orgStudyIdInfo id: AQP-DCL-026, briefTitle: Enhancing Fluid Transfer Through the Skin, by Increased Sweat Rate, on Hemodialysis Patients, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-03-29, primaryCompletionDateStruct date: 2023-11-02, completionDateStruct date: 2023-11-07, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: AquaPass Medical Ltd., class: INDUSTRY, descriptionModule briefSummary: To demonstrate safety and performance of AquaPass System for improving fluid balance in hemo-dialysis patients, by increasing fluid loss via the skin., conditionsModule conditions: Acute Kidney Failure, conditions: Chronic Kidney Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 5, type: ACTUAL, armsInterventionsModule interventions name: The AquaPass System, outcomesModule primaryOutcomes measure: Differences in weight gain over the long interdialytic period, primaryOutcomes measure: Device related Adverse Events, secondaryOutcomes measure: Changes in NT-proBNP, secondaryOutcomes measure: Changes in Blood Urea Nitrogen, secondaryOutcomes measure: Effect on Quality of Life, secondaryOutcomes measure: Affect on Ultrafiltration Rates after the long inter dialytic gap, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Nazareth Hospital EMMS, city: Nazareth, state: Al Wadi Al Jawani 1611, zip: 16100, country: Israel, geoPoint lat: 32.69925, lon: 35.30483, hasResults: False
protocolSection identificationModule nctId: NCT06358326, orgStudyIdInfo id: Karabuk-1, briefTitle: Dry Needling and Rehabilitatin Carpal Tunnel Syndrome, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-05, primaryCompletionDateStruct date: 2024-08-30, completionDateStruct date: 2024-09-30, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Karabuk University, class: OTHER, descriptionModule briefSummary: Dry needling is used for myofascial release. However, its effectiveness in carpal tunnel syndrome (CTS) is not well known. It is thought that dry needling may also be an effective treatment for CTS by providing relaxation in the fascial tissue. Therefore, this study will examine the effects of dry needling treatment on pain, function, range of motion, proprioception and disability in patients with CTS., conditionsModule conditions: Dry Needling, conditions: Carpal Tunnel Syndrome, conditions: Myofacial Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Parallel Assignment, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: Triple-blind study; the patients will not be informed about their groups (training group or the control group) and they will be evaluated and trained at different places and times., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Dry needling, interventions name: Control group, outcomesModule primaryOutcomes measure: Pain severity, primaryOutcomes measure: Wrist range of motion, primaryOutcomes measure: Position sense, primaryOutcomes measure: Severity of symptoms, primaryOutcomes measure: Functional status, primaryOutcomes measure: Hands activity level, primaryOutcomes measure: neuropathic pain severity, primaryOutcomes measure: Nerve cross-sectional area, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Pursaklar State Hospital, status: RECRUITING, city: Ankara, country: Turkey, contacts name: Fidan Yılmaz, Msc, role: CONTACT, phone: 0551 207 2954, email: fdnylmz07@gmail.com, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False
protocolSection identificationModule nctId: NCT06358300, orgStudyIdInfo id: Usakpcos2, briefTitle: Visceral Adiposity Index Differences Between Subtypes of Polycystic Ovary Syndrome, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-01-01, primaryCompletionDateStruct date: 2022-09-01, completionDateStruct date: 2023-07-20, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Uşak University, class: OTHER, descriptionModule briefSummary: We aimed to investigate visceral adiposity index (VAI) in patients with different phenotype of policystic ovary syndrome (PCOS) and to compare healthy controls., conditionsModule conditions: Visceral Adiposity Index, conditions: Polycystic Ovary Syndrome, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 300, type: ACTUAL, armsInterventionsModule, outcomesModule primaryOutcomes measure: Visceral Adiposity Index Differences Between Subtypes of Polycystic Ovary Syndrome, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: Usak Training and Research Hospital, city: Usak, zip: 64100, country: Turkey, geoPoint lat: 38.67351, lon: 29.4058, hasResults: False
protocolSection identificationModule nctId: NCT06358287, orgStudyIdInfo id: STUDY19030375, briefTitle: Neural Correlates of Auriculotherapy, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-07-15, primaryCompletionDateStruct date: 2022-11-07, completionDateStruct date: 2022-11-07, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Keith M. Vogt, MD, PhD, class: OTHER, descriptionModule briefSummary: Chronic pain continues to be a major health issue, creating a significant societal burden, as it is an independent risk factor for opioid use disorder (OUD) and deaths. Acute pain episodes can often engender OUD due to lack of effective strategies to treat pain and prevent the transition to chronic pain. One potential non-opioid method for pain relief is auriculotherapy (AT), where acupuncture-like treatment is administered to the ear. The objective of this pilot study is to illustrate that AT-related brain effects can be found using functional connectivity MRI (fcMRI) in patients with low back pain., conditionsModule conditions: Chronic Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ACTUAL, armsInterventionsModule interventions name: cryogenic auriculotherapy, outcomesModule primaryOutcomes measure: Default Mode Network (DMN)-to-Anterior Cingulate Cortex (ACC) connectivity, secondaryOutcomes measure: Brief Pain Inventory (BPI) Severity Scores MRI #1, secondaryOutcomes measure: BPI Pain Severity Scores MRI #2, secondaryOutcomes measure: General Anxiety Disorder-7 (GAD-7) Scoring, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UPMC Montefiore, city: Pittsburgh, state: Pennsylvania, zip: 15213, country: United States, geoPoint lat: 40.44062, lon: -79.99589, hasResults: False