hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06376604, orgStudyIdInfo id: LNT55, briefTitle: Fasting Mimicking Diet in Chemotherapy of Gynecologic Malignancies, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-09-08, primaryCompletionDateStruct date: 2025-09-01, completionDateStruct date: 2025-12-30, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: L-Nutra Inc, class: INDUSTRY, collaborators name: University of Tennessee Medical Center, descriptionModule briefSummary: This study evaluates how lifestyle modifications that may be made to manage chemotherapy side effects in patients with gynecologic malignancies., conditionsModule conditions: Cancer, Ovarian, conditions: Chemotherapy Effect, conditions: Calorie Deficiency, conditions: Fasting, Intermittent, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, maskingDescription: Outcomes Assessor, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Fasting Mimicking Diet, interventions name: Chemotherapy, outcomesModule primaryOutcomes measure: Quality of life by National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy Ovarian Cancer Symptom Index (NFOSI-18) questionnaire, primaryOutcomes measure: Rate of Adherence, secondaryOutcomes measure: Change in Body Weight, secondaryOutcomes measure: Change in Body Composition, secondaryOutcomes measure: Change in HbA1c, secondaryOutcomes measure: Change in Insulin Like Growth Factor 1 (IGF-1) Concentration, secondaryOutcomes measure: Change in Fasting Insulin Concentration, secondaryOutcomes measure: Change in Fasting Glucose Concentration, secondaryOutcomes measure: Change in High-sensitivity C reactive protein Concentration, secondaryOutcomes measure: Change in Leptin Concentration, secondaryOutcomes measure: Change in planned chemotherapy regimen, secondaryOutcomes measure: Number of Hospitalization Days, secondaryOutcomes measure: Rate of Chemotherapy Side Effects, eligibilityModule sex: FEMALE, minimumAge: 35 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The University of Tennessee Medical Center, status: RECRUITING, city: Knoxville, state: Tennessee, zip: 37920, country: United States, contacts name: Jonathan D Boone, MD, role: CONTACT, phone: 865-305-5622, email: jboone@utmck.edu, geoPoint lat: 35.96064, lon: -83.92074, hasResults: False
protocolSection identificationModule nctId: NCT06376591, orgStudyIdInfo id: LUMHS/B12/Temp/12.04.2024, briefTitle: Assessing the Efficacy of Different Carrier Systems in Oral Vitamin B12 Supplementation in Healthy Adults With B12 Deficiency, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-22, primaryCompletionDateStruct date: 2024-07-31, completionDateStruct date: 2024-08-31, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Liaquat University of Medical & Health Sciences, class: OTHER, descriptionModule briefSummary: Vitamin B12, a vital nutrient, plays a crucial role in red blood cell formation, neurological function, and DNA synthesis. Deficiency in B12 can lead to anemia, neurological symptoms such as tingling or numbness, and cognitive impairment. Oral B12 supplementation serves as an effective strategy to address B12 deficiency, especially for individuals with limited dietary intake or absorption issues. Regular B12 supplementation can help restore body B12 levels, alleviate deficiency-related symptoms, and support overall health and well-being., conditionsModule conditions: Vitamin B 12 Deficiency, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Oral Vitamin B12 supplement, interventions name: Control group, outcomesModule primaryOutcomes measure: Supplementation effect on circulatory vitamin B12 levels, secondaryOutcomes measure: Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability), secondaryOutcomes measure: Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability), secondaryOutcomes measure: Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Liaquat University of Medical and Health Sciences, city: Jamshoro, zip: 76090, country: Pakistan, contacts name: Dr. Ikram Ujjan, MBBS, PhD, role: CONTACT, phone: 03000506955, email: ikramujjan@lumhs.edu.pk, geoPoint lat: 25.43773, lon: 68.28522, hasResults: False
protocolSection identificationModule nctId: NCT06376578, orgStudyIdInfo id: 245256, briefTitle: Exercise Interventions for Improving Health in Breast Cancer Survivors, statusModule overallStatus: COMPLETED, startDateStruct date: 2018-09-05, primaryCompletionDateStruct date: 2020-01-30, completionDateStruct date: 2020-01-30, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: University of Bath, class: OTHER, descriptionModule briefSummary: Supervised, prescribed exercise has positive effects on body composition, physical functioning, psychological wellbeing and quality of life for patients after breast cancer treatment. However, exercise interventions are often time consuming, commonly take place at a health or fitness facility, and usually require a trained professional to be present. Cost-effective, enjoyable and practical approaches, that can be adopted at home or in local surroundings are needed. For example, an alternative approach is using an electronic physical activity tracking wristwatch to help patients engage with exercise or physical activity. Research demonstrates the importance of structured and supervised exercise for breast cancer survivors. However, it is not known whether other approaches (e.g. home-based exercise and physical activity) alongside the use of personalised technology-enabled feedback, can cause similar improvements to health when compared to structured exercise. The overall aim of this study is to determine whether cardiorespiratory fitness is changed by a technology enabled, remotely delivered exercise intervention and to determine whether this change is similar to the change caused by a partly supervised, prescribed exercise intervention. This study will also determine the influence of both interventions on physical functioning, body composition and blood pressure., conditionsModule conditions: Breast Cancer Female, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 30, type: ACTUAL, armsInterventionsModule interventions name: Exercise intervention, interventions name: Polar A380 wristwatch physical activity tracker, outcomesModule primaryOutcomes measure: Change in VO2max (maximum oxygen uptake), secondaryOutcomes measure: Change in Body composition, otherOutcomes measure: Change in physical functioning, otherOutcomes measure: Change in Psychological measures, otherOutcomes measure: Change in immune profiles and function, eligibilityModule sex: FEMALE, minimumAge: 35 Years, maximumAge: 69 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Bath, city: Bath, zip: BA2 7AY, country: United Kingdom, geoPoint lat: 51.3751, lon: -2.36172, hasResults: False
protocolSection identificationModule nctId: NCT06376565, orgStudyIdInfo id: 22-000647, secondaryIdInfos id: NCI-2024-02090, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: R01CA271034, type: NIH, link: https://reporter.nih.gov/quickSearch/R01CA271034, briefTitle: Improving Colonoscopy Surveillance for Patients With High Risk Colon Polyps, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-05, primaryCompletionDateStruct date: 2027-03-31, completionDateStruct date: 2028-03, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Jonsson Comprehensive Cancer Center, class: OTHER, collaborators name: National Cancer Institute (NCI), descriptionModule briefSummary: This clinical trial tests a multilevel intervention at the clinic, provider and patient levels, to improve colonoscopy surveillance in patients with high risk colon polyps. Colorectal cancer (CRC) is a common and deadly disease that is largely preventable through the detection and removal of colorectal polyps. One million Americans are diagnosed with high risk polyps of the colon or rectum annually and are at increased risk for CRC; however, uptake of recommended repeat colonoscopy in 3 years to reduce CRC risk is low in this group. This multilevel intervention may work to improve timely colonoscopy screening for patients with high risk colon polyps., conditionsModule conditions: Colorectal Carcinoma, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SCREENING, maskingInfo masking: NONE, enrollmentInfo count: 1680, type: ESTIMATED, armsInterventionsModule interventions name: Best Practice, interventions name: Communication Intervention, interventions name: Communication Intervention, interventions name: Communication Intervention, interventions name: Interview, interventions name: Interview, outcomesModule primaryOutcomes measure: Stakeholder perspectives on the multilevel intervention (Aim 1), primaryOutcomes measure: Completion of surveillance colonoscopy (Aim 2), primaryOutcomes measure: Implementation quality (Aim 3a), primaryOutcomes measure: Cost effectiveness (Aim 3b), secondaryOutcomes measure: Time from high risk neoplasia (HRN) diagnosis to colonoscopy (Aim 2), eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UCLA / Jonsson Comprehensive Cancer Center, city: Los Angeles, state: California, zip: 90095, country: United States, contacts name: Folasade P. May, role: CONTACT, phone: 617-620-7806, email: FMAY@MEDNET.UCLA.EDU, contacts name: Folasade P. May, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.05223, lon: -118.24368, hasResults: False
protocolSection identificationModule nctId: NCT06376552, orgStudyIdInfo id: AI4Cardio, briefTitle: Artificial Intelligence for the Prioritization of Genetic Background in Brugada Syndrome, acronym: AI4Cardio, statusModule overallStatus: COMPLETED, startDateStruct date: 2018-12-19, primaryCompletionDateStruct date: 2022-06-06, completionDateStruct date: 2022-06-06, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: IRCCS San Raffaele, class: OTHER, descriptionModule briefSummary: Brugada Syndrome (BS) is an inherited heart condition that can cause sudden cardiac arrest in young individuals. It's diagnosed through specific changes seen on an electrocardiogram (ECG). Currently, the only treatment option is a cardioverter defibrillator (ICD). Despite advances, much about BS remains unclear, including its genetic basis. This study aims to use advanced genetic sequencing and artificial intelligence to uncover new genetic factors contributing to BS. By understanding these factors better, we hope to improve risk assessment and treatment for affected individuals., conditionsModule conditions: Brugada Syndrome, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 200, type: ACTUAL, armsInterventionsModule, outcomesModule primaryOutcomes measure: New candidate genes, likely associated with Brugada Syndrome using an AI based approach., secondaryOutcomes measure: Identification of genetic risk factors associated with the worse phenotype., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS San Raffaele, city: Milan, zip: 20132, country: Italy, geoPoint lat: 45.46427, lon: 9.18951, locations facility: Milano-Bicocca University, city: Milan, country: Italy, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
protocolSection identificationModule nctId: NCT06376539, orgStudyIdInfo id: CEAVEC: 111/2024/Oss/IOR, briefTitle: Functional Recovery of Patients Undergoing Resection and Reconstruction of the Lower Limbs for Bone Tumor., acronym: FISIO-ONCO, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2024-05, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Istituto Ortopedico Rizzoli, class: OTHER, descriptionModule briefSummary: The aim of the present study is to describe the course of functional recovery of patients with musculoskeletal tumours and undergone resection and reconstruction operations of lower limbs in the first six months post-surgery, differentiating them on the basis of the anatomical level involved., conditionsModule conditions: Bone Neoplasm, conditions: Rehabilitation, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, outcomesModule primaryOutcomes measure: Toronto Extremity Salvage Score (TESS), primaryOutcomes measure: Toronto Extremity Salvage Score (TESS), secondaryOutcomes measure: Range of motion (ROM), secondaryOutcomes measure: Rang of motion - 2 (ROM), secondaryOutcomes measure: Number of participants able to walk, secondaryOutcomes measure: Time Up and Go -2 (TUG), secondaryOutcomes measure: Time Up and Go (TUG), secondaryOutcomes measure: Muscle Strength, secondaryOutcomes measure: Muscle Strength-2, secondaryOutcomes measure: Number of day from surgery to first walking, eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 70 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06376526, orgStudyIdInfo id: 20230236, briefTitle: IMMUNOPLANT for Newly Diagnosed Multiple Myeloma, acronym: IMMUNOPLANT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-30, primaryCompletionDateStruct date: 2027-06-30, completionDateStruct date: 2029-06-30, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Dickran Kazandjian, MD, class: OTHER, collaborators name: Regeneron Pharmaceuticals, descriptionModule briefSummary: The purpose of this study is to determine whether Linvoseltamab therapy in patients with newly diagnosed multiple myeloma will convert the disease status from minimal residual disease (MRD)-positive to MRD-negative, and increase the length of time that the disease is controlled. The researchers also want to find out the effects (good and bad) that Linvoseltamab has on participants and the condition., conditionsModule conditions: Multiple Myeloma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 28, type: ESTIMATED, armsInterventionsModule interventions name: Linvoseltamab, outcomesModule primaryOutcomes measure: Minimal Residual Disease (MRD) Negativity Rate, secondaryOutcomes measure: Sustained MRD-Negativity Rate, secondaryOutcomes measure: Progression-Free Survival (PFS), secondaryOutcomes measure: Overall Survival, secondaryOutcomes measure: Number of Participants Experiencing Treatment-Related Adverse Events, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Miami, city: Miami, state: Florida, zip: 33136, country: United States, contacts name: Dickran Kazandjian, MD, role: CONTACT, phone: 305-243-5001, email: dkazandjian@miami.edu, contacts name: Dickran Kazandjian, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 25.77427, lon: -80.19366, hasResults: False
protocolSection identificationModule nctId: NCT06376474, orgStudyIdInfo id: HM005PS1S06, briefTitle: To Evaluate the Pharmacokinetics of Hemay005 Tablets in Subjects With Liver Damage, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Ganzhou Hemay Pharmaceutical Co., Ltd, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study was to evaluate the pharmacokinetics of Hemay 005 tablets in subjects with mild, moderate liver impairment and normal liver function, and to provide a basis for the formulation of clinical medication regimens for patients with liver impairment., conditionsModule conditions: Psoriasis, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Hemay005, outcomesModule primaryOutcomes measure: Relevant pharmacokinetic parameters，Peak Plasma Concentration（Cmax）, primaryOutcomes measure: Relevant pharmacokinetic parameters，Area under the plasma concentration versus time curve（AUC0-t）, primaryOutcomes measure: Relevant pharmacokinetic parameters，Area under the curve from time 0 extrapolated to infinite time (AUC0-inf), primaryOutcomes measure: Relevant pharmacokinetic parameters，half-life (T1/2), primaryOutcomes measure: Relevant pharmacokinetic parameters，clearance (CL/F), primaryOutcomes measure: Relevant pharmacokinetic parameters，volume of distribution (Vz/F), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06376448, orgStudyIdInfo id: cc-obs-01, briefTitle: An Observational Study Using Novel Questionnaire to Characterize Cough Phenotypes in Patients With Chronic Cough, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-10-24, primaryCompletionDateStruct date: 2024-10-04, completionDateStruct date: 2025-02-10, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Hull University Teaching Hospitals NHS Trust, class: OTHER_GOV, descriptionModule briefSummary: Cough has previously been described by the type of cough you have ie such as wet, dry, and chesty, and also by its features such as how often you are coughing its,intensity, and severity, but never has the varying patterns of cough been studied in any detail and it could be that the pattern of the cough is closely related to patient-perceived intensity, frequency and most importantly severity. Cough is a symptom and like any other symptom (such as pain) the severity of it can only be gauged by the patient experiencing it.We have created a one-page brand newl questionnaire that shows 4 distinct cough patterns that we believe exist and an empty field designed so that patients can record a pattern of cough they experience which is not already a choice on the questionnaire. The questionnaire also records patients' experience of how frequent, and intense, the cough is, and how it disrupts their lives, on a 1-10 scale (Visual analogue scale), the sum of these scores is collated and this gives us a severity score. The first phase of the project is to determine whether 30 Chronic cough patients understand the questionnaire, and are able to complete it with little direction, and if the cough patterns we identified encompassed all pattern types. second part of the study is to look at how repeatable the questionnaire is when completed over a 6 week period., conditionsModule conditions: Chronic Cough, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 60, type: ESTIMATED, outcomesModule primaryOutcomes measure: The primary objective of the study is to characterize and identify the different patterns of cough in chronic cough patients, secondaryOutcomes measure: measure of cough severity, secondaryOutcomes measure: describe any correlation between severity of cough and cough pattern, secondaryOutcomes measure: reproducibility of questionnnare, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Redspiratory Medicine, First Floor, Daisy Building, Castle Hill Hospital, status: RECRUITING, city: Cottingham, state: East Yorkshiure, zip: HU16 5JQ, country: United Kingdom, contacts name: Caroline Wright, role: CONTACT, phone: 01482624067, email: c.wright@hull.ac.uk, contacts name: Rachel H Thompson, Bsc, role: CONTACT, phone: 01482 461800, phoneExt: Thompson, email: r.h.thompson@hull.ac.uk, contacts name: Caroline Wright, Bsc, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 52.50243, lon: -0.7554, hasResults: False
protocolSection identificationModule nctId: NCT06376435, orgStudyIdInfo id: HBHQ-CTIT-RWS, briefTitle: A Multicentre Real-world Study of Heptapopal Ethanolamine Tablets in Concurrent/Sequential Radioimmunoinduced Thrombocytopenia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-20, primaryCompletionDateStruct date: 2026-07-01, completionDateStruct date: 2026-07-01, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Hebei Medical University Fourth Hospital, class: OTHER, descriptionModule briefSummary: The objective of this study was to observe and evaluate the efficacy and safety of hexapopal ethanolamine tablets in the treatment of synchronous/sequential radioimmunoinduced thrombocytopenia in the real world.The subjects of this study were patients with solid malignant tumors who had received radioimmunoinduced thrombocytopenia.This study will retrospectively and prospectively collect real-world data related to investigational drugs, and will observe 500 patients to observe the diagnosis and treatment pattern of radiochemo-induced thrombocytopenia. The study included a screening period (no more than one week) and a treatment period (at least two cycles).Participants meeting protocol inclusion criteria were defined as having platelet values \< 100×109/L during radioimmunotherapy., conditionsModule conditions: Cancer, Therapy-Related, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: Herombopag Olamine Tablets, outcomesModule primaryOutcomes measure: The proportion of patients recovered to 100×109/L, secondaryOutcomes measure: The proportion of patients recovered to 75×109/L, secondaryOutcomes measure: Time for platelet recovery to 100×109/L, secondaryOutcomes measure: Proportion of patients with treatment delay or dose reduction, secondaryOutcomes measure: TRAE, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False