hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06363682, orgStudyIdInfo id: 2023PI225, briefTitle: Interventional Reference Levels (IRL) in Digestive Endoscopy, acronym: EndoscopX, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-06-11, completionDateStruct date: 2024-06-11, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Central Hospital, Nancy, France, class: OTHER, descriptionModule briefSummary: Scopy uses X-rays and is not without risk (deterministic and stochastic effects) for the patient and the nursing staff present in the room at the time of an endoscopic procedure requiring its use: its use must be reasoned with a benefit/risk balance in favour of carrying out the interventional procedure. In France, there is currently no multicentre study exploring the radiation doses used for each type of endoscopic procedure.Main objective: To define IRL (interventional reference levels) adapted to each type of endoscopic procedure.Secondary objective(s) :* Application of regulatory texts* Assessment of patient radiation protection* Radiation protection assessment for workers, conditionsModule conditions: Each Endoscopic Intervention Using X-rays, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 1000, type: ESTIMATED, armsInterventionsModule interventions name: ERCP, interventions name: endoscopic ultrasound, interventions name: gastroscopy, interventions name: Colonoscopy, interventions name: placement of a nasojejunal tube, outcomesModule primaryOutcomes measure: To define IRL (interventional reference levels) adapted to each type of endoscopic procedure., secondaryOutcomes measure: Application of regulatory texts, secondaryOutcomes measure: Assessment of patient radiation protection, secondaryOutcomes measure: Radiation protection assessment for workers, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital University of Nancy, city: Nancy, state: Meurthe-et-Moselle, zip: 54000, country: France, contacts name: MUNIER W Munier Wendy, role: CONTACT, phone: +3383155457, email: w.munier@chru-nancy.fr, contacts name: CHEVAUX JB Doctor CHEVAUX Jean-Baptiste, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.68439, lon: 6.18496, hasResults: False
protocolSection identificationModule nctId: NCT06363669, orgStudyIdInfo id: 1_CAF_AWF, briefTitle: Effects of Caffeine-based Supplement on Physical Performance, statusModule overallStatus: COMPLETED, startDateStruct date: 2018-01-15, primaryCompletionDateStruct date: 2024-03-30, completionDateStruct date: 2024-03-30, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: University School of Physical Education, Krakow, Poland, class: OTHER, descriptionModule briefSummary: The aim of the study was to determine the acute effects of multi-ingredient pre-workout supple-ment (MIPS) containing: beta-alanine, taurine, caffeine, L-tyrosine, and cayenne pepper (capsaicin) on physical performance in untrained men, conditionsModule conditions: Muscle Power, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: DIAGNOSTIC, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 12, type: ACTUAL, armsInterventionsModule interventions name: multi-ingredient pre-workout dietary supplement (caffeine-based), outcomesModule primaryOutcomes measure: anaerobic power, primaryOutcomes measure: aerobic power, eligibilityModule sex: MALE, minimumAge: 19 Years, maximumAge: 30 Years, stdAges: ADULT, contactsLocationsModule locations facility: University School of Physical Education in Cracow, city: Krakow, zip: 31-571, country: Poland, geoPoint lat: 50.06143, lon: 19.93658, hasResults: False
protocolSection identificationModule nctId: NCT06363656, orgStudyIdInfo id: 76455623.5.0000.0068, briefTitle: Assessment of Smartwatch SAMSUNG to Monitor Sleep Quality: an Observational Prospective Study - SleepEx2 Protocol, acronym: SLEEP-EX2, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-15, primaryCompletionDateStruct date: 2024-05-28, completionDateStruct date: 2024-07-30, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: University of Sao Paulo General Hospital, class: OTHER, collaborators name: Samsung Eletrônica da Amazônia Ltda, collaborators name: Academic Research Organization of Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da USP, descriptionModule briefSummary: The goal of this study is to learn if a smartwatch is effective to identify factors related to sleep quality and habits of adults (30 years old or more), enabling the improvement and/or creation of instruments to assess overall health status and sleep quality.The main question it aims to answer is:- Does the smartwatch application (software) indicate sleep habits and measure sleep quality in accordance to the standardized clinical instruments commonly used to assess sleep?, conditionsModule conditions: Insomnia, conditions: Sleep Initiation and Maintenance Disorders, conditions: Health Status, conditions: Wearable Electronic Devices, conditions: Sleep, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 158, type: ESTIMATED, armsInterventionsModule interventions name: Wears the smartwatch during the sleep time to capture sleep characteristics and answer questionaires, outcomesModule primaryOutcomes measure: Concordance between the smartwatch application and clinical assessment, eligibilityModule sex: ALL, minimumAge: 30 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Instituto do Coracao do Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo, status: RECRUITING, city: São Paulo, zip: 05403-900, country: Brazil, contacts name: ARO-InCor Academic Research Organization Office, role: CONTACT, phone: +55 11 2661-5795, email: aro@incor.usp.br, contacts name: Daniel Queiroz, PhD, role: CONTACT, phone: +55 11 9-4138-5473, email: daniel.queiroz@incor.usp.br, contacts name: Geraldo Lorenzi Filho, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -23.5475, lon: -46.63611, hasResults: False
protocolSection identificationModule nctId: NCT06363630, orgStudyIdInfo id: CA073-1000, briefTitle: A Study to Evaluate the Effect of Cytochrome P450 (CYP) 3A Inhibitor (Itraconazole) and Inducer (Rifampin) on the Drug Levels of Golcadomide (BMS-986369) in Healthy Participants, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-16, primaryCompletionDateStruct date: 2024-08-19, completionDateStruct date: 2024-08-19, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Celgene, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to evaluate the drug-drug interaction (DDI) potential of coadministration of itraconazole or rifampin on the single dose drug levels of golcadomide., conditionsModule conditions: Healthy Volunteers, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: Itraconazole, interventions name: Rifampin, interventions name: Golcadomide, outcomesModule primaryOutcomes measure: Maximum observed plasma concentration (Cmax), primaryOutcomes measure: Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T)), primaryOutcomes measure: Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)), secondaryOutcomes measure: Number of participants with adverse events (AEs), secondaryOutcomes measure: Number of participants with physical exam abnormalities, secondaryOutcomes measure: Number of participants with vital sign abnormalities, secondaryOutcomes measure: Number of participants with clinical laboratory safety test abnormalities, secondaryOutcomes measure: Number of participants with electrocardiogram abnormalities, secondaryOutcomes measure: Number of participants with concomitant medications, secondaryOutcomes measure: Number of participants with concomitant procedures, secondaryOutcomes measure: Time of maximum observed plasma concentration (Tmax), secondaryOutcomes measure: Apparent terminal phase half-life (T-HALF), secondaryOutcomes measure: Apparent total body clearance (CLT/F), secondaryOutcomes measure: Apparent volume of distribution (Vz/F), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Local Institution - 0001, city: Lenexa, state: Kansas, zip: 66219, country: United States, contacts name: Site 0001, role: CONTACT, geoPoint lat: 38.95362, lon: -94.73357, hasResults: False
protocolSection identificationModule nctId: NCT06363617, orgStudyIdInfo id: CSAPG-58, briefTitle: Implementation of the Fatty Liver Index in Primary Care, acronym: FLI-AP, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2025-05, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Consorci Sanitari de l'Alt Penedès i Garraf, class: OTHER, descriptionModule briefSummary: This trial aims to evaluate the impact on cardiovascular risk control in individuals in risk of being affected by hepatic steatosis through the implementation of a screening test (Fatty Liver Index) in Primary Care. Medical teams in a primary care center will be divided into 2 groups, with one group using the screening test in their clinical practice. The number of interventions on cardiovascular risk occurring in patients attended by each group of medical teams will be evaluated and compared., conditionsModule conditions: Hepatic Steatosis, conditions: Overweight and Obesity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 434, type: ESTIMATED, armsInterventionsModule interventions name: FLI, outcomesModule primaryOutcomes measure: Lifestyle Intervention, secondaryOutcomes measure: Low-density lipoprotein cholesterol, secondaryOutcomes measure: Triglycerides, secondaryOutcomes measure: Gamma-glutamyl transpeptidase, secondaryOutcomes measure: Medical and nursing visits, secondaryOutcomes measure: Analytical checks in the first year, secondaryOutcomes measure: Lipid-lowering drugs, secondaryOutcomes measure: Healthcare spending, secondaryOutcomes measure: FLI administration, eligibilityModule sex: ALL, minimumAge: 14 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Centro de Salud Vilanova i la Geltrú 3 Baix A Mar, city: Vilanova I La Geltrú, state: Barcelona, country: Spain, contacts name: M Carmen Rosas, MD, role: CONTACT, phone: +34 938 10 30 03, email: mrosas@csapg.cat, contacts name: Noemí Casaponsa, role: CONTACT, phone: +34 938960026, phoneExt: 43197, email: recerca@csapg.cat, contacts name: M Carmen Rosas, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.22392, lon: 1.72511, hasResults: False
protocolSection identificationModule nctId: NCT06363604, orgStudyIdInfo id: XHEC-C-2023-128-2, briefTitle: Evaluation of PWI Assisted by Marshall Ethanolization in Ablation of Persistent Atrial Fibrillation, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-01, primaryCompletionDateStruct date: 2026-09, completionDateStruct date: 2026-11, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, class: OTHER, descriptionModule briefSummary: This is a prospective, randomized controlled, single-blind, multi-center clinical trial study aiming to investigate whether the strategy of posterior wall isolation (PWI) assisted by vein of Marshall ethanol infusion (VOMEI) could improve the success rate of persistent atrial fibrillation ablation., conditionsModule conditions: Atrial Fibrillation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A total of 260 participants with persistent AF who undergo radiofrequency catheter ablation and received VOMEI + PVI will be randomized assigned to two groups at 1:1 ratio.Group 0 (Control): VOMEI + PVI + linear ablation of mitral isthmus. Group 1 (Experimental): VOMEI + PVI + linear ablation of mitral isthmus + PWI, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: This study used a single-blind design for the subjects. A statistician created a random sequence of numbers using a randomization scheme. The sequence was then placed in opaque coded envelopes and sealed in numerical order. When a patient met the inclusion and exclusion criteria and was assigned a number, the researcher notified the manager to obtain the corresponding envelope and perform the intervention according to the grouping plan inside the envelope. Group 0 correspond to the control group not receiving PWI isolation, while group 1 correspond to the experimental group for PWI isolation., whoMasked: PARTICIPANT, enrollmentInfo count: 260, type: ESTIMATED, armsInterventionsModule interventions name: VOMEI + PVI + linear ablation of mitral isthmus, interventions name: Posterior wall isolation, outcomesModule primaryOutcomes measure: Recurrence of atrial arrhythmias, secondaryOutcomes measure: Procedural complications, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Xinhua Hospital, Shanghai Jiao Tong University, status: RECRUITING, city: Shanghai, state: Shanghai, zip: 200092, country: China, contacts name: Mu Chen, role: CONTACT, phone: +86 021 25077275, email: chenmu@xinhuamed.com.cn, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
protocolSection identificationModule nctId: NCT06363591, orgStudyIdInfo id: Wise vs wide, briefTitle: Single- vs Two-staged Excisions of Thin Melanoma, acronym: WvW, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-10-01, primaryCompletionDateStruct date: 2034-12-31, completionDateStruct date: 2034-12-31, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Vastra Gotaland Region, class: OTHER_GOV, collaborators name: Stockholm Region, collaborators name: Region Skane, collaborators name: Region Västerbotten, collaborators name: Region Örebro County, collaborators name: Blekinge County Council Hospital, collaborators name: Region Östergötland, collaborators name: Dalarna County Council, Sweden, descriptionModule briefSummary: The overall aim of this national, multicenter, prospective, randomized, and controlled study is to enhance the management of patients with thin melanoma (≤1 mm Breslow thickness). The investigators hypothesize that wide local excisions (WLEs) following complete excision of thin melanoma do not affect the risk of recurrence, defined as the occurrence of local, regional, distant disease, or melanoma-specific death during a 5- to 10-year follow-up period., conditionsModule conditions: Melanoma (Skin), conditions: Surgery, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Patients with thin (≤1.0 mm) invasive melanomas excised with a histopathological margin ≥1.5 mm will be offered to participate following informed consent and randomization (1:1) to either:1. Standard treatment with a WLE of the diagnostic excision scar with a lateral clinical surgical margin of 10 mm and a deep clinical surgical margin down to the muscular fascia as recommended by the Swedish national guidelines.   or2. Experimental treatment with no WLE., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 2486, type: ESTIMATED, armsInterventionsModule interventions name: Wise vs wide, outcomesModule primaryOutcomes measure: Recurrence rate at 5 years., secondaryOutcomes measure: Recurrence rate at 10 years., secondaryOutcomes measure: Postoperative complications, secondaryOutcomes measure: Scar length, width and quality, secondaryOutcomes measure: Scar length, width and quality, secondaryOutcomes measure: Patients' quality of life, secondaryOutcomes measure: Patient satisfaction, secondaryOutcomes measure: Patients' quality of life, secondaryOutcomes measure: Patient satisfaction, secondaryOutcomes measure: Patients' quality of life, secondaryOutcomes measure: Patient satisfaction, secondaryOutcomes measure: Direct and indirect costs per patient, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06363578, orgStudyIdInfo id: 36264PR604/3/24, briefTitle: Different Doses of Dexmedetomidine in External Oblique Intercostal Plane Block in Splenectomy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-20, primaryCompletionDateStruct date: 2024-10-01, completionDateStruct date: 2024-10-01, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Tanta University, class: OTHER, descriptionModule briefSummary: The aim of this study is to compare the analgesic effects of different doses of dexmedetomidine as an adjuvant in external oblique intercostal plane block (EOIPB) in splenectomy., conditionsModule conditions: Dexmedetomidine, conditions: External Oblique Intercostal Plane Block, conditions: Splenectomy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Dexmedetomidine 0.5 μg/kg, interventions name: Dexmedetomidine 1 μg/kg, outcomesModule primaryOutcomes measure: Time to the 1st rescue analgesia, secondaryOutcomes measure: Intraoperative fentanyl consumption, secondaryOutcomes measure: Total morphine consumption, secondaryOutcomes measure: Degree of pain, secondaryOutcomes measure: Heart rate, secondaryOutcomes measure: Mean arterial pressure, secondaryOutcomes measure: The incidence of adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Tanta University, city: Tanta, state: El-Gharbia, zip: 31527, country: Egypt, contacts name: Mohammed S Elsharkawy, MD, role: CONTACT, phone: 00201148207870, email: mselsharkawy@med.tanta.edu.eg, contacts name: Saad A Moharam, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.78847, lon: 31.00192, hasResults: False
protocolSection identificationModule nctId: NCT06363565, orgStudyIdInfo id: MN-2022-11, briefTitle: Effects of Supplementation of Compound Nutrients on Plasma Homocysteine in Chinese Adults, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-06-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Sun Yat-sen University, class: OTHER, descriptionModule briefSummary: The purpose of this study is to determine whether supplementation of compound nutrients, including folic acid, vitamin B6, vitamin B12, and betaine, will decrease the level of plasma homocysteine in Chinese adults with homocysteine levels above 10 μmol/L., conditionsModule conditions: Homocysteine, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 220, type: ESTIMATED, armsInterventionsModule interventions name: supplementation of compound nutrients, interventions name: placebo control, outcomesModule primaryOutcomes measure: levels of homocysteine, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: SunYat-sen University, status: RECRUITING, city: Guangzhou, state: Guangdong, zip: 510080, country: China, contacts name: Zhu Huilian, role: CONTACT, geoPoint lat: 23.11667, lon: 113.25, hasResults: False
protocolSection identificationModule nctId: NCT06363552, orgStudyIdInfo id: WETARI, briefTitle: A Study of SC-0191 in Subjects With Metastatic Colorectal Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Tianshu Liu, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to evaluate the preliminary safety and efficacy of SC0191 as single agent or in combination with bevacizumab or 5-FU/LV in advanced colorectal cancer., conditionsModule conditions: Metastatic Colorectal Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: SC0191, interventions name: SC0191 + Bevacizumab, interventions name: SC0191 + 5-FU/LV, outcomesModule primaryOutcomes measure: Objective Response Rate, primaryOutcomes measure: Incidence and Severity of Dose Limiting Toxicities (DLTs), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Zhongshan Hospital Affiliated to Fudan University, city: Shanghai, state: Shanghai, zip: 200032, country: China, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False