hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06345755, orgStudyIdInfo id: VX23-407-001, briefTitle: A Phase 1 Study to Evaluate Safety, Tolerability, and Pharmacokinetics (PK) of VX-407 in Healthy Participants, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Vertex Pharmaceuticals Incorporated, class: INDUSTRY, descriptionModule briefSummary: The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetic parameters of VX-407 in healthy participants., conditionsModule conditions: Autosomal Dominant Polycystic Kidney Disease (ADPKD), designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 95, type: ESTIMATED, armsInterventionsModule interventions name: VX-407, interventions name: Placebo, interventions name: Midazolam, outcomesModule primaryOutcomes measure: Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs), primaryOutcomes measure: Part B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs), primaryOutcomes measure: Part C: Maximum Observed Plasma Concentration (Cmax) of MDZ in Absence and Presence of VX-407, primaryOutcomes measure: Part C: Area Under the Concentration Versus Time Curve (AUC) of MDZ in Absence and Presence of VX-407, secondaryOutcomes measure: Part A: Maximum Observed Plasma Concentration (Cmax) of VX-407, secondaryOutcomes measure: Part B: Maximum Observed Plasma Concentration (Cmax) of VX-407, secondaryOutcomes measure: Part A: Area Under the Concentration Versus Time Curve (AUC) of VX-407, secondaryOutcomes measure: Part B: Area Under the Concentration Versus Time Curve (AUC) of VX-407, secondaryOutcomes measure: Part C: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: ICON Lenexa, status: RECRUITING, city: Lenexa, state: Kansas, zip: 66219, country: United States, geoPoint lat: 38.95362, lon: -94.73357, hasResults: False
protocolSection identificationModule nctId: NCT06345742, orgStudyIdInfo id: ATADEK-2023-10/396, briefTitle: The Effect of Parental Participation on Newborn Comfort During Diaper Care, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-19, primaryCompletionDateStruct date: 2025-02-01, completionDateStruct date: 2025-02-01, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Acibadem University, class: OTHER, descriptionModule briefSummary: It was aimed to determine the effect of parental participation on newborn comfort during diaper care practice in preterm infants.H1: Parental participation during infant diaper care practice in preterm infants has an effect on newborn comfort.H2: There is a difference in the effect of parent diaper care practice and the participation of the mother or father on newborn comfort in preterm infants.H3: There is a difference between the stress levels of parents before the application of infant diaper care in preterm infants., conditionsModule conditions: Preterm, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 105, type: ESTIMATED, armsInterventionsModule interventions name: No parental participation, interventions name: Mother participation, interventions name: Father participation, outcomesModule primaryOutcomes measure: Level of Parental Stress, primaryOutcomes measure: Change in Level of Comfort, eligibilityModule sex: ALL, minimumAge: 1 Day, maximumAge: 28 Days, stdAges: CHILD, contactsLocationsModule locations facility: Acıbadem University, status: RECRUITING, city: İstanbul, state: Ataşehir, zip: 34750, country: Turkey, contacts name: Tuğba Türker, Nurse, role: CONTACT, email: tugba.turker@live.acibadem.edu.tr, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
protocolSection identificationModule nctId: NCT06345716, orgStudyIdInfo id: renal colic 2024, briefTitle: Paracetamol-Tramadol and Paracetamol-caffeine Versus Placebo in the Emergency Discharge Treatment of Renal Colic, acronym: RC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-10, primaryCompletionDateStruct date: 2025-03-15, completionDateStruct date: 2025-11-30, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: University of Monastir, class: OTHER, descriptionModule briefSummary: This is a prospective, randomized, single-blind study. Patients included in the study after successful treatment of the acute attack were randomized upon discharge from the Emergency Department into three groups: oral paracetamol-tramadol group, oral paracetamol-caffeine group and oral placebo group., conditionsModule conditions: Renal Colic, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 1500, type: ESTIMATED, armsInterventionsModule interventions name: paracétamol tramadol, interventions name: Paracétamol cafeine, interventions name: Placebo, outcomesModule primaryOutcomes measure: Pain recurrence, secondaryOutcomes measure: Painful recurrence, secondaryOutcomes measure: number of patient who revist the ED for residual pain, otherOutcomes measure: Adverse effects, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06345703, orgStudyIdInfo id: NeuShen Therapeutics, briefTitle: First-into-human Study of NS-136 in Healthy Subjects, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-11, completionDateStruct date: 2025-02, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: NeuShen Therapeutics, class: INDUSTRY, descriptionModule briefSummary: The goal of this clinical trial is to exlplore the profile of NS-136 in health conditions. The main questions it aims to answer are:* Is NS-136 safe and tolerable in heathy subjects under tested dosing regimen?* What is the pharmacokinectic profile of NS-136 in healthy subjects under tested dosing regimen?, conditionsModule conditions: Healthy Subjects, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: The trial consists of three parts: the first part is a single ascending dose (SAD) study, the second part is a multiple ascending dose (MAD) study, and the third part is food effect (FE) study. The first two parts (SAD and MAD) will be randomized, double-blind, single or multiple ascending dose and placebo-controlled study designs. The third part (FE) will be a randomized, open-label, two-period, crossover study design. To evaluate the safety, tolerability, pharmacokinetic profile, and the effect of food on the PK profile of NS-136 in healthy subjects and to determine the maximum tolerated dose (MTD), primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Placebo, interventions name: NS-136 tablet, outcomesModule primaryOutcomes measure: Number of Participants with Treatment-Related Adverse Events, primaryOutcomes measure: Main pharmacokinetic parameters, primaryOutcomes measure: Main pharmacokinetic parameters, primaryOutcomes measure: Main pharmacokinetic parameters, primaryOutcomes measure: Main pharmacokinetic parameters, primaryOutcomes measure: Main pharmacokinetic parameters, primaryOutcomes measure: Main pharmacokinetic parameters, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CMAX Clinical Research Pty Ltd, city: Adelaide, state: South Australia, zip: 5000, country: Australia, contacts name: Study Services Director, role: CONTACT, phone: +61 08 7088 7900, email: cmax@cmax.com.au, geoPoint lat: -34.92866, lon: 138.59863, hasResults: False
protocolSection identificationModule nctId: NCT06345690, orgStudyIdInfo id: VIA-2023-003, briefTitle: VIA Disc NP Registry 3.0, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-27, primaryCompletionDateStruct date: 2027-01-01, completionDateStruct date: 2027-01-01, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: VIVEX Biologics, Inc., class: INDUSTRY, collaborators name: Moxie Clinical, descriptionModule briefSummary: Registry is to observe and trend patterns of care and outcomes for patients treated with VIA Disc NP., conditionsModule conditions: Discogenic Pain, conditions: Back Pain, conditions: Back Pain, Low, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: VIA Disc NP, outcomesModule primaryOutcomes measure: Numeric Pain Rating Scale (NPRS), primaryOutcomes measure: Oswestry Disability Index (ODI), primaryOutcomes measure: Patient Satisfaction, primaryOutcomes measure: Pain Medication, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Denver Spine & Pain Institute, status: RECRUITING, city: Greenwood Village, state: Colorado, zip: 80111, country: United States, contacts name: Josephine Steinbrecher, role: CONTACT, email: josephine@denverpaininstitute.com, contacts name: Scott Bainbridge, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.61721, lon: -104.95081, locations facility: The Orthopedic Institute, status: RECRUITING, city: Gainesville, state: Florida, zip: 32605, country: United States, contacts name: Carole Newell, role: CONTACT, email: cnewell@toi-health.com, contacts name: Ajay Antony, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.65163, lon: -82.32483, locations facility: Interventional Pain Specialists - Pain Clinic, status: RECRUITING, city: Opelousas, state: Louisiana, zip: 70570, country: United States, contacts name: Lisa Briggs, role: CONTACT, email: lisa@ipspain.org, contacts name: Albert Gros, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.53353, lon: -92.08151, locations facility: Premier Pain Solutions, status: RECRUITING, city: Asheville, state: North Carolina, zip: 28803, country: United States, contacts name: Courtney Musser, role: CONTACT, email: courtney@premierpainnc.com, contacts name: Javid Baksh, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.60095, lon: -82.55402, locations facility: Crystal Coast Pain Management, status: RECRUITING, city: New Bern, state: North Carolina, zip: 28560, country: United States, contacts name: Amy Harum, role: CONTACT, email: aharum@crystalcoastpm.com, contacts name: Kirk Harum, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.10849, lon: -77.04411, hasResults: False
protocolSection identificationModule nctId: NCT06345638, orgStudyIdInfo id: 854343, briefTitle: Sex Hormones and Inflammatory Biomarkers in Patients With Sickle Cell Disease, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-04-30, completionDateStruct date: 2025-05-31, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: University of Pennsylvania, class: OTHER, descriptionModule briefSummary: This study aims to characterize sex differences in the pathophysiology of vaso-occlusive crises (VOC) occurring among individuals with sickle cell disease (SCD).* The study will compare CRP and other biomarkers between females with SCD in the follicular phase of the menstrual cycle and males with SCD.* The study will explore potential sex differences in biomarker changes between females and males with SCD during and following resolution of VOC.* The study will compare neutrophil and platelet adhesion to the endothelium and real time fibrin deposition in the blood., conditionsModule conditions: Sickle Cell Disease, conditions: Vaso-occlusive Crisis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: C-reactive protein level, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Penn Medicine University City, city: Philadelphia, state: Pennsylvania, zip: 19104, country: United States, geoPoint lat: 39.95233, lon: -75.16379, locations facility: Pennsylvania Hospital, city: Philadelphia, state: Pennsylvania, zip: 19107, country: United States, geoPoint lat: 39.95233, lon: -75.16379, locations facility: Hospital of the University of Pennsylvania, city: Philadelphia, state: Pennsylvania, zip: 19143, country: United States, geoPoint lat: 39.95233, lon: -75.16379, hasResults: False
protocolSection identificationModule nctId: NCT06345625, orgStudyIdInfo id: 6012, briefTitle: Gait and Postural Balance Analysis During Head-motion Perturbed Standing and Walking in Older Adults, acronym: BALANCAR, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2027-01, completionDateStruct date: 2028-01, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Universiteit Antwerpen, class: OTHER, descriptionModule briefSummary: The main aim of this study is to unravel the biomechanics of postural balance reactions during head-motion perturbed standing and walking in older adults who fall, while integrating the influence of frailty, sensory functioning and cognitive processing., conditionsModule conditions: Aged, conditions: Accidental Fall, conditions: Postural Balance, conditions: Gait, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Cognition, interventions name: Sensory function, interventions name: Frailty, interventions name: Biomechanical movement analysis, interventions name: Screening, interventions name: Follow up, outcomesModule primaryOutcomes measure: Spatio-temporal parameters of gait, primaryOutcomes measure: Foot placement estimator, primaryOutcomes measure: Onset latency, primaryOutcomes measure: Peak amplitude, primaryOutcomes measure: Fixation duration, primaryOutcomes measure: Gain, primaryOutcomes measure: Latency, primaryOutcomes measure: Fall characteristics, secondaryOutcomes measure: Multisensory integration, secondaryOutcomes measure: Digit symbol substitution test, secondaryOutcomes measure: Trail making test, secondaryOutcomes measure: Go/No Go test, secondaryOutcomes measure: Head Repositioning Accuracy, secondaryOutcomes measure: Fly test, secondaryOutcomes measure: Fly test, secondaryOutcomes measure: vHIT, secondaryOutcomes measure: fHIT, secondaryOutcomes measure: Frailty, otherOutcomes measure: Age, otherOutcomes measure: Gender, otherOutcomes measure: Medical history, otherOutcomes measure: Fall history, eligibilityModule sex: ALL, minimumAge: 65 Years, maximumAge: 100 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Antwerp, status: RECRUITING, city: Antwerp, zip: 2160, country: Belgium, contacts name: Ann Hallemans, PhD, role: CONTACT, phone: +32 3 265 29 12, email: ann.hallemans@uantwerpen.be, contacts name: PhD, role: CONTACT, geoPoint lat: 51.21989, lon: 4.40346, hasResults: False
protocolSection identificationModule nctId: NCT06345612, orgStudyIdInfo id: Hypoxia-Exercise-DiabetesT1, briefTitle: Impact of Eccentric Training in Hypoxia With Creatine on Metabolic Control and VO2max in Patients With Type 1 Diabetes, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-15, primaryCompletionDateStruct date: 2025-06, completionDateStruct date: 2025-07, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Silesian Centre for Heart Diseases, class: OTHER, descriptionModule briefSummary: Exercise plays an important role in treatment of diabetes. In recent years exercise training in normobaric hypoxia is used in training programs for athletes and in rehabilitation and also commercially. The aim of the study is to assess the impact of eccentric training conducted in conditions of normobaric hypoxia or normoxia and creatine supplementation on metabolic control: profile and stability of glucose concentration, HbA1c value, hypoglycemia and insulin demand, as well as the level of muscle strength, VO2max and anthropometric parameters, conditionsModule conditions: Type 1 Diabetes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 28, type: ESTIMATED, armsInterventionsModule interventions name: hypoxia, interventions name: normoxia, interventions name: creatine supplementation, interventions name: no creatine supplementation, outcomesModule primaryOutcomes measure: Metabolic control of diabetes, primaryOutcomes measure: Time in range, primaryOutcomes measure: Time below range, primaryOutcomes measure: Maximum oxygen consumption (VO2max), eligibilityModule sex: MALE, minimumAge: 20 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Department of Internal Diseases, Diabetology and Cardiometabolic Disorders, School of Medicine with the Division of Dentistry in Zabrze, Medical University of Silesia in Katowice, Poland, status: RECRUITING, city: Zabrze, state: Silesia, zip: 41-800, country: Poland, contacts name: Marta Wróbel, PhD, role: CONTACT, phone: 48606873060, email: mwrobel@sum.edu.pl, geoPoint lat: 50.32492, lon: 18.78576, hasResults: False
protocolSection identificationModule nctId: NCT06345599, orgStudyIdInfo id: LK2023100, briefTitle: PRaG Therapy in Combination With Locally Advanced Pancreatic Ductal Adenocarcinoma (PDAC) (NeoPRAG Study), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2027-01-10, completionDateStruct date: 2027-01-10, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Second Affiliated Hospital of Soochow University, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to learn about Phase I+Phase II Clinical Study of PRaG Therapy in Combination With Chemotherapy (AG Regimen) for Neoadjuvant Treatment of Locally Advanced Pancreatic Ductal Adenocarcinoma (PDAC) (NeoPRAG Study).The main question it aims to answer is to investigate the safety and efficacy of the PRaG treatment modality combined with chemotherapy neoadjuvant therapy for locally advanced pancreatic cancer., conditionsModule conditions: Pancreatic Ductal Adenocarcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 66, type: ESTIMATED, armsInterventionsModule interventions name: Radiotherapy, interventions name: Immunotherapy:Granulocyte macrophage-colony stimulating factor(GM-CSF)、Cadumilimab, interventions name: Chemotherapy:Albumin-bound paclitaxel、Gemcitabine, outcomesModule primaryOutcomes measure: Adverse events, primaryOutcomes measure: Serious adverse events, primaryOutcomes measure: 1-year overall survival, secondaryOutcomes measure: Objective response rate, secondaryOutcomes measure: Disease control rate, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: R0 resection rate, secondaryOutcomes measure: Progression free survival, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2023-09-22, uploadDate: 2024-03-26T10:41, filename: Prot_SAP_000.pdf, size: 1237855, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2023-11-27, uploadDate: 2024-03-26T10:44, filename: ICF_001.pdf, size: 376918, hasResults: False
protocolSection identificationModule nctId: NCT06345586, orgStudyIdInfo id: 078066, briefTitle: Drospirenone Only Pills and Cervical Mucus Changes: A Pre- and Post-Bariatric Surgery Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Chulalongkorn University, class: OTHER, descriptionModule briefSummary: The purpose of this study is to study the effect of Drospirenone on cervical mucus change by modified Insler score, pre-bariatric surgery and post-bariatric surgery, conditionsModule conditions: Contraception, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Participants received Drospirenone will be assess for cervical mucus change by modified Insler score, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 16, type: ESTIMATED, armsInterventionsModule interventions name: Drospirenone, outcomesModule primaryOutcomes measure: Cervical mucus by modified Insler score, secondaryOutcomes measure: Estrogen and progesterone levels versus time, secondaryOutcomes measure: Number of Participants With Treatment-Related Adverse Events, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Chulalongkorn University, city: Bangkok, zip: 10330, country: Thailand, geoPoint lat: 13.75398, lon: 100.50144, hasResults: False