hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06264635, orgStudyIdInfo id: HS26227, briefTitle: Evaluating the Efficacy of Platelet-Rich-Plasma (PRP) for Erectile Dysfunction, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: University of Manitoba, class: OTHER, descriptionModule briefSummary: There is great interest in restorative therapies (platelet-rich plasma (PRP) injections, shockwave therapy and stem cell therapy) for ED given their non-invasive nature. However, data is still limited and requires further research prior to widespread adoption. Unfortunately, therapies such as PRP injections are being widely used without clinical evidence demonstrating its safety or effectiveness for the treatment of erectile dysfunction. 2-7 To date, there are no treatments that address the underlying cause of endothelial dysfunction, although low-intensity shockwave therapy for ED has shown promising results. Platelet-derived therapies targeting inflammation and promoting tissue/nerve regeneration and may represent a potential treatment option towards this direction. The investigators propose to perform Canada's first pilot RCT to evaluate and safety and efficacy of PRP for the treatment of ED., conditionsModule conditions: Erectile Dysfunction, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: The provider and patient are both blinded to which treatment (PRP vs saline) the patient is receiving, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Platelet-Rich-Plasma, interventions name: Saline, outcomesModule primaryOutcomes measure: International Index of Erectile Function (IIEF), secondaryOutcomes measure: Adverse Events, eligibilityModule sex: MALE, minimumAge: 30 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Men's Health Clinic, city: Winnipeg, state: Manitoba, zip: R3K 1M3, country: Canada, contacts name: Premal Patel, MD, role: CONTACT, phone: 2042214476, email: ppatel5@hsc.mb.ca, contacts name: Jainik Shah, BFSc, role: CONTACT, phone: 6477721737, email: shahj4@myumanitoba.ca, geoPoint lat: 49.8844, lon: -97.14704, hasResults: False
protocolSection identificationModule nctId: NCT06264622, orgStudyIdInfo id: CEIC-2996, briefTitle: ABG+/GarlACE Effects on Cardiovascular Risk Factors in Subjects With Grade I Hypertension, acronym: GARDOSE, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-26, primaryCompletionDateStruct date: 2024-10-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Universitat de Lleida, class: OTHER, collaborators name: Pharmactive Biotech Products S.L.U, descriptionModule briefSummary: The goal of this clinical trial is to evaluate the dose response effect on cardiovascular disease risk factors of a Black Garlic Extract in subjects with Grade I Hypertension. The main questions it aims to answer are:* If the reduction in blood pressure (systolic and diastolic) is in a dose-response manner* If the changes in lipid profile are in a dose-response mannerParticipants will be randomly assign to a low dose (250 mg/day), high dose (600 mg/day) or placebo of a standardized Garlic Extract (ABG+/GarlACE) during 12 weeks, conditionsModule conditions: Hypertension, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 180, type: ESTIMATED, armsInterventionsModule interventions name: Low dose, interventions name: High dose, interventions name: Placebo, outcomesModule primaryOutcomes measure: Blood Pressure, secondaryOutcomes measure: Blood Lipid Profile, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Lleida, status: RECRUITING, city: Lleida, zip: 25198, country: Spain, contacts name: Jose Serrano, PhD, role: CONTACT, phone: 973702408, email: josecarlos.serrano@udl.cat, contacts name: Manuel Portero, PhD, role: CONTACT, phone: 973702408, email: manuel.portero@udl.cat, geoPoint lat: 41.61674, lon: 0.62218, hasResults: False
protocolSection identificationModule nctId: NCT06264609, orgStudyIdInfo id: 91026, briefTitle: Precision Medicine Approach for Osteoporosis - Follow Up Study, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2029-12-31, completionDateStruct date: 2029-12-31, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Hartmut Malluche, MD, class: OTHER, descriptionModule briefSummary: Osteoporosis is a health problem of major proportions. It affects more than 40 million Americans and results in more than 2 million fractures annually among Medicare patients alone. Hospital admissions for osteoporotic fractures exceed those of heart attacks, strokes and breast cancer combined. Osteoporosis is commonly considered a disease associated with menopause. This estrogen deficiency related bone loss is characterized by high bone turnover with increased resorption without commensurate changes in bone formation. It is in contrast to age-related bone loss, which starts as early as in the fourth decade of life and continues with increasing age. Age-related bone loss is usually associated with lower bone turnover and decreased bone formation is the main abnormality.Current therapies do not address age-related bone loss and the special needs of the age-related osteoporosis population is currently ignored. This is to a great degree due to difficulties associated with the bone biopsy necessary for unequivocal determination of bone turnover status. Thus, the current standard of care relies on starting with an antiresorber, which is of limited effectiveness in age-related osteoporosis, and in fact impedes the effectiveness of the appropriate anabolic medication. In a current ongoing study - Novel precision medicine approach to treatment of osteoporosis based on bone turnover. EIRB#70781; efforts are focused on addressing this particular problem.Our follow-up study seeks to achieve one specific aim: to compare effectiveness of Alendronate vs Teriparatide after participants have been switched at the end of treatment at year one, to the other drug at year two for the same duration of treatment., conditionsModule conditions: Osteoporosis, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NON_RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Alendronate, interventions name: Teriparatide, interventions name: Alendronate, outcomesModule primaryOutcomes measure: Percent change in bone loss, secondaryOutcomes measure: Percent change in Bone Mass Density at the hip, otherOutcomes measure: Trabecular bone score (TBS), eligibilityModule sex: FEMALE, minimumAge: 45 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Kentucky, city: Lexington, state: Kentucky, zip: 40536, country: United States, geoPoint lat: 37.98869, lon: -84.47772, hasResults: False
protocolSection identificationModule nctId: NCT06264596, orgStudyIdInfo id: 2310-72, briefTitle: Epinephrine in Irrigation Fluid for Visualization During Ankle Surgery, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2026-04, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: The Guthrie Clinic, class: OTHER, descriptionModule briefSummary: The purpose of this study is to evaluate the effect of epinephrine in irrigation fluid for visual clarity in ankle arthroscopic surgery., conditionsModule conditions: Intraoperative Bleeding, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: Concealed irrigation bags, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 78, type: ESTIMATED, armsInterventionsModule interventions name: Epinephrine, interventions name: Normal Saline irrigation fluid, outcomesModule primaryOutcomes measure: visual clarity during ankle arthroscopic surgery, which will be evaluated by visual analog scale, primaryOutcomes measure: surgeon's discomfort related to bleeding, measured by visual numeric rating scale, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Robert Packer Hospital, city: Sayre, state: Pennsylvania, zip: 18840, country: United States, contacts name: Wonyong Lee, MD, role: CONTACT, phone: 570-887-4882, email: Wonyong.Lee@guthrie.org, contacts name: Wonyong Lee, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.97896, lon: -76.5155, hasResults: False
protocolSection identificationModule nctId: NCT06264544, orgStudyIdInfo id: SW006, briefTitle: Trial to Evaluate the Efficacy of a Zinc, Selenium, and L-Tyrosine Supplement in the Prevention of Thyrotoxicosis in Subjects With r25191G/A SEPP1 Polymorphism, acronym: ZEST-PREP, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-30, primaryCompletionDateStruct date: 2024-10-15, completionDateStruct date: 2024-12-30, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: S.LAB (SOLOWAYS), class: OTHER, collaborators name: Center of New Medical Technologies, descriptionModule briefSummary: This randomized, double-blind, placebo-controlled trial evaluates the efficacy of a zinc, selenium, and L-tyrosine supplement in preventing thyrotoxicosis among adults aged 18-85 with elevated TPOAb levels and the r25191G/A SEPP1 polymorphism. The study excludes those with thyroid disease, pregnant/breastfeeding women, and individuals allergic to the supplement. Key endpoints include changes in thyroid antibodies and hormones over a 6-month period. With an estimated sample size of 150 participants per group, accounting for a 20% dropout rate, the trial seeks to demonstrate the supplement's potential in reducing thyrotoxicosis risk through a genetically-informed approach., conditionsModule conditions: Thyrotoxicosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: zinc, selenium, and L-tyrosine in SEPP1, interventions name: Placebo, outcomesModule primaryOutcomes measure: Percent change of Thyroid Peroxidase Antibodies (TPOAb) in subjects with r25191 SEPP1 polymorphism, secondaryOutcomes measure: Percent change in Thyroglobulin Antibodies (TgAb) in subjects with r25191 SEPP1 polymorphism, secondaryOutcomes measure: Free Thyroxine (Free T4) change in subjects with r25191 SEPP1 polymorphism, secondaryOutcomes measure: Free Triiodothyronine (Free T3) change in subjects with r25191 SEPP1 polymorphism, secondaryOutcomes measure: Thyroid Receptor Antibodies (TRAb) change in subjects with r25191 SEPP1 polymorphism, secondaryOutcomes measure: TSH Receptor Antibodies (TSHR-Ab) change in subjects with r25191 SEPP1 polymorphism, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Center of New Medical Technologies, city: Novosibirsk, state: Novosibisk Region, zip: 630090, country: Russian Federation, geoPoint lat: 55.0415, lon: 82.9346, hasResults: False
protocolSection identificationModule nctId: NCT06264518, orgStudyIdInfo id: 56168915, briefTitle: An Observational Exploration of Clinical Trials Targeting Traumatic Brain Injury, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2025-03, primaryCompletionDateStruct date: 2026-03, completionDateStruct date: 2027-03, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Power Life Sciences Inc., class: INDUSTRY, descriptionModule briefSummary: Clinical study participation has historically been heavily biased toward specific demographics.Several people will be invited to enroll in this study so that it may collect a variety of data about traumatic brain injury clinical trial experiences and identify barriers to participation as well as the causes of participants' failure or withdrawal.People with traumatic brain injury who are invited to take part in medical research will benefit from the analysis of the data., conditionsModule conditions: Traumatic Brain Injury, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CROSSOVER, timePerspective: PROSPECTIVE, enrollmentInfo count: 500, type: ESTIMATED, outcomesModule primaryOutcomes measure: Number of patients who decide to enroll in a traumatic brain injury clinical trial, primaryOutcomes measure: Rate of patients who remain in traumatic brain injury clinical trial to trial completion, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Power Life Sciences, city: San Francisco, state: California, zip: 94107, country: United States, contacts name: Michael B Gill, role: CONTACT, phone: 415-900-4227, email: https://www.withpower.com/contact-us@withpower.com, geoPoint lat: 37.77493, lon: -122.41942, documentSection largeDocumentModule largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2024-02-09, uploadDate: 2024-02-09T11:16, filename: ICF_000.pdf, size: 79118, hasResults: False
protocolSection identificationModule nctId: NCT06264505, orgStudyIdInfo id: 55955210, briefTitle: Investigative Analysis of Soft Tissue Sarcoma Clinical Trials: An Observational Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2025-03, primaryCompletionDateStruct date: 2026-03, completionDateStruct date: 2027-03, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Power Life Sciences Inc., class: INDUSTRY, descriptionModule briefSummary: Generally, specific demographic cohorts exhibit higher participation rates in medical research, yet there exists a scarcity of research elucidating the trial attributes impacting the engagement of these particular demographics.The primary objective of this study is to gather extensive data on the clinical trial experiences of individuals diagnosed with soft tissue sarcoma, with the aim of identifying factors hindering patient enrollment or trial completion., conditionsModule conditions: Soft Tissue Sarcoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CROSSOVER, timePerspective: PROSPECTIVE, enrollmentInfo count: 500, type: ESTIMATED, outcomesModule primaryOutcomes measure: Rate of patients in soft tissue sarcoma clinical research, primaryOutcomes measure: Number of soft tissue sarcoma study participants who maintain involvement until study finish, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Power Life Sciences, city: San Francisco, state: California, zip: 94107, country: United States, contacts name: Michael B Gill, role: CONTACT, phone: 415-900-4227, email: https://www.withpower.com/contact-us@withpower.com, geoPoint lat: 37.77493, lon: -122.41942, documentSection largeDocumentModule largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2024-02-09, uploadDate: 2024-02-09T10:34, filename: ICF_000.pdf, size: 80606, hasResults: False
protocolSection identificationModule nctId: NCT06264492, orgStudyIdInfo id: 55777205, briefTitle: Delving Into Participation Trends of Scleroderma Clinical Trials, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2025-03, primaryCompletionDateStruct date: 2026-03, completionDateStruct date: 2027-03, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: Power Life Sciences Inc., class: INDUSTRY, descriptionModule briefSummary: Typically, specific demographic subsets tend to exhibit greater engagement in medical research. Nonetheless, there is insufficient research elucidating the trial characteristics influencing the participation of these particular demographics.The study will analyze data from diverse demographic viewpoints to uncover recurring trends that could provide valuable insights for future patients with scleroderma., conditionsModule conditions: Scleroderma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CROSSOVER, timePerspective: PROSPECTIVE, enrollmentInfo count: 500, type: ESTIMATED, outcomesModule primaryOutcomes measure: Rate of patients in clinical research for scleroderma, primaryOutcomes measure: Number of scleroderma study participants who stay committed until clinical study wraps up, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Power Life Sciences, city: San Francisco, state: California, zip: 94107, country: United States, contacts name: Michael B Gill, role: CONTACT, phone: 415-900-4227, email: https://www.withpower.com/contact-us@withpower.com, geoPoint lat: 37.77493, lon: -122.41942, documentSection largeDocumentModule largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2024-02-09, uploadDate: 2024-02-09T10:51, filename: ICF_000.pdf, size: 71611, hasResults: False
protocolSection identificationModule nctId: NCT06264453, orgStudyIdInfo id: KH-001-D201, briefTitle: A Study to Evaluate the Efficacy and Safety of KH001 in Patients With Dentin Hypersensitivity, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-11, primaryCompletionDateStruct date: 2024-08-23, completionDateStruct date: 2024-08-30, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: HysensBio Co., Ltd, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to evaluate the efficacy and safety of KH001 in patients with dentin hypersensitivity., conditionsModule conditions: Dentin Hypersensitivity, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 171, type: ESTIMATED, armsInterventionsModule interventions name: KH001, interventions name: Placebo, outcomesModule primaryOutcomes measure: Change from baseline in Schiff sensitivity score, secondaryOutcomes measure: Change from baseline in a Schiff sensitivity score, secondaryOutcomes measure: Change from baseline in a Tactile threshold, secondaryOutcomes measure: Change from baseline in Visual Analogue Scale, eligibilityModule sex: ALL, minimumAge: 19 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06264440, orgStudyIdInfo id: 283HV104, briefTitle: A Study to Assess the Potential for Gastric-pH Dependent Drug-Drug Interactions of BIIB122 With a Proton Pump Inhibitor in Healthy Participants, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-02-12, primaryCompletionDateStruct date: 2024-05-07, completionDateStruct date: 2024-05-07, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Biogen, class: INDUSTRY, descriptionModule briefSummary: The primary objective of the study is to evaluate the effects of a proton pump inhibitor (PPI) \[rabeprazole\] on BIIB122 pharmacokinetics (PK) after a single dose in healthy participants. The secondary objective of the study is to evaluate the safety and tolerability of BIIB122, with and without a PPI (rabeprazole), after a single dose in healthy participants., conditionsModule conditions: Healthy Volunteer, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 18, type: ACTUAL, armsInterventionsModule interventions name: BIIB122, interventions name: Rabeprazole, outcomesModule primaryOutcomes measure: Maximum Observed Concentration (Cmax) of BIIB122, primaryOutcomes measure: Area Under the Concentration-Time Curve From Time Zero to Time of the Last Measurable Concentration (AUClast) of BIIB122, primaryOutcomes measure: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUCinf) of BIIB122, secondaryOutcomes measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs), eligibilityModule sex: ALL, minimumAge: 30 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: PPD Development, LP, city: Austin, state: Texas, zip: 78744, country: United States, geoPoint lat: 30.26715, lon: -97.74306, hasResults: False