hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06338358, orgStudyIdInfo id: 44519568, briefTitle: Understanding Participation Habits Among Plaque Psoriasis Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2025-04, primaryCompletionDateStruct date: 2026-04, completionDateStruct date: 2027-04, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Power Life Sciences Inc., class: INDUSTRY, descriptionModule briefSummary: The study intends to investigate the personal experiences of plaque psoriasis patients who take part in a separate clinical study including a specific medication intervention. The major focus will be on closely following individuals' rates of trial completion and withdrawal.The data collected from this study will help improve future outcomes for all plaque psoriasis as well as those in under-represented demographic groups., conditionsModule conditions: Plaque Psoriasis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CROSSOVER, timePerspective: PROSPECTIVE, enrollmentInfo count: 500, type: ESTIMATED, outcomesModule primaryOutcomes measure: Rate of patients who decide to enroll in a plaque psoriasis clinical research., primaryOutcomes measure: Number of plaque psoriasis study participants who remain in clinical study until 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: 2024-03-22, uploadDate: 2024-03-22T09:21, filename: ICF_000.pdf, size: 67831, hasResults: False
protocolSection identificationModule nctId: NCT06338319, orgStudyIdInfo id: 23-048-E, briefTitle: Book Sharing for Toddlers With Clefts, acronym: BOOST, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2028-04, completionDateStruct date: 2028-08, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Seattle Children's Hospital, class: OTHER, collaborators name: University of Washington, collaborators name: Nationwide Children's Hospital, collaborators name: Children's Hospital Los Angeles, collaborators name: Ohio State University, descriptionModule briefSummary: Children with clefts exhibit difficulty with language and literacy compared to children without clefts. However, little is known about interventions to address these difficulties in the cleft population. This study will test the efficacy of a parent-focused dialogic book-sharing intervention for toddlers with isolated cleft palate. The study will use a randomized controlled trial (RCT) design and Intention to Treat (ITT) analyses. Child outcomes include expressive and receptive language. Parent outcomes of interest include the frequency and quality of shared reading interactions. To assess mechanisms of action, the study will test whether changes in child outcomes are mediated by changes in parents' behavior. Analyses will also explore heterogeneity in outcomes to determine whether the intervention is more effective in certain clinical or demographic sub-groups., conditionsModule conditions: Cleft Palate, conditions: Cleft Lip and Palate, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 320, type: ESTIMATED, armsInterventionsModule interventions name: Book-Sharing for Toddlers with Clefts (BOOST), outcomesModule primaryOutcomes measure: Expressive One Word Picture Vocabulary Test-Fourth Edition, primaryOutcomes measure: Receptive One Word Picture Vocabulary Test-Fourth Edition, primaryOutcomes measure: Child Language Sample, primaryOutcomes measure: MacArthur-Bates Communicative Development Inventory - Computer Adaptive Test, secondaryOutcomes measure: Child Speech Sample - Percent Consonants Correct - Revised, Total Number of Unique Consonants, otherOutcomes measure: Frequency of Shared Reading, otherOutcomes measure: Quality of Shared Reading, otherOutcomes measure: Child Language During Reading, eligibilityModule sex: ALL, minimumAge: 24 Months, maximumAge: 32 Months, stdAges: CHILD, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06338293, orgStudyIdInfo id: KY20240123-02, briefTitle: Effects of Inclisiran Combined With Statins on the Morphology of Coronary Vulnerable Plaques, acronym: EItoCVP, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2025-05, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Nanjing First Hospital, Nanjing Medical University, class: OTHER, descriptionModule briefSummary: Effects of inclisiran + statins vs. statins on the morphology and vascular function of coronary vulnerable plaques, in order to provide a better treatment and more detailed imaging basis for the treatment of coronary vulnerable plaques., conditionsModule conditions: Coronary Artery Disease, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Inclisiran sodium, interventions name: Rosuvastatin, outcomesModule primaryOutcomes measure: The change rate of the thinnest fibrous cap of vulnerable plaque at the target vascular lesion from baseline to one-year follow-up(△ FCT%), secondaryOutcomes measure: The change rate of TAV and plaque load of the target vascular lesion;, secondaryOutcomes measure: The change rate of lipid composition of plaque: including the lipid volume, the maximum area and angle of lipid, the length of vulnerable plaque, etc., secondaryOutcomes measure: The change rates of other components of plaque (fiber, calcification, crystal, macrophage), secondaryOutcomes measure: The change rates of lesion OFR and target vessel OFR, secondaryOutcomes measure: The change rates of other indexes (low density lipoprotein level, Lp-PLA2, hs-CRP, etc.), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06338280, orgStudyIdInfo id: VDW002, briefTitle: Remotely Observed Methadone Evaluation II, acronym: ROME II, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2027-05-01, completionDateStruct date: 2027-05-01, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Sonara Health, class: INDUSTRY, descriptionModule briefSummary: Methadone is an effective treatment for severe opioid use disorder (OUD), but access is limited due to the requirement of daily observed dosing by most opioid treatment programs (OTPs). Sonara Health designed a HIPAA-compliant web-application called Sonara that features integrated video dosing recording, a tamper-evident seal, and an innovative measurement-based care (MBC) framework called the Opioid Craving Visual Analogue Scale (OC-VAS) to facilitate methadone take-homes while providing evidence of appropriate use and monitoring patient outcomes. Phase II of this SBIR aims to compare Sonara against usual take-homes to assess its impact on retention in care, opioid use, patient outcomes, and costs of care., conditionsModule conditions: Opioid Use Disorder, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Sonara, outcomesModule primaryOutcomes measure: Retention, primaryOutcomes measure: Take homes received over time, secondaryOutcomes measure: Opioid cravings, secondaryOutcomes measure: Urine toxicology, secondaryOutcomes measure: Opioid withdrawal severity, secondaryOutcomes measure: Health-related quality of life, secondaryOutcomes measure: Drug Abuse Treatment Costs Analysis, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
protocolSection identificationModule nctId: NCT06338254, orgStudyIdInfo id: E-10840098-772.02-5416, briefTitle: Efficacy of Percussion Massage Therapy Applied to the Lower Extremity on Pain, Edema in Pregnant Women, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-09-04, primaryCompletionDateStruct date: 2023-06-04, completionDateStruct date: 2023-06-10, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Istanbul Medipol University Hospital, class: OTHER, descriptionModule briefSummary: This study aim is to examine the effect of percussion massage therapy applied to lower extremity on pain, edema, fatigue and quality of life in pregnant women., conditionsModule conditions: Pregnancy Complications, conditions: Edema Leg, conditions: Physiotherapy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: The participants are blinded., whoMasked: PARTICIPANT, enrollmentInfo count: 60, type: ACTUAL, armsInterventionsModule interventions name: percussion massage therapy, outcomesModule primaryOutcomes measure: The Visual Analog Scale (VAS), primaryOutcomes measure: Evaluation of edema, primaryOutcomes measure: Fatigue Severity Scale (FSS), primaryOutcomes measure: Short Form-36 (SF-36), eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Istanbul Medipol University, city: Istanbul, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
protocolSection identificationModule nctId: NCT06338241, orgStudyIdInfo id: CPP2021-008391, briefTitle: Osteogenic Action of a Biphasic Bioceramic With Statin in a Third Molar Extraction Model, acronym: Galibone, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-02, primaryCompletionDateStruct date: 2025-06-02, completionDateStruct date: 2025-09-02, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Mario Pérez Sayáns, class: OTHER, collaborators name: Universidad de Murcia, descriptionModule briefSummary: The clinical study aims to assess the osteogenic effects of Galibone+ in bone regeneration post-extraction of impacted mandibular third molars., conditionsModule conditions: Bone Loss, conditions: Regenerative Inflammation, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Biphasic bioceramic of tricalcium phosphate and hydroxyapatite with simvastatin, interventions name: Bovine Hydroxyapatite, outcomesModule primaryOutcomes measure: Bone Regeneration_Reduction in radiolucent volume, primaryOutcomes measure: Bone Regeneration_bone volume, primaryOutcomes measure: Bone Regeneration_bone density, primaryOutcomes measure: Bone Regeneration_Fractal dimension, secondaryOutcomes measure: Pain levels through visual analog scale, secondaryOutcomes measure: Clinical Inflammation evaluating by presence/absence, secondaryOutcomes measure: Healing measured by healing index, secondaryOutcomes measure: Post-surgical complications evaluated by presence or absense, secondaryOutcomes measure: Oral Health-related Quality of Life measured by OHIP-14 test, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Faculty of Dentistry of Universidade de Santiago de Compostela, status: RECRUITING, city: Santiago De Compostela, state: A Coruña, zip: 15705, country: Spain, contacts name: MARIO PEREZ SAYANS GARCIA, PHD, PHD, role: CONTACT, email: mario.perez@usc.es, geoPoint lat: 42.88052, lon: -8.54569, locations facility: Faculty of Dentistry University of Murcia, status: RECRUITING, city: Murcia, country: Spain, contacts name: FABIO CAMACHO ALONSO, PHD, role: CONTACT, email: fcamacho@um.es, geoPoint lat: 37.98704, lon: -1.13004, hasResults: False
protocolSection identificationModule nctId: NCT06338202, orgStudyIdInfo id: CV027-1137, briefTitle: Real-World Effectiveness of Mavacamten in Canada, acronym: MAVEN, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-08-31, completionDateStruct date: 2024-08-31, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Bristol-Myers Squibb, class: INDUSTRY, descriptionModule briefSummary: The purpose of this observational, retrospective, physician survey study is to describe the real-world effectiveness and use of mavacamten in participants who initiated treatment for obstructive hypertrophic cardiomyopathy (oHCM) in Canada., conditionsModule conditions: Obstructive Hypertrophic Cardiomyopathy (oHCM), designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Mavacamten, outcomesModule primaryOutcomes measure: Change in New York Heart Association (NYHA) functional class following mavacamten treatment initiation, secondaryOutcomes measure: Change in left ventricular outflow tract (LVOT) with Valsalva maneuver (vLVOT) gradient following mavacamten treatment initiation, secondaryOutcomes measure: Proportion of patients with left ventricular outflow tract (LVOT) with Valsalva maneuver gradient (vLVOT) < 20mmHg following mavacamten treatment initiation, secondaryOutcomes measure: Age, secondaryOutcomes measure: Sex at birth, secondaryOutcomes measure: Ethnicity, secondaryOutcomes measure: Employment status, secondaryOutcomes measure: Body mass index (BMI), secondaryOutcomes measure: Obstructive hypertrophic cardiomyopathy (oHCM) disease duration, secondaryOutcomes measure: Proportion of patients in each New York Heart Association (NYHA) functional class II and III, secondaryOutcomes measure: Left ventricular outflow tract (LVOT) with Valsalva maneuver (vLVOT) gradient, secondaryOutcomes measure: Left ventricular ejection fraction by 2D echocardiogram (LVEFb), secondaryOutcomes measure: Mavacamten dose regimen, secondaryOutcomes measure: Proportion of patients who discontinued mavacamten, secondaryOutcomes measure: Duration of treatment prior to mavacamten discontinuation, secondaryOutcomes measure: Left ventricular ejection fraction by 2D echocardiogram (LVEF) at the time of mavacamten treatment discontinuation, secondaryOutcomes measure: Proportion of patients with left ventricular ejection fraction by 2D echocardiogram (LVEF) < 50% at the time of mavacamten treatment discontinuation, secondaryOutcomes measure: Reason for discontinuing mavacamten treatment, secondaryOutcomes measure: Functional assessment schedule, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: London Health Science Centre (LHSC), city: London, state: Ontario, zip: N6A 5A5, country: Canada, geoPoint lat: 42.98339, lon: -81.23304, hasResults: False
protocolSection identificationModule nctId: NCT06338176, orgStudyIdInfo id: Pro00128904, briefTitle: Optimizing the Management of Staphylococcus Aureus Bacteremia (OPTIMUS-SAB), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-10-30, completionDateStruct date: 2026-04-30, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: University of Alberta, class: OTHER, collaborators name: Alberta Health services, descriptionModule briefSummary: Staphylococcus aureus bacteremia (SAB) is associated with high morbidity and mortality rates with an incidence disproportionately higher in vulnerable populations. Management according to evidence-based care parameters, in particular Infectious Diseases (ID) consultation, is associated with improved mortality. SAB management is suboptimal in Alberta compared to other jurisdictions. An Alberta-based pilot study confirmed that timely recommendations to optimize SAB care, including ID consultation, was associated with improved adherence to all evidence-based quality-of-care indicators.Leveraging this pilot work, the investigators aim to implement OPTIMUS-SAB, an enhanced model of the pilot, to optimize and standardize SAB management across Alberta. The implementation study will be a zone-based acute care site stepped wedge design. OPTIMUS-SAB will consist of a centralized SAB care team whom will receive automated notification of all blood cultures positive for S. aureus allowing them to review the patient's medical chart and make preliminary management recommendations according to an evidence-based care bundle.The investigators will evaluate adherence to evidence-based SAB quality-of-care indicators before and after OPTIMUS-SAB implementation and expect this to improve with a resultant reduction in duration of bacteremia, length of stay, readmission rates, and mortality. In turn, this will translate into cost savings for the health care system., conditionsModule conditions: Staph Aureus Bacteremia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 1800, type: ESTIMATED, armsInterventionsModule interventions name: OPTIMUS-SAB clinical care pathway, outcomesModule primaryOutcomes measure: Adherence to quality-of-care indicators, secondaryOutcomes measure: Length of stay, secondaryOutcomes measure: Hospital re-admission rates, secondaryOutcomes measure: All-cause mortality, secondaryOutcomes measure: In hospital mortality, secondaryOutcomes measure: Costing evaluation, secondaryOutcomes measure: Implementation evaluation, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06338137, orgStudyIdInfo id: 4-2024urol, briefTitle: Comparison of High and Low Pulse Energy Dusting Protocols Using Holmium: YAG-laser in Flexible Ureteroscopy for Renal Stones Treatment, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-08-25, primaryCompletionDateStruct date: 2023-08-25, completionDateStruct date: 2024-01-01, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Menoufia University, class: OTHER, descriptionModule briefSummary: Rcompare high-energy versus low-energy laser settings in renal stone lithotripsy using low power machines) Holmium YAG 30 watts, examining their respective advantages, limitations, and overall efficacy., conditionsModule conditions: Renal Stone, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 160, type: ACTUAL, armsInterventionsModule interventions name: Holmium Yag laser, outcomesModule primaryOutcomes measure: Stone free rates, secondaryOutcomes measure: Preoperative complications, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hossam Kandeel, city: Shibīn Al Kawm, state: State Or Province, zip: 32511, country: Egypt, geoPoint lat: 30.55258, lon: 31.00904, hasResults: False
protocolSection identificationModule nctId: NCT06338124, orgStudyIdInfo id: David Ibrahim, briefTitle: Value of Laboratory Biomarkers in Prediction of Outcome in Septic Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-03-15, completionDateStruct date: 2025-04-01, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Egymedicalpedia, class: INDUSTRY, descriptionModule briefSummary: Sepsis is defined as a dysregulated host response to infection . Despite ongoing efforts, both the incidence and mortality of sepsis have demonstrated limited reductions over the past years,There are several biomarkers that have already been studied for the early diagnosis of sepsis. Some of these markers can be used in risk prediction and monitoring the outcome of sepsis .Some of these markers as procalcitonin and CD14, are costly and not feasible options for low- and middle-income countries . While other biomarkers are feasible and accessible to be evaluated as Triglyceride\\glucose index (TyG), Relative Distributive Width of red blood corpuscles to albumin ratio (RAR), C-reactive protein,Neutrophile \\Lympocyte ratio and serum lactate levels ., conditionsModule conditions: Sepsis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Triglyceride glucose index, outcomesModule primaryOutcomes measure: Mortality, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Assuit University Hospital, city: Assiut, country: Egypt, contacts name: Dina Hamad, Assist.Prof, role: CONTACT, phone: +201063040703, email: dinaalihamad@yahoo.com, geoPoint lat: 27.18096, lon: 31.18368, hasResults: False