hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06358651, orgStudyIdInfo id: PH94B-CL042, briefTitle: Fasedienol Nasal Spray for the Acute Treatment of Anxiety in Adults With Social Anxiety Disorder (PALISADE-3), acronym: PALISADE-3, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-28, primaryCompletionDateStruct date: 2025-06, completionDateStruct date: 2026-06, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: VistaGen Therapeutics, Inc., class: INDUSTRY, descriptionModule briefSummary: This U.S. Phase 3 clinical trial is designed to evaluate the efficacy, safety, and tolerability of the acute intranasal (i.n.) administration of Fasedienol Nasal Spray (fasedienol) (3.2 µg) to relieve symptoms of acute anxiety in adult subjects ages 18 through 65 with Social Anxiety Disorder induced by a public speaking challenge (PSC) in a clinical setting. In addition, safety and tolerability of i.n. administration of 3.2 µg of fasedienol, as-needed, up to 6 times per day for up to 12 months, will be assessed in those subjects who complete PALISADE-3 and choose to enter the distinct open-label extension phase of the study., conditionsModule conditions: Social Anxiety Disorder, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 236, type: ESTIMATED, armsInterventionsModule interventions name: Fasedienol Nasal Spray, interventions name: Placebo Nasal Spray, outcomesModule primaryOutcomes measure: Subjective Units of Distress Scale (SUDS), secondaryOutcomes measure: Global Impression Scale of Improvement (CGI-I), secondaryOutcomes measure: Patient Global Impression of Change (PGI-C), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Vistagen Clinical Site, status: RECRUITING, city: Oceanside, state: California, zip: 92056, country: United States, geoPoint lat: 33.19587, lon: -117.37948, locations facility: Vistagen Clinical Site, status: RECRUITING, city: Jacksonville, state: Florida, zip: 32256, country: United States, geoPoint lat: 30.33218, lon: -81.65565, locations facility: Vistagen Clinical Site, status: RECRUITING, city: Orlando, state: Florida, zip: 32801, country: United States, geoPoint lat: 28.53834, lon: -81.37924, locations facility: Vistagen Clinical Site, status: RECRUITING, city: New York, state: New York, zip: 10128, country: United States, geoPoint lat: 40.71427, lon: -74.00597, locations facility: Vistagen Clinical Site, status: RECRUITING, city: Memphis, state: Tennessee, zip: 38119, country: United States, geoPoint lat: 35.14953, lon: -90.04898, hasResults: False
protocolSection identificationModule nctId: NCT06358612, orgStudyIdInfo id: DALNSHA2024ABR001, briefTitle: Evaluation of an Anxiety Reduction Tool During Thyroid and Prostate Biopsy Procedures, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-12-20, completionDateStruct date: 2025-08-31, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Nova Scotia Health Authority, class: OTHER, descriptionModule briefSummary: Patients undergoing either thyroid or prostate biopsy under local anesthetic will be asked to fill out a questionnaire that evaluates their anxiety level before and after a thyroid or prostate biopsy procedure that they undergo. Patients will be randomly assigned to either use an anxiety reducing tool (stress balls in each hand) to take their mind off the procedure or will not receive an anxiety reducing tool., conditionsModule conditions: Anxiety State, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized Controlled Trial, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Stress Balls, interventions name: No Stress Balls, outcomesModule primaryOutcomes measure: Change in anxiety level of greater than 20% based on Visual Analog Score (VAS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06358599, orgStudyIdInfo id: TUO-UR-21-01, briefTitle: The Impact of Neoadjuvant Chemotherapy on Survival Outcomes in Patients With Variant Histologies Bladder Cancer Who Underwent Radical Cystectomy, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-01-07, primaryCompletionDateStruct date: 2023-10-20, completionDateStruct date: 2024-01-15, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Ankara Etlik City Hospital, class: OTHER_GOV, descriptionModule briefSummary: The World Health Organization 2016 bladder tumor classification reported that the diagnosis of variant histology has increased from 6% to 33% in the last 2 decades, and there is an increasing interest in investigating the effects on disease management, treatment options, and survival outcomes in bladder tumors with variant histology. In bladder tumors, variant histology is known to be more aggressive and has a worse prognosis than pure urothelial cancer, and most cases are muscle invasive at diagnosis. Neoadjuvant cisplatin-containing combination chemotherapy is known to improves overall survival in patients with urothelial cancers. However, it is unclear whether patients with non-pure urothelial cancer (variant) histology will also benefit from neoadjuvant chemotherapy. The investigators aimed to evaluate the role of Neoadjuvant cisplatin-containing combination chemotherapy in the final treatment plan and its impact on survival in patients with bladder cancer who were diagnosed with variant histology in the radical cystectomy specimen., conditionsModule conditions: Bladder Cancer, conditions: Bladder Cancer Stage I, conditions: Bladder Cancer Stage II, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 221, type: ACTUAL, armsInterventionsModule interventions name: Cisplatin, outcomesModule primaryOutcomes measure: Change in survival outcomes at postoperative 2-year follow-up in patients with variant histology who received neoadjuvant chemotherapy before radical cystectomy., secondaryOutcomes measure: Factors associated with worse survival outcomes in cox-regression analysis at 2-year follow-up of all patients with variant histology who underwent radical cystectomy., eligibilityModule sex: ALL, minimumAge: 45 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ankara Etlik City Hospital, city: Ankara, zip: 06170, country: Turkey, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False
protocolSection identificationModule nctId: NCT06358586, orgStudyIdInfo id: 044(H)MD21176, secondaryIdInfos id: CRO-PK-21-356, type: OTHER, domain: CRO code, briefTitle: New Paediatric Formulation of Tachipirina®, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-04-09, primaryCompletionDateStruct date: 2022-04-25, completionDateStruct date: 2022-04-25, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Aziende Chimiche Riunite Angelini Francesco S.p.A, class: INDUSTRY, collaborators name: Cross S.A., descriptionModule briefSummary: This is a single centre, single dose, single-arm, open-label, palatability study.The aim of the present study is to investigate the palatability of the newly developed Tachipirina® 120 mg/5 mL oral suspension with strawberry flavour. The study will be conducted in paediatric volunteers that represent the target population for this product., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Single centre, single dose, single-arm, open-label, palatability study, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ACTUAL, armsInterventionsModule interventions name: Tachipirina® 120 mg/5 mL oral suspension, new flavour, outcomesModule primaryOutcomes measure: Palatability of new flavour - Taste (1), primaryOutcomes measure: Palatability of new flavour - Taste (2), primaryOutcomes measure: Palatability of new flavour - Smell, primaryOutcomes measure: Palatability of new flavour - Aftertaste (1), primaryOutcomes measure: Palatability of new flavour - Aftertaste (2), primaryOutcomes measure: Palatability of new flavour - Aftertaste (3), primaryOutcomes measure: Palatability of new flavour - Texture (mouthfeel), primaryOutcomes measure: Palatability of new flavour - Overall, secondaryOutcomes measure: Treatment emergent adverse events (TEAEs), eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: CROSS Research S.A. - Phase I Unit,, city: Arzo, zip: CH-6864, country: Switzerland, geoPoint lat: 45.87606, lon: 8.94103, hasResults: False
protocolSection identificationModule nctId: NCT06358560, orgStudyIdInfo id: BrainHealthClinics, briefTitle: Applied Clinical Neuroscience and Its Effect on Self-reported Stress and Other Physiological Markers, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-04, primaryCompletionDateStruct date: 2024-12-15, completionDateStruct date: 2024-12-15, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Dylan Saulsbery, class: OTHER, descriptionModule briefSummary: The purpose of this study is to see if an applied clinical neuroscience (ACN) approach to the symptom of 'stress' has a measurable effect on an individual's self-reported stress level. Physiological markers will be measured and analyzed to potentially allow for greater insight and aid in setting up any future research on this topic. This is an independent research study., conditionsModule conditions: Stress, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: Therapeutic exercises, outcomesModule primaryOutcomes measure: NIH Toolbox® Item Bank v3.0 - Perceived Stress (Ages 18+) - Fixed Form, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Brain Health Clinics, status: RECRUITING, city: Nashville, state: Tennessee, zip: 37217, country: United States, contacts name: Tyler Hurst, DC, role: CONTACT, phone: 615-922-0977, email: drhurst@thebrainhealthclinics.com, contacts name: Dylan Saulsbery, DC, role: PRINCIPAL_INVESTIGATOR, contacts name: Tyler Hurst, DC, role: SUB_INVESTIGATOR, contacts name: Dominic Fetterly, DC, role: SUB_INVESTIGATOR, geoPoint lat: 36.16589, lon: -86.78444, hasResults: False
protocolSection identificationModule nctId: NCT06358547, orgStudyIdInfo id: H-23072469, briefTitle: Preimplantation Genetic Testing for Aneuploidy (PGT-A) in Women Aged 37-41 Years, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2028-04-01, completionDateStruct date: 2029-04-01, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Rigshospitalet, Denmark, class: OTHER, descriptionModule briefSummary: A multinational multi-centre, randomized, controlled non-blinded trial with participation of three fertility clinics in Denmark and one in Spain to assess the efficacy and safety of preimplantation genetic testing for aneuploidy (PGT-A) in 37-41-year-old women., conditionsModule conditions: Infertility, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 590, type: ESTIMATED, armsInterventionsModule interventions name: PGT-A, outcomesModule primaryOutcomes measure: Live birth rate per first embryo transfer, primaryOutcomes measure: Cumulative live birth rate after one complete ART treatment, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 41 Years, stdAges: ADULT, contactsLocationsModule locations facility: Rigshospitalet, city: København Ø, zip: 2100, country: Denmark, contacts name: Nathalie F Wang, MD, role: CONTACT, phone: +4535454071, email: nathalie.friis.wang.03@regionh.dk, contacts name: Kristine Løssl, MD, role: CONTACT, email: kristine.loessl@regionh.dk, geoPoint lat: 55.67594, lon: 12.56553, hasResults: False
protocolSection identificationModule nctId: NCT06358534, orgStudyIdInfo id: RTEU-SBF-KB-01, briefTitle: The Effect of Acceptance and Commitment Therapy in Patients With Chronic Renal Failure, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-06-01, primaryCompletionDateStruct date: 2023-11-30, completionDateStruct date: 2024-07-30, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Recep Tayyip Erdogan University, class: OTHER, descriptionModule briefSummary: Psychological flexibility, life satisfaction and adaptation to the disease of individuals with chronic kidney disease were increased with psychoeducation based on acceptance and commitment therapy to be given to individuals with chronic kidney disease., conditionsModule conditions: Kidney Failure, Chronic, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: pretest-posttest, control and intervention groups, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 32, type: ACTUAL, armsInterventionsModule interventions name: psychoeducation based on acceptance and commitment therapy, outcomesModule primaryOutcomes measure: Chronic Disease Adaptation Scale (CHAS):, primaryOutcomes measure: Acceptance and Action Questionnaire-II Scale (AAQ-II), primaryOutcomes measure: Life Satisfaction Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Recep Tayyip Erdoğan University Faculty of Health Sciences, city: Rize, state: Güneysu, zip: 53100, country: Turkey, geoPoint lat: 41.02083, lon: 40.52194, hasResults: False
protocolSection identificationModule nctId: NCT06358508, orgStudyIdInfo id: VP-0786, briefTitle: Sapphire 3 CTO Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2025-07, completionDateStruct date: 2025-07, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: OrbusNeich, class: INDUSTRY, collaborators name: Avania, descriptionModule briefSummary: A prospective, open label, multi-center, single arm, observational study designed to evaluate the acute safety and device performance of the Sapphire 3 0.85, 1.0 and 1.25mm diameter coronary dilatation catheter in predilatation of Chronic Total Occlusion (CTO) lesions during percutaneous coronary intervention.One hundred seventy (170) subjects will be enrolled with a target of one hundred fifty-three (153) evaluable subjects by the angiographic core laboratory at up to 15 clinical sites with the Sapphire 3 0.85, 1.0 and 1.25mm diameter PTCA dilatation catheter to pre-dilate CTO lesions in coronary arteries during their index procedure. All subjects will be screened according to the protocol inclusion and exclusion criteria and will be followed through study completion, which is defined as 24-hours post-procedure or hospital discharge, whichever comes first., conditionsModule conditions: Coronary Artery Disease, conditions: Coronary Disease, conditions: Myocardial Ischemia, conditions: Heart Diseases, conditions: Arteriosclerosis, conditions: Cardiovascular Diseases, conditions: Chronic Total Occlusion, conditions: Chronic Total Occlusion of Coronary Artery, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 170, type: ESTIMATED, armsInterventionsModule interventions name: Sapphire 3 Coronary Dilatation Catheter, outcomesModule primaryOutcomes measure: Number of Participants With Device Procedural Success, secondaryOutcomes measure: Number of Participants With In-hospital Major Adverse Cardiac Events (MACE), secondaryOutcomes measure: Number of Deaths (Cardiac and Non-Cardiac), secondaryOutcomes measure: Number of Participants With Myocardial Infarctions (MI), secondaryOutcomes measure: Number of Participants With Target Lesion Revascularization (TLR), secondaryOutcomes measure: Number of Participants With In-hospital stent thrombosis (ST) Within the Target Vessel, secondaryOutcomes measure: Number of Participants With Clinically Significant Arrhythmias (Requiring Intervention), secondaryOutcomes measure: Number of Participants With Absence of Sapphire 3 Study Balloon Rupture, secondaryOutcomes measure: Number of Participants That Had Improvement in the Minimum Lumen Diameter (MLD) following use of Sapphire 3 catheter (independently measured by the Angiographic Core Lab using QCA), secondaryOutcomes measure: Number of Participants With Technical Success, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06358495, orgStudyIdInfo id: REB24-0253, briefTitle: Improving Sleep to Prevent Depression & Anxiety in Adolescents at High Risk, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-04-30, completionDateStruct date: 2025-07-30, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: University of Calgary, class: OTHER, collaborators name: Hotchkiss Brain Institute, University of Calgary, descriptionModule briefSummary: Emerging evidence has shown that sleep interventions such as Cognitive Behavioral Therapy for Insomnia (CBT-I) improve depressive and anxiety symptoms in adults, even when the intervention is brief, such as four to six sessions. The overarching aim of the proposed research is to conduct a pilot trial to evaluate whether a brief intervention for insomnia adapted for improves sleep and subthreshold depressive and anxiety symptoms in adolescents at risk (i.e., with a parental history of depressive or anxiety disorders)., conditionsModule conditions: Insomnia, conditions: Sleep Disturbance, conditions: Depressive Symptoms, conditions: Anxiety Symptoms, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants will be randomly assigned to either CBT for insomnia or TAU waitlist with a psychoeducational pamphlet about sleep hygiene., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Outcomes assessor will be blinded to participants' assigned condition., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Cognitive Behavioral Therapy for Insomnia, interventions name: Active Control, outcomesModule primaryOutcomes measure: Insomnia Severity Index, primaryOutcomes measure: Pittsburgh Sleep Quality Index, primaryOutcomes measure: Internalizing Symptoms Subscale of the Youth Self-Report, secondaryOutcomes measure: Sleep Logs - Total sleep time, secondaryOutcomes measure: Sleep Logs - Onset latency, secondaryOutcomes measure: Sleep Logs - Wake after sleep onset, secondaryOutcomes measure: Sleep Logs - Sleep efficiency, eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06358482, orgStudyIdInfo id: ORAL1, briefTitle: Electric Toothbrush Efficacy in Preventing Dental Plaque Development, acronym: E-TOOTH, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-01-30, primaryCompletionDateStruct date: 2024-04-30, completionDateStruct date: 2024-07-30, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Riccardo Polosa, class: OTHER, descriptionModule briefSummary: The present study will be the first to compared dental plaque quantitation between an oscillating-rotating electric toothbrush and a manual toothbrush with a new QLF technology., conditionsModule conditions: Dental Plaque, conditions: Calculus, Dental, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: oscillating toothbrush, interventions name: standard manual toothbrush, outcomesModule primaryOutcomes measure: fluorescence intensity of at least 30% (ΔR30), primaryOutcomes measure: the fluorescence intensity of at least 120% (ΔR120), secondaryOutcomes measure: oral hygiene (SOH) scoring, The score can be from 0, 1, .. to 5. A SOH value of 0 indicates no plaque, and 5 is the maximum and stands for maximum plaque teeth coverage an is the worst state., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: ADDENDO, status: RECRUITING, city: Catania, zip: 95100, country: Italy, geoPoint lat: 37.49223, lon: 15.07041, hasResults: False