hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06300112, orgStudyIdInfo id: Amasya Univ_emine.akca, briefTitle: Prenatal Yoga on Stress, Quality of Sexual Life and Sleep Level, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2024-05-31, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Amasya University, class: OTHER, descriptionModule briefSummary: The study will investigate the effects of pregnancy yoga on perceived stress, quality of sexual life and sleep level. A total of 100 pregnant women are planned to be included in the study. Data will be collected with the "Personal Information Form", "Perceived Stress Scale" and "Sexual Quality of Life Questionnaire-Female". Yoga will be applied to the experimental group for a total of 12 sessions, two sessions per week (90 minutes) for six weeks. The research predicts that yoga will reduce the stress perceived by pregnant women, increase the quality of sexual life and positively affect sleep patterns., conditionsModule conditions: Stress, conditions: Sexuality, conditions: Sleep, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A randomized-controlled trial with pretest-posttest control group, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: YOGA, outcomesModule primaryOutcomes measure: Perceived stress level, primaryOutcomes measure: Sexual Quality of Life, otherOutcomes measure: Sleep patterns, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Amasya University, city: Amasya, zip: 05100, country: Turkey, contacts name: Emine İbici Akça, Ph.D, role: CONTACT, phone: 03582115005-4723, email: emine.akca@amasya.edu.tr, geoPoint lat: 40.65333, lon: 35.83306, hasResults: False
protocolSection identificationModule nctId: NCT06300099, orgStudyIdInfo id: AZAST/Research/52/20-Jan-2024, briefTitle: Dexamethasone Versus Dexmedetomidine as Adjuncts to Serratus Anterior Plane Block, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-10-01, completionDateStruct date: 2024-10-01, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Al-Azhar University, class: OTHER, descriptionModule briefSummary: Modified radical mastectomy is the most commonly performed surgical approach for breast cancer. The procedure enables surgeons to remove the main tumor mass, adjacent glandular tissue and regional lymph nodes. Moreover, it provides a cosmetic outcome that clearly surpasses the standard radical mastectomy and allows subsequent breast reconstruction with favorable results.The present randomized study aims to compare the postoperative analgesic effects of dexamethasone and dexmedetomidine as adjuncts to serratus anterior plane block in women undergoing modified radical mastectomy., conditionsModule conditions: Breast Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 126, type: ESTIMATED, armsInterventionsModule interventions name: Dexamethasone, interventions name: Dexmedetomidine, outcomesModule primaryOutcomes measure: postoperative visual assessment scale for pain., eligibilityModule sex: FEMALE, minimumAge: 20 Years, maximumAge: 60 Years, stdAges: ADULT, hasResults: False
protocolSection identificationModule nctId: NCT06300073, orgStudyIdInfo id: AB-360-001-2022, briefTitle: Plaque Removal Efficacy of a U-Shaped Sonic Power Toothbrush in Children, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-02-14, primaryCompletionDateStruct date: 2023-02-17, completionDateStruct date: 2023-02-17, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Lander Enterprises, LLC, class: INDUSTRY, descriptionModule briefSummary: The objective of this single-use, examiner blinded, randomized, two-period, cross-over, IRB-approved clinical study is to evaluate the safety and plaque removal efficacy of AutoBrush®, a new children's 360° sonic toothbrush, compared to a marketed children's manual toothbrush., conditionsModule conditions: Dental Plaque, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: single-use, randomized, two-period, cross-over study, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Examiner and data recorder will not have access to the room for test materials dispensing and instructions., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 22, type: ACTUAL, armsInterventionsModule interventions name: Experimental: U-shaped Power Toothbrush, interventions name: Placebo Comparator: Soft Manual Toothbrush, outcomesModule primaryOutcomes measure: Within-Treatment Whole-Mouth Differences (vs Baseline) - Plaque removal Mean Change from baseline (pre-brushing to post-brushing) in plaque score after single supervised use based on all tooth surfaces of the whole mouth., eligibilityModule sex: ALL, minimumAge: 5 Years, maximumAge: 8 Years, stdAges: CHILD, contactsLocationsModule locations facility: Salus Research, Inc, city: Fort Wayne, state: Indiana, zip: 46825, country: United States, geoPoint lat: 41.1306, lon: -85.12886, hasResults: False
protocolSection identificationModule nctId: NCT06300047, orgStudyIdInfo id: REB23-0679, briefTitle: Diabetes Transition Coordinator Study, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2028-12-31, completionDateStruct date: 2028-12-31, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: University of Calgary, class: OTHER, collaborators name: Juvenile Diabetes Research Foundation, collaborators name: Canadian Institutes of Health Research (CIHR), descriptionModule briefSummary: The goal of this interventional study is to assess the effects and evaluate the implementation of a pediatric to adult care transition intervention in youth with T1D on clinical, patient-reported, and implementation outcomes, including an economic analysis.The 3 main aims are:1. To assess the effects of our transition intervention on clinical and patient-reported outcomes.2. To implement the transition intervention and evaluate the implementation outcomes.3. To evaluate the economic impacts of the transition intervention. Participants will have access to a transition coordinator before, during, and after their planned transition from pediatric to adult care as standard of care.Researchers will compare a pre-intervention cohort to evaluate the impact of the transition coordinator intervention., conditionsModule conditions: Type 1 Diabetes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: The usual care group is defined as the group who receives usual care and serves as the control group. This group is defined prior to the implementation of the intervention. We include a two month wash out period between our two groups to avoid care providers 'holding on' to patients they feel may benefit from the intervention, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 324, type: ESTIMATED, armsInterventionsModule interventions name: Non-Medical Transition Coordinator, outcomesModule primaryOutcomes measure: Lost to Followup, secondaryOutcomes measure: Patient Reported Outcome Survey 1, secondaryOutcomes measure: Patient Reported Outcome Survey 2, secondaryOutcomes measure: Patient Reported Outcome Survey 3, secondaryOutcomes measure: Clinical Outcome 1, secondaryOutcomes measure: Clinical Outcome 2, secondaryOutcomes measure: Clinical outcome 3, secondaryOutcomes measure: Clinical outcome 4, secondaryOutcomes measure: Clinical Outcome 5, secondaryOutcomes measure: Clinical Outcome 6, eligibilityModule sex: ALL, minimumAge: 17 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Alberta Children's Hospital, city: Calgary, state: Alberta, country: Canada, geoPoint lat: 51.05011, lon: -114.08529, hasResults: False
protocolSection identificationModule nctId: NCT06300034, orgStudyIdInfo id: bagattoni2, briefTitle: Parental Perceptions and Acceptance of Silver Diamine Fluoride in Italy, acronym: SDF, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-09-01, primaryCompletionDateStruct date: 2022-02-01, completionDateStruct date: 2022-03-01, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: University of Bologna, class: OTHER, descriptionModule briefSummary: Parental perceptions on staining due to Silver Diamine Fluoride (SDF) could affect its implementation in pediatric dentistry. This study represents the second part of a wider project focused on SDF aesthetic acceptability among Italian parents., conditionsModule conditions: Perceptions, conditions: Acceptability, conditions: SDF, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 234, type: ACTUAL, outcomesModule primaryOutcomes measure: Parental overall acceptance of SDF staining on anterior and posterior teeth, secondaryOutcomes measure: Parental willingness to accept SDF treatment on anterior and posterior teeth depending on child's behavior, secondaryOutcomes measure: Parental overall acceptability of SDF staining according to demographic background, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Servizio di Assistenza Odontoiatrica per disabili in età evolutiva e di odontoiatria infantile, city: Bologna, country: Italy, geoPoint lat: 44.49381, lon: 11.33875, hasResults: False
protocolSection identificationModule nctId: NCT06300008, orgStudyIdInfo id: OrthoTU13, briefTitle: Cetylated Fatty Acid for Reducing Pain After TKA, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-12, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Thammasat University, class: OTHER, descriptionModule briefSummary: To compare efficacy of cetylated fatty acid with placebo for reducing postoperative pain after unilateral TKA. The hypothesis is topical cetylated fatty acid can mitigate postoperative pain after TKA., conditionsModule conditions: Postoperative Pain, conditions: Postoperative Inflammation, 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: 80, type: ESTIMATED, armsInterventionsModule interventions name: cetylated fatty acid, interventions name: Placebo, outcomesModule primaryOutcomes measure: Visual analog scale, primaryOutcomes measure: Visual analog scale, primaryOutcomes measure: Visual analog scale, primaryOutcomes measure: Visual analog scale, primaryOutcomes measure: inflammatory marker, primaryOutcomes measure: inflammatory marker, primaryOutcomes measure: inflammatory marker, primaryOutcomes measure: inflammatory marker, primaryOutcomes measure: Knee skin temperature, primaryOutcomes measure: Knee skin temperature, primaryOutcomes measure: Knee skin temperature, primaryOutcomes measure: Knee skin temperature, secondaryOutcomes measure: Knee circumference (cm), secondaryOutcomes measure: Knee circumference (cm), secondaryOutcomes measure: Knee circumference (cm), secondaryOutcomes measure: Knee circumference (cm), secondaryOutcomes measure: Knee Range of Motion, secondaryOutcomes measure: Knee Range of Motion, secondaryOutcomes measure: Knee Range of Motion, secondaryOutcomes measure: Knee Range of Motion, secondaryOutcomes measure: Modified WOMAC, secondaryOutcomes measure: Modified WOMAC, secondaryOutcomes measure: Modified WOMAC, secondaryOutcomes measure: Thai forgotten joint score, secondaryOutcomes measure: Thai forgotten joint score, secondaryOutcomes measure: Thai forgotten joint score, eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: department of orthopaedic surgery, Faculty of medicine, Thammasat university, status: RECRUITING, city: Khlong Luang, state: Pathumthani, zip: 066, country: Thailand, contacts name: supakit kanitnate, role: CONTACT, phone: 6629260000, email: naypeng@hotmail.com, contacts name: Nattapol Tammachote, M.D., role: PRINCIPAL_INVESTIGATOR, contacts name: Supakit Kanitnate, M.D., role: SUB_INVESTIGATOR, geoPoint lat: 14.06467, lon: 100.64578, hasResults: False
protocolSection identificationModule nctId: NCT06299982, orgStudyIdInfo id: SSGJ-608-PsO-III-02, briefTitle: An Phase III Study of Recombinant Anti-IL-17A Humanized Monoclonal Antibody in Chinese Participants With PsO, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-15, primaryCompletionDateStruct date: 2025-01-30, completionDateStruct date: 2025-03-20, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to examin the efficacy and safety of the study drug recombinant anti-IL-17A humanized monoclonal antibody in Chinese participants with moderate-to-severe plaque psoriasis., conditionsModule conditions: Plaque Psoriasis Patients, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 750, type: ESTIMATED, armsInterventionsModule interventions name: 608 Q2W, interventions name: 608 Q4W, outcomesModule primaryOutcomes measure: Percentage of Participants Achieving a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75), primaryOutcomes measure: Percentage of Participants With a Static Physician Global Assessment (sPGA) Score of Clear (0) or Minimal (1) With at Least a 2 Point Improvement, secondaryOutcomes measure: Percentage of Participants Achieving a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90), secondaryOutcomes measure: Percentage of Participants Achieving a ≥100% Improvement in Psoriasis Area and Severity Index (PASI 100), secondaryOutcomes measure: Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of Clear (0), secondaryOutcomes measure: Adverse events (AE), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06299969, orgStudyIdInfo id: StBernwardH, briefTitle: Feedback Intervention and Treatment Trial in Patients With Out-of-Hospital Cardiac Arrest, acronym: FITT-OHCA, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: St.Bernward Hospital, class: OTHER, collaborators name: University Medical Center Goettingen, descriptionModule briefSummary: The trial collects and analyzes data from Cardiac Arrest Centres in patients with out-of-hospital cardiac arrest (OHCA)., conditionsModule conditions: Out-Of-Hospital Cardiac Arrest, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 3000, type: ESTIMATED, outcomesModule primaryOutcomes measure: In-hospital mortality, secondaryOutcomes measure: CPC score, secondaryOutcomes measure: MRS, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: St Bernward Hospital, status: RECRUITING, city: Hildesheim, state: Niedersachsen, zip: 31134, country: Germany, contacts name: Karl H Scholz, MD, role: CONTACT, phone: +4955139, phoneExt: 64940, email: k.scholz@fitt-stemi.de, contacts name: Sebastian Riedel, role: CONTACT, phone: +4955139, phoneExt: 64940, email: s.riedel@bernward-khs.de, geoPoint lat: 52.15077, lon: 9.95112, hasResults: False
protocolSection identificationModule nctId: NCT06299956, orgStudyIdInfo id: 2023-SFHHB-IC-001, briefTitle: Supervised Exercise-based Rehabilitation for People With Intermittent Claudication in Denmark, acronym: StRiDE, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-01, primaryCompletionDateStruct date: 2029-01, completionDateStruct date: 2029-01, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Slagelse Hospital, class: OTHER, collaborators name: Region Zealand, collaborators name: Vordingborg Municipality, collaborators name: Kalundborg municipality, collaborators name: Køge Municipality, collaborators name: Næstved municipality, collaborators name: Solrød Municipality, descriptionModule briefSummary: The goal of this project is to implement a protocol for a supervised exercise therapy intervention including smoking cessation in the municipalities in region Zealand in Denmark. The participants are adults with intermittent claudication.The objective of this project is to describe:1. The development and design of the implementation process of a rehabilitative intervention including SET and smoking cessation in Region Zealand with a 6-month follow-up period after completion of the SET.2. The ongoing quality monitoring process of the implementation in terms of referral, recruitment, retention, data completeness, intervention delivery and attendance and to collect feedback that will guide refinements of the intervention delivery and data collection.3. Outcomes available for assessment of benefits and harms from the SET intervention.Participants will be asked to do supervised exercise therapy by walking on a treadmill for 3 times a week for 12 weeks, and engage in smoking cessation, if they are smoking., conditionsModule conditions: Intermittent Claudication, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 600, type: ESTIMATED, armsInterventionsModule interventions name: Supervised exercise therapy, outcomesModule primaryOutcomes measure: Maximal Walking Distance, secondaryOutcomes measure: Pain-free walking distance, secondaryOutcomes measure: Vascular Quality of Life Questionnaire-6 (VASCUQoL-6), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: PROgrez, status: RECRUITING, city: Slagelse, zip: 4700, country: Denmark, contacts name: Helle Bøgard, role: CONTACT, email: hboga@regionsjaelland.dk, contacts name: Lars Tang, role: CONTACT, email: larta@reggionsjaelland.dk, geoPoint lat: 55.40276, lon: 11.35459, hasResults: False
protocolSection identificationModule nctId: NCT06299930, orgStudyIdInfo id: LRR after NACT vs ACT, briefTitle: Locoregional Recurrence After Neoadjuvant Versus Adjuvant Chemotherapy, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-04-22, primaryCompletionDateStruct date: 2023-08-16, completionDateStruct date: 2023-09-12, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Seoul National University Hospital, class: OTHER, descriptionModule briefSummary: Neoadjuvant chemotherapy (NACT) for early-stage breast cancer is associated with an increased risk of locoregional recurrence (LRR). However, few studies have conducted subgroup analyses of patients with various molecular subtypes, which are one of the determinant factors for treatments. The aim of the study is to investigate whether the risk of LRR after NACT varies across tumor subtypes. The investigators retrospectively reviewed the medical records of female breast cancer patients who underwent breast-conserving surgery at three institutions between January 1, 2004, and Dec 31, 2018., conditionsModule conditions: Breast Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: RETROSPECTIVE, enrollmentInfo count: 10328, type: ACTUAL, armsInterventionsModule interventions name: Neoadjuvant chemotherapy, interventions name: Adjuvant chemotherapy, outcomesModule primaryOutcomes measure: Locoregional recurrence-free survival (LRR), secondaryOutcomes measure: Distant metastasis-free survival, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Seoul National University Hospital, city: Seoul, zip: 03080, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2022-04-22, uploadDate: 2024-03-01T20:58, filename: Prot_SAP_000.pdf, size: 151396, hasResults: False