hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06348355, orgStudyIdInfo id: D5084C00016, secondaryIdInfos id: 2023-508334-34-00, type: OTHER, domain: EMA-CTIS, briefTitle: A Positron-emission Tomography Study to Determine Brain Exposure of [11C]Savolitinib in Healthy Volunteers, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-22, primaryCompletionDateStruct date: 2024-06-28, completionDateStruct date: 2024-06-28, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: AstraZeneca, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to measure brain exposure of \[11C\]savolitinib in healthy volunteers.This study will determine brain exposure of \[11C\]savolitinib in up to 8 healthy volunteers under physiological conditions, ie, when the BBB is intact. The study design allows up to 3 site visits. Two PET examinations will be performed for each healthy volunteer. The first PET examination will use IV administration of \[11C\]savolitinib. The second PET examination using \[11C\]savolitinib will occur after a single oral dose of 300 mg of savolitinib. PET image analysis will include kinetic compartment modelling using arterial input function, and will generate a set of brain exposure parameters (eg, maximum %ID, maximum \[11C\]savolitinib concentration in brain, partition coefficients between brain and plasma)., conditionsModule conditions: Healthy Volunteers, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 8, type: ESTIMATED, armsInterventionsModule interventions name: [11C]savolitinib, interventions name: Savolitinib, outcomesModule primaryOutcomes measure: Percentage of injected radioactivity entering the brain (%ID) as %IDmax_brain, secondaryOutcomes measure: The following endpoint: Cmax_brain SUV, secondaryOutcomes measure: The following endpoint: Tmax brain, secondaryOutcomes measure: The following endpoint: AUCbrain 0-90, secondaryOutcomes measure: The following endpoint: AUCplasma 0-90, secondaryOutcomes measure: The following endpoint: Kp, secondaryOutcomes measure: The following endpoint: Kp,uu, secondaryOutcomes measure: The following endpoint: VT, secondaryOutcomes measure: The following endpoint: Cmax_brain SUV, secondaryOutcomes measure: The following endpoint: Tmax brain, secondaryOutcomes measure: The following endpoints: AUCbrain 0-90, secondaryOutcomes measure: The following endpoints: AUCplasma 0-90, secondaryOutcomes measure: The following endpoints: Kp, secondaryOutcomes measure: The following endpoints: Kp,uu, secondaryOutcomes measure: The following endpoints: VT, otherOutcomes measure: Number of participants with safety findings, AEs, eligibilityModule sex: ALL, minimumAge: 45 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Research Site, city: Solna, zip: 171 64, country: Sweden, geoPoint lat: 59.36004, lon: 18.00086, hasResults: False
protocolSection identificationModule nctId: NCT06348329, orgStudyIdInfo id: TÜTF-GOBAEK 2023/41, briefTitle: Pregnant Women Participating in Birth Preparation Training With Their Spouses on the Parenting Role, Attitudes of Their Spouses Towards Participating in the Birth, and Birth Self-Efficacy, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-06-29, primaryCompletionDateStruct date: 2023-10-15, completionDateStruct date: 2024-04-15, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Trakya University, class: OTHER, descriptionModule briefSummary: In this prospective, randomized controlled study, it was aimed to examine the effect of pregnant women participating in birth preparation training together with their partners on the parenting role, spouses' attitudes towards participation in birth, and birth self-efficacy.The study was shared via the web on social media (Facebook, Instagram, Twitter, Telegram) forum pages between 25.09.2023-25.03.2025, and n=158 pregnant women who met the inclusion criteria and volunteered to participate in the study (79= education without spouse participation, 79= spouse Participatory education) will be conducted randomly in two groups: case and control.Before starting the research, two groups will be randomly formed among pregnant women. As a randomization method, pregnant women who meet the sampling inclusion criteria determined in the research will be identified and listed. Individuals to be taken into two groups will be determined by randomization method from the random numbers table. (http://www.stattrek.com/statistics/randomnumber-generator.aspx)., conditionsModule conditions: Birth Order, conditions: Parenting, conditions: Self Efficacy, conditions: Pregnancy Related, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 158, type: ESTIMATED, armsInterventionsModule interventions name: Birth Preparation Training, outcomesModule primaryOutcomes measure: Parenting behavior evaluated using the Postpartum Parenting Behavior Scale, primaryOutcomes measure: Parenting self-efficacy in labor evaluated using the Self-Efficacy in Labor Scale, primaryOutcomes measure: Spouse support evaluated using the Spouse Support Scale, primaryOutcomes measure: Father candidates towards participating in the birth evaluated using the Attitude Scale for Father Candidates Towards Participating in the Birth, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 49 Years, stdAges: ADULT, contactsLocationsModule locations facility: Trakya University, status: RECRUITING, city: Edirne, zip: 22030, country: Turkey, contacts name: Burcu Küçükkaya, role: CONTACT, phone: 05422931357, email: burcukucukkaya1992@gmail.com, geoPoint lat: 41.67719, lon: 26.55597, hasResults: False
protocolSection identificationModule nctId: NCT06348316, orgStudyIdInfo id: TÜTF-GOBAEK 2023/45, briefTitle: Early Half Swaddling and Kangaroo Care Practices on Maternal Sleep Quality and Postpartum Depression in Term Babies, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-30, primaryCompletionDateStruct date: 2024-04-02, completionDateStruct date: 2024-07-30, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Trakya University, class: OTHER, descriptionModule briefSummary: Aim: In this prospective, randomized controlled study, it was aimed to examine the effects of early half-swaddle and kangaroo care practices in term babies on maternal sleep quality and postpartum depression.Design: The prospective, randomized controlled study, conditionsModule conditions: Mothers, conditions: Postpartum Depression, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 136, type: ESTIMATED, armsInterventionsModule interventions name: Half swaddle, interventions name: Kangaroo care, outcomesModule primaryOutcomes measure: Mother sleep quality evaluated using the Pittsburgh Sleep Quality Index (PSQI), primaryOutcomes measure: Postpartum depression evaluated using the Edinburgh Postnatal Depression Scale (EPDS), eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 49 Years, stdAges: ADULT, contactsLocationsModule locations facility: Trakya University, status: RECRUITING, city: Edirne, zip: 22030, country: Turkey, contacts name: Burcu Küçükkaya, role: CONTACT, phone: 05422931357, email: burcukucukkaya1992@gmail.com, geoPoint lat: 41.67719, lon: 26.55597, hasResults: False
protocolSection identificationModule nctId: NCT06348303, orgStudyIdInfo id: PMMD-01, briefTitle: Study to Assess Drowsiness, Cognition, Fall Risk After Metaxalone 640 mg and Metaxalone 800 mg, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2025-03-15, completionDateStruct date: 2025-03-15, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Primus Pharmaceuticals, class: INDUSTRY, collaborators name: ClinOhio Research Services, LLC, descriptionModule briefSummary: Every participant will receive Metaxalone in two (2) stages, one week after the other. A single dose of each Metaxalone dose will be taken one (1) time after a high fat meal which must be eaten within 30 minutes. Every participant will be given written tests to measure drowsiness, reaction time and thinking process and will also be asked to take walking tests to assess fall risk. Participation in this study will last approximately 2-4 weeks., conditionsModule conditions: Healthy Participants, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NON_RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Each participant will be enrolled to two (2), single dose, study treatment arms in a crossover design. The treatments will occur consecutively with seven (7) days separating days of dosing., primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, maskingDescription: Single mask of participants. Participants will be prevented from knowing product dose., whoMasked: PARTICIPANT, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Metaxalone m640 mg oral tablet, interventions name: Metaxalone 800 mg oral tablet, outcomesModule primaryOutcomes measure: Percentage of participants unable to maintain Tandem Stand Position for more than 10 seconds (position 3 of the 4-Stage Balance Test)., primaryOutcomes measure: Change from baseline of gait during a stopwatch timed, stand, and walk activity from a seated position along a 30 foot path, primaryOutcomes measure: Change from baseline of correct number of steps taken on a fixed 4 inch wide, 9 feet long path, secondaryOutcomes measure: Change from baseline of participants' subjective report of drowsiness on a 10-point scale, secondaryOutcomes measure: Change from baseline of reaction to stimulus by computer generated visual prompts measured in milliseconds, secondaryOutcomes measure: Change from baseline of participants' reasoning ability to recognize differences in six (6) computer generated shapes for 30 minutes, secondaryOutcomes measure: The number of product related adverse events experienced by participants from Visit 2 through Visit 4, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: ClinOhio Research Institute, status: RECRUITING, city: Columbus, state: Ohio, zip: 43213, country: United States, contacts name: J Sanders, role: CONTACT, phone: 614-683-4900, geoPoint lat: 39.96118, lon: -82.99879, hasResults: False
protocolSection identificationModule nctId: NCT06348290, orgStudyIdInfo id: JY-JM1899-105, briefTitle: Study to Evaluate the Drug-drug Interaction of JMKX001899 in Healthy Subjects, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-05-31, completionDateStruct date: 2024-09-15, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Jemincare, class: INDUSTRY, descriptionModule briefSummary: This is an open-label, non-randomized, clinical study to evaluate the drug interaction between itraconazole, rifampin or Cocktail and JMKX001899 in healthy subjects. A total of three cohorts of 72 healthy subjects were planned to be enrolled in each cohort., conditionsModule conditions: Solid Tumor, Adult, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 72, type: ESTIMATED, armsInterventionsModule interventions name: JMKX001899, interventions name: Itraconazole, interventions name: Midazolam, interventions name: Rifampin, interventions name: dextromethorphan, interventions name: Rosuvastatin, interventions name: digoxin, outcomesModule primaryOutcomes measure: maximum concentrations (Cmax ) for plasma, primaryOutcomes measure: area under the curve from time 0 to infinity(AUC0-inf) for plasma, primaryOutcomes measure: area under the curve from time 0 to the last time point (AUC0-t) for plasma, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06348277, orgStudyIdInfo id: 121119, briefTitle: Brief App-based Mood Monitoring and Mindfulness Intervention for First-year College Students, statusModule overallStatus: COMPLETED, startDateStruct date: 2018-01-02, primaryCompletionDateStruct date: 2020-04-07, completionDateStruct date: 2020-06-17, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Lawrence University, class: OTHER, descriptionModule briefSummary: The investigators examined whether brief, app-based interventions were helpful in alleviating mental health symptoms during the transition to college. In particular, the investigators were interested in whether a brief mobile-app mindfulness intervention combined with mood monitoring was more effective in alleviating first-year students' psychological distress than mood monitoring alone., conditionsModule conditions: Depression, Anxiety, conditions: Self-Injurious Behavior, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 130, type: ACTUAL, armsInterventionsModule interventions name: Mindfulness plus mood monitoring, interventions name: Mood monitoring, outcomesModule primaryOutcomes measure: Depressive Symptoms, primaryOutcomes measure: Anxiety Symptoms, primaryOutcomes measure: Urges to Self-injure, primaryOutcomes measure: Rumination, primaryOutcomes measure: Worry, secondaryOutcomes measure: Depressive Symptoms, secondaryOutcomes measure: Depressive Symptoms, secondaryOutcomes measure: Anxiety Symptoms, secondaryOutcomes measure: Anxiety Symptoms, secondaryOutcomes measure: Urges to self-injure, secondaryOutcomes measure: Urges to self-injure, secondaryOutcomes measure: Rumination, secondaryOutcomes measure: Rumination, secondaryOutcomes measure: Worry, secondaryOutcomes measure: Worry, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Lawrence University, city: Appleton, state: Wisconsin, zip: 54911, country: United States, geoPoint lat: 44.26193, lon: -88.41538, hasResults: False
protocolSection identificationModule nctId: NCT06348264, orgStudyIdInfo id: SDC-1, briefTitle: Adjuvant Rezvilutamide in Combination With Androgen Deprivation Therapy in Androgen Receptor-positive, High-risk Salivary Duct Carcinoma, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-30, primaryCompletionDateStruct date: 2029-03-30, completionDateStruct date: 2031-03-30, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Peking University First Hospital, class: OTHER, collaborators name: Jiangsu Hengrui Pharmaceutical Co., Ltd., collaborators name: Beijing Biote Pharmaceutical Co.,Ltd, descriptionModule briefSummary: The purpose of the study is to evaluate the efficacy and safety of rezvilutamide in combination with androgen deprivation therapy (ADT) in participants with androgen receptor (AR) positive, high-risk salivary duct carcinoma (SDC).The procedures include screening, treatment and follow-up period. The treatment includes rezvilutamide plus Luteinizing Hormone Releasing Hormone agonist (LHRHa) for up to 2 years., conditionsModule conditions: Salivary Gland Neoplasm Duct, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 37, type: ESTIMATED, armsInterventionsModule interventions name: Rezvilutamide, interventions name: Leuprolide Acetate, outcomesModule primaryOutcomes measure: 3-year disease-free survival (DFS), secondaryOutcomes measure: 3-year overall survival (OS), secondaryOutcomes measure: 3-year disease-specific survival (DSS), secondaryOutcomes measure: 3-year distant-metastatic free survival (DMFS), secondaryOutcomes measure: Adverse events, secondaryOutcomes measure: 5-year disease-free survival (DFS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Peking University First Hospital, status: RECRUITING, city: Beijing, state: Beijing, zip: 100034, country: China, contacts name: Xueying Ren, MD, role: CONTACT, phone: +86 10 83572408, email: xy_ren1031@126.com, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Peking University School and Hospital of Stomatology, status: RECRUITING, city: Beijing, state: Beijing, country: China, contacts name: Xiaofeng Shan, MD, role: CONTACT, phone: +86 10 82195390, email: kqsxf@263.net, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
protocolSection identificationModule nctId: NCT06348251, orgStudyIdInfo id: STU00219612, briefTitle: FoodSteps for Binge Eating & Food Insecurity, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-26, primaryCompletionDateStruct date: 2024-11-30, completionDateStruct date: 2024-11-30, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Northwestern University, class: OTHER, descriptionModule briefSummary: The purpose of this study is to conduct a pilot trial of a mobile intervention that targets binge eating and weight-related behaviors, to determine the feasibility, acceptability, and preliminary efficacy of the intervention among adults with recurrent binge eating, diabetes, and food insecurity., conditionsModule conditions: Binge Eating, conditions: Type 2 Diabetes, conditions: Food Insecurity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: FoodSteps, outcomesModule primaryOutcomes measure: Recruitment and retention rates, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Northwestern University Feinberg School of Medicine, status: RECRUITING, city: Chicago, state: Illinois, zip: 60611, country: United States, contacts name: Andrea K Graham, PhD, role: CONTACT, phone: 312-503-5266, email: andrea.graham@northwestern.edu, geoPoint lat: 41.85003, lon: -87.65005, hasResults: False
protocolSection identificationModule nctId: NCT06348225, orgStudyIdInfo id: FY24-10, briefTitle: Post-exercise Hot Water Immersion to Improve Overnight Blood Pressure, acronym: ExHT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Providence College, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to test whether putting your legs in a hot bath after exercise improves blood pressure in people with higher blood pressure.. The main questions it aims to answer are:* Whether exercise alone, hot water leg bath alone, or both treatments together cause blood pressure to be lower during sleep.* If there are any changes in heart rhythm or blood vessel health after exercise, hot water leg bath, or the two treatments together that relate to changes in blood pressure.Participants will complete four different trials:* 30 minutes of walking with a 45-minute lukewarm leg bath after* 30 minutes of walking with a 45-minute hot leg bath after* 45 minutes of a hot leg bath with no exercise* A day with no exercise or leg bath Researchers will look at their heart rhythm, blood vessels, and blood pressure after each of these trials to see if there are differences, and if exercise and heat together can improve heart health more than exercise or heat alone., conditionsModule conditions: Elevated Blood Pressure, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: A repeated-measures design will be used with all participants completing the three acute interventions (exercise, heat, or exercise + heat) as well as a control day., primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, maskingDescription: It is not possible to mask the participant to treatments (exercise/no exercise, water temperature, etc) or the PI who is monitoring them during treatment. However, all data (hourly blood pressure, heart rate variability, and flow-mediated dilation) will be analyzed by an individual blinded to the trial/intervention., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Exercise or heat treatment, outcomesModule primaryOutcomes measure: Ambulatory blood pressure, primaryOutcomes measure: Heart Rate Variability, primaryOutcomes measure: Flow-mediated dilation, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2024-03-28, uploadDate: 2024-03-28T10:14, filename: Prot_SAP_000.pdf, size: 198276, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2024-03-28, uploadDate: 2024-03-28T10:15, filename: ICF_001.pdf, size: 162356, hasResults: False