hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06354712, orgStudyIdInfo id: 2024-45, briefTitle: Efficacy of N-acetylcysteine in Preventing Radiotherapy-Induced Oral Mucositis in Head and Neck Cancer Patients., statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-04, primaryCompletionDateStruct date: 2025-03-01, completionDateStruct date: 2025-03-01, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Mansoura University, class: OTHER, descriptionModule briefSummary: A prospective, randomized, controlled, parallel clinical trial will be conducted at Clinical Oncology and Nuclear Medicine Center at Mansoura University Hospital to assess the efficacy of N-acetylcysteine in the prevention of radiotherapy induced oral mucositis in Head and Neck cancer patients., conditionsModule conditions: Oral Mucositis (Ulcerative) Due to Radiation, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: N-Acetyl-Cysteine with Institutional standard care, interventions name: Institutional standard care, outcomesModule primaryOutcomes measure: Incidence of oral mucositis with grade ≥ 2 assessed weekly by World Health Organization scale for Oral Mucositis., secondaryOutcomes measure: Time to develop oral mucositis with grade ≥ 2., secondaryOutcomes measure: Duration of oral mucositis with grade ≥ 2., secondaryOutcomes measure: Pain assessed by Visual Analog Scale (VAS)., secondaryOutcomes measure: Functional oral intake scale, secondaryOutcomes measure: Patient's quality of life assessed by Functional Assessment of Cancer Therapy in Head and Neck Cancer (FACT-H&N) version 4, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Clinical Oncology and Nuclear Medicine of Mansoura University Hospital, status: RECRUITING, city: Mansoura, country: Egypt, contacts name: Rasha Abd-Ellatif, Professor, role: CONTACT, geoPoint lat: 31.03637, lon: 31.38069, hasResults: False
protocolSection identificationModule nctId: NCT06354699, orgStudyIdInfo id: RGS0000003993, briefTitle: A Longitudinal Study Looking at the Prevalence, Risk Factors & Consequences of Persistent Post-surgical Pain in Children, acronym: POPSICLE, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-06-26, primaryCompletionDateStruct date: 2028-06, completionDateStruct date: 2028-07, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Telethon Kids Institute, class: OTHER, descriptionModule briefSummary: The purpose of this study is to investigate the prevalence, risk factors and consequences of chronic post-surgical pain in children aged 0-16 years through a number of questionnaires completed at various timepoints, from before surgery up to 1 year post surgery., conditionsModule conditions: Chronic Pain, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 5000, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: The prevalence of chronic post-surgical pain after 10- 12 months., secondaryOutcomes measure: Identifying potential risk factors for chronic post-surgical pain, eligibilityModule sex: ALL, maximumAge: 16 Years, stdAges: CHILD, contactsLocationsModule locations facility: Telethon Kids Institute, status: RECRUITING, city: Perth, state: Western Australia, country: Australia, contacts name: Natalie P Jowett, role: CONTACT, phone: 08 6456 4809, email: Natalie.Jowett@telethonkids.org.au, contacts name: Lliana Slevin, role: CONTACT, phone: 08 64564806, email: Lliana.slevin@telethonkids.org.au, contacts name: Britta von Ungern-Sternberg, Professor, role: PRINCIPAL_INVESTIGATOR, contacts name: David Sommerfield, Associate, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -31.95224, lon: 115.8614, hasResults: False
protocolSection identificationModule nctId: NCT06354686, orgStudyIdInfo id: STUDY00004245, briefTitle: Characterizing the Scalp Tolerability of TMS, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-12, primaryCompletionDateStruct date: 2026-05, completionDateStruct date: 2027-05, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Florida State University, class: OTHER, descriptionModule briefSummary: The primary objective is to characterize the tolerability of TMS by scalp location (over parietal, motor, modified Beam F3 prefrontal, THREE-D prefrontal, orbitofrontal, and medial prefrontal) and stimulation parameters (single pulse, 10 Hz, theta burst). The secondary objective is to evaluate the knee as a surrogate location to safely trial tolerability of novel TMS parameters., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: TMS Tolerability, outcomesModule primaryOutcomes measure: Tolerability of TMS - Scalp Location, primaryOutcomes measure: Tolerability of TMS - Stimulation parameters (single pulse, 10 Hz, theta burst)., secondaryOutcomes measure: Tolerability of TMS (Knee Location), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Florida State University, status: RECRUITING, city: Tallahassee, state: Florida, zip: 32306, country: United States, contacts name: Isabelle Taylor, MA, role: CONTACT, phone: 850-645-8882, email: imtaylor@fsu.edu, geoPoint lat: 30.43826, lon: -84.28073, hasResults: False
protocolSection identificationModule nctId: NCT06354647, orgStudyIdInfo id: HM20028419, briefTitle: Zirconia-based Primary Anterior Crowns With Retention Grooves Versus Without Retention Grooves, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2027-05-01, completionDateStruct date: 2027-06-01, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Virginia Commonwealth University, class: OTHER, descriptionModule briefSummary: The purpose of this research study is to test the effectiveness of two different crowns/caps on teeth for restoration of primary anterior teeth. The two different materials of crowns are esthetic crowns with retentive grooves and without retentive crowns. These crowns are placed on the teeth to restore function, esthetics and prevent further caries and infection., conditionsModule conditions: Dental Caries, conditions: Tooth Decay, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 75, type: ESTIMATED, armsInterventionsModule interventions name: Zirconia-based primary anterior crowns with retention grooves, interventions name: Zirconia-based primary anterior crowns without retention grooves, outcomesModule primaryOutcomes measure: Success of prefabricated Zirconia-based primary anterior crowns with retention grooves compared to Zirconia-based primary anterior crowns without retention grooves through clinical outcomes, primaryOutcomes measure: Success of prefabricated Zirconia-based primary anterior crowns with retention grooves compared to Zirconia-based primary anterior crowns without retention grooves through radiographic outcomes, secondaryOutcomes measure: Parental satisfaction, secondaryOutcomes measure: Child satisfaction, secondaryOutcomes measure: Oral health impact during early childhood, eligibilityModule sex: ALL, minimumAge: 2 Years, maximumAge: 6 Years, stdAges: CHILD, contactsLocationsModule locations facility: Virginia Commonwealth University, city: Richmond, state: Virginia, zip: 23298, country: United States, contacts name: Jayakumar Jayaraman, BDS, MDS, FDSRCS, MS, PhD, role: CONTACT, phone: (804) 828-9095, email: jayaramanj@vcu.edu, contacts name: Alpna Khatri, role: CONTACT, phone: (571) 302-6719, email: khatria4@vcu.edu, geoPoint lat: 37.55376, lon: -77.46026, hasResults: False
protocolSection identificationModule nctId: NCT06354634, orgStudyIdInfo id: HM20028439, briefTitle: Resin Polymer (NuSmile BioFlx) Compared to Stainless Steel Crowns (3M ESPE) for Restoration of Primary Molar Teeth, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2027-07, completionDateStruct date: 2027-07, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Virginia Commonwealth University, class: OTHER, descriptionModule briefSummary: The purpose of this research study is to test the effectiveness of two different crowns/caps on teeth for restoration of primary molar teeth. The two different materials of crowns are resin polymer and stainless steel crowns. These crowns are placed on the teeth to restore function and prevent further caries and infection., conditionsModule conditions: Dental Caries, conditions: Tooth Decay, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Each participant will receive both interventions., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Resin polymer (NuSmile Bioflx) crown, interventions name: Stainless steel crown, outcomesModule primaryOutcomes measure: The success of Bioflx crown in primary molars in comparisons with stainless steel molars through clinical assessments, primaryOutcomes measure: The success of Bioflx crown in primary molars in comparisons with stainless steel molars through radiographic assessments, secondaryOutcomes measure: Parental satisfaction, secondaryOutcomes measure: Child satisfaction, eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 7 Years, stdAges: CHILD, contactsLocationsModule locations facility: Virginia Commonwealth University, city: Richmond, state: Virginia, zip: 23298, country: United States, contacts name: Jayakumar Jayaraman, role: CONTACT, phone: 804-828-2362, email: jayaramanj@vcu.edu, geoPoint lat: 37.55376, lon: -77.46026, hasResults: False
protocolSection identificationModule nctId: NCT06354621, orgStudyIdInfo id: D/185/FIMS, briefTitle: Impact of Vitamin D Supplementation on Fetomaternal Outcomes in LTBI Pregnant Females, acronym: RCT, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-09-01, primaryCompletionDateStruct date: 2024-02-28, completionDateStruct date: 2024-03-20, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: University of the Punjab, class: OTHER, descriptionModule briefSummary: The goal of this randomized controlled trial is to see the effect of vitamin D supplementation on fetomaternal outcomes in pregnant females with Latent Tuberculosis infectionThe main question\[s\] it aims to answer are:If Vitamin D supplementation has any impact on maternal outcomes. If Vitamin D supplementation has any impact on fetal outcomes., conditionsModule conditions: Maternal and Child Health, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 99, type: ACTUAL, armsInterventionsModule interventions name: Vitamin-D supplementation, outcomesModule primaryOutcomes measure: Pre-Eclampsia (Maternal Outcome), primaryOutcomes measure: Gestational Diabetes Mellitus (Maternal Outcome), primaryOutcomes measure: C/Section delivery (Maternal Outcomes), primaryOutcomes measure: Low Birth Weight (Foetal Outcome), primaryOutcomes measure: Pre-Term delivery (Foetal Outcome), primaryOutcomes measure: Apgar Score (Foetal Outcome), secondaryOutcomes measure: Improvement in maternal vitamin-D levels, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of the Punjab, city: Lahore, state: Punjab, zip: 54600, country: Pakistan, geoPoint lat: 31.558, lon: 74.35071, hasResults: False
protocolSection identificationModule nctId: NCT06354608, orgStudyIdInfo id: duygudemirr, briefTitle: The Effect of Audio Book and Local Vibration on Pain and Fear in Intramuscular Injection in Children, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-25, primaryCompletionDateStruct date: 2024-04-01, completionDateStruct date: 2024-04-30, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: University of Yalova, class: OTHER, descriptionModule briefSummary: The study is conducted based on a randomized controlled experimental design to determine the effect of an audio book and local vibration on intramuscular injection in pediatric emergency unit patients aged 4-6 years on pain and fear., conditionsModule conditions: Procedural Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This study is an experimental, parallel-group (intervention-control), randomized controlled design, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Audio Book Group, interventions name: Local Vibration Group, outcomesModule primaryOutcomes measure: Comparison of the pain score values of the groups Pain assesed by Wong-Baker FACES, primaryOutcomes measure: Comparison of the fear score values of the groups, primaryOutcomes measure: Comparison of the fear score values of the groups, eligibilityModule sex: ALL, minimumAge: 4 Years, maximumAge: 6 Years, stdAges: CHILD, contactsLocationsModule locations facility: University of Yalova, status: RECRUITING, city: Yalova, country: Turkey, contacts name: Duygu Demir, PhD, role: CONTACT, phone: +905053662358, email: duygu.emir@yalova.edu.tr, geoPoint lat: 40.65501, lon: 29.27693, hasResults: False
protocolSection identificationModule nctId: NCT06354595, orgStudyIdInfo id: XiamenU1, briefTitle: Feasibility Study of Multidimensional Rehabilitation in the Metaverse, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-04-30, completionDateStruct date: 2024-05-01, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Qu Shen, class: OTHER, collaborators name: The First Affiliated Hospital of Xiamen University, descriptionModule briefSummary: The investigators evaluated and optimized the Metaverse multi-dimensional rehabilitation platform based on the use of the Metaverse multi-dimensional rehabilitation platform by colorectal cancer survivors and their families, and finally launched the Metaverse multi-dimensional rehabilitation platform., conditionsModule conditions: Colorectal Neoplasms, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DEVICE_FEASIBILITY, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Multidimensional Rehabilitation in the Metaverse, outcomesModule primaryOutcomes measure: Post-Study System Usability Questionnaire (PSSUQ) Third Edition, primaryOutcomes measure: System Usability Scale (SUS), secondaryOutcomes measure: Semi-structured interview, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Yuru Hu, status: RECRUITING, city: Xiamen, state: Fujian, zip: 361005, country: China, contacts name: Yuru HU, role: CONTACT, phone: 18189530895, email: 15903017593@163.com, geoPoint lat: 24.47979, lon: 118.08187, hasResults: False
protocolSection identificationModule nctId: NCT06354582, orgStudyIdInfo id: 2024-085-01, briefTitle: Effect of Intravenous Vitamin C on Intrapartum Maternal Fever After Epidural Labor Analgesia, acronym: EIVCIMFAELA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-01, completionDateStruct date: 2025-02, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Kunyue Li, class: OTHER, collaborators name: Third Affiliated Hospital of Zhengzhou University, descriptionModule briefSummary: This study aims to explore the effect of intravenous vitamin C infusion on intrapartum fever after epidural labor analgesia, to reduce the impact of intrapartum fever on maternal and infant, improve maternal and infant outcomes, and provide a reference for clinical preventive medication., conditionsModule conditions: Obstetric Labor Complications, conditions: Fever, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Parturients are randomly assigned to either vitamin C(1,2,3) or control. The vitamin C group received 1 g, 2g, and 3g of vitamin C intravenously respectively and the control group received normal saline, administered after the induction of epidural labor anesthesia. There will be 100 cases in each group. The infusion speed will be set at 5ml/min., primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule interventions name: Vitamin C Injection, interventions name: Normal saline, outcomesModule primaryOutcomes measure: Intrapartum fever or not, primaryOutcomes measure: The temperature of parturients, primaryOutcomes measure: The duration of intrapartum fever, primaryOutcomes measure: Complete blood count indicators, secondaryOutcomes measure: Visual analogue scale(VAS), secondaryOutcomes measure: Amount of total analgesics, secondaryOutcomes measure: Side effects on mothers, secondaryOutcomes measure: the duration of total labor, secondaryOutcomes measure: Incidence of rupture of membranes, secondaryOutcomes measure: Delivery characteristics 2, secondaryOutcomes measure: Record the weight of the baby., secondaryOutcomes measure: Record the gender of the baby., secondaryOutcomes measure: Apgar score, secondaryOutcomes measure: the incidence of fetal distress, secondaryOutcomes measure: Record the infant ward administration., eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06354569, orgStudyIdInfo id: 2022.232, briefTitle: Risk Factors and Risk Grading Prediction of Perioperative Respiratory Adverse Events in Children, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-12-31, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Sichuan Provincial People's Hospital, class: OTHER, descriptionModule briefSummary: to explore the risk factors of perioperative respiratory adverse events in children, and to establish a risk prediction model of perioperative respiratory adverse events in children, conditionsModule conditions: Perioperative Respiratory Adverse Events, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 600, type: ESTIMATED, outcomesModule primaryOutcomes measure: The occurrence of perioperative respiratory adverse events, eligibilityModule sex: ALL, minimumAge: 1 Month, maximumAge: 12 Years, stdAges: CHILD, contactsLocationsModule locations facility: Sichuan provincial Peopel'Hospital, status: RECRUITING, city: Chengdu, state: Sichuan, country: China, contacts name: Yanyu Liu, role: CONTACT, phone: +8613438348895, email: 43197113@qq.com, contacts name: Ting Xu, role: CONTACT, phone: +8317708130267, geoPoint lat: 30.66667, lon: 104.06667, hasResults: False
protocolSection identificationModule nctId: NCT06354556, orgStudyIdInfo id: HRS-1893-102, briefTitle: Effect of Verapamil Tablets on the Pharmacokinetic of HRS-1893 Tablets in Healthy Subjects, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2024-05-05, completionDateStruct date: 2024-05-30, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Shandong Suncadia Medicine Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: The purpose of this phase Ⅰ study is to evaluate the effect of oral verapamil tablets on the pharmacokinetics of HRS-1893 in healthy subjects., conditionsModule conditions: Obstructive Hypertrophic Cardiomyopathy, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Single center, open, single arm, fixed sequence, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 14, type: ESTIMATED, armsInterventionsModule interventions name: HRS-1893 tablet, interventions name: Verapamil tablet, outcomesModule primaryOutcomes measure: Maximum observed serum concentration (Cmax) for HRS-1893 after Single dose, primaryOutcomes measure: Area under the plasma concentration versus time curve from time zero to last measurable timepoint (AUC0-t) for HRS-1893 after single dose, primaryOutcomes measure: Area under the plasma concentration versus time curve from time zero extrapolated to infinity (AUC0-inf) for HRS-1893 after single dose, secondaryOutcomes measure: Time to maximum observed serum concentration (Tmax) for HRS-1893 after single dose, secondaryOutcomes measure: Elimination half-life (T1/2) for HRS-1893 after single dose, secondaryOutcomes measure: Apparent oral clearance (CL/F) for HRS-1893 after single dose, secondaryOutcomes measure: Apparent volume of distribution (Vz/F) for HRS-1893 after single dose, secondaryOutcomes measure: Accumulated amount of excretion (Ae) for HRS-1893 after single dose, secondaryOutcomes measure: Urinary excretion fraction（fe）for HRS-1893 after single dose, secondaryOutcomes measure: Renal clearance（CLr）for HRS-1893 after single dose, secondaryOutcomes measure: Number of subjects with adverse events and the severity of adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False