hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06310746, orgStudyIdInfo id: HLX6018-FIH101, briefTitle: A Randomized, Double-Blind, Placebo-Controlled, Single-Dose Escalation Phase I Clinical Study to Assess the Safety, Pharmacokinetics, and Immunogenicity of HLX6018 in Healthy Subjects, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2025-12-30, completionDateStruct date: 2026-12-30, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Shanghai Henlius Biotech, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to investigate the safety, PK, and immunogenicity of a single intravenous administration of HLX6018 in healthy subjects, based on the preliminary efficacy and safety established through in vitro and in vivo experiments.This is a randomized, double-blind, placebo-controlled study with single dose escalation design to assess the safety, PK, and immunogenicity of HLX6018 in healthy subjects. It is planned to enroll 8-10 subjects in each of seven dose groups (0.25 mg/kg, 1.0 mg/kg, 4.0 mg/kg, 12 mg/kg, 25 mg/kg, 50 mg/kg, and 70 mg/kg). This is the first-in-human study of the investigational product., conditionsModule conditions: IPF, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 66, type: ESTIMATED, armsInterventionsModule interventions name: GARP/TGF-β1 monoclonal antibody, interventions name: Placebo, outcomesModule primaryOutcomes measure: The number of subjects experiencing adverse events (AEs) and serious adverse events (SAEs), secondaryOutcomes measure: AUC0-inf, secondaryOutcomes measure: Cmax, secondaryOutcomes measure: Tmax, secondaryOutcomes measure: T1/2, secondaryOutcomes measure: CL, secondaryOutcomes measure: λz, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, hasResults: False
protocolSection identificationModule nctId: NCT06310720, orgStudyIdInfo id: 23-10026618, briefTitle: Postpartum Video Education in High Risk Populations, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Weill Medical College of Cornell University, class: OTHER, descriptionModule briefSummary: This is a prospective, single-center, randomized control study to determine if video education at the time of postpartum discharge improves patient knowledge on the warning signs for the top three causes of severe maternal morbidity (infection, hemorrhage, and blood pressure disorders) in the first seven days following delivery for self-identified, Black, Latinx, other with two or more self-identified races, Medicaid, and/or uninsured postpartum individuals. Participants will be randomized to written discharge education + video education (intervention) vs standard discharge education (control). They will complete a baseline questionnaire and a post-discharge education questionnaire during their postpartum stay to assess for knowledge improvement. The investigators hypothesize that video education will improve patient's knowledge of severe maternal morbidity warning signs., conditionsModule conditions: Postpartum Hemorrhage, conditions: Postpartum Depression, conditions: Postpartum Sepsis, conditions: Postpartum Preeclampsia, conditions: Patient Empowerment, conditions: Patient Education, conditions: Postpartum Care, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Video Education, outcomesModule primaryOutcomes measure: Change in baseline and post-education questionnaire score, secondaryOutcomes measure: Change in post-education and post-discharge questionnaire score, secondaryOutcomes measure: Number of participants who attended 6 week postpartum visit, secondaryOutcomes measure: Healthcare utilization: Number of clinic visits, secondaryOutcomes measure: Healthcare utilization: Number of phone calls, secondaryOutcomes measure: Healthcare utilization: Number of urgent care/emergency room visits, secondaryOutcomes measure: Mean difference in patient satisfaction rating, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Alexandra Cohen Hospital for Women and Newborns, city: New York, state: New York, zip: 10065, country: United States, contacts name: Heather Lipkind, MD, MSce, role: CONTACT, phone: 212-746-3045, email: hlipkind@weill.cornell.edu, contacts name: Heather Lipkind, MD, MSce, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.71427, lon: -74.00597, hasResults: False
protocolSection identificationModule nctId: NCT06310694, orgStudyIdInfo id: EGE-HEM-SL-01, briefTitle: Additional Circular Dressing Material, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-04-27, primaryCompletionDateStruct date: 2023-09-30, completionDateStruct date: 2023-12-30, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Ege University, class: OTHER, descriptionModule briefSummary: The study was conducted to determine the effect of fixing peripheral intravenous catheter (PIVC) with additional circular dressing material on the duration of PIVC stay and complications related to peripheral intravenous catheterization. In our study, a comparison was made of PIVCs applied to patients in the control (fixation of PIVC with a sterile transparent dressing) and intervention (fixation of PIVC with a sterile transparent dressing and application of an elastane circular dressing on it) groups in a public hospital in Turkey. All-cause PIVC failure was significantly higher in the intervention group (70.2%) compared to the control group (45.5%). It has been determined that fixing the PIVC with additional circular dressing material prolongs the duration of PIVC stay at the site., conditionsModule conditions: Nurse's Role, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: In our study, a comparison was made of PIVCs applied to patients in the control (fixation of PIVC with a sterile transparent dressing) and intervention (fixation of PIVC with a sterile transparent dressing and application of an elastane circular dressing on it) groups., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 91, type: ACTUAL, armsInterventionsModule interventions name: intervention group (Elastane circular dressing on sterile transparent dressing), outcomesModule primaryOutcomes measure: Skin Penetration Difficulty Rating Scale, primaryOutcomes measure: Visual Infusion Phlebitis Diagnostic Scale, primaryOutcomes measure: Infiltration Rating Scale, primaryOutcomes measure: Data Collection Form for the Patient Who Had a Peripheral Intravenous Catheter, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Şeyma Turan, city: Turgutlu, state: Manisa, zip: 45400, country: Turkey, geoPoint lat: 38.49533, lon: 27.6997, hasResults: False
protocolSection identificationModule nctId: NCT06310668, orgStudyIdInfo id: CBT IN substance use disorder, briefTitle: Has CBT an Effect on Emotional Intelligence in Patients With Substance Use Disorder?, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2024-10, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Egyptian Medical Syndicate, class: OTHER, descriptionModule briefSummary: Aim of the study: In this study, the change in emotional intelligence will be assessed before and after group CBT sessions in male patients with substance use disorder in the inpatient department of the addiction unit at Mansoura University Hospital., conditionsModule conditions: Substance Use Disorders, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: randomized clinical trial, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 84, type: ESTIMATED, armsInterventionsModule interventions name: group cognitive behavioral therapy sessions, outcomesModule primaryOutcomes measure: emotional intelligence, eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06310642, orgStudyIdInfo id: 2020-217, briefTitle: Efficacy of Prophylactic Treatment of Oral Prochlorperazine for Acute Mountain Sickness, acronym: PAMS, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-05-20, primaryCompletionDateStruct date: 2023-03-13, completionDateStruct date: 2023-03-13, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: CHRISTUS Health, class: OTHER, descriptionModule briefSummary: A field-based trial was conducted to determine if oral prochlorperazine demonstrates efficacy in the prophylactic treatment of AMS, and/or decreases the incidence of the symptoms of acute mountain sickness including headache, GI symptoms, fatigue and dizziness based on data collected in the Lake Louise AMS score., conditionsModule conditions: AMS, conditions: Acute Mountain Sickness, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Enrolled a cohort of consenting, healthy subjects aged \>17 years. Thirty subjects enrolled in the study. 15 subjects received prochlorperazine. 15 subjects received placebo., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Patients were blinded in this study., whoMasked: PARTICIPANT, enrollmentInfo count: 30, type: ACTUAL, armsInterventionsModule interventions name: Immediate descent from altitude., interventions name: Diphenhydramine, interventions name: Prochlorperazine 10 mg, outcomesModule primaryOutcomes measure: Mean Lake Louise Acute Mountain Sickness Score (LLAMS) was utilized to compare symptoms of acute mountain sickness between the prochlorperazine and placebo groups, secondaryOutcomes measure: Subjects meeting Lake Louise Acute Mountain Sickness Score (LLAMS) criteria for acute mountain sickness between the prochlorperazine and placebo groups, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CHRISTUS Health-Texas A&M Spohn Emergency Medicine Residency, city: Corpus Christi, state: Texas, zip: 78405, country: United States, geoPoint lat: 27.80058, lon: -97.39638, hasResults: False
protocolSection identificationModule nctId: NCT06310603, orgStudyIdInfo id: IRB-23-42, briefTitle: Determinants and Outcomes of High vs. Low Ultra-processed Feeding, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-08-09, primaryCompletionDateStruct date: 2024-05-15, completionDateStruct date: 2025-08-09, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Oklahoma State University, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to learn about, test, and compare health outcomes of high vs. low-processed feeding. The main question\[s\] it aims to answer are:• Does consuming a diet rich in unprocessed food improve various health outcomes? Participants will either be instructed to consume a diet rich in unprocessed food for 6 months, or consume their typical diet for 6 months. At various points in the study there will be metabolic health data collected.If there is a comparison group: Researchers will compare the low-processed group to the typical diet group to see if there are improvements in metabolic health., conditionsModule conditions: Healthy Nutrition, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Low-Processed Food Diet, outcomesModule primaryOutcomes measure: Body Weight, primaryOutcomes measure: Body Composition, primaryOutcomes measure: Fat Mass Percentage, primaryOutcomes measure: Fat-Free Mass Percentage, secondaryOutcomes measure: Triglyceride Levels, secondaryOutcomes measure: Glucose Levels, secondaryOutcomes measure: Cholesterol Levels, secondaryOutcomes measure: HDL, secondaryOutcomes measure: LDL, secondaryOutcomes measure: Alanine transaminase (ALT), secondaryOutcomes measure: Aspartate transaminase (AST), otherOutcomes measure: Energy Intake, otherOutcomes measure: Energy Expenditure, otherOutcomes measure: Gut Microbiome Collection, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Laboratory for Applied Nutrition and Exercise Science (LANES), status: RECRUITING, city: Stillwater, state: Oklahoma, zip: 74075, country: United States, contacts name: Sam Emerson, PhD, role: CONTACT, email: sam.emerson@okstate.edu, contacts name: Tyler Godsey, B.S., role: CONTACT, phone: 405-744-7708, email: tylgods@okstate.edu, contacts name: Sam Emerson, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 36.11561, lon: -97.05837, hasResults: False
protocolSection identificationModule nctId: NCT06310577, orgStudyIdInfo id: EH23-343, briefTitle: Evaluation of Leak-Free Bronchoscope Adapter to Limit Ventilated Air Volume Loss During Bronchoscopy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-11, completionDateStruct date: 2026-11, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: NorthShore University HealthSystem, class: OTHER, descriptionModule briefSummary: The purpose of this research is to evaluate the ability of a new bronchoscope adapter called "leak-free adapter" to limit the amount of air leaking out to the operating room (OR) from the ventilator in intubated patients who undergo bronchoscopy., conditionsModule conditions: Pulmonary Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Self-controlled, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 44, type: ESTIMATED, armsInterventionsModule interventions name: Leak-free bronchoscope adapter, outcomesModule primaryOutcomes measure: Number of participants able to undergo bronchoscopic evaluation using the "leak-free adapter", primaryOutcomes measure: Heart rate (bpm), primaryOutcomes measure: Blood pressure (mmHg), primaryOutcomes measure: Oxygenation as measured by SpO2, primaryOutcomes measure: Assessment of adverse events, secondaryOutcomes measure: Evaluation of bronchoscope adapter tidal volume loss efficacy, secondaryOutcomes measure: Evaluation of bronchoscope adapter aerosolization efficacy, secondaryOutcomes measure: Peak airway pressure (cmH2O), secondaryOutcomes measure: Dynamic compliance (mL/CmH2O), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06310538, orgStudyIdInfo id: 2024BZYLL0110, briefTitle: Clinical Study on the Treatment of Breast Hyperplasia With Kou Sha Therapy Based on Real World, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-05, completionDateStruct date: 2024-05, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Hongguo Rong, class: OTHER, descriptionModule briefSummary: In this study, epidemiological prospective real-world cohort study design was adopted. The Third Affiliated Hospital of Beijing University of Chinese Medicine and the First Hospital of Handan City, Hebei Province were selected. From the same time appointed before the study, all breast hyperplasia participants who met the admission criteria choosing Kou Sha therapy or routine treatment of western medicine were selected in the sample hospitals.The first 30 participants were included in the planned Kou Sha therapy group while the first 30 participants were included in the control group.Taking the change of the total score of breast pain (McGill Pain Questionnaire Short Form score+breast pain score) as the main curative effect index, and taking McGill pain questionnaire score, breast color ultrasound score, palpation lump score, quality of life, anxiety and depression symptoms, sleep and so on as the secondary curative effect indexes to observe the clinical effect of the method of Kou Sha therapy on breast hyperplasia. The research period is from March 2024 to May 2024., conditionsModule conditions: Breast Hyperplasia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: kou sha, interventions name: Hongjin Xiaojie Capsules, outcomesModule primaryOutcomes measure: Breast pain score, primaryOutcomes measure: Short Form McGill Pain Inquiry Scale (SF-MPQ), secondaryOutcomes measure: Breast color ultrasound score, secondaryOutcomes measure: Palpation lump score, secondaryOutcomes measure: Depression symptoms, secondaryOutcomes measure: Anxiety symptoms, secondaryOutcomes measure: The quality of life rating scale (QOL), eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06310525, orgStudyIdInfo id: DROWN_DDF2, briefTitle: Using Machine Learning to Optimise the Danish Drowning Formula, acronym: DROWN_DDF2, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Prehospital Center, Region Zealand, class: OTHER, descriptionModule briefSummary: The Danish Drowning Formula (DDF) was designed to search the unstructured text fields in the Danish nationwide Prehospital Electronic Medical Record on unrestricted terms with comprehensive search criteria to identify all potential water-related incidents and achieve a high sensitivity. This was important as drowning is a rare occurrence, but it resulted in a low Positive Predictive Value for detecting drowning incidents specifically. This study aims to augment the positive predictive value of the DDF and reduce the temporal demands associated with manual validation., conditionsModule conditions: Drowning, conditions: Drowning and Submersion While in Bath-Tub, conditions: Drowning and Submersion While in Natural Water, conditions: Drowning and Submersion While in Swimming-Pool, conditions: Drowning and Submersion Due to Fall Off Ship, conditions: Drowning and Nonfatal Submersion, conditions: Drowning, Near, conditions: Drowning; Asphyxia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 1500, type: ESTIMATED, armsInterventionsModule interventions name: Drowning incident, outcomesModule primaryOutcomes measure: Sensitivity of the machine learning algorithm as a drowning identification tool, primaryOutcomes measure: Specificity of the machine learning algorithm as a drowning identification tool, primaryOutcomes measure: PPV of the machine learning algorithm, primaryOutcomes measure: NPV of the machine learning algorithm, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Prehospital Center, city: Næstved, state: Region Zealand, zip: 4700, country: Denmark, geoPoint lat: 55.22992, lon: 11.76092, hasResults: False
protocolSection identificationModule nctId: NCT06310512, orgStudyIdInfo id: ANZHEN HOSPITOL-LY-04, briefTitle: Efficacy of Pharmacist Interventions Through the "Medication Therapy Management Pathway in Hypertensive Patients", acronym: PharmMTMH, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-06-30, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Beijing Anzhen Hospital, class: OTHER, descriptionModule briefSummary: The goal of this Randomized Controlled Trial is to carry out in adult patients with primary hypertension whose blood pressure control is not up to standard. The main question it aims to answer are:To explore the effect of pharmacists' implementation of "the medication therapy management pathway in hypertensive patients"on the patients with hypertension.Participants will receive structured drug treatment management at the first diagnosis. During on-site follow-up in the first, third and sixth months, as well as telephone follow-up in the second week, second and fourth months, patients will be evaluated, corresponding information will be collected and possible interventions will be taken.Researchers will compare the non intervention group to see if patients' blood pressure will also be reduced without intervention., conditionsModule conditions: Hypertension, conditions: Medication Therapy Management, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 420, type: ESTIMATED, armsInterventionsModule interventions name: Structured drug therapy management, outcomesModule primaryOutcomes measure: systolic blood pressure, secondaryOutcomes measure: diastolic blood pressure, secondaryOutcomes measure: Change from baseline in mean sitting systolic blood pressure at 3 months, secondaryOutcomes measure: Change from baseline in number of medication-related problems (MRP) at 6 months, secondaryOutcomes measure: Average number of medication-related problems (MRP) resolved after 6 months, secondaryOutcomes measure: The compliance rate of blood pressure after 6 months, secondaryOutcomes measure: Effective rate of blood pressure lowering after 6 months, secondaryOutcomes measure: Time to BP Attainment in Intervention and Non-Intervention Groups, secondaryOutcomes measure: Changes from baseline in adherence scores at 6 months,the General Medication Compliance Scale (GMAS) was used., secondaryOutcomes measure: Economic indicators，mainly including the cost of implementing intervention measures and the impact of intervention measures on patient diagnosis and treatment costs, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Beijing Anzhen Hospital, city: Beijing, state: Beijing, zip: 100029, country: China, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False