hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06380517, orgStudyIdInfo id: ATS23, secondaryIdInfos id: 2UG1EY011751, type: NIH, link: https://reporter.nih.gov/quickSearch/2UG1EY011751, briefTitle: Dichoptic Treatment for Amblyopia in Children 4 to 7 Years of Age, acronym: ATS23, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-12-01, completionDateStruct date: 2027-05-01, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Jaeb Center for Health Research, class: OTHER, collaborators name: National Eye Institute (NEI), collaborators name: Pediatric Eye Disease Investigator Group, descriptionModule briefSummary: In children 4 to 7 years of age, to determine if treatment with 1 hour per day 6 days per week of watching dichoptic movies/shows wearing the Luminopia headset is non-inferior to treatment with 2 hours of patching per day 7 days per week with respect to change in amblyopic eye distance VA from randomization to 26 weeks., conditionsModule conditions: Amblyopia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 238, type: ESTIMATED, armsInterventionsModule interventions name: Luminopia, interventions name: Eye Patch, outcomesModule primaryOutcomes measure: Change in amblyopic eye logMAR distance VA between randomization and 26 weeks, eligibilityModule sex: ALL, minimumAge: 4 Years, maximumAge: 7 Years, stdAges: CHILD, contactsLocationsModule, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2024-04-01, uploadDate: 2024-04-18T09:58, filename: Prot_000.pdf, size: 715474, largeDocs typeAbbrev: SAP, hasProtocol: False, hasSap: True, hasIcf: False, label: Statistical Analysis Plan, date: 2024-04-17, uploadDate: 2024-04-18T15:02, filename: SAP_001.pdf, size: 4154847, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2024-04-17, uploadDate: 2024-04-18T09:59, filename: ICF_002.pdf, size: 248300, hasResults: False
protocolSection identificationModule nctId: NCT06380491, orgStudyIdInfo id: REF.2338, secondaryIdInfos id: UNAM-PAPIIT 32-IN216919, type: OTHER, domain: Universidad Nacional Autonoma de Mexico (UNAM), briefTitle: Melatonin's Effect on Nighttime Blood Pressure and Sleep in OSA Patients (MEBP-OSA), acronym: MEBP-OSA, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-06-22, primaryCompletionDateStruct date: 2024-11-22, completionDateStruct date: 2025-01-22, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, class: OTHER, collaborators name: Universidad Nacional Autonoma de Mexico, collaborators name: Emory University, descriptionModule briefSummary: The goal of this clinical trial is to learn if melatonin works to treat comorbid insomnia in adults with OSA and nocturnal non-dipping blood pressure pattern.The main question it aims to answer is:Does melatonin maintain sleep during night and recover the dipping blood pressure pattern?, conditionsModule conditions: Obstructive Sleep Apnea of Adult, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Patients with a non-dipper pattern in blood pressure will randomly enter one of two options: 1) usual medical treatment; 2) treatment with melatonin plus usual care., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Melatonin 3 MG Oral Tablet, outcomesModule primaryOutcomes measure: Melatonin at a dose of 3 mg before sleep time, after a period of 30 days changes the time awake after sleep onset (WASO), and recovers the dipper pattern of blood pressure, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: National Institute of Medical Sciences and Nutrition Salvador Zubirán (INCMNSZ), status: RECRUITING, city: Mexico City, country: Mexico, geoPoint lat: 19.42847, lon: -99.12766, hasResults: False
protocolSection identificationModule nctId: NCT06380478, orgStudyIdInfo id: CPRO-000012, briefTitle: Safety and Efficacy of the Bi-Aspheric Monofocal IOL, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-05, primaryCompletionDateStruct date: 2024-12-05, completionDateStruct date: 2024-12-25, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: ICARES Medicus, Inc., class: INDUSTRY, collaborators name: AST Products, Inc., descriptionModule briefSummary: This is an observational, single-center, non-control, open-label post-marketing study. Patients implanted with an aspicio™ Monofocal Intraocular Lens will be scheduled for a follow-up visit at least 3 months after the surgery to undergo a routine basic ophthalmological examination., conditionsModule conditions: Cataract, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: RETROSPECTIVE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: aspicio Monofocal IOL, outcomesModule primaryOutcomes measure: CDVA, primaryOutcomes measure: Defocus curve, secondaryOutcomes measure: UDVA, secondaryOutcomes measure: UIVA, secondaryOutcomes measure: CIVA, secondaryOutcomes measure: IOL glistening, secondaryOutcomes measure: PCO, secondaryOutcomes measure: Satisfaction questionnaire, secondaryOutcomes measure: AE, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Chang Gung University Hospital, status: RECRUITING, city: Taoyuan, state: Guishan District, zip: 333, country: Taiwan, contacts name: Lisa Chen, role: CONTACT, email: lisa.phchen@gmail.com, contacts name: Yih-Shiou Hwang, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 24.95233, lon: 121.20193, hasResults: False
protocolSection identificationModule nctId: NCT06380452, orgStudyIdInfo id: SKABUP, secondaryIdInfos id: 2023-507925-41-00, type: OTHER, domain: EU-Trial-Nr. (EMA), briefTitle: Therapy for Scabies With Two Differently Concentrated Permethrin Creams, acronym: SKABUP, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2027-07, completionDateStruct date: 2028-12, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Infectopharm Arzneimittel GmbH, class: INDUSTRY, collaborators name: Winicker Norimed GmbH, descriptionModule briefSummary: The multi-center, prospective, randomized, double-blind phase III clinical trial will primarily investigate the efficacy and safety of treatment of scabies with Permethrin Cream 5% (approved drug InfectoScab 5% Cream) in direct comparison with Permethrin Cream 10%.The trial participants will be randomly assigned and blinded to either Permethrin Cream 5% or Permethrin Cream 10%., conditionsModule conditions: Scabies, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The SKABUP study is a prospective, randomized, double-blind, 2-arm superiority study in a group sequential design with recruitment stop and interim analysis after 172 patients. If there is no evidence of superiority in the interim analysis, the study will be continued unchanged up to the planned number of 220 patients and will be terminated and analyzed regularly., primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: double-blind, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 220, type: ESTIMATED, armsInterventionsModule interventions name: 5% Permethrin Creme, interventions name: 10% Permethrin Creme, outcomesModule primaryOutcomes measure: clinical efficacy (yes/no), secondaryOutcomes measure: effectiveness at Visit 1, secondaryOutcomes measure: frequency of therapy success, secondaryOutcomes measure: itching, secondaryOutcomes measure: patients with evidence of mites, secondaryOutcomes measure: patients with use of antiscabiosa not compliant with the protocol, secondaryOutcomes measure: patients with new scabies efflorescences, secondaryOutcomes measure: patients with "additional confirmed" treatment failure, secondaryOutcomes measure: AEs, SAEs, ADRs, SUAWs, eligibilityModule sex: ALL, minimumAge: 2 Years, maximumAge: 85 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06380439, orgStudyIdInfo id: 23-10-1763, briefTitle: The Effect of Wrist Ankle Acupuncture on Post-Total Hip Arthroplasty Pain, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-23, primaryCompletionDateStruct date: 2024-07, completionDateStruct date: 2024-07, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Indonesia University, class: OTHER, descriptionModule briefSummary: Total hip arthroplasty is one of the most cost-effective orthopedic surgical procedures which can restore hip function and improve the patient's quality of life. However, total hip arthroplasty is significantly associated with postoperative pain. Pain after total hip arthroplasty surgery can adversely affect the patient's early postoperative recovery, postoperative mobility, and hinder rehabilitation.Wrist ankle acupuncture (WAA) is a simpler acupuncture technique, using fewer points, shallow needle insertion and lighter stimulation. Wrist-ankle acupuncture as multimodal analgesia after orthopedic surgery is useful for reducing pain and reduce the incidence of post-surgical side effects. The primary aim of this study is to investigate whether wrist ankle acupuncture therapy gives better and results for post total hip arthroplasty pain than sham wrist ankle acupuncture, conditionsModule conditions: Pain, Postoperative, conditions: Hip Osteoarthritis, conditions: Hip Fractures, conditions: Hip Injuries, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 32, type: ESTIMATED, armsInterventionsModule interventions name: wrist ankle acupuncture, outcomesModule primaryOutcomes measure: Visual Analog Scale, secondaryOutcomes measure: recovery rate, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Cipto Mangunkusumo Hospital, status: RECRUITING, city: Jakarta Pusat, state: Jakarta, zip: 10430, country: Indonesia, contacts name: Cipto Mangunkusumo Hospital, role: CONTACT, phone: 1 500 135, geoPoint lat: -6.1818, lon: 106.8223, locations facility: Fatmawati Hospital, status: RECRUITING, city: Jakarta, zip: 12430, country: Indonesia, contacts name: Fatmawati Hospital, role: CONTACT, phone: 0217501524, geoPoint lat: -6.21462, lon: 106.84513, locations facility: Persahabatan Hospital, status: RECRUITING, city: Jakarta, zip: 13230, country: Indonesia, contacts name: Persahabatan Hospital, role: CONTACT, phone: (021) 4891708, geoPoint lat: -6.21462, lon: 106.84513, hasResults: False
protocolSection identificationModule nctId: NCT06380400, orgStudyIdInfo id: 0000-0001-5786-4385, briefTitle: The Effect of Foot Bath on Birth Pain and Birth Comfort, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2024-07-30, completionDateStruct date: 2024-07-30, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Selcuk University, class: OTHER, descriptionModule briefSummary: Although childbirth is seen as a natural, happy, meaningful and universal experience, women are often faced with severe pain, discomfort and a sensory state that can be overwhelming. There are two ways to reduce labour pain: pharmacological (drugs) and non-pharmacological (non-drug methods). Non-pharmacological methods, in particular, attempt to relieve pain by addressing emotional, cognitive, behavioural and socio-cultural dimensions. These methods provide relief and reduce the perception of pain. One of the non-pharmacological methods used to reduce labour pain is footbaths. Footbaths are widely used as a nurse/midwife intervention in many countries. Footbathing is a simple technique used to induce a sense of comfort and relaxation. It involves gently immersing the patient's legs and feet (below the knees) in a basin of warm water. Local heat treatments are generally safe and are considered an effective form of complementary medicine. In its simplest form it means "a tool to be part of supportive care, promoting peace, positive emotions, comfort, satisfaction and enjoyment". The mechanisms responsible for the effects of footbathing are not fully understood, but soaking the feet in warm water and stimulating the sense of touch through massage or washing can reduce sympathetic nerve activity, thereby reducing pain and increasing comfort. In other words, reducing pain during labour means providing support and comfort to the woman. This study was designed to evaluate the effect of a foot bath applied in the first stage of labour on labour pain and comfort in nulliparous women., conditionsModule conditions: Parturition, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 196, type: ESTIMATED, armsInterventionsModule interventions name: Foot bath, outcomesModule primaryOutcomes measure: Visuell analog scale score of the pregnant woman, secondaryOutcomes measure: Birth comfort scale score of the pregnant woman, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Habibe Bay Ozcalik, status: RECRUITING, city: Konya, zip: 42250, country: Turkey, contacts name: Habibe Bay Ozcalik, role: CONTACT, phone: 05424469343, email: habiberk@hotmail.com, geoPoint lat: 37.87135, lon: 32.48464, hasResults: False
protocolSection identificationModule nctId: NCT06380374, orgStudyIdInfo id: 2024\01, briefTitle: Gamification in Disaster Nursing Education, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-22, primaryCompletionDateStruct date: 2024-07-01, completionDateStruct date: 2024-07-22, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Selcuk University, class: OTHER, descriptionModule briefSummary: This research will be conducted as a randomized controlled study with a parallel design to evaluate the effectiveness of the disaster nursing training program prepared with a gamification strategy based on multiple intelligence theory for final-year public health nursing students. Research hypothesis "H1a: The disaster nursing knowledge level of the students participating in the program, which is prepared with a Gamification Strategy Based on Multiple Intelligence Theory, differs from the control group. H1b: The perception of volunteering towards disaster nursing differs for the students included in the Program Prepared with Gamification Strategy Based on Multiple Intelligence Theory compared to the control group. H1c: The self-efficacy level of students involved in the Program Prepared with Gamification Strategy Based on Multiple Intelligences Theory regarding disaster nursing differs from the control group.", conditionsModule conditions: Gamification, conditions: Nursing Students, conditions: Multiple Intelligence Theory, conditions: Disaster Nursing, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 72, type: ESTIMATED, armsInterventionsModule interventions name: Gamification in Disaster Nursing Education, outcomesModule primaryOutcomes measure: Level of knowledge related to disaster nursing services, primaryOutcomes measure: Volunteer intention to become a disaster nurse, primaryOutcomes measure: Perception of self-efficacy related to disaster nursing, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Selcuk University Faculty of Nursing, city: Konya, state: Selcuklu, zip: 42000, country: Turkey, contacts name: Sema Yilmaz Dean, MD, role: CONTACT, phone: +903322230763, email: hemsirelikfakultesi@selcuk.edu.tr, geoPoint lat: 37.87135, lon: 32.48464, hasResults: False
protocolSection identificationModule nctId: NCT06380361, orgStudyIdInfo id: SEN-ONCO-1, briefTitle: InvestigatioN of a Smart Probe for Lung lEsion Characterization Using Impedance Technology, acronym: INSPECT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-20, primaryCompletionDateStruct date: 2025-03-31, completionDateStruct date: 2025-04-01, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Sensome, class: INDUSTRY, descriptionModule briefSummary: The objective of the study is to evaluate the feasibility of the BioSpy System sensor to differentiate tissues that are encountered during bronchoscopic biopsy of endobronchial tumors and peripheral lung nodules and masses., conditionsModule conditions: Lung Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Patient with suspected lung cancer coming to the hospital for bronchoscopic biopsy will be selected for this trial., primaryPurpose: OTHER, maskingInfo masking: NONE, maskingDescription: No masking, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: BioSpy System, outcomesModule primaryOutcomes measure: The ability of BioSpy System to acquire electrophysiological measurements in the relevant tissues during bronchoscopic biopsy., secondaryOutcomes measure: The ability of BioSpy Sysem to differentiate the lesion from healthy tissue, secondaryOutcomes measure: The ability of BioSpy Sysem to differentiate various lesion types, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06380348, orgStudyIdInfo id: JMT101-012, briefTitle: JMT101 in Combination With Osimertinib, Versus Cisplatin-pemetrexed in Participants With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Characterized by Epithermal Growth Factor Receptor (EGFR) Exon 20ins Mutations, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-26, primaryCompletionDateStruct date: 2027-03-26, completionDateStruct date: 2028-03-26, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Shanghai JMT-Bio Inc., class: INDUSTRY, descriptionModule briefSummary: This is a multicenter, randomized, open-label, parallel-controlled phase 3 study. This study aims to evaluate the efficacy and safety of JMT101 combined with Osimertinib compared with Cisplatin combined with pemetrexed in participants with local advanced or metastatic non-small-cell lung cancer harboured EGFR 20ins mutation without prior systemic therapy.Primary objective of this study is to assess the efficacy of JMT101 combined with Osimertinib versus Cisplatin combined with pemetrexed using by （Independent Review Center）IRC-assessed Progression Free Survival (PFS) per RECIST 1.1 as primary endpoint. Approximately 398 participants are estimated to be randomized into the study. Participants enrolled will be randomized to JMT101 or Cisplatin chemotherapy in a 1:1 manner, stratified by baseline brain metastasis (with/without) and Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) (0 versus 1)., conditionsModule conditions: Local Advanced or Metastatic NSCLC, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 398, type: ESTIMATED, armsInterventionsModule interventions name: JMT101 Injection, interventions name: Osimertinib tablet, interventions name: Cisplatin injection, interventions name: Pemetrexed injection, outcomesModule primaryOutcomes measure: Progression Free Survival (PFS) as assessed by Independent Review Center (IRC) per RECIST 1.1, secondaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: Overall Response Rate (ORR) by IRC per RECIST 1.1, secondaryOutcomes measure: Duration of Response (DoR) by IRC per RECIST 1.1, secondaryOutcomes measure: PFS by investigator per RECIST 1.1, secondaryOutcomes measure: ORR by investigator per RECIST 1.1, secondaryOutcomes measure: DoR by investigator per RECIST 1.1, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False