hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06382025, orgStudyIdInfo id: Alkinstorybook, briefTitle: Preoperative Information With Storybook for Pediatric Anesthesia, statusModule overallStatus: COMPLETED, startDateStruct date: 2018-03-09, primaryCompletionDateStruct date: 2020-02-20, completionDateStruct date: 2020-05-29, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Trakya University, class: OTHER, descriptionModule briefSummary: Impacts of non-pharmacologic methods that help patients get prepared cognitively for processes of surgery and anesthesia on pediatric surgery patients' preoperational stress levels and anxiety levels had been examined in the scope of this comprehensive research project. In this project, a goal-oriented 8-9 minutes animation cartoon that is informative and educational had been developed, and pediatric surgery patients had been asked to watch this animation during preoperative period., conditionsModule conditions: Animation, Cartoons, Preoperative Care, Anesthesia, Pediatric, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: SINGLE, whoMasked: INVESTIGATOR, enrollmentInfo count: 168, type: ACTUAL, armsInterventionsModule interventions name: showing cartoons -storybook, interventions name: showing cartoons - standard, outcomesModule primaryOutcomes measure: preoperative anxiety scale, primaryOutcomes measure: State-trait anxiety inventory (STAI FORM TX-1, TX-2) for parents, primaryOutcomes measure: Children's Hospital of Eastern Ontario Pain (CHEOP) Scale, primaryOutcomes measure: Pediatric Anesthesia Emergence Delirium (PAED) scale, eligibilityModule sex: ALL, minimumAge: 5 Years, maximumAge: 10 Years, stdAges: CHILD, contactsLocationsModule locations facility: Trakya University, city: Edirne, state: Edi̇rne, zip: 22030, country: Turkey, geoPoint lat: 41.67719, lon: 26.55597, hasResults: False
protocolSection identificationModule nctId: NCT06381999, orgStudyIdInfo id: M602011083, briefTitle: Validity and Inter-rater Reliability for Early Recognition of Spasticity Using the Decision Tree Tool, acronym: I-REFER, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-10-27, primaryCompletionDateStruct date: 2024-02-26, completionDateStruct date: 2024-02-26, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Merz Therapeutics GmbH, class: INDUSTRY, descriptionModule briefSummary: The aim of this study is to investigate the validity and Inter-rater reliability for early recognition of spasticity by nurses and physiotherapists using the decision tree tool., conditionsModule conditions: Post-stroke Spasticity, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 73, type: ACTUAL, outcomesModule primaryOutcomes measure: Assessment of the level of agreement between the nurse group and gold-standard group (trained, specialized physicians) in their decision for toxin treatment referral, secondaryOutcomes measure: Assessment of the level of agreement between the physiotherapist and/or occupational therapist group and gold-standard group (trained, specialized physicians) in their decision for toxin treatment referral, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Gailtal-Klinik, city: Hermagor, zip: 9620, country: Austria, geoPoint lat: 46.62722, lon: 13.36722, hasResults: False
protocolSection identificationModule nctId: NCT06381986, orgStudyIdInfo id: SHJ002-SJP2, briefTitle: Efficacy and Safety of SHJ002 Ophthalmic Solution in the Treatment of Corneal Erosion in Sjogren's Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-01, completionDateStruct date: 2025-02, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Sunhawk Vision Biotech, Inc., class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to measure efficacy and safety with 0.25% SHJ002 sterile ophthalmic solution compared to vehicle in treating corneal erosion in Sjogren's patients.SHJ002 is an antisense oligonucleotide to neutralize a specific microRNA., conditionsModule conditions: Corneal Erosion, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Double-Blinded, Parallel, Vehicle-Controlled, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: Double-Blinded, Parallel, Vehicle-Controlled, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 122, type: ESTIMATED, armsInterventionsModule interventions name: SHJ002, interventions name: Vehicle, outcomesModule primaryOutcomes measure: To assess the efficacy of SHJ002 sterile ophthalmic solution relative to vehicle as measured by corneal fluorescein staining (CFS) score, secondaryOutcomes measure: To assess the efficacy of SHJ002 sterile ophthalmic solution relative to the vehicle as measured by central corneal fluorescein staining (cCFS) score, secondaryOutcomes measure: To assess the efficacy of SHJ002 sterile ophthalmic solution relative to the vehicle as measured by Visual Analogue Scale (VAS), secondaryOutcomes measure: To assess the efficacy of SHJ002 sterile ophthalmic solution relative to the vehicle as measured by Symptom Assessment in Dry Eye (SANDE), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Kaohsiung Medical Chung-Ho Memorial Hospital, city: Kaohsiung, zip: 807, country: Taiwan, contacts name: Shiuh-Liang Hsu, MD, role: CONTACT, phone: +886-73121101, email: shiuhlianghsu@gmail.com, contacts name: Shiuh-Liang Hsu, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Li-Yi Chiu, MD, role: SUB_INVESTIGATOR, geoPoint lat: 22.61626, lon: 120.31333, hasResults: False
protocolSection identificationModule nctId: NCT06381973, orgStudyIdInfo id: ELTGOL, briefTitle: Ventilation Distribution in COPD Patients During Breathing Exercises, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2024-08-01, completionDateStruct date: 2024-08-01, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: William Poncin, PT, PhD, class: OTHER, descriptionModule briefSummary: ELTGOL (Slow Expiration with the Opened Glottis in the Lateral posture) is an airway clearance technique performed in the lateral decubitus position. This technique focuses on optimizing ventilation of the infralateral lung (when the subject is lying in the lateral posture) to enhance local air-liquid interaction. Previous studies on ventilation differences between the infra- and supralateral lungs were conducted on healthy, young, male subjects, without the application of thoracic or abdominal pressure.This study aimed to assess ventilation distribution in right lateral recumbency in patients with chronic obstructive pulmonary disease (COPD), as well as healthy individuals, and investigate the impact of thoracic and abdominal manual pressures during ELTGOL on ventilation distribution., conditionsModule conditions: Chronic Obstructive Pulmonary Disease, conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: ELTGOL_Physio, interventions name: ELTGOL_Auto, interventions name: PEP, interventions name: 1L-Tidal-Breathing, interventions name: Spontaneous Breathing, outcomesModule primaryOutcomes measure: Impedance variation using Electrical Impedance Tomography, eligibilityModule sex: ALL, minimumAge: 40 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Cliniques universitaires Saint-Luc, status: RECRUITING, city: Brussels, state: Brussels Capital, zip: 1200, country: Belgium, contacts name: William Poncin, role: CONTACT, phone: +320470592032, phoneExt: +320470592032, email: william.poncin@uclouvain.be, geoPoint lat: 50.85045, lon: 4.34878, hasResults: False
protocolSection identificationModule nctId: NCT06381934, orgStudyIdInfo id: 2024-00335; kt23ChristCrain4, briefTitle: Validation of New Diagnostic Indices to Simplify Hyponatremia Therapy Assessment in Patients on Thiazide Diuretics, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2027-04, completionDateStruct date: 2027-04, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: University Hospital, Basel, Switzerland, class: OTHER, descriptionModule briefSummary: This study is looking at two new parameters, aSID and ChU, to see if these can help physicians to distinguish between different causes of low sodium levels (hyponatremia) in Patients taking a medicament against high blood pressure (thiazide). Researchers also want to see if using these new parameters to decide on treatment works just as well, or better, than the current standard treatments., conditionsModule conditions: Thiazide Associated Hyponatremia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 136, type: ESTIMATED, armsInterventionsModule interventions name: Standard Care, interventions name: aSID/ChU Guided Therapy, outcomesModule primaryOutcomes measure: Serum Sodium Level, secondaryOutcomes measure: Descriptive analyses: Changes in aSID in relation to changes in serum sodium levels, secondaryOutcomes measure: Descriptive analyses: Changes in ChU in relation to changes in serum sodium levels, secondaryOutcomes measure: Diagnostic performance analyses of: aSID and ChU, secondaryOutcomes measure: Diagnostic performance analyses of: aSID measured in blood gas analysis, secondaryOutcomes measure: Diagnostic performance analyses of: clinical volume status assessment, secondaryOutcomes measure: Diagnostic performance analyses of: not-invasive instrumental volume status assessment, secondaryOutcomes measure: Diagnostic performance analyses of: other hormones such as aldosterone, renin, arginine-vasopressin, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital Basel, city: Basel, zip: 4031, country: Switzerland, contacts name: Laura Potasso, Dr. med. sc., role: CONTACT, phone: +41 61 328 58 76, email: laura.potasso@usb.ch, contacts name: Mirjam Christ-Crain, Prof. Dr. med., role: CONTACT, phone: +41 61 328 70 80, email: mirjam.christ-crain@usb.ch, contacts name: Laura Potasso, Dr. med. sc., role: PRINCIPAL_INVESTIGATOR, contacts name: Mirjam Christ-Crain, Prof. Dr. med., role: SUB_INVESTIGATOR, geoPoint lat: 47.55839, lon: 7.57327, hasResults: False
protocolSection identificationModule nctId: NCT06381921, orgStudyIdInfo id: B2023-0046, briefTitle: Objective Integrated Multimodal Electrophysiological Index for the Quantification of Visceral Pain, acronym: OIME, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2025-05-01, primaryCompletionDateStruct date: 2027-10-31, completionDateStruct date: 2029-02-28, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: University of Connecticut, class: OTHER, collaborators name: Yale University, descriptionModule briefSummary: The objectives of the study are to 1) Conduct telemetric biosignals (EDA, ECG, and EMG) recording in healthy controls and IBS participants experiencing cutaneous and visceral pain; and 2) Validate the OIME index as a biomarker for quantifying pain in IBS participants and its capability to assess the treatment of IBS pain via an ambulatory trial., conditionsModule conditions: Abdominal Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: randomized controlled ambulatory trial, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: IBS-PPSM intervention, outcomesModule primaryOutcomes measure: Pain intensity and interference, primaryOutcomes measure: IBS-related symptoms, primaryOutcomes measure: Electrodermal activity (EDA), primaryOutcomes measure: Electrocardiogram (ECG), primaryOutcomes measure: Electromyogram (EMG), primaryOutcomes measure: Objective integrated multimodal electrophysiological index, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, hasResults: False
protocolSection identificationModule nctId: NCT06381895, orgStudyIdInfo id: SYSKY-2023-467-01, briefTitle: The Efficacy of Radiomics to Predict Tumor Microenvironment Markers and Comprehensive Therapy for Bladder Cancer, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-05-30, primaryCompletionDateStruct date: 2024-02-01, completionDateStruct date: 2024-02-20, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, class: OTHER, descriptionModule briefSummary: The aim of this study was to develop an radiomic model based on CT images to evaluate markers of the bladder cancer microenvironment, such as TSR,TIL, and IP. Secondly, the association of the radiomic model with clinical outcomes and immunotherapy response was investigated., conditionsModule conditions: Bladder Cancer, conditions: Radiomics, conditions: Immunotherapy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 1200, type: ACTUAL, armsInterventionsModule, outcomesModule primaryOutcomes measure: Tumour-infiltrating lymphocytes (TIL), secondaryOutcomes measure: overall survival, secondaryOutcomes measure: cancer-specific survival, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sun Yat-sen Memorial Hospital, city: Guangzhou, state: Guangdong, country: China, geoPoint lat: 23.11667, lon: 113.25, hasResults: False
protocolSection identificationModule nctId: NCT06381882, orgStudyIdInfo id: MiPac, briefTitle: The Role of the Human Microbiome in Patients After Pancreatic Resection., acronym: MiPac, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-05-01, completionDateStruct date: 2026-11-01, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: St. Antonius Hospital, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to classify patients that undergo pancreatic resection for presumed pancreatic or periampullary malignancy into high and low risk groups for postoperative complications based on longitudinal saliva, rectal/faecal, tumor, blood and/or bile microbiome profiles.To identify the dynamics of the microbiome, as well as the possibly related short-term and long-term complications, multiple samples at different timepoints are needed from the patients., conditionsModule conditions: Pancreas Cancer, conditions: Pancreas Neoplasm, conditions: Pancreas Adenocarcinoma, conditions: Periampullary Cancer, conditions: Periampullary Carcinoma, conditions: Microbial Colonization, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Pancreatic resection, outcomesModule primaryOutcomes measure: Risk stratification postoperative complications, secondaryOutcomes measure: Long time oncological outcomes - site of recurrence, secondaryOutcomes measure: Long time oncological outcomes - disease free survival, secondaryOutcomes measure: Long time oncological outcomes - overall survival, secondaryOutcomes measure: Complications neoadjuvant chemotherapy, secondaryOutcomes measure: Complications adjuvant chemotherapy, secondaryOutcomes measure: Response to neoadjuvant chemotherapy, secondaryOutcomes measure: Complications bile duct drainage, secondaryOutcomes measure: Postoperative endocrine insufficiency, secondaryOutcomes measure: Postoperative exocrine insufficiency, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06381869, orgStudyIdInfo id: CRNHA 2018-2, briefTitle: Bioavailability of Pea Protein in Young and Old Volunteers, acronym: NUTRALYS, statusModule overallStatus: COMPLETED, startDateStruct date: 2019-01-10, primaryCompletionDateStruct date: 2019-06-13, completionDateStruct date: 2019-06-13, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Roquette Freres, class: INDUSTRY, collaborators name: CRNH Auvergne, collaborators name: Université d'Auvergne, descriptionModule briefSummary: The aim of this study done in healthy, non-malnourished young and elderly subjects, is to measure the bioavailability of protein intake and the variation of metabolic markers following consumption of pea protein " NUTRALYS ® S85 plus" or a reference protein brought in water either alone or at the end of a standardized meal., conditionsModule conditions: Healthy Male Volunteers, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ACTUAL, armsInterventionsModule interventions name: Pea protein (NUTRALYS ® S85 plus) in water, interventions name: Pea protein (NUTRALYS ® S85 plus) within meal, interventions name: Whey protein in water, interventions name: Whey protein within meal, outcomesModule primaryOutcomes measure: Leucine blood concentration, secondaryOutcomes measure: Essential amino acids blood concentration (µmol/L), secondaryOutcomes measure: Non essential amino acid blood concentration (µmol/L), secondaryOutcomes measure: Blood glucose concentration (g/L), secondaryOutcomes measure: Blood insulin concentration (μIU/ml), secondaryOutcomes measure: Blood lipid profile (glycerol concentration in mg/l and non-esterified fatty acids concentration in mg/l), secondaryOutcomes measure: Blood inflammatory profile (TNF-α blood concentration in pg/ml and IL-6 blood concentration in pg/ml), eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Unité d'Exploration en Nutrition Centre de Recherche en Nutrition Humaine d'Auvergne, city: Clermont-Ferrand, zip: 63009, country: France, geoPoint lat: 45.77966, lon: 3.08628, hasResults: False
protocolSection identificationModule nctId: NCT06381856, orgStudyIdInfo id: EPM_2024-00227-01, briefTitle: Improving Participation of Autistic Children and Adolescents in the Habilitation Process, acronym: IMPAC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Region Örebro County, class: OTHER, descriptionModule briefSummary: This project aims to explore the impact of a survey-based and a meeting-based needs assessment models on 7 to 17 year old autistic children's participation in the needs assessment process at the initial reception when enrolled at a Child and Youth Habilitation Centre., conditionsModule conditions: Autism Spectrum Disorders, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: The child's involvement, secondaryOutcomes measure: The Mental Health Continuum - Short Form, secondaryOutcomes measure: The "Your child's strengths, abilities and special needs"-questionnaire., secondaryOutcomes measure: The collaboration with the neuropsychiatric team questionnaire, secondaryOutcomes measure: Cantril ladder, otherOutcomes measure: Individual interviews, otherOutcomes measure: Type and number of goals in the childrens' individual habilitation plans, eligibilityModule sex: ALL, minimumAge: 7 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: University Health Care Research Center, city: Örebro, zip: 70182, country: Sweden, geoPoint lat: 59.27412, lon: 15.2066, hasResults: False