hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06298435, orgStudyIdInfo id: 17536, briefTitle: Optimising Ventilatory Strategies by Using Positive Respiratory Integer Measurements, acronym: OPTIMVSPRIME, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-04-01, completionDateStruct date: 2025-04-01, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: University Medical Center Groningen, class: OTHER, descriptionModule briefSummary: • Background Intermittent Positive Pressure Ventilation is used during general anesthesia but can lead to serious complications. Respiratory parameter settings can be adjusted to minimize the detrimental effects of this unphysiological artificial respiration. Determining optimal ventilator settings is a multifactorial problem with many possible realisations. Knowledge of the relationship of patient outcomes with mathematically identifiable integer sets of ventilator setting parameters may help to understand which effects ventilator settings have on patient outcomes. An exploratory database study can provide a basis for further, prospective, interventional studies to find the optimal combination of ventilator settings.Main research question* To determine the relationship between the use of mathematically identifiable integer ventilator parameter sets and patient outcomes* Design (including population, confounders/outcomes) Retrospective database study of all cases of adult patients undergoing procedures in the UMCG under general anesthesia with IPPV between 01-01-2018 and 01-04-2023. Multivariate and mixed-model analyses, where appropriate, will be corrections for patient specific characteristics such as ASA PS, age, BMI, sex.* Expected results Using mathematically identifiable integer ventilatory parameter sets improves respiratory and/or hemodynamic patient outcomes., conditionsModule conditions: Hypoxemia, conditions: Hypercapnia, conditions: Ventilator Associated Pneumonia, conditions: Complication of Anesthesia, conditions: Postoperative Complications, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 20000, type: ESTIMATED, armsInterventionsModule interventions name: Intermittent Positive pressure ventilation, outcomesModule primaryOutcomes measure: SpO2/FiO2 ratio, primaryOutcomes measure: SpO2, primaryOutcomes measure: etCO2, primaryOutcomes measure: Blood Pressure, primaryOutcomes measure: Heart Rate, primaryOutcomes measure: Positive end Expiratory Pressure, primaryOutcomes measure: Plateau Pressure, primaryOutcomes measure: Respiration rate, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UMCG, city: Groningen, zip: 9700RB, country: Netherlands, contacts name: Rob Spanjersberg, role: CONTACT, phone: +31503616161, email: r.spanjersberg@umcg.nl, geoPoint lat: 53.21917, lon: 6.56667, hasResults: False
protocolSection identificationModule nctId: NCT06298422, orgStudyIdInfo id: 806433, briefTitle: Oxygen Saturations Across Tones of Skin, acronym: O2SATS, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-03-01, completionDateStruct date: 2025-06-30, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: University of California, San Diego, class: OTHER, descriptionModule briefSummary: Pulse oximetry, or SpO2, is a vital sign used across healthcare systems to gauge how much oxygen blood is carrying as a percentage of the maximum it could carry. Recent research has suggested that current SpO2 monitors may inaccurately report high SpO2 in patients with darker skin tones when the actual oxygenation is at unsafe, low levels. Additionally, this new research suggests as the SpO2 levels decrease, the risk of occult hypoxia rises. The investigators hypothesize melanin interferes with the pulse oximetry accuracy. Investigators will use spectrophotometry to measure melanin indices and other variables to test this hypothesis., conditionsModule conditions: Generalised Melanin Pigmentation, conditions: Pulse Oximetry, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 20, type: ESTIMATED, outcomesModule primaryOutcomes measure: Difference observed between SpO2 and SaO2., primaryOutcomes measure: Melanin Index, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UCSD Health, status: RECRUITING, city: San Diego, state: California, zip: 92103, country: United States, contacts name: Pamela DeYoung, role: CONTACT, phone: 858-232-0343, email: pdeyoung@health.ucsd.edu, geoPoint lat: 32.71533, lon: -117.15726, hasResults: False
protocolSection identificationModule nctId: NCT06298409, orgStudyIdInfo id: EB04, briefTitle: Evaluating the Effect Of Rifaximin on the Gut Microbiota and Metabolome in SIBO Using CapScan®, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-15, primaryCompletionDateStruct date: 2024-09-15, completionDateStruct date: 2024-12-15, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Envivo Bio Inc, class: INDUSTRY, descriptionModule briefSummary: We will sample intestinal microbiota using a microbiome sampling capsule in patients with Small Intestinal Bacterial Overgrowth (SIBO), conditionsModule conditions: Small Intestinal Bacterial Overgrowth, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 34, type: ESTIMATED, armsInterventionsModule interventions name: CapScan collection capsule, outcomesModule primaryOutcomes measure: Sampling of gut microbiota, primaryOutcomes measure: Sampling of gut metabolome, secondaryOutcomes measure: Effect of rifaximin on gut microbiota, secondaryOutcomes measure: Effect of rifaximin on gut metabolome, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Silicon Valley Gastroenterology, status: RECRUITING, city: Mountain View, state: California, zip: 94040, country: United States, contacts name: Jennifer Taufui, role: CONTACT, email: svgistaff@gmail.com, geoPoint lat: 37.38605, lon: -122.08385, hasResults: False
protocolSection identificationModule nctId: NCT06298396, orgStudyIdInfo id: CLTD5853, briefTitle: Investigating Stimulation Parameter and Electrode Mode Changes on Speech Perception in Experienced Adult Cochlear Implant Recipients, acronym: DUAL, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Cochlear, class: INDUSTRY, collaborators name: Avania, descriptionModule briefSummary: This study aims to investigate the effect of stimulation parameters and different electrode modes on speech perception in adult cochlear implant recipients., conditionsModule conditions: Hearing Loss, Sensorineural, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: There is no masking in this study as all participants receive all MAPs (single group study model). The term "single-blinded" in the official title refers to the fact that participants are blinded to the order in which they receive the MAPs., enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Program using default MAP, interventions name: Program using low-power 1 (LP1) MAP, interventions name: Program using low-power 2 (LP2) MAP, interventions name: Program using low-power 3 (LP3) MAP, outcomesModule primaryOutcomes measure: Paired difference in percentage CNC words correct between default and LP1 MAPs in quiet setting, primaryOutcomes measure: Paired difference in dB SRT (AuSTIN) between default and LP1 MAPs in noise, secondaryOutcomes measure: Paired difference in percentage CNC words correct between LP1 MAP and LP2 MAP in quiet setting, secondaryOutcomes measure: Paired difference in dB SRT (AuSTIN) between LP1 and LP2 MAPs in noise, secondaryOutcomes measure: Paired difference in percentage CNC words correct between LP1 and LP3 MAPs in quiet setting, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Cochlear Macquarie, city: Macquarie Park, state: New South Wales, zip: 2109, country: Australia, contacts name: Esti Nel, role: CONTACT, phone: +61448495008, email: Enel@cochlear.com, geoPoint lat: -33.7751, lon: 151.11272, hasResults: False
protocolSection identificationModule nctId: NCT06298383, orgStudyIdInfo id: ERU1, briefTitle: The Effect of Three Different Medications on Anesthetic Success and Postoperative Pain, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2024-07-15, completionDateStruct date: 2024-09-15, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, collaborators name: Egyptian Russian University, descriptionModule briefSummary: Pain is a very important factor in Endodontic treatment, Both intra- and Post-operatively. In case of symptomatic Irreversible pulpitis, a build up of inflammatory mediators makes it very difficult for the operator to reach the desired level of anesthesia in order to deliver a pain free treatment as well as to eliminate or at least reduce post-operative pain incidence and severity. therefore, a number of pre- medications was suggested with variable success rates. Therefore this trial aims at the use of a new category of anti-inflammatory medications which would be less harmful than the standard NSAIDs or steroids., conditionsModule conditions: Symptomatic Irreversible Pulpitis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Trypsin, Bromelain and Rutoside, interventions name: Diclofenac Potassium, interventions name: Prednisolone Oral Tablet, interventions name: Placebo, outcomesModule primaryOutcomes measure: Success of Anesthesia, primaryOutcomes measure: Post-operative pain, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06298370, orgStudyIdInfo id: PENG study, briefTitle: The Efficacy of Combined Intrathecal Morphine and PENG Block on Postoperative Pain in Hip Arthroplasty, acronym: PENG, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-18, primaryCompletionDateStruct date: 2024-06-08, completionDateStruct date: 2024-07-08, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Bezmialem Vakif University, class: OTHER, descriptionModule briefSummary: This study aims to compare the postoperative 48-hour period in terms of morphine consumption, postoperative pain, and quality of recovery scores by combining the Pericapsular Nerve Group (PENG) block with low-dose intrathecal morphine in hip arthroplasty, as opposed to PENG alone and intrathecal morphine alone., conditionsModule conditions: Postoperative Pain Management, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: prospective, double-blind, randomized clinical trial, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 3, type: ESTIMATED, armsInterventionsModule interventions name: Pericapsular nerve group block plus intrathecal bupivacaine, interventions name: Intrathecal bupivacaine and morphine, interventions name: Pericapsular nerve group block plus intrathecal bupivacaine and morphine, outcomesModule primaryOutcomes measure: Morphine consumption, secondaryOutcomes measure: Postoperative pain scores, secondaryOutcomes measure: The quality of recovery score, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Bezmialem Vakif University, status: RECRUITING, city: Istanbul, state: Fatih, zip: 34093, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2023-11-01, uploadDate: 2024-02-03T12:32, filename: Prot_SAP_000.pdf, size: 160574, hasResults: False
protocolSection identificationModule nctId: NCT06298357, orgStudyIdInfo id: 300012601, secondaryIdInfos id: LAIKPRI02012024, type: OTHER_GRANT, domain: Kaul Pediatric Research Institute Pilot Grant, briefTitle: Virtual Reality Gaming for Exercise and Mindfulness Among Pediatric Cancer Rehabilitation, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-03-31, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: University of Alabama at Birmingham, class: OTHER, descriptionModule briefSummary: This study will explore the potential benefits of a virtual reality gaming program that focuses on mindfulness and exercise among pediatric cancer rehabilitation patients. The program will last 8 weeks outside of the hospital. Participants will start immediately in the hospital (immediate start group) or wait 8 weeks after hospital discharge to start the program (waitlist control group)., conditionsModule conditions: Pediatric Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: There will be 2 parallel groups, immediate start group and waitlist control group. Once control participants finish the wait period (8 weeks), they will start the intervention (8 weeks). Participants in the immediate start group will start exercise and mindfulness in the hospital and continue the program for 8 weeks outside of the hospital., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 16, type: ESTIMATED, armsInterventionsModule interventions name: Immediate Start - Virtual Reality, interventions name: Delayed Start - Virtual Reality, outcomesModule primaryOutcomes measure: Physical activity, secondaryOutcomes measure: Minutes of gameplay, secondaryOutcomes measure: Global Health, secondaryOutcomes measure: Forced Expiratory Volume in the first second (FEV1), eligibilityModule sex: ALL, minimumAge: 8 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Children's Hospital of Alabama, city: Birmingham, state: Alabama, zip: 35233, country: United States, geoPoint lat: 33.52066, lon: -86.80249, hasResults: False
protocolSection identificationModule nctId: NCT06298344, orgStudyIdInfo id: 002, briefTitle: The Role of Thiamine After Transcatheter Closure in Children With Left-to-Right Shunt Congenital Heart Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-01-01, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Universitas Sumatera Utara, class: OTHER, descriptionModule briefSummary: Currently, research on the effect of thiamine administration during transcatheter closure on the structure and function of the left ventricle by examining levels of matrix metalloproteinase-9 and tissue inhibitor of metalloproteinase-1 in children with left to right shunt congenital heart disease has never been carried out in Indonesia, so it is necessary carried out this research. This research was carried out by administering 100 mg of thiamine once per day to patients post transcatheter closure for 28 days. The parameters assessed were MMP-9, TIMP-1, and echocardiography to assess the structure and function of the left ventricle in CHD patients with left to right shunt lesions., conditionsModule conditions: Congenital Heart Disease, conditions: Thiamine Deficiency, conditions: Patent Ductus Arteriosus, conditions: Ventricular Septal Defect, conditions: Atrial Septal Defect, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Double blind, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 88, type: ESTIMATED, armsInterventionsModule interventions name: Thiamine, outcomesModule primaryOutcomes measure: Correlation between transcatheter closure and left ventricular structure change after thiamine treatment, secondaryOutcomes measure: Correlation between transcatheter closure and left ventricular function change after thiamine treatment, secondaryOutcomes measure: Correlation between transcatheter closure and serum matrix metalloproteinase-9 level change after thiamine treatment, secondaryOutcomes measure: Correlation between transcatheter closure and serum tissue inhibitor of metalloproteinase-1 level change after thiamine treatment, eligibilityModule sex: ALL, minimumAge: 6 Months, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Universitas Sumatera Utara, city: Medan, state: North Sumatera, zip: 20155, country: Indonesia, contacts name: Putri Amelia, role: CONTACT, phone: +6285261000273, email: putri.amelia@usu.ac.id, geoPoint lat: 3.58333, lon: 98.66667, hasResults: False
protocolSection identificationModule nctId: NCT06298318, orgStudyIdInfo id: Acute Binge Drink, briefTitle: Metabolic Changes in Healthy Subjects With Acute Binge Drink, acronym: MeABD, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-04-18, primaryCompletionDateStruct date: 2024-07-19, completionDateStruct date: 2026-07-18, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Zhejiang Chinese Medical University, class: OTHER_GOV, descriptionModule briefSummary: The goal of this double-blinded, randomized trial is to investigate the effects of acute binge drink on liver function, liver fat content and lipid metabolism in healthy young subjects. The main questions it aims to answer are:1. if acute binge drink could alleviate liver injury and hepatic steatosis., conditionsModule conditions: Binge Drinking, conditions: Liver Injury, conditions: Hepatic Steatosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: vodka, interventions name: water, outcomesModule primaryOutcomes measure: Hepatic fibrosis change, primaryOutcomes measure: hepatic function change, primaryOutcomes measure: hepatic injury change, primaryOutcomes measure: Lipid metabolism change, primaryOutcomes measure: Laboratory markers of inflammation, secondaryOutcomes measure: Fecal metabolites, secondaryOutcomes measure: Ethanol concentration, secondaryOutcomes measure: Acetaldehyde concentration, secondaryOutcomes measure: hangover cognition assessment tools after drinking, eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 30 Years, stdAges: ADULT, contactsLocationsModule locations facility: Zhejiang Chinese Medical University, city: Hangzhou, state: Zhejiang, zip: 310053, country: China, geoPoint lat: 30.29365, lon: 120.16142, hasResults: False
protocolSection identificationModule nctId: NCT06298305, orgStudyIdInfo id: QUANTIB, briefTitle: Artificial Intelligence & Prostate Cancer, acronym: QUANTIB, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2022-09-01, primaryCompletionDateStruct date: 2023-10-10, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: IRCCS San Raffaele, class: OTHER, descriptionModule briefSummary: This is a single center, blinded (the mpMRI will be read by expert personnel not aware of the patient's diagnosis ), retrospective study. A total of 200 patients with suspicious prostate cancer (PCa) who underwent, between January 2014 and January 2022, mpMRI of the prostate and subsequent prostate biopsy will identified. All mpMRI images will be retrospectively collected and evaluated using the Quantib Prostate software. In particular, 200 mpMRI with endorectal coil will be read by the expert radiologist and by the Quantib prostate (Quantib B.V. Rotterdam, The Netherlands) software, thus evaluating the predictive characteristics of Quantib Prostate for the identification of suspicious lesions. The sensitivity, specificity, negative predictive value, positive predictive value and accuracy of Quantib Prostate vs. radiologist in detecting csPCa will be evaluated using the biopsy report as reference standard., conditionsModule conditions: Prostate Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 200, type: ACTUAL, armsInterventionsModule interventions name: Quantib prostate (Quantib B.V. Rotterdam, The Netherlands) software, outcomesModule primaryOutcomes measure: To evaluate the sensitivity, specificity, positive predictive value, negative predictive value, and accuracy in detecting csPCa of Quantib Prostate vs. traditional radiologist reading of mpMRI, secondaryOutcomes measure: To assess the impact of Quantib Prostate in predicting pathologic outcomes in patients who received radical prostatectomy, secondaryOutcomes measure: To report time reduction in the diagnosis of suspicious PCa, eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Ospedale San Raffaele, city: Milan, state: MI, zip: 20132, country: Italy, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False