hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06372977, orgStudyIdInfo id: kappa index in ms, briefTitle: Kappa Index Versus Csf Oligoclonal Bands in Diagnosis of ms and Prediction of Disease Activity, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2026-05, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: To:1. Compare the diagnostic performance of cerebrospinal fluid kappa index to that of cerebrospinal fluid IgG oligoclonal bands in differentiating multiple sclerosis from other inflammatory and non-inflammatory neurological diseases .2. Assess the role of kappa free light chain and oligoclonal bands in predicting disease activity (conversion from clinical isolated syndrome to multiple sclerosis), conditionsModule conditions: Multiple Sclerosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 140, type: ESTIMATED, armsInterventionsModule interventions name: kappa index, outcomesModule primaryOutcomes measure: Assess the diagnostic performance of CSF k index in differentiating MS from other inflammatory and non-inflammatory neurological diseases ., primaryOutcomes measure: Assess the diagnostic performance of CSF IgG OCBs in differentiating MS from other inflammatory and non-inflammatory neurological diseases ., secondaryOutcomes measure: Assess the role of k FLC in predicting disease activity (conversion from CIS to MS), secondaryOutcomes measure: Assess the role of OCBs in predicting disease activity (conversion from CIS to MS), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06372951, orgStudyIdInfo id: Lung ultrasound in neonate, briefTitle: Lung Ultrasound in Neonatal Intensive Care Units, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-03, completionDateStruct date: 2026-03, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: Identification of lung diseases causing neonatal respiratory distress by lung ultrasound as a tool that can replace x-ray ., conditionsModule conditions: Neonatal Respiratory Distress, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 132, type: ESTIMATED, armsInterventionsModule interventions name: Ultrasound, outcomesModule primaryOutcomes measure: Identifying causes of neonatal respiratory distress, eligibilityModule sex: ALL, minimumAge: 1 Day, maximumAge: 28 Days, stdAges: CHILD, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06372938, orgStudyIdInfo id: AEŞH-BADEK-2024-43, briefTitle: Role of Inflammatory Markers and Doppler Parameters in Late-Onset Fetal Growth Restriction: A Machine Learning Approach, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-01-31, primaryCompletionDateStruct date: 2024-04-30, completionDateStruct date: 2024-04-30, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Ankara Etlik City Hospital, class: OTHER_GOV, descriptionModule briefSummary: Fetal growth restriction (FGR) is a serious complication in pregnancy that can lead to various adverse outcomes. It's classified into early-onset (before 32 weeks) and late-onset (after 32 weeks), with late-onset associated with long-term risks like hypoxemia and developmental delays. The study focuses on the role of inflammation in FGR, introducing new blood markers for better understanding and diagnosis. It also addresses the challenges of using advanced diagnostic tools in low-resource settings and explores the use of machine learning to predict FGR based on inflammatory markers, highlighting the potential of artificial intelligence in overcoming these challenges., conditionsModule conditions: Fetal Growth Restriction, conditions: Inflammatory Response, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 240, type: ACTUAL, armsInterventionsModule interventions name: Ultrasound measurement, interventions name: Laboratory Tests and Inflammatory Markers, outcomesModule primaryOutcomes measure: Evaluation of data, secondaryOutcomes measure: Machine learning modeling, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Etlik City Hospital, city: Ankara, state: Yenimahalle, zip: 06170, country: Turkey, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False
protocolSection identificationModule nctId: NCT06372925, orgStudyIdInfo id: CKJX839A1CN04, secondaryIdInfos id: CKJX839A1CN04, type: OTHER, domain: Novartis, briefTitle: Intravascular Imaging Study of the Effect of Inclisiran on Plaque in Patients With Acute Myocardial Infarction, acronym: V-ACCELERATE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-23, primaryCompletionDateStruct date: 2026-06-24, completionDateStruct date: 2026-06-24, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Novartis Pharmaceuticals, class: INDUSTRY, descriptionModule briefSummary: This study is to evaluate the effect of Inclisiran on coronary atherosclerosis using intravascular ultrasound (IVUS) and optical coherence tomography (OCT) in patients with acute myocardial infarction and elevated low-density lipoprotein cholesterol (LDL-C)., conditionsModule conditions: Plaque, Atherosclerotic, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: IVUS/OCT will be conducted in local lab and blinded analyzed to Independent Review Committee(IRC)., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 318, type: ESTIMATED, armsInterventionsModule interventions name: atorvastatin, interventions name: IVUS/OCT, interventions name: inclisiran, outcomesModule primaryOutcomes measure: Change in percent atheroma volume (PAV), secondaryOutcomes measure: Change in minimum fibrous cap thickness (FCT), secondaryOutcomes measure: Change in mean minimum FCT of all images, secondaryOutcomes measure: Change in normalized total atheroma volume (NTAV), secondaryOutcomes measure: Proportion of participants with progression, regression, or no change in PAV, secondaryOutcomes measure: Change in LDL-C, secondaryOutcomes measure: Change in TC, secondaryOutcomes measure: Change in HDL-C, secondaryOutcomes measure: Change in non-HDL-C, secondaryOutcomes measure: Change in ApoB, secondaryOutcomes measure: Change in ApoA1, secondaryOutcomes measure: Change in Lp(a), secondaryOutcomes measure: Change in TG, secondaryOutcomes measure: Proportion of participants with LDL-C target attainment, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06372912, orgStudyIdInfo id: Complications-Bariatric-TJ, briefTitle: Early Postoperative Complications in Patients Undergoing Bariatric Surgery, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Instituto Mexicano del Seguro Social, class: OTHER_GOV, descriptionModule briefSummary: This study examined immediate postoperative complications in patients undergoing various bariatric surgeries, aiming to evaluate the safety and efficacy of these interventions. Conducted at specialized high-volume bariatric surgery centers in Tijuana, Mexico. Predominantly female patients with severe obesity underwent procedures like sleeve gastrectomy and Roux-en-Y gastric bypass. Immediate complications were rare, occurring in only 0.38% of patients, with bleeding being the most common issue. Surgical reintervention within 48 hours was required in 0.33% of cases. The study's low complication rate suggests that surgeon expertise is crucial in minimizing risks and improving postoperative outcomes in bariatric surgery., conditionsModule conditions: Bariatric Surgery Candidate, conditions: Complication,Postoperative, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 3000, type: ESTIMATED, armsInterventionsModule interventions name: Sleeve gastrectomy, Roux-en-Y gastric bypass, mini-gastric bypass, SADIS, intragastric balloon insertion, and gastric band placement are bariatric surgeries., outcomesModule primaryOutcomes measure: Rate of Postoperative Complications, secondaryOutcomes measure: Long-term Weight Loss Efficacy, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Elias Ortiz & Company Mexico Weight Loss Specialists. Ernesto Sarmiento 2308, Tijuana 22046, Baja California, Mexico., status: RECRUITING, city: Tijuana, state: Baja California, zip: 22046, country: Mexico, contacts name: José a Guzmán Barba, MD, PhD, role: CONTACT, phone: 3471043237, email: • aldogbarba@hotmail.com, geoPoint lat: 32.5027, lon: -117.00371, hasResults: False
protocolSection identificationModule nctId: NCT06372899, orgStudyIdInfo id: 855140, secondaryIdInfos id: R01CA290541-01A1, type: NIH, link: https://reporter.nih.gov/quickSearch/R01CA290541-01A1, briefTitle: Alternative Nicotine Delivery Systems as Potential Harm Reduction Tools for Persistent Cigarette Smokers, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2027-11, completionDateStruct date: 2028-03-31, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: University of Pennsylvania, class: OTHER, collaborators name: National Cancer Institute (NCI), descriptionModule briefSummary: This between-subjects study aims to evaluate whether e-cigarettes (ECIGS) versus oral nicotine pouches (ONPS) more readily substitute for combustible cigarettes among 200 cigarette smokers. After measuring baseline cigarette smoking rate, participants will be randomized to ECIGS or ONPS and be instructed to switch (versus smoking cigarettes) over a 6-week period. Relative reductions in biomarkers of exposure will be measured. ECIG- and ONP-associated subjective reward and the reinforcing value of ECIGS and ONPS relative to combustible cigarettes will be assessed as mechanisms., conditionsModule conditions: E-cigarette Use, conditions: Cigarette Smoking, conditions: Harm Reduction, conditions: Tobacco Use, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: E-cigarettes, interventions name: Oral nicotine pouches, outcomesModule primaryOutcomes measure: Cigarette Consumption, primaryOutcomes measure: Cigarette Smoking Across Follow-Up, secondaryOutcomes measure: Biomarkers of Exposure: Carbon Monoxide (CO), secondaryOutcomes measure: Biomarkers of Exposure: Mean mid-expiratory forced expiratory flow (FEF25% - 75%), secondaryOutcomes measure: Biomarkers of Exposure: 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL), secondaryOutcomes measure: Biomarkers of Exposure:1-hydroxypyrene (1-HOP), eligibilityModule sex: ALL, minimumAge: 21 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
protocolSection identificationModule nctId: NCT06372886, orgStudyIdInfo id: 2402-147-1516, briefTitle: Clinical Outcomes of Preservation Versus Resection of Portal/Superior Mesenteric Vein During Pancreaticoduodenectomy in Pancreatic Cancer Patients Who Respond to Neoadjuvant Treatment, statusModule overallStatus: COMPLETED, startDateStruct date: 2012-01-01, primaryCompletionDateStruct date: 2022-01-01, completionDateStruct date: 2024-03-01, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Seoul National University Hospital, class: OTHER, descriptionModule briefSummary: 1. There is a lack of evidence on the need to perform portal/superior mesenteric vein (PV/SMV) resection routinely in pancreatic ductal adenocarcinoma (PDAC) patients with venous involvement who responded to neoadjuvant treatment (NAT).2. There is no significant differences in R0 rate, 5-year overall survival and recurrence-free survival between the PV/SMV preservation (PVP) group and PV/SMV resection (PVR) group.3. PVP group showed significantly better 5-year PV/SMV stenosis free survival than the PVR group.4. We propose that if dissection is possible and there is a high likelihood of achieving R0 resection after NAT, routine PVR may be unnecessary in PDAC patients with venous involvement., conditionsModule conditions: Pancreatic Head Cancer Patients Who Underwent Surgery After Neoadjuvant Treatment, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 264, type: ACTUAL, armsInterventionsModule interventions name: portal/superior vein resection, outcomesModule primaryOutcomes measure: 5-year overall survival, primaryOutcomes measure: 5-year portal/superior mesenteric vein stenosis free survival, eligibilityModule sex: ALL, maximumAge: 79 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
protocolSection identificationModule nctId: NCT06372873, orgStudyIdInfo id: 2023PHB211-001, briefTitle: Deep-learning For Ultrasound Classification of Anterior Talofibular Ligament Injury, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-04-30, completionDateStruct date: 2025-05-30, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Peking University People's Hospital, class: OTHER, descriptionModule briefSummary: Ultrasound (US) is a more cost-effective, accessible, and available imaging technique to assess anterior talofibular ligament (ATFL) injuries compared with magnetic resonance imaging (MRI). However, challenges in using this technique and increasing demand on qualified musculoskeletal (MSK) radiologists delay the diagnosis. Using datasets from multiple clinical centers, the investigators aimed to develop and validate a deep convolutional network (DCNN) model that automates classification of ATFL injuries using US images with the goal of providing interpretable assistance to radiologists and facilitating a more accurate diagnosis of ATFL injuries.The investigators collected US images of ATFL injuries which had arthroscopic surgery results as reference standard form 13 hospitals across China;Then the investigators divided the images into training dataset, internal validation dataset, and external validation dataset in a ratio of 8:1:1; the investigators chose an optimal DCNN model to test its diagnostic performance of the model, including the diagnostic accuracy, sensitivity, specificity, F1 score. At last, the investigators compared the diagnostic performance of the model with 12 radiologists at different levels of expertise., conditionsModule conditions: Deep Learning, conditions: Ultrasound, conditions: Anterior Talofibular Ligament, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: RETROSPECTIVE, enrollmentInfo count: 3000, type: ESTIMATED, armsInterventionsModule interventions name: re-evaluate by two senior radiologists in our medical center, outcomesModule primaryOutcomes measure: To evaluate whether the US images are in consensus with the ATFL injury classification of the reference standard, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Peking University People's Hospital, city: Beijing, state: Beijing, zip: 100032, country: China, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
protocolSection identificationModule nctId: NCT06372860, orgStudyIdInfo id: RKS2018350, secondaryIdInfos id: 3P20GM144269-02S2, type: NIH, link: https://reporter.nih.gov/quickSearch/3P20GM144269-02S2, briefTitle: DPP Feasibility Study of Breastfeeding - eMOMS 2.0, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2025-02, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: University of Kansas Medical Center, class: OTHER, collaborators name: Ascension Health, collaborators name: National Institute of General Medical Sciences (NIGMS), descriptionModule briefSummary: The purpose of this study is to investigate the impact of a comprehensive intervention that combines breastfeeding support with a diabetes prevention-based program (DPP) on postpartum weight retention and lactation duration among women with pre-pregnancy overweight or obesity. This intervention, named eMOMS, is delivered by a certified health coach via a mobile health (mHealth) application., conditionsModule conditions: Overweight or Obesity, conditions: Pregnancy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Diabetes Prevention Program, interventions name: Breastfeeding, interventions name: Usual Care, outcomesModule primaryOutcomes measure: Maternal weight, primaryOutcomes measure: Maternal body mass index (BMI), primaryOutcomes measure: Initiation of Lactation, primaryOutcomes measure: Duration of Lactation, primaryOutcomes measure: Type of Infant Feeding, secondaryOutcomes measure: Recruitment Rate, secondaryOutcomes measure: Retention Rate, secondaryOutcomes measure: Research Engagement, secondaryOutcomes measure: Mobile Application Usage, secondaryOutcomes measure: Health Coach Interaction, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2024-02-07, uploadDate: 2024-04-09T16:15, filename: Prot_SAP_000.pdf, size: 1164859, hasResults: False
protocolSection identificationModule nctId: NCT06372847, orgStudyIdInfo id: Project ID 6214, briefTitle: DISE-HNS Effect Study, acronym: DISE-HNS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-23, primaryCompletionDateStruct date: 2028-03-31, completionDateStruct date: 2028-03-31, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: University Hospital, Antwerp, class: OTHER, descriptionModule briefSummary: The purpose of this study is to assess the site, pattern and degree of upper airway collapse before and during hypoglossal nerve stimulation (HNS) treatment using clinical standard drug-induced sleep endoscopy (DISE) and using a novel, non-invasive method predicting site of collapse from raw polysomnography (PSG) data.Furthermore, outcomes will be compared between responders and non-responders., conditionsModule conditions: Obstructive Sleep Apnea, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Before-and-after study, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 58, type: ESTIMATED, armsInterventionsModule interventions name: Hypoglossal nerve stimulation implant, interventions name: Polysomnography, interventions name: Drug-induced sleep endoscopy (DISE), outcomesModule primaryOutcomes measure: Δ%area-of-collapse at the level of the lateral walls, secondaryOutcomes measure: Δ%area-of-collapse at the level of the palate, tongue base and epiglottis, secondaryOutcomes measure: Δ%area-of-collapse at each possible site of upper airway collapse (palate, lateral walls, tongue base, epiglottis) in responders and non-responders, secondaryOutcomes measure: DISE-score during baseline DISE and during one-year follow-up DISE., secondaryOutcomes measure: Non-invasive site and pattern of collapse, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2024-02-29, uploadDate: 2024-04-04T04:58, filename: Prot_SAP_000.pdf, size: 425782, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2024-02-29, uploadDate: 2024-04-04T04:58, filename: ICF_001.pdf, size: 336420, hasResults: False