hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06380153, orgStudyIdInfo id: HM005PS1S07, briefTitle: To Evaluate the Pharmacokinetics of Hemay005 Tablets in Patients With Renal Impairment, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Ganzhou Hemay Pharmaceutical Co., Ltd, class: INDUSTRY, descriptionModule briefSummary: The aim of this study was to evaluate the pharmacokinetics of Hemay005 tablets in subjects with mild to moderate renal impairment and normal renal function, and to provide a basis for the formulation of clinical medication regimens for patients with renal impairment., conditionsModule conditions: Psoriasis, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Hemay005, outcomesModule primaryOutcomes measure: Relevant pharmacokinetic parameters，Peak Plasma Concentration（Cmax）, primaryOutcomes measure: Relevant pharmacokinetic parameters，Area under the plasma concentration versus time curve（AUC0-t）, primaryOutcomes measure: Relevant pharmacokinetic parameters，Area under the curve from time 0 extrapolated to infinite time (AUC0-inf), primaryOutcomes measure: Relevant pharmacokinetic parameters，half-life (T1/2), primaryOutcomes measure: Relevant pharmacokinetic parameters，clearance (CL/F), primaryOutcomes measure: Relevant pharmacokinetic parameters，volume of distribution (Vz/F), primaryOutcomes measure: Relevant pharmacokinetic parameters ，Renal clearance rate（CLr）, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06380140, orgStudyIdInfo id: cami3zgmxf3vqyc30ndmdqh6gfjid1, briefTitle: Relationship Between Acute Phase Markers and Post-operative Pain in Open Tension-free Inguinal Hernia Repair: An Observational Study, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-05-03, primaryCompletionDateStruct date: 2024-03-03, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: University of Roma La Sapienza, class: OTHER, descriptionModule briefSummary: Many patients undergoing inguinal hernia repair are prone to developing acute and chronic post-operative pain.The aim of the study is to show a possible correlation between pain and acute phase proteins in order to:* predict the severity of pain;* select most suitable pain relief therapy for the patient., conditionsModule conditions: Post Operative Pain, conditions: Inguinal Hernia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 71, type: ESTIMATED, armsInterventionsModule interventions name: Open Tension-free Inguinal Hernia Repair, outcomesModule primaryOutcomes measure: Relationship Between Post-operative Pain and C Reactive Protein (CRP) in Open Tension-free Inguinal Hernia Repair, primaryOutcomes measure: Relationship Between Post-operative Pain and D-dimer in Open Tension-free Inguinal Hernia Repair, primaryOutcomes measure: Relationship Between Post-operative Pain and Fibrinogen in Open Tension-free Inguinal Hernia Repair, primaryOutcomes measure: Relationship Between Post-operative Pain and white blood cell count in Open Tension-free Inguinal Hernia Repair, primaryOutcomes measure: Relationship Between Post-operative Pain and Neutrophil to Lymphocyte Ratio (NLR) in Open Tension-free Inguinal Hernia Repair, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Augusto Lauro, status: RECRUITING, city: Roma, zip: 000186, country: Italy, contacts name: Augusto Lauro, role: CONTACT, phone: +39 388 8663 879, email: augusto.lauro@uniroma1.it, geoPoint lat: 41.89193, lon: 12.51133, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2023-05-03, uploadDate: 2024-04-18T14:17, filename: Prot_SAP_000.pdf, size: 274127, hasResults: False
protocolSection identificationModule nctId: NCT06380127, orgStudyIdInfo id: CEFADE012021, briefTitle: Feasibility and Effectiveness of Concurrent Exercise Training on Frail Older Adults Living in Nursing Homes, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-10-01, primaryCompletionDateStruct date: 2023-09-30, completionDateStruct date: 2023-12-15, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Universidade do Porto, class: OTHER, descriptionModule briefSummary: The present study is a crossover randomized controlled trial that aims to investigate the effects of concurrent exercise training over usual care on physical performance, muscle strength, and myokines concentrations in frail older adults living in nursing homes.The main questions it aims to answer is: Can a 12-week exercise intervention provide beneficial effects on physical performance, muscle strength and myokines among the most frail participants? Researchers will compare this intervention to usual care. Nursing homes (comprising participants) will be randomly assigned to a sequence of interventions (AB or BA), being A -exercise and B usual care. Participants will be assessed before and after each intervention., conditionsModule conditions: Frailty, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: The trial will follow a 28-week crossover design: 12 weeks for the first intervention period, a 4-week washout, and another 12 weeks for the second intervention period. Nursing homes (clusters) were randomized into sequences (AB or BA), where intervention A involve concurrent exercise training, and B is usual care.Data collection will occurre at four points: baseline, post-first intervention period, post-washout/pre-second intervention period and post-crossover., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 46, type: ACTUAL, armsInterventionsModule interventions name: Exercise training, outcomesModule primaryOutcomes measure: Change from Baseline on Short Physical Performance Battery (SPBB), secondaryOutcomes measure: Change from Baseline on Handgrip test, secondaryOutcomes measure: Change from baseline on isokinetic knee strength, secondaryOutcomes measure: Change from Baseline on circulating levels of myostatin, secondaryOutcomes measure: Change from Baseline on circulating levels of Decorin, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Faculty of Sports, University of Porto, city: Porto, zip: 4000, country: Portugal, geoPoint lat: 41.14961, lon: -8.61099, hasResults: False
protocolSection identificationModule nctId: NCT06380114, orgStudyIdInfo id: STUDY00009296, briefTitle: Stand Up 2 HPV: Standing Orders to Improve HPV Vaccination, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07, primaryCompletionDateStruct date: 2026-04, completionDateStruct date: 2027-11, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: University of Rochester, class: OTHER, collaborators name: National Institutes of Health (NIH), descriptionModule briefSummary: Each year in the U.S., ≥20,000 women and 14,000 men are affected by HPV-related cancers, including cervical and oropharyngeal cancer. However, in 2020, only 59% of U.S. adolescents aged 13-17 were up-to-date for HPV vaccination, and rates for 11-12 year olds, the primary target age group for HPV vaccination (when the immune reaction is better and before exposure to HPV infection), are even lower. Standing orders (written protocols that authorize designated members of the healthcare team to vaccinate without first obtaining a patient-specific physician order) have been shown to work in inpatient settings and for adults, but have not been evaluated for HPV vaccine, which some parents consider controversial. Also, the ways in which organizational readiness for change (resources, motivation, staff attributes, leadership support and culture) moderate the effect of standing orders has not been studied. A physician's recommendation is correlated with HPV vaccine acceptance, and the investigators have developed a successful online, interactive, communication education program that will be adapted to train nurses and staff in addition to physicians. The investigators propose testing standing orders for HPV vaccine in an Accountable Care Organization (ACO) in Western New York, and assessing which provider and practice factors moderate the effect of standing orders. Advantages of this setting include a diverse group of rural, urban and suburban practices, and the ACO provides data infrastructure and analytics that allow practices to evaluate vaccination rates in real time.Using a 2-arm cluster randomized trial (n=40 practices), the investigators will assess the effectiveness of standing orders (SO) + HPV communication education (intervention arm) relative to HPV communication education alone (control arm) on HPV vaccination for 11-17 year-olds., conditionsModule conditions: Hpv, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 16000, type: ESTIMATED, armsInterventionsModule interventions name: Communication, interventions name: Standing Orders, outcomesModule primaryOutcomes measure: HPV vaccination, eligibilityModule sex: ALL, minimumAge: 11 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06380101, orgStudyIdInfo id: NEAAR-LARC, briefTitle: Evaluating a Nonessential Amino Acid Restriction (NEAAR) Medical Food With Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer (LARC), acronym: NEAAR-LARC, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-08, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: University of South Florida, class: OTHER, descriptionModule briefSummary: This clinical study aims to assess feasibility, safety, tolerability, and compliance of a Nonessential Amino Acid Restriction (NEAAR) medical food in adult patients with locally advanced rectal cancer during standard of care short course radiotherapy followed by standard of care chemotherapy., conditionsModule conditions: Rectal Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: NEAAR Medical Food, outcomesModule primaryOutcomes measure: Rate of CTCAE v5.0 non-hematological Grade 3 and higher diarrhea, secondaryOutcomes measure: Proportion of clinical complete response 8 weeks post SCRT-TNT with NEAAR medical food defined by the MSK Regression Schema, secondaryOutcomes measure: Absolute and relative change from baseline of circulating non-essential amino acids, secondaryOutcomes measure: Proportion of clinical complete response at Week 4 post SCRT with NEAAR medical food, secondaryOutcomes measure: molecular ctDNA response., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of South Florida, status: RECRUITING, city: Tampa, state: Florida, zip: 33606, country: United States, contacts name: Jennifer Burgess, MS, role: CONTACT, phone: 434-806-6445, email: jburgess@tgh.org, contacts name: Veronique Perry, MSHA, role: CONTACT, phone: 2549873658, email: vperry@tgh.org, contacts name: Richard Tuli, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 27.94752, lon: -82.45843, hasResults: False
protocolSection identificationModule nctId: NCT06380088, orgStudyIdInfo id: VEM-DINOGMI-24, briefTitle: Improving Motor Skills: The Role of Music and Encouragement, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-07-01, primaryCompletionDateStruct date: 2023-08-05, completionDateStruct date: 2024-03-15, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Universita degli Studi di Genova, class: OTHER, descriptionModule briefSummary: This study used a randomised crossover design to analyse the effect of three different experimental interventions - i.e. standard conditions, music and verbal encouragement - on performance in an isometric endurance task, comparing results between untrained and trained individuals. The interval between each intervention was set at seven days. The outcome measures are muscle activity and fatigue, assessed by surface electromyography, and task duration.Isometric endurance task requires participants to keep their arm flexed at a 90° angle while holding a dumbbell with a supine grip loaded to 80% of 1RM on the dominant side of the body. During execution, the back and head should remain in contact with a vertical wall, with the feet shoulder width apart and firmly planted on the floor. The bar is held with the dominant arm while the other arm remains in a neutral position close to the body. It is imperative to avoid any form of rocking or movement that would make it easier to maintain the position. The test officially begins when the bar is handed to the subject, who is already in the correct position, and ends as soon as the angle of the arm varies by more than five degrees from the starting position., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 25, type: ACTUAL, armsInterventionsModule interventions name: Isometric Task, outcomesModule primaryOutcomes measure: Duration of the task, primaryOutcomes measure: Biceps Brachii muscle fatigue, primaryOutcomes measure: Triceps Brachii muscle fatigue, primaryOutcomes measure: Biceps Brachii activity, primaryOutcomes measure: Triceps Brachii activity, eligibilityModule sex: ALL, minimumAge: 27 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Università degli Studi di Genova, city: Genova, zip: 16122, country: Italy, geoPoint lat: 44.40478, lon: 8.94438, hasResults: False
protocolSection identificationModule nctId: NCT06380075, orgStudyIdInfo id: 2024-0480, secondaryIdInfos id: A536000, type: OTHER, domain: UW Madison, secondaryIdInfos id: SMPH/OPHTHAL&VIS SCI/GEN, type: OTHER, domain: UW Madison, secondaryIdInfos id: Protocol Version 3/22/24, type: OTHER, domain: UW Madison, briefTitle: COmparison of Clarus and Optos Ultrawide Field Imaging Systems for Inherited Retinal Disease, acronym: COCO-IRD, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2025-05, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: University of Wisconsin, Madison, class: OTHER, descriptionModule briefSummary: The goal of this research study is to compare two ultrawide field cameras to the gold standard imaging system to evaluate the back of the eye. The main question it aims to answer is the same results and information can be acquired from all of the cameras for evaluating and monitoring inherited retinal diseases (IRDs).Participants will:* undergo pupillary dilation* have photographs taken of the inside of the eyes using three different cameras, conditionsModule conditions: Retinal Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Spectralis FAF imaging, interventions name: Optos imaging, interventions name: Clarus imaging, outcomesModule primaryOutcomes measure: Compare FAF retinal patterns by Clarus and standard Spectralis FAF imaging, primaryOutcomes measure: Compare FAF retinal patterns by Optos and standard Spectralis FAF imaging, primaryOutcomes measure: Compare FAF retinal patterns by Clarus and Optos FAF imaging, primaryOutcomes measure: Compare Spectralis FAF imaging to Spectralis OCT imaging, secondaryOutcomes measure: Prevalence of FAF retinal pattern changes beyond the standard 30 degress in Clarus and Optos ultrawide field images, secondaryOutcomes measure: Prevalence of other autofluorescence abnormalities unique to the IRD across all imaging, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Ophthalmology and Visual Sciences, city: Madison, state: Wisconsin, zip: 53705, country: United States, contacts name: Amy Remm, role: CONTACT, phone: 608-262-3377, email: amy.remm@wisc.edu, contacts name: Kimberly Stepien, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.07305, lon: -89.40123, hasResults: False
protocolSection identificationModule nctId: NCT06380062, orgStudyIdInfo id: Choline Prostate Cancer, briefTitle: Choline Metabolites in People With Prostate Cancer and Those With Benign Hyperplasia, statusModule overallStatus: COMPLETED, startDateStruct date: 2012-01-12, primaryCompletionDateStruct date: 2015-11-30, completionDateStruct date: 2015-11-30, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Universität des Saarlandes, class: OTHER, descriptionModule briefSummary: The aim of this study was to investigate plasma concentrations of one-carbon metabolites and phospholipid classes in participants with primary prostate cancer and those with benign hyperplasia. Moreover, the metabolites were studied in relation to tumor grade and age., conditionsModule conditions: Primary Prostate Urothelial Cancer, conditions: Benign Prostatic Hyperplasia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 350, type: ACTUAL, armsInterventionsModule interventions name: Plasma concentration of choline, outcomesModule primaryOutcomes measure: Plasma choline concentrations, primaryOutcomes measure: Whole blood choline concentrations, secondaryOutcomes measure: Plasma and whole blood folate forms, secondaryOutcomes measure: Plasma phospholipids, secondaryOutcomes measure: Plasma S-adenosylmethionine concentrations, secondaryOutcomes measure: Plasma betaine concentrations, secondaryOutcomes measure: Plasma methylmalonic acid concentrations, secondaryOutcomes measure: Plasma homocysteine concentrations, eligibilityModule sex: MALE, minimumAge: 50 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Saarland, city: Homburg, state: Saarland, zip: 66424, country: Germany, geoPoint lat: 49.32637, lon: 7.33867, hasResults: False
protocolSection identificationModule nctId: NCT06380049, orgStudyIdInfo id: 0720242110, secondaryIdInfos id: 20240012366, type: OTHER, domain: Ministry of Food and Drug Safety, briefTitle: Predicting Fall Risk in Stroke Patients Using a Machine Learning Model and Multi-Sensor Data, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-29, primaryCompletionDateStruct date: 2025-04-28, completionDateStruct date: 2026-04-28, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Seoul National University Hospital, class: OTHER, collaborators name: Ministry of Trade, Industry & Energy, Republic of Korea, descriptionModule briefSummary: The study assesses a machine learning model developed to predict fall risk among stroke patients using multi-sensor signals. This prospective, multicenter, open-label, sponsor-initiated confirmatory trial aims to validate the safety and efficacy of the model which utilizes electromyography (EMG) signals to categorize patients into high-risk or low-risk fall categories. The innovative approach hopes to offer a predictive tool that enhances preventative strategies in clinical settings, potentially reducing fall-related injuries in stroke survivors., conditionsModule conditions: Stroke, conditions: Fall, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: EMG Analysis Software, outcomesModule primaryOutcomes measure: Sensitivity of the Machine Learning Model, secondaryOutcomes measure: Specificity of the Machine Learning Model, otherOutcomes measure: Area Under the Receiver Operating Characteristic Curve, otherOutcomes measure: Matthews Correlation Coefficient, eligibilityModule sex: ALL, minimumAge: 19 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06380036, orgStudyIdInfo id: 003AEstb/EC/01/2022, briefTitle: Two Approaches to Lower the Chances of Recurrence of Anal Fistula After Surgery, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-11-01, primaryCompletionDateStruct date: 2023-10-31, completionDateStruct date: 2023-10-31, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Sairah Sadaf, class: OTHER_GOV, descriptionModule briefSummary: A total of 80 patients with complex fistula in ano of both genders were included. All patients in Group A underwent a loose seton technique. In group B, video-assisted fistula tract surgery (VAAFTS) was performed.Twice daily Sitz baths, analgesics, and stool bulking agents (bran) were used in follow-up care. Repeated examinations were carried out every four weeks and recurrence was noted at the end of three months, conditionsModule conditions: Fistula in Ano, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ACTUAL, armsInterventionsModule interventions name: video assisted fistula tract surgery, outcomesModule primaryOutcomes measure: recurrence, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sheikh Zayed Medical College, city: Rahim yar khan, state: Punjab, zip: 64200, country: Pakistan, geoPoint lat: 28.41987, lon: 70.30345, hasResults: False