hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06314841, orgStudyIdInfo id: LBG-AUVA, briefTitle: Polytrauma and Resuscitation Impact on Innate Immunity, acronym: PRIME, statusModule overallStatus: TERMINATED, startDateStruct date: 2017-06-01, primaryCompletionDateStruct date: 2022-01-01, completionDateStruct date: 2022-01-01, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Ludwig Boltzmann Gesellschaft, class: OTHER, collaborators name: AUVA, descriptionModule briefSummary: Major trauma can lead to a dysregulated response to secondary infection. Severe injuries are accompanied by pro- and antiinflammatory changes that affect both adaptive and innate immunity. In this study we aim to assess cellular immuno-competence early during treatment in an attempt to identify signs of immuno-suppression., conditionsModule conditions: Wounds and Injuries, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 62, type: ACTUAL, outcomesModule primaryOutcomes measure: Immunocompetence, secondaryOutcomes measure: Changes in cellular immuno-status, secondaryOutcomes measure: Release of extracellular vesicles and associated content, secondaryOutcomes measure: Platelet-leukocyte aggregates, secondaryOutcomes measure: Immunocompetence clusters, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Trauma Center Vienna, Meidling, city: Vienna, zip: 1120, country: Austria, geoPoint lat: 48.20849, lon: 16.37208, locations facility: Ludwig Boltzmann Institute for Experimental and Clinical Traumatology, AUVA Trauma Research Center, city: Vienna, zip: 1200, country: Austria, geoPoint lat: 48.20849, lon: 16.37208, locations facility: Trauma Center Vienna, Lorenz Böhler, city: Vienna, zip: 1200, country: Austria, geoPoint lat: 48.20849, lon: 16.37208, hasResults: False
protocolSection identificationModule nctId: NCT06314828, orgStudyIdInfo id: RJMty19-B-NHL002, briefTitle: A Tolerability, Safety and Efficacy Study of RJMty19 in Subjects With Relapsed or Refractory B-NHL, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-20, primaryCompletionDateStruct date: 2025-05-20, completionDateStruct date: 2027-05-20, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Guangdong Ruishun Biotech Co., Ltd, class: INDUSTRY, collaborators name: Ruijin Hospital, collaborators name: Southern Medical University, China, collaborators name: Beijing GoBroad Hospital, descriptionModule briefSummary: This is a Phase 1, open-label, single-arm study to evaluate tolerability, safety and efficacy of RJMty19 in adult subjects with r/r B-NHL., conditionsModule conditions: B-cell Non-Hodgkin's Lymphoma, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: RJMty19 (CD19-CAR-DNT cells), outcomesModule primaryOutcomes measure: Dose-Limiting Toxicity (DLT), primaryOutcomes measure: Maximum Tolerated Dose (MTD), primaryOutcomes measure: Incidence of abnormalities, secondaryOutcomes measure: Pharmacokinetics (PK) indicator (Cmax), secondaryOutcomes measure: Pharmacokinetics (PK) indicator (AUC), secondaryOutcomes measure: Pharmacokinetics (PK) indicator (Tmax), secondaryOutcomes measure: Pharmacokinetics (PK) indicator (T1/2), secondaryOutcomes measure: Overall Response Rate, secondaryOutcomes measure: Disease Control Rate, secondaryOutcomes measure: Duration of Response, secondaryOutcomes measure: Progression Free Survival, secondaryOutcomes measure: Overall Survival, secondaryOutcomes measure: Overall Response Rate at 3 months, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06314802, orgStudyIdInfo id: LCSR, briefTitle: Learning Curve of the Shouldice Procedure, acronym: LCSR, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-11, primaryCompletionDateStruct date: 2024-05-11, completionDateStruct date: 2024-06-10, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Shouldice Hospital, class: OTHER, descriptionModule briefSummary: Hernia repair surgery is common, especially the Shouldice repair for primary inguinal hernias, which is considered a top-notch nonmesh technique. However, outcomes can vary, possibly due to differences in surgical skill and experience. Many surgeons are trained more in mesh repairs like the Lichtenstein technique, rather than nonmesh repairs like Shouldice.Understanding a surgeon's learning curve-how many surgeries they need to do to become proficient-is crucial. Yet, there's not much research on this for the Shouldice repair. This project aims to fill that gap and improve surgeon education.The study's goal is to find out how the learning curve affects Shouldice repair for primary inguinal hernias. They'll look at how operative time changes over a surgeon's first 300 repairs compared to their 900-1000th. They'll also check for complications and recurrence rates.The study objectives are:1. Explore the learning curve and factors affecting Shouldice repair.2. Compare operative times between a surgeon's early and later surgeries.3. Look at complications during the learning curve.4. Determine how long training takes at Shouldice Hospital and the surgeons' previous experience.5. Review recurrence rates between the first 300 and 900-1000 surgeries.This research aims to give surgeons and the hernia community valuable insights into improving surgical techniques and patient outcomes., conditionsModule conditions: Groin Hernia, conditions: Shouldice Procedure, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 1600, type: ESTIMATED, armsInterventionsModule interventions name: no intervention, outcomesModule primaryOutcomes measure: Operating time I, secondaryOutcomes measure: Operating time II, secondaryOutcomes measure: Operating time III, eligibilityModule sex: ALL, minimumAge: 16 Years, maximumAge: 99 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Shouldice hospital, status: RECRUITING, city: Thornhill, state: Ontario, zip: L3T 4A3, country: Canada, contacts name: Christoph Paasch, role: CONTACT, phone: 9058891125, email: cpaasch@shouldice.com, contacts name: Marguerite Mainprize, role: CONTACT, phone: 9058891125, email: mmainprize@shouldice.com, hasResults: False
protocolSection identificationModule nctId: NCT06314776, orgStudyIdInfo id: NEURO24, briefTitle: Whole-Body Vibration Therapy in the Gait of Children With Cerebral Palsy, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-11, primaryCompletionDateStruct date: 2024-06-01, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Universidad de Almeria, class: OTHER, descriptionModule briefSummary: Observation of the effect of vibration therapy on the gait of children with cerebral palsy and the analysis of their functional evolution, conditionsModule conditions: Cerebral Palsy, conditions: Neurologic Disorder, conditions: Gait Disorders in Children, conditions: Hemiplegia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Usual physiotherapy without Whole-Body Vibration, interventions name: Pre-Usual physiotherapy, interventions name: Post-Usual physiotherapy, outcomesModule primaryOutcomes measure: Test Time Up and Go, primaryOutcomes measure: Timed 10-Meter Walk Test, primaryOutcomes measure: Gross Motor Function Measure, eligibilityModule sex: ALL, minimumAge: 2 Years, maximumAge: 11 Years, stdAges: CHILD, contactsLocationsModule locations facility: María del Mar Sánchez-Joya, status: RECRUITING, city: Almería, zip: 04120, country: Spain, contacts name: María del Mar Sánchez-Joya, PhD, role: CONTACT, contacts name: Pilar Pérez Guillén, role: SUB_INVESTIGATOR, geoPoint lat: 36.83814, lon: -2.45974, hasResults: False
protocolSection identificationModule nctId: NCT06314750, orgStudyIdInfo id: 2023ZSLYEC-680, briefTitle: Deep Learning Based MRI Radiomics in Predicting the Clinical Risk of Locally Advanced Rectal Cancer, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2010-01-01, primaryCompletionDateStruct date: 2023-09-30, completionDateStruct date: 2027-09-30, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Sixth Affiliated Hospital, Sun Yat-sen University, class: OTHER, descriptionModule briefSummary: Neoadjuvant therapy is the standard diagnosis and treatment strategy for locally advanced rectal cancer defined by MRI in order to achieve tumor regression, thus affecting the selection of surgical strategy and circumferential margin, improving the safety of operation and the prognosis of patients. This study focused on the related clinical factors such as tumor regression before and after neoadjuvant therapy, combined with preoperative high-dimensional features such as radiomics, to predict the related factors of tumor regression of locally advanced rectal cancer, and validate it with multicenter. In order to develop an accurate model that can be applied to the real world and stratify the risk of locally advanced rectal cancer patients before treatment., conditionsModule conditions: Locally Advanced Rectal Carcinoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 186, type: ACTUAL, armsInterventionsModule, outcomesModule primaryOutcomes measure: OS, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06314737, orgStudyIdInfo id: 2021ZSLYEC-192, briefTitle: Assessment of Efficacy of Neoadjuvant Therapy in Locally Advanced Rectal Cancer, statusModule overallStatus: COMPLETED, startDateStruct date: 2010-10-02, primaryCompletionDateStruct date: 2018-12-06, completionDateStruct date: 2024-01-01, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Sixth Affiliated Hospital, Sun Yat-sen University, class: OTHER, descriptionModule briefSummary: This study analyzed the efficacy differences between neoadjuvant therapy and direct surgical treatment in patients with locally advanced rectal cancer in the real world. The aim was to evaluate the impact of neoadjuvant therapy on overall survival, disease-free survival, and local recurrence-free survival in patients with locally advanced rectal cancer, explore the population benefiting most from neoadjuvant therapy, and provide evidence-based medicine for the benefits of neoadjuvant therapy in patients with colorectal cancer in the real world., conditionsModule conditions: Locally Advanced Rectal Carcinoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 3515, type: ACTUAL, armsInterventionsModule, outcomesModule primaryOutcomes measure: Overall Survival, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06314724, orgStudyIdInfo id: PRO-VZV-4006, briefTitle: Immunogenicity and Safety of Varicella Vaccine, Live in Healthy Children Aged 12~15 Months in the Philippines, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-05-15, completionDateStruct date: 2024-06-15, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Sinovac (Dalian) Vaccine Technology Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: This is a Phase Ⅲ, randomized, double-blind, active-controlled study to assess the immunogenicity and safety of the varicella vaccine,Live (hereinafter referred to as "varicella vaccine")manufactured by Sinovac (Dalian) Vaccine Technology Co., LTD.(hereinafter referred to as "Sinovac")., conditionsModule conditions: Varicella, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 642, type: ESTIMATED, armsInterventionsModule interventions name: Varicella Vaccine, interventions name: Varivax, outcomesModule primaryOutcomes measure: Seroresponse rate of varicella-zoster virus (VZV) antibody, secondaryOutcomes measure: Geometric mean concentrations (GMCs) of VZV antibody, secondaryOutcomes measure: GMC of VZV antibody, secondaryOutcomes measure: seropositive rate, secondaryOutcomes measure: Geometric mean fold rise (GMFR) from before vaccination of VZV antibody, secondaryOutcomes measure: Incidence of adverse reactions within 0~42 days after vaccination, secondaryOutcomes measure: Incidence of adverse reactions within 0~14 days after vaccination, secondaryOutcomes measure: Incidence of serious adverse events (SAE) within 0~42 days after vaccination, eligibilityModule sex: ALL, minimumAge: 12 Months, maximumAge: 15 Months, stdAges: CHILD, contactsLocationsModule locations facility: San Juan de Dios Educational Foundation, lnc., city: Pasay, zip: 1300, country: Philippines, geoPoint lat: 14.53748, lon: 121.00144, locations facility: Cardinal Santos Medical Center, city: San Juan City, zip: 1502, country: Philippines, geoPoint lat: 14.6, lon: 121.0333, hasResults: False
protocolSection identificationModule nctId: NCT06314711, orgStudyIdInfo id: Ex Vivo US for OPC, briefTitle: Ex Vivo 3D-ultrasound for Oropharyngeal Cancer, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-10-01, primaryCompletionDateStruct date: 2024-02-01, completionDateStruct date: 2024-02-01, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Rigshospitalet, Denmark, class: OTHER, descriptionModule briefSummary: Patients with biopsy-verified oropharyngeal squamous cell carcinoma or Human Papillomavirus (HPV)-positive unknown primary treated with transoral robotic surgery are included. Immediately post-operatively, freshly resected specimens are examined with ex vivo 3D ultrasound (US).Ex vivo 3D US will be used to match US slices of the specimen with corresponding histopathology slices. The US slices will be reviewed by a panel of head and neck surgeons blinded to histopathology.The primary aim is to explore perioperative ex vivo 3D US for oropharyngeal tumor detection, delineation from normal tissue, tumor size and volume, and margin assessment., conditionsModule conditions: Oropharyngeal Squamous Cell Carcinoma, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 15, type: ACTUAL, armsInterventionsModule interventions name: Ultrasound, outcomesModule primaryOutcomes measure: Fresh ex vivo US Tumor detection (blinded to histopathology), primaryOutcomes measure: Margin assessment (blinded to histopathology), primaryOutcomes measure: Fresh ex vivo US tumor volume (blinded to histopathology), primaryOutcomes measure: Fresh ex vivo US margin distance (blinded to histopathology), primaryOutcomes measure: Fresh ex vivo tumor visible on specimen mecrophoto (blinded to histopathology), secondaryOutcomes measure: Fresh ex vivo US tumor volume (unblinded to histopathology), secondaryOutcomes measure: Formalin-fixed ex vivo US tumor volume (unblinded to histopathology), secondaryOutcomes measure: Fresh ex vivo US margin distance (unblinded to histopathology), secondaryOutcomes measure: Formalin-fixed ex vivo US margin distance (unblinded to histopathology), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Dept. of Otorhinolaryngology, Head & Neck Surg, Rigshospitalet, city: Copenhagen, zip: 2100, country: Denmark, geoPoint lat: 55.67594, lon: 12.56553, hasResults: False
protocolSection identificationModule nctId: NCT06314698, orgStudyIdInfo id: IIT-2024-0011, briefTitle: Narlumosbart Compared With Denosumab in Patients With Multiple Myeloma Bone Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2027-04-30, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: RenJi Hospital, class: OTHER, collaborators name: Shanghai JMT-Bio Inc., descriptionModule briefSummary: The purpose of this study is to determine if narlumosbart is non-inferior to denosumab in the treatment of bone diseases from multiple myeloma (MM)., conditionsModule conditions: Multiple Myeloma, conditions: Bone Diseases, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 478, type: ESTIMATED, armsInterventionsModule interventions name: Narlumosbart, interventions name: Denosumab, outcomesModule primaryOutcomes measure: Percent change from baseline in urinary N-terminal telopeptide of type 1 collagen corrected for urinary creatinine (uNTx/uCr) at week 13, secondaryOutcomes measure: The proportion of subjects with a change in uNTx/uCr greater than 65% from baseline to week 13, secondaryOutcomes measure: Time to first on-study skeletal related event, secondaryOutcomes measure: Percentage of participants with an on-study SRE at different time points, secondaryOutcomes measure: Time to first and subsequent on-study SRE, secondaryOutcomes measure: Percent changes of serum bone alkaline phosphatase (BALP) and serum C-terminal telopeptide of type 1 collagen (sCTX-I), secondaryOutcomes measure: Overall Survival, secondaryOutcomes measure: Incidence and type of adverse events (AEs), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06314685, orgStudyIdInfo id: 2020040C-2, briefTitle: Immunogenicity and Safety of MCV4 in Volunteers Aged 6 Months-5 Years, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2021-12-10, primaryCompletionDateStruct date: 2024-08-30, completionDateStruct date: 2024-08-30, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to evaluate the immunogenicity and safety of Group ACYW135 Meningococcal Polysaccharide Conjugate Vaccine in healthy volunteers aged from 3 months to 5 years old., conditionsModule conditions: Healthy Population, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 2450, type: ACTUAL, armsInterventionsModule interventions name: Group ACYW135 Meningococcal Polysaccharide Conjugate Vaccine, interventions name: Group A and C Meningococcal Polysaccharide Vaccine, interventions name: Group ACYW135 Meningococcal Polysaccharide Vaccine, outcomesModule primaryOutcomes measure: Antibody positive conversion rate, eligibilityModule sex: ALL, minimumAge: 6 Months, maximumAge: 5 Years, stdAges: CHILD, contactsLocationsModule locations facility: Hunan Center for Disease Control and Prevention, city: Changsha, state: Hunan, zip: 410005, country: China, geoPoint lat: 28.19874, lon: 112.97087, hasResults: False
protocolSection identificationModule nctId: NCT06314659, orgStudyIdInfo id: 2020020C, briefTitle: Immunogenicity and Safety of Group A and C Meningococcal Polysaccharide Conjugate Vaccine in Volunteers Aged 3-5 Months, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2021-09-17, primaryCompletionDateStruct date: 2024-12-30, completionDateStruct date: 2024-12-30, studyFirstPostDateStruct date: 2024-03-18, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to evaluate the immunogenicity and safety of Group A and C Meningococcal Polysaccharide Conjugate Vaccine in healthy volunteers aged from 3 to 5 months old., conditionsModule conditions: Healthy Population, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 630, type: ACTUAL, armsInterventionsModule interventions name: Group A and C Meningococcal Polysaccharide Conjugate Vaccine (producted by Zhifei Lvzhu), interventions name: Group A and C Meningococcal Polysaccharide Conjugate Vaccine (producted by Walvax), interventions name: Group A and C Meningococcal Polysaccharide Conjugate Vaccine (producted by Olymvax), outcomesModule primaryOutcomes measure: Analysis of antibody positivity conversion rate of serogroup A, primaryOutcomes measure: Analysis of antibody positivity conversion rate of serogroup C, eligibilityModule sex: ALL, minimumAge: 3 Months, maximumAge: 5 Months, stdAges: CHILD, contactsLocationsModule locations facility: Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention, city: Nanning, state: Guangxi, zip: 530028, country: China, geoPoint lat: 22.81667, lon: 108.31667, hasResults: False