hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06360900, orgStudyIdInfo id: 2024P000849, briefTitle: Synergistic Gut-brain Axis Modulation Via Vagal Stimulation and Cognitive Behavioral Therapy in Functional Dyspepsia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2029-03, completionDateStruct date: 2029-03, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Spaulding Rehabilitation Hospital, class: OTHER, descriptionModule briefSummary: The primary aims of this randomized, single-blinded, 2x2 sham-controlled trial are to 1) evaluate synergistic impact of 8-weeks of transcutaneous auricular vagus nerve stimulation (taVNS) + cognitive-behavioral therapy (CBT) on post-meal gut-brain communication; 2) determine the sequential relationship between treatment-associated changes in gastrointestinal-related anxiety and both clinical functional dyspepsia (FD) improvements and meal-induced physiological outcomes; 3) investigate whether post-treatment changes in gut-brain physiology mediate improvements in FD clinical outcomes. Using a fully non-invasive framework including gastric and brain magnetic resonance imaging (MRI) and taVNS, the investigators aim to evaluate the potential synergy of taVNS and CBT in FD, by assessing the gut-brain physiological response to prandial challenge, linking physiological with symptom improvements., conditionsModule conditions: Functional Dyspepsia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: FACTORIAL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: taVNS, interventions name: CBT, interventions name: Education Control, interventions name: Sham taVNS, outcomesModule primaryOutcomes measure: Nepean Dyspepsia Index (NDI), primaryOutcomes measure: Visceral Sensitivity Index (VSI), secondaryOutcomes measure: Gastric peristaltic velocity, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06360887, orgStudyIdInfo id: DRKS00030614, briefTitle: Management of Proximal Humerus Fractures in Adults: a Clinical Trial, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2028-01-31, completionDateStruct date: 2028-01-31, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Regional Hospital of Bolzano, class: OTHER, descriptionModule briefSummary: Prospective patient registry examining the outcome of three different treatment methods for proximal humerus fractures in elderlies: conservative treatment, open and minimal invasive surgical treatment., conditionsModule conditions: Shoulder Fractures, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 351, type: ESTIMATED, armsInterventionsModule interventions name: Conservative, interventions name: ORIF, interventions name: CRPP, outcomesModule primaryOutcomes measure: Oxford Shoulder Score, secondaryOutcomes measure: The visual analogue scale, secondaryOutcomes measure: Rate of complications, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Academic Hospital of Bolzano (SABES-ASDAA), city: Bolzano, state: Alto Adige, zip: 39100, country: Italy, contacts name: Malte Nikolas Witte, Dr., role: CONTACT, phone: 00393885787726, email: maltewitte@posteo.de, geoPoint lat: 46.49067, lon: 11.33982, hasResults: False
protocolSection identificationModule nctId: NCT06360874, orgStudyIdInfo id: ND003-I-06, briefTitle: A Study to Evaluate Safety, Tolerability and Pharmacokinetic of ND-003 Tablets in Healthy Adults, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2025-02, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Shenzhen NewDEL Biotech, Co., Ltd, class: INDUSTRY, collaborators name: Shenzhen Innovation Center for Small Molecule Drug Discovery Co., Ltd., descriptionModule briefSummary: The purpose of this study is to evaluate Safety, Tolerability and Pharmacokinetic of ND-003 tablets in Healthy Adults, conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: Double-blind, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 104, type: ESTIMATED, armsInterventionsModule interventions name: ND-003 40mg, interventions name: ND-003 placebo 40mg, interventions name: ND-003 80mg, interventions name: ND-003 placebo 80mg, interventions name: ND-003 160mg, interventions name: ND-003 placebo 160mg, interventions name: ND-003 240mg, interventions name: ND-003 placebo 240mg, interventions name: ND-003 300mg, interventions name: ND-003 placebo 300mg, interventions name: MAD_ND003_Dose 1, interventions name: MAD_placebo_Dose 1, interventions name: MAD_ND003_Dose 2, interventions name: MAD_placebo_Dose 2, interventions name: MAD_ND003_Dose 3, interventions name: MAD_ placebo_Dose 3, interventions name: Food effect_Cohort 1, interventions name: Food effect_Cohort 2, outcomesModule primaryOutcomes measure: Adverse Events (AE), secondaryOutcomes measure: maximum concentration (Cmax), secondaryOutcomes measure: Time to maximum concentration (Tmax), secondaryOutcomes measure: Elimination Half-life (t1/2), secondaryOutcomes measure: Clearance (CLz/F), secondaryOutcomes measure: AUC from time 0 to last time of quantifiable concentration (AUC0-t), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06360848, orgStudyIdInfo id: IRB00001192, briefTitle: Surgical Treamtment of Pseudarthrosis of the Humerus (Study of a Series of 53 Cases), statusModule overallStatus: COMPLETED, startDateStruct date: 2005-01-01, primaryCompletionDateStruct date: 2021-01-01, completionDateStruct date: 2021-01-01, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Ibn Jazzar Hospital, class: OTHER, descriptionModule briefSummary: Pseudarthrosis of the humerus is a serious complication of humerus fractures, of particular interest to subjects young working people with pseudoarthrogenic risk factors (tobacco++). It represents a real problem therapeutic given the long period of treatment, its disabling socio-professional repercussions and the cost which resulting.The aim of our work is to evaluate the anatomical and functional results of different surgical techniques. used., conditionsModule conditions: Humerus Fracture, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 53, type: ACTUAL, armsInterventionsModule interventions name: surgery, outcomesModule primaryOutcomes measure: Distribution of atrophic pseudarthrosis according to technique surgical procedure used (in Number of patients), primaryOutcomes measure: Distribution of hypertrophic pseudarthrosis according to technique surgical procedure used (in Number of patients), primaryOutcomes measure: Time to consolidation depending on the type of pseudarthrosis (in months), primaryOutcomes measure: Average Constant score postoperatively according to the means of restraint, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
protocolSection identificationModule nctId: NCT06360835, orgStudyIdInfo id: IRB00001193, briefTitle: Our Experience in the Management of Therapeutic Failures of Fractures of the Proximal End of the Femur (About 35 Cases), statusModule overallStatus: COMPLETED, startDateStruct date: 2015-01-01, primaryCompletionDateStruct date: 2021-12-01, completionDateStruct date: 2021-12-02, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Ibn Jazzar Hospital, class: OTHER, descriptionModule briefSummary: Osteosyntheses employed in treating fractures at the upper end of the femur play a critical role in facilitating a swift recovery by minimizing immobilization periods and enabling early rehabilitation of the affected joints, thereby promoting a speedy return to normal walking function.Osteosynthesis alters the mechanical dynamics of the bone segment, which undergoes continual changes during the consolidation and mobilization phases of recovery. Throughout these stages, a range of mechanical complications may arise, posing challenges despite the successful prevention of infections. Non-infectious complications associated with the presence of osteosynthesis materials, especially in weight-bearing areas like the lower limb, remain a concern.In light of these considerations, surgeons must exercise meticulous care in selecting synthetic materials to mitigate the risk of osteosynthesis failures. In cases where internal fixation fails, the standard recourse often involves converting to total hip arthroplasty (THA).However, it is essential to note that THA subsequent to complications arising from proximal femur osteosynthesis presents a higher incidence of both intraoperative and postoperative complications compared to the implantation of primary total hip prostheses. Thus, while osteosynthesis remains a valuable intervention for femur fractures, careful attention to material selection and postoperative management is crucial in optimizing patient outcomes and minimizing complications., conditionsModule conditions: Proximal Femur Fractures, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 35, type: ACTUAL, armsInterventionsModule interventions name: total hip arthroplasty, outcomesModule primaryOutcomes measure: Surgical Approach, primaryOutcomes measure: Preparation of the Patient, primaryOutcomes measure: Anesthesia, primaryOutcomes measure: Type of Surgical Revision, primaryOutcomes measure: Types of Prosthesis, secondaryOutcomes measure: Age Distribution, secondaryOutcomes measure: Distribution by Sex, secondaryOutcomes measure: Distribution According to Affected Side, secondaryOutcomes measure: Distribution According to Circumstances of Trauma, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IBN jazzar hospital, city: Kairouan, zip: 3190, country: Tunisia, geoPoint lat: 35.6781, lon: 10.09633, hasResults: False
protocolSection identificationModule nctId: NCT06360822, orgStudyIdInfo id: 19317, briefTitle: Increasing Equity in Lung Cancer Screening, acronym: LUCARE, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-01, primaryCompletionDateStruct date: 2027-02-01, completionDateStruct date: 2027-02-01, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Indiana University, class: OTHER, collaborators name: Eskenazi Health, descriptionModule briefSummary: The overall objective of this mixed methods study is to: 1) Refine the Emergency Department Lung Cancer Screening (ED-LCS) intervention using qualitative interviews among key stakeholders; 2) pilot test the ED-LCS intervention evaluating the intervention efficacy, acceptability, and feasibility; and 3) provide an in-depth description of stakeholders' experiences with the ED-LCS intervention for future refinement., conditionsModule conditions: Lung Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 144, type: ESTIMATED, armsInterventionsModule interventions name: ED-LCS, outcomesModule primaryOutcomes measure: Rate of patients receive Lung Cancer Screening, secondaryOutcomes measure: Patients ratings of intervention, eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Eskenazi Health, status: RECRUITING, city: Indianapolis, state: Indiana, zip: 46202, country: United States, contacts name: Nicholas Pettit, MD, role: CONTACT, phone: 317-962-5975, email: nrpettit@iu.edu, geoPoint lat: 39.76838, lon: -86.15804, hasResults: False
protocolSection identificationModule nctId: NCT06360796, orgStudyIdInfo id: 2023-ADC189-I-010, briefTitle: Study of Pharmacokinetics and Metabolism on [(14)C]ADC189, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-24, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-07-30, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Jiaxing AnDiCon Biotech Co.,Ltd, class: INDUSTRY, descriptionModule briefSummary: This study is designed to determined the metabolism, excretion, and substance balance of almonertinib of ADC189. The pharmacokinetic characteristics and safety profile of ADC189 was investigated following a single oral dose (45 mg/100 µCi) in healthy Chinese male participants., conditionsModule conditions: Pharmacokinetics, conditions: Metabolism, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 6, type: ESTIMATED, armsInterventionsModule interventions name: [(14)C]ADC189, outcomesModule primaryOutcomes measure: The Area Under the Curve (AUC) of [(14)C]ADC189 and its metabolites, primaryOutcomes measure: The Maximum Plasma Concentration [Cmax] of [(14)C]ADC189 and its metabolites, primaryOutcomes measure: The whole blood and serum concentrations of total radioactivity of [(14)C]ADC189 (about 100 μCi), primaryOutcomes measure: The urinary and fecal recovery of total radioactivity of [(14)C]ADC189 (about 100 μCi), eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: The First Affilicated Hospital of Bengbu Medical University, status: RECRUITING, city: Bengbu, state: Anhui, zip: 233004, country: China, contacts name: Huan Zhou, role: CONTACT, phone: +8613665527160, email: zhouhuanbest@vip.163.com, geoPoint lat: 32.94083, lon: 117.36083, hasResults: False
protocolSection identificationModule nctId: NCT06360783, orgStudyIdInfo id: Pro00111388, briefTitle: COVID-19 Quick Start - Test and Treat in Africa, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-02-01, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-06, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Duke University, class: OTHER, collaborators name: Duke Clinical Research Institute, collaborators name: Clinton Health Access Initiative, Nigeria, descriptionModule briefSummary: Duke University and the Clinton Health Access Initiative (CHAI), in partnership with the Ministries of Health (MoH) of Ghana, Malawi, Rwanda, Zambia, and Zimbabwe, aim to assess the implementation and impact of COVID-19 test -and -treat (T\&T) demonstration programs, conditionsModule conditions: COVID-19, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: RETROSPECTIVE, enrollmentInfo count: 1000, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Stakeholder Perspectives, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Duke Global Health Institute, city: Durham, state: North Carolina, zip: 27705, country: United States, geoPoint lat: 35.99403, lon: -78.89862, hasResults: False
protocolSection identificationModule nctId: NCT06360770, orgStudyIdInfo id: NIRSCovidSBCelje, briefTitle: Assessement of Microcirculation With NIRS Predicts Sepsis Development in Patients With Severe Covid-19 Pneumonia, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-12-01, primaryCompletionDateStruct date: 2023-02-28, completionDateStruct date: 2023-04-30, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: General and Teaching Hospital Celje, class: OTHER, descriptionModule briefSummary: Sepsis and septic shock are among main causes of death in patients with severe Covid-19 pneumonia. A few factors are proven to predict sepsis in these patients. WIth near infrared spectroscopy it is possible to detect microcirculatory changes typical for sepsis early in the course of disease. The hypothesis that changes in tissue oxygene saturation during vasoocclusive test predict sepsis as well as mortality in mechancally ventilated patients withe severe Covid-19 pneumonia will be tested., conditionsModule conditions: Sepsis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 35, type: ACTUAL, outcomesModule primaryOutcomes measure: sepsis development, secondaryOutcomes measure: mortality, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: SB Celje, city: Celje, zip: 3000, country: Slovenia, geoPoint lat: 46.23092, lon: 15.26044, hasResults: False
protocolSection identificationModule nctId: NCT06360757, orgStudyIdInfo id: DHF-21-2141-1, briefTitle: Clinical Evaluation of the NeuMoDx SARS-CoV-2 Assay (COVID-19), statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-06, primaryCompletionDateStruct date: 2024-09-01, completionDateStruct date: 2024-09-01, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: QIAGEN Gaithersburg, Inc, class: INDUSTRY, descriptionModule briefSummary: A multicenter study, using prospectively collected, fresh (Category I) and frozen (Category II), residual/leftover nasopharyngeal (NP) swab in UTM/UVT specimens obtained from symptomatic individuals suspected of COVID-19 infection. This study will evaluate the NeuMoDx SARS-CoV-2 Assay's clinical performance on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems., conditionsModule conditions: SARS-CoV-2 Acute Respiratory Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 1432, type: ESTIMATED, armsInterventionsModule interventions name: NeuMoDx SARS-CoV-2 Assay, outcomesModule primaryOutcomes measure: Sensitivity as compared to the comparator method, secondaryOutcomes measure: Specificity, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: QIAGEN Gaithersburg, Inc, status: RECRUITING, city: Manchester, zip: M130BH, country: United Kingdom, contacts name: Sarah G Johnson, role: CONTACT, phone: 44 7825866041, email: Sarah.Johnson@qiagen.com, contacts name: Helen Green, role: CONTACT, phone: 44 7825866041, email: Helen.Green@qiagen.com, geoPoint lat: 53.48095, lon: -2.23743, hasResults: False
protocolSection identificationModule nctId: NCT06360744, orgStudyIdInfo id: ENFORCE PLUS, briefTitle: A Phase IV Vaccine Study Under the National Cohort Study of Effectiveness and Safety of SARS-CoV-2 (COVID-19) Vaccines., statusModule overallStatus: COMPLETED, startDateStruct date: 2021-07-05, primaryCompletionDateStruct date: 2023-12-31, completionDateStruct date: 2023-12-31, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Jens D Lundgren, MD, class: OTHER, collaborators name: Ministry of the Interior and Health, Denmark, descriptionModule briefSummary: A phase IV study to assess if the SARS-CoV-2 vaccine from Johnson \& Johnson/Janssen (J\&J) results in change in number and activation of platelets and anti-PF4 Level. As well as compare whether the vaccine is causing a greater activation of platelets and anti-PF4 than the mRNA vaccines.The Danish Medicines Agency has approved the vaccine from J\&J for use in Denmark, however it is not currently part of the national vaccine programme.The design is an open-labelled, non-randomised, parallel group, phase IV study with historical controls. A sub-study will be embedded within this master protocol addressing basic and translational research questions requiring additional sampling of biological material (under separate participant informed consent)., conditionsModule conditions: SARS CoV 2 Infection, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: The design is an open-labelled, non-randomised, parallel group, phase IV study with historical controls., primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 25, type: ACTUAL, armsInterventionsModule interventions name: Johnson & Johnson, outcomesModule primaryOutcomes measure: Assessment of the J& J vaccine, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Aarhus Universitetshospital, Skejby, city: Aarhus, state: Aarhus N, zip: 8200, country: Denmark, geoPoint lat: 56.15674, lon: 10.21076, locations facility: Aalborg Universitetshospital Syd, city: Aalborg, zip: 8000, country: Denmark, geoPoint lat: 57.048, lon: 9.9187, locations facility: Hvidovre Hospital, city: Hvidovre, zip: 2600, country: Denmark, geoPoint lat: 55.65719, lon: 12.47364, locations facility: Odense Universitetshospital, city: Odense, zip: 5000, country: Denmark, geoPoint lat: 55.39594, lon: 10.38831, locations facility: Sjællandsuniversitetshospital, city: Roskilde, zip: 4000, country: Denmark, geoPoint lat: 55.64152, lon: 12.08035, hasResults: False