hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06331754, orgStudyIdInfo id: ATMANHEALTH001, briefTitle: Technology-Enabled Remote Hypertension Management To Advance Health Equity, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-18, primaryCompletionDateStruct date: 2025-09-17, completionDateStruct date: 2026-03-17, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Atman Health, Inc, class: INDUSTRY, descriptionModule briefSummary: The primary objective of this study is to reliably estimate the difference in blood pressure control of a technology-enabled solution for blood pressure (BP) management over usual care. The study will also assess patient and provider satisfaction with the solution. Finally, the investigators will estimate the economic impact of the intervention in terms of resource utilization., conditionsModule conditions: Hypertension, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: non-blinded pragmatic cluster-randomized controlled trial with a single intervention, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 1500, type: ESTIMATED, armsInterventionsModule interventions name: Technology-enabled blood pressure management, outcomesModule primaryOutcomes measure: Difference in SBP change, secondaryOutcomes measure: HEDIS proportion, secondaryOutcomes measure: Difference in DBP change, otherOutcomes measure: Home measured change in SBP and DBP, otherOutcomes measure: Patient satisfaction, otherOutcomes measure: Provider satisfaction, otherOutcomes measure: Mean time required per patient for provider, otherOutcomes measure: Mean time required per patient for navigator, otherOutcomes measure: Proportion of patients measuring blood pressure at directed frequency, otherOutcomes measure: Resource utilization, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06331741, orgStudyIdInfo id: 0403, briefTitle: Collagen for Treatment of Musculoskeletal Injuries, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-03-01, completionDateStruct date: 2026-03-01, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: I.M. Sechenov First Moscow State Medical University, class: OTHER, descriptionModule briefSummary: The purpose of the study:Evaluation of the clinical efficacy and safety of the use of collagen matrix/membrane in the surgical treatment of the consequences of injuries and diseases of the musculoskeletal system (anterior cruciate ligament tears, rigid first toe) by using IKDC, KOOS, ACLOAS, VAS, AOFAS, SF-36 scales, conditionsModule conditions: Anterior Cruciate Ligament Injuries, conditions: Hallux Rigidus, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Main group for ACL: 5 patients with ACL injury, who undergo ACL reconstruction with collagen membrane augmentation; Reference group for ACL: 5 patients with ACL injury, who undergo ACL reconstruction without collagen membrane augmentation; Main group for HR (Hallux Rigidus): 5 patients with Hallux Rigidus, who undergo resection arthroplasty with introduction of collagen membrane Reference group: none, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: Anterior cruciate ligament reconstruction, using graft, augmented with collagen membrane, interventions name: Anterior cruciate ligament reconstruction, using graft, not augmented with collagen membrane (control group), interventions name: Resection arthroplasty of the first metatarsophalangeal joint with the introduction of a collagen membrane into the joint cavity, outcomesModule primaryOutcomes measure: The International Knee Documentation Committee score, primaryOutcomes measure: The Knee injury and Osteoarthritis Outcome Score, primaryOutcomes measure: Modified Lysholm scale, primaryOutcomes measure: Anterior Cruciate Ligament OsteoArthritis Score, primaryOutcomes measure: American Orthopaedic Foot and Ankle Society, Ankle-Hindfoot Score, primaryOutcomes measure: 36-Item Short Form Survey, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: university clinical hospital № 1I.M.Sechenov First Moscow State Medical University. The Department of Traumatology, Orthopedics and Disaster Surgery, status: RECRUITING, city: Moscow, zip: 119991, country: Russian Federation, contacts name: Marina M Lipina, MD, PhD, role: CONTACT, phone: +79253122096, email: marina.lipina@icloud.com, geoPoint lat: 55.75222, lon: 37.61556, hasResults: False
protocolSection identificationModule nctId: NCT06331728, orgStudyIdInfo id: IGNX-T1, briefTitle: Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of IGNX001, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07, primaryCompletionDateStruct date: 2025-08, completionDateStruct date: 2025-10, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: IgGenix Australia Pty Ltd, class: INDUSTRY, descriptionModule briefSummary: The goal of this randomized, double-blind, placebo-controlled, single ascending dose clinical trial is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of IGNX001 in peanut-allergic adults and older Adolescents., conditionsModule conditions: Peanut Allergy, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized, double-blind, placebo-controlled, single ascending dose study with single blind sentinel period, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: With the exception of the single sentinel participants for each cohort who will be single blinded (participant blinded), the study will be designed as a double-blind study thus the Investigator, site staff (other than pharmacists), sponsor, sponsors delegates (if applicable) and participants are all blinded to treatment., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: IGNX001, interventions name: Placebo, outcomesModule primaryOutcomes measure: Incidence and Severity of Treatment Emergent Adverse Events, primaryOutcomes measure: Incidence of Serious Adverse Events and Suspected Unexpected Serious Adverse Reactions, primaryOutcomes measure: Number of Participants with Clinically significant Changes from Baseline - Hematology, primaryOutcomes measure: Number of Participants with Clinically Significant Changes from Baseline - Chemistry, primaryOutcomes measure: Number of Participants with Clinically Significant Changes from Baseline - 12-lead ECGs for HR, PR, QRS, QT, RR and QTcF, and information on T- and U-waves, primaryOutcomes measure: Number of Participants with Clinically Significant Changes from Baseline - Physical Examinations, secondaryOutcomes measure: Concentration of IGNX001 in the Plasma, secondaryOutcomes measure: Measurement of Area under the Plasma/Serum Concentration Curve (AUC), secondaryOutcomes measure: Peak Serum Concentration (Cmax), secondaryOutcomes measure: Time to Peak Serum Concentration (Tmax), secondaryOutcomes measure: Elimination Half-life (t1/2), secondaryOutcomes measure: Changes Over Time to Anti-drug Antibodies, eligibilityModule sex: ALL, minimumAge: 15 Years, maximumAge: 55 Years, stdAges: CHILD, stdAges: ADULT, hasResults: False
protocolSection identificationModule nctId: NCT06331715, orgStudyIdInfo id: ML1005, briefTitle: Bioequivalence Study of Palbociclib 125 mg Capsules of Iclos vs. Ibrance (Palbociclib) Capsules 125 mg, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-06, primaryCompletionDateStruct date: 2024-08-01, completionDateStruct date: 2024-08-31, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Megalabs, class: INDUSTRY, descriptionModule briefSummary: An open label, balanced, randomized, two treatments, two sequences, two periods, cross over, single dose, bioequivalence study of Palbociclib 125 mg Capsules of Iclos Uruguay S.A and IBRANCE® (Palbociclib) 125 mg Capsules of Pfizer Europe (Belgium) in healthy, adult, human subjects under fed condition., conditionsModule conditions: Bioequivalence, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Palbociclib 125mg, outcomesModule primaryOutcomes measure: AUC 0-t, primaryOutcomes measure: Cmax, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06331702, orgStudyIdInfo id: CDBJEIV2023001, briefTitle: Immunogenicity of Japanese Encephalitis Vaccine Co-administered With Measles-Mumps-Rubella Vaccine (MMR), statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-02, primaryCompletionDateStruct date: 2024-09-30, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Liaoning Chengda Biotechnology CO., LTD, class: INDUSTRY, descriptionModule briefSummary: This is a phase IV, randomized, controlled, open-label study proceed in healthy children aged 8 months in China. The primary objective is to demonstrate the immunogenicity of simultaneous administration of JEV-I and MMR is not inferior to that of separate administration, as measured by seroconversion rates and antibody titers against the four antigens. The secondary objective is to describe the safety of the vaccines when administered simultaneously or separately., conditionsModule conditions: Japanese Encephalitis, conditions: Measles, conditions: Mumps, conditions: Rubella, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 396, type: ESTIMATED, armsInterventionsModule interventions name: Vero cell-drived inactive Japanese encephalitis vaccine, interventions name: Measles-Mumps-Rubella Vaccine, outcomesModule primaryOutcomes measure: Antibody Titer for Post Vaccination, primaryOutcomes measure: Seroconversion Rate for Post Vaccination, secondaryOutcomes measure: Incidence of Any Local and Systemic Adverse Events Within 30 Minutes of Each Vaccination, secondaryOutcomes measure: Incidence of Solicited Local and Systemic Adverse Events Within 7 Days of Each Vaccination, secondaryOutcomes measure: Incidence of Unsolicited Adverse Events and Serious Adverse Events Within 30 Days of Post Vaccination, eligibilityModule sex: ALL, minimumAge: 8 Months, maximumAge: 12 Months, stdAges: CHILD, contactsLocationsModule locations facility: Jiangsu Provincial Center for Disease Control and Prevention, status: RECRUITING, city: Nanjing, state: Jiangsu, zip: 210009, country: China, contacts name: Zhiguo Wang, Master, role: CONTACT, phone: +86 18118996978, email: 120714991@QQ.com, contacts name: Zhiguo Wang, Master, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.06167, lon: 118.77778, hasResults: False
protocolSection identificationModule nctId: NCT06331689, orgStudyIdInfo id: HP-epidemıology, briefTitle: EPIDEMIOLOGY AND ITS RESULTS IN HIP FRACTURES FOLLOWED IN POSTOPERATIVE INTENSIVE CARE, acronym: Hip fractures, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-02-01, primaryCompletionDateStruct date: 2021-04-01, completionDateStruct date: 2021-07-01, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Kutahya Health Sciences University, class: OTHER, descriptionModule briefSummary: Type of study: Observational study Goal of this : We conducted a retrospective evaluation of patients with HF who received postoperative ICU, with a focus on 30-day, 90-day and 1-year mortality outcomes.Participant population/health conditions:Patients over the age of 18 who are hospitalized in the intensive care unit of our hospital after hip fracture operation., conditionsModule conditions: Hip Fracture, conditions: Mortality Rate, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 68, type: ACTUAL, outcomesModule primaryOutcomes measure: mortalite ratio, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Kütahya Health Sciences University, city: Kütahya, zip: 43100, country: Turkey, geoPoint lat: 39.42417, lon: 29.98333, hasResults: False
protocolSection identificationModule nctId: NCT06331663, orgStudyIdInfo id: KMUHIRB-F(II)-20240055, briefTitle: SPI and Remifentanil in Skull Pin Fixation, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-06-20, completionDateStruct date: 2024-06-20, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Kaohsiung Medical University Chung-Ho Memorial Hospital, class: OTHER, descriptionModule briefSummary: Forty patients were enrolled, and all patients used total intravenous anesthesia (remifentanil-propofol based total intravenous analgesia) as anesthesia induction and maintenance. According to the preliminary data of this department, patients who underwent intracranial surgery for skull pin fixation used remifentanil 5.0-6.0 ng/ml, while the hemodynamics is relatively stable. Therefore, when this plan is implemented, the patient needs to be under the same depth of anesthesia (monitored by electroencephalography, maintaining a value of 40-60), first start with remifentanil 5.0 ng/ml, and use the up and down method as adjust 0.5 ng/ml of concentration of remifentanil each time. Inadequate antinociception (Surgical Pleth Index(SPI) \> 80 and hyperdynamics (the increased heart rate (HR) and mean blood pressure (MBP) above 20% of baseline or HR\>100bpm and arterial blood pressure(ABP)\>180/100mmHg)) is defined as failure, therefore we increase remifentanil by 0.5 ng/ml; otherwise, the setting is considered successful without abovementioned situations.Data collection: heart rate, mean blood pressure, Surgical Pleth Index, bispectral Index, pulse pressure variance, systolic pressure variance, concentrations of propofol and remifentanil before 2 mins, during, 5, and 15 mins of skull pin fixation were recorded and analyzed., conditionsModule conditions: Pain, Procedural, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 27, type: ESTIMATED, armsInterventionsModule interventions name: Remifentanil, outcomesModule primaryOutcomes measure: 50% effect concentration of remifentanil, primaryOutcomes measure: 90% effect concentration of remifentanil, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Kaohsiung Medical University Chung-Ho Memorial Hospital, city: Kaohsiung, country: Taiwan, contacts name: Zhi-Fu Wu, MD, role: CONTACT, phone: 07-3121101, phoneExt: 7035, email: aneswu@gmail.com, geoPoint lat: 22.61626, lon: 120.31333, hasResults: False
protocolSection identificationModule nctId: NCT06331650, orgStudyIdInfo id: CROC202314, briefTitle: A Single-arm Pilot Study of First-line Treatment With Carbognilumab Combined With Chemotherapy in Patients With STK11-mutated Advanced or Postoperative Recurrent Non-small Cell Lung Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-08-09, primaryCompletionDateStruct date: 2025-08, completionDateStruct date: 2025-10, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Guangzhou Institute of Respiratory Disease, class: OTHER, descriptionModule briefSummary: To evaluate the safety and tolerability of carbognilumab combined with chemotherapy as the first-line treatment for patients with STK11 mutated advanced or postoperative recurrent non-small cell lung cancer (NSCLC)., conditionsModule conditions: Non-small Cell Lung Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: cadonilimab, outcomesModule primaryOutcomes measure: Safety assessments and ORR, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The First Affiliated Hospital of Guangzhou Medical University, status: RECRUITING, city: Guangdong, state: Guangzhou, zip: 510000, country: China, contacts name: zhou chegnzhi, doctor, role: CONTACT, phone: 13560351186, email: doctorzcz@163.com, hasResults: False
protocolSection identificationModule nctId: NCT06331637, orgStudyIdInfo id: 3782, briefTitle: Outcomes of Transanal Tran-section and Single-stapled (TTSS) Ileal Pouch-Anal Anastomosis, acronym: TTSS-Pouch, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-31, primaryCompletionDateStruct date: 2026-07-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Istituto Clinico Humanitas, class: OTHER, descriptionModule briefSummary: This study aims to compare the functional and surgical outcomes of Ulcerative Colitis (UC) patients undergoing Transanal Transection and Singl-Stapled (TTSS) versus Double-stapled Ileal Pouch-Anal Anastomosis (IPAA), conditionsModule conditions: Ulcerative Colitis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 174, type: ESTIMATED, armsInterventionsModule interventions name: Transanal Transection and Single-Stapled anastomosis (TTSS), interventions name: Double-stapled anastomosis, outcomesModule primaryOutcomes measure: Pouch Function Score (PFS), secondaryOutcomes measure: Pouch Function Score (PFS), secondaryOutcomes measure: Pouch Function Score (PFS), secondaryOutcomes measure: Postoperative complications, secondaryOutcomes measure: Anastomotic leak, secondaryOutcomes measure: Patients fit for stoma closure, secondaryOutcomes measure: Healthcare costs, secondaryOutcomes measure: Rectal cuff lenght, secondaryOutcomes measure: Pouch complications, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Humanitas Research Hospital, city: Rozzano, state: MI, zip: 20089, country: Italy, contacts name: Annalisa Maroli, PhD, role: CONTACT, phone: 02 8224 7776, phoneExt: 0039, email: colorapp@humanitas.it, contacts name: Stefano De Zanet, MS, role: CONTACT, phone: 02 8224 4623, phoneExt: 0039, email: colorapp@humanitas.it, geoPoint lat: 45.38193, lon: 9.1559, hasResults: False
protocolSection identificationModule nctId: NCT06331624, orgStudyIdInfo id: GRI-0621-IPF-02, briefTitle: Biomarker Modulation and the Inhibition of NKT1 Cells by Oral GRI-0621 in Patients With IPF, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-01, completionDateStruct date: 2025-01, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: GRI Bio Operations, Inc., class: INDUSTRY, descriptionModule briefSummary: This is a Phase 2a, randomized, double-blind, multi-center, placebo-controlled, parallel-design, 2-arm study. Approximately 36 subjects with IPF will be randomized in a 2:1 ratio for GRI-0621 4.5mg or Placebo. GRI-0621 dose of 4.5mg will be compared with placebo following once daily oral administration for 12 weeks. Concurrently, a Sub-Study will be conducted, examining the number and activity of NKT cells in BAL, for up to 12 eligible subjects (across various centers). An interim analysis will be performed when 24 subjects complete 6 weeks of treatment (approximately 8 placebo subjects)., conditionsModule conditions: Idiopathic Pulmonary Fibrosis, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: Tazarotene (GRI-0621), interventions name: Placebo, outcomesModule primaryOutcomes measure: Safety and Tolerability of oral GRI-0621, secondaryOutcomes measure: Change from baseline biomarkers, secondaryOutcomes measure: Plasma concentrations of GRI-0621, secondaryOutcomes measure: Pharmacodynamics of GRI-0621 in blood (Study Population), secondaryOutcomes measure: Pharmacodynamics of GRI-0621 in BAL fluid (Optional Sub-Study), otherOutcomes measure: Exploratory - Pulmonary Function, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Newport Native MD, Inc., status: RECRUITING, city: Newport Beach, state: California, zip: 92663, country: United States, contacts name: Brandon Vu, role: CONTACT, phone: 949-791-8599, email: Brandon@newportnativemd.com, geoPoint lat: 33.61891, lon: -117.92895, locations facility: Southeastern Research Center, status: RECRUITING, city: Winston-Salem, state: North Carolina, zip: 27103, country: United States, contacts name: Karen McCutcheon, role: CONTACT, phone: 336-659-8414, email: kmccutcheon@southeasternresearchcenter.com, geoPoint lat: 36.09986, lon: -80.24422, hasResults: False