hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06374173, orgStudyIdInfo id: TGI6-T1-01, briefTitle: A Phase 1 Study to Evaluate TGI-6 in Subjects With Locally Advanced/Metastatic Solid Tumors, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-03, primaryCompletionDateStruct date: 2027-09, completionDateStruct date: 2027-12, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Hefei TG ImmunoPharma Co., Ltd., class: OTHER, descriptionModule briefSummary: A Phase 1 Study to Evaluate TGI-6 in Subjects with Locally Advanced/Metastatic Solid Tumors, conditionsModule conditions: Advanced or Metastatic Solid Tumors, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 123, type: ESTIMATED, armsInterventionsModule interventions name: TGI-6 Injection, outcomesModule primaryOutcomes measure: Dose-limiting Toxicity (DLT), primaryOutcomes measure: Dose-Finding, primaryOutcomes measure: Frequency and Severity of Adverse Events (AE), secondaryOutcomes measure: Pharmacokinetics of TGI-6, secondaryOutcomes measure: Pharmacokinetics of TGI-6, secondaryOutcomes measure: Number of subjects with Anti-TGI-6 antibody positive, secondaryOutcomes measure: Objective Response Rate (ORR), secondaryOutcomes measure: Duration of Response (DoR), secondaryOutcomes measure: Disease Control Rate (DCR), secondaryOutcomes measure: Progression Free Survival (PFS), secondaryOutcomes measure: Overall Survival (OS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Beijing Cancer Hospital, status: RECRUITING, city: Beijing, country: China, contacts name: Hang Zhou, role: CONTACT, email: hang.zhou@tgimmunopharma.com, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
protocolSection identificationModule nctId: NCT06374147, orgStudyIdInfo id: STUDY00004467, briefTitle: "Prapela® SVS Incubator Pad for Apnea of Prematurity, acronym: Prapela AOP, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-15, primaryCompletionDateStruct date: 2026-06-01, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Tufts Medical Center, class: OTHER, collaborators name: University of Alabama at Birmingham, descriptionModule briefSummary: The study proposes to complete the development of and then establish the safety, efficacy, and clinical risk/benefit of a novel hospital incubator pad with stochastic vibrotactile stimulation (SVS) that will provide a complementary treatment and the first improvement in the clinical management of apnea of prematurity (AOP) in over 20 years. Currently, the only approved therapy for AOP is Caffeine Citrate. The SVS mattress pad can prove to be an effective, non-invasive adjunct to Caffeine Citrate for preterm infants with potential to shorten the need for respiratory support as well as overall shortened length of stay., conditionsModule conditions: Apnea of Prematurity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: SVS mattress, outcomesModule primaryOutcomes measure: Reduce apnea events by 30% or more in the three days after study entry, secondaryOutcomes measure: Reduce the number of days caffeine citrate is used after study entry by 3 days or more, secondaryOutcomes measure: Reduce the number of days of respiratory support by 3 days or more, eligibilityModule sex: ALL, minimumAge: 0 Days, maximumAge: 3 Months, stdAges: CHILD, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06374134, orgStudyIdInfo id: STUDY00004835, briefTitle: The Impact of Community and Patient Engagement Practices on Vaccine Confidence in the United States, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2024-11, completionDateStruct date: 2025-02, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Tufts University, class: OTHER, collaborators name: Merck Sharp & Dohme LLC, descriptionModule briefSummary: The primary objective of this study is to demonstrate an empirical relationship between community- engagement practices, and between patient-centric clinical trial design, execution and communication practices, and vaccine adoption experience.Our hypothesis is that patient-centric clinical trial activity, and community engagement in late-stage clinical trials and early-stage commercialization, reduces vaccine hesitancy and increases vaccine confidence among health care providers overall and within diverse patient communities and ultimately drives faster vaccine adoption., conditionsModule conditions: Vaccine Hesitancy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: ECOLOGIC_OR_COMMUNITY, timePerspective: RETROSPECTIVE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Community Engagement Practice, interventions name: Patient-Centric Protocol Element, outcomesModule primaryOutcomes measure: Units of Vaccine Dispensed, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06374095, orgStudyIdInfo id: ONSET, briefTitle: 1 vs 7 RATG Infusions in Renal Transplantation, acronym: ONSET, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2025-06, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Mario Negri Institute for Pharmacological Research, class: OTHER, descriptionModule briefSummary: This trial is to compare the risk/benefit profile over six-month follow-up of two induction immunosuppressive regimens based on one or seven low-dose perioperative RATG infusions on top of the same induction therapy with basiliximab and steroid (progressively tapered post-transplant) and maintenance therapy with calcineurin inhibitors and mycophenolate mofetil/mycophenolic acid in 75 recipients (25 Patients and 50 Reference-Patients) of a single or dual first kidney transplant from an ideal or marginal donor at a single Renal Transplant Center., conditionsModule conditions: Kidney Replacement, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 75, type: ESTIMATED, armsInterventionsModule interventions name: RATG, interventions name: Basiliximab, outcomesModule primaryOutcomes measure: Incidence of thrombocytopenia and/or leukopenia, secondaryOutcomes measure: Occurrence of anemia, secondaryOutcomes measure: Occurrence of viral infections, secondaryOutcomes measure: Occurrence of pneumonia, secondaryOutcomes measure: Occurrence of opportunistic infections, secondaryOutcomes measure: Occurrence of delayed graft function, secondaryOutcomes measure: Occurrence of allograft rejection, secondaryOutcomes measure: Occurrence of biopsy proven rejection, secondaryOutcomes measure: Survival, secondaryOutcomes measure: Platelet and WBC counts, secondaryOutcomes measure: Creatinine levels, secondaryOutcomes measure: Adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: ASST HPG23 - Unità di Nefrologia, city: Bergamo, state: BG, zip: 24127, country: Italy, geoPoint lat: 45.69601, lon: 9.66721, hasResults: False
protocolSection identificationModule nctId: NCT06374069, orgStudyIdInfo id: NL81887.058.23, briefTitle: Longevity Families of the Netherlands, acronym: LOF-NL, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-11, primaryCompletionDateStruct date: 2026-12, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Leiden University Medical Center, class: OTHER, collaborators name: Jacobijn Gussekloo, Prof. dr., collaborators name: Simon P. Mooijaart, Prof. dr., descriptionModule briefSummary: The demographic life expectancy enhancement of the past 150 years imposes an urgent challenge in Western and economically growing societies to stimulate the healthy lifespan that is lagging behind. Families surviving into exceptionally high ages (longevity) in good physical and mental health illustrate that this is physiologically possible. Such families harbor cross generational socio-genetic mechanisms that mediate healthy aging and protection from (multi)morbidity.The purpose of our research is: to identify gene variants associated with healthy aging and protection from (multi)morbidity; to study the social-, environment- and behavioral factors of familial longevity, their role in (multi-)morbidity and its interaction with the genetic component., conditionsModule conditions: Longevity, conditions: Familial Longevity, conditions: Extreme Longevity, conditions: Aging, designModule studyType: OBSERVATIONAL, designInfo observationalModel: FAMILY_BASED, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 600, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Identifying the genetic variants of Familial Longevity, secondaryOutcomes measure: Studying the environmental factor of Familial Longevity through questionnaires and its interaction with the genetic component, eligibilityModule sex: ALL, minimumAge: 75 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Leiden University Medical Center, status: RECRUITING, city: Leiden, state: South Holland, zip: 2333ZA, country: Netherlands, geoPoint lat: 52.15833, lon: 4.49306, hasResults: False
protocolSection identificationModule nctId: NCT06374056, orgStudyIdInfo id: 0458, briefTitle: Kintsugi Voice Device Pilot Study, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-22, primaryCompletionDateStruct date: 2025-03-22, completionDateStruct date: 2025-07-22, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Kintsugi Mindful Wellness, Inc., class: INDUSTRY, collaborators name: Sonar Strategies, collaborators name: Vituity Psychiatry, descriptionModule briefSummary: A prospective, single arm, non-randomized, pilot clinical validation study to evaluate the ability of the Kintsugi Voice Device (the Device) to aid clinical assessment for depression by comparing its output with a diagnosis made by a clinician using the Structured Clinical Interview for DSM-5 (SCID-5-CT) for up to 500 English speaking adult patients ages 22 and older living in the United States. Recruitment will occur for 1 year and participation will be for up to 2 weeks., conditionsModule conditions: Depression, conditions: Depression Moderate, conditions: Depression Severe, conditions: Depression Mild, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: Kintsugi Voice Device, outcomesModule primaryOutcomes measure: Sensitivity and Specificity of Kintsugi Voice Device Relative to the SCID-5, secondaryOutcomes measure: PPV, NPV, AUC, F-Score of Kintsugi Voice Device Relative to the SCID-5, secondaryOutcomes measure: Sensitivity, Specificity, PPV, NPV, AUC, F-Score of Kintsugi Voice Device Relative to the Severity of the SCID-5-CT, secondaryOutcomes measure: Sensitivity, Specificity, PPV, NPV, AUC, F-Score of Kintsugi Voice Device Relative to the PHQ-9, eligibilityModule sex: ALL, minimumAge: 22 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Kintsugi Mindful Wellness Inc., status: RECRUITING, city: Berkeley, state: California, zip: 94707, country: United States, contacts name: Alexa A Mazur, BA, role: CONTACT, phone: 610-724-1431, email: alexa@kintsugihealth.com, contacts name: Victoria Graham, MS, role: CONTACT, email: victoria@kintsugihealth.com, contacts name: Albert Ihochi, MBA, role: PRINCIPAL_INVESTIGATOR, contacts name: Prentice Tom, MD, role: SUB_INVESTIGATOR, geoPoint lat: 37.87159, lon: -122.27275, hasResults: False
protocolSection identificationModule nctId: NCT06374030, orgStudyIdInfo id: EDSAM2024, briefTitle: Retrospective Study of Airway Management in Dutch ED's, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2019-01-01, primaryCompletionDateStruct date: 2023-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Medical Centre Leeuwarden, class: OTHER, collaborators name: VieCuri Medical Centre, collaborators name: Catharina Ziekenhuis Eindhoven, collaborators name: Rijnstate Hospital, collaborators name: Zuyderland Medical Centre, descriptionModule briefSummary: Describing characteristics of the practice of airway management in Dutch emergency departments, including information about patient demographics, indications, performer characteristics, equipment and medication used and complications due to intubation., conditionsModule conditions: Endotracheal Intubation, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 1000, type: ESTIMATED, armsInterventionsModule interventions name: Endotracheal intubation, outcomesModule primaryOutcomes measure: Different complications of endotracheal intubation, otherOutcomes measure: Intubator characteristics, otherOutcomes measure: Indication for intubation, otherOutcomes measure: Sedation agent used, otherOutcomes measure: Paralytic agent used, otherOutcomes measure: Sedative agent after intubation, otherOutcomes measure: Method of intubation, otherOutcomes measure: Patient characteristics, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Leeuwarden Medical Centre, city: Leeuwarden, zip: 8934AD, country: Netherlands, geoPoint lat: 53.20139, lon: 5.80859, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2023-12-15, uploadDate: 2024-03-20T05:01, filename: Prot_SAP_000.pdf, size: 247439, hasResults: False
protocolSection identificationModule nctId: NCT06374017, orgStudyIdInfo id: N-258-2023, briefTitle: Evaluation of Lidocaine Spray Versus Dexmetomidine Spray on Stress Response, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-20, primaryCompletionDateStruct date: 2024-04-30, completionDateStruct date: 2024-05-10, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Kasr El Aini Hospital, class: OTHER, descriptionModule briefSummary: Many studies discussed attenuating stress response by various measures but to the interest of our study, No one compared topical spray of both lidocaine and dexmedetomidine in attenuating the haemodynamic stress responses of laryngoscopy and endotracheal intubation, avoiding undesired systemic effects of drugs, , conditionsModule conditions: To Measure Systolic Blood Pressure Postintubation, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, whoMasked: INVESTIGATOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Normal saline, Lidocaine, dexmetomidine, outcomesModule primaryOutcomes measure: To measure systolic blood pressure immediately after intubation., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Cairo University hospitals, status: RECRUITING, city: Cairo, zip: 11559, country: Egypt, contacts name: Dina M Mohamed, MD, role: CONTACT, phone: 01005249134, phoneExt: MD, email: Dinamahmoud@kasralainy.edu.eg, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False
protocolSection identificationModule nctId: NCT06374004, orgStudyIdInfo id: HU-FTR-MC-01, briefTitle: The Effect of Thoracic Mobilization in Individuals With Subacromial Pain Syndrome, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-04-10, primaryCompletionDateStruct date: 2024-07-05, completionDateStruct date: 2024-07-05, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Hacettepe University, class: OTHER, descriptionModule briefSummary: The purpose of this study is to investigate the effect of six-week thoracic mobilization on pain intensity, muscle tone, functional and muscle activation in individuals with subacromial pain syndrome., conditionsModule conditions: Subacromial Pain Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: One group received exercise therapy and the other group received manual therapy (thoracic mobilization) in addition to exercise therapy, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Participants will be randomly divided into two groups and participants will not know which group participants are in., whoMasked: PARTICIPANT, enrollmentInfo count: 32, type: ESTIMATED, armsInterventionsModule interventions name: Exercise Group, interventions name: Thoracic Mobilization Group, outcomesModule primaryOutcomes measure: Electromyography (EMG), primaryOutcomes measure: Acromiohumeral Distance (AHD), secondaryOutcomes measure: Muscle Tone, secondaryOutcomes measure: Functional Activity Level, secondaryOutcomes measure: Pain Intensity, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Hacettepe University, Faculty of Physical Therapy and Rehabilitation, city: Ankara, zip: 06100, country: Turkey, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False
protocolSection identificationModule nctId: NCT06373991, orgStudyIdInfo id: EDI-901-SLE01, briefTitle: A Study to Evaluate the Safety and Efficacy of ATHENA CAR-T in Subjects With Systemic Lupus Erythematosus, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-24, primaryCompletionDateStruct date: 2027-04-30, completionDateStruct date: 2027-04-30, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: EdiGene Inc., class: INDUSTRY, collaborators name: The First Affiliated Hospital of Henan University of Science and Technology, collaborators name: Changping Laboratory, descriptionModule briefSummary: The goal of this clinical trial is to test ATHENA CAR-T injection in adults with moderate to severe Systemic Lupus Erythematosus. The main question it aims to answer is:• To evaluate the safety and tolerability of ATHENA CAR-T.After screening, participants will be subjected to lymphodepletion regimen. After recovery, participants will be injected with ATHENA CAR-T injection and followed up to 24 months., conditionsModule conditions: Lupus Erythematosus, Systemic, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: ATHENA CAR-T, interventions name: Fludarabine, interventions name: Cyclophosphamide, outcomesModule primaryOutcomes measure: Dose Limiting Toxicity, primaryOutcomes measure: Frequency of AEs, SAEs, lab abnormalities, AESIs, secondaryOutcomes measure: Efficacy: Percent of patients achieved SRI-4, secondaryOutcomes measure: Efficacy: Patients SLEDAI-2000 change compared with baseline, secondaryOutcomes measure: Efficacy: Patients BILAG-2004 change compared with baseline, secondaryOutcomes measure: Efficacy: Percent of patients' PGA not worsen, secondaryOutcomes measure: Percent of patients responded by BILAG-2004, secondaryOutcomes measure: Efficacy: Immunologic parameters, secondaryOutcomes measure: Efficacy: Immunologic parameters (cont), otherOutcomes measure: PK characteristics, otherOutcomes measure: PK characteristics (cont), otherOutcomes measure: PK characteristics (cont), otherOutcomes measure: PD characteristics, otherOutcomes measure: PD characteristics (cont), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The First Affiliated Hospital of Henan University of Science and Technology, status: RECRUITING, city: Luoyang, state: Henan, zip: 471003, country: China, contacts name: Muchen Liu, role: CONTACT, phone: (86)-13663884080, geoPoint lat: 34.68361, lon: 112.45361, hasResults: False
protocolSection identificationModule nctId: NCT06373965, orgStudyIdInfo id: B2024-000, briefTitle: Integrated Online-to-offline (O2O) Model of Care for HIV Prevention and Treatment Among Transgender Women (CINTAI), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-19, primaryCompletionDateStruct date: 2025-01-06, completionDateStruct date: 2025-02-18, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: University of Connecticut, class: OTHER, collaborators name: University of Malaya, descriptionModule briefSummary: The proposed research focuses on developing and testing a web-based platform, called Jom-TestPlus, that will incorporate HIV self-testing (HIVST) with real-time e-counseling (eHIVST) with online-to-offline (O2O) linkage to HIV prevention and treatment services while simultaneously co-addressing chemsex-related needs for transgender women (TGW) in Malaysia. This model represents a potentially impactful strategy for reaching marginalized populations, like TGW, and allows immediate engagement in the post-test linkage process to prevention or treatment services., conditionsModule conditions: HIV Prevention Program, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Online to offline counseling, outcomesModule primaryOutcomes measure: HIVST uptake, primaryOutcomes measure: Linkage to PrEP, primaryOutcomes measure: Linkage to HIV treatment services, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Centre of Excellence For Research in AIDS (CERiA), city: Kuala Lumpur, country: Malaysia, geoPoint lat: 3.1412, lon: 101.68653, hasResults: False