hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06376266, orgStudyIdInfo id: 202305083RSC, briefTitle: Assessment of the Intervention Effectiveness of Branched-chain Amino Acids(BCAA) Combined With Medium-chain Fatty Acid(MCFA) Products in Sarcopenia Among Middle-aged and Elderly Individuals, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-01, primaryCompletionDateStruct date: 2023-12-29, completionDateStruct date: 2024-09-30, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: National Taiwan University Hospital, class: OTHER, descriptionModule briefSummary: Taiwan entered an aging society in 2018 and is expected to transition into a super-aged society by 2025. With the increasing elderly population, age-related diseases pose urgent challenges to modern society. According to the Ministry of Health and Welfare's National Health Statistics in 2018, the prevalence of sarcopenia in Taiwan among individuals aged 65 and older is 23.6% for males and 18.6% for females. Sarcopenia, characterized by the loss of skeletal muscle mass due to aging, coupled with decreased muscle strength and/or reduced physical performance, poses a significant risk for disability, decreased quality of life, and increased mortality.Existing research indicates that appropriate nutrition and exercise can slow the onset of sarcopenia and even increase muscle mass to reverse its effects. This study is an interventional clinical trial recruiting middle-aged and elderly patients with sarcopenia or pre-sarcopenia. The intervention involves a combination of branched-chain amino acids and medium-chain triglyceride products, and the study aims to assess the effectiveness of this intervention for sarcopenia in middle-aged and elderly individuals., conditionsModule conditions: Sarcopenia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: nutritional supplements, outcomesModule primaryOutcomes measure: the scale of sarcopenia, primaryOutcomes measure: the scale of sarcopenia, primaryOutcomes measure: the scale of sarcopenia, eligibilityModule sex: ALL, minimumAge: 50 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Geriatrics and Gerontology, National Taiwan University Hospital, status: RECRUITING, city: Taipei, zip: 100, country: Taiwan, contacts name: Ding-cheng Chan, DR, role: CONTACT, phone: +886-2-23123456, phoneExt: 67095, email: dingchengchan@ntu.edu.tw, geoPoint lat: 25.04776, lon: 121.53185, hasResults: False
protocolSection identificationModule nctId: NCT06376253, orgStudyIdInfo id: CGIZ943A12101, secondaryIdInfos id: 2023-507674-41-00, type: OTHER, domain: CTIS, briefTitle: A Phase I Study of [177Lu]Lu-EVS459 in Patients With Ovarian and Lung Cancers, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09-06, primaryCompletionDateStruct date: 2030-08-30, completionDateStruct date: 2030-08-30, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Novartis Pharmaceuticals, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to evaluate the safety, tolerability, dosimetry and preliminary efficacy of \[177Lu\]Lu-EVS459 and the safety and imaging properties of \[68Ga\]Ga-EVS459 in patients aged ≥ 18 years with advanced high-grade serous ovarian cancer (OC) or locally advanced unresectable or metastatic non-squamous non-small cell lung carcinoma (non-sq. NSCLC)., conditionsModule conditions: Ovarian Cancer, conditions: Lung Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 96, type: ESTIMATED, armsInterventionsModule interventions name: [68Ga]Ga-EVS459, interventions name: [177Lu]Lu-EVS459, outcomesModule primaryOutcomes measure: Number of participants with dose limiting toxicities of [177Lu]Lu-EVS459, primaryOutcomes measure: Incidence and severity of adverse events and serious adverse events of [177Lu]Lu- EVS459, primaryOutcomes measure: Dose modifications for [177Lu]Lu- EVS459, primaryOutcomes measure: Dose intensity for [177Lu]Lu- EVS459, secondaryOutcomes measure: Overall response rate (ORR), secondaryOutcomes measure: Duration of Response (DOR), secondaryOutcomes measure: Disease control rate (DCR), secondaryOutcomes measure: Progression free survival (PFS), secondaryOutcomes measure: Area Under the Curve (AUC) of [177Lu]Lu-EVS459, secondaryOutcomes measure: Total body clearance of [177Lu[Lu-EVS459, secondaryOutcomes measure: Observed maximum plasma concentration (Cmax) of [177Lu]Lu-EVS459, secondaryOutcomes measure: Volume of distribution during the terminal phase following intravenous elimination (Vz) of [177Lu]Lu-EVS459, secondaryOutcomes measure: Terminal elimination half-life (T1/2) of [177Lu]Lu-EVS459, secondaryOutcomes measure: Urinary excretion of radioactivity expressed as a percentage of injected activity (%IA), secondaryOutcomes measure: Renal clearance of [177Lu]Lu- EVS459, secondaryOutcomes measure: Absorbed dose of [177Lu]Lu- EVS459, secondaryOutcomes measure: Time-activity curves (TACs) related to [177Lu]Lu-EVS459 uptake in organs and tumor lesions, secondaryOutcomes measure: Incidence and severity of adverse events and serious adverse events of [68Ga]Ga-EVS459, secondaryOutcomes measure: Visual and quantitative assessment of [68Ga]Ga-EVS459 uptake in normal tissues and tumor lesions over time, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06376227, orgStudyIdInfo id: jamesdukeryan, briefTitle: Robotic-Assisted or Laparoscopic Radical Resection for Rectal Cancer With or Without Left Colic Artery Preservation, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-04-01, primaryCompletionDateStruct date: 2023-05-31, completionDateStruct date: 2023-12-28, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Northern Jiangsu People's Hospital, class: OTHER, descriptionModule briefSummary: Brief SummaryBackground The preservation of the left colic artery (LCA) during rectal cancer resection remains a topic of controversy, and there is a notable absence of robust evidence regarding the outcomes associated with LCA preservation. And the advantages of robotic-assisted laparoscopy (RAL) surgery in rectal resection remain uncertain. The objective of this study was to assess the influence of LCA preservation surgery and RAL surgery on intraoperative and postoperative complications of rectal cancer resection.Methods Participants who underwent laparoscopic (LSC) or RAL with or without LCA preservation resection for rectal cancer between April 2020 and May 2023 were retrospectively assessed. The patients were categorized into two groups: low ligation (LL) which with preservation of LCA and high ligation (HL) which without preservation of LCA. A one-to-one propensity score-matched analysis was performed to decrease confounding. The primary outcome was operative findings, operative morbidity, and postoperative genitourinary function., conditionsModule conditions: Rectal Cancer, conditions: Left Colic Artery Stenosis (Diagnosis), conditions: Robotic Assisted Laparoscopic Surgery, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 1164, type: ACTUAL, armsInterventionsModule interventions name: with or without Left Colic Artery Preservation, outcomesModule primaryOutcomes measure: The incidence of anastomotic leakage in postoperative patients with or without left colic artery preservation., secondaryOutcomes measure: The genitourinary function of the patients after the radical resection with or without left colic artery preservation., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Northern Jiangsu People's Hospital Affiliated to Yangzhou University, General Surgery Institute of Yangzhou, Yangzhou University, Yangzhou, city: Yangzhou, state: Jiangsu, zip: 225001, country: China, geoPoint lat: 32.39722, lon: 119.43583, hasResults: False
protocolSection identificationModule nctId: NCT06376214, orgStudyIdInfo id: 2024-02, briefTitle: Daratumumab for Patients With Light Chain Amyloidosis, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Nanjing University School of Medicine, class: OTHER, descriptionModule briefSummary: This is a prospective, single-center study exploratory clinical trial, aim to exploring the efficacy and safety of daratumumab in patients with AL amyloidosis, patients were divided into three groups: one group received long-term treatment with daratumumab based regimen, and the other group received autologous stem cell transplantation after two standard treatment courses with daratumumab based regimen, and the third group consists of newly diagnosed stage IIIb AL amyloidosis patients who plan to receive DPD treatment. The purpose of this study is to observe the efficacy and safety of Daratumumab, in the treatment of newly diagnosed systemic AL amyloidosis., conditionsModule conditions: Light Chain (AL) Amyloidosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Dratumumab / Hyaluronidase Injection [Darzalex Faspro], interventions name: Pomalidomide 4 MG, interventions name: autologous stem cell transplantation (ASCT), outcomesModule primaryOutcomes measure: Hematological complete response rate, primaryOutcomes measure: Organ response rate, secondaryOutcomes measure: Time to Next Treatment, secondaryOutcomes measure: Progression-free survival, secondaryOutcomes measure: Overall survival, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: National Clinical Research Center for Kidney Diseases, Jinling Hospital, status: RECRUITING, city: Nanjing, state: Jiangsu, zip: 210016, country: China, contacts name: Xianghua Huang, MD, role: CONTACT, phone: 02580862351, email: hxhszb@163.com, geoPoint lat: 32.06167, lon: 118.77778, hasResults: False
protocolSection identificationModule nctId: NCT06376201, orgStudyIdInfo id: NFEC-2024-018, briefTitle: A Clinical Study on the Efficacy and Safety of ABCD in the Treatment of Patients With Invasive Fungal Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-02, completionDateStruct date: 2025-09, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Nanfang Hospital, Southern Medical University, class: OTHER, descriptionModule briefSummary: This study is a prospective, multicenter, single-arm study, that aims to evaluate the efficacy and safety of amphotericin B cholesterol-sulfate complex (ABCD) for injection in the first-line treatment of patients with invasive fungal diseases, hoping to provide a reference for the clinical treatment of invasive fungal diseases. Patients with hematologic diseases who meet the criteria for inclusion and discharge with febrile neutropenia and suspected fungal infection were treated with ABCD antifungal therapy for 14 days while receiving treatment for underlying diseases, and the response rate of treatment was observed., conditionsModule conditions: Invasive Fungal Disease, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 125, type: ESTIMATED, armsInterventionsModule interventions name: Amphotericin B cholesterol-sulfate complex for injection, outcomesModule primaryOutcomes measure: Treatment is effective, secondaryOutcomes measure: Incidence of the single index in the five criteria of treatment success, secondaryOutcomes measure: Completion rate of ABCD treatment for at least 14 days, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06376188, orgStudyIdInfo id: 1582/2021 SimCom, briefTitle: Improving Breaking Bad News in Pediatrics by Simulated Communication, acronym: SimCom, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-09-01, primaryCompletionDateStruct date: 2022-08-31, completionDateStruct date: 2022-09-30, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Medical University of Vienna, class: OTHER, descriptionModule briefSummary: Breaking bad news, especially a death notice, is an essential part of the medical profes-sional communication. Being inadequately trained in those skills this may result in un-pleasant psychosocial consequences for everyone involved.This prospective, single-center, randomized controlled trial evaluated the delivery of a death notice to simulation parents out of the perspective of these parents (professional actors), the participants (students) and by video analysis. The simulation patient has prior unexpectedly died during a simulated resuscitation. The intervention group broke the bad news after receiving a short communication, conditionsModule conditions: Communication, conditions: End of Life, conditions: Pediatric ALL, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 46, type: ACTUAL, armsInterventionsModule interventions name: communication training, outcomesModule primaryOutcomes measure: score by simulation parents, secondaryOutcomes measure: score by participants, secondaryOutcomes measure: score of video analysis, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Medical University of Vienna, city: Vienna, zip: 1090, country: Austria, geoPoint lat: 48.20849, lon: 16.37208, hasResults: False
protocolSection identificationModule nctId: NCT06376175, orgStudyIdInfo id: LL-016, briefTitle: Task Atlas: Study to Develop a Task Atlas of Brain Recruitment During a Digital Game-based Program, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2024-08-31, completionDateStruct date: 2024-08-31, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Lumos Labs, Inc., class: INDUSTRY, descriptionModule briefSummary: Healthy volunteers ages 25-40 from the general US population who meet the eligibility criteria and are enrolled will (a) play Lumosity games at least 20 times each in under 60 days and (b) then complete one session of task-based functional magnetic resonance imaging (fMRI) while playing Lumosity games., conditionsModule conditions: Healthy Adults, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 40, type: ESTIMATED, outcomesModule primaryOutcomes measure: BOLD response during gameplay, primaryOutcomes measure: Responder rates, primaryOutcomes measure: Structural MRI volumetrics: Volume, primaryOutcomes measure: Structural MRI volumetrics: Cortical thickness, primaryOutcomes measure: Structural MRI volumetrics: Brain-Predicted Age Difference, primaryOutcomes measure: Behavior response: Game score, primaryOutcomes measure: BAMS-7 (Brief Attention and Mood Scale of 7 Items), primaryOutcomes measure: VGPQ (Video Game Playing Questionnaire), eligibilityModule sex: ALL, minimumAge: 25 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: UC Davis Imaging Research Center (IRC), city: Sacramento, state: California, zip: 95817, country: United States, contacts name: Kevin Madore, PhD, role: CONTACT, geoPoint lat: 38.58157, lon: -121.4944, hasResults: False
protocolSection identificationModule nctId: NCT06376162, orgStudyIdInfo id: ITCC-101/APAL2020K, secondaryIdInfos id: 2023-505262-28-00, type: CTIS, briefTitle: Ziftomenib in Combination With Chemotherapy for Children With Relapsed/Refractory Acute Leukemia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2027-08, completionDateStruct date: 2027-08, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: LLS PedAL Initiative, LLC, class: OTHER, collaborators name: Kura Oncology, descriptionModule briefSummary: The primary objective of the study is to determine the recommended phase 2 dose (RP2D) of ziftomenib in combination with chemotherapy (FLA) in children with relapsed or refractory KMT2A-r, NUP98-r, or NPM1-m acute leukemia based on safety and pharmacokinetics (PK)., conditionsModule conditions: Relapsed/Refractory KMT2A-r Acute Leukemia, conditions: Relapsed/Refractory NUP98-r Acute Leukemia, conditions: Relapsed/Refractory NPM1-m Acute Leukemia, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Ziftomenib, interventions name: Cytarabine, interventions name: Fludarabine, outcomesModule primaryOutcomes measure: Number of Participants Who Experience a Dose-limiting Toxicity (DLT), primaryOutcomes measure: Area Under the Plasma Concentration-time Curve (AUC) of Ziftomenib, secondaryOutcomes measure: Number of Participants Who Experience an Adverse Event (AE), secondaryOutcomes measure: Number of AEs by Severity, secondaryOutcomes measure: Maximum Observed Plasma Concentration (Cmax) of Ziftomenib, secondaryOutcomes measure: Minimum Observed Plasma Concentration (Cmin) of Ziftomenib, secondaryOutcomes measure: Time to Cmax (Tmax), secondaryOutcomes measure: Truncated AUC (AUC0-t) of Ziftomenib in Combination with FLA Chemotherapy, secondaryOutcomes measure: Extrapolated AUC (AUC0-∞) of Ziftomenib in Combination with FLA Chemotherapy, secondaryOutcomes measure: Oral Plasma Clearance (CL/F) of Ziftomenib in Combination with FLA Chemotherapy, secondaryOutcomes measure: Volume of Distribution (Vz/F) of Ziftomenib in Combination with FLA Chemotherapy, secondaryOutcomes measure: Terminal Elimination Half-life (t1/2) of Ziftomenib in Combination with FLA Chemotherapy, secondaryOutcomes measure: HSCT Rate, secondaryOutcomes measure: Morphological Overall Response Rate (ORR), secondaryOutcomes measure: Flow-based ORR, secondaryOutcomes measure: Flow-based Measurable Residual Disease (MRD) Negativity Rate, secondaryOutcomes measure: Duration of Response (DOR), secondaryOutcomes measure: Event-free Survival (EFS), secondaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: Cumulative Incidence of Relapse (CIR), eligibilityModule sex: ALL, minimumAge: 0 Years, maximumAge: 21 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06376136, orgStudyIdInfo id: BAT-8010+1006-001-CR, briefTitle: An Evaluation of BAT 8010 for Injection in Combination With BAT 1006 in Locally Advanced or Metastatic Entities Safety, Tolerability, Pharmacokinetic Profile, and Initial Clinical Efficacy of the Tumor in Patients Multicenter, Open Phase Ib/IIa Clinical Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2024-05-24, completionDateStruct date: 2026-12-09, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Bio-Thera Solutions, class: INDUSTRY, descriptionModule briefSummary: This study is a multicenter, open, exploratory Phase Ib/IIa clinical trial in humans The combination of BAT8010 and BAT1006 was administered in patients with locally advanced or metastatic solid tumors(HER-2 expression, including IHC3+, IHC2+/FISH+, and IHC2+/FISH- patients)Tolerance and PK characteristics, to explore the maximum tolerated dose (MTD) and provide recommendations for subsequent clinical studies Recommended dose (RP2D) and rational administration regimen, and preliminary evaluation of antitumor efficacy. There are two main studies In the first stage, the "3+3" dose escalation rule is proposed to explore the safety and tolerance of the drug Sex; The second stage selects the appropriate dose and administration according to the preliminary safety and efficacy results of the previous stage The drug regimen and tumor species were expanded to further explore the combination of BAT8010 and BAT1006 for injection，The safety and clinical effectiveness of drug administration provided the basis for the follow-up clinical study., conditionsModule conditions: Advanced Solid Tumors, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 108, type: ESTIMATED, armsInterventionsModule interventions name: BAT8010 for Injection, interventions name: BAT1006 for Injection, outcomesModule primaryOutcomes measure: Dose-limiting toxicity (DLT), primaryOutcomes measure: vital signs, primaryOutcomes measure: Physical examination, primaryOutcomes measure: Adverse events, primaryOutcomes measure: Clinical laboratory tests, primaryOutcomes measure: Number of participants with abnormal clinical auxiliary tests, primaryOutcomes measure: Duration of Response(DOR), primaryOutcomes measure: Disease Control Rate (DCR), secondaryOutcomes measure: Pharmacokinetic, secondaryOutcomes measure: Pharmacokinetic, secondaryOutcomes measure: Pharmacokinetic, secondaryOutcomes measure: Pharmacokinetic, secondaryOutcomes measure: Antibody, secondaryOutcomes measure: Antibody, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False