hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06342050, orgStudyIdInfo id: STU-2023-0548, secondaryIdInfos id: R01MD011686, type: NIH, link: https://reporter.nih.gov/quickSearch/R01MD011686, briefTitle: Socioecological Factors Associated With Ethnic Disparities in Bariatric Surgery Utilization and Post-WLS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-02, completionDateStruct date: 2025-08, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: University of Texas Southwestern Medical Center, class: OTHER, collaborators name: National Institute on Minority Health and Health Disparities (NIMHD), descriptionModule briefSummary: The goal of this cross-sectional observational study is to examine potential relationships between the blood and gut microbiota of patients with obesity before and after weight loss surgery (WLS) and evaluate potential ethnic differences in the blood and gut microbiotas before and after the WLS.The main aims / objectives of this sub-study are:* Aim 1. Compare the relationship between the blood and the gut microbiomes among a sample of (1) pre-WLS and (2) 6-month post-WLS participants.Hypothesis: Blood bacterial composition will resemble that of the gut microbiome among pre-WLS participants. Because the effect of WLS on the blood microbiome is not known, our post-WLS results will be mostly exploratory.* Aim 2. Determine racial differences in the blood microbiome of the pre- and post-WLS groups.Hypothesis2: Ethnic differences will be detected in both the pre- and post-WLS groups., conditionsModule conditions: Obesity, conditions: Metabolic Syndrome, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Gut Microbial Composition, primaryOutcomes measure: Blood Microbial Composition, primaryOutcomes measure: Body Weight (kg), primaryOutcomes measure: Body Height (meters), primaryOutcomes measure: Fat Mass (Kg), primaryOutcomes measure: Fat-free Mass (Kg), primaryOutcomes measure: Body water (%), primaryOutcomes measure: Skeletal Muscle Mass (kg), primaryOutcomes measure: Fasting Glucose (mg/dL), primaryOutcomes measure: Fasting Insulin (mIU/L), primaryOutcomes measure: Lipopolysaccharides (%), primaryOutcomes measure: Lipopolysaccharides binding protein (mIU/L), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2024-03-19, uploadDate: 2024-03-27T14:38, filename: Prot_SAP_000.pdf, size: 316789, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2024-03-19, uploadDate: 2024-03-27T14:39, filename: ICF_001.pdf, size: 297665, hasResults: False
protocolSection identificationModule nctId: NCT06342037, orgStudyIdInfo id: N22TON, briefTitle: NOvel Immunotherapy Strategies for Advanced Triple Negative Breast Cancer (TNBC) Patients: TONIC-3 Trial, acronym: TONIC-3, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-15, primaryCompletionDateStruct date: 2026-04-01, completionDateStruct date: 2030-04-01, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: The Netherlands Cancer Institute, class: OTHER, collaborators name: Hoffmann-La Roche, descriptionModule briefSummary: This is a single center, non-blinded, multi-cohort, non-comparative phase II trial to study the safety and efficacy of tiragolumab with atezolizumab and/or ipilimumab in advanced triple-negative breast cancer., conditionsModule conditions: Metastatic Breast Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Tiragolumab, interventions name: Atezolizumab, interventions name: Ipilimumab, outcomesModule primaryOutcomes measure: PFS-12, primaryOutcomes measure: Incidence of adverse events, secondaryOutcomes measure: Objective response rate, secondaryOutcomes measure: Clinical benefit rate, secondaryOutcomes measure: Progression-free survival, secondaryOutcomes measure: Overall survival, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06342011, orgStudyIdInfo id: KY-2024-039, briefTitle: Effect of Anti-inflammatory Diet in Patients With Inflammatory Bowel Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-05-01, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: The Fourth Affiliated Hospital of Zhejiang University School of Medicine, class: OTHER, descriptionModule briefSummary: For the first time, this study developed an anti-inflammatory diet （AID） recipe suitable for Inflammatory bowel disease（IBD） patients and developed an AID application program to verify the intervention effect of AID on IBD patients, which not only promoted the application of AID in IBD patients and promoted the promotion of AID model, but also provided new ideas for the prevention and treatment strategies for IBD patients., conditionsModule conditions: Inflammatory Bowel Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 88, type: ESTIMATED, armsInterventionsModule interventions name: Anti-inflammatory diet group, outcomesModule primaryOutcomes measure: C-reactive protein, primaryOutcomes measure: Erythrocyte sedimentation rate (ESR), primaryOutcomes measure: Leukocyte, secondaryOutcomes measure: Self-Rating Anxiety Scale，SAS, secondaryOutcomes measure: Self-Rating depression scale，SDS, secondaryOutcomes measure: Simplified Chinese version of Inflammatory Bowel Disease Quality of Life Scale (IBDQ), secondaryOutcomes measure: Inflammatory Bowel Disease Self-Efficacy Scale (IBD-SES), secondaryOutcomes measure: Body Mass Index, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Fourth Affiliated Hospital of Zhejiang University School of Medicine, city: Yiwu, state: Zhejiang, zip: 322000, country: China, contacts name: Xia Qian, BA, role: CONTACT, phone: 15968110117, email: 1632936247@qq.com, geoPoint lat: 29.31506, lon: 120.07676, hasResults: False
protocolSection identificationModule nctId: NCT06341998, orgStudyIdInfo id: HERO2020, briefTitle: Clinical Study of Chemotherapy in the Treatment of Recurrent/Refractory Yolk Sac Tumor in Children, acronym: SCRRYST, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-06-01, primaryCompletionDateStruct date: 2024-01-01, completionDateStruct date: 2024-02-01, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Shandong First Medical University, class: OTHER, descriptionModule briefSummary: Remarkable progress has been made in treating germ-cell tumor (GCT) through the use of platinum-based regimens. However, part of yolk sac tumor (YST) with cisplatin resistance or recurrence is nevertheless prone to relapse after second-line treatment. This leaves a gap in effective treatment, which needs to be filled by novel therapeutic approaches. This paper is the first one to report the treatment combining sirolimus with nab-paclitaxel, ifosfamide, and carboplatin (S-TIC) for children with repeated relapsed or refractory yolk sac tumor (rrrYST)., conditionsModule conditions: Germ Cell Tumor, conditions: Yolk Sac Tumor, designModule studyType: INTERVENTIONAL, phases: PHASE2, phases: PHASE3, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 32, type: ACTUAL, armsInterventionsModule interventions name: sirolimus combined with chemotherapy in the treatment of recurrent/refractory yolk sac tumor in children, outcomesModule primaryOutcomes measure: Objective Response Rate Allocation 'Non-Randomized' implies that this is a multi-arm study, but only one arm has been specified. Objective Response Rate, secondaryOutcomes measure: Progression-free Survival, eligibilityModule sex: ALL, minimumAge: 1 Year, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Shandong Cancer Hospital and Institute, city: Jinan, state: Shandong, zip: 250117, country: China, geoPoint lat: 36.66833, lon: 116.99722, hasResults: False
protocolSection identificationModule nctId: NCT06341959, orgStudyIdInfo id: GerodentPLUS1, briefTitle: Can a Low-threshold Check-up Motivate Older People to Schedule a Dental Visit?, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-12-30, completionDateStruct date: 2024-12-30, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: University Ghent, class: OTHER, descriptionModule briefSummary: There is little research on the effect of oral screening campaigns for improving oral health in older people. Therefore, the aim of this study is to investigate the effect of a low-threshold contact with an oral health professional, including an oral health examination, on dental attendance of older people (65 years of age or older)., conditionsModule conditions: Oral Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The intervention group will be provided with tools to facilitate dental contact and will be informed about the importance of regular dental visits. Participants are given the opportunity to receive an oral examination. Afterwards, each participant will receive brochures with oral hygiene instructions to take home. Participants will receive information about any identified oral pathology. A referral letter for the dentist and a report for the general practitioner will also be prepared to increase social influence. If the participant doesn't have a dentist, the participant will receive a list of contact information for dentists in the area.In the control group, no oral examination will be performed. However, participants will be given a list of nearby dentists and flyers with oral hygiene instructions., primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 194, type: ESTIMATED, armsInterventionsModule interventions name: Oral screening, outcomesModule primaryOutcomes measure: Contacted a dentist, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP_ICF, hasProtocol: True, hasSap: True, hasIcf: True, label: Study Protocol, Statistical Analysis Plan, and Informed Consent Form, date: 2024-03-25, uploadDate: 2024-03-25T05:59, filename: Prot_SAP_ICF_000.pdf, size: 743439, hasResults: False
protocolSection identificationModule nctId: NCT06341946, orgStudyIdInfo id: Soh-Med-24-02-05MD, briefTitle: Role of Endoscopic Third Ventriculostomy in Management of Malfunctioning Ventriculoperitoneal Shunt, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-05, primaryCompletionDateStruct date: 2025-10-01, completionDateStruct date: 2025-11, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Sohag University, class: OTHER, descriptionModule briefSummary: The aim of this study is to analyze our experience in management of malfunctioning ventriculoperitoneal shunt by using endoscopic third ventriculostomy (ETV)., conditionsModule conditions: Hydrocephalus, conditions: Shunt Malfunction, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: All patients with malfunctioning VP shunt will be included in this study, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Endoscopic third ventriculostomy, outcomesModule primaryOutcomes measure: Glasgow Coma Scale (GCS), primaryOutcomes measure: visual analogue scale( VAS ), primaryOutcomes measure: visual acuity, secondaryOutcomes measure: radiological CT brain and or MRI brain, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06341920, orgStudyIdInfo id: RS198 - 332551, briefTitle: BoneFit: Multimodal Prehabilitation for People Preparing for Orthopaedic Surgery, acronym: BoneFit, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2027-07-01, completionDateStruct date: 2027-12-01, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: University of Hull, class: OTHER, collaborators name: Hull University Teaching Hospitals NHS Trust, descriptionModule briefSummary: To conduct a pilot feasibility study to determine the effect of a student-led prehabilitation service in people awaiting total hip or knee replacement surgery., conditionsModule conditions: Orthopedic Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Intervention v control, primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: Masking is not possible - referrals/care providers know whether they/referral is involved in the intervention or not., enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Experimental: BoneFit intervention, interventions name: Placebo Comparator: Control, outcomesModule primaryOutcomes measure: Recruitment, primaryOutcomes measure: Adherence and attendance, primaryOutcomes measure: Acceptability, secondaryOutcomes measure: Physical fitness, secondaryOutcomes measure: Length of stay, secondaryOutcomes measure: Readmission rates, secondaryOutcomes measure: Overall quality of life, secondaryOutcomes measure: Knee or hip specific pain, function and quality of life, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2024-02-13, uploadDate: 2024-03-12T06:12, filename: Prot_000.pdf, size: 218343, hasResults: False
protocolSection identificationModule nctId: NCT06341907, orgStudyIdInfo id: SAHoWMU-CR2024-07-107, briefTitle: Application of MRD Combined With Personalized Vaccine in the Treatment of Postoperative Recurrence Prevention of EOC, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Second Affiliated Hospital of Wenzhou Medical University, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is as follows:(1) Establish a clinical technical system for ctDNA dynamic monitoring of MRD in postoperative EOC patients, providing a new technical means for postoperative recurrence prevention and monitoring of EOC patients.(2) Establish a clinical technical system for adjuvant treatment of postoperative recurrence prevention for EOC patients with conventional protocols combined with personalized vaccines, so as to provide a new treatment method for postoperative recurrence prevention for EOC patients, with a view to obtaining a better survival prognosis.(3) To establish and improve the prediction process of Neoantigen for ovarian cancer and the in vitro evaluation system of the effectiveness of neoantigen vaccine, achieve independent innovation of tumor neoantigen vaccine treatment technology, and cultivate a group of technical forces to master the development of modern tumor vaccine drugs.(4) The new technology system has been promoted and applied in 5 hospitals in the province., conditionsModule conditions: Epithelial Ovarian Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, phases: PHASE3, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Neoantigen polypeptide vaccine, outcomesModule primaryOutcomes measure: ORR, primaryOutcomes measure: PFS, primaryOutcomes measure: OS, primaryOutcomes measure: CA 125, secondaryOutcomes measure: Safety Index, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Second Affiliated Hospital of Wenzhou Medical University, status: RECRUITING, city: Wenzhou, state: Zhejiang, zip: 325000, country: China, contacts name: Xinxin Zhang, role: CONTACT, phone: +86 150 6781 0815, email: zhxinxin1122@163.com, geoPoint lat: 27.99942, lon: 120.66682, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2024-01-13, uploadDate: 2024-03-13T05:17, filename: Prot_SAP_000.pdf, size: 541225, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2024-01-16, uploadDate: 2024-03-13T05:18, filename: ICF_001.pdf, size: 254239, hasResults: False
protocolSection identificationModule nctId: NCT06341894, orgStudyIdInfo id: OBU-II-BC-126, briefTitle: Efficacy and Safety of Dalpiciclib With Endocrine Therapy as Adjuvant Treatment in HR+/ HER2- Early Breast Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-17, primaryCompletionDateStruct date: 2027-06, completionDateStruct date: 2029-06, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: The First Affiliated Hospital with Nanjing Medical University, class: OTHER, descriptionModule briefSummary: The investigator conduct a phase II multi-center, open-label trial to evaluate efficacy and safety of dalpiciclib with endocrine therapy as adjuvant treatment in patients with medium /high risk hormone receptor-positive, HER2-negative Early Breast Cancer., conditionsModule conditions: Early Breast Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 1163, type: ESTIMATED, armsInterventionsModule interventions name: Dalpiciclib, interventions name: Endocrine therapy, outcomesModule primaryOutcomes measure: invasive Disease-free Survival (iDFS), secondaryOutcomes measure: Disease-free Survival (DFS), secondaryOutcomes measure: AEs and SAEs, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The First Affiliated Hospital of Nanjing Medical University, status: RECRUITING, city: Nanjing, state: Jiangsu, country: China, contacts name: Xiaoan Liu, Professor, role: CONTACT, phone: 025-68308162, email: liuxiaoan@126.com, geoPoint lat: 32.06167, lon: 118.77778, hasResults: False
protocolSection identificationModule nctId: NCT06341855, orgStudyIdInfo id: 23K294001, briefTitle: Exploring the Potential of ctDNA-MRD for Recurrence Surveillance and Prognostic Evaluation in High-risk Endometrial Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-25, primaryCompletionDateStruct date: 2026-01-30, completionDateStruct date: 2026-01-30, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: The First Hospital of Jilin University, class: OTHER, collaborators name: Geneplus-Beijing Co. Ltd., descriptionModule briefSummary: Patients with high-risk endometrial cancer may have MRD after surgical treatment, which is a potential source of follow-up early recurrence and metastasis, and because of its limited resolution, traditional imaging (including PET/CT) or laboratory methods may not be reliable to detect. For patients with radical treatment, the uncured population can be identified by the detection of MRD, suggesting that patients may benefit from further intervention. The purpose of this study is to explore the prognostic value and recurrence monitoring value of ctDNA-MRD in patients with endometrial carcinoma., conditionsModule conditions: Endometrial Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SCREENING, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: MRD-ctDNA, outcomesModule primaryOutcomes measure: monitoring recurrence and evaluating prognosis, primaryOutcomes measure: Treatment benefit, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: the 1st hospital of Jilin University, status: RECRUITING, city: Chang Chun, state: Jilin, country: China, contacts name: Xiaosen Li Li, role: CONTACT, phone: +8618343116682, email: xiaosensen@jlu.edu.cn, geoPoint lat: 42.74694, lon: 126.24667, hasResults: False