hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06357897, orgStudyIdInfo id: 0093/67, briefTitle: The Efficacy and Palatability of Developed Polyethylene Glycol-based Formula for Children With Functional Constipation, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2026-05, completionDateStruct date: 2026-06, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Chulalongkorn University, class: OTHER, descriptionModule briefSummary: This study aims to evaluate the efficacy and palatability of a developed polyethylene glycol-based formula compared with the standard polyethylene glycol (PEG) in the treatment of children with functional constipation for 8 weeks. Besides, we also aim to assess the side effects of a developed PEG-based formula as well as evaluate the change of rectal diameter from baseline at each visit between 2 groups., conditionsModule conditions: Functional Constipation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Intervention group received PEG-Chula Control group received Forlax, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: The intervention and control were prepared in the similar sachet and was blinded to investigatiors, participants and guardians, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 52, type: ESTIMATED, armsInterventionsModule interventions name: Local PEG4000, interventions name: Commercial PEG4000, outcomesModule primaryOutcomes measure: The frequency of stool, primaryOutcomes measure: Stool consistency assessed by Bristol stool chart, secondaryOutcomes measure: Fecal incontinence, secondaryOutcomes measure: Rectal diameter, secondaryOutcomes measure: Adverse events, secondaryOutcomes measure: Palatability of medication assessed by facial Hedonic scale, eligibilityModule sex: ALL, minimumAge: 6 Months, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Faculty of Medicine, Chulalongkorn University, city: Bangkok, zip: 10330, country: Thailand, geoPoint lat: 13.75398, lon: 100.50144, hasResults: False
protocolSection identificationModule nctId: NCT06357871, orgStudyIdInfo id: 2023PI178, briefTitle: Role of Renal Biopsy in the Suspicion of Nephrotoxicity of Immunotherapy (Checkpoint Inhibitors) in Solid Cancer, acronym: NEPHROTOX, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-28, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Central Hospital, Nancy, France, class: OTHER, collaborators name: University Hospital, Strasbourg, France, collaborators name: CHU de Reims, collaborators name: Centre Hospitalier Régional Metz-Thionville, collaborators name: European Georges Pompidou Hospital, descriptionModule briefSummary: Checkpoint inhibitors represent a new class of widely used immunotherapy, however with immune-mediated adverse effects, with renal damage estimated at 1.4% and 4.9% depending on the series.Acute tubulointerstitial nephritis (ATNI) represents the most common type of damage, although there are other types of damage, associated or not with NTIA.We aim to establish a probability score for the presence of histological NTIA lesions in a patient treated with CPI who presents with acute renal failure in order to guide the nephrologist and oncologist in their management in the event of AKI at the CPI, and determine the usefulness of a PBR to guide the suspension/resumption of immunotherapy +/- associated corticosteroid therapy; avoiding a PBR exposing to a high iatrogenic risk and sometimes impossible., conditionsModule conditions: Chemotherapeutic Toxicity, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: No intervention, outcomesModule primaryOutcomes measure: Estimation using a multivariate model of the factors associated with the histological presence of NTIA vs NTA lesions in a patient treated with CPI, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CHRU de Nancy, status: RECRUITING, city: Vandoeuvre les nancy, zip: 54500, country: France, contacts name: Adrien Flahault, MD PhD, role: CONTACT, phone: 0383858585, email: a.flahault@chru-nancy.fr, geoPoint lat: 48.65, lon: 6.18333, hasResults: False
protocolSection identificationModule nctId: NCT06357858, orgStudyIdInfo id: CASE6323, briefTitle: ASTX727 and Nivolumab in Squamous Cell Carcinoma of the Head and Neck, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2025-02-28, completionDateStruct date: 2026-02-28, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Case Comprehensive Cancer Center, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to see if the combination of experimental drug ASTX727 and Nivolumab enhances the antitumor immune response in participants will recurrent or metastatic squamous cell carcinoma of the head and neck.Participants will take a pill called ASTX727 for 4 or 5 days every month followed by an injection of Nivolumab one week after the first dose of study medication., conditionsModule conditions: Recurrent Squamous Cell Carcinoma of the Head and Neck, conditions: Metastatic Squamous Cell Carcinoma, conditions: Head and Neck Squamous Cell Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: INQOVI (decitabine and cedazuridine), interventions name: Nivolumab, outcomesModule primaryOutcomes measure: Pharmacodynamics Effect of ASTX727 on global DNA methylation status, primaryOutcomes measure: Immunogenicity of ASTX27 in combination with Nivolumab, primaryOutcomes measure: Maximum Tolerated Dose, primaryOutcomes measure: Safety of ASTX, secondaryOutcomes measure: Objective Response Rate (ORR), secondaryOutcomes measure: Overall Survival (OS), eligibilityModule sex: ALL, minimumAge: 19 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center, city: Cleveland, state: Ohio, zip: 44106, country: United States, contacts name: Kyunghee Burkitt, DO, PhD, role: CONTACT, phone: 216-844-0512, email: Kyunghee.Burkitt@UHhospitals.org, geoPoint lat: 41.4995, lon: -81.69541, hasResults: False
protocolSection identificationModule nctId: NCT06357845, orgStudyIdInfo id: CASE5Z24, secondaryIdInfos id: 1R21ES036031-01, type: NIH, link: https://reporter.nih.gov/quickSearch/1R21ES036031-01, briefTitle: Linking Somatic Mutation Rate With Baseline Exposure in East Palestine, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-09-01, completionDateStruct date: 2026-01-31, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Case Comprehensive Cancer Center, class: OTHER, collaborators name: National Institutes of Health (NIH), collaborators name: National Institute of Environmental Health Sciences (NIEHS), descriptionModule briefSummary: The goal of this study is to This research team is conducting this study to develop methods to measure the biological impact of exposure to the chemicals released following the February 3, 2023 train derailment on residents of East Palestine, Ohio, and surrounding communities. The main question it aims to answer is:* What biological impact will be measured based on DNA damage?* In participants who provide a biospecimen, how are biomarker changes related to proximity to the derailment and variations in residents' health histories and behaviors?Participants will:* Complete a brief survey asking about experiences related to the February 3, 2023 train derailment, health experiences, and concerns following the derailment, and background information regarding health history.* Possibly contribute biospecimens such as blood, spit, hair, and/or toenail clippings.* Receive communication about study updates and future research opportunities.* A total of 40 study participants will be recruited to participate in a 90-minute interview. The interviews will be video and audio recorded., conditionsModule conditions: Somatic Mutation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: A cross-sectional study design will be implemented., primaryPurpose: SCREENING, maskingInfo masking: NONE, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: Survey, interventions name: Biological specimen collection, interventions name: Communications about study updates and future research opportunities, interventions name: Qualitative interview, outcomesModule primaryOutcomes measure: Geographic Association of Somatic Mutation Rates, secondaryOutcomes measure: Self-reported Symptomology Association of Somatic Mutation Rates, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06357819, orgStudyIdInfo id: CLS-017A, secondaryIdInfos id: HSTAR010, type: OTHER, domain: HSTAR Programme, secondaryIdInfos id: EZIMOM012, type: OTHER, domain: Ezintsha, briefTitle: INSTI® HCV (Hepatitis C Virus) Antibody Self-Test Contrived Result Interpretation, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-10-12, primaryCompletionDateStruct date: 2023-12-17, completionDateStruct date: 2023-12-17, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: bioLytical Laboratories, class: INDUSTRY, descriptionModule briefSummary: The purpose of this Interpretation Assessment was to document if "lay" people, non-professional and inexperienced in self-testing, were able to successfully perform the steps to use a Hepatitis C Virus (HCV) Self-Test (HCVST) device, without product familiarization \[demonstration\]., conditionsModule conditions: Hepatitis C, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 405, type: ACTUAL, armsInterventionsModule interventions name: INSTI HCV Self Test, outcomesModule primaryOutcomes measure: Successful Interpretation of contrived devices, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: bioLytical Laboratories Inc., city: Richmond, state: British Columbia, zip: V6V 2A2, country: Canada, geoPoint lat: 49.17003, lon: -123.13683, hasResults: False
protocolSection identificationModule nctId: NCT06357806, orgStudyIdInfo id: PIN-CHB-1, briefTitle: The Treatment of PD-1 Antibody Combined With Peg-IFNα in NAs-suppressed CHB Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-09-30, completionDateStruct date: 2025-09-30, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Beijing 302 Hospital, class: OTHER, descriptionModule briefSummary: This is a prospective, open-labled, randomized controlled study to assess efficacy and safety of treatment with Sintilimab (PDL-1 antibody) combined Peg-IFNα-2b in CHB patients on stable NAs treatment., conditionsModule conditions: Chronic Hepatitis B, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 45, type: ESTIMATED, armsInterventionsModule interventions name: Sintilimab, interventions name: Peg-IFNα-2b, interventions name: NAs, outcomesModule primaryOutcomes measure: The rate of HBsAg loss at 24 weeks and 48 weeks., primaryOutcomes measure: Incidence of treatment-emergent adverse events/serious adverse events, secondaryOutcomes measure: The rate of HBsAg decline > 1log(IU/ml) at 24 weeks and 48 weeks, secondaryOutcomes measure: The rate of HBsAb positive at 24 weeks and 48 weeks., secondaryOutcomes measure: The concentration of HBcrAg at baseline, 12 weeks, 24 weeks and 48 weeks., secondaryOutcomes measure: The concentration of pgRNA at baseline, 12 weeks, 24 weeks and 48 weeks., secondaryOutcomes measure: The concentration of anti-HBc at baseline, 12 weeks, 24 weeks and 48 weeks., secondaryOutcomes measure: Immune response of T cell, B cell, NK cell at baseline, 12 weeks, 24 weeks and 48 weeks., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: the Fifth Medical Center, Chinese PLA General Hospital, city: Beijing, state: Beijing, zip: 100039, country: China, contacts name: Junliang Fu, MD, role: CONTACT, phone: 010-66933214, email: fjunliang@163.com, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
protocolSection identificationModule nctId: NCT06357793, orgStudyIdInfo id: camsakuraftr, briefTitle: Evaluation of Work Productivity and Activities of the Fibromyalgia Patients' Relatives, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2024-11-15, completionDateStruct date: 2024-12-15, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Başakşehir Çam & Sakura City Hospital, class: OTHER_GOV, descriptionModule briefSummary: Patients suffering from fibromyalgia (FM) are challenged by symptoms such as chronic pain, fatigue, sleep disturbance and emotional distress. Patients diagnosed with fibromyalgia can also negatively affect the relatives they live with due to their existing complaints. It is possible that their relatives accompanying them may lose their workforce due to untreated pain complaints and frequent hospital admissions. The main purpose of our study is to examine whether there is any impact on the working life of the people they live with and whether there is a decrease in their work productivity., conditionsModule conditions: Fibromyalgia, conditions: Work Productivity, conditions: Quality of Life, conditions: Pain, Chronic, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 122, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Work Productivity and Activity of Fibromyalgia Patients' Relatives, secondaryOutcomes measure: Quality of life Fibromyalgia Patients' Relatives, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06357767, orgStudyIdInfo id: S06GM146079, type: NIH, link: https://reporter.nih.gov/quickSearch/S06GM146079, briefTitle: Smoking Cessation Intervention for American Indian Women Experiencing Intimate Partner Violence, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-07-31, completionDateStruct date: 2026-01-31, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Black Hills Center for American Indian Health, class: OTHER, collaborators name: Yale University, descriptionModule briefSummary: The goal of this project is to refine and test a culturally-tailored smoking cessation intervention for American Indian women who have experienced intimate partner violence (IPV). The primary aims of this study are to: (a) use a community-based participatory approach to refine intervention materials and finalize pilot intervention methodology for a culturally tailored, trauma-informed smoking cessation intervention for AI women who have experienced IPV; (b) examine feasibility, acceptability, satisfaction, and preliminary efficacy of the intervention; and (c) explore changes in alcohol and drug use over the course of the intervention.Participants will be asked to participate in the 8-week Healing Within: Smoking Cessation Intervention for American Indian Women Experiencing Intimate Partner Violence, and complete interviews at baseline, end-of-treatment, and three months from the end of treatment., conditionsModule conditions: Smoking Cessation, conditions: Cigarette Smoking, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 48, type: ESTIMATED, armsInterventionsModule interventions name: Healing Within: Smoking Cessation Intervention for American Indian Women Experiencing Intimate Partner Violence, outcomesModule primaryOutcomes measure: Trauma-Informed Practice Scales (TIPS), primaryOutcomes measure: Session Rating Scale (SRS), primaryOutcomes measure: Group Attitude Scale (GAS), secondaryOutcomes measure: Biochemical verification of smoking status, secondaryOutcomes measure: Biochemical verification of smoking status, secondaryOutcomes measure: Biochemical verification of smoking status, secondaryOutcomes measure: Quit Attempts, secondaryOutcomes measure: Quit Attempts, secondaryOutcomes measure: Quit Attempts, otherOutcomes measure: Alcohol Use Disorders Identification Test (AUDIT), otherOutcomes measure: Alcohol Use Disorders Identification Test (AUDIT), otherOutcomes measure: Alcohol Use Disorders Identification Test (AUDIT), otherOutcomes measure: NIDA ASSIST, otherOutcomes measure: NIDA ASSIST, otherOutcomes measure: NIDA ASSIST, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06357754, orgStudyIdInfo id: CA082-085, briefTitle: Transgene Assay Testing Service of Tumor Samples From Patients Who Received a Bristol-Myers Squibb Manufactured Gene Modified Cell Therapy and Have a Qualifying Secondary Malignancy, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-06, primaryCompletionDateStruct date: 2038-10-06, completionDateStruct date: 2038-10-06, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Bristol-Myers Squibb, class: INDUSTRY, descriptionModule briefSummary: The purpose of this transgene assay testing service is to evaluate the tumor samples for transgene levels in patients who received a Bristol-Myers Squibb manufactured gene modified cellular therapy and have reported a qualifying secondary malignancy., conditionsModule conditions: Non-Hodgkin Lymphoma, conditions: Chronic Lymphocytic Leukaemia, conditions: Multiple Myeloma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Idecabtagene vicleucel, interventions name: Lisocabtagene maraleucel, outcomesModule primaryOutcomes measure: Participant in situ hybridization (ISH) transgene testing results, primaryOutcomes measure: Participant insertion site (ISA) analysis testing results, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CellCarta, status: RECRUITING, city: Antwerp, country: Belgium, geoPoint lat: 51.21989, lon: 4.40346, hasResults: False
protocolSection identificationModule nctId: NCT06357741, orgStudyIdInfo id: 202286, briefTitle: Clinical Study of Desuzumab in the Treatment of Knee Osteoarthritis, acronym: CSODITTOKO, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-03-02, primaryCompletionDateStruct date: 2024-02-02, completionDateStruct date: 2024-03-10, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Wuhan Union Hospital, China, class: OTHER, descriptionModule briefSummary: As an activator of inhibiting nuclear factor kB receptor, denosumab affects osteoclast differentiation and development by inhibiting OPG/RANKL-RANK bone regulatory axis pathway. Therefore, denosumab is widely used in the treatment of bone diseases such as osteoporosis. Osteoporosis is closely related to knee osteoarthritis. RANKL-RANK pathway also plays a key role in the pathogenesis of knee osteoarthritis. Therefore, the investigators propose the hypothesis that denosumab can effectively treat knee osteoarthritis., conditionsModule conditions: Knee Osteoarthritis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 8, type: ACTUAL, armsInterventionsModule interventions name: Denosumab, outcomesModule primaryOutcomes measure: Knee pain relief, eligibilityModule sex: ALL, minimumAge: 45 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Wuhan Union Hospital, city: Wuhan, state: Hubei, zip: 430000, country: China, geoPoint lat: 30.58333, lon: 114.26667, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2024-04-03, uploadDate: 2024-04-04T11:01, filename: Prot_000.pdf, size: 398739, hasResults: False