hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06322264, orgStudyIdInfo id: 2023-05435-01, briefTitle: Promoting Children's Participation in Conventional X-ray Examinations, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-25, primaryCompletionDateStruct date: 2024-12-14, completionDateStruct date: 2025-04-04, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Lund University, class: OTHER, collaborators name: Skane University Hospital, descriptionModule briefSummary: The goal of this explorative observational study is to map the procedure and child centered approach in the examination for children that undergo conventional X-ray examinations. The main questions aim to answer:* How many images need to be retaken during conventional X-ray examinations?* What is the reason why the pictures need to be redone?* What is the time required for the various examinations?* What experience of the procedure of the examination is there among those involved?* Can the physical impact be observed through variation in heart rate in children that undergo conventional X-ray examinations?Participants will answer questionnaires about the children's participation in the procedure and the variation in heart rate will be measured on the children who undergo the examinations., conditionsModule conditions: Heart Rate Determination, conditions: Patient Participation, designModule studyType: OBSERVATIONAL, designInfo observationalModel: FAMILY_BASED, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 220, type: ESTIMATED, armsInterventionsModule interventions name: Measurement of variation in heart rate, outcomesModule primaryOutcomes measure: Variation in heart rate, eligibilityModule sex: ALL, minimumAge: 4 Years, maximumAge: 12 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06322238, orgStudyIdInfo id: 23-008706, briefTitle: Pharmacogenetic Panel to Prevent Adverse Drug Reactions in Daily Primary Care Practice:, acronym: PREPARE-Mayo, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-04, completionDateStruct date: 2026-04, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Mayo Clinic, class: OTHER, descriptionModule briefSummary: The purpose of this study is to determine whether the implementation of pre-emptive pharmacogenomic (PGx) testing of a panel of clinically relevant PGx markers, to guide the dose and drug selection for 39 commonly prescribed drugs, will result in an overall reduction in the number of clinically relevant drug-genotype associated ADRs which are causally related to the initial drug of inclusion (referred to as 'index drug')., conditionsModule conditions: Pharmacogenomic Drug Interaction, conditions: Side Effect of Drug, conditions: Ineffective Drug Action, conditions: Drug Metabolism, Poor, CYP2D6-Related, conditions: Drug Metabolism, Poor, CYP2C19-Related, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 66, type: ESTIMATED, armsInterventionsModule interventions name: PGx panel test, outcomesModule primaryOutcomes measure: Adverse Drug Reaction (ADR), secondaryOutcomes measure: PREPARE-MAYO Clinicians' and pharmacists' Questionnaire., secondaryOutcomes measure: Patient-Reported Outcomes Measurement Information System (PROMIS-10) Global Health Questionnaire, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mayo Clinic, city: Rochester, state: Minnesota, zip: 55902, country: United States, contacts name: Elisa Houwink, MD, PhD, role: CONTACT, phone: 507-319-2037, email: houwink.elisa@mayo.edu, contacts name: Mary Johnson, role: CONTACT, email: johnson.mary15@mayo.edu, contacts name: Jessica Wright, PharmD, role: SUB_INVESTIGATOR, geoPoint lat: 44.02163, lon: -92.4699, hasResults: False
protocolSection identificationModule nctId: NCT06322225, orgStudyIdInfo id: 2023YFC2507401, briefTitle: Establishment of Big Data Platform and Biobank for Colorectal Tubular Adenoma Lesions, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Sixth Affiliated Hospital, Sun Yat-sen University, class: OTHER, collaborators name: National Key Research and Development Program of China, descriptionModule briefSummary: Colorectal tubular adenoma is the most common precancerous lesion of colorectal cancer, and the point is that its precise prevention and treatment can reduce the incidence of colorectal cancer.However, the epidemiological characteristics of colorectal tubular adenoma in China are unclear, the rate of missed diagnosis by colonoscopy is high, and the existing diagnosis and treatment techniques are lack of unified quality control standards,which makes it difficult to diagnose and achieve accurate prevention and control. How to improve the precise prevention and treatment of colorectal tubular adenoma and reduce the incidence of colorectal cancer is a major clinical scientific problem that needs to be solved urgently. For this purpose, this study was conducted in colorectal guided by the needs of accurate prevention and treatment of tubular adenoma lesions,and a multi-center colorectal tubular adenoma data management platform and a high-risk population database covering a full range of data including demographic characteristics, lifestyle factors, clinical information, endoscopic data and pathological images were established, biological sample databases of patients with pathological changes and high-risk populations were established, and data quality control and sample quality control standards were formulated standards-based.The pathological prediction model and accurate risk assessment system of colorectal tubular adenoma were constructed by the pathological database., conditionsModule conditions: Colorectal Tubular Adenoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 30000, type: ESTIMATED, outcomesModule primaryOutcomes measure: Clinical information such as demographic characteristics, clinical data, endoscopy and pathological images, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
protocolSection identificationModule nctId: NCT06322212, orgStudyIdInfo id: 23-001083, briefTitle: Type 2 Diabetes and Blood Brain Barrier Improvement, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2026-04, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: University of California, Los Angeles, class: OTHER, descriptionModule briefSummary: The majority of T2DM adults show thiamine (vitamin B1) deficiency which may contribute to impaired function. This study will examine patients with T2DM through brain MRI scans, cognition assessments, blood tests, and questionnaires. Our goal is to see if a thiamine treatment (taking vitamin B1 capsules) can improve function. Patients will be asked to come to UCLA two times three months apart and each visit will last about 2.5-3 hours., conditionsModule conditions: Type2diabetes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Compare BBB function, cognition, and mood in T2DM adults with and without Thiamine treatment., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Participants will be assigned a number to be used instead of their names with double-blind randomization until visits are complete and data is analyzed., whoMasked: PARTICIPANT, enrollmentInfo count: 52, type: ESTIMATED, armsInterventionsModule interventions name: Thiamine, interventions name: Placebo, outcomesModule primaryOutcomes measure: Assess if BBB function has been repaired., primaryOutcomes measure: Analyze blood serum S100β levels., primaryOutcomes measure: Examine cognition in T2DM adults with thiamine treatment., primaryOutcomes measure: Cognition assessment in T2DM adults after thiamine treatment., primaryOutcomes measure: Examine depression in T2DM adults with thiamine treatment., primaryOutcomes measure: Assess anxiety in T2DM adults with thiamine treatment., eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UCLA, city: Los Angeles, state: California, zip: 90095, country: United States, geoPoint lat: 34.05223, lon: -118.24368, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_ICF, hasProtocol: True, hasSap: False, hasIcf: True, label: Study Protocol and Informed Consent Form, date: 2023-11-17, uploadDate: 2024-03-07T13:21, filename: Prot_ICF_000.pdf, size: 309752, hasResults: False
protocolSection identificationModule nctId: NCT06322173, orgStudyIdInfo id: 2022-13, briefTitle: Molecular Diagnostics of Bacterial Infections and Antibiotic Resistance in Blood Samples and Rectal Swabs Using Advanced NGS Sequencing Methods, acronym: ARES_NGS, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-06-28, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: IRCCS Sacro Cuore Don Calabria di Negrar, class: OTHER, descriptionModule briefSummary: This is an experimental study without drug and device, non-profit, on biological samples stored at the Tropica Biobank of the DITM. The aim of the project is to verify the performance of NGS-based assays, which can be used in the field of microbiology. The clinical evaluation investigations of NGS technology will be conducted on an adequate number of clinical blood samples and rectal swabs. The analyzes will be compared with the standard microbiology methods used in the DITM diagnostic routine., conditionsModule conditions: Resistance Bacterial, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: NGS Analysis, outcomesModule primaryOutcomes measure: Microorganism presence (positive/negative), primaryOutcomes measure: Microorganism identification, secondaryOutcomes measure: Identification of Gene mutations that convey resistance to antibiotics (resistant/susceptible), eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Sacro Cuore Don Calabria hospital, status: RECRUITING, city: Negrar, state: Verona, zip: 37024, country: Italy, contacts name: Elena Pomari, role: CONTACT, phone: +390456013111, email: elena.pomari@sacrocuore.it, contacts name: Elena Pomari, role: PRINCIPAL_INVESTIGATOR, contacts name: Pierantonio Orza, role: SUB_INVESTIGATOR, contacts name: Francesca Perandin, role: SUB_INVESTIGATOR, geoPoint lat: 45.52918, lon: 10.93899, hasResults: False
protocolSection identificationModule nctId: NCT06322160, orgStudyIdInfo id: 5714, briefTitle: The Role of tHyroid cAncer Specific Patient Concerns iNventory (PCI-TC) in Enhancing Shared decisiOn Making, acronym: HANSOM, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-05-03, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Royal Marsden NHS Foundation Trust, class: OTHER, collaborators name: ENTUK, descriptionModule briefSummary: Multiple clinical equipoises exist for the management of thyroid cancers. Shared decision-making (SDM) process where patients are supported to consider options, to achieve informed preferences with their clinicians have been recommended to improve patients' satisfaction and their overall quality of life. However, SDM can be difficult to achieve in our standard clinical encounters due to clinician's lack of confidence and time limitation to elicit patient's concerns and preferences. PCI as a decision-making support tool has shown to enhances clinician's awareness of patient's needs and allows for a more effective communication while the consultation time is unaffected. The successful development, testing and implementation of a PCI-TC could improve patient satisfaction, clinical efficiency and ensure that unmet need is appropriately addressed. This study will support the development of PCI-TC to better understand the wide-ranging needs of our patients and to improve the SDM process in the thyroid cancer management pathway., conditionsModule conditions: Thyroid Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 32, type: ESTIMATED, armsInterventionsModule interventions name: Interview, outcomesModule primaryOutcomes measure: To explore patients' and clinicians' view and experience of the current decision-making process for low risk differentiated thyroid cancer, primaryOutcomes measure: • To explore clinicians' and patients' user experience of thyroid cancer specific patient concerns inventory (PCI-TC) in thyroid cancer outpatient clinics., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Guys & St Thomas, status: RECRUITING, city: London, country: United Kingdom, contacts name: Aleix Mr Rovira, PhD, role: CONTACT, geoPoint lat: 51.50853, lon: -0.12574, locations facility: UCLH, status: RECRUITING, city: London, country: United Kingdom, contacts name: Francis Mr Vaz, FRCS, role: CONTACT, geoPoint lat: 51.50853, lon: -0.12574, hasResults: False
protocolSection identificationModule nctId: NCT06322147, orgStudyIdInfo id: KYLL-202304-31, briefTitle: Chemotherapy With Cetuximab as Conversion Therapy in RAS/BRAF WT Unresectable Liver Metastasis Right-sided Colon Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-06-01, primaryCompletionDateStruct date: 2024-12-30, completionDateStruct date: 2025-12-30, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Qilu Hospital of Shandong University, class: OTHER, descriptionModule briefSummary: This study was designed as multi-center, ambispective observational trial to evaluate the efficacy and safety of addition of cetuximab to doublet or triplet chemotherapy as conversion therapy in right-sided BRAF/RAS wild-type CRLM with curative intent. The primary endpoint was radical resection rate (R0). The secondary endpoint was response rate, rate of NED, depth of remission, early tumor shrinkage, progression free survival and safety., conditionsModule conditions: Colon Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: OTHER, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Doublet or triplet chemotherapy combined with cetuximab, outcomesModule primaryOutcomes measure: R0 resection rate, secondaryOutcomes measure: Objective response rate, secondaryOutcomes measure: Reported adverse events, secondaryOutcomes measure: Progression free survival, secondaryOutcomes measure: no evidence of disease, secondaryOutcomes measure: depth of response, secondaryOutcomes measure: Early Tumor Shrinkage, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Qilu hospital of Shandong University, status: RECRUITING, city: Jinan, state: Shandong, zip: 250012, country: China, contacts name: xiangling Wang, Dr., role: CONTACT, phone: 8653182169841, email: xlwang71@163.com, contacts name: Jing Hao, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 36.66833, lon: 116.99722, hasResults: False
protocolSection identificationModule nctId: NCT06322134, orgStudyIdInfo id: DROWN_SAR, briefTitle: Drowning Incidents Treated by the Danish SAR Helicopters, acronym: DROWN_SAR, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Prehospital Center, Region Zealand, class: OTHER, descriptionModule briefSummary: Improving oxygenation and ventilation in drowning patients early in the field is critical and may be lifesaving. This may be achieved by helicopter emergency medical services (HEMS) such as the Danish Air Ambulance, or the Royal Danish Air Force's Search And Rescue (SAR) helicopters. The SAR operates in all weather conditions and is equipped with a hoist system, able to hoist patients from the sea or small ships without helipads. This study aimed to estimate the incidence of drowning missions attended by the Royal Danish Air Force's SAR helicopter and describe patient characteristics and prehospital interventions., conditionsModule conditions: Drowning, conditions: Drown, conditions: Drowning; Anoxia, conditions: Drowning, Near, conditions: Drowning and Nonfatal Submersion, conditions: Drowning or Immersion of Unknown Intent, conditions: Drowning and Submersion, Undetermined Intent, conditions: Drowning and Submersion While in Natural Water, conditions: Drowning and Submersion Due to Sailboat Sinking, conditions: Drowning and Submersion Due to Fall Off Ship, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Drowning incident, outcomesModule primaryOutcomes measure: Annual incidence of drowning treated by the Danish SAR helicopters from 2014-2023, primaryOutcomes measure: Annual incidence rate of drowning treated by the Danish SAR helicopters from 2014-2023, primaryOutcomes measure: Spatial distribution of drowning patients treated by the Danish SAR helicopters from 2014-2023, secondaryOutcomes measure: Drowning to water rescue ratio, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Prehospital Center, city: Næstved, state: Region Zealand, zip: 4700, country: Denmark, geoPoint lat: 55.22992, lon: 11.76092, hasResults: False
protocolSection identificationModule nctId: NCT06322121, orgStudyIdInfo id: NL83653.058.23, briefTitle: Vascular Aspects in Dementia: Part 2, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-04, primaryCompletionDateStruct date: 2026-09, completionDateStruct date: 2026-09, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Leiden University Medical Center, class: OTHER, descriptionModule briefSummary: Cerebral amyloid angiopathy (CAA), a common cerebrovascular small vessel disease (SVD), is a frequently (98%) found co-morbidity at autopsy in patients with Alzheimer's disease (AD). Current in vivo hallmarks of CAA represent changes relatively late in the disease process and leaves CAA in AD often undetected. Recently, it was shown that decreased vascular reactivity (VR) measured with blood oxygen level dependent (BOLD) MRI, after visual stimulus, is an early CAA marker. With BOLD-MRI to detect decreased VR in different stages of AD, it was shown that increasing stages of AD associate with decreasing VR independent of age, classic SVD markers and atrophy. Moreover, VR is associated with cognitive deficits. Therefore, cross-sectional data indicate that decreased VR is an important co-morbidity already in early stages of AD with an independent effect on disease severity. In this respect, the study aim is to determine the natural course of the decrease of VR in both controls and (early stage) AD patients to monitor AD disease progression. This is an essential step to aid in the development and application of effective treatment as it is expected that CAA can cause/worsen AD pathology., conditionsModule conditions: Dementia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: MRI, outcomesModule primaryOutcomes measure: Vascular reactivity - BOLD amplitude, primaryOutcomes measure: Vascular reactivity - time-to-peak, primaryOutcomes measure: Vascular reactivity - time-to-baseline, secondaryOutcomes measure: Intracranial hemorrhage, secondaryOutcomes measure: Lobar microbleeds, secondaryOutcomes measure: Subarachnoidal hemorrhage, secondaryOutcomes measure: Superficial siderosis, secondaryOutcomes measure: Lacunes, secondaryOutcomes measure: Volume of white matter hyperintensities (WMHs), secondaryOutcomes measure: Perivascular spaces in the basal ganglia, secondaryOutcomes measure: Perivascular spaces in the centrum semiovale, secondaryOutcomes measure: Gray matter volume, eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Leids Universitair Medisch Centrum, status: RECRUITING, city: Leiden, zip: 2333 ZA, country: Netherlands, contacts name: Suzanne E van Dijk, drs, role: CONTACT, email: S.E.van_Dijk.RADI@lumc.nl, geoPoint lat: 52.15833, lon: 4.49306, hasResults: False
protocolSection identificationModule nctId: NCT06322095, orgStudyIdInfo id: GH21C202, briefTitle: A Study of GH21 Combined With Previous Target Therapy or Immunotherapy in Patients With Advanced Solid Tumors, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-22, primaryCompletionDateStruct date: 2025-09-30, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Suzhou Genhouse Bio Co., Ltd., class: OTHER, descriptionModule briefSummary: This study is aim to evaluate the preliminary efficacy of GH21 combined with previous target therapy or immunotherapy in patients with advanced solid tumors., conditionsModule conditions: Patient With Advanced Solid Tumor, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 72, type: ESTIMATED, armsInterventionsModule interventions name: GH21+ Previous Target Therapy or Immunotherapy, outcomesModule primaryOutcomes measure: Objective response rate (ORR), secondaryOutcomes measure: Number of participants with adverse events, secondaryOutcomes measure: Duration of response (DOR), secondaryOutcomes measure: Duration of response (DCR), secondaryOutcomes measure: Progression-free survival (PFS), secondaryOutcomes measure: Plasma concentration (Cmax), secondaryOutcomes measure: Time to achieve Cmax (Tmax), secondaryOutcomes measure: Area under the plasma concentration-time curve (AUC), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Cancer Hospital Chinese Academy of Medical Science, city: Beijing, state: Beijing, zip: 100029, country: China, contacts name: Ning Li, Doctorate, role: CONTACT, phone: +86-10-87788495, email: lining@cicams.ac.cn, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False