hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06359821, orgStudyIdInfo id: Z-001, briefTitle: Evaluate Safety, Whole-Body Distribution and Radiation Dosimetry in Metastatic Castration Resistant Prostate Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-09, primaryCompletionDateStruct date: 2025-04-15, completionDateStruct date: 2026-04-15, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Sichuan University, class: OTHER, descriptionModule briefSummary: A Study to Evaluate Safety, Whole-Body Distribution and Radiation Dosimetry of ZA-001, an Alpha-particle-emitting Radiopharmaceutical, in metastatic castration resistant prostate cancer, conditionsModule conditions: Metastatic Prostate Cancer, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 5, type: ESTIMATED, armsInterventionsModule interventions name: ZA-001, outcomesModule primaryOutcomes measure: The absorbed radiation doses (Gray [Gy] /Megabecquerel [MBq] )for whole body and organ, primaryOutcomes measure: Adverse Event, eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06359808, orgStudyIdInfo id: KY20232370, briefTitle: Clinical Characteristics of Sleep Disorders in Patients With Ulcerative Colitis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Xijing Hospital, class: OTHER, descriptionModule briefSummary: Ulcerative colitis(UC) is one of the two main forms of inflammatory bowel disease(IBD), which seriously affects the quality of life of patients. Previous studies have demonstrated that more than 60% of IBD patients have sleep disorders, which is emerging as an important risk factor for disease recurrence and poor prognosis. However, the mechanisms by which sleep disorders regulates the occurrence and development of IBD remain undefined. This study aims to explore the clinical characteristics of ulcerative colitis patients with sleep disorders based on the microbiota-gut-brain axis, to analyze the effects of sleep disorders on autonomic nervous function, gut microbiota, and metabolites in UC patients., conditionsModule conditions: Colitis, Ulcerative, conditions: Sleep Quality, conditions: Gastrointestinal Microbiome, conditions: Autonomic Nervous System Imbalance, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 152, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Pittsburgh Sleep Quality Index (PSQI), primaryOutcomes measure: Disease activity, primaryOutcomes measure: Heart Rate Variability (HRV), primaryOutcomes measure: Functional Magnetic Resonance Imaging, primaryOutcomes measure: Neurotransmitter Agents, primaryOutcomes measure: Gastrointestinal Microbiome, secondaryOutcomes measure: Patient Health Questionnaire (PHQ-9), secondaryOutcomes measure: Generalized Anxiety Disorder (GAD-7), secondaryOutcomes measure: Inflammatory Bowel Diseases Questionnaire (IBDQ), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06359795, orgStudyIdInfo id: FAPI-TED, briefTitle: Exploring the Value of 18F-AlF-FAPI PET/CT in Assessing the Activity of Thyroid Eye Disease, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-15, primaryCompletionDateStruct date: 2027-12-31, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Peking University Third Hospital, class: OTHER, descriptionModule briefSummary: FAPI PET has been developed as a promising approach for the evaluation of fibroinflammatory, such as in inflammatory bowel disease. This prospective study aims to explore the value of 18F-AlF-FAPI PET/CT in assessing the activity of Thyroid Eye Disease (TED) and investigate whether FAPI PET/CT may be superior to 99mTc-DTPA SPECT/CT for the diagnosis, therapy response assessment, and follow-up of TED., conditionsModule conditions: Thyroid Eye Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: 18F-AlF-FAPI PET/CT, 99mTc-DTPA SPECT/CT, outcomesModule primaryOutcomes measure: Diagnostic accuracy, secondaryOutcomes measure: The value to predict therapy response, secondaryOutcomes measure: Diagnostic accuracy comparison, secondaryOutcomes measure: FAPI expression and SUV metrics, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Dept. of Nuclear Medicine, Peking University Third Hospital, status: RECRUITING, city: Beijing, state: Beijing, zip: 100191, country: China, contacts name: Hui Li, Dr., role: CONTACT, phone: 86-13121136769, email: huilee1990@163.com, contacts name: Lingge Suo, Dr., role: CONTACT, phone: 86-010-82264935, email: suolingge_1019@126.com, contacts name: Hui Li, Dr., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
protocolSection identificationModule nctId: NCT06359769, orgStudyIdInfo id: GROUPCET, briefTitle: Group Cognitive Evolutionary Therapy for Depression, acronym: GRCET, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2025-06-01, completionDateStruct date: 2025-12-01, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: University of Bucharest, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to measure the effects of Group Cognitive Evolutionary Therapy on mental health, especially on depressive symptoms and anxiety.Participants will be allocated in one of two conditions: (1) Group Cognitive Evolutionary Therapy (intervention) or (2) Waitlist. The intervention will consist of two 8-hour sessions of Group Cognitive Therapy, in two consecutive days.The Group Cognitive Evolutionary Therapy group will be compared to the waitlist group to test the efficacy of the intervention., conditionsModule conditions: Depression, conditions: Anxiety, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: Group Cognitive Evolutionary Therapy, outcomesModule primaryOutcomes measure: Depressive symptomatology, primaryOutcomes measure: Anxiety symptomatology, secondaryOutcomes measure: Sleep quality, secondaryOutcomes measure: Perceived stress, secondaryOutcomes measure: Social provisions, secondaryOutcomes measure: Satisfaction with life, secondaryOutcomes measure: Self-perceived mate value, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06359756, orgStudyIdInfo id: BRAIN-SAVE1, briefTitle: Ischemic Postconditioning in Carotid Surgery, acronym: BRAIN-SAVE, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-01, primaryCompletionDateStruct date: 2024-05-01, completionDateStruct date: 2024-09-01, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Institute for Cardiovascular Diseases "Dedinje", class: OTHER, descriptionModule briefSummary: Analyzing changes in cerebral oximetry, transcranial Doppler and biomarkers of neuronal ischemic injury and blood-brain barrier integrity assessing the safety and efficacy of ischemic postconditioning in carotid surgery (IPCT)., conditionsModule conditions: Ischemic Postconditioning, conditions: Carotid Surgery, conditions: Stroke, conditions: Carotid Artery Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 250, type: ESTIMATED, armsInterventionsModule interventions name: Ischemic postconditioning in carotid surgery, interventions name: Eversion Carotid Endarterectomy, outcomesModule primaryOutcomes measure: Number of Participants with perioperative stroke, primaryOutcomes measure: Number of Participants with perioperative death, eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Institute for Cardiovascular Diseases Dedinje, status: RECRUITING, city: Belgrade, zip: 11000, country: Serbia, contacts name: Jovan Petrović, MD, role: CONTACT, phone: +381113601705, email: jovanpetrovic1997@gmail.com, contacts name: Slobodan Pešić, MD, role: SUB_INVESTIGATOR, geoPoint lat: 44.80401, lon: 20.46513, hasResults: False
protocolSection identificationModule nctId: NCT06359743, orgStudyIdInfo id: 271/7, briefTitle: Ultrasound Guided QLB Versus Laparoscopic Superior Hypogastric Plexus Block for Postoperative Analgesia After Laparoscopic Hysterectomy, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-08-01, completionDateStruct date: 2024-09-01, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Zagazig University, class: OTHER_GOV, descriptionModule briefSummary: Pain following laparoscopic hysterectomy may interfere with early ambulation, discharge of patient from hospital and interfere with enhanced recovery with more opioid consumption. Most of methods for postoperative pain depend on the use of high doses of opioids with more side effects such as nausea, vomiting, respiratory center depression, delay bowel motility and hemodynamics instability. To decrease of opioid consumption in postoperative pain management as well as related side effects, previous studies showed that quadratus lumborum block or superior hypogastric plexus block (SHPB) had shown promising success in management of postoperative pain in patients undergoing laparoscopic hysterectomy. The present study will be conducted to compare of ultrasound guided QL block and laparoscopic superior hypogastric plexus block as a part of multimodal analgesia may allow adequate analgesia and decrease the overall use of opioids and allow patient enhanced recovery., conditionsModule conditions: Post Hysterectomy Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 34, type: ESTIMATED, armsInterventionsModule interventions name: Quadratus Lamborum versus superior hypogatric, outcomesModule primaryOutcomes measure: Opioid consumption decrease, eligibilityModule sex: FEMALE, minimumAge: 45 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Faculty of medicine, Zagazig university, city: Zagazig, state: Sharkia, country: Egypt, geoPoint lat: 30.58768, lon: 31.502, hasResults: False
protocolSection identificationModule nctId: NCT06359730, orgStudyIdInfo id: 253/26-March-2024, briefTitle: Incidence and Risk Factors of Low Anterior Resection Syndrome, statusModule overallStatus: COMPLETED, startDateStruct date: 2017-12-01, primaryCompletionDateStruct date: 2022-12-01, completionDateStruct date: 2022-12-01, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Zagazig University, class: OTHER_GOV, descriptionModule briefSummary: Sphincter sparing surgery is oftentimes associated with bowel dysfunction complaints, namely the low anterior resection syndrome (LARS). The LARS questionnaire is widely used to assess this syndrome.With advances in colorectal surgery, sparing sphincter surgeries are gaining popularity. But symptoms after surgery can affect the quality of life which has psychomotor effects. Low anterior resection syndrome score is a worldwide known questionnaire. Many countries have accredited validation and translation of this questionnaire, but to our knowledge; it is the first time in Egypt., conditionsModule conditions: Colorectal Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 120, type: ACTUAL, armsInterventionsModule interventions name: LARS score questionnaire, outcomesModule primaryOutcomes measure: age, primaryOutcomes measure: sex, primaryOutcomes measure: medical disease, primaryOutcomes measure: site of tumor, primaryOutcomes measure: neoadjuvant therapy, primaryOutcomes measure: site of anastmosis, primaryOutcomes measure: type of meso-rectal excision, primaryOutcomes measure: adjuvant therapy, primaryOutcomes measure: type of surgery, primaryOutcomes measure: type of anastmosis, primaryOutcomes measure: LARS score, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Zagazig University Hospitals, city: Zagazig, zip: 44519, country: Egypt, geoPoint lat: 30.58768, lon: 31.502, hasResults: False
protocolSection identificationModule nctId: NCT06359717, orgStudyIdInfo id: ZU-10490, briefTitle: Prospective Validation of PSMA-RADS, acronym: PSMA-RADS, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2024-04-10, completionDateStruct date: 2024-04-20, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Zagazig University, class: OTHER_GOV, descriptionModule briefSummary: This is a prospective, multicenter study aimed at evaluating the diagnostic accuracy and reliability of the Prostate-Specific Membrane Antigen Reporting and Data System (PSMA-RADS) version 1.0 in detecting prostate cancer using 68Ga-PSMA-11 PET/CT imaging. The study also compared the performance of PSMA-RADS v1.0 with the updated version 2.0.Key points:* 186 patients with newly diagnosed or recurrent prostate cancer underwent 68Ga-PSMA-11 PET/CT imaging.* Three radiologists independently evaluated the scans and assigned PSMA-RADS scores using v1.0, then retrospectively using v2.0.* Diagnostic accuracy was assessed against histopathology and follow-up imaging as reference standards.* Inter-rater agreement was evaluated using Fleiss\&#39; kappa statistic.* The study aimed to validate the diagnostic utility of PSMA-RADS v1.0 and compare it to the updated v2.0., conditionsModule conditions: Cancer Prostate, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 208, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Diagnostic Accuracy of PSMA-RADS v1.0 and v2.0, secondaryOutcomes measure: Inter-rater Agreement of PSMA-RADS v1.0 and v2.0, eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mohammad Abd Alkhalik Basha, city: Zagazig, state: Select, zip: 44631, country: Egypt, geoPoint lat: 30.58768, lon: 31.502, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2024-01-21, uploadDate: 2024-04-05T07:38, filename: Prot_SAP_000.pdf, size: 692777, hasResults: False
protocolSection identificationModule nctId: NCT06359704, orgStudyIdInfo id: kevinszc, briefTitle: Intervention for Emotions in Caregivers of Dementia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2024-10-01, completionDateStruct date: 2025-02-01, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: The University of Hong Kong, class: OTHER, descriptionModule briefSummary: This study aims to evaluate the effectiveness of a 6-week Caregivers Of dementia Processing Emotions (COPE) program using the integrative therapy to reduce EE (primary outcome) in family caregiver of PLwD to alleviate the caregivers' depression, improve social dynamic with the PLwD, and mitigate the perceived stress from BPSD (secondary outcomes)., conditionsModule conditions: BPSD, conditions: Expressed Emotion, conditions: Depressive Symptoms, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: controlled arm with waitlist treatment, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 56, type: ESTIMATED, armsInterventionsModule interventions name: Caregivers Of dementia Processing Emotions (COPE) program, outcomesModule primaryOutcomes measure: Expressed emotions, secondaryOutcomes measure: depressive symptoms, secondaryOutcomes measure: social dynamics, secondaryOutcomes measure: BPSD, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06359678, orgStudyIdInfo id: NL85844.015.23, briefTitle: The Northstar Trial, acronym: Northstar, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2025-01-01, completionDateStruct date: 2025-01-01, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Amsterdam UMC, location VUmc, class: OTHER, descriptionModule briefSummary: The introduction of real-time MRI-guided cardiac ablation therapy, a significant advancement in interventional medicine, necessitates precise catheter tracking for accurate navigation within the complex cardiac anatomy. The introduction of the NorthStar software as an active tracking system holds promise for improving the precision and efficiency of catheter manipulation during these procedures. However, a rigorous evaluation of its accuracy and reliability in a clinical setting is crucial to validate its viability.The objective of this study is to evaluate the accuracy of catheter localization using the NorthStar software during real-time MRI-guided cardiac ablation therapy., conditionsModule conditions: Flutter, Atrial, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: NorthStar, outcomesModule primaryOutcomes measure: Accuracy of Catheter Localization, secondaryOutcomes measure: Influences of breathing pattern, secondaryOutcomes measure: Influences of procedure duration, secondaryOutcomes measure: Influences of complications during ablation, secondaryOutcomes measure: Influences of patient characteristics, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Amsterdam UMC, status: RECRUITING, city: Amsterdam, country: Netherlands, contacts name: Marco Gotte, role: CONTACT, geoPoint lat: 52.37403, lon: 4.88969, hasResults: False
protocolSection identificationModule nctId: NCT06359652, orgStudyIdInfo id: IRB24-0421, briefTitle: Get Fit for Function, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2029-04, completionDateStruct date: 2029-04, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: University of Chicago, class: OTHER, descriptionModule briefSummary: The purpose of this study will be to implement and evaluate a prehab program for pre-frail and frail adults who need to undergo thoracic surgery. The study team hypothesizes using an implementation framework will increase the reach, effectiveness, adoption, and implementation of the prehab program., conditionsModule conditions: Thoracic, conditions: Frailty, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DEVICE_FEASIBILITY, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Prehabilitation Program (Apple Watch Series 6 with exercise flipbook), outcomesModule primaryOutcomes measure: The change of functional status using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework for implementation evaluation., secondaryOutcomes measure: Number of Participants with Postoperative Complications, secondaryOutcomes measure: Number of Participants length of hospital stay post-operative., secondaryOutcomes measure: Number of Participants discharge to not-home post-operative., eligibilityModule sex: ALL, minimumAge: 50 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The University of Chicago, city: Chicago, state: Illinois, zip: 60637, country: United States, contacts name: Viviana Camacho, role: CONTACT, phone: 773-795-4391, email: vcamacho@bsd.uchicago.edu, contacts name: Leila Yazdanbakhsh, role: CONTACT, phone: 773-834-5087, email: leila.yazdanbakhsh@bsd.uchicago.edu, contacts name: Maria Madariaga, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.85003, lon: -87.65005, hasResults: False