hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06325488, orgStudyIdInfo id: H-23035668, briefTitle: Fibrosis, Inflammation, Oxygenation of Renal Tissue In FabrY Disease, acronym: FORTIFY, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-03-01, completionDateStruct date: 2025-06-01, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Caroline Michaela Kistorp, class: OTHER, collaborators name: Sanofi, descriptionModule briefSummary: The overall objective of this study is to investigate Fabry-associated renal organ involvement by using a novel magnetic resonance imaging (MRI) approach, focusing on changes in renal oxygen levels by blood oxygenation-level dependent (BOLD) imaging. Furthermore, to correlate renal oxygenation to the phenotypic presentation of patients with Fabry-associated nephropathy regarding circulating and imaging-derived biomarkers of kidney inflammation, fibrosis and injury as compared with healthy age- and sex-matched controls.The study will achieve this by:1) Using a non-invasive, contrast-free MRI protocol focusing on parameters of oxygenation, inflammation, fibrosis, and injury in the kidney.2) Using an extensive, in-depth biomarker blood panel to investigate the pathological pathways associated with Fabry disease and Fabry-associated nephropathy., conditionsModule conditions: Fabry Disease, conditions: Chronic Kidney Diseases, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Renal hypoxia (Fabry patients according to renal impairment), secondaryOutcomes measure: Renal hypoxia (Fabry patient vs controls), secondaryOutcomes measure: Renal cortical perfusion (Fabry vs. controls), secondaryOutcomes measure: Renal medullar perfusion (Fabry vs. controls), secondaryOutcomes measure: Renal inflammation (Fabry vs. controls), secondaryOutcomes measure: Renal fibrosis (Fabry vs. controls), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Rigshospitalet, city: Copenhagen, zip: 2100, country: Denmark, geoPoint lat: 55.67594, lon: 12.56553, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2023-07-14, uploadDate: 2023-09-18T03:04, filename: Prot_000.pdf, size: 808560, largeDocs typeAbbrev: SAP, hasProtocol: False, hasSap: True, hasIcf: False, label: Statistical Analysis Plan, date: 2024-01-14, uploadDate: 2024-02-21T07:14, filename: SAP_001.pdf, size: 1460496, hasResults: False
protocolSection identificationModule nctId: NCT06325475, orgStudyIdInfo id: B.30.2.ATA.0.01.00/530, briefTitle: Comparison of Patients' Postpartum Recovery Using ObsQoR-10 Score in Pregnant Women in Vaginal Delivery With and Without Neuraxial Labor Analgesia, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-26, primaryCompletionDateStruct date: 2024-07-26, completionDateStruct date: 2024-08-26, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Ataturk University, class: OTHER, descriptionModule briefSummary: The aim of this study was to compare the postpartum recovery of pregnant women who had vaginal delivery with and without neuraxial labor analgesia using the ObsQoR-10 scoring system., conditionsModule conditions: Analgesia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: labor with neuraxial labor analgesia, interventions name: labour without noroaxial labor analgesia, outcomesModule primaryOutcomes measure: ObsQoR-10 scores of postpartum patients, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Atatürk University, status: RECRUITING, city: Erzurum, country: Turkey, contacts name: Ayşenur Dostbil, role: CONTACT, phone: +905333677796, email: adostbil@hotmail.com, geoPoint lat: 39.90861, lon: 41.27694, hasResults: False
protocolSection identificationModule nctId: NCT06325462, orgStudyIdInfo id: E2232/2023, briefTitle: The Influence of Anesthetic Technique on Cerebral Oxygenation During Spinal Surgery, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-10, primaryCompletionDateStruct date: 2024-08, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Prince Sultan Military Medical City, class: OTHER, descriptionModule briefSummary: Postural changes during anesthesia can lead to decreased cerebral blood flow and oxygenation, especially when moving from a supine to a prone position. This is particularly relevant during spinal surgery with controlled hypotension. Cerebral oximetry, monitored in the frontal cortex using an O3 sensor, is a noninvasive and continuous method to investigate the impact of anesthetic techniques on cerebral oxygenation in such scenarios., conditionsModule conditions: Cerebral Oxygenation, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 54, type: ESTIMATED, armsInterventionsModule interventions name: sensors of regional cerebral oxygen saturation (O3 regional oximeter, Masimo Corp, Irvine, CA) FDA Reg No. 3011353843, outcomesModule primaryOutcomes measure: regional cerebral oxygen saturation, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 68 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Prince Sultan Military Medical City, status: RECRUITING, city: Riyadh, zip: 11159, country: Saudi Arabia, contacts name: Muteb AlOtaibi, M.D., role: CONTACT, phone: 00966544793370, email: muteb612@gmail.com, contacts name: Rashid Al-Otaibi, M.D., role: SUB_INVESTIGATOR, contacts name: Osama Shalaan, M.D., role: SUB_INVESTIGATOR, contacts name: Muteb Al-Otaibi, M.D., role: SUB_INVESTIGATOR, contacts name: Majid Al-Sherif, role: SUB_INVESTIGATOR, geoPoint lat: 24.68773, lon: 46.72185, hasResults: False
protocolSection identificationModule nctId: NCT06325449, orgStudyIdInfo id: 5323, briefTitle: Correlating Improvement in PCOS Symptoms to the Percentage of Body Weight Lost in Females Also Living With Obesity, acronym: FLOWERS-PCOS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-01-01, completionDateStruct date: 2026-01-01, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Ottawa Hospital Research Institute, class: OTHER, collaborators name: LEAF Weight Loss Clinic, descriptionModule briefSummary: The goal of this clinical trial is to study the effects of a intensive weight loss program (STREAM) in patients living with PCOS. The main questions the investigators aim to answer are: how much weight will these patients lose over a 24-week program, and what other health markers (ie., insulin sensitivity) will improve and by how much?Participants will complete a 24-week weight loss program (STREAM). During this program they will:* weigh themselves* complete regular bloodwork and* fill out a Quality of Life questionnaire at regular intervals, conditionsModule conditions: Polycystic Ovary Syndrome, conditions: Obesity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Clinic patients with PCOS will be recruited to participate in a 24-week weight loss program. They will all receive the program. There is no control group., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: STREAM program, outcomesModule primaryOutcomes measure: Weight loss, primaryOutcomes measure: Change in Endocrine parameters (EP) as measure by blood test, primaryOutcomes measure: Change in insulin sensitivity (IS) as measure by blood test, primaryOutcomes measure: Change in Lipid profile (LP) as measure by blood test, primaryOutcomes measure: Change in liver enzyme profile (LEP) as measure by blood test, primaryOutcomes measure: Change in Menstrual Cyclicity, primaryOutcomes measure: Quality of Life (QoL) Scale, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: LEAF Weight Management Clinic, city: Ottawa, state: Ontario, zip: K1J9L3, country: Canada, contacts name: Judy Shiau, MD, role: CONTACT, phone: 613-701-1222, email: dr.shiau@leafwmc.ca, contacts name: Julie Laroche, role: CONTACT, phone: 613-701-1222, email: info@leafwmc.ca, geoPoint lat: 45.41117, lon: -75.69812, hasResults: False
protocolSection identificationModule nctId: NCT06325436, orgStudyIdInfo id: scores in variceal bleeding, briefTitle: Objective Scores in Variceal Bleeding, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-05-01, completionDateStruct date: 2026-01-01, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: To assess the prognostic performance of the ALBI associated scores (ALBI, PALBI and INR-ALBI score) and new MELD .3 in predicting the short-term outcomes (early re-bleeding and early mortality) of patients with cirrhosis presenting with acute variceal bleeding, comparable to the CTP and MELD and MELD Na scores., conditionsModule conditions: Variceal Hemorrhage, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 85, type: ESTIMATED, outcomesModule primaryOutcomes measure: assess the prognostic performance of the ALBI_associated scores and new MELD .3 in predicting the short-term outcomes of patients with cirrhosis presenting with acute variceal bleeding., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06325423, orgStudyIdInfo id: response to NAC in MIBC, briefTitle: Predicting Response to Neoadjuvant Chemotherapy in Muscle-invasive Bladder Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-06, completionDateStruct date: 2027-06, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: Bladder cancer (BC) is the 10th most commonly diagnosed cancer worldwide and the second most common cancer among Egyptian males.The mainstay of treatment of muscle-invasive BC( MIBC) is neoadjuvant chemotherapy (NAC) followed by radical cystectomy (RC) or bladder preservation(BP) using maximal transurethral resection of the bladder tumor followed by chemoradiation. The rationale to use NAC before RC or BP is to eradicate micro-metastasis and to downstage the primary tumor.The 5-year cancer-specific survival for responders to NAC is 90%, in contrast to 30-40% for those not obtaining an objective response. Drawbacks of NAC are disappointing delay of surgery in non-responders and the potential toxicity. So, predictors of response to NAC are necessary to identify patients who may achieve pathologic complete response and will benefit from BP, and the others who may not respond to NAC and spare them NAC toxicity and RC delay.Tumor microenvironment (TME), including neutrophil extracellular traps (NETs), and CD8+ T lymphocytes is a promising predictor of response to NAC in MIBC.NETs are reticulated DNA structures decorated with various protein substances (e.g., histones, myeloperoxidase, neutrophil elastase).NETs are involved in tumor growth, metastasis, and treatment resistance. Moreover, NETs can inhibit T cell responses, thereby promoting tumor growth.On the other hand, immune cells that are present in the TME play a major role in slowing down tumor progression. CD8+T lymphocytes play a central role in immune-mediated control of cancer . Also, they have been found to be a prognostic tool for advanced BC., conditionsModule conditions: Muscle-Invasive Bladder Carcinoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: OTHER, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: neoadjuvant chemotherapy, outcomesModule primaryOutcomes measure: Evaluation of the expression of NETs and CD8 in paraffin-embedded TUR biopsies, primaryOutcomes measure: - Response to platinum-based chemotherapy in localized MIBC in relation to: NETs expression, CD8 expression, NET/CD8 ratio and baseline clinicopathological features, secondaryOutcomes measure: Local recurrence-free survival (RFS), eligibilityModule sex: ALL, minimumAge: 19 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06325410, orgStudyIdInfo id: #11279-20-11-2023, briefTitle: Prognostic Factors Influencing the Recurrence Rate and Survival of Patients With Colorectal Cancer: a Single Institution Experience, statusModule overallStatus: COMPLETED, startDateStruct date: 2013-01, primaryCompletionDateStruct date: 2022-12, completionDateStruct date: 2022-12, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Zagazig University, class: OTHER_GOV, descriptionModule briefSummary: over the past decade colon cancer has emerged as the second most deadly and the third most common type of cancer in the world with increasing incidence in Egypt due to life style and diet change. some research showed relation between colon cancer recurrence and advanced tumor staging. To investigators knowledge, this is the first time to be done in Zagazig University.Data was collected from records in a retrospective cohort study, conditionsModule conditions: Colorectal Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 200, type: ACTUAL, armsInterventionsModule interventions name: resection of colorectal cancer, outcomesModule primaryOutcomes measure: age, primaryOutcomes measure: sex, primaryOutcomes measure: medical disease, primaryOutcomes measure: previous surgery, primaryOutcomes measure: CEA, primaryOutcomes measure: tumor grade, primaryOutcomes measure: tumor site, primaryOutcomes measure: tumor size, primaryOutcomes measure: surgical margins of resected tumor, primaryOutcomes measure: neoadjuvant therapy, primaryOutcomes measure: adjuvant therapy, primaryOutcomes measure: diet, primaryOutcomes measure: occupation, primaryOutcomes measure: family history, primaryOutcomes measure: type of surgery(laparoscopic or open), primaryOutcomes measure: soiling by during surgery, primaryOutcomes measure: hand sewen or stappled anastmosis, primaryOutcomes measure: post operative complications, primaryOutcomes measure: site of recurrence, primaryOutcomes measure: type of resected tumor, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_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: NCT06325397, orgStudyIdInfo id: IIT #88313865, briefTitle: Less Discomfort and Less Pharmacology. Cataract Surgery at Physiologic Intraocular Pressure (IOP), statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-23, primaryCompletionDateStruct date: 2024-04, completionDateStruct date: 2024-06, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Matthew Rauen, class: OTHER, descriptionModule briefSummary: To investigate the impact of high vs low Intraocular Pressure (IOP) on the intraoperative experience for the patient and surgeon. Operating at a more physiologic IOP using Active Sentry hand piece during cataract surgery will result in significantly less discomfort/pain as assessed by the decreased need for rescue medication, conditionsModule conditions: Nuclear Cataract, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 75, type: ESTIMATED, armsInterventionsModule interventions name: High Intraocular Pressure (IOP), interventions name: Low Intraocular Pressure (IOP), outcomesModule primaryOutcomes measure: Medication Rescue, secondaryOutcomes measure: Physiologic Responses associated with pain/inflammation:, secondaryOutcomes measure: Physiologic Responses associated with pain/inflammation:, secondaryOutcomes measure: Surgeon Experience: Assessment on patient cooperation, secondaryOutcomes measure: Surgeon Experience: Surgeon intraoperative experience, secondaryOutcomes measure: Cost- analysis, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Wolfe Eye Clinic, status: RECRUITING, city: West Des Moines, state: Iowa, zip: 50266, country: United States, contacts name: Robyn Kohler, RN, role: CONTACT, phone: 515-223-8685, phoneExt: 2305, email: rkohler@wolfeclinic.com, contacts name: Hillery Joiner, role: CONTACT, phone: 5152238685, phoneExt: 2085, email: hjoiner@wolfeclinic.com, contacts name: Matthew Rauen, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.57721, lon: -93.71133, hasResults: False
protocolSection identificationModule nctId: NCT06325384, orgStudyIdInfo id: IRAS ID:1008701, briefTitle: Real World Evaluation of Lifelight®: A Contactless Vital Signs Monitor for Self-monitoring Blood Pressure and Its Comparison to Standard of Care, acronym: VISION-RWE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2025-08-31, completionDateStruct date: 2025-08-31, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Xim Limited, class: INDUSTRY, collaborators name: Barts & The London NHS Trust, collaborators name: Mind Over Matter Medtech Ltd, collaborators name: Health Innovation Wessex, descriptionModule briefSummary: A randomised controlled trial for comparison of real-world feasibility and clinical outcomes of two different methods of home blood pressure monitoring Participants aged 18 years or over with diagnosed and treated hypertension (including via lifestyle interventions) that is not controlled (i.e. in-clinic measurement is 140/90 mmHg or greater) will be recruited from hypertension hospital clinics, conditionsModule conditions: Hypertension, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: Lifelight, interventions name: Blood Pressure Cuff, outcomesModule primaryOutcomes measure: Blood Pressure Measurement Non Inferiority, secondaryOutcomes measure: Adherance to Blood Pressure Measurement, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
protocolSection identificationModule nctId: NCT06325371, orgStudyIdInfo id: 0028201, briefTitle: Italian Multicentric Study on the Treatment of Visceral Aneurysms With the Flow Diversion Stent Derivo Peripher and Derivo 2, acronym: DEDICATE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-06-30, completionDateStruct date: 2025-06-30, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: University of Turin, Italy, class: OTHER, descriptionModule briefSummary: This is a multicentric voluntary observational study with a retrospective evaluation of prospectively collected data concerning the treatment of visceral aneurysms with flow diversion stent Derivo Peripher and Derivo 2 (DED, Acandis GmbH) Follow-up will include clinical and radiological (CT) evaluation at least 12 months after the intervention.The enrollment period will be of 54 months (01/01/2020-30/06/2024). Minimum sample size will be of 50 Patients., conditionsModule conditions: Aneurysm Abdominal, conditions: Arterial Aneurysm, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Visceral aneurysm stenting, outcomesModule primaryOutcomes measure: Efficacy of the stenting in terms of patency and side branches, primaryOutcomes measure: Efficacy of the stenting in terms of aneurysm thrombosis rate, primaryOutcomes measure: Efficacy of the stenting in terms of aneurysm volume assessment, primaryOutcomes measure: Safety in terms of morbidity, primaryOutcomes measure: Safety in terms of mortality, primaryOutcomes measure: Safety in terms of technical issues, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False