hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06265428, orgStudyIdInfo id: DB-1303-O-3001, secondaryIdInfos id: CTR20233403, type: OTHER, domain: CENTER FOR DRUG EVALUATION, NMPA, briefTitle: A Study to Compare DB-1303/BNT323 Versus T-DM1 in Breast Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-29, primaryCompletionDateStruct date: 2026-02, completionDateStruct date: 2026-02, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: DualityBio Inc., class: INDUSTRY, collaborators name: BioNTech SE, descriptionModule briefSummary: This study is designed to compare efficacy and safety of DB-1303/BNT323 versus T-DM1 in HER2-positive, unresectable and/or metastatic breast cancer patients previously treated with trastuzumab and taxane., conditionsModule conditions: HER2-positive Breast Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 224, type: ESTIMATED, armsInterventionsModule interventions name: DB-1303/BNT323, interventions name: T-DM1, outcomesModule primaryOutcomes measure: Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) assessment per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), secondaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: Progression Free Survival (PFS) by Investigator assessment per RECIST 1.1, secondaryOutcomes measure: Objective response rate (ORR) by BICR and investigator assessment per RECIST 1.1, secondaryOutcomes measure: Duration of response (DoR) by BICR and investigator assessment per RECIST 1.1, secondaryOutcomes measure: PK parameters: maximum observed concentration (Cmax), secondaryOutcomes measure: PK parameters: time to maximum concentration (Tmax), secondaryOutcomes measure: Adverse events (AEs), secondaryOutcomes measure: Patient reported outcomes (PROs): European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) - C30, secondaryOutcomes measure: Patient reported outcomes (PROs): EORTC QLQ-BR45, secondaryOutcomes measure: Patient reported outcomes (PROs): European Quality of Life Five Dimension Five Level Scale (EQ-5D-5L), secondaryOutcomes measure: European Quality of Life Five Dimension Five Level Scale (EQ-5D-5L), secondaryOutcomes measure: Anti-drug antibodies (ADA), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Fifth Medical Center of the Chinese People's Liberation Army General Hospital, status: NOT_YET_RECRUITING, city: Beijing, state: Beijing, zip: 100039, country: China, contacts name: Zefei Jiang, role: CONTACT, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Fudan University Shanghai Cancer Center, status: RECRUITING, city: Shanghai, state: Shanghai, zip: 200032, country: China, contacts name: Jian Zhang, role: CONTACT, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
protocolSection identificationModule nctId: NCT06265415, orgStudyIdInfo id: Soh-Med-24-01-07MS, briefTitle: Comparative Study of Intravenous Labetalol Versus Intravenous Nitroglycerin Versus Sublingual Nifedipine, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-30, primaryCompletionDateStruct date: 2025-03-30, completionDateStruct date: 2025-03-30, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Sohag University, class: OTHER, descriptionModule briefSummary: Pre-eclampsia (PE) is one of the most frequent pregnancy complications and is one of the main causes of maternal and fetal morbidity and mortality in its severe form.control of blood pressure is of crucial importance to avoid maternal and fetal complications.Therapeutic modalities that can target the underlying pathophysiological changes and reverse the endothelial dysfunction could help to ameliorate the systemic manifestations in patients with severe PE. Either Intravenous labetalol and nitroglycerine as well as sublingual nifedipine have been frequantly used for the management of acute severe hypertension in PE, conditionsModule conditions: Severe Preeclampsia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Labetalol, interventions name: Nitroglycerine, interventions name: Nifedipine, outcomesModule primaryOutcomes measure: duration of control blood pressure, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06265402, orgStudyIdInfo id: 36264, briefTitle: Retrolaminar Block Versus Tab Block in Abdomioasty, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-15, primaryCompletionDateStruct date: 2025-10-15, completionDateStruct date: 2025-12-15, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Tanta University, class: OTHER, descriptionModule briefSummary: The aim of the study is to compare the analgesic efficacy of Us guided retrolaminar block versus transversus abdominis plane block in patient under going abdominal plastic surgery, conditionsModule conditions: Block, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: Tab block versus retrolaminar block in abdominal plastic surgery, outcomesModule primaryOutcomes measure: Total dose of morphine consumption in the first postoperative 24hours, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: TantaU U, status: RECRUITING, city: Tanta, country: Egypt, contacts name: Hadeel Elsagheer, Master, role: CONTACT, geoPoint lat: 30.78847, lon: 31.00192, hasResults: False
protocolSection identificationModule nctId: NCT06265389, orgStudyIdInfo id: Pentoxifylline in pneumonia, briefTitle: Pentoxifylline as an Adjuvant Therapy in the Treatment of Pediatric Pneumonia; A New Perspective of an Old Drug, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-08-31, completionDateStruct date: 2024-10-30, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Tanta University, class: OTHER, descriptionModule briefSummary: Pentoxifylline is a xanthine-derived, commercially produced drug approved for the management of intermittent claudication in patients suffering from a chronic occlusive arterial disease of the limbs. Pentoxifylline has been documented to display anti-inflammatory and immunomodulatory effects, as well as some antithrombotic and antiviral effects. This drug has also been shown to reduce lung fibrosis in patients with COVID-19, as well as to prevent thromboembolic events. This work aims to assess the benefit of oral Pentoxifyllin supplementation, in addition to standard antibiotic and other supportive therapy, in the management of hospitalized children with community-acquired pneumonia, conditionsModule conditions: Pentoxifylline as an Adjunct Therapy in the Treatment of Pneumonia, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Pentoxifylline Oral Tablet, outcomesModule primaryOutcomes measure: Respiratory distress, primaryOutcomes measure: Temperature, primaryOutcomes measure: Oxygen saturation, primaryOutcomes measure: CRP, primaryOutcomes measure: LDH, primaryOutcomes measure: D-dimer, primaryOutcomes measure: Interleukin 6, secondaryOutcomes measure: Hospital stays, secondaryOutcomes measure: Pneumonia complications, otherOutcomes measure: Surgical intervention, eligibilityModule sex: ALL, minimumAge: 2 Months, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, hasResults: False
protocolSection identificationModule nctId: NCT06265376, orgStudyIdInfo id: IRB22-046, briefTitle: Do Patient Educational Videos Improve Pain and Recovery After Laparoscopic Hysterectomy?, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-03-13, primaryCompletionDateStruct date: 2024-05-01, completionDateStruct date: 2024-07-01, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Benaroya Research Institute, class: OTHER, descriptionModule briefSummary: The use of multi-model patient education has been used in a variety of medical specialties to educate patients on expectations for various medical procedures and improve patients' understanding of their own health care. However, it is unknown what type of audio and/or visual materials work best in a given clinical setting. By surveying overall pain/post-operative recovery satisfaction we can measure how well our video intervention educates and reinforces post-operative management at home when compared to the current method of education that patients receive at the pre-operative visit prior to laparoscopic hysterectomy at this institution., conditionsModule conditions: Pain, Postoperative, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Educational Video, outcomesModule primaryOutcomes measure: Overall satisfaction score (5 point Likert scale) with post operative pain control after laparoscopic hysterectomy, secondaryOutcomes measure: Pain score at the time of survey completion (0=no pain 10=worst pain, secondaryOutcomes measure: Average pain score for the first 7 days as perceived by the patients (likert scale), secondaryOutcomes measure: Number of post-op phone calls received, secondaryOutcomes measure: Number of post-op emergency room visits, secondaryOutcomes measure: Number of readmissions, secondaryOutcomes measure: Number of patients with steri-strips still in place, secondaryOutcomes measure: Number opioids taken since surgery, secondaryOutcomes measure: Overall satisfaction with pre-operative education regarding surgery (5 point Likert scale), secondaryOutcomes measure: ding surgery (5 point likert scale) Overall satisfaction with educations regarding what to expect post-operatively (5 point Likert scale), eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Virginia Mason Medical Center, status: RECRUITING, city: Seattle, state: Washington, zip: 98101, country: United States, contacts name: Michelle Gruttadauria, MD, role: CONTACT, phone: 206-223-6191, email: Michelle.Gruttadauria@virginiamason.org, geoPoint lat: 47.60621, lon: -122.33207, hasResults: False
protocolSection identificationModule nctId: NCT06265350, orgStudyIdInfo id: Liver Project 5, briefTitle: Cryoablation Combined With Cardonilizumab and Bevacizumab in Hepatocellular Carcinoma With Pulmonary Metastases, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-02, primaryCompletionDateStruct date: 2026-01-30, completionDateStruct date: 2027-01-30, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Sun Yat-sen University, class: OTHER, descriptionModule briefSummary: This study intends to evaluate the efficacy and safety of cryoablation combined with Cardonilizumab and Bevacizumab in hepatocellular carcinoma with pulmonary metastases., conditionsModule conditions: Hepatocellular Carcinoma, conditions: Liver Cancer Stage IV, conditions: Pulmonary Metastases, conditions: Cadonilimab, conditions: Bevacizumab, conditions: Cryoablation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Cadonilimab, interventions name: Bevacizumab, interventions name: Cryoablation, outcomesModule primaryOutcomes measure: Objective response rate (ORR), secondaryOutcomes measure: Progression free survival (PFS), secondaryOutcomes measure: Overall survival (OS), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sun Yat-sen University Cancer Center, status: RECRUITING, city: Guanzhou, state: Guangdong, zip: 510000, country: China, contacts name: Qunfang Zhou, MD, role: CONTACT, phone: 86 19868000115, email: zhouqun988509@163.com, locations facility: Sun Yat-sen University Cancer Center, status: RECRUITING, city: Guanzhou, state: Guangdong, zip: 510000, country: China, contacts name: Qunfang Zhou, MD, role: CONTACT, phone: 8619868000115, email: zhouqun988509@163.com, hasResults: False
protocolSection identificationModule nctId: NCT06265337, orgStudyIdInfo id: LAMETA-OGTT, briefTitle: Does Co-administration of Lactate to an Oral Glucose Tolerance Test Lower the Glucose Response?, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02, primaryCompletionDateStruct date: 2025-01, completionDateStruct date: 2025-01, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: University of Aarhus, class: OTHER, descriptionModule briefSummary: To investigate whether co-administration of lactate with a glucose load affects postprandial glucose levels/handling, gastrointestinal hormones, gastric emptying, and appetite sensations in individuals with pre-diabetes when compared to placebo.Hypothesis:Oral lactate administration improves/lowers glucose excursions following an oral glucose tolerance test (OGTT) by stimulating insulin secretion and delaying glucose absorption., conditionsModule conditions: PreDiabetes, conditions: Metabolic Syndrome, conditions: Insulin Resistance, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: In a randomized, double-blinded, placebo-controlled crossover trial, we will investigate the effect of addition of 25 g lactate vs. placebo to an OGTT on two trial days separated by a minimum of fourteen days and a maximum of one month. We will include 12 individuals with pre-diabetes \[9\], having HbA1c 39-47 mmol/L and being above 40 years of age., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: Lactate, interventions name: Placebo, outcomesModule primaryOutcomes measure: Difference in integrated glucose concentrations between CTR and LAC following an OGTT, secondaryOutcomes measure: Difference in glucose absorption, secondaryOutcomes measure: Difference in insulin sensitivity, secondaryOutcomes measure: Difference in insulin secretion, secondaryOutcomes measure: Difference in free fatty acids concentration, secondaryOutcomes measure: Difference in ventricular emptying rate, secondaryOutcomes measure: Difference in subjective appetite sensation, secondaryOutcomes measure: Difference in integrated GLP-1 concentrations, eligibilityModule sex: ALL, minimumAge: 40 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06265324, orgStudyIdInfo id: Soh-Med-23-12-04MD, briefTitle: Drug-coated Balloon Treatment in Coronary Lesions, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-10, primaryCompletionDateStruct date: 2024-06-10, completionDateStruct date: 2025-02-10, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Sohag University, class: OTHER, descriptionModule briefSummary: This study is multicenter registry for drug-coated balloon treatment for de novo and in-stent restenosis lesions, conditionsModule conditions: Drug-coated Balloon, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Angioplasty, outcomesModule primaryOutcomes measure: Major adverse cardiac events at 6 months, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sohag faculty of medicine, city: Sohag, country: Egypt, contacts name: Sharaf Eldin Shazly, PHD, role: CONTACT, phone: 0112 9999792, contacts name: Imran Saber, MA, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 26.55695, lon: 31.69478, hasResults: False
protocolSection identificationModule nctId: NCT06265311, orgStudyIdInfo id: 20221307-2, briefTitle: IDUS in CBD Stone Recurrence High Risk Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-11-02, primaryCompletionDateStruct date: 2024-01-31, completionDateStruct date: 2024-06, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Shanghai Municipal Hospital of Traditional Chinese Medicine, class: OTHER, descriptionModule briefSummary: This study is designed to observed CBD stones cases with high recurrence risks applying IDUS or not during ERCP.Patients with CBD stone high recurrence risks were enrolled in this study, and prospectively randomized into IUDS group and control group during lithotomy.Operation time, radiation time, hospitalization cost, retain of nasobiliary tube, deployment of stent were recorded.Symptoms and conditions after ERCP were also followed up including blood amylase, routine blood test, abdominal pain, post-ERCP pancreatitis, resection of gallbladder, recurrence of CBD stone and onset of cholangitis., conditionsModule conditions: Choledocholithiasis, conditions: Cholangiopancreatography, Endoscopic Retrograde, conditions: Ultrasonography, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: IDUS examination, outcomesModule primaryOutcomes measure: recurrence of bile duct stone or cholangitis, primaryOutcomes measure: need for a nasobiliary tube, primaryOutcomes measure: need for stents, secondaryOutcomes measure: operation time, secondaryOutcomes measure: radiation time, secondaryOutcomes measure: hospitalization cost, secondaryOutcomes measure: Questionnaire of Symptoms and conditions after ERCP, secondaryOutcomes measure: White blood cell count, secondaryOutcomes measure: Red blood cell count, secondaryOutcomes measure: Platelet count, secondaryOutcomes measure: total bilirubin, direct bilirubin, secondaryOutcomes measure: Liver function test (ALT, AST), secondaryOutcomes measure: albumin, secondaryOutcomes measure: total protein, secondaryOutcomes measure: Gamma-glutamyl transferase (GGT) test, secondaryOutcomes measure: An alkaline phosphatase (ALP) test, secondaryOutcomes measure: whether have a resection of gallbladder checklist, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Shang General Hospital, status: RECRUITING, city: Shanghai, zip: 200080, country: China, contacts name: Hang Zhao, role: CONTACT, phone: 18621186288, email: drzhaohang@163.com, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
protocolSection identificationModule nctId: NCT06265272, orgStudyIdInfo id: 2022P002594, briefTitle: Value of [68Ga]Ga-PSMA-11 PET/MRI in the Assessment of Liver Cirrhosis, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-10, primaryCompletionDateStruct date: 2026-12-19, completionDateStruct date: 2026-12-19, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Massachusetts General Hospital, class: OTHER, descriptionModule briefSummary: A total of fifty-five (55) patients with liver cirrhosis will be enrolled in this study to produce and validate dedicated Ga-PSMA-PET/MRI acquisition protocols.The specific hypotheses include:* Ga-PSMA PET/MRI may allow robust and reproducible noninvasive in vivo quantitation of hepatic macro and microhemodynamics in cirrhotic patients* Dedicated simultaneously acquired DWI sequences might quantitate liver fibrosis and improve hemodynamic quantitation.* Ga-PSMA PET/MRI may allow noninvasive and reproducible quantitation of portal venous hypertension and predict its evolution, as well as response to treatments* Ga-PSMA PET/MRI may improve noninvasive and reproducible qualitative and quantitative assessment of liver function, structure, nodules and predict evolution of cirrhosis, conditionsModule conditions: Liver Cirrhosis, conditions: Hepatic Cell Carcinoma, conditions: Portal Hypertension, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 45, type: ESTIMATED, armsInterventionsModule interventions name: Injection of a gadolinium contrast agen, interventions name: Radiotracer Injection, interventions name: Imaging, outcomesModule primaryOutcomes measure: Assessment of LI-RADS with Ga-PSMA-PET/MRI, secondaryOutcomes measure: Quantification of Macro- and Microperfusion in Cirrhotic Liver with Ga-PSMA-PET/MRI, secondaryOutcomes measure: Quantification of liver fibrosis with Ga-PSMA-PET/MRI vs. MRI and stand-alone PET, secondaryOutcomes measure: PET/MR protocol in liver cirrhosis, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, status: RECRUITING, city: Charlestown, state: Massachusetts, zip: 02129, country: United States, contacts name: Onforio Catalano, MD, Ph.D, role: CONTACT, phone: 617-724-4030, email: ocatalano@mgh.harvard.edu, contacts name: Diandrea Galloway, role: CONTACT, phone: 617-643-1407, email: dgalloway@mgh.harvard.edu, geoPoint lat: 42.37787, lon: -71.062, hasResults: False