hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06367465, orgStudyIdInfo id: 202308056, briefTitle: Feasibility and Acceptability of HCV Treatment in Pregnancy, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2026-02-28, completionDateStruct date: 2026-02-28, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Washington University School of Medicine, class: OTHER, descriptionModule briefSummary: Pregnant adults over the age of 18 who are seen in the Washington University obstetrics and gynecology, maternal fetal medicine or infectious diseases clinic or admitted to BJH with hepatitis C virus infection who have a history of past or current drug useParticipant Duration: Approximately 1 year.Aims:Aim 1 - Evaluate adherence and treatment completion rates when glecaprevir-pibrentasvir is started during pregnancy for women who use drugs.Aim 2 - Evaluate patient experience with hepatitis C virus treatment during pregnancy., conditionsModule conditions: Hepatitis C, conditions: Pregnancy Complications, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Glecaprevir-pibrentasvir, outcomesModule primaryOutcomes measure: Medication adherence and treatment completion rates., secondaryOutcomes measure: Patient satisfaction Questionnaire, secondaryOutcomes measure: Virologic outcome and clinical success at Day 28 post treatment, secondaryOutcomes measure: Sample size estimation for future study, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Barnes Jewish Hospital, status: RECRUITING, city: Saint Louis, state: Missouri, zip: 63110, country: United States, contacts name: Tracey Bach, role: CONTACT, phone: 314-273-6075, email: habrockt@wustl.edu, contacts name: Laura Marks, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.62727, lon: -90.19789, locations facility: Washington Univeristy, status: RECRUITING, city: Saint Louis, state: Missouri, zip: 63110, country: United States, contacts name: Laura Marks, MD,PhD, role: CONTACT, email: marks@wustl.edu, contacts name: Tracey Habrock-Bach, MBA, role: CONTACT, phone: 314-273-6075, email: habrockt@wustl.edu, geoPoint lat: 38.62727, lon: -90.19789, hasResults: False
protocolSection identificationModule nctId: NCT06367452, orgStudyIdInfo id: CAEP 107.001.23, briefTitle: Exploratory Pilot Study to Evaluate the Pharmacokinetic Profile of Magaldrate, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-10-31, primaryCompletionDateStruct date: 2024-01-15, completionDateStruct date: 2024-03-30, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Tecnoquimicas, class: INDUSTRY, descriptionModule briefSummary: The goal of this clinical pilot study is to evaluate the pharmacokinetic profile of magaldrate in a group of 10 healthy women, after the administration of a 10 mL drug suspension containing 500 mg of sodium alginate, 267 mg of sodium bicarbonate, 800 mg of magaldrate and 120 mg of simeticone. The main question it aims to answer is the amount of magnesium and/or aluminum, if any, absorbed into the plasma from this oral administration.Participants will take the medication 30 minutes after a standard breakfast. Both groups of participants will take the standard meal but one group will take the medication and the other one won't.Researchers will compare the levels of both ions in plasma in a group to see if there is any absorption, quantifying the basal plasma levels and comparing with the levels obtained after the meal and the medication, when it applies., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ACTUAL, armsInterventionsModule interventions name: Sodium alginate + sodium bicarbonate + magaldrate + simeticone, outcomesModule primaryOutcomes measure: Cmax for Aluminum, primaryOutcomes measure: AUC for Aluminum, primaryOutcomes measure: Cmax for Magnesium, primaryOutcomes measure: AUC for Magnesium, secondaryOutcomes measure: Amount of aluminum ions absorbed after drug administration vs amount provided by food, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: CAEP, city: Campinas, state: Sao Paulo, zip: 13087-567, country: Brazil, geoPoint lat: -22.90556, lon: -47.06083, hasResults: False
protocolSection identificationModule nctId: NCT06367400, orgStudyIdInfo id: SwePSQ, briefTitle: Validation of Pediatric Sleep Questionnaire on a Swedish Cohort, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2034-12-31, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Uppsala University, class: OTHER, collaborators name: Karolinska Institutet, collaborators name: Örebro University, Sweden, collaborators name: Umeå University, collaborators name: Göteborg University, descriptionModule briefSummary: This study is aimed to validate the questionnaire called Pediatric Sleep Questionnaire on a Swedish cohort of children from 18 months to 15 years old with obstructive sleep disordered breathing., conditionsModule conditions: Obstructive Sleep Apnea, conditions: Sleep Disorder, conditions: Sleep Disorders in Children, conditions: Obstructive Sleep Apnea of Child, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 520, type: ESTIMATED, armsInterventionsModule interventions name: Pediatric Sleep Questionnaire, outcomesModule primaryOutcomes measure: Level of baseline PSQ, primaryOutcomes measure: Changes of baseline PSQ after treatment, secondaryOutcomes measure: PSQ vs OSA-18, secondaryOutcomes measure: PSQ vs. PSG, secondaryOutcomes measure: PSQ levels of healthy controls vs children with OSDB, otherOutcomes measure: 5 and 10 years follow-up, eligibilityModule sex: ALL, minimumAge: 18 Months, maximumAge: 15 Years, stdAges: CHILD, contactsLocationsModule locations facility: Akademiska hospital, status: RECRUITING, city: Uppsala, country: Sweden, contacts name: Isabella Sjölander, role: CONTACT, phone: 018-6110000, email: isabella.sjolander@uu.se, geoPoint lat: 59.85882, lon: 17.63889, hasResults: False
protocolSection identificationModule nctId: NCT06367374, orgStudyIdInfo id: BGB-11417-2002-IIT；BDH-CLL-004, briefTitle: MRD Guided Sonrotoclax and Zanubrutinib in Newly Diagnosed CLL/SLL, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-30, primaryCompletionDateStruct date: 2030-02-28, completionDateStruct date: 2030-07-30, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Institute of Hematology & Blood Diseases Hospital, China, class: OTHER, descriptionModule briefSummary: This is a single-arm, open-label study of sonrotoclax plus zanubrutinib with MRD-driven treatment duration in patients with previously untreated Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL).The primary goal of this study is to evaluate the efficacy of MRD-guided zanubrutinib plus sonrotoclax for first-line CLL/SLL treatment., conditionsModule conditions: Chronic Lymphocytic Leukemia, conditions: Small Lymphocytic Lymphoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 66, type: ESTIMATED, armsInterventionsModule interventions name: Sonrotoclax, interventions name: Zanubrutinib, outcomesModule primaryOutcomes measure: 4-Year Progressive Free Survival (PFS) Rate, secondaryOutcomes measure: Rate of peripheral blood (PB) and Bone marrow (BM) undetectable minimal residual disease (uMRD), secondaryOutcomes measure: Complete Response Rate (CRR; Complete Response/Complete Response with Incomplete Blood Count Recovery [CR/CRi]) Rate, secondaryOutcomes measure: Overall Response Rate (ORR), secondaryOutcomes measure: Duration of Response (DOR), secondaryOutcomes measure: Progression Free Survival (PFS), secondaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: Time to Next Therapy (TTNT), secondaryOutcomes measure: Overall survival rate, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06367335, orgStudyIdInfo id: ETIC, briefTitle: Characteristics and Predictors of Liver Injury in Cyclin-dependent Kinase Inhibitors 4/6 (CDK4/6)-Treated Patients With Advanced Breast Cancer, acronym: ETIC, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-06-01, primaryCompletionDateStruct date: 2022-09-01, completionDateStruct date: 2022-12-31, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: University of Milano Bicocca, class: OTHER, descriptionModule briefSummary: The main objective of the study is to evaluate the presence of predictors (single characteristics at the baseline and / or a combination of two or more parameters) useful for predicting the development of Drug-Induced liver Injury (DILI) during treatment with cyclin-dependent kinase inhibitors (CKI) with the possibility of obtaining a pre-treatment prognostic score that can assist the clinician in pre-therapy decision making., conditionsModule conditions: DILI, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 128, type: ACTUAL, armsInterventionsModule interventions name: Ribociclib, palbociclib, abemaciclib, outcomesModule primaryOutcomes measure: Incidence of DILI, secondaryOutcomes measure: withdrawal of therapy, secondaryOutcomes measure: delayed reprise of antineoplastic therapy, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Milano-Bicocca,, city: Monza, zip: 20900, country: Italy, geoPoint lat: 45.58005, lon: 9.27246, hasResults: False
protocolSection identificationModule nctId: NCT06367322, orgStudyIdInfo id: EMP-PARA-20170-01, briefTitle: Statins and Post-ERCP Acute Pancreatitis (Stark Project), acronym: Stark, statusModule overallStatus: COMPLETED, startDateStruct date: 2017-01-10, primaryCompletionDateStruct date: 2018-07-31, completionDateStruct date: 2018-09-30, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Hospital General Universitario de Alicante, class: OTHER, collaborators name: European Pancreatic Club (EPC), Pancreas 2000 Educational Program, descriptionModule briefSummary: Post-endoscopic retrograde cholangiopancrepatography (ERCP) acute pancreatitis (PEAP) is a frequent complication of this endoscopic procedure. Chronic statin intake has been linked to lower incidence and severity of acute pancreatitis (AP). Periprocedural rectal administration of non-steroidal anti-inflammatory drugs is protective against PEP, but the role of chronic acetylsalicylic acid (ASA) treatment is unclear. The aim of the study is to investigate whether statins and chronic ASA intake are associated with lower risk of PEAP., conditionsModule conditions: Post-ERCP Acute Pancreatitis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 1016, type: ACTUAL, armsInterventionsModule interventions name: Statin, outcomesModule primaryOutcomes measure: To assess the incidence and relative risk of PEAP according to statin use., secondaryOutcomes measure: To assess the effect of chronic use of other drugs on the incidence and relative risk of PEAP., secondaryOutcomes measure: To assess the effect of other factors (demographic and endoscopic) on the incidence and relative risk of PEAP and severity of PEAP (severity according to the Revised Atlanta Classification)., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Alicante, city: Alicante, zip: 03010, country: Spain, geoPoint lat: 38.34517, lon: -0.48149, locations facility: Hospital General Universitario de Alicante, city: Alicante, zip: 03010, country: Spain, geoPoint lat: 38.34517, lon: -0.48149, hasResults: False
protocolSection identificationModule nctId: NCT06367309, orgStudyIdInfo id: 2023 - 02357, briefTitle: ExtrAperitoneaL Plasty vs Intraperitoneal oNlay mEsh in Ventral Hernia Repair, acronym: ALPINE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2030-12-31, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: University Hospital, Basel, Switzerland, class: OTHER, collaborators name: St. Clara Hospital, Basel, Switzerland, collaborators name: Innklinikum Altötting, Germany, descriptionModule briefSummary: This study investigates on the effect of two different operative techniques to treat abdominal wall hernias.The goal of this clinical trial is to learn if the eTEP (Extended totally extraperitoneal repair) technique leads to a better outcome than the IPOM (Intraperitoneal onlay mesh) technique.The main questions it aims to answer are:* pain after the operation* rate of complications* rate of recurrence and reoperations* quality of life.Participants will:Either be operated using the eTEP or the IPOM technique. Be followed up either in person or via email / phone call at day 1, day 7, day 14, 6 weeks, 6 months, 1, 3 and 5 years after the surgery to asses the above-stated main and some more outcomes., conditionsModule conditions: Ventral Hernia, conditions: Abdominal Wall Defect, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: The trial participants and the assessors (trained investigators not involved in the operative procedures) of the primary outcome are blinded regarding the performed procedure during the first seven days after the procedure to reduce bias. The blinding is guaranteed by not sharing the detailed operation report with anyone involved in the aftercare of the patient or in the assessment of study outcomes., whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 138, type: ESTIMATED, armsInterventionsModule interventions name: Extended totally extraperitoneal repair, interventions name: Intraperitoneal onlay mesh, outcomesModule primaryOutcomes measure: primary outcome: pain numeric rating scale (NRS), primaryOutcomes measure: pain outcome using the Patient-Reported Outcome Measurement Information System (PROMIS) Pain Intensity Short Form 3a, secondaryOutcomes measure: pain mid-term, secondaryOutcomes measure: recurrence and reoperation, secondaryOutcomes measure: LOS, secondaryOutcomes measure: Functional recovery, secondaryOutcomes measure: Adverse events, secondaryOutcomes measure: Quality of life (SF 12), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: St. Clara Hospital, city: Basel, state: Basel-Stadt, zip: 4058, country: Switzerland, contacts name: Fiorenzo Angehrn, MD, role: CONTACT, email: fiorenzo.angehrn@clarunis.ch, geoPoint lat: 47.55839, lon: 7.57327, hasResults: False
protocolSection identificationModule nctId: NCT06367283, orgStudyIdInfo id: 2023-509181-38-00, briefTitle: Metformin Treatment of Patients With Hand Osteoarthritis, acronym: METRO, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2026-04, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Marius Henriksen, class: OTHER, descriptionModule briefSummary: To compare metformin (2 g daily), or maximum tolerated dose, for 16 weeks with placebo as a treatment of hand osteoarthritis symptoms., conditionsModule conditions: Hand Osteoarthritis, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Metformin, interventions name: Placebo, outcomesModule primaryOutcomes measure: Finger pain, secondaryOutcomes measure: Function, secondaryOutcomes measure: Thumb base pain, secondaryOutcomes measure: Hand pain, secondaryOutcomes measure: Physician tender joint count, secondaryOutcomes measure: Patient global assessment, secondaryOutcomes measure: Quality of life assessed by the European Quality of life - 5 dimensions (EQ-5D) scale, secondaryOutcomes measure: Hand strength, secondaryOutcomes measure: Number of treatment responders, otherOutcomes measure: Stiffness of both hands, otherOutcomes measure: Composite of pain, function and stiffness, otherOutcomes measure: Physical function, otherOutcomes measure: Physician global assessment, otherOutcomes measure: Swollen joint count, otherOutcomes measure: Fatigue, otherOutcomes measure: Sleep quality, otherOutcomes measure: Absence or presence of inflammation of target hand, otherOutcomes measure: Change in use of analgesics, otherOutcomes measure: Inflammatory biomarker, otherOutcomes measure: Metabolic outcomes, otherOutcomes measure: Metabolic outcomes, otherOutcomes measure: Vitamin K, otherOutcomes measure: Proteomics, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Parker Institute, Bispebjerg and Frederiksberg hospital, city: Copenhagen, state: Frederiksberg, zip: 2000, country: Denmark, contacts name: Kasper Staberg Madsen, MD, role: CONTACT, phone: +4538164162, email: kasperstabergmadsen@regionh.dk, geoPoint lat: 55.67594, lon: 12.56553, hasResults: False
protocolSection identificationModule nctId: NCT06367257, orgStudyIdInfo id: Emento App, briefTitle: App-based Recording and Optimization of the Nutritional Status in Patients With Head and Neck Tumors During and After Radio(Chemo)Therapy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-04-30, completionDateStruct date: 2026-06-30, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: University of Erlangen-Nürnberg Medical School, class: OTHER, descriptionModule briefSummary: Patients with head and neck cancer requiring definitive or adjuvant radio(chemo)therapy can take part in the study. The aim is to record the nutritional status and diet of the patients during the trial and regularly at a period of 8 weeks after irradiation and to reduce the rate of weight loss and malnutrition., conditionsModule conditions: Squamous Cell Carcinoma of Head and Neck, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 148, type: ESTIMATED, armsInterventionsModule interventions name: App Usage, interventions name: Standard of Care, outcomesModule primaryOutcomes measure: Change in rates of weight loss with additional app-based Patient Care, secondaryOutcomes measure: Frequency of deteriorations in health status subjectively reported by patients and recorded via the app., secondaryOutcomes measure: Frequency of additional app-triggered contacts of the clinic with the patients, secondaryOutcomes measure: Frequency of critical health conditions (physician-verified) detected earlier by the app., secondaryOutcomes measure: Change in quality of life measured per questionnaires, secondaryOutcomes measure: Change of incidence of malnutrition and sarcopenia before, during and after radio(chemo)therapy., secondaryOutcomes measure: Change of course of malnutrition and sarcopenia before, during and after radio(chemo)therapy., secondaryOutcomes measure: Rate of therapy interruptions/discontinuations, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Disease-free/progression-free survival, secondaryOutcomes measure: Change of Loco-regional tumor control, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Universitätsklinikum Erlangen, Strahlenklinik, city: Erlangen, state: Bavaria, zip: 91054, country: Germany, contacts name: Marlen Haderlein, PD, role: CONTACT, phone: +49913185, phoneExt: 33968, email: marlen.haderlein@uk-erlangen.de, contacts name: Studiensekretariat, role: CONTACT, phone: +49913185, phoneExt: 33968, email: studiensekretariat.ST@uk-erlangen.de, contacts name: Allison Lamrani, role: PRINCIPAL_INVESTIGATOR, contacts name: Charlotte Schmitter, Dr., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 49.59099, lon: 11.00783, hasResults: False