hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06350955, orgStudyIdInfo id: 2022-01389, briefTitle: IV Iron-induced Hypophosphatemia After RYGB, acronym: IVORY, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2026-06, completionDateStruct date: 2026-06, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Lucie Favre, class: OTHER, descriptionModule briefSummary: The primary objective of the study is to compare the incidence of hypophosphatemia in RYGB patients treated with intravenous (IV) single dose of iron isomaltoside (Monofer®) or ferric carboxymaltose (Ferinject®)., conditionsModule conditions: Hypophosphatemia, conditions: Roux-en-Y Gastric Bypass, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 94, type: ESTIMATED, armsInterventionsModule interventions name: Iron isomaltoside, interventions name: Iron Carboxymaltose, outcomesModule primaryOutcomes measure: incidence of hypophosphatemia in RYGB patients treated with intravenous iron, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
protocolSection identificationModule nctId: NCT06350942, orgStudyIdInfo id: 1451_01/BVNTW-VNCSKTE, briefTitle: One Trocar-assisted Retroperitoneoscopic Ureteroureterostomy for Ureteral Duplication, statusModule overallStatus: COMPLETED, startDateStruct date: 2016-09, primaryCompletionDateStruct date: 2020-12, completionDateStruct date: 2024-02, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: National Children's Hospital, Vietnam, class: OTHER, collaborators name: Vinmec Research Institute of Stem Cell and Gene Technology, descriptionModule briefSummary: Ureteral duplication, a common anomaly affecting about 0.8% of the population, presents challenges in pediatric urology due to its diverse clinical presentations and anatomical complexity. Traditional treatments like upper pole moiety (UPM) heminephrectomy can lead to loss of renal function in the remaining lower pole moiety (LPM). Ureteroureterostomy (UU) is a safer alternative, increasingly preferred regardless of renal function or reflux presence. Minimally invasive techniques like laparoscopic and robotic procedures show promise, but robotic-assisted UU is costly, while laparoscopic UU has technical challenges. A novel approach is proposed: single-trocar retroperitoneoscopic-assisted UU, combining laparoscopic visualization advantages with simplified extracorporeal suturing, offering a promising solution for managing complete ureteral duplication. The present study was designed to describe the operative technique and outcome of OTAU in 40 cases of complete ureteral duplication in children., conditionsModule conditions: Ureteral Duplication, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 40, type: ACTUAL, armsInterventionsModule interventions name: one trocar-assisted retroperitoneoscopic ureteroureterostomy (OTAU), outcomesModule primaryOutcomes measure: Mean operating time, primaryOutcomes measure: Intraoperative complications, primaryOutcomes measure: Conversion to open, primaryOutcomes measure: Early postoperative complications, primaryOutcomes measure: Median length of hospital stays, primaryOutcomes measure: Mean UPM renal pelvis' APD, primaryOutcomes measure: Mean SFU of UPM renal pelvis, primaryOutcomes measure: Mean UPM ureter's diameter, primaryOutcomes measure: Mean UPM DRF, primaryOutcomes measure: Mean DRF of operated side, eligibilityModule sex: ALL, minimumAge: 1 Month, maximumAge: 10 Years, stdAges: CHILD, contactsLocationsModule locations facility: The National Hospital of Pediatrics, city: Hanoi, country: Vietnam, geoPoint lat: 21.0245, lon: 105.84117, locations facility: Vinmec Research Institute of Stem Cell and Gene Technology, city: Hanoi, country: Vietnam, geoPoint lat: 21.0245, lon: 105.84117, hasResults: False
protocolSection identificationModule nctId: NCT06350929, orgStudyIdInfo id: RC31/24/0017, briefTitle: Norepinephrine in the Management of General Anesthesia-Induced Arterial Hypotension in Chronic Heart Failure Patients, acronym: NORAFLOW, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2025-05, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: University Hospital, Toulouse, class: OTHER, descriptionModule briefSummary: Arterial hypotension is a frequent complication of general anesthesia and a significant contributor to postoperative complications. It is a critical marker for the development of acute renal failure and postoperative myocardial infarction. Chronic heart failure (CHF) patients are increasingly encountered in the operating room, and their perioperative morbidity and mortality are substantial, with specific management lacking precise recommendations.The main objective is to assess the impact of a diluted norepinephrine bolus on cardiac output in chronic heart failure patients experiencing arterial hypotension after anesthesia induction., conditionsModule conditions: Hypotension, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Cardiac output monitoring by the Starling™ SV Sebac®, outcomesModule primaryOutcomes measure: Evaluation of the impact of a bolus of diluted norepinephrine on cardiac output in chronic heart failure patients presenting with arterial hypotension after anesthetic induction., secondaryOutcomes measure: Evaluation of the role of preload dependence before anesthetic induction in the variation of cardiac output after a norepinephrine bolus., secondaryOutcomes measure: Evaluation of the impact of the norepinephrine bolus on blood pressure correction., secondaryOutcomes measure: Evaluation of the impact of the norepinephrine bolus on heart rate., secondaryOutcomes measure: Evaluation of the safety of use of norepinephrine in chronic heart failure patients during hospitalization., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CHU Toulouse Rangueil, city: Toulouse, zip: 31400, country: France, contacts name: François LABASTE, Dr, role: CONTACT, phone: 0561322822, phoneExt: +33, email: labaste.f@chu-toulouse.fr, geoPoint lat: 43.60426, lon: 1.44367, hasResults: False
protocolSection identificationModule nctId: NCT06350916, orgStudyIdInfo id: IRB00082594, secondaryIdInfos id: LCI-GI-CRC-SEAMLESS-2020, type: OTHER, domain: Atrium Health, briefTitle: Application to Improve Patient Engagement and Decrease Postoperative Opioid Consumption in Patients for Colorectal Surgery, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-01-28, primaryCompletionDateStruct date: 2021-07-30, completionDateStruct date: 2021-10-01, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Wake Forest University Health Sciences, class: OTHER, collaborators name: Atrium Health Levine Cancer Institute, descriptionModule briefSummary: The purpose of this study is to evaluate whether patient-centered educational material delivered before and immediately after surgery can help improve outcomes for patients undergoing colorectal surgery., conditionsModule conditions: Colorectal Surgery, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 75, type: ACTUAL, armsInterventionsModule interventions name: SeamlessMD® Mobile Application, outcomesModule primaryOutcomes measure: Perioperative ERAS metric completion rate, primaryOutcomes measure: Postoperative hospital length of stay, primaryOutcomes measure: Postoperative complications, primaryOutcomes measure: 30-day readmission, secondaryOutcomes measure: Postoperative Opioid Consumption, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Levine Cancer Institute, city: Charlotte, state: North Carolina, zip: 28204, country: United States, geoPoint lat: 35.22709, lon: -80.84313, hasResults: False
protocolSection identificationModule nctId: NCT06350903, orgStudyIdInfo id: ICM 2024-3356, briefTitle: Suppression With Empagliflozin as an Alternative To High-Fat Low-Carbohydrate Diet for Myocardial F-fluorodeoxyglucose Positron Emission Tomography (FDG-PET) Imaging, acronym: SWEET-HEART, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2025-06, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Matthieu Pelletier-Galarneau, MD MSc, class: OTHER, descriptionModule briefSummary: The overall objective of this study is to assess if the empagliflozin has the potential to substitute the high fat low carb (HFLC) diet for the preparation of cardiovascular FDG-PET studies., conditionsModule conditions: Myocardial Suppression, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: Fast + High-fat low-carbohydrate diet, interventions name: Fast + Empagliflozin, outcomesModule primaryOutcomes measure: Levels of serum Beta-hydroxybutyrate (BHB) mmol/L, secondaryOutcomes measure: Proportions of serum Beta-hydroxybutyrate (BHB) >0.5 mmol/L, secondaryOutcomes measure: Proportions of glycemia levels (mmol/L) <3.5 mmol/L, secondaryOutcomes measure: Acceptability and tolerance of each protocol, as reported by patients by a dedicated survey., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06350851, orgStudyIdInfo id: BA161WP1, briefTitle: Development of a New Rapid Diagnostic Test to Support Onchocerciasis Elimination, acronym: Obi1, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Bioaster, class: OTHER, descriptionModule briefSummary: Onchocerciasis, also known as river blindness, is one of the disease targeted for elimination by the World Health Organization (WHO) in the group of Neglected Tropical Diseases. Existing diagnostic tools for onchocerciasis have limitations that make mapping, epidemiological assessments and verification of elimination of onchocerciasis difficult. It is in this context that WHO, in its 2021-2030 roadmap for onchocerciasis, has identified the development of new diagnostic tests, or the improvement of existing diagnostic tests, as a critical condition for achieving the goal of eliminating onchocerciasis transmission.To this end, a series of cross-sectional studies will be carried out in Cameroun over a one year period to collect and characterize biological samples for the development and evaluation of a new rapid diagnostic test for onchocerciasis. The study will target individuals aged 18 and over, mono-infected with one of the filarial species Onchocerca volvulus, Loa loa or Mansonella perstans; and non-infected.At the end of this study, data on the endemicity of onchocerciasis, loiasis and mansonellosis in the selected communities will be updated. More importantly, a new rapid diagnostic test will be developed, which can then be used to monitor the activities of onchocerciasis control programs., conditionsModule conditions: Onchocerciasis, conditions: Loiasis, conditions: Mansonelliasis, conditions: Healthy Volunteers, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule interventions name: Biological samples collection (blood drawing + feces), outcomesModule primaryOutcomes measure: Evaluation of the performance of the prototype diagnostic test, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Higher Institute for Scientific and Medical Research, city: Yaounde, zip: 5797, country: Cameroon, contacts name: Joseph KAMGNO, role: CONTACT, phone: +237 6 75 06 91 58, email: contact@ismcm.org, contacts name: Joseph KAMGNO, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 3.86667, lon: 11.51667, hasResults: False
protocolSection identificationModule nctId: NCT06350825, orgStudyIdInfo id: 2023-SR-543, briefTitle: Cytoreductive Prostatectomy Combined With Triple or Dual Systemic Therapy in mHSPC Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2016-01-01, primaryCompletionDateStruct date: 2027-12-31, completionDateStruct date: 2028-12-31, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: The First Affiliated Hospital with Nanjing Medical University, class: OTHER, descriptionModule briefSummary: To evaluate: The radiographic progression-free survival (rPFS) of metastatic hormone-sensitive prostate cancer (mHSPC) patients treated with androgen deprivation therapy (ADT) + second-generation antiandrogens±chemotherapy combined with cytoreductive prostatectomy (CRP), conditionsModule conditions: Metastatic Prostate Cancer, conditions: Therapy, Directly Observed, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: randomized control, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Cytoreductive prostatectomy or brachytherapy, interventions name: ADT+second-generation antiandrogens ± chemotherapy, outcomesModule primaryOutcomes measure: rPFS, secondaryOutcomes measure: Safety of CRP in mHSPC patients, eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The First Affiliated Hospital of Nanjing Medical University, status: RECRUITING, city: Nanjing, state: Jiangsu, zip: 210029, country: China, contacts name: Shangqian Wang, M.D., role: CONTACT, phone: 13770561625, email: wsq5501@126.com, contacts name: Lixin Hua, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.06167, lon: 118.77778, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_ICF, hasProtocol: True, hasSap: False, hasIcf: True, label: Study Protocol and Informed Consent Form, date: 2024-03-20, uploadDate: 2024-03-20T11:18, filename: Prot_ICF_000.pdf, size: 125657, hasResults: False
protocolSection identificationModule nctId: NCT06350812, orgStudyIdInfo id: PB119110, briefTitle: A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PB-119 Injection in Chinese Obese Subjects, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-30, primaryCompletionDateStruct date: 2025-04-29, completionDateStruct date: 2025-04-29, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: PegBio Co., Ltd., class: OTHER, descriptionModule briefSummary: The trial is conducted in a single-center, randomized, double-blind, placebocontrolled, dose-increasing design. To evaluate the safety, tolerability, PK characteristics, efficacy and immunogenicity of PB-119 injection in Chinese obese subjects., conditionsModule conditions: Obesity, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 32, type: ESTIMATED, armsInterventionsModule interventions name: PB-119, interventions name: Placebo, outcomesModule primaryOutcomes measure: Incidence of Treatment-Emergent Adverse Events, secondaryOutcomes measure: Pharmacokinetic profile, secondaryOutcomes measure: Pharmacokinetic profile, secondaryOutcomes measure: Pharmacokinetic profile, secondaryOutcomes measure: Pharmacokinetic profile, secondaryOutcomes measure: Effectiveness index, secondaryOutcomes measure: Effectiveness index, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06350799, orgStudyIdInfo id: 01741, briefTitle: Chronic Obstructive Pulmonary Disease and Community Health Worker Home-visits, statusModule overallStatus: COMPLETED, startDateStruct date: 2019-03-14, primaryCompletionDateStruct date: 2021-05-27, completionDateStruct date: 2023-04-28, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: VA Puget Sound Health Care System, class: FED, collaborators name: Public Health - Seattle and King County, collaborators name: University of Washington, descriptionModule briefSummary: We examined a Community Health Worker (CHW) program for Chronic Obstructive Pulmonary Disease (COPD) in Veteran Participants. The goal of this study was to assess participants' perceived acceptability, appropriateness, and feasibility of the intervention, explore participants' COPD health outcomes, and gather insights from participants and CHWs to inform potential improvements.Veteran participants enrolled in the 12-week intervention and received a series of 9 CHW home, phone, or video visits. These visits provided education and chronic disease self-management practices to improve COPD health.Researchers examined the participant and CHW perception of the intervention through qualitative interviews and surveys., conditionsModule conditions: COPD, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 9, type: ACTUAL, outcomesModule primaryOutcomes measure: Acceptability, Appropriateness, Feasibility, eligibilityModule sex: ALL, minimumAge: 45 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: VA Puget Sound Health Care System, city: Seattle, state: Washington, zip: 98108, country: United States, geoPoint lat: 47.60621, lon: -122.33207, hasResults: False
protocolSection identificationModule nctId: NCT06350786, orgStudyIdInfo id: ROM Study, secondaryIdInfos id: PZ00P1_201972, type: OTHER_GRANT, domain: Swiss National Science Foundation, briefTitle: Conditioned Open-label Placebos to Facilitate Opioid Reduction in Patients With Chronic Non-cancer Pain, acronym: ROM, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2025-07, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Cosima Locher, class: OTHER, collaborators name: Brown University, collaborators name: University of Basel, descriptionModule briefSummary: This study aims to evaluate whether the reduction of the daily morphine equivalent dose (MED) in patients with chronic non-cancer pain (CNCP) can be decreased with an open-label placebo (OLP) intervention in comparison to an electronic monitoring (EM) control group. The participants will receive the intervention (OPL or EM) over the duration of six weeks. Diverse psychological and health measures will be assessed with questionnaires over the course of the intervention. Furthermore, evaluation outcomes, qualitative outcomes and safety outcomes will be assessed. It is hypothesized that the OLP-intervention group in comparison to the EM-control group will have a significantly lower consumption of MED over the course of the study. Furthermore, this study aims to evaluate whether the OLP intervention can reduce opioid withdrawal symptoms in comparison to the control group., conditionsModule conditions: Chronic Non-cancer Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 86, type: ESTIMATED, armsInterventionsModule interventions name: P-Dragees blue Lichtenstein, Placebo dragees, interventions name: Control group (EM), outcomesModule primaryOutcomes measure: Daily opioid consumption (MED):, secondaryOutcomes measure: Subjective opioid withdrawal symptoms, secondaryOutcomes measure: Pain severity, secondaryOutcomes measure: Pain disability, secondaryOutcomes measure: Anxiety, secondaryOutcomes measure: Depression, secondaryOutcomes measure: Pain Opioid Analgesics Beliefs Scale - Cancer, secondaryOutcomes measure: Treatment Expectancy, secondaryOutcomes measure: Placebo pill count, secondaryOutcomes measure: Opioid adherence, otherOutcomes measure: Rationale credibility, otherOutcomes measure: Placebo understanding, otherOutcomes measure: Patient Provider Connection, otherOutcomes measure: Medication history, otherOutcomes measure: Primary treating physicians' acceptability of the OLP approach:, otherOutcomes measure: Primary treating physicians' treatment expectancies, otherOutcomes measure: Qualitative Outcomes, otherOutcomes measure: Safety Outcomes, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False