hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06336733, orgStudyIdInfo id: APHP220828, briefTitle: Randomized Controlled Trial in Patients on Long-term Colchicine With Colchicine-resistant Familial Mediterranean Fever (FMF) to Evaluate the Efficacy of On-demand Anakinra Treatment for Painful Attacks in Patients Who Refuse Continuous Daily Therapy, acronym: KIN-ATTACK-FMF, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2026-03-03, completionDateStruct date: 2026-09-15, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Assistance Publique - Hôpitaux de Paris, class: OTHER, descriptionModule briefSummary: To evaluate the efficacy on clinical symptoms in case of FMF attack among FMF patients resistant to Colchicine of* on demand anakinra treatment (100 mg/d from the prodromal phase of the attack until 24 hours of remission (during 7 days maximum) associated with daily colchicine.* compared to analgesic associated with daily colchicine in patients refusing continuous anti-IL-1 treatment., conditionsModule conditions: FMF, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: ANAKINRA, outcomesModule primaryOutcomes measure: Mean number of FMF-attacks per month at 6 months of treatment., secondaryOutcomes measure: Cumulative days of FMF attack treatment, secondaryOutcomes measure: AIDAI (Auto-inflammatory Diseases activity index) score, secondaryOutcomes measure: Number of painful days and severity of FMF attacks occurring between randomization and M6, secondaryOutcomes measure: Quality of life score measured by EuroQOL questionnaire (EQ-5D5L), secondaryOutcomes measure: Number of local cutaneous reactions at 6 months (erythema and oedema involving the injection sites) in the anakinra arm, secondaryOutcomes measure: Proportion of Adverse events, eligibilityModule sex: ALL, minimumAge: 6 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Service de Médecine interne Hopital Tenon, city: Paris, zip: 75020, country: France, contacts name: Léa SAVEY, role: CONTACT, phone: 00 33 1 56 01 60 77, email: lea.savey@aphp.fr, contacts name: Sophie Georgin-Lavialle, MD,PHD, role: CONTACT, phone: 0 33 1 56 01 74 31, email: sophie.georgin-lavialle@aphp.fr, geoPoint lat: 48.85341, lon: 2.3488, hasResults: False
protocolSection identificationModule nctId: NCT06336720, orgStudyIdInfo id: HMI-SA-PoNS-STK001, briefTitle: PoNS® Therapy for Gait and Balance Deficits in Chronic Stroke Survivors: A Single-Arm Study, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-04-30, completionDateStruct date: 2025-08-30, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Helius Medical Inc, class: INDUSTRY, descriptionModule briefSummary: Primary Objective: To further evaluate the aspects of safety related to PoNS therapy in chronic stroke survivors.Secondary Objectives: To further evaluate the efficacy of PoNS on improving dynamic gait and balance, establishing durability of effect, risk of falling and fall rate. As well as adherence to PoNS device utilization.Exploratory Objectives: To further evaluate quality of life to measure physical, mental, behavioral, and general health, as well as functional decline (\> 30% on gait or balance improvement at endpoint) during the 12-week follow-up., conditionsModule conditions: Chronic Stroke Survivors, designModule studyType: INTERVENTIONAL, phases: PHASE2, phases: PHASE3, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Portable Neuromodulation Stimulator (PoNS), outcomesModule primaryOutcomes measure: Primary safety endpoints, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Brooks Rehabilitation, status: RECRUITING, city: Jacksonville, state: Florida, zip: 32216, country: United States, contacts name: Mark Bowden, PhD. PT, role: CONTACT, phone: 904-345-6626, email: Mark.Bowden@Brooksrehab.org, geoPoint lat: 30.33218, lon: -81.65565, locations facility: Shepherd Center, status: RECRUITING, city: Atlanta, state: Georgia, zip: 30309, country: United States, contacts name: Cathy Furbish, PT, DPT, CCRP, role: CONTACT, phone: 404-350-7591, email: cathy.furbish@shepherd.org, geoPoint lat: 33.749, lon: -84.38798, locations facility: Neurology Center of New England, P.C., status: RECRUITING, city: Foxboro, state: Massachusetts, zip: 02035, country: United States, contacts name: Rachel O'Donnell, role: CONTACT, phone: 781-551-5812, phoneExt: 101, email: rodonnell@myneurodr.com, contacts name: MD, role: CONTACT, geoPoint lat: 42.06538, lon: -71.24783, locations facility: Rehabologym Corp, status: RECRUITING, city: Tarrytown, state: New York, zip: 10591, country: United States, contacts name: Avrielle Peltz, MA OTR/L, role: CONTACT, phone: 914-603-8600, email: avrielle.peltz@rehabologym.com, geoPoint lat: 41.07621, lon: -73.85875, hasResults: False
protocolSection identificationModule nctId: NCT06336707, orgStudyIdInfo id: HS-20089-103, briefTitle: HS-20089 Combination Treatment in Subjects With Advanced Solid Tumors, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-08, primaryCompletionDateStruct date: 2026-04-08, completionDateStruct date: 2028-04-08, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Hansoh BioMedical R&D Company, class: INDUSTRY, descriptionModule briefSummary: HS-20089 is an investigational antibody-drug conjugate (ADC) composed of a humanized IgG1 anti-B7-H4 monoclonal antibody conjugated to the topoisomerase I inhibitor payload via a protease-cleavable linker, with an average drug-to-antibody ratio of about 6.This is a phase Ⅰ, open-label, multi-center study to evaluate the safety, tolerability, pharmacokinetics (PK) and efficacy of HS-20089 in combination with other antitumor agents (Adebrelimab with or without platinum; Bevacizumab with or without platinum) in subjects with advanced solid tumors., conditionsModule conditions: Advanced Solid Tumors, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 1048, type: ESTIMATED, armsInterventionsModule interventions name: HS-20089, interventions name: Adebrelimab, interventions name: Bevacizumab, interventions name: Cisplatin / carboplatin, outcomesModule primaryOutcomes measure: Maximum tolerated dose (MTD) or maximum applicable dose (MAD) of HS-20089 in combination therapy, secondaryOutcomes measure: Incidence and severity of adverse events (AEs), secondaryOutcomes measure: Observed maximum plasma concentration (Cmax) of HS-20089, secondaryOutcomes measure: Time to reach maximum plasma concentration (Tmax) of HS-20089 following the first dose, secondaryOutcomes measure: Area under plasma concentration versus time curve from zero to last sampling time (AUC0-t) following the first dose of HS-20089, secondaryOutcomes measure: Area under the plasma concentration versus time curve from time zero to infinity (AUC0-∞) after single dose of HS-20089, secondaryOutcomes measure: Objective response rate (ORR) assessed by investigators according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, secondaryOutcomes measure: Duration of response (DoR) assessed by investigators according to RECIST 1.1, secondaryOutcomes measure: Disease control rate (DCR) assessed by investigators according to RECIST 1.1, secondaryOutcomes measure: Progression-free survival (PFS) assessed by investigators according to RECIST 1.1, secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Percentage of participants with antibodies to HS-20089 in serum, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
protocolSection identificationModule nctId: NCT06336694, orgStudyIdInfo id: SYSUFAH2021-025, briefTitle: A Deep Learning Radiomics Model for Predicting Occult Peritoneal Metastases of Pancreatic Adenocarcinoma, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-01-01, primaryCompletionDateStruct date: 2022-10-31, completionDateStruct date: 2023-07-30, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: First Affiliated Hospital, Sun Yat-Sen University, class: OTHER, descriptionModule briefSummary: Occult peritoneal metastases (OPM) in patients with pancreatic ductal adenocarcinoma (PDAC) are frequently overlooked during imaging. We aimed to develop and validate a CT-based deep learning-based radiomics (DLR) model with clinical-radiological characteristics to identify OPM in patients with PDAC before treatment., conditionsModule conditions: Pancreatic Neoplasms, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 302, type: ACTUAL, armsInterventionsModule interventions name: surgery or diagnostic staging laparoscopy, outcomesModule primaryOutcomes measure: diagnosed with peritoneal metastases, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Shi Siya, city: Guangzhou, state: Guangdong, zip: 510000, country: China, geoPoint lat: 23.11667, lon: 113.25, hasResults: False
protocolSection identificationModule nctId: NCT06336681, orgStudyIdInfo id: #12966, briefTitle: Inspiratory Muscle Training on The Severity of Exercise-Induced Bronchoconstriction and Time-Trial Performance (IMT_EIB), acronym: IMT_EIB, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-02-10, primaryCompletionDateStruct date: 2025-08, completionDateStruct date: 2025-08, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Indiana University, class: OTHER, descriptionModule briefSummary: Due to the lack of studies examining the impact of inspiratory muscle training (IMT) on the severity of exercise-induced bronchoconstriction (EIB) and exercise performance, the specific aim of this study is to assess the efficacy of flow-resistive IMT on EIB severity and symptoms, short-acting beta-2-agonist medication use, operating lung volumes, respiratory and limb locomotor muscle deoxygenation during constant-load cycling exercise, exertional dyspnea, and cycling time-trial performance., conditionsModule conditions: Exercise Induced Bronchospasm, conditions: Exercise Induced Asthma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: PrO2Fit Device, outcomesModule primaryOutcomes measure: Exercise-Induced Bronchoconstriction (EIB) Severity, primaryOutcomes measure: Maximum Inspiratory Pressure and Sustained Maximum Inspiratory Pressure, primaryOutcomes measure: 16-km Cycling Time-Trial Time to Completion, primaryOutcomes measure: 16-km Cycling Time-Trial Power Output, primaryOutcomes measure: Constant Load Performance, secondaryOutcomes measure: Perception of Breathing Intensity and Unpleasantness and Leg Fatigue, secondaryOutcomes measure: Deoxygenation of the respiratory and limb locomotor muscles by near-infrared spectroscopy, secondaryOutcomes measure: Femoral blood flow (FBF) of the limb locomotor muscles by ultrasound, secondaryOutcomes measure: Lung Volumes, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: School of Public Health-Bloomington, status: RECRUITING, city: Bloomington, state: Indiana, zip: 47405, country: United States, contacts name: Tim Mickleborough, Ph.D., role: CONTACT, phone: 812-855-0753, email: tmickleb@indiana.edu, geoPoint lat: 39.16533, lon: -86.52639, hasResults: False
protocolSection identificationModule nctId: NCT06336668, orgStudyIdInfo id: REB23-1283, briefTitle: Source of Human Milk Fortifier and Intestinal Oxygenation in Preterm Infants <30 Weeks Gestation, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-02-28, completionDateStruct date: 2026-02-28, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: University of Calgary, class: OTHER, descriptionModule briefSummary: Preterm infants require higher nutritional intakes during the neonatal phase than they do at any other stage of their development. Standard volumes of human milk alone do not offer sufficient nourishment to these infants. There are multiple options for fortifying human milk, which vary depending on whether the fortifier is derived from bovine sources (B-HMF) or human sources (H-HMF). Fortifying human milk has been proven to enhance growth in preterm infants without raising the risk of necrotizing enterocolitis (NEC), though it could potentially affect feeding tolerance. Changes in blood flow and oxygen levels in the intestines are commonly observed in infants experiencing feeding intolerance. Research indicates that feeding a mother's own milk (MOM) doesn't affect splanchnic (intestinal) oxygenation, whereas it decreases when feeding bovine-derived human milk fortifiers (B-HMF) or preterm formula, indicating greater oxygen requirements in the intestines of preterm infants fed these alternatives.The goal of this clinical trial is to compare the effect of H-HMF and B-HMF on splanchnic oxygenation in infants less than 30 weeks., conditionsModule conditions: Feeding; Difficult, Newborn, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Prospective randomized-controlled crossover trial comparing 2 different HMFs and 2 intestinal rSO2S periods in random order: 6 hours while on B-HMF and 6 hours on H-HMF with at least 6 hours washing period, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: SINGLE, maskingDescription: Randomizing the participants to either Bovine-HMF or Human Milk based-HMF will mask the Investigator, whoMasked: INVESTIGATOR, enrollmentInfo count: 18, type: ESTIMATED, armsInterventionsModule interventions name: Human milk-based HMF, outcomesModule primaryOutcomes measure: Change in Splanchnic regional oxygenation(rSO2S) measured by Near Infrared Spectroscopy, secondaryOutcomes measure: Changes in SMA doppler peak flow velocity (PSV), secondaryOutcomes measure: Changes in SMA doppler end-diastolic velocity (EDV), secondaryOutcomes measure: Changes in SMA doppler Porcelout's resistance index (RI), eligibilityModule sex: ALL, maximumAge: 30 Weeks, stdAges: CHILD, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06336655, orgStudyIdInfo id: 153309, briefTitle: Physiology of Unloading VA ECMO Trial, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2028-02-01, completionDateStruct date: 2029-02-01, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: University of Utah, class: OTHER, collaborators name: University of Minnesota, descriptionModule briefSummary: The goal of this clinical trial is to compare the use of veno-arterial extracorporeal membrane oxygenation (VA ECMO) with and without left ventricular (LV) unloading in patients being treated for non-postoperative cardiogenic shock (CS). The main aims of the study are:1. To determine the physiologic effects on cardiopulmonary congestion of adding LV unloading to VA ECMO2. To determine the effects on myocardial function of adding LV unloading to ECMO3. To test the effects on myocardial recovery of adding LV unloading to VA ECMOParticipants who are being treated with VA ECMO will be randomized to receive or not receive LV unloading in the form of an intra-aortic balloon pump (IABP). Over the course of the study, the investigators will obtain measurements via lab work, echocardiography, and pulmonary artery catheter that will allow comparison of the two groups., conditionsModule conditions: Cardiogenic Shock, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 104, type: ESTIMATED, armsInterventionsModule interventions name: IABP, outcomesModule primaryOutcomes measure: Change in pulmonary capillary wedge pressure, secondaryOutcomes measure: Change in pulmonary artery diastolic pressure, secondaryOutcomes measure: Change in left ventricular end diastolic diameter, secondaryOutcomes measure: Change in N-terminal pro b-type natriuretic peptide, secondaryOutcomes measure: Hemodynamic stability, secondaryOutcomes measure: Global cardiovascular function, secondaryOutcomes measure: Difference in partial pressure of carbon dioxide (pCO2), secondaryOutcomes measure: Lactate, secondaryOutcomes measure: Cardiac BIN1, secondaryOutcomes measure: Troponin I, secondaryOutcomes measure: Tumor necrosis factor alpha, secondaryOutcomes measure: Ejection fraction percentage, secondaryOutcomes measure: Interferon gamma, secondaryOutcomes measure: Limb ischemia, secondaryOutcomes measure: Mortality, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Utah, status: RECRUITING, city: Salt Lake City, state: Utah, zip: 84132, country: United States, contacts name: Joseph E. Tonna, MD, FAAEM, role: CONTACT, phone: 801-587-9373, email: joseph.tonna@hsc.utah.edu, geoPoint lat: 40.76078, lon: -111.89105, hasResults: False
protocolSection identificationModule nctId: NCT06336642, orgStudyIdInfo id: 2023-0933, secondaryIdInfos id: NCI-2024-02452, type: OTHER, domain: NCI-CTRP Clinical Trials Registry, briefTitle: Structured Personalized Oxygen and Supportive Therapies for Dyspnea in Oncology, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09-30, primaryCompletionDateStruct date: 2030-03-31, completionDateStruct date: 2032-03-31, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: M.D. Anderson Cancer Center, class: OTHER, descriptionModule briefSummary: To learn about the effect of Structured Personalized Oxygen and Supportive Therapies for Dyspnea in Oncology (SPOT-ON) treatment on the severity of shortness of breath in patients with cancer., conditionsModule conditions: Dyspnea, designModule studyType: INTERVENTIONAL, phases: PHASE2, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: SPOT-ON Early Start, interventions name: SPOT-ON Delayed Start, outcomesModule primaryOutcomes measure: Primary Outcome Measure: 1.Safety and adverse events (AEs), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: MD Anderson Cancer Center, city: Houston, state: Texas, zip: 77030, country: United States, contacts name: David Hui, MD, role: CONTACT, phone: 713-792-6258, email: dhui@mdanderson.org, geoPoint lat: 29.76328, lon: -95.36327, hasResults: False
protocolSection identificationModule nctId: NCT06336629, orgStudyIdInfo id: WIN2023, briefTitle: A Study Assessing the Efficacy of Combined Use of Clascoterone 1% Cream and Duac Gel (Benzoyl Peroxide/Clindamycin) for the Treatment of Acne, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-11-15, primaryCompletionDateStruct date: 2024-10, completionDateStruct date: 2024-10, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Sun Pharmaceutical Industries Limited, class: INDUSTRY, descriptionModule briefSummary: Winlevi is the first topical anti androgen and sebum inhibitor approved for acne vulgaris. There is no study assessing Winlevi in combination treatment for acne .Therefore this study assesses Winlevi with Duac gel in combination to emulate real life practice., conditionsModule conditions: Acne Vulgaris, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Winlevi (clascoterone) 1% & Duac gel, outcomesModule primaryOutcomes measure: The primary endpoint of this study is the percent of patients who achieve clear or almost clear on IGA at week 16., secondaryOutcomes measure: Percent of total lesion reduction at week 16 compared to baseline, secondaryOutcomes measure: Percent of inflammatory lesion reduction at week 16 compared to baseline, secondaryOutcomes measure: Percent of non-inflammatory lesion reduction at week 16 compared to baseline., secondaryOutcomes measure: Tolerability measures of erythema based on 5-point severity scale, secondaryOutcomes measure: Tolerability measures of dryness based on 5-point severity scale, secondaryOutcomes measure: Tolerability measures of peeling based on 5-point severity scale, secondaryOutcomes measure: Assessment of skin oiliness based on 5-point severity scale, secondaryOutcomes measure: Tolerability measures of burning/stinging based on 6-point severity scale, secondaryOutcomes measure: Tolerability measures of pruritus based on 6-point severity scale, eligibilityModule sex: ALL, minimumAge: 12 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Skin Sciences, PLLC, city: Louisville, state: Kentucky, zip: 40217, country: United States, geoPoint lat: 38.25424, lon: -85.75941, hasResults: False