hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06309576, orgStudyIdInfo id: PBRC 2023-069, briefTitle: Experimental Approach to Test Predictions of Body Weight Regulation Models, acronym: DIP, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-11, completionDateStruct date: 2025-02, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Pennington Biomedical Research Center, class: OTHER, collaborators name: Tulane University, descriptionModule briefSummary: The regulation of human body weight and fatness is not fully understood. Although some models of regulation have been proposed (set point, dual-intervention point, others), no studies have been designed to test their predictions. In this pilot and feasibility study, the investigators will implement an experimental approach to test the predictions of models of body weight regulation in humans. Men and women with either underweight or obesity will be exposed to a 2-day fasting followed by a 2-day ad-libitum refeeding. During the entire fasting-refeeding period, energy intake and expenditure will be accurately measured within metabolic chambers. The investigators will therefore determine the compensatory responses to fasting elicited to prevent weight loss. The results will serve to design and power future studies to better understand body weight regulation., conditionsModule conditions: Obesity, conditions: Underweight, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: Fasting-refeeding cycle, outcomesModule primaryOutcomes measure: Compensatory response, secondaryOutcomes measure: Timing of the compensatory response, secondaryOutcomes measure: Protein balance, secondaryOutcomes measure: Carbohydrate balance, secondaryOutcomes measure: Lipid balance, secondaryOutcomes measure: Overall appetite, secondaryOutcomes measure: Food preference, secondaryOutcomes measure: Physical activity, secondaryOutcomes measure: Sleeping metabolic rate, secondaryOutcomes measure: Leptin, secondaryOutcomes measure: Appetite-regulating hormones, secondaryOutcomes measure: Metabolites, secondaryOutcomes measure: Gonadotrophic axis, secondaryOutcomes measure: Thyroid axis, secondaryOutcomes measure: Hypothalamic-pituitary-adrenal axis, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06309563, orgStudyIdInfo id: 31J301, briefTitle: Metabolic Effects of a Diet Replaced With Essential Amino Acids, acronym: AMINOB, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-08-30, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Istituto Auxologico Italiano, class: OTHER, descriptionModule briefSummary: The effectiveness of low-protein diets supplemented with essential aminoacid (EAA) formulas in genetic disorders of amino acid (AA) catabolism, such as maple syrup urine disease (MSUD), is widely recognized (Blackburn PR et al. 2017). The main aim of the present study is to evaluate a difference in the effectiveness of a multidisciplinary rehabilitation program in patients with high degree of obesity with and without supplementation of this new formula of amino acids (essential + tricarboxylic acids - EAA-AC). For this reason, patients of both sexes, aged between 45 and 65, suffering from high-grade obesity will be recruited in Piancavallo. The enrolled patients divided, randomly, into two groups will be given: EAA-AC group a low-calorie and low-protein diet integrated with 4 sachets of EAA-AC supplement per day; the control group will follow a low-calorie and low-protein diet only with placebo. The parameters considered, after two weeks of treatment, will be: weight loss; the maintenance/recovery of muscle mass assessed through changes in body composition and functional tests (Hand grip, 6MWT or TUG) but also through the analysis of mitochondrial function in PBMC and circulating levels of mtDNA; the improvement of the glucose picture and the lipid profile.1 month after discharge, patients will carry out an outpatient check-up to evaluate the maintenance of muscle mass using impedance testing., conditionsModule conditions: Obesity Morbid, conditions: Weight Loss, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Aminoacid supplementation, interventions name: Placebo, outcomesModule primaryOutcomes measure: Muscle mass, secondaryOutcomes measure: 6 minute walking test (6MWT), eligibilityModule sex: ALL, minimumAge: 45 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Istituto Auxologico Italiano, Site Piancavallo, status: RECRUITING, city: Oggebbio, state: Verbania, zip: 28921, country: Italy, contacts name: Amelia Brunani, MD, role: CONTACT, phone: 390323514232, email: brunani@auxologico.it, geoPoint lat: 45.99088, lon: 8.64663, hasResults: False
protocolSection identificationModule nctId: NCT06309550, orgStudyIdInfo id: 09W002, briefTitle: Provocative Tests for HFpEF, acronym: TEST-PEF, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-03-10, primaryCompletionDateStruct date: 2028-03, completionDateStruct date: 2028-03, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Istituto Auxologico Italiano, class: OTHER, descriptionModule briefSummary: Diagnosing heart failure with preserved ejection fraction (HFpEF) in patients complaining exertional breathlessness can be challenging: diagnostic algorithms and scores have low sensitivity, and ageing-associated comorbidities can complicate the interpretation of symptoms. Thus, exercise right heart catheterization (RHC) or invasive cardiopulmonary exercise test (iCPET) have been advocated as gold-standard methods for HFpEF diagnosis. However, exercise RHC and iCPET are still not widely standardized methods, with results mainly coming from US cohorts (that may differ from Italian cohorts), and other provocative tests (e.g. non-invasive CPET, passive leg raising) may offer complementary diagnostic information., conditionsModule conditions: Heart Failure With Preserved Ejection Fraction, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: exercise test, outcomesModule primaryOutcomes measure: Mortality, primaryOutcomes measure: Hospitalization for heart failure, primaryOutcomes measure: Atrial fibrillation, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ospedale San Luca IRCCS Istituto Auxologico Italiano, status: RECRUITING, city: Milan, zip: 20149, country: Italy, contacts name: Sergio Caravita, MD, PhD, role: CONTACT, phone: +39 02 61911 2930, email: s.caravita@auxologico.it, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
protocolSection identificationModule nctId: NCT06309537, orgStudyIdInfo id: 09C830, briefTitle: Chemoreflex Sensitivity in HFpEF, acronym: CHEMO-HFpEF, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-10, primaryCompletionDateStruct date: 2029-12, completionDateStruct date: 2029-12, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Istituto Auxologico Italiano, class: OTHER, descriptionModule briefSummary: Patients with heart failure and a preserved left ventricular ejection fraction (HFpEF) almost invariably complain of exertional breathlessness. Abnormal cardiac hemodynamics with pulmonary congestion are believed to trigger dyspnea in this patients. However, some patients may complain of exertional breathlessness which seems to be out of proportion as compared with hemodynamic abnormalities.Chemoreflex sensitivity accounts for the ventilatory responses to a variety of chemical stimuli, including carbon dioxide produced by the organism during exercise. Chemoreflex sensitivity can be augmented in heart failure with reduced left ventricular ejection fraction, and an increased chemoreflex sensitivity has been linked to symptoms, neurohumoral activation, breathing disturbances, and adverse prognosis.However, the clinical correlates and implications of chemoreflex sensitivity in HFpEF have not been accurately studied.We aim to characterize chemoreflex sensitivity in patients with a diagnosis of HFpEF, and to correlate chemoreflex sensitivity with clinical and hemodynamic characteristics., conditionsModule conditions: Heart Failure With Preserved Ejection Fraction, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: chemoreflex evaluation, outcomesModule primaryOutcomes measure: difference in chemoreflex sensitivity between HFpEF and healthy controls, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ospedale San Luca IRCCS Istituto Auxologico Italiano, city: Milan, zip: 20149, country: Italy, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
protocolSection identificationModule nctId: NCT06309524, orgStudyIdInfo id: 09C332, briefTitle: Assessing the Right Heart Remodeling After Transcatheter Tricuspid Edge-to-edge Repair, acronym: HERITAGE, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-02-15, primaryCompletionDateStruct date: 2025-01-01, completionDateStruct date: 2025-01-01, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Istituto Auxologico Italiano, class: OTHER, descriptionModule briefSummary: In the recent years, secondary tricuspid regurgitation (STR) has gained interest due to its high prevalence and impact on outcomes. Transcatheter tricuspid valve replacement or repair represents novel and less invasive alternatives to surgery and has shown early promising results. Treatment options mimic surgical techniques such as leaflet approximation, direct annuloplasty, and heterotopic caval valve implantation, as well as not yet commercially available transcatheter TV replacement systems using orthotopic valve implantation. (5) Among leaflet approximation techniques, the Tricuspid transcatheter edge-to-edge repair (T-TEER) using the TriClip™ (Abbott Vascular, Santa Clara, CA, USA) or leaflet approximation with the PASCAL systems (Edwards Lifesciences, Irvine, CA, USA) are approved in Europe for minimally invasive TV repair.The purposes of the present study are: i. to use 3DE and CCT to evaluate the effect of T-TEER on the geometry and function of the right heart chambers in patients with STR; ii. to identify the predictors of procedural success potentially related to features of both right chambers geometry and TR jet; iii. to compare the accuracy of 3DE assessment of the right ventricle, the right atrium, and the tricuspid annulus, with the same parameters obtained by CCT, in the setting of T-TEER; and iv. to assess patients' outcome., conditionsModule conditions: Tricuspid Regurgitation, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 17, type: ESTIMATED, armsInterventionsModule interventions name: Tricuspid transcatheter edge-to-edge repair, outcomesModule primaryOutcomes measure: Inverse remodeling of right heart chambers, primaryOutcomes measure: Heart failure hospitalization, primaryOutcomes measure: Death, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Istituto Auxologico Italiano, status: RECRUITING, city: Milan, state: Lombardia, zip: 20149, country: Italy, contacts name: Michele Tomaselli, role: CONTACT, phone: +3902619112992, email: michetomaselli@gmail.com, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
protocolSection identificationModule nctId: NCT06309498, orgStudyIdInfo id: 05C307, briefTitle: Residual Adrenal Function in Addison's Disease, acronym: ADD-RES, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2024-10-30, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Istituto Auxologico Italiano, class: OTHER, descriptionModule briefSummary: The main aim of this study is to assess the role of 11-deoxycortisol as surrogate marker of Residual adrenal function.11-deoxycortisol levels will be assessed in all recruited patients, conditionsModule conditions: Adrenal Insufficiency, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: blood test, outcomesModule primaryOutcomes measure: prevalence of RAF, secondaryOutcomes measure: prevalence of adrenal crisis, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Istituto Auxologico Italiano, status: RECRUITING, city: Milan, zip: 20135, country: Italy, contacts name: Valentina Morelli, role: CONTACT, phone: 02619112547, email: v.morelli@auxologico.it, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
protocolSection identificationModule nctId: NCT06309485, orgStudyIdInfo id: WGI0301-P2G-01, briefTitle: Phase 2 Study of WGI-0301 in Combination With Sorafenib for Advanced HCC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-08, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Zhejiang Haichang Biotech Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to determine the MTD of WGI-0301 in combination with Sorafenib for advanced Hepatocellular Carcinoma (HCC) and assess its safety and efficacy in adults with advanced unresectable HCC who have previously received PD-1 / PD-L1 immune checkpoint inhibitors., conditionsModule conditions: Advanced Hepatocellular Carcinoma (HCC), designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: WGI-0301 at MTD/RP2D dose IV infusion, QW, interventions name: WGI-0301 at MTD/RP2D -1 dose IV infusion, QW, interventions name: Sorafenib 400 mg PO, BID continuously, interventions name: Sorafenib 400 mg PO, BID, outcomesModule primaryOutcomes measure: Efficacy of WGI-0301 in combination with Sorafenib based on ORR per RECIST 1.1., secondaryOutcomes measure: Safety of each dose group., secondaryOutcomes measure: Tolerability of each dose group., secondaryOutcomes measure: Anti-tumor activity if WGI-0301 in combination with Sorafenib based on ORR., secondaryOutcomes measure: Anti-tumor activity if WGI-0301 in combination with Sorafenib based on DCR., secondaryOutcomes measure: Anti-tumor activity if WGI-0301 in combination with Sorafenib based on DoR., secondaryOutcomes measure: Anti-tumor activity if WGI-0301 in combination with Sorafenib based on PFS., secondaryOutcomes measure: Anti-tumor activity if WGI-0301 in combination with Sorafenib based on TTP per RECIST 1.1., secondaryOutcomes measure: Anti-tumor activity if WGI-0301 in combination with Sorafenib based on OS., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06309459, orgStudyIdInfo id: IRB 2023/04-34, briefTitle: Carbonic Anhydrase IX Enzyme in Triple Negative Breast Carcinoma, statusModule overallStatus: COMPLETED, startDateStruct date: 2018-08-01, primaryCompletionDateStruct date: 2023-05-01, completionDateStruct date: 2023-05-01, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Kahramanmaras Sutcu Imam University, class: OTHER, descriptionModule briefSummary: Triple-negative breast carcinoma is characterized by the absence of estrogen receptors, progesterone receptors, and HER2/neu receptors. Carbonic anhydrase IX (CA IX) is a tumor-associated cell surface glycoprotein that is involved in adaptation to hypoxia-induced acidosis and plays a role in cancer progression. This study aimed to investigate CA IX expression in TNBC and its relationship with treatment effect., conditionsModule conditions: Triple Negative Breast Cancer, conditions: Carbonic Anhydrase IX, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 40, type: ACTUAL, armsInterventionsModule interventions name: Carbonic anhydrase staining levels, outcomesModule primaryOutcomes measure: Poor prognostic factors in patients with TNBC, primaryOutcomes measure: The treatment success with inhibiting the CA IX enzyme levels' effectiveness, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Kahramanmaraş Sütçü İmam University, city: Kahramanmaraş, zip: 46000, country: Turkey, geoPoint lat: 37.5847, lon: 36.92641, hasResults: False
protocolSection identificationModule nctId: NCT06309446, orgStudyIdInfo id: 381001BS, briefTitle: Assessment of Wound Healing, Cooling Efficacy and Local Tolerability of a Wound Care Hydrogel, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-01-14, primaryCompletionDateStruct date: 2020-02-19, completionDateStruct date: 2020-07-02, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Oystershell NV, class: INDUSTRY, collaborators name: Bioskin GmbH, descriptionModule briefSummary: Test the wound healing properties of the product as well as the cooling effect and tolerability of a wound care gel., conditionsModule conditions: Wound, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: INVESTIGATOR, enrollmentInfo count: 33, type: ACTUAL, armsInterventionsModule interventions name: Zoralan Wound, outcomesModule primaryOutcomes measure: Wound healing efficacy (clinical), primaryOutcomes measure: Wound healing efficacy (global), primaryOutcomes measure: Cooling properties, secondaryOutcomes measure: Local tolerability (clinical), secondaryOutcomes measure: Local tolerability (global), secondaryOutcomes measure: Signs of infection, secondaryOutcomes measure: Time until 100% healing, secondaryOutcomes measure: Time until 75% healing, secondaryOutcomes measure: Presence of crusts, secondaryOutcomes measure: Questionnaire on product performance, secondaryOutcomes measure: Cosmetic outcome/acceptance, secondaryOutcomes measure: Photographic documentation of the wound - visual of the wound to support previous outcomes., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Bioskin GmbH, city: Hamburg, zip: 20095, country: Germany, geoPoint lat: 53.57532, lon: 10.01534, hasResults: False
protocolSection identificationModule nctId: NCT06309420, orgStudyIdInfo id: 19E0566, briefTitle: Clinical Trial to Evaluate Efficacy and Safety of a Cryogenic Medical Device for Treatment of Common and Plantar Warts, statusModule overallStatus: COMPLETED, startDateStruct date: 2019-11-07, primaryCompletionDateStruct date: 2020-08-10, completionDateStruct date: 2020-08-10, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Oystershell NV, class: INDUSTRY, descriptionModule briefSummary: The present study was set-up to evaluate clinical efficacy of Pixie CO2 versus a comparator product (Wortie®) for the treatment of common and plantar warts., conditionsModule conditions: Warts, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Investigator-blinded, Randomized,Tested product versus comparator (benchmark product), In parallel groups, With multiple applications, Single centre., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: INVESTIGATOR, enrollmentInfo count: 54, type: ACTUAL, armsInterventionsModule interventions name: Cryogenic treatment of warts (Pixie CO2), interventions name: Cryogenic treatment of warts (Wortie®), outcomesModule primaryOutcomes measure: Percentage of subjects with clinical wart remission, secondaryOutcomes measure: Number of treatments, secondaryOutcomes measure: Efficacy of the freezing process (Surface Area), secondaryOutcomes measure: Diameter of the wart, secondaryOutcomes measure: Roughness of the wart, secondaryOutcomes measure: Thickness of the wart (For common warts only), secondaryOutcomes measure: Presence of small dark spot (For plantar warts only), secondaryOutcomes measure: Healing process of the wart, secondaryOutcomes measure: Local & general tolerance, eligibilityModule sex: ALL, minimumAge: 4 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Dermscan Poland, city: Gdansk, zip: 80-288, country: Poland, geoPoint lat: 54.35205, lon: 18.64637, hasResults: False