hackint0sh/New-Dataset huggingface dataset:
This study will be conducted in 2 Parts (Part A and B), with up to 5 cohorts in each part (Part A; Cohorts A1 to A5 and Part B; Cohorts B1 to B5). conditions: Healthy conditions: Overweight studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 90 type: ESTIMATED name: PG-102(MG12) name: Placebo measure: Number of participants with treatment-emergent adverse events (TEAEs) for Part A measure: Number of participants with treatment-emergent adverse events (TEAEs) for Part B measure: Number of participants with Serious adverse events (SAEs) as assessed by CTCAE v5.0 for Part A measure: Number of participants with Serious adverse events (SAEs) as assessed by CTCAE v5.0 for Part B measure: Number of participants with clinically significant abnormalities in vital signs for Part A measure: Number of participants with clinically significant abnormalities in vital signs for Part B measure: Number of participants with clinically significant abnormalities in 12-lead ECGs for Part A measure: Number of participants with clinically significant abnormalities in 12-lead ECGs for Part B measure: Maximum plasma concentration (Cmax) for Part A measure: Maximum plasma concentration (Cmax) for Part B measure: Time to maximum plasma concentration (tmax) for Part A measure: Time to maximum plasma concentration (tmax) for Part B measure: Area under the concentration-time curve up to the last quantifiable time-point (AUC0-t) for Part A measure: Area under the concentration-time curve up to the last quantifiable time-point (AUC0-t) for Part B measure: Terminal half-life (t1/2) for Part A measure: Terminal half-life (t1/2) for Part B measure: Apparent total clearance (CL/F) for Part A measure: Apparent total clearance (CL/F) for Part B sex: ALL minimumAge: 19 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Catholic University Seoul St.Mary Hospital, status: RECRUITING city: Seocho state: Seoul zip: 06591 country: Korea, Republic of name: Kyunghwa Son, Ph.D role: CONTACT phone: 02-6098-2818 email: bd@progen.co.kr lat: 37.49056 lon: 127.02 hasResults: False
nctId: NCT06309641 id: MetHb 001 briefTitle: Methemoglobinemia Following Intravenous Iron Treatment overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2025-12 date: 2025-12 date: 2024-03-13 date: 2024-03-19 name: Claudia Seiler class: OTHER briefSummary: Methemoglobinemia as a side effect of treatment with intravenous iron has not previously been described. This study aims to assess methemoglobin levels in patients with anemia following treatment with intravenous iron, administered as ferric carboxymaltose or ferric derisomaltose. conditions: Methemoglobinemia conditions: Anemia conditions: Iron Deficiencies conditions: Side Effect studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 80 type: ESTIMATED name: Blood sample after treatment name: Case reports measure: Difference in methemoglobin after ferric derisomaltose measure: Difference in methemoglobin after ferric carboxymaltose measure: Difference in methemoglobin depending on drug dosage measure: Difference in methemoglobin depending on age measure: Difference in methemoglobin depending on sex measure: Difference in methemoglobin depending on hemoglobin level before treatment measure: Difference in methemoglobin depending on blood levels of ferritin, transferrin or iron. measure: Association between difference in methemoglobin and venous lactate sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Center of Clinical Research Dalarna city: Falun zip: 79182 country: Sweden name: Claudia Seiler, MD role: CONTACT phone: +46 70 2896416 email: claudia.seiler@regiondalarna.se lat: 60.60357 lon: 15.62597 hasResults: False
nctId: NCT06309628 id: PGX-006 briefTitle: Analysis of Volatile Organic Compounds in the Breath of Lung Transplant Rejection Patients Using Infrared Spectroscopy overallStatus: ENROLLING_BY_INVITATION date: 2023-09-21 date: 2024-07-31 date: 2024-12-31 date: 2024-03-13 date: 2024-03-13 name: Paragonix Technologies class: INDUSTRY name: Picomole Inc briefSummary: This study will sample and analyze volatile organic compounds (VOCs) from participants considered to be at risk for developing rejection following lung transplant by using infrared spectroscopy. conditions: Lung Transplant Rejection studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 60 type: ESTIMATED name: Breathe sample measure: Volatile Organic Compound profile sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Duke University city: Durham state: North Carolina zip: 27710 country: United States lat: 35.99403 lon: -78.89862 hasResults: False
nctId: NCT06309615 id: PDX-001_2 briefTitle: Decision Impact Study of PreciseDx Breast acronym: PDxBRUTILITY overallStatus: NOT_YET_RECRUITING date: 2024-03-30 date: 2025-05-30 date: 2029-05-30 date: 2024-03-13 date: 2024-03-13 name: Precise Dx, Inc. class: INDUSTRY name: The Cleveland Clinic briefSummary: The investigator's developed a digital LDT to predict invasive breast cancer (IBC) recurrence within 6 years by combining histologic features extracted from an H\&E image of the patients IBC with clinical data including the patients age, tumor size, stage and number of positive lymph nodes. The development of an artificial-intelligent (AI)-grade provides not only an objective, quantitative advancement of classical breast cancer grading but also improves upon the accuracy and utility of clinical risk. The investigator's sought to understand how such a PreciseDx Breast would be used in clinical practice post-surgical resection for women with early-stage IBC. conditions: Breast Cancer studyType: OBSERVATIONAL observationalModel: CASE_CROSSOVER timePerspective: PROSPECTIVE count: 300 type: ESTIMATED name: Standard of Care measure: Decision Impact Study of PreciseDx Breast on treating Oncologist measure: Decision Impact Study of PreciseDx Breast on Diagnostic Pathologist measure: Decision Impact on long term outcomes sex: FEMALE minimumAge: 23 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06309602 id: 22-0465 briefTitle: Investigation of a Free Water Protocol overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2028-01-01 date: 2028-01-01 date: 2024-03-13 date: 2024-03-13 name: Poudre Valley Health System class: OTHER briefSummary: Hypothesis: Use of a Free Water Protocol (FWP) will improve patient satisfaction scores (Dysphagia Handicap Index), will not increase the risk of aspiration pneumonia/pneumonitis, and will result in improved oral hygiene (as assessed by the Oral Assessment Guide). Aim: To demonstrate that improvement in patient satisfaction and quality of life scores outweighs the potential risks of aspiration of plain water in an acute care setting; to qualitatively assess the implementation of a Free Water Protocol from the viewpoints of the patient and family/caregivers; to quantify changes in oral hygiene practices for individuals on the Free Water Protocol. conditions: Oropharyngeal Dysphagia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 136 type: ESTIMATED name: Free Water Protocol name: Control / Standard Care measure: Dysphagia Handicap Index measure: Oral Assessment Guide measure: Qualitative data measure: Adverse events: Aspiration pneumonia/pneumonitis measure: Liquid intake sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Medical Center of the Rockies city: Loveland state: Colorado zip: 80538 country: United States name: Emily Main, MS, CCC-SLP role: CONTACT phone: 970-624-4369 email: emily.main@uchealth.org name: Brian Daily, MD role: SUB_INVESTIGATOR name: Cordelie Witt, MD role: SUB_INVESTIGATOR name: Lucie Uncapher, MD role: SUB_INVESTIGATOR name: Brandon Petrun, MD role: SUB_INVESTIGATOR lat: 40.39776 lon: -105.07498 hasResults: False
nctId: NCT06309589 id: YIHM briefTitle: The Effectiveness of Combining Ursodeoxycholic Acid With Vitamin D in Treating Patients With Primary Biliary Cholangitis overallStatus: COMPLETED date: 2021-05-01 date: 2023-09-30 date: 2023-12-31 date: 2024-03-13 date: 2024-03-13 name: Yilihamu·Abilitifu class: OTHER briefSummary: The goal of this clinical trial is to compare in the effectiveness of combining ursodeoxycholic acid and vitamin D in treating patients with primary biliary cholangitis. conditions: Primary Biliary Cholangitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 60 type: ACTUAL name: Vitamin D measure: UDCA response: Paris I criteria measure: UDCA response: Barcelona criteria sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: People's Hospital of Xinjiang Uygur Autonomous Region city: Urumqi state: Xinjiang zip: 830001 country: China lat: 43.80096 lon: 87.60046 hasResults: False
nctId: NCT06309576 id: PBRC 2023-069 briefTitle: Experimental Approach to Test Predictions of Body Weight Regulation Models acronym: DIP overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-11 date: 2025-02 date: 2024-03-13 date: 2024-03-13 name: Pennington Biomedical Research Center class: OTHER name: Tulane University 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. conditions: Obesity conditions: Underweight studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 12 type: ESTIMATED name: Fasting-refeeding cycle measure: Compensatory response measure: Timing of the compensatory response measure: Protein balance measure: Carbohydrate balance measure: Lipid balance measure: Overall appetite measure: Food preference measure: Physical activity measure: Sleeping metabolic rate measure: Leptin measure: Appetite-regulating hormones measure: Metabolites measure: Gonadotrophic axis measure: Thyroid axis measure: Hypothalamic-pituitary-adrenal axis sex: ALL minimumAge: 20 Years maximumAge: 40 Years stdAges: ADULT hasResults: False
nctId: NCT06309563 id: 31J301 briefTitle: Metabolic Effects of a Diet Replaced With Essential Amino Acids acronym: AMINOB overallStatus: RECRUITING date: 2023-08-30 date: 2025-12-31 date: 2025-12-31 date: 2024-03-13 date: 2024-03-15 name: Istituto Auxologico Italiano class: OTHER 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. conditions: Obesity Morbid conditions: Weight Loss studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: Aminoacid supplementation name: Placebo measure: Muscle mass measure: 6 minute walking test (6MWT) sex: ALL minimumAge: 45 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Istituto Auxologico Italiano, Site Piancavallo status: RECRUITING city: Oggebbio state: Verbania zip: 28921 country: Italy name: Amelia Brunani, MD role: CONTACT phone: 390323514232 email: brunani@auxologico.it lat: 45.99088 lon: 8.64663 hasResults: False
nctId: NCT06309550 id: 09W002 briefTitle: Provocative Tests for HFpEF acronym: TEST-PEF overallStatus: RECRUITING date: 2023-03-10 date: 2028-03 date: 2028-03 date: 2024-03-13 date: 2024-03-13 name: Istituto Auxologico Italiano class: OTHER 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. conditions: Heart Failure With Preserved Ejection Fraction studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 500 type: ESTIMATED name: exercise test measure: Mortality measure: Hospitalization for heart failure measure: Atrial fibrillation sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Ospedale San Luca IRCCS Istituto Auxologico Italiano status: RECRUITING city: Milan zip: 20149 country: Italy name: Sergio Caravita, MD, PhD role: CONTACT phone: +39 02 61911 2930 email: s.caravita@auxologico.it lat: 45.46427 lon: 9.18951 hasResults: False
nctId: NCT06309537 id: 09C830 briefTitle: Chemoreflex Sensitivity in HFpEF acronym: CHEMO-HFpEF overallStatus: NOT_YET_RECRUITING date: 2024-10 date: 2029-12 date: 2029-12 date: 2024-03-13 date: 2024-03-13 name: Istituto Auxologico Italiano class: OTHER 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.
We aim to characterize chemoreflex sensitivity in patients with a diagnosis of HFpEF, and to correlate chemoreflex sensitivity with clinical and hemodynamic characteristics. conditions: Heart Failure With Preserved Ejection Fraction studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 60 type: ESTIMATED name: chemoreflex evaluation measure: difference in chemoreflex sensitivity between HFpEF and healthy controls sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Ospedale San Luca IRCCS Istituto Auxologico Italiano city: Milan zip: 20149 country: Italy lat: 45.46427 lon: 9.18951 hasResults: False
nctId: NCT06309524 id: 09C332 briefTitle: Assessing the Right Heart Remodeling After Transcatheter Tricuspid Edge-to-edge Repair acronym: HERITAGE overallStatus: RECRUITING date: 2023-02-15 date: 2025-01-01 date: 2025-01-01 date: 2024-03-13 date: 2024-03-13 name: Istituto Auxologico Italiano class: OTHER 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. conditions: Tricuspid Regurgitation studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 17 type: ESTIMATED name: Tricuspid transcatheter edge-to-edge repair measure: Inverse remodeling of right heart chambers measure: Heart failure hospitalization measure: Death sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Istituto Auxologico Italiano status: RECRUITING city: Milan state: Lombardia zip: 20149 country: Italy name: Michele Tomaselli role: CONTACT phone: +3902619112992 email: michetomaselli@gmail.com lat: 45.46427 lon: 9.18951 hasResults: False
nctId: NCT06309511 id: 09C218 briefTitle: Subendocardial Viability Ratio in Hypertension acronym: SEVR-HT overallStatus: RECRUITING date: 2022-10-01 date: 2026-12-31 date: 2026-12-31 date: 2024-03-13 date: 2024-03-13 name: Istituto Auxologico Italiano class: OTHER briefSummary: The aim of the research is to evaluate the Subendocardial Viability Ratio (SEVR) in hypertensive patients, using non-invasive arterial tonometry, and to establish the influencing factors and the possibility of predicting cardiovascular morbidity and mortality in arterial hypertension.
The SEVR will be correlated with the anthropometric and pathology variables which will be collected in an appropriate database. conditions: Hypertension studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 3000 type: ESTIMATED name: Arterial tonometry measure: Buckberg index sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centro di Prevenzione e Cura dell'Ipertensione Arteriosa "Alessandro Filippi" status: RECRUITING city: Mascalucia state: Catania country: Italy name: Antonino Di Guardo, MD role: CONTACT email: ninodiguardo58@gmail.com name: Massimo Catanuso, MD role: CONTACT email: catanusomassimo@hotmail.it lat: 37.57465 lon: 15.04964 facility: Unità Operativa Semplice Dipartimentale Ipertensione Arteriosa "Anna Maria Pirrelli", Università degli Studi di Bari "Aldo Moro". Policlinico Consorziale di Bari status: RECRUITING city: Bari country: Italy name: Pietro Nazzaro, MD role: CONTACT email: pietro.nazzaro@uniba.it name: Sebastiano Cicco, MD role: CONTACT email: sebastiano.cicco@uniba.it lat: 41.11148 lon: 16.8554 facility: Istituto Auxologico Italiano IRCCS status: RECRUITING city: Milano zip: 20145 country: Italy name: Paolo Salvi, MD role: CONTACT phone: +390261911 phoneExt: 2968 email: p.salvi@auxologico.it lat: 45.46427 lon: 9.18951 facility: Medicina II Cardiovascolare, AUSL-IRCCS di Reggio Emilia status: RECRUITING city: Reggio Emilia country: Italy name: Angelo Ghirarduzzi, MD role: CONTACT email: ghirarduzzi.angelo@ausl.re.it name: Chiara Grasselli, MD role: CONTACT email: chiara.grasselli@ausl.re.it lat: 44.69825 lon: 10.63125 facility: Dipartimento di Scienze Mediche, Chirurgiche e della Salute, Università degli studi di Trieste status: RECRUITING city: Trieste country: Italy name: Andrea Grillo, MD role: CONTACT email: andr.grillo@gmail.com name: Bruno Fabris, MD role: CONTACT email: b.fabris@fmc.units.it lat: 45.64953 lon: 13.77679 hasResults: False
nctId: NCT06309498 id: 05C307 briefTitle: Residual Adrenal Function in Addison's Disease acronym: ADD-RES overallStatus: RECRUITING date: 2023-01-01 date: 2024-10-30 date: 2024-12-31 date: 2024-03-13 date: 2024-03-13 name: Istituto Auxologico Italiano class: OTHER 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 conditions: Adrenal Insufficiency studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 50 type: ESTIMATED name: blood test measure: prevalence of RAF measure: prevalence of adrenal crisis sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Istituto Auxologico Italiano status: RECRUITING city: Milan zip: 20135 country: Italy name: Valentina Morelli role: CONTACT phone: 02619112547 email: v.morelli@auxologico.it lat: 45.46427 lon: 9.18951 hasResults: False
nctId: NCT06309485 id: WGI0301-P2G-01 briefTitle: Phase 2 Study of WGI-0301 in Combination With Sorafenib for Advanced HCC overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-08 date: 2026-12 date: 2024-03-13 date: 2024-03-13 name: Zhejiang Haichang Biotech Co., Ltd. class: INDUSTRY 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. conditions: Advanced Hepatocellular Carcinoma (HCC) studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: WGI-0301 at MTD/RP2D dose IV infusion, QW name: WGI-0301 at MTD/RP2D -1 dose IV infusion, QW name: Sorafenib 400 mg PO, BID continuously name: Sorafenib 400 mg PO, BID measure: Efficacy of WGI-0301 in combination with Sorafenib based on ORR per RECIST 1.1. measure: Safety of each dose group. measure: Tolerability of each dose group. measure: Anti-tumor activity if WGI-0301 in combination with Sorafenib based on ORR. measure: Anti-tumor activity if WGI-0301 in combination with Sorafenib based on DCR. measure: Anti-tumor activity if WGI-0301 in combination with Sorafenib based on DoR. measure: Anti-tumor activity if WGI-0301 in combination with Sorafenib based on PFS. measure: Anti-tumor activity if WGI-0301 in combination with Sorafenib based on TTP per RECIST 1.1. measure: Anti-tumor activity if WGI-0301 in combination with Sorafenib based on OS. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False