[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Collegium Medicum w Bydgoszczy\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":124},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,48,97],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100610773","use-of-flozins-empagliflozindapagliflozin-for-prevention-of-aki-100610773",false,"NCT07231939","Use of Flozins (Empagliflozin\u002FDapagliflozin) for Prevention of AKI","FLOzins for pREveNtion of Contrast-inducEd Acute Kidney Injury (FLORENCE) Study","FLORENCE","Inclusion Criteria:\n\n* all consecutive patients who underwent PCI or coronary angiography during the study period for whom the variables required for the analysis are available\n\nExclusion Criteria:\n\n* unavailability of variables required for the analysis, volume\n* contrast agent volume \\\u003C50 mL or \\>500 mL.","ALL","18 Years",{"count":20,"type":21},4000,"ESTIMATED","OBSERVATIONAL","All consecutive patients hospitalized from 01.01.2020 to 30.09.2025 who underwent coronary angiography or PCI will be eligible for inclusion.\n\nThe final analysis will be limited to individuals in whom the volume of ICM administered during the index procedure was between 50 and 500 mL and for whom both pre- and post-procedure serum creatinine measurements were available.\n\nThe primary objective of the study is the effect of short-term and long-term SGLT2i therapy on the occurrence of CI-AKI in patients undergoing diagnostic or therapeutic procedures with ICM.",[25,26,27,28],"Coronary Artery Disease","Acute Kidney Injury","Contrast-Induced Acute Kidney Injury","Percutaneous Coronary Intervention",[30,31,32,33,34],"AKI","contrast-induced acute kidney injury","PCI","coronary angiography","acute kidney injury","RECRUITING","2025-11-14",{"date":38,"type":39},"2025-11-17","ACTUAL",{"date":41,"type":39},"2025-11-01",{"date":43,"type":21},"2026-03-31",{"name":45,"class":46},"Collegium Medicum w Bydgoszczy","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":77,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":47},"100608614","phase-4-modulation-of-gut-microflora-with-rifaximin-to-reduce-high-platelet-reactivity-in-post-acs-patients-on-ticagrelor-100608614","NCT07203846","Modulation of Gut MicroFLORA With Rifaximin to Reduce High Platelet Reactivity in Post-ACS Patients on Ticagrelor","Modulation of Gut Microflora With Rifaximin to Reduce High Platelet Reactivity in Post-Acute Coronary Syndrome Patients on Ticagrelor (FLORA-ACS)","FLORA-ACS","Inclusion criteria:\n\n* Between 18 and 80 years of age\n* History of acute coronary syndrome no sooner than 1 month and no later than 12 months prior to study inclusion\n* Current treatment with ticagrelor (90 mg orally twice a day)\n* High platelet reactivity assessed with multiple electrode aggregometry method (AUC of \\>46 U)\n* Provision of informed consent prior to any study procedures\n\nExclusion criteria:\n\n* History of hypersensitivity to rifaximin or other rifamycin-derived agent\n* Ongoing treatment with rifamycins\n* Platelet count \\\u003C 100×10\\^9\u002FL or \\> 450×10\\^9\u002FL\n* Treatment with antibiotics, probiotics, or glucocorticoids within 3 months prior to study inclusion\n* History of gastrointestinal diseases such as inflammatory bowel disease, bowel obstruction, or gastrointestinal tumor\n* Infection, including gastrointestinal infection, within a month prior to study inclusion\n* History of Clostridium difficile infection\n* Current use of specific medications (warfarin, glycoprotein IIb\u002FIIIa inhibitors, immunosuppressants, bile acid sequestrants, antidiarrheal agents)\n* Impaired liver function classified as Child-Pugh class B or C\n* Hemodynamic instability\n* Pregnancy or breastfeeding\n* Patients considered by the investigator to be uncooperative","80 Years",{"count":58,"type":21},50,"INTERVENTIONAL",[61],"PHASE4","The FLORA-ACS study aims to evaluate the relationship between dysbiosis and high platelet reactivity during treatment with ticagrelor in patients with a history of acute coronary syndromes and investigate the use of rifaximin to eliminate dysbiosis and thus provide effective antiplatelet treatment.",[64,65,66,67,68,69,70,71,72,73,74,75,76],"ACS - Acute Coronary Syndrome","Ticagrelor","Microbiota","Platelet Aggregation","Myocardial Infarction (MI)","Blood Platelets","Drug Effects","Platelet Aggregation Inhibitors","Drug Resistance","Platelet Function Tests","Dysbiosis","Anti-Bacterial Agents","Rifaximin",[78,79,80,81,82,83,84,85,86,87],"high platelet reactivity","HPR","Multiplate aggregometry","multiple electrode aggregometry","MEA","microbiome","gut flora","eubiotic","16S rRNA sequencing","P2Y12 inhibitor","NOT_YET_RECRUITING","2025-09-25",{"date":91,"type":39},"2025-10-02",{"date":93,"type":21},"2026-01-01",{"date":95,"type":21},"2027-06-30",{"name":45,"class":46},{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":103,"eligibilityCriteria":104,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":105,"enrollmentInfo":106,"targetDuration":4,"studyType":59,"phases":108,"briefSummary":110,"conditions":111,"keywords":113,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":123,"locationsCount":47},"100508864","phase-3-efficacy-of-double-vs-standard-empapagliflozin-dose-for-metabolic-syndrome-treatment-100508864","NCT05905965","Efficacy of Double vs Standard Empapagliflozin Dose for METabolic syndromE tReatment","Efficacy of Double vs Standard Empapagliflozin Dose for METabolic syndromE tReatment (DEMETER - SIRIO 11) Study","DEMETER","Inclusion Criteria:\n\n* diagnosis of metabolic syndrome as follows: the presence of obesity (waist circumference ≥ 88 cm in women; ≥102 cm or body mass index (BMI) ≥30 kg\u002Fm2) and two of the three following criteria:\n\n  1. high blood pressure (systolic blood pressure - in-office measurement: ≥ 130 and\u002For diastolic blood pressure ≥85 mm Hg or systolic blood pressure - ambulatory measurement: ≥130 and\u002For diastolic blood pressure ≥ 80 mm Hg) or on anti-hypertensive treatment;\n  2. impaired glucose metabolism (fasting glucose ≥100 mg\u002FdL or ≥ 140 mg\u002FdL after 120 min in oral glucose tolerance test or HbA1c ≥5.7%) or on glucose-lowering drug treatment;\n  3. elevated non-high-density lipoprotein (non-HDL ≥130 mg\u002FdL) cholesterol level (atherogenic dyslipidemia) or on lipid-lowering drug treatment\n\nExclusion Criteria:\n\n* current treatment with SGLT2 inhibitor\n* chronic kidney disease with estimated glomerular filtration rate (eGFR) \\&lt; 30 mL\u002Fmin or on dialysis\n* severely impaired liver function\n* known hypersensitivity to the active empagliflozin or to any of the excipients contained in Jardiance\n* history of ketoacidosis\n* diabetes treated with insulin\n* pregnancy\n* decompensated heart failure\n* acute coronary syndrome\n* active thromboembolic disease\n* current treatment for neoplastic disease\n* active inflammatory disease within 1 month prior to enrollment\n* expected lifetime \\\u003C1 year\n* non-cooperative patients","85 Years",{"count":107,"type":21},200,[109],"PHASE3","The DEMETER - SIRIO 11 study is a phase III, multicenter, randomized, open-labled, investigator-initiated clinical trial with a 6 month follow-up.\n\nThe study population will include 200 subjects with diagnosis of metabolic syndrome.\n\nAll enrolled patients (nn=200) will be randomly assigned in 1:1 ratio to one of the two study arms:\n\n1. Empagliflozin 20 mg - experimental arm\n2. Empagliflozin 10 mg - control arm. Primary co-endpoints of the study include: BMI and HbA1c. Secondary endpoints include: LDL-C, triglycerides, CRP, NT-proBNP, LVEF (echocardiography), body composition, VO2max (ergospirometry), waist-hip ratio (WHR), liver steatosis assessment (LSA) by computed tomography (CT), major adverse cardiovascular events - MACE (based on medical history: heart attack, stroke, death), cardiovascular hospitalizations.",[112],"Metabolic Syndrome",[114,115,116],"metabolic syndrome","empagliflozin","adherence","2024-08-26",{"date":119,"type":39},"2024-08-27",{"date":121,"type":39},"2023-05-01",{"date":43,"type":21},{"name":45,"class":46},""]