[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"placebo-control-design\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:placebo-control-design":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,52,88],{"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":23,"briefSummary":25,"conditions":26,"keywords":33,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":5},"100645401","phase-2-sglt2i-effect-on-ptdm-development-and-kidney-allograft-function-in-non-diabetic-kidney-transplant-recipients-a-randomized-doubleblind-placebo-controlled-national-multicenter-trial-100645401",false,"NCT07682350","SGLT2i Effect on PTDM Development and Kidney Allograft Function in Non-diabetic Kidney Transplant Recipients: A Randomized, Doubleblind, Placebo Controlled, National Multicenter Trial","SGL-TX-PTDM: SGLT2i Effect on PTDM Development and Kidney Allograft Function in Kidney Transplant Recipients: A Randomized, Doubleblind, Placebo Controlled, National Multicenter Trial","SGL-TX-PTDM","Inclusion Criteria:\n\n* Obtained written informed consent\n* Male or female patients, age ≥ 18 years.\n* Non-diabetic KTR\n* Immunosuppressive must include Tacrolimus\n\nExclusion Criteria:\n\n* Patients who is treated (diet or antidiabetics) for diabetes type 1 or 2 before randomization\n* eGFR\\\u003C 25 ml\u002Fmin\u002F1.73m2 (before randomization)\n* Alanine aminotransferase (ALAT) \\> 3 x upper normal limit\n* Bilirubin \\> 2 x upper normal limit\n* Pregnancy\n* Positive plasma hCG\n* Breastfeeding\n* Known allergy towards SGLT2i or the content substance\n* Patients with chronic intestinal diseases, including inflammatory bowel diseases (e.g., Crohn's disease and ulcerative colitis) and structural conditions such as short bowel syndrome.","ALL","18 Years",{"count":20,"type":21},184,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The goal of this clinical trial is to find out whether 12 months of treatment with the SGLT2 inhibitor Forxiga® (dapagliflozin 10 mg once daily), compared with placebo, can reduce the risk of developing post-transplant diabetes in kidney transplant recipients who do not have diabetes at the time of transplantation.\n\nThe main questions it aims to answer are:\n\n* Does Forxiga reduce the risk of developing post-transplant diabetes and prediabetes compared with placebo?\n* Does Forxiga help preserve the function of the transplanted kidney compared with placebo?\n* Is Forxiga safe for kidney transplant recipients who do not have diabetes?\n* Does Forxiga affect the occurrence of urinary tract infections, the amount of protein in the urine, and other kidney- and heart-related health measures compared with placebo?\n\nResearchers will compare Forxiga with a placebo (a look-alike tablet containing no active medicine) to see whether it can reduce the risk of post-transplant diabetes while maintaining kidney function and remaining safe to use.\n\nAdults who have recently received a kidney transplant and do not have diabetes may take part if they meet the study requirements.\n\nParticipants will be randomly assigned to receive either Forxiga or placebo once daily for 12 months. They will attend study visits 3, 6, and 12 months after joining the study. These visits will include health checks, blood tests, and urine tests. Neither the participants nor the study doctors will know which treatment each participant is receiving.",[27,28,29,30,31,32],"Kidney Transplant Recipient","Sodium Glucose Co-Transporter 2 Inhibitors","Non-Diabetic Patients","Randomized Controlled Trial (RCT)","Placebo Control Design","Post Transplant Diabetes Mellitus",[34,35,36,37,38,39,15],"SGLT2i","Kidney Transplant","Kidney Transplant Recipients","non-diabetic patients","Sodium-glucose Transporter 2 inhibitors","RCT","NOT_YET_RECRUITING","2026-06-26",{"date":43,"type":44},"2026-07-02","ACTUAL",{"date":46,"type":21},"2026-09-01",{"date":48,"type":21},"2029-10-01",{"name":50,"class":51},"Odense University Hospital","OTHER",{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":4,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":59,"enrollmentInfo":60,"targetDuration":4,"studyType":22,"phases":62,"briefSummary":64,"conditions":65,"keywords":70,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":87},"100638885","extracorporeal-shock-wave-therapy-in-lower-extremity-lymphedema-100638885","NCT07626645","Extracorporeal Shock Wave Therapy in Lower Extremity Lymphedema","Efficacy of Extracorporeal Shock Wave Therapy (ESWT) in Lower Extremity Lymphedema: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Adults aged 18 to 80 years\n* Clinical diagnosis of lower extremity lymphedema established at least 6 months prior to enrollment\n* Completion of at least one cycle of CDT Phase 1 (intensive decongestive phase) within the preceding six months\n* Currently in CDT Phase 2 (maintenance phase) with active use of compression garments\n* Ability and willingness to provide written informed consent\n\nExclusion Criteria:\n\n* Active chemotherapy or radiotherapy\n* Active infection\n* Lower extremity vascular diseases including deep vein thrombosis or arterial insufficiency\n* Presence of a cardiac pacemaker\n* Pregnancy\n* Bleeding disorders","80 Years",{"count":61,"type":21},36,[63],"NA","Lower extremity lymphedema is a chronic and progressive condition associated with significant functional impairment and reduced quality of life. The current gold-standard treatment is Complex Decongestive Therapy (CDT); however, a substantial proportion of patients continue to experience persistent symptoms during the maintenance phase. This prospective, randomized, double-blind, placebo-controlled clinical trial aims to evaluate the effectiveness of Extracorporeal Shock Wave Therapy (ESWT) as an adjunct to standard CDT maintenance therapy in patients with lower extremity lymphedema. Participants will be randomly allocated to either an active ESWT group or a sham ESWT group, with both groups continuing standard CDT maintenance throughout the study. ESWT will be administered twice weekly for five sessions. Changes in limb volume, skin thickness and subcutaneous tissue thickness assessed by ultrasonography, pain, functional status, and quality of life will be evaluated at baseline, after treatment, and at one-month follow-up.",[66,67,68,69,31],"Lymphedema, Lower Limb","Extracorporeal Shock Wave Therapy","Edema Leg","Sham-controlled",[71,72,73,74,75,76,77],"Lower Extremity Lymphedema","Extracorporeal Shock Wave Therapy (ESWT)","Complex Decongestive Therapy (CDT)","Limb Volume","Ultrasonography","skin and subcutaneous tissue thickness","Quality of Life","2026-06-02",{"date":80,"type":44},"2026-06-04",{"date":82,"type":21},"2026-06-22",{"date":84,"type":21},"2027-02-01",{"name":86,"class":51},"Gazi University",1,{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":94,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":96,"targetDuration":4,"studyType":22,"phases":98,"briefSummary":100,"conditions":101,"keywords":105,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":87},"100603996","phase-4-sglt2i-safety-and-efficacy-on-kidney-allograft-function-in-non-diabetic-kidney-transplant-recipients-100603996","NCT07143773","SGLT2i Safety and Efficacy on Kidney Allograft Function in Non-diabetic Kidney Transplant Recipients","SGLT2i Safety and Efficacy on Kidney Allograft Function in Non-diabetic Kidney Transplant Recipients: A Randomized, Double-blind, Placebo Controlled, National, Multicenter Trial","SGL-TX-GFR","Inclusion Criteria:\n\n* Obtained written informed consent\n* Male or female patients, age ≥ 18 years.\n* Non-diabetic KTR\n* \\> 6 months post-transplant\n* eGFR\\> 25 ml\u002Fmin\u002F1.73m2 within the last 3 months pre randomization\n* Immunosuppressive must include Tacrolimus\n* Negative plasma hCG in fertile women\\*, and acceptance of the use of contraception during the course of the study.\n\nExclusion Criteria:\n\n* Patients treated (diet or antidiabetics) for diabetes type 1 or 2 before randomization\n* eGFR\\\u003C 25 ml\u002Fmin\u002F1.73m2 (before randomization)\n* Alanine aminotransferase (ALAT) \\> 3 x upper normal limit\n* Bilirubin \\> 2 x upper normal limit\n* Pregnancy\n* Breastfeeding\n* Known allergy towards SGLT2i or the content substance\n* Known intestinal bowel disease",{"count":97,"type":21},88,[99],"PHASE4","This clinical trial investigates whether 18 months of daily SGLT2i (10 mg Forxiga) preserves kidney function and evaluates safety, based on eGFR changes and adverse event occurrence in non-diabetic kidney transplant recipients.\n\nThe main questions it aims to answer are:\n\n* Does SGLT2i versus placebo, as an add-on to standard care, preserve kidney transplant function in non-diabetic recipients?\n* Is SGLT2i treatment safe for non-diabetic transplant recipients when evaluating adverse events?\n* Does SGLT2i versus placebo affect the occurrence of urinary tract infections, post-transplant diabetes mellitus (PTDM) and prediabetes incidence, U-ACR, as well as renal and cardiovascular parameters?\n\nResearchers will compare a daily dose of SGLT2i (10 mg Forxiga) with a placebo (a look-alike tablet with no active medicine).\n\nKidney transplant recipients who do not have diabetes can take part if they meet the study's requirements. Participants will be randomly assigned to receive either Forxiga or placebo once daily for 18 months. All participants will have check-ups every 3 months, which will include urine tests and blood samples. Neither the participants nor the study doctors will know which treatment they are receiving.",[102,103,29,104,31],"Kidney Transplantation Recipients","Sodium-Glucose Transporter 2 Inhibitors","Randomized Controlled Trial",[34,35,36,37,38,39],"RECRUITING","2025-08-22",{"date":109,"type":44},"2025-08-27",{"date":111,"type":21},"2025-09-01",{"date":113,"type":21},"2027-08-01",{"name":50,"class":51}]