[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Yonsei University\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":636},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,183,0,25,[9,52,84,107,130,159,193,219,246,274,297,318,338,357,382,402,427,447,470,496,522,543,568,591,614],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":31,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":4},"100651477","erector-spinae-oxygen-saturation-and-aki-after-opcab-100651477",false,"NCT07760129","Erector Spinae Oxygen Saturation and AKI After OPCAB","Erector Spinae Muscle Oxygen Saturation as an Early Predictor of Acute Kidney Injury in Patients Undergoing Off-Pump Coronary Artery Bypass Surgery","Inclusion Criteria:\n\n1. Adults aged 19 years or older scheduled for elective off-pump coronary artery bypass (OPCAB) surgery.\n2. Able to receive a full explanation of the purpose and procedures of the study and to provide written informed consent voluntarily.\n3. Depth from the skin to the erector spinae muscle at the level of the left renal hilum, measured by ultrasonography in the operating room before anesthetic induction, of less than 2.0 cm, so that stable near-infrared spectroscopy measurement is considered feasible. Consenting patients who do not meet this criterion are not enrolled and are classified as screen failures.\n\nExclusion Criteria:\n\n1. Emergency surgery.\n2. Concomitant surgery performed by another department.\n3. Preoperative or postoperative cardiogenic shock, or need for mechanical circulatory support.\n4. Estimated glomerular filtration rate below 30 mL\u002Fmin\u002F1.73 m2.\n5. Previous kidney transplantation.\n6. Left renal disease or a solitary kidney.\n7. Body mass index above 30 kg\u002Fm2.\n8. Active bleeding or active infection.\n9. Inability to read and voluntarily consent to the informed consent document (for example, because of illiteracy, language barrier, or cognitive impairment).\n10. Refusal to participate in the study.","ALL","19 Years",{"count":20,"type":21},138,"ESTIMATED","OBSERVATIONAL","Acute kidney injury (AKI) is a frequent and serious complication after cardiac surgery, including off-pump coronary artery bypass (OPCAB). Because AKI is diagnosed on the basis of serum creatinine, which rises 1 to 2 days after the actual renal insult, early detection and timely intervention remain difficult. Near-infrared spectroscopy (NIRS) allows non-invasive and continuous measurement of regional tissue oxygen saturation, but the effective penetration depth of commercially available devices is only approximately 2 to 2.5 cm. In most adults the renal cortex lies deeper than this, so the signal obtained from a flank sensor may originate largely from the abdominal wall musculature rather than from renal parenchyma. This limitation may explain the inconsistent association between renal regional oxygen saturation (renal rSO2) and AKI reported so far.\n\nThe erector spinae muscle at the level of the renal hilum lies within 2 cm of the skin in most patients and is supplied by the lumbar arteries and by vessels adjacent to the renal hilum. Erector spinae muscle regional oxygen saturation (ESrSO2) may therefore provide a technically more reliable NIRS signal that reflects perfusion of a vascular territory close to that of the kidney, particularly during the transient low cardiac output state induced by mechanical displacement of the heart for coronary anastomosis during OPCAB.\n\nThis single-center prospective observational cohort study will enroll 138 adult patients scheduled for elective OPCAB at Severance Hospital, Yonsei University Health System, Seoul, Republic of Korea. ESrSO2 and renal rSO2 will be measured continuously with an INVOS oximeter from before anesthetic induction until the end of surgery, in addition to cerebral rSO2, which is part of standard care at the participating institution. The ESrSO2 and renal rSO2 channels will be physically masked on the monitor display during surgery, no alarms will be set for these two channels, and their values will not be used for any intraoperative clinical decision. The recorded data will be extracted after surgery using the INVOS Analytics Tool. Apart from placement of the additional NIRS sensors and a brief pre-induction ultrasound measurement of tissue depth, no study-specific procedure, laboratory test, or imaging study will be performed, and all anesthetic, surgical, and postoperative care will follow the standard institutional protocol.\n\nThe primary objective is to identify which ESrSO2-derived variable best predicts postoperative AKI, defined by the Kidney Disease: Improving Global Outcomes (KDIGO) criteria within 7 days after surgery. The candidate variables are the baseline value, the intraoperative nadir, the area under the threshold (AUT), and the duration under the threshold below absolute values of 60%, 55%, and 50% and below 80% of the baseline value, calculated separately for the period before cardiac displacement and for the cardiac displacement period. Secondary objectives are to assess whether the selected ESrSO2 variable provides independent and incremental predictive information beyond a pre-specified baseline risk model, to compare the predictive performance of ESrSO2 with that of cerebral rSO2 and renal rSO2, and to evaluate the prediction of severe AKI (KDIGO stage 2 to 3) and persistent AKI (lasting 48 hours or longer).\n\nIf ESrSO2 proves to be a useful early marker of AKI, it could allow real-time, non-invasive identification of patients at high risk during surgery and provide a basis for future trials of renal protective strategies.",[25,26,27,28,29,30],"Acute Kidney Injury","Coronary Artery Disease","Coronary Artery Bypass, Off-Pump","Postoperative Complications","Cardiac Surgical Procedures","Spectroscopy, Near-Infrared",[32,33,34,35,36,37,38,39],"rector spinae muscle regional oxygen saturation (ESrSO2)","near-infrared spectroscopy (NIRS)","regional oxygen saturation (rSO2","off-pump coronary artery bypass (OPCAB)","acute kidney injury (AKI)","KDIGO","area under the threshold (AUT)","tissue oximetry","NOT_YET_RECRUITING","2026-08-06",{"date":43,"type":44},"2026-08-12","ACTUAL",{"date":46,"type":21},"2026-10-01",{"date":48,"type":21},"2029-12-31",{"name":50,"class":51},"Yonsei University","OTHER",{"id":53,"slug":54,"hasResults":12,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":4,"eligibilityCriteria":58,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":67,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":4},"100650855","opticross-hd-ivus-for-assessing-invasion-depth-in-upper-tract-urothelial-carcinoma-100650855","NCT07751796","OptiCross HD IVUS for Assessing Invasion Depth in Upper Tract Urothelial Carcinoma","A Prospective, Single-center, Single-arm, Investigator-Initiated Exploratory Clinical Trial to Evaluate the Lesion Invasion Depth Using Intraluminal Images of a Percutaneous Catheter for Intravascular Ultrasound (OptiCross™ HD) Compared With Pathological Results in Patients With Upper Tract Urothelial Carcinoma","Inclusion Criteria:\n\n1. Adults aged 19 years or older, male or female.\n2. UTUC diagnosed or strongly suspected based on preoperative CT or MRI and ureteroscopic biopsy.\n3. A lesion identified on imaging for which the depth of invasion is difficult to determine and surgery is considered necessary.\n4. RNU has been definitively selected by the treating physician, allowing direct comparison of IVUS findings with postoperative pathology.\n5. Upper urinary tract anatomy permits safe passage of the 3.1-F IVUS catheter to the lesion.\n6. Ability and willingness to provide written informed consent.\n\nExclusion Criteria:\n\n1. Ureteral stricture, severe angulation, congenital anomaly, or other anatomy that prevents safe catheter advancement.\n2. Definite distant metastasis (M1) or adjacent-organ invasion (T4) on imaging.\n3. Active urinary tract infection or uncontrolled coagulopathy that increases the risk of ureteroscopic manipulation.\n4. Pregnancy or breastfeeding.\n5. Any systemic condition or other circumstance judged by the investigator to make participation inappropriate or to interfere with interpretation of the study results.",{"count":60,"type":21},15,"INTERVENTIONAL",[63],"NA","Upper tract urothelial carcinoma (UTUC) is difficult to stage accurately because cross-sectional imaging and ureteroscopic biopsy may not reliably demonstrate muscular or periureteral invasion. This exploratory study evaluates whether a 60-MHz OptiCross HD intravascular ultrasound (IVUS) catheter can be safely introduced into the renal pelvis or ureter during planned surgery and provide intraluminal images that correspond to the final pathologic T stage.\n\nFifteen adults with suspected or confirmed UTUC who are already scheduled for radical nephroureterectomy (RNU) will undergo one IVUS examination immediately before surgery. The IVUS result will not alter the planned treatment. Three independent reviewers who are blinded to clinical and pathologic information will assess invasion depth and image quality. IVUS-based T stage will be compared with postoperative pathology. Technical success, visualization of ureteral wall layers and lesion boundaries, and adverse events will also be evaluated through 3 months after surgery.",[66],"Upper Tract Urothelial Carcinoma",[68,69,70,71,72,73,74,75],"UTUC","intravascular ultrasound","IVUS","intraluminal ultrasound; ureter","renal pelvis","invasion depth","T stage","radical nephroureterectomy","2026-08-03",{"date":78,"type":44},"2026-08-07",{"date":80,"type":21},"2026-09-01",{"date":82,"type":21},"2028-06-23",{"name":50,"class":51},{"id":85,"slug":86,"hasResults":12,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":92,"targetDuration":94,"studyType":22,"phases":4,"briefSummary":95,"conditions":96,"keywords":4,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},"100212105","gangwon-pci-prospective-registry-100212105","NCT02038127","Gangwon PCI Prospective Registry","Prospective Registry for Patients Undergoing Coronary Angiography and Percutaneous Coronary Intervention in Gangwon Province","GWPCI","Inclusion Criteria:\n\n* Age \\> 19 years\n* Subject is able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the drug-eluting stent(s) and he\u002Fshe or his\u002Fher legally authorized representative provides written informed consent prior to any study related procedure\n* Subject must have significant stenosis (\\>50% by visual estimate) on a native or in-stent coronary artery\n* Subject must have evidence of myocardial ischemia (e.g., stable, unstable angina, recent infarction, acute myocardial infarction, positive functional study or a reversible changes in the ECG consistent with ischemia). In subjects with coronary artery stenosis \\>75%, evidence of myocardial ischemia does not have to be documented\n\nExclusion Criteria:\n\n* Subject has a known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel, prasugrel, ticagrelor, biolimus A9, everolimus, zotarolimus, stainless steel, cobalt chromium, contrast media (Patients with documented sensitivity to contrast media, which can be effectively premedicated with steroid and diphenhydramine may be enrolled. However, those with true anaphylaxis to prior contrast media should not be enrolled.)\n* Subject in use of systemic (intravenous) biolimus A9, everolimus or zotarolimus within 12 months.\n* Female subject of childbearing potential, unless a recent pregnancy test is negative, who possibly plans to become pregnant any time after enrollment into this study\n* Subject planned an elective surgical procedure that would necessitate interruption of antiplatelet during the first 12 months post enrollment\n* Subject with non-cardiac co-morbid condition with life expectancy \\\u003C 2 year or that may result in protocol non-compliance (per site investigator's medical judgment)\n* Subject with cardiogenic shock at presentation\n* Subject who are actively participating in another drug or device investigational study, who have not completed the primary end point follow-up period",{"count":93,"type":21},5000,"3 Years","Comparison of\n\n* Biolimus-eluting stent, Biomatrix, or Biomatrix Flex stent, Biosensors, Singapore\n* Everolimus-eluting stent, Xience V, or Xience Prime, or Xience Xpedition stent, Abbott, USA\n* Zotarolimus-eluting stent, Endeavor Resolute, or Endeavor Resolute Integrity stent Medtronic, USA in patients with coronary artery disease treated with percutaneous coronary intervention",[26],"RECRUITING","2026-07-29",{"date":100,"type":44},"2026-07-30",{"date":102,"type":44},"2013-01-01",{"date":104,"type":21},"2031-12-31",{"name":50,"class":51},3,{"id":108,"slug":109,"hasResults":12,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":4,"eligibilityCriteria":113,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":114,"enrollmentInfo":115,"targetDuration":4,"studyType":61,"phases":117,"briefSummary":119,"conditions":120,"keywords":4,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},"100555791","phase-2-efficacy-of-risk-stratified-treatment-in-newly-diagnosed-infant-leukemia-100555791","NCT06516679","Efficacy of Risk-Stratified Treatment in Newly Diagnosed Infant Leukemia","Efficacy of Risk-Stratified Treatment in Newly Diagnosed Infant Leukemia: A Multicenter, Prospective Study","Inclusion Criteria:\n\n* The age of diagnosis is less than 1 year old\n* The disgnosisi of ALL or ALAL(lymphoid predominant)\n* Informed consent of the parents(guardians) before participation in this study\n\nExclusion Criteria:\n\n* Burkitt leukemia\u002Flymphoma or mature B-cell leukemia\n* Down syndrome, Bloom syndrome, ataxia-telangiectasia, Fanconi anemia, Kostmann syndrome, Shwachman syndrome or other bone marrow failure syndrome, hematopoietic stem cell transplantation\n* Relapsed infant leukemia\n* Participants with contraindication to medication\n* Administered systemic steroid therapy within 4 weeks prior to this study (However, steroid administration is allowable in oncologic emergencies only after the subject's disease diagnosis and risk group classification are completed.)\n* Participants in other interventional studies other than this protocol","2 Years",{"count":116,"type":21},40,[118],"PHASE2","This clinical trial is an open-label, multicenter, prospective phase 2 clinical trial targeting pediatric leukemia patients of infant age. The goal is to improve survival rates by varying the presence or absence of chemotherapy and hematopoietic stem cell transplantation based on genetic characteristics at the time of diagnosis and minimal residual disease (MRD) values measured by various methods after treatment.\n\nIn addition, by clearly defining the patient group that requires hematopoietic stem cell transplantation, it is expected that the role of hematopoietic stem cell transplantation in infantile leukemia, for which there have been various guidelines for hematopoietic stem cell transplantation, can be confirmed. Additionally, due to the characteristics of infants, this study aim to identify long-term sequelae or prognosis related to treatment by prospectively collecting side effect data related to treatment during and after treatment.",[121],"Leukemia, Lymphoid","2026-07-28",{"date":98,"type":44},{"date":125,"type":44},"2024-12-11",{"date":127,"type":21},"2032-12-31",{"name":50,"class":51},10,{"id":131,"slug":132,"hasResults":12,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":4,"eligibilityCriteria":136,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":137,"targetDuration":4,"studyType":61,"phases":139,"briefSummary":140,"conditions":141,"keywords":148,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":4},"100648515","heartmate-app-based-remote-monitoring-for-cardiovascular-risk-factor-management-100648515","NCT07721584","HeartMate App-Based Remote Monitoring for Cardiovascular Risk Factor Management","Effect of HeartMate Application-Based Remote Patient Monitoring on Cardiovascular Risk Factor Management: An Exploratory Randomized Controlled Pilot Study","Inclusion Criteria:\n\n1. Adults aged 19 years or older\n2. Patients with cardiac disease judged to require cardiac rehabilitation (e.g., heart failure, valvular heart disease, coronary artery disease, peripheral arterial disease)\n3. Able to be followed for at least 6 weeks during the study period\n4. Able to consent to blood testing and PPG measurement at baseline and endpoint\n5. Able to use a smartphone application\n\nExclusion Criteria:\n\n1. Judged unable to undergo PPG measurement\n2. Atrial fibrillation\n3. Condition or disease making participation in cardiac rehabilitation difficult\n4. Psychiatric illness, cognitive impairment, or expected poor adherence that may affect study participation",{"count":138,"type":21},200,[63],"This exploratory pilot randomized controlled trial evaluates whether a HeartMate application-based remote patient monitoring (RPM) and digital cardiac rehabilitation program improves cardiovascular, functional, and psychological outcomes in patients with cardiac disease. A total of 200 participants with cardiovascluar disease requiring rehabilitation are randomly assigned in a 1:1 ratio to an intervention group or a control group. The intervention group uses the HeartMate app-based remote cardiac rehabilitation program for 6 weeks, including a daily heart check using smartphone remote photoplethysmography (rPPG), aerobic and resistance exercise, breathing training, and a cognitive-behavioral 'mind' program, with weekly remote coaching. The control group receives usual outpatient care and lifestyle education materials, with the app installed only for rPPG measurement so that digital-biomarker measurement is identical across groups. Clinical assessments (6-minute walk distance, grip strength, blood pressure, blood lipids and metabolic markers), questionnaires (SF-12, PHQ-9, GAD-7, KOSS-24), and digital biomarkers (rPPG-derived heart rate, heart rate variability, respiration, activity) are collected at baseline and at 6 weeks. The primary outcome is the between-group difference in the change in 6-minute walk distance from baseline to 6 weeks. Because this is an exploratory pilot, the results are intended to estimate the effect size and variance for a future definitive randomized controlled trial, and to assess the validity of digital biomarkers as well as the safety, feasibility, and adherence of the program.",[142,143,26,144,145,146,147],"Cardiovascular Diseases","Heart Failure, Systolic","Heart Valve Diseases","Peripheral Arterial Disease","Cardiac Rehabilitation","Cardiovascular Risk Factor",[142,149,26,150,145,146,147],"Heart Failure","Heart Valve Diseases;","2026-07-22",{"date":153,"type":44},"2026-07-23",{"date":155,"type":21},"2026-07-14",{"date":157,"type":21},"2028-08-31",{"name":50,"class":51},{"id":160,"slug":161,"hasResults":12,"nctId":162,"briefTitle":163,"officialTitle":164,"acronym":4,"eligibilityCriteria":165,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":166,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":168,"conditions":169,"keywords":174,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":192},"100648562","long-term-outcomes-after-percutaneous-patent-foramen-ovale-closure-severance-pfo-registry-100648562","NCT07724171","Long-term Outcomes After Percutaneous Patent Foramen Ovale Closure (Severance PFO Registry)","Long-term Clinical Outcomes and Prognostic Factors After Percutaneous Patent Foramen Ovale Closure: A Retrospective Cohort Study With Prospective Registry Extension","Inclusion Criteria:\n\n1. Age 19 years or older\n2. Percutaneous patent foramen ovale closure\n3. Retrospective cohort: closure performed between 2010 and March 2026, with at least one post-procedural agitated saline transthoracic echocardiography\n4. Prospective cohort: closure performed after institutional review board approval, with written informed consent\n\nExclusion Criteria:\n\n1. Atrial septal defect closure (defect other than patent foramen ovale)\n2. Device embolization or device removal\n3. Echocardiographic image quality inadequate for assessment of shunt\n4. Prospective cohort: refusal of informed consent",{"count":167,"type":21},400,"Patent foramen ovale (PFO) is a congenital interatrial communication present in about one quarter of the general population and is recognized as a major cause of cryptogenic stroke. Percutaneous PFO closure reduces recurrent stroke, but a residual right-to-left shunt persists in 20 to 40 percent of patients after device implantation. Long-term data on device performance, the evolution of residual shunt over time, new-onset atrial fibrillation and other prognostic factors remain limited.\n\nThis single-center registry evaluates the long-term efficacy and safety of percutaneous PFO closure and identifies the clinical, anatomical, procedural and pharmacological factors associated with clinical and echocardiographic outcomes. The registry combines a retrospective cohort of patients treated at Severance Hospital between 2010 and March 2026 with a prospective registry extension that enrolls patients undergoing PFO closure after institutional review board approval, with follow-up for up to 119 months.\n\nClinical outcomes include recurrent ischemic stroke or transient ischemic attack, all-cause death, device-related complications and new-onset atrial fibrillation. Echocardiographic outcomes are assessed by serial agitated saline transthoracic echocardiography, which allows the presence, grade and longitudinal trajectory of residual shunt to be characterized.",[170,171,172,173],"Patent Foramen Ovale","Cryptogenic Stroke","Transient Ischemic Attack Due to Embolism","Atrial Fibrillation",[175,176,177,178,179,180,181,182,183,184],"patent foramen ovale (PFO)","percutaneous closure","residual shunt","right-to-left shunt","agitated saline contrast echocardiography","transthoracic echocardiography (TTE)","recurrent stroke","transient ischemic attack (TIA)","registry","prognostic factors","2026-07-21",{"date":153,"type":44},{"date":188,"type":44},"2026-06-05",{"date":190,"type":21},"2036-05-04",{"name":50,"class":51},1,{"id":194,"slug":195,"hasResults":12,"nctId":196,"briefTitle":197,"officialTitle":198,"acronym":4,"eligibilityCriteria":199,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":200,"enrollmentInfo":201,"targetDuration":4,"studyType":61,"phases":203,"briefSummary":204,"conditions":205,"keywords":207,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":214,"completionDateStruct":216,"leadSponsor":218,"locationsCount":192},"100648077","evaluate-the-effectiveness-and-safety-of-at-home-rehabilitation-gait-training-using-a-hip-assisted-wearable-robot-in-stroke-patients-100648077","NCT07716475","Evaluate the Effectiveness and Safety of At-Home Rehabilitation Gait Training Using a Hip-assisted Wearable Robot in Stroke Patients","A Study to Evaluate the Effectiveness and Safety of At-Home Rehabilitation Gait Training Using a Hip-assisted Wearable Robot in Stroke Patients: An Investigator-Initiated, Single-Center, Single-Arm Exploratory Trial","Inclusion Criteria:\n\n1. Adults aged 19 years or older and under 80 years\n2. Persons diagnosed with cerebral infarction or intracerebral hemorrhage confirmed by magnetic resonance imaging or computed tomography\n3. Persons for whom at least 1 month has elapsed since the diagnosis of stroke\n4. Persons showing a spastic hemiplegic gait pattern due to stroke\n5. Patients with a Functional Ambulatory Category score below 4\n6. Persons who can sit without assistance at the edge of a bed and can stand for 10 seconds with or without assistance\n7. Persons with sufficient cognitive ability to follow simple instructions and understand the content and purpose of the study (Mini-Mental State Examination score \\>= 20)\n\nExclusion Criteria:\n\n1. Persons with contraindications to lower-extremity weight bearing, such as severe lower-extremity joint contracture or an untreated fracture\n2. Persons for whom wearing the device is difficult due to skin disease or open wounds\n3. Persons with a severe difference in the length of the two lower extremities\n4. Persons with severe deformity or joint contracture in the lower extremities\n5. Persons unable to maintain a sitting posture or a standing posture on their own\n6. Persons with severe lower-extremity spasticity (Modified Ashworth Scale (MAS) grade 2 or higher)\n7. Persons who cannot cooperate with gait therapy using the robot-assisted orthopedic exercise device due to severe cognitive decline (Mini-Mental State Examination score \\\u003C 20), delirium, or severe language function impairment\n8. Persons who cannot maintain prolonged standing or walking due to underlying conditions such as orthostatic hypotension or reduced cardiopulmonary function\n9. Persons with other concomitant conditions affecting gait, such as peripheral neuropathy or parkinsonism due to alcoholism or severe diabetes\n10. Pregnant women or patients with the possibility of pregnancy\n11. Persons currently participating in another clinical trial\n12. Persons at high risk in the event of a fall or bleeding due to a coagulation disorder or the like\n13. Persons with a height less than 140 cm or greater than 190 cm\n14. Persons for whom wearing the robot is not possible\n15. Persons with clinically significant findings that, in the medical judgment of the principal investigator or a sub-investigator, are considered inappropriate for this study other than the above","80 Years",{"count":202,"type":21},8,[63],"The goal of this clinical trial is to learn whether a wearable monitoring system can help adults who have had a stroke get more out of a home exercise program. The system tracks how participants walk and move, then gives them feedback. Researchers want to know if this feedback improves walking, thinking and memory, and daily activity.\n\nThe wearable monitoring system has three parts:\n\nA shoe insole sensor that measures how a person walks A wrist band that tracks daily activity, like a fitness watch A mobile app that gives feedback and lets participants report how they feel\n\nThe main questions this study aims to answer are:\n\nDoes feedback from the wearable system improve physical function, thinking and memory, and daily activity during a home exercise program? How satisfied are participants with using the wearable system?\n\nResearchers will compare two groups. Both groups do the same home exercise program for 6 weeks. One group uses the wearable system and gets feedback. The other group does the program without the wearable system or feedback. This comparison shows whether the feedback itself makes a difference.\n\nWho can take part: adults who have had a stroke and \\[key eligibility in plain words, e.g., \"can walk a short distance with or without help\"\\]. The study plans to enroll about \\[number\\] participants.\n\nParticipants in the wearable group will:\n\nGet an insole sensor, a wrist activity tracker, and access to a mobile app Learn a home exercise program from the study team Wear the insole sensor and activity tracker while exercising at home for 6 weeks Use the app to see their feedback and report daily health information Complete a survey about their experience at the end\n\nParticipants in the comparison group will:\n\nDo the same home exercise program for 6 weeks, without the wearable system or feedback.",[206],"Stroke",[208,209,210,211,206],"Home-based rehabilitation","Robot-assisted gait training","Telehealth","Exoskeleton Device","2026-07-15",{"date":185,"type":44},{"date":215,"type":44},"2026-07-06",{"date":217,"type":21},"2027-07-30",{"name":50,"class":51},{"id":220,"slug":221,"hasResults":12,"nctId":222,"briefTitle":223,"officialTitle":224,"acronym":4,"eligibilityCriteria":225,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":226,"targetDuration":4,"studyType":61,"phases":228,"briefSummary":229,"conditions":230,"keywords":232,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":240,"lastUpdatePostDateStruct":241,"startDateStruct":242,"completionDateStruct":243,"leadSponsor":245,"locationsCount":4},"100645448","phase-2-a-study-of-polatuzumab-vedotin-and-glofitamab-in-patients-with-relapsed-or-refractory-diffuse-large-b-cell-lymphoma-within-12-months-after-r-chop-100645448","NCT07702851","A Study of Polatuzumab Vedotin and Glofitamab in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma Within 12 Months After R-CHOP","A PROSPECTIVE MULTICENTER PHASE 2 STUDY OF THE CHEMOTHERAPY-FREE COMBINATION OF POLATUZUMAB VEDOTIN AND GLOFITAMAB IN PATIENTS WITH RELAPSED OR REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA WITHIN 12 MONTHS OF R-CHOP TREATMENT","Inclusion Criteria:\n\n1. Histologically proven DLBCL\n2. Relapsed or refractory disease after first-line chemoimmunotherapy containing both rituximab and anthracycline A.Refractory disease defined as no complete remission to first-line therapy; subjects who are intolerant to first-line therapy are excluded\n\n   * Progressive disease (PD) as best response to first-line therapy\n   * Stable disease (SD) as best response after at least 4 cycles of first-line therapy\n   * Partial response (PR) as best response after at least 6 cycles, and biopsy-proven residual disease or disease B.Relapsed disease defined as complete remission to first-line therapy followed by biopsy- proven disease relapse ≤ 12 months of initiating first-line therapy\n3. Signed Informed Consent Form\n4. Age ≥ 19 years at the time of signing Informed Consent Form and willingness to comply with study protocol procedures\n5. Life expectancy ≥ 12 weeks\n6. Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1, or 2\n7. At least one bi-dimensionally measurable (≥ 1.5 cm) nodal lesion, or one bi-dimensionally measurable (≥ 1 cm) extranodal lesion, as measured on CT scan\n8. Negative severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test within 7 days prior to enrollment\n9. Negative HIV test at screening, with the following exception:\n\n   i.Individuals with a positive HIV test at screening are eligible provided, prior to enrollment, they are stable on antiretroviral therapy, have a CD4 count ≥ 200\u002FµL, and have an undetectable viral load.\n10. For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agree to refrain from donating eggs, as defined below:\n\n    i.Female participants must remain abstinent or use contraceptive methods with a failure rate of \\\u003C 1% per year during the treatment period and for at least 18 months after pretreatment with obinutuzumab, 2 months after the final dose of glofitamab, 9 months after the final dose of polatuzumab vedotin, and 3 months after the final dose of tocilizumab (as applicable), whichever is longer. Women must refrain from donating eggs during this same period ii.A female participant is considered to be of childbearing potential if she is postmenarchal, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and is not permanently infertile due to surgery (i.e., removal of ovaries, fallopian tubes, and\u002For uterus) or another cause as determined by the investigator (e.g., Müllerian agenesis). Per this definition, a female participant with tubal ligation is considered to be of childbearing potential. The definition of childbearing potential may be adapted for alignment with local guidelines or regulations.\n\n    iii.Examples of contraceptive methods with a failure rate of \\\u003C 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.\n\n    Hormonal contraceptive methods must be supplemented by a barrier method. iv.The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the individual. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not adequate methods of contraception. If required per local guidelines or regulations, locally recognized adequate methods of contraception and information about the reliability of abstinence will be described in the local Informed Consent Form.\n11. For male participants: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agree to refrain from donating sperm, as defined below:\n\n    i.With a female partner of childbearing potential or pregnant female partners, male participants must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of \\\u003C 1% per year during the treatment period and for at least 3 months after pretreatment with obinutuzumab, 2 months after the final dose of glofitamab, 6 months after the final dose of polatuzumab vedotin, or 2 months after the last dose of tocilizumab (as applicable), whichever is longer. Male participants must refrain from donating sperm during this same period.\n\n    ii.The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the individual. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not adequate methods of contraception. If required per local guidelines or regulations, locally recognized adequate methods of contraception and information about the reliability of abstinence will be described in the local Informed Consent Form.\n12. Adequate hematologic function (unless due to underlying disease, as established for example, by extensive bone marrow involvement or due to hypersplenism secondary to involvement of the spleen by LBCL per the investigator for which blood product transfusions are permitted) defined as follows:\n\n    * Hemoglobin ≥ 9.0 g\u002FdL without packed RBC transfusion during 7 days before first treatment.\n    * ANC ≥1.0x109\u002FL\n    * Platelet count ≥75 x 109\u002FL\n13. Adequate renal function, defined as measured or estimated creatinine clearance ≥50 mL\u002Fmin\n\nExclusion Criteria:\n\nPatients who meet any of the following criteria will be excluded from study entry:\n\nContraindication to any of the individual components of glofitamab or history of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products\n\n1. Prior solid organ transplantation\n2. Prior treatment with a regimen containing polatuzumab vedotin or glofitamab\n3. Prior treatment with systemic immunotherapeutic agents, including but not limited to, radio-immuno-conjugates, antibody-drug conjugates, immune\u002Fcytokines and monoclonal antibodies (mAbs) (e.g., anti-cytotoxic T lymphocyte associated protein 4, anti-PD-1, and anti-PD-L1) within 4 weeks or five half-lives of the drug, whichever is shorter\n4. Prior use of any monoclonal antibody for the purposes of treating cancer within 3 months of the start of Cycle 1\n5. Any investigational therapy for the purposes of treating cancer within 28 days prior to the start of Cycle 1\n6. Prior radiotherapy to the mediastinal\u002Fpericardial region(Radiotherapy to non-target lesion sites will be permitted.)\n7. Current Grade \\> 1 peripheral neuropathy\n8. Corticosteroid use \\> 50 mg\u002Fday of prednisone or equivalent, for purposes other than lymphoma symptom control i.Participants receiving corticosteroid treatment with ≤ 50 mg\u002Fday of prednisone or equivalent for reasons other than lymphoma symptom control (e.g., rheumatoid arthritis) must be documented to be on a stable dose of at least 4 weeks duration prior to the start of Cycle 1.\n\n   * Corticosteroid therapy for control of cancer symptoms or side effects of prior treatment (e.g., nausea or B-symptoms) is permitted\n   * The use of inhaled corticosteroids is permitted.\n   * The use of mineralocorticoids for management of orthostatic hypotension is permitted.\n   * The use of physiologic doses of corticosteroids for management of adrenal insufficiency is permitted.\n\n   ii.Participants who require lymphoma symptom control during screening may receive steroids in the following manner:\n   * Up to 50 mg\u002Fday of prednisone or equivalent may be used for lymphoma symptom control during screening, including prior to finalization of staging (not included as part of pre-phase treatment).\n   * If glucocorticoid treatment is urgently required at higher doses for lymphoma symptom control prior to the start of study treatment, tumor assessments must be completed prior to initiation of \\> 30-100 mg\u002Fday of prednisone or equivalent. Prednisone \\> 30-100 mg\u002Fday or equivalent may be given for a maximum of 10-14 days as a pre-phase treatment. As part of the pre-phase treatment, vincristine may not be administered.\n9. History of other malignancy that could affect compliance with the protocol or interpretation of results:\n\n   i.Participants with a history of curatively treated basal or squamous cell carcinoma or melanoma of the skin or in situ carcinoma of the cervix at any time prior to the study are eligible.\n\n   ii.Participants with any malignancy appropriately treated with curative intent and the malignancy has been in remission without treatment for ≤ 2 years prior to enrollment are eligible.\n\n   iii.Participants with low-grade, early-stage prostate cancer (Gleason score 6 or below, Stage 1 or 2) with no requirement for therapy at any time prior to study are eligible.\n10. Significant or extensive history of cardiovascular disease such as New York Heart Association Class III or IV cardiac disease or Objective Assessment Class C or D, myocardial infarction within the last 3 months prior to the start of Cycle 1, unstable arrhythmias, or unstable angina\n11. Recent major surgery (within 4 weeks prior to the start of Cycle 1), other than for diagnosis\n12. Current or past history of CNS disease, such as stroke, epilepsy, CNS vasculitis or neurodegenerative disease i.Participants with a history of stroke who have not experienced a stroke or transient ischemic attack in the past 2 years and have no residual neurological deficits, as judged by the investigator, are allowed.\n13. Current or past history of CNS lymphoma\n14. Known or suspected history of hemophagocytic lymphohistiocytosis (HLH)\n15. Current or past history of Waldenström macroglobulinemia\n16. History or presence of an abnormal ECG that is clinically significant in the investigator's opinion\n17. Patients with known or suspected active infection, or reactivation of a latent infection, whether bacterial, viral (including, but not limited to, SARS-Cov-2, Epstein-Barr virus (EBV), cytomegalovirus (CMV), hepatitis B, and hepatitis C), fungal, mycobacterial, or other pathogens (excluding fungal infections of nail beds) or any major episode of infection requiring hospitalization or treatment with IV antibiotics (for IV antibiotics this pertains to completion of last course of antibiotic treatment) within 4 weeks of dosing\n18. History of treatment-emergent immune-related adverse events associated with prior immunotherapeutic agents, as follows:\n\n    i.Grade ≥ 3 adverse events with the exception of Grade 3 endocrinopathy managed with replacement therapy.\n\n    ii.Grade 1\u002F2 adverse events that did not resolve to baseline after treatment discontinuation.\n19. History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis i.Participants with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone may be eligible for this study.\n\n    ii.Participants with a history of disease-related immune thrombocytopenic purpura or autoimmune hemolytic anemia may be eligible for this study.\n\n    iii.Participants with controlled Type I diabetes mellitus who are on an insulin regimen are eligible for the study.\n\n    iv.Participants with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only are eligible (e.g., participants with psoriatic arthritis are excluded) if all the following conditions are met:\n    * Rash covers \\\u003C 10% of body surface area.\n    * Disease is well controlled for the last 12 months and requires only low-potency topical corticosteroids.\n20. Clinically significant liver disease, including active viral or other hepatitis or cirrhosis\n21. Illicit drug or alcohol abuse within 12 months prior to screening, in the investigator's judgment\n22. Any of the following abnormal laboratory values (unless any of these abnormalities are due to underlying lymphoma):\n\n    * INR or PT \\>1.5 Xupper limit of normal (ULN) in the absence of therapeutic anticoagulation.\n    * PTT or aPTT \\> 1.5 XULN in the absence of a lupus anticoagulant.\n    * Serum AST and ALT ≥ 2.5 XULN\n    * Total bilirubin ≥ 1.5XULN Participants with documented Gilbert disease may be enrolled if total bilirubin is ≤ 3.0XULN\n23. Live, attenuated vaccine within 4 weeks before study treatment infusion on Day 1 of Cycle 1 or anticipation that such a live, attenuated vaccine will be required during the study. Live vaccines during the study and until participants B cells recover, are prohibited Influenza vaccination should be given during influenza season only. Participants must not receive live, attenuated influenza vaccine at any time during the study treatment period.\n24. Suspected active or latent tuberculosis (as confirmed by a positive interferon-gamma release assay)\n25. Positive test results for chronic hepatitis B infection (defined as positive hepatitis B surface antigen \\[HBsAg\\] serology) Participants with occult or prior hepatitis B infection (defined as positive total hepatitis B core antibody and negative HBsAg) may be included if hepatitis B virus (HBV) DNA is undetectable at the time of screening. Such participants must be willing to undergo HBV DNA testing on Day 1 of every cycle and every 3 months for at least 12 months after the final cycle of study treatment and appropriate antiviral therapy as indicated.\n26. Positive test results for hepatitis C (hepatitis C virus \\[HCV\\] antibody serology testing) Participants positive for HCV antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA.\n27. Participants with a history of progressive multifocal leukoencephalopathy\n28. Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 18 months after pretreatment with obinutuzumab or 2 months after the final dose of glofitamab, whichever is longer\n29. Positive SARS-CoV-2 test within 7 days prior to enrollment. Rapid antigen test result is also acceptable",{"count":227,"type":21},47,[118],"Patients with diffuse large B-cell lymphoma (DLBCL) who are primary refractory to first-line R-CHOP therapy or relapse within 12 months after R-CHOP have a poor prognosis and limited treatment options. Conventional salvage chemotherapy has limited efficacy, and CAR-T cell therapy may be limited by manufacturing time, accessibility, and patient condition. Therefore, an immediately available, chemotherapy-free treatment strategy that may reduce the cumulative toxicity of conventional cytotoxic chemotherapy is needed.\n\nPolatuzumab vedotin is a CD79b-targeted antibody-drug conjugate that delivers a cytotoxic agent to malignant B cells, and glofitamab is a CD20×CD3 bispecific antibody that activates T cells and induces immune-mediated antitumor activity. The combination of these two agents may provide complementary antitumor effects through direct tumor cell killing and T-cell-mediated immune response.\n\nThis single-arm, open-label, phase 2 study will evaluate the efficacy and safety of polatuzumab vedotin in combination with glofitamab in patients with DLBCL who are primary refractory to or relapse within 12 months after first-line R-CHOP therapy. Approximately 47 participants will be enrolled. The primary endpoint is the complete response rate at the end of treatment, as assessed by the investigator according to Lugano 2014 criteria.",[231],"Diffuse Large B-cell Lymphoma",[233,234,235,236,237,238,239],"Diffuse large B-cell lymphoma","Relapsed or refractory DLBCL","Polatuzumab vedotin","Glofitamab","Phase 2","Complete response rate","Lugano 2014","2026-07-12",{"date":155,"type":44},{"date":80,"type":21},{"date":244,"type":21},"2030-08-31",{"name":50,"class":51},{"id":247,"slug":248,"hasResults":12,"nctId":249,"briefTitle":250,"officialTitle":251,"acronym":4,"eligibilityCriteria":252,"healthyVolunteers":253,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":254,"targetDuration":256,"studyType":22,"phases":4,"briefSummary":257,"conditions":258,"keywords":261,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":267,"lastUpdatePostDateStruct":268,"startDateStruct":270,"completionDateStruct":271,"leadSponsor":273,"locationsCount":4},"100646104","perioperative-hypoglycemia-in-diabetic-patients-undergoing-vitrectomy-a-masked-cgm-prospective-observational-study-100646104","NCT07696910","Perioperative Hypoglycemia in Diabetic Patients Undergoing Vitrectomy: a Masked CGM Prospective Observational Study","Incidence of Perioperative Hypoglycemia Assessed by Masked Continuous Glucose Monitoring in Patients With Diabetes Undergoing Vitrectomy: a Prospective Observational Cohort Study","Inclusion Criteria:\n\n1. Adults aged 19 years or older\n2. Diagnosed with diabetes mellitus\n3. Scheduled to undergo pars plana vitrectomy (TPPV)\n4. Able to provide written informed consent\n\nExclusion Criteria:\n\n1. CGM sensor placement not feasible\n2. Known allergy to the CGM sensor\n3. Unable to obtain valid CGM data\n4. Unable to provide voluntary informed consent",true,{"count":255,"type":21},85,"3 Months","Patients with diabetes are at increased risk of perioperative glycemic disturbances due to preoperative fasting, the surgical stress response, and the use of insulin or oral hypoglycemic agents. Hypoglycemia, in particular, is an important clinical concern associated with neurological injury and cardiovascular complications. In routine practice, intraoperative glucose monitoring often relies on intermittent fingerstick testing or blood gas analysis, and these intermittent methods may fail to detect hypoglycemic episodes that occur during and immediately after surgery.\n\nContinuous glucose monitoring (CGM), which estimates glucose concentrations from interstitial fluid, allows continuous tracking of glycemic trends and may provide a more precise assessment of glycemic variability and hypoglycemia in the perioperative period. Although current guidelines recommend periodic intraoperative glucose measurement in patients with diabetes-especially those receiving insulin-glucose monitoring is frequently omitted during relatively short and stable ophthalmic procedures such as vitrectomy. Because vitrectomy is commonly performed in patients with diabetes, perioperative hypoglycemia in this population may go undetected.\n\nThis is a single-center, prospective, observational cohort study conducted in patients with diabetes undergoing pars plana vitrectomy (TPPV). A masked CGM device (FreeStyle Libre 2®, an approved continuous glucose monitor) is applied for observational purposes only and does not influence clinical care. The sensor is placed on the upper arm before surgery. After an approximately one-hour warm-up period, glucose data are collected at 15-minute intervals from the completion of CGM warm-up until discharge from the post-anesthesia care unit (PACU); this interval defines the perioperative period for data collection. Throughout this period the CGM operates in a masked mode-no reader is provided, the device is not linked to the participant's smartphone, and alarms are disabled-so that real-time glucose values are not displayed to clinicians or participants. All glycemic management follows the existing standard of care based on point-of-care testing (POCT), and CGM data do not contribute to clinical decision-making. After all participants have completed data collection, CGM data are unblinded and analyzed.\n\nThe primary objective is to estimate the incidence of perioperative hypoglycemia, defined as a CGM glucose value below 70 mg\u002FdL (Level 1), during the perioperative period. Secondary objectives include the incidence of clinically significant hypoglycemia (below 54 mg\u002FdL, Level 2); indices of glycemic variability (Time Below Range, maximum and minimum glucose, and glucose excursion); identification of clinical risk factors associated with perioperative hypoglycemia (such as age, diabetes characteristics, HbA1c, insulin use, fasting duration, and operative time); the exploratory association between perioperative hypoglycemia and postoperative ophthalmic outcomes (changes in best-corrected visual acuity and ophthalmic complications such as recurrent vitreous hemorrhage, retinal redetachment, elevated intraocular pressure, and the need for additional procedures); and an exploratory, opportunistic concordance analysis between standard-of-care POCT glucose values and time-matched CGM values (within ±5 minutes). Hypoglycemia is classified according to ADA\u002FDanne et al. criteria.\n\nEligible participants are adults aged 19 years or older with diabetes who are scheduled for vitrectomy and able to provide written informed consent. Participants are excluded if CGM sensor placement is not feasible, if they have a known sensor allergy, if valid data cannot be obtained, or if voluntary informed consent is not possible. Based on the institution's monthly surgical volume and the estimated proportion of patients with diabetes, a target enrollment of 85 participants over a 12-month study period is considered feasible. Postoperative ophthalmic outcomes are assessed using medical records from routine outpatient follow-up visits (for example, at approximately one week and one to three months after surgery) without any additional study-specific visits.\n\nBecause the primary aim is to estimate the incidence of perioperative hypoglycemia, ophthalmic outcomes and POCT-CGM concordance are analyzed as exploratory endpoints. This study aims to characterize the limitations of current perioperative glucose monitoring strategies and to provide foundational data for future risk-based monitoring strategies and CGM-based interventional research.",[259,260],"Diabetes Mellitus","Hypoglycemia",[262,263,264,265,266],"Continuous glucose monitoring (CGM)","Perioperative hypoglycemia","Diabetes mellitus","Vitrectomy","Blood glucose monitoring","2026-07-08",{"date":269,"type":44},"2026-07-10",{"date":212,"type":21},{"date":272,"type":21},"2027-07-15",{"name":50,"class":51},{"id":275,"slug":276,"hasResults":12,"nctId":277,"briefTitle":278,"officialTitle":279,"acronym":280,"eligibilityCriteria":281,"healthyVolunteers":12,"sex":17,"minAge":282,"maxAge":4,"enrollmentInfo":283,"targetDuration":4,"studyType":61,"phases":285,"briefSummary":286,"conditions":287,"keywords":289,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":215,"lastUpdatePostDateStruct":290,"startDateStruct":291,"completionDateStruct":293,"leadSponsor":295,"locationsCount":296},"100639793","comparison-of-operator-radiation-exposure-during-percutaneous-coronary-intervention-between-left-distal-and-right-conventional-radial-access-100639793","NCT07579169","Comparison of Operator Radiation Exposure During Percutaneous Coronary Intervention Between Left Distal and Right Conventional Radial Access","Comparison of Operator Radiation Exposure During Percutaneous Coronary Intervention Between Left Distal and Right Conventional Radial Access: A Multicenter, Randomized Trial","DOSE-PCI","Inclusion Criteria:\n\n1. Patients aged 19 years or older\n2. Patients scheduled for PCI\n\nExclusion Criteria:\n\n1. Non-palpable left distal radial artery pulse\n2. Non-palpable right radial artery pulse\n3. Presence of arteriovenous fistula\n4. Need for femoral access as determined by the investigator\n5. Refusal to provide informed consent\n6. Pregnant or breastfeeding women","20 Years",{"count":284,"type":21},748,[63],"This study aims to compare the operator's radiation exposure between left distal radial access (LDRA) and right transradial access (RTRA) in patients undergoing percutaneous coronary intervention (PCI).",[288],"Radiation Exposure",[280],{"date":267,"type":44},{"date":292,"type":44},"2026-06-18",{"date":294,"type":21},"2029-04-21",{"name":50,"class":51},4,{"id":298,"slug":299,"hasResults":12,"nctId":300,"briefTitle":301,"officialTitle":301,"acronym":4,"eligibilityCriteria":302,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":303,"targetDuration":4,"studyType":61,"phases":305,"briefSummary":306,"conditions":307,"keywords":4,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":310,"lastUpdatePostDateStruct":311,"startDateStruct":313,"completionDateStruct":315,"leadSponsor":317,"locationsCount":192},"100493488","effects-of-pitavastatin-or-combination-of-pitavastatin-and-ezetimibe-on-glucose-metabolism-compared-to-atorvastatin-in-atherosclerotic-cardiovascular-disease-patients-with-metabolic-syndrome-the-ez-pearl-randomized-trial-100493488","NCT05705804","Effects of Pitavastatin or Combination of Pitavastatin and Ezetimibe on Glucose Metabolism Compared to AtoRvastatin in atheroscLerotic Cardiovascular Disease Patients With Metabolic Syndrome: The EZ-PEARL Randomized Trial","Inclusion Criteria:\n\n1. Patients with dyslipidemia\n2. Patient with diagnosis of clinical atherosclerotic cardiovascular disease (acute coronary syndrome, history of myocardial infarction, stable or unstable angina, history of coronary artery reperfusion, stroke or transient stroke, history of peripheral arterial disease or peripheral arterial reperfusion)\n3. Patients with metabolic syndrome but without diabetes\n\nExclusion Criteria:\n\n1. Diagnosis of clinical atherosclerotic cardiovascular disease within 1 year\n2. Acute liver disease or persistent unexplained serum AST or ALT three times the upper limit of normal\n3. Allergy or hypersensitivity to statins or ezetimibe\n4. Solid organ transplant recipients\n5. History of side effects requiring discontinuation of statin administration\n6. Pregnant women, potentially pregnant or lactating women\n7. Life expectancy less than 3 years\n8. If it is judged that follow-up for more than 1 year is not possible\n9. If the patient is unable to understand or read the consent form",{"count":304,"type":21},250,[63],"The purpose of this study was to investigate the effect of pitavastatin or pitavastatin and ezetimibe combination therapy on glucose metabolism compared to atorvastatin in patients with atherosclerotic cardiovascular disease with metabolic syndrome.",[308,309],"Dyslipidemias","Atherosclerotic Cardiovascular Disease","2026-07-03",{"date":312,"type":44},"2026-07-07",{"date":314,"type":44},"2023-06-13",{"date":316,"type":21},"2027-06-01",{"name":50,"class":51},{"id":319,"slug":320,"hasResults":12,"nctId":321,"briefTitle":322,"officialTitle":323,"acronym":4,"eligibilityCriteria":324,"healthyVolunteers":12,"sex":325,"minAge":18,"maxAge":4,"enrollmentInfo":326,"targetDuration":4,"studyType":61,"phases":328,"briefSummary":329,"conditions":330,"keywords":4,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":310,"lastUpdatePostDateStruct":332,"startDateStruct":333,"completionDateStruct":335,"leadSponsor":337,"locationsCount":192},"100432379","phase-2-consolidation-nivolumab-after-concurrent-chemoradiotherapy-in-locally-advanced-nasopharyngeal-carcinoma-100432379","NCT04910347","Consolidation Nivolumab After Concurrent Chemoradiotherapy in Locally Advanced Nasopharyngeal Carcinoma","A Phase 2, Open-label Trial of Consolidation Nivolumab After Concurrent Chemoradiotherapy in Locally Advanced Nasopharyngeal Carcinoma","Inclusion Criteria:\n\n1. Male or female\n2. Age (at the time of informed consent): 19 years and older\n3. Subjects with histologically- or cytologically-confirmed advanced Nasopharyngeal cancer (Stage II -IVa) according to 8th edition clinical staging system of the American Joint Committee on Cancer before the start of concurrent chemoradiotherapy\n4. Patients who have recovered from previous toxicities of standard chemoradiotherapy (Grade ≤1).\n5. ECOG (Eastern Cooperative Oncology Group) Performance Status Score 0 or 1\n6. Patients with a life expectancy of at least 3 months\n7. Patients whose latest laboratory data meet the below criteria within 7 days before registration. If the date of the laboratory tests at the time of registration is not within 7 days before the first dose of the investigational product, testing must be repeated within 7 days before the first dose of the investigational product, and these latest laboratory tests must meet the following criteria. Of note, laboratory data will not be valid if the patient has received a granulocyte colony-stimulating factor (G-CSF) or blood transfusion within 14 days before testing.\n\n   * White blood cells ≥2,000\u002Fmm3 and neutrophils ≥1,500\u002Fmm3\n   * Platelets ≥100,000\u002Fmm3\n   * Hemoglobin ≥9.0 g\u002FdL\n   * AST (GOT) and ALT (GPT) ≤3.0-fold the upper limit of normal (ULN) of the study site (or ≤5.0-fold the ULN of the study site in patients with liver metastases)\n   * Total bilirubin ≤1.5-fold the ULN of the study site\n   * Creatinine ≤1.5-fold the ULN of the study site or creatinine clearance (either the measured or estimated value using the Cockcroft-Gault equation) \\>45 mL\u002Fmin\n8. Women of childbearing potential (including women with chemical menopause or no menstruation for other medical reasons) #1 must agree to use contraception#2 from the time of informed consent until 5 months or more after the last dose of the investigational product. Also, women must agree not to breastfeed from the time of informed consent until 5 months or more after the last dose of the investigational product.\n9. Men must agree to use contraception#2 from the start of study treatment until 7 months or more after the last dose of the investigational product.\n\n   * Women of childbearing potential are defined as all women after the onset of menstruation who are not postmenopausal and have not been surgically sterilized (e.g., hysterectomy, bilateral tubal ligation, bilateral oophorectomy). Postmenopause is defined as amenorrhea for ≥12 consecutive months without specific reasons. Women using oral contraceptives, intrauterine devices, or mechanical contraception such as contraceptive barriers are regarded as having childbearing potential.\n   * The subject must consent to use any two of the following methods of contraception: vasectomy or condom for patients who are male or female subject's partner and tubal ligation, contraceptive diaphragm, intrauterine device, spermicide, or oral contraceptive for patients who are female or male subject's partner.\n\nExclusion Criteria:\n\n1. Patients with multiple primary cancers (with the exception of completely resected basal cell carcinoma, stage I squamous cell carcinoma, carcinoma in situ, intramucosal carcinoma, or superficial bladder cancer, or any other cancer that has not recurred for at least 5 years)\n2. Patients with residual adverse effects of prior therapy or effects of surgery that would affect the safety evaluation of the investigational product in the opinion of the investigator or sub-investigator.\n3. Patients with current or past history of severe hypersensitivity to any other antibody products\n4. Patients with concurrent autoimmune disease or history of chronic or recurrent autoimmune disease\n5. Patients with a current or past history of interstitial lung disease or pulmonary fibrosis diagnosed based on imaging or clinical findings. Patients with radiation pneumonitis may be randomized if the radiation pneumonitis has been confirmed as stable (beyond acute phase) without any concerns about recurrence.\n6. Patients with concurrent diverticulitis or symptomatic gastrointestinal ulcerative disease\n7. Patients with any metastasis in the brain or meninx that is symptomatic or requires treatment. Patients may be randomized if the metastasis is asymptomatic and requires no treatment.\n8. Patients with pericardial fluid, pleural effusion, or ascites requiring treatment\n9. Patients with uncontrollable, tumor-related pain\n10. Patients who have experienced a transient ischemic attack, cerebrovascular accident, thrombosis, or thromboembolism (pulmonary arterial embolism or deep vein thrombosis) within 180 days before registration\n11. Patients with a history of uncontrollable or significant cardiovascular disease meeting any of the following criteria:\n\n    * Myocardial infarction within 180 days before registration\n    * Uncontrollable angina pectoris within 180 days before registration\n    * New York Heart Association (NYHA) Class III or IV congestive heart failure\n    * Uncontrollable hypertension despite appropriate treatment (e.g., systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥ 90 mmHg lasting 24 hours or more)\n    * Arrhythmia requiring treatment\n12. Patients receiving or requiring anticoagulant therapy for a disease. Patients receiving antiplatelet therapy including low-dose aspirin may be enrolled.\n13. Patients with uncontrollable diabetes mellitus\n14. Patients with systemic infections requiring treatment\n15. Patients who have received systemic corticosteroids (except for temporary use, e.g., for examination or prophylaxis of allergic reactions) or immunosuppressants within 28 days before registration\n16. Patients who have received antineoplastic drugs (e.g., chemotherapy agents, molecular-targeted therapy agents, or immunotherapy agents) within 28 days before registration\n17. Patients who have undergone surgical adhesion of the pleura or pericardium within 28 days before registration\n18. Patients who have undergone surgery under general anesthesia within 28 days before registration\n19. Patients who have undergone surgery involving local or topical anesthesia within 14 days before registration\n20. Patients who have received radiotherapy within 28 days before registration, or radiotherapy to bone metastases within 14 days before registration\n21. Patients who have received any radiopharmaceuticals (except for examination or diagnostic use of radiopharmaceuticals) within 56 days before registration\n22. Patients with a positive test result for any of the following: HIV-1 antibody, HIV-2 antibody, HTLV-1 antibody, HBs antigen, or HCV antibody (except if HCV-RNA negative)\n23. Patients with a negative HBs antigen test but a positive test result for either HBs antibody or HBc antibody with a detectable level of HBV-DNA\n24. Women who are pregnant or breastfeeding, or possibly pregnant\n25. Patients who have received any other unapproved drug (e.g., investigational use of drugs, unapproved combined formulations, or unapproved dosage forms) within 28 days before registration\n26. Patients who have previously received Nivolumab, anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody, anti-CD137 antibody, anti-CTLA-4 antibody or other therapeutic antibodies or pharmacotherapies for regulation of T-cells\n27. Patients judged to be incapable of providing consent for reasons such as concurrent dementia\n28. Other patients judged by the investigator or sub-investigator to be inappropriate as subjects of this study\n29. Patient with current or past history of hypersensitivity to Nivolumab.","MALE",{"count":327,"type":21},57,[118],"The clinical efficacy of nivolumab for locally advanced nasopharyngeal carcinoma patients with residual disease after standard chemoradiotherapy is not known. In this study, we aim to investigate the role of nivolumab in locally advanced NPC after chemoradiotherapy the safety profile and antitumor activity of the anti-programmed death 1 (PD-1) receptor monoclonal antibody, nivolumab after in patients with advanced nasopharyngeal carcinoma",[331],"Locally Advanced Nasopharyngeal Carcinoma",{"date":312,"type":44},{"date":334,"type":44},"2022-02-07",{"date":336,"type":21},"2031-05",{"name":50,"class":51},{"id":339,"slug":340,"hasResults":12,"nctId":341,"briefTitle":342,"officialTitle":342,"acronym":4,"eligibilityCriteria":343,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":344,"targetDuration":4,"studyType":61,"phases":346,"briefSummary":347,"conditions":348,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":350,"lastUpdatePostDateStruct":351,"startDateStruct":353,"completionDateStruct":354,"leadSponsor":356,"locationsCount":4},"100646250","phase-2-a-phase-2-multicenter-single-arm-clinical-trial-of-zanzalintinib-and-pembrolizumab-in-subjects-with-resectable-clear-cell-renal-cell-carcinoma-100646250","NCT07691476","A Phase 2 Multicenter Single-Arm Clinical Trial of Zanzalintinib and Pembrolizumab in Subjects With Resectable Clear Cell Renal Cell Carcinoma","Inclusion Criteria:\n\n1. Subjects with clear cell renal cell carcinoma (clear cell RCC) confirmed by pathological or cytological diagnosis.\n\n   meeting one or more of the following criteria:\n   * Locally advanced disease or resectable metastatic disease.\n   * Resectable intermediate- to high-risk or high-risk patients are eligible for enrollment.\n   * Resectability is determined by multidisciplinary Resectability will be determined based on multidisciplinary evaluation. Resectable metastatic disease is defined as cases in which, in the presence of a primary tumor, complete resection of both the primary tumor and all identifiable metastatic lesions is deemed feasible by multidisciplinary assessment. All metastatic lesions must be amenable to complete resection within the planned surgical schedule. Subjects will be excluded from enrollment if metastatic lesions have already been completely resected prior to study entry, are deemed unresectable, or are expected to have residual disease after attempted resection.\n\n   Intermediate-High Risk Group cT2· Grade 4· or· Sarcomatoid cT3, any Grade, N0 High Risk Group cT4, any Grade, N0 any cT, any Grade, N+ Resectable Metastatic Disease any cT, any cN, any Grade, M1\n2. Age 19 years or older on the day of consent\n3. ECOG performance status 0\\~1\n4. Female subjects of childbearing potential must have a negative result on a serum or urine pregnancy test conducted during the clinical trial screening period. If the urine test result is positive or cannot be confirmed as negative, a serum pregnancy test must be performed.\n5. Sexually active fertile subjects and their partners must agree to use highly effective method of contraception (defined in Appendix E) during the course of the study and for a specified period after the last dose of treatment, as defined below. Subjects and their partners must consistently use highly effective contraception, and an additional contraceptive method (e.g., condom) is required.\n\n   * Male subjects: Must use a condom during the treatment period and for 120 days after the last dose and must agree not to donate sperm during this period.\n   * Female subjects: Women of childbearing potential (WOCBP) must comply with protocol-specified contraceptive methods during the treatment period and for 186 days after the last dose.\n\n   The durations reflect the longer washout period between Zanzalintinib and Pembrolizumab.\n6. Measurable disease according to Response Evaluation Criteria in Solid Tumors version 1.1 as determined by the Investigator.\n7. Capable of understanding and complying with the protocol requirements and must have signed the informed consent document.\n8. Adequate organ and marrow function as defined by the table below.\n\nTable 2. Organ function requirements for eligibility evaluation Organ System Laboratory Test Criteria Hematological Absolute neutrophil count (ANC) ≥1,500\u002FμL Platelets ≥100,000\u002FμL Hemoglobin ≥9.0 g\u002FdL or ≥5.6 mmol\u002FL Renal Creatinine OR creatinine clearance (CrCl) (If CrCl is used, estimated GFR may also be acceptable) ≤1.5 × ULN OR CrCl ≥60 mL\u002Fmin (if applicable to the study population)\n\nUrine protein-to-creatinine ratio (UPCR) ≤1.5 mg\u002Fmg Hepatic\n\nTotal bilirubin ≤1.5 × ULN OR, if subject has known Gilbert's syndrome:\n\ndirect bilirubin ≤1.5 × ULN (Subjects with other causes of hyperbilirubinemia: total bilirubin ≤3 × ULN and ALT \\\u003C3 × ULN) AST (SGOT) and ALT (SGPT) ≤2.5 × ULN (or ≤5 × ULN for subjects with liver metastasis) Coagulation International Normalized Ratio (INR) or Prothrombin Time (PT) and Activated Partial Thromboplastin Time (aPTT) ≤1.5 × ULN, or if the subject is receiving anticoagulant therapy within the treatment range, no restrictions apply.\n\nExclusion Criteria:\n\n1. Concurrent anticancer treatments other than the investigational therapy, including chemotherapy, curative radiotherapy, surgery, immunotherapy, biological therapy, or tumor embolization.\n2. Radiation therapy for bone metastasis within 2 weeks, any other radiation therapy within 4 weeks before first dose of study treatment. Systemic treatment with radionuclides within 6 weeks before first dose of study treatment. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible.\n3. Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and\u002For surgery (including radiosurgery) and stable for at least 4 weeks before first dose of study treatment.\n4. History of prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2 therapies, or vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitors.\n5. Any complementary medicine within 2 weeks prior to first dose of treatment.\n6. History of another malignancy within the 2 years prior to the first dose of study treatment, except for basal cell carcinoma or squamous cell carcinoma treated solely by local excision, cervical carcinoma in situ, or completely resected papillary thyroid carcinoma.\n7. Diagnosis of immunodeficiency or is receiving systemic steroid therapy (\\> 10 mg daily prednisone equivalent) or any other form of immunosuppressive therapy within 2 weeks prior to first dose of study treatment. Inhaled, intranasal, intraarticular, and topical corticosteroids and mineralocorticoids are allowed\n8. Presence of untreated fistulas, irrespective of cancer status.\n9. Presence of uncontrolled concomitant diseases, including but not limited to ongoing or active infections, symptomatic congestive heart failure, unstable angina, cardiac arrhythmias, immunosuppressive conditions, autoimmune diseases, underlying pulmonary disorders, or psychiatric or social conditions that may limit compliance with clinical trial requirements.\n10. Active autoimmune diseases requiring systemic treatment (e.g., disease-modifying agents, corticosteroids, or immunosuppressants) within 2 years before the treatment of trial. Physiologic corticosteroid replacement for thyroid hormone, insulin, or adrenal\u002Fpituitary insufficiency is excluded from this criterion.\n11. Thrombotic, embolic, venous, or arterial events (e.g., cerebrovascular accident including transient ischemic attack, deep vein thrombosis, pulmonary embolism) within 6 months before the treatment of trial.\n12. Concomitant anticoagulation with oral anticoagulants and platelet inhibitors. Only low-dose aspirin and LMWH are permitted.\n13. Subjects must have discontinued anticoagulant within 3 days or 5 half-lives prior to the first dose of treatment (whichever is longer)\n14. History of non-infectious pneumonitis requiring corticosteroid therapy or presence of current pneumonitis.\n15. Uncontrolled hypertension (\\>140 mmHg systolic or \\>90 mmHg diastolic despite optimal antihypertensive treatment\n16. Prior history of myocarditis\n17. Known gastric or esophageal varices\n18. Ascites, pleural effusion, or pericardial fluid requiring drainage in last 4 weeks\n19. Clinically significant hematuria, hematemesis, or hemoptysis of \\> 0.5 tsp of red blood, or other history of significant bleeding within 12 weeks before first dose of study treatment\n20. Symptomatic cavitating pulmonary lesion(s) or endobronchial disease (asymptomatic or radiated lesions allowed)\n21. Lesions invading or encasing any major blood vessels\n22. Serious non-healing wound\u002Fulcer\u002Fbone fracture. Note: non-healing wounds or ulcers are permitted if due to tumor-associated skin lesions\n23. Malabsorption syndrome\n24. Pharmacologically uncompensated, symptomatic hypothyroidism\n25. Moderate to severe hepatic impairment (Child-Pugh B-C)\n26. Requirement for hemodialysis or peritoneal dialysis\n27. History of solid organ or allogeneic stem cell transplant\n28. Major surgery within 8 weeks or minor surgery within 14 days prior to study treatment. Subjects must have complete wound healing following major or minor surgery prior to the first dose of study treatment.\n\n    If a tumor biopsy is performed prior to treatment initiation, study treatment may only be initiated after at least 14 days have elapsed from the date of the biopsy and complete wound healing at the biopsy site has been clinically confirmed.\n\n    Complete wound healing is defined as closure of the biopsy site without the need for dressing, and absence of active bleeding, hematoma, infection, erythema, drainage, worsening pain, or wound dehiscence.\n\n    If complications such as bleeding, hematoma, infection, persistent pain, drainage, wound dehiscence, or any complication requiring additional intervention occur after biopsy, study treatment must not be initiated until such complications have resolved and complete wound healing has been confirmed.\n\n    The investigator may further delay the initiation of study treatment if additional waiting time is considered necessary, taking into account the biopsy location, procedure, and risk of bleeding.\n29. History of psychiatric illness likely to interfere with ability to comply with protocol requirements or give informed consent.\n30. Inability to swallow tablets or ingest a suspension either orally or by a NG or PEG tube\n31. Previously identified allergy or hypersensitivity to components of treatment\n32. Other conditions, which in the opinion of the investigator, would compromise the safety of the patient or the patient's ability to complete the study\n33. Known positive test for tuberculosis infection if supported by clinical or radiographic evidence of disease\n34. History of idiopathic pulmonary fibrosis, organizing pneumonia, drug induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan. History of radiation pneumonitis in the radiation field is permitted.\n35. Free thyroxine (FT4) outside the laboratory normal reference range. Asymptomatic subjects with FT4 abnormalities can be eligible after Principal Investigator approval.\n36. Administration of a live, attenuated vaccine within 30 days before first dose of study treatment.\n37. Pregnancy or breastfeeding. Negative serum or urine pregnancy test results must be confirmed within 1 week before the treatment of trial.\n38. History of HIV infection or chronic or active hepatitis C requiring antiviral therapy. In cases of hepatitis B, enrollment is permitted if the patient is receiving appropriate antiviral treatment and viral DNA is undetectable.",{"count":345,"type":21},48,[118],"This is a multicenter, single-arm, phase 2 clinical trial designed to evaluate the clinical efficacy of combination therapy with zanzalintinib and pembrolizumab in patients with locally advanced intermediate- to high-risk, high-risk, or resectable metastatic clear cell renal cell carcinoma.\n\nThe neoadjuvant treatment period consists of a total of 6 cycles; pembrolizumab is administered every 3 weeks, and zanzalintinib is administered orally once daily. A drug washout period of at least 21 days is required prior to the last dose before surgery.\n\nSurgery will be performed after completion of the neoadjuvant treatment and following a drug washout period of at least 21 days.\n\nThe adjuvant treatment period begins at least 28 days after surgery, and pembrolizumab is administered every 3 weeks for a total of 11 cycles.\n\nRadiologic response assessments are conducted at predefined time points during the neoadjuvant period, and pathologic response is evaluated using resected tissue obtained at the time of surgery.\n\n* Study duration: Approximately 30 months (18 months for enrollment + 12 months for treatment and follow-up)\n* Planned sample size: 48 patients (including an estimated 10% dropout rate) Tumor size and disease stage will be assessed using baseline imaging performed prior to treatment, and tumor response will be evaluated through predefined scheduled imaging assessments conducted during treatment. Tumor response will be evaluated during treatment via imaging at regular intervals per cycle. Surgery will be scheduled after the completion of 6 cycles, following a minimum 21-day washout period (±7 days at the investigator's discretion). If postoperative recovery is adequate (at least 28 days, ±14 days at the investigator's discretion), adjuvant Pembrolizumab treatment will commence.",[349],"Patients With Locally Advanced or Metastatic But Resectable Clear Cell Renal Cell Carcinoma","2026-07-02",{"date":352,"type":44},"2026-07-09",{"date":46,"type":21},{"date":355,"type":21},"2029-02-01",{"name":50,"class":51},{"id":358,"slug":359,"hasResults":12,"nctId":360,"briefTitle":361,"officialTitle":362,"acronym":4,"eligibilityCriteria":363,"healthyVolunteers":12,"sex":17,"minAge":282,"maxAge":200,"enrollmentInfo":364,"targetDuration":4,"studyType":61,"phases":366,"briefSummary":368,"conditions":369,"keywords":373,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":375,"lastUpdatePostDateStruct":376,"startDateStruct":377,"completionDateStruct":379,"leadSponsor":381,"locationsCount":4},"100646779","phase-4-a-phase-iv-randomized-trial-of-maxigesic-versus-standard-analgesia-after-radical-gastrectomy-100646779","NCT07687394","A Phase IV Randomized Trial of Maxigesic® Versus Standard Analgesia After Radical Gastrectomy","A Phase IV, Multicenter, Double-blind, Randomized Controlled Trial to Evaluate the Superiority of Maxigesic® Over Standard Analgesia in Patients Undergoing Radical Gastrectomy","Inclusion Criteria:\n\n* Patients aged 20 to 80 years diagnosed with gastric cancer by endoscopic biopsy who are scheduled for minimally invasive radical gastrectomy (laparoscopic or robotic)\n* Patients scheduled for distal, proximal, or total gastrectomy among minimally invasive procedures (wedge resection, pylorus-preserving gastrectomy, and segmental gastrectomy are not eligible)\n* Patients with an ECOG performance status of 0 or 1 and an ASA classification of I-III\n* Patients who have voluntarily agreed to participate after receiving a full explanation of the study's purpose and content, and who have signed the written informed consent form approved by the Institutional Review Board\n* Patients residing in Korea who are able to complete follow-up for 3 months after surgery\n\nExclusion Criteria:\n\n* Patients with a reported history of hypersensitivity, allergy, or adverse reaction to NSAIDs, opioids, or acetaminophen\n* Patients currently taking medications that may affect the study results, such as opioid or non-opioid analgesics, aspirin, warfarin or other anticoagulants, steroids, or high-dose hepatotoxic drugs\n* Pregnant or breastfeeding patients\n* Patients with a contraindication to NSAIDs or acetaminophen identified from medical history or preoperative evaluation-for example, active liver disease, heart failure, chronic kidney disease, thrombocytopenia, or a history of asthma (peptic ulcer disease is not an exclusion criterion)\n* Patients unable to read or understand the informed consent form\n* Patients weighing less than 45 kg\n* Patients scheduled for transfer to the intensive care unit instead of a general ward after surgery (ICU preparation)\n* Patients scheduled for emergency surgery",{"count":365,"type":21},160,[367],"PHASE4","Background: Radical gastrectomy causes moderate-to-severe pain during the first 48 hours after surgery. Opioids are effective but carry adverse effects and risks of prolonged use, so ERAS-based care recommends multimodal analgesia. Acetaminophen is the most commonly used non-opioid analgesic in gastrectomy patients; adding ibuprofen as a fixed-dose combination has shown improved analgesia and opioid-sparing effects compared with acetaminophen alone in other surgical populations, but direct evidence in gastrectomy patients is limited.\n\nObjective: To evaluate whether scheduled administration of an acetaminophen-ibuprofen fixed-dose combination (Maxigesic® IV) is superior to acetaminophen alone for pain relief after radical gastrectomy, with exploratory assessment of cost-effectiveness and of differences in analgesic efficacy according to genetic polymorphisms.\n\nHypothesis: When given on an identical scheduled regimen, the acetaminophen-ibuprofen fixed-dose combination produces significantly lower pain scores (NRS) over the first 48 postoperative hours than acetaminophen alone (superiority).\n\nStudy plan: This is a phase IV, multicenter, double-blind, randomized controlled trial in which 160 gastric cancer patients scheduled for minimally invasive radical gastrectomy (80 per arm) are randomized 1:1 with stratification by institution. In both arms, the assigned drug is given as a 15-minute intravenous infusion every 6 hours, starting 30 minutes before the end of surgery through 48 hours postoperatively. The primary endpoint is the between-group difference in the time-weighted average (TWA) of repeatedly measured resting and active NRS over 48 hours, analyzed using a mixed model for repeated measures (MMRM); secondary endpoints include opioid consumption (MME), the Quality of Recovery score (QoR-15K), the incidence of chronic postsurgical pain (CPSP), and in-hospital costs.",[370,371,372],"Stomach Neoplasms","Pain","Postoperative",[374],"Gastrectomy","2026-06-29",{"date":312,"type":44},{"date":378,"type":21},"2026-07-01",{"date":380,"type":21},"2028-12-31",{"name":50,"class":51},{"id":383,"slug":384,"hasResults":12,"nctId":385,"briefTitle":386,"officialTitle":387,"acronym":4,"eligibilityCriteria":388,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":389,"targetDuration":4,"studyType":61,"phases":391,"briefSummary":392,"conditions":393,"keywords":4,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":375,"lastUpdatePostDateStruct":395,"startDateStruct":397,"completionDateStruct":399,"leadSponsor":401,"locationsCount":192},"100477184","aspirin-vs-clopidogrel-after-tavr-100477184","NCT05493657","Aspirin vs Clopidogrel After TAVR","Aspirin Versus Clopidogrel for Leaflet Thrombosis Prevention in Patients Undergoing Transcatheter Aortic Valve Replacement: ACLO-TAVR Trial","Inclusion Criteria:\n\n1. Patients \\>19 years old\n2. Patients who underwent TAVR symptomatic severe AS\n3. Provision of informed consent\n\nExclusion Criteria:\n\n1. Patients requiring dual antiplatelet therapy longer than 4 weeks\n2. Any conditions requiring specific antiplatelet therapy aspirin or clopidogrel\n3. History of stroke or transient ischemic attack (TIA) within 6 months\n4. Planned major surgery\n5. Cardiogenic shock or hemodynamic instability\n6. Chronic kidney disease stage 4 or 5 (eGFR \\\u003C30mL\u002Fmin)\n7. Valve-in-valve TAVR procedure\n8. Hypersensitivity or contraindication to aspirin or clopidogrel\n9. Indication for anticoagulation therapy",{"count":390,"type":21},270,[63],"Currently, the optimal antithrombotic therapy after transcatheter aortic valve replacement (TAVR) remains still unknown., The purpose of the study is to compare aspirin versus clopidogrel monoantiplatelet therapy for preventive effect on leaflet thrombosis in patients undergoing TAVR for severe aortic stenosis. This study is designed as a prospective, multicenter, open label, randomized controlled study. Eligible patients will be randomized to aspirin or clopidogrel monotherapy after TAVR. Patients will have dual antiplatelet therapy of aspirin 100 mg and clopidogrel 75 mg for 4 weeks after TAVR and then subsequent monoantiplatelet therapy of either aspirin 100 mg or clopidogrel 75 mg according to the randomization. Leaflet thrombosis will be assessed with cardiac computed tomography (CT) and transthoracic echocardiography at 3 months after TAVR. Patients will be clinically followed for 6 months. The primary endpoint is the Incidence of leaflet thrombosis on cardiac CT at 3 months.",[394],"Severe Aortic Stenosis",{"date":396,"type":44},"2026-06-30",{"date":398,"type":44},"2023-02-02",{"date":400,"type":21},"2027-07-21",{"name":50,"class":51},{"id":403,"slug":404,"hasResults":12,"nctId":405,"briefTitle":406,"officialTitle":407,"acronym":4,"eligibilityCriteria":408,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":409,"enrollmentInfo":410,"targetDuration":4,"studyType":61,"phases":412,"briefSummary":413,"conditions":414,"keywords":4,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":419,"lastUpdatePostDateStruct":420,"startDateStruct":422,"completionDateStruct":424,"leadSponsor":426,"locationsCount":192},"100633239","moderate-intensity-statin-plus-ezetimibe-in-ckd-and-ascvd-100633239","NCT07524101","Moderate-Intensity Statin Plus Ezetimibe in CKD and ASCVD","Utilizing Lipid-lowering Therapy With Moderate-intensity Statin Plus Ezetimibe in Chronic Kidney Disease Patients With Concomitant Atherosclerotic Cardiovascular Disease: ULTRA-CKD Trial","Inclusion Criteria:\n\n1. Age 19-85 years.\n2. Chronic kidney disease stage III, IV, or V (CKD-EPI eGFR \\\u003C60 \u002F \\\u003C30 \u002F \\\u003C15 mL\u002Fmin\u002F1.73 m² or on dialysis).\n3. Established ASCVD, meeting at least one of the following:\n\n   * Prior acute coronary syndrome (myocardial infarction or unstable angina).\n   * Stable angina confirmed by imaging studies.\n   * History of coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting).\n   * Peripheral artery disease.\n   * Ischemic stroke or transient ischemic attack.\n\nExclusion Criteria:\n\n1. Baseline LDL cholesterol \\\u003C55 mg\u002FdL in the absence of statin therapy.\n2. Acute liver disease or persistently unexplained serum AST\u002FALT ≥2 × the upper limit of normal.\n3. Allergy or hypersensitivity to statins.\n4. Life expectancy \\\u003C1 year.\n5. Expected inability to complete at least 1 year of follow-up.\n6. Inability to read or understand the informed consent form.","85 Years",{"count":411,"type":21},1952,[63],"The ULTRA-CKD trial is a prospective, randomized, open-label, multicenter trial designed to compare the efficacy and safety of moderate-intensity statin plus ezetimibe combination therapy versus high-intensity statin monotherapy in patients with chronic kidney disease (CKD) and concomitant atherosclerotic cardiovascular disease (ASCVD).\n\nPatients with CKD are at very high risk for ASCVD. In this population, it is important to establish a lipid-lowering strategy that optimizes cardiovascular outcomes while ensuring long-term safety. While high-intensity statins are generally considered as initial treatment option for secondary prevention, the optimal strategy for CKD patients remains to be clinicaly defined. This study aims to evaluate whether the combination of moderate-intensity statin and ezetimibe is non-inferior to high-intensity statin monotherapy in terms of 3-year composite of major adverse cardiovascular events.",[415,416,417,418,142],"Renal Insufficiency","Atherosclerosis","Dyslipidemia","Hypercholesterolemia","2026-06-11",{"date":421,"type":44},"2026-06-16",{"date":423,"type":44},"2026-05-28",{"date":425,"type":21},"2031-01-22",{"name":50,"class":51},{"id":428,"slug":429,"hasResults":12,"nctId":430,"briefTitle":431,"officialTitle":432,"acronym":433,"eligibilityCriteria":434,"healthyVolunteers":12,"sex":17,"minAge":282,"maxAge":4,"enrollmentInfo":435,"targetDuration":4,"studyType":61,"phases":437,"briefSummary":438,"conditions":439,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":441,"startDateStruct":442,"completionDateStruct":444,"leadSponsor":446,"locationsCount":192},"100643392","phase-2-lurbinectedin-plus-paclitaxel-versus-paclitaxel-in-patients-with-previously-treated-small-cell-lung-cancer-100643392","NCT07640932","Lurbinectedin Plus Paclitaxel Versus Paclitaxel in Patients With Previously Treated Small Cell Lung Cancer","Lurbinectedin in Combination With Paclitaxel Versus Paclitaxel for Patients With Previously Treated Small Cell Lung Cancer: Randomized, Phase II, Open-label, Multi-center, Prospective Trial(LUPINE)","LUPINE","Inclusion Criteria:\n\n1. Age ≥ 19 years.\n2. Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC).\n3. Patients who have experienced disease progression following at least one prior platinum-based systemic therapy for extensive-stage small cell lung cancer, including all of the following conditions:\n\n   * Patients who failed treatment within 6 months after curative-intent chemotherapy are considered as having failed first-line therapy.\n   * For platinum-sensitive patients, participation in the third-line cohort is allowed after re-treatment with a platinum-based regimen as second-line therapy (limited-stage).\n   * For platinum-resistant patients, participation in the second-line cohort is allowed (limited-stage).\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.\n5. At least one measurable target lesion according to RECIST v1.1 criteria.\n6. Predicted life expectancy of at least 12 weeks (3 months).\n7. Adequate hematologic, renal, metabolic, and hepatic function within 14 days prior to enrollment, defined as:\n\n   Absolute neutrophil count (ANC) ≥ 1,500\u002FμL Platelet count ≥ 100,000\u002FμL Hemoglobin (Hb) ≥ 9.0 g\u002FdL Serum creatinine ≤ 1.5 × upper limit of normal (ULN) or calculated creatinine clearance (cCr) ≥ 60 mL\u002Fmin Total bilirubin ≤ 1.0 × ULN AST and ALT ≤ 3.0 × ULN (regardless of liver metastasis) PT and aPTT ≤ 1.5 × ULN\n8. Willingness to provide unstained slides (minimum 5, ideally 15) from archived or freshly biopsied tissue for exploratory analyses.\n9. Female participants of childbearing potential must have a negative pregnancy test (urine) at screening. If the urine test is positive or inconclusive, a negative serum pregnancy test is required.\n\n   Female participants of childbearing potential must agree to use effective contraception during the study.\n10. Male participants of reproductive potential must agree to use effective contraception during the study (see appendix for acceptable methods).\n11. Voluntary written informed consent to participate in this clinical trial.\n\nExclusion Criteria:\n\n1. Patients who have not received prior systemic therapy for small cell lung cancer (SCLC).\n2. Patients previously treated with Lurbinectedin or Paclitaxel.\n3. Patients with limited-stage small cell lung cancer (LS-SCLC).\n4. Patients with symptomatic or clinically significant brain metastases (patients with asymptomatic or stable brain metastases may be eligible; any treatment for brain metastases must have been completed at least 1 week prior to the first dose of study drug).\n5. Concomitant use of medications that may prolong the QTc interval, potent immunosuppressive agents, or drugs that may cause interstitial lung disease (ILD) is prohibited during the treatment period. If co-administration is unavoidable, prior discussion with the coordinating center is required.\n6. Patients with active primary immunodeficiency (e.g., HIV infection), active hepatitis B, or active hepatitis C:\n\n   * HBsAg-positive patients may be eligible if HBV DNA is negative or appropriate antiviral therapy is being administered.\n   * HCV antibody-positive patients may be eligible if HCV RNA is negative or the patient has been cured after treatment.\n7. Patients with active interstitial lung disease (ILD) or a history of non-infectious pneumonitis requiring steroid therapy, including immune-therapy- or chemotherapy-related ILD or Grade ≥3 pulmonary complications. (Patients with previously resolved infectious pneumonia without current clinical significance may be eligible.)\n8. Pregnant or breastfeeding women.\n9. Patients with clinically significant cardiovascular disease within the past 12 months (e.g., congestive heart failure, symptomatic coronary artery disease, arrhythmias, myocardial infarction).\n10. Patients whose toxicities from prior anticancer therapy have not recovered to baseline or ≤ Grade 2.\n11. Patients who received any prior anticancer therapy within 14 days or localized radiotherapy within 7 days before the first dose of the study drug.\n12. Patients with a known hypersensitivity to the study drugs.\n13. Any condition that, in the opinion of the investigator, makes the patient unsuitable for participation in the study.",{"count":436,"type":21},69,[118],"This clinical trial is designed to compare and evaluate the efficacy and safety of the combination therapy of Lurbinectedin plus Paclitaxel (Combination Arm) versus Paclitaxel monotherapy (Monotherapy Arm) in patients with extensive-stage small-cell lung cancer whose disease has progressed after first-line chemotherapy.",[440],"Carcinoma, Small Cell Lung",{"date":419,"type":44},{"date":443,"type":21},"2026-06",{"date":445,"type":21},"2029-02",{"name":50,"class":51},{"id":448,"slug":449,"hasResults":12,"nctId":450,"briefTitle":451,"officialTitle":452,"acronym":4,"eligibilityCriteria":453,"healthyVolunteers":253,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":454,"targetDuration":4,"studyType":61,"phases":456,"briefSummary":457,"conditions":458,"keywords":460,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":463,"lastUpdatePostDateStruct":464,"startDateStruct":466,"completionDateStruct":467,"leadSponsor":469,"locationsCount":192},"100641018","the-purpose-of-this-clinical-trial-is-to-evaluate-the-accuracy-of-blood-pressure-measurement-of-hicardi-m350-compared-to-blood-pressure-measured-by-auscultatory-sphygmomanometer-in-adult-volunteers-including-those-meeting-blood-pressure-distribution-requirements-in-accordance-with-iso-81060-22018-100641018","NCT07622498","The Purpose of This Clinical Trial is to Evaluate the Accuracy of Blood Pressure Measurement of HiCardi M350 Compared to Blood Pressure Measured by Auscultatory Sphygmomanometer in Adult Volunteers (Including Those Meeting Blood Pressure Distribution Requirements) in Accordance With ISO 81060-2:2018","A Prospective, Single-center, Single-arm, Pivotal Clinical Trial to Evaluate the Accuracy of Blood Pressure Measurements From the HiCardi M350(Patient Monitor) in Comparison With Those Measured Using an Auscultatory Sphygmomanometer","Inclusion Criteria:\n\n1. Adults aged 19 years or older.\n2. Individuals who visit Severance Hospital and voluntarily provide written informed consent after receiving and understanding sufficient explanation of the study.\n3. Individuals with hypertension-range blood pressure may be included to meet the blood pressure distribution requirements. Participants receiving antihypertensive medication may be included only if the type and dose of medication have remained stable for at least 4 weeks before screening. Individuals with dose changes, medication additions, or medication discontinuation within 4 weeks before screening will be excluded.\n\nExclusion Criteria:\n\n1. Individuals in whom Korotkoff phase V cannot be clearly identified during auscultatory blood pressure measurement.\n2. Individuals for whom blood pressure measurement is difficult or expected to be difficult.\n3. Individuals with bilateral arm circumference greater than 42 cm.\n4. Pregnant women.\n5. Individuals currently participating in another clinical trial or who have participated in another clinical trial within 30 days before the screening date.\n6. Individuals judged by the investigator to be inappropriate for participation in the clinical trial.",{"count":455,"type":21},100,[63],"This prospective, single-center, single-arm pivotal clinical trial is designed to evaluate the accuracy of blood pressure measurements obtained using the HiCardi M350 patient monitor compared with measurements obtained using an auscultatory sphygmomanometer.\n\nThe study will enroll adult volunteers aged 19 years or older, including participants needed to satisfy the blood pressure distribution requirements of ISO 81060-2:2018. The planned enrollment is 100 participants, considering the ISO 81060-2:2018 minimum requirement of 85 participants and an estimated dropout rate of approximately 15%. The study is also designed to obtain at least 255 valid paired blood pressure values.\n\nAfter written informed consent, participants will undergo screening assessments, including demographics, vital signs, medical and surgical history, prior and concomitant medications, pregnancy testing for women of childbearing potential, bilateral arm circumference measurement, eligibility assessment, and adverse event assessment. On the blood pressure test day, eligibility will be reconfirmed, an enrollment number will be assigned, HiCardi M350 calibration will be performed, and blood pressure measurements will be obtained using both HiCardi M350 and the reference auscultatory method.\n\nThe primary effectiveness endpoint is the difference between systolic and diastolic blood pressure values measured by HiCardi M350 and the reference sphygmomanometer under resting conditions. Accuracy will be evaluated according to ISO 81060-2:2018 using Criteria 1 and Criteria 2. Safety will be evaluated based on adverse events, adverse device effects, serious adverse events, serious adverse device effects, unanticipated adverse device effects, and device deficiencies.",[459],"No Restriction on Disease",[461,462],"HiCardi M350","Blood Pressure","2026-06-01",{"date":465,"type":44},"2026-06-03",{"date":463,"type":44},{"date":468,"type":21},"2026-08-31",{"name":50,"class":51},{"id":471,"slug":472,"hasResults":12,"nctId":473,"briefTitle":474,"officialTitle":475,"acronym":4,"eligibilityCriteria":476,"healthyVolunteers":12,"sex":17,"minAge":282,"maxAge":4,"enrollmentInfo":477,"targetDuration":4,"studyType":61,"phases":479,"briefSummary":480,"conditions":481,"keywords":484,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":463,"lastUpdatePostDateStruct":492,"startDateStruct":493,"completionDateStruct":494,"leadSponsor":495,"locationsCount":192},"100640379","in-hospital-wearable-based-monitoring-versus-standard-care-in-cardiovascular-disease-inspire-100640379","NCT07622485","In-Hospital Wearable-Based Monitoring Versus Standard Care in Cardiovascular Disease (INSPIRE)","In-Hospital Efficacy and Safety of Wearable-Based Monitoring Versus Standard Care in Cardiovascular Disease: A Stepped-Wedge Cluster Randomized Controlled Trial (INSPIRE Trial)","Inclusion Criteria:\n\nAdults aged 20 years or older\n\n* Hospitalized for cardiovascular disease, with at least one of: acute coronary syndrome; chronic coronary syndrome; acute heart failure (NYHA class III-IV or acute decompensated heart failure); arrhythmia (atrial fibrillation, ventricular tachycardia, complete AV block, or other clinically significant arrhythmia); peripheral arterial or aortic disease; post-cardiovascular-procedure observation (PCI, CABG, valve surgery, or electrophysiology study); or thromboembolic disease\n* Able to provide written informed consent\n* Able to wear the wearable monitoring device\n\nExclusion Criteria:\n\n* Hemodynamically unstable shock (sustained systolic blood pressure \\\u003C 90 mmHg requiring vasopressors; cardiogenic shock; septic shock)\n* Planned or current intensive care unit admission\n* Within 24 hours after cardiopulmonary resuscitation\n* Physical condition precluding device wearing (bilateral upper-limb amputation; severe skin lesion, burn, or open wound at the device site; known allergy to device materials)\n* Severe cognitive impairment or delirium precluding informed consent Extracorporeal membrane oxygenation (ECMO) or intra-aortic balloon pump (IABP) in use\n* Continuous renal replacement therapy (CRRT) in use (patients on CRRT may participate if hemodynamically stable and device wearing is technically feasible)\n* Unable to communicate in Korean for study explanation and the consent process\n* Previously enrolled in this study (re-admitted patients are not re-enrolled; each participant is enrolled only at the first admission)\n* Considered inappropriate for participation by the investigator",{"count":478,"type":21},1500,[63],"Patients hospitalized with cardiovascular disease require timely detection of clinical deterioration to prevent adverse outcomes. Standard inpatient care relies on intermittent nursing vital-sign measurements performed every 4 to 8 hours, which can miss hemodynamic or arrhythmic events occurring between measurements. This trial evaluates whether digital wearable-based monitoring - wireless continuous measurement of vital signs and electrocardiography with a real-time alerting system - reduces major adverse cardiovascular events (MACE) compared with standard intermittent monitoring in patients hospitalized for cardiovascular disease. The trial uses a stepped-wedge cluster-randomized design in which four inpatient ward zones (clusters) are sequentially transitioned from standard care to wearable monitoring over five periods.",[142,482,149,483,145],"Acute Coronary Syndrome","Cardiac Arrhythmia",[485,486,487,488,489,490,491],"wearable device","continuous monitoring","remote monitoring","stepped-wedge cluster trial","major adverse cardiovascular events","digital health","inpatient monitoring",{"date":465,"type":44},{"date":378,"type":21},{"date":48,"type":21},{"name":50,"class":51},{"id":497,"slug":498,"hasResults":12,"nctId":499,"briefTitle":500,"officialTitle":501,"acronym":4,"eligibilityCriteria":502,"healthyVolunteers":12,"sex":17,"minAge":503,"maxAge":504,"enrollmentInfo":505,"targetDuration":4,"studyType":61,"phases":507,"briefSummary":508,"conditions":509,"keywords":511,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":515,"lastUpdatePostDateStruct":516,"startDateStruct":518,"completionDateStruct":519,"leadSponsor":521,"locationsCount":4},"100639110","phase-2-everolimus-and-lenvatinib-versus-everolimus-for-bone-sarcoma-100639110","NCT07619950","EVERolimus and LenvAtinib Versus Everolimus for Bone Sarcoma","EVERolimus and LenvAtinib Versus Everolimus for Bone Sarcoma Progressing After Standard Treatmen : a Randomized, Phase 2, Multi-center Trial [EVERLAST]","Inclusion Criteria:\n\n1. Histologically confirmed advanced Osteosarcoma, Ewing sarcoma, Chondrosarcoma with 1-2 prior chemotherapy\n\n   : neoadjuvnat or adjuvant chemotherapy is counted as one regimen\n2. Age ≥19 years, \\\u003C80 years\n3. ECOG performance status of 0-1\n4. Has at least 1 measurable lesion (as defined by Response Evaluation Criteria in Solid Tumors Version 1.1).\n5. Has adequate organ function defined by the following criteria:\n\n   * Hb ≥ 9.0 g\u002FdL\n   * Absolute neutrophil count (ANC) ≥ 1000 \u002FµL\n   * Platelet ≥ 75,000\u002F µL\n   * Serum Creatinine: ≥ 50 mL\u002Fmin\n   * Total Bilirubin: ≤ 1.5 × UNL (upper normal limit)\n   * AST(SGOT)): ≤ 3.0 × UNL or ≤ 5.0 × UNL (in patients with liver metastasis)\n   * ALT(SGPT): ≤ 3.0 × UNL or ≤ 5.0 × UNL (in patients with liver metastasis)\n6. Female patient of childbearing potential has a negative serum or urine pregnancy test for β-hCG\n7. Able to provide written informed consent and comply with the protocol requirements\n\n   Exclusion Criteria:\n   * Any concurrent chemotherapy, biologic, or hormonal therapy for cancer treatment within 2 weeks prior to entering the study. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable\n\n     * Any previous treatment to lenvatinib or mTOR inhibitor\n\n       * Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria\n\n         * Major surgical procedure (as defined by the Investigator) within 14 days prior to the first dose of IP ⑤Active or prior documented autoimmune or inflammatory disorders\n\n           -including inflammatory bowel disease \\[e.g., colitis or Crohn's disease\\], diverticulitis \\[with the exception of diverticulosis\\], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \\[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.\n           * History of the following conditions within the past 6 months.\n\n             * coronary angioplasty or stent placement, myocardial infarction, unstable angina, coronary artery bypass grafting, peripheral arterial disease (Grade III) or congestive heart failure (Grade IV) according to the New York Heart Association classification, thromboembolism (patients on stable anticoagulation for ≥6 weeks are eligible), hemoptysis, intracranial hemorrhage, or clinically significant gastrointestinal bleeding ⑦Has an active infection requiring parenteral treatment\n\n               * History of another primary malignancy.\n\n   However, enrollment is permitted in the following cases:\n   * Basal cell or squamous cell carcinoma of the skin after curative resection\n   * Cervical carcinoma in situ after at least 1 year following successful treatment\n   * Patients who have been disease-free for at least 3 years after completion of treatment\n\n     ⑨Known or active CNS metastasis and\u002For carcinomatous meningitis\n   * Participants with previously treated brain metastases are eligible if radiologically stable.\n\n     * female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to emply effective birth control from screening to 90 days after the last dose","15 Years","79 Years",{"count":506,"type":21},94,[118],"Those studies demonstrate strong rationale to combine a multikinase inhibitor targeting VEGFR, PDGFR with mTOR inhibitor. Moreover, another multi-targeted TKI, lenvatinib monotherapy showed promising activity in osteosarcoma. Therefore, clinical trial with Lenvatinib in combined with everolimus is ongoing for solid tumors (NCT03245151). Considering lenvatinib and everolimus (18 mg\u002Fday and 5 mg\u002Fday) already approved as standard treatment for renal cell carcinoma based on the powerful ORR, PFS, and OS14, these noteworthy findings advance the treatment paradigm for bone sarcoma patients.\n\nBecause all those trials for sarcoma were done in the absence of a control group, based on such clinical studies, a confirmatory trial comparing mTOR inhibitor and a multi-targeted tyrosine kinase inhibitor (multi-TKI) combination versus monotherapy is essential. Therefore, we planned to conduct the randomized phase II trial of everolimus in combination with lenvatinib for advanced\u002Fmetastatic bone sarcomas. In addition, we will explore predictive biomarkers by repeated biopsies and blood samplings during the treatment.",[510],"Neoplasms of Bone and Articular Cartilage With Unspecified Anatomical Site",[512,513,514],"Everolimus","Lenvatinib","Bone Sarcoma","2026-05-26",{"date":517,"type":44},"2026-06-02",{"date":378,"type":21},{"date":520,"type":21},"2028-11-30",{"name":50,"class":51},{"id":523,"slug":524,"hasResults":12,"nctId":525,"briefTitle":526,"officialTitle":527,"acronym":4,"eligibilityCriteria":528,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":529,"targetDuration":4,"studyType":61,"phases":531,"briefSummary":533,"conditions":534,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":536,"lastUpdatePostDateStruct":537,"startDateStruct":539,"completionDateStruct":540,"leadSponsor":542,"locationsCount":4},"100631024","phase-1-ultra-hypofractionated-carbon-ion-therapy-for-prostate-cancer-100631024","NCT07495293","Ultra-hypofractionated Carbon-ion Therapy for Prostate Cancer","Carbon-ion Therapy With Ultra-hypofractionated RadiothErapy for Localized Prostate Cancer (CURE-PC-1): Phase I Clinical Trial","Inclusion Criteria:\n\n1. Male patients aged 19 years or older who are able to provide written informed consent\n2. Histologically confirmed prostatic adenocarcinoma within 6 months prior to the first treatment (either carbon ion radiotherapy or androgen deprivation therapy, whichever comes first)\n3. Documented pre-biopsy serum prostate-specific antigen (PSA) level available\n4. Classified as one of the following risk groups based on NCCN Guidelines Version 5.2026:\n\n   * Low risk: PSA ≤10 ng\u002FmL AND Gleason score 6 (Grade Group 1) AND cT1-T2a\n   * Intermediate risk: PSA 10-20 ng\u002FmL OR Gleason score 7 (Grade Group 2-3) OR cT2b-T2c, without any high-risk features\n5. No evidence of distant metastasis or regional lymph node metastasis\n6. Adequate general condition for prostate cancer treatment as determined by ECOG Performance Status 0 or 1\n7. Multiparametric prostate MRI performed prior to biopsy\n\nExclusion Criteria:\n\n1. Prior history of pelvic radiotherapy or prostate surgery\n2. History of malignancy other than prostate cancer, except for the following: cervical carcinoma in situ, completely resected non-melanoma skin cancer, or any cancer with disease-free status maintained for 5 or more years after treatment\n3. Patients deemed inappropriate for carbon ion radiotherapy due to active infection, bleeding disorders, or severe cardiac, hepatic, or renal dysfunction, or patients who have undergone major surgery or experienced a major cardiovascular event (e.g., myocardial infarction, cerebral infarction, or cerebral hemorrhage) within the past 6 months\n4. Patients with evidence of prostatitis or urinary tract infection on screening urinalysis and urine culture (However, enrollment is permitted if the condition improves on follow-up evaluation prior to carbon ion radiotherapy.)\n5. Patients with psychiatric disorders or cognitive impairment considered unable to comply with the treatment plan\n6. Patients currently participating in another investigational drug or medical device study concurrently with this study\n7. Patients for whom carbon ion radiotherapy is physically difficult due to artificial hip prostheses or other metallic implants\n8. Patients who underwent multiparametric prostate MRI after biopsy\n9. Patients with a history of surgical treatment for benign prostatic hyperplasia, such as transurethral resection of the prostate (TURP) or holmium laser enucleation of the prostate (HoLEP)",{"count":530,"type":21},20,[532],"PHASE1","This is a single-arm, exploratory phase I clinical trial evaluating the safety and efficacy of ultra-hypofractionated carbon ion radiotherapy (CIRT) in 6 fractions compared to the conventional 12-fraction regimen in patients with low- and intermediate-risk localized prostate cancer. A total of 20 patients will be enrolled sequentially and treated with CIRT at 7 GyE per fraction, delivered twice weekly on alternating days, for a total of 6 fractions (total prescribed dose: 42 GyE). Androgen deprivation therapy for 6 months will be administered concurrently in patients classified as unfavorable intermediate-risk. The primary endpoint is the incidence of acute treatment-related toxicity of Grade 3 or higher per CTCAE v5.0 occurring within 90 days after completion of CIRT. Secondary endpoints include the incidence of late toxicity, biochemical relapse-free survival (bRFS), and quality of life assessed by EPIC-26 and IPSS questionnaires. Patients will undergo scheduled follow-up visits for 2 years after treatment completion, followed by long-term follow-up through electronic medical record review up to 5 years.",[535],"Prostate Cancer","2026-05-20",{"date":538,"type":44},"2026-05-22",{"date":463,"type":21},{"date":541,"type":21},"2031-03-08",{"name":50,"class":51},{"id":544,"slug":545,"hasResults":12,"nctId":546,"briefTitle":547,"officialTitle":547,"acronym":548,"eligibilityCriteria":549,"healthyVolunteers":253,"sex":17,"minAge":550,"maxAge":4,"enrollmentInfo":551,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":553,"conditions":554,"keywords":557,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":536,"lastUpdatePostDateStruct":562,"startDateStruct":563,"completionDateStruct":565,"leadSponsor":567,"locationsCount":192},"100621228","exercise-echocardiography-registry-for-ischemic-and-non-ischemic-heart-disease-100621228","NCT07367893","Exercise Echocardiography Registry for Ischemic and Non-Ischemic Heart Disease","Exercise-Echo","Inclusion Criteria:\n\n* Adults aged 18 years or older\n* Patients referred for clinically indicated exercise echocardiography as part of routine clinical care\n* Patients evaluated for suspected or known ischemic heart disease, or non-ischemic heart disease, including but not limited to: Cardiomyopathy, Heart failure, Valvular heart disease, Structural heart disease\n* Ability to perform exercise-based stress testing using treadmill or bicycle protocols\n* Availability of baseline clinical data and interpretable echocardiographic images obtained during rest and exercise\n* Provision of informed consent, or eligibility for consent waiver in accordance with institutional review board approval\n\nExclusion Criteria:\n\n* Inability to perform exercise testing due to non-cardiac limitations, such as severe orthopedic, neurologic, or pulmonary conditions\n* Poor echocardiographic image quality that does not allow meaningful interpretation of exercise-induced changes\n* Any condition deemed by the treating physician to make participation inappropriate or unsafe, even within an observational framework","18 Years",{"count":552,"type":21},10000,"Exercise echocardiography is a widely used non-invasive test that evaluates cardiac structure and function during physical stress. It provides important information on myocardial ischemia, cardiac performance, hemodynamic responses, and exercise capacity in patients with a broad range of heart diseases. However, real-world prospective data integrating exercise echocardiographic findings across both ischemic and non-ischemic heart disease remain limited.\n\nThis prospective observational registry aims to systematically collect clinical, exercise, and echocardiographic data from patients undergoing clinically indicated exercise echocardiography. The registry includes patients with suspected or established ischemic heart disease as well as those with non-ischemic cardiac conditions, such as cardiomyopathies, heart failure, valvular heart disease, and exercise-related symptoms.\n\nThe collected data will be used to evaluate exercise-induced changes in cardiac structure and function, identify phenotypes associated with adverse clinical outcomes, and improve risk stratification in routine clinical practice. The registry is observational in nature and does not alter standard clinical care.",[555,556],"Ischemic Heart Diease","Non-ischemic Heart Disease",[558,559,560,561],"Exercise echocardiography","Ischemic heart disease","non-ischemic heart disease","clinical outcome",{"date":538,"type":44},{"date":564,"type":44},"2026-04-01",{"date":566,"type":21},"2035-12-31",{"name":50,"class":51},{"id":569,"slug":570,"hasResults":12,"nctId":571,"briefTitle":572,"officialTitle":573,"acronym":4,"eligibilityCriteria":574,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":575,"enrollmentInfo":576,"targetDuration":4,"studyType":61,"phases":578,"briefSummary":579,"conditions":580,"keywords":4,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":583,"lastUpdatePostDateStruct":584,"startDateStruct":586,"completionDateStruct":588,"leadSponsor":590,"locationsCount":192},"100611316","clinical-effectiveness-of-a-motivational-interviewing-based-conversational-mobile-application-for-high-risk-drinkers-100611316","NCT07238998","Clinical Effectiveness of a Motivational Interviewing-Based Conversational Mobile Application for High-Risk Drinkers","Evaluating the Clinical Effectiveness of a Motivational Interviewing-Based Conversational Mobile Application for High-Risk Drinkers","Inclusion Criteria:\n\n1. Individuals aged 19 to 59 years who are capable of providing valid written informed consent.\n2. Individuals who meet the definition of high-risk drinking (AUDIT score ≥ 8).3.- Individuals who express a desire to reduce their alcohol consumption.\n3. Individuals who own and use an Android smartphone (version 8 or higher).\n4. Individuals who have no difficulty using mobile applications.\n5. Individuals who are able to communicate adequately with the research team.\n6. Individuals who fully understand the study procedures and voluntarily agree to participate.\n\nExclusion Criteria:\n\n1. Individuals who are unable to read or understand the consent form (e.g., illiterate individuals, non-Korean speakers).\n2. Individuals with impaired decision-making capacity.\n3. Pregnant individuals or those planning to become pregnant during the study period.\n4. Individuals who are currently participating in another clinical study.\n5. Individuals who are receiving treatment or counseling for alcohol-related problems.\n6. Individuals who use two or more mobile phones.\n7. Individuals who are expected to change their mobile phone or SIM card, or who plan to travel 8. abroad during the intervention period.\n8. Any individual deemed inappropriate for study participation at the discretion of the investigator.","59 Years",{"count":577,"type":21},220,[63],"This study aims to evaluate and compare the degree of alcohol reduction between high-risk drinkers who use a motivational interviewing-based conversational agent (chatbot) application for four weeks and those in the control group who do not use the application, in order to verify its clinical effectiveness.",[581,582],"Alcohol Drinking","High-Risk Drinking Patterns","2026-05-11",{"date":585,"type":44},"2026-05-13",{"date":587,"type":44},"2025-12-19",{"date":589,"type":21},"2027-04",{"name":50,"class":51},{"id":592,"slug":593,"hasResults":12,"nctId":594,"briefTitle":595,"officialTitle":595,"acronym":4,"eligibilityCriteria":596,"healthyVolunteers":12,"sex":17,"minAge":282,"maxAge":4,"enrollmentInfo":597,"targetDuration":4,"studyType":61,"phases":599,"briefSummary":600,"conditions":601,"keywords":603,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":583,"lastUpdatePostDateStruct":607,"startDateStruct":609,"completionDateStruct":611,"leadSponsor":613,"locationsCount":192},"100339034","phase-1-concurrent-neoadjuvant-chemoradiotherapy-plus-durvalumab-medi4736-in-resectable-stage-iii-nsclc-100339034","NCT03694236","Concurrent Neoadjuvant Chemoradiotherapy Plus Durvalumab (MEDI4736) in Resectable Stage III NSCLC","Inclusion Criteria:\n\nFor inclusion in the study subjects must fulfill all of the following criteria:\n\n1. Histologically confirmed NSCLC\n2. Clinical stage III (including N2 stage and potential candidate for resection)\n3. Written informed consent and any locally-required authorization (IRB) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations\n4. Age \\> 20 years at time of study entry\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n6. Adequate normal organ and marrow function as defined below:\n\n   * Haemoglobin ≥ 9.0 g\u002FdL\n   * Absolute neutrophil count (ANC) ≥ 1,500μL\n   * Platelet count ≥ 100,000μL\n   * Serum bilirubin ≤ 1.5 x institutional upper limit of normal (ULN). \\\u003CThis will not apply to subjects with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician.\\>\\>\n   * AST (SGOT)\u002FALT (SGPT) ≤ 2.5 x institutional upper limit of normal unless liver metastases are present, in which case it must be ≤ 5x ULN\n   * Serum creatinine CL\\>40 mL\u002Fmin by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance:\n\n     * Males:\n\nCreatinine CL (mL\u002Fmin) = Weight (kg) x (140 - Age) 72 x serum creatinine (mg\u002FdL)\n\n--Females: Creatinine CL (mL\u002Fmin) = Weight (kg) x (140 - Age) x 0.85 72 x serum creatinine (mg\u002FdL) 6. Life expectancy of 6 months 8. Female subjects must either be of non-reproductive potential (ie, post-menopausal by history: ≥50 years old and no menses for 1 year without an alternative medical cause; OR history of hysterectomy, OR history of bilateral tubal ligation, OR history of bilateral oophorectomy) or must have a negative serum pregnancy test upon study entry.\n\n9\\. Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.\n\nExclusion Criteria:\n\nSubjects should not enter the study if any of the following exclusion criteria are fulfilled:\n\n1. Patients with metastatic lesions or clinical N3 lymph nodes\n2. Participation in another clinical study with an investigational product during the last 60 months\n3. Involvement in the planning and\u002For conduct of the study (applies to both AstraZeneca staff and\u002For staff at the study site) Previous enrollment in the present study\n4. Any previous treatment (chemotherapy, radiotherapy or surgery) to current disease - NSCLC\n5. Any previous treatment with a PD1 or PD-L1 inhibitor, including durvalumab\n6. History of leptomeningeal carcinomatosis\n7. Brain metastases or spinal cord compression. Subjects with suspected brain metastases at screening should have an MRI (preferred) or CT each preferably with IV contrast of the brain prior to study entry\n8. Receipt of the last dose of anti-cancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies, other investigational agent) ≤ 36months prior to the first dose of study drug\n9. Mean QT interval corrected for heart rate (QTc) ≥470 ms calculated from 3 electrocardiograms (ECGs) using Frediricia's Correction\n10. Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg\u002Fday of prednisone, or an equivalent corticosteroid\n11. Current or prior use of immunosuppressive medication within 14days (use 28 days if combining durvalumab with a novel agent) before the first dose of durvalumab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg\u002Fday of prednisone, or an equivalent corticosteroid. The following are exceptions to this criterion:\n\n    * Intranasal, inhaled, topical steroids, or local steroid injections (eg, intra articular injection)\n    * Systemic corticosteroids at physiologic doses not to exceed 10 mg\u002Fday of prednisone or its equivalent\n    * Steroids as premedication for hypersensitivity reactions (eg, chemotherapy, CT scan premedication)\n12. Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (eg, hormone replacement therapy) is acceptable.\n13. History of allogeneic organ transplant\n14. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \\[eg, colitis or Crohn's disease\\], diverticulitis \\[with the exception of diverticulosis\\], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \\[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc\\]). The following are exceptions to this criterion:\n\n    * Subjects with vitiligo or alopecia\n    * Subjects with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement\n    * Any chronic skin condition that does not require systemic therapy\n    * Subjects without active disease in the last 5 years may be included but only after consultation with the study physician\n    * Subjects with celiac disease controlled by diet alone\n15. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, active bleeding diatheses including any subject known to have evidence of acute or chronic hepatitis B, hepatitis C or human immunodeficiency virus (HIV), or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements or compromise the ability of the subject to give written informed consent\n16. History of another primary malignancy except for Malignancy treated with curative intent and with no known active disease ≥5 years before the first dose of IP and of low potential risk for recurrence\n\n    * Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease\n    * Adequately treated carcinoma in situ without evidence of disease\n    * Adequately treated thyroid cancer (except. Anaplastic thyroid cancer)\n17. History of primary immunodeficiency\n18. Active pulmonary tuberculosis (Patients with old tuberculosis can be enrolled) Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, active bleeding diatheses including any subject known to have evidence of acute or chronic hepatitis B, hepatitis C or human immunodeficiency virus (HIV), or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements or compromise the ability of the subject to give written informed consent\n19. Receipt of live attenuated vaccination within 30 days prior to study entry or within 30 days of receiving durvalumab\n20. 21\\. Female subjects who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control\n21. History of hypersensitivity to the combination or comparator agent\n22. Past medical history of ILD, drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease.\n23. Inability to comply with protocol or study procedures.",{"count":598,"type":21},39,[532,118],"Combination treatment of Durvalumab with chemoradiotherapy is ongoing for head\u002Fneck cancer, renal cell carcinoma, melanoma, and non-small cell lung cancer (NCT02318771) and pancreatic cancer (NCT02305186).Combining Durvalumab with neoadjuvant chemoradiotherapy is a promising strategy to improve clinical outcome in stage III lung cancer. Using serial biopsied and surgically resected fresh tissue through the novel\u002Fhigh-throughput RNA sequencing technologies, we want to identify the change immune signature in tumor microenvironment of NSCLC patients after Durvalumab treatment. With hypothesis that PD-1 inhibitor as a component of neoadjuvant chemoradiotherapy followed by surgery could increase complete pathologic response rate and disease free survival, and overall survival, we suggest adding Durvalumab to neoadjuvant chemoradiation in stage II\u002FIII resectable NSCLC. And with immune marker study using FACS, whole exome sequencing, or RNAsequencing, we can find the potential predictive biomarker for anti-PD-L1 blockade. And in this study, we can get \"whole\" surgical specimen not biopsy sample after Durvalumab treatment so the analysis for immune marker, tumor microenvironment, and various tumor infiltrating immune cells and their changes will be available.",[602],"Potentially Resectable Stage II\u002FIIIa NSCLC",[604,605,606],"NSCLC","Durvalumab","medi4736",{"date":608,"type":44},"2026-05-14",{"date":610,"type":44},"2019-02-12",{"date":612,"type":21},"2027-05",{"name":50,"class":51},{"id":615,"slug":616,"hasResults":12,"nctId":617,"briefTitle":618,"officialTitle":619,"acronym":620,"eligibilityCriteria":621,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":622,"enrollmentInfo":623,"targetDuration":4,"studyType":61,"phases":625,"briefSummary":626,"conditions":627,"keywords":4,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":628,"lastUpdatePostDateStruct":629,"startDateStruct":631,"completionDateStruct":633,"leadSponsor":635,"locationsCount":192},"100556681","phase-4-effect-of-enavogliflozin-on-recurrence-of-atrial-fibrillation-after-catheter-ablation-100556681","NCT06528262","Effect of Enavogliflozin on Recurrence of Atrial Fibrillation After Catheter Ablation","ENavogliflozin And preVention Of Atrial Fibrillation Recurrence After Catheter Ablation for Atrial Fibrillation With Heart Failure (ENAVO-AF): Prospective, Multicenter, Randomized, Placebo-controlled Double-blind Clinical Trial","ENAVO-AF","Inclusion Criteria:\n\n1. Adults aged 19 to under 85\n2. Patients who consent to participate in the study and can be followed up during the study\n3. Patients with AF and heart failure who have undergone atrial fibrillation catheter ablation within the last three months or are scheduled to undergo the procedure\n\nExclusion Criteria:\n\n1. Under 19 or over 85 years old\n2. Patients who have participated in another clinical trial within the last three months\n3. Life expectancy of less than one year\n4. Pregnant or breastfeeding women\n5. Currently being treated with an SGLT-2 inhibitor\n6. Three or more urinary or genital infections within the last year\n7. Uncontrolled hypertension: systolic blood pressure ≥ 180mmHg or diastolic blood pressure ≥ 110mmHg\n8. Systolic blood pressure \\\u003C 90mmHg\n9. Acute cardiovascular event within the last 12 weeks\n10. Severe valvular disease or presence of artificial valves\n11. Renal impairment (eGFR CKD-EPI \\\u003C 60 ml\u002Fmin\u002F1.73m²)\n12. Clinically confirmed liver dysfunction\n13. Uncontrolled thyroid dysfunction\n14. Patients with active cancer (including those undergoing treatment) or history of cancer within the last five years at the time of screening; however, borderline cancers are not excluded if successfully treated and recurrence-free for 2-3 years.\n15. Continuous use of oral prednisolone at 10mg\u002Fday or equivalent, or higher doses of steroids, within the last month\n16. Patients with hypersensitivity or history of hypersensitivity to the active or inactive ingredients of this drug\n17. Patients with type 1 diabetes or diabetic ketoacidosis\n18. History of alcohol or substance abuse\n19. Women of childbearing potential who do not agree to use adequate contraception during the clinical trial period","84 Years",{"count":624,"type":21},390,[367],"Objective: The purpose of this study is to determine if there is a difference in the recurrence rate of atrial fibrillation (AF) between a group of patients with AF and heart failure undergoing catheter ablation who are administered the SGLT2 inhibitor, Enavogliflozin, and a control group (placebo group). This study aims to investigate whether SGLT2 inhibitors can prevent the recurrence of AF after the procedure.\n\nBackground: AF is the most common arrhythmia requiring treatment, with its prevalence increasing with age. In the US, AF affected 5.2 million people in 2010 and is projected to reach 12.1 million by 2030. In South Korea, prevalence rose from 0.73% in 2006 to 1.53% in 2015. Early-stage AF patients benefit more from rhythm control therapy than from heart rate control alone, as shown by the 2020 EAST-AFNET-4 trial, which reported a 21% reduction in adverse cardiovascular events. Catheter ablation for rhythm control significantly reduces AF recurrence compared to antiarrhythmic drugs, leading to more patients undergoing this procedure. AF and heart failure often coexist, forming a vicious cycle that exacerbates both conditions and leads to poorer outcomes. They share common risk factors like hypertension, diabetes, ischemic heart disease, and valvular disease. Heart failure increases left atrial filling pressure and alters intracellular calcium levels, raising AF risk. Further research is needed on their pathophysiological link. SGLT2 inhibitors reduce glucose reabsorption in the kidneys to control hyperglycemia in diabetics and have been shown in large studies (DAPA-HF, EMPEROR-Reduced) to significantly reduce heart failure worsening and cardiovascular mortality, regardless of diabetes status. These benefits were seen in both HFrEF and HFpEF. In the DAPA-HF trial, 55% of participants were non-diabetic, and reductions in heart failure worsening or cardiovascular death were similar between those with and without diabetes (25% vs. 27%). Adverse events, including volume depletion and renal function decline, were not significantly different between diabetic and non-diabetic patients, and no hypoglycemia or ketoacidosis occurred in non-diabetic patients. Recent studies show SGLT2 inhibitors reduce AF incidence and benefit heart failure. A sub-analysis of the DECLARE-TIMI 58 trial reported a 19% reduction in AF risk among diabetic patients with SGLT2 inhibitors. Meta-analyses by Okunrintemi and Zheng showed an 18% reduction in AF risk irrespective of diabetes status. Interest is growing in the relationship between SGLT2 inhibitors and AF recurrence post-catheter ablation. Luo et al. reported a nearly 39% reduction in AF recurrence post-ablation with dapagliflozin in diabetic patients. Kishima et al. found a 49% reduction in AF recurrence post-ablation with SGLT2 inhibitors versus DPP-IV inhibitors in a small prospective randomized study. However, most studies were retrospective, sub-analyses, or small-scale studies limited to diabetics. Prospective randomized studies involving AF patients regardless of diabetes status are urgently needed for validation.",[173],"2026-05-07",{"date":630,"type":44},"2026-05-12",{"date":632,"type":44},"2025-04-03",{"date":634,"type":21},"2027-05-31",{"name":50,"class":51},""]