[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Cedars-Sinai Medical Center\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":633},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,86,0,25,[9,45,70,93,122,147,170,195,223,250,279,300,320,341,367,389,414,435,463,489,512,534,558,580,603],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100324511","coronary-atherosclerosis-t1-weighted-characterization-catch-100324511",false,"NCT03504956","Coronary Atherosclerosis T1-Weighted Characterization (CATCH)","CATCH","Inclusion:\n\n* Healthy Volunteers: male or female ≥ 18 years of age with a BMI\\\u003C30, with no history of cardiovascular disease\n* Patients: Medically stable, male or female ≥ 18 years of age who is have not suspected of having or has been diagnosed with coronary artery disease and undergone stenting or bypass surgery\n\nExclusion:\n\n* Contraindications to MR imaging including mechanically, magnetically, or electrically activated implants, ferromagnetic implants and ferromagnetic foreign bodies, pregnancy.\n* Inability to tolerate MR imaging secondary to an inability to hold breath for a short time or have claustrophobia.\n* Non-compliant with visit instructions, including following procedure instructions\n* Severe allergy to animal dander or animal-instigated asthma\n* Specific to gadolinium-based contrast agents: Renal function test does not meet CSMC standard of care MRI contrast protocol requirements (GFR \\\u003C45ml\u002Fmin) or previous allergic reaction to gadolinium-based contrast agents.\\*\n* Volunteers who have had four or more prior previous gadolinium contrast scan",true,"ALL","18 Years",{"count":21,"type":22},150,"ESTIMATED","INTERVENTIONAL",[25],"NA","This study proposes to develop an MRI technique named Coronary Atherosclerosis T1-weighed Characterization (CATCH) that will improve the quality and reliability of coronary atherosclerosis evaluation, as well as simplify the scanning process and significantly shorten imaging time compared with conventional imaging methods.",[28],"Coronary Atherosclerosis",[30,31],"MRI technique","High Resolution MRI Technique","RECRUITING","2026-08-20",{"date":35,"type":36},"2026-08-21","ACTUAL",{"date":38,"type":36},"2018-07-30",{"date":40,"type":22},"2027-12-31",{"name":42,"class":43},"Cedars-Sinai Medical Center","OTHER",1,{"id":46,"slug":47,"hasResults":12,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":55,"conditions":56,"keywords":59,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":64,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":44},"100253752","wise-cvd---continuation-wise-hfpef-100253752","NCT02582021","WISE CVD - Continuation (WISE HFpEF)","Women's Ischemia Syndrome Evaluation (WISE) - Coronary Microvascular Dysfunction (CMD) and Heart Failure With Preserved Ejection Fraction (HFpEF)","Inclusion Criteria:\n\nFor the new cohort n=120 women undergoing coronary angiography:\n\n* Symptomatic angina or anginal equivalent\n* Age ≥ 18\n* Participant is willing to give written informed consent\n\nFor the cohort n=100 women and men hospitalized for HFpEF (defined by ESC guidelines):\n\n* Age ≥ 18\n* Signs and symptoms of heart failure\n* Preserved ejection fraction, left ventricular ejection fraction (LVEF) ≥45% prior to study entry.\n* Structural evidence of cardiovascular abnormalities: elevated brain naturetic peptide, evidence of abnormal filling or relaxation, left ventricular hypertrophy, or an increased left atrial size\n* Evidence of elevated filling pressures: LVEDP or PCWP at rest \\> 15 mmHg and\u002For with exercise ≥25 mmHg, exercise E\u002Fe' \\>13, elevated BNP, or use of diuretic\n* Participant is willing to give written informed consent\n\nExclusion Criteria:\n\nFor the new cohort n=120 women undergoing invasive coronary angiography:\n\n* Obstructive CAD ≥ 50% luminal diameter stenosis in ≥ 1 epicardial coronary artery\n* STEMI within 3-7 days post MI, or Acute coronary syndrome\u002FNSTEMI with with symptoms or signs of acute myocardial ischemia within the last 12 to 24 hours prior to the research procedure, as outlined in ACC\u002FAHA guidelines.\n* Primary valvular heart disease clearly indicating the need for valve repair or replacement\n* Patients with concurrent cardiogenic shock or requiring inotropic or intra-aortic balloon support or LVEF\\\u003C45%\n* Prior or planned percutaneous coronary intervention or coronary artery bypass grafting for obstructive coronary atherosclerosis\n* Non-cardiac illness with a life expectancy \\\u003C four years\n* Unable to give informed consent\n* Chest pain which has an alternative non-ischemic etiology, i.e. pericarditis, pulmonary embolism, pleurisy, pneumonia, esophageal spasm, etc.\n* Contraindications to CMRI, such as internal cardiac defibrillator, untreatable claustrophobia or known angioedema\n* Contraindications to adenosine or regadenoson including severe COPD and asthma\n* End stage renal or liver disease\n* Women with intermediate coronary stenoses (\\>20% but \\\u003C50% luminal diameter stenosis assessed visually at the time of angiography) will undergo clinically indicated fractional flow reserve (FFR) based on the judgment of the operator; those determined to have flow-obstructing stenosis will be excluded.\n* Documented allergy to gadolinium\n\nFor the new cohort n=100 women and men hospitalized for HFpEF:\n\n* Current LVEF \\\u003C45%\n* STEMI within 3-7 days post MI, or Acute coronary syndrome\u002FNSTEMI with with symptoms or signs of acute myocardial ischemia within the last 12 to 24 hours prior to the research procedure, as outlined in ACC\u002FAHA guidelines.\n* Acute coronary syndrome (defined by ACC\u002FAHA guidelines, including MI) within 3 months of entry. Patients who have had an MI or other event within the 6 months prior to entry unless an echo measurement performed after the event confirms a LVEF ≥45%.\n* Primary valvular heart disease (moderate regurgitation or\\>mild stenosis), primary cardiomyopathies (hypertrophic, infiltrative or restrictive), constrictive pericarditis, high-output heart failure, and right ventricular myopathies)\n* Patients with concurrent cardiogenic shock or requiring inotropic or intra-aortic balloon support or current acute decompensated HF requiring therapy including due to trauma, infection.\n* Alternative reason for shortness of breath such as: significant pulmonary disease or severe COPD, hemoglobin (Hgb) \\\u003C10 g\u002Fdl, or body mass index (BMI) \\> 40 kg\u002Fm2.\n* Systolic blood pressure (SBP) ≥ 180 mmHg at entry, or SBP \\>150 mmHg and \\\u003C180 mmHg at entry unless the patient is receiving 3 or more antihypertensive drugs.\n* Prior or planned percutaneous coronary intervention or coronary artery bypass grafting for obstructive coronary atherosclerosis\n* Non-cardiac illness with a life expectancy \\\u003C four years\n* Unable to give informed consent\n* Contraindications to CMRI, such as internal cardiac defibrillator, untreatable claustrophobia or known angioedema\n* Contraindications to adenosine or regadenoson including severe COPD and asthma.\n* Obstructive stenoses (≥50% luminal diameter stenosis assessed visually at the time of research CTA) will be excluded from further analyses. Subjects with obstructive or borderline obstructive coronary CTA stenoses will be referred to their clinicians for further clinical care and clinical decision making. End stage renal or liver disease",{"count":53,"type":22},220,"OBSERVATIONAL","The Women's Ischemia Study Evaluation (WISE), a cohort study of over 1000 women, has made many contributions to the understanding of cardiovascular disease. A milestone acknowledged in the 2011 AHA Herrick Lecture is the role of Coronary Microvascular Dysfunction (CMD) in women with symptoms\u002Fsigns of ischemia without obstructive coronary artery disease (CAD). While in 1996, CMD was considered \"an imaging artifact\", in 2013, it is a widely accepted as a pathophysiologic process requiring systematic cohesive scientific pursuit. CMD is prevalent, associated with adverse clinical outcomes, poor quality of life and healthcare costs rivaling obstructive CAD. There are 2-3 million US women with CMD, and 100,000 new cases projected annually placing CMD prevalence, morbidity and costs higher than all female reproductive cancers combined.\n\nAmong women with ischemia, preserved ejection fraction and no obstructive CAD, it has been observed that there are relatively more new onset heart failure (HF) hospitalizations than nonfatal myocardial infarction (MI). It has been hypothesized that CMD contributes to left ventricular (LV) diastolic dysfunction and subsequent heart failure with preserved ejection fraction (HFpEF). Preliminary data further suggests that left ventricular diastolic dysfunction is linked to CMD via a mechanism of augmentation and\u002For perpetuation by cardiomyocyte fat accumulation. HFpEF is prevalent in women and older men, but poorly understood. Mechanistic understanding is critical to HFpEF intervention and guideline development.\n\nThe study hypotheses are as follows:\n\n1. Risk factor conditions (hypertension, dyslipidemia, dysglycemia, loss of estrogen) promote an inflammatory and pro-oxidative state making the microvasculature vulnerable;\n2. Vulnerable coronary microvasculature becomes dysregulated (sympathetic nervous system activation, endothelial dysfunction, changes in vascular smooth muscle activation, spasm) causing repeated episodes of transient ischemia;\n3. Repeated ischemia-reperfusion episodes facilitate preconditioning with preservation of cardiomyocyte contractile and microvascular function against ischemic injury;\n4. Ischemia-reperfusion and preconditioning lead to cardiomyocyte fat accumulation and relaxation impairment resulting in diastolic dysfunction and heart failure with preserved ejection fraction (HFpEF).",[57,58],"Microvascular Coronary Dysfunction","Cardiovascular Disease",[60,61,62,63],"Microvascular Coronary Dysfunction (MCD)","Magnetic resonance imaging (MRI)","Coronary angiography","Coronary Vascular Dysfunction (CVD)",{"date":35,"type":36},{"date":66,"type":36},"2015-10",{"date":68,"type":22},"2030-02",{"name":42,"class":43},{"id":71,"slug":72,"hasResults":12,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":77,"targetDuration":79,"studyType":54,"phases":4,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":44},"100355637","the-cedars-sinai-smidt-heart-institute-takotsubo-registry--proteomic-study-100355637","NCT03910569","The Cedars-Sinai Smidt Heart Institute Takotsubo Registry & Proteomic Study","Smidt Heart Institute Takotsubo Registry","Inclusion Criteria:\n\n* Have received a diagnosis of Takotsubo from their physician and consent to enroll\n* Submit full medical records needed for Takotsubo adjudication\n\nExclusion Criteria:\n\n* Younger than 18 years\n* Unable to provide informed consent\n* Unable to provide the necessary documentation needed for screening purposes",{"count":78,"type":22},1000,"30 Years","The Cedars-Sinai SHI Takotsubo Registry and Proteomic Study is an observational registry that will collect retrospective and prospective demographic, clinical, hemodynamic, laboratory and other diagnostic parameters, therapy and outcome data from individuals who meet the inclusion\u002Fexclusion criteria of Takotsubo Registry protocol. Subjects will also be invited to provide a blood sample utilizing a Mitra kit sent to their homes. Researchers from the Barbra Streisand Women's Heart Center will analyze Registry data to identify Takotsubo phenotypes, improve diagnostic capabilities, better predict recurrence rates, and develop targeted Takotsubo treatments.",[82],"Takotsubo Cardiomyopathy",[84],"Takotsubo","2026-08-18",{"date":87,"type":36},"2026-08-19",{"date":89,"type":36},"2019-01-03",{"date":91,"type":22},"2029-02",{"name":42,"class":43},{"id":94,"slug":95,"hasResults":12,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":4,"eligibilityCriteria":99,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":100,"targetDuration":4,"studyType":23,"phases":102,"briefSummary":103,"conditions":104,"keywords":4,"overallStatus":113,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":44},"100638123","active-vs-passive-vr-during-office-based-ent-procedures-100638123","NCT07599826","Active vs. Passive VR During Office-based ENT Procedures","Active vs. Passive Virtual Reality for Reducing Pain and Anxiety During Office-based ENT Procedures","Inclusion Criteria Active and Passive VR:\n\n* Individuals 18 years old and older are included\n* Individuals undergoing the following common office-based ENT procedures: turbinate reduction, nasal debridement, balloon sinuplasty, radiofrequency ablation (RhinAer\u002FVivAer), nasal polypectomy, eustachian tube dilation, vocal fold injection, or subglottic steroid injection\n* Able to consent\n* English speaking\n\nExclusion Criteria Active VR:\n\n* History of neurologic or seizure disorder, developmental delay, uncorrected visual impairment, motion sickness, vertigo, or inability to use a handheld controller\n* Any records flagged \"break the glass\" or \"research opt out.\"\n\nExclusion Criteria Passive VR:\n\n* History of neurologic or seizure disorder, developmental delay, uncorrected visual impairment, motion sickness, or vertigo\n* Any records flagged \"break the glass\" or \"research opt out.\"",{"count":101,"type":22},132,[25],"The purpose of this research is to evaluate whether active virtual reality reduces pain and anxiety more effectively than passive virtual reality during office-based ENT procedures. The main procedures include exposure to virtual reality (passive calming scenery or interactive puzzle game) via Paperplane Therapeutics software with VR headset or glasses during common in-office ENT procedures, participant self-report surveys (GAD-7, PHQ-9, PEG, VAS, SUDS, Likert, experience questions), and physician post-procedure survey. The study will enroll individuals 18 years or older who are scheduled to undergo common office-based ENT procedures (turbinate reduction, nasal debridement, balloon sinuplasty, radiofrequency ablation, nasal polypectomy, eustachian tube dilation, vocal fold injection, or subglottic steroid injection) at Cedars-Sinai.",[105,106,107,108,109,110,111,112],"Pain","Anxiety","Chronic Rhinosinusitis (CRS)","Nasal Obstruction","Nasal Polyp","Eustachian Tube Dysfunction","Dysphonia","Subglottic Stenosis (SGS)","NOT_YET_RECRUITING","2026-08-13",{"date":116,"type":36},"2026-08-17",{"date":118,"type":22},"2026-09",{"date":120,"type":22},"2027-12",{"name":42,"class":43},{"id":123,"slug":124,"hasResults":12,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":128,"eligibilityCriteria":129,"healthyVolunteers":12,"sex":18,"minAge":130,"maxAge":4,"enrollmentInfo":131,"targetDuration":4,"studyType":23,"phases":133,"briefSummary":134,"conditions":135,"keywords":137,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":44},"100624771","tavr-vs-savr-in-severe-bicuspid-aortic-stenosis-100624771","NCT07413965","TAVR vs SAVR in Severe Bicuspid Aortic Stenosis","Bicuspid Aortic Valve Replacement: EvaLuatIon of transcathetEr VERsus Surgery (BELIEVERS) Trial","BELIEVERS","Inclusion Criteria:\n\n1. 50 years of age or older at time of consent\n2. Severe AS deemed suitable for a bioprosthesis by a local heart team (unsuitable or patient declined a mechanical valve or Ross procedure, following demonstration of evidence-based shared decision making with a validated decision-aid(1)\n3. Gated contrast CT available and suitable for core laboratory analysis;\n4. BAV anatomy confirmed by CT core laboratory analysis\n\nExclusion Criteria:\n\n1. Recent cardiovascular intervention within 30 days prior to randomization.\n2. Presence of an existing TAVR or SAVR device\n3. Pregnancy or lactation\n4. Extreme or prohibitive TAVR or SAVR risk, adjudicated by Patient Selection Committee (PSC) Review\n5. Active enrollment in another investigational study\n6. Disproportionate TAVR vs SAVR risk, as adjudicated by the patient selection committee\n7. Associated aortopathy (AA≥45mm by maximal cross-sectional dimension, as confirmed by CT core laboratory analysis, or AA\\\u003C45mm but site plan for surgery of the aorta in the event of randomization to surgery\n8. Site plan for treatment of concomitant non-coronary cardiovascular disease in the event of randomization to surgery (for instance, concomitant valve surgery, septal defect or coarctation repair, aorta or root replacement or repair)\n9. In the presence of coronary artery disease deemed necessary for revascularization in the event of randomization to SAVR or TAVR, Syntax score ≥ 32 or deemed unsuitable for PCI, or deemed unsuitable for coronary artery bypass grafting (CABG)\n10. Plan to use any device other than commercially approved Edwards balloon expandable or Medtronic self-expanding TAVR\n11. Leukopenia (WBC \\\u003C 3000 cells\u002FµL), anemia (Hgb \\\u003C 8 g\u002FdL), Thrombocytopenia (Plt \\\u003C 50,000 cells\u002FµL) on latest available labs within 30 days prior to randomization\n12. Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation, or mechanical heart assistance within 30 days prior to randomization\n13. LVEF \\\u003C 25% within 90 days prior to randomization\n14. Stroke or transient ischemic attack (TIA) within 90 days prior to randomization\n15. Renal insufficiency (eGFR \\\u003C 30 ml\u002Fmin per the Cockcroft-Gault formula)\n16. Severe lung disease (FEV1 \\\u003C 50% predicted), unresolved prior to randomization\n17. History of liver disease defined as MELD Score ≥ 10 or Child-Pugh Class B or C\n18. Unable to complete the KCCQ due cognitive impairment or other medical condition","50 Years",{"count":132,"type":22},1200,[25],"The study is a multicenter, randomized superiority trial of standard of care therapies for severe aortic stenosis (AS) in patients with a bicuspid aortic valve (BAV).\n\nThe two primary comparators in this study are: Transcatheter Aortic Valve Replacement (TAVR), and Surgical Aortic Valve Replacement (SAVR).\n\nTAVR is a minimally invasive transcatheter procedure to treat aortic valve disease..\n\nSAVR is involving the open chest surgery to replace the aortic valve.\n\nThe devices and international procedures in this Trial (TAVR or SAVR) are commercially approved by the FDA.\n\nConsented patients who are qualifying for the Trial will be randomized 1:1, meaning they will have an equal chance to be treated with either TAVR or SAVR procedure.\n\nConsented patients who will not qualify for the randomized part of the study will be followed up clinically in either TAVR or SAVR Registry arms.\n\nThe study objective is to provide evidence to guide patients and their providers on the most appropriate therapy for valve replacement on this particular BAV anatomy.",[136],"Bicuspid Aortic Valve Disease",[138],"Severe Bicuspid Aortic Valve intervention: TAVR vs SAVR","2026-08-12",{"date":141,"type":36},"2026-08-14",{"date":143,"type":36},"2026-07-23",{"date":145,"type":22},"2040-05-10",{"name":42,"class":43},{"id":148,"slug":149,"hasResults":12,"nctId":150,"briefTitle":151,"officialTitle":151,"acronym":4,"eligibilityCriteria":152,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":153,"enrollmentInfo":154,"targetDuration":4,"studyType":23,"phases":156,"briefSummary":157,"conditions":158,"keywords":159,"overallStatus":113,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":164,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":44},"100375079","the-role-of-virtual-reality-during-regional-anesthesia-100375079","NCT04163809","The Role of Virtual Reality During Regional Anesthesia","Inclusion Criteria:\n\n1. Elective pre-operative patients at Cedars-Sinai Medical Center who are receiving regional anesthesia\n2. Between ages 18-64\n3. Patient must be able to provide informed consent\n\nExclusion Criteria:\n\n1. Patients under the age of 18 \\& above age 64\n2. Visual impairment\n3. Pregnant women\n4. Diagnosis of epilepsy\u002Fseizures, dementia, and\u002For cognitive impairment","64 Years",{"count":155,"type":22},80,[25],"In this study, we will analyze the role of virtual reality in acute pain and anxiety management for regional anesthesia in pre-operative patients at Cedars-Sinai Medical Center.",[106,105],[160,161,162,163],"virtual reality","anxiety","pain","regional anesthesia",{"date":141,"type":36},{"date":166,"type":22},"2027-01-01",{"date":168,"type":22},"2028-06",{"name":42,"class":43},{"id":171,"slug":172,"hasResults":12,"nctId":173,"briefTitle":174,"officialTitle":175,"acronym":4,"eligibilityCriteria":176,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":177,"targetDuration":4,"studyType":23,"phases":179,"briefSummary":180,"conditions":181,"keywords":183,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":189,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":44},"100595591","functional-outcomes-in-ulcerative-colitis-patients-with-ileal-pouch-anal-anastomosis-treated-with-high-intensity-focused-electromagnetic-stimulation-100595591","NCT07034443","Functional Outcomes in Ulcerative Colitis Patients With Ileal Pouch Anal Anastomosis Treated With High Intensity Focused Electromagnetic Stimulation","Functional Outcomes in Ulcerative Colitis Patients With Ileal Pouch Anal Anastomosis Treated With High Intensity Focused Electromagnetic Stimulation: A Prospective Pilot Study","Inclusion Criteria:\n\n* Individuals 18 years old or older are included.\n* Patients who have a J pouch reconstruction due to Ulcerative Colitis or IBDU\n* Must be at least 1 year out from J pouch surgery\n* Have fecal incontinence\n\nExclusion Criteria:\n\n* Any records flagged \"break the glass\" or \"research opt out.\"\n* Pediatric Patients \\\u003C18 years of age\n* Did not receive a J pouch\n* Patients who received a J pouch for any other indication, including but not limited to Crohn's disease, familial adenosis polyposis\n* Have active pouchitis\n* Have an active fistula\n* If reclassified to de novo Crohn's after surgery\n* Have implanted metal devices or medical devices\n* Pregnant patients",{"count":178,"type":22},20,[25],"The purpose of this research is to evaluate functional outcomes in patients with Ulcerative Colitis and IBDU who have received an ileal pouch anal anastomosis (IPAA), commonly referred to as a J pouch, after treatment with the Emsella chair. We will specifically look at fecal incontinence and patient health related quality of life outcomes before, during and after course of treatment.",[182],"Fecal Incontinence",[184,182,185,186,187],"Ulcerative colitis","Functional Outcomes","High Intensity Focused Electromagnetic Stimulation","J pouch","2026-08-11",{"date":139,"type":36},{"date":191,"type":22},"2026-08-01",{"date":193,"type":22},"2027-07-01",{"name":42,"class":43},{"id":196,"slug":197,"hasResults":12,"nctId":198,"briefTitle":199,"officialTitle":200,"acronym":4,"eligibilityCriteria":201,"healthyVolunteers":12,"sex":202,"minAge":19,"maxAge":4,"enrollmentInfo":203,"targetDuration":4,"studyType":23,"phases":205,"briefSummary":206,"conditions":207,"keywords":209,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":217,"startDateStruct":218,"completionDateStruct":220,"leadSponsor":222,"locationsCount":44},"100510226","nlp-based-feedback-to-improve-risk-comms-and-informed-shared-decision-making-100510226","NCT05923684","NLP-Based Feedback to Improve Risk Comms and Informed Shared Decision Making","Natural Language Processing-Based Feedback to Improve Physician Risk Communication and Informed Shared Decision Making in Men With Clinically Localized Prostate Cancer","Inclusion Criteria:\n\n1. Men undergoing initial treatment consultation for clinically localized prostate cancer;\n2. Men with upgraded prostate cancer on active surveillance considering conversion to definitive local therapy.\n3. Cedars-Sinai patient.\n4. Ability to read and write in English.\n\nExclusion Criteria:\n\n1. Under 18 years of age;\n2. Subjects with difficulty communicating or dementia;\n3. Non-English speakers, given that our NLP-based tools cannot be used with languages other than English;\n4. Men with locally advanced or metastatic prostate cancer;\n5. Men who have already been treated for clinically localized prostate cancer","MALE",{"count":204,"type":22},30,[25],"In this pilot study, the investigators will show feasibility of the NLP-based feedback system in 20 consultations of men with newly diagnosed prostate cancer. The investigators will recruit from the practices of up to 10 physicians who typically see these patients. The investigators will report the top five sentences from each consultation across key content areas (cancer prognosis, life expectancy, erectile dysfunction, urinary incontinence, and irritative urinary symptoms) to both patients and physicians within 2 weeks of the consultation.",[208],"Prostate Cancer",[210,211,212,213,214,215,216],"prostate","cancer","consultation","review","feedback","natural","process",{"date":139,"type":36},{"date":219,"type":36},"2023-11-15",{"date":221,"type":22},"2027-07-15",{"name":42,"class":43},{"id":224,"slug":225,"hasResults":12,"nctId":226,"briefTitle":227,"officialTitle":227,"acronym":4,"eligibilityCriteria":228,"healthyVolunteers":12,"sex":202,"minAge":229,"maxAge":4,"enrollmentInfo":230,"targetDuration":4,"studyType":23,"phases":231,"briefSummary":233,"conditions":234,"keywords":238,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":243,"lastUpdatePostDateStruct":244,"startDateStruct":246,"completionDateStruct":247,"leadSponsor":249,"locationsCount":44},"100610115","phase-2-high-cardiovascular-risk-intervention-with-cardio-oncology-consultation-for-prostate-cancer-following-androgen-receptor-pathway-inhibitor-arpi-therapy-heart-safe-100610115","NCT07223385","High Cardiovascular Risk Intervention With Cardio-Oncology Consultation for Prostate Cancer Following Androgen Receptor Pathway Inhibitor (ARPI) Therapy (Heart-Safe)","Inclusion Criteria:\n\n* Prostate cancer with localized, very-high risk, lymph-node positive, and\u002For metastatic (Stage IV) disease.\n* Being treated with ARPI therapy with intended duration ≥ 18 months.\n* Age \\> 65 years old and at least one CV risk factor, or age 45-65 years with at least two CV risk factors:\n\n  * Hypertension\n  * Hyperlipidemia\n  * Diabetes mellitus\n  * Family history of early CAD (male first-degree relative (father or brother) with CAD before age 55; female first-degree relative (mother or sister) with CAD before age 65)\n  * Presence of coronary artery calcium (CAC) on chest CT imaging\n* ECOG 0-2\n* Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.\n\nExclusion Criteria:\n\n* Prior ARPI therapy exposure \\> 6 months duration.\n* Established care with cardio-oncologist (cardiologist with expertise in CV risks of cancer and cardiotoxic cancer therapies).","45 Years",{"count":155,"type":22},[232],"PHASE2","In patients with prostate cancer (PC), cardiovascular disease (CVD) causes significant morbidity and is the second leading cause of death. Both pre-existing CVD and the use of androgen deprivation therapy (ADT)-a key cornerstone of treatment for men with locally advanced or metastatic PC1,2 contribute to increased CV risk. ADT has been associated with adverse metabolic effects, including increased central adiposity, elevated low-density lipoprotein (LDL) levels, impaired glycemic control, and arterial wall remodeling and endothelial dysfunction\n\nThe data demonstrates that for most patients, the status quo is insufficient6 and there remains a critical gap in the early identification of high CV-risk PC patients who may benefit most from aggressive risk mitigation strategies. Mitigation strategies, like the addition of statins as primary prevention, have shown decrease in MI\u002FCHD death across thousands of patients. Age-related expansion of hematopoietic clones carrying recurrent somatic mutations, termed clonal hematopoiesis of indeterminate potential (CHIP) has recently been identified as a significant driver of atherosclerosis, doubling the risk of coronary heart disease. Notably, while CHIP is detectable in \\~10% of persons over 70 years old, it is enriched in patients with solid malignancies, and radiotherapy exposure is among the most decisive risk factors for developing CHIP12-15. The inflammation-related metabolic signals are activated androgen signaling and exacerbated in patients with CHIP. However, the mechanistic link and clinical consequence are less understood. Therefore, it is critical to study the CV impact of CHIP and metabolic perturbations in patients with PC treated with ARSI therapy.\n\nWe plan to address these critical gaps by testing our innovative hypothesis that early cardio-oncology intervention with aggressive guidelines-based CV optimization during ARPI therapy will reduce CV risk and that CHIP and metabolomics will help identify adverse metabolic remodeling to improve CV risk prediction.\n\nRobust epidemiological and clinical trial data consistently demonstrate that patients with PC are poorly optimized from a CV risk modification perspective, and existing CV risk models do not perform well in patients with cancer. The data demonstrates that for most patients, the status quo is insufficient and there remains a critical gap in the early identification of high CV-risk PC patients who may benefit most from aggressive risk mitigation strategies.",[235,236,237],"Prostate Cancer (Diagnosis)","Prostate Cancer Stage IV","CV Risk",[239,240,241,242],"High-Risk","Lymph-node positive","ARPI Therapy","CV Risk Factors","2026-08-04",{"date":245,"type":36},"2026-08-06",{"date":191,"type":22},{"date":248,"type":22},"2030-08",{"name":42,"class":43},{"id":251,"slug":252,"hasResults":12,"nctId":253,"briefTitle":254,"officialTitle":255,"acronym":4,"eligibilityCriteria":256,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":257,"targetDuration":4,"studyType":23,"phases":259,"briefSummary":260,"conditions":261,"keywords":265,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":271,"lastUpdatePostDateStruct":272,"startDateStruct":273,"completionDateStruct":275,"leadSponsor":277,"locationsCount":278},"100594302","phase-2-phase-ii-trial-of-ivonescimab-in-combination-with-carboplatin--docetaxel-in-patients-with-early-stage-triple-negative-breast-cancer-100594302","NCT07017673","Phase II Trial of Ivonescimab in Combination With Carboplatin + Docetaxel in Patients With Early-Stage Triple Negative Breast Cancer","Phase II Trial of Ivonescimab in Combination With Carboplatin + Docetaxel in Patients With Early Stage Triple Negative Breast Cancer","Inclusion Criteria\n\n* Age ≥ 18 years of age\n* ECOG ≤ 1\n* High-risk early stage triple negative breast cancer (TNBC), defined by ER≤10%, PR≤10% and HER2 negative (by IHC or FISH), per ASCO\u002FCAP guidelines\n* Clinically ≥T1cN0, or any T, N1-2\n* Plan to receive neoadjuvant chemotherapy and immune checkpoint inhibitor before surgery as standard-of-care treatment\n* Adequate organ function as defined in the following. Specimens must be collected within 14 days prior to the start of study treatment.\n\n  * ANC ≥ 1,500\u002Fmm3\n  * Platelets ≥ 100,000\u002Fmm3\n  * Hemoglobin ≥ 9.0 g\u002FdL.\n  * Total serum bilirubin ≤ 1.5 x ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels \\>1.5 x ULN\n  * AST \\\u003C 3 x ULN\n  * ALT \\\u003C 3 x ULN\n  * Creatinine clearance ≥ 30 mL\u002Fmin\n  * INR or PT, aPTT \\\u003C 1.5 x ULN\n* Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test within 14 days of start of study treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. Note: If egg harvesting was completed prior to enrollment, the pregnancy test may be falsely positive and the PI will assess and determine eligibility for these cases.\n* Female participants: A female participant is eligible to participate if she is not pregnant (see Appendix B), not breastfeeding, and at least one of the following conditions applies:\n\n  \\-- Not a woman of childbearing potential (WOCBP) as defined in Appendix B OR Females of child-bearing potential must be willing to use effective contraception during study and for 120 days after the last dose.\n* Male participants: A male participant must agree to use a contraception as detailed in Appendix B of this protocol during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period.\n* Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.\n\nExclusion Criteria\n\n* Evidence of metastatic disease.\n* Is currently participating in or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.\n* History of bleeding tendencies or coagulopathy and\u002For clinically significant bleeding symptoms or risk within 4 weeks prior to start of study treatment, including but not limited to:\n\n  * Hemoptysis (defined as coughing up ≥ 0.5 teaspoon of fresh blood or small blood clots) Note: transient hemoptysis associated with diagnostic bronchoscopy is allowed.\n  * Nasal bleeding\u002Fepistaxis (bloody nasal discharge is allowed)\n  * Current use of prophylactic or full-dose anticoagulants or anti-platelet agents for therapeutic purposes that is not stable, in the opinion of the treating investigator, prior to start of study treatment is not allowed. The use of full-dose anticoagulants is permitted as long as the INR or activated partial thromboplastin time (aPTT) is within therapeutic limits according to the medical standard of the enrolling institution.\n* Poorly controlled hypertension with repeated systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg after oral antihypertensive therapy\n* Women who are or are planning to become pregnant or breastfeed\n* Known allergy to any of the components within the study agents and\u002For their excipients\n* Medical history and concurrent diseases\n\n  * Autoimmune diseases\n  * Any prior malignancy except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for at least three years\n  * History of (non-infectious) pneumonitis that required steroids or has current pneumonitis\n  * Active infection requiring systemic therapy\n  * Known history of Human Immunodeficiency Virus (HIV) infection\n  * Known history of active Hepatitis B (defined as Hepatitis B surface antigen \\[HBsAg\\] reactive) or known active Hepatitis C virus (defined as HCV RNA \\[qualitative\\] is detected) infection. Note: no testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority\n  * Known history of active TB (Mycobacterium tuberculosis)\n  * History of unstable angina, myocardial infarction, congestive heart failure (New York Heart Association \\[NYHA\\] classification ≥ grade 2) or unstable vascular disease (eg, aortic aneurysm at risk of rupture, Moyamoya disease) that required hospitalization within 12 months prior to randomization, or other cardiac impairment that may affect the safety evaluation of the study drug (eg, poorly controlled arrhythmias, myocardial ischemia)\n  * Prolongation of QTc interval \\>480 msec\n  * Prior allogeneic bone marrow transplantation or prior solid organ transplantation\n  * History of esophageal gastric varices, severe ulcers, wounds that do not heal, abdominal fistula, intra-abdominal abscesses, or acute gastrointestinal bleeding within 6 months prior to start of study treatment\n  * History of any grade arterial thromboembolic event, Grade 3 and above venous thromboembolic event, as specified in National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 5.0, transient ischemic attack, cerebrovascular accident, hypertensive crisis, or hypertensive encephalopathy within 12 months prior to start of study treatment\n  * Acute exacerbation of chronic obstructive pulmonary disease within 4 weeks before start of study treatment\n  * History of perforation of the gastrointestinal tract and\u002For fistula, history of gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive bowel resection (partial colectomy or extensive small bowel resection) within 6 months prior to start of study treatment\n* Prohibited Treatments and\u002For Therapies\n\n  * Other non-protocol specified anti-cancer therapy: systemic radiotherapy, immunotherapy, biologic, or hormonal therapy. tretinoin therapy, nitrosourea, mitomycin C, small molecule tyrosine kinase inhibitor therapy\n\n    \\--- Concomitant use of hormones for non-tumor-related conditions (e.g., insulin and hormone replacement therapy for diabetes mellitus) is acceptable\n  * Any live vaccine within 30 days prior to the first dose of study drug and up to 120 days after the last dose. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed\n  * Prior systemic therapy or radiation therapy with curative intent for the current breast cancer\n  * A previous definitive ipsilateral breast surgery for the current breast cancer\n  * Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g. CTLA-4, OX-40, CD137).\n  * Immunosuppressive drugs, including, but not limited to, prednisone or equivalent, methotrexate, azathioprine, and TNF-α antagonists at doses exceeding 10 mg per day. The following exceptions are allowed:\n\n    * The use of immunosuppressive drugs for the treatment of study drug-associated AEs or the use of immunosuppressive drugs in subjects with contrast allergy is acceptable.\n    * The use of inhaled, topical, and intranasal glucocorticoids is permitted.\n    * Corticosteroids are allowed as a prophylactic drug for hypersensitivity reactions (eg, before CT or MRI).\n    * Corticosteroids are allowed as antiphylactic and therapeutic agents for chemotherapy-induced vomiting.\n    * Short-term use of glucocorticoids for underlying or intercurrent conditions may be permitted after discussion with the PI.\n* Major surgery within 28 days prior to start of study treatment and within 4 weeks after first dose. Participants must have fully recovered from the effects of prior major surgery in the opinion of the treating investigator.\n* Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures.",{"count":258,"type":22},34,[232],"This is a single arm phase II trial combination of ivonescimab and carbo-docetaxel every 3 weeks for 6 cycles in patients with early-stage triple negative breast cancer. The trial is designed to test the safety and efficacy of adding ivonescimab in patients with early TNBC undergoing neoadjuvant chemotherapy with carboplatin and docetaxel. Patients will receive ivonescimab 20 mg\u002Fkg IV on Day 1 of each cycle, and carboplatin AUC6 and docetaxel 75 mg\u002Fm2 on Day 1 of each cycle for 6 cycles. Cycles will be 21 days for a total of 6 cycles. Curative intent surgery will be performed within 6 weeks (maximum 12 weeks) time frame upon completion of last dose of chemoimmunotherapy. The surgical pathology information will be used for assessment of pathological response, which serve as the primary endpoint of this study. Patients will undergo assessment at baseline, C1D1 of each cycle and end of treatment visit for collection of treatment-emergent adverse events, evaluated by CTCAE v5.0. Patient reported outcomes will be collected at cycles 1, 4, and 6, and at EOT. All study patients will be followed for at least 5 years for EFS and OS follow up. Research biopsies, peripheral blood and stool samples will be collected at the following time points: baseline, C4D1 (+\u002F-14 days), and surgery (+\u002F-14 days). Baseline and EOT breast MRI will be performed as standard of care for assessment of clinical response. Mid treatment breast ultrasound (C4D1 +\u002F-14 days) will be repeated as standard of care to assess clinical response to treatment. Mid-treatment C4D1 tumor biopsy may be omitted if the primary tumor is no longer visible or the tumor deemed too small for biopsy by radiologist.",[262,263,264],"TNBC","TNBC - Triple-Negative Breast Cancer","Early Stage Triple-Negative Breast Carcinoma",[266,267,268,269,262,270],"Ivonescimab","Carboplatin","Docetaxel","Neoadjuvant chemotherapy","High-risk early stage TNBC","2026-08-03",{"date":243,"type":36},{"date":274,"type":36},"2025-07-25",{"date":276,"type":22},"2032-11",{"name":42,"class":43},4,{"id":280,"slug":281,"hasResults":12,"nctId":282,"briefTitle":283,"officialTitle":284,"acronym":4,"eligibilityCriteria":285,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":286,"enrollmentInfo":287,"targetDuration":4,"studyType":23,"phases":288,"briefSummary":289,"conditions":290,"keywords":4,"overallStatus":113,"whyStopped":4,"lastUpdateSubmitDate":271,"lastUpdatePostDateStruct":293,"startDateStruct":295,"completionDateStruct":297,"leadSponsor":299,"locationsCount":44},"100543923","vr-pilot-for-pancreatitis-100543923","NCT06362187","VR Pilot for Pancreatitis","A Feasibility Study on Gut-Directed Virtual Reality for Chronic Pain Related to Chronic Pancreatitis","Inclusion Criteria:\n\n* Diagnosis of CP \\[as determined by Cambridge 3-4 imaging classification (using CT, MRI, or MRCP) or a histologic diagnosis of CP\\]\n* Clinically significant abdominal pain, measured using the standardized NIH PROMIS GI Pain Scale14 and defined as scoring at least 5 points above the nationally normed score (0.5 SD effect size), indicating equal or greater than the minimally clinically important difference (MCID) of abdominal pain\n* Are 18-75 years of age\n* Are able to read\u002Fwrite English. The study does not include non-English speakers as to current study material are only available in English.\n\nExclusion Criteria:\n\n* Patients who are presenting with a condition that interferes with VR usage (e.g., seizures, facial injury precluding safe placement of headset, visual impairment)\n* Patients who have cognitive impairment that affects protocol participation\n* Patients who are recommended for long-term hospitalization\n* Patients who are estimated to live \\\u003C3 months from the time of enrollment\n* Patients who have been diagnosed with a pancreatic tumor\n* Patients who have been enrolled in an interventional\u002Ftherapeutic drug trial for chronic or recurrent pancreatitis within the last 6 months","75 Years",{"count":178,"type":22},[25],"The purpose of the research is to test the feasibility and preliminary impact of a home-based, standardized, gut-directed, virtual reality cognitive behavioral therapy (VR CBT) on clinical and functional outcomes of patients with chronic pancreatitis (CP) pain. The primary research procedures are questionnaires and biometric Fitbit data. The study will enroll adult patients with CP.",[291,292],"Chronic Pancreatitis","Recurrent Pancreatitis",{"date":294,"type":36},"2026-08-05",{"date":296,"type":22},"2027-07-22",{"date":298,"type":22},"2029-05",{"name":42,"class":43},{"id":301,"slug":302,"hasResults":12,"nctId":303,"briefTitle":304,"officialTitle":304,"acronym":305,"eligibilityCriteria":306,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":286,"enrollmentInfo":307,"targetDuration":4,"studyType":23,"phases":309,"briefSummary":311,"conditions":312,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":271,"lastUpdatePostDateStruct":314,"startDateStruct":315,"completionDateStruct":317,"leadSponsor":318,"locationsCount":319},"100498547","early-phase-1-simvastatin-treatment-to-improve-patient-reported-outcomes-in-patients-with-chronic-pancreatitis-100498547","NCT05771675","Simvastatin Treatment to Improve Patient-reported Outcomes in Patients With Chronic Pancreatitis","SMV in CP","Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form\n2. Stated willingness to comply with all study procedures and availability for the duration of the study\n3. Male or female, aged 18-75 at time of enrollment\n4. Diagnosis of Recurrent Acute or Chronic Pancreatitis not attributable to gallstones (i.e., suspected or definite biliary etiology), medications, trauma or autoimmune pancreatitis. For CP, imaging studies that can be used for diagnosis classification using Cambridge criteria46,47.\n5. Ability to take oral medication and be willing to adhere to the dosing regimen.\n6. For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional one month after administration of study medication.\n7. For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional one month after administration of study medication.\n8. No prior pancreatic surgery\n9. No current statin use for 6 months.\n\nExclusion Criteria:\n\n1. Pregnancy or lactation\n2. History of autoimmune, medication caused or traumatic pancreatitis.\n3. Primary pancreatic tumors - pancreatic ductal adenocarcinoma, suspected cystic neoplasm (\\>1 cm. in size or main duct involvement), neuroendocrine tumors, and other uncommon tumors.\n4. Pancreatic metastasis from other malignancies.\n5. History of solid organ transplant, HIV\u002FAIDS.\n6. Known isolated pancreatic exocrine insufficiency (i.e.., in the absence of any eligible inclusion criteria).\n7. Subjects required to take itraconazole, ketoconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, nefazodone, gemfibrozil, cyclosporine, danazol, amiodarone, or verapamil for other clinical indications.\n8. Current simvastatin use within the past 6 months.\n9. Participants must not have medical or psychiatric illnesses or ongoing substance abuse that in the investigator's opinion would compromise their ability to tolerate study interventions or participate in longitudinal follow up.\n10. Patients with active liver disease.\n11. Known Pregnancy. All participants of childbearing potential, except if post-menopausal (i.e., no menses for ≥2 years) or had a hysterectomy, bilateral tubal ligation\u002Fclip (surgical sterilization) or surgical removal of both the ovaries), must have a negative urine or serum B-HCG pregnancy test documented within 2 days prior to any endoscopic or radiologic procedures done for research purposes. Any standard of care tests will follow institutional policies regarding pregnancy test.\n12. Currently incarcerated.\n13. Inability to comply with study activities.",{"count":308,"type":22},90,[310],"EARLY_PHASE1","The purpose of this pilot study to examine the feasibility and acceptability of simvastatin in adults with Recurrent Acute Pancreatitis (RAP) and Chronic Pancreatitis (CP).",[313,291],"Recurrent Acute Pancreatitis",{"date":294,"type":36},{"date":316,"type":36},"2024-10-24",{"date":168,"type":22},{"name":42,"class":43},5,{"id":321,"slug":322,"hasResults":12,"nctId":323,"briefTitle":324,"officialTitle":325,"acronym":4,"eligibilityCriteria":326,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":327,"targetDuration":4,"studyType":23,"phases":329,"briefSummary":330,"conditions":331,"keywords":333,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":271,"lastUpdatePostDateStruct":335,"startDateStruct":336,"completionDateStruct":338,"leadSponsor":340,"locationsCount":319},"100493684","phase-2-a-phase-2-study-of-the-ketogenic-diet-vs-standard-anti-cancer-diet-guidance-for-patients-with-glioblastoma-in-combination-with-standard-of-care-treatment-100493684","NCT05708352","A Phase 2 Study of the Ketogenic Diet vs Standard Anti-cancer Diet Guidance for Patients With Glioblastoma in Combination With Standard-of-care Treatment","A Randomized Controlled Phase 2 Study of the Ketogenic Diet Versus Standard Dietary Guidance for Patients With Newly Diagnosed Glioblastoma in Combination With Standard-of-care Treatment","Inclusion Criteria:\n\n* Adults 18 years or older\n* Newly diagnosed glioblastoma (Within 2 months of initial diagnosis by histopathology)\n* Not started standard of care chemotherapy and\u002For radiation therapy for glioblastoma\n* Karnofsky Performance Status (KPS) ≥ 70\n* Ability to read, write and understand either English OR Spanish\n* Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.\n\nExclusion Criteria:\n\n* Patients with recurrent glioblastoma\n* Genetic disorders that affect lipid metabolism. Including but not limited to pyruvate carboxylase deficiency, porphyria, primary carnitine deficiency, carnitine palmitoyltransferase I or II deficiency, carnitine translocase deficiency, beta-oxidation defects\n* Inability to wean steroids below 8mg dexamethasone \u002F day or equivalent\n* Body Mass Index (BMI) \\\u003C 21kg\u002Fm2, unless the site Principal Investigator deems safe\n* Currently pregnant or nursing\n* Patients receiving other experimental therapy Note: Off-label therapy use is permitted\n* Comorbidities that in the opinion of the investigator limit the patient's ability to complete the study\n* Food preferences incompatible with keto diet\n* Using a pacemaker, implantable cardiac defibrillator, neurostimulator, cochlear implants (removable hearing aids permitted), or other electronic medical equipment, unless the site Principal Investigator deems safe\n* Inability to participant in standard of care MRIs",{"count":328,"type":22},170,[232],"This is a Phase 2, randomized two-armed, multi-site study of 170 patients with newly diagnosed glioblastoma multiforme. Patients will be randomized 1:1 to receive Keto Diet, or Standard Anti-Cancer Diet. All patients will receive standard of care treatment for their glioblastoma. The Keto Diet intervention will be for an 18-week period and conducted by trained research dietitians. Daily ketone and glucose levels will be recorded to monitor Keto Diet adherence.\n\nThis two-armed randomized multi-site study aims to provide evidence to support the hypothesis that a Keto Diet vs. Standard Anti-Cancer Diet improves overall survival in newly diagnosed glioblastoma multiforme patients who receive standard of care treatment.",[332],"Glioblastoma Multiforme",[334],"Keto Diet",{"date":294,"type":36},{"date":337,"type":36},"2023-06-27",{"date":339,"type":22},"2029-09-30",{"name":42,"class":43},{"id":342,"slug":343,"hasResults":12,"nctId":344,"briefTitle":345,"officialTitle":345,"acronym":4,"eligibilityCriteria":346,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":347,"targetDuration":4,"studyType":23,"phases":348,"briefSummary":349,"conditions":350,"keywords":354,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":359,"lastUpdatePostDateStruct":360,"startDateStruct":362,"completionDateStruct":364,"leadSponsor":366,"locationsCount":44},"100583503","staged-kidney-transplantation-during-combined-heartkidney-transplantation-100583503","NCT06877169","Staged Kidney Transplantation During Combined Heart\u002FKidney Transplantation","Inclusion Criteria:\n\n* Adult patients (18 years or older) undergoing combined heart and kidney transplantation at Cedars-Sinai Medical Center.\n\nExclusion Criteria:\n\n* Patients who undergo simultaneous heart\u002Fkidney transplantation in a single operative event due to medical necessity will be excluded.\n* Patients with medical records flagged as \"break-the-glass\" or \"research opt-out\" within the center's electronic health record.",{"count":178,"type":22},[25],"The primary purpose of this study is to evaluate the safety and efficacy of ex vivo machine perfusion with staged implantation of kidney allografts during combined heart\u002Fkidney transplantation.",[351,352,353],"Heart Failure","Chronic Kidney Disease","End-stage Kidney Disease",[355,356,357,358],"combined heart and kidney transplant","simultaneous heart and kidney transplant","hypothermic oxygenated machine perfusion","organ preservation","2026-07-22",{"date":361,"type":36},"2026-07-24",{"date":363,"type":36},"2025-04-07",{"date":365,"type":22},"2035-02-28",{"name":42,"class":43},{"id":368,"slug":369,"hasResults":12,"nctId":370,"briefTitle":371,"officialTitle":372,"acronym":4,"eligibilityCriteria":373,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":374,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":376,"conditions":377,"keywords":379,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":382,"lastUpdatePostDateStruct":383,"startDateStruct":384,"completionDateStruct":386,"leadSponsor":388,"locationsCount":44},"100450000","artificial-intelligence-guided-echocardiographic-screening-of-rare-diseases-echonet-screening-100450000","NCT05139797","Artificial Intelligence Guided Echocardiographic Screening of Rare Diseases (EchoNet-Screening)","Artificial Intelligence Guided Echocardiographic Screening of Rare Diseases","Inclusion Criteria:\n\n* Patients who have a high suspicion for cardiac amyloidosis by AI algorithm\n\nExclusion Criteria:\n\n* Patients who decline to be seen at specialty clinic\n* Patients who have passed away",{"count":375,"type":22},300,"Despite rapidly advancing developments in targeted therapeutics and genetic sequencing, persistent limits in the accuracy and throughput of clinical phenotyping has led to a widening gap between the potential and the actual benefits realized by precision medicine.\n\nRecent advances in machine learning and image processing techniques have shown that machine learning models can identify features unrecognized by human experts and more precisely\u002Faccurately assess common measurements made in clinical practice.\n\nThe investigators have developed an algorithm, termed EchoNet-LVH, to identify cardiac hypertrophy and identify patients who would benefit from additional screening for cardiac amyloidosis and will prospectively evaluate its accuracy in identifying patients whom would benefit from additional screening for cardiac amyloidosis.",[378],"Cardiac Amyloidosis",[380,381],"Echocardiogram","Artificial Intelligence","2026-07-21",{"date":359,"type":36},{"date":385,"type":36},"2021-11-18",{"date":387,"type":22},"2027-06-01",{"name":42,"class":43},{"id":390,"slug":391,"hasResults":12,"nctId":392,"briefTitle":393,"officialTitle":394,"acronym":4,"eligibilityCriteria":395,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":396,"targetDuration":4,"studyType":23,"phases":398,"briefSummary":399,"conditions":400,"keywords":402,"overallStatus":113,"whyStopped":4,"lastUpdateSubmitDate":406,"lastUpdatePostDateStruct":407,"startDateStruct":409,"completionDateStruct":411,"leadSponsor":413,"locationsCount":4},"100646588","pre-clinic-visit-online-education-for-thyroid-cancer-100646588","NCT07690839","Pre-Clinic Visit Online Education for Thyroid Cancer","A Randomized Controlled Trial Evaluating Educational Resources for Patients With Thyroid Cancer","Inclusion Criteria:\n\n* Newly diagnosed with either:\n\n  1. ≤2cm Bethesda 6 thyroid nodule (papillary thyroid carcinoma) (T1N0)\n  2. ≤2cm Bethesda 5 thyroid nodule\n  3. ≤2cm Bethesda 3-4 thyroid nodule with molecular testing that confers \\>75% risk of malignancy\n* Able to understand and complete questionnaires independently in English\n* Access to an internet-enabled device for online surveys and intervention access\n\nExclusion Criteria:\n\n* Cognitive impairment or other condition that, in the opinion of the investigators, would interfere with protocol participation\n* Has nodule \\>2cm in size, or with non-papillary thyroid carcinoma histology\n* High-grade or poorly differentiated papillary thyroid carcinoma (PTC) variants\n* Central or lateral neck lymphadenopathy suspicious for PTC\n* Unfavorable nodule location, to be determined by the surgeon (e.g. Near dorsal surface (by recurrent laryngeal nerve); adjacent to trachea (risk of cartilage invasion)\n* Recurrent thyroid cancer case",{"count":397,"type":22},60,[25],"Through a pilot randomized controlled trial (RCT), we aim to test the feasibility and preliminary impact of two online educational resources among adult patients with thyroid cancer. Each online program can be accessed on the patient's personal device, and will be provided to the patient following a diagnosis of thyroid cancer but before meeting with their surgeon to discuss treatment options. The goal of the resource is to educate patients on the various treatment options for thyroid cancer prior to surgical consultation, so that clinic visit time can be better utilized to discuss patient questions and priorities, and support shared decision making. Clinical (TC-MAX; thyroid cancer related anxiety) and behavioral outcomes (decisional conflict, shared-decision making, treatment decision) will be assessed via online surveys 1-day and 14-days post-visit.",[401],"Thyroid Cancer",[403,404,405],"Online Education","Remote Monitoring","Shared Decision Making","2026-07-02",{"date":408,"type":36},"2026-07-08",{"date":410,"type":22},"2026-08",{"date":412,"type":22},"2027-09",{"name":42,"class":43},{"id":415,"slug":416,"hasResults":12,"nctId":417,"briefTitle":418,"officialTitle":419,"acronym":4,"eligibilityCriteria":420,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":421,"enrollmentInfo":422,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":424,"conditions":425,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":427,"lastUpdatePostDateStruct":428,"startDateStruct":430,"completionDateStruct":432,"leadSponsor":433,"locationsCount":434},"100405852","predicting-bcg-response-100405852","NCT04564781","Predicting BCG Response","A Novel Multiplex Immunoassay for Predicting Intravesical BCG Response in Patients With Intermediate or High-risk Non-muscle Invasive Bladder Cancer","Inclusion Criteria:\n\n* Age 18 years or older\n* Patients must have histologically proven Ta, carcinoma in situ (CIS) or T1 stage urothelial cell carcinoma of the bladder diagnosed within 90 days prior to scheduled BCG\n* Patients must have had all grossly visible papillary tumors removed within 30 days prior to scheduled BCG or cystoscopy confirming no grossly visible papillary tumors within 30 days prior to scheduled BCG\n* Patients with T1 disease must have cross-sectional imaging of abdomen\u002Fpelvis demonstrating no evidence of nodal involvement or metastatic disease (CT scan or MRI scan) within 90 days prior to scheduled BCG\n* Patients must have intermediate or high-grade bladder cancer as defined by 2004 WHO\u002FISUP classification\n* Patients must not have pure squamous cell carcinoma or adenocarcinoma.\n* Patients' disease must not have micropapillary components.\n* Patients must have no evidence of upper tract (renal pelvis or ureters) cancer confirmed by one of the following tests performed within 90 days prior to BCG: CT urogram, intravenous pyelogram, MR urogram, or retrograde pyelograms.\n* No other prior non-bladder malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years. Patients with localized prostate cancer who are being followed by an active surveillance program are also eligible.\n* Participants may be treated with immediate post-operative intravesical instillation of a chemotherapeutic agent\n* Scheduled to undergo intravesical BCG therapy within 4 weeks of signing consent.\n* Willing and able to give written informed consent (see Appendix 1)\n* Willing to provide voided urine sample\n\nExclusion Criteria:\n\n* Previous intravesical BCG therapy\n* Patients must not be taking oral glucocorticoids at the time of registration.\n* Patients must not be planning to receive concomitant biologic therapy, hormonal therapy, chemotherapy, surgery, or other cancer therapy while on study.\n* Patients must not have known history of tuberculosis.\n* Have incomplete TUR, i.e., visible residual disease\n* Have had radical cystectomy\n* Have a known active urinary tract infection or urinary retention\n* Have active stone disease (renal or bladder) or renal insufficiency (creatinine \\>2.0 mg\u002FdL) - Serum creatinine value can be up to 2 years before consent, otherwise repeat.\n* Have ureteral stents, nephrostomy tubes or bowel interposition\n* Have recent genitourinary instrumentation (within 7 days prior to signing consent)\n* Be unable or unwilling to complete BCG induction and maintenance regimen","90 Years",{"count":423,"type":22},400,"To date, there are no diagnostics capable of predicting treatment response to intravesical BCG. Because of this severe limitation, nearly 50% of patients treated with BCG fail therapy and will a) require additional intravesical therapy or b) require cystectomy. A urine-based diagnostic that possesses the potential to accurately identify patients who will respond favorably to intravesical BCG is desperately needed.",[426],"Bladder Cancer","2026-07-01",{"date":429,"type":36},"2026-07-06",{"date":431,"type":36},"2020-09-18",{"date":68,"type":22},{"name":42,"class":43},6,{"id":436,"slug":437,"hasResults":12,"nctId":438,"briefTitle":439,"officialTitle":440,"acronym":441,"eligibilityCriteria":442,"healthyVolunteers":17,"sex":18,"minAge":443,"maxAge":4,"enrollmentInfo":444,"targetDuration":4,"studyType":23,"phases":446,"briefSummary":447,"conditions":448,"keywords":450,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":457,"lastUpdatePostDateStruct":458,"startDateStruct":459,"completionDateStruct":461,"leadSponsor":462,"locationsCount":44},"100644840","phase-2-ongoing-lung-decline-with-age-intensified-response-100644840","NCT07676435","Ongoing Lung Decline With Age Intensified Response","A PHASE II, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THE ONGOING LUNG DECLINE WITH AGE INTENSIFIED RESPONSE (OLD AIR)","OLD AIR","Inclusion Criteria:\n\n* Adults aged 60 years and older who are physically capable of participating in study procedures;\n* Willing to be randomized to fisetin or placebo; weight stable within the previous 2 months (\\\u003C5-pound change);\n* No blood donation within 2 months before screening; absence of unstable chronic disease;\n* Willing to maintain baseline activity level throughout the study;\n* Body mass index \\\u003C30 kg\u002Fm²;\n* Either a history of at least 10 pack-years of cigarette smoking or never-smoking status.\n\nExclusion Criteria:\n\n* Electrocardiogram (ECG) abnormalities, including prolonged QTc.\n* Use of fisetin, other flavonoid supplements, or known senolytic compounds within 6 months prior to screening.\n* Resting systolic blood pressure \\>160 mmHg or diastolic blood pressure \\>110 mmHg.\n* Known allergy or hypersensitivity to fisetin or any component of the study product.\n* Active malignancy, except non-melanoma skin cancer.\n* Clinically significant hepatic, renal, cardiovascular, endocrine, immunologic, metabolic, or other uncontrolled medical conditions that, in the opinion of the investigator, would interfere with study participation or interpretation of results.\n* Clinically significant laboratory abnormalities, including severe anemia, leukopenia, thrombocytopenia, uncontrolled diabetes, advanced kidney disease, significant liver dysfunction, or evidence of systemic inflammation.\n* Human immunodeficiency virus (HIV) infection, active hepatitis B or hepatitis C infection, or invasive fungal infection.\n* History of diverticulitis or diverticulosis with gastrointestinal bleeding.\n* Current use of systemic corticosteroids.\n* Current use of warfarin.\n* Current use of medications with significant interaction potential with fisetin, including selected CYP450 or transporter substrates, inhibitors, or inducers, unless such medications can be safely withheld according to protocol requirements.\n* Recent medication, supplement, or lifestyle changes that may affect study outcomes, in the opinion of the investigator.\n* Inability to perform required study procedures, including pulmonary function testing, exercise testing, or other protocol assessments.\n* Unwillingness or inability to provide informed consent.\n* Pregnancy or breastfeeding.\n* Any other condition that, in the opinion of the investigator, would make participation unsafe or compromise study integrity.","60 Years",{"count":445,"type":22},40,[232],"This Phase II, randomized, double-blind, placebo-controlled pilot study will evaluate the effects of fisetin, a senolytic flavonoid compound, on lung function and biomarkers of cellular senescence in older adults aged 60 years and older. Participants will include individuals with a history of at least 10 pack-years of smoking as well as age-matched never-smokers. Forty participants will be randomized to receive either fisetin or placebo using a short-course \"hit-and-run\" dosing strategy (approximately 20 mg\u002Fkg\u002Fday orally for 2 consecutive days on Days 1-2 and Days 8-9).",[449],"Age-Related Lung Function Decline",[451,452,453,454,455,456],"Aging","Cellular Senescence","Healthy Aging","Smoking-Related Lung Function Decline","Pulmonary Function","Smoking","2026-06-30",{"date":427,"type":36},{"date":460,"type":36},"2026-06-17",{"date":221,"type":22},{"name":42,"class":43},{"id":464,"slug":465,"hasResults":12,"nctId":466,"briefTitle":467,"officialTitle":468,"acronym":4,"eligibilityCriteria":469,"healthyVolunteers":12,"sex":470,"minAge":19,"maxAge":4,"enrollmentInfo":471,"targetDuration":4,"studyType":23,"phases":473,"briefSummary":474,"conditions":475,"keywords":479,"overallStatus":113,"whyStopped":4,"lastUpdateSubmitDate":483,"lastUpdatePostDateStruct":484,"startDateStruct":485,"completionDateStruct":486,"leadSponsor":488,"locationsCount":44},"100646910","debriefing-consult-for-psychiatric-symptoms-after-severe-maternal-morbidity-100646910","NCT07684521","Debriefing Consult for Psychiatric Symptoms After Severe Maternal Morbidity","Does a Debriefing Intervention After a Delivery Complicated by Severe Maternal Morbidity Reduce Post-traumatic, Depression, or Anxiety Symptoms? A Randomized Controlled Trial","Inclusion Criteria:\n\n\\- Individuals with a delivery complicated by severe maternal morbidity, defined as intensive care unit (ICU) admission and\u002For blood product transfusion \\>4 units\n\nExclusion Criteria:\n\n* Age \\\u003C18 years\n* Non-English speakers\n* Any records flagged \"break the glass\" or \"research opt out\"","FEMALE",{"count":472,"type":22},52,[25],"The primary objective of this study is to determine if a maternal fetal medicine (MFM) debriefing consult six to eight weeks postpartum reduces self-reported post-traumatic stress, depression, and anxiety symptoms following a delivery complicated by severe maternal morbidity (SMM). Individuals with a delivery complicated an intensive care unit (ICU) admission and\u002For blood product transfusion \\>4 units will be included in this study. Participants will be randomized to an intervention or control group; all participants will complete patient questionnaires that screen for post-traumatic stress disorder, depression, and anxiety. Those in the control group will receive a virtual MFM debriefing consult at six weeks postpartum and those in the intervention group will have the option for a consult at twelve weeks postpartum, after the completion of the questionnaires.",[476,477,478,106],"PTSD (Childbirth-Related)","Severe Maternal Morbidity","Depression - Major Depressive Disorder",[480,481,161,482],"severe materal morbidity","PTSD","depression","2026-06-29",{"date":429,"type":36},{"date":427,"type":22},{"date":487,"type":22},"2030-07",{"name":42,"class":43},{"id":490,"slug":491,"hasResults":12,"nctId":492,"briefTitle":493,"officialTitle":494,"acronym":4,"eligibilityCriteria":495,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":496,"targetDuration":4,"studyType":23,"phases":497,"briefSummary":498,"conditions":499,"keywords":503,"overallStatus":113,"whyStopped":4,"lastUpdateSubmitDate":506,"lastUpdatePostDateStruct":507,"startDateStruct":509,"completionDateStruct":510,"leadSponsor":511,"locationsCount":44},"100644584","online-pain-education-for-crohns-disease-and-ulcerative-colitis-100644584","NCT07671313","Online Pain Education for Crohn's Disease and Ulcerative Colitis","Randomized Controlled Trial of Online Pain Education Programs for Inflammatory Bowel Disease","Inclusion Criteria:\n\n* Physician-confirmed diagnosis of Crohn's disease or ulcerative colitis\n* Chronic pain (visceral and\u002For somatic) related to IBD for at least 3 months\n* NIH PROMIS Pain Interference scale T-score ≥60\n* Medically stable, defined as:\n\n  1. No acute IBD-related hospitalization within the past 3 months; AND\n  2. No planned IBD surgery or planned therapeutic escalation within the next 2 months, including initiation of a new advanced therapy, dose escalation or switch of advanced therapy, or corticosteroid taper\n* Able to understand and complete questionnaires independently in English\n* Access to an internet-enabled device for online surveys and intervention access.\n\nExclusion Criteria:\n\n* Cognitive impairment or other condition that, in the opinion of the investigators, would interfere with protocol participation\n* Current use of standing opioid medications, given the often severe impact of opioids on GI motility and potential for pharmacological visceral hyperalgesia\n* Prior participation in cognitive behavioral therapy (CBT) specifically targeting chronic IBD-related pain",{"count":397,"type":22},[25],"Through a pilot randomized controlled trial (RCT), we aim to test the feasibility and preliminary impact of two online pain educations programs among adult patients with inflammatory bowel disease (IBD) who experience chronic pain. Each online program can be accessed on the patient's personal device, and will take about 2 hours to complete. Clinical outcomes (pain intensity, pain interference, quality of life) will be assessed via online surveys at baseline and then weekly for 8-weeks post-treatment.",[500,501,502],"Crohn's Disease","Ulcerative Colitis (UC)","Inflammatory Bowel Disease (Crohn's Disease; Ulcerative Colitis)",[504,404,505],"Pain Education","Chronic pain","2026-06-22",{"date":508,"type":36},"2026-06-26",{"date":410,"type":22},{"date":412,"type":22},{"name":42,"class":43},{"id":513,"slug":514,"hasResults":12,"nctId":515,"briefTitle":516,"officialTitle":517,"acronym":518,"eligibilityCriteria":519,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":520,"targetDuration":4,"studyType":23,"phases":522,"briefSummary":523,"conditions":524,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":526,"lastUpdatePostDateStruct":527,"startDateStruct":529,"completionDateStruct":531,"leadSponsor":533,"locationsCount":44},"100233562","assessment-of-transcatheter-and-surgical-aortic-bioprosthetic-valve-thrombosis-and-its-treatment-with-anticoagulation-100233562","NCT02318342","Assessment of TRanscathetEr and Surgical Aortic BiOprosthetic Valve Thrombosis and Its TrEatment With Anticoagulation","Assessment of TRanscathetEr and Surgical Aortic BiOprosthetic Valve Dysfunction With Multimodality Imaging and Its TrEatment With Anticoagulation","RESOLVE","Inclusion Criteria:\n\n* Presence of transcatheter or surgical bioprosthetic aortic valve implanted at least 48 hours prior to enrollment\n* Age 18 years or older\n* Ability to provide informed consent and follow-up with protocol procedures.\n\nExclusion Criteria:\n\n* Renal insufficiency (creatinine \\> 1.5 mg\u002FdL)\n* Known allergy to iodinated contrast agents",{"count":521,"type":22},3000,[25],"This is a prospective study designed to evaluate the structural and functional integrity of transcatheter or surgical bioprosthetic valves with multimodality imaging. The study further aims to confirm resolution of the early bioprosthetic valve thrombotic changes with anticoagulation.",[525],"Prosthetic Valve Thrombosis","2026-06-15",{"date":528,"type":36},"2026-06-16",{"date":530,"type":4},"2014-12",{"date":532,"type":22},"2028-12",{"name":42,"class":43},{"id":535,"slug":536,"hasResults":12,"nctId":537,"briefTitle":538,"officialTitle":539,"acronym":540,"eligibilityCriteria":541,"healthyVolunteers":12,"sex":18,"minAge":443,"maxAge":4,"enrollmentInfo":542,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":543,"conditions":544,"keywords":546,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":550,"lastUpdatePostDateStruct":551,"startDateStruct":553,"completionDateStruct":555,"leadSponsor":557,"locationsCount":44},"100637625","transcatheter-vs-surgical-treatment-of-degenerative-mitral-regurgitation-100637625","NCT07605715","Transcatheter vs. Surgical Treatment of Degenerative Mitral Regurgitation","Transcatheter vs. Surgical Treatment of Degenerative Mitral Regurgitation: A Comparative Study of Clinical Outcomes, Patient Experiences, and Mechanistic Insights With Multimodality Imaging","DMR","Inclusion Criteria:\n\n* Patients older than 60 years who have DMR will be included in the study\n\nExclusion Criteria:\n\n* Patients with prior history of mitral intervention or surgery will be excluded.\n* Patient records flagged \"break the glass\" or \"research opt out\" will be excluded.\n* Persons with allergy to animal dander or animal-instigated asthma will be excluded.",{"count":397,"type":22},"The goal of this observational study is to compare the outcomes of transcatheter edge-to-edge repair (TEER) versus surgical mitral valve repair for degenerative mitral regurgitation (DMR) over the long term. The study aims to:\n\n1. Evaluate the effectiveness and safety of TEER versus surgery in patients with DMR over long term.\n2. Investigate the predictors of left ventricular dysfunction and clinical outcomes using advanced imaging techniques, such as cardiac MRI\n3. Assess patient-reported recovery and quality of life outcomes using validated tools.\n\nThe study focuses on improving care strategies for patients with DMR, particularly those at higher surgical risk, by identifying optimal treatment approaches and predictors of recovery.",[545],"Degenerative Mitral Valve Disease",[547,548,549],"TEER","Transcatheter mitral repair","Surgical mitral repair","2026-05-18",{"date":552,"type":36},"2026-05-26",{"date":554,"type":36},"2025-02-19",{"date":556,"type":22},"2027-08",{"name":42,"class":43},{"id":559,"slug":560,"hasResults":12,"nctId":561,"briefTitle":562,"officialTitle":563,"acronym":564,"eligibilityCriteria":565,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":566,"targetDuration":4,"studyType":23,"phases":568,"briefSummary":569,"conditions":570,"keywords":4,"overallStatus":113,"whyStopped":4,"lastUpdateSubmitDate":572,"lastUpdatePostDateStruct":573,"startDateStruct":575,"completionDateStruct":577,"leadSponsor":579,"locationsCount":4},"100637535","phase-2-beta-3-enhanced-autonomic-therapy-for-pots-100637535","NCT07585513","Beta-3 Enhanced Autonomic Therapy for POTS","A Randomized Placebo-Controlled Clinical Trial Evaluating Mirabegron's Effectiveness in Alleviating POTS Symptoms","BEAT-POTS","Inclusion Criteria:\n\n1. Provision of a signed and dated informed consent form.\n2. Male or female, age ≥ 18 years old.\n3. Confirmed POTS diagnosis, which includes chronic (\\>3 months) orthostatic intolerance, an increase in heart rate (HR) of ≥30 beats per minute (bpm) without orthostatic hypotension (\\>20 mmHg drop of systolic BP) during orthostatic tests.\n\nExclusion Criteria:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Patients who are pacemaker-dependent because the pacing artifacts will complicate skin sympathetic nerve activity (SKNA) analysis.\n2. Clinically unstable (for example, acute myocardial infarction, decompensated heart failure, undergoing cancer chemotherapy, and other acute illnesses requiring hospitalization)\n3. Uncontrolled hypertension (systolic blood pressure ≥180 mm Hg or diastolic blood pressure ≥110 mm Hg, or both)18\n4. Active thyrotoxicosis\n5. Any experimental medication concomitantly or within 4 weeks of participation in the study\n6. Currently participating in a different clinical trial\n7. Severe renal impairment (CrCl \\\u003C 30 ml\u002Fmin)\n8. Hepatic disease (Child-Pugh Class C)\n9. Prisoners\n10. Pregnant\n11. Breastfeeding\n12. Cannot speak, write, or answer questions in English (Validated symptom questionnaires used in this study are available only in English.)\n13. Does not have the capacity to consent\n14. Patients who are known to be allergic to mirabegron or skin patch electrodes\n15. Patients taking codeine, oxycodone, thioridazine, flecainide, propafenone, and digoxin. (see explanation below)",{"count":567,"type":22},36,[232],"The study will test the hypothesis that mirabegron is more effective than a placebo in alleviating postural orthostatic tachycardia (POTS) symptoms.",[571],"Postural Orthostatic Tachycardia Syndrome (POTS)","2026-05-09",{"date":574,"type":36},"2026-05-13",{"date":576,"type":22},"2026-05",{"date":578,"type":22},"2028-05",{"name":42,"class":43},{"id":581,"slug":582,"hasResults":12,"nctId":583,"briefTitle":584,"officialTitle":584,"acronym":585,"eligibilityCriteria":586,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":587,"targetDuration":4,"studyType":23,"phases":588,"briefSummary":589,"conditions":590,"keywords":592,"overallStatus":113,"whyStopped":4,"lastUpdateSubmitDate":597,"lastUpdatePostDateStruct":598,"startDateStruct":600,"completionDateStruct":601,"leadSponsor":602,"locationsCount":4},"100636478","phase-2-using-mirabegron-to-control-arrhythmia-1-100636478","NCT07566208","Using Mirabegron to Control Arrhythmia-1","MACH-1","Inclusion Criteria:\n\n* In order to be eligible to participate in this study, an individual must meet all the following criteria:\n\n  1. Provision of signed and dated informed consent form.\n  2. Age \\> 18 years old.\n  3. Documented VT on ICD.\n\n     1. with \\> 2 episodes of VT per month (on average) over the past 2 months.\n     2. despite guideline-recommended medical therapy (GRMT).\n\nExclusion Criteria:\n\n* An individual who meets any of the following criteria will be excluded from participation in this study:\n\n  1. Patients who are pacemaker-dependent because the pacing artifacts will complicate skin sympathetic nerve activity (SKNA) analysis.\n  2. Clinically unstable (for example, acute myocardial infarction, decompensated heart failure, undergoing cancer chemotherapy, and other acute illness requiring hospitalization)\n  3. Uncontrolled hypertension (systolic blood pressure ≥180 mm Hg or diastolic blood pressure ≥110 mm Hg, or both)25\n  4. Active thyrotoxicosis\n  5. Any experimental medication concomitantly or within 4 weeks of participation in the study\n  6. Currently participating in a different clinical trial\n  7. Severe renal impairment (CrCl \\\u003C 30 ml\u002Fmin)\n  8. Hepatic disease (Child-Pugh Class C)\n  9. Pregnant\n  10. Breastfeeding\n  11. Cannot speak, write, and answer questions in English\n  12. Does not have the capacity to consent\n  13. Severe renal impairment (CrCl \\\u003C 30 ml\u002Fmin)\n  14. Hepatic disease (Child-Pugh Class C)\n  15. Pregnant\n  16. Breastfeeding\n  17. Cannot speak, write, and answer questions in English\n  18. Does not have the capacity to consent\n  19. Patients who are known to be allergic to mirabegron or skin patch electrodes\n  20. Patients taking codeine, oxycodone, thioridazine, flecainide, propafenone, and digoxin. (see explanation below)",{"count":178,"type":22},[232],"To evaluate mirabegron's effect on ventricular arrhythmia control. The study will be conducted in ambulatory patients with ventricular tachycardia (VT), organic heart diseases, and an implantable cardioverter-defibrillator (ICD). The investigators will perform a pilot study involving 20 patients. Each will receive 50 mg of mirabegron. All will have neuECG recordings made before and 2 months after mirabegron. The data will be analyzed to test the proposed hypothesis.",[591],"Ventricular Arrhythmias and Cardiac Arrest",[593,594,595,596],"mirabegron","Ventricular tachycardia","Ventricular fibrillation","ICD","2026-05-04",{"date":599,"type":36},"2026-05-06",{"date":576,"type":22},{"date":578,"type":22},{"name":42,"class":43},{"id":604,"slug":605,"hasResults":12,"nctId":606,"briefTitle":607,"officialTitle":608,"acronym":4,"eligibilityCriteria":609,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":610,"targetDuration":4,"studyType":23,"phases":611,"briefSummary":612,"conditions":613,"keywords":621,"overallStatus":113,"whyStopped":4,"lastUpdateSubmitDate":625,"lastUpdatePostDateStruct":626,"startDateStruct":627,"completionDateStruct":629,"leadSponsor":631,"locationsCount":632},"100535953","phase-2-same-in-prevention-of-oxaliplatin-associated-liver-injury-100535953","NCT06258525","SAMe in Prevention of Oxaliplatin-associated Liver Injury","A Phase II, Open-Label Trial of S-Adenosylmethionine (SAMe) in Prevention of Oxaliplatin Associated Liver Injury","Inclusion Criteria:\n\n* Stage IV patients with resectable liver predominant metastatic colorectal cancer (new diagnosis or recurrent) referred to Cedars Sinai Medical Center for oxaliplatin based systemic therapy.\n* Age ≥ 18 years.\n* Patients who are planning to undergo liver resection following oxaliplatin based chemotherapy treatment.\n* ECOG Performance Status 0-2 or Karnofsky Performance Status (KPS) ≥ 60%.\n* Demonstrate adequate organ and marrow function (within 28 days of study treatment initiation)\n* Female subjects of childbearing potential should have a negative urine or serum pregnancy within 14 days prior to receiving the first dose of study medication for eligibility verification purposes. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n* Female subjects of childbearing potential should be willing to use adequate methods of birth control (hormonal or barrier method of birth control) or be surgically sterile or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \\>1 year.\n* Male subjects should agree to use an adequate method of contraception starting with the first dose of therapy through 120 days after the last dose of therapy.\n* Subjects taking vitamin E ≥800 IU\u002Fday must be on a stable dose defined as:\n\n  1. No changes in prescribed dose within 180 days of the screening visit and\n  2. No new vitamin E-containing medications within 180 days of the screening visit or\n  3. Discontinuation of vitamin E ≥800 IU\u002Fday for at least 180 days prior to the screening visit.\n* Subjects taking anti-diabetic medications must be on a stable dose for at least 90 days prior to the date of the screening visit.\n* Written informed consent obtained from subject and ability for subject to comply with the requirements of the study\n\nExclusion Criteria:\n\n* Currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of treatment.\n* No other anti-cancer therapy (chemotherapy, hormonal therapy, radiation therapy, surgery, immunotherapy, biologic therapy, or tumor embolization) or investigational agent may be used from 28 days prior to registration and until the end-of-study visit.\n* Has previously received chemotherapy for metastatic disease (neoadjuvant or adjuvant therapy is allowed as long as treatment was completed ≥6 months prior to recurrence).\n* Has pre-existing grade ≥ 3 neuropathy precluding use of oxaliplatin.\n* Has known additional malignancy that is progressing or requires active treatment.\n* Has a known hypersensitivity to any of the study supplement\u002Fdrugs (SAMe, oxaliplatin, flourouacil, folinic acid and capecitabine).\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.\n* Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.\n* Has any gastrointestinal disorder (e.g., bowel obstruction) or neurologic condition (e.g., oropharyngeal dysphagia) that may result in impairment of oral intake, inability to swallow the oral supplement, and\u002For impairment of absorption of study drug in the opinion of the treating investigator.\n* Has previous clinical diagnosis of cirrhosis, has had known history of Hep A\u002FB\u002FC or nonalcoholic fatty liver disease (NAFLD), liver transplantation, or any other cause for decompensated liver disease.\n* Known human immunodeficiency virus (HIV) infection.\n* Any of the following within 6 months prior to the screening visit: unstable cardiovascular disease, myocardial infarction, coronary artery bypass surgery, coronary angioplasty, transient ischemic attack, or cerebrovascular accident.\n* Any other condition that, in the investigator's opinion, would impede competence or compliance or delay completion of the study.\n* History of Parkinson's disease or bipolar disorder.\n\nPatients taking the following prohibited medications:\n\n* Olanzapine\n* MAO inhibiters, including:\n\n  * Isocarboxazid\n  * Linezolid\n  * Methylene blue injection\n  * Phenelzine\n  * Rasagiline\n  * Selegiline\n  * Tranylcypromine\n  * Any other MAO inhibitors The above prohibited medications cannot be taken -14 days prior to Day 0 and during study treatment.. Patients currently on or plan to be prescribed anti-psychotic medications not listed above may be excluded at the discretion of the Investigator. - Active infection as evidenced by positive urine culture, blood culture, or pneumonia.",{"count":204,"type":22},[232],"This is an open-label, phase II study that may provide evidence that taking S-adenosylmethionine (SAMe) supplementation prevents oxaliplatin, a type of chemotherapy drug, associated liver toxicity in patients with resectable colorectal liver metastases. Resectable means that it is able to removed with surgery. Patients will take two SAMe tablets in the morning and one tablet in the evening for 3-6 months (about 6-8 cycles of chemotherapy) in addition to oxaliplatin based chemotherapy followed by surgical removal of the colorectal liver metastases.",[614,615,616,617,618,619,620],"Colorectal Cancer","Liver Metastases","Liver Metastasis Colon Cancer","Liver Injury","Sinusoidal Obstruction Syndrome","5-Fluorouracil Toxicity","Liver Toxicity, Chemically-Induced",[622,623,624],"S-adenosylmethionine","Oxaliplatin","Stage IV colorectal cancer","2026-05-01",{"date":599,"type":36},{"date":628,"type":22},"2026-07",{"date":630,"type":22},"2028-08",{"name":42,"class":43},2,""]