[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Vanderbilt University Medical Center\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":690},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,132,0,25,[9,45,72,98,116,151,178,203,227,262,302,327,362,386,406,428,454,478,504,532,562,588,618,640,662],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100643110","neural-basis-of-human-working-memory-100643110",false,"NCT07617506","Neural Basis of Human Working Memory","Inclusion Criteria:\n\n* Undergoing SEEG monitoring at Vanderbilt University Medical Center\n* Age \\>18\n* English speaking\n\nExclusion Criteria:\n\n* Age \\\u003C18\n* Not able to complete questionnaires (unable to comprehend instructions or follow directions)","ALL","18 Years",{"count":19,"type":20},100,"ESTIMATED","INTERVENTIONAL",[23],"NA","This ClinicalTrials.gov entry corresponds to the Neural Basis of Human Working Memory protocol approved under Vanderbilt University Medical Center IRB #251231.\n\nThis study investigates the neural activity underlying human working memory, via local field potential changes (macro level) and\u002For single neuronal spiking changes (micro level) from depth electrodes placed for invasive seizure monitoring. Subjects will complete neurocognitive tasks while neural recordings are collected. Some patients will complete neurocognitive tasks while stimulation is applied via depth electrodes. Further understanding the neural activity changes underlying normal and impaired working memory may help to identify novel diagnostic methods and treatments for impaired working memory and may support the use of stimulation for treatment of memory disorders.",[26],"Memory Disorders",[28,29,30,31],"Neural stimulation","Memory disorders","Working Memory","Stereo Electroencephalography (SEEG)","RECRUITING","2026-08-18",{"date":35,"type":36},"2026-08-20","ACTUAL",{"date":38,"type":36},"2025-06-04",{"date":40,"type":20},"2027-04",{"name":42,"class":43},"Vanderbilt University Medical Center","OTHER",1,{"id":46,"slug":47,"hasResults":12,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":12,"sex":53,"minAge":54,"maxAge":17,"enrollmentInfo":55,"targetDuration":4,"studyType":21,"phases":57,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":66,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":44},"100606239","phase-1-sodiumglucose-cotransporter-2-inhibitors-sglt2i-therapy-in-duchenne-cardiomyopathy-100606239","NCT07172971","Sodium\u002FGlucose Cotransporter-2 Inhibitors (SGLT2i) Therapy in Duchenne Cardiomyopathy","duCHennE caRdiomyopathy mItigation Sglt2 inHibitor","CHERISH","Inclusion Criteria:\n\n* Clinical phenotype of DMD confirmed with muscle biopsy or genotype\n* Presence of late gadolinium enhancement (LGE) imaging by CMR\n* Either normal or mildly depressed systolic function (LVEF\\>40%)\n* ≥8 years old and ≤18 years old\n\nExclusion Criteria:\n\n* Current investigational therapy that may affect cardiovascular function\n\n  * Additional genetic or congenital abnormality that may affect cardiovascular function or progression\n  * Contraindication to or inability to undergo CMR\n  * Symptomatic heart failure\n  * History of ketoacidosis or hypersensitivity to SGLT2i therapy\n  * Type 1 diabetes\n  * Renal disease or history of frequent urinary tract infections or genitourinary skin infections","MALE","8 Years",{"count":56,"type":20},10,[58],"PHASE1","This is a pharmacokinetic study (PK Study) to better understand empagliflozin dosing in pediatric Duchenne muscular dystrophy patients. Empagliflozin is currently used off-label in this population due to the mortality benefits seen in adult cardiomyopathy and heart failure. Investigators will perform PK studies in DMD patients of various ages and weights to better understand the PK profile (absorption, distribution, metabolism, excretion) and dosing to better treat Duchenne cardiomyopathy.",[61],"Duchenne Muscular Dystrophy (DMD)",[63,64,65],"Cardiomyopathy","Heart failure","Muscular dystrophy",{"date":35,"type":36},{"date":68,"type":36},"2026-07-01",{"date":70,"type":20},"2028-02-01",{"name":42,"class":43},{"id":73,"slug":74,"hasResults":12,"nctId":75,"briefTitle":76,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":78,"enrollmentInfo":79,"targetDuration":4,"studyType":21,"phases":81,"briefSummary":82,"conditions":83,"keywords":86,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":92,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":44},"100592130","visualization-of-the-colon-through-use-of-the-magnetic-flexible-endoscope-mfe-in-participants-with-inflammatory-bowel-disease-ibd-100592130","NCT06989424","Visualization of the Colon Through Use of the Magnetic Flexible Endoscope (MFE) in Participants With Inflammatory Bowel Disease (IBD)","Inclusion Criteria:\n\n* Male or female, 18 to 70 years of age\n* Able to provide written informed consent\n* American Society of Anesthesiologists (ASA) class \\\u003C 3\n* No significant medical problems\n* Abdominal circumference \\\u003C 96 cm\n* Stable, non-flaring inflammatory bowel disease (e.g. Ulcerative Colitis and Crohn's Disease)\n\nExclusion Criteria:\n\n* Patients who do not meet inclusion criteria\n* Patients who are unable or unwilling to provide informed consent\n* Magnetic implants and wearable devices (such as insulin pumps)\n* Females who are pregnant. As part of routine pre-operative care, all females of childbearing potential will undergo either urine or blood pregnancy testing.\n* Cancer positive subjects or any patients currently undergoing any treatment or therapy to treat, cure, or mitigate cancer.\n* Symptoms consistent with coronavirus (COVID-19) --- pyrexia, new persistent cough, or anosmia --- or a positive coronavirus (COVID-19) polymerase chain reaction (PCR) swab result\n* Previous incomplete or failed colonoscopy\n* Colonic resection\n* Severe diverticulosis\n* Known or suspected colonic stricture\n* Previous radiation therapy to the abdomen or pelvis\n* Actively flaring inflammatory bowel condition (e.g. active flare of IBD or diverticulitis)\n* Known or suspected bowel obstruction\n* Presence of ascites\n* Participants taking anticoagulant medications or antiplatelet therapy (excluding aspirin) within the last 3 days\n* Known coagulation disorder (INR ≥ 1.5 or platelets \\\u003C 150 x 109)\n* Known to have phenylketonuria or Glucose-6-Phosphate-Dehydrogenase (G6PD) deficiency\n* Abdominal surgery within the last 6 months\n* Drug or alcohol abuse","70 Years",{"count":80,"type":20},6,[23],"In this study, the investigators will test the ability of the Magnetic Flexible Endoscope (MFE) to travel through the colon of people with Inflammatory Bowel Disease (IBD). The MFE is a device made of ultra-flexible tubing that contains a camera, light, and magnet at the tip. The tip of the tube is about the size of a penny. The magnet inside the tip allows the MFE to be moved through the colon by a second magnet attached to a robotic arm that is outside the body. The purpose of this study is to see how the MFE travels through the colon of IBD patients and if it is tolerable.",[84,85],"Inflammatory Bowel Disease (IBD)","Colonoscopy",[85,87,88,89,90,84],"Colon","Robotic","Magnetic","Endoscopy","NOT_YET_RECRUITING",{"date":35,"type":36},{"date":94,"type":20},"2026-12",{"date":96,"type":20},"2029-01",{"name":42,"class":43},{"id":99,"slug":100,"hasResults":12,"nctId":101,"briefTitle":102,"officialTitle":102,"acronym":103,"eligibilityCriteria":104,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":105,"targetDuration":4,"studyType":21,"phases":106,"briefSummary":107,"conditions":108,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":110,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":44},"100474914","the-mobile-health-intervention-in-pulmonary-arterial-hypertension-move-pah-study-100474914","NCT05464095","The MObile Health InterVEntion in Pulmonary Arterial Hypertension (MOVE PAH) Study","MOVE PAH)","Inclusion Criteria:\n\n* Adults aged 18 or older.\n* Diagnosed with idiopathic, heritable, or associated (connective tissue disease, drugs, or toxins) pulmonary arterial hypertension (PAH), or PAH due to simple congenital heart disease (i.e. atrial septal defect).\n* WHO functional class I-III\n* Stable PAH-specific medication regimen for three months prior to enrollment. Subjects with only a single diuretic adjustment in the prior three months will be included. Adjustments in IV prostacyclin for side effect management are allowed.\n* Forced vital capacity \\>65% predicted with no or minimal interstitial lung disease based on reviews of imaging studies by PI and medical monitor.\n\nExclusion Criteria:\n\n* Prohibited from normal activity due to wheelchair bound status, bed bound status, reliance on a cane\u002Fwalker, activity-limiting angina, activity-limiting osteoarthritis, or other condition that limits activity.\n* Pregnancy\n* Diagnosis of PAH etiology other than idiopathic, heritable, or associated.\n* Functional class IV heart failure\n* Requirement of \\> 2 diuretic adjustment in the prior three months.\n* Preferred form of activity is not measured by an activity tracker (swimming, yoga, ice skating, stair master, or activities on wheels such as bicycling or rollerblading).",{"count":19,"type":20},[23],"Patients with pulmonary arterial hypertension (PAH) have reduced health related quality of life (HRQOL) and impaired exercise capacity. Despite fourteen approved therapies, most patients die within ten years. Increasing physical activity is highly efficacious in PAH, resulting in six-minute walk distance (6MWD) and HRQOL improvement that often exceeds the effect of medications. Prior activity studies required inpatient rehabilitation, which is impractical, hard to sustain, and poorly scalable to a rare disease.\n\nThe Investigators propose a randomized trial of smart texts versus usual care for 6 months. The Investigators will randomize 100 PAH patients to the mHealth intervention or usual care. The Investigators will test the effect of a text-based mHealth intervention on HRQOL in PAH using the PAH-specific emPHasis-10 questionnaire. The Investigators will also test the effect of an mHealth intervention on exercise capacity, measured by a supervised home-based 6MWD test. Finally, the Investigators will examine the effect of the intervention on time to clinical worsening (composite of PAH therapy escalation, PAH hospitalization, and death) one year after randomization.",[109],"Pulmonary Arterial Hypertension",{"date":35,"type":36},{"date":112,"type":36},"2023-01-01",{"date":114,"type":20},"2027-08-31",{"name":42,"class":43},{"id":117,"slug":118,"hasResults":12,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":122,"eligibilityCriteria":123,"healthyVolunteers":12,"sex":16,"minAge":124,"maxAge":125,"enrollmentInfo":126,"targetDuration":4,"studyType":128,"phases":4,"briefSummary":129,"conditions":130,"keywords":136,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":150},"100652159","non-invasive-prediction-of-early-cardiac-rejection-100652159","NCT07770659","Non-invasive Prediction of EArly Cardiac rEjection","Predictive Modeling of Acute Rejection in Pediatric Heart Transplant Recipients","PEACE","Inclusion Criteria:\n\n* Received heart transplant at age \\\u003C 21 years old\n* \\> 2 months from transplant\n* ≥6 years old and ≤ 25 years old and able to undergo cardiac MRI (CMR)\n* CMR can be scheduled within 5 days from heart biopsy\\*\n* Heart catheterization with biopsy is scheduled \"for cause\" to confirm suspected AR or Heart catheterization with biopsy is scheduled for surveillance\n\nExclusion Criteria:\n\n* No endomyocardial biopsy scheduled\n* Other illness or disease process that could potentially lead to myocardial edema or fibrosis\n* Contraindication to CMR with contrast\n* Previously enrolled in this study, UNLESS previous enrollment was heart biopsy scheduled for surveillance with no suspicion of AR AND final study status was documented as \"no AR\" AND current enrollment is heart biopsy is scheduled \"for cause\" to confirm suspected AR\n* Multiple transplanted organs\n* Requires anesthesia for CMR","6 Years","25 Years",{"count":127,"type":20},200,"OBSERVATIONAL","Acute rejection remains a major cause of morbidity and mortality in pediatric patients after heart transplant. In order to screen for rejection, most centers perform heart catheterizations with endomyocardial biopsies frequently in the first year post transplant and then every 1-2 years thereafter; these biopsies are associated with complications, can cause significant anxiety in patients and family members, and are a significant cost for the healthcare system. This project will evaluate non-invasive methods of detecting rejection using cardiac magnetic resonance imaging and blood testing with a goal to reduce the required number of cardiac catheterizations.",[131,132,133,134,135],"Heart Transplant","Pediatric Heart Transplant","Rejection","Cardiac MRI","Cell Free DNA",[137,138,139,140,141,142],"Pediatric heart transplant","acute rejection","acute cellular rejection","antibody mediated rejection","cardiac mri","cell free DNA","2026-08-17",{"date":35,"type":36},{"date":146,"type":36},"2023-03-29",{"date":148,"type":20},"2027-06-30",{"name":42,"class":43},22,{"id":152,"slug":153,"hasResults":12,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":157,"eligibilityCriteria":158,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":159,"enrollmentInfo":160,"targetDuration":4,"studyType":21,"phases":161,"briefSummary":162,"conditions":163,"keywords":166,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":171,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":177},"100624235","rehabilitation-with-empowered-strategies-to-optimize-recovery-100624235","NCT07406997","Rehabilitation With Empowered STrategies to Optimize REcovery","Rehabilitation With Empowered STrategies to Optimize REcovery After Spine Surgery","RESTORE","Inclusion Criteria:\n\n* Surgical treatment of a lumbar degenerative condition using a laminectomy and\u002For fusion procedure\n* English speaking\n* Age between 18-85 years\n\nExclusion Criteria:\n\n* Surgery due to trauma, fracture, tumor, infection, or spinal deformity\n* Revision surgery\n* Prior history of lumbar spine surgery in last 12 months\n* Involved in litigation or a workers' compensation claim due to injury\n* Currently undergoing treatment for cancer\n* Unable to access a reliable internet connection\n* Unable to provide a stable telephone or physical address\n* Unable to participate in follow-up assessment for 6 months after surgery","85 Years",{"count":19,"type":20},[23],"The main goal of this clinical trial is to understand the benefits of remotely delivered Empowered Relief in patients undergoing lumbar spine surgery. The main question the trial aims to answer is:\n\nDoes a postoperative behavioral intervention, Empowered Relief, performed early after back surgery have a measurable impact on postoperative outcomes?\n\nAdditional questions are whether changes in pain catastrophizing are related to improvements in outcomes and whether preoperative pain catastrophizing is a moderator of response to treatment.\n\nResearchers will compare remotely delivered Empowered Relief to remotely delivered education to see if Empowered Relief helps patients manage their pain and functional limitations after back surgery.\n\nParticipants will:\n\n* Complete one group session of remotely delivered Empowered Relief or Education after back surgery\n* Complete surveys before surgery and 3- and 6-months after surgery",[164,165],"Lumbar Spine Degenerative Changes","Lumbar Spine Surgery",[167,168,169,170],"behavioral research","Patient Reported Outcomes Measures","Pain","Pain Catastrophizing",{"date":35,"type":36},{"date":173,"type":36},"2026-02-24",{"date":175,"type":20},"2029-08-31",{"name":42,"class":43},4,{"id":179,"slug":180,"hasResults":12,"nctId":181,"briefTitle":182,"officialTitle":182,"acronym":183,"eligibilityCriteria":184,"healthyVolunteers":12,"sex":16,"minAge":125,"maxAge":185,"enrollmentInfo":186,"targetDuration":4,"studyType":21,"phases":187,"briefSummary":188,"conditions":189,"keywords":192,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":197,"startDateStruct":198,"completionDateStruct":200,"leadSponsor":202,"locationsCount":44},"100593837","transition-to-ambulatory-bariatric-surgery-tabs-trial-100593837","NCT07011628","Transition to Ambulatory Bariatric Surgery (TABS) Trial","TABS","Inclusion Criteria:\n\n* BMI ≤ 60 kg\u002Fm2\n* Primary Sleeve gastrectomy or Gastric Bypass,\n* Undergoing bariatric surgery at sponsor site\n\nExclusion Criteria:\n\n* Type 1 Diabetes\n* Myocardial Infarction\n* Unstable Angina or Heart Failure\n* Prior Stroke\n* Solid organ transplantation\n* Systemic glucocorticoid prior 28 days\n* Severe Obstructive Sleep Apnea\n* Uncontrolled Hypertension (Systolic \\> 150, Diastolic \\> 90)\n* Untreated Hyperthyroidism\n* Chronic Kidney Disease (EGFR \\\u003C 60)\n* Current anticoagulant use,\n* Poorly controlled Type 2 diabetes (Hemoglobin A1c in last 3 months \\> 8.5%)\n* Chronic opioid use\n* Insulin dependence.\n* Need for extended venous thromboembolic event prophylaxis,\n* \\> 1 lifetime bariatric surgery (revisional or conversion bariatric surgery)\n* Patient lives \\> 130 miles from the hospital.\n* Tobacco use in last 12 months\n* Desire to become pregnant or active pregnancy\n* Prisoners\n* Unable or unwilling to follow-up\n* Unable to understand or provide consent","55 Years",{"count":127,"type":20},[23],"This study will compare same day discharge and at least one night stay in the hospital after bariatric surgery. Patients undergoing bariatric surgery will be randomized (i.e. have an equal chance of either plan) to either group. The study's primary outcome is the frequency patients in the study require a visit to the emergency room within 7 days of their surgery.",[190,191],"Obesity and Obesity-related Medical Conditions","Bariatric Surgery",[193,194,195,196],"ambulatory surgery","same day discharge","gastric bypass","sleeve gastrectomy",{"date":33,"type":36},{"date":199,"type":20},"2026-10-01",{"date":201,"type":20},"2028-05-01",{"name":42,"class":43},{"id":204,"slug":205,"hasResults":12,"nctId":206,"briefTitle":207,"officialTitle":208,"acronym":209,"eligibilityCriteria":210,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":211,"targetDuration":4,"studyType":21,"phases":213,"briefSummary":215,"conditions":216,"keywords":4,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":219,"lastUpdatePostDateStruct":220,"startDateStruct":222,"completionDateStruct":224,"leadSponsor":226,"locationsCount":44},"100610217","phase-4-the-impact-of-perioperative-lidocaine-infusions-on-enhanced-recovery-after-non-cardiac-surgery-100610217","NCT07224711","The Impact of Perioperative Lidocaine Infusions on Enhanced Recovery After Non-Cardiac Surgery","The Impact of Perioperative Lidocaine Infusions on Enhanced Recovery After Non-Cardiac Surgery (IMPALA ERAS)","IMPALA ERAS","Inclusion criteria:\n\n* Age greater than or equal to 18\n* American Society of Anesthesiologists (ASA) class II-IV\n* Presenting for major elective, non-cardiac surgery on the colorectal, emergency general surgery, urology, ventral hernia, surgical oncology, or spine services on a weekday\n* First surgery in the study period (if a patient has multiple surgeries, only the first will be included)\n\nExclusion criteria:\n\n* ASA class \\>IV\n* Emergent procedures\n* Allergy or any contraindication to lidocaine infusion\n* Patient refusal\n* Unable to receive or refusal to receive a regional nerve block\n* Patients who receive an epidural due to standard of care\n* Direct transfer from operating room to ICU with endotracheal tube in place\n* Treating team determines patient ineligible prior to study drug administration\n* Same day surgery\n* Pregnancy (all female patient of child-bearing age will undergo a pregnancy test the day of surgery)",{"count":212,"type":20},2290,[214],"PHASE4","The goal of this single-center, pragmatic, randomized, blinded, placebo-controlled trial is to evaluate the impact of intravenous (IV) lidocaine within the existing Enhanced Recovery After Surgery (ERAS)program on outcomes in patients after major non-cardiac surgery. The main questions the trial aims to answer are:\n\nThe primary hypothesis is that utilization of IV lidocaine as part of a perioperative multimodal pain regimen will result in a reduction in hospital Case Mix Index-Adjusted Resource Length of Stay (CARLOS).\n\nThe secondary hypotheses are that lidocaine infusion will result in a reduction in total inpatient opioid consumption (oral morphine milligram equivalents, oMMEs) and pain scores, and improved surgical outcomes (including return of bowel function, ileus, nausea, rapid responses called, surgical site infections, and ICU transfers), while also having minimal incidence of side effects (including double\u002Fblurry vision, tinnitus, sedation, and adverse events requiring early cessation).",[169,217,218],"Post Operative Analgesia","Opioid Consumption, Postoperative","2026-08-09",{"date":221,"type":36},"2026-08-11",{"date":223,"type":20},"2026-10-31",{"date":225,"type":20},"2028-10-31",{"name":42,"class":43},{"id":228,"slug":229,"hasResults":12,"nctId":230,"briefTitle":231,"officialTitle":232,"acronym":233,"eligibilityCriteria":234,"healthyVolunteers":12,"sex":16,"minAge":235,"maxAge":78,"enrollmentInfo":236,"targetDuration":4,"studyType":21,"phases":238,"briefSummary":239,"conditions":240,"keywords":244,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":255,"lastUpdatePostDateStruct":256,"startDateStruct":258,"completionDateStruct":259,"leadSponsor":261,"locationsCount":4},"100651335","metabolic-flux-analysis-in-metabolic-dysfunction-associated-steatotic-liver-disease-100651335","NCT07760909","Metabolic Flux Analysis in Metabolic Dysfunction-Associated Steatotic Liver Disease","Metabolic Flux Analysis in MASLD","MASLD","Inclusion Criteria:\n\n* Scheduled and clinically cleared for protocol-eligible bariatric surgery at Vanderbilt University Medical Center.\n* BMI ≥40 kg\u002Fm², or BMI \\>35 kg\u002Fm² with at least one obesity-associated comorbidity, such as type 2 diabetes, cardiovascular disease, hypertension, hyperlipidemia, obstructive sleep apnea, MASLD, osteoarthritis, or polycystic ovarian syndrome.\n* Able and willing to complete study procedures, including informed consent, questionnaires, blood draws, MRI\u002FMRE imaging, stable isotope tracer infusion, and research tissue collection during planned bariatric surgery.\n* Able to provide informed consent in English.\n\nExclusion Criteria:\n\n* Contraindication to MRI\u002FMRE, including implanted cardiac defibrillator, pacemaker, or other MRI-incompatible implanted device.\n* Prior gastric or intestinal surgery, pancreatic surgery, or other prior surgery that, in the judgment of the study team or bariatric surgeon, would interfere with study procedures or outcome interpretation.\n* Active cancer or ongoing cancer treatment.\n* Presence or history of HIV infection.\n* Alcohol use above study-defined limits: more than 14 alcoholic drinks per week for men or more than 7 alcoholic drinks per week for women, or illicit drug use that would interfere with safe participation or interpretation of study results.\n* Anemia or other hematologic condition that would increase risk from study blood collection.\n* Abnormal ECG or clinically significant cardiovascular finding that would increase risk from study procedures.\n* Impaired renal function or other clinically significant condition that would increase risk from study participation.\n* Known Wilson's disease, alpha-1 antitrypsin deficiency, hemochromatosis, or other non-MASLD chronic liver disease that would confound interpretation of study outcomes.\n* Any medical, surgical, or safety condition that, in the judgment of the PI, clinical co-investigator, CRC staff, anesthesia team, or bariatric surgeon, would make participation unsafe or interfere with completion of study procedures.","21 Years",{"count":237,"type":20},20,[23],"This prospective, single-center pilot study will evaluate metabolic flux dysregulation in adults with obesity and suspected or confirmed metabolic dysfunction-associated steatotic liver disease (MASLD) who are scheduled for protocol-eligible bariatric surgery at Vanderbilt University Medical Center. Participants will undergo research assessments before surgery, during the planned bariatric surgery encounter, and approximately 6 months after surgery. The study uses non-radioactive stable isotope tracer infusions, serial blood sampling, abdominal MRI\u002FMRE, and research tissue specimens collected only during clinically planned bariatric surgery to quantify hepatic and extrahepatic metabolic fluxes. The primary objective is to determine how hepatic citric acid cycle flux and related metabolic pathways change after bariatric surgery and how these metabolic measures relate to liver fat, liver stiffness, and biopsy-graded MASLD\u002FMASH severity.",[241,242,243,191],"Metabolic Dysfunction-Associated Steatotic Liver Disease","Metabolic Dysfunction-Associated Steatohepatitis","Obesity",[233,245,246,247,248,249,196,250,251,252,253,254],"MASH","metabolic flux analysis","stable isotope tracer","bariatric surgery","Roux-en-Y gastric bypass","liver fat","magnetic resonance elastography","citric acid cycle","gluconeogenesis","free fatty acid turnover","2026-08-07",{"date":257,"type":36},"2026-08-12",{"date":199,"type":20},{"date":260,"type":20},"2060-01-01",{"name":42,"class":43},{"id":263,"slug":264,"hasResults":12,"nctId":265,"briefTitle":266,"officialTitle":267,"acronym":268,"eligibilityCriteria":269,"healthyVolunteers":12,"sex":16,"minAge":270,"maxAge":159,"enrollmentInfo":271,"targetDuration":4,"studyType":21,"phases":273,"briefSummary":275,"conditions":276,"keywords":281,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":255,"lastUpdatePostDateStruct":296,"startDateStruct":297,"completionDateStruct":299,"leadSponsor":301,"locationsCount":44},"100651334","phase-2-hmb-plus-vitamin-d-to-preserve-muscle-in-older-adults-starting-semaglutide-100651334","NCT07760948","HMB Plus Vitamin D to Preserve Muscle in Older Adults Starting Semaglutide","Preserving the Metabolic Engine: HMB Supplementation to Combat Iatrogenic Sarcopenia and Metabolic Adaptation in Older Adults Initiating Semaglutide Therapy","PRESERVE-HMB","Inclusion Criteria:\n\n* Age 65 to 85 years, inclusive.\n* Type 2 diabetes mellitus, defined by HbA1c at or above 6.5% or current use of antihyperglycemic medication.\n* Body mass index at or above 27 kg\u002Fm2.\n* Newly initiating semaglutide as standard clinical care under the direction of a treating clinician.\n* Able to walk 400 meters without assistance; use of a cane is permitted.\n* Able to understand and provide legally effective informed consent.\n* English speaking for the initial study because the consent documents, questionnaires, study-product instructions, safety instructions, and procedure-specific materials are available only in English.\n\nExclusion Criteria:\n\n* Estimated glomerular filtration rate below 45 mL\u002Fmin\u002F1.73 m2.\n* Use of HMB, creatine, or high-dose whey protein supplements within the previous 3 months.\n* Weight change greater than 5% during the previous 3 months.\n* Recent fracture within the previous 6 months.\n* Neuromuscular disease, including Parkinson disease, or another condition that would interfere with study outcomes or safe participation.\n* Chronic corticosteroid use.\n* Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2.\n* History of pancreatitis.\n* Smoking more than 7 cigarettes per day.\n* Previous malabsorptive or restrictive intestinal surgery or a malabsorptive syndrome.\n* Pregnancy or breastfeeding.\n* Recent history of neoplasia within the previous 5 years, as defined by the protocol.\n* Other active inflammatory conditions or neuromuscular disorders that could interfere with study outcomes or safety.\n* Serum 25-hydroxyvitamin D below 15 ng\u002FmL.\n* Any medical, functional, laboratory, medication-related, or safety condition that the investigator determines makes study participation unsafe or prevents completion of essential procedures.","65 Years",{"count":272,"type":20},90,[274],"PHASE2","This randomized, double-blind, placebo-controlled trial will evaluate whether daily calcium beta-hydroxy-beta-methylbutyrate (calcium-HMB) plus vitamin D3 preserves muscle mass, physical function, and resting metabolism in adults aged 65 to 85 years with type 2 diabetes who are newly starting semaglutide as part of usual clinical care. Participants will receive calcium-HMB plus vitamin D3 or matching placebo for approximately 6 months. The primary outcome is change in appendicular lean mass measured by dual-energy X-ray absorptiometry from baseline to month 6. Secondary assessments include body composition, muscle strength, physical performance, gait, physical activity, resting metabolic rate, metabolic measures, and whole-body quantitative computed tomography. An optional mechanistic substudy of up to 36 participants will include D3-creatine dilution, nonradioactive stable isotope infusions, repeated blood sampling, a standardized meal, breath sampling, and vastus lateralis muscle biopsies at baseline and month 6.",[277,278,243,279,280],"Type 2 Diabetes Mellitus (T2DM)","Sarcopenia","Muscle Loss","Older Adults",[282,283,284,285,286,287,288,289,290,291,292,293,294,295],"semaglutide","GLP-1 receptor agonist","beta-hydroxy-beta-methylbutyrate","HMB","calcium-HMB","vitamin D3","appendicular lean mass","metabolic adaptation","resting metabolic rate","skeletal muscle","older adults","D3-creatine","muscle protein synthesis","muscle protein breakdown",{"date":257,"type":36},{"date":298,"type":20},"2026-12-01",{"date":300,"type":20},"2030-11",{"name":42,"class":43},{"id":303,"slug":304,"hasResults":12,"nctId":305,"briefTitle":306,"officialTitle":307,"acronym":4,"eligibilityCriteria":308,"healthyVolunteers":12,"sex":16,"minAge":309,"maxAge":310,"enrollmentInfo":311,"targetDuration":4,"studyType":21,"phases":313,"briefSummary":314,"conditions":315,"keywords":317,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":255,"lastUpdatePostDateStruct":320,"startDateStruct":321,"completionDateStruct":323,"leadSponsor":325,"locationsCount":326},"100634845","creation-of-a-decision-aid-for-coronary-anomalies-100634845","NCT07544979","Creation of a Decision Aid for Coronary Anomalies","Development of a Shared Decision Aid for Anomalous Aortic Origin of a Coronary Artery","Inclusion Criteria:\n\n* Patients\n\n  * English-speaking\n  * 10-35 years of age\n  * Diagnosis of R-AAOCA without evidence of myocardial ischemia\n\nParents\n\n* English-speaking\n* Child 10-17 years of age\n* Diagnosis of R-AAOCA without evidence of myocardial ischemia\n\nExclusion Criteria:\n\n* Patients\n\n  * Other significant cardiac anomalies\n  * Unwilling or unable to provide consent\n  * Non-English Speaking Parents\n  * Child with other significant cardiac anomalies\n  * Unwilling or unable to provide consent\n  * Non-English Speaking","10 Years","35 Years",{"count":312,"type":20},60,[23],"The coronary arteries supply blood to the heart muscle. Typically, the left coronary artery comes from the left side of the aorta and the right coronary artery comes from the right side. In some cases the coronary artery comes from the wrong side of the aorta. This is known as anomalous aortic origin of a coronary artery (AAOCA). In AAOCA, the major concern is the risk of sudden cardiac death (SCD). The risk of is significantly higher in left AAOCA (L-AAOCA) compared to right AAOCA (R-AAOCA). With the increased risk in L-AAOCA, surgery is recommended to \"normalize\" the coronary artery position. R-AAOCA has a low absolute risk of SCD. But the risk is higher than the general population. Patients, families, and clinicians must weigh the risks of surgery with the risks of observation. This leads to stress and anxiety around making the management choice. There is no \"right\" management choice. Shared decision making (SDM) is a strategy of including patient values, preferences, and risk tolerance in medical choices. SDM is particularly useful in settings where there is no clear correct management choice. Decision aids support SDM. No decision aid exists in R-AAOCA. This proposal will create a decision aid and collect pilot data of its implementation. We hypothesize that the use of an aid in R-AAOCA will improve SDM, comfort in the choice, and quality of life. We will engage patients, families, and clinicians to understand their needs to make management choices. This will inform the development of the aid. We will gather feedback on the aid from stakeholders and will revise it. The aid will include data and methods for patients to identify their preferences. When the aid is optimized, we will run a pilot study to evaluate its impact compared to not using the aid. We will evaluate SDM, comfort in the choice made, and quality of life at that time, at 3 months and at 6 months. The pilot data will be used to inform a larger study of the aid. This proposal can be an example how to design decision aids for other congenital heart conditions. This aligns with the AHA's mission of improving lifelong health of the whole person. By improving SDM , patients can feel more confident in their choice and relieve anxiety from the diagnosis. Overall, this proposal supports a shift to patient-centered care with a focus on improving meaningful lifelong outcomes.",[316],"AAOCA",[316,318,319],"Coronary Anomalies","Shared Decision Making",{"date":221,"type":36},{"date":322,"type":36},"2026-08-01",{"date":324,"type":20},"2029-03-30",{"name":42,"class":43},5,{"id":328,"slug":329,"hasResults":12,"nctId":330,"briefTitle":331,"officialTitle":331,"acronym":332,"eligibilityCriteria":333,"healthyVolunteers":12,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":334,"targetDuration":4,"studyType":21,"phases":336,"briefSummary":338,"conditions":339,"keywords":346,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":354,"lastUpdatePostDateStruct":355,"startDateStruct":357,"completionDateStruct":359,"leadSponsor":361,"locationsCount":44},"100646440","deformable-tissue-modelling-and-augmented-reality-based-guidance-for-head-and-neck-tumor-re-resection-task-100646440","NCT07686211","Deformable Tissue Modelling and Augmented Reality Based Guidance for Head and Neck Tumor Re-Resection Task","SPeAR","Inclusion Criteria:\n\n1. Post-graduate year 1, 2, 3, 4 and 5 (PGY2-5) resident physicians. (no age limit)\n2. Surgical fellows.\n3. Attending physicians.\n4. Prior cadaver lab or surgical experience.\n5. Any surgeon, regardless of training and experience, who has been involved in the surgeon-pathologist interaction during surgical resection for frozen section and margin clearance assessment.\n\nExclusion Criteria:\n\n1\\. Non-physician surgery providers.",{"count":335,"type":20},30,[337],"EARLY_PHASE1","Head and neck cancers have one of the highest recurrence rates among solid malignancies, and recurrence is strongly correlated with overall survival. Reducing recurrence rates depends, in part, on the surgeon's ability to accurately re-resect areas of positive or close margins during surgery. Currently, margin status is communicated primarily through verbal descriptions between the surgeon and pathologist, which can be imprecise. This challenge is further compounded by the deformable nature of soft tissues, as once the specimen is resected, the shape and size of the specimen change, making it difficult to accurately map the specimen's margins back onto the surgical site.\n\nEmerging technologies -such as augmented reality (AR), 3D scanning, and advanced soft tissue modeling- offer promising solutions for improving surgical navigation and precision. Building on these advances, an AR-based surgical navigation system was developed specifically for head and neck tumor resections. The system uses a 3D scanner to generate virtual models of both the resected specimen and the patient's surgical site, as demonstrated in prior work. A soft tissue modeling algorithm is then applied to account for specimen shrinkage and deformation, enabling accurate tracking of positive tumor margins. This guidance information is visualized through an AR headset, which overlays the margin data directly onto the patient's surgical site, providing surgeons with real-time visual guidance during re-resection.\n\nIn this study, the goal is to evaluate the benefits and usability of this novel navigation software, compared to the standard of care. By assessing surgeon performance and user experience in cadaveric tasks with and without the AR system to identify strengths, limitations, and opportunities for refinement of the system, ultimately advancing surgical precision and improving patient outcomes by reducing recurrence rates.",[340,341,342,343,344,345],"Physician","Surgeon","Resident Doctor","Resident Surgeon","Surgical","Fellow",[347,348,349,350,351,352,353],"physician","surgeon","resident doctor","doctor","surgical","fellow","resident surgeon","2026-08-05",{"date":356,"type":36},"2026-08-10",{"date":358,"type":36},"2026-02-18",{"date":360,"type":20},"2029-06",{"name":42,"class":43},{"id":363,"slug":364,"hasResults":12,"nctId":365,"briefTitle":366,"officialTitle":366,"acronym":4,"eligibilityCriteria":367,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":368,"enrollmentInfo":369,"targetDuration":4,"studyType":21,"phases":371,"briefSummary":372,"conditions":373,"keywords":375,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":354,"lastUpdatePostDateStruct":380,"startDateStruct":381,"completionDateStruct":383,"leadSponsor":385,"locationsCount":44},"100434777","phase-2-2-hydroxybenzylamine-2-hoba-to-reduce-hdl-modification-and-improve-hdl-function-in-familial-hypercholesterolemia-fh-100434777","NCT04941599","2-Hydroxybenzylamine (2-HOBA) to Reduce HDL Modification and Improve HDL Function in Familial Hypercholesterolemia (FH)","Inclusion Criteria:\n\n* Individuals with heterozygous Familial Hypercholesterolemia.\n\nExclusion Criteria:\n\n* Myocardial infarction or stroke within the last 6 months\n* unstable angina, symptoms of angina within the last 3 months\n* NYHA class III or IV heart failure or LVEF \\\u003C 30%\n* poorly controlled hypertension: SBP \\> 180 mm Hg or DBP \\> 110 mm Hg,\n* pregnancy,\n* evidence of a previous acute coronary syndrome,\n* current smokers,\n* individuals with Type 2 Diabetes Mellitus, obesity (BMI \\> 30),\n* hypertriglyceridemia (fasting TG \\> 250 mg\u002Fdl),\n* renal insufficiency (Cr \\> 1.8),\n* hepatic disease (aspartate aminotransferase(AST) or alanine aminotransferase (ALT) \\> 2x ULN),\n* hypothyroidism,\n* nephrotic syndrome,\n* rheumatoid arthritis,\n* systemic lupus erythematosus,\n* AIDS or HIV\n* history of malignancy of any organ in last 5 years.","69 Years",{"count":370,"type":20},72,[274],"The Investigators will test the hypothesis that 2-HOBA will reduce modification of HDL and LDL and improve HDL function in humans with heterozygous FH. The Investigators plan to first study subjects with Familial Hypercholesterolemia (FH), treating them with 750 mg of 2-HOBA or placebo every 8 hours for 6 weeks.",[374],"Familial Hypercholesterolemia",[374,376,377,378,379],"HDL","LDL","2-HOBA","HDL Function",{"date":255,"type":36},{"date":382,"type":36},"2024-02-14",{"date":384,"type":20},"2027-12-31",{"name":42,"class":43},{"id":387,"slug":388,"hasResults":12,"nctId":389,"briefTitle":390,"officialTitle":390,"acronym":391,"eligibilityCriteria":392,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":393,"targetDuration":4,"studyType":21,"phases":395,"briefSummary":396,"conditions":397,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":399,"lastUpdatePostDateStruct":400,"startDateStruct":401,"completionDateStruct":403,"leadSponsor":405,"locationsCount":44},"100513983","phase-1-the-effect-of-sglt2-inhibition-on-adipose-inflammation-and-endothelial-function-100513983","NCT05972564","The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function","SADIE2","Inclusion Criteria:\n\n1. Age 18+ years old\n2. Metabolic syndrome as defined by 3 or more of 5 criteria:\n\n   1. Systolic blood pressure ≥ 130 mmHg or diastolic blood pressure ≥ 85 mmg Hg or treatment with anti-hypertensive medications for minimum of 1 month\n   2. Triglycerides ≥ 150 mg\u002FdL or treatment with a triglyceride-targeted medication (fenofibrate, gemfibrozil, niacin, high dose omega-3 fatty acids)\n   3. High-density lipoprotein (HDL) \\\u003C 40 mg\u002FdL in males or \\\u003C 50 mg\u002FdL in females\n   4. Fasting blood glucose ≥ 100mg\u002FdL or treatment with glucose-lowering medications\n   5. Waist circumference ≥ 102 cm in males or ≥ 88cm in females\n3. BMI ≥ 35 kg\u002FM2\n4. Scheduled gastric bypass or gastric sleeve in approximately 90 days (range 90-270 days)\n5. The ability to provide informed consent\n\n   Exclusion Criteria:\n6. Type 1 diabetes.\n7. Poorly controlled type 2 diabetes as defined by HbA1c ≥ 9%.\n8. Use of anti-diabetic medications other than stable dose of metformin or a sulfonylurea in the last 1 month.\n9. Treatment with a glucagon-like peptide-1 receptor agonist or co-agonist in the last 3 months.\n10. Treatment with an SGLT2 inhibitor in the last 3 months.\n11. Pregnancy or breast-feeding. Women of child-bearing potential will be required to have undergone surgical sterilization or to be using an intra-uterine device, hormonal contraceptive, or barrier methods of birth control.\n12. Cardiovascular disease such as myocardial infarction within six months prior to enrollment, presence of angina pectoris, significant arrhythmia, congestive heart failure (left ventricular hypertrophy acceptable), deep vein thrombosis, pulmonary embolism, -second- or third-degree heart block, mitral valve stenosis, aortic stenosis, or hypertrophic cardiomyopathy\n13. Presence of implanted cardiac defibrillator or pacemaker\n14. History of serious neurologic disease such as cerebral hemorrhage, stroke, or transient ischemic attack\n15. History of pancreatitis or pancreatic surgery\n16. History or presence of immunological or hematological disorders\n17. Clinically significant gastrointestinal impairment that could interfere with drug absorption\n18. History of advanced liver disease with cirrhosis\n19. Individuals with an eGFR\\\u003C45 mL\u002Fmin\u002F1.73 m2, where eGFR is determined by the four-variable Modification of Diet in Renal Disease (MDRD) equation, where serum creatinine is expressed in mg\u002FdL and age in years: eGFR (mL\u002Fmin\u002F1.73m2)=186 • Scr-1.154 • age-0.203 • (0.742 if female)\n20. Treatment with chronic systemic glucocorticoid therapy (more than 7 consecutive days in 1 month)\n21. Treatment with anticoagulants\n22. Any underlying or acute disease requiring regular medication which could possibly pose a threat to the subject or make implementation of the protocol or interpretation of the study results difficult\n23. History of alcohol abuse (\\>14 per week for men and \\>7 per week for women) or illicit drug use\n24. Treatment with any investigational drug in the one month preceding the study\n25. Previous randomization in this trial\n26. Mental conditions rendering a subject unable to understand the nature, scope and possible consequences of the study\n27. Inability to comply with the protocol in the opinion of the principal investigator, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study\n\n    Criteria Related to Known Adverse Effects of Drug:\n28. Uncircumcised men or men with history of balanitis\n29. History of urinary incontinence\n30. History of recurrent (\\>3) episodes of vulvovaginitis per year, or severe symptoms\n31. History of Fournier's gangrene\n32. History of recurrent (≥3) UTIs per year or pyelonephritis\n33. History of symptomatic hypotension or conditions predisposing to volume depletion\n34. Known peripheral vascular disease, neuropathy, history of foot ulcers or lower limb amputations\n35. Treatment with loop diuretics furosemide, torsemide, bumetanide, ethacrynic acid\n36. Known or suspected allergy to trial medications, excipients, or related products\n37. Contraindications to study medications, worded specifically as stated in the product's prescribing information",{"count":394,"type":20},74,[58,274],"Obesity is associated with increased cardiometabolic disease risk due, in part, to heightened chronic inflammation arising from adipose tissue. There are no current targeted therapies to prevent or reverse the chronic inflammation of obesity, and a better understanding of these inflammatory pathways in humans is key to future therapeutic interventions. This trial will determine both the anti-inflammatory potential of the SGLT2 inhibitor empagliflozin, and the contribution of adipose inflammation to surrogate measures of cardiovascular disease in a randomized controlled trial of obese patients.",[243,398],"Metabolic Syndrome","2026-08-04",{"date":354,"type":36},{"date":402,"type":36},"2023-09-06",{"date":404,"type":20},"2026-12-30",{"name":42,"class":43},{"id":407,"slug":408,"hasResults":12,"nctId":409,"briefTitle":410,"officialTitle":410,"acronym":4,"eligibilityCriteria":411,"healthyVolunteers":412,"sex":16,"minAge":413,"maxAge":159,"enrollmentInfo":414,"targetDuration":4,"studyType":21,"phases":416,"briefSummary":417,"conditions":418,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":399,"lastUpdatePostDateStruct":422,"startDateStruct":423,"completionDateStruct":425,"leadSponsor":427,"locationsCount":44},"100466736","phase-4-characterization-of-the-serotonin-2a-receptor-selective-pet-tracer-18fmhmz-in-patients-with-neurodegenerative-diseases-100466736","NCT05357612","Characterization of the Serotonin 2A Receptor Selective PET Tracer [18F]MH.MZ in Patients With Neurodegenerative Diseases","Inclusion Criteria:\n\n* Patient arm - clinical diagnosis of Parkinson disease, diffuse Lewy body disease, multiple systems atrophy, Huntington's Disease, Frontotemporal Dementia, and other variants\n* Healthy arm - age and gender matched to patient arm\n* Psychosis (presence of hallucinations or delusions) starting after the diagnosis of Parkinson's disease, occurring at least weekly for 4 weeks, severe enough to warrant treatment.\n* Study partner available for study visits\n\nExclusion Criteria:\n\n* Prior stroke or other uncontrolled serious neurological or medical illness\n* Contra-indication or inability to tolerate MRI scan\n* Use of serotonergic medications in the last 6 weeks\n* Incapable of providing independent consent.\n* Pregnant or breastfeeding women\n* psychosis due to a metabolic, toxic, or primary psychiatric disease\n* Deemed unable to complete neurocognitive testing\n* For PD Participants: current or prior use of pimavanserin\n* Use of antipsychotics in the last 2 weeks",true,"50 Years",{"count":415,"type":20},75,[214],"It is hypothesize that patients with clinically diagnosed neurodegenerative diseases will have significantly different receptor occupancy of 5HT2A receptors compared to a healthy age\u002Fsex-matched control group. This will be tested by measuring 5HT2A receptor density using the PET radioligand (R)-\\[18F\\]MH.MZ in both populations.",[419,420,421],"Neurodegenerative Diseases","Parkinson Disease","Parkinson Disease Psychosis",{"date":255,"type":36},{"date":424,"type":36},"2023-01-23",{"date":426,"type":20},"2027-08",{"name":42,"class":43},{"id":429,"slug":430,"hasResults":12,"nctId":431,"briefTitle":432,"officialTitle":432,"acronym":433,"eligibilityCriteria":434,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":270,"enrollmentInfo":435,"targetDuration":4,"studyType":21,"phases":436,"briefSummary":437,"conditions":438,"keywords":440,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":445,"lastUpdatePostDateStruct":446,"startDateStruct":448,"completionDateStruct":450,"leadSponsor":452,"locationsCount":453},"100628119","vanderbilt-integrated-community-tms-for-opioid-recovery-100628119","NCT07457489","Vanderbilt Integrated Community TMS for Opioid Recovery","VICTORY","Inclusion Criteria:\n\n1. Age between 18-65 years\n2. Diagnosis of OUD according to DSM-5 criteria and confirmed by SCID (First et al. 2015)\n3. Meets either of the following criteria: (1) reports opioid craving of 2 or greater on a 0-10 scale, or (2) has returned to opioid use at least once within the past 12 months.\n4. Currently Prescribed Buprenorphine for the treatment of opioid use disorder\n5. Must be able to read, speak and understand English\n6. Must be judged by study staff to be capable of completing the study procedures\n7. Participants will be in stable outpatient psychiatric treatment and psychiatrically stable.\n\nExclusion Criteria:\n\n1. DSM-5 intellectual disability\n2. Substance use disorder (other than opioid, nicotine, or cannabis) within the past three months\n3. Current, active suicidal ideation with intent or plan\n4. Positive urine drug screen for illicit substance use that can increase seizure risk (cocaine, benzodiazepines, amphetamine, methamphetamine)\n5. History of psychosis in the past 3 months or diagnosis of a primary psychotic disorder\n6. Any history of a progressive or genetic neurologic disorder (e.g. Parkinson's disease, multiple sclerosis, tuberous sclerosis, Alzheimer's Disease) or acquired neurological disease (e.g. stroke, traumatic brain injury, tumor), including intracranial lesions\n7. History of head trauma resulting in any loss of consciousness (\\>15 minutes) or neurological sequelae\n8. Current history of poorly controlled headaches including chronic medication for migraine prevention\n9. History of fainting spells of unknown or undetermined etiology that might constitute seizures\n10. History of seizures, diagnosis of epilepsy, or immediate (1st degree relative) family history epilepsy with the exception of a single seizure of benign etiology (e.g. febrile seizures) in the judgment of a board-certified neurologist\n11. Chronic (particularly) uncontrolled medical conditions that may cause a medical emergency in case of a provoked seizure (cardiac malformation, cardiac dysrhythmia, asthma, etc.)\n12. Any metal in the brain or skull (excluding dental fillings) or elsewhere in the body unless cleared by the responsible covering MD (e.g. MRI compatible joint replacement)\n13. Any devices such as pacemaker, medication pump, nerve stimulator, TENS unit, ventriculo-peritoneal shunt unless cleared by the responsible covering MD\n14. All female participants of child-bearing age will be required to have a pregnancy test; any participant who is pregnant or planning to become pregnant will not be enrolled in the study\n15. Medications will be reviewed by the responsible covering physician and a decision about inclusion will be made based on the participant's past medical history, drug dose, history of recent medication changes or duration of treatment, and use of CNS active drugs. The published TMS guidelines review of medications to be considered with rTMS will be taken into consideration given their described effects on cortical excitability measures.\n16. Participants who, in the investigator's opinion, might not be suitable for the study or would be unable to tolerate the study visit",{"count":19,"type":20},[23],"The main purpose of this study is to learn how stimulating a region in the brain influences craving and opioid use. The brain will be stimulated using TMS. Participants may choose to receive brain imaging (magnetic resonance imaging, MRI) as part of this study. The MRI will be used to identify areas in the brain that to stimulate and to measure brain changes as a result of TMS.\n\nParticipants will be asked to attend a total of 12 visits over about 5 months. Each visit will last between 1-2 hours with breaks. The study will involve interviews, questionnaires, computer tasks, TMS, and optional MRIs.\n\nThere are minor risks associated with this study. Answering some of the study questionnaires may cause stress or fatigue. The physical risks of TMS are low. Participants may experience mild pain or headache during or after receiving TMS. These symptoms may extend to adjacent areas of the face. The discomfort may be associated with twitching or movement of these areas during stimulation. This is generally transient and can be treated with over-the-counter pain medication. To minimize any risk of hearing loss during TMS, participants wear earplugs for the entire procedure. An evaluation of the participant's medical history will also be completed to ensure that it will be safe for participants to receive TMS. There is no direct benefit to participants from being in this study. However, participation may help others in the future as a result of knowledge gained from the research. The physical risks of the optional MRI are minimal, and a health questionnaire will be filled out before to determine if it is safe for participants to complete the MRI.\n\nConfidentiality:\n\nAll efforts, within reason, will be made to keep personal information in participants' research records confidential but total confidentiality cannot be guaranteed. Documents containing identifiable subject information, like this consent form, will be stored in locked filing cabinets located in the Departments of Psychiatry and Radiology at Vanderbilt. Electronic files containing identifiable information will be stored on password protected systems at Vanderbilt. If a Week 10, 12, or 20 study visit is conducted over video-conferencing, links to the video-call will be sent only to the research participant and approved staff. Video-calls will take place in private locations where the risk of someone hearing or seeing the research visit is minimized. Subjects will be assigned a numeric code that will be used to label all research data, including brain imaging scans. Only Dr. Ward and approved research staff will have access to this data. Only de-identified data will be stored on this server.\n\nDisclosures that participants consent to in this document are not protected. This includes putting research data in the medical record or sharing research data for this study or future research. Disclosures that participants make are also not protected.\n\nPrivacy:\n\nAny samples and information about participants may be made available to others to use for research. To protect privacy, participant's name's will not be released. Participants will not receive any benefit as a result of the tests done on samples. These tests may help us or other researchers learn more about the causes, risks, treatments, or how to prevent this and other health problems.\n\nStudy Results:\n\nParticipant's individual study results will not be shared with them. The final results of the study will potentially be published in the scientific literature.",[439],"Opiod Use Disorder",[441,442,443,444],"opioid use disorder","TMS","Brain Imaging","L DLPFC","2026-08-03",{"date":447,"type":36},"2026-08-06",{"date":449,"type":36},"2026-01-01",{"date":451,"type":20},"2028-01-01",{"name":42,"class":43},2,{"id":455,"slug":456,"hasResults":12,"nctId":457,"briefTitle":458,"officialTitle":459,"acronym":460,"eligibilityCriteria":461,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":462,"targetDuration":4,"studyType":21,"phases":464,"briefSummary":465,"conditions":466,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":445,"lastUpdatePostDateStruct":472,"startDateStruct":473,"completionDateStruct":475,"leadSponsor":477,"locationsCount":44},"100501707","phase-4-sgc-stimulation-perioperative-vascular-reactivity-and-organ-injury-in-cardiac-surgery-100501707","NCT05812755","SGC Stimulation, Perioperative Vascular Reactivity, and Organ Injury in Cardiac Surgery","The Effects of Soluble Guanylyl Cyclase Stimulation on Perioperative Vascular Reactivity and Organ Injury in Cardiac Surgery","SOLSTICE","Inclusion Criteria:\n\n1. Age ≥18 years\n2. Elective open-heart surgery, defined as surgery on the heart or aorta that requires sternotomy or thoracotomy\n\nExclusion Criteria:\n\n1. Intolerance to vericiguat\n2. Use of other soluble guanylyl cyclase stimulators or current use of phosphodiesterase-5 inhibitors\n3. Pregnancy or breast feeding. Pregnancy will be excluded in women of child-bearing potential by a urine or serum beta hcg test\n4. Renal replacement therapy within 30 days prior to screening\n5. Estimated glomerular filtration rate \\\u003C15 ml\u002Fmin per 1.73 m2 per Chronic Kidney Disease Epidemiology collaboration (CKD-EPI) equation at time of screening\n6. Systolic blood pressure less than 120 mmHg at the time of screening\n7. Prior kidney transplantation\n8. History of significant liver dysfunction (defined as Child-Pugh class C)\n9. Surgery scheduled to be performed with circulatory arrest\n10. Surgery scheduled to correct a major congenital heart defect\n11. Extracorporeal membrane oxygenation (ECMO) prior to surgery\n12. Active systemic infection or surgery for infectious endocarditis\n13. Ventricular assist device or intraaortic balloon pump support prior to surgery\n14. Prisoners",{"count":463,"type":20},170,[214],"The goal of this mechanistic clinical trial is to learn about the effects of medications called soluble guanylyl cyclase stimulators on vascular function and markers of kidney and brain injury in patients having heart surgery. The main questions it aims to answer are:\n\n1. Does soluble guanylyl cyclase stimulation improve blood vessel function compared to placebo?\n2. Does soluble guanylyl cyclase stimulation decrease markers of kidney injury and brain injury compared to placebo?\n\nParticipants will be randomized to a soluble guanylyl cyclase stimulator called vericiguat or placebo, and researchers will compare vascular function and markers of brain and kidney injury to see if vericiguat improves vascular function and reduces markers of injury.\n\nThis will provide important information to determine the underlying reasons that patients have some kidney and brain function problems after having heart surgery.",[467,468,469,470,471],"Endothelial Dysfunction","Vascular Diseases","Kidney Injury","Brain Disease","Vascular Inflammation",{"date":447,"type":36},{"date":474,"type":36},"2023-05-19",{"date":476,"type":20},"2029-07",{"name":42,"class":43},{"id":479,"slug":480,"hasResults":12,"nctId":481,"briefTitle":482,"officialTitle":482,"acronym":483,"eligibilityCriteria":484,"healthyVolunteers":12,"sex":16,"minAge":485,"maxAge":486,"enrollmentInfo":487,"targetDuration":4,"studyType":128,"phases":4,"briefSummary":488,"conditions":489,"keywords":492,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":497,"lastUpdatePostDateStruct":498,"startDateStruct":499,"completionDateStruct":501,"leadSponsor":503,"locationsCount":44},"100563159","point-of-care-ophthalmic-diagnostic-imaging-of-retinopathy-of-prematurity-100563159","NCT06612541","Point-of-Care Ophthalmic Diagnostic Imaging of Retinopathy of Prematurity","ROP Imaging","Inclusion Criteria:\n\n* Preterm male and female infants born at 24-34 weeks gestational age and weighing \\<1500g at birth\n\nExclusion Criteria:\n\n* Infants surgically treated for ROP\n* Infants with significant health concern that would preclude noninvasive retinal imaging as noted by the primary inpatient team","24 Weeks","34 Weeks",{"count":272,"type":20},"The goal of this proposal is to develop novel HH-SECTR technology for visualizing and quantifying diagnostic disease features in prematurely born infant retinopathy of prematurity (ROP) patients that lead to more informed clinical decision making. Providing depth-resolved vascular information has not been adequately investigated for its diagnostic potential. Furthermore, we seek to identify disease features not currently accessible by standard examination methods to better inform clinical decisions.",[490,491],"Retinopathy of Prematurity (ROP)","ROP Examination",[493,494,495,496],"Retinopathy of Prematurity","ROP","Prematurity","OCT Imaging","2026-08-02",{"date":399,"type":36},{"date":500,"type":36},"2025-02-01",{"date":502,"type":20},"2030-02",{"name":42,"class":43},{"id":505,"slug":506,"hasResults":12,"nctId":507,"briefTitle":508,"officialTitle":508,"acronym":4,"eligibilityCriteria":509,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":510,"targetDuration":4,"studyType":21,"phases":512,"briefSummary":513,"conditions":514,"keywords":517,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":525,"lastUpdatePostDateStruct":526,"startDateStruct":528,"completionDateStruct":529,"leadSponsor":531,"locationsCount":44},"100649528","optimizing-dysphagia-treatment-delivery-in-acute-care-a-hybrid-efficacy-implementation-trial-100649528","NCT07736105","Optimizing Dysphagia Treatment Delivery in Acute Care: A Hybrid Efficacy Implementation Trial","Inclusion criteria for critically ill adults will be:\n\n1. Adult ≥ 18 years old\n2. Not pregnant\n3. Underwent a clinical flexible endoscopic evaluation of swallowing (FEES) or videofluoroscopy swallow study (VFSS) with a penetration aspiration scale (PAS) score ≥ 5\n4. Hospitalized in non-neuro intensive care unit (ICU) setting at Vanderbilt University Medical Center (VUMC) at some point during admission\n5. Dysphagia is primarily related to ICU stay and not other medical conditions that may cause dysphagia\n6. medically cleared with no contraindications for expiratory muscle strength training (EMST) or other treatments\n7. Cognitive capacity to follow basic directions\n8. Willing to undergo testing and treatment for the study.\n\nInclusion criteria for speech-language pathologists (SLPs) will be:\n\n1. Adult acute care speech-language pathologist who works at VUMC.\n2. Willing to complete surveys and\u002For participate in a focus group.",{"count":511,"type":20},120,[23],"This research study is investigating the efficacy and implementation of expiratory muscle strength training (EMST), standard of care dysphagia treatment, and intensive dysphagia treatment in critically ill adults in the acute care setting. Currently, no targeted, effective, and feasible dysphagia treatment approaches currently exist for use in critically ill adults in the acute care setting. The current study will investigate the impact of EMST, standard of care dysphagia treatment, and intensive dysphagia treatment on pulmonary function, cough function, swallow function, frailty, patient-reported swallow function, and health outcomes in critically ill adults. This study will also examine patient perceptions and clinical speech-language pathologists' perceptions of the acceptability, appropriateness, and feasibility of these interventions.\n\nCritically ill adults will: undergo tests of breathing, cough, and swallow function, complete questionnaires about the treatment, and their swallow function, and complete their respective treatment as prescribed.\n\nClinical speech-language pathologists will complete questionnaires about the interventions.\n\nA subset of critically ill adults and clinical speech-language pathologists will also have the opportunity to participate in focus groups.",[515,516],"Dysphagia","Critical Illness",[515,518,519,520,521,522,523,516,524],"Swallowing","Deglutition","Deglutition Disorders","Swallowing Disorders","Breathing","Cough","Treatment","2026-07-29",{"date":527,"type":36},"2026-07-30",{"date":40,"type":20},{"date":530,"type":20},"2029-02",{"name":42,"class":43},{"id":533,"slug":534,"hasResults":12,"nctId":535,"briefTitle":536,"officialTitle":537,"acronym":4,"eligibilityCriteria":538,"healthyVolunteers":12,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":539,"targetDuration":541,"studyType":128,"phases":4,"briefSummary":542,"conditions":543,"keywords":546,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":553,"lastUpdatePostDateStruct":554,"startDateStruct":556,"completionDateStruct":558,"leadSponsor":560,"locationsCount":561},"100644920","modeling-mortality-in-duchenne-muscular-dystrophy-cardiomyopathy-identification-of-surrogate-outcome-measures-for-dmd-drug-trials-100644920","NCT07674758","Modeling Mortality in Duchenne Muscular Dystrophy Cardiomyopathy: Identification of Surrogate Outcome Measures for DMD Drug Trials","Evaluating Cardiac Function in Patients With Duchenne Muscular Dystrophy","Inclusion Criteria:\n\n* Clinical phenotype of Duchenne muscular dystrophy (DMD), Becker muscular dystrophy (BMD), or muscular dystrophy carrier (MDC) confirmed with muscle biopsy or genotype\n\nExclusion Criteria:\n\n* Additional genetic or congenital abnormality that may affect cardiovascular function or progression\n* Current investigational therapy that may affect cardiovascular function (would preclude ongoing data collection but prior data would still be used)",{"count":540,"type":20},1000,"5 Years","Dystrophin associated heart dysfunction is a leading cause of death in patients with Duchenne and Becker Muscular dystrophy (DMD\u002FBMD) and Duchenne and Becker muscular dystrophy carriers (MDC); however, the evolution of heart dysfunction is not well-understood. The central objectives of this proposal are to elucidate this evolution of heart dysfunction and identify measures from cardiac MRI images that can predict death or significant heart disease in patients with DMD\u002FBMD\u002FMDC. This study will create a large clinical and cardiac MRI registry of dystrophin associated heart dysfunction, will utilize advanced image analysis techniques, including deep learning neural networks, to comprehensively evaluate every patient, and will create a risk toolkit accessible to clinicians around the world; this proposal has the potential to improve the quality of life in patients with dystrophin associated heart dysfunction by allowing for earlier and more intensive therapy in patients with severe disease and by identifying surrogate outcome measures for use in therapeutic trials.",[61,63,544,545],"Becker Muscular Dystrophy","Carrier of Duchenne Muscular Dystrophy",[547,548,549,550,551,552],"Duchenne Muscular Dystrophy","cardiomyopathy","machine learning","cardiac MRI","Biomarker","Outcome measures","2026-07-26",{"date":555,"type":36},"2026-07-28",{"date":557,"type":36},"2025-01-06",{"date":559,"type":20},"2029-02-01",{"name":42,"class":43},9,{"id":563,"slug":564,"hasResults":12,"nctId":565,"briefTitle":566,"officialTitle":566,"acronym":4,"eligibilityCriteria":567,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":568,"targetDuration":4,"studyType":21,"phases":569,"briefSummary":570,"conditions":571,"keywords":576,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":581,"lastUpdatePostDateStruct":582,"startDateStruct":583,"completionDateStruct":585,"leadSponsor":587,"locationsCount":44},"100639675","phase-2-effect-of-an-isolevuglandin-scavenger-on-salt-sensitivity-of-blood-pressure-and-immune-cell-activation-in-humans-100639675","NCT07602166","Effect of an Isolevuglandin Scavenger on Salt Sensitivity of Blood Pressure and Immune Cell Activation in Humans","Inclusion Criteria:\n\n* We will perform analyses in participants previously phenotyped for SSBP, defined as a change in systolic blood pressure ≥10 mmHg from salt-loading to salt-depletion,\n* Over 18 years of age. Able to give informed consent,\n\nExclusion criteria:\n\n* Salt-resistant people,\n* Acute cardiovascular event(s) within the previous 6 months,\n* inability to understand the nature, scope, and possible consequences of the study or to participate in\u002Fcomply with the protocol,\n* Current excessive alcohol or illicit drug use,\n* BP below the inclusion criteria levels after discontinuation of therapy,\n* Concomitant diabetes mellitus, type I or II,\n* Autoimmune disease,\n* Recent vaccination,\n* Younger or older than inclusion criteria,\n* Pregnant or breastfeeding\n* Women of childbearing potential unwilling to use highly effective contraceptive (see Risk section),\n* Confirmed or suspected renal, renovascular or endocrine causes of secondary hypertension,\n* Treatment with agents known to increase BP (e.g., adrenergic agonists for ADHD, SSRI and SNRI antidepressants, chronic use of decongestants or non-steroidal anti-inflammatory drugs,\n* Active or ongoing infection, including HIV\u002FAIDS,\n* Active or ongoing malignancy with the exception of basal cell carcinoma of the skin,\n* Severe psychiatric disorders,\n* Any condition that may alter the immunological results of the study including rheumatoid arthritis, systemic lupus erythematosus, dermatomyositis, giant cell arteritis, psoriasis, inflammatory bowel disease, and multiple sclerosis,\n* Use of glucocorticoids, immunosuppressants, direct immunomodulators or chemotherapeutic drugs that in the judgment of the investigators may include a major inflammatory component,\n* Individuals who have contraindications to high salt diets (e.g. heart, renal, or liver failure) or low salt diets (e.g. postural orthostatic tachycardia syndrome, prescribed salt tablets, fludrocortisone or midodrine) or 24-hr ambulatory blood pressure monitoring (e.g. women with bilateral upper extremity lymphedema following breast cancer surgeries),\n* Prior diagnosis of liver cirrhosis or the following abnormal liver function studies: AST or ALT \\>1.5x the upper limit of normal or total bilirubin ≥1.5 mg\u002Fdl,\n* Use of Aspirin,\n* Use of monoamine oxidase inhibitors (MAO-I),\n* Individuals with medical contraindications to certain food content,\n* Use of nitrate therapy. (Participants who are taking PDE-5 inhibitors will be instructed to discontinue use at least 48 hours prior to testing),\n* Patients with resistant hypertension, defined as above-goal blood pressure despite the concurrent use of three antihypertensive drug classes at screening, will be excluded for safety reasons,\n* Average of three office-based blood pressure readings greater than 160 mmHg systolic or 100 mmHg diastolic will not be eligible for enrollment,\n* Use of drugs such as anticoagulants (e.g., warfarin), beta-blockers, antiarrhythmics, antidepressants\u002Fantipsychotics, and other medications primarily metabolized by CYP2C9, CYP2C19, and CYP2D6 that may cause drug-drug interaction.",{"count":237,"type":20},[274],"Hypertension is the leading cause of preventable deaths globally, driven by complications such as myocardial infarction, stroke, heart failure, and kidney disease. Recent updates in hypertension classification by the American Heart Association (AHA) place nearly half of the U.S. population in the hypertensive category. Excess dietary salt is a major risk factor for hypertension, with 50% of hypertensive individuals exhibiting salt-sensitivity of blood pressure (SSBP). SSBP is an independent predictor of cardiovascular events and death. While kidney mechanisms in salt-sensing have been extensively studied, emerging evidence suggests that immune cells can also sense sodium (Na+).\n\nThis trial hypothesizes that myeloid cell-derived isolevuglandins (IsoLGs) drive endothelial dysfunction, perpetuating the salt-sensitive phenotype. Preliminary data indicate that targeting IsoLGs with the IsoLG scavenger 2-hydroxybenzylamine (2-HOBA) may interrupt this immune-vascular axis, reducing salt sensitivity and associated cardiovascular risks.\n\nThis phase 2 clinical trial aims to investigate the role of 2-HOBA in modulating immune cell function within blood vessels in hypertensive patients. The study will explore the impact of immunity on salt sensitivity and assess 2-HOBA's potential to reduce endothelial dysfunction, improve immune cell activation, and alleviate SSBP.",[572,573,574,575],"Salt Sensitivity of Blood Pressure","High Blood Pressure","Inflammation","Renin-Angiotensin-Aldosterone System",[577,578,579,580],"salt sensitivity","hypertension","renin-angiotensin-aldosterone system","immune cells","2026-07-24",{"date":555,"type":36},{"date":584,"type":20},"2026-09",{"date":586,"type":20},"2031-07",{"name":42,"class":43},{"id":589,"slug":590,"hasResults":12,"nctId":591,"briefTitle":592,"officialTitle":593,"acronym":594,"eligibilityCriteria":595,"healthyVolunteers":12,"sex":16,"minAge":596,"maxAge":270,"enrollmentInfo":597,"targetDuration":4,"studyType":128,"phases":4,"briefSummary":599,"conditions":600,"keywords":605,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":581,"lastUpdatePostDateStruct":611,"startDateStruct":613,"completionDateStruct":615,"leadSponsor":617,"locationsCount":326},"100451089","cooperative-assessment-of-late-effects-for-scd-curative-therapies-100451089","NCT05153967","Cooperative Assessment of Late Effects for SCD Curative Therapies","U01 Cooperative Assessment of Late Effects for Sickle Cell Disease Curative Therapies","COALESCE","Inclusion Criteria\n\n* Confirmed laboratory diagnosis of SCD\n* Ability to give informed consent\n* Ability to provide pre- and post-curative therapy data\n* Treated with either one HSCT or with standard disease-modifying therapy\n\nExclusion Criteria\n\n•History of non-compliance","4 Years",{"count":598,"type":20},750,"Sickle Cell Disease is one of the most common genetic diseases in the United States, occurring in approximately 1 in 400 births. Approximately 100,000 individuals are diagnosed with SCD in the United States. Mortality for children with SCD has decreased substantially over the past 4 decades, with \\>99% of those born in high resource settings, including the United States, France, and England, now surviving to 18 years of age. However, the life expectancy of adults with SCD is severely shortened. Dysfunction of the heart, lung, and kidney is directly associated with decreased life expectancy. With the variety of curative therapies that are now available for SCD, long-term health outcomes studies are time-sensitive. As of now, efforts to determine long-term health outcomes following curative therapies for SCD have been limited. Though curative therapies initially should provide a cure for symptoms of SCD, there is the risk of late health outcomes to consider. Defining health outcomes following curative therapy is essential to improve personalized decision-making when considering curative versus disease-modifying therapeutic options. The primary goal of this study is to determine whether curative therapies for individuals with SCD will result in improved or worsening heart, lung, and kidney damage when compared to individuals with SCD receiving standard therapy. The investigators will also explore whether certain genes are associated with a good or bad outcome after curative therapy for SCD.",[601,602,603,604],"Sickle Cell Disease","Pulmonary Disease","Renal Disease","Heart Disease",[606,607,608,609,610],"Myeloablative Autologous Gene Editing","Myeloablative Autologous Gene Therapy","Myeloablative allo-HSCT","Nonmyeloablative allo-HSCT","Disease-Modifying Therapy",{"date":612,"type":36},"2026-07-27",{"date":614,"type":36},"2022-07-12",{"date":616,"type":20},"2027-02",{"name":42,"class":43},{"id":619,"slug":620,"hasResults":12,"nctId":621,"briefTitle":622,"officialTitle":623,"acronym":624,"eligibilityCriteria":625,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":626,"targetDuration":4,"studyType":21,"phases":628,"briefSummary":629,"conditions":630,"keywords":631,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":634,"lastUpdatePostDateStruct":635,"startDateStruct":637,"completionDateStruct":638,"leadSponsor":639,"locationsCount":44},"100622340","a-study-of-electronic-clinical-decision-support-tools-for-steatotic-liver-disease-100622340","NCT07382349","A Study of Electronic Clinical Decision Support Tools for Steatotic Liver Disease","Randomized Controlled Trial of Electronic Clinical Decision Support Systems for Improving Care Management and Clinical Outcomes for Adults With Steatotic Liver Disease","eMPOWER","Inclusion Criteria:\n\n* Adult patients (age ≥ 18 years)\n* Outpatient clinic visit (in-person or telemedicine) at a participating clinic site\n* Demonstrated Screening Need due to High Risk Profile, which includes the following: Diagnostic Codes for MASLD or Hepatic Steatosis on Imaging PLUS at least one cardiometabolic risk factors; OR Chronically Elevated Liver Enzymes (\\> 6 months); OR patient with impaired glycemic control (prediabetes\u002Fdiabetes); OR 2 or more cardiometabolic risk factors present\n\nExclusion Criteria:\n\n* Solid Organ Transplant Recipient\n* Existing Hepatology Relationship Evidenced by Prior Hepatology Visit Within 3 Years\n* Active Cancer Diagnoses\n* Diagnoses for Alcohol-Related Conditions\n* Pregnant Individuals\n* Receiving Palliative Care Services",{"count":627,"type":20},7200,[23],"The overall objectives of this study are to determine the effectiveness of a participant-specific guided electronic decision support system on provider decision making for participants with metabolic-dysfunction associated steatotic liver disease (MASLD), and to determine the acceptance and barriers for use of an electronic health record embedded algorithm for MASLD care management within ambulatory primary care, endocrinology, and general gastroenterology settings.",[233],[632,233,633],"Electronic Health Record","Clinical Decision Support","2026-07-20",{"date":636,"type":36},"2026-07-21",{"date":634,"type":36},{"date":502,"type":20},{"name":42,"class":43},{"id":641,"slug":642,"hasResults":12,"nctId":643,"briefTitle":644,"officialTitle":644,"acronym":645,"eligibilityCriteria":646,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":647,"targetDuration":4,"studyType":128,"phases":4,"briefSummary":649,"conditions":650,"keywords":652,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":655,"lastUpdatePostDateStruct":656,"startDateStruct":657,"completionDateStruct":659,"leadSponsor":661,"locationsCount":453},"100641193","prospective-investigation-of-cirrhotic-cardiomyopathy-in-humans-100641193","NCT07658222","Prospective Investigation of Cirrhotic Cardiomyopathy in Humans","PITCH","Inclusion Criteria:\n\n1. Decompensated cirrhosis, defined as cirrhosis with current or prior occurrence of one or more of the following:\n\n   * portal hypertension-related bleeding,\n   * hepatic encephalopathy, and\u002For\n   * clinical ascites.\n2. Model for End Stage Liver Disease version 3.0 (MELD 3.0) ≥ 15 or Child Pugh Class B-C\n3. Age ≥ 18 years\n4. Longitudinal follow up in either at Vanderbilt University Medical Center (VUMC) or University of Texas Southwestern (UTSW) hepatology clinics\n5. Willing to adhere to study protocol\n6. Able to provide written informed consent\n\nExclusion Criteria:\n\n1. Current or prior obstructive coronary artery disease, ≥ moderate valvular disease, \\> mild pericardial effusion, cardiac amyloidosis, congenital heart disease, pacemaker, or implantable cardioverter defibrillator\n2. End-stage heart, kidney, or lung disease\n3. Pulmonary Arterial Hypertension\n4. Acute on Chronic Liver Failure (ACLF) grade 2-3 (i.e., ≥ 2 extrahepatic organ failures)\n5. Advanced hepatocellular carcinoma (i.e., Barcelona Clinic Liver Cancer (BCLC) Stage C or D)\n6. Ongoing alcohol use, by patient reporting or by phosphatidyl ethanol testing\n7. Pregnancy\n8. Prior TIPS",{"count":648,"type":20},440,"Cirrhotic Cardiomyopathy (CCM) is a recognized complication of cirrhosis, but understudied despite recent retrospective data suggesting it may be common, affecting one in three patients with decompensated cirrhosis, and associated with significantly increased risk of death and adverse hepatic and cardiac events. Moreover, evidence from preclinical models and children suggest elevated bile acids in the blood may contribute to CCM, but data from adults with cirrhosis are scarce. Therefore, this study will be the first contemporary prospective multicenter investigation of CCM in adults with cirrhosis in the United States. The study will characterize risk factors for CCM, determine its impact on clinical outcomes, and investigate the contribution of circulating bile acids to disease development.",[651],"Cirrhotic Cardiomyopathy",[653,654],"Cirrhotic cardiomyopathy","Cirrhosis","2026-07-17",{"date":636,"type":36},{"date":658,"type":36},"2026-01-20",{"date":660,"type":20},"2030-06-30",{"name":42,"class":43},{"id":663,"slug":664,"hasResults":12,"nctId":665,"briefTitle":666,"officialTitle":667,"acronym":4,"eligibilityCriteria":668,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":669,"targetDuration":4,"studyType":21,"phases":671,"briefSummary":672,"conditions":673,"keywords":678,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":683,"lastUpdatePostDateStruct":684,"startDateStruct":686,"completionDateStruct":687,"leadSponsor":689,"locationsCount":44},"100648202","phase-4-impact-of-dysport-on-pmff-donor-scar-100648202","NCT07720726","Impact of Dysport on PMFF Donor Scar","The Impact of Pre-Operative Abobotulinumtoxin-A Injection on Paramedian Forehead Flap Donor Site Scar Aesthetics- A Randomized Controlled Trial","Inclusion Criteria:\n\n* Adults at least 18 years of age with a post-mohs micrographic surgery nasal defect requiring PMFF reconstruction in the operating room or clinic at our institution\n* No other facial plastic surgery procedure or skin cancer reconstruction performed simultaneously\n* Lack all the below Exclusion Criteria\n\nExclusion Criteria:\n\n* Documented allergy to Abobotulinumtoxin-A\n* Previous hypersensitivity to Abobotulinumtoxin-A\n* Hypersensitivity to any botulinum toxin product or excipients\n* Previous adverse reaction to any botulinum toxin product or excipients\n* Allergy to cow's milk protein\n* Infection at proposed injection site\n* Previous scar or surgery at proposed injection site\n* Inability to follow-up in clinic\n* Inability to provide informed consent\n* Patient currently on aminoglycoside or other agent interfering with neuromuscular transmission\n* Patient on anticholinergic medication\n* Pregnancy",{"count":670,"type":20},50,[214],"The purpose of this research study is to investigate the effect of pre-operative injections of Dysport (Abobotulinumtoxin-A, commonly known as \"Botox\") on the cosmetic appearance of and overall satisfaction with study participant's forehead scar following paramedian forehead flap reconstruction for a nasal skin cancer defect. Participating in this research involves study participants being randomly placed in one of two treatment groups. The first treatment group will have \"Botox\" injected at the site of the planned forehead incision once the study participant is in the operating room and asleep, but prior to the start of the operation. The second treatment group will have normal saline injected at the site of the planned forehead incision to act as a control group. The study participant will then undergo paramedian forehead flap reconstruction of the nasal defect in the standard fashion by a facial plastic and reconstructive surgeon. At all post-operative appointments, photographs will be taken of the study participant's forehead scar, and the study participant will be asked to complete two short surveys. These two surveys will take approximately 5 minutes total to complete. Study participants may choose to participate in this research study so that the investigators may learn more about the cosmetic benefit of \"Botox\" when it comes to scar prevention which could potentially help future patients having the same surgery.",[674,675,676,677],"Skin Cancer Excision Site","Basal Cell Carcinoma","Squamous Cell Carcinoma","Melanoma",[679,680,681,682],"Mohs Micrographic Surgery","Nasal Defect","Paramedian Forehead Flap","Wound Healing","2026-07-16",{"date":685,"type":36},"2026-07-22",{"date":68,"type":20},{"date":688,"type":20},"2029-06-30",{"name":42,"class":43},""]