[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"University of Virginia\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":693},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,112,0,25,[9,45,68,95,118,142,172,194,217,244,274,298,330,367,402,428,465,491,515,542,569,589,621,642,662],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":4},"100651552","early-phase-1-echocardiographic-molecular-imaging-for-poc-detection-of-ischemia-100651552",false,"NCT07762495","Echocardiographic Molecular Imaging for POC Detection of Ischemia","Inclusion Criteria:\n\n* Age ≥18 years of age\n* Patients with possible or suspected ACS based on clinical criteria (history, ECG, laboratories) and HEART score \\>3.\n\nExclusion Criteria:\n\n* Cardiogenic shock\n* Inability to obtain consent\n* Severe heart failure (NYHA class IV)\n* Mechanical complication of MI (ischemic VSD, papillary muscle rupture, ventricular free wall rupture)\n* Ongoing life-threatening arrhythmias\n* Neutropenia (\\\u003C1,500\u002Fmm3)\n* Pregnancy\n* Lactation\n* Allergy to ultrasound contrast agents or eggs\n* History of autoimmune or inflammatory disease with myocardial involvement (SLE, sarcoidosis, giant cell myocarditis, etc.)","ALL","18 Years","99 Years",{"count":20,"type":21},80,"ESTIMATED","INTERVENTIONAL",[24],"EARLY_PHASE1","Molecular imaging with myocardial contrast echocardiography (MCE) relies on the non-invasive detection of targeted microbubbles (MBs) or other acoustically active agents. The confinement of MBs to the vascular compartment makes them ideal for assessing acute inflammatory responses involving endothelial cell activation and immune cell recruitment. A construct for imaging inflammation and endothelial activation can be achieved by altering amphipathic lipid shell composition in MBs. Specifically, incorporation of phosphatidylserine (PS) into the shell of MBs promotes adhesion to activated leukocytes and endothelial cells which can be used to detect ischemia, whether active or resolved. Our first in human studies to use myocardial contrast echocardiography (MCE) to detect inflammation secondary to ischemia was performed with a PS-containing MB contrast agent (Sonazoid) where we studied patients with known acute coronary syndrome (ACS) who had just undergone acute percutaneous coronary intervention. In this study, we will conduct a proof-of-concept clinical trial where MCE molecular imaging with Sonazoid will be performed in 80 patients with suspected rather than known ACS. We will test whether MCE ischemic memory imaging with MB-PS can diagnose or exclude ACS, and assess risk based on spatial extent of signal enhancement.",[27],"Acute Coronary Syndrome",[29,30,31,32],"acute coronary syndrome","echocardiography","Microbubbles","Myocardial contrast echocardiography","NOT_YET_RECRUITING","2026-08-17",{"date":36,"type":37},"2026-08-20","ACTUAL",{"date":39,"type":21},"2026-09-30",{"date":41,"type":21},"2030-07-30",{"name":43,"class":44},"University of Virginia","OTHER",{"id":46,"slug":47,"hasResults":12,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":61,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":67},"100634350","early-phase-1-mce-molecular-imaging-for-ici-myocarditis-100634350","NCT07538544","MCE Molecular Imaging for Myocarditis","MCE Molecular Imaging in Myocarditis","Inclusion Criteria:\n\n* Age ≥18 years of age\n* At least two of the following manifestations of myocarditis:\n\n  1. new or suspected new high-sensitivity troponin \\>3 times upper limit of normal\n  2. new or suspected new LV dysfunction with LVEF \\\u003C50% or any segmental wall motion abnormality in the absence of prior ischemic event\n  3. ECG changes consistent with myocarditis defined as either diffuse ST elevation or ST-T abnormalities that are documented to be new,\n  4. unexplained severe ventricular arrhythmias,\n  5. Cardiac MR evidence for myocarditis\n  6. Predisposing condition or therapy associated with heightened risk of acute myocarditis (i.e. SARS-CoV-2, Parvovirus, Immune checkpoint inhibitors)\n\nExclusion Criteria:\n\n* Inability to obtain consent\n* High pre-test likelihood for ACS based on ECG and history\n* Pregnancy or planned pregnancy\n* Lactation\n* Allergy to ultrasound contrast agents or eggs\n* Treatment with potent immunosuppressive therapy beyond corticosteroids\n* Conditions associated with inflammatory myopathy (SLE, giant cell myocarditis, sarcoidosis, etc.)",{"count":53,"type":21},30,[24],"Inflammation of the heart (myocarditis) is a serious condition that can cause heart failure, abnormal heart rhythms, cardiac arrest, and death. Rapid diagnosis of this condition is key to reversing it. The purpose of this study is to determine whether myocarditis such as that which occurs with viral illness, autoimmune conditions, or certain therapies (i.e. immune checkpoint inhibitors) can be diagnosed using a new form of ultrasound imaging of the heart (echocardiography) that uses a contrast agent that is targeted to inflammation (Sonazoid).",[57],"Myocarditis Acute",[59,32,60],"Myocarditis","Molecular imaging",{"date":36,"type":37},{"date":63,"type":21},"2026-09-15",{"date":65,"type":21},"2030-07-01",{"name":43,"class":44},1,{"id":69,"slug":70,"hasResults":12,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":12,"sex":16,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":4,"studyType":22,"phases":79,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":67},"100627633","phase-2-comparative-efficacy-of-antibiotics-for-small-intestine-bacterial-overgrowth-in-bangladeshi-children-100627633","NCT07451171","Comparative Efficacy of Antibiotics for Small Intestine Bacterial Overgrowth in Bangladeshi Children","A Phase II Trial to Prevent Linear Growth Stunting and Malnutrition in Impoverished Children From a Low-Income Country by Treating Small Intestine Bacterial Overgrowth","Inclusion Criteria:\n\n* Positive glucose hydrogen breath test (GHBT)\n* Weight-for-age Z score \\> -1\n* Length-for-age Z score \\> -1\n\nExclusion Criteria:\n\n* Presence of known chronic or congenital illness, including developmental delay\n* Presence of acute gastrointestinal illness in the preceding 14 days\n* Antibiotic use in the preceding 14 days\n* Previous adverse reaction to any of the three study medications or other drugs in the same antibiotic classes\n* Sibling previously enrolled in this study","1 Year","2 Years",{"count":78,"type":21},60,[80],"PHASE2","The purpose of this Phase IIa study is to identify the most effective antibiotic regimen to treat small intestine bacterial overgrowth (SIBO) in impoverished Bangladeshi children.",[83],"Small Intestine Bacterial Overgrowth",[85],"environmental enteric dysfunction","RECRUITING","2026-08-14",{"date":89,"type":37},"2026-08-18",{"date":91,"type":37},"2026-04-18",{"date":93,"type":21},"2026-12-02",{"name":43,"class":44},{"id":96,"slug":97,"hasResults":12,"nctId":98,"briefTitle":99,"officialTitle":99,"acronym":4,"eligibilityCriteria":100,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":101,"enrollmentInfo":102,"targetDuration":4,"studyType":22,"phases":104,"briefSummary":106,"conditions":107,"keywords":4,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":67},"100519030","optimizing-pain-self-management-in-total-knee-arthroplasty-100519030","NCT06038240","Optimizing Pain Self-Management in Total Knee Arthroplasty","Inclusion Criteria:\n\n* 18-85 years old.\n* Have a physician-confirmed treatment plan to undergo unilateral TKA along with physician-confirmed knee osteoarthritis diagnosis.\n* Willingness and ability to comply with scheduled sessions and study procedures\n\nExclusion Criteria:\n\n* Member of a vulnerable population including pregnant women, children, prisoners, cognitively impaired, and non-English-speaking subjects.\n* Current unstable, severe medical comorbidity.\n* Current severe psychiatric comorbidity (e.g., schizophrenia, psychosis, or other unstable psychiatric disorder).\n* Current severe alcohol or substance use disorder.\n* Weekly or more frequent use of opioids in the past 30 days (other than tramadol and\u002For codeine) for therapeutic or non-therapeutic purposes.\n* Other surgery of the affected knee in the last 6 months.\n* Previous TKA.","85 Years",{"count":103,"type":21},150,[105],"NA","The purpose of this study is to investigate the efficacy of a positive affect enhancing intervention designed to reduce pain and augment reward system function in knee osteoarthritis (KOA) patients undergoing total knee arthroplasty (TKA). The scientific premise is that patient use of a positive emotion generative practice - savoring meditation, which has been demonstrated to reduce pain in experimental laboratory settings, enhanced with a pain neuroscience education component about reward system dysfunction as a chronic pain mechanism - is optimally suited to reduce postsurgical pain and augment reward system functioning relative to a Pain Self-Management and Education (PSME) condition. We will randomize 150 patients with KOA undergoing unilateral TKA to a brief, 4-session (20-30 minutes each) course of Savoring Meditation (SM; n = 75) or PSME (n = 75) delivered remotely by trained interventionists in a one-on-one format. We will assess pain and as well as pain-related risk and protective factors both via questionnaire and via weeklong ecological momentary assessment (EMA) data bursts on the following schedule: baseline, post-surgery, and 3-month follow-up. In addition, participants will attend laboratory testing sessions at baseline and 6-weeks post-surgery, during which affective pain modulation and electroencephalographic (EEG) brain biomarkers associated with pain and affect will be recorded. Participants in SM be encouraged to practice their savoring for 5 minutes\u002Fday during the week following surgery, as well as to use it to manage pain flares in a self-directed manner.",[108,109,110],"Osteo Arthritis Knee","Knee Pain Chronic","Surgery","2026-08-13",{"date":34,"type":37},{"date":114,"type":37},"2023-11-27",{"date":116,"type":21},"2027-09",{"name":43,"class":44},{"id":119,"slug":120,"hasResults":12,"nctId":121,"briefTitle":122,"officialTitle":122,"acronym":123,"eligibilityCriteria":124,"healthyVolunteers":125,"sex":16,"minAge":126,"maxAge":127,"enrollmentInfo":128,"targetDuration":4,"studyType":22,"phases":129,"briefSummary":131,"conditions":132,"keywords":4,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":67},"100353555","phase-4-effect-of-exercise-andor-liraglutide-on-vascular-dysfunction-and-insulin-sensitivity-in-type-2-diabetes--zql007-100353555","NCT03883412","Effect of Exercise and\u002For Liraglutide on Vascular Dysfunction and Insulin Sensitivity in Type 2 Diabetes ( ZQL007)","ZQL007","Inclusion Criteria:\n\n* Age 21-60\n* A1C ≤ 8.5%\n* Never on GLP-1RA (eg: exenatide, liraglutide) or DPP4I ( eg: Sitaglipton)\n* On stable dose of oral hypoglycemic agents \\>4 months\n* On stable dose of other medications for \\>4 months\n\nExclusion Criteria:\n\n* Taking Insulin\n* Smoking presently or in the past 6 months\n* BP \\>160\u002F90\n* BMI \\>35\n* Family history of medullary thyroid cancer or multiple endocrine neoplasia syndrome\n* History of congestive heart failure, ischemic heart disease, severe pulmonary disease, liver or kidney disease.\n* Any vascular disease such as myocardial infarction, stroke, peripheral vascular disease\n* Presence of an intracardiac or intrapulmonary shunt (we will screen for this by auscultation during the physical exam by PI).\n* Pregnant or breastfeeding.\n* Known hypersensitivity to perflutren (contained in Definity)",true,"21 Years","60 Years",{"count":78,"type":21},[130],"PHASE4","The primary objective of this study is to examine whether exercise training alone, liraglutide treatment alone or exercise training plus liraglutide treatment increases cardiac and muscle capillary blood volume, improves vascular function in the larger conduit vessels, and enhances insulin's metabolic action in humans with Type 2 diabetes. Subjects will be randomized to one of the three groups: exercise training, liraglutide treatment, and exercise + liraglutide. They will be studied at the baseline and then after 16 weeks of intervention.",[133],"Type2 Diabetes","2026-08-10",{"date":136,"type":37},"2026-08-12",{"date":138,"type":37},"2019-02-28",{"date":140,"type":21},"2027-12",{"name":43,"class":44},{"id":143,"slug":144,"hasResults":12,"nctId":145,"briefTitle":146,"officialTitle":147,"acronym":4,"eligibilityCriteria":148,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":149,"enrollmentInfo":150,"targetDuration":4,"studyType":22,"phases":152,"briefSummary":153,"conditions":154,"keywords":157,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":67},"100606637","phase-4-epicardial-adipose-tissue-composition-and-heart-failure-with-preserved-ejection-fraction-100606637","NCT07178145","Epicardial Adipose Tissue Composition and Heart Failure With Preserved Ejection Fraction","MRI of Epicardial Adipose Tissue Composition: Development of Methods and Application to Heart Failure With Preserved Ejection Fraction","Inclusion Criteria:\n\n* Age ≥ 18 years - 90 years;\n* LVEF ≥ 50%;\n* ≥ 2 risk factors for HFpEF or symptoms that could be related to HFpEF (e.g., dyspnea, orthopnea, paroxysmal nocturnal dyspnea, lower extremity edema, pulmonary edema, etc);\n* Not currently being treated with GLP-1RA therapy.\n\nExclusion Criteria:\n\n* • Previously or currently reduced EF (\\\u003C50%), including heart transplant; (2) Obstructive un-revascularized coronary disease by coronary CT or invasive coronary angiography;\n\n  * MI\u002FPCI\u002FCABG within the past 6 months;\n  * Untreated severe stenotic or regurgitant valvular disease;\n  * Infiltrative cardiomyopathy (Fabry\u002FHCM\u002Fsarcoid\u002Famyloid, etc);\n  * Myocarditis;\n  * Claustrophobia\u002Finability to tolerate MRI;\n  * Implants that are a contraindication for MRI or may negatively impact image quality (e.g. pacemakers and ICDs);\n  * Active systemic inflammatory disorder;\n  * Atrial fibrillation with rapid ventricular response at time of study; and\n  * Hemodynamic instability\n  * Pregnancy\n  * Prisoners\n  * Inability to provide informed consent\n\nExclusion Criteria for Optional Cardiac Stress Imaging Procedure\n\n* allergy to gadolinium-based contrast agents\n* Acute kidney injury\n* Estimated glomerular filtration rate (eGFR) \\\u003C 30 mL\u002Fmin\u002F1.73 m²\n* Hepatorenal syndrome\n* History of liver transplant\n* High-grade atrioventricular (AV) block\n* Active asthma exacerbation\n* Known allergy to vasodilator agents\n* Recent seizure","90 Years",{"count":151,"type":21},192,[130],"This study seeks to develop improved cardiac MRI (CMR) methods to quantify epicardial adipose tissue (EAT) composition and to demonstrate the advantages of EAT composition imaging (a) in advancing the understanding of the relationship between EAT and heart failure with preserved ejection fraction (HFpEF) and (b) for understanding mechanisms of and guiding medical therapy in HFpEF. The investigators recently developed the first method for quantifying EAT FAC in human subjects, utilizing a rate-6 accelerated radial 2D multi-echo gradient-echo breathhold acquisition with a local low rank reconstruction. In this project the first specific aim is to develop a rapid free-breathing 3D EAT FAC MRI method that reduces motion-related artifacts, increases coverage, and facilitates higher spatial resolution and improved FAC reproducibility. The second specific aim is to show that EAT FAC is more strongly associated than EAT volume with cardiometabolic HFpEF. In this context, individuals with known or suspected HFpEF will undergo CMR, echocardiography, and other testing to (a) diagnose cardiometabolic HFpEF; (b) characterize features associated with the severity of HFpEF; and (c) assess EAT volume and FAC. The investigators will determine if EAT FAC is more strongly associated than EAT volume with HFpEF and with features associated with the severity of HFpEF. The third specific aim is to show, in the context of cardiometabolic HFpEF and pre-HFpEF, (a) that GLP-1 receptor agonism with semaglutide (SEMA) shifts the EAT FAC to a less proinflammatory profile and (b) that baseline EAT FAC is a stronger predictor than EAT volume of improved cardiovascular function due to SEMA. Cardiometabolic HFpEF and pre-HFpEF subjects will undergo echocardiography and CMR with EAT FAC at baseline and after 3 months to serve as a self-control. Subjects will then undergo repeat imaging 6 months after the initiation of SEMA. The change in FAC after treatment with SEMA will be compared to the change in FAC prior to SEMA. Data will be analyzed to show that SEMA changes EAT FAC, and that baseline EAT FAC is a stronger predictor than EAT volume of improvements in severity of HFpEF.",[155,156],"Heart Failure Preserved Ejection Fraction","Epicardial Adipose Tissue",[158,159,160,156,161,162,163],"HFpEF","Heart Failure preserved Ejection Fraction","Cardiac MRI","GLP-1","EAT FAC","cardiovascular function","2026-08-08",{"date":166,"type":37},"2026-08-11",{"date":168,"type":37},"2025-11-20",{"date":170,"type":21},"2029-12",{"name":43,"class":44},{"id":173,"slug":174,"hasResults":12,"nctId":175,"briefTitle":176,"officialTitle":176,"acronym":177,"eligibilityCriteria":178,"healthyVolunteers":12,"sex":16,"minAge":179,"maxAge":4,"enrollmentInfo":180,"targetDuration":4,"studyType":22,"phases":182,"briefSummary":183,"conditions":184,"keywords":4,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":187,"startDateStruct":189,"completionDateStruct":191,"leadSponsor":193,"locationsCount":67},"100564040","bridging-the-treatment-gap-by-expanding-access-to-care-for-people-with-epilepsy-in-kenya-beacon-100564040","NCT06623994","Bridging the Treatment Gap by Expanding Access to Care for People With Epilepsy in Kenya (BEACON)","BEACON","Inclusion Criteria:\n\n* Individuals ≥12 years\n* Residents of Busia or Trans Nzoia County\n* Diagnosed with possible epilepsy through initial screening and confirmed diagnosis by an epilepsy-trained professional with the BEACON project or physician\n* Have a diagnosis of epilepsy but are not adherent to antiseizure medication treatment.\n\nExclusion Criteria:\n\n* Individuals receiving care from a neurosurgeon or neurologist for a serious brain disorder\n* Unable or unwilling to provide voluntary informed consent or assent (12-18 years)","12 Years",{"count":181,"type":21},650,[105],"This cluster randomized trial aims to learn about the effectiveness of task-sharing supported by an epilepsy medical records system (EMRS) (hereafter referred to as BEACON) with patient-tracking data in improving treatment adherence and retention in care in people with epilepsy in western Kenya.",[185],"Epilepsy","2026-07-28",{"date":188,"type":37},"2026-07-29",{"date":190,"type":37},"2025-08-04",{"date":192,"type":21},"2028-10",{"name":43,"class":44},{"id":195,"slug":196,"hasResults":12,"nctId":197,"briefTitle":198,"officialTitle":198,"acronym":4,"eligibilityCriteria":199,"healthyVolunteers":12,"sex":200,"minAge":17,"maxAge":4,"enrollmentInfo":201,"targetDuration":4,"studyType":22,"phases":203,"briefSummary":204,"conditions":205,"keywords":208,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":211,"startDateStruct":213,"completionDateStruct":214,"leadSponsor":216,"locationsCount":67},"100648236","evaluating-the-impact-of-digital-behavioral-interventions-to-address-insomnia-and-depression-in-breast-cancer-survivors-using-an-adaptive-design-100648236","NCT07721064","Evaluating the Impact of Digital Behavioral Interventions to Address Insomnia and Depression in Breast Cancer Survivors Using an Adaptive Design","Inclusion Criteria:\n\n* (1) age ≥18 years\n* (2) Diagnosed with stage 0-3 breast cancer\n* (3) Primary treatment for cancer (i.e., chemotherapy, immunotherapy, radiation, and surgical procedures intended to remove malignant tissue) finished between 3 months to 5 years from enrollment, with the exception of adjuvant hormonal, endocrine, and immunotherapy\n* (4) elevated insomnia severity as measured by the Insomnia Severity Index (ISI) score ≥ 10, and elevated symptoms of depression as measured by the Patient Health Questionnaire-8 (PHQ-8) score ≥ 10\n* (5) meets DSM 5 criteria for insomnia and depression.\n\nExclusion Criteria:\n\n* (1) Current behavioral or psychological treatment for insomnia or depression\n* (2) a change in medication for insomnia or depression within the past 4 weeks\n* (3) irregular sleep schedules or shift work (i.e., usual bedtimes outside 8:00 p.m.-2:00 a.m. or arising time outside 4:00 a.m.-10:00 a.m.)\n* (4) mental health condition deemed to interfere with study procedures or put the participant at undue risk based on self-reported history of psychosis or bipolar disorder, or active suicidal ideation that necessitates more intense care (as indicated from the Pitt-Optimum Suicide Management Protocol)\n* (5) other self-reported untreated sleep disorders (i.e., obstructive sleep apnea, restless legs syndrome)\n* (6) no reliable internet access (e.g., home broadband, public network, personal data plan) by smartphone\n* (7) cannot read and speak English\n* (8) does not reside within the US.","FEMALE",{"count":202,"type":21},747,[105],"Co-occurring symptoms of insomnia and depression is very common in breast cancer survivors, and it is critical that scalable and easily accessible digital behavioral interventions are made available. Digital health interventions are scalable and accessible. Moreover, behavioral digital interventions have been shown to be effective in reducing symptoms of insomnia and depression, respectively, in breast cancer survivors, suggesting strong potential for public impact, though their potential for addressing co-occurring symptoms of insomnia\u002Fdepression has not been tested. The purpose of this study is to evaluate the efficacy of a digital insomnia program and a digital mental health program in multiple ways: 1) as standalone interventions to reduce both symptoms of co-occurring insomnia and depression for breast cancer survivors; and 2) as components in adaptive behavioral treatment strategies that optimally sequence them for survivors who need additional support, resulting in a multifaceted supportive approach that is low cost, easily accessible, and highly efficient.",[206,207],"Insomnia","Depression",[209],"breast cancer","2026-07-22",{"date":212,"type":37},"2026-07-24",{"date":39,"type":21},{"date":215,"type":21},"2029-08-30",{"name":43,"class":44},{"id":218,"slug":219,"hasResults":12,"nctId":220,"briefTitle":221,"officialTitle":221,"acronym":4,"eligibilityCriteria":222,"healthyVolunteers":125,"sex":16,"minAge":223,"maxAge":224,"enrollmentInfo":225,"targetDuration":4,"studyType":22,"phases":227,"briefSummary":228,"conditions":229,"keywords":231,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":236,"lastUpdatePostDateStruct":237,"startDateStruct":239,"completionDateStruct":241,"leadSponsor":243,"locationsCount":67},"100491897","optimizing-ultrasound-induced-anti-inflammation-in-human-subjects-100491897","NCT05685108","Optimizing Ultrasound-induced Anti-inflammation in Human Subjects","Inclusion Criteria:\n\n* Male or female, aged 25-50 years\n* Provision of signed and dated informed consent form\n* Able to comprehend the study goals and procedures, stated willingness to comply with all study procedures, and availability for the duration of the study\n* Considered English proficient so that the subject can follow verbal commands during the ultrasound procedure\n* In good general health, as evidenced by medical history\n* Laboratory results indicating normal blood count and adequate organ function\n* Agreement to adhere to Lifestyle Considerations throughout study duration.\n\nExclusion Criteria:\n\n* Chronic medical conditions, including cancer (in remission or active cancer), cerebrovascular disease, chronic kidney disease, heart conditions (such as heart failure, coronary artery disease, cardiomyopathies), lung disease, liver disease, hypertension, diabetes mellitus type 1 and 2, human immunodeficiency virus infection, primary immunodeficiencies, solid organ or hematopoietic cell transplantation, tuberculosis, and cystic fibrosis, autoimmune disorders (e.g., rheumatoid arthritis, inflammatory bowel disease), sickle cell anemia or other anemia syndromes\n* Mean systolic and diastolic blood pressure values during screening of ≥160 and ≥100 mm Hg, respectively, hypertension on non-selective beta-blockers and\u002For alpha-methyl dopa, or hypertension requiring more than two anti-hypertension medications\n* Obesity (body mass index ≥30 kg\u002Fm2)\n* Use of anti-inflammatory or immunomodulatory medication, such as non- steroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or other immunosuppressants, within one week of receiving ultrasound delivery\n* Use of anticoagulant drugs (e.g., coumadin, direct oral anticoagulants) or antiplatelet drugs (e.g., aspirin, clopidogrel) within one week of receiving ultrasound delivery\n* Pregnancy, breastfeeding, or planning to become pregnant during the study\n* Active bacterial or viral infection; febrile illness within 2 weeks of receiving ultrasound delivery\n* Known allergic reactions to ultrasound gel\n* Treatment with another investigational drug or other intervention within 1 month of receiving ultrasound delivery\n* Any vaccination received within 1 month of receiving ultrasound delivery\n* Current smoker or nicotine use within 2 weeks of receiving ultrasound delivery\n* Use of recreational drugs within 2 weeks of receiving ultrasound delivery\n* History of arrythmia (e.g., clinically significant bradycardia, atrial flutter, atrial fibrillation, ventricular arrythmias)\n* History of deep vein thrombosis or pulmonary embolism\n* History of bleeding disorder\n* History of seizure\n* History of unilateral or bilateral vagotomy\n* Participants with an implantable medical device, such as pacemaker, hearing aid implant, or any implanted electronic device\n* Surgery or traumatic injury (e.g., visceral injury, cerebral injury) in the past 3 months\n* Prior surgery on thyroid or parathyroid glands, esophagus, stomach, or spleen\n* Participant is considered by the Investigator, after reviewing medical and psychiatric history, physical examination, and laboratory evaluations, to be unsuitable for any other reason that may either place the patient at increased risk during participation or interfere with the interpretation of the study. outcomes.","25 Years","50 Years",{"count":226,"type":21},40,[105],"This is a feasibility study to determine whether pulsed ultrasound stimulation targeting the splenic nerve or the cervical vagus nerve can elicit an anti-inflammatory immune response in healthy volunteers.",[230],"Healthy Subjects",[232,233,234,235],"Cholinergic anti-inflammatory pathway","Vagus nerve","Cytokines","Neuromodulation","2026-07-20",{"date":238,"type":37},"2026-07-21",{"date":240,"type":37},"2024-09-15",{"date":242,"type":21},"2026-10-01",{"name":43,"class":44},{"id":245,"slug":246,"hasResults":12,"nctId":247,"briefTitle":248,"officialTitle":249,"acronym":4,"eligibilityCriteria":250,"healthyVolunteers":12,"sex":200,"minAge":251,"maxAge":252,"enrollmentInfo":253,"targetDuration":4,"studyType":22,"phases":254,"briefSummary":255,"conditions":256,"keywords":260,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":265,"lastUpdatePostDateStruct":266,"startDateStruct":268,"completionDateStruct":270,"leadSponsor":272,"locationsCount":273},"100593723","phase-2-role-of-estrogen-on-skeletal-outcomes-in-fha-100593723","NCT07010146","Role of Estrogen on Skeletal Outcomes in FHA","Role of Estrogen Formulation and Route of Delivery on Skeletal Outcomes in Functional Hypothalmic Amenorrhea","Inclusion Criteria:\n\n* Females, age 14-30 years, skeletally mature with bone age ≥ 14 years (only 2% of growth left)\n* Women of reproductive age: use of an effective non-hormonal contraceptive method or a progestin releasing intrauterine device (no systemic skeletal effects) for study duration if sexually active. Note: Women who receive a progestin implant for contraception after study enrollment will be allowed to continue and will not be excluded from study.\n* Biochemical criteria: negative βHCG (pregnancy test), TSH within 2x the upper limit of normal, prolactin \\\u003C10 ng\u002FmL above upper limit of normal, potassium between 3.0-5.0, ALT ≤3 times upper limit of normal, LDL ≤190 mg\u002Fdl.\n* Patients with known hypothyroidism will be included if appropriately treated with levothyroxine and have a TSH within 2x the upper limit of normal for at least a month preceding the baseline study visit.\n* Menstrual criteria: \\\u003C 3 menses in the preceding 6 months.\n\nExclusion Criteria:\n\n* Disease other than FHA known to affect bone, including untreated thyroid dysfunction, Cushing's disease, renal failure, diabetes mellitus\n\n  1. Primary thyroid dysfunction will be defined as a TSH level more than 2X the upper limit of normal per given reference range with unknown thyroid antibody status, or an abnormal TSH if known positive antibodies.\n  2. Patients with hypothyroidism will be excluded if not appropriately treated with levothyroxine and if they do not have a TSH level within 2X the upper limit of normal for at least a month preceding the baseline study visit, given possible effects on the reproductive axis and bone.\n* Use of other medications known to affect bone metabolism within 3 months of the study (other than calcium and vitamin D supplementation)\n* Substance use disorder; current smoker (\\>10 cigarettes per day)\n* Pregnant, planning to become pregnant within 12 months of the end of treatment and\u002For breastfeeding\n* Hypertension or use of anti-hypertensive medications\n* Other conditions causing oligo-amenorrhea such as PCOS, premature ovarian insufficiency\n* Known sensitivity or absolute contraindication to any component of study medications (high risk thromboembolic disease, breast cancer or other estrogen- or progestin-sensitive cancer, liver tumors, acute viral hepatitis, decompensated cirrhosis, undiagnosed abnormal uterine bleeding\n* BMI ≥ 25 kg\u002Fm2 (efficacy of the contraceptive patch being used in the study is lower at higher BMIs)","14 Years","30 Years",{"count":103,"type":21},[80],"The purpose of this study is to assess whether the natural form of estrogen (17-beta estradiol) given as a patch so that it is absorbed through your skin, is better at improving bone strength over 1 year than natural estrogen (17-beta estradiol) taken by mouth, or a synthetic form oestrogen (ethinyl estradiol) given as a patch that also provides birth control.\n\nParticipants will:\n\n1. Take estrogen for 1 year either (i) in its natural form as a patch twice a week (and progesterone by mouth for 12 days of each month), or (ii) in its natural form as a pill daily (and progesterone by mouth for 12 days of each month), or (iii) in a synthetic form as a birth control patch weekly for 3 weeks with 1 week off the patch. You will not be able to choose which form of estrogen you will receive as this will be assigned to you based on a pre-existing randomization sequence (like the flip of a coin)\n2. Take provided calcium and vitamin D supplements\n3. Attend 4 study visits over 12 months with two at the beginning and then every 6 months that include:\n\n   * History and Physical Exams\n   * Lab Work\n   * Imaging studies\n   * Questionnaires\n   * Dietary recalls",[257,258,259],"Bone Strength","Bone Density","FHA (Functional Hypothalamic Amenorrhea)",[261,262,263,264],"Estrogen","Functional hypothalamic amenorrhea","Transdermal","Oral","2026-07-15",{"date":267,"type":37},"2026-07-17",{"date":269,"type":37},"2025-10-01",{"date":271,"type":21},"2030-05-31",{"name":43,"class":44},2,{"id":275,"slug":276,"hasResults":12,"nctId":277,"briefTitle":278,"officialTitle":279,"acronym":4,"eligibilityCriteria":280,"healthyVolunteers":125,"sex":200,"minAge":281,"maxAge":282,"enrollmentInfo":283,"targetDuration":4,"studyType":22,"phases":284,"briefSummary":285,"conditions":286,"keywords":288,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":265,"lastUpdatePostDateStruct":292,"startDateStruct":293,"completionDateStruct":295,"leadSponsor":297,"locationsCount":67},"100553023","exercise-training-intensity-and-nitrate-supplementation-in-post-menopausal-females-100553023","NCT06480695","Exercise Training Intensity and Nitrate Supplementation in Post-Menopausal Females","Effects of Exercise Training Intensity and Inorganic Nitrate Supplementation on Vascular Health and Fitness in Post-Menopausal Females","Inclusion Criteria:\n\n* Post-menopausal female (greater than age 45 but less than age 75)\n* Sedentary (does not exercise regularly or less than 2 bouts of exercise per week)\n* No major changes in medication in the last 3 months\n\nExclusion Criteria:\n\n* Smokers within last 5 years\n* Weight unstable (loss\u002Fgain of more than 3kg in the past 3 months)\n* Any medical condition that prevents the subject from exercising safely\n* Hormone replacement therapy (current or within last 3 months)\n* Diabetes\n* Currently or recently on vasoactive medications (i.e., calcium channel blockers, statins, ACE or renin inhibitors, ARBs, nitrates, alpha- or beta-blockers, diuretics, proton pump inhibitors, etc.)\n* Oral antibiotic use within previous four weeks\n* Oral disease or poor oral health as determined by the Oral Health Questionnaire\n* Using an antibacterial mouthwash or a mouthwash containing chlorhexidine and unwilling to discontinue use","45 Years","75 Years",{"count":226,"type":21},[105],"Menopause greatly increases cardiovascular disease risk (CVD). Current exercise guidelines are inadequate to ameliorate this risk and higher intensity exercise may be necessary for cardiovascular benefits in postmenopausal females. Oral nitrate supplementation enhances exercise performance and CVD risk profile in several clinical conditions. The investigators recently reported that 3-days of nitrate supplementation in postmenopausal females enhances acute post-exercise vascular function, in an intensity dependent manner. The effects of nitrate supplementation and exercise training over a longer training program remains unexplored. This investigation will examine the impact of exercise training intensity with and without inorganic nitrate supplementation, on CVD and fitness outcomes. Postmenopausal females will be tested for maximal oxygen uptake and lactate threshold before randomization to one of four groups: that inorganic nitrate-rich beetroot juice, or beetroot juice with nitrate extracted; and assigned to one-month of calorie matched high-intensity or moderate-intensity exercise training. Vascular function and fitness will be evaluated before and after training.",[287],"Menopause",[289,287,290,291],"Inorganic Nitrate","High Intensity Exercise","Vascular Health",{"date":267,"type":37},{"date":294,"type":37},"2025-07-01",{"date":296,"type":21},"2026-12-31",{"name":43,"class":44},{"id":299,"slug":300,"hasResults":12,"nctId":301,"briefTitle":302,"officialTitle":303,"acronym":4,"eligibilityCriteria":304,"healthyVolunteers":125,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":305,"targetDuration":4,"studyType":22,"phases":307,"briefSummary":308,"conditions":309,"keywords":311,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":322,"lastUpdatePostDateStruct":323,"startDateStruct":325,"completionDateStruct":327,"leadSponsor":329,"locationsCount":67},"100646351","vergerx-for-smokers-not-ready-to-quit-100646351","NCT07693660","VergeRx for Smokers Not Ready to Quit","Optimizing Pharmacist-Led Tobacco Treatment for Individuals Who Smoke and Are Not Ready to Make a Quit Attempt in Federally-Qualified Health Centers","Inclusion Criteria:\n\n* Not ready to quit smoking in the next 30 days\n* Age ≥ 18 years\n* Able to read, speak, and understand English\n* Report smoking ≥ 5 cigarettes per day for the past 6 months\n* Own a cell phone\n* Willing and able to use nicotine replacement therapy (NRT) in the form of patch and lozenge\n\nExclusion Criteria:\n\n* Currently pregnant, or planning to become pregnant in the next 6 months",{"count":306,"type":21},592,[105],"This study uses a factorial optimization experiment to identify which treatment components help adults who smoke and are not ready to quit in the next 30 days (smokers not ready to quit, or SNRTQ) achieve smoking cessation. Participants are recruited through Federally Qualified Health Centers (FQHCs) in Virginia and West Virginia. All participants receive at least 8 weeks of nicotine replacement therapy (NRT) patch. Using a 2×2×2×2 factorial design, the study independently tests four components: a pharmacist-delivered behavioral program (VergeRx), a text-message support program (SmokefreeTXT), the addition of an NRT lozenge to the patch, and an extended 16-week course of the NRT patch versus the standard 8 weeks. The goal is to estimate the effect of each component on biochemically confirmed smoking abstinence so that an optimized treatment package can be assembled. The primary outcome is abstinence at 26 weeks; a secondary outcome is abstinence at 52 weeks.",[310],"Tobacco Use Cessation",[312,313,314,315,316,317,318,319,320,321],"federally qualified health center","rural","urban","appalachia","smoking cessation","readiness to quit","smokers not ready to quit","pharmacists","low income","medicaid","2026-07-02",{"date":324,"type":37},"2026-07-09",{"date":326,"type":21},"2027-12-01",{"date":328,"type":21},"2032-11-01",{"name":43,"class":44},{"id":331,"slug":332,"hasResults":12,"nctId":333,"briefTitle":334,"officialTitle":335,"acronym":4,"eligibilityCriteria":336,"healthyVolunteers":125,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":337,"targetDuration":4,"studyType":22,"phases":339,"briefSummary":340,"conditions":341,"keywords":345,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":322,"lastUpdatePostDateStruct":360,"startDateStruct":362,"completionDateStruct":364,"leadSponsor":366,"locationsCount":67},"100646196","feasibility-of-a-medical-legal-partnership-model-to-connect-coal-miners-quitaid-100646196","NCT07694492","Feasibility of a Medical-Legal Partnership Model to Connect Coal Miners QuitAid","Determining the Feasibility of Utilizing a Medical-Legal Partnership Model to Reach Coal Miners Who Use Tobacco and Nicotine Products and Connect Them to a Pharmacy-based Cessation Program","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Able to read, speak, and understand English\n* A coal miner who uses tobacco and nicotine products, lives in the U.S., and has a current black-lung workers' compensation case with a participating law office\n* Reports using tobacco and nicotine products daily for the past 6 months\n* Willing and able to use NRT in the form of patch or gum\n* Not pregnant or planning to become pregnant in the next 6 months\n\nExclusion Criteria:\n\n* Medical contraindication to NRT (e.g., within the past 30 days: heart attack or stroke; within the past 6 months: serious or worsening angina, or very rapid or irregular heartbeat requiring medication)\n* Pregnant or breastfeeding, or planning to become pregnant during the next 6 months",{"count":338,"type":21},120,[105],"Coal miners in Central Appalachia have among the highest rates of tobacco and nicotine product (TNP) use of any occupational group and face elevated rates of lung cancer and coal workers' pneumoconiosis (\"black lung\"). This study tests a novel medical-legal partnership (MLP) that \"flips\" the traditional referral direction: lawyers representing coal miners in black-lung workers' compensation cases identify clients who use TNPs and, through an ask-advise-connect process, connect them to community pharmacists who deliver QuitAid, a pharmacist-delivered medication therapy management (MTM) program, together with nicotine replacement therapy (NRT). The study has two aims: (1) an implementation-science evaluation of the ask-advise-connect process in black-lung law offices, and (2) a randomized feasibility pilot in which coal miners who use TNPs are randomized to receive QuitAid or not, with all participants receiving 24 weeks of NRT. As a feasibility pilot, the study is designed to estimate recruitment, randomization, retention, fidelity, and dose parameters to inform a future NCI R01, and is not powered to detect differences between conditions.",[310,342,343,344],"Tobacco Use Disorder","Nicotine Dependence","Smokeless Tobacco Use",[346,347,348,349,350,351,352,353,354,355,356,357,358,359],"Smoking Cessation","Lawyers","medical-legal partnership;","ask-advise-connect","pharmacist-delivered intervention","coal miners","medication therapy management (MTM)","nicotine replacement therapy","QuitAid","tobacco and nicotine products","Central Appalachia","black lung","workers' compensation","feasibility pilot",{"date":361,"type":37},"2026-07-10",{"date":363,"type":21},"2026-09-01",{"date":365,"type":21},"2027-12-31",{"name":43,"class":44},{"id":368,"slug":369,"hasResults":12,"nctId":370,"briefTitle":371,"officialTitle":372,"acronym":373,"eligibilityCriteria":374,"healthyVolunteers":12,"sex":200,"minAge":375,"maxAge":4,"enrollmentInfo":376,"targetDuration":4,"studyType":22,"phases":378,"briefSummary":380,"conditions":381,"keywords":383,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":393,"lastUpdatePostDateStruct":394,"startDateStruct":396,"completionDateStruct":398,"leadSponsor":400,"locationsCount":401},"100555094","phase-3-pre-operative-window-of-et-to-inform-rt-decisions-power-ii-100555094","NCT06507618","Pre-Operative Window of ET to Inform RT Decisions (POWER II)","A Randomized, Phase III Trial of Pre-Operative Window of Endocrine Therapy to Inform Radiation Therapy Decisions in Older Women With Early-Stage Breast Cancer (POWER II)","POWER II","Inclusion Criteria (summary):\n\n* Diagnosis of ER+, PR +\u002F-, and HER2- non amplified invasive breast cancer and clinically negative nodes\n* ECOG performance status 0-2\n* Females, aged ≥ 65 years\n* Patient is eligible for BCS and opted for BCS\n* Patient is a candidate for radiation therapy\n* Patient is a candidate for endocrine therapy (tamoxifen or an aromatase inhibitor)\n* Ability to take oral medication and be willing to adhere to endocrine therapy for the 3-month period prior to BCS\n* Agreement to adhere to Lifestyle Considerations (details in protocol) throughout study duration\n* Provision of signed and dated informed consent form\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n\nExclusion Criteria:\n\n* Bilateral synchronous breast cancer\n* Multicentric disease\n* Prior use of Tamoxifen or aromatase inhibitors\n* History of ipsilateral breast radiation therapy\n* Has a known additional malignancy that is progressing and\u002For requires active treatment with cytotoxic chemotherapy or radiation therapy. Malignancies deemed stable and low risk for complication per investigator's judgment may be allowed after discussion with multi-site PI.\n* Current or planned use of a strong CYP2D6 inhibitor (e.g., Fluvoxamine, Paroxetine) and is not able to receive an endocrine therapy agent that does not use the CYP2D6 pathway.","65 Years",{"count":377,"type":21},354,[379],"PHASE3","This is a Phase III, multisite exploratory study for women ≥ 65 years of age with early stage estrogen receptor positive (ER+) breast cancer. These individuals will be treated randomly assigned to one of two groups:\n\nIntervention, treated with 3 months of pre-operative endocrine therapy (pre-ET) OR Control, participants follow standard of care and proceed directly to breast cancer surgery.\n\nBoth arms will be assessed for tolerance and compliance to the endocrine therapy by patient reported outcome (PRO) measures (patient surveys).",[382],"Breast Cancer Female",[209,384,385,386,387,388,389,390,391,392],"endocrine therapy","radiation","letrozole","anastrozole","exemestane","tamoxifen","survey","questionnaire","geriatric","2026-06-25",{"date":395,"type":37},"2026-06-30",{"date":397,"type":37},"2024-07-19",{"date":399,"type":21},"2034-03-01",{"name":43,"class":44},6,{"id":403,"slug":404,"hasResults":12,"nctId":405,"briefTitle":406,"officialTitle":407,"acronym":4,"eligibilityCriteria":408,"healthyVolunteers":12,"sex":200,"minAge":17,"maxAge":4,"enrollmentInfo":409,"targetDuration":4,"studyType":22,"phases":411,"briefSummary":412,"conditions":413,"keywords":416,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":420,"lastUpdatePostDateStruct":421,"startDateStruct":423,"completionDateStruct":425,"leadSponsor":427,"locationsCount":67},"100644213","a-pre-post-pilot-of-a-smartphone-intervention-100644213","NCT07665346","A Pre-post Pilot of a Smartphone Intervention","A Pre-post Pilot of Behavioral Interventions Delivered Through Smartphones","Inclusion Criteria:\n\n* age = 18 years\n* 0-5 years post-diagnosis of Stage I, II, or III female breast cancer\n* elevated symptoms of depression and\u002For anxiety as measured by the PHQ-8 (score \\> 9) or GAD-7 (score \\> 7).\n\nExclusion Criteria:\n\n* receiving individual (1 on 1) treatment for depression and\u002For anxiety to avoid treatment interference (note, individuals will be permitted to enroll if they are taking antidepressant medication and have not had an appointment to adjust the dosage over the past 2 weeks)\n* active suicidal ideation during the enrollment\u002Fscreening call based on a trained staff member orally administering the suicidality item from the PHQ-9 to individuals on the phone (\"In the last 2 weeks, have you had thoughts that you would be better off dead, or thoughts of hurting yourself in some way?\"). If an individual responds in any way other than \"not at all\" based on the available response options (i.e., either \"several days\", \"more than half the days\", or \"nearly every day\"), or if they mention having suicidal ideation or thoughts of death during the enrollment\u002Fscreening call, the Pitt-Optimum risk assessment tool will be administered. Only participants deemed low risk may proceed in enrollment; all will be given additional resources\n* do not have an app-compatible phone\n* cannot read and speak English (intervention and measures only available in English).",{"count":410,"type":21},44,[105],"Digital mental and behavioral health interventions have potential to significantly improve accessibility for the large number of breast cancer survivors who need treatments. However, the landscape of digital interventions tested in this population remains limited, with the few that have been tested primarily focused on reducing symptoms of mental disorders. This is problematic given the range of psychosocial needs among breast cancer survivors, including those who may not have active mental health symptoms, yet could benefit from learning effective coping skills.\n\nDigital health interventions delivered through smartphones have strong potential to improve access to care for the large number of breast cancer survivors who need mental and behavioral health support. There is a need to evaluate a range of supportive interventions that target different aspects of mental health, including negative thinking, coping skills, and knowledge. Our research team has previously tested individual digital interventions in relatively small samples, and found that they were effective in reducing mood symptoms among women with breast cancer.\n\nThe ultimate goal of this project is to evaluate how integrating these interventions into a single 8-week long app program affects mood and overall mental health in breast cancer survivors. The digital micro-interventions to be tested in this study are brief interventions that target specific behavioral and cognitive mechanisms of mental health. These include skills such as reducing negative thinking patterns, increasing knowledge of mental health factors, fostering a grateful outlook, promoting the practice of relaxation breathing, savoring positive memories, and acceptance-based mindfulness approaches.",[414,415],"Mental Health Issue","Breast Cancer",[417,418,419],"depression","anxiety","well-being","2026-06-18",{"date":422,"type":37},"2026-06-24",{"date":424,"type":21},"2026-07",{"date":426,"type":21},"2026-09",{"name":43,"class":44},{"id":429,"slug":430,"hasResults":12,"nctId":431,"briefTitle":432,"officialTitle":433,"acronym":4,"eligibilityCriteria":434,"healthyVolunteers":125,"sex":200,"minAge":17,"maxAge":435,"enrollmentInfo":436,"targetDuration":4,"studyType":22,"phases":438,"briefSummary":439,"conditions":440,"keywords":448,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":420,"lastUpdatePostDateStruct":458,"startDateStruct":460,"completionDateStruct":462,"leadSponsor":464,"locationsCount":67},"100635054","carrii-native-intervention-optimization-trial-100635054","NCT07547696","CARRII Native Intervention Optimization Trial","CARRII Native Intervention Optimization Trial 3-month Factorial Experiment With 512 Participants Randomized to 8 Conditions","Inclusion Criteria:\n\n* Native American\u002FAmerican Indian\u002FAlaska Native,\n* who are not surgically sterile,\n* who report alcohol consumption at risk levels and risk for pregnancy in the past 90 days due to having sex with a man with inconsistent, ineffective, or no contraception.\n* Participants must have access to the Internet via a mobile device they can access daily\n\nExclusion Criteria:\n\n* cognitive disorders including mental retardation, dementia, or psychotic disorders that could impair ability to understand the intervention material or give informed consent.","44 Years",{"count":437,"type":21},512,[105],"The purpose of this study is to identify the best combination of new intervention components to use with CARRII, the first automated online intervention for alcohol-exposed pregnancies (AEP). This intervention is specifically designed for Native women and others who can become pregnant. Our goal is to maximize the effectiveness of the online intervention while keeping costs manageable for Native communities.",[441,442,443,444,445,446,447],"Fetal Alcohol Spectrum Disorders","Pregnancy","Alcohol-Related Disorders","Drinking, Alcohol","Contraception Behavior","Alcohol Exposed Pregnancy","Sexual Behavior",[449,450,451,452,453,454,455,456,457],"Native American","female","adult","contraception","alcohol","digital intervention","mobile health (mHealth)","optimization","risk reduction",{"date":459,"type":37},"2026-06-23",{"date":461,"type":37},"2026-06-02",{"date":463,"type":21},"2028-07-30",{"name":43,"class":44},{"id":466,"slug":467,"hasResults":12,"nctId":468,"briefTitle":469,"officialTitle":470,"acronym":4,"eligibilityCriteria":471,"healthyVolunteers":125,"sex":16,"minAge":17,"maxAge":375,"enrollmentInfo":472,"targetDuration":4,"studyType":22,"phases":474,"briefSummary":475,"conditions":476,"keywords":478,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":420,"lastUpdatePostDateStruct":485,"startDateStruct":486,"completionDateStruct":488,"leadSponsor":490,"locationsCount":67},"100571748","early-phase-1-psilocybin-for-prolonged-grief-disorder-100571748","NCT06724289","Psilocybin for Prolonged Grief Disorder","Psilocybin-Assisted Therapy for Prolonged Grief","Inclusion Criteria:\n\n* Ages 18 years old up to and including 65 years of age\n* Negative UDS results for illicit drugs at screening and prior to each drug administration session\n* Consent to all study procedures\n* Have an existing diagnosis of Prolonged Grief Disorder. May also be determined to have Complicated Grief Disorder without official diagnosis as determined by PI or designate based on DSM V criteria\n* Score of greater than 25 on the Inventory of Complicated Grief\n* Agree to abstain from any psychoactive drugs on the day prior to and the day of the drug administration session\n* People of childbearing potential that are sexually active must agree to continue or initiate practice of a highly effective means of birth control, alone or in combination with another, throughout the study. Highly effective options are: implants, intrauterine devices (IUD), and sterilization. Exclusive use of condoms is not effective.\n* Be judged by study team clinicians to be at low risk for suicidality as determined by MINI, Columbia Suicide Severity Scale, and the Patient Health Questionnaire-9.\n* Concurrent psychotherapy or pharmacotherapy with SSRIs, SNRIs, and\u002For bupropion (\\\u003C 300 mg bupropion) is allowed if the type and frequency of the therapy has been stable for at least two months prior to screening and is expected to remain stable during participation in the study\n* Be otherwise medically stable as determined by screening for medical problems via a personal interview, a medical questionnaire, a physical examination, an electrocardiogram (ECG), urine beta-HCG, and urine toxicology screen\n* Participant must agree to consume approximately the same amount of caffeine-containing beverage (e.g., coffee, tea) that they consume on a usual morning, before arriving at the research unit on the mornings of drug session days. If the participant does not routinely consume caffeinated beverages, they must agree not to do so on session days\n* Agree not to take any PRN medications on the mornings of drug sessions\n* Agree not to take sildenafil (Viagra®), tadalafil, or similar medications within 72 hours of each drug administration\n* Agree that for one week before each drug session, participant will refrain from taking any nonprescription medication, nutritional supplement, or herbal supplement except when approved by the study investigators. Exceptions will be evaluated by the study investigators and will include acetaminophen, non-steroidal anti-inflammatory drugs, and common doses of vitamins and minerals\n* Willingness and ability to remain within the observation room for the duration of the study visits up to 10 hours\n* Willingness and ability to follow study protocol as directed by research staff\n* Willing and able to attend all sessions in the study and complete follow up assessments\n* Fluent in English\n* Ability to provide one photo of a deceased loved one and one photo of a living loved one, as required for the grief elicitation task.\n\nExclusion Criteria:\n\nGeneral medical exclusion criteria:\n\n* Previous use of a psychedelic drug may be exclusionary depending on frequency, context, and participant safety as determined by the PI or designate.\n* Person who is pregnant, nursing, or planning to get pregnant determined at screening and before drug session by urine test or self-report\n* People of childbearing potential that are sexually active who are not practicing an effective means of birth control\n* Cardiovascular conditions: coronary artery disease, stroke, angina, a clinically significant ECG abnormality (e.g., atrial fibrillation), prolonged QTc interval (i.e., QTc \\> 450 msec), heart valve, or TIA in the past year.\n* History of head trauma with neurological deficit; seizures, or neurologic disorders including cerebrovascular disease, epilepsy, or neurogenerative diseases\n* Type 1 diabetes\n* BMI \\\u003C18\n* Currently taking on a regular (e.g., daily) basis any antidepressant medications other than SSRIs, SNRIs, or bupropion, or any other medications that have a primary centrally-acting serotonergic effect, including MAOIs. Bupropion dosage must be \\\u003C 300 mg in order to be included\n* Nicotine dependence that would be incompatible with remaining in study area for the entirety of the visit\n* Prescribed or illicit use of benzodiazepines or opioids within 4 weeks prior to screening\n* Baseline blood pressure greater than 139\u002F79 (after repeat measures) unless stable with medication as determined by PI or PI designate\n* Taking any muscle relaxers, antihistamines, or other medications known to cause lethargy or impair cognitive ability within one day prior to psilocybin session\n* Serious medical comorbidity requiring medical intervention or close supervision\n* History of claustrophobia\n* Any court mandated or legal restrictions that would impair the participant from attending all visits\n* Inability to follow and comply with all study procedures\n* Deemed unable to meaningfully or safely participate in the study\n* Any legal judgement toward subject determined to interfere with study attendance or jeopardize compliance with study protocol determined by PI or designate\n* Individuals who are unable to undergo MRI as determined by MRI pre-screening.\n\nGeneral psychiatric exclusion criteria:\n\n* Score of less than 25 on the Inventory of Complicated Grief\n* Severe psychiatric disorder (other than depression) within 6 months or lifetime history of serious psychiatric or neurological disorders, including bipolar disorder, or active psychosis\n* Clinically significant suicidal ideation (e.g., with strong intent or means) within past 6 months or lifetime history of suicide attempt based on the MINI, Patient Health Questionnaire-9 or Columbia-Suicide Severity Scale. At any point during the study, a participant may be withdrawn from the study for concerns of suicidality and provided follow-up care by our team or a referral to care if needed.\n* Current or past history of meeting DSM-5 criteria for schizophrenia spectrum or other psychotic disorders, or bipolar I disorder\n* Current or previous history within one year of meeting DSM-5 criteria for a moderate or severe alcohol, or other drug use disorder (excluding tobacco, caffeine, and cannabis)\n* Nicotine dependence that would be incompatible with an individual to be nicotine free for 8-10 hours on a psilocybin session day\n* Have a first degree relative with schizophrenia or other psychotic disorders (except substance\u002Fmedication-induced or due to another medical condition), or bipolar I disorder",{"count":473,"type":21},12,[24],"The primary purpose of this study is to explore the feasibility of conducting a clinical trial on the effects of psilocybin for individuals with prolonged grief disorder (PGD).",[477],"Prolonged Grief Disorder",[479,480,481,482,483,484],"prolonged grief disorder","psilocybin","psychedlic-assisted treatment","psilocybin-assisted therapy","grief","grief disorder",{"date":459,"type":37},{"date":487,"type":37},"2026-03-24",{"date":489,"type":21},"2027-08",{"name":43,"class":44},{"id":492,"slug":493,"hasResults":12,"nctId":494,"briefTitle":495,"officialTitle":496,"acronym":497,"eligibilityCriteria":498,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":499,"targetDuration":4,"studyType":22,"phases":501,"briefSummary":503,"conditions":504,"keywords":4,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":507,"lastUpdatePostDateStruct":508,"startDateStruct":510,"completionDateStruct":512,"leadSponsor":514,"locationsCount":67},"100552911","phase-1-study-of-egfrbi-armed-fresh-pbmc-in-metastatic-or-unresectable-pancreatic-cancer-100552911","NCT06479239","Study of EGFRBi Armed Fresh PBMC in Metastatic or Unresectable Pancreatic Cancer","Phase I\u002FII Study of Anti-CD3 x Anti-EGFR Bispecific Antibody (EGFRBi) Armed Fresh Peripheral Blood Mononuclear Cells (EGFR FPBMC) in Metastatic or Unresectable Pancreatic Cancer","Panc 002","Inclusion Criteria:\n\n1. Histologically confirmed locally advanced pancreatic cancer (LAPC)\u002Funresectable pancreatic cancer (UPC) or metastatic pancreatic cancer (MPC) not eligible for curative intent therapy\n2. Received at least 1 line of chemotherapy and have stable disease (SD) or better for 3 months prior to enrollment. Therapy should consist of either a gemcitabine, 5FU-based (including capecitabine) or albumin-bound paclitaxel-based regimen. Patients with actionable mutations should have received targeted therapy prior to enrollment on trial. Patients who qualify for immunotherapy due to mismatch repair protein\u002Fmicrosatellite stable and tumor mutational burden status should also have received immunotherapy prior to enrollment on trial.\n3. Measurable disease by immune-related Response Evaluation Criteria in Solid Tumors (irRECIST)\n4. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1\n5. Age ≥ 18 years\n6. Females of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment\u002Fregistration\n7. Females of childbearing potential and males must agree to use an effective method for contraception for the duration of the treatment with study drug plus 90 days (duration of sperm turnover). Males must also abstain from sperm donations during study treatment and for at least 90 days after the last dose of study drug.\n8. Adequate organ function within 14 days prior to registration, defined as the following:\n\n   * Absolute neutrophil count \\>= 500\u002Fmm3\n   * Absolute lymphocyte count \\>= 400\u002Fmm3\n   * Platelets \\>= 75,000\u002Fmm3\n   * Hemoglobin \\>= 8 g\u002FdL\n   * Serum creatinine \\\u003C 2.0mg\u002FdL or calculated\u002Fmeasured creatinine clearance \\>= 50 ml\u002Fmin\n   * Bilirubin \\\u003C= 2 mg\u002FdL\n   * Aspartate transferase (AST) and Alanine transaminase (ALT) \\\u003C= 5.0 x upper limit of normal (ULN)\n   * Alpha gal \\\u003C 0.35 IU\u002Fml or \"negative\"\n9. Ability to provide informed consent and provision of written informed consent\n10. Stated willingness to comply with all study procedures and availability for the duration of the study\n11. Adequate cardiac function as defined as:\n\n    * No uncontrolled angina or severe ventricular arrhythmias\n    * No clinically significant pericardial disease\n    * No history of myocardial infarction (MI) in the last year before registration\n    * No Class 3 or higher New York Heart Association Congestive Heart Failure\n\nExclusion Criteria:\n\n1. Known hypersensitivity to cetuximab\n2. Treatment with investigational agent within 3 weeks prior to registration\n3. Serious non-healing wound, ulcer, bone fracture, major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to registration\n4. Known active liver disease, human immunodeficiency virus (HIV)+ or evidence of active Hepatitis C or B virus; bleeding or condition associated with high-risk bleeding (anticoagulation is allowed)\n5. Active infection; prior antibiotic\u002Fantifungal\u002Fantiviral therapies within 2 weeks prior to registration\n6. History of a myocardial infarction within 1 year prior to registration\n7. Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n8. Autoimmune disease that has required systemic treatment with chronic steroids or immunosuppressive therapy in the 2 years prior to registration (thyroxine, insulin, or corticosteroid replacement is allowed)\n9. History or evidence of any condition that might confound the results of the trial, interfere with the subject's participation, or is not in the best interest of the subject to participate, in the opinion of the treating investigator\n10. Females must not be currently breast feeding.\n11. The treating investigator feels the patient is not able to be compliant.\n12. History of active Bacillus Tuberculosis (TB).\n13. Has received a live vaccine within 30 days of registration.\n14. Prisoners or patients who are incarcerated.\n15. Patients who are compulsorily detained for treatment of a psychiatric or physical illness.",{"count":500,"type":21},23,[502,80],"PHASE1","The purpose of this study is to understand the safety and estimate the efficacy of combining anti-cluster of differentiation 3 (CD3) x anti-Epidermal Growth Factor Receptor (EGFR) bispecific antibody fresh peripheral blood mononuclear cells (EGFR FPBMC) for patients with metastatic or unresectable pancreas cancer. Participants receive 8 twice weekly doses and then 8 more doses every 2 weeks of EGFR FPBMC by intravenous infusion.",[505,506],"Pancreas Cancer","Pancreatic Cancer","2026-06-12",{"date":509,"type":37},"2026-06-16",{"date":511,"type":37},"2024-11-06",{"date":513,"type":21},"2031-06",{"name":43,"class":44},{"id":516,"slug":517,"hasResults":12,"nctId":518,"briefTitle":519,"officialTitle":519,"acronym":520,"eligibilityCriteria":521,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":522,"targetDuration":4,"studyType":22,"phases":524,"briefSummary":525,"conditions":526,"keywords":529,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":534,"lastUpdatePostDateStruct":535,"startDateStruct":537,"completionDateStruct":539,"leadSponsor":541,"locationsCount":67},"100641655","evaluating-a-decision-aid-for-sentinel-lymph-node-biopsy-in-intermediate-risk-melanoma-100641655","NCT07653087","Evaluating a Decision Aid for Sentinel Lymph Node Biopsy in Intermediate-Risk Melanoma","Mel73","Inclusion Criteria:\n\n1. Adults (≥18 years old) with a histologically confirmed diagnosis of cutaneous melanoma.\n2. Clinical stage I or II disease, for whom sentinel lymph node biopsy (SLNB) is being considered.\n3. Patients with either:\n\n   * An estimated risk of sentinel lymph node metastasis between 5 and 10 percent based on the MIA risk calculator, or\n   * A discordant risk scenario will be defined as a case in which the individualized probability of sentinel lymph node metastasis predicted by the MIA model falls into a different risk category (\\\u003C5%, 5-10%, or \\>10%) than the category suggested by clinicopathologic staging features used in NCCN guideline-based counseling.\n4. Willingness and ability to comply with study procedures.\n5. Ability to provide informed consent.\n6. Pregnant women, and other vulnerable populations are not specifically excluded unless they meet other exclusion criteria; the study presents minimal risk.\n\nExclusion Criteria:\n\n1. Patients with clinical evidence of nodal or distant metastatic disease at the time of consultation.\n2. Patients with prior sentinel lymph node biopsy or nodal surgery for the current melanoma diagnosis.\n3. Inability to speak or read English.\n4. Inability or unwillingness to provide informed consent.\n5. Prisoners",{"count":523,"type":21},66,[105],"This research study is testing a decision aid to help patients think through whether to have sentinel lymph node biopsy for melanoma.\n\nSentinel lymph node biopsy (SLNB) can be a difficult decision for some patients because the potential benefits and risks may not be clear. This study is being done to learn whether providing structured, easy-to-understand information helps patients feel more informed and less uncertain about their decision.\n\nPatients in this study will be given a paper decision aid (DA). Patients will be given other short questionnaires to complete before and after the decision aid.",[527,528],"Sentinel Lymph Node Biopsy (SLNB)","Melanoma (Skin Cancer)",[530,531,532,533],"SLNB","Melanoma","Sentinel Lymph Node Biopsy","Decision Aid","2026-06-11",{"date":536,"type":37},"2026-06-17",{"date":538,"type":21},"2026-06",{"date":540,"type":21},"2028-01",{"name":43,"class":44},{"id":543,"slug":544,"hasResults":12,"nctId":545,"briefTitle":546,"officialTitle":547,"acronym":4,"eligibilityCriteria":548,"healthyVolunteers":125,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":549,"targetDuration":4,"studyType":22,"phases":551,"briefSummary":552,"conditions":553,"keywords":557,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":561,"lastUpdatePostDateStruct":562,"startDateStruct":564,"completionDateStruct":566,"leadSponsor":568,"locationsCount":67},"100540602","text-based-messaging-strategies-for-preventing-subsequent-problematic-alcohol-use-100540602","NCT06318975","Text-Based Messaging Strategies for Preventing Subsequent Problematic Alcohol Use","The Effectiveness of Text-Based Messaging Strategies for Preventing Subsequent Problematic Alcohol Use Among Technical Trainees in the US Air Force","Inclusion Criteria:\n\n* Must be a United States Air Force Technical Training student in one of the following training groups or wings: 37th Training Wing, 81st Training Wing, 82nd Training Wing, or 59th Training Group.\n* Must be 18 years of Age\n* Must be able to understand English\n* Must be able to receive text messages\n\nExclusion Criteria:\n\n* Under 18 years of age\n* Not in the specified Technical Training groups or wings",{"count":550,"type":21},7000,[105],"Binge drinking, and its health\u002Fsocial consequences are substantial public health concerns, with a high prevalence in young adults, especially in the US military. Alcohol consumption in the military is very high and normative, but there is zero tolerance for alcohol-related legal trouble, and Air Force Airmen who experience this (e.g., DUI, sexual assault) typically receive a disciplinary action referred to as an Alcohol Related Incident (ARI).\n\nBrief Alcohol Interventions (BAIs) for alcohol misuse are effective in young adults who report binge drinking. Many BAI studies targeted young adults who drink hazardously; these individuals are typically not interested in abstaining but may try decreasing the amount or change the manner in which they drink in order to reduce harmful consequences. The investigators previously published the results of a BAI group-based intervention that reduced ARIs in over 150,000 Airmen on average by 16%. Since 2010, the BAI has been disseminated to most USAF Airmen in Technical Training. However, it is clear additional research is needed to enhance the efficacy of the intervention and reduce risks associated with problem drinking. One strategy to improve health outcomes is well-timed, tailored, and automated text messages. Building on the researchers' preliminary study where text messages reduced driving after drinking as well as total drinks consumed before driving, text messaging may be highly effective when sent at the precise time that Airmen gain access to alcohol (the first time they are allowed off base), a standard time for all Technical Trainees.\n\nOne challenge to conducting alcohol research in the military is the lack of privileged communication. As a result, it is difficult to obtain valid self-reports due to a tendency to deny or minimize use. The investigators recently developed and validated a method for collecting anonymous data over time. This will be the first study in the military, as well as the first large scale, adequately powered trial, where intervention effects will be tracked out to a 6-month follow-up. The study's Specific Aims are to randomize approximately 7000 Airmen to either the current BAI versus the BAI+Text messages timed to occur before, during, and after Airmen have access to alcohol; and to evaluate the efficacy of the intervention at the end of training and 6 months post-training using repeated surveys with unique identifiers allowing researchers to match surveys while maintaining anonymity.",[554,555,556],"Alcohol Drinking","Binge Drinking","Text Messaging",[558,559,560],"Military Population Health","Brief Alcohol Intervention","BAI","2026-06-10",{"date":563,"type":37},"2026-06-15",{"date":565,"type":37},"2023-12-01",{"date":567,"type":21},"2028-12-31",{"name":43,"class":44},{"id":570,"slug":571,"hasResults":12,"nctId":572,"briefTitle":573,"officialTitle":574,"acronym":4,"eligibilityCriteria":575,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":576,"targetDuration":4,"studyType":22,"phases":577,"briefSummary":578,"conditions":579,"keywords":581,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":583,"lastUpdatePostDateStruct":584,"startDateStruct":585,"completionDateStruct":586,"leadSponsor":588,"locationsCount":67},"100626919","phase-1-her2-fpbmc-in-patients-with-metastatic-breast-and-prostate-cancer-am006-100626919","NCT07441889","HER2 FPBMC in Patients With Metastatic Breast and Prostate Cancer (AM006)","Phase I\u002FII Study of Anti-CD3 x Anti-HER2 Bispecific Antibody (HER2Bi) Armed Fresh Peripheral Blood Mononuclear Cells (HER2 FPBMC) in Metastatic Castrate Resistant Prostate Cancer (mCRPC) and Metastatic Breast Cancer (MBC)","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. Age ≥ 18 years at the time of signing informed consent\n4. Expected survival ≥ 3 months in the judgment of the investigator\n5. ECOG PS 0-1\n6. Adequate Organ Function per the following criteria (within 10 days of study registration):\n\n   * Absolute lymphocyte count ≥ 400\u002Fmm3\n   * Absolute neutrophil count ≥ 1000\u002Fmm3\n   * Platelets ≥ 75,000\u002Fmm3\n   * Hemoglobin ≥ 9g\u002FdL\n   * Serum creatinine \\\u003C 2.0 mg\u002FdL OR measured or calculated creatinine clearance ≥ 50 ml\u002Fmm\n   * Total bilirubin ≤ mg\u002FdL\n   * Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) \\\u003C 5.0 times normal\n7. Agreement to adhere to Lifestyle Considerations throughout study duration\n8. A diagnosis of either of the following:\n\n   a. Prostate Cancer: i. Histological and\u002For cytological confirmation of prostate adenocarcinoma. ii. Participants must have progressive mCRPC at screening iii. Serum testosterone levels \\\u003C50 ng\u002FdL during screening. iv. Must have progressed on at least one prior ARPI (abiraterone acetate, enzalutamide, apalutamide, or darolutamide).\n\n   v. Participants must have ≥1 metastatic lesion that is present on baseline CT, MRI, or bone scan obtained ≤28 days prior to registration.\n\n   b. Breast Cancer i. Histological and\u002For cytological confirmation of invasive breast cancer. ii. Participants must have previously treated metastatic breast cancer at screening. Metastatic breast cancer must be evaluable by RECIST 1.1 criteria.\n\niii. Must have progressed on at least two prior endocrine or targeted therapies or at least two lines of cytotoxic chemotherapy. If HER2 positive, then must have progressed on or been intolerant of at least one HER2 targeted therapy.\n\niv. Participants must have ≥1 metastatic lesion that is present on baseline CT, MRI, or bone scan obtained ≤28 days prior to registration.\n\nExclusion Criteria:\n\n1. Pregnancy (must have negative pregnancy test within 7 days prior to study registration) or lactation\n2. History of a recent myocardial infarction (within one year) or a past myocardial infarction (more than one year prior to enrollment) who are actively requiring nitroglycerine more than once per week\n3. Inadequate cardiac function, as defined as any of the following:\n\n   * Uncontrolled angina or severe ventricular arrhythmias\n   * Clinically significant pericardial disease\n   * History of myocardial infarction (MI) in the last year before registration\n   * Class 3 or higher New York Heart Association Congestive Heart Failure\n4. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to study registration. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.\n5. Serious non-healing wound, ulcer, bone fracture, major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to registration\n6. Active liver disease such as cirrhosis, chronic active hepatitis, or chronic persistent hepatitis\n7. Is HIV positive or has evidence of active Hepatitis C virus or active Hepatitis B virus.\n8. Active bleeding or a pathological condition that is associated with a high risk of bleeding (therapeutic anticoagulation is allowed)\n9. Has an active infection requiring systemic therapy\n10. A serious uncontrolled medical disorder that in the opinion of the Investigator may be jeopardized by the treatment with protocol therapy\n11. Has a known history of active TB (Bacillus Tuberculosis)\n12. Has received a live vaccine within 30 days of study registration.\n13. Treatment with any investigational agent within 3 weeks prior to study registration\n14. Active second malignancy requiring systemic treatment. Exceptions include basal cell carcinoma of the skin, treated cervical cancer, and squamous cell carcinoma of the skin\n15. Has active autoimmune disease that has required systemic treatment in the 2 years prior to registration (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.\n16. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator.\n17. Patient may be excluded if, in the opinion of the PI and investigator team, the patient is not capable of being compliant\n\nAdditional Exclusion Criteria for Patients with Prostate Cancer:\n\n1. Has small cell neuroendocrine carcinoma (pure or mixed) on prior or current histologic evaluation of primary or metastatic lesions\n2. Has an actionable BRCA1 or BRCA2 alteration, for which approved therapies are available, e.g., PARP inhibitors, unless these therapies are not appropriate for the participant as determined by the investigator or the participant refuses such therapy. Participants with one of these mutations and who have progressed on targeted therapy are eligible.\n\nAdditional Exclusion Criteria for Patients with Breast Cancer:\n\n1. Has an actionable BRCA1 or BRCA2 alteration, for which approved therapies are available, e.g., PARP inhibitors, unless these therapies are not appropriate for the participant as determined by the investigator or the participant refuses such therapy. Participants with one of these mutations and who have progressed on targeted therapy are eligible.\n2. Participants in visceral crisis at risk of immediately life-threatening complications in the short term, including participants with massive uncontrolled effusions (pleural, pericardial, and peritoneal), pulmonary lymphangitis, or liver involvement \\> 50%.",{"count":500,"type":21},[502,80],"The purpose of this study is to understand the safety and estimate the efficacy of anti-CD3 x anti-HER2 bispecific antibody (HER2Bi) armed fresh peripheral blood mononuclear cells (HER2 FPBMC) for patients with metastatic breast or prostate cancer. Participants receive 5 weekly doses of CD33 FPBMC by intravenous infusion followed by 4 infusions every other week.",[415,580],"Prostate Cancer",[582],"FPBMC","2026-06-09",{"date":507,"type":37},{"date":538,"type":21},{"date":587,"type":21},"2032-10",{"name":43,"class":44},{"id":590,"slug":591,"hasResults":12,"nctId":592,"briefTitle":593,"officialTitle":594,"acronym":595,"eligibilityCriteria":596,"healthyVolunteers":12,"sex":597,"minAge":17,"maxAge":4,"enrollmentInfo":598,"targetDuration":4,"studyType":22,"phases":600,"briefSummary":601,"conditions":602,"keywords":604,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":614,"lastUpdatePostDateStruct":615,"startDateStruct":616,"completionDateStruct":618,"leadSponsor":620,"locationsCount":67},"100634119","a-feasibility-study-of-biometric-measurements-via-wearable-smart-watch-technology-for-evaluation-of-vasomotor-symptoms-in-patients-treated-with-androgen-deprivation-therapy-for-prostate-cancer-prostate-007-100634119","NCT07535541","A Feasibility Study of Biometric Measurements Via Wearable Smart Watch Technology for Evaluation of Vasomotor Symptoms in Patients Treated With Androgen Deprivation Therapy for Prostate Cancer (Prostate 007)","A Feasibility Study of Biometric Measurements Via Wearable Smart Watch Technology for Evaluation of Vasomotor Symptoms in Patients Treated With Androgen Deprivation Therapy for Prostate Cancer (BioWEAR)","BioWEAR","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 (biologic sex), aged ≥18 years of age\n4. Diagnosis of prostate cancer\n5. Must be receiving active treatment with ADT at the time of enrollment\n\n   a. ADT is defined as any medical or surgical intervention intended to lower the serum testosterone to \\\u003C50 mg\u002FdL for the purpose of treating prostate cancer\n6. Evidence of castrate level testosterone by either of the following:\n\n   1. A documented serum testosterone level of \\\u003C50 ng\u002FdL at any time point since initiation of ADT or\n   2. A documented decrease in PSA following initiation of ADT and no evidence of PSA progression per PCWG3 criteria (PSA progression defined as a rise in PSA of ≥25% from PSA nadir and absolute increase of ≥1 ng\u002FmL confirmed by a second measurement at least 3 weeks later)\n7. Duration of ADT expected to extend for a minimum of 4 weeks from time of study enrollment\n8. Report experiencing VMS that began after initiation of ADT and occur with a minimum frequency of once per day\n9. Own a smartphone with Bluetooth 5 compatibility and be willing to use cellular data and\u002For Wi-Fi on their smartphone. Participants must agree to download the Empatica Care app on their smartphone.\n\n   1. iPhone 8 or higher with iOS 16.0 or higher\n   2. Android devices version 12, 12.1, 13, 14, 15, or higher\n10. Ability to read, speak, and understand English\n11. ECOG performance status of 0, 1, or 2\n\nExclusion Criteria:\n\n1. Wrist circumference less than 95 mm or greater than 222 mm\n2. Known allergic reactions to components of the EmbracePlus smart watch, specifically any skin allergy to silicone\n3. Presence of VMS prior to initiation of ADT, regardless of severity or duration\n4. Active febrile illness (temperature \\>38°C) or on active treatment for febrile illness\n5. Inability to press button on smart watch crown\n6. Those receiving any experimental therapy for treatment of their prostate cancer (other standard of care prostate cancer therapies are permitted)\n7. Evidence of progression of prostate cancer as defined by PCWG3 criteria","MALE",{"count":599,"type":21},18,[105],"The purpose of this study is to find out if patients with prostate cancer who have vasomotor symptoms, commonly called hot flashes, from their Androgen Deprivation Therapy (ADT) will consistently wear a smartwatch device to track their health data, log hot flashes on their smartwatch, and how these data compare with daily surveys about their hot flashes. Participants will be asked to wear the smartwatch for 4 weeks and to log their hot flashes on their smart watch pressing a button on the watch. Participants will be asked to complete surveys (sent through a text message link) to describe their experiences with hot flashes.",[580,603],"Hot Flashes",[605,606,607,580,608,609,610,611,612,613],"VMS","Hot flashes","ADT","vasomotor symptoms","vasomotor symptom event","Smartwatch","Survey","EMA","androgen deprivation therapy","2026-06-05",{"date":583,"type":37},{"date":617,"type":37},"2026-05-21",{"date":619,"type":21},"2027-05",{"name":43,"class":44},{"id":622,"slug":623,"hasResults":12,"nctId":624,"briefTitle":625,"officialTitle":626,"acronym":4,"eligibilityCriteria":627,"healthyVolunteers":12,"sex":16,"minAge":224,"maxAge":101,"enrollmentInfo":628,"targetDuration":4,"studyType":22,"phases":630,"briefSummary":631,"conditions":632,"keywords":4,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":614,"lastUpdatePostDateStruct":637,"startDateStruct":638,"completionDateStruct":640,"leadSponsor":641,"locationsCount":67},"100582901","early-versus-delayed-rehabilitation-after-reverse-total-shoulder-arthroplasty-for-proximal-humerus-fracture-100582901","NCT06869343","Early Versus Delayed Rehabilitation After Reverse Total Shoulder Arthroplasty for Proximal Humerus Fracture","A Randomized Controlled Trial of Early Versus Delayed Rehabilitation After Reverse Total Shoulder Arthroplasty for Proximal Humerus Fracture","Inclusion Criteria:\n\n* aged 50-85 undergo reverse Total Shoulder Arthroplasty by a single surgeon for proximal humerus fractures\n\nExclusion Criteria:\n\n* previous rTSA to ipsilateral shoulder\n* undergoing elective rTSA\n* Prisoners\n* unwilling to be randomized\n* unwilling or unable to attend follow up visits",{"count":629,"type":21},10,[105],"Proximal humerus fractures can be a debilitating injury in the elderly, impacting the ability to function independently or complete activities of daily living due to pain and restricted shoulder motion. Evidence has shown that reverse total shoulder arthroplasty (rTSA) is an effective option to improve pain and function for patients with acute displaced proximal humerus fractures. Given that patients undergoing rTSA for proximal humerus fractures typically experience worse functional outcomes, worse patient-reported outcomes, and higher rates of complication compared to those with elective indications for surgical intervention, it is critical to determine a secure path to recovery for these patients after surgery. Early rehabilitation has been proposed to be safe and effective for patients who undergo rTSA for elective indications; however, there is a paucity of research evaluating safety and effectiveness of timing of rehabilitation for rTSA patients in the trauma setting. Currently, there exists a great variability in postoperative rehabilitation protocols across orthopaedic practices. This study's objective is to determine the safety and effectiveness of early postoperative rehabilitation on the outcomes and postoperative complications of patients undergoing rTSA for proximal humerus fractures in order to provide more specific recommendations for this patient population.",[633,634,635,636],"Orthopedic Disorder","Humerus Fracture","Shoulder Arthroplasty","Reverse Shoulder Replacement",{"date":583,"type":37},{"date":639,"type":37},"2025-05-19",{"date":296,"type":21},{"name":43,"class":44},{"id":643,"slug":644,"hasResults":12,"nctId":645,"briefTitle":646,"officialTitle":647,"acronym":4,"eligibilityCriteria":648,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":375,"enrollmentInfo":649,"targetDuration":4,"studyType":22,"phases":650,"briefSummary":651,"conditions":652,"keywords":4,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":614,"lastUpdatePostDateStruct":655,"startDateStruct":657,"completionDateStruct":659,"leadSponsor":661,"locationsCount":67},"100460823","simplified-post-op-rehabilitation-for-ankle-and-pilon-fractures-100460823","NCT05280639","Simplified Post Op Rehabilitation for Ankle and Pilon Fractures","Ankle and Pilon Fracture Post Operative Rehabilitation: A Randomized Control Trial Exploring a Simplified Wooden Block Protocol","Inclusion Criteria:\n\n* Ages 18-65\n* Surgically treated open or closed fractures of the ankle or tibial plafond\n\nExclusion Criteria:\n\n* Contralateral lower extremity injuries that would limit weight bearing after 6 weeks\n* Severe injury requiring flap coverage or vascular reconstruction (Gustilo-Anderson Type IIIB and C respectively)\n* Neurological deficits that would impede ability to stand safely unassisted for home exercise regiment\n* Desire to participate in formal physical therapy program\n* Additional injury that would compromise subjects ability to follow either Home Exercise Program\n* Non ambulatory prior to injury\n* Previous ankle or tibial plafond injury on ipsilateral extremity\n* BMI \\> 50\n* Severe problems maintaining follow up\n* Previous ankle\u002Ftibial plafond fracture\n* Prisoners\n* Neurological impairments that impair balance",{"count":53,"type":21},[105],"The aim of this study is to compare standard post operative rehabilitation with a simplified wooden block stretching protocol that will yield similar results.",[653,654],"Ankle Fractures","Pilon Fracture",{"date":656,"type":37},"2026-06-08",{"date":658,"type":37},"2022-10-03",{"date":660,"type":21},"2027-06-01",{"name":43,"class":44},{"id":663,"slug":664,"hasResults":12,"nctId":665,"briefTitle":666,"officialTitle":667,"acronym":668,"eligibilityCriteria":669,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":127,"enrollmentInfo":670,"targetDuration":4,"studyType":22,"phases":672,"briefSummary":673,"conditions":674,"keywords":680,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":461,"lastUpdatePostDateStruct":686,"startDateStruct":688,"completionDateStruct":690,"leadSponsor":692,"locationsCount":67},"100603043","interaction-between-inorganic-nitrate-supplementation-and-metformin-in-individuals-with-prediabetes-100603043","NCT07131384","Interaction Between Inorganic Nitrate Supplementation and Metformin in Individuals With Prediabetes","The Interaction Between Inorganic Nitrate Supplementation and Metformin on Exercise Capacity, Vascular Function, and Insulin Sensitivity in Individuals With Pre-Diabetes","NO3-PreDM","Inclusion Criteria:\n\n* Individuals who can communicate meaningfully with the investigator and can provide written consent.\n* Confirmed prediabetic individuals (ages 18-60 years old) (2-hour glucose of 140-199 mg\u002FdL following OGTT test or HbA1c between 5.7-6.4% tested on two occasions within 6 months).\n* Taking metformin (stable dose for at least a week) or naïve to metformin\n* Sedentary (\\\u003C1 day\u002Fweek of structured exercise)\n* Be able to perform exercise on a cycle ergometer without assistance\n* Stable medication regimen for the last 6 months\n* If female, have a normal menstrual cycle\n\nExclusion Criteria:\n\n* Estimated Glomerular filtration rate (GFR) ≤ 45\n* Body mass index ≥ 40 Kg\u002Fm2\n* HbA1c \\> 6.4%\n* Smokers within the last 5 years\n* Has experienced significant weight loss \\~3 kg in the last three months or is taking any weight loss drugs\n* Current medical condition that prohibits exercising at high intensities\n* Currently on hormone replacement of any kind\n* History of myocardial infarction, cerebrovascular event, acute or unstable disease other than pre-diabetes or obesity\n* Currently taking any of the following medications (calcium channel blockers, statins, ACE or renin inhibitors, angiotensin receptor blockers, organic nitrates (e.g., nitroglycerine) or recent regular use of inorganic nitrates, alpha- or beta-blockers, diuretics, proton pump inhibitors, PDE-5 inhibitors (e.g.,: Cialis, Viagra), or xanthine oxidase inhibitors (e.g.,: Allopurinol))\n* Oral antibiotic use within the previous four weeks, including over-the-counter antibacterial mouthwash or a mouthwash containing chlorhexidine and unwilling to discontinue use\n* Oral cancer\u002Fsevere oral disease\n* Uncontrolled hypertension (\\>140\u002F90)\n* Had hysterectomy or oophorectomy\n* Fetuses, neonates, children, prisoners, cognitively impaired, non-English speaking participants",{"count":671,"type":21},24,[105],"This study is examining whether short-term supplementation with inorganic nitrate, in the form of beetroot juice, can enhance blood vessel health, insulin sensitivity, and exercise capacity in individuals with prediabetes. We will be comparing the responses in individuals who are taking metformin to those who are naive to metformin. The results from this study may help identify non-pharmacological interventions in prediabetes.",[675,676,677,678,679],"Males","Females","Sedentary","Metformin","Prediabetes",[681,682,683,684,685],"Prediabetic Individuals","Exercise Capacity","Vascular health","Inorganic nitrate","Insulin Sensitivity",{"date":687,"type":37},"2026-06-03",{"date":689,"type":37},"2026-01-01",{"date":691,"type":21},"2027-06-30",{"name":43,"class":44},""]