[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Columbia University\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":713},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,184,0,25,[9,54,86,112,139,169,195,217,250,271,301,325,395,421,446,472,499,525,544,564,592,615,635,662,691],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100643896","phase-1-topical-tor-582-treatment-of-epistaxis-in-hht-100643896",false,"NCT07667413","Topical TOR-582 Treatment of Epistaxis in HHT","A Phase I Trial of TOR-582, a Topical Sirolimus-based Treatment for Epistaxis in Adults With Hereditary Hemorrhagic Telangiectasia","Inclusion Criteria:\n\n1. Age 18 years or older at the time of consent.\n2. Confirmed diagnosis of HHT, defined as meeting at least three of the four Curaçao criteria or preferably by genetic testing.\n3. Moderate nasal epistaxis represented by an Epistaxis Severity Score (ESS) between 3 and 8 at screening, average NOSE-HHT score of 1.01-2, with a self-reported history of at least four spontaneous nosebleeds per week and a cumulative weekly bleeding duration of at least 60 minutes.\n4. Stable nasal hygiene regimen and epistaxis-related medical management for at least 3 months prior to enrollment.\n5. Stable epistaxis pattern for at least 3 months prior to enrollment\n6. Adequate bone marrow function defined as:\n\n   1. Platelet count ≥ 100 × 10⁹\u002FL (≥ 100,000\u002Fmm3)\n   2. WBC count ≥ 2.5 × 10⁹\u002FL at screening (≥ 2,500\u002Fmm3)\n   3. Hgb ≥ 6g\u002FdL with no transfusion in the prior 2 months\n7. INR ≤ 1.4 and activated partial thromboplastin time (aPTT) within institutional normal limits.\n8. Willingness to avoid initiation of other investigational or targeted therapeutic agents for epistaxis (including antiangiogenic or mTOR-modulating therapies) from the time of enrollment through study completion.\n9. Female participants of childbearing potential must have a negative pregnancy test at screening and agree to use effective contraception during the study and for 28 days following the final dose.\n10. Ability to comply with study procedures and follow-up visits, and capacity to provide written informed consent.\n\nExclusion Criteria:\n\n1. Any medical contraindication to systemic sirolimus use.\n2. Prior use of any mTOR inhibitor within the past 3 months.\n3. Endoscopic evaluation of nasal cavity (HES-based)\n\n   1. Site: No numerical site exclusion\n   2. Pattern: AVM-type vascular pattern (HES pattern score = 2).\n   3. Crusting: Moderate to severe nasal crusting (HES crusting score ≥ 2).\n   4. Location: Telangiectasias isolated to the middle or posterior turbinates (HES location score ≥ 2).\n   5. Perforation: Presence of a nasal septal perforation\n4. Surgical cautery or sclerotherapy within the past 3 months prior to enrollment\n5. Vascular embolization of nasal vasculature within the past 3 months prior to enrollment\n6. Clinically significant peripheral vascular disease or circulatory compromise.\n7. Current use of strong CYP3A4 modulators, including inhibitors (e.g., ketoconazole, clarithromycin) or inducers (e.g., rifampin, phenytoin, carbamazepine, St. John's wort).\n8. Use of anti-angiogenic therapies within 30 days prior to screening (e.g., bevacizumab, pazopanib, thalidomide, lenalidomide).\n9. Use of illicit substances within the past 30 days, excluding marijuana.\n10. Use of anticoagulant, antiplatelet, or fibrinolytic medications within the past 30 days, except for low-dose aspirin (81 mg or less).\n11. Use of octreotide or systemic estrogen therapy within the past 30 days.\n12. Clinical laboratory evaluation:\n\n    1. Renal dysfunction, defined as a serum creatinine level greater than 2.0 mg\u002FdL.\n    2. Hepatic impairment, indicated by total bilirubin above 2.0 mg\u002FdL (or above 4.0 mg\u002FdL in patients with a known diagnosis of Gilbert's syndrome) or liver transaminases exceeding three times the upper limit of normal.\n    3. Known SMAD4 mutation with a history of significant gastrointestinal polyposis, unless colonoscopy within the past 18 months demonstrated either no polyps or ≤5 polyps judged to be clinically insignificant by a gastroenterologist.\n13. History of unprovoked venous thromboembolism, confirmed by imaging.\n14. Diagnosis of peripheral neuropathy as confirmed by neurologic evaluation.\n15. Documented hyperproliferative anemia (myelodysplastic syndrome, aplastic anemia, etc.).\n\n    a. Current pregnancy or planned pregnancy within the next 6 months, or active breastfeeding.\n16. Concurrent participation in another interventional research study.\n17. Any condition, circumstance, language, or literacy limitation, that in the judgment of the investigator, would interfere with study participation or completion.","ALL","18 Years",{"count":20,"type":21},27,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","People with hereditary hemorrhagic telangiectasia (HHT) often experience frequent and severe nosebleeds that can disrupt daily life and lead to anemia, medical procedures, and reduced quality of life. This study is testing a new nasal ointment called TOR-582, which contains sirolimus, to determine whether it can be used safely when applied inside the nose. Adults with HHT and frequent nosebleeds will be invited to participate. Participants will first complete one week of observation without treatment, followed by up to 12 weeks of applying the study ointment inside each nostril twice daily. Different participants will receive different strengths of the ointment so researchers can identify the safest dose. During the study, participants will attend study visits, complete questionnaires about their nosebleeds and quality of life, keep a daily nosebleed diary, undergo nasal examinations, and have blood tests to monitor safety and medication levels. The information gained from this study will help determine whether this topical treatment can be safely studied further and will support the development of a new, less invasive option for managing nosebleeds in people with HHT.",[27,28],"Hereditary Hemorrhagic Telangiectasia (HHT)","Epistaxis",[30,31,28,32,33,34,35,36,37,38,39,40],"Hereditary Hemorrhagic Telangiectasia","HHT","Nosebleeds","Sirolimus","Rapamycin","Topical Sirolimus","Intranasal Therapy","Nasal Telangiectasia","Vascular Malformations","mTOR Inhibitor","Osler-Weber-Rendu Syndrome","NOT_YET_RECRUITING","2026-08-19",{"date":44,"type":45},"2026-08-21","ACTUAL",{"date":47,"type":21},"2026-10",{"date":49,"type":21},"2027-12",{"name":51,"class":52},"Columbia University","OTHER",1,{"id":55,"slug":56,"hasResults":12,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":4,"eligibilityCriteria":60,"healthyVolunteers":61,"sex":17,"minAge":18,"maxAge":62,"enrollmentInfo":63,"targetDuration":4,"studyType":22,"phases":65,"briefSummary":66,"conditions":67,"keywords":72,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":53},"100652893","phase-1-alpelisib-challenge-test-act-100652893","NCT07778524","Alpelisib Challenge Test (ACT)","Alpelisib Challenge Test (ACT) for Assessment of Pancreatic β-Cell Reserve, Pilot & Feasibility Study","Inclusion Criteria:\n\n* Adults aged 18-70 years\n* Able to understand wrifen and spoken English and\u002For Spanish\n* Body mass index of 18-45 kg\u002Fm2 (or 18-42 kg\u002Fm2 for those of Asian ancestry)\n\n  * For Lean group: BMI 18.0-24.9 kg\u002Fm2 (or 18.0-22.9 kg\u002Fm2 for those of Asian ancestry)\n  * For Overweight group: BMI 25.0-29.9 kg\u002Fm2 (or 23.0-27.4 kg\u002Fm2 for those of Asian ancestry)\n  * For Obesity group: BMI 30.0-45.0 kg\u002Fm2 (or 27.5-42 kg\u002Fm2 for those of Asian ancestry)\n\nExclusion Criteria:\n\n* Inability to provide informed consent in English or Spanish\n* Unwillingness to fast (except water) for up to 18 hours\n* Unwillingness not to get out of bed and to use bedpan\u002Furinal to void for up to 15 hours\n* Documented weight change of ≥ 5.0% of baseline within the previous 3 months\n* Abnormal blood pressure\n\n  * Systolic blood pressure \\\u003C 90 mm Hg or \\> 160 mm Hg, and\u002For\n  * Diastolic blood pressure \\\u003C 55 mm Hg or \\> 100 mm Hg\n* Abnormal resting heart rate \\\u003C 55 bpm or ≥ 110 bpm\n\n  * Sinus tachycardia that has been extensively worked up and considered benign by the recruit's personal physician may be permitted at the PI's discretion\n  * Sinus bradycardia between heart rates of 45 and 54 bpm may be permitted at the PI's discretion if in a clinically appropriate setting (e.g., toned athlete, taking beta blockers)\n* Abnormal (i.e., non-regular) heart rhythm detected on physical exam\n* Abnormal screening serum electrolytes judged by the PI to be potentially clinically significant\n* Liver function abnormalities (either of the following)\n\n  * Transaminases (AST or ALT) \\> 3.0 x the upper limit of normal\n  * Total bilirubin \\> 1.25 x the upper limit of normal\n* Laboratory evidence of diabetes mellitus:\n\n  * Hemoglobin A1c ≥ 6.5%, and\u002For\n  * Fasting plasma glucose ≥ 126 mg dL-1\n* Positive qualitative β-hCG (i.e., pregnancy test) in women of childbearing potential\n* Women currently pregnant\n* Women currently breastfeeding\n* History of having met any of the American Diabetes Association's definitions of diabetes mellitus (i.e., overt diabetes):\n\n  * Hemoglobin A1c ≥ 6.5%, or rapid rise in documented HbA1c values causing clinical concern for evolving insulin deficiency\n  * Plasma glucose ≥ 126 mg\u002FdL after 8-h fast\n  * Plasma glucose of ≥ 200 mg\u002FdL at 2 h after ingestion of a 75-g glucose load\n  * Random plasma glucose ≥ 200 mg\u002FdL associated with typical hyperglycemic symptoms, diabetic ketoacidosis, or hyperglycemic-hyperosmolar state\n* History of gestational diabetes mellitus within the previous 5 years\n* Use of most antidiabetic medications within the 90 days prior to screening\n\n  * Exceptions: thiazolidinediones, sulfonylureas, meglitinides, DPP4 inhibitors, GLP-1 receptor agonists, SGLT2 inhibitors, amylin mimetics, acarbose, insulin\n  * Metformin is acceptable provided that recruits meet all of the inclusion criteria at screening\n* Clinical concern for absolute insulin deficiency (e.g., type 1 diabetes, pancreatic disease)\n* Cardiovascular diseases (N.B. uncomplicated hypertension is not exclusionary)\n\n  * Atherosclerotic cardiovascular disease\n  * Stable or unstable angina\n  * Myocardial infarction\n  * Ischaemic or hemorrhagic stroke\n  * Peripheral arterial disease (claudication)\n  * Use of dual antiplatelet therapy (aspirin + P2Y12 inhibitor)\n  * History of percutaneous coronary intervention\n  * Congestive heart failure (NYHA Class ≥ 2)\n  * Severe valvular heart disease (e.g., aortic stenosis)\n  * Pulmonary hypertension\n* Advanced or severe liver disease, including but not limited to:\n\n  * Advanced liver fibrosis, as determined by non-invasive testing\n  * Cirrhosis of any etiology\n  * Autoimmune hepatitis or other rheumatologic disorder affecting the liver\n  * Biliopathy (e.g., progressive sclerosing cholangitis, primary biliary cholangitis)\n  * Chronic liver infection (e.g., viral hepatitis, parasitic infestation)\n  * Hepatocellular carcinoma\n  * Infiltrative disorders (e.g., sarcoidosis, hemochromatosis, Wilson disease)\n* Psychiatric diseases causing functional impairment that:\n\n  * Are or have been decompensated within 1 year of screening, and\u002For\n  * Require use of anti-dopaminergic antipsychotic drugs associated with significant weight gain\u002Fmetabolic dysfunction (e.g., clozapine, olanzapine)\n* Venous thromboembolic disease (deep vein thrombosis or pulmonary embolism) or any required use of therapeutic anticoagulation\n* Bleeding disorders, including due to anticoagulation, or significant anemia (see above)\n* Active malignancy, or hormonally active benign neoplasm, except allowances for:\n\n  * Non-melanoma skin cancer\n  * Differentiated thyroid cancer (AJCC Stage I only)\n* Clinical concern for increased risk of volume overload, including due to medications and\u002For heart\u002Fliver\u002Fkidney problems, as listed above\n* Use of certain medications currently or within 30 days prior to screening:\n\n  * Prescribed medications used for any of the indications in the preceding list of excluded conditions, or their use within 30 d prior to screening, except allowances for:\n\n    * Use of drugs prescribed for indications other than the exclusionary diagnoses\u002Fpurposes listed above (e.g., ACEi\u002FARB used for uncomplicated hypertension rather than for congestive heart failure, etc.)\n    * Note, as above, that antidiabetic drugs except metformin within 30 d of screening are excluded\n  * Oral or parenteral corticosteroids (at greater than prednisone 5 mg daily, or equivalent) for more than 3 days within the previous 30 days; topical and inhaled formulations are permitted\n* History of certain weight-loss (bariatric) surgery, including:\n\n  * Roux-en-Y gastric bypass\n  * Biliopancreatic diversion\n  * Restrictive procedures (lap band, sleeve gastrectomy) performed within the past 6 months\n* Clinical concern for alcohol overuse based on chart review and\u002For by recruit's report of more than 14 standard drinks per week for males or more than 7 standard drinks per week for females\n* Regular tobacco use (smoking more than 1 cigarette per week) or regular nicotine vaping (daily)\n* Clinical concern for use of illicit drugs other than marijuana or lawfully prescribed medications based on recruit's report, chart review, and point-of-care urine drug test at screening\n* History of or ongoing febrile illness within 14 days of screening\n* Any other disease or condition or laboratory value that, in the opinion of the investigator, would place the participant at an unacceptable risk and\u002For interfere with the analysis of study data.\n* Known allergy\u002Fhypersensitivity to any component of the medicinal product formulations (including soy, cow dairy, or gluten), other biologics, venipuncture materials, plastics, adhesive or silicone, or ongoing clinically important allergy\u002Fhypersensitivity as judged by the investigator.\n* Concurrent enrollment in another clinical study of any investigational drug\u002Fbiologic therapy within 5 half-lives of an investigational agent or biologic.",true,"70 Years",{"count":64,"type":21},15,[24],"The goal of this study is to test a potentially easier method for measuring how much insulin a person is capable of producing than the current gold-standard method, the \"hyperglycemic clamp.\" Participants will come in for a two-day (overnight) visit in which they will first undergo a \"hyperglycemic clamp,\" in which they receive an intravenous (into the vein) infusion of glucose (sugar) in order to measure the maximum amount of insulin their body produces in response. They will then consume a series of three standardized meals throughout the rest of the day. At 23:00, they will take a single dose of alpelisib, a drug that interferes within insulin's actions in the body. Then, the following morning, they will undergo a \"Mixed Meal Tolerance Test\" in which they consume a standardized liquid nutritional beverage and have blood drawn periodically before and during the test.",[68,69,70,71],"Insulin Resistance","Type 2 Diabetes","Obesity & Overweight","Healthy Adult Participants",[73,74,75,76,77,78],"Insulin resistance","Type 2 diabetes","Hyperinsulinemia","Obesity","Overweight","Healthy volunteers","2026-08-18",{"date":44,"type":45},{"date":82,"type":21},"2026-09-01",{"date":84,"type":21},"2028-08-31",{"name":51,"class":52},{"id":87,"slug":88,"hasResults":12,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":4,"eligibilityCriteria":92,"healthyVolunteers":61,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":93,"targetDuration":4,"studyType":95,"phases":4,"briefSummary":96,"conditions":97,"keywords":100,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":53},"100577624","impella-reverse-remodeling-in-end-stage-heart-failure-100577624","NCT06800716","Impella Reverse Remodeling in End-Stage Heart Failure","A Prospective Study of Recovery Mechanisms in Heart Transplant Eligible Patients With Cardiogenic Shock on Impella 5.5 Support","Inclusion Criteria:\n\n* Age 18 years or older\n* Dilated cardiomyopathy (LVEDD \\> 5.5 cm and LVEF \\\u003C25%)\n* Indication for temporary mechanical circulatory support therapy with Impella 5.5 LVAD as a bridge to transplant or bridge to transplant decision based on treating physician's discretion\n\nExclusion Criteria:\n\n* Intra-aortic balloon pump (IABP) use for more than 7 days at the time of Impella 5.5 implantation\n* Percutaneous mechanical circulatory support device, extracorporeal membrane oxygenation (ECMO) or paracorporeal ventricular assist device (VAD) support prior to Impella 5.5 implantation\n* Congenital heart disease\n* Restrictive or hypertrophic Cardiomyopathy including hypertrophic obstructive cardiomyopathy (HOCM) Amyloidosis, and Sarcoidosis\n* Evidence of acute myocarditis by endomyocardial biopsy\n* Prior heart transplantation\n* Mechanical aortic \u002F mitral valve\n* Patient with known aortic diseases such as Marfan-Syndrome, Morbus Erdheim-Gsell or others\n* Left Ventricular thrombus\n* Left Ventricular rupture\n* Cardiac tamponade\n* Presence of an Atrial or Ventricular Septal Defect\n* Severe right ventricular (RV) Failure requiring mechanical RV support\n* Severe peripheral vascular disease precluding placement of the Impella System\n* Recent stroke resulting in significant neurological deficit\n* Hypercoagulable disease precluding device implantation\n* Severe thrombocytopenia (\\\u003C50,000)\n* Contraindication to anticoagulation\n* Suspected or known pregnancy or lactating women\n* Subject belongs to a vulnerable population",{"count":94,"type":21},50,"OBSERVATIONAL","This observational study is being done to learn more about heart attack recovery in patients supported with the Impella 5.5 left ventricular assist device (LVAD) as part of their standard of care. There are three stages in this study: screening, treatment and post treatment. There will be two phases of enrollment: First phase will enroll 10 patients; second phase will enroll an additional 40 patients. Approximately 50 participants will take part in the study at Columbia University Irving Medical Center.\n\nParticipation in this research is expected to last approximately 14 months. This time estimate includes a screening period for about 1- 3 days, treatment period of 40 days and post treatment follow-up period for 1 year. Data will be collected through 1- year after heart transplant. Clinical data (medical history, vital signs, laboratory assessments) from medical records, to perform functional testing, and to obtain blood and discarded heart tissue fromfor the purpose of this research study.\n\nParticipants will be asked to share their records for echocardiography, right heart catheterization, laboratory data and clinical information. Participants are required to complete an assessment a 6-minute walk, and hand grip strength test.",[98,99],"Heart Failure","Cardiomyopathy",[101,102,103],"cardiogenic shock and transplant","impella","LVAD","RECRUITING","2026-08-17",{"date":42,"type":45},{"date":108,"type":45},"2024-12-04",{"date":110,"type":21},"2029-11",{"name":51,"class":52},{"id":113,"slug":114,"hasResults":12,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":4,"eligibilityCriteria":118,"healthyVolunteers":12,"sex":17,"minAge":119,"maxAge":120,"enrollmentInfo":121,"targetDuration":4,"studyType":22,"phases":123,"briefSummary":125,"conditions":126,"keywords":4,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":138},"100637491","bilevel-positive-airway-pressure-bpap-for-severe-asthma-100637491","NCT07582211","Bilevel Positive Airway Pressure (BPAP) for Severe Asthma","Bilevel Positive Airway Pressure (BPAP) for Severe Asthma Exacerbations: A Randomized Controlled Trial","Inclusion Criteria:\n\n1. 5 to 17 years of age (inclusive) presenting to the ED with an asthma exacerbation.\n2. Demonstrate moderate-severe asthma exacerbation at triage (i.e., receive an institutional asthma score equivalent to moderate-severe asthma exacerbation or a Pediatric Respiratory Assessment Measure (PRAM) score of 6 or above).\n\nExclusion Criteria:\n\n1. Prior participation in the study.\n2. Use of BPAP at any time within approximately 12 hours for this acute asthma exacerbation, including in prehospital, ED, or inpatient settings, prior to randomization.\n3. Receipt of continuous albuterol for over 150 minutes prior to being approached for consent.\n4. If a blood gas is obtained, PaCO2 greater than 60 mmHg on the most recent blood gas prior to being approached for consent.\n\n   Note: Blood gas values are not required for eligibility confirmation.\n5. Anticipated immediate need (i.e., within approximately an hour after completion of first-line therapy) for invasive mechanical ventilation (e.g., endotracheal tube or laryngeal mask airway) or non-invasive mechanical ventilation (e.g., continuous positive airway pressure (CPAP) or BPAP), as determined by the treating physician.\n6. Presence of a tracheostomy or a baseline requirement for noninvasive ventilation.\n7. Wheezing due to non-asthma causes (e.g., foreign body, tracheomalacia, vocal cord dysfunction, pulmonary edema, uncorrected congenital heart disease, cystic fibrosis, or anaphylaxis).\n8. Absolute or relative contraindication to BPAP, defined as any of the following:\n\n   1. Facial trauma within the area where the face mask would be applied for BPAP (excluding minor abrasion or cuts on forehead or skull).\n   2. Uncontrollable vomiting (i.e., \\> 3 episodes within approximately 1 hour prior to being approached for consent).\n   3. Hypotension for age, defined as systolic blood pressure (SBP) less than 70 plus twice the patient's age in years (i.e., SBP \\\u003C 70 + \\[2 x age in years\\]).\n   4. Glasgow Coma Score of 8 or less.\n   5. Known or clinical suspicion for air leak syndrome (e.g., pneumothorax, pneumomediastinum, pneumopericardium, or subcutaneous emphysema).\n9. Weight \\\u003C 20 kg.\n10. Presence of an intra-abdominal mass compressing the stomach (e.g., due to tumor or large volume ascites) through EMR or medical history.\n11. Known or suspected pregnancy by history or if pregnancy test completed by clinical team.\n12. Any medical condition that, in the opinion of a site investigator, could 1) lead to difficulty complying with protocol procedures, 2) interfere with the safe completion of the study, or 3) affect the validity of the endpoint assessments.\n13. PRAM score less than 7 or greater than 10 based on concurrent clinical assessment by a healthcare provider after completion of standard first-line therapies, which is defined as receiving all of the following prior to ED arrival or during the ED encounter for this acute asthma exacerbation:\n\n    1. Albuterol with or without ipratropium bromide, either at least 3 albuterol doses via inhalation method (e.g., metered-dose inhaler (MDI) or nebulized) or at least one hour of continuous albuterol (i.e., continuous nebulized albuterol or three consecutive intermittent nebulized albuterol treatments as bridging therapy).\n    2. Corticosteroids (e.g., Prednisolone, Prednisone, Dexamethasone\u002FDecadron, or Methylprednisolone) via enteral, intravenous, or intramuscular methods.\n\n    Note: Oxygen is not a required first-line therapy.\n14. Do not require continuous albuterol or a second round of albuterol treatments (e.g., three back-to-back treatments or one hour of burst albuterol treatment) following completion of standard first-line therapies.","5 Years","17 Years",{"count":122,"type":21},36,[124],"NA","The goal of this clinical trial is to assess the feasibility of early initiation of bilevel positive airway pressure (BPAP) in the emergency department (ED) for children with severe asthma exacerbations. It will also collect preliminary data on the safety and potential effectiveness of this approach.\n\nThe main questions it aims to answer are:\n\n1. Can eligible patients be successfully enrolled and complete study procedures across multiple sites?\n2. What safety events occur with early BPAP use in this population?\n3. How do clinical outcomes (such as symptom improvement and need for intensive care) compare between early BPAP and standard care?\n\nResearchers will compare early initiation of BPAP plus standard asthma therapy to standard asthma therapy alone to determine whether early BPAP is a feasible and potentially beneficial treatment strategy.\n\nParticipants will 1) receive standard asthma therapy with or without early BPAP in the ED, 2) be monitored closely during the ED visit and hospitalization, and 3) have clinical data collected from routine care, including asthma severity scores, treatments, and outcomes.\n\nThe study will enroll approximately 36 participants (about 12 per site) across three sites over one year to inform a future multicenter randomized controlled trial.",[127,128,129,130],"Pediatric Asthma","Acute Asthma","BiPAP","Non-invasive Positive Pressure Ventilation","2026-08-16",{"date":79,"type":45},{"date":134,"type":21},"2026-08-31",{"date":136,"type":21},"2027-08",{"name":51,"class":52},3,{"id":140,"slug":141,"hasResults":12,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":4,"eligibilityCriteria":145,"healthyVolunteers":61,"sex":17,"minAge":18,"maxAge":146,"enrollmentInfo":147,"targetDuration":4,"studyType":22,"phases":149,"briefSummary":150,"conditions":151,"keywords":153,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":165,"completionDateStruct":166,"leadSponsor":168,"locationsCount":53},"100636106","adaptive-recruitment-curve-analysis-using-bayesian-modeling-100636106","NCT07561372","Adaptive Recruitment Curve Analysis Using Bayesian Modeling","Enhancing Speed and Accuracy of Motor Evoked Potential Recruitment Curve Analysis Using Hierarchical Bayesian Modeling","Inclusion Criteria:\n\n* Healthy adult volunteers aged 18 years and older.\n* Able to understand study procedures and provide written informed consent.\n\nExclusion Criteria:\n\n* 1\\. History of adverse reaction to Transcranial Magnetic Stimulation (TMS) or non-invasive neurostimulation.\n* 2\\. History of seizures, epilepsy, or family history of epilepsy.\n* 3\\. History of stroke, brain injury, or illness causing brain injury.\n* 4\\. History of head injury or neurosurgery.\n* 5\\. History of neurological diseases, or central nervous system lesions.\n* 6\\. Presence of metallic implants or foreign bodies in the head (outside of dental work\u002Ffillings).\n* 7\\. Presence of implanted electronic or medical devices (e.g., cardiac pacemakers, medical pumps, implanted stimulators).\n* 8\\. Current pregnancy or possibility of pregnancy.\n* 9\\. Currently taking medications that alter cortical excitability or lower seizure threshold.","90 Years",{"count":148,"type":21},14,[124],"The purpose of this study is to better understand how electrical or magnetic stimulation affect the nervous system by optimizing the way researchers measure muscle responses. The relationship between stimulation intensity and muscle response is described by \"neural recruitment curves,\" which are critical for monitoring the state of the nervous system during therapies like transcranial magnetic stimulation (TMS) and spinal cord stimulation (SCS).\n\nThis study tests a new, real-time computational approach based on our previously developed methods (Hierarchical Bayesian models) to estimate these recruitment curves more efficiently. The primary goal is to use this model to dynamically guide the experiment, automatically selecting the optimal stimulation intensities to test.\n\nThe investigators hypothesize that this optimized approach will accurately estimate the entire recruitment curve, or specific targets components of it like the motor threshold, using significantly fewer samples than standard methods. By reducing the number of measurements required, this approach aims to decrease experimental time and minimize participant burden, making future TMS and SCS therapies and experiments more feasible and efficient.",[152],"Modeling of Recruitment Curves",[154,155,156,157,158,159,160,161],"TMS","SCS","SCI","Hierarchical Bayesian","Motor threshold","Transcranial Magnetic Stimulation","Spinal cord stimulation","Evoked Potentials","2026-08-12",{"date":164,"type":45},"2026-08-14",{"date":82,"type":21},{"date":167,"type":21},"2027-03-31",{"name":51,"class":52},{"id":170,"slug":171,"hasResults":12,"nctId":172,"briefTitle":173,"officialTitle":174,"acronym":4,"eligibilityCriteria":175,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":176,"targetDuration":4,"studyType":22,"phases":178,"briefSummary":179,"conditions":180,"keywords":182,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":189,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":53},"100585503","rfa-for-superficial-lipomas-100585503","NCT06903208","RFA for Superficial Lipomas","Radiofrequency Ablation as a Scar-free, Non-operative Approach to Treatment of Superficial Lipomas","Inclusion Criteria:\n\n* Patients \\>18 years old\n* Patients with a lipoma \\\u003C5 cm, above the fascia on the trunk, abdomen or extremities\n\nExclusion Criteria:\n\n* Lipomas of the face or neck\n* Angiolipomas (identified on exam as a firm, mobile, occasionally discolored mass)\n* Patients with history of hereditary retinoblastoma, Li-Fraumeni syndrome, familial adenomatous polyposis, neurofibromatosis, tuberous sclerosis and Werner syndrome\n* A history of exposure to herbicides, arsenic and dioxin\n* A history of radiation treatment for other cancers",{"count":177,"type":21},10,[124],"Lipomas are non-cancerous growths of fatty tissue that develop under the skin in approximately 1 in 1000 people, though this number may be higher. While rarely symptomatic, they often cause emotional distress due to the unappealing appearance of the mass. Treatment of unsightly lipomas is excision with local anesthetic in the office or with sedation in the operating room. The recovery period is short and the procedure is low risk; however, the result of the operation is a visible scar over the site of the lipoma. Many patients defer surgical excision because excision of a lipoma is a cosmetic procedure, but the aesthetic outcome is undesirable.\n\nRadiofrequency ablation (RFA) is a technique that applies heat generated by a high frequency, alternating current to soft tissue. The hyperthermia produced by the current causes tissue necrosis that ablates the tissue into which the energy is directed. RFA has been successfully applied to thyroid nodules, pancreatic lesions, esophageal dysplasia and liver tumors. However, the manufacturers of the RFA technology have been focused on its application in pre-malignant and malignant lesions and have not yet considered its application to benign tumors. This study will test the success of RFA for superficial lipomas as a non-surgical option for treatment.",[181],"Lipoma",[183,184,185,186,187,188],"lipoma","ablation","fatty tissue","fatty tumor","scarring","minimally invasive",{"date":164,"type":45},{"date":191,"type":45},"2025-04-02",{"date":193,"type":21},"2027-07",{"name":51,"class":52},{"id":196,"slug":197,"hasResults":12,"nctId":198,"briefTitle":199,"officialTitle":199,"acronym":4,"eligibilityCriteria":200,"healthyVolunteers":12,"sex":201,"minAge":18,"maxAge":4,"enrollmentInfo":202,"targetDuration":4,"studyType":22,"phases":204,"briefSummary":205,"conditions":206,"keywords":4,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":53},"100456139","medical-imaging-and-thermal-treatment-for-breast-tumors-using-harmonic-motion-imaging-hmi-100456139","NCT05219695","Medical Imaging and Focused Ultrasound Treatment for Breast Tumors Using Harmonic Motion Imaging (HMI)","Focused Ultrasound Surgery\n\nInclusion criteria:\n\n* Women age 18 years or older with benign tumors or early-stage, non-metastatic breast cancer (stage I without the involvement of axillary lymph nodes)\n* Scheduled to receive surgical resection of the tumor by their clinical care team\n\nExclusion criteria:\n\n* Patients who have received or are scheduled to receive thermal ablation or treatment of the tumor as part of their clinical care\n* Pregnant or lactating\n* Presence of breast implants\n* Have a history of laser or radiation therapy to the targeted breast.\n\nMicrobubble-mediated LIFU, i.e., sonoporation\n\nInclusion criteria:\n\n* Women 18 years or older\n* Deemed eligible to receive neoadjuvant systemic therapy as per the treating physician, with the dose and schedule deemed appropriate by the treating physician\n* Any stage invasive breast cancer provided the primary breast tumor size is at least 4 mm\n\nExclusion criteria:\n\n* Pregnant or lactating\n* Presence of breast implants\n* History of laser or radiation therapy to the affected breast\n* Contraindication history or hypersensitivity to ultrasound contrast agents, e.g., Definity, including polyethylene glycol (PEG) allergy.","FEMALE",{"count":203,"type":21},82,[24],"This study will investigate Harmonic Motion Imaging guided Focused Ultrasound (HMIgFUS) method for ablation and sonoporation monitoring of breast tumors. The aim of this study is to evaluate the efficacy of real-time guidance\u002Fmonitoring and ablation\u002Fsonoporation method. The hypothesis behind this proposed study is that High Intensity Focused Ultrasound (HIFU) can be used to ablate tumor tissue, and microbubble-mediated Low Intensity Focused Ultrasound (LIFU) can be used to sonoporate tumor vasculature. The investigators of this study also hypothesize that HMI can be used to monitor HIFU ablation by measuring the changes in tissue stiffness that occur as a result of thermal ablation, guide LIFU sonoporation and HIFU ablation targeting stiff tumor tissue, and the HMI-monitored stiffness changes during ablation will correlate with post-treatment immune response. The ultimate goals of this study are: first, to assess whether these techniques can be used in the clinic in order to provide a well-monitored, noninvasive tumor ablation\u002Fsonoporation method for benign tumors and breast cancers, to minimize side effects due to invasiveness and enhance therapeutic effects of current methods; second, to make full use of the real-time monitoring capability of HMIgFUS for more precise, point-of-care treatment planning to ensure success of ablation\u002Fsonoporation and immune activation.",[207,208],"Fibroadenoma","Breast Cancer Stage I","2026-08-11",{"date":211,"type":45},"2026-08-13",{"date":213,"type":45},"2022-01-19",{"date":215,"type":21},"2031-05",{"name":51,"class":52},{"id":218,"slug":219,"hasResults":12,"nctId":220,"briefTitle":221,"officialTitle":222,"acronym":223,"eligibilityCriteria":224,"healthyVolunteers":12,"sex":17,"minAge":225,"maxAge":226,"enrollmentInfo":227,"targetDuration":4,"studyType":22,"phases":229,"briefSummary":230,"conditions":231,"keywords":235,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":243,"lastUpdatePostDateStruct":244,"startDateStruct":245,"completionDateStruct":247,"leadSponsor":249,"locationsCount":53},"100529458","early-age-related-hearing-loss-investigation-earhli-100529458","NCT06174038","Early Age-Related Hearing Loss Investigation (EARHLI)","Early Age-Related Hearing Loss Investigation (EARHLI): A Randomized Controlled Trial to Assess the Mechanisms Linking Early Age-Related Hearing Loss and Alzheimer's Disease and Related Dementias","EARHLI","Inclusion Criteria:\n\n* Age 55-75 years of age\n* Adult-onset hearing loss of approximately mild to moderate in severity (4-frequency 0.5, 1, 2, 4 kHz pure tone average 20 dB to 55 dB HL in better hearing ear)\n* Aidable hearing loss, defined by word recognition score in quiet ≥ 60% in better hearing ear\n* Amnestic mild cognitive impairment (MCI) defined by Mini-Mental State Exam (MMSE2) score \\>23, Clinical Dementia Rating (CDR) global score equivalent = 0.5, and ADNI3 criteria of Logical Memory II score of ≤6 if 0-7 years of education, ≤9 if 8-15 years, and ≤11 if ≥16 years\n* Availability of a study partner (informant) for the administration of the cognitive screen and the ADCS-Activities of Daily Living-Prevention Instrument (ADCS-ADL-PI)\n* Community-dwelling\n* Fluent in English or Spanish\n* Availability of participant in area for study duration\n\nExclusion Criteria:\n\n* Self-reported congenital hearing loss, known genetic mutation-related hearing loss, or hearing loss onset before middle age (\\\u003C45 years old)\n* Prior dementia diagnosis\n* Reported disability in ≥ 2 activities of daily living (ADLs)\n* Current or previous consistent hearing aid user (such as utilization of hearing aids within the past 6 months beyond brief trials)\n* Unwillingness to wear hearing aids regularly (≥8 hours\u002Fday)\n* Medical contraindications to the use of hearing aids (e.g., actively draining ear)\n* Corrected vision impairment (worse than 20\u002F63 on MNRead Acuity Chart in worse eye)\n* Untreatable conductive hearing loss with air-bone gap \\> 15 dB in two or more contiguous octave frequencies in both ears","55 Years","75 Years",{"count":228,"type":21},150,[124],"Early Age-Related Hearing Loss Investigation (EARHLI) is a single site study that will randomize late middle age adults to either a hearing intervention (including hearing aids) or a health education intervention. Participants will be followed for 1 year. This study will provide information on reducing cognitive decline in those at risk for Alzheimer's Disease and Alzheimer's Disease Related Dementias (AD\u002FADRD).",[232,233,234],"Alzheimer Disease","Hearing Loss","Cognitive Impairment",[233,236,237,238,239,240,241,242],"Alzheimer's","Alzheimer","Hearing Aid","Memory Loss","Memory","Audiogram","Cognition","2026-08-10",{"date":162,"type":45},{"date":246,"type":45},"2024-08-01",{"date":248,"type":21},"2027-12-31",{"name":51,"class":52},{"id":251,"slug":252,"hasResults":12,"nctId":253,"briefTitle":254,"officialTitle":255,"acronym":4,"eligibilityCriteria":256,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":257,"targetDuration":4,"studyType":95,"phases":4,"briefSummary":258,"conditions":259,"keywords":261,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":264,"lastUpdatePostDateStruct":265,"startDateStruct":266,"completionDateStruct":268,"leadSponsor":270,"locationsCount":53},"100651179","ursodeoxycholic-acid-in-barretts-endotherapy-100651179","NCT07756710","Ursodeoxycholic Acid in Barrett's Endotherapy","Cohort Study of Patients With Barrett's Esophagus-Associated Neoplasia Receiving Ursodeoxycholic Acid in the Setting of Endoscopic Ablation","Inclusion Criteria:\n\n* Barrett's esophagus, defined as endoscopic evidence of BE with esophageal biopsies showing intestinal metaplasia.\n* Pre-treatment histology of low- or high-grade dysplasia or intramucosal adenocarcinoma.\n* BE length ≥2 cm (Prague classification: any C, M≥2). The decision was made to exclude patients with BE segments shorter than 2 cm, as assessment of % neosquamous regrowth in shorter segments is likely neither reliable nor highly reproducible.\n* Prior endoscopic resection of focal lesions is permitted. Endoscopic resection of nodular lesions must be performed prior to initiating ablation therapy.\n* Taking UDCA 13-15 mg\u002Fkg divided into twice daily dosing.\n* Either one of the following:\n\n  * No prior endoscopic ablation therapy, OR\n  * Single prior ablation treatment and \\\u003C50% response (i.e. \\\u003C50% neosquamous replacement of original BE segment) and ≥2 cm of residual BE\n\nExclusion Criteria:\n\n* Allergy, hypersensitivity, or intolerance to UDCA.\n* Age ≤18 years.\n* Pregnant or planning to get pregnant during the study period.\n* Unable to give informed consent.\n* Known acute cholecystitis, cholangitis, biliary obstruction, gallstone pancreatitis, or biliary-gastrointestinal fistula (contraindications to UDCA use).",{"count":64,"type":21},"Barrett's esophagus (BE) is a condition in which the normal lining of the esophagus is replaced by abnormal tissue that can increase the risk of esophageal cancer. Endoscopic eradication therapy (EET) removes this abnormal tissue, but most patients need several treatment sessions, leading to higher costs, inconvenience, and cumulative risk. Research suggests that bile reflux, especially a bile acid called deoxycholic acid (DCA), may interfere with healing after treatment by promoting regrowth of Barrett's tissue. Ursodeoxycholic acid (UDCA), an FDA-approved medication used for certain liver and gallbladder conditions, lowers harmful bile acids and may help the normal esophageal lining grow back more effectively. In this pilot study, patients undergoing endoscopic treatment and taking UDCA will be followed to see whether UDCA treatment improves healing and reduces the number of procedures needed. If successful, this approach could lower costs, decrease risks, and make treatment more accessible for patients at risk of esophageal cancer.",[260],"Barrett's Esophagus With Dysplasia",[262,263],"ursodeoxycholic acid","Barrett's Esophagus","2026-08-07",{"date":209,"type":45},{"date":267,"type":21},"2026-11",{"date":269,"type":21},"2027-11",{"name":51,"class":52},{"id":272,"slug":273,"hasResults":12,"nctId":274,"briefTitle":275,"officialTitle":276,"acronym":4,"eligibilityCriteria":277,"healthyVolunteers":61,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":278,"targetDuration":4,"studyType":22,"phases":280,"briefSummary":281,"conditions":282,"keywords":287,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":295,"lastUpdatePostDateStruct":296,"startDateStruct":297,"completionDateStruct":299,"leadSponsor":300,"locationsCount":53},"100296200","project-i-test-implementing-hiv-testing-in-opioid-treatment-programs-100296200","NCT03135886","Project I Test: Implementing HIV Testing in Opioid Treatment Programs","A Cluster RCT to Increase HIV Testing in Substance Use Treatment Programs","Inclusion Criteria:\n\n* Eligible sites must:\n\n  1. See at least 150 unduplicated patients\u002Fyear\u002Fsite\n  2. Be capable and willing to prospectively collect data on the number of patients who a) are offered any HIV and\u002For HCV tests; b) completed these tests; c) are referred to care\u002Fevaluation (and type of referral) if positive; and d) are linked to care\u002Fevaluation within 30 days of diagnosis\n  3. Be capable and willing to provide patient demographics, testing data within demographic categories of gender and race\u002Fethnicity (in aggregate) and data on HIV\u002FHCV test reimbursement processes and outcomes\n  4. Have key staff willing to consent to participate in study surveys, qualitative interviews and intervention coaching throughout the study\n\nExclusion Criteria:\n\n* Sites will be excluded if:\n\n  1. Over 50% of patients served in the prior 6 months were HIV or HCV tested\n  2. They are terminated via PI decision\u002Fdiscretion",{"count":279,"type":21},418,[124],"This study will test two active evidence-based \"practice coaching\" (PC) interventions to improve opioid treatment programs' (OTPs') provision and sustained implementation of on-site 1) HIV testing and linkage to care and 2) HIV\u002FHepatitis C virus (HCV) testing and linkage to care among patients seeking\u002Freceiving substance use disorder treatment.\n\nAims are:\n\nAim 1: To evaluate the effectiveness of the PC interventions on improving patient uptake of HIV testing in OTPs including the incremental impact of the HIV\u002FHCV intervention on HIV testing.\n\nAim 2: To examine, using mixed-methods, the impact of the PC interventions on the initiation and sustained provision of HIV testing and timely linkage to care.\n\nAim 3: To evaluate the health outcomes, health care utilization, and cost-effectiveness of the PC interventions compared incrementally to one another and to the control condition.\n\nPrimary Hypothesis:\n\n1. The two PC interventions will result in significantly higher proportions of patients tested for HIV than the information control condition during the \"initial impact\" period (7-12 months post-randomization or T3), controlling for the proportion of patients tested during the baseline period, T1 (Primary) and during the \"sustained impact\" period, 13-18 months post-randomization or T4 (Secondary).\n2. The HIV\u002FHCV PC intervention will result in significantly higher proportions of patients tested for HIV than the HIV PC intervention during the initial impact period (7-12 months post-randomization or T3), controlling for the proportion of patients tested during the baseline period, T1 (Secondary) and during the \"sustained impact\" period, 13-18 months post-randomization or T4 (Secondary).",[283,284,285,286],"HIV\u002FAIDS","Hepatitis C","Substance Use Disorders","Opioid-use Disorder",[288,289,290,291,292,293,294],"HIV","HIV Testing","Hepatitis C Virus Testing","Opioid Use Disorder Treatment","Substance Use Disorders Treatment","Hepatitis C Virus","Practice Coaching","2026-08-05",{"date":264,"type":45},{"date":298,"type":45},"2017-06-12",{"date":134,"type":21},{"name":51,"class":52},{"id":302,"slug":303,"hasResults":12,"nctId":304,"briefTitle":305,"officialTitle":305,"acronym":4,"eligibilityCriteria":306,"healthyVolunteers":61,"sex":17,"minAge":225,"maxAge":146,"enrollmentInfo":307,"targetDuration":4,"studyType":95,"phases":4,"briefSummary":309,"conditions":310,"keywords":313,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":317,"lastUpdatePostDateStruct":318,"startDateStruct":320,"completionDateStruct":322,"leadSponsor":324,"locationsCount":53},"100380860","autoimmune-features-of-neurodegenerative-disorders-100380860","NCT04239079","Autoimmune Features of Neurodegenerative Disorders","PD and age matched controls:\n\nFor PD participants (n=30):\n\nInclusion criteria:\n\n* Clinical diagnosed PD based on UK Brain Bank criteria for the clinical diagnosis of PD. And must demonstrate two of the following three, as modified from BioFIND criteria: rest tremor, rigidity, or bradykinesia, with dopaminergic medication benefit\n* Age at recruitment ≥ 55\n* Age at motor onset \\> 45\n* PD onset age between 50-75 years\n* Willingness to have genotyping and genetic studies\n\nExclusion criteria:\n\n* Atypical features indicative of a Parkinson-Plus disorder (Progressive Supranuclear Palsy (PSP), Multiple System Atrophy (MSA), Corticobasal Degeneration (CBD)) including cerebellar signs, supranuclear gaze palsy, apraxia and other cortical signs, or prominent autonomic failure, neuroleptic treatment at time of onset of parkinsonism, active treatment with a neuroleptic at time of study entry, history of repeated strokes with stepwise progression of parkinsonism, history of repeated head injury, history of definite encephalitis, prominent gait imbalance early in the course (\\\u003C 5 years)\n* History of Dementia\n* Recent history of cancer (past 3 years), except skin cancer\n* Autoimmune disease\n* Disease of the immune system (e.g. chronic leukemia, HIV)\n* On chronic immune-modulatory therapy (e.g. oral steroids, azathioprine, rituximab)\n* Inability to provide informed consent.\n\nFor age-matched control participants (n=30):\n\nInclusion criteria:\n\n* Ages ≥55 years old\n* With lack of PD in first-degree blood relatives\n* Montreal Cognitive Assessment (MoCA): ≥26\n* Willingness to have genotyping and genetic studies\n\nExclusion criteria:\n\n* Recent history of cancer (past 3 years), except skin cancer\n* Autoimmune disease\n* Disease of the immune system (e.g. chronic leukemia, HIV)\n* On chronic immune-modulatory therapy (e.g. oral steroids, azathioprine, rituximab)\n* Inability to provide informed consent\n\nAD\u002FaMCI and age matched controls:\n\nFor AD\u002FaMCI participants (n=30):\n\nInclusion criteria:\n\n* Clinically diagnosed mild AD\u002Famnestic MCI. The severity will be accessed through the Clinical Dementia Rating Scale (CDR). CDR equal to 0.5 or 1 will be necessary to meet criteria. Participants with advanced AD stage will not be capable to give their consent.\n* Age ≥55 years old\n* Mini-Mental State Exam (MMSE): 20-26\n* Willingness to have genotyping and genetic studies\n\nExclusion criteria:\n\n* Other forms of dementia including frontotemporal dementia or other dementia associated with parkinsonism such as Dementia with Lewy bodies (DLB), or Parkinson's disease Dementia (PDD), Progressive Supranuclear Palsy or corticobasal degeneration.\n* History of Parkinson's disease (PD)\n* Recent history of cancer (past 3 years), except skin cancer\n* Autoimmune disease\n* Disease of the immune system (e.g. chronic leukemia, HIV)\n* On chronic immune-modulatory therapy (e.g. oral steroids, azathioprine, rituximab)\n* Inability to provide informed consent\n\nFor age-matched control participants (n=30):\n\nInclusion criteria:\n\n* Healthy volunteers ≥55 years old\n* CDR: 0\n* MoCA: ≥26\n* Willingness to have genotyping and genetic studies\n\nExclusion criteria:\n\n* History of Parkinson's disease (PD)\n* Recent history of cancer (past 3 years), except skin cancer\n* Autoimmune disease\n* Disease of the immune system (e.g. chronic leukemia, HIV)\n* On chronic immune-modulatory therapy (e.g. oral steroids, azathioprine, rituximab)\n* Inability to provide informed consent",{"count":308,"type":21},120,"This study is being conducted to better understand the role of inflammation in Parkinson's disease (PD) and Alzheimer's disease (AD). The investigators plan to recruit 30 PD, 30 AD\u002FAmnestic Mild Cognitive Impairment (aMCI), and 60 age matched healthy controls in this study to study the role of immune response in PD and AD.\n\nThe study involves up to two study visits involving brief questionnaires and blood draw of up to 250cc (approximately 17 tablespoons) to be collected. More ways to participate, including 1) smaller amount blood donation (up to 100cc per visit for 1-2 visits); and 2) participation via tele-visit and mobile phlebotomy visits (blood donation up to 50cc, \\~5 tubes, by a certified mobile phlebotomist at home\u002Flocation of choice) now available.",[311,232,312],"Parkinson Disease","Mild Cognitive Impairment",[314,315,316,312],"Autoimmune features","Parkinson's disease","Alzheimer's disease","2026-07-31",{"date":319,"type":45},"2026-08-04",{"date":321,"type":45},"2019-05-01",{"date":323,"type":21},"2028-07",{"name":51,"class":52},{"id":326,"slug":327,"hasResults":12,"nctId":328,"briefTitle":329,"officialTitle":330,"acronym":4,"eligibilityCriteria":331,"healthyVolunteers":12,"sex":17,"minAge":332,"maxAge":333,"enrollmentInfo":334,"targetDuration":4,"studyType":22,"phases":336,"briefSummary":337,"conditions":338,"keywords":340,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":388,"lastUpdatePostDateStruct":389,"startDateStruct":390,"completionDateStruct":392,"leadSponsor":394,"locationsCount":53},"100635997","adapting-youth-nominated-support-team-yst-to-prevent-suicide-100635997","NCT07559955","Adapting Youth Nominated Support Team (YST) to Prevent Suicide","Adapting Youth Nominated Support Team (YST) to Prevent the Escalation of Suicide Risk Among Youth on Probation","Inclusion Criteria:\n\nYST-P Pilot Youth on probation, referred to study by YST Intervention Specialist (n=40)\n\n1. Conversational in English (self-report\u002Fcaregiver)\n2. Age 12-17years 11months (self-report\u002Fcaregiver)\n3. Probation involvement (probation staff)\n4. Have a caregiver who is willing to participate (caregiver)\n5. Endorsed PY suicidal ideation (probation staff)\n6. Nominated 2-4 supportive adults, at least 2 of whom are willing to participate (Intervention Specialist, supportive adult)\n\nCaregivers, referred to study by YST Intervention Specialist (n=40)\n\n1. Conversational in English (self-report)\n2. Caregiver of a youth who is eligible and willing to participate (probation referral, youth report)\n\nSupportive adults, referred to study by YST Intervention Specialist (n=40)\n\n1. Participating as a supportive adult in YST-P as indicated by completion of YST-P psychoeducational session (Intervention Specialist report)\n2. Conversational in English (self-report)\n3. Approved by youths' caregiver (caregiver)\n4. Be appropriate as determined by the YST-P Intervention Specialist (Intervention Specialist).\n\nProbation staff, assisted by agency leadership (n=15)\n\n1. Conversational in English (self-report)\n2. Employed by Suffolk or Nassau County Probation working with youth (self-report\u002Fagency leadership)\n\nIntervention Specialists, assisted by agency leadership (n=2)\n\n1. Conversational in English (self-report)\n2. Employed by Hope for Youth Licensed behavioral health clinician (self-report\u002Fagency leadership)\n3. Trained as YST-P Intervention Specialists (Research team)\n4. Facilitating the YST-P intervention (Research team)\n\nExclusion Criteria:\n\n\\- Participants not meeting all inclusion criteria will be excluded from research activities.","12 Years","80 Years",{"count":335,"type":21},137,[124],"The goal of this study is to conduct a pilot test of a mental health support program called the Youth-Nominated Support Team - Probation (YST-P) for young people ages 12-17 on probation, experiencing suicidal ideation and behaviors (SIB). Young people on probation experience SIB at higher rates than youth in the general population, but often do not receive the mental health care they need due to multi-level barriers. YST-P is adapted from an existing evidence-based, social support intervention, Youth-Nominated Support Team (YST), which is a psychoeducational, social support intervention originally created as an adjunctive to standard behavioral health (BH) treatment for youth with suicide risk following psychiatric hospitalization. YST-P is an adaptation of YST designed to meet the unique needs of youth on probation, addressing their SIB and increasing their uptake of treatment, by leveraging their existing social networks. YST-P is designed as an early intervention program to prevent escalation of SIB and increase probation youths' treatment uptake, bridging them to care. The study entails a single-arm pilot to examine reductions in SIB (within-subject comparison), and increased treatment uptake (comparing YST-P participants to a propensity-matched, historical control). This study will additionally explore theorized mechanisms of intervention action as well as implementation outcomes and barriers\u002Ffacilitators to YST-P. The goal is for results from this study to inform a larger, fully powered effectiveness trial, as well as future studies leveraging youths' existing social support networks to prevent SIB and bridge them to care.",[339],"Suicidal Ideation and Behavior",[341,342,339,343,344,345,346,347,348,349,350,351,352,353,354,355,356,357,358,359,360,361,362,363,364,365,366,367,368,369,370,371,372,373,374,375,376,377,378,379,380,381,382,383,384,385,386,387],"Behavioral Health","Suicide","Suicidal Ideation and Behaviors","Suicidal Ideation in Teens","Mental Health","Teen Mental Health","Adolescent Mental Health","Probation","Teens Probation Mental Health","Probation Mental Health","Probation Behavioral Health","Implementation","Implementation Science","Partnerships","e-Connect","YST","Youth Nominated Support Team","Caregiver Teens","Caregiver Mental Health","Teen Behavioral Health","Caregiver Behavioral Health","Probation Officer","Probation Officer Mental Health","Probation Staff Mental Health","Probation Staff","Social Workers","Social Workers Mental Health","Intervention","Interventions","Mental Health Interventions","Behavioral Health Interventions","Teen Probation Intervention","Youth Intervention","Youth Mental Health Intervention","Adolescent Probation","Juvenile Justice System","Juvenile Justice System Mental Health","Juvenile Probation","Juvenile Probation Mental Health","SIB","Teen SIB","Youth SIB","Adolescent SIB","Teen Suicidal Ideation and Behavior","Youth Suicidal Ideation and Behavior","Adolescent Suicidal Ideation and Behavior","Implementations","2026-07-30",{"date":317,"type":45},{"date":391,"type":21},"2027-02-01",{"date":393,"type":21},"2028-07-31",{"name":51,"class":52},{"id":396,"slug":397,"hasResults":12,"nctId":398,"briefTitle":399,"officialTitle":399,"acronym":4,"eligibilityCriteria":400,"healthyVolunteers":61,"sex":17,"minAge":401,"maxAge":402,"enrollmentInfo":403,"targetDuration":4,"studyType":22,"phases":405,"briefSummary":406,"conditions":407,"keywords":409,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":388,"lastUpdatePostDateStruct":415,"startDateStruct":416,"completionDateStruct":418,"leadSponsor":420,"locationsCount":53},"100549136","mechanistic-effect-of-walnut-consumption-on-sleep-quality-100549136","NCT06430086","Mechanistic Effect of Walnut Consumption on Sleep Quality","Inclusion Criteria:\n\n* Equal numbers of men and women (12 male and 12 post-menopausal female)\n* Equal number of individuals with normal weight (18.5-24.9 kg\u002Fm2) and overweight (25-29.9 kg\u002Fm2)\n* Participants will self-report poor sleep quality, reflected by a global score \\>5 on Pittsburgh Sleep Quality Index\n\nExclusion Criteria:\n\n* Diagnosed sleep disorder\n* Participants with conditions that could affect sleep will be excluded:\n\n  * smoking, excessive caffeine intake (\\>300 mg\u002Fday)\n  * shift work\n  * chronic pain\n  * diagnosis of a chronic disease (e.g., uncontrolled hypertension, pre-diabetes, type 2 diabetes, chronic kidney disease, chronic obstructive pulmonary disease),\n  * autoimmune diseases\n  * cardiovascular event or cancer in the past 24 months\n  * psychiatric\u002Fneurologic disease or disorder, or sleep disorder (diagnosed or high risk for sleep apnea, chronic insomnia, restless leg syndrome, narcolepsy)\n  * use of medications that influence CYP1A2 enzymes\n* Allergy\u002Fintolerance to nuts, tree nuts, or unwilling to eat study foods","45 Years","65 Years",{"count":404,"type":21},24,[124],"Poor sleep quality is very common in modern society. Walnuts contain many nutrients that may be helpful for sleep, including melatonin and polyphenols. Some studies show that eating foods high in melatonin and polyphenols improves sleep quality, but walnuts have not been studied specifically. This study proposes to test if eating walnuts improves sleep compared to a food that lacks these sleep-promoting factors. The investigators expect that walnut consumption for 4 days will increase melatonin levels and lead to better sleep quality compared to a high-carbohydrate, high-sugar food. The study will enroll middle-aged and older adults with sleep complaints to participate in this study. Each person will eat the two different foods for 4 days each in random order. The 4-day periods will be separated by at least 2-3 weeks. Sleep quality will be measured by questionnaire and with a wrist monitor every day. The investigators will also do a sleep study using electroencephalography (EEG) on night 3 and take measures of circadian physiology (natural body rhythms) in the laboratory on day 4 (including overnight) by measuring body temperature and blood and urine melatonin. The study findings may provide new options to improve sleep health from increased walnut consumption.",[408],"Poor Sleep Quality",[410,411,412,413,414],"Randomized crossover study","Controlled feeding","Dietary intervention","Inpatient visit","Outpatient monitoring",{"date":317,"type":45},{"date":417,"type":45},"2024-06-28",{"date":419,"type":21},"2026-12-31",{"name":51,"class":52},{"id":422,"slug":423,"hasResults":12,"nctId":424,"briefTitle":425,"officialTitle":426,"acronym":4,"eligibilityCriteria":427,"healthyVolunteers":12,"sex":17,"minAge":332,"maxAge":428,"enrollmentInfo":429,"targetDuration":4,"studyType":22,"phases":430,"briefSummary":431,"conditions":432,"keywords":437,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":440,"lastUpdatePostDateStruct":441,"startDateStruct":442,"completionDateStruct":443,"leadSponsor":445,"locationsCount":4},"100643545","the-use-of-a-comfort-tote-to-improve-recovery-in-pediatric-and-adolescent-patients-after-surgery-100643545","NCT07632833","The Use of a Comfort Tote to Improve Recovery in Pediatric and Adolescent Patients After Surgery","The Use of the Comfort Tote Following Posterior Spinal Fusion for Adolescent Idiopathic Scoliosis: a Randomized Controlled Trial Pilot Study","Inclusion Criteria:\n\n* Patients of all genders, racial, and ethnic groups aged between 10 and 21 that have had been diagnosed with AIS requiring surgical correction with PSF.\n* Patients must be scheduled to undergo PSF at Morgan Stanley Children's Hospital of NYP.\n* The patients and their parent(s)\u002Flegal guardian(s) must also provide informed consent, for those under 18 years old.\n* The patient population will include mental health conditions such as anxiety and\u002For depression and all surgery levels.\n\nExclusion Criteria:\n\n* Patients who have had growing rods and revisions, those who have local or systemic infections, those with anemia, cardiovascular diseases, or osteoporosis, and patients with severe medical comorbidities such as neurological or developmental condition that precludes engagement with the Comfort Tote\n* Patients with two or more chronic conditions (excluding AIS)","21 Years",{"count":94,"type":21},[124],"The goal of this clinical trial is to learn if the use of Comfort Tote can treat pain and anxiety in adolescents with idiopathic scoliosis undergoing posterior spinal fusion. The study aims to answer two questions:\n\n1. To characterize the effectiveness and determine the impact of integrative therapy interventions of the Comfort Tote use in reducing self-reported pain, anxiety, and stress among pediatric patients with AIS undergoing PSF. By comparing self-reported pain, anxiety, and stress scores, as well as documented Morphine Milligram Equivalents (MMEs) and Numeric Rating Scale (NRS) pain scores, between patients using non-therapeutic and therapeutic Comfort Totes.\n2. To evaluate the impact of an educational video on the use of the Comfort Tote. This will assess whether the inclusion of instructional content enhances understanding and application of the Comfort Tote, thereby improving patient outcomes in pain management, anxiety reduction, and overall satisfaction with care. It is hypothesized that the therapeutic Comfort Tote intervention with the educational video will provide the highest patient satisfaction and greater tote usage, with decreased patient pain, stress, and anxiety levels. The findings from this pilot study will provide crucial insights into establishing a new standard of care for pediatric patients undergoing PSF and potentially provide baseline data for use in larger, multicenter randomized controlled trials.",[433,434,435,436],"Adolescent Idiopathic Scoliosis","Postoperative Pain, Acute","Postoperative Nausea and Vomiting","Anxiety",[438,439],"Posterior spinal fusion","Integrative therapy","2026-07-29",{"date":388,"type":45},{"date":243,"type":21},{"date":444,"type":21},"2028-06-30",{"name":51,"class":52},{"id":447,"slug":448,"hasResults":12,"nctId":449,"briefTitle":450,"officialTitle":451,"acronym":452,"eligibilityCriteria":453,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":225,"enrollmentInfo":454,"targetDuration":4,"studyType":22,"phases":456,"briefSummary":458,"conditions":459,"keywords":462,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":466,"lastUpdatePostDateStruct":467,"startDateStruct":468,"completionDateStruct":469,"leadSponsor":471,"locationsCount":53},"100638428","phase-3-migraine-headaches-elimination-with-patent-foramen-ovale-directed-therapy-100638428","NCT07629635","Migraine Headaches Elimination With Patent Foramen Ovale-Directed Therapy","Cessation of Migraine Headaches With Patent Foramen Ovale-Directed Therapy (COMFORT - PFO): An Investigator-Initiated Study","COMFORT-PFO","Patient Inclusion Criteria:\n\n* Age: ≥18 and \\\u003C55 at time of screening\n* Migraine headache with aura, or migraine headache without aura, fulfilling conditions of the Neurology Screening Tool (meeting ICHD-3 criteria)\n* Diagnosis of migraine for ≥ 1 year; onset of migraine symptoms \\\u003C 40 years of age\n* By history, an average headache burden of greater than one migraine headache day per week:\n* without current preventative therapy, OR\n* despite preventative therapy, OR\n* with reason to come off effective therapy (e.g. cost, aversion to injections, side effects)\n* If patient is taking preventive migraine medications, dose must be stable for at least 3 months prior to the screening visit. Patient agrees to continue preventive medication at the current dosage throughout the duration of the Baseline and On-treatment monitoring periods (Study Weeks 1 - 17).\n* Female patients capable of becoming pregnant agree to use two forms of birth control or abstinence during their participation in the study.\n\nPatient Exclusion Criteria:\n\nExclusions due to underlying patient medical issues:\n\n* Headache disorder other than migraine with aura, or migraine without aura\n* Patient has history of stroke, TIA, or intracranial hemorrhage.\n* Patient has a history of thrombocytopenia within one year, or platelet count \\\u003C100,000\u002Fmm3 identified during the screening laboratory evaluation.\n* Patient has severe hepatic impairment with reduced synthetic function as documented by prolongation of PT\u002FPTT, or with total bilirubin \\>3.0 mg\u002FdL identified during the screening laboratory evaluation.\n* Patient has previously implanted pacemaker, IVC filter, PFO closure device, ASD closure device, or left atrial appendage closure device or any cardiac history which, in the investigator's opinion, would preclude them from study participation.\n* Patient has documented right-to-left shunt source in addition to PFO such as atrial septal defect or pulmonary arteriovenous malformation.\n* Patient has a history of clinically significant bleeding within 6 months of the screening visit, any active bleeding, or active peptic ulcer disease.\n* Patient has an uncontrolled arrhythmia, or if on therapy, has evidence of arrhythmia control failure within the past 90 days (e.g., supraventricular tachycardia or atrial fibrillation while under rhythm control).\n* Patient has elevated PVR which in the opinion of the implanting physician precludes safe PFO closure.\n* Patient has active infection at the time of screening that cannot be treated.\n* Patient is planning surgery during the study timeframe.\n* A female patient is pregnant or is planning pregnancy during the anticipated duration of the study. Urine or blood pregnancy screening will be performed as part of the screening laboratory evaluation.\n* Patient has documented nickel allergy\u002Fsensitivity\n* Patient has a documented history of non-compliance with medical care, which would preclude them, in the opinion of the study team\n\nExclusion Due to Medication Restrictions:\n\n* Patient has known hypersensitivity or contraindication to thienopyridines\n* Patient has another medical condition requiring chronic antithrombotic therapy with antiplatelet, oral anticoagulant or injectable agents\n* Patient has need for daily use of NSAIDs other than for treatment of migraines",{"count":455,"type":21},32,[457],"PHASE3","Migraine is a common and often disabling condition, but its exact causes are not fully understood. Some people with migraines have a small opening in the heart wall called a patent foramen ovale (PFO). In some of these patients, closing this opening or taking a medication that inhibits blood platelets (prasugrel) has been shown to reduce migraines. However, not everyone benefits, and it is unclear why. This study is being done to better understand whether closing a PFO can provide lasting migraine relief - especially in patients whose migraines improve with prasugrel.\n\nThe goal of this study is to find out whether, in patients whose migraines improve while taking prasugrel, closing the PFO along with 24 weeks of prasugrel leads to better long-term migraine relief after stopping the medication, than by taking prasugrel for 24 weeks alone.\n\nParticipants will track their migraines daily using an electronic diary, then take prasugrel and compare their migraines while on the medication. Only patients whose migraines improve on this medication will continue in the study. Eligible participants will be randomly assigned (like flipping a coin) to one of two groups: 1) Medication-only group: Continue prasugrel for 24 weeks. 2) Procedure group: Undergo a minimally invasive procedure to close the PFO and continue prasugrel for 24 weeks. After treatment, the medication will be stopped in both groups, and participants will again track their migraines for about 8 weeks.\n\nThe main question is: Do patients who have PFO closure continue to have fewer migraines after stopping prasugrel compared with those who did not have the procedure?",[460,461],"Migraine Disease","Patent Foramen Ovale",[463,461,464,452,465],"Migraine Headaches","Thienopyridine","Prasugrel","2026-07-28",{"date":440,"type":45},{"date":82,"type":21},{"date":470,"type":21},"2028-03",{"name":51,"class":52},{"id":473,"slug":474,"hasResults":12,"nctId":475,"briefTitle":476,"officialTitle":477,"acronym":478,"eligibilityCriteria":479,"healthyVolunteers":61,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":480,"targetDuration":4,"studyType":22,"phases":482,"briefSummary":483,"conditions":484,"keywords":488,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":492,"lastUpdatePostDateStruct":493,"startDateStruct":494,"completionDateStruct":496,"leadSponsor":498,"locationsCount":4},"100649609","screening-with-portable-x-rays-for-rapid-recognition-of-tb-100649609","NCT07737275","Screening With Portable X-rays for Rapid Recognition of TB","Mobilizing Innovative Strategies to Improve Tuberculosis (TB) Diagnosis and Retention in the TB Care Cascade for Migrant Communities in New York City","SPOT-TB","Inclusion Criteria:\n\n* Adult persons 18 years or older\n* Self-identifying as migrants to the US\n* Self-reporting migration within the 24 months\n\nExclusion Criteria:\n\n* Lack capacity for informed consent\n* Unable to perform translation\u002Fstudy materials not available in appropriate language\n* Unwilling to participate\n* Prisoner\n* Pregnancy",{"count":481,"type":21},1000,[124],"SPOT-TB (Screening with Portable X-rays for rapid recOgniTion of TB) is a prospective study evaluating a community-based tuberculosis (TB) screening strategy for migrant populations in New York City. The screening intervention integrates mobile ultra-portable digital chest radiography with artificial intelligence-assisted image interpretation, tuberculosis symptom assessment, latent tuberculosis infection testing, and HIV testing. Participants with concerning screening findings are referred for appropriate clinical evaluation. The study will evaluate the feasibility, acceptability, and effectiveness of this integrated screening strategy for improving early identification of active pulmonary tuberculosis and linkage to care in community settings.",[485,486,487],"Tuberculosis (TB)","Tuberculosis Infection, Latent","HIV (Human Immunodeficiency Virus)",[489,490,491,288],"Tuberculosis","Mobile Screening","Chest x-ray","2026-07-27",{"date":388,"type":45},{"date":495,"type":21},"2026-08-15",{"date":497,"type":21},"2028-03-10",{"name":51,"class":52},{"id":500,"slug":501,"hasResults":12,"nctId":502,"briefTitle":503,"officialTitle":503,"acronym":504,"eligibilityCriteria":505,"healthyVolunteers":12,"sex":17,"minAge":225,"maxAge":506,"enrollmentInfo":507,"targetDuration":4,"studyType":22,"phases":509,"briefSummary":511,"conditions":512,"keywords":515,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":492,"lastUpdatePostDateStruct":518,"startDateStruct":519,"completionDateStruct":521,"leadSponsor":523,"locationsCount":524},"100562343","phase-2-cognitive-training-and-neuroplasticity-in-mild-cognitive-impairment-cogit-2-trial-100562343","NCT06601933","Cognitive Training and Neuroplasticity in Mild Cognitive Impairment: COGIT-2 Trial","COGIT-2","Inclusion Criteria:\n\n1. Access to a home desktop or laptop computer or tablet at acceptable internet speed for the study duration.\n2. Participants need to be 55 to 89 years of age (inclusive) at the time of informed consent.\n3. Females need to be post-menopausal (last period more than 12 months earlier by history).\n4. Subjective cognitive complaints, i.e., memory or other cognitive complaints, e.g., naming\u002Flanguage.\n5. Meets criteria for cognitive impairment (CI), including either EMCI (early MCI) or LMCI (late MCI), defined as memory impairment documented by scoring below the education adjusted cutoff on the Logical Memory II subscale (Story A, Delayed Paragraph Recall) from the Wechsler Memory Scale - III (WMS-III) (the maximum score is 25). The criteria for MCI (includes EMCI and LMCI) and used in COGIT-2 are as follows: EMCI is defined by a WMS-III Logical memory delayed recall score of 3-6 with 0-7 years of education, score of 5-9 with 8-15 years of education, and score of 9-11 with 16 or more years of education. LMCI is defined by a WMS-III Logical Memory delayed recall score ≤ 2 with 0-7 years of education, score ≤ 4 with 8-15 years of education, and score ≤ 8 with ≥ 16 years of education.\n6. Montreal Cognitive Assessment (MoCA) score ≥ 20\u002F30.\n7. An informant (relative, friend, other caregiver) who contacts the participant at least weekly is required to provide information about the participant's functioning. This can be a telephone informant in the case of participants who do not have a live-in informant or close significant other. If the informant drops out, an alternate informant can be designated by the participant but the new informant will need to sign the informant information sheet.\n8. Must be English-speaking: Wide Range Achievement Test (WRAT3) score must indicate at least a 6th grade reading level with a score of ≥ 37.\n\nExclusion Criteria:\n\n1. Diagnosis of dementia of any type.\n2. Current clinical diagnosis of schizophrenia, schizoaffective disorder, psychosis, or bipolar I disorder (Diagnostic and Statistical Manual of Mental Disorders (DSM-5 TR) criteria).\n3. Current unstable or untreated major depression, or active suicidality based on a Suicide Severity Rating Scale (C-SSRS Screen version: positive answer to question 1 or 2 followed by item 6 positive answer leads to exclusion. Negative answer to questions 1 and 2: interview ends and the participant is not excluded for active suicidality).\n4. Current or recent (past 6 months) alcohol or substance use disorder (DSM-5 TR criteria).\n5. Clinical stroke with residual neurological deficits. While we will not exclude participants with cerebrovascular disease or transient ischemic attacks (TIAs), we do not wish to include participants with a frank clinical stroke because it is not clear that this type of participant is similar to the MCI participant generally, and clear-cut neurological impairment, e.g., hemiplegia\u002Fhemiparesis or speech impairment, may compromise the ability to do the procedures and to complete the neuropsychological test battery.\n6. Use of medications known to have a negative impact on cognition: benzodiazepines in lorazepam equivalents greater than or equal to 1 mg daily, narcotics, anticholinergic medications at ACB Calculator level 3), large number of sedating medications in combination. Current use of lecanemab or donanemab will be exclusionary.\n7. Presence of any of the following disorders: a) Central Nervous System Infections, with cerebrospinal fluid evidence of meningitis, encephalitis, or other infectious process; b) dementia of any type; c) Huntington's disease; d) Multiple sclerosis; e) Parkinson's disease; f) Other neurologic disorders with focal signs, e.g., amyotrophic lateral sclerosis.\n8. Acute, severe unstable medical illness in the judgment of the clinician. For cancer, acutely ill participants (including those with metastases) are excluded, but history of successfully treated cancer does not result in exclusion.\n9. Contraindication to MRI scan: MRI incompatible pacemakers and metal implants, any other contraindication to MRI. For participants with possible claustrophobia, they must be willing to do the MRI with adjunct lorazepam 0.5 mg to reduce anxiety. For participants who are recruited and are eligible for MRI but are unable to complete the baseline MRI, a repeat MRI for the same time-point can be attempted if the subject is willing. Baseline MRI is required for study inclusion.\n10. Regular use of crosswords or formal computerized cognitive training platforms averaging once per week or more than once per week in the past year. Eligible participants who join the trial are instructed not to do these procedures on their own during the trial, i.e., independent of the study.\n11. Participation concurrently in another therapeutic clinical trial of a cognitive enhancing drug or device or procedure.\n12. Geriatric Depression Scale (Short Form) score of ≥ 6.","89 Years",{"count":508,"type":21},240,[510],"PHASE2","Effective, clinically meaningful treatments are lacking for patients with mild cognitive impairment (MCI), which is associated with increased risk of transition to dementia. Cognitive training represents an important therapeutic strategy. In a previous study, crossword puzzles were found to be superior to computerized cognitive training on the primary cognitive outcome and function with decreased brain atrophy. Building on these findings, this study will evaluate and compare the impact of high dose crosswords (4 puzzles per week) to low dose crosswords (1 puzzle per week) and a health education control group on the cognition and function of participants.",[513,514],"Mild Cognitive Impairment (MCI)","Cognitive Training",[312,514,516,517],"Crossword Puzzles","Health Education",{"date":466,"type":45},{"date":520,"type":45},"2024-12-17",{"date":522,"type":21},"2030-08-31",{"name":51,"class":52},4,{"id":526,"slug":527,"hasResults":12,"nctId":528,"briefTitle":529,"officialTitle":529,"acronym":530,"eligibilityCriteria":531,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":532,"targetDuration":4,"studyType":22,"phases":534,"briefSummary":535,"conditions":536,"keywords":4,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":492,"lastUpdatePostDateStruct":537,"startDateStruct":538,"completionDateStruct":540,"leadSponsor":542,"locationsCount":543},"100552370","community-health-workers-and-mhealth-to-improve-viral-suppression-plus-champs-100552370","NCT06472206","Community Health Workers And MHealth to ImProve Viral Suppression Plus (CHAMPS+)","CHAMPS+","Inclusion Criteria:\n\n* Be able to speak, read, and write in English;\n* Be above 18 years of age;\n* Be willing to participate in any assigned arm of the intervention;\n* Have an HIV-1 RNA level \\>200 copies\u002FmL;\n* Own a smartphone;\n* Be able and willing to provide informed consent for study participation and consent for access to medical records.\n* Live, work and or receive care in AL, LA, or MS\n\nExclusion Criteria:\n\n* Reside in a nursing home, prison, and\u002For receiving in-patient psychiatric care at time of enrollment;\n* Terminal illness with life expectancy \\\u003C6 months; and\n* Planning to move out of the area in the next 12 months.",{"count":533,"type":21},420,[124],"Although global efforts have been made to end the HIV epidemic, there are still some gaps in HIV testing, antiretroviral therapy (ART) adherence, and viral suppression (VS) among people with HIV (PWH). These gaps are particularly prominent in the Deep South of the United States (US), where PWH face challenges in accessing healthcare services. In response, a team of experienced researchers has developed and tested the Community Health Workers And MHealth to ImProve Viral Suppression (CHAMPS) intervention. This intervention uses mobile health (mHealth) technology and a team of community health workers (CHW) to design an intervention to improve ART adherence and VS. The CHAMPS+ intervention adds a CHW delivered supportive risk reduction counseling during periods of non-suppression to prevent HIV transmission. The study will engage the participants by developing culturally relevant materials and retention strategies, evaluating the clinical effectiveness and sustainability of the intervention in Deep South settings, and assessing regionalized implementation factors. Ultimately, the study will test the effectiveness of CHAMPS+ on ART adherence and viral load suppression for PWH in Alabama, Louisiana, and Mississippi.",[283],{"date":440,"type":45},{"date":539,"type":45},"2024-09-23",{"date":541,"type":21},"2027-12-22",{"name":51,"class":52},5,{"id":545,"slug":546,"hasResults":12,"nctId":547,"briefTitle":548,"officialTitle":549,"acronym":4,"eligibilityCriteria":550,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":551,"enrollmentInfo":552,"targetDuration":4,"studyType":22,"phases":554,"briefSummary":555,"conditions":556,"keywords":4,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":492,"lastUpdatePostDateStruct":558,"startDateStruct":559,"completionDateStruct":561,"leadSponsor":563,"locationsCount":53},"100525416","adherence-intervention-in-patients-with-metastatic-breast-cancer-100525416","NCT06121453","Adherence Intervention in Patients With Metastatic Breast Cancer","P50 Supplement: Improving Medications Adherence Equitably Among Patients With Metastatic Breast Cancer and Cardiovascular Disease","Inclusion Criteria:\n\n* Women or men age \\>18 years\n* Diagnosed with stage IV\u002Fmetastatic breast cancer prescribed endocrine therapy and a CDK4\u002F6i\n* Prescribed at least 1 antihypertensive or statin medication for CVD prevention or treatment\n* Self-report of at least some nonadherence ET\u002FCDK4\u002F6i or CVD medication on nonadherence screener or verbally to a treating clinician, or nonadherent to ET, CDK4\u002F6i, and\u002For CVD medication on pharmacy fill data in the EHR (proportion of days covered over prior 180 days \\\u003C80%).\n\nExclusion Criteria:\n\n* Non-English or Non-Spanish speaking\n* Not cognitively able to complete study requirements\n* Inability to provide informed consent for any other reason (e.g, severe psychiatric illness, active substance use)\n* Unavailable for 28 weeks of follow-up","99 Years",{"count":553,"type":21},35,[124],"To evaluate the preliminary efficacy of a multicomponent adherence intervention focused on enhancing digital equity and pharmaco-equity among nonadherent patients with metastatic breast cancer (MBC) and cardiovascular disease (CVD) risk factors on endocrine therapy (ET), CDK4\u002F6 inhibitor (CDK 4\u002F6i), and CVD medications. To assess the acceptability and appropriateness of this intervention in patients with MBC and CVD risk factors through validated measures of implementation outcomes. To gain a deeper understanding of the impact of social determinants of health (SDOH) on medication nonadherence through semi-structured interviews with a subset of study participants.",[557],"Breast Cancer",{"date":466,"type":45},{"date":560,"type":45},"2024-04-12",{"date":562,"type":21},"2026-12-10",{"name":51,"class":52},{"id":565,"slug":566,"hasResults":12,"nctId":567,"briefTitle":568,"officialTitle":569,"acronym":570,"eligibilityCriteria":571,"healthyVolunteers":61,"sex":17,"minAge":572,"maxAge":4,"enrollmentInfo":573,"targetDuration":4,"studyType":22,"phases":574,"briefSummary":575,"conditions":576,"keywords":578,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":584,"lastUpdatePostDateStruct":585,"startDateStruct":587,"completionDateStruct":589,"leadSponsor":591,"locationsCount":53},"100589174","navigating-financial-and-health-related-social-needs-in-adolescent-and-young-adult-cancer-survivors-aya-nav-100589174","NCT06950983","Navigating Financial and Health-Related Social Needs in Adolescent and Young Adult Cancer Survivors (AYA-NAV)","Navigating Financial and Health-Related Social Needs in Adolescent and Young Adult Cancer Survivors (AYA-NAV): A Digital Intervention Pilot Study","AYA-NAV","Inclusion Criteria:\n\nAim 1:\n\n* AYAs (age 18-39) who have\u002Fhad a diagnosis of cancer are eligible to participate.\n* English or Spanish-speaking\n\nAim 2 and 3:\n\n* AYAs (age 15-39) who were diagnosed with cancer or began treatment for cancer within the past 6 months, or those who are still on first treatment for cancer (non-relapse)\n* English or Spanish-speaking\n* For AYAs who are \\\u003C 18 years, caregiver participation will be required; for AYAs \\> 18 years, caregivers may co-participate if desired; the primary unit of focus is the AYA patient.\n\nExclusion Criteria:\n\n* Dyad with caregiver or younger AYA that previously participated in study AAAU2405 or AAAY9477\n* Unable to complete financial survey questions or contraindicated (as outlined in Protection of Human Subjects)\n* Dyad with younger AYAs who are enrolled on hospice or receiving other end-of-life care","15 Years",{"count":308,"type":21},[124],"Aim 1: Refine the HRSN navigation model to integrate a digital platform (Findhelp.org) to meet the needs of AYAs. The investigators will conduct iterative co-design sessions with AYAs and caregivers to understand their views on the existing Findhelp.org website and the likely need for other human-to-human and digital strategies to augment platform engagement (e.g., text reminders) and to address vocational needs.\n\nAim 2: Evaluate the feasibility and acceptability of the refined hybrid intervention that includes digital + person-to-person HRSN navigation.\n\nAim 3: Explore the preliminary impact of the refined hybrid intervention, compared to elevated usual care (a one-time referral to FindHelp.org alone), on reduction in financial distress (AYA and caregiver) and on AYA global health (i.e., mental, social, physical).",[577],"Cancer in Adolescence",[579,580,581,582,583],"Cancer","Adolescents","Young adults","Financial needs","Social needs","2026-07-22",{"date":586,"type":45},"2026-07-23",{"date":588,"type":45},"2025-07-23",{"date":590,"type":21},"2027-07-31",{"name":51,"class":52},{"id":593,"slug":594,"hasResults":12,"nctId":595,"briefTitle":596,"officialTitle":596,"acronym":597,"eligibilityCriteria":598,"healthyVolunteers":61,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":599,"targetDuration":4,"studyType":22,"phases":601,"briefSummary":602,"conditions":603,"keywords":605,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":607,"lastUpdatePostDateStruct":608,"startDateStruct":610,"completionDateStruct":612,"leadSponsor":614,"locationsCount":138},"100640578","guideseq-genomic-understanding-impact-decision--ethics-in-prenatal-sequencing-100640578","NCT07610590","guideSEQ: Genomic Understanding, Impact, Decision & Ethics in Prenatal Sequencing","guideSEQ","Inclusion Criteria:\n\n* Patient planned chorionic villus sampling (CVS) or amniocentesis in the absence of major fetal structural anomalies (minor anomalies are eligible, the HPO (Human Phenotype Ontology) will not be used by the analyst)\n* Certified genetic counselor involved in care\n\nExclusion Criteria:\n\n* A major structural anomaly\n* Maternal or paternal age less than 18 years old\n* Parental unwillingness to participate in 1 year of postnatal follow-up\n* Language barrier (non-English or Spanish speaking)",{"count":600,"type":21},1042,[124],"This study looks at whether genome sequencing should be used more routinely during pregnancy, even when ultrasounds look normal. Genome sequencing can examine nearly all of a baby's genes and may find genetic conditions that standard tests do not detect. Researchers will compare this test with current prenatal testing to see if it provides helpful information for families and doctors. The study will also explore how parents decide what kinds of genetic information they want to receive and how this information affects their experience during pregnancy. The goal is to understand whether genome sequencing can be used in a way that is helpful, responsible, and supportive for families in the future.",[604],"Prenatal Genetic Diagnosis",[606],"Genome Sequencing","2026-07-14",{"date":609,"type":45},"2026-07-15",{"date":611,"type":45},"2026-04-29",{"date":613,"type":21},"2029-07-31",{"name":51,"class":52},{"id":616,"slug":617,"hasResults":12,"nctId":618,"briefTitle":619,"officialTitle":620,"acronym":4,"eligibilityCriteria":621,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":551,"enrollmentInfo":622,"targetDuration":4,"studyType":22,"phases":624,"briefSummary":625,"conditions":626,"keywords":4,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":628,"lastUpdatePostDateStruct":629,"startDateStruct":631,"completionDateStruct":633,"leadSponsor":634,"locationsCount":53},"100484265","opioid-dispensing-device-for-post-operative-pain-in-cancer-patients-100484265","NCT05585788","Opioid Dispensing Device for Post-Operative Pain in Cancer Patients","Efficacy of a Pill-Dispensing System to Increase Disposal of Unused Opioids and to Reduce Refills After Cancer-Related Surgery","Inclusion Criteria:\n\n* Adult patients (age greater than or equal to 18 years)\n* Planned for major cancer-related surgery and expected to receive a postoperative opioid prescription\n* Must speak English or Spanish\n* Must have access to a smartphone or an alternative smart device (e.g., iPhone, Android phone, iPad, Surface, etc.).\n* Co-enrollment in trials involving pharmacologic therapy is allowed\n\nExclusion Criteria:\n\n* Patients who are taking opioids daily prior to the surgical procedure\n* Patients unable to physically utilize the device\n* Patients unable to self-administer medications\n* Patients uncomfortable with using iPhone or iPad-based technology",{"count":623,"type":21},140,[124],"This research study will evaluate the use of, and participants experience with, a new device called Addinex that safely stores and dispenses opioid medication. The purpose of this study is to evaluate the use of the Addinex device in cancer patients undergoing cancer-related surgery that require pain control with opioids after the surgery. Participants will be asked to answer questions about their medical history and background, fill out questionnaires, use a mobile application associated with the device, and undergo a phone interview one month after stopping use of the device. This study aims to find out how participants like using the Addinex device as opposed to a traditional pill bottle. Results of this study will help determine if the Addinex device could be useful to patients in the future after surgeries, as opposed to typical pill bottles.",[627,557],"Opioid Use","2026-07-09",{"date":630,"type":45},"2026-07-10",{"date":632,"type":45},"2020-10-05",{"date":193,"type":21},{"name":51,"class":52},{"id":636,"slug":637,"hasResults":12,"nctId":638,"briefTitle":639,"officialTitle":640,"acronym":4,"eligibilityCriteria":641,"healthyVolunteers":61,"sex":201,"minAge":18,"maxAge":642,"enrollmentInfo":643,"targetDuration":4,"studyType":95,"phases":4,"briefSummary":645,"conditions":646,"keywords":649,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":654,"lastUpdatePostDateStruct":655,"startDateStruct":657,"completionDateStruct":659,"leadSponsor":661,"locationsCount":53},"100615707","in-vitro-fertilization-ivf-and-prenatal-effects-independent-of-genetics-100615707","NCT07296107","In Vitro Fertilization (IVF) and Prenatal Effects Independent of Genetics","Leveraging IVF to Identify Prenatal Effects Independent of Shared Maternal-Child Genes","Inclusion Criteria:\n\n1. Individuals at 18-28 gestational weeks with donor and homologous IVF pregnancies, ages 18-50.\n2. Participants must be patients receiving their perinatal health care through Columbia University Irving Medical Center's Department of OB\u002FGYN and delivering at New York-Presbyterian Morgan Stanley Children's Hospital.\n3. Participants must be patients delivering at Columbia University Irving Medical Center's Department of OB\u002FGYN and delivering at New York-Presbyterian Morgan Stanley Children's Hospital.\n4. Participants will include the offspring of patients receiving care and delivering at the above institutions.\n5. Enrollment Location(s): Columbia University Irving Medical Center's Department of OB\u002FGYN, delivering at New York-Presbyterian Morgan Stanley Children's Hospital.\n\nExclusion Criteria:\n\n1. Identified addiction disorder\n2. Severe psychiatric condition (defined as symptoms that significantly impair daily functioning and are untreated or not effectively managed)\n3. Multiple fetal pregnancy\n4. Known chromosomal, genetic, or major fetal malformations (unlikely due to routine preimplantation genetic testing)\n5. Inflammatory conditions including rheumatoid arthritis, lupus, and multiple sclerosis\n6. Not planning to deliver at a CUIMC-affiliated hospital","50 Years",{"count":644,"type":21},360,"This study examines how maternal stress during pregnancy affects infant brain and behavioral development, focusing on whether these effects are due to the prenatal environment or shared genes. By comparing IVF pregnancies using donor eggs\u002Fembryos (no shared genetics) with non-donor IVF pregnancies, the investigators aim to understand how stress influences the baby's development independent of genetic factors.\n\nParticipants will complete questionnaires, provide blood samples, and take part in placenta and cord blood collection, fetal monitoring, and newborn brain activity assessments.\n\nAim 1: The influence of maternal distress on perinatal neurobehavioral development.\n\nHypotheses: Independent of IVF group status, higher maternal AL will be associated with higher 3rd trimester FHR reactivity, lower FHR variability, AND lower FHR-movement coupling\n\nAim 2: Maternal distress affecting placenta gene methylation.\n\nHypotheses: Independent of IVF group status, maternal AL will be associated with placenta differential DNA methylation in glucocorticoid-regulating genes (FKBP5 and HSD11B2),\n\nAim 3: Maternal experiences associated with unique placenta transcriptomic profiles.\n\nHypotheses: Independent of IVF group status, maternal AL and well-being each will be associated with unique placenta gene expression in pro-inflammatory genes",[647,648],"Maternal Distress","Child Development",[650,651,652,653],"Developmental Origins of Health and Disease (DOHaD)","Maternal Health","Child development","IVF","2026-07-06",{"date":656,"type":45},"2026-07-07",{"date":658,"type":45},"2026-05-08",{"date":660,"type":21},"2030-07-31",{"name":51,"class":52},{"id":663,"slug":664,"hasResults":12,"nctId":665,"briefTitle":666,"officialTitle":667,"acronym":4,"eligibilityCriteria":668,"healthyVolunteers":12,"sex":201,"minAge":18,"maxAge":669,"enrollmentInfo":670,"targetDuration":4,"studyType":22,"phases":672,"briefSummary":673,"conditions":674,"keywords":676,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":683,"lastUpdatePostDateStruct":684,"startDateStruct":685,"completionDateStruct":687,"leadSponsor":689,"locationsCount":690},"100511885","music-intervention-for-preterm-birth-100511885","NCT05945264","Music Intervention for Preterm Birth","The Impact of a Culturally-based Live Music Intervention on the Metabolites and Metabolic Pathways Associated With Chronic Stress and the Risk of Pre-term Birth in Black Women","Inclusion Criteria\n\n* Aged 18 to 40 years\n* Generally healthy pregnant women in the first trimester of pregnancy\n\nExclusion Criteria:\n\n* Non-pregnant women\n* Women with a chronic medical condition that could impact pregnancy health or duration\n* Women regularly taking any medications other than prenatal vitamins","40 Years",{"count":671,"type":21},142,[124],"This study will test a music intervention (MI) versus a sham control (SC) arm which only includes a verbal intervention, to determine if the effects of the music intervention will reduce the biological impact of chronic stress among pregnant Black women, reduce preterm birth, and improve infant outcomes.",[675],"Preterm Birth",[677,678,679,680,681,682],"Chronic stress","Preterm birth","Black women stress","Metabolomics of chronic stress","Music and medicine","Music intervention","2026-07-02",{"date":654,"type":45},{"date":686,"type":21},"2026-07-26",{"date":688,"type":21},"2027-08-29",{"name":51,"class":52},2,{"id":692,"slug":693,"hasResults":12,"nctId":694,"briefTitle":695,"officialTitle":696,"acronym":4,"eligibilityCriteria":697,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":402,"enrollmentInfo":698,"targetDuration":4,"studyType":22,"phases":699,"briefSummary":700,"conditions":701,"keywords":704,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":707,"lastUpdatePostDateStruct":708,"startDateStruct":709,"completionDateStruct":710,"leadSponsor":712,"locationsCount":53},"100623974","phase-1-effect-of-insulin-lowering-on-lipogenesis-100623974","NCT07403604","Effect of Insulin Lowering on Lipogenesis","Human Models of Selective Insulin Resistance: Diazoxide, Part I","Inclusion Criteria:\n\n* Adults aged 18-65 years\n* Body mass index of 30-45 kg\u002Fm2\n* Able to understand written and spoken English and\u002For Spanish\n* Able to have pre-randomization screening labs drawn and study protocol initiated within 60 days of eligibility determination\n* Presence of uncomplicated metabolic dysfunction-associated steatotic liver disease (MASLD) by vibration-controlled transient elastography (VCTE)\n\n  * Steatosis score of S1-S3\n  * Fibrosis score of F0-F2 (Note that if VCTE result is available from within past 6 months, then do not have to repeat VCTE for study purposes)\n* Evidence of insulin resistance, represented by any or all of the following criteria:\n\n  * Meeting either of the American Diabetes Association's definitions for prediabetes or impaired fasting glucose (IFG) on screening labs:\n\n    * Prediabetes: Hemoglobin A1c 5.7-6.4%\n    * IFG: plasma glucose of 100-125 mg dL-1 after ≥ 8-h fast\n  * Homeostasis Model of Insulin Resistance (HOMA-IR) score ≥ 2.73\n* Fasting hyperinsulinemia (fasting insulin level ≥ 13 μU\u002FmL) on screening labs\n* Written informed consent (in English or Spanish) and any locally required authorization (e.g., Health Insurance Portability and Accountability Act) obtained from the participant prior to performing any protocol-related procedures, including screening evaluations.\n\nExclusion Criteria:\n\n* Unable to provide informed consent in English or Spanish\n* Concerns arising at screening visit (any of the following):\n\n  * Documented weight loss of ≥ 5.0% of baseline within the previous 3 months\n  * Abnormal blood pressure (including on treatment, if prescribed)\n\n    * Systolic blood pressure (SBP) \\\u003C 90 mm Hg or \\> 160 mm Hg, and\u002For\n    * Diastolic blood pressure (DBP) \\\u003C 60 mm Hg or \\> 100 mm Hg\n  * Resting heart rate \\\u003C 55 bpm or ≥ 110 bpm\n  * Abnormal screening electrocardiogram (or if on file, performed within previous 90 days)\n  * Laboratory evidence of diabetes mellitus:\n\n    * Hemoglobin A1c ≥ 6.5%, and\u002For\n    * Fasting plasma glucose ≥ 126 mg\u002FdL\n  * Positive qualitative serum β-human chorionic gonadotropin (β-hCG, i.e., pregnancy test) in women of childbearing potential\n  * Liver function abnormalities: transaminases (aspartate aminotransferase or alanine aminotransferase) \\> 3.0 x the upper limit of normal, and\u002For total bilirubin \\> 1.25 x the upper limit of normal\n  * Abnormal screening fasting triglycerides \\> 500 mg\u002FdL\n  * Abnormal screening serum electrolytes that are considered clinically significant according to the clinical judgment of the PI\n  * Creatinine equating to estimated glomerular filtration rate \\\u003C 60 mL\u002Fmin\u002F1.73 m2\n  * Abnormal screening blood counts (any of the following):\n\n    * Hemoglobin \\\u003C 10 g\u002FdL\n    * White blood cell count below the lower limit of normal for sex\n    * Platelet count below the lower limit of normal for sex\n  * Uric acid level above the upper limit of normal\n* Reproductive concerns\n\n  * Women currently pregnant (tested by serum and\u002For urine β-hCG)\n  * Women currently breastfeeding\n* Concerns related to glucose metabolism\n\n  * History of having met any of the American Diabetes Association's definitions of diabetes mellitus (i.e., overt diabetes):\n\n    * Hemoglobin A1c ≥ 6.5%\n    * Plasma glucose ≥ 126 mg\u002FdL after 8-h fast\n    * Plasma glucose of ≥ 200 mg\u002FdL at 2 h after ingestion of a 75-g glucose load\n    * Random plasma glucose ≥ 200 mg\u002FdL associated with typical hyperglycemic symptoms, diabetic ketoacidosis, or hyperglycemic-hyperosmolar state\n  * History of gestational diabetes mellitus within the previous 5 years\n  * Use of antidiabetic medications except metformin within the 90 days prior to screening\n  * Clinical concern for absolute insulin deficiency (e.g., type 1 diabetes, pancreatic disease)\n* Concerns related to lipid metabolism\n\n  * Known diagnoses of familial hypercholesterolemia, familial combined hyperlipidemia, or familial hyperchylomicronemia\n  * Use of fibrates, prescription-strength omega-3 fatty acids, or high-dose niacin within the 90 days prior to screening:\n* Known, documented history (i.e., not to be newly screened\u002Ftested for study purposes), at the time of screening, of any of the following medical conditions:\n\n  * Pancreatic pathology, including but not limited to neoplasia, pancreatitis, pancreatectomy\n  * Cardiovascular disease (N.B. uncomplicated hypertension is not exclusionary)\n\n    * Atherosclerotic cardiovascular disease: stable or unstable angina, myocardial infarction, ischaemic or hemorrhagic stroke, or transient ischaemic attack, peripheral arterial disease (claudication), use of dual antiplatelet therapy (aspirin + P2Y12 inhibitor), history of percutaneous coronary intervention\n    * Heart rhythm abnormalities\n    * Congestive heart failure of any New York Heart Association class\n    * Symptomatic valvular heart disease (e.g., aortic stenosis)\n    * Pulmonary hypertension\n  * Chronic kidney disease, Stage 3 or higher (estimated glomerular filtration rate \\\u003C 60 mL\u002Fmin\u002F 1.73 m2), of any cause\n  * Chronic liver disease other than uncomplicated MASLD, including but not limited to:\n\n    * Advanced liver fibrosis, as determined by non-invasive testing, including fibrosis scores of F3-F4 on VCTE\n    * Cirrhosis of any etiology\n    * Autoimmune hepatitis or other rheumatologic disorder affecting the liver\n    * Biliopathy (e.g., progressive sclerosing cholangitis, primary biliary cholangitis)\n    * Chronic liver infection (e.g., viral hepatitis, parasitic infestation)\n    * Hepatocellular carcinoma\n    * Infiltrative disorders (e.g., sarcoidosis, hemochromatosis, Wilson disease)\n  * Gout\n  * Chronic infection with hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)\n  * Malabsorptive conditions\n  * Active seizure disorder (including controlled with antiepileptic drugs)\n  * Psychiatric diseases that are or have been decompensated within 1 year of screening, and\u002For require use of antipsychotic drugs associated with significant weight gain\u002Fmetabolic dysfunction (e.g., clozapine, olanzapine), monoamine oxidase inhibitors, tricyclic antidepressants, or lithium\n  * Known glucose-6-phosphate dehydrogenase (G6PD) deficiency\n  * Other clinically significant endocrinopathies\n  * Venous thromboembolic disease (deep vein thrombosis or pulmonary embolism) or any required use of therapeutic anticoagulation\n  * Active malignancy, or hormonally active benign neoplasm, except allowances for non-melanoma skin cancer and differentiated thyroid cancer (Stage I only)\n  * Clinical concern for increased risk of volume overload or hypotension (SBP \\\u003C90 and\u002For DBP \\\u003C60 mm Hg), including due to medications and\u002For heart\u002Fliver\u002Fkidney problems, as listed above\n* Clinical concern for increased risk of volume overload or hypotension (SBP \\\u003C90 and\u002For DBP \\\u003C60 mm Hg), including due to medications and\u002For heart\u002Fliver\u002Fkidney problems, as listed above\n* Use of certain medications currently or within 90 d prior to screening:\n\n  * Prescribed medications used for any of the indications in the preceding list of excluded conditions, or their use within 90 d prior to screening, except allowances for:\n\n    * Statins for primary prevention of cardiovascular disease\n    * Use of drugs prescribed for indications other than the exclusionary diagnoses\u002Fpurposes listed above (e.g., non-hydantoin antiepileptic drugs used for non-seizure indications, angiotensin converting enzyme inhibitor\u002Fangiotensin receptor blocker used for uncomplicated hypertension rather than for congestive heart failure, etc.)\n    * Vasodilating drugs for any indication: hydralazine, nitrates, phosphodiesterase-5 inhibitors (e.g., sildenafil, tadalafil), minoxidil (oral)\n    * Phenytoin or fosphenytoin for any indication\n    * Oral or parenteral corticosteroids (at greater than prednisone 5 mg daily, or equivalent) for more than 3 days within the previous 90 days; topical and inhaled formulations are permitted\n* History of certain weight-loss (bariatric) surgeries, including:\n\n  * Roux-en-Y gastric bypass\n  * Biliopancreatic diversion\n  * Restrictive procedures (lap band, sleeve gastrectomy) performed within past year\n* Clinical concern for alcohol overuse, including based on chart review and\u002For by participant's report of consuming more than 14 standard drinks per week for males or more than 7 standard drinks per week for females\n* Regular use of tobacco, either daily or an average of at least 1 cigarette per day, and\u002For nicotine vaping more than 1 day per week\n* Positive urine drug screen, except for lawfully prescribed medications or marijuana\u002Ftetrahydrocannabinol positivity, provided that the participant agrees not to use it during the same period that they will abstain from alcohol)\n* Atypical circadian rhythm, such as due to night shift work, within 30 days of screening or expected within 30 days of each treatment period\n* History of severe infection or ongoing febrile illness within 14 days of screening\n* Any other disease or condition or laboratory value that, in the opinion of the investigator, would place the participant at an unacceptable risk and\u002For interfere with the analysis of study data.\n* Known allergy\u002Fhypersensitivity to any component of the medicinal product formulations (including sulfa drugs), other biologics, intravenous (IV) infusion equipment, plastics, adhesive or silicone, history of infusion site reactions with IV administration of other medicines, or ongoing clinically important allergy\u002Fhypersensitivity as judged by the investigator.\n* Concurrent enrollment in another clinical study of any investigational drug therapy or use of any biologicals within 5 half-lives of an investigational agent or biologic",{"count":7,"type":21},[24],"The goal of this clinical trial is to compare a one-week course of diazoxide (2 mg\u002Fkg per dose x 14 doses) and placebo in people with obesity and insulin resistance (IR) with metabolic dysfunction-associated steatotic liver disease (MASLD). The main question it aims to answer are how mitigation of compensatory hyperinsulinemia with diazoxide affects hepatic de novo lipogenesis, a major contributor to MASLD pathophysiology.\n\nParticipants will:\n\n* Take 14 doses of placebo over 7 days, followed 4-12 weeks later by either 14 doses of diazoxide (at 2 mg per kg of body weight per dose \\[mpk\\]) or another 14 doses of placebo, over 7 days\n* Take 18 doses of heavy (deuterated) water (50 mL each) over 7 days, twice\n* Have blood drawn and saliva collected after an overnight fast on four mornings over the course of the study\n* Undergo insulin suppression tests (IST) to assess the degree of insulin resistance at the end of each 1-week study period\n* Consume their total calculated daily caloric needs as divided into three meals per day\n\nResearchers will compare blood tests at the beginning and end of each 1-week study period in participants randomized (like the flip of a coin) to receive either placebo followed by diazoxide or placebo followed by placebo, to see how the drug treatment affects de novo lipogenesis, serum insulin, plasma glucose, and other serum lipid parameters (triglycerides, free fatty acids), among others.",[75,68,702,703,76],"Non-Alcoholic Fatty Liver Disease","Prediabetic State",[75,68,705,702,706],"Metabolic Dysfunction-Associated Steatotic Liver Disease","Triglycerides","2026-07-01",{"date":654,"type":45},{"date":707,"type":45},{"date":711,"type":21},"2029-09-30",{"name":51,"class":52},""]