[{"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:":741},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,188,0,25,[9,50,78,111,139,173,202,232,255,279,313,342,373,417,438,460,485,509,534,555,579,602,627,656,722],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100618737","impact-of-barostimulation-on-hemodynamics-in-adults-with-heart-failure-100618737",false,"NCT07335510","Impact of Barostimulation on Hemodynamics in Adults With Heart Failure","Impact of Barostimulation in Cardiac Hemodynamics and Clinical Outcomes Through Use of the Barostim™ CVRx Device","BREATHE-HF","Inclusion Criteria:\n\n* Diagnosis of heart failure with reduced ejection fraction (defined as ejection fraction ≤ 35% for the purposes of this study) (should be within 12 months of screen)\n* Symptoms consistent with one of:\n\n  1. current New York Heart Association (NYHA) Class III or\n  2. current NYHA Class II and historical NYHA Class III\n* Laboratories with last N-terminal pro-B-type natriuretic peptide (NT-proBNP) \\\u003C 1600 pg\u002Fml (should be within 3 months of screen)\n* Management with maximally-tolerated GDMT medications and devices\n* Age \\>= 18 years\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years\n* Myocardial infarction (MI), syncope, cerebrovascular accident (CVA), aborted sudden cardiac death (SCD) (and implantable cardioverter defibrillator (ICD) therapy) within 3 months of screening\n* Bilateral carotid bifurcations located above the level of the mandible\n* Carotid artery stenosis greater than 50% caused by atherosclerosis\n* Ulcerative plaques in the carotid artery\n* Baroreflex failure or autonomic neuropathy\n* Symptomatic un-controlled bradyarrhythmias\n* Severe chronic lung disease\n* Current treatment with inotropes\n* Pacemaker or ICD within 3 months of screening\n* Cardiac resynchronization therapy (CRT) devices within 6 months of screening or anticipated to be placed in the next 90 days following screening\n* Prior surgery, radiation, endovascular stent in the carotid sinus\n* History or consideration of solid organ transplantation\n* History or consideration of left ventricular assist device (LVAD)\n* Life expectancy \\\u003C1 year from time of screening\n* Non-cardiovascular conditions interfering with 6MWT distance assessment\n* Inability to fulfill protocol requirements\n* Known allergy to silicone or titanium","ALL","18 Years",{"count":21,"type":22},58,"ESTIMATED","INTERVENTIONAL",[25],"NA","This study evaluates the effects of the implantation and adjustment of the CVRx Barostim device in adult patients with heart failure with reduced ejection fraction who are receiving maximally tolerated doses of guideline directed medical and device therapies. The study aims to assess how therapy using this device affects heart function, symptoms, and exercise capacity, with particular focus on how the device affects blood flow and heart pressures during exercise. Information from this study may help inform patient selection and device management in patients with heart failure.",[28],"HFrEF - Heart Failure With Reduced Ejection Fraction",[30,31,32,33,34,35,36],"Baroreflex activation therapy","Exercise hemodynamics","Barostim","Cardiopulmonary exercise testing","Neuromodulation","Functional capacity","Heart failure with reduced ejection fraction","RECRUITING","2026-06-25",{"date":40,"type":41},"2026-06-29","ACTUAL",{"date":43,"type":41},"2026-03-30",{"date":45,"type":22},"2028-03",{"name":47,"class":48},"Columbia University","OTHER",7,{"id":51,"slug":52,"hasResults":12,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":57,"sex":58,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":4,"studyType":23,"phases":63,"briefSummary":64,"conditions":65,"keywords":67,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},"100573080","mypeeps-mobile-plus-a-multi-level-hiv-prevention-intervention-for-young-msm-100573080","NCT06741618","MyPEEPS Mobile Plus: A Multi-Level HIV Prevention Intervention for Young MSM","MyPEEPS Mobile Plus","Inclusion Criteria:\n\n* 16-25 years of age\n* identify as male or non-binary\n* male sex assigned at birth\n* understand and read English\n* own a smartphone\n* report condomless anal sex with a male in the past year\n* HIV-negative (OraQuick verified)\n\nExclusion Criteria:\n\n* HIV Positive\n* If study staff determine participant unable to consent due to obvious and severe cognitive impairment or under the influence of drugs or alcohol\n* currently report consistent use of PrEP\n* currently enrolled in another HIV prevention study",true,"MALE","16 Years","25 Years",{"count":62,"type":22},500,[25],"MyPEEPS Mobile Plus, a multi-level intervention for improving HIV prevention outcomes in YMSM, is a novel and evidence-driven approach using mobile technology to deliver HIV prevention information specifically developed for YMSM. Building on strong preliminary work, the proposed research is the next logical step in a body of work designed to assess whether refinement of this mobile intervention used in combination with virtual PrEP Peer Navigation will result in improvements in PrEP uptake and a reduction in HIV-related behavior. This is key to advancing HIV prevention among HIV-negative US persons at extremely high-risk for HIV seroconversion.",[66],"HIV\u002FAIDS",[68,69],"PrEP","care navigation",{"date":71,"type":41},"2026-06-26",{"date":73,"type":41},"2026-04-20",{"date":75,"type":22},"2029-06-30",{"name":47,"class":48},1,{"id":79,"slug":80,"hasResults":12,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":86,"enrollmentInfo":87,"targetDuration":4,"studyType":23,"phases":89,"briefSummary":90,"conditions":91,"keywords":94,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":105,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":77},"100534638","the-cardioclip-study-100534638","NCT06241430","The CardioClip Study","Hemodynamic-Guided Optimization With the CardioMEMS Device of Patients With Heart Failure and Secondary Mitral Regurgitation Undergoing Mitral Transcatheter Edge-to-Edge Repair With the MitraClip Device","CardioClip","Inclusion Criteria:\n\n* Significant (moderate-severe \\[3+\\] or severe \\[4+\\] secondary MR)\n* Left ventricular dysfunction (ejection fraction \\>20% and \\\u003C50%)\n* New York Heart Association (NYHA) class II-IVa symptoms\n* Sign informed consent to participate in the study\n\nExclusion Criteria:\n\n* Left ventricular (LV) end-systolic dimension 70 mm\n* PA systolic pressure 70 mmHg (fixed)\n* Mitral valve (MV) orifice area \\\u003C4.0 cm2\n* Commissural MR jet or leaflet anatomy not suitable for mTEER\n* Likely to undergo heart transplantation or LV assist device implantation in the next 12 months\n* Recurrent (i.e., \\>1) pulmonary embolism or deep vein thrombosis\n* Complex congenital heart disease\n* Mechanical right heart valve (tricuspid or pulmonic)\n* Cardiac resynchronization therapy implanted within 3 months of enrollment\n* Hypersensitivity to aspirin and\u002For clopidogrel\n* History of medication non-adherence","90 Years",{"count":88,"type":22},60,[25],"The CardioClip study is exploring the use of a wireless sensor to monitor pressure in the pulmonary artery. This sensor is inserted much like the mTEER procedure, a non-surgical method through a vein in the groin. The investigators want to find out if the sensor, by constantly sending information about heart function, can help improve patient outcomes. This means doctors could adjust medications based on real-time pressure changes detected by the sensor. The results from this study will help pave the way for future trials, asking if using these wireless sensors could benefit people with valve disease and heart failure.",[92,93],"Heart Failure With Reduced Ejection Fraction","Mitral Regurgitation",[95,96,97,98,99,100,101,102,103,104],"Heart failure","Reduced ejection fraction","Mitral regurgitation","mTEER (mitral transcatheter edge-to-edge repair)","CardioMems (implantable pulmonary artery pressure sensor)","Guideline-directed medical therapy (GDMT)","HF hospitalization (HFH)","Clinical trial","Hemodynamic monitoring","Cardiovascular outcomes",{"date":40,"type":41},{"date":107,"type":41},"2024-12-18",{"date":109,"type":22},"2030-06",{"name":47,"class":48},{"id":112,"slug":113,"hasResults":12,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":117,"eligibilityCriteria":118,"healthyVolunteers":57,"sex":18,"minAge":119,"maxAge":120,"enrollmentInfo":121,"targetDuration":4,"studyType":23,"phases":123,"briefSummary":124,"conditions":125,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":133,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":77},"100519373","kids-with-iron-deficiency-and-scoliosis-100519373","NCT06042699","Kids With Iron Deficiency and Scoliosis","Kids With Iron Deficiency and Scoliosis (KIDS) Study","KIDS","Inclusion Criteria:\n\n1. 10-26 years old;\n2. diagnosis of scoliosis or kyphosis;\n3. self-reported ability to swallow a tablet;\n4. spinal fusion procedure planned approximately 6 to 24 weeks from an orthopedic surgical clinic visit at which patient agrees to phlebotomy for screening blood work;\n5. serum ferritin less than or equal to 25 µg\u002FL.\n\nExclusion Criteria:\n\n1. taking or planning to take iron-containing supplement on patient's own volition, and not willing to stop for duration of study;\n2. taking or planning to take iron-containing supplement as prescribed or recommended under the care of a physician;\n3. Hg \\\u003C10mg\u002FdL if post-menarchal, Hg \\\u003C 11 if premenarchal or male\n4. C-reactive protein \\> 10 mg\u002FL\n5. receiving nutritional support by report in the medical chart;\n6. self-reported history of hypersensitivity reaction to iron-containing supplements;\n7. self-reported history of or suspected non-iron deficient hematologic disorder;\n8. self-reported history of iron overloaded state such as hereditary hemochromatosis or hemosiderosis;\n9. objection to receiving red blood cell transfusions;\n10. current pregnancy (by self-report);\n11. prisoners;\n12. patient or parent decides against study participation.","10 Years","26 Years",{"count":122,"type":22},275,[25],"This study is a randomized controlled trial of preoperative oral iron supplementation, to identify whether iron deficiency is a modifiable risk factor for adverse surgical outcomes such as red blood cell transfusion and diminished postoperative cognitive and physical capacity in adolescents undergoing scoliosis surgery.\n\nResearch Question(s)\u002FHypothesis(es):\n\nPrimary\n\n* Iron supplementation will reduce the incidence of perioperative RBC transfusion in iron deficient scoliosis patients undergoing spinal fusion.\n\nSecondary\n\n* Iron supplementation will reduce postoperative neurocognitive functional declines in iron deficient scoliosis patients undergoing spinal fusion.\n* Iron supplementation will improve patient-reported physical functioning in iron deficient scoliosis patients undergoing spinal fusion.",[126,127,128,129,130,131,132],"Adolescent Idiopathic Scoliosis","Neuromuscular Scoliosis","Perioperative\u002FPostoperative Complications","Iron Deficiencies","Anemia","Spinal Fusion","Postoperative Cognitive Dysfunction",{"date":71,"type":41},{"date":135,"type":41},"2024-01-11",{"date":137,"type":22},"2028-02-01",{"name":47,"class":48},{"id":140,"slug":141,"hasResults":12,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":4,"eligibilityCriteria":145,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":146,"targetDuration":4,"studyType":23,"phases":148,"briefSummary":150,"conditions":151,"keywords":154,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":77},"100643896","phase-1-topical-tor-582-treatment-of-epistaxis-in-hht-100643896","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.",{"count":147,"type":22},27,[149],"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.",[152,153],"Hereditary Hemorrhagic Telangiectasia (HHT)","Epistaxis",[155,156,153,157,158,159,160,161,162,163,164,165],"Hereditary Hemorrhagic Telangiectasia","HHT","Nosebleeds","Sirolimus","Rapamycin","Topical Sirolimus","Intranasal Therapy","Nasal Telangiectasia","Vascular Malformations","mTOR Inhibitor","Osler-Weber-Rendu Syndrome","2026-06-18",{"date":38,"type":41},{"date":169,"type":22},"2026-07",{"date":171,"type":22},"2027-05",{"name":47,"class":48},{"id":174,"slug":175,"hasResults":12,"nctId":176,"briefTitle":177,"officialTitle":178,"acronym":179,"eligibilityCriteria":180,"healthyVolunteers":57,"sex":181,"minAge":19,"maxAge":4,"enrollmentInfo":182,"targetDuration":4,"studyType":23,"phases":184,"briefSummary":185,"conditions":186,"keywords":190,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":197,"completionDateStruct":199,"leadSponsor":201,"locationsCount":77},"100581669","an-effectiveness-trial-of-the-prep-for-wings-study-100581669","NCT06853314","An Effectiveness Trial of the PrEP for WINGS Study","An Effectiveness Trial of WINGS+PrEP: a Syndemic mHealth Intervention to Increase PrEP Uptake Among Women Impacted by Heavy Alcohol Use and Partner Violence in the Criminal Legal System","PFW","Inclusion Criteria:\n\nIdentify as a cis-gender woman Aged 18 or older HIV-negative Previous engagement with the criminal legal system or child protective services.\n\nMeet criteria for hazardous alcohol use Previous experience of intimate partner veiolence Report not taking PrEP in the past 90 days Recent experiences of HIV risk due to HIV risk exposure\n\nExclusion Criteria:\n\nAbility to speak and understand English is not sufficient to participate in assessments or intervention sessions.\n\nInability to complete informed consent process due to a psychiatric or cognitive impairment (assessed by the Mini Folstein exam)","FEMALE",{"count":183,"type":22},307,[25],"(Effectiveness Aim 1) To test the comparative effectiveness of PreP for WINGS versus PrEP alone on primary outcomes of increasing PrEP initiation measured by self-report\u002Fmedical records, recent adherence and longer-term adherence by self-report\u002Fmedical records over the 6-month follow-up; and secondary outcomes of decreasing IPV, hazardous drinking, recidivism, and HIV risks.\n\n(Moderation Aim 2) To test if the effectiveness of WINGS+PrEP on study outcomes is moderated by key participant subgroups based on race\u002Fethnicity, sexual orientation, age, education, incarceration history, IPV severity, substance use disorders (SUDs), digital access and literacy, housing stability, and medical mistrust.",[187,188,189],"HIV Infections","Alcohol Use Disorder","Violence, Gender-Based",[191,192,193,68],"Intimate partner violence","Hazardous alcohol use","HIV infection","2026-06-17",{"date":196,"type":41},"2026-06-22",{"date":198,"type":41},"2026-04-09",{"date":200,"type":22},"2027-06-01",{"name":47,"class":48},{"id":203,"slug":204,"hasResults":12,"nctId":205,"briefTitle":206,"officialTitle":207,"acronym":4,"eligibilityCriteria":208,"healthyVolunteers":57,"sex":18,"minAge":19,"maxAge":86,"enrollmentInfo":209,"targetDuration":4,"studyType":23,"phases":211,"briefSummary":212,"conditions":213,"keywords":215,"overallStatus":224,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":226,"startDateStruct":227,"completionDateStruct":229,"leadSponsor":231,"locationsCount":77},"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 adults\n\nExclusion Criteria\n\n* Presence of any neurological disorder\n* History of seizures\n* History of autonomic dysfunction\n* Current use of seizure-threshold lowering medications\n* Presence of metal implants\n* History of prior neurosurgical interventions",{"count":210,"type":22},10,[25],"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.",[214],"Modeling of Recruitment Curves",[216,217,218,219,220,221,222,223],"TMS","SCS","SCI","Hierarchical Bayesian","Motor threshold","Transcranial Magnetic Stimulation","Spinal cord stimulation","Evoked Potentials","NOT_YET_RECRUITING","2026-06-16",{"date":166,"type":41},{"date":228,"type":22},"2026-08-01",{"date":230,"type":22},"2027-03-31",{"name":47,"class":48},{"id":233,"slug":234,"hasResults":12,"nctId":235,"briefTitle":236,"officialTitle":237,"acronym":4,"eligibilityCriteria":238,"healthyVolunteers":12,"sex":18,"minAge":239,"maxAge":240,"enrollmentInfo":241,"targetDuration":4,"studyType":23,"phases":243,"briefSummary":244,"conditions":245,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":249,"startDateStruct":250,"completionDateStruct":252,"leadSponsor":254,"locationsCount":77},"100575602","digital-strategies-to-advance-help-seeking---aim-3-100575602","NCT06774417","Digital Strategies to Advance Help-Seeking - Aim 3","Digital Strategies to Advance Help-Seeking in Youth at Clinical High Risk for Developing Psychosis","Inclusion Criteria:\n\n* Ages 12-29 years\n* Living within a 50-mile radius of a US based AMP-SCZ site\n* Able to complete the English language PQ-B on MHA's screening platform","12 Years","29 Years",{"count":242,"type":22},25000,[25],"This proposal aims to establish a Digital Laboratory focused on advancing help-seeking and expediting treatment initiation in youth ages 12-29 who are at Clinical High-Risk (CHR) for developing psychosis. Leveraging the Health Action Process Approach (HAPA) model, this study will identify help-seeking subtypes in 25,000 youth who screen positive for psychosis-risk on Mental Health America's national online screening platform, iteratively develop and test theory and data-driven, personalized strategies to advance help-seeking using Micro-Randomized Trials and a Sequential Multiple Assignment Randomized Trial, identify the most accurate CHR screening threshold in an online environment, and link youth, when indicated, to local clinical care via AMP-SCZ, a NIH funded national network of CHR programs throughout the US. This academic-industry partnership aims to curate one of the largest datasets of youth with CHR, and to develop effective strategies to enhance early help-seeking, in a population where help-seeking is critical and a significant barrier to care.",[246,247,248],"Clinical High Risk","Early Psychosis","First Episode Psychosis",{"date":166,"type":41},{"date":251,"type":41},"2026-02-02",{"date":253,"type":22},"2028-05-31",{"name":47,"class":48},{"id":256,"slug":257,"hasResults":12,"nctId":258,"briefTitle":259,"officialTitle":260,"acronym":4,"eligibilityCriteria":261,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":262,"targetDuration":4,"studyType":23,"phases":264,"briefSummary":266,"conditions":267,"keywords":269,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":272,"startDateStruct":273,"completionDateStruct":275,"leadSponsor":277,"locationsCount":278},"100473967","phase-1-venetoclax-dexamethasone-in-relapsed-andor-refractory-t1114-amyloidosis-100473967","NCT05451771","Venetoclax-Dexamethasone in Relapsed and\u002For Refractory t(11;14) Amyloidosis","An Open-label Phase I\u002FII Trial of Venetoclax-Dexamethasone in Relapsed and\u002For Refractory t(11;14) Systemic Light-Chain Amyloidosis","Inclusion Criteria:\n\n* Age ≥ 18 years at time of signing Informed Consent Form\n* Ability to comply with the study protocol, in the investigator's judgment\n* Confirmed diagnosis of systemic AL amyloidosis by mass spectrometry or immunohistochemistry (IHC) on a tissue biopsy\n* Has received ≥1 prior lines of therapy, including an anti-cluster of differentiation 38 (CD 38) monoclonal antibody\n* Participants with a history of autologous hematopoietic cell transplantation must have recovered from any transplant-related toxicities\n* Presence of t(11;14) on FISH at any time since diagnosis (Eligibility must confirmed by FISH testing at Columbia University Irving Medical Center (CUIMC)\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2\n\nExclusion Criteria:\n\n* Known hypersensitivity to any of the study drugs\n* History of other malignancy that could affect compliance with the protocol or interpretation of results (Patients with a history of curatively treated basal or squamous cell carcinoma of the skin, in situ carcinoma of the cervix, breast cancer, or Hodgkin's Lymphoma are generally eligible. Patients with a malignancy that has been treated, but not with curative intent, will be excluded, unless the malignancy has been in remission without treatment for ≥ 2 years prior to enrollment.)\n* Evidence of other clinically significant uncontrolled condition(s) including, but not limited to, uncontrolled systemic infection (viral, bacterial, or fungal)\n* Patients on renal replacement therapy\n* Known GI disease or GI procedure that could interfere with oral absorption (including difficulty swallowing)\n* New York Heart Association (NYHA) Class III or IV heart failure\n* Mayo stage three-B (IIIB) with N-terminal pro-hormone B-type natriuretic peptide (NT-Pro BNP) \\> 8500 pg\u002FmL\n* Prior exposure to anti-apoptotic protein B-cell lymphoma 2 (BCL-2) inhibitors\n* Patients with human immunodeficiency virus (HIV) who are not on highly active antiretroviral therapy (HAART) or those with active hepatitis A, B, or C infection\n* Patients meeting criteria for symptomatic multiple myeloma by one of the following:(a) Lytic lesions on imaging (b) Plasmacytoma, (c) Hypercalcemia without any alternate etiology, or (c) Bone marrow plasma cell infiltrate of greater than 60%",{"count":263,"type":22},53,[149,265],"PHASE2","The purpose of this study is assess safety, safest dose, and effectiveness of venetoclax in combination with dexamethasone in participants with t(11;14) positive relapsed (comes back) or refractory (did not get better) light chain amyloidosis.",[268],"AL Amyloidosis",[270,271],"Light Chain Amyloidosis","Protein Misfolding Disorder",{"date":166,"type":41},{"date":274,"type":41},"2022-10-26",{"date":276,"type":22},"2027-09",{"name":47,"class":48},6,{"id":280,"slug":281,"hasResults":12,"nctId":282,"briefTitle":283,"officialTitle":283,"acronym":284,"eligibilityCriteria":285,"healthyVolunteers":57,"sex":18,"minAge":19,"maxAge":286,"enrollmentInfo":287,"targetDuration":4,"studyType":23,"phases":289,"briefSummary":291,"conditions":292,"keywords":296,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":306,"startDateStruct":307,"completionDateStruct":309,"leadSponsor":311,"locationsCount":312},"100451833","early-phase-1-spinal-cord-associative-plasticity-study-100451833","NCT05163639","Spinal Cord Associative Plasticity Study","SCAP","NON-INVASIVE\n\nInclusion Criteria:\n\n(All participants)\n\n* Age between 18-80 years.\n* Must have stable prescription medication for 30 days prior to screening\n* Must be able to: abstain from alcohol, smoking and caffeine consumption on the day of each experiment; abstain from recreational drugs for the entirety of the study; commit to study requirements (i.e., 7 visits); provide informed consent.\n\n(Able-bodied participants)\n\n* No known central or peripheral neurological disease or injury.\n\n(SCI participants - including patients scheduled for intraoperative procedures)\n\n* Score of 1-4 (out of 5) on manual muscle testing of finger extension, finger flexion, or finger abduction in left or right hand.\n\nExclusion criteria:\n\n(All participants)\n\n* Personal or extensive family history of seizures;\n* Ventilator dependence or patent tracheostomy site;\n* Use of medications that significantly lower seizure threshold, such as amphetamines, neuroleptics, dalfampridine, and bupropion;\n* History of stroke, brain tumor, brain abscess, or multiple sclerosis;\n* History of moderate or severe head trauma (loss of consciousness for greater than one hour or evidence of brain contusion or hemorrhage or depressed skull fracture on prior imaging);\n* History of implanted brain\u002Fspine\u002Fnerve stimulators, aneurysm clips, ferromagnetic metallic implants in the head (except for inside mouth); cochlear implants; cardiac pacemaker\u002Fdefibrillator; intracardiac lines; currently increased intracranial pressure; or other contraindications to brain or spine stimulation;\n* Significant coronary artery or cardiac conduction disease; recent history of myocardial infarction and heart failure with an ejection fraction of less than 30% or with a New York Heart Association Functional Classification of Class III or IV;\n* Recent history (within past 6 months) of recurrent autonomic dysreflexia, defined as a syndrome of sudden rise in systolic pressure greater than 20 mm Hg or diastolic pressure greater than 10 mm Hg, without rise in heart rate, accompanied by symptoms such as headache, facial flushing, sweating, nasal congestion, and blurry vision (this will be closely monitored during all screening and testing procedures);\n* History of significant hearing problems;\n* History of bipolar disorder;\n* History of suicide attempt;\n* Active psychosis;\n* Recent history (\\>1 year) of chemical substance dependency or significant psychosocial disturbance;\n* Heavy alcohol consumption (greater than equivalent of 5oz of liquor) within previous 48 hours;\n* Open skin lesions over the face, neck, shoulders, or arms;\n* Pregnancy; and\n* Unsuitable for study participation as determined by study physician.\n\nINTRA-OPERATIVE\n\nInclusion Criteria:\n\n* Clinical indication for cervical spine surgery.\n\nExclusion criteria:\n\n(For experiments involving cortical stimulation)\n\n* Epilepsy;\n* A history of skull surgery with metal implants;\n* Cochlear implants;\n* Patients with aneurysm stents in neck or brain blood vessels;\n* Evidence of skull shrapnel; (For experiments involving spinal cord stimulation)\n* Stimulation devices in the neck or chest (e.g., vagal nerve stimulation, cardiac patients with pacemakers)","80 Years",{"count":288,"type":22},92,[290],"EARLY_PHASE1","Spinal cord associative plasticity (SCAP) is a combined cortical and spinal electrical stimulation technique developed to induce recovery of arm and hand function in spinal cord injury.\n\nThe proposed study will advance understanding of SCAP, which is critical to its effective translation to human therapy. The purpose of the study is to:\n\n1. Determine whether signaling through the spinal cord to the muscles can be strengthened by electrical stimulation.\n2. Improve our understanding of the spinal cord and how it produces movement.\n3. Determine whether spinal surgery to relieve pressure on the spinal cord can improve its function.\n\nAim 1 is designed to advance mechanistic understanding of spinal cord associative plasticity (SCAP).\n\nAim 2 will determine whether SCAP increases spinal cord excitability after the period of repetitive pairing. In rats, SCAP augments muscle activation for hours after just 5 minutes of paired stimuli.\n\nWhereas Aims 1 and 2 focused on the effects of paired stimulation in the context of uninjured spinal cord, Aim 3 assesses whether paired stimulation can be effective across injured cord segments. Aim 3 will incorporate the experiments from Aim 1 and 2 but in people with SCI, either traumatic or pre-operative patients with myelopathy in non-invasive experiments, or targeting myelopathic segments in intraoperative segments.",[293,294,295],"Cervical Spinal Cord Injury","Tetraplegia\u002FTetraparesis","Cervical Myelopathy",[297,298,299,300,301,302,303,304,305],"spinal cord injury","paired brain and spinal cord stimulation","convergent stimulation","spinal cord associative plasticity","transcutaneous spinal cord stimulation","intraoperative monitoring","upper-limb muscle activation","motor cortex","cervical spinal cord",{"date":166,"type":41},{"date":308,"type":41},"2021-09-10",{"date":310,"type":22},"2027-12-30",{"name":47,"class":48},3,{"id":314,"slug":315,"hasResults":12,"nctId":316,"briefTitle":317,"officialTitle":318,"acronym":319,"eligibilityCriteria":320,"healthyVolunteers":57,"sex":18,"minAge":321,"maxAge":322,"enrollmentInfo":323,"targetDuration":4,"studyType":23,"phases":325,"briefSummary":326,"conditions":327,"keywords":331,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":334,"lastUpdatePostDateStruct":335,"startDateStruct":337,"completionDateStruct":339,"leadSponsor":341,"locationsCount":77},"100642665","multidimensional-sleep-health-intervention-for-couples-100642665","NCT07603245","Multidimensional Sleep Health Intervention for Couples","DREAM-COUPLES: A Dyadic Multidimensional Sleep Health Intervention","DREAM-COUPLES","Inclusion Criteria:\n\n* Adults aged 30-65 years\n* English-speaking\n* Systolic blood pressure greater than or equal to 120 mmHg (at minimum one individual in dyad)\n* Sub-optimal sleep health (at minimum short\u002Flong sleep duration and\u002For irregular sleep patterns)\n\nExclusion Criteria:\n\n* Optimal sleep health\n* History of cardiovascular disease or cancer\n* Not cognitively able to complete study requirements\n* Known medical conditions that would prevent them from safely participating in the study (severe psychiatric disorders, neurological degenerative disease, substance abuse\u002Fdependence)\n* History of severe depression or high risk of sleep apnea\u002Fuse of a Continuous Positive Airway Pressure (CPAP) device\n* Inability to provide informed consent","30 Years","65 Years",{"count":324,"type":22},50,[25],"The goal of this pilot dyadic study is to adapt a multidimensional sleep health (MDSH) intervention, previously disseminated at the individual level, for relationship partners, determine whether it improves sleep health and aspects of cardiometabolic health, and understand the role of dyadic dynamics in intervention effects.\n\nCan a dyadic MDSH intervention improve sleep health and blood pressure (primary outcomes) in relationship partners?\n\nCan a dyadic MDSH intervention improve anthropometric markers of adiposity, psychosocial indicators, stress, dyadic adjustment and coping, self-rated health (secondary outcomes) in relationship partners?\n\nAs this is a single-arm study, there is no control group. All relationship partners will complete a three-tier screening process, attend two in-person visits to receive intervention materials, have blood pressure measured and sleep data collected using in-office and out-of-office monitors, participate in weekly check-in phone calls with research staff over the 8 weeks to support adherence and complete a voluntary follow-up phone call at 16 weeks to provide additional sleep health information. The multidimensional sleep health promotion intervention is based on evidence-based sleep hygiene education and established behavior change techniques and includes: report-back of sleep health profiles, S.M.A.R.T (specific, measurable, attainable, realistic, and timely) goal-setting and establishing a sleep health plan with a fixed sleep schedule, sleep health coaching and dyadic action planning, self-monitoring, virtual sleep hygiene education, motivational feedback, and addressing light and noise in the sleep environment. Mixed methods will be used to understand implementation metrics, processes, and outcomes to establish the successful completion and future expansion of the intervention within this context.",[328,329,330],"Blood Pressure","Sleep","Cardiovascular Health",[328,329,330,332,333],"Couples","Dyads","2026-06-10",{"date":336,"type":41},"2026-06-12",{"date":338,"type":41},"2026-06-08",{"date":340,"type":22},"2027-06",{"name":47,"class":48},{"id":343,"slug":344,"hasResults":12,"nctId":345,"briefTitle":346,"officialTitle":347,"acronym":4,"eligibilityCriteria":348,"healthyVolunteers":12,"sex":18,"minAge":239,"maxAge":349,"enrollmentInfo":350,"targetDuration":4,"studyType":23,"phases":352,"briefSummary":353,"conditions":354,"keywords":356,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":338,"lastUpdatePostDateStruct":367,"startDateStruct":368,"completionDateStruct":370,"leadSponsor":372,"locationsCount":77},"100594149","phase-1-131i-apamistamab-based-conditioning-for-hematopoietic-stem-cell-transplant-hsct-in-advanced-sickle-cell-disease-scd-100594149","NCT07015684","131I-apamistamab-based Conditioning for Hematopoietic Stem Cell Transplant (HSCT) in Advanced Sickle Cell Disease (SCD)","Open-label, Single-Center, Phase 1 Study to Estimate the Minimum Effective Dose (MED) of 131I-apamistamab for Non-myeloablative Conditioning in Patients With Severe Sickle Cell Disease","Inclusion Criteria:\n\n* Availability of an HLA-matched sibling donor\n* Patients with sickle cell anemia (Hb SS, Sβ0 thalassemia or severe SC) who are 12 - 50 years of age inclusive AND who have 1 or more of the following:\n\n  1. Clinically significant neurologic event (stroke) or any neurological deficit lasting at least 24 hours. Stroke will be defined as a clinically significant neurologic event that is accompanied by an infarct on cerebral MRI or cerebral arteriopathy requiring chronic transfusion therapy.\n  2. History of two or more episodes of ACS in the 2-year period preceding enrollment despite supportive care measures (i.e. asthma therapy and\u002For hydroxyurea).\n  3. History of three or more severe vaso-occlusive pain crises per year in the 2-year period preceding enrollment despite the institution of supportive care measures (i.e. a pain management plan and\u002For treatment with hydroxyurea).\n  4. Administration of regular RBC transfusion therapy, defined as receiving 8 or more transfusions per year for 1 year or more to prevent vaso-occlusive clinical complications (i.e. pain, stroke, and ACS)\n  5. An echocardiographic finding of tricuspid valve regurgitant jet (TRJ) velocity \\> or equal to 2.7 m\u002Fsec or pulmonary hypertension diagnosed by right heart catherization.\n  6. Sickle hepatopathy defined as EITHER ferritin \\>1000mcg\u002FL OR direct bilirubin \\>0.4mg\u002Fdl but \\\u003C5xULN AND platelet count \\\u003C250,000\u002FuL at baseline\n* Adequate organ functions as defined as:\n\n  1. ECOG performance status of 2 or better\n  2. Cardiac function: LVEF of 40% or greater\n  3. Pulmonary Function: Pulse oximetry with a baseline oxygen saturation of 85% or greater and corrected DLCO of 40% or greater\n  4. Hepatic Function: Serum conjugated (direct) bilirubin less than 5x upper limit of normal for age as per local laboratory, ALT and AST less than 5 x upper limit of normal as per local laboratory. Patients whose hyperbilirubinemia is the result of hyperhaemolysis, or a sever drop in hemoglobin post blood transfusion are not excluded.\n  5. Absence of liver cirrhosis, bridging fibrosis and active hepatitis as documented by liver biopsy for patients with evidence of iron overload by serum ferritin or MRI. The histological grading and scale described by Ishak and colleagues (1995) will be used.\n\nDonor Eligibility and Selection Criteria\n\n1. Donor should be evaluated for eligibility to donate by an independent physician not directly caring for the patient on study protocol.\n2. Donor is willing to sign informed consent allowing the use of the PBSC product for the HSCT of the recipient.\n3. Donor cannot be pregnant or lactating and must agree to contraception until after the donation procedure is complete.\n4. Testing negative for HIV and viral hepatitis\n5. Free of Hb S (defined as Hb S less than 50%) and other hemoglobinopathies that are symptomatic or of clinical significance.\n6. Targeted minimum stem cell dose of 5.0 x 10e6 CD34 cells\u002FKg of recipient weight\n7. Fulfills standard criteria for eligibility as a donor for HSCT.\n\nNote: HSCT can be deleterious for the developing fetus and pregnant mother due to the conditioning regimen, GVHD prophylaxis and treatment. Agents used in this study such as cyclophosphamide are pregnancy risk factor category D. Sirolimus is pregnancy risk factor category C. Radiotherapy also used (TBI) is a well-known teratogenic agent. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study and for at least 1 year post transplant.\n\nFinally, pregnancy and lactation restrictions and contraception requirements are also applicable to the donor. Filgrastim or other G-CSF analogous are pregnancy risk factor category C. The restriction lasts for 4 weeks after stem cell donation.\n\nExclusion Criteria:\n\n1. Pulmonary dysfunction defined as DLCO (corrected for hemoglobin and alveolar volume) \\\u003C 40% of predicted OR baseline oxygen saturation of \\\u003C85% or PaO2 \\\u003C70.\n2. Severe cardiac dysfunction defined as ejection fraction \\\u003C35%.\n3. Impaired renal function defined as GFR \\\u003C40.\n4. Hepatic dysfunction defined as bridging (portal to portal) fibrosis or cirrhosis of the liver OR transaminases \\>5x ULN for age.\n5. Clinical stroke within 6 months of anticipated transplant\n6. Karnofsky performance score \\\u003C 50%\n7. HIV infection\n8. Uncontrolled viral, bacterial, fungal, or protozoal infection at the time of study enrollment.\n9. Have circulating HAMA noted on initial screening.\n10. Have received prior radiation to maximally tolerated levels to any critical normal organs\n11. Patients with unspecified chronic toxicity serious enough to detrimentally affect the patient's capacity to tolerate HSCT.\n12. Patients' unable to understand the nature and risks inherent in the HSCT process.\n13. History of non-compliance severe enough in the estimation of the treating team to preclude the patient from undergoing unrelated donor transplantation.\n14. Patient is pregnant or lactating.\n15. Inability to provide adequate transfusion support or increased risk immunohematological complications due presence of anti-RBC antibody against stem cell donor.\n16. Patients with any history of radiation therapy.","50 Years",{"count":351,"type":22},24,[149],"The purpose of this study is to find the smallest amount of the 131 I-apamistamab needed for preparing patients with severe sickle cell disease (SCD) for a bone marrow transplant. This is the first time 131 I-apamistamab is being used for advanced Sickle Cell Disease (SCD) in the setting of allogeneic stem cell transplant. 131 I-apamistamab is an investigational product. This means that 131 I-apamistamab has not been approved by the Food and Drug Administration (FDA) for medical use in patients.\n\nThe study treatment that is given before the transplant is called the conditioning regimen. In this study, the investigators are adding a drug called 131 I-apamistamab instead of the conditioning regimen typically given before a stem cell transplant.",[355],"Sickling Disorder Due to Hemoglobin S",[357,358,359,360,361,362,363,364,365,366],"severe sickle cell disease","severe SCD","sickle cell disease","sickle cell","advanced SCD","advanced sickle cell disease","anemia","sickle cell disorders","hemoglobin S (HbS) Disease","Hemoglobin S Disease",{"date":334,"type":41},{"date":369,"type":41},"2025-04-28",{"date":371,"type":22},"2032-03-12",{"name":47,"class":48},{"id":374,"slug":375,"hasResults":12,"nctId":376,"briefTitle":377,"officialTitle":378,"acronym":379,"eligibilityCriteria":380,"healthyVolunteers":12,"sex":18,"minAge":381,"maxAge":382,"enrollmentInfo":383,"targetDuration":4,"studyType":23,"phases":385,"briefSummary":387,"conditions":388,"keywords":393,"overallStatus":224,"whyStopped":4,"lastUpdateSubmitDate":338,"lastUpdatePostDateStruct":409,"startDateStruct":411,"completionDateStruct":413,"leadSponsor":415,"locationsCount":416},"100580300","phase-3-morphine-or-ketamine-for-analgesia-100580300","NCT06835504","Morphine or Ketamine for Analgesia","Efficacy of Intravenous Sub-Dissociative Ketamine Versus Intravenous Morphine in Children With Acute Pain","MoKA","Inclusion Criteria:\n\n1. Abdominal pain or isolated long-bone extremity fracture (suspected or proven)\n2. Self-reported pain score of ≥ 6\u002F10\n3. Requires IV morphine for analgesia as determined by the treating physician\n\nExclusion Criteria:\n\n1. Weight \\> 82.4 kg\n2. Known allergy\u002Fcontraindication to morphine or ketamine\n3. Antecedent receipt of ketamine related to presenting complaint\n4. Inability to use self-report measures of pain or questionnaires\n5. Chronic disease associated with pain\n6. Chronic pain condition requiring use of opioids as outpatient\n7. Hemodynamic instability or critical illness per treating physician\n8. Altered mental state (e.g., GCS , 14 or clinical intoxication)\n9. Known history of schizophrenia, liver or kidney problems, or osteogenesis imperfecta\n10. Concern for open fracture, neurovascular compromise, or compartment syndrome\n11. Injuries in addition to the extremity injury (e.g., head, neck, abdomen)\n12. Known or reported pregnancy\n13. Does not speak English or Spanish\n14. Patient previously enrolled in this study\n15. Wards of state, foster children, or children in custody","6 Years","17 Years",{"count":384,"type":22},1010,[386],"PHASE3","Pain is common in children presenting to the emergency department but is frequently undertreated, leading to both short- and long-term consequences. Morphine is the standard treatment for children with moderate to severe acute pain, but its use is associated with serious side effects and caregiver and clinician concerns related to opioid administration. The investigators aim to determine if sub-dissociative ketamine is non-inferior to morphine for treating acute pain and a preferable alternative for treating acute pain in children because of its more favorable side effect profile and potential long-term benefits related to pain-related function, analgesic use\u002Fmisuse, and mental and behavioral health outcomes.",[389,390,391,392],"Abdominal Pain","Isolated Extremity Fracture","Pain","Pediatrics",[394,395,396,397,398,399,400,401,402,403,404,405,406,407,408],"Ketamine","Morphine","Pediatric","Children","Sub-dissociative","Opioid-sparing","Emergency medicine","Emergency care","Emergency department","Post-traumatic stress","Anxiety","Depression","Abdominal pain","Fracture","Analgesia",{"date":410,"type":41},"2026-06-09",{"date":412,"type":22},"2026-09-01",{"date":414,"type":22},"2030-02-28",{"name":47,"class":48},8,{"id":418,"slug":419,"hasResults":12,"nctId":420,"briefTitle":421,"officialTitle":421,"acronym":422,"eligibilityCriteria":423,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":424,"enrollmentInfo":425,"targetDuration":4,"studyType":23,"phases":427,"briefSummary":428,"conditions":429,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":338,"lastUpdatePostDateStruct":431,"startDateStruct":432,"completionDateStruct":434,"leadSponsor":436,"locationsCount":437},"100520680","gluten-technology-and-education-for-celiac-health-100520680","NCT06059716","Gluten Technology and Education for Celiac Health","GLUTECH","Inclusion Criteria:\n\n* Any gender; Age 18-75 years\n* Celiac disease diagnosis by serology and duodenal biopsy (corresponding to •Marsh 3 histology), adequate sampling and interpretable villus height to crypt depth ratio upon review by our study pathologist\n* Diagnosed with celiac disease within 4 months of initial study screening\n* Willingness to use gluten-detection technology\n* Not currently using a gluten detection technology that tests for gluten in urine or stool\n\nExclusion Criteria:\n\n* Currently pregnant or planning to become pregnant during the study\n* Not planning to follow a gluten-free diet\n* Concurrent participation in a clinical trial of an experimental pharmacologic agent (for any condition).","75 Years",{"count":426,"type":22},200,[25],"The investigators propose to plan for a multi-center randomized controlled trial (M-RCT) to test the effectiveness of novel gluten detection technologies as an adjunct to telemedicine to manage celiac disease in newly diagnosed adults. If successful, the proposed intervention will improve mucosal recovery, promote a shift in current practice of celiac disease management toward long-term monitoring, and represent a significant step toward reducing the severe physical and psychological consequences of celiac disease.",[430],"Celiac Disease",{"date":334,"type":41},{"date":433,"type":41},"2024-10-08",{"date":435,"type":22},"2028-08-31",{"name":47,"class":48},4,{"id":439,"slug":440,"hasResults":12,"nctId":441,"briefTitle":442,"officialTitle":443,"acronym":4,"eligibilityCriteria":444,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":322,"enrollmentInfo":445,"targetDuration":4,"studyType":23,"phases":447,"briefSummary":449,"conditions":450,"keywords":452,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":338,"lastUpdatePostDateStruct":454,"startDateStruct":455,"completionDateStruct":457,"leadSponsor":459,"locationsCount":77},"100509927","phase-4-weight-loss-study-genetics-and-response-to-naltrexonebupropion-100509927","NCT05919797","Weight Loss Study: Genetics and Response to Naltrexone\u002FBupropion","Association of Genetic Variations and Weight Loss Response to Naltrexone\u002FBupropion","Inclusion Criteria:\n\n* Men and women ages 18-65 years\n* BMI 30-50 kg\u002Fm2 or\n* BMI 27-29.99 kg\u002Fm2 with at least one weight-related comorbidity including controlled hypertension, dyslipidemia, obstructive sleep apnea, or osteoarthritis of a weight-bearing joint.\n\nExclusion Criteria:\n\n* Obesity of known endocrine or hypothalamic origin\n* HbA1c \\> 6.5%\n* Cerebrovascular, cardiovascular, hepatic or renal disease\n* History of seizures, serious psychiatric illness or suicide attempts, drug or alcohol misuse within prior 24 months\n* Glaucoma\n* Current tobacco use on a regular basis\n* Use of dopamine agonists, opioid analgesics, antipsychotics, antidepressants, neuroleptics, naltrexone, diabetes medications\n* Use of Monoamine oxidase (MAO) inhibitors \\\u003C 14 days prior to screening\n* Concomitant use of CYP2B6 inhibitors\n* History of anorexia nervosa or bulimia\n* Previous surgery for obesity\n* Weight loss device intervention within prior 2 years\n* Currently pregnant or lactating, planning pregnancy or refusal to use birth control when appropriate (Women of childbearing potential will be required to use effective contraception.)\n* Blood pressure \\> 145\u002F95 (use of anti-hypertensives will be allowed with the exception of verapamil, which can cause hyperprolactinemia)\n* Clinically significant thyroid disease\n* Triglycerides \\> 499 mg\u002Fdl\n* Current use or use of weight loss medication within prior six months\n* Any lifetime weight change deemed significant by Principal Investigator\n* An affirmative answer to any question in the Columbia-Suicide Severity Rating Scale",{"count":446,"type":22},120,[448],"PHASE4","The goal of this clinical trial is to understand if genetic variations are associated with the amount of weight loss with diet and while taking an FDA-approved medication for weight loss. The main question\\[s\\] it aims to answer are:\n\n* In Aim One, the investigators propose to rigorously test the hypothesis that presence of the Taq1A A1+ polymorphism is associated with greater weight loss with NB compared with the A1- genotype.\n* In Aim Two, the investigators will explore other genetic polymorphisms that might influence the efficacy of NB such as the fat mass and obesity-associated (FTO) gene which modulates DRD2 signaling, as carriers of risk alleles in both the FTO and ANKK1 gene demonstrate altered responses to reward-learning tasks associated with negative outcomes.\n\nParticipants will be in the study for 40 weeks, which consists of two phases:\n\n1. From baseline to week 12, participants will receive individual nutritional counseling on a calorie restricted diet. This phase includes in-person visits, blood tests, an EKG, vital signs, questionnaires, body weight, and nutritional visits.\n2. From week 12 to week 40, participants will continue to receive dietary counseling and will receive treatment with naltrexone\u002Fbupropion for 28 weeks. This phase includes in-person and phone visits, blood tests, vital signs, questionnaires, body weight, and nutritional visits.",[451],"Obesity",[451,453],"Weight loss",{"date":334,"type":41},{"date":456,"type":41},"2023-06-08",{"date":458,"type":22},"2027-06-30",{"name":47,"class":48},{"id":461,"slug":462,"hasResults":12,"nctId":463,"briefTitle":464,"officialTitle":465,"acronym":4,"eligibilityCriteria":466,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":467,"targetDuration":4,"studyType":23,"phases":469,"briefSummary":470,"conditions":471,"keywords":476,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":338,"lastUpdatePostDateStruct":479,"startDateStruct":480,"completionDateStruct":482,"leadSponsor":484,"locationsCount":77},"100453357","phase-1-r-mvst-cells-for-treatment-of-viral-infections-100453357","NCT05183490","R-MVST Cells for Treatment of Viral Infections","Phase I Study of Adoptive Immunotherapy of Refractory Viral Infection With ex Vivo Expanded Rapidly Generated Virus Specific T (R-MVST) Cells","Recipient Inclusion Criteria:\n\n* Men and women ages 18 years or older of all ethnic groups will be eligible for the treatment\n* Patients with history of HCT or SOT who demonstrate evidence of viral reactivation and\u002For infection manifesting as end-organ or systemic disease due to one or more of the following viruses: EBV, CMV, ADV or BK virus and suboptimal response to the standard of care therapy.\n* Recurrent or Multiple Viral Infection. RVI defined as occurrence of more than one episode of reactivation that required intervention or symptomatic disease in recipient of allogeneic HCT that required standard of care treatment. MVI defined as more than one virus reactivating (defined by PCR positivity) or causing symptomatic systemic or end-organ disease. At least one of those viral reactivations required standard of care intervention. No standard of care therapy is defined for ADV and BK. Patients with multiple infections\u002Freactivations will be eligible as long as at least one of those viral infections meet the criterium of \"refractory\".\n\nRecipient Exclusion Criteria:\n\n* Patients with other uncontrolled infections, except for CMV, EBV, ADV or BK. For bacterial infections, patients must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to the day of infusion. For fungal infections, patients must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection for 1 week prior to R-MVST infusion. Progressing infection is defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection\n* Patients who receive corticosteroids at ≥ 0.5mg\u002Fkg prednisone or equivalent.\n* Patients who received anti-thymocyte globulin (ATG, Alemtuzumab (Campath), or other T-Cell immunosupressive monoclonal antibodies in the last 28 days.\n* Patients who received methotrexate, or other antimetabolite-type immunosuppressants that are toxic to proliferating T cells in the last 7 days.\n* Patients who received extracorporeal photopheresis within the last 28 days.\n* Patients who received checkpoint inhibitor agents (e.g., nivolumab, pembrolizumab, ipilimumab) within 3 drug half-lives of the most recent dose to the infusion of R-MVST.\n* Received donor lymphocyte infusion in last 28 days.\n* Evidence of GVHD ≥ grade 2\n* Evidence of biopsy-proven acute rejection in SOT recipients\n* Active and uncontrolled relapse of malignancy\n* Patients who are pregnant, or breastfeeding.\n* Female of childbearing potential, or male with a female partner of childbearing potential, unwilling to use a highly effective method of contraception.\n* Uncontrolled intercurrent illness including, but not limited to symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Patients who have received investigational (IND) product within 14 days of infusion of the the R-MVST cells.\n\nDonor inclusion and exclusion criteria will be followed as per the most current BMT SOP (Donor selection, Donor evaluation and Donor Deferral).",{"count":468,"type":22},36,[149],"The primary objective is to determine the safety and feasibility of administering R-MVST cells to patients with refractory viral reactivation and\u002For symptomatic disease caused by Epstein Barr Virus (EBV), cytomegalovirus (CMV), adenovirus (ADV) or BK virus. R-MVST cells will be generated on-demand from the closest partially human leukocyte antigen (HLA)-matched (minimum haploidentical) healthy donors or from the original allo-transplant donor if available. The investigator will closely monitor the recipients for potential toxicities including graft-versus-host disease (GVHD) post-infusion.\n\nSecondary objectives are to determine the effect of R-MVST infusion on viral load, possible recovery of antiviral immunity post-infusion and for evidence of clinical responses and overall survival. Recipients will be monitored for secondary graft failure at day 28 post R-MVST infusion.",[472,473,474,475],"Epstein-Barr Virus Infections","Cytomegalovirus Infections","Adenovirus","BK Virus Infection",[477,478],"Rapidly generated virus specific T cells (R-MVST)","Refractory viral reactivation",{"date":334,"type":41},{"date":481,"type":41},"2022-05-03",{"date":483,"type":22},"2028-06",{"name":47,"class":48},{"id":486,"slug":487,"hasResults":12,"nctId":488,"briefTitle":489,"officialTitle":490,"acronym":4,"eligibilityCriteria":491,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":492,"targetDuration":4,"studyType":494,"phases":4,"briefSummary":495,"conditions":496,"keywords":498,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":338,"lastUpdatePostDateStruct":503,"startDateStruct":504,"completionDateStruct":506,"leadSponsor":508,"locationsCount":312},"100161566","study-on-basal-joint-arthritis-prospective-100161566","NCT01376024","Study on Basal Joint Arthritis Prospective","Prospective Study on Basal Joint Arthritis of the Thumb","Inclusion Criteria:\n\n* Patients who have symptomatic basal joint arthritis.\n* Patients who are capable of providing informed consent.\n\nExclusion Criteria:\n\n* Patients younger than 18 years old at the time of enrollment.\n* Patients with neuromuscular disease affecting the operated hand, not caused by the CMC operation.\n* Patients with known inflammatory arthritic conditions, such as rheumatoid or psoriatic arthritis.\n* Patients with a history of or current infection of the basal joint of the affected hand.\n* Patients who are demented or are unable to provide informed consent.\n* Patients unable to comply with study guidelines.\n* Patients who have metacarpophalangeal joint hyperextension are NOT excluded. These patients will be followed and if they receive a capsulodesis or other procedure at the MCPJ at the same time as their basal joint arthroplasty this will be noted in their data records.",{"count":493,"type":22},800,"OBSERVATIONAL","The data in this prospective registry will be used 1) to define which surgical and nonoperative techniques are most effective at providing pain relief, restoring function, are cost effective, and patients are satisfied with their outcomes; and 2) to design focused clinical questions regarding the optimal treatment of basal joint arthritis of the thumb in future randomized controlled trials. There are no interventions or changes in patient care associated with this study.",[497],"Osteoarthrosis of the Carpometacarpal Joint of the Thumb",[499,500,501,502],"Carpometacarpal arthritis","Basal joint arthritis","CMC arthritis","Osteoarthritis",{"date":334,"type":41},{"date":505,"type":41},"2007-03-02",{"date":507,"type":22},"2027-02",{"name":47,"class":48},{"id":510,"slug":511,"hasResults":12,"nctId":512,"briefTitle":513,"officialTitle":514,"acronym":4,"eligibilityCriteria":515,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":516,"targetDuration":4,"studyType":23,"phases":518,"briefSummary":519,"conditions":520,"keywords":523,"overallStatus":224,"whyStopped":4,"lastUpdateSubmitDate":527,"lastUpdatePostDateStruct":528,"startDateStruct":530,"completionDateStruct":532,"leadSponsor":533,"locationsCount":77},"100640961","phase-4-post-op-prednisone-and-glucose-monitoring-in-tka-100640961","NCT07630896","Post-op Prednisone and Glucose Monitoring in TKA","Postoperative Prednisone Regimen in TKA and Its Effect on Continuous Glucose Levels","Inclusion Criteria:\n\n* Undergoing Primary Unicompartmental Knee Arthroplasty or Total Hip Arthroplasty\n* Age 18 and above\n\nExclusion Criteria:\n\n* Steroid therapy\n* Narcotic use within past 3 months\n* History of corticosteroid intolerance\n* Pregnancy\n* Uncontrolled diabetes\n* Doesn't own smart phone\n\nDrop Criteria:\n\n\\- 2nd dose of IV dexamethasone",{"count":517,"type":22},104,[448],"This study compares the efficacy of a 5-day post-operative oral prednisone regimen (40 mg daily) with the standard intraoperative steroid regimen, focusing on pain, swelling, range of motion, opioid use, and glucose levels monitored continuously.",[502,521,522],"Unicompartmental Knee Arthroplasty","Total Hip Arthroplasty (THA)",[524,525,526],"Post-operative pain","Prednisone","Continuous Glucose Monitoring","2026-06-03",{"date":529,"type":41},"2026-06-05",{"date":531,"type":22},"2026-07-01",{"date":45,"type":22},{"name":47,"class":48},{"id":535,"slug":536,"hasResults":12,"nctId":537,"briefTitle":538,"officialTitle":539,"acronym":4,"eligibilityCriteria":540,"healthyVolunteers":12,"sex":58,"minAge":19,"maxAge":4,"enrollmentInfo":541,"targetDuration":4,"studyType":494,"phases":4,"briefSummary":543,"conditions":544,"keywords":546,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":527,"lastUpdatePostDateStruct":549,"startDateStruct":550,"completionDateStruct":552,"leadSponsor":554,"locationsCount":77},"100462683","tumor-microenvironment-analysis-of-prostate-cancer-metastasis-100462683","NCT05304858","Tumor Microenvironment Analysis of Prostate Cancer Metastasis","Connecting Lineage Target Expression and Immune Tumor Microenvironment Analysis of Prostate Cancer Metastasis","Inclusion Criteria:\n\n* Be willing and able to provide written informed consent for the trial.\n* Age ≥18 years of age on day of signing informed consent.\n* Eastern Cooperative Oncology Group (ECOG) performance status: 0,1 or 2\n* Histologically proven adenocarcinoma of the prostate. (Rarely pathology is not available but if clinical situation confirms prostate cancer - such as prior response to androgen ablation and\u002For metastatic disease typical of prostate cancer, i.e. involving bone or pelvic\u002Fextra pelvic lymph nodes or para-aortic lymph nodes, AND an elevated serum concentration of prostate-specific antigen (PSA) typical of prostate cancer) pathology is not required and patient can be enrolled after discussed with study PI.\n* Clinical stage N1 or M1\n* Evidence of nodal or distant metastasis by MRI\u002FCT scan, bone scan or positron emission tomography (PET) scan\n* Planned specimen from subjects that undergo core needle biopsy must allow for cores of at least 21 gauge with depth of 5 mm. A goal of 3-8 core specimens (3 to 8 passages of the needle into the lesion) will be sought during the procedure, if felt to be safe by the performing physician.\n* Laboratory tests meet minimum safety requirements:\n* Hemoglobin \\>7mg\u002FdL\n* Platelet count ≥75,000\u002Fmm3\n* Coagulation: prothrombin time (PT)\u002Finternational normalized ratio (INR), Partial thromboplastin time (PTT) ≤ 1.5 upper limit of normal (ULN) (except if on therapeutic anticoagulation in which case the patient can be enrolled if stable and anticoagulation levels are appropriate for their condition per good clinical practice).\n\nExclusion Criteria:\n\n* A psychiatric disorder, medical condition, or other life circumstance, which in the opinion of the investigators, would make it difficult for a patient to successfully complete the informed consent process.\n* Acute illness or any medical condition in the judgment of the study physician making specimen collection inadvisable",{"count":542,"type":22},16,"The purpose of this study is to collect prostate cancer tissue from males with metastatic prostate cancers in order to study the tumor microenvironment (TME), which is the area surrounding the tumor including cells, blood vessels, etc., in men with metastatic prostate cancer. The type of research performed on these tissue samples include genetic \\& molecular analyses.",[545],"Recurrent Prostate Cancer",[547,548],"Metastasis","Prostate Cancer",{"date":529,"type":41},{"date":551,"type":41},"2021-09-15",{"date":553,"type":22},"2028-02",{"name":47,"class":48},{"id":556,"slug":557,"hasResults":12,"nctId":558,"briefTitle":559,"officialTitle":560,"acronym":4,"eligibilityCriteria":561,"healthyVolunteers":12,"sex":18,"minAge":239,"maxAge":562,"enrollmentInfo":563,"targetDuration":4,"studyType":23,"phases":564,"briefSummary":565,"conditions":566,"keywords":569,"overallStatus":224,"whyStopped":4,"lastUpdateSubmitDate":572,"lastUpdatePostDateStruct":573,"startDateStruct":574,"completionDateStruct":576,"leadSponsor":578,"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":324,"type":22},[25],"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.",[126,567,568,404],"Postoperative Pain, Acute","Postoperative Nausea and Vomiting",[570,571],"Posterior spinal fusion","Integrative therapy","2026-06-02",{"date":338,"type":41},{"date":575,"type":22},"2026-06-15",{"date":577,"type":22},"2028-06-30",{"name":47,"class":48},{"id":580,"slug":581,"hasResults":12,"nctId":582,"briefTitle":583,"officialTitle":583,"acronym":4,"eligibilityCriteria":584,"healthyVolunteers":57,"sex":18,"minAge":349,"maxAge":4,"enrollmentInfo":585,"targetDuration":4,"studyType":494,"phases":4,"briefSummary":587,"conditions":588,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":572,"lastUpdatePostDateStruct":595,"startDateStruct":597,"completionDateStruct":599,"leadSponsor":601,"locationsCount":278},"100518735","analysis-of-lumbar-spine-stenosis-specimens-for-identification-of-transthyretin-cardiac-amyloidosis-100518735","NCT06034405","Analysis of Lumbar Spine Stenosis Specimens for Identification of Transthyretin Cardiac Amyloidosis","Inclusion Criteria:\n\n1. Clinically indicated spinal decompressive surgery within 20 years prior to enrollment.\n2. Age ≥50 years at the time of the surgery.\n3. Able to understand and sign the informed consent document after the nature of the study has been fully explained.\n\nExclusion Criteria:\n\nThe presence of any of the following excludes eligibility for enrollment in this study:\n\n1. Confirmed primary amyloidosis (AL) or secondary amyloidosis (AA).\n2. Known TTR amyloidosis.\n3. Other reason that would make the subject inappropriate for entry into this study.",{"count":586,"type":22},1663,"Primary objective:\n\nTo identify older adults with transthyretin cardiac amyloidosis (ATTR-CA) early in the course of the illness, at a time when disease modifying therapies are most effective.\n\nThe specific aims of this epidemiologic investigation include:\n\n1. To identify subjects with previous lumbar spinal stenosis (LSS) Surgery who have evidence of transthyretin (TTR) amyloid deposits in spinal specimens and could be at risk for ATTR cardiac amyloidosis.\n2. To evaluate for ATTR-CA among those with localized TTR in the spinal tissue.\n\nThe study will also explore the following:\n\n1. The prevalence of amyloid in lumbar spinal stenosis specimens by Congo Red staining.\n2. The prevalence of TTR deposits among subjects with amyloid as determined by mass spectrometry.\n3. Evaluation of a novel artificial intelligence technique for that can identify amyloid histologically with standard H\\&E staining.\n4. Difference in ATTR-CA prevalence between subjects with TTR and indeterminate amyloid deposits in subject's spine by myocardial uptake of technetium pyrophosphate scan (Tc99-PYP).",[589,590,591,592,593,594],"Lumbar Spinal Stenosis","Cardiac Amyloidosis","ATTR Amyloidosis Wild Type","ATTR Gene Mutation","ATTRV122I Amyloidosis","Cardiomyopathy, Hypertrophic",{"date":596,"type":41},"2026-06-04",{"date":598,"type":41},"2023-09-19",{"date":600,"type":22},"2028-05",{"name":47,"class":48},{"id":603,"slug":604,"hasResults":12,"nctId":605,"briefTitle":606,"officialTitle":607,"acronym":608,"eligibilityCriteria":609,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":610,"enrollmentInfo":611,"targetDuration":4,"studyType":23,"phases":613,"briefSummary":614,"conditions":615,"keywords":618,"overallStatus":224,"whyStopped":4,"lastUpdateSubmitDate":622,"lastUpdatePostDateStruct":623,"startDateStruct":624,"completionDateStruct":625,"leadSponsor":626,"locationsCount":77},"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","55 Years",{"count":612,"type":22},32,[386],"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?",[616,617],"Migraine Disease","Patent Foramen Ovale",[619,617,620,608,621],"Migraine Headaches","Thienopyridine","Prasugrel","2026-06-01",{"date":529,"type":41},{"date":412,"type":22},{"date":45,"type":22},{"name":47,"class":48},{"id":628,"slug":629,"hasResults":12,"nctId":630,"briefTitle":631,"officialTitle":632,"acronym":4,"eligibilityCriteria":633,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":634,"targetDuration":4,"studyType":23,"phases":636,"briefSummary":637,"conditions":638,"keywords":641,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":649,"lastUpdatePostDateStruct":650,"startDateStruct":651,"completionDateStruct":653,"leadSponsor":655,"locationsCount":77},"100634540","teleheartcr-vs-clinic-based-cardiac-rehabilitation-after-acute-coronary-syndrome-100634540","NCT07541014","TeleheartCR vs. Clinic-Based Cardiac Rehabilitation After Acute Coronary Syndrome","Comparing a Novel Telehealth-enabled Hybrid Cardiac Rehabilitation Program to Clinic-based Cardiac Rehabilitation for Improving Patient Engagement and Functional Outcomes After ACS","Inclusion Criteria:\n\n* Age 18 years or older\n* Diagnosis of acute coronary syndrome within the past 12 months\n* Eligible for outpatient cardiac rehabilitation\n* Able to read and speak English or Spanish\n* Resides in New York State\n\nExclusion Criteria:\n\n* Severe medical or psychiatric comorbidities that would prevent safe or adequate participation\n* High risk for adverse exercise-related cardiovascular events\n* Initiation of cardiac rehabilitation prior to enrollment (i.e., \\>1 session completed)\n* Conditions that would interfere with safe or consistent participation in study procedures\n* Home environment or willingness not compatible with safe or adequate participation\n* Not expected to be available for follow-up during the study period\n* Current participation in another interventional clinical trial that may affect study outcomes",{"count":635,"type":22},250,[25],"Cardiac rehabilitation (CR) is an effective evidence-based intervention that improves outcomes in patients with acute coronary syndrome (ACS), but many eligible patients do not complete the program. A hybrid CR intervention that combines telehealth, home-based, and clinic-based components (TeleheartCR) may increase participation by addressing barriers to access while maintaining the functional capacity benefits of traditional CR. The purpose of this study is to conduct a randomized controlled trial comparing TeleheartCR with traditional clinic-based CR in patients with ACS to evaluate differences in program adherence and pre-to-post program change in functional capacity.",[639,640],"Acute Coronary Syndrome (ACS)","Myocardial Infarction",[642,643,644,645,646,647,648],"Cardiac Rehabilitation","Hybrid Cardiac Rehabilitation","Virtual Cardiac Rehabilitation","Implementation Science","Adherence","Functional Capacity","Telehealth","2026-05-30",{"date":527,"type":41},{"date":652,"type":41},"2026-05-19",{"date":654,"type":22},"2029-05",{"name":47,"class":48},{"id":657,"slug":658,"hasResults":12,"nctId":659,"briefTitle":660,"officialTitle":661,"acronym":4,"eligibilityCriteria":662,"healthyVolunteers":12,"sex":18,"minAge":239,"maxAge":286,"enrollmentInfo":663,"targetDuration":4,"studyType":23,"phases":665,"briefSummary":666,"conditions":667,"keywords":669,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":716,"lastUpdatePostDateStruct":717,"startDateStruct":718,"completionDateStruct":719,"leadSponsor":721,"locationsCount":77},"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.",{"count":664,"type":22},137,[25],"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.",[668],"Suicidal Ideation and Behavior",[670,671,668,672,673,674,675,676,677,678,679,680,681,645,682,683,684,685,686,687,688,689,690,691,692,693,694,695,696,697,698,699,700,701,702,703,704,705,706,707,708,709,710,711,712,713,714,715],"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","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","2026-05-29",{"date":572,"type":41},{"date":412,"type":22},{"date":720,"type":22},"2028-07-31",{"name":47,"class":48},{"id":723,"slug":724,"hasResults":12,"nctId":725,"briefTitle":726,"officialTitle":727,"acronym":4,"eligibilityCriteria":728,"healthyVolunteers":12,"sex":58,"minAge":729,"maxAge":730,"enrollmentInfo":731,"targetDuration":119,"studyType":494,"phases":4,"briefSummary":733,"conditions":734,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":716,"lastUpdatePostDateStruct":735,"startDateStruct":736,"completionDateStruct":738,"leadSponsor":740,"locationsCount":77},"100638754","cuimc-focal-therapy-registry-100638754","NCT07623941","CUIMC Focal Therapy Registry","Columbia University Prostate Cancer Focal Therapy Registry","Inclusion Criteria:\n\n* Organ-confined prostate adenocarcinoma diagnosed by MRI\u002Fultrasound fusion biopsy within a multiparametric MRI derived region of interest\n* Clinical stage T2cN0M0 (radiological T3a is permitted)\n* Multi-parametric MRI at New York-Presbyterian hospital (NYPH) within the past 6 months demonstrating region of interest suspicion level 2 by the Prostate Imaging Reporting and Data System version 2.0 scoring criteria\n* Transrectal or transperineal ultrasound-guided biopsy with 10 template biopsy cores and 2 MRI-ultrasound fusion targeted biopsy cores from the above MRI-derived region of interest demonstrating:\n\n  1. histologically confirmed prostate adenocarcinoma from targeted biopsy cores\n  2. unilateral Gleason score 4+3 prostate adenocarcinoma\n* Age 40 to 85 years of age\n* Subjects choose to undergo focal therapy and decline alternative treatment (such as active surveillance, radical prostatectomy, radiation therapy, cryosurgery or hormone therapy)\n* Signed informed consent\n\nExclusion Criteria:\n\n* Any Gleason score 4+4 outside an MRI-identified region of interest\n* Prostatic calcifications which in the opinion of the investigator would impede delivery of the energy to tumor in patients choosing HIFU\n* Any medical condition that would compromise the subject's ability to safely participate in the study\n* American Society of Anesthesiologists (ASA) criteria of IV or higher\n* Active urinary tract infection\n* Rectal fissure, fibrosis, stenosis, or other anatomic abnormality precluding insertion of transrectal device\n* Active, uncontrolled inflammatory bowel disease\n* Urinary tract or rectal fistula\n* Previous urethral sling, artificial urinary sphincter, or penile prosthesis surgery\n* Any contraindication to MRI (such as contrast allergy, sever claustrophobia, MRI-incompatible prosthesis)","40 Years","85 Years",{"count":732,"type":22},1000,"Patients undergoing high intensity focused ultrasound (HIFU) or irreversible electroporation (IRE) for prostate cancer will be invited to consent to have their data collected in a detailed comprehensive system to record and store patient, disease, and treatment-related characteristics. No treatment will be given, no randomization will occur, and each patient seen and treated for prostate cancer specifically with HIFU and IRE method in the Department of Urology division of Urologic Oncology within Columbia University Irving Medical Center will be eligible to be enrolled in the database.",[548],{"date":527,"type":41},{"date":737,"type":41},"2026-01-01",{"date":739,"type":22},"2040-12-31",{"name":47,"class":48},""]