[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Tulane University\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":654},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,32,0,25,[9,48,74,100,124,147,172,195,219,247,275,296,328,347,370,395,420,447,478,502,526,550,577,601,632],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":4},"100612505","castle-hfpef-catheter-ablation-for-atrial-fibrillation-patients-with-heart-failure-with-mildly-reduced-and-preserved-ejection-fraction-100612505",false,"NCT07254455","CASTLE-HFpEF (Catheter Ablation for Atrial Fibrillation Patients With Heart Failure With Mildly Reduced and Preserved Ejection Fraction)","Catheter Ablation Versus Standard Conventional Treatment in Atrial Fibrillation Patients With Heart Failure With Mildly Reduced and Preserved Left Ventricular Ejection Fraction - A Prospective, Randomized, Multi-national Study Using Two Systems for Rhythm Monitoring","Inclusion Criteria:\n\n1. ≥18 years of age at screening visit.\n2. Clinical signs and symptoms of HF (26).\n3. Left ventricular ejection fraction (LVEF) \\>40% within the past 12 months (most recent LVEF measurement)\n4. Elevated NT-proBNP levels during screening or within 12 months prior to screening (most recent value; blood test):\n\n   * For patients in normal sinus rhythm (NSR) at the time of blood sampling: NT proBNP ≥300 pg\u002FmL\n   * For patients in AF at the time of blood sampling: NT-proBNP ≥600 pg\u002FmL\n5. Echocardiographic evidence of HFmrEF\u002FHFpEF, with at least one of the following during screening or within the 12 months prior to screening:\n\n   1. Left atrial volume index (LAVI) ≥34 mL\u002Fm2 for patients in NSR, or LAVI ≥40 mL\u002Fm2 for patients in AF.\n   2. Tricuspid regurgitation (TR) peak velocity \\>2.8 m\u002Fs.\n   3. Mitral E\u002Fe' ratio at rest ≥9.\n   4. Left ventricular mass index (LVMI) ≥115 g\u002Fm2 for men and ≥95 g\u002Fm2 for women.\n   5. Septal thickness or posterior wall thickness ≥1.1 cm.\n6. Patients previously diagnosed with persistent AF since ≤4 months prior to screening with an indication for anticoagulation, OR Patients previously diagnosed with paroxysmal AF since ≤4 months prior to screening with an already known AF burden of ≥1% and\u002For an AF episode of ≥24 hours, with an indication for anticoagulation OR Patients with paroxysmal AF without known AF burden (diagnosed since ≤4 months prior to screening) or no previously diagnosed AF who are subsequently diagnosed with AF after receiving a single-lead electrocardiography (ECG) patch for 30 days. These patients should have an AF burden of ≥1% and\u002For an AF episode of ≥24 hours on the ECG patch (more details down below in section 8.1.1) and an indication for anticoagulation.\n7. Stable optimal medical therapy for HFmrEF\u002FHFpEF for at least 4 weeks (diuretics \\& SGLT2 inhibitors unless contraindicated; angiotensin receptor-neprilysin inhibitors \\& mineralocorticoid receptor antagonists as deemed appropriate by the treating physician; Amiodarone and Beta-blockers are not considered for defining heart failure therapy).\n8. Signed written informed consent obtained from the participant or participant's legal representative and ability for participant to comply with the requirements of the study.\n\nExclusion Criteria:\n\n* Participants will be excluded from the study for any of the following reasons:\n\n  1. Previous catheter ablation for AF.\n  2. Known infiltrative cardiomyopathy, hypertrophic cardiomyopathy and amyloidosis.\n  3. Documented left atrial diameter \\>6cm.\n  4. Any contraindication for chronic anticoagulation therapy or heparin, including hypersensitivity to any of the components.\n  5. Acute coronary syndrome, cardiac surgery, angioplasty, or cerebrovascular accident within 2 months prior to enrollment.\n  6. Planned cardiovascular intervention during the follow-up period.\n  7. Patients with severe valvular disease\n  8. Life expectancy ≤12 months.\n  9. Untreated hypothyroidism or hyperthyroidism (blood test).\n  10. Requirement for dialysis due to end-stage chronic kidney disease.\n  11. Mental or physical inability to participate in the study.\n  12. Women currently pregnant (blood test) or breastfeeding or not using reliable contraceptive measures during fertility age.\n  13. Enrollment in another investigational drug or device study within the last 30 days before registration.\n  14. Medical or psychological conditions that would not permit the participant to complete the study or sign informed consent.\n  15. Known alcohol or drug abuse.\n  16. Presence of a condition, abnormality or disease that in the opinion of the investigator would compromise the safety of the participant or the quality of the data.\n  17. Legal incapacity or limited legal capacity.","ALL","18 Years","120 Years",{"count":21,"type":22},900,"ESTIMATED","INTERVENTIONAL",[25],"NA","The clinical equipoise in the treatment of Atrial Fibrillation (AF) in patients with Heart Failure with mildly reduced Ejection Fraction\u002FHeart Failure with Preserved Ejection Fraction (HFmrEF\u002FHFpEF) reflects the scarcity of randomized trials on different treatment modalities. By generating high-quality, evidence-based, randomized data on the impact of treatment on hard outcomes, Catheter Ablation Versus Standard Conventional Treatment in Atrial Fibrillation Patients with Heart Failure with Preserved Ejection Fraction (CASTLE-HFpEF) will provide clinical decision-making guidance and help physicians in the management of patients with HFmrEF\u002FHFpEF and AF.\n\nThe main hypothesis is that Catheter Ablation (CA) for AF is associated with improved clinical outcomes in patients with HFmrEF\u002FHFpEF and AF compared to medical AF treatment strategies on top of optimal medical HF treatment. CASTLE-HFpEF aims to study these hard clinical outcomes in a randomized cohort of patients with AF and HFmrEF\u002FHFpEF.",[28,29],"Atrial Fibrillation","Heart Failure With Preserved Ejection Fraction",[31,32,33,34,35],"A-fib","HFpEF","HFmrEF","AF","Catheter ablation","NOT_YET_RECRUITING","2026-06-11",{"date":39,"type":40},"2026-06-15","ACTUAL",{"date":42,"type":22},"2026-07",{"date":44,"type":22},"2031-10",{"name":46,"class":47},"Tulane University","OTHER",{"id":49,"slug":50,"hasResults":12,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":12,"sex":17,"minAge":56,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":23,"phases":59,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":73},"100453378","medication-adherence-program-100453378","NCT05183763","Medication Adherence Program","Supporting Tailored Adaptive Change and Reinforcement for Medication Adherence Program: Randomized Trial of a Novel Approach to Improve Adherence in Older Hypertensive Women and Men","MAP","Inclusion Criteria:\n\n* fully insured by Blue Cross Blue Shield of Louisiana (BCBSLA)\n* continuously enrolled in BCBSLA for one year\n* planning to remain a member of BCBSLA for next year\n* English-speaking\n* telephone access\n* aged ≥40 years\n* diagnosis of essential hypertension (ICD-10-CM code I10)\n* currently filling antihypertensive medication\n* low antihypertensive medication refill (proportion of days covered (PDC) \\\u003C0.8)\n* low self-report adherence (4-item Krousel-Wood Medication Adherence Scale (K-Wood-MAS-4) score ≥1)\n* uncontrolled blood pressure (BP) (systolic BP ≥130 mm Hg or diastolic BP ≥80 mm Hg)\n* desire to improve BP\n\nExclusion Criteria:\n\n* living in a household with someone already enrolled in the study\n* enrollment in another clinical trial for drug adherence or BP control\n* moderate to severe cognitive impairment","40 Years",{"count":58,"type":22},402,[25],"Randomized controlled trial testing the efficacy of the Supporting Tailored Adaptive change and Reinforcement for Medication Adherence Program (STAR-MAP), a health coaching approach that aims to improve antihypertensive medication adherence, blood pressure control, and quality of life. Participants (n=402) \\>=40 years old with a diagnosis of hypertension, uncontrolled blood pressure, and low antihypertensive medication adherence will be recruited through a statewide health insurer, Blue Cross Blue Shield of Louisiana, and randomized to receive either interactive health coaching sessions with medication reminder tools (intervention) or medication reminder tools only (control) over one year. Data will be collected from participants at baseline, 6 months, 12 months, and 24 months using questionnaires, physical measurement (height, weight, blood pressure), a computer-based single-category implicit association test, and laboratory analysis of antihypertensive medication urinary metabolites.",[62,63,64],"Hypertension","Medication Adherence","Behavior and Behavior Mechanisms","RECRUITING",{"date":67,"type":40},"2026-06-12",{"date":69,"type":40},"2022-03-07",{"date":71,"type":22},"2027-04-30",{"name":46,"class":47},5,{"id":75,"slug":76,"hasResults":12,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":12,"sex":17,"minAge":56,"maxAge":19,"enrollmentInfo":81,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":84,"conditions":85,"keywords":89,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":93,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},"100440400","baseline-atrial-fibrosis-predicts-risk-for-post-operative-atrial-fibrillation-in-patients-undergoing-cardiac-surgery-100440400","NCT05014802","Baseline Atrial Fibrosis Predicts Risk for Post-operative Atrial Fibrillation in Patients Undergoing Cardiac Surgery","Baseline Atrial Fibrosis Predicts Risk for Post-operative Atrial Fibrillation in Patients Undergoing Cardiac Surgery: A Pilot Study for SAPPORO-AF","Inclusion Criteria:\n\n* Male or female patients age 40 years of age or older\n* Patients with no history of atrial arrhythmia (atrial fibrillation, atrial flutter, atrial tachycardia) scheduled to undergo cardiac surgery (These surgeries include but are not limited to coronary artery bypass graft (CABG), valvular repair\u002Freconstruction, aneurysm repair, and insertion of pacemaker).\n\nExclusion Criteria:\n\n* Patients with a history of atrial arrhythmia (atrial fibrillation, atrial flutter, atrial tachycardia)\n* Patients with a history of cardiac or open chest surgery\n* Patients with a history of catheter ablation\n* Patients under the age of 40\n* Patients with left ventricular assist device (LVAD) or scheduled to have LVAD implanted\n* Patients who have previously undergone extracorporeal membrane oxygenation (ECMO)\n* Patients who have undergone or will undergo heart transplantation\n* Patients with any health related Late Gadolinium Enhancement (LGE)-MRI contraindications (including previous allergic reaction to gadolinium, pacemakers, defibrillators, other devices\u002Fimplants contraindicated for MRI)\n* Acute or chronic severe renal disease with a low glomerular filtration rate (GFR), \\\u003C30 mL per minute per 1.73 m2 will be excluded from the trial. (A creatinine measurement should be available within the last 6 months. If not, a creatinine blood test will be drawn to assess for renal function before the MRI acquisition).\n* Patients weighing \\> 300 lbs. (MRI image quality decreases due to increased body mass index)\n* Patients currently pregnant or breastfeeding, or plan to become pregnant during the study period\n* Patients with cognitive impairment preventing them from giving informed consent will be excluded from the study\n* Patients who cannot read, speak, and\u002For understand English",{"count":82,"type":22},50,"OBSERVATIONAL","The study aims to evaluate and compare the incidence of atrial arrhythmias (including Post-Operative Atrial Fibrillation (POAF), atrial flutter, and atrial tachycardia) stratified by baseline Utah fibrosis stages and overall fibrosis (%) of the left atrial wall area. The investigators hypothesize that patients with a higher baseline Utah fibrosis staging will experience a higher incidence of POAF.\n\nThe study also aims to evaluate and compare the in-hospital mortality, length-of-stay (LOS), complication rates (strokes, pneumonia, respiratory failure etc.) of the different Utah fibrosis stage cohorts. Perform cost analysis and compare between patients with POAF and patients without POAF. The investigators hypothesize that patients experiencing POAF will have a higher mortality rate, longer LOS, greater complications, and therefore, additional hospital costs.",[28,86,87,88],"Atrial Arrhythmia","Atrial Flutter","Atrial Tachycardia",[90,91,92],"Atrial Fibrosis","Cardiac Magnetic Resonance Imaging","Cardiac surgery",{"date":39,"type":40},{"date":95,"type":40},"2021-11-21",{"date":97,"type":22},"2026-12",{"name":46,"class":47},3,{"id":101,"slug":102,"hasResults":12,"nctId":103,"briefTitle":104,"officialTitle":104,"acronym":4,"eligibilityCriteria":105,"healthyVolunteers":106,"sex":17,"minAge":18,"maxAge":107,"enrollmentInfo":108,"targetDuration":4,"studyType":23,"phases":110,"briefSummary":111,"conditions":112,"keywords":114,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":118,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":99},"100425016","atrial-fibrosis-in-obstructive-sleep-apnea-patients-a-pilot-study-100425016","NCT04814420","Atrial Fibrosis in Obstructive Sleep Apnea Patients: A Pilot Study","Inclusion Criteria:\n\nGroup A: 10 patients 18-75-year-old With mild OSA (5\\\u003CAHI\\\u003C15), confirmed by polysomnography. No previous AF diagnosis on the medical chart\n\nGroup B: 10 patients 18-75-year-old With moderate OSA (15\\\u003CAHI\\\u003C30), confirmed by polysomnography. No previous AF diagnosis on the medical chart\n\nGroup C: 10 patients 18-75-year-old With severe OSA (AHI\\>30), confirmed by polysomnography. No previous AF diagnosis on the medical chart\n\nGroup D (mild OSA+ AF): 10 patients 18-75-year-old With mild OSA (5\\\u003CAHI\\\u003C15), confirmed by polysomnography. Previous AF diagnosis\n\n* In this group, patients with AF and OSA who already have done MRI might be included.\n\nGroup E (severe OSA +AF): 10 patients 18-75-year-old With severe OSA (AHI\\>30), confirmed by polysomnography. Previous AF diagnosis\n\n\\*In this group, patients with AF and OSA who already have done MRI might be included.\n\nGroup F (Control): 10 Patients 18-75-year-old No previous OSA and\u002For AF Diagnosis on the medical chart\n\nExclusion Criteria:\n\n* History of chronic heart failure (LVEF \\\u003C 50%), AF, myocardial infarction, valvular disease.\n* Prior cardiac or chest surgery.\n* Other advanced pulmonary disease (severe Chronic Obstructive Pulmonary Disease (COPD) or asthma, pulmonary hypertension) or central sleep apnea.\n* Contraindications to DE-MRI (e.g. allergy to gadolinium, pacemakers, defibrillators (ICD's), other devices\u002Fimplants contraindicated for MRI, glomerular filtration rate \\\u003C30 ml\u002Fmin, etc.).\n* Pregnancy.\n* Inability to give informed consent.",true,"75 Years",{"count":109,"type":22},60,[25],"The investigators hypothesize that Obstructive Sleep Apnea (OSA) is an independent risk factor for atrial fibrosis development. The investigators aim to prove the presence of atrial fibrosis on Delayed Enhancement Magnetic Resonance Imaging (DE-MRI) in OSA patients without atrial fibrillation (AF).",[28,113],"Obstructive Sleep Apnea",[115,90,116,117],"Ablation","Delayed Enhancement Magnetic Resonance Imaging","Electrocardiogram",{"date":39,"type":40},{"date":120,"type":40},"2021-07-12",{"date":122,"type":22},"2026-11",{"name":46,"class":47},{"id":125,"slug":126,"hasResults":12,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":130,"eligibilityCriteria":131,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":107,"enrollmentInfo":132,"targetDuration":4,"studyType":23,"phases":134,"briefSummary":135,"conditions":136,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":146},"100580314","collaborative-multi-level-obesity-intervention-engaging-underserved-communities-trial-100580314","NCT06835686","Collaborative Multi-level Obesity Intervention Engaging Underserved Communities Trial","LA-CEAL CONNECT: Louisiana Community Engagement Alliance (LA-CEAL) Collaborative Multi-level Obesity Intervention Engaging Underserved Communities Trial (CONNECT)","CONNECT","Inclusion Criteria:\n\n* being 18 to 75 years of age\n* living with obesity, defined as a BMI between 30 and 50 kg\u002Fm2 for non-Asian identifying participants and BMI between 27.5 and 50 kg\u002Fm2 for Asian-identifying participants\n* weighing less than 400 pounds\n* receiving care from or willing to register at a participating FQHC clinic\n* able to understand and speak English\n* able to complete the study within the next year (e.g., not planning to move from the area within study period)\n\nExclusion Criteria:\n\n* having given birth within the past year, pregnant or planning to become pregnant during study period (within 1 year)\n* currently participating in a weight-loss program\n* having lost more than 10 pounds in the last 6 months\n* being an employee or a family member of an employee of any participating FQHC\n* having a disease that can interfere with or be aggravated by exercise or weight loss",{"count":133,"type":22},522,[25],"The goal of this clinical trial is to test the effectiveness of an evidence-based multi-level intervention for weight loss and the feasibility, fidelity, and sustainability of implementing the intervention in low-income and underserved people living with obesity in Louisiana. The main questions it aims to answer are:\n\n* Will an evidence-based multi-level obesity intervention (called LA-CEAL CONNECT) in adults living with obesity in low-income and underserved communities achieve weight loss at 6 months compared to enhanced usual care?\n* Will LA-CEAL CONNECT sustain weight loss at 12 months?\n* Will LA-CEAL CONNECT improve waist circumference, diet quality, physical activity, quality of life, and blood pressure at 6 and 12 months?\n* Will LA-CEAL CONNECT be feasible to implement in adults living with obesity in low-income and underserved communities?\n\nResearchers will compare the LA-CEAL CONNECT multilevel weight loss intervention to enhanced usual care to evaluate if LA-CEAL CONNECT leads to greater weight loss and greater changes in waist circumference, diet, physical activity, quality of life, and blood pressure than enhanced usual care.\n\nParticipants in both arms will:\n\n* Receive health literacy-tailored educational materials and resources for weight loss\n* Visit the clinic site for baseline, 6-month and 12-month study visits to collect clinical and survey measurements\n\nParticipants in the CONNECT intervention arm will also:\n\n* receive health coaching\n* self-monitor weight and physical activity using digital technologies\n* attend group meetings to identify and increase utilization of community health and wellness resources",[137],"Obesity","2026-05-18",{"date":140,"type":40},"2026-05-19",{"date":142,"type":40},"2025-03-14",{"date":144,"type":22},"2028-03-31",{"name":46,"class":47},18,{"id":148,"slug":149,"hasResults":12,"nctId":150,"briefTitle":151,"officialTitle":151,"acronym":4,"eligibilityCriteria":152,"healthyVolunteers":106,"sex":17,"minAge":153,"maxAge":19,"enrollmentInfo":154,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":156,"conditions":157,"keywords":159,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":165,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":171},"100435916","collection-of-sars-cov-2-covid-19-virus-secretions-and-serum-for-countermeasure-development-100435916","NCT04956445","Collection of SARS CoV-2 (COVID-19) Virus Secretions and Serum for Countermeasure Development","Population 1:\n\nInclusion Criteria:\n\n1. Positive diagnostic test for COVID-19, influenza A or B virus, non COVID-19 coronavirus, parainfluenza virus, rhinovirus, adenovirus, or metapneumovirus\n2. Patient or legally authorized representative has provided verbal consent \u002F verbal HIPAA (or parental permission form and assent form, as appropriate)\n\nExclusion Criteria:\n\n* None\n\nPopulation 2:\n\nInclusion Criteria:\n\n1. Positive diagnostic test for COVID-19 \\>14 days prior, OR potential to have been exposed to (and mounted antibodies against) COVID-19, OR positive diagnostic test for influenza A or B virus, non COVID-19 coronavirus, parainfluenza virus, rhinovirus, adenovirus, or metapneumovirus\n2. Patient or legally authorized representative has signed informed consent (or parental permission form and assent form, as appropriate)\n\nExclusion Criteria:\n\nPatients with the following criteria:\n\n* Aged under 6 months old\n* Anemia (Hgb \\\u003C7)\n* Platelet \\\u003C80","6 Months",{"count":155,"type":22},2000,"Collection of SARS-COV-2 Secretions and Serum for Countermeasure Development (aka ClinSeqSer) is an observational study to understand natural history of SARS-COV-2 infections among special populations and characterise post-covid morbidity through immune response, virus genome sequencing, cytokine response, and virus shedding. Given the descriptions of infection course of patients over the outbreak of 2003 (SARS-Cov01) and since January 2019 in China and Europe, and now worldwide:\n\n1. Acutely infected patients shed virus that could be of major interest to characterize (viral quantification, characterization of virus shedding -of infective and of non-infective virus) the former reflecting\u002Fpredictive of severity of disease and the latter reflecting extent\u002Fsource of contagiosity.\n2. Convalescent infected patients develop a specific anti-virus antibody response that is (likely) protective and therefore suits the preliminary requirement for the potential benefits of the convalescent patient plasma therapeutic infusion approach. In addition, long term effects of COVID-19 commonly known as long-haulers remains clinically unclear.\n\nThousands of patients have now been diagnosed with COVID-19 in Louisiana (444,000 cases, 10,122 deaths, 2.2% mortality in Louisiana (LA), as of March 2021), and numerous patients are now also complaining of post-acute sequelae of SARS-CoV-2 (PASC). The investigators want to further clarify questions surrounding rational confinement duration and therapeutic approach by collecting plasma of convalescent patients to identify optimal antibody titer by ELISA, specificity of naturally occurring inflammatory (protein\u002Fantibody and RNA) response, and possibly test in vitro antibody neutralization activity.",[158],"Covid19",[160,161,162,163,164],"SARS-CoV-2","Data registry","Convalescent plasma","Post COVID-19","Post acute sequelae of COVID-19",{"date":140,"type":40},{"date":167,"type":40},"2020-03-17",{"date":169,"type":22},"2027-12",{"name":46,"class":47},2,{"id":173,"slug":174,"hasResults":12,"nctId":175,"briefTitle":176,"officialTitle":177,"acronym":4,"eligibilityCriteria":178,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":179,"enrollmentInfo":180,"targetDuration":4,"studyType":23,"phases":181,"briefSummary":183,"conditions":184,"keywords":186,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":190,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":194,"locationsCount":171},"100508925","phase-3-ultra-low-contrast-angiography-in-aki-100508925","NCT05906758","Ultra-Low Contrast Angiography in AKI","Randomized Controlled Trial of Ultra-Low Contrast Coronary Angiography During Acute Kidney Injury (AKI)","Inclusion Criteria:\n\n* Hospitalized patients who have AKI at admission or who develop AKI during admission and require invasive coronary angiography will be included in the trial.\n\nExclusion Criteria:\n\n* Stabilized renal function manifested by unchanged or downtrending serum creatinine during a 24-hour period prior to enrollment.\n* Contraindication for invasive coronary angiography other than AKI.\n* Percutaneous coronary intervention is indicated and cannot be postponed by 7 days.\n* Need for renal replacement therapy before coronary angiography or planned renal replacement therapy after coronary angiography (if premeditated before coronary angiography).\n* Administration of intravascular contrast media during 7 days prior to the coronary angiography or within 6 days after coronary angiography.\n* Pregnant patients, prisoners, cognitively impaired subjects, age below 18 years, unable or unwilling to provide informed consent.","100 Years",{"count":5,"type":22},[182],"PHASE3","The aim of this study is to evaluate the safety of ultra-low contrast coronary angiography in patients with pre-existing acute kidney injury.",[185],"Acute Kidney Injury",[187,188],"Coronary angiography","Ultra low contrast","2026-05-13",{"date":138,"type":40},{"date":192,"type":40},"2025-09-05",{"date":169,"type":22},{"name":46,"class":47},{"id":196,"slug":197,"hasResults":12,"nctId":198,"briefTitle":199,"officialTitle":200,"acronym":4,"eligibilityCriteria":201,"healthyVolunteers":106,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":202,"targetDuration":4,"studyType":23,"phases":204,"briefSummary":206,"conditions":207,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":211,"startDateStruct":213,"completionDateStruct":215,"leadSponsor":217,"locationsCount":218},"100536208","phase-4-refining-treatment-options-for-trichomonas-vaginalis-infection-a-comparative-analysis-of-metronidazole-and-secnidazole-100536208","NCT06261840","Refining Treatment Options for Trichomonas Vaginalis Infection: A Comparative Analysis of Metronidazole and Secnidazole","Refining Treatment Options for Trichomonas Vaginalis Infection in Women and Men: A Comparative Analysis of Oral Multi-Dose Metronidazole and Single-Dose Secnidazole","Inclusion Criteria:\n\n* Women and men aged 18 years or older of any race\u002Fethnicity will be included in the study.\n* Participants must have either a positive T. vaginalis rapid antigen test (OSOM), or wet mount microscopy with motile trichomonads, or nucleic acid amplification test (NAAT) urinalysis or Pap smear positive for TV within two weeks of available results (and have not yet been treated) that is confirmed by repeat T. vaginalis NAAT testing at study enrollment,\n* Willing and able to provide and understand informed consent to comply with the study protocol,\n* Have a method of contact (either phone, email or social media),\n* Be willing to be randomized.\n\nExclusion Criteria:\n\n* Pregnant\u002Flactating or seeking to be pregnant\n* Have been treated for with a 5-nitroimidazole (i.e. Metronidazole (MTZ), tinidazole (TDZ), or secnidazole \\[SEC\\]) in the last 28 days\n* Used intravaginal boric acid or any other intravaginal treatment for T. vaginalis in the last 14 days\n* Have a history of a type 1 hypersensitivity reaction to 5-nitroimidazole medications\n* Are taking phenytoin (Dilantin) and\u002For warfarin (Coumadin) due to drug-drug interactions with oral MTZ\n* Use of medications which may alter the metabolism of MTZ including Lithium and barbiturates (amobarbital, butalbital, methohexital, phenobarbital, pentobarbital, primidone, secobarbital)\n* Have been previously enrolled in the study",{"count":203,"type":22},1200,[205],"PHASE4","This is a multi-centered, randomized, open-label, parallel, phase IV clinical trial comparing the effectiveness and cost-effectiveness of oral multi-dose metronidazole (MTZ) and oral single-dose secnidazole (SEC) for the treatment of Trichomonas vaginalis in both women and men.",[208,209],"Trichomonas Vaginitis","Bacterial Vaginitis","2026-05-04",{"date":212,"type":40},"2026-05-06",{"date":214,"type":40},"2025-05-06",{"date":216,"type":22},"2029-07-31",{"name":46,"class":47},4,{"id":220,"slug":221,"hasResults":12,"nctId":222,"briefTitle":223,"officialTitle":224,"acronym":4,"eligibilityCriteria":225,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":107,"enrollmentInfo":226,"targetDuration":4,"studyType":23,"phases":227,"briefSummary":228,"conditions":229,"keywords":233,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":239,"startDateStruct":241,"completionDateStruct":243,"leadSponsor":245,"locationsCount":246},"100603362","continuous-glucose-monitoring-cgm-in-an-underserved-population-100603362","NCT07135531","Continuous Glucose Monitoring (CGM) in an Underserved Population","Continuous Glucose Monitoring in an Underserved Population: Impact on Glucose Control, Patient Reported Outcomes, Healthcare Utilization, and Long Term Complications","Inclusion Criteria:\n\n* Age 18-75 years\n* Type 2 diabetes mellitus\n* HbA1C ≥ 7.5%\n* At least on 1 insulin injection therapy daily\n* Patients established with primary care clinic or endocrinology clinic or diabetes clinics in the New Orleans and surrounding areas\n* Patients with Medicaid or free care or uninsured\n* Patients must be able to speak and understand English and be capable of providing informed consent to participate in the study\n\nExclusion Criteria:\n\n* Type 1 diabetes mellitus\n* Currently on CGM or using insulin pump\n* Advanced renal disease or Estimated Glomerular Filtration Rate (eGFR) \\\u003C40\n* Serious co-morbidities which in the investigator's opinion, will make it challenging for patients to participate\n* The patient has been diagnosed with end-stage renal disease, is on dialysis, or has had a kidney transplant, Hemoglobinopathies, iron therapy or other condition that interferes with HbA1c measurement\n* Pregnant",{"count":82,"type":22},[25],"The investigators aim is to conduct a randomized clinical trial in an underserved population who are either uninsured or on Medicaid and taking at least one injection of insulin daily. The investigators believe that this study will lead to considerable alleviation of health disparities and provide better care for an underserved population. This will be a pilot study to evaluate the feasibility of such a trial in this population before doing a larger multicenter trial.",[230,231,232],"Diabetes","Diabetes Mellitus","Diabetes Type 2",[234,235,236,237],"Medicaid","Underinsured","Continuous glucose monitoring","Uninsured","2026-05-03",{"date":240,"type":40},"2026-05-05",{"date":242,"type":40},"2026-03-19",{"date":244,"type":22},"2027-07",{"name":46,"class":47},1,{"id":248,"slug":249,"hasResults":12,"nctId":250,"briefTitle":251,"officialTitle":252,"acronym":4,"eligibilityCriteria":253,"healthyVolunteers":106,"sex":17,"minAge":254,"maxAge":255,"enrollmentInfo":256,"targetDuration":4,"studyType":23,"phases":258,"briefSummary":259,"conditions":260,"keywords":265,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":268,"lastUpdatePostDateStruct":269,"startDateStruct":270,"completionDateStruct":272,"leadSponsor":274,"locationsCount":246},"100549025","a-seek-test-and-treat-intervention-to-reduce-chlamydia-trachomatis-disparities-100549025","NCT06428643","A Seek, Test, and Treat Intervention to Reduce Chlamydia Trachomatis Disparities","A Seek, Test, and Treat Intervention to Reduce Chlamydia Trachomatis Disparities in Black Youth Living in the Deep South","Inclusion Criteria:\n\n* Identifies as African American or Black\n* 15-26 years of age\n* Lives or spends most of their time in Orleans Parish\n* Had vaginal sex at least once\n\nExclusion Criteria:\n\n* Unwilling or unable to provide informed consent\n* Unable to speak or understand English\n* Previously enrolled in the study\n* Known to be pregnant\n* Known HIV positive status","15 Years","26 Years",{"count":257,"type":22},2322,[25],"This study includes testing for four STIs (chlamydia, gonorrhea, syphilis, and HIV) at no cost. If positive, individual subjects will also be counseled and offered options for treatment for themselves and their sex partners that may include no cost expedited treatment and the option to be rescreened 3 months after treatment.",[261,262,263,264],"Chlamydia","Gonorrhea","Hiv","Syphilis",[266,267],"Screening","Expedited Treatment","2026-04-30",{"date":240,"type":40},{"date":271,"type":40},"2025-08-14",{"date":273,"type":22},"2029-09-01",{"name":46,"class":47},{"id":276,"slug":277,"hasResults":12,"nctId":278,"briefTitle":279,"officialTitle":280,"acronym":4,"eligibilityCriteria":281,"healthyVolunteers":12,"sex":17,"minAge":56,"maxAge":4,"enrollmentInfo":282,"targetDuration":4,"studyType":23,"phases":284,"briefSummary":285,"conditions":286,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":288,"lastUpdatePostDateStruct":289,"startDateStruct":291,"completionDateStruct":293,"leadSponsor":295,"locationsCount":246},"100597739","enhancing-diabetes-care-by-treating-insomnia-100597739","NCT07062406","Enhancing Diabetes Care by Treating Insomnia","Enhancing Diabetes Care: Implementing Cognitive Behavioral Therapy for Insomnia to Improve Sleep and Cardiometabolic Outcomes","Inclusion Criteria:\n\n* aged 40 or older\n* receive primary care from participating clinic\n* diagnosis of type 2 diabetes\n* most recent hemoglobin A1c (HbA1c) \\>7% within the past year\n* Insomnia Severity Index (ISI) score ≥15\n* able to speak English\n\nExclusion Criteria:\n\n* diagnosed or self-reported sleep apnea\n* pregnant or planning to become pregnant during the study period\n* having a psychiatric or medical condition that would interfere with the ability to complete study procedures\n* participating in another diabetes clinical trial\n* living in same household as another participant\n* required to work night shifts",{"count":283,"type":22},30,[25],"Insomnia is highly prevalent in individuals with type 2 diabetes (T2D) and is associated with poor glycemic control. Louisiana has one of the highest diabetes prevalence rates in the U.S., with significant disparities by race, income, and rural residence. Despite growing recognition of sleep's role in diabetes management, sleep disturbances remain largely unaddressed in diabetes care. Cognitive behavioral therapy for insomnia (CBT-I) is the first-line treatment for chronic insomnia, yet it is underutilized in primary care clinics such as federally qualified health centers (FQHCs) that serve high-risk populations.\n\nThe long-term goal of this research is to improve cardiometabolic health and reduce diabetes disparities by integrating sleep interventions into diabetes care. This pilot study aims to: (1) evaluate the impact of CBT-I on sleep and diabetes-related outcomes, and (2) assess the acceptability, feasibility, and fidelity of implementing a 6-week CBT-I program in an FQHC setting.\n\nThe investigators will conduct a randomized controlled trial (RCT) with 30 FQHC patients (aged 40+) with uncontrolled T2D (HbA1c \\>7%) and comorbid insomnia (Insomnia Severity Index (ISI) score ≥15). Participants will be randomly assigned to either the CBT-I intervention or usual care. Sleep (ISI scores, actigraphy) and cardiometabolic (HbA1c, fasting glucose, insulin) outcomes will be assessed at baseline and three months post-randomization. Implementation success will be evaluated using fidelity, feasibility, and acceptability measures. Findings will provide preliminary evidence for integrating CBT-I into primary care, informing larger trials to improve diabetes outcomes and reduce disparities in Louisiana.",[232,287],"Insomnia","2026-04-20",{"date":290,"type":40},"2026-04-22",{"date":292,"type":22},"2026-06-01",{"date":294,"type":22},"2027-02-28",{"name":46,"class":47},{"id":297,"slug":298,"hasResults":12,"nctId":299,"briefTitle":300,"officialTitle":301,"acronym":302,"eligibilityCriteria":303,"healthyVolunteers":106,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":304,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":306,"conditions":307,"keywords":309,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":320,"lastUpdatePostDateStruct":321,"startDateStruct":323,"completionDateStruct":325,"leadSponsor":327,"locationsCount":99},"100573958","health-electronic-assessment-of-risks-and-trends-using-biometric-equipment-and-technology-100573958","NCT06753045","Health Electronic Assessment of Risks and Trends Using Biometric Equipment and Technology","Health Electronic Assessment of Risks and Trends Using Biometric Equipment and Technology: HEARTBEAT","HEARTBEAT","Inclusion Criteria:\n\n* Patients with at least one cardiovascular disease (heart failure, cardiac arrhythmias, chronic kidney disease, coronary artery disease, history of stroke\u002FTransient Ischemic Attack (TIA), or diabetes mellitus).\n* Patients visiting a primary care provider for any reason without any of the previously mentioned cardiovascular diseases. (Healthy cohort, limited up to 500 patients throughout the study).\n\nExclusion Criteria:\n\n* Participants who cannot read, speak, and\u002For understand English.\n* Participants with cognitive impairments who are unable to give informed consent or sign their HIPAA form.\n* Participants with cognitive impairments affecting their ability to be compliant with wearing and maintaining wearable devices.\n* Participants who are pregnant.\n* Participants with tattoos, scars, or skin adhesions that would not allow for Photoplethysmography (PPG) recordings to be collected from a wrist-worn device.\n* Participants with neurological disorders that may interfere with device signal quality (e.g., hand tremors).\n* Participants with a pacemaker.\n* Participants with allergies to watch and\u002For wristband materials.\n* Participants with known plans to permanently leave the state of Louisiana within the observational period.\n* Participants who have no known medical history with any of the enrolling institutions.\n* Patients without a compatible smartphone (iOS 13 \\& Android 11 at minimum).",{"count":305,"type":22},10000,"This is a phase 0, non-interventional, longitudinal, electronic data capture (EDC) study to facilitate the HEARTBEAT Study project has set out to explore the potential use of smartwatches in collecting and analyzing biometric data to improve the detection, identification, and understanding of cardiovascular diseases and related conditions by SAMSUNG and Tulane. The study will include up to ten thousand adult subjects tasked with wearing a smartwatch to collect digital biomarker data over a 1 year period. Concurrent to smartwatch data collection, subjects will be instructed to complete questionnaires via the Huma Decentralized Clinical Trials (HUMADCT) platform. There are no investigational drugs or interventions administered as part of this study.",[308],"Heart Diseases",[310,311,312,313,314,315,316,317,31,318,319],"Heart failure","Coronary artery disease","Stroke\u002FTIA","Diabetes mellitus","Chronic kidney disease","Cardiac arrhythmias","Smart watch","Atrial fibrillation","Artificial intelligence","Machine learning","2026-03-03",{"date":322,"type":40},"2026-03-05",{"date":324,"type":40},"2024-10-08",{"date":326,"type":22},"2027-10",{"name":46,"class":47},{"id":329,"slug":330,"hasResults":12,"nctId":331,"briefTitle":332,"officialTitle":333,"acronym":4,"eligibilityCriteria":334,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":335,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":337,"conditions":338,"keywords":339,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":320,"lastUpdatePostDateStruct":342,"startDateStruct":343,"completionDateStruct":345,"leadSponsor":346,"locationsCount":99},"100435242","the-coagulation-biomarkers-and-atrial-fibrillation-coag-af-pilot-study-100435242","NCT04947657","The CoAGulation Biomarkers and Atrial Fibrillation (COAG-AF) Pilot Study","Correlation Of CoAGulation Biomarkers and Atrial Fibrillation Burden in Patients Post Catheter Ablation: the COAG-AF Pilot Study","Inclusion Criteria:\n\n* Patients, male or female and older than 18 years of age.\n* Patients diagnosed with persistent or paroxysmal AF.\n* Patients that are undergoing catheter ablation at Tulane University Medical Center.\n* Patients that had a cardiac MRI prescribed by their physician as part of their standard of care.\n\nExclusion Criteria:\n\n* Patients with coagulation disorders such as, von Willebrand disease, hemophilia, Immune Thrombocytopenic Purpura, etc.\n* Patients who are pregnant or breast-feeding or plan to become pregnant during the study period.\n* Are not surgically sterile.\n* Are of childbearing potential and are unwilling to practice two acceptable methods of birth control.\n* Do not plan to continue practicing two acceptable methods of birth control throughout the trial (highly effective methods of birth control are defined as those, used alone or in combination, that result in a low failure rate i.e. less than 1% per year when used consistently and correctly).\n* Patients with mental and\u002For physical ailments which may prohibit them from actively participating in the study.\n* Any health-related gadolinium\u002FMRI contraindications (e.g. allergy to gadolinium, pacemakers, Implantable Cardioverter Defibrillators (ICD's), other devices\u002Fimplants contraindicated for use of MRI, etc.)\n* Patients who have a known terminal illness with a prognosis less than 12 months at the time of the informed consent process.\n* Planned cardiovascular intervention.\n* Patient with diagnosed acute or chronic severe kidney disease or with a low glomerular filtration rate (GFR), \\\u003C30 mL per minute per 1.73 m2\n* Patients who cannot read, speak, and\u002For understand English.\n* Patients with cognitive impairments who are unable to give informed consent.",{"count":336,"type":22},20,"The aim of the Correlation Of CoAGulation-Atrial Fibrillation (COAG-AF) study is to prove that an increase in pro-thrombotic biomarkers in AF is associated with an increase in AF burden.\n\nSecondary objectives of the study are the following:\n\n* To investigate the impact of catheter ablation on serum pro-thrombotic biomarkers in patients with AF.\n* To correlate coagulation biomarkers with imaging features such as, the degree of fibrosis found on Late Gadolinium Enhancement Magnetic Resonance Imaging (LGE-MRI) scans, which is a part of standard of care.\n* To determine baseline values of coagulation and pro-thrombotic biomarkers in the AF population and compare those baseline values with the general population values.\n* To compare central and peripheral thrombotic biomarkers in patients with atrial fibrillation.",[28],[35,340,341],"Coagulation","Atrial Fibrillation burden",{"date":322,"type":40},{"date":344,"type":40},"2021-09-22",{"date":169,"type":22},{"name":46,"class":47},{"id":348,"slug":349,"hasResults":12,"nctId":350,"briefTitle":351,"officialTitle":352,"acronym":4,"eligibilityCriteria":353,"healthyVolunteers":106,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":354,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":356,"conditions":357,"keywords":361,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":320,"lastUpdatePostDateStruct":365,"startDateStruct":366,"completionDateStruct":368,"leadSponsor":369,"locationsCount":99},"100427235","ppg-to-predict-ejection-fraction-and-other-echographic-data-in-the-general-population-100427235","NCT04843371","PPG to Predict Ejection Fraction and Other Echographic Data in the General Population","Photoplethysmography (PPG) to Predict Ejection Fraction and Other Echographic Data in the General Population","Inclusion Criteria:\n\n* Male or Female aged18 years or older.\n* Patients scheduled to undergo an echocardiogram at Tulane Medical Center.\n\nExclusion Criteria:\n\n* Participants under 18 years of age.\n* Participants with cognitive impairments.\n* Participants with a physical inability to wear the Biostrap during the echocardiogram.\n* Individuals who cannot read, speak, and\u002For understand English.",{"count":355,"type":22},500,"The investigators are aiming to investigate the association between ejection fraction (EF) determined by echocardiography and signals obtained from Photoplethysmography (PPG) in the general population. The investigators are also aiming to investigate the association between blood pressure and signals obtained from PPG in the general population.\n\nFinally, the investigators are also aiming to investigate the association between signals obtained from PPG in the general population to cardioechographic findings such as, valvular heart disease, structural heart diseases, cardiomyopathies, pericardial disease etc.",[358,359,360],"Valvular Heart Disease","Pericardial Disease","Cardiomyopathies",[362,363,364],"Structural heart disease","Photoplethysmography","Ejection Fraction",{"date":322,"type":40},{"date":367,"type":40},"2021-08-20",{"date":97,"type":22},{"name":46,"class":47},{"id":371,"slug":372,"hasResults":12,"nctId":373,"briefTitle":374,"officialTitle":375,"acronym":4,"eligibilityCriteria":376,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":107,"enrollmentInfo":377,"targetDuration":4,"studyType":23,"phases":378,"briefSummary":379,"conditions":380,"keywords":382,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":388,"lastUpdatePostDateStruct":389,"startDateStruct":390,"completionDateStruct":392,"leadSponsor":394,"locationsCount":246},"100583763","the-resplash-study-100583763","NCT06880562","The RESPLASH Study","Renal and Splanchnic Sympathetic Denervation as an Alternative Therapy for Resistant Hypertension and Type 2 Diabetes (RESPLASH Study)","Inclusion Criteria:\n\n* Patients aged 18-75.\n* History of Type 2 Diabetes Mellitus at least 5 years prior to enrollment.\n* HbA1c level ≥6.5%\n* Use of at least 1 oral antidiabetic agent and no changes in the last 30 days.\n* History of essential hypertension with systolic Blood pressure of 160 mmHg or more (≥150 mmHg in patient with Type 2 Diabetes Mellitus), despite compliance with three of more antihypertensive drugs.\n* Stable drug regimen of at least 3 antihypertensive medications with no changes for 2 weeks before enrollment.\n\nExclusion Criteria:\n\n* Estimated glomerular filtration rate of less than 30 mL\u002Fmin per 1.73m2.\n* Type 1 diabetes mellitus.\n* History of aortic pathologies such as aneurysm or dissection confirmed by immediate preprocedural angiography that would preclude the Endovascular Denervation (EDN) procedure.\n* Orthostatic hypotension.\n* Acute or severe systemic infection.\n* History of myocardial infarction, unstable angina, or cerebrovascular accident in the previous 3 months.\n* History of previous renal artery CDN.\n* Pregnancy or planned pregnancy during the study period.\n* Unable to provide informed consent.",{"count":336,"type":22},[25],"To assess the safety and effectiveness of renal artery denervation with subsequent splanchnic nerves denervation via catheter-based radiofrequency ablation in improving blood pressure and glycemic control in patients with resistant hypertension and type 2 diabetes.",[381],"Resistant Hypertension",[383,384,62,313,385,386,387],"Renal Sympathetic Denervation","Splanchnic Sympathetic Denervation","Catheter-based radiofrequency ablation","Lowering blood pressure","Control of glycemic levels","2026-02-27",{"date":320,"type":40},{"date":391,"type":22},"2026-06",{"date":393,"type":22},"2027-06",{"name":46,"class":47},{"id":396,"slug":397,"hasResults":12,"nctId":398,"briefTitle":399,"officialTitle":400,"acronym":4,"eligibilityCriteria":401,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":107,"enrollmentInfo":402,"targetDuration":4,"studyType":23,"phases":404,"briefSummary":405,"conditions":406,"keywords":410,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":414,"lastUpdatePostDateStruct":415,"startDateStruct":417,"completionDateStruct":418,"leadSponsor":419,"locationsCount":246},"100460769","phase-3-the-ultrasound-guided-dextrose-prolotherapy-in-ehlers-danlos-syndrome-patients-100460769","NCT05279937","The Ultrasound-Guided Dextrose Prolotherapy in Ehlers-Danlos Syndrome Patients","The Use of Ultrasound-Guided Dextrose Prolotherapy in Low Back Pain in Patients With Hypermobile-Type, Ehlers-Danlos Syndrome","Inclusion Criteria:\n\n* Men and women between the ages of 18-75\n* Subjects who resent to Tulane Institute of Sports Medicine and Tulane Lakeside with low back pain that is diagnosed as chronic (\\>3 months) SI dysfunction or myofascial lumbar pain with a diagnosis of hEDS per The International Consortium on Ehlers-Danlos Syndrome and Related Disorders diagnostic criteria.\n* Diagnosis will include but not be limited to physical exam findings consistent with tenderness to palpation over the sacroiliac joint (SIJ) or posterior superior iliac crest, and upper outer quadrant of the gluteus maximus.\n* Diagnosis will also include US-guided tenderness to palpation of the thoracolumbar facial complex insertion into the posterior superior iliac spine (PSIS), SI, or gluteus maximus.\n* Further testing will include US evaluation using a General Electric Logiq E ultrasound machine to look for any evidence of structural abnormality or reactive hyperemia of the TLFC, LPSL, multifidus or gluteus maximus.\n\nExclusion Criteria:\n\n* Patients \\>75 and \\\u003C 18 years old.\n* Any patient with evidence of lumbar radiculopathy, acute lower back pain, pregnancy, prior lumbosacral surgery, opiate use within the last 6 months, steroid exposure within 6 weeks, NSAID exposure within 2 weeks.\n* Patients who are unwilling to stop taking or admit to receiving NSAIDs or any form of corticosteroids during the study.\n* Patients with a history of bleeding disorders, severe thrombocytopenia, immunodeficiency disorder, and hypersensitivity of local anesthetics of amide type will be excluded along with any patient who actively has systemic bacterial infection with fever, skin infection over the injection site, or takes anti-platelet\u002Fanti-coagulant medication.\n* Patients with comorbidities such as diabetes mellitus, rheumatoid arthritis, lupus, or any other condition that increases risk of infection may be excluded from the study pending severity and current treatment of their condition.\n* Patients receiving workers compensation, disability or who are involved in litigation will also be excluded due to risk of secondary gain.\n* Physical exam findings, X-rays, and US imaging will be utilized to determine eligibility.",{"count":403,"type":22},40,[182],"1. Specific Aim: To show the safety and efficacy of prolotherapy injection for chronic sacroiliac and myofascial lumbar pain while standardizing an ultrasound guided injection technique\n2. Specific Aim: To demonstrate that dextrose prolotherapy subjectively decreases lumbar back pain (LBP) associated with chronic sacroiliac (SI) and myofascial lumbar back pain\u002Finjury in patients with Hypermobile-Type Ehlers-Danlos Syndrome (hEDS).\n3. Specific Aim: To use ultrasound (US) guidance to identify SI and myofascial lumbar back pain\u002Finjury for targeted dextrose prolotherapy treatment and to provide objective measures of decreasing inflammation via Power Doppler and ligament repair.\n4. Specific Aim: To determine if US-guided dextrose prolotherapy decreases the direct costs of care for chronic LBP in contrast to conventional therapies by reducing return visits, specialty referrals, physical therapy, medications, and unnecessary procedures.",[407,408,409],"Ehlers-Danlos Syndrome","Low Back Pain","Sacroiliac Instability",[411,412,413],"Prolotherapy","Dextrose","Ultrasound","2026-02-26",{"date":416,"type":40},"2026-03-02",{"date":391,"type":22},{"date":393,"type":22},{"name":46,"class":47},{"id":421,"slug":422,"hasResults":12,"nctId":423,"briefTitle":424,"officialTitle":425,"acronym":4,"eligibilityCriteria":426,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":427,"enrollmentInfo":428,"targetDuration":4,"studyType":23,"phases":430,"briefSummary":432,"conditions":433,"keywords":435,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":439,"lastUpdatePostDateStruct":440,"startDateStruct":442,"completionDateStruct":444,"leadSponsor":446,"locationsCount":218},"100598931","phase-2-a-study-for-evaluating-safety--efficacy-of-topical-roflumilast-03-foam-in-hidradenitis-suppurativa-100598931","NCT07077902","A Study for Evaluating Safety & Efficacy of Topical Roflumilast 0.3% Foam in Hidradenitis Suppurativa","An Open Label Study for Evaluating Safety & Efficacy of Topical Roflumilast 0.3% Foam as a Mono or add-on Therapy in the Treatment of Hidradenitis Suppurativa With Correlative Analysis.","Inclusion Criteria:\n\n* Must understand the risks and the benefits\u002Fpurpose of the study and provide signed and dated informed consent.\n* Must be 18 years at time of signing informed consent form.\n* Willing to participate in all required evaluations and procedures in the study including the ability to apply topical medication without difficulty.\n* Patients must have a diagnosis of HS based upon the clinical criteria of a history of more than or equal 5 typical lesions (erythematous papules, nodules, or abscesses) in flexural sites with a recurring nature over time.\n* Patients must be candidate for topical therapy defined by active Hurley stage I or Hurley stage II\u002FIII with active disease after an adequate trial of systemic antibiotics\u002Fhormonal\u002Fimmunomodulatory or biologic therapy.\n* Patient is required to be on stable dose of concomitant therapy for at least 3 months before enrollment and throughout the study period.\n* Females of childbearing potential must have a negative urine pregnancy test at baseline visit and be on adequate contraception throughout the study time.\n\nExclusion Criteria:\n\n* Concomitant use of topical antibiotics, topical corticosteroids, resorcinol, benzoyl peroxide, vitamin D analogs, Hibiclens wash (except for emollients) within 1 week of enrollment.\n* Increasing or changing dosing for concurrent therapy agents within 90 days before study day 0 and during the study period.\n* History of any clinically significant (as determined by the investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic, or other major uncontrolled disease.\n* Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he\u002Fshe were to participate in the study or confounds the ability to interpret data from the study.\n* Pregnant or breastfeeding.\n* Prior major surgery or major life-threatening medical illness within 2 weeks.\n* Active hepatitis B or C infection with detectible viral nucleic acid in the blood or known Human Immunodeficiency Virus (HIV) positivity.\n* Patients with known active malignancy.\n* Any severe systemic illness requiring Intravenous (IV) antibiotics within the two weeks prior to initiation of the study drug.\n* Active substance abuse or a history of substance abuse within 6 months prior to screening.\n* Use of any investigational drug within 4 weeks prior to randomization, or 5 pharmacokinetic\u002Fpharmacodynamic half-lives, if known (whichever is longer).","90 Years",{"count":429,"type":22},10,[431],"PHASE2","This is a phase 2a, open label study.\n\nAs psoriasis and Hidradenitis Suppurativa (HS) share multiple inflammatory pathways, the investigators hypothesize that the use of topical roflumilast 0.3% foam is a safe and efficacious option as a monotherapy for patients with mild disease and as add-on therapy for maintenance and flares in patients with moderate to severe disease. The study will include correlative analysis to study gene expression profiling before and after therapy.",[434],"Hidradenitis Suppurativa",[436,437,438],"Topical roflumilast","Inflammatory skin condition","Painful nodules and abscesses in axilla and groin","2025-12-19",{"date":441,"type":40},"2025-12-23",{"date":443,"type":40},"2025-09-25",{"date":445,"type":22},"2026-09",{"name":46,"class":47},{"id":448,"slug":449,"hasResults":12,"nctId":450,"briefTitle":451,"officialTitle":452,"acronym":453,"eligibilityCriteria":454,"healthyVolunteers":12,"sex":455,"minAge":456,"maxAge":457,"enrollmentInfo":458,"targetDuration":4,"studyType":23,"phases":460,"briefSummary":461,"conditions":462,"keywords":464,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":470,"lastUpdatePostDateStruct":471,"startDateStruct":473,"completionDateStruct":475,"leadSponsor":477,"locationsCount":246},"100578395","the-womens-screening-and-self-testing-program-prometa-study-100578395","NCT06810739","The Women's Screening and Self-Testing Program (PROMETA) Study","A Hybrid Type III Effectiveness - Implementation, Pragmatic Intervention Trial for Cervical Cancer Screen and Treat in Mozambique","PROMETA","Inclusion Criteria:\n\n* Women 25-49 years\n* Accessing HIV care and treatment services\n* Not being pregnant\n* Patients with a cervix\n\nExclusion Criteria:\n\n* Physical or mental impairment that inhibits participation in the study\n* Pregnant women or \\\u003C6 weeks post-partum\n* Women who have undergone a total hysterectomy with removal of the cervix","FEMALE","25 Years","49 Years",{"count":459,"type":22},8445,[25],"This proposal directly addresses the ability to safely scale-up a Screen-Triage-Treat approach to cervical cancer screening. The investigators propose to capitalize on a pool of screen-eligible women accessing routine care within targeted human immunodeficiency virus (HIV) care and treatment services. The primary outcome of interest is the number of women screened and the proportion of screen-positive women undergoing treatment. Secondary outcomes will focus on other implementation outcomes, and if successful, will be utilized to inform future research to take this approach to scale across Mozambique.",[463],"Human Papilloma Virus Related Cervical Carcinoma",[465,466,467,468,469],"Human Immunodeficiency Virus","Self swab","Mozambique","Cervical cancer","Implementation science","2025-12-12",{"date":472,"type":40},"2025-12-17",{"date":474,"type":22},"2026-01-01",{"date":476,"type":22},"2028-08-31",{"name":46,"class":47},{"id":479,"slug":480,"hasResults":12,"nctId":481,"briefTitle":482,"officialTitle":483,"acronym":4,"eligibilityCriteria":484,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":485,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":486,"conditions":487,"keywords":489,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":495,"lastUpdatePostDateStruct":496,"startDateStruct":498,"completionDateStruct":500,"leadSponsor":501,"locationsCount":246},"100451512","tulane-abdominal-transplant-institute-tati-of-solid-organ-transplantation-of-hiv-positive-recipients-from-hiv-positive-donors-100451512","NCT05159466","Tulane Abdominal Transplant Institute (TATI) of Solid Organ Transplantation of HIV-Positive Recipients From HIV-Positive Donors","Tulane Abdominal Transplant Institute (TATI) of Solid Organ Transplantation of HIV-Positive Recipients From HIV-Positive Donors (TATI HOPE Act)","Recipient Criteria\n\nInclusion Criteria:\n\n* Participant meets standard listing criteria for transplant.\n* Greater than or equal to 18 years of age.\n* Participant has documented HIV infection using an FDA-licensed, approved, or cleared test device(s).\n* CD4+ T-cell count ≥200\u002FμL within 16 weeks prior to transplant; any patient with history of Opportunistic Infections must have a CD4 positive T-cell count ≥200\u002FuL.\n* HIV RNA less than 50 copies\u002FmL and on a stable antiretroviral regimen.\n* No evidence of active opportunistic complications of HIV infection.\n* On a stable antiretroviral regimen. Participants unable to tolerate ART due to organ failure may still be considered eligible if the study team is confident there will be a safe, tolerable, and effective antiretroviral regimen once organ function is restored after transplantation.\n* No history of primary CNS lymphoma or progressive PML\n\nExclusion Criteria:\n\n* Participant has concomitant conditions that, in the judgment of the investigators, would preclude transplantation or immunosuppression.\n* Less than 18 years of age.\n* Requires multi-organ transplantation.\n* Participant is pregnant or breastfeeding.\n* Participant has a history of progressive multifocal leukoencephalopathy (PML), chronic intestinal cryptosporidiosis of \\> 1 month duration, or primary CNS lymphoma.\n* Participant has a history of any neoplasm except for the following: resolved Kaposi's sarcoma, in situ anogenital carcinoma, adequately treated basal or squamous cell carcinoma of the skin, solid tumors (except primary CNS lymphoma) treated with curative therapy and disease free for more than 5 years. History of renal cell carcinoma requires disease-free state for 2 years. History of leukemia and disease free duration will be per site policy.\n* Participants who are unable or unwilling to provide informed consent.\n\nDonor Criteria Deceased Donor Criteria\n\n1. Must meet all clinical criteria for HIV-uninfected organ donors.\n2. No evidence of invasive opportunistic complications of HIV infection.\n3. Pre-implant donor organ biopsy showing no disease process that would put the recipient at increased risk of rapid progression to end-stage organ failure, to be stored for the duration of the study.\n4. Donor has documented HIV infection (by any licensed ELISA and confirmation by Western Blot, positive HIV ab IFA, or history of detectable HIV-1 RNA) from a CLIA approved laboratory.\n5. If known history of HIV infection and prior antiretroviral therapy, the study team must describe the anticipated post-transplant antiretroviral regimen(s) to be prescribed for the recipient and justify its conclusion that the regimen will be safe, tolerable and effective.\n6. Pre-implant donor organ biopsy to be stored, at a minimum, for the duration of the study (or at least 5 years).\n7. For donors with newly diagnosed\u002Fdiscovered HIV-1 infection, any HIV-1 RNA viral load is allowed assuming the donor meets other criteria and the HIV\u002FTransplant Infectious Diseases team is able to predict a tolerable and effective ART regimen for the recipient.\n8. If there is any history of documented antiretroviral resistance in the donor by medical chart review, the HIV\u002FTransplant Infectious Diseases team is able to predict a tolerable and effective ART regimen for the recipient.\n9. Donors with documented chronic hepatitis C virus (HCV+) co-infection (detectable HCV nucleic acid using any licensed assay in a CLIA certified lab) can be used only for HCV+ participants.\n\nLiving Donor Criteria\n\n1. Greater than or equal to 18 years of age\n2. Donor meets all clinical criteria to be a living donor other than being HIV positive.\n3. Donor has consented to participate as a HIV-Positive Donor under the separate Addendum protocol.\n4. Documented HIV infection using an FDA-licensed, approved, or cleared test device.\n5. Well-controlled HIV infection, as evidenced by:\n\n   1. CD4+ T-cell count ≥500\u002FmL for the 6-month period preceding donation.\n   2. Fewer than 50 copies\u002FmL of HIV- 1 RNA detectable by ultrasensitive or real-time polymerase chain reaction (PCR) assay.\n6. No evidence of invasive opportunistic complications of HIV infection\n7. A kidney biopsy showing no evidence of a disease process that would put the donor at increased risk of progressing to end-stage organ failure after donation, or that would present a risk of poor graft function to the recipient.\n8. A complete history of ART regimens and ART resistance.\n9. The study team must be able to predict a safe, tolerable, and effective regimen to be prescribed for the recipient based on the donor's current ART regimen as well as the donor's history of ART resistance.",{"count":283,"type":22},"The U.S. Department of Health and Human Services (HHS), through the National Institutes of Health (NIH), published Final Human Immunodeficiency Virus (HIV) Organ Policy Equity (HOPE) Act Safeguards and Research Criteria for Transplantation of Organs Infected With HIV. All such transplants must occur under an institutional review board (IRB) approved research protocol that is compliant with federal regulations governing human subjects research. This is an investigator-initiated, observational prospective study of solid organ transplantation utilizing HIV-positive donors in HIV positive recipients. Stable HIV-infected adults in need of a solid organ transplant (kidney) who meet standard and study specified HIV criteria for organ transplantation will be offered enrollment in the study. Deceased donors (kidney) and living donors (kidney) will be utilized in this protocol.\n\nThe goal of this research is to increase knowledge about the safety, efficacy, and effectiveness of solid organ transplantation (SOT) utilizing HIV-positive donors in HIV-positive recipients.",[465,488],"End Stage Renal Disease",[490,491,492,493,494],"Organ donor","Organ recipient","Kidney Transplant","HOPE Act","HIV","2025-09-30",{"date":497,"type":40},"2025-10-02",{"date":499,"type":40},"2021-11-15",{"date":122,"type":22},{"name":46,"class":47},{"id":503,"slug":504,"hasResults":12,"nctId":505,"briefTitle":506,"officialTitle":507,"acronym":4,"eligibilityCriteria":508,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":509,"targetDuration":4,"studyType":23,"phases":510,"briefSummary":511,"conditions":512,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":495,"lastUpdatePostDateStruct":519,"startDateStruct":521,"completionDateStruct":523,"leadSponsor":525,"locationsCount":246},"100363058","phase-4-the-effect-of-lumify-on-ocular-redness-intraocular-pressure-and-eyelid-position-in-glaucoma-patients-100363058","NCT04007276","The Effect of Lumify™ on Ocular Redness, Intraocular Pressure, and Eyelid Position in Glaucoma Patients","The Effect of Lumify™ (Brimonidine Tartrate Ophthalmic Solution 0.025%) on Ocular Redness, Intraocular Pressure, and Eyelid Position in Glaucoma Patients Using Brimonidine 0.2%, 0.15%, or 0.1%","Inclusion Criteria:\n\n* Age \\> 18 years\n* Diagnosis of primary open angle glaucoma\n* Willing and able to give informed consent\n* Current and greater than 6 weeks of brimonidine 0.2%, 0.15% or 0.1% use\n\nExclusion Criteria:\n\n* Pregnancy\n* Prisoners\n* Known allergy or sensitivities to brimonidine\n* No surgery within the past 6 months\n* No history of lid surgery or botox\n* Any other significant ophthalmologic disorder or condition with relevant effect on ocular redness, IOP, or eyelid position as evaluated by principal investigator\n* Inability to sit comfortably for 30 minutes\n* Prior use of eye whiteners (eg, vasoconstrictors), decongestants, antihistamines, or phenylephrine dilating drops within 1 week of study",{"count":109,"type":22},[205],"Glaucoma represents a group of conditions that cause damage to the optic nerve and can lead to irreversible vision loss. Current treatments are aimed at lowering intraocular pressure while minimizing medication side effects. Lumify™ (Brimonidine Tartrate Ophthalmic Solution 0.025%) is an FDA-approved medication for alleviating eye redness, a common side effect of glaucoma medications. The purpose of this study is to evaluate the effect of Lumify™ on eye redness, intraocular pressure, and eyelid position in patients with glaucoma who are already using the Brimonidine 0.1%, 0.15% or 0.2% eye drops.",[513,514,515,516,517,518],"Glaucoma","Glaucoma, Open-Angle","Glaucoma; Drugs","Droopy Eyelid","Ptosis","Glaucoma, Primary Open Angle",{"date":520,"type":40},"2025-10-01",{"date":522,"type":22},"2026-11-10",{"date":524,"type":22},"2036-06-01",{"name":46,"class":47},{"id":527,"slug":528,"hasResults":12,"nctId":529,"briefTitle":530,"officialTitle":530,"acronym":4,"eligibilityCriteria":531,"healthyVolunteers":106,"sex":455,"minAge":18,"maxAge":4,"enrollmentInfo":532,"targetDuration":4,"studyType":23,"phases":534,"briefSummary":535,"conditions":536,"keywords":539,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":542,"lastUpdatePostDateStruct":543,"startDateStruct":545,"completionDateStruct":547,"leadSponsor":549,"locationsCount":246},"100503680","m-o-m-s-on-the-bayou-implementation-of-an-intervention-for-mental-health-in-pregnancy-100503680","NCT05838404","M-O-M-S on the Bayou: Implementation of an Intervention for Mental Health in Pregnancy","Inclusion Criteria:\n\n* Pregnant\n* Below 20 weeks' gestation\n* Enrolled in prenatal care\n\nExclusion Criteria:\n\n* Not pregnant\n* Under age 18\n* Does not speak English or Spanish\n* Does not plan to carry to term\n* Does not plan to remain in the study area through pregnancy\n* Fetal defects likely to lead to death or extensive hospitalization postpartum",{"count":533,"type":22},240,[25],"Disasters have negative effects in the short term (physical trauma, adverse environmental exposures, and unstable housing) and the long term (relocation, changes in family functioning, and negative economic effects), which interact with social determinants to worsen health among the most vulnerable women, infants, and communities. Trauma and severe stress are directly linked to pregnancy complications, and raise blood pressure during pregnancy, alter stress hormones, and increase vulnerability to infection, all of which predispose to reduced fetal growth and preterm birth. Disasters also worsen mental health, and depression during pregnancy and postpartum, for instance, is associated with worse physical health during pregnancy, maternal impairment, poorer quality parenting, negative child behavior, and poorer infant cognitive development.The goal of this intervention is to improve mental health in pregnant women living in a disaster-affected region.\n\nThe main questions this intervention aims to answer are:\n\n* Assess the implementation outcomes (acceptability, adaptation, adoption, feasibility, fidelity, and sustainability) of a pilot intervention in a disaster recovery environment.\n* Assess the effectiveness of the M-O-M-S pilot intervention in a disaster recovery environment.\n\nThe study will recruit pregnant women in areas that have experienced a natural disaster. Women will be recruited in early pregnancy and attend a series of classes on the cognitive and relationship changes of pregnancy and motherhood, and mental preparation for labor, led by a \"mentor,\" a mother who has experienced pregnancy, labor, and motherhood.",[537,538],"Anxiety","Depression",[540,541],"Pregnancy","Pregnancy-related anxiety","2025-09-19",{"date":544,"type":40},"2025-09-24",{"date":546,"type":40},"2023-11-01",{"date":548,"type":22},"2025-11-30",{"name":46,"class":47},{"id":551,"slug":552,"hasResults":12,"nctId":553,"briefTitle":554,"officialTitle":555,"acronym":4,"eligibilityCriteria":556,"healthyVolunteers":106,"sex":17,"minAge":557,"maxAge":19,"enrollmentInfo":558,"targetDuration":4,"studyType":23,"phases":560,"briefSummary":561,"conditions":562,"keywords":564,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":570,"lastUpdatePostDateStruct":571,"startDateStruct":573,"completionDateStruct":575,"leadSponsor":576,"locationsCount":171},"100593824","the-cooking-for-health-optimization-and-disease-prevention-chop-trial-100593824","NCT07011459","The Cooking for Health Optimization and Disease Prevention (CHOP) Trial","Community Teaching Kitchen-based Culinary Education as a 'Food is Medicine' Solution for Improving Health Equity Among Racially\u002FEthnically Diverse Seniors","Inclusion Criteria:\n\n* Age 55 years or older\n* English speaking\n* Ability to provide informed consent.\n\nExclusion Criteria:\n\n* Medical history of cardiovascular disease (CVD) or cancer.\n* Food allergies including, but not limited to, milk, eggs, shellfish, nuts, wheat or gluten, and soy.\n* Special diets including, but not limited to, Mediterranean, veganism, vegetarianism, gluten-free, and the ketogenic diet.\n* Current use of medications that could affect blood glucose and lipids levels including, but not limited to, insulins (Humalog, Novolog, insulin detemir, etc.), anti-diabetic medications (metformin, sulfonylureas, meglitinides, etc.), Ozempic. HAART, and beta blockers.\n* No children are involved.\n* No other vulnerable subjects will be involved.","55 Years",{"count":559,"type":22},96,[25],"Poor nutrition-related diseases disproportionately impact seniors and racial\u002Fethnic minorities who are more likely to experience disparities in proper nutrition. Culinary medicine is a new evidence-based educational approach that blends the art of food and cooking with the science of medicine. Recently, culinary medicine is proposed by the 2020-2030 Strategic Plan for NIH Nutrition Research and national 'Food is Medicine (FIM)' Movement as potential solutions for improving healthy eating, creating social and emotional connections, and nutrition-related health equity. Built upon the well-established community teaching kitchen at The Goldring Center for Culinary Medicine (GCCM) at Tulane University and nearly 10 years of experience in delivering culinary education of Mediterranean diet (MedDiet), the investigators will conduct a randomized controlled trial (RCT) to test the feasibility and effectiveness of 3-month community teaching kitchen-based culinary education of MedDiet on improving cardiometabolic and mental health among racially and ethnically diverse seniors.",[563],"Cardiovascular Diseases",[565,566,567,568,569],"Culinary","Cardiometabolic health","Mental health","Mediterranean Diet","Nutrition","2025-09-10",{"date":572,"type":40},"2025-09-11",{"date":574,"type":40},"2025-07-07",{"date":97,"type":22},{"name":46,"class":47},{"id":578,"slug":579,"hasResults":12,"nctId":580,"briefTitle":581,"officialTitle":581,"acronym":4,"eligibilityCriteria":582,"healthyVolunteers":12,"sex":17,"minAge":583,"maxAge":584,"enrollmentInfo":585,"targetDuration":583,"studyType":83,"phases":4,"briefSummary":587,"conditions":588,"keywords":590,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":594,"lastUpdatePostDateStruct":595,"startDateStruct":596,"completionDateStruct":598,"leadSponsor":600,"locationsCount":246},"100524832","diagnostic-innovations-for-pediatric-tuberculosis-in-bolivia-100524832","NCT06113861","Diagnostic Innovations for Pediatric Tuberculosis in Bolivia","Inclusion Criteria:\n\n* Children presenting for evaluation for symptomatic respiratory disease and suspicion of tuberculosis will be eligible for enrollment (inclusion criteria based on Bolivian Ministry of Health guidelines for suspect cases of tuberculosis in children\n\nExclusion Criteria:\n\n* prior treatment for TB within the past year,\n* current treatment for prevention of TB,\n* weight \\\u003C 2.5 kg., or\n* clinical instability,\n* positive COVID-19 diagnostic test","2 Months","14 Years",{"count":586,"type":22},1220,"Pediatric tuberculosis (TB) continues to pose diagnostic challenges in low- and middle-income countries with high rates of TB disease, due to the well-described impact of paucibacillary disease in children, and current TB culture and polymerase-chain reaction tests are of limited usefulness due to cost, restricted availability, and poor sensitivity in specimens available from younger children. Our team of experts from Tulane, Johns Hopkins University, Universidad Peruana Cayetano Heredia, and Asociación Benéfica Prisma have confronted all of these challenges through more than 25 years of collaboration in Peru and Bolivia. Our goal is to directly address the challenges of TB in children by evaluating a new diagnostic approach developed by MPI Tony Hu at Tulane University using a CRISPR-mediated TB assay (CRISPR-TB) optimized to detect circulating Mycobacterium tuberculosis cell-free DNA (Mtb-cfDNA), and used to analyze cryopreserved serum in pilot studies from adults and children with presumptive TB, their asymptomatic household contacts, and a cohort of symptomatic children living with HIV (CLHIV) at high risk for TB. Results from symptomatic adult cohorts yielded a pooled sensitivity of 93%; specificity of 93%; positive predictive value of 95%; and negative predictive value of 92%. In limited pilot studies in CLHIV CRISPR-TBD results accurately identified all confirmed TB (13\u002F13) and most children with unconfirmed TB (80%; 52\u002F65). We propose to enroll 200 presumptive TB cases and an equal number of well control subjects in each of 2 study populations (test population and validation population) identified through clinics associated with the \"Dr. Mario Ortiz Suarez\" Children's Hospital in Santa Cruz, Bolivia. We will determine the distribution of cfDNA concentrations in peripheral blood in a \"test population\" composed of two age-based groups of children (2 months-6 years, 7-14 years) with respiratory disease grouped by likelihood of TB based on the NIH consensus case definitions (confirmed TB, unconfirmed TB, and unlikely TB) and in age-matched controls grouped by presence of latent TB infection (LTBI), with cfDNA measured serially in time among TB cases receiving antibiotic therapy. We will also validate standard ranges of quantitative cfDNA established for clinical subgroups of children with TB disease or LTBI in an independent validation cohort. An additional aim will determine the correlation between quantitative cfDNA and quantitative imaging-based TB scores based on evidence of disease in the lung, the primary target organ in TB disease, by (1) chest radiograph, measured by computer-aided analysis using the CAD4TB v7 system, and by (2) lung ultrasound, performed with a portable\u002Flow-cost probe assisted by machine learning algorithms for automatic interpretation. These biomarkers will be tested as potential cofactors that may be combined with cfDNA levels in peripheral blood, to improve the detection of TB disease in children. The results of this study will be the first step in a process to find a path to allow detection of the many \"unconfirmed\" TB cases and ideally make the diagnosis of pediatric TB in reach for low resource settings where it is so critically needed.",[589],"Tuberculosis",[591,592,593],"Diagnostic testing","Children","Imaging analysis","2025-09-03",{"date":192,"type":40},{"date":597,"type":40},"2024-04-15",{"date":599,"type":22},"2028-10",{"name":46,"class":47},{"id":602,"slug":603,"hasResults":12,"nctId":604,"briefTitle":605,"officialTitle":606,"acronym":607,"eligibilityCriteria":608,"healthyVolunteers":12,"sex":17,"minAge":609,"maxAge":610,"enrollmentInfo":611,"targetDuration":4,"studyType":23,"phases":613,"briefSummary":614,"conditions":615,"keywords":617,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":624,"lastUpdatePostDateStruct":625,"startDateStruct":627,"completionDateStruct":629,"leadSponsor":631,"locationsCount":246},"100387946","the-allergen-reduction-and-child-health-study-archs-100387946","NCT04331353","The Allergen Reduction and Child Health Study (ARCHS)","Comparative Effectiveness of Multi Versus Single Intervention Allergen Reduction Strategies on Asthma Morbidity","ARCHS","Inclusion Criteria:\n\n* Age 5 - 17 years; with uncontrolled persistent asthma defined as the child experiencing at least one of the following: one overnight hospitalization for asthma within the past six months OR two unscheduled clinic or emergency department visits for asthma within the last 12 months; and either on a long term controller medication for asthma, or have asthma symptoms 3 or more days per week over the past 2 weeks or nighttime asthma symptoms at least 3 times in the past month exposure to cockroach - defined as trapping at least one cockroach in a 3 day period OR visual evidence of cockroaches by field staff; and the child must sleep in the target home at least 4 nights per week on average. Caregiver ability to speak English or Spanish.\n\nExclusion Criteria:\n\n* Other serious medical or chronic illnesses including chronic respiratory infections that require daily medication, cardiovascular disease that requires daily medication, excluding hypertension, taking a beta-blocker, a current active smoker, currently receiving immunotherapy or plans to move within the 12 month follow-up.","5 Years","17 Years",{"count":612,"type":22},290,[25],"The Allergen Reduction and Child Health Study (ARCHS) is a 12-month, two group randomized control trial of children with asthma and who are exposed to cockroaches. Children ages 5 - 17 living in the Greater New Orleans area will be recruited from a variety of clinic and community settings. The overall goal of the study is to improve patient-centered asthma outcomes (asthma symptom days, health care utilization, asthma control and quality of life) by targeting one key allergen - cockroach exposure in the child's home. The investigators propose a simple intervention of insecticidal bait that is low cost, simple to implement, and which is lower toxicity than other forms of pest control. The reduction in the number of cockroaches in the home is an environmental outcome that is patient-centered and is likely to add to its acceptance by families of children with asthma.",[616],"Asthma in Children",[618,619,620,621,622,623],"asthma","cockroach allergen","indoor allergens","pulmonary function","childhood asthma","environmental intervention","2025-09-02",{"date":626,"type":40},"2025-09-09",{"date":628,"type":40},"2020-11-15",{"date":630,"type":22},"2028-04-30",{"name":46,"class":47},{"id":633,"slug":634,"hasResults":12,"nctId":635,"briefTitle":636,"officialTitle":637,"acronym":4,"eligibilityCriteria":638,"healthyVolunteers":12,"sex":639,"minAge":18,"maxAge":4,"enrollmentInfo":640,"targetDuration":4,"studyType":23,"phases":641,"briefSummary":642,"conditions":643,"keywords":647,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":648,"lastUpdatePostDateStruct":649,"startDateStruct":651,"completionDateStruct":652,"leadSponsor":653,"locationsCount":246},"100408650","phase-4-testosterone-treatment-for-erectile-dysfunction-and-multiple-sclerosis-100408650","NCT04601233","Testosterone Treatment for Erectile Dysfunction and Multiple Sclerosis","Testosterone TReatment for Erectile Dysfunction in Male Multiple Sclerosis Patients With Low Testosterone (TTRED-MS Study)","Inclusion Criteria:\n\n* Males, age 18 years and older, with a definite diagnosis of multiple sclerosis.\n* Low testosterone (\\\u003C300 ng\u002Fdl) on two successive blood draws before 9:00 am\n* Not in an intercurrent relapse.\n* Sexually active.\n* Have subjective complaints about erectile function and libido.\n* Must be willing and able to get labs drawn, complete questionnaires (BDI, MFIS, MSNQ, SDMT, MSQOL, ADAM, AUASS, SHIM, MSHQ, ICIQ, UDI, IIQ, MPQ) and commit to site visits schedule.\n\nExclusion Criteria:\n\n* Males unable to fulfill the above criteria and all female patients.\n* Males who have been on sex hormone treatment including androgens, estrogens, or anti-estrogens for hypogonadism or other medical condition during the 12 months prior to study.\n* Males who have taken dehydroepiandrosterone (DHEA) during the 3 months prior to study.\n* Patients who are taking anticoagulants or have thrombosis, serious cardiac, pulmonary, renal, gastrointestinal, hepatic, immunologic, infectious, neoplastic (with particular focus on patients with known or suspected estrogen or testosterone-dependent tumors), urologic disease especially prostatic hypertrophy\u002Fnodules and testicular mass, or insulin-dependent diabetes.\n* Patients with an abnormal prostate as evidenced by known history of prostatic disease, symptoms suggestive of prostatic disease or elevated levels of prostatic specific antigen (PSA 4 ng\u002Fml or higher) measured within the last 12 months.\n* Patients with history or complaint of testicular mass.\n* Patients with hematocrit greater than 50%\n* Patients with major psychiatric illness\n* Patients with active alcoholism.\n* Patients with a history of drug abuse within the past five years.\n* Patients with BMI ≥ 35\n* Patients with generalized skin disease that may affect absorption of testosterone (e.g. psoriasis) or a known skin intolerance to alcohol.\n* Patients with history of pituitary disease.\n* Patients with a cholesterol level greater than 300 mg\u002Fdl.\n* Patients who are receiving or have received experimental therapies in the six months preceding enrollment.\n* Patients who have history of positive titers to Human Immunodeficiency Virus (HIV)1 and 2; HTLV1; or Venereal Disease Research Laboratory (VDRL).\n* Patients who have clinical evidence of Lyme disease.\n* Males who are trying to get their partner pregnant.\n* Patients on Finasteride\n* Patients who are mentally or emotionally incompetent in the opinion of the examining neurologist or unable to give informed consent, or to understand and comply with the study protocol.\n* Any other contraindications according to the manufacturer's exclusion criteria.","MALE",{"count":336,"type":22},[205],"The purpose of the study is to determine the effects of testosterone treatment on erectile function, fatigue, depression, cognitive function, quality of life, urinary incontinence, pain, and damage to neurons in male Multiple Sclerosis patients with low testosterone, using questionnaires, blood samples and a rectal exam in volunteers 55 years and older.",[644,645,646],"Multiple Sclerosis","Erectile Dysfunction","Testosterone Deficiency",[644,645,646],"2025-08-28",{"date":650,"type":40},"2025-08-29",{"date":391,"type":22},{"date":97,"type":22},{"name":46,"class":47},""]