[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"endothelial-dysfunction\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:endothelial-dysfunction":34},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,50,0,25,[9,55,84,112,144,169,203,240,273,302,334,365,392,424,449,470,492,520,539,564,594,614,633,657,676],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":18,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":35,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"100641377","polyphenol-intake-mediterranean-diet-adherence-and-oxidative-stress-in-pregnancy-100641377",false,"NCT07656532","Polyphenol Intake, Mediterranean Diet Adherence, and Oxidative Stress in Pregnancy","Effect of Polyphenol Intake and Adherence to the Mediterranean Diet on Oxidative Stress During Pregnancy","PREGPOLY","Inclusion Criteria:\n\n* Pregnant women aged 18 years or older.\n* Singleton pregnancy.\n* Gestational age between 8 and 11 weeks at enrollment.\n* Receiving prenatal care within the Salamanca Health Area.\n* Able to understand the study information and provide written informed consent.\n* No clinical restrictions that would contraindicate dietary modifications.\n\nExclusion Criteria:\n\n* Medical or obstetric conditions that contraindicate dietary modifications.\n* Active metabolic, renal, or hepatic disease.\n* Severe hyperemesis gravidarum or gastrointestinal disorders limiting food intake.\n* Allergy or intolerance to cocoa.\n* Habitual high cocoa or chocolate consumption (\\>30 g\u002Fday).\n* Multiple pregnancy.\n* Severe obstetric complications diagnosed before enrollment.\n* Inability to comply with study procedures, attend follow-up visits, or communication barriers that could interfere with participation.",true,"FEMALE","18 Years",{"count":22,"type":23},60,"ESTIMATED","INTERVENTIONAL",[26],"NA","This study is a randomized controlled clinical trial designed to evaluate the effect of a polyphenol-rich dietary intervention during pregnancy on endothelial function, oxidative stress biomarkers, and maternal and neonatal outcomes.\n\nPregnancy is associated with metabolic and vascular adaptations, and complications such as gestational diabetes and hypertensive disorders are linked to endothelial dysfunction and increased oxidative stress. Dietary factors, particularly adherence to the Mediterranean diet and intake of polyphenol-rich foods, may play a protective role.\n\nPregnant women will be randomly assigned to either an intervention group or a control group. The intervention consists of daily consumption of 10 g of natural non-alkalized cocoa and structured dietary counseling aimed at achieving at least five daily servings of fruits and vegetables, alongside general Mediterranean diet recommendations.\n\nThe intervention will last 12 weeks, from early to mid-pregnancy. Biomarkers of endothelial function and oxidative stress will be measured at different time points, along with clinical maternal outcomes (including gestational diabetes and hypertensive disorders) and neonatal outcomes.\n\nThe aim is to determine whether this dietary intervention improves endothelial function, reduces oxidative stress, and contributes to better pregnancy outcomes.",[29,30,31,32,33,34],"Pregnancy","Gestational Diabetes Mellitus (GDM)","Preeclampsia","Hypertension, Pregnancy-Induced","Oxidative Stress","Endothelial Dysfunction",[36,37,38,39,40,41],"Mediterranean diet","Polyphenols","Cocoa supplementation","Oxidative stress","Endothelial function","Randomized controlled trial","NOT_YET_RECRUITING","2026-06-14",{"date":45,"type":46},"2026-06-18","ACTUAL",{"date":48,"type":23},"2026-09-01",{"date":50,"type":23},"2028-10-01",{"name":52,"class":53},"University of Salamanca","OTHER",1,{"id":56,"slug":57,"hasResults":12,"nctId":58,"briefTitle":59,"officialTitle":59,"acronym":4,"eligibilityCriteria":60,"healthyVolunteers":18,"sex":61,"minAge":20,"maxAge":62,"enrollmentInfo":63,"targetDuration":4,"studyType":24,"phases":65,"briefSummary":68,"conditions":69,"keywords":70,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":54},"100421546","phase-1-enhancing-parasympathetic-activity-to-improve-endothelial-dysfunction-vascular-oxidative-stress-in-african-americans-100421546","NCT04769206","Enhancing Parasympathetic Activity to Improve Endothelial Dysfunction, Vascular Oxidative Stress in African Americans","Inclusion Criteria:\n\n1. African American women and men\n2. Age 18 to 60 years old\n3. BMI \\>28\n\nExclusion Criteria:\n\n1. Individuals with a history of physician diagnosed myocardial infarction, angina, heart failure, stroke, or transient ischemic attack, or who had undergone an invasive procedure for CVD (coronary artery bypass graft, angioplasty, valve replacement, pacemaker placement or other vascular surgeries)\n2. Uncontrolled hypertension defined as persistent blood pressure \\>140\u002F90 despite the use of anti-hypertensive agents.\n3. Diabetes Mellitus type 1 or type 2, as defined by a fasting plasma glucose of 126 mg\u002FdL or greater hemoglobin A1C (HbA1C) 6.5% or above or the use of anti-diabetic medication\n4. The use of nitrates.\n5. The metabolism of galantamine is primarily through the cytochrome P450 system, specifically the CYP2D6 and CYP3A4 isoenzymes. We will exclude subjects who have impaired hepatic function and\u002For who are currently using strong inhibitors of CYP3A4 and CYP2D6 (e.g. ketoconazole and paroxetine, respectively).\n6. Pregnancy or breast-feeding. Women of child-bearing potential will be required to have undergone tubal ligation or to be using an oral contraceptive or barrier methods of birth control.\n7. Post-menopausal women.\n8. The use of any other central or peripheral acetylcholinesterase inhibitor (donezepil (Aricept(R)), pyridostigmine (Mestinon(R)), rivastigmine (Exelon(R)), tacrine (Cognex(R)).\n9. First, second or third-degree AV block detected during the screening visit with an ECG\n10. Seizures or history of seizures.\n11. Current smokers defined as those who smoked a cigarette in the last 30 days.\n12. History of recurrent syncope.\n13. History of serious neurologic disease such as cerebral hemorrhage, stroke, or transient ischemic attack.\n14. History of cardiac shunts.\n15. Allergy to eggs or soy.\n16. Impaired hepatic function (aspartate amino transaminase \\[AST\\] and\u002For alanine amino transaminase \\[ALT\\] \\>3.0 x upper limit of normal range)\n17. Impaired renal function test (eGFR\\\u003C60 mL\u002Fmin\u002F1.73m2)\n18. Anemia (hematocrit \\\u003C34%)\n19. Ongoing substance abuse.\n20. Treatment with any investigational drug in the one month preceding the study\n21. Mental conditions rendering a subject unable to understand the nature, scope and possible consequences of the study\n22. Inability to comply with the protocol, e.g. uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study","ALL","60 Years",{"count":64,"type":23},160,[66,67],"PHASE1","PHASE2","Specific Aim 1: To test the hypothesis that prolonged (3-month) treatment with galantamine inhibits NADPH IsoLG-protein adducts formation and improves markers of endothelial cell (EC) dysfunction in AAs.\n\nAim 1a: The investigators will determine if galantamine inhibits NADPH IsoLG-protein adducts formation, superoxide production, and immune cell activation compared to placebo.\n\nFor this purpose, the investigators will study peripheral blood mononuclear cell (PBMC), a critical source of systemic oxidative stress, collected from study participants.\n\nAim 1b: The investigators will determine if galantamine reduces intracellular Iso-LGs, ICAM-1, and 3-nitrotyrosine, a marker of vascular oxidative stress, in ECs harvested from study participants.\n\nSpecific Aim 2: To determine if prolonged (3-month) treatment with galantamine improves endothelial dysfunction as measured by vascular reactivity in AAs. The investigators will measure vascular reactivity in response to ischemia in two vascular beds: (a) in conduit arteries (brachial artery) using brachial artery diameter flow-mediated dilation (FMD), and (b) in the microvasculature (MBV) using contrast-enhanced ultrasonography in skeletal muscle.\n\nSub-study (optional) Will study the effect of trans-auricular vagus nerve stimulation (TaVNS) during a period of enhanced vascular oxidative stress\n\nThis proposal will study a novel mechanism that could alter the oxidative and immunogenic responses that contributes to endothelial dysfunction in AAs and will offer a potential pathway for the development of more effective therapies aimed at decreasing the progression of endothelial dysfunction to cardiovascular disease in this population.",[34],[71,72,73],"African American","Flow-mediated dilation (FMD)","Vascular Oxidative Stress","RECRUITING","2026-05-15",{"date":77,"type":46},"2026-05-18",{"date":79,"type":46},"2021-12-20",{"date":81,"type":23},"2028-06-01",{"name":83,"class":53},"Vanderbilt University Medical Center",{"id":85,"slug":86,"hasResults":12,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":4,"eligibilityCriteria":90,"healthyVolunteers":18,"sex":61,"minAge":20,"maxAge":91,"enrollmentInfo":92,"targetDuration":4,"studyType":24,"phases":94,"briefSummary":95,"conditions":96,"keywords":4,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":54},"100305377","phase-1-cerebral-blood-flow-and-ventilatory-responses-during-sleep-in-normoxia-and-intermittent-hypoxia-100305377","NCT03255408","Cerebral Blood Flow and Ventilatory Responses During Sleep in Normoxia and Intermittent Hypoxia","Role of Cerebral Blood Flow on Ventilatory Stability During Sleep in Normoxia and Intermittent Hypoxia","Inclusion Criteria:\n\n* Healthy adults\n* 18 - 45 years of age\n* Living in Calgary for the past one year\n* Have no medical condition or should not be taking any blood pressure medications.\n* The participant should not be lactose intolerant\n\nExclusion Criteria:\n\n* Cerebrovascular, cardio-respiratory, renal and metabolic diseases\n* Bleeding disorders and upper gastrointestinal diseases e.g. peptic ulcer disease\n* Pregnancy, obese and sleep-disordered breathing\n* Drug allergies to non-steroidal anti-inflammatories\n* Currently smoking","45 Years",{"count":93,"type":23},12,[66,67],"A prospective double blind, placebo-controlled, randomized cross-over trial to evaluate the effect of lowering cerebral blood flow on the ventilatory chemoreflexes (acute hypoxic and hypercapnic ventilatory responses).",[97,98,99,100,101,102,34,33],"Obstructive Sleep Apnea of Adult","Hypoxia, Brain","Sleep Apnea","Sleep Disorder","Stroke","Blood Pressure","2026-04-27",{"date":105,"type":46},"2026-05-01",{"date":107,"type":46},"2023-01-01",{"date":109,"type":23},"2027-12-30",{"name":111,"class":53},"University of Calgary",{"id":113,"slug":114,"hasResults":12,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":4,"eligibilityCriteria":118,"healthyVolunteers":18,"sex":61,"minAge":20,"maxAge":119,"enrollmentInfo":120,"targetDuration":4,"studyType":122,"phases":4,"briefSummary":123,"conditions":124,"keywords":127,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":54},"100305247","samples-from-human-subjects-to-facilitate-basic-translational-and-clinical-research-100305247","NCT03253705","Samples From Human Subjects to Facilitate Basic, Translational and Clinical Research","Obtaining Samples From Human Subjects to Facilitate Basic, Translational and Clinical Research","* INCLUSION CRITERIA FOR RESEARCH SUBJECTS WITH DISEASES RELATED TO CARDIOVASCULAR SYSTEM AND\u002FOR INFLAMMATION AND\u002FOR ENDOTHELIAL DYSFUNCTION SUCH AS BUT NOT LIMITED TO ARTERIOSCLEROSIS, TRANSPLANTATION, PULMONARY HYPERTENSION, OTHER ADVANCED LUNG OR HEART DISEASE\n\n  1. Males or females of age greater than or equal to 18 years old.\n  2. Subjects unable to provide informed consent must have a surrogate decision maker or another legally authorized representative (such as a legal guardian or holder of the DPA)\n\nEXCLUSION CRITERIA FOR RESEARCH SUBJECTS WITH DISEASES RELATED TO CARDIOVASCULAR SYSTEM AND\u002FOR INFLAMMATION AND\u002FOR ENDOTHELIAL DYSFUNCTION SUCH AS BUT NOT LIMITED TO ARTERIOSCLEROSIS, TRANSPLANTATION, PULMONARY HYPERTENSION, OTHER ADVANCED LUNG OR HEART DISEASE\n\n1. Hemoglobin \\\u003C7.0 g\u002FdL\n2. Currently receiving infusion of epinephrine; or dopamine at an infusion rate of \\>2.5 microgram\u002Fkg\u002Fmin, norepinephrine of \\> 20mcg\u002Fmin, or vasopressin \\> 0.04 units\u002Fmin\\*\n3. In the presence of known coronary artery disease (CAD) a systolic blood pressure (SBP) \\\u003C90 mmHg. In the absence of known CAD a SBP \\\u003C80 mmHg or mean arterial pressure (MAP) \\\u003C60 mmHg with or without vasopressors\\*.\n\n   * For critically ill patients with shock (on vasopressors), no more than 20mL of blood may be obtained within a 24 hour period. (No more than 200ml over eight weeks.)\n\nResearch subjects may be excluded if in the opinion of the study investigators they have a condition that may adversely affect the outcome of the study or the safety of the volunteer.\n\nINCLUSION CRITERIA FOR SUBJECTS WHO ARE TO RECEIVE CRRT (IRRESPECTIVE OF DIAGNOSIS) IN WHOM THE TOTAL AMOUNT OF PROTOCOL RELATED BLOOD WILL NOT EXCEED 8 ML.\n\n1. Males or females of age greater than or equal to 18 years old.\n2. Subjects unable to provide informed consent must have a surrogate decision maker or another legally authorized representative (such as a legal guardian or holder of the DPA)\n\nEXCLUSION CRITERIA FOR SUBJECTS WHO ARE TO RECEIVE CRRT (IRRESPECTIVE OF DIAGNOSIS) IN WHOM THE TOTAL AMOUNT OF PROTOCOL RELATED BLOOD WILL NOT EXCEED 8 ML)\n\n1. Hemoglobin \\\u003C7.0 g\u002FdL\n2. In the presence of known coronary artery disease (CAD) a systolic blood pressure (SBP) \\\u003C90 mmHg. In the absence of known CAD a SBP \\\u003C80 mmHg or mean arterial pressure (MAP) \\\u003C60 mmHg.\n\nINCLUSION CRITERIA FOR HEALTHY VOLUNTEERS:\n\n1. Males or females of age greater than or equal to 18 years old\n2. Ability of subjects to understand and the willingness to sign an informed consent document.\n\nEXCLUSION CRITERIA FOR HEATLHY VOLUNTEERS:\n\n1. Blood or platelet donation within the last 6 weeks.\n2. Hemoglobin below normal (e.g. below 11.2 g\u002Fdl for females and below 13.7 mg\u002Fdl for males at the NIH CC); subjects may return for evaluation at a later date. (After initial enrollment, hematocrit does not need to be done prior to subsequent blood draws unless there is interval development of symptomatic anemia)\n3. History of recreational drug use with the exception of marijuana (as long as marijuana use was \\>3 months from the time of study screening).\n4. Active acute illness (i.e viral syndrome). Subjects may return for evaluation at a later date once the acute illness resolves.\n5. Volunteers may be excluded if in the opinion of the study investigators they have a condition that may adversely affect the outcome of the study or the safety of the volunteer, such as, active tobacco use (\\> 6 months) in the past ten years, any tobacco use within 3 months prior to the screening evaluation, a history of clinically relevant and active cardiopulmonary disease (e.g. Including but not limited to any cardiopulmonary diseases not well controlled by medications, EKG with evidence of clinically relevant heart disease, COPD with hypoxemia and forced expiratory volume\u002Fforced vital capacity (FEV1\u002FFVC) \\> 2 standard deviations from normal, etc.).","100 Years",{"count":121,"type":23},1000,"OBSERVATIONAL","Background:\n\nThis study is designed to provide samples to help us study the genes your blood cells are making as well as the proteins, sugars, fats, vitamins and other metabolites found in your blood or urine. Blood samples may also be collected to make special cells. These are called induced pluripotent stem cells or iPSCs. Pluripotent stem cells are cells that can be converted into any type of cell. Researchers want to study in the lab iPSCs that are derived from blood samples.\n\nObjective:\n\nTo collect samples to help study genes, proteins, sugars, fats, vitamins, and other metabolites found in blood or urine.\n\nEligibility:\n\nHealthy volunteers and patients ages 18 and older\n\nDesign:\n\nFirst-time research study participants at NIH will have an initial visit for this study that should last no more than 1 hour. All other visits should last 20 30 minutes.\n\nParticipants will undergo a limited history and physical exam.\n\nParticipants may have routine blood and urine tests.\n\nIf participants are giving a blood sample, they must have a hemoglobin level checked in the past 12 months to make sure it is safe for them to give a blood sample for research.\n\nParticipants may have a venous blood collection. They may do this at several visits. They will lie on a recliner or couch or sit in a chair. A needle will be placed into a vein in the hand or arm, using sterile techniques. Blood will be withdrawn into multiple syringes or tubes.\n\nParticipants may be asked to provide urine in an appropriate container...",[34,125,126],"Inflammation in Cardiopulmonary and Vascular Disease States","Healthy Volunteers",[128,129,130,131,132,133],"Assay Development","Gene Expression","Metabolomics","Induced Pluripotent Stem Cells","PBMCs\u002FDNA\u002FRNA","Natural History","2026-04-23",{"date":136,"type":46},"2026-04-24",{"date":138,"type":46},"2017-09-14",{"date":140,"type":23},"2027-08-01",{"name":142,"class":143},"National Institutes of Health Clinical Center (CC)","NIH",{"id":145,"slug":146,"hasResults":12,"nctId":147,"briefTitle":148,"officialTitle":149,"acronym":150,"eligibilityCriteria":151,"healthyVolunteers":12,"sex":61,"minAge":20,"maxAge":152,"enrollmentInfo":153,"targetDuration":4,"studyType":24,"phases":155,"briefSummary":156,"conditions":157,"keywords":4,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":54},"100511476","impact-of-the-mandibular-advancement-device-on-sleep-apnea-during-cpap-withdrawal-100511476","NCT05939934","Impact of the Mandibular Advancement Device on Sleep Apnea During CPAP Withdrawal","Impact of the Mandibular Advancement Device on Sleep Apnea Syndrome During Discontinuation of Treatment With Continuous Positive Airway Pressure: Randomized Controlled Trial","ORTAP","Inclusion Criteria:\n\n* Patient accepting MAD treatment\n* Patient with an apnea-hypopnea index (AHI) greater than 15 events per hour on the initial recording\n* Patient with excessive daytime sleepiness during initial treatment (ESE\\>10)\n* Patient treated for more than 12 months by CPAP with average compliance greater than 5 hours per night\n\nExclusion Criteria:\n\n* Initial severe daytime sleepiness characterized\n* OSAS with ≥ 5 central apneas per hour of sleep at baseline recording\n* Previously diagnosed severe cardiac and\u002For respiratory pathology:\n* Body mass index ≥ 35 kg\u002Fm2\n* Known contraindication to OAM treatment","75 Years",{"count":154,"type":23},40,[26],"Obstructive sleep apnea hypopnea syndrome (OSAS) is a frequent disease with neuropsychological and cardiovascular (CV) consequences. Continuous positive pressure (CPAP), the main treatment for OSAHS, is effective on the majority of symptoms but restrictive, which can promote non-compliance. Treatment interruptions are often observed in connection with intercurrent events such as nasal obstructions or even when patients are on the move. However, randomized trials have shown that stopping treatment, even for a short time, leads to a recurrence of symptoms and significant CV disturbances (increase in blood pressure, endothelial dysfunction, cardiac repolarization disorders). It seems important to consider strategies that promote therapeutic continuity. The mandibular advancement device (MAD) is an interesting tool in this regard. MAD is as effective as CPAP on symptoms and CV data. The investigators want to assess its effectiveness as a complementary treatment during treatment discontinuation on the main consequences of OSAHS.",[158,34],"Sleep Apnea, Obstructive","2026-03-31",{"date":161,"type":46},"2026-04-06",{"date":163,"type":46},"2024-03-05",{"date":165,"type":23},"2026-11",{"name":167,"class":168},"University Hospital, Angers","OTHER_GOV",{"id":170,"slug":171,"hasResults":12,"nctId":172,"briefTitle":173,"officialTitle":174,"acronym":175,"eligibilityCriteria":176,"healthyVolunteers":12,"sex":61,"minAge":177,"maxAge":152,"enrollmentInfo":178,"targetDuration":4,"studyType":24,"phases":180,"briefSummary":181,"conditions":182,"keywords":184,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":54},"100630414","phase-1-tb-500-thymosin-beta-4-17-23-fragment-for-cardiovascular-biomarkers-in-stable-ascvd-100630414","NCT07487363","TB-500 (Thymosin Beta 4 17-23 Fragment) for Cardiovascular Biomarkers in Stable ASCVD","A Phase 1\u002F2, Randomized, Double-Blind, Placebo-Controlled, Sequential Dose-Escalation Study of TB-500 (Thymosin Beta 4 17-23 Fragment) in Adults With Stable Atherosclerotic Cardiovascular Disease to Evaluate Safety, Tolerability, Pharmacokinetics, and Exploratory Cardiovascular Biomarkers","TBRIDGE-CV","Inclusion Criteria:\n\n* Age 40-75 years, able to provide written informed consent.\n* Documented stable ASCVD (e.g., prior myocardial infarction \\>6 months ago, prior coronary revascularization, stable angina with objective evidence of ischemia, or symptomatic peripheral artery disease).\n* On stable guideline-directed medical therapy (e.g., statin and antiplatelet therapy unless contraindicated) for at least 8 weeks before screening.\n* Resting systolic blood pressure \\\u003C160 mmHg and diastolic blood pressure \\\u003C100 mmHg (with or without therapy).\n* Able and willing to comply with study visits and procedures.\n\nExclusion Criteria:\n\n* Acute coronary syndrome, stroke\u002Ftransient ischemic attack, or coronary revascularization within 6 months before screening.\n* New York Heart Association (NYHA) class III-IV heart failure or left ventricular ejection fraction \\\u003C35%.\n* Clinically significant arrhythmia requiring recent hospitalization or unstable antiarrhythmic therapy.\n* Severe renal impairment (eGFR \\\u003C30 mL\u002Fmin\u002F1.73 m\\^2) or end-stage renal disease.\n* Clinically significant hepatic impairment (e.g., Child-Pugh class B\u002FC) or ALT\u002FAST \\>3x upper limit of normal at screening.\n* Active malignancy requiring systemic therapy (except adequately treated non-melanoma skin cancer) within the past 2 years.\n* Known autoimmune disease requiring systemic immunosuppression, or use of chronic systemic corticosteroids above physiologic replacement.\n* Pregnant or breastfeeding, or unwilling to use effective contraception during the study (if of childbearing potential).\n* Known hypersensitivity to peptide therapeutics or study formulation components.\n* Participation in another interventional clinical study or receipt of an investigational product within 30 days (or 5 half-lives, whichever is longer) prior to screening.","40 Years",{"count":179,"type":23},80,[66,67],"This fictional study is an example of a ClinicalTrials.gov-style record. It describes a Phase 1\u002F2 trial evaluating the safety and tolerability of TB-500 (a 17-23 fragment of thymosin beta 4) versus placebo in adults with stable atherosclerotic cardiovascular disease (ASCVD). Exploratory endpoints assess vascular function and inflammation biomarkers",[183,34],"Atherosclerotic Cardiovascular Diseases",[185,186,187,188,189,190,191,192],"TB-500","thymosin beta 4 fragment","vascular repair","endothelial function","flow-mediated dilation","inflammation","hs-CRP","atherosclerosis","2026-03-17",{"date":195,"type":46},"2026-03-23",{"date":197,"type":46},"2026-02-05",{"date":199,"type":23},"2028-02-17",{"name":201,"class":202},"Hudson Biotech","INDUSTRY",{"id":204,"slug":205,"hasResults":12,"nctId":206,"briefTitle":207,"officialTitle":208,"acronym":4,"eligibilityCriteria":209,"healthyVolunteers":12,"sex":210,"minAge":177,"maxAge":211,"enrollmentInfo":212,"targetDuration":4,"studyType":24,"phases":214,"briefSummary":215,"conditions":216,"keywords":222,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":232,"startDateStruct":234,"completionDateStruct":236,"leadSponsor":238,"locationsCount":54},"100628386","phase-2-trial-of-statin-therapy-effect-on-androgen-status-and-erectile-function-in-men-100628386","NCT07460960","TRIal of STatin Therapy Effect on Androgen Status and Erectile functioN in Men","A Randomized Controlled Trial of Statin Therapy Effect on Androgen Status and Erectile Function in Men With High and Very High Cardiovascular Risk","Inclusion Criteria:\n\n* male patients aged 40-65 years, sexually active\n* high and very high risk of cardiovascular events (The Systematic Coronary Risk Evaluation 2 (SCORE2))\n* absence of previous statin therapy for 3 months\n* there are no known cardiovascular diseases requiring the appointment of statins in high doses from the start of treatment\n* the invariance of concomitant therapy for 3 months, if the patient needs it.\n\nExclusion Criteria:\n\n* known statin intolerance\n* known hypogonadism\n* persistent forms of atrial fibrillation\n* active malignant neoplasm requiring treatment at the time of screening\n* known chronic inflammatory diseases (rheumatoid arthritis, systemic connective tissue diseases, metabolically associated fatty liver disease, etc.)\n* impaired renal function (estimated glomerular filtration rate \\\u003C30 ml\u002Fmin\u002F1.73 m2) and liver (transaminase levels more than 3 times reference values, bilirubin levels more than 2 times reference values)\n* chronic heart failure\n* a well-known diagnosis of mental illness\n* alcoholism and drug addiction\n* glucocorticoid therapy and regular therapy with nonsteroidal anti-inflammatory drugs (80% of the time for 3 months before switching on)\n* participation in any other clinical trial during this trial, including participation in the trial for 30 days prior to providing informed consent\n* the patient's inability to understand the essence of the study and consent to participate in it","MALE","65 Years",{"count":213,"type":23},150,[67],"Aim. To study the effect of different intensities of statin therapy on androgen status and erectile function in men aged 40-65 years with high and very high cardiovascular risk. Additionally, to assess the association between sex hormone levels, erectile function parameters, and traditional cardiovascular risk factors, arterial stiffness, and endothelial function in this patient category.\n\nMaterial and methods. It is planned to conduct a prospective randomized controlled trial, including 150 male patients aged 40-65 years, undergoing routine preventive examinations in the clinic of Moscow State University, having a high and very high risk of cardiovascular diseases and meeting the inclusion criteria. Group Pit (n=75) will receive pitavastatin at a starting dose of 1 mg\u002Fday. Group Ros (n=75) will receive rosuvastatin 20 mg\u002Fday. After 3 months, the biochemical parameters will be monitored, and dose titration of pitavastatin to 2-4 mg\u002Fday and\u002For rosuvastatin to 40 mg\u002Fday will be performed if necessary. Patient recruitment to the study will occur over 9 months at a single research center. Patients will be monitored with an objective assessment of erectile function parameters, blood analysis (including androgen status), central arteries stiffness, and endothelial function for 6 months from the moment of activation. Follow-up visits are scheduled at 1, 3 and 6 months.\n\nResults. The expected result of testing the research hypothesis is that statin therapy will not have a negative effect on androgen status and erectile function in men. Intensive statin therapy will have a greater positive effect on endothelial function, which may lead to an improvement in men's erectile function.\n\nConclusion. The study was planned under the assumption that statin therapy would not have a negative effect on androgen status and erectile function in men aged 40-65 years. It is also suggested that the positive effect of statins on endothelial function and vascular stiffness may lead to an improvement in erectile function among men with high and very high cardiovascular risk. If the hypothesis is confirmed, the results obtained will help improve statin treatment adherence in male patients and, as a result, increase the effectiveness of prevention of cardiovascular events.",[217,218,219,34,220,221],"Erectile Dysfunction Due to Arterial Disease","Atheroscleroses","Erectile Disfunction","Androgen Profile","Testosterone",[223,224,225,192,226,227,228,229,230],"cardiovascular diseases","erectile dysfunction","androgen status","statins","statin therapy","coronary artery disease","endothelial dysfunction","testosterone","2026-03-12",{"date":233,"type":46},"2026-03-16",{"date":235,"type":46},"2026-03-05",{"date":237,"type":23},"2027-12",{"name":239,"class":53},"Lomonosov Moscow State University Medical Research and Educational Center",{"id":241,"slug":242,"hasResults":12,"nctId":243,"briefTitle":244,"officialTitle":245,"acronym":4,"eligibilityCriteria":246,"healthyVolunteers":18,"sex":61,"minAge":247,"maxAge":62,"enrollmentInfo":248,"targetDuration":4,"studyType":122,"phases":4,"briefSummary":250,"conditions":251,"keywords":255,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":265,"lastUpdatePostDateStruct":266,"startDateStruct":267,"completionDateStruct":269,"leadSponsor":271,"locationsCount":54},"100629404","associations-between-dietary-patterns-ldl-aggregation-and-cardiometabolic-health-a-cross-sectional-analysis-100629404","NCT07474233","Associations Between Dietary Patterns, LDL Aggregation, and Cardiometabolic Health: A Cross-sectional Analysis.","Associations Between Dietary Pattern Adherence, LDL Aggregation, and Cardiometabolic Health: A Cross-sectional Analysis.","Inclusion Criteria:\n\n* Adults aged 25-60 years.\n* BMI range (18.5-29.9 kg\u002Fm²).\n* Following one of the specified dietary patterns (vegan\u002Fplant-based, carnivore, or omnivorous) for a minimum of 6 months.\n* Self-identified as health-focused (i.e., intentionally following the diet for perceived health benefits).\n\nExclusion Criteria:\n\n* BMI outside the stated range (\\\u003C18.5 or ≥30 kg\u002Fm²).\n* Use of lipid-lowering medications or supplements that may interfere with LDL levels.\n* Pregnancy or breastfeeding.\n* Any significant deviation from the specified diet within the last month.","25 Years",{"count":249,"type":23},90,"This study aims to investigate the extent to which vegan or plant-based, omnivorous, and carnivore dietary patterns affect LDL aggregation susceptibility (the affinity for LDL cholesterol particles to clump together in the blood), which may promote plaque build-up in arteries. Using a cross-sectional mixed-methods design, the study will measure LDL aggregation, blood lipids, and other metabolic biomarkers in individuals following these diets, and combine these data with dietary and behavioural information to examine links with cardiovascular and metabolic health.",[252,253,254,34],"Atherosclerosis Cardiovascular Disease","Metabolic Syndrome","Dyslipidaemia",[256,257,258,259,260,261,262,263,264],"LDL aggregation","Dietary patterns","Atherosclerosis","Cardiovascular disease","Onmivore diet","Vegan diet","Carnivore diet","Lipid profile","Cardiometabolic health","2026-03-11",{"date":233,"type":46},{"date":268,"type":23},"2026-05",{"date":270,"type":23},"2027-05",{"name":272,"class":53},"Liverpool John Moores University",{"id":274,"slug":275,"hasResults":12,"nctId":276,"briefTitle":277,"officialTitle":278,"acronym":279,"eligibilityCriteria":280,"healthyVolunteers":18,"sex":61,"minAge":20,"maxAge":152,"enrollmentInfo":281,"targetDuration":4,"studyType":122,"phases":4,"briefSummary":283,"conditions":284,"keywords":287,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":293,"lastUpdatePostDateStruct":294,"startDateStruct":295,"completionDateStruct":297,"leadSponsor":299,"locationsCount":301},"100617921","the-effect-of-lipoprotein-a-on-arterial-stiffness-endothelial-function-and-myocardial-deformation-100617921","NCT07324902","The Effect of Lipoprotein (a) on Arterial Stiffness, Endothelial Function and Myocardial Deformation","The Effect of Lipoprotein (a) on Arterial Stiffness, Endothelial Function and Left Atrial and Left Ventricular Deformation - An Observational Study.","Lpa_endo","Inclusion Criteria:\n\n* Adults participants 18-75 years old\n* Willing to sign the informed consent and paerticipate in the study\n\nExclusion Criteria:\n\n* History of autoimmune\u002Fautoinflammatory disease,\n* Severe valvular heart disease,\n* severe chronic kidney disease(eGFR\\\u003C60 ml\u002Fmin\u002F1.73 m2),\n* Active Pregnancy\n* Severe hepatic impairment.",{"count":282,"type":23},300,"1. Introduction Lipoprotein(a), or Lp(a), is a type of lipoprotein that is structurally similar to LDL (low-density lipoprotein) but carries an additional protein called apolipoprotein (a).\n2. Purpose of the Study\n\n   The primary purpose of this study is to investigate the effect of Lp(a) levels on arterial stiffness, endothelial function, and left atrial (LA) and left ventricular (LV) deformation over a 12-month follow-up period.\n\n   Secondarily, the study will investigate:\n   * a) The incidence of major adverse cardiovascular events (MACE), including cardiovascular death, acute myocardial infarction, and acute stroke.\n   * b) The correlation between MACE incidence and parameters of arterial stiffness, endothelial function, and LA\u002FLV deformation.\n   * c) The levels of oxidative load markers.\n3. Materials and Methods This observational study will include adults aged 18-75 years (regardless of gender) who visit the outpatient clinics of the 2nd University Cardiology Clinic at \"Attikon\" General Hospital. All participants will sign a consent form. A full medical history, clinical examination, and blood collection will be performed to determine levels of Total Cholesterol, LDL-C, HDL-C, triglycerides, and Lp(a) at each visit..\n\nParticipants will be divided into three groups:\n\n* Group A: Lp(a) ≥50 mg\u002FdL with Total Cholesterol\\\u003C200 mg\u002Fdl\n* Group B : Lp(a) \\\u003C50 mg\u002FdL. with Total Cholesterol\\>200 mg\u002Fdl\n* Group C (Control): Lp(a) \\\u003C50 mg\u002FdL. with Total Cholesterol\\\u003C200 mg\u002Fdl At each group n ≥ 100 participants are anticipated.\n\nMeasurements at baseline, at 6 and at 12 months:\n\n* Arterial Stiffness: Determination of carotid-femoral pulse wave velocity (cf-PWV) using the Complior SP device and 24-hour pulse wave analysis with the Mobil-O-Graph device.\n* Endothelial Function: Measurement of the endothelial glycocalyx thickness of sublingual capillaries using a Sidestream Dark Field (SDF) camera (GlycoCheck). This is expressed through the perfused boundary region (PBR) index.\n* Cardiac Deformation: Use of two-dimensional strain (speckle tracking) to calculate the Global Longitudinal Strain (GLS) of the LV and LA strain.\n* Oxidative Load: Determination of malondialdehyde (MDA) and protein carbonyls (PCs) levels as markers of oxidative stress using spectrophotometric kits.\n\nStatistical Analysis: Comparisons regarding the changes in these markers over 6 and 12 months will be conducted between the three groups.",[285,286,34],"Lipoprotein Disorder","Arterial Stiffness",[288,289,290,291,292],"lipoprotein a","artrial stiffness","endothelial glycocalyx","myocardial deformation","oxidative stress","2026-03-10",{"date":265,"type":46},{"date":296,"type":46},"2024-09-25",{"date":298,"type":23},"2027-08-17",{"name":300,"class":53},"University of Athens",2,{"id":303,"slug":304,"hasResults":12,"nctId":305,"briefTitle":306,"officialTitle":307,"acronym":4,"eligibilityCriteria":308,"healthyVolunteers":12,"sex":61,"minAge":20,"maxAge":152,"enrollmentInfo":309,"targetDuration":4,"studyType":24,"phases":311,"briefSummary":313,"conditions":314,"keywords":321,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":325,"lastUpdatePostDateStruct":326,"startDateStruct":328,"completionDateStruct":330,"leadSponsor":332,"locationsCount":54},"100539831","phase-4-atorvastatin-pretreatment-in-cerebrovascular-events-apices-after-flow-diverter-implantation-100539831","NCT06308952","Atorvastatin Pretreatment in Cerebrovascular Events (APICES) After Flow Diverter Implantation","Atorvastatin Pretreatment in Cerebrovascular Events (APICES) After Flow Diverter Implantation: Protocol of a Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial","Inclusion criteria:\n\n1. Aged 18 to 75 years old, male or non-pregnant female;\n2. UIA diagnosed by CTA, MRA, or DSA;\n3. Maximal aneurysmal diameter between 3 and 25mm;\n4. Understands the nature of the procedure and provision of written informed consent;\n5. Indications for FD implantation with or without adjunctive coiling;\n6. Is willing to return to the investigational site for follow-up according to our protocol.\n\nExclusion criteria:\n\nPatients will be excluded if they meet any of the following criteria:\n\n1. Contraindications to atorvastatin treatment or known allergy to atorvastatin;\n2. Pregnancy or lactation;\n3. Presence of other vascular lesions (coronary artery disease, abdominal aortic aneurysm, intracranial atherosclerotic stenosis, arteriovenous malformation, dural arteriovenous fistula, Moyamoya disease, etc.);\n4. Prolonged statin therapy (≥30 days) or prior indications for atorvastatin therapy according to the Chinese guidelines for lipid management (2023) 21;\n5. Ruptured aneurysms or target aneurysm received previous operative or endovascular treatment;\n6. Patient currently using drugs that interact with atorvastatin metabolism (including transporter inhibitors, cyclosporine, protease inhibitors, other lipid-lowering medications (such as fibrates, ezetimibe, pcsk9 inhibitor, etc.), antacids, erythromycin, cytochrome P450 enzyme, colchicine, etc.);\n7. Patients diagnosed with multiple intracranial aneurysms who require treatment for two or more intracranial aneurysms within a one-year period;\n8. The target aneurysm is non-saccular (dissecting, fusiform, pseudo, infectious, etc.)\n9. Other situations that the researcher deems unsuitable for inclusion in the study (inability to receive anti-platelet or anticoagulant medication; allergy or contraindication for the use of FD alloy, history of life-threatening allergy to contrast dye, ect).\n10. Patient was determined that intravenous general anesthesia or general anesthesia with tracheal intubation could not be tolerated.\n11. Unwilling to be followed up or likely to have poor treatment compliance at initial screening;\n12. Life expectancy less than 3 years;\n13. Severe neurological deficit that renders the patient unable to live independently (modified Rankin score ≥4);\n14. Enrollment in another trial.\n\nWithdrawal criteria\n\nIn this trial, participants who have provided written informed consent but are unable to complete the entire study for any reason will be withdrawn. These circumstances include the following:\n\n1. The participants voluntarily quit the trial for various reasons;\n2. Occurrence of serious adverse events (SAEs). The study may be terminated by the participants, principal investigators, ethics committee, sponsor, or regulatory authorities based on ethical considerations;\n3. Early termination of the process based on the investigator's judgment in order to prevent development of severe complications;\n4. Significant deviation in implementation, or the subject failed to comply with the scheduled protocol;\n5. Miss the follow-up due to changes in working\u002Fliving places, or fortuitous accident (traffic accident, bone fracture, accidental death, ect.). Thus, close follow-up should be conducted to determine their relationship with the usage of FD and experimental drug;\n6. Flawed or absence of informed consents.",{"count":310,"type":23},354,[312],"PHASE4","APICES trial is an investigator-initiated, multicenter, multicenter, randomized, double-blind, placebo-controlled clinical trial that plans to enroll 396 patients with a 1-year follow-up, including a neurovascular imaging examination \\[digital subtraction angiography (DSA), CT angiography (CTA) or magnetic resonance angiography (MRA)\\] at 6 months after index treatment. It was designed in compliance with the Declaration of Helsinki and the International Conference on Harmonization Good Clinical Practice guidelines. The study was approved by the Ethics Committee of Zhujiang Hospital of South Medical University (2024-KY-032-02) and registered at ClinicalTrials.gov (NCT06308952). The participants will be recruited from twelve advanced stroke centers in China.",[315,316,317,318,319,320,34],"Cerebrovascular Event","Stent Stenosis","Ischemic Stroke","Hemorrhagic Stroke","Stent Thrombosis","Death, Brain",[322,323,324,101],"Atorvastatin","Intracranial aneurysm","Flow-diverter devices","2026-02-27",{"date":327,"type":46},"2026-03-03",{"date":329,"type":46},"2024-07-30",{"date":331,"type":23},"2027-12-31",{"name":333,"class":53},"Duan Chuanzhi",{"id":335,"slug":336,"hasResults":12,"nctId":337,"briefTitle":338,"officialTitle":339,"acronym":340,"eligibilityCriteria":341,"healthyVolunteers":12,"sex":61,"minAge":20,"maxAge":4,"enrollmentInfo":342,"targetDuration":344,"studyType":122,"phases":4,"briefSummary":345,"conditions":346,"keywords":350,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":356,"lastUpdatePostDateStruct":357,"startDateStruct":359,"completionDateStruct":361,"leadSponsor":363,"locationsCount":54},"100625464","perioperative-outcomes-after-neoadjuvant-therapy-in-colorectal-cancer-100625464","NCT07422974","Perioperative Outcomes After Neoadjuvant Therapy in Colorectal Cancer","The Impact of Neoadjuvant Therapy on Perioperative Complications and Treatment Outcomes in Patients Undergoing Colorectal Cancer Resection","Neocolon","Inclusion Criteria:\n\n* Adults aged ≥18 years with histologically confirmed colorectal cancer\n* Planned surgical treatment for colorectal cancer (either laparoscopic LPSC or open laparotomy)\n* Ability to understand the study protocol and provide written informed consent.\n* Both sexes\n* ASA classification II or III\n* Patients who received neoadjuvant therapy is investigational group and patients who did not receive neoadjuvant therapy is control group\n\nExclusion Criteria:\n\n* Age \\\u003C18 years\n* Patients who are not conscious, not oriented, or unable to provide informed consent\n* Patients unable to understand the study protocol\n* Emergency surgical cases\n* Patients on chronic corticosteroid therapy",{"count":343,"type":23},68,"2 Months","This prospective study investigates the effects of neoadjuvant therapy on endothelial function, microvascular tissue density, and tissue fibrosis in patients with colorectal cancer and their association with perioperative complications. The primary objective is to assess differences in microvascular tissue density between patients who received neoadjuvant therapy and those who did not, biomarkers, and demographic factors between patients who received neoadjuvant therapy and those who underwent surgery as initial treatment, and to compare clinical outcomes. The study will include 34 patients treated with neoadjuvant therapy and 34 patients for whom surgery is the first-line treatment. Patients will be followed until discharge from the hospital, and complications after discharge will be monitored through medical records one month after surgery.",[347,348,349,34],"Colorectal Carcinoma (CRC)","Complications","Neoadjuvant Therapy",[351,349,352,353,354,355],"Colorectal Carcinoma","Microvascular Density","Treatment Outcome","Wound Healing","Critical care","2026-02-13",{"date":358,"type":46},"2026-02-20",{"date":360,"type":46},"2026-01-09",{"date":362,"type":23},"2027-05-01",{"name":364,"class":53},"Osijek University Hospital",{"id":366,"slug":367,"hasResults":12,"nctId":368,"briefTitle":369,"officialTitle":370,"acronym":4,"eligibilityCriteria":371,"healthyVolunteers":12,"sex":210,"minAge":20,"maxAge":4,"enrollmentInfo":372,"targetDuration":4,"studyType":24,"phases":374,"briefSummary":375,"conditions":376,"keywords":379,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":383,"lastUpdatePostDateStruct":384,"startDateStruct":386,"completionDateStruct":388,"leadSponsor":390,"locationsCount":54},"100571464","endopat-device-for-endothelial-dysfunction-in-ed-100571464","NCT06720597","EndoPAT Device for Endothelial Dysfunction in ED","Utilizing EndoPAT Device for Endothelial Dysfunction Assessment in Erectile Dysfunction and Hormonal Therapy","Inclusion Criteria:\n\n* Males 18 years old and above\n* Diagnosed with erectile dysfunction or hypogonadism\n\nExclusion Criteria:\n\n* Patients without the above criteria",{"count":373,"type":23},120,[26],"To assess endothelial dysfunction in young men (aged 30-50) with vasculogenic ED identified through penile Doppler ultrasound.\n\nTo evaluate changes in endothelial function using EndoPAT before and 3-6 months after daily low-dose phosphodiesterase type 5 (PDE5) inhibitor therapy.\n\nTo investigate endothelial function alterations in hypogonadal patients before and 3-6 months after initiating testosterone (T) therapy",[377,378,34],"Erectile Dysfunction","Hypogonadism, Male",[380,377,381,34,382,221],"EndoPAT","Hypogonadism","ED","2026-01-29",{"date":385,"type":46},"2026-02-02",{"date":387,"type":46},"2025-08-13",{"date":389,"type":23},"2027-01",{"name":391,"class":53},"University of California, Irvine",{"id":393,"slug":394,"hasResults":12,"nctId":395,"briefTitle":396,"officialTitle":397,"acronym":4,"eligibilityCriteria":398,"healthyVolunteers":18,"sex":61,"minAge":20,"maxAge":62,"enrollmentInfo":399,"targetDuration":400,"studyType":122,"phases":4,"briefSummary":401,"conditions":402,"keywords":405,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":416,"lastUpdatePostDateStruct":417,"startDateStruct":419,"completionDateStruct":421,"leadSponsor":422,"locationsCount":54},"100620866","nailfold-capillaroscopy-and-endothelial-biomarkers-in-healthcare-workers-exposed-to-chronic-low-dose-ionizing-radiation-100620866","NCT07363187","Nailfold Capillaroscopy and Endothelial Biomarkers in Healthcare Workers Exposed to Chronic Low-Dose Ionizing Radiation","Evaluation of Microvascular Changes by Nailfold Capillaroscopy and Serum ADMA, Von Willebrand Factor, Hs-CRP, and D-dimer Levels in Healthcare Workers Exposed to Chronic Low-Dose Ionizing Radiation","Inclusion Criteria:\n\n* Healthcare workers aged between 18 and 60 years.\n* For the control group: Employment in a healthcare institution with either occupational exposure to low-dose ionizing radiation or no occupational radiation exposure.\n* For the exposed group: chronic occupational exposure to ionizing radiation for at least 3 years.\n* Willingness and ability to provide written informed consent.\n* Ability to comply with study procedures, including nailfold capillaroscopy and blood sample collection.\n\nExclusion Criteria:\n\n* History of cardiovascular disease, cerebrovascular disease, or peripheral vascular disease.\n* Presence of systemic diseases that may affect microvascular structure or endothelial function, including diabetes mellitus, uncontrolled hypertension, dyslipidemia, or chronic kidney disease.\n* Known autoimmune, connective tissue, or systemic inflammatory diseases (e.g., systemic sclerosis, lupus erythematosus, vasculitis).\n* Active infection or acute inflammatory condition at the time of enrollment.\n* Use of systemic medications that may affect endothelial function or microcirculation within the past 4 weeks, including vasodilators, antihypertensive agents, statins, antiplatelet or anticoagulant drugs.\n* Current smoking or history of smoking within the past 6 months.\n* Pregnancy or breastfeeding.\n* History of malignancy or current cancer treatment.\n* Previous finger trauma, surgery, or local conditions affecting the nailfold area that may interfere with capillaroscopic evaluation.",{"count":249,"type":23},"1 Day","Chronic occupational exposure to low-dose ionizing radiation may lead to subclinical endothelial dysfunction and early microvascular alterations in healthcare workers. Nailfold capillaroscopy is a non-invasive method that allows direct visualization of microcirculatory changes. This observational study aims to evaluate microvascular alterations using nailfold capillaroscopy and to assess their association with serum endothelial and inflammatory biomarkers, including asymmetric dimethylarginine (ADMA), von Willebrand factor (vWF), high-sensitivity C-reactive protein (hs-CRP), and D-dimer levels. Healthcare workers with chronic low-dose radiation exposure will be compared with non-exposed controls. The study seeks to improve understanding of early vascular effects of occupational radiation exposure.",[403,34,404],"Microvascular Dysfunction","Occupational Radiation Exposure",[406,407,408,409,410,411,412,413,414,415],"Nailfold capillaroscopy","Microvascular changes","Low-dose ionizing radiation","Occupational radiation exposure","Healthcare workers","Endothelial dysfunction","Inflammation biomarkers","D-dimer","High-sensitivity C-reactive protein","Asymmetric dimethylarginine","2026-01-22",{"date":418,"type":46},"2026-01-26",{"date":420,"type":23},"2026-02-01",{"date":105,"type":23},{"name":423,"class":168},"Istanbul Training and Research Hospital",{"id":425,"slug":426,"hasResults":12,"nctId":427,"briefTitle":428,"officialTitle":428,"acronym":4,"eligibilityCriteria":429,"healthyVolunteers":18,"sex":19,"minAge":430,"maxAge":4,"enrollmentInfo":431,"targetDuration":4,"studyType":24,"phases":432,"briefSummary":433,"conditions":434,"keywords":437,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":440,"lastUpdatePostDateStruct":441,"startDateStruct":443,"completionDateStruct":445,"leadSponsor":447,"locationsCount":54},"100439301","inspiratory-muscle-strength-training-for-lowering-blood-pressure-and-improving-endothelial-function-in-postmenopausal-women-comparison-with-standard-of-care-aerobic-exercise-100439301","NCT05000515","Inspiratory Muscle Strength Training for Lowering Blood Pressure and Improving Endothelial Function in Postmenopausal Women: Comparison With \"Standard of Care\" Aerobic Exercise","Inclusion Criteria:\n\n* Postmenopausal women (\\>12 months of amenorrhea)\n* Estrogen deficient (no hormone therapies within the previous 12 months)\n* Age 50 years and older\n* Ability to provide informed consent\n* Willing to accept random assignment to condition\n* Resting systolic blood pressure of 120 mmHg or greater\n* Body mass index \\\u003C40 kg\u002Fm2\n* Weight stable in the prior 3 months (\\\u003C2 kg weight change) and willing to remain weight stable throughout study\n* No change in blood pressure medications or other medications (prescription or dosing) in the prior 3 months and willing to maintain current medication regimen\n* Free from clinical disease with the exception of hypertension\n\nExclusion Criteria:\n\n* Younger than age 50 years\n* Early menopause (menopause before age 45 years)\n* Having had a hysterectomy\n* History of uncontrolled hypertension (systolic blood pressure \\>180 mmHg and\u002For diastolic blood pressure \\>120 mmHg)\n* Current smoker\n* Alcohol dependence or abuse\n* Abnormal blood pressure response to exercise (drop in systolic blood pressure below resting levels or systolic blood pressure \\>260 mmHg or diastolic blood pressure \\>115 mmHg)\n* Regular vigorous aerobic\u002Fendurance exercise (\\>4 bouts\u002Fweek, \\>30 min\u002Fbout at a workload \\>6 METS)","50 Years",{"count":249,"type":23},[26],"High blood pressure (BP) is the major modifiable risk factor for cardiovascular diseases (CVD) and related health conditions, particularly among postmenopausal (PM) women. In adults age ≥50 years this risk is primarily driven by above-normal systolic BP (SBP ≥120 mmHg), as diastolic BP plateaus, then decreases in older adulthood. Although SBP is lower in premenopausal women vs. age-matched men, SBP reaches, then surpasses men after age 60. As such, \\>75% of PM women in the U.S. have above-normal SBP, which, in turn, is responsible for a 2-fold increase in risk of hypertension and corresponding increases in risk of CVD, chronic kidney disease and many other disorders. A key process linking high SBP to CVD and related conditions is vascular endothelial dysfunction, mediated by excessive reactive oxygen species (ROS)-induced oxidative stress and reductions in nitric oxide (NO) bioavailability. As the number of PM women is rapidly growing, further increases in SBP-related CV disorders are projected without effective intervention.\n\n* Aerobic exercise (AE) is a first-line, standard-of-care therapy for lowering BP. In PM women with baseline SBP ≥120 mmHg, AE reduces casual (resting) SBP by \\~3 mmHg (back to baseline ≤4 weeks post-training), whereas 24-hour SBP is typically unchanged. However, only 25-30% of PM women meet guidelines for 150 min\u002Fweek of moderate-intensity AE, citing the extensive time requirement, facility access and travel disruptions as major barriers. Another, far less recognized, limitation is that AE training consistently improves endothelial function in midlife\u002Folder men, but not in estrogen-deficient PM (PMe-) women, i.e., in \\>95% of the 60+million PM women in the U.S. Thus, establishing new lifestyle therapies that induce and sustain reductions in SBP and increases in endothelial function in PMe- women with above-normal SBP is an important public health goal.\n* High-resistance inspiratory muscle strength training (IMST) is a time-efficient (5 minutes per session) lifestyle intervention consisting of 30 inspiratory maneuvers performed against a high resistance. Preliminary data suggest 6-weeks of IMST performed 6 days\u002Fweek reduces SBP by 9 mmHg in adults with above-normal SBP (i.e., greater than 120 mmHg) at baseline. Importantly, this reduction in SBP is equal to or greater than the reduction in blood pressure typically achieved with time- and effort-intensive healthy lifestyle strategies like conventional aerobic exercise. In addition, IMST improved endothelial function in the PMe- women in a small pilot study.\n* To translate these promising preliminary results towards clinical practice, this randomized clinical trial is being conducted to directly compare the efficacy of a longer, clinically relevant treatment duration of IMST (3 months) against home-based, moderate-intensity (standard-of-care) AE in PMe-women. The primary outcome will be the change in casual SBP (IMST vs. AE). Changes in 24-hour SBP and endothelial function will serve as secondary outcomes. Effects on NO bioavailability, ROS\u002Foxidative stress, and the role of \"circulating factors\" will provide insight into mechanisms of action. The sustained effects on SBP and endothelial function also will be assessed.\n* Accordingly, a randomized, blinded, sham-controlled, parallel group design clinical trial will be conducted to assess the efficacy of 3-months of IMST (75 percent maximal inspiratory pressure) vs. brisk walking (40-60% heart rate reserve; an established healthy lifestyle strategy) for lowering SBP and improving endothelial function in PMe- women age 50 years and older with above-normal SBP. It is hypothesized that IMST will lower SBP and improve endothelial function by decreasing oxidative stress and increasing nitric oxide bioavailability. It is also expect that adherence to the intervention will be excellent (over 80 percent of all training sessions completed at the appropriate intensity).\n* To test this hypothesis, 90 PMe- women age 50 years and older who have SBP \\>\u002F= 120 mmHg will be recruited. Participants will undergo baseline testing for casual (resting) SBP, 24-hour ambulatory SBP and endothelial function. Innovative mechanistic probes including pharmaco-dissection with vitamin C, analysis of biopsied endothelial cells, and high-throughput metabolomics, will be performed to assess oxidative stress and nitric oxide bioavailability at baseline.\n* After baseline testing, subjects will be randomized to perform either 3-months of high-resistance IMST or brisk walking. Subjects will train 6 days\u002Fweek. Following 3 months of training, subjects will redo all the tests that were done during baseline testing to assess training-induced changes in SBP, physiological functions, and underlying mechanisms. Subjects will then cease training for 6 weeks before returning to the lab for follow-up testing to determine the persistent effects of IMST.",[435,102,34,436],"Aging","Hypertension",[438,439],"Above-normal blood pressure","Inspiratory muscle strength training","2026-01-12",{"date":442,"type":46},"2026-01-14",{"date":444,"type":46},"2022-04-19",{"date":446,"type":23},"2027-02-28",{"name":448,"class":53},"University of Colorado, Boulder",{"id":450,"slug":451,"hasResults":12,"nctId":452,"briefTitle":453,"officialTitle":453,"acronym":4,"eligibilityCriteria":454,"healthyVolunteers":18,"sex":19,"minAge":20,"maxAge":430,"enrollmentInfo":455,"targetDuration":4,"studyType":24,"phases":456,"briefSummary":458,"conditions":459,"keywords":4,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":462,"lastUpdatePostDateStruct":463,"startDateStruct":465,"completionDateStruct":467,"leadSponsor":468,"locationsCount":54},"100558169","early-phase-1-role-of-et-1-physical-activity-and-sedentary-behavior-in-microvascular-dysfunction-following-gdm-100558169","NCT06547619","Role of ET-1, Physical Activity, and Sedentary Behavior in Microvascular Dysfunction Following GDM","INCLUSION CRITERIA\n\n* history of pregnancy within 5 years of the study visit\n* had healthy pregnancy OR had gestational diabetes diagnosed by their obstetrician and confirmed according to the American College of Obstetricians and Gynecologists criteria for gestational diabetes.\n\nEXCLUSION CRITERIA\n\n* skin diseases,\n* current tobacco or electronic cigarette\u002Fvape pen use,\n* diagnosed or suspected hepatic or metabolic disease including diabetes,\n* statin or other cholesterol-lowering medication,\n* current antihypertensive medication,\n* history of preeclampsia or gestational hypertension\n* current hypertension,\n* current pregnancy,\n* body mass index \\\u003C18.5 kg\u002Fm2,\n* allergy to materials used during the experiment.(e.g. latex), known allergies to study drugs.",{"count":154,"type":23},[457],"EARLY_PHASE1","Women with a history of gestational diabetes mellitus (GDM) are at a 2-fold greater risk for the development of overt cardiovascular disease (CVD) following the effected pregnancy. While subsequent development of type II diabetes elevates this risk, prior GDM is an independent risk factor for CVD morbidity, particularly, within the first decade postpartum. GDM is associated with impaired endothelial function during pregnancy and decrements in macro- and microvascular function persist postpartum, despite the remission of insulin resistance following delivery. Collectively, while the association between GDM and elevated lifetime CVD risk is clear, and available evidence demonstrates a link between GDM and vascular dysfunction in the decade following pregnancy, the mechanisms mediating this persistent dysfunction remain unexamined.\n\nThe purpose of this investigation is to examine the role of endothelin-1, a potent vasoconstrictor, in aberrant microvascular function in otherwise healthy women with a history of GDM and to identify whether this mechanism is influenced by physical activity and sedentary behavior.",[460,34,461],"Gestational Diabetes","Physical Inactivity","2025-12-08",{"date":464,"type":46},"2025-12-09",{"date":466,"type":46},"2024-10-01",{"date":270,"type":23},{"name":469,"class":53},"Anna Stanhewicz, PhD",{"id":471,"slug":472,"hasResults":12,"nctId":473,"briefTitle":474,"officialTitle":474,"acronym":4,"eligibilityCriteria":475,"healthyVolunteers":18,"sex":61,"minAge":20,"maxAge":476,"enrollmentInfo":477,"targetDuration":4,"studyType":24,"phases":479,"briefSummary":480,"conditions":481,"keywords":4,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":462,"lastUpdatePostDateStruct":484,"startDateStruct":486,"completionDateStruct":488,"leadSponsor":490,"locationsCount":301},"100553681","early-phase-1-role-of-inflammation-in-vascular-phenotype-associated-with-e-cigarette-use-100553681","NCT06489249","Role of Inflammation in Vascular Phenotype Associated With E-cigarette Use","Inclusion Criteria:\n\n* 18 - 24 years of age\n* no history of e-cigarette use (control) OR current with 6 months or more history of e-cigarette use (chronic use).\n\nExclusion Criteria:\n\n* tobacco cigarette use (current or history of)\n* use of stimulant drugs\n* skin diseases\n* cardiovascular disease\n* diagnosed or suspected hepatic or metabolic disease including diabetes\n* statin or other cholesterol-lowering medication\n* antihypertensive medication\n* current pregnancy or breastfeeding\n* blood pressure greater than or equal to 140mmHg systolic and\u002For greater than or equal to 90mmHg diastolic\n* allergy to materials used during the experiment\n* known allergies to salsalate or other study drugs","24 Years",{"count":478,"type":23},24,[457],"The use of electronic nicotine delivery systems, or e-cigarettes - colloquially referred to as \"vaping\" - in the United States has increased exponentially since their introduction to the US market in 2007. Prevalence of ever and current e-cigarette use is highest among teenagers and young adults with 16-28% of this population having reported vaping. While the majority of e-cigarette users are current tobacco smokers, 32.5% of current e-cigarette users are never- or former-smokers, representing a growing population of young adults who exclusively vape. While e-cigarettes have been marketed as a safer alternative to tobacco cigarettes, clinical studies examining these claims are limited. Cardiovascular disease (CVD) is the primary cause of premature death among tobacco cigarette smokers and reductions in vascular endothelial function, a significant predictor of future CVD, are detectible in otherwise healthy young adults who smoke. Despite the explosion in e-cigarette use among young adults, the health effects - especially the effects on mechanisms of vascular function - of these devices remain relatively unexplored. The purpose of this study is to directly asses the mechanistic role of inflammation in this dysfunction.",[482,34,483],"Electronic Cigarette Use","Inflammation",{"date":485,"type":46},"2025-12-15",{"date":487,"type":46},"2024-08-15",{"date":489,"type":23},"2026-10",{"name":491,"class":53},"University of Iowa",{"id":493,"slug":494,"hasResults":12,"nctId":495,"briefTitle":496,"officialTitle":497,"acronym":4,"eligibilityCriteria":498,"healthyVolunteers":18,"sex":61,"minAge":20,"maxAge":499,"enrollmentInfo":500,"targetDuration":4,"studyType":24,"phases":502,"briefSummary":503,"conditions":504,"keywords":4,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":511,"lastUpdatePostDateStruct":512,"startDateStruct":514,"completionDateStruct":516,"leadSponsor":518,"locationsCount":54},"100550996","the-iowa-aces-and-sleep-cohort-and-manipulating-sleep-in-young-adults-with-aces-studies-100550996","NCT06454344","The Iowa ACEs and Sleep Cohort and Manipulating Sleep in Young Adults With ACEs Studies","Associations of Adverse Childhood Experiences, Sleep Disruption, and Vascular Dysfunction in Young Adults: The Iowa ACEs and Sleep Cohort and Manipulating Sleep in Young Adults With ACEs Studies","AIM 1\n\nInclusion Criteria:\n\n1. 18-29 years of age\n2. SBP \\\u003C129 and DBP \\\u003C90 mmHg\n3. Body Mass Index \\> 18.5 kg\u002Fm2 and \\\u003C35 kg\u002Fm2\n4. Willing to complete in-home sleep studies\n\nExclusion Criteria:\n\n1. Currently undergoing treatment for a sleep disorder or diagnosed with restless leg syndrome, hypersomnia, parasomnia or narcolepsy, or obstructive sleep apnea\n2. Currently performing overnight shift work\n3. Lifetime history of any psychiatric disorder with psychotic features or bipolar disorder, currently undergoing treatment for substance-induced mood disorder\n4. Endorsed suicidal ideation as indicated by a Moderate or High risk determination on the Columbia Suicide Risk Protocol\n5. Diagnosed neurological disorder or illness affecting the central nervous system\n6. Diagnosed acute or chronic autoimmune disease or chronic inflammatory condition\n7. Current or previous cancer diagnosis\n8. History of moderate or severe traumatic brain injury\n9. Current or previous history of CBT-I treatment or sleep restriction or cognitive restructuring therapy for sleep\n10. History of cardiometabolic disease (e.g., ischemic heart disease, coronary artery disease, stroke, chronic kidney disease, diabetes mellitus), pulmonary disease, or renal disease\n11. Current or recent (within past month) use of anti-hypertensive (including clonidine), lipid lowering, glucose- controlling, or prescription anti-inflammatory medications\n12. Current or recent (within past month) opiates, benzodiazepine or benzodiazepine receptor agonists, or trazodone\n13. Recent changes to or unstable treatment (changes within last 6 mo.) with prescription medications\n14. Currently smoking or using nicotine\n15. Current use of hormone therapy\n16. Current heavy alcohol use, as defined as binge drinking on 5 or more days in the last month, or consuming more than 7 (women) or 14 (men) drinks per week in the last month (per NIAAA definition)\n17. Current or recent (within the last 6 mo.) illicit drug use disorder as indicated by a score of 3 or greater on the Drug Abuse Screening Test (DAST-10)\n18. Current or recent (within 6 mo.) pregnancy OR current or recent breastfeeding (within 3 mo.) OR children under the age of 2 years old in the home\n19. Currently completing greater than 300 minutes of moderate intensity, or greater than 150 minutes of vigorous intensity physical activity, or an equal combination per week\n20. Unstable housing\n\nAIM 2\n\nInclusion Criteria:\n\n1. 18-29 years of age\n2. SBP \\\u003C129 and DBP \\\u003C90 mmHg\n3. Body Mass Index \\> 18.5 kg\u002Fm2 and \\\u003C35 kg\u002Fm2\n4. Willing to complete in-home sleep studies\n5. \\>= 3 Adverse Childhood Experiences\n6. PSQI Global Score \\>5\n7. Sleep Efficiency Score \\\u003C90%\n\nExclusion Criteria:\n\n1. Currently undergoing treatment for a sleep disorder or diagnosed with restless leg syndrome, hypersomnia, parasomnia or narcolepsy, or obstructive sleep apnea\n2. Currently performing overnight shift work\n3. Lifetime history of any psychiatric disorder with psychotic features or bipolar disorder, currently undergoing treatment for substance-induced mood disorder\n4. Endorsed suicidal ideation as indicated by a Moderate or High risk determination on the Columbia Suicide Risk Protocol\n5. Diagnosed neurological disorder or illness affecting the central nervous system\n6. Diagnosed acute or chronic autoimmune disease or chronic inflammatory condition\n7. Current or previous cancer diagnosis\n8. History of moderate or severe traumatic brain injury\n9. Current or previous history of CBT-I treatment or sleep restriction or cognitive restructuring therapy for sleep\n10. History of cardiometabolic disease (e.g., ischemic heart disease, coronary artery disease, stroke, chronic kidney disease, diabetes mellitus), pulmonary disease, or renal disease\n11. Current or recent (within past month) use of anti-hypertensive (including clonidine), lipid lowering, glucose- controlling, or prescription anti-inflammatory medications\n12. Current or recent (within past month) opiates, benzodiazepine or benzodiazepine receptor agonists, or trazodone\n13. Recent changes to or unstable treatment (changes within last 6 mo.) with prescription medications\n14. Currently smoking or using nicotine\n15. Current use of hormone therapy\n16. Current heavy alcohol use, as defined as binge drinking on 5 or more days in the last month, or consuming more than 7 (women) or 14 (men) drinks per week in the last month (per NIAAA definition)\n17. Current or recent (within the last 6 mo.) illicit drug use disorder as indicated by a score of 3 or greater on the Drug Abuse Screening Test (DAST-10)\n18. Current or recent (within 6 mo.) pregnancy OR current or recent breastfeeding (within 3 mo.) OR children under the age of 2 years old in the home\n19. Currently completing greater than 300 minutes of moderate intensity, or greater than 150 minutes of vigorous intensity physical activity, or an equal combination per week\n20. Unstable housing\n21. Likely Obstructive Sleep Apnea, as indicated by an apnea-hypopnea index (AHI) \\>= 15 events\u002Fhour or persistent hypoxemia, as indicated by an arterial oxygen saturation \\\u003C= 88% for \\>5 minutes per night.","29 Years",{"count":501,"type":23},70,[26],"The overall purpose of this study is to understand the role of disrupted sleep in the association of exposure to early life adversity (adverse childhood experiences (ACEs)) with vascular endothelial (dys)function.\n\nIn Aim 1 (The Iowa ACEs and Sleep Cohort Study), the investigators will utilize a cross-sectional cohort design with a state-of-the-art translational approach. Participants will be recruited to objectively characterize the degree to which lower sleep quality and quantity contribute to ACEs-related endothelial dysfunction, inflammation, and oxidative stress in young adults using:\n\n1. rigorous at home sleep monitoring using 7-nights of wrist actigraphy and 2 nights of home-based polysomnography to objectively measure sleep quality (sleep efficiency, wakefulness after sleep onset and sleep depth), and total sleep duration,\n2. in vivo assessment of endothelial function via flow-mediated dilation testing, and\n3. in vitro determination of endothelial cell inflammation and oxidative stress from biopsied endothelial cells. This study to achieve this Aim.\n\nIn Aim 2, approximately 70 eligible participants from Aim 1 (The Iowa ACEs and Sleep Cohort Study) will then be randomized to either a 6-week behavioral sleep intervention (cognitive behavioral therapy for insomnia) or a wait-list control to determine the mechanistic contribution of sleep disruption to vascular dysfunction in young adults with moderate-to-high exposure to adverse childhood experiences (ACEs). Following the intervention, participants will again complete:\n\n1. rigorous at home sleep monitoring using 7-nights of wrist actigraphy and 2 nights of home-based polysomnography to objectively measure sleep quality (sleep efficiency, wakefulness after sleep onset and sleep depth), and total sleep duration,\n2. in vivo assessment of endothelial function via flow-mediated dilation testing, and\n3. in vitro determination of endothelial cell inflammation and oxidative stress from biopsied endothelial cells.",[505,506,507,508,509,510,34,483,33],"Adverse Childhood Experiences","Vascular Dilatation","Sleep","Sleep Disturbance","Psychosocial Stressor","Psychological Trauma","2025-12-05",{"date":513,"type":46},"2025-12-11",{"date":515,"type":46},"2024-05-01",{"date":517,"type":23},"2028-10-31",{"name":519,"class":53},"Nathaniel Jenkins",{"id":521,"slug":522,"hasResults":12,"nctId":523,"briefTitle":524,"officialTitle":525,"acronym":4,"eligibilityCriteria":526,"healthyVolunteers":18,"sex":61,"minAge":20,"maxAge":91,"enrollmentInfo":527,"targetDuration":4,"studyType":24,"phases":528,"briefSummary":529,"conditions":530,"keywords":4,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":511,"lastUpdatePostDateStruct":532,"startDateStruct":533,"completionDateStruct":535,"leadSponsor":537,"locationsCount":54},"100369232","microvascular-dysfunction-in-obesity-100369232","NCT04087655","Microvascular Dysfunction in Obesity","NADPH Oxidase Activity and Muscle Microvascular Dysfunction in Obesity","Inclusion Criteria:\n\n* There will be no restrictions with regard to race, sex, or socioeconomic status.\n* Women will be premenopausal\n* Women will be on combined estrogen\u002Fprogestin hormonal contraceptive therapy (oral pill, transdermal patch or vaginal ring).\n* Sedentary obese individuals will have been weight stable for the preceding 6 months.\n* Sedentary obese individuals will have the Metabolic Syndrome as defined according to the Third Report of the National Cholesterol Education Program Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III).\n* Individuals with the Metabolic Syndrome will have at least three of the following:\n\n  1. Central obesity as measured by waist circumference (men \\>40 inches; women \\>35 inches);\n  2. Fasting blood triglycerides \\> 150 mg\u002FdL;\n  3. Blood HDL cholesterol in men\\\u003C40 mg\u002FdL and women \\\u003C50 mg\u002FdL;\n  4. Blood pressure \\> 130\u002F85 mmHg; 5) Fasting blood glucose \\> 110 mg\u002FdL, and (not per ATP III) a 2-hour GTT glucose of 140-200 mg\u002Fdl.\n\nExclusion Criteria:\n\n* Subjects participating in purposeful endurance exercise training (\\>20 min\u002Fday, \\>1 day\u002Fweek) will be excluded.\n* Pre-menopausal female subjects must not be pregnant or lactating, and must have had regular menstrual cycles for the past year.\n* Individuals taking medications that may affect central or peripheral circulation,\n* Individuals on nonsteroidal anti-inflammatory agents or serotonin reuptake inhibitors,\n* Individuals who smoke or chew tobacco,\n* Individuals with diabetes (fasting blood glucose \\>125 mg\u002FdL),\n* hypertension \\>160\u002F95 mmHg\n* Individuals with congestive heart failure, angina, or peripheral vascular disease. --Individuals with ECG evidence of serious arrhythmias and\u002For acute myocardial ischemia reflected in ST-segment depression of 1 mm or greater at rest or during exercise.\n* Individuals with chronic infections, paralysis due to stroke, advanced Parkinson's Disease, severe rheumatoid arthritis or other serious orthopedic problems that would prevent performance of the exercise training tasks will be excluded.\n* Individuals taking antioxidant, herbal or vitamin supplementation for at least 2 weeks prior to investigation.\n* Individuals ingesting caffeine the day of the experiment.\n* Individuals whose weight changes by more than 5% during the training program.\n* Individuals whose exercise adherence is below 90% of the exercise sessions or total exercise time.",{"count":7,"type":23},[26],"Impaired endothelial function is observed in disease states related to obesity, such as atherosclerosis, coronary artery disease, and diabetes. Reactive oxygen species (ROS) production and resultant oxidative stress contribute to the development of these obesity-related diseases. The enzyme NADPH-oxidase is a major source of oxidative stress within the vasculature, and has been linked with the Metabolic Syndrome. In the investigator's previously funded studies, the investigators demonstrated for the first time that: 1) in vivo ROS were elevated in skeletal muscle of obese as compared to lean or overweight human subjects, 2) perfusion of the NADPH-oxidase inhibitor apocynin locally into muscle normalized ROS levels and reversed local microvascular endothelial dysfunction in the obese individuals, and 3) aerobic exercise training was effective at attenuating in vivo hydrogen peroxide production and reversing microvascular endothelial dysfunction in the obese individuals. The investigators will investigate in this R15 renewal application the mechanism of exercise training-induced alterations in ROS production and action on endothelial dysfunction in obesity using our newly developed microdialysis methodology of monitoring ROS production, in combination with analysis of muscle biopsy samples obtained before and after our previously tested 8-week intervention of aerobic interval exercise training. The objectives of this study are to determine the impact of in vivo NADPH oxidase activity on endothelial function in obese individuals, and to determine the mechanism of training-induced improvements in endothelial function. The investigator's unique microdialysis methodology will allow monitoring of microvascular\u002Fendothelial function and ROS generation, as well as the administration of pharmacological agents directly into muscle. The central hypothesis is that it is upregulation of both mitochondrial ROS and NADPH oxidase-derived ROS that results in endothelial dysfunction in obesity, and that exercise training down-regulates mitochondrial-derived ROS, and NADPH oxidase 4, thereby improving endothelial function. The aims of this proposal are to: 1) determine the contributions of mitochondrial ROS and specific NADPH oxidase isoforms to the NADPH oxidase dependent endothelial dysfunction in skeletal muscle of obese individuals; 2) determine the mechanism of ROS reduction and improved endothelial function resulting from an 8-week aerobic interval training program.",[531,34],"Obesity",{"date":513,"type":46},{"date":534,"type":46},"2019-11-20",{"date":536,"type":23},"2027-05-31",{"name":538,"class":53},"Florida State University",{"id":540,"slug":541,"hasResults":12,"nctId":542,"briefTitle":543,"officialTitle":544,"acronym":4,"eligibilityCriteria":545,"healthyVolunteers":12,"sex":61,"minAge":20,"maxAge":4,"enrollmentInfo":546,"targetDuration":4,"studyType":24,"phases":547,"briefSummary":548,"conditions":549,"keywords":4,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":557,"lastUpdatePostDateStruct":558,"startDateStruct":559,"completionDateStruct":561,"leadSponsor":562,"locationsCount":54},"100488166","phase-1-study-to-assess-safety-and-tolerability-of-multiple-doses-of-eo2002-100488166","NCT05636579","Study to Assess Safety and Tolerability of Multiple Doses of EO2002","Phase 1, Multiple Dose, Open-Label Study to Assess the Safety and Tolerability of EO2002 Intracameral Injections With or Without Topical Ripasudil in the Treatment of Corneal Edema","Inclusion Criteria:\n\nAll ocular criteria apply to the study eye unless otherwise noted.\n\n1. Age ≥ 18 years.\n2. Subject is phakic or pseudophakic with a posterior chamber intraocular lens (lens in the bag or sulcus).\n3. Symptomatic corneal edema associated with endothelial dysfunction which may be secondary to Fuchs' corneal dystrophy or pseudophakic bullous keratopathy.\n\nKey Exclusion Criteria:\n\nAll ocular criteria apply to the study eye unless otherwise noted.\n\n1. Other corneal disease\n2. Anterior chamber intraocular lens\n3. Sutured or scleral-fixated intraocular lens.\n4. Macular disease that in the investigator and\u002For sponsor's opinion would limit the ability of the subject to demonstrate improvement in BCVA.\n5. History of refractive surgery.\n6. History of Vitrectomy\n7. Descemet membrane detachment.\n8. History of uveitis or other ocular inflammatory disease.\n9. History of incisional glaucoma surgery (e.g.,trabeculectomy, glaucoma drainage implant).\n10. IOP \\>21 or \\\u003C7 mm Hg\n11. Prior incisional eye surgery within 3 months prior to study treatment or penetrating or endothelial keratoplasty.\n\n11\\. History of ocular neoplasm. 12. ETDRS BCVA in the fellow eye is worse than 35 letters (Snellen equivalent of 20\u002F200).\n\n13\\. Female who is pregnant, nursing, or planning to become pregnant, or who is of childbearing potential and not using a reliable means of contraception during the study.\n\n14\\. Subject is currently participating in or has participated within the last 3 months in any other clinical trial of an investigational drug by ocular or systemic administration.\n\n15\\. Any concomitant medical or psychological condition that could interfere with study participation or is otherwise not suitable for entry into the study in the opinion of the investigator.",{"count":93,"type":23},[66],"The goal of this clinical study is to assess the safety of multiple intracameral injections of EO2002 with and without topical Ripasudil.",[550,551,34,552,553,554,555,556],"Corneal Edema","Corneal Endothelial Dystrophy","Fuchs Dystrophy","Fuchs' Endothelial Dystrophy","Bullous Keratopathy","Pseudophakic Bullous Keratopathy","Corneal Edema Pseudophakic","2025-12-02",{"date":462,"type":46},{"date":560,"type":46},"2022-11-08",{"date":464,"type":23},{"name":563,"class":53},"Asociación para Evitar la Ceguera en México",{"id":565,"slug":566,"hasResults":12,"nctId":567,"briefTitle":568,"officialTitle":569,"acronym":4,"eligibilityCriteria":570,"healthyVolunteers":12,"sex":210,"minAge":20,"maxAge":571,"enrollmentInfo":572,"targetDuration":4,"studyType":122,"phases":4,"briefSummary":574,"conditions":575,"keywords":578,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":585,"lastUpdatePostDateStruct":586,"startDateStruct":588,"completionDateStruct":590,"leadSponsor":592,"locationsCount":54},"100610450","testosterone-deficiency-and-endothelial-dysfunction-after-spinal-cord-injury-100610450","NCT07227740","Testosterone Deficiency and Endothelial Dysfunction After Spinal Cord Injury","Testosterone Deficiency and Endothelial Dysfunction in Spinal Cord Injury Related Cardiovascular Disease Mechanistic Insights and Therapeutic Prospects","Inclusion Criteria:\n\n* Between ages 18-89 years of age\n* Male Sex\n* History of motor complete (AIS A\u002FB) paraplegia (NLI T3 or Below)\n* Time since injury \\\u003C6 months at time of enrollment (Subacute injury)\n* Testosterone Deficiency defined as \\\u003C 300ng\u002FdL\n\nExclusion Criteria:\n\n* Overt cardiovascular disease assessed by a) medical history, b) physical examination c) electrocardiogram\n* Anaphylaxis to betadine, lidocaine, iodine\n* Active infection at time of enrollment.\n* Recent surgery (\\\u003C1 month) at time of enrollment.\n* History smoking tobacco (currently or in the past 12 months)\n* History of more than low-risk history of alcohol consumption\n* History of drug abuse\n* History of use of cardiovascular-acting (i.e. statins, beta-blockers) therapeutics\n* History of other health habits, medications, and supplements that could influence the outcome measures deemed by principal investigators and investigative team.","89 Years",{"count":573,"type":23},48,"Heart attacks and strokes are among the most common causes of premature death in individuals living with spinal cord injury (SCI) and appear to occur earlier in life. The factors that lead to the heighten and accelerated risk of heart attacks and strokes in adults living with SCI remain poorly understood. The investigators aim to uncover why this happens and find ways to prevent it. Our research focuses on how important cells which line blood vessels, called endothelial cells, function after SCI. The investigators test endothelial function in live conscious people with SCI. The investigators also study signaling molecules endothelial cells release called endothelial cell derived microvesicles (EMVs), which the investigators can measure in blood to tell us the health of endothelial cells. By using these rigorous tests of vascular function, the investigators have determined that endothelial cells appear dysfunctional after SCI. The investigators also know that many men with SCI have low testosterone levels. Our team has studied testosterone's effects on endothelial dysfunction and believe low testosterone may be contributing to endothelial dysfunction after SCI. By understanding these mechanisms, the investigators hope to improve the lives of those living with SCI and reduce their risk for heart attacks and strokes. The investigators propose to study the influence of testosterone on endothelial function by using state-of-the-art clinical and laboratory experiments to assess endothelial function in men with SCI with low and normal testosterone levels.",[576,34,577],"Spinal Cord Injuries","Testosterone Deficiency",[579,229,580,581,582,583,584],"spinal cord injury","testosterone deficiency","extracellular vesicles","microvesicles","vasodilation","fibrinolysis","2025-11-20",{"date":587,"type":46},"2025-11-21",{"date":589,"type":46},"2025-07-15",{"date":591,"type":23},"2028-07-14",{"name":593,"class":53},"Craig Hospital",{"id":595,"slug":596,"hasResults":12,"nctId":597,"briefTitle":598,"officialTitle":598,"acronym":4,"eligibilityCriteria":599,"healthyVolunteers":18,"sex":61,"minAge":20,"maxAge":600,"enrollmentInfo":601,"targetDuration":4,"studyType":24,"phases":602,"briefSummary":603,"conditions":604,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":606,"lastUpdatePostDateStruct":607,"startDateStruct":609,"completionDateStruct":610,"leadSponsor":612,"locationsCount":54},"100610486","role-of-endothelial-dysfunction-on-exercise-pressor-reflex-in-type-2-diabetes-100610486","NCT07228208","Role of Endothelial Dysfunction on Exercise Pressor Reflex in Type 2 Diabetes","Inclusion Criteria:\n\n* Type 2 Diabetes: 18 - 80 years old, able to give informed consent, \\> 6 months post-diagnosis, \\> 6 months stable medications for management\n* Healthy controls: 18 - 80 years old, able to give informed consent\n\nExclusion Criteria:\n\n* Type 2 Diabetes: Type 1 diabetes, symptomatic coronary artery disease, cardiovascular event in last year (MI, stroke), uncontrolled or unmanaged hypertension (\\>160\u002F90 mmHg), heart failure, renal impairments, current or recent (\\\u003C6 months) tobacco use, hormone replacement therapy, documented neuromuscular disorders, pregnancy\n* Healthy Controls: Same as listed in Type 2 Diabetes with Type 2 Diabetes as an exclusion factor","80 Years",{"count":154,"type":23},[26],"Exaggerated blood pressure responses to exercise in individuals with Type 2 Diabetes significantly increase the risk of heart attack, stroke, and cardiovascular death, while also limiting exercise capacity and therapeutic benefits of physical activity. This research will determine whether impaired blood vessel function and excessive cellular damage from oxygen-containing molecules cause these dangerous blood pressure responses during exercise. The findings will establish whether targeting cellular antioxidant systems represents a new therapeutic approach to improve exercise tolerance and reduce cardiovascular risk in t Americans living with diabetes.",[605,34],"Type 2 Diabetes (T2DM)","2025-11-12",{"date":608,"type":46},"2025-11-14",{"date":48,"type":23},{"date":611,"type":23},"2031-12-31",{"name":613,"class":53},"Medical College of Wisconsin",{"id":615,"slug":616,"hasResults":12,"nctId":617,"briefTitle":618,"officialTitle":619,"acronym":620,"eligibilityCriteria":621,"healthyVolunteers":18,"sex":61,"minAge":20,"maxAge":4,"enrollmentInfo":622,"targetDuration":4,"studyType":122,"phases":4,"briefSummary":623,"conditions":624,"keywords":625,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":606,"lastUpdatePostDateStruct":627,"startDateStruct":628,"completionDateStruct":630,"leadSponsor":632,"locationsCount":54},"100610449","endothelial-dysfunction-after-sci-100610449","NCT07227727","Endothelial Dysfunction After SCI","Endothelial Dysfunction After SCI: Mechanism and Therapeutic Target for SCI-related Cardiovascular Disease","EDASCI","SCI Inclusion Criteria\n\n* Over age 18 years\n* Chronic (\\>12 months) SCI\n* Motor complete (AIS A\u002FB) SCI\n* Paraplegia (neurological level of injury \\[NLI\\] at T2 or below)\n\nNon-injured Inclusion Criteria\n\n• Over age 18 years\n\nExclusion Criteria (Both SCI and Non-injured)\n\n* Overt chronic diseases as assessed by: a) clinically documented medical history; b) physical examination; c) blood pressure and ECG at rest; and d) complete blood chemistries and hematological evaluation.\n* Active infection\n* Recent (\\\u003C 3 months) surgery\n* Current smoking history (within past 12 months)\n* Report more than low-risk alcohol consumption\n* History of drug abuse\n* Currently taking cardiovascular (statins, beta-blockers) therapeutics and\u002For other medications that could influence the outcome measures",{"count":154,"type":23},"This study plans to learn how endothelial cells, single cell lining of blood vessels may be dysfunctional after a spinal cord injury. Endothelial dysfunction will be measured by the capacity of blood vessels to vasodilate (increase in size) and alter blood flow is lower in adults with a spinal cord injury in comparison to adults without a spinal cord injury. The mechanisms which may alter this function may be critical in reducing the risk of heart attacks and strokes in people with spinal cord injuries.",[576,34],[579,626,581,582],"endothelium-dependent vasodilation",{"date":608,"type":46},{"date":629,"type":46},"2025-07-31",{"date":631,"type":23},"2027-07-30",{"name":593,"class":53},{"id":634,"slug":635,"hasResults":12,"nctId":636,"briefTitle":637,"officialTitle":637,"acronym":4,"eligibilityCriteria":638,"healthyVolunteers":18,"sex":61,"minAge":211,"maxAge":639,"enrollmentInfo":640,"targetDuration":4,"studyType":24,"phases":641,"briefSummary":642,"conditions":643,"keywords":645,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":649,"lastUpdatePostDateStruct":650,"startDateStruct":652,"completionDateStruct":654,"leadSponsor":656,"locationsCount":54},"100501394","phase-2-ischemic-conditioning-to-promote-microvascular-resiliency-in-frail-individuals-100501394","NCT05808686","Ischemic Conditioning to Promote Microvascular Resiliency in Frail Individuals","Inclusion Criteria:\n\n* Women and men ages 65-85 years of age\n\nExclusion Criteria:\n\n* Myocardial infarction in last 6 months\n* morbid obesity (BMI \\>40)\n* heart failure\n* uncontrolled hypertension\n* other condition that precludes high intensity exercise (ex, neurological disorder, acute systemic infection)\n* history of blood clots in the extremities\n* any condition in which compression of the arm or transient ischemia is contraindicated (e.g., wounds in the arm).","85 Years",{"count":22,"type":23},[67],"The goal of this clinical trial is to see how small blood vessels respond to the stress of high intensity exercise, and if a safe and simple intervention called ischemic conditioning can protect blood vessels from the stress of exercise.\n\nParticipants will come in for 3 study visits and get home-based ischemic conditioning. At Study Visit 1, participants will be assessed for their frailty and physical function. Afterwards, they will perform an exercise test. At Study Visit 2, patients will undergo 2 microvascular assessments, perform a high-intensity exercise, then undergo the same 2 microvascular assessments again. Participants will be given a handheld sphygmomanometer and a blood pressure cuff to take home. Depending on which group the participants get randomized into, participants will place the blood pressure cuff around their non-dominant upper arm and inflate to either a low or high pressure for 2 weeks at home. Participants will repeat the same steps in Study Visit 2 for Study Visit 3. In addition, participants will also be assessed for their frailty and physical function.",[435,644,34],"Fragility",[646,647,648],"Vasodilation","Exercise","Fitness","2025-09-22",{"date":651,"type":46},"2025-09-23",{"date":653,"type":46},"2023-05-02",{"date":655,"type":23},"2029-12",{"name":613,"class":53},{"id":658,"slug":659,"hasResults":12,"nctId":660,"briefTitle":661,"officialTitle":662,"acronym":4,"eligibilityCriteria":663,"healthyVolunteers":12,"sex":61,"minAge":177,"maxAge":152,"enrollmentInfo":664,"targetDuration":4,"studyType":24,"phases":666,"briefSummary":667,"conditions":668,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":649,"lastUpdatePostDateStruct":670,"startDateStruct":672,"completionDateStruct":674,"leadSponsor":675,"locationsCount":4},"100449685","effect-of-propionic-acid-supplementation-on-endothelial-function-100449685","NCT05135702","Effect of Propionic Acid Supplementation on Endothelial Function","Effect of Propionic Acid Supplementation on Endothelial Function in Patients With Coronary Artery Disease","Inclusion Criteria:\n\nHistory of known coronary artery disease as defined by having one or more of the following:\n\n* history of myocardial infarction\n* angiogram demonstrative \\>=50% stenosis in at least 1 major epicardial coronary artery\n* a previous stress test that showed evidence of ischemia (that has not been revealed to be a false positive test by angiography)\n* CT coronary study showing EITHER a coronary artery calcium (CAC) score of \\>400, OR a description of \"significant stenosis\" of one or more epicardial arteries.\n\nExclusion Criteria:\n\n1. Unstable angina or myocardial infarction by history, ECG, and\u002For enzymatic criteria within 1 month of enrollment.\n2. LV dysfunction as defined by an LV ejection fraction documented as \\\u003C 45% within 1 year of enrollment by an echocardiogram, MRI, or nuclear imaging.\n3. Uncontrolled hypertension with a blood pressure greater than 170\u002F100 mmHg at the screening visit.\n4. Known history of chronic renal insufficiency, liver dysfunction, or cancer besides non-melanoma skin carcinomas or localized prostate cancer requiring systemic treatment within five years of enrollment.\n5. Known history of cognitive impairment or inability to follow study procedures.\n6. Patient with GI tract illness such as short gut syndrome, inflammatory bowel disease, or an ileostomy.\n7. Patient with an implanted defibrillator or permanent pacemaker on which the potential participant is known to rely upon for greater than 50% of ventricular depolarizations.\n8. Patients who received probiotics, prebiotics, or short chain fatty acid supplements (e.g. propionate, butyrate, acetate-containing supplements) within the past 4 weeks.\n9. Patients who received antibiotics in the last 12 weeks.\n10. Patients with dosing changes of vasoactive medications and HMG-CoA reductase inhibitors in the 6 weeks prior to enrollment.\n11. Pregnancy\n12. Those who are daily drinkers or use illicit drugs.",{"count":665,"type":23},20,[26],"Coronary Artery Disease (CAD) remains a leading cause of morbidity and mortality worldwide despite improved mitigation of traditional risk factors. Large association studies have linked the gut microbiome alterations with inflammation, CAD, and traditional CAD risk factors. Subsequent studies have shown concomitant improvements in gut dysbiosis, inflammation, and cardiometabolic diseases using probiotics and other gut-modulating therapies. To date, many studies have shown a correlative relationship between intestinal bacteria composition and the presence of CAD, or severity of heart attacks, but few have begun to elucidate potential metabolic and immunologic mechanisms.\n\nThe investigator's recently supplemented Lactobacillus plantarum 299v in men with stable CAD, which improved systemic inflammation and brachial artery flow-mediated dilation (BA-FMD) - a measure of endothelial function and a predictive CAD precursor. Improvement in BA-FMD positively correlated with increased serum propionic acid (PA) concentrations. PA is a gut microbiome-derived short chain fatty acid (SCFA) with known human vascular receptors and implicated in endothelial function, innate immunity, and glucose homeostasis.\n\nWhether PA is mediating improvement in endothelial dysfunction or inflammation in the investigator's prior experiment remains unknown. The investigator's objective is to determine whether endothelial cell function is improved by dietary supplementation of sodium propionate in patients with established coronary artery disease. Furthermore, the investigators wish to elucidate to what extent inflammation is reduced by this therapy, by both measuring serum inflammatory markers and by seeing if plasma from treated patients induces anti-inflammatory transcriptomic responses from cultured endothelial cells and peripheral blood mononuclear cells, both of which are involved in atherosclerosis.\n\nSpecific Aim 1 will determine the impact of dietary PA supplementation on endothelial function and traditional CAD risk factors in patients with CAD. The investigators will utilize ultrasound to assess the percent change in BA-FMD before and after dietary PA supplementation. The extent of endothelium-dependency of these responses will be tested by measuring BA-FMD following nitroglycerin administration. The investigators will also measure markers representative of traditional CAD risk factors, such as lipid levels and HgbA1C.\n\nSpecific Aim 2 will determine anti-inflammatory changes in vivo and in transcriptomic signatures of cultured EC and PBMCs induced by dietary PA. The investigators will measure changes to systemic serum inflammatory markers involved in atherosclerotic processes using a targeted metabolomics approach, using plasma from the investigator's cohort before and after PA supplementation. Plasma samples will be used to incubate aforementioned cells to compare transcriptomic signatures of cells subjected to pre-supplementation plasma versus post-supplementation plasma. The investigators will use Ingenuity Pathway Analysis to determine changes to inflammatory pathways and i.i.com to determine whether more anti-inflammatory signatures were induced.\n\nSpecific Aim 3 will determine the impact of PA supplementation on gut microbiome taxonomy and diversity. As an optional additional clinical study activity, the investigators will collect stool samples before and after dietary PA supplementation, subject samples to multiplex 16S RNA sequencing, and calculate the Shannon Diversity Index. This will help us determine changes in individual gut microbiome constituents and diversity of the entire population.",[669,34],"Cardiovascular Diseases",{"date":671,"type":46},"2025-09-25",{"date":673,"type":23},"2027-07",{"date":655,"type":23},{"name":613,"class":53},{"id":677,"slug":678,"hasResults":12,"nctId":679,"briefTitle":680,"officialTitle":681,"acronym":4,"eligibilityCriteria":682,"healthyVolunteers":18,"sex":61,"minAge":683,"maxAge":684,"enrollmentInfo":685,"targetDuration":4,"studyType":24,"phases":687,"briefSummary":688,"conditions":689,"keywords":695,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":704,"lastUpdatePostDateStruct":705,"startDateStruct":707,"completionDateStruct":709,"leadSponsor":711,"locationsCount":54},"100548358","nightware-and-cardiovascular-health-in-veterans-with-ptsd-100548358","NCT06419959","NightWare and Cardiovascular Health in Veterans With PTSD","Improving Cardiovascular Health in Veterans With PTSD by Treating Trauma-Related Nightmares With NightWare","Inclusion Criteria:\n\n1. Diagnosis of PTSD via American Psychiatric Association PTSD diagnostic criteria in the fifth edition of its Diagnostic and Statistical Manual of Mental Disorders (DSM-5).\n2. Self-report having repetitive nightmares contributing to disrupted sleep;\n3. Age 22 years (rationale is because the device has only been used in adults in 22 years and older);\n4. Resting blood pressure (BP, \\\u003C160\u002F100 mmHg);\n5. Fasted glucose \\\u003C126 mg\u002FdL;\n6. Poor overall sleep quality as indicated by a Pittsburgh Sleep Quality Index (PSQI) score 6 or higher;\n7. Epworth Sleepiness Scale (ESS): Question #8 score above \"0\" will prompt an additional question: Do you drive (\"get behind the wheel\") when you are drowsy? The answer must be \"No\" to be enrolled in the study due to safety concerns;\n8. Wireless Internet and two power outlets in sleeping location;\n9. Willingness not to use any other application which collects heart rate data on the phone and watch that is used for NightWare;\n\nExclusion Criteria:\n\n1. Unstable medical condition (e.g., uncontrolled hypertension or active CVD or cancer);\n2. Active infection (note, anyone with an active infection would become eligible once the infection has ended);\n3. Thyroid dysfunction, defined as an ultrasensitive TSH \\\u003C0.5 or \\>5.0 mU\u002FL; volunteers with abnormal TSH values will be re-considered for participation in the study after follow-up evaluation by the PCP with initiation or adjustment of thyroid hormone replacement; or other problems that would interfere with participation in the study;\n4. Use of insulin or sulfonylureas\n5. Pregnancy or currently breast feeding;\n6. Current history (past 3 months) of substance (excluding marijuana) or alcohol abuse per the SCID-5. Adults with past substance or alcohol use disorders will be allowed to participate;\n7. Participants will be excluded if they report elevated acute risk for suicidal self-directed violence warranting immediate hospitalization (e.g., suicidal ideation with intent, evaluated by the Columbia-Suicide Severity Rating Scale \\[C-SSRS\\]).\n8. Shift workers (due to circadian rhythm disruption);\n9. Diagnosis of active disorder of arousal from non-rapid eye movement sleep, rapid eye movement sleep behavior disorder, or narcolepsy;\n10. Nocturia that causes awakening from sleep;\n11. Known sleep walking or acting out dreams (contraindication to NW use);\n12. Diagnosis or suspicion of dementia;\n13. Seizure disorder\n14. Participants experiencing severe cognitive impairment or current psychiatric symptoms of such severity that would preclude participation (e.g., active psychosis, imminently suicidal)","22 Years","88 Years",{"count":686,"type":23},125,[26],"The purpose of this study is to learn more about the effectiveness of a prescription wrist-wearable device called NightWare (NW) on improving sleep in Veterans with nightmares related to posttraumatic stress disorder (PTSD). The investigators also want to learn whether it improves cardiovascular health among this population.",[690,669,691,692,693,34,694],"Post-traumatic Stress Disorder (PTSD)","Autonomic Dysfunction","Vascular Stiffness","Nightmare","Veteran",[507,39,696,697,694,698,699,700,701,702,669,703],"aging, inflammation","sex\u002Fgender","Trauma and Stressor Related Disorders","Mental Disorders","Nervous System Diseases","Autonomic Nervous System Diseases","Primary Dysautonomias","Stress Disorders, Post-Traumatic","2025-09-11",{"date":706,"type":46},"2025-09-12",{"date":708,"type":46},"2025-09-10",{"date":710,"type":23},"2026-12-31",{"name":712,"class":713},"VA Office of Research and Development","FED"]