23 Clinical Trials for Various Conditions
This study attempts to learn more about the activity levels of adolescent and young adult (AYA) cancer patients or survivors at risk for cardiovascular morbidity and frailty by using a smartphone application called Beiwe. Collecting activity level data on AYA cancer patients or survivors may help patients achieve better quality of life.
Oral zinc supplementation in patients with diabetes mellitus can improve glycemic control. However, there is reluctance to recommend zinc supplements to these patients because there is no evidence that the zinc-dependent improvement in glycemic control offers protections from the cardiovascular morbidities associated with diabetes mellitus, especially myocardial infarction and thrombotic stroke. The investigators are conducting a randomized, double blind, cross over study to test the hypothesis that oral zinc supplementation will block the enhanced cardiovascular, cerebrovascular, and platelet reactivity that lead to myocardial infarction and stroke in research participants with diabetes mellitus.
This randomized controlled clinical trial tests the hypothesis that a selected stress reduction approach, the Transcendental Meditation program will reduce all-cause mortality, myocardial infarction and stroke in African American patients with coronary heart disease. Secondary hypotheses include effects on other cardiovascular clinical events, blood pressure and psychosocial stress.
Children with premature pubarche will have radiological and radial artery tonometry evidence of cardiovascular morbidity at diagnosis when compared to matched controls.
The rate of complication and death of patients with acute digestive tract bleeding is increased in the setting of acute coronary heart disease. The aim of the study is to establish the relative importance of the risk factors contributing to the death rate from acute digestive tract bleeding in patients admitted with acute coronary heart disease.
The purpose of this study is to evaluate the impact of community health screening, health education and nutritional intervention on risk factors for cardiovascular disease in a predominantly African American population. The health fair and intervention will take place in a church that typically improves their lifestyle by "giving up for Lent" certain foods or habits. Participation in this nutrition intervention is voluntary and each participant will sign an informed consent along with a waiver. On the waiver, the participant can agree to have all testing performed but can withdraw consent at any time or decide to have only some of the testing. It was hypothesized that a community-based health screening and nutritional intervention will have a positive impact on the participants by: 1. Measuring baseline risk factors 2. Educating them about their individual risk for heart disease 3. Providing education on healthy lifestyle 4. Providing a nutritional intervention for 40 days with home- delivered plant-based meals nutrition that has been shown to lower cardiac risk factors 5. Repeating the risk factor assessment at the end of the intervention, to demonstrate the degree of, if any, reduction in cardiac risk as assessed by the American College of Cardiology/American Heart Association (ACC/AHA) Atherosclerotic Cardiovascular Disease (ASCVD) Risk Calculator 6. Motivating at-risk subjects to seek continued appropriate medical care and to institute more permanent relevant lifestyle changes (e.g., diet, exercise, medication compliance).
To better understand postpartum blood pressure changes, we are proposing a study to monitor blood pressure after delivery in 100 patients who we expect to have normal blood pressure (i.e. low-risk group), 100 patients who we expect to be at risk of new-onset high blood pressure postpartum (i.e. intermediate-risk group), and 100 patients who had high blood pressure prior to pregnancy (or very early, before 20 weeks in pregnancy) who we know are at high risk of blood-pressure related complications postpartum (i.e. high-risk group). Patients will be given a non-invasive wearable device that monitors blood pressure continuously for 6 weeks postpartum. We expect that the daily changes in blood pressure will be different between these groups, which may allow us to better predict who is at risk, how much monitoring is needed, and when to intervene before the blood pressure abnormalities cause complications. The blood pressure device that will be given to patients is the YHE® BP Doctor Med Blood Pressure Smartwatch. This is a highly-accurate medical grade device that has not received FDA clearance. As such, the device is not being used to make blood pressure management and treatment decisions, but rather to gather data on postpartum cardiovascular physiology. Safety stops are built into the protocol such that elevated readings detected by the watch will trigger clinical referrals and validation by standard blood pressure cuffs prior to determine need for treatment.
This observational study will follow participants who completed follow-up in the FOURIER OUTCOMES trial to evaluate the long-term effects of evolocumab treatment. Long-term post-trial (legacy) beneficial effects have been reported with statins, niacin, hypoglycemic therapy and fibrates. Whether similar effects are seen after LDL cholesterol (LDL-c) lowering by PCSK9 inhibition is currently unknown. Evolocumab therapy causes a profound reduction in LDL cholesterol of approximately 60%. Statins have shown legacy effects over 5 years post-trial, including a 7% reduction in total mortality in meta-analysis and 12% reduction in coronary mortality. It would therefore be hypothesized that additional effects beyond the trial period would be conferred by previous evolocumab treatment. It is also important to assess the long-term safety of prior evolocumab treatment.
A comparison study of two combination drugs, amlodipine/benazepril and benazepril/HCTZ to evaluate the effectiveness of the combination on reducing heart disease and death in a high risk hypertensive population.
The purpose of this study is to determine whether avosentan (SPP301) is effective in decreasing morbidity and mortality in patients with diabetic nephropathy.
This is a single site, single-blinded parallel randomized control trial that investigates a multi-level intervention to improve postpartum blood pressure in women with hypertensive disorder pregnancy. The investigators will recruit women diagnosed with a hypertensive disorder of pregnancy, identified between 3rd trimester and 2 weeks post-delivery. The investigators will randomize participants to receive usual care home blood pressure monitoring for 6 weeks versus an intervention of usual care + blood pressure and weight monitoring + a doula trained in heart health. This trial will be conducted in partnership with a local community-based organization, Healthy Start Inc.
The study will evaluate the efficacy and safety of LCZ696 compared to enalapril on morbidity and mortality in patients with chronic heart failure (NYHA Class II - IV and EF =\< 35%).
This study evaluated the effect of early initiation of aliskiren therapy, compared to standard therapy, in the reduction of cardiovascular death and heart failure re-hospitalization events within 6 months, in congestive heart failure (CHF) patients hospitalized for an episode of acute decompensated heart failure.
The study will evaluate the efficacy and safety of both aliskiren monotherapy and aliskiren/enalapril combination therapy as compared to enalapril monotherapy, on morbidity and mortality in patients with chronic heart failure (NYHA Class II - IV.
The purpose of this study was to determine whether, in patients with type 2 diabetes and pre-existing disease of the heart and the circulatory system and/or the kidney, aliskiren at a target dose of 300 mg once daily (compared to placebo), on top of conventional treatment, reduces death and disease caused by the heart, the circulatory system and the kidney. AMENDMENT 4 RATIONALE (MARCH 2012) : Protocol amendment 4 served to address the data monitoring committee recommendation dated 14 Dec 2011 to discontinue study treatment in all participating patients. It also addressed the subsequent Health Authorities request to implement a 12 month safety follow-up period (actual duration was 9 months in average) post study drug discontinuation.
Aggressive intraoperative and postoperative management of blood glucose may substantially decrease perioperative cardiovascular and infectious complications in diabetic and non-diabetic patients undergoing vascular surgery. The purpose of this study is to compare the tight versus traditional blood glucose control in diabetics and non-diabetics undergoing vascular surgery in regard to their postoperative fatal and nonfatal cardiac outcomes, and the secondary effects such as rate of infections, overall morbidity and 30-day mortality.
To study the entire population of Olmsted County, Minnesota, including all age categories, to examine the secular trends in coronary heart disease (CHD) mortality, myocardial infarction (MI) incidence, and natural history, including MI severity, case fatality and post-MI morbidity. Also, to examine the time trends in the prevalence of CHD at post-mortem because of the uniquely high autopsy rate in Olmsted County.
The objective of this study is the development, implementation and management of a registry of patient data that captures clinically meaningful, real-world, data on the diagnosis, nature, course of infection, treatment(s) and outcomes in patients with complex disease globally.
The purpose of the study is to determine the efficacy of treatment of anemia with darbepoetin alfa compared to placebo on the composite of time to death from any cause or first hospital admission for worsening heart failure in patients with symptomatic left ventricular systolic dysfunction and anemia.
LHMoms is a novel integrated care intervention that focuses intensively on care continuity and community-to-healthcare linkages for postpartum birthing individuals. The intervention starts prior to discharge in the delivery hospitalization and extends to six months post-partum, thus covering critical windows to prevent long-term physical and mental health sequelae.
For aim 1, the proposed studies will be performed in 150 patients with RA and 25 subjects without RA (healthy volunteers) who will function as controls. For aim 2, 25 of the patients enrolled in aim 1 (who are in need for further treatment due to increased RA activity despite their current treatment) will be recruited to continue in the study for an additional 24 (+/- 2) weeks (or 6 months). These patient will receive a TNF inhibitor in addition to their current treatment in an open label protocol for increased disease activity and in the context of standard of care. The investigators hypothesize that anti-TNF agents in RA patients without heart disease will not adversely affect the heart (will not cause a detrimental change in heart structure or its function).
The focus of this secondary data analysis is to determine whether pain due to a combination of both cardiac and non cardiac sources operates as a mediator of behavior change, an area that has not been previously evaluated.
This research study is being performed to begin to determine the effectiveness of two dominant bariatric surgery procedures versus an intensive lifestyle intervention to induce weight loss in patients and promote improvements in Type 2 diabetes mellitus (T2DM) in moderately obese patients. T2DM is currently the 6th leading cause of mortality in the United States and is a major cause of kidney failure, blindness, amputations, heart attack, and other vascular and gastro-intestinal dysfunctions. Traditionally, treatments include intensive lifestyle modifications with or without glucose lowering agents. Neither treatment alone, or in combination, results in complete resolution of diabetes and its potential long-term complications. Bariatric surgery has been proven as an effective treatment to accomplish sustained and significant weight loss for those with severe obesity and has been shown to induce long-term remission of T2DM. However, despite enthusiasm for these potential treatment options, it is not clear whether diabetes is influenced by the type of surgery or by the amount of weight lost or if bariatric surgery is more effective than non-surgical weight loss induced by diet and physical activity in T2DM patients with moderate BMIs (30-40kg/m2; Class I and Class II obesity, or approximately 65-95 pounds overweight depending on your height). More well-controlled studies are needed to more completely inform health care decision making and clinical practice in this area. This research study aims to obtain preliminary information regarding the effectiveness of two major types of bariatric surgery, Laparoscopic Roux-en-Y Gastric Bypass and Laparoscopic Adjustable Gastric Banding versus an intensive lifestyle intervention to induce weight loss with diet and increased physical activity.