16 Clinical Trials for Various Conditions
This study will adapt a physical activity lifestyle intervention to emerging adult congenital heart disease (CHD) survivors with the primary goal of increasing physical activity levels. The study will be split into 2 phases. In Phase 1, participants will be asked to complete questionnaires, wear an accelerometer around the waist for 7 days, and undergo an exercise stress test. The accelerometer and exercise stress test will be used to determine whether participants are eligible to be randomized for the intervention study. In Phase 2, participants will be randomized to one of two conditions: 1) receiving a physical activity tracker (a Fitbit) or 2) receiving a Fitbit AND engaging in videoconferencing sessions with a physical activity coach. During Phase 2, participants will also be asked to complete 3 assessments (weeks 9 and 22, and a 6-month follow-up). The week 9 assessment will consist of completing questionnaires and wearing an accelerometer for 7 days. Week 22 will be similar to week 9 with the addition of a final exercise stress test. The 6-month follow-up will mirror the week 9 assessment. Participants who are randomized to the videoconferencing condition will be asked to meet with a physical activity coach 8 times over the course of 20 weeks. Coaches will help participants to (1) change attitudes toward physical activity, (2) increase perception of others' approval of physical activity (e.g., family members, peers), and (3) increase participants' perceived control by troubleshooting barriers and increasing efficacy for physical activity. Coaches will use the Fitbit to facilitate self-monitoring and goal setting. Participants in the intervention arm will be asked to participate in a focus group at the conclusion of the study to share their experiences.
This study will adapt a physical activity lifestyle intervention to adolescent and emerging adult congenital heart disease (CHD) survivors with the primary goal of increasing physical activity levels. The study will be split into 2 phases. In Phase 1, participants will be asked to complete questionnaires, wear an accelerometer around the waist for 7 days, and undergo an exercise stress test. The accelerometer and exercise stress test will be used to determine whether participants are eligible to be randomized for the intervention study. For adolescent participants, a parent will be asked to complete questionnaires at baseline as well. In Phase 2, participants will be randomized to one of two conditions: 1) receiving a physical activity tracker (a Fitbit) or 2) receiving a Fitbit AND engaging in videoconferencing sessions with a physical activity coach. During Phase 2, participants will also be asked to complete 3 assessments (weeks 9 and 22, and a 6-month follow-up). The week 9 assessment will consist of completing questionnaires and wearing an accelerometer for 7 days. Week 22 will be similar to week 9 with the addition of a final exercise stress test. The 6-month follow-up will mirror the week 9 assessment. For adolescent participants, the same parent will be asked to complete questionnaires at the final assessment as well. Participants who are randomized to the videoconferencing condition will be asked to meet with a physical activity coach 8 times over the course of 20 weeks. Coaches will help participants to (1) change attitudes toward physical activity, (2) increase perception of others' approval of physical activity (e.g., family members, peers), and (3) increase participants' perceived control by troubleshooting barriers and increasing efficacy for physical activity. Coaches will use the Fitbit to facilitate self-monitoring and goal setting. Participants in the intervention arm will be asked to participate in a focus group at the conclusion of the study to share their experiences.
To determine the feasibility and engagement of participants in the SUSTAIN intervention compared to enhanced usual care over 24 weeks through mixed-methods measurement of participant enrollment, adherence, retention, and engagement (counseling, screenings, referrals, and uptake). Methods: Leveraging rigorous quantitative and qualitative evaluation, the study team will identify mechanisms driving intervention feasibility and engagement. Hypothesis: SUSTAIN will be feasible with a high degree of engagement among Medicaid-enrolled participants with Stage 2 CKMS in comparison to enhanced usual care.
The Congenital Heart Disease Physical Activity Lifestyle Intervention Study (CHD-PALS) V.2 seeks to determine the efficacy of a lifestyle intervention program for adolescents and young adults (AYAs) with congenital heart disease (CHD). This trial was adapted from the original CHD-PAL trial to continue improving cardiovascular outcomes for transition-aged CHD survivors.
Brief Summary: Black adults have a higher incidence of hypertension (HTN) and a greater risk of HTN-related cardiovascular disease (CVD) compared with White adults. Even mild elevations in blood (BP) above 115/75 mm Hg are associated with increased CVD risk. Accordingly, emphasis is being placed on early interventions for high BP, particularly in those who are low cardiovascular risk(systolic BP 110-139 and diastolic BP \< 90 mm Hg), for participants lifestyle modification is recommended. Although lifestyle modifications are effective to lower BP, implementation is suboptimal in Black communities, especially those participants residing in low-income urban settings. Pervasive negative social determinants of health (SDoH), such as poor access to healthcare, food insecurity, limited availability of healthy foods, lack of safe places to engage in physical activity, and low health literacy are major drivers of inequities in HTN and a critical barrier to implementation of recommended lifestyle modifications in Black communities. To achieve health equity, effective strategies must address negative SDoH that are root causes of racial disparities in health outcomes as clearly demonstrated by the coronavirus disease (COVID-19) pandemic. Predominantly Black cities like Detroit, Michigan, where the mortality rate from heart disease is nearly twice the national average, have been devastated by COVID-19. To address this, the investigators developed an innovative mobile health unit (MHU) program that uses geospatial health and social vulnerability data to direct deployment of testing and vaccination services to communities with highest needs. Since April 2020, the investigators conducted 500 events with 220 community partners where 40,000 people have been tested or vaccinated for COVID in MHUs. Using a hybrid type I effectiveness-implementation design in the proposed Linkage, Empowerment, and Access to Prevent Hypertension (LEAP-HTN) study, the investigators will implement a novel approach that links low cardiovascular risk Black adult participants without stage-2 hypertension to collaborative care delivered in deprived neighborhoods by community health workers (CHWs) using a personalized, adaptable approach to lifestyle and life circumstance (PAL2) intervention. The investigators will leverage our MHU program, layering on top of existing services to streamline access for screening, recruitment and all ongoing follow-up throughout the study period. Our specific aims are: AIM 1: To compare the effect of PAL2 intervention versus usual care (MHU engagement without PAL2) on systolic BP reduction and prevention of stage 2 HTN (systolic BP ≥ 140 mm Hg and/or diastolic BP \>90 mm Hg) among 500 Black adults with baseline untreated systolic BPs below stage 2 (ranging 110-139 mm Hg) and a diastolic BP \< 90 mm Hg. Hypothesis (H) 1a: Systolic BP (primary outcome) will be reduced more in those randomized to PAL2 intervention versus usual care at 6 and 12 months. H1b: Diastolic BP levels and the incidence of stage 2 HTN (systolic BP ≥ 140 mm Hg and/or diastolic BP \>90 mmm Hg) at 6 and 12 months (secondary outcomes) will be lower in participants randomized to the PAL2 intervention versus usual care. AIM 2: To use the RE-AIM framework to assess the reach, adoption, effectiveness, sustainability and cost of LEAP-HTN at 12 months post-randomization. H2a: The rates of adoption and sustainability of the PAL2 intervention will increase from baseline to 12 and up to 24 months in subjects with available data, respectively. H2b: PAL2 intervention will be more cost-effective than usual care at 12 months and projected to be more cost-effective at 10 years. Health Equity Impact: Targeted deployment of MHUs and PAL2 can mitigate several key adverse SDoH. LEAP-HTN contributes to the RESTORE Network by testing a sustainable and scalable approach to advance health equity and prevent HTN in Black adults participants. If successful, the use of MHU can be easily implemented in similar urban Black communities across the U.S.
Background: Hyperthyroidism is a common disease. It is very common for women. It is usually treated with Radioiodine (I-131). Some people think that this might cause cancer, even many years later. Past studies of people with hyperthyroidism have not been clear about cancer risks after I-131. Researchers want to look at a group of people with the disease who got I-131 many years ago. They want to look at how their health was months and years later. Objective: To learn more about disease risks in relation to radiation from I-131 treatment for hyperthyroidism. Eligibility: People who were part of the previous study. These are people who were diagnosed with hyperthyroidism at U.S. and U.K. hospitals from 1946 to 1964. About 95% of the participants have already died. Design: Researchers will examine data already collected by the past study. This includes data on participants later cancers and other health outcomes after they had I-131 treatment. Researchers will compare that data to a National Death Index search. This was already done for data up through 2003. This study will cover 2004 2014. Researchers will not be in touch with study participants or their next of kin....
Psoriasis patients are known to be at increased risk for heart disease. This may be due to the increased prevalence of cardiovascular disease risk factors in this population, including high blood pressure, diabetes, obesity, and high cholesterol. Although cholesterol levels are known to be altered in psoriasis, most studies have used standard lipid profiles to measure cholesterol. These tests indirectly measure LDL (bad cholesterol) and become less accurate when triglyceride levels are high, as often see in individuals with psoriasis. We have designed a case-control study that uses a more specific and detailed cholesterol test to measure serum lipid levels in psoriasis patients, allowing for more accurate determination of LDL and better assessment of the lipid-contribution to cardiovascular risk. We will also measure other markers of inflammation that may contribute to cardiovascular disease.
Elevated plasma triglycerides (TG) are due to an excess of TG-rich lipoproteins of several different types, most commonly of very-low-density lipoproteins (VLDL), but also intermediate-density lipoproteins (IDL, or VLDL remnants), chylomicrons, and/or chylomicron remnants. Epidemiologic evidence that a moderate elevation in TG is often associated with increased atherosclerotic cardiovascular disease (ASCVD) risk, and more recent evidence from Mendelian randomization studies has shown that elevated TG associated with genetic variants may be a causal factor for ASCVD and possibly for premature all-cause mortality.\[1-6\] Fasting plasma TG concentrations may be categorized as: normal (\< 150 mg/dL ), borderline (150-199 mg/dL), high TG (HTG, 200-499 mg/dL), and very high TG (VHTG, ≥ 500 mg/dL).\[7, 8\] Risk of acute pancreatitis is increased in VHTG patients, especially those with TG ≥ 1000 mg/dL.\[9\] For VHTG, the primary goal of therapy is to reduce TG to \< 500 mg/dL,\[10\] whereas there is no specific treatment goal for HTG nor prescription indication. However, the omega-3 fatty acids, EPA and DHA have well-established efficacy in reducing TG in the range of 150-500 when administered at doses of \> or = 3 g/d EPA+DHA (reviewed in Skulas-Ray et al. in press). Importantly, administration of omega-3 fatty acids to people with TG in this range lead to a 25% reduction in major adverse cardiovascular endpoints in the recently completed "Reduction of Cardiovascular Events with EPA Intervention Trial" (REDUCE-IT).\[11\] The results of REDUCE-IT provide compelling evidence for the use 3 g/d omega-3 fatty acid supplementation to reduce cardiovascular risk among patients with TG 150-500 mg/dL. The concentrated EPA supplement used in REDUCE-IT is just one of three long chain n-3 omega-3 fatty acids that influence lipids and lipoproteins and other aspects of cardiovascular risk. Most research has focused on the evaluation of EPA and DHA, which are the two predominant n-3 FA in fish and in n-3 agents, but docosapentaenoic acid (DPA) is present in fish oil, as well, and accumulates in the blood at similar concentrations. The carbon length of the n-3 FA appears important for physiological effects. EPA has a carbon length of 20, DHA has a carbon length of 22, and DPA, the metabolic intermediate of EPA and DHA, is a 22-carbon n-3 FA. DPA may have significant potential for treating HTG and VHTG,\[12, 13\] but research on this fatty acid remains limited. In a 2-week open-label crossover comparison of 4 g/d of a DPA concentrate (containing unspecified amounts of free DPA and EPA) vs. 4 g/d EPA concentrate in people with HTG, plasma TG were reduced 33% by the DPA concentrate, which was significantly more than the 11% reduction with EPA.\[13\] Thus, a recent scientific advisory from the American Heart Association (Skulas-Ray et al, in press) concluded that more research is needed to elaborate the lipid and lipoprotein effects of DPA. Additional biomarker research suggests DPA similarly can influence health outcomes that respond to EPA and DHA. For instance, decreased serum concentrations of DPA and DPA + DHA have been associated with increased risk of risk of acute coronary events\[14\] and myocardial infarction\[15\], respectively. Plasma DPA was also inversely associated with incident cardiovascular disease (CVD) in some ethnic groups.\[16\] In conclusion evidence supports a potential role of DPA in improving health, but results from clinical supplementation studies are needed to clarify the effect of DPA supplementation on lipids and lipoproteins as well as other cardiovascular disease risk factors-relative to supplementation with EPA and DHA-to ascertain whether enrichment of omega-3 concentrates with DPA could offer health benefits above and beyond concentrates that only contain EPA and DHA.
This study will evaluate the effects of walnut-derived ALA and bioactives on multiple CVD risk factors, including central blood pressure, arterial stiffness indices, inflammatory markers, urinary isoprostanes, vascular adhesion markers, and changes in lipids and lipoproteins. Gut microbiome changes due to walnut consumption will also be assessed using the 16S rRNA gene.
The National Registry of Genetically Triggered Thoracic Aortic Aneurysms and Cardiovascular Conditions (GenTAC) was initiated in 2006 by the National Heart, Lung, and Blood Institute (NHLBI) and the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). GenTAC established a registry of 3706 patients with genetic conditions that may be related to thoracic aortic aneurysms and collected medical data and biologic samples. The study ended in September 2016. Data and samples are available from NHLBI and requests should be made to BioLINCC. See the NHLBI website for more information: https://www.nhlbi.nih.gov/research/resources/gentac/.
The purpose of this study is to determine whether saxagliptin can reduce the risk of cardiovascular events when used alone or added to other diabetes medications
Background: Scoliosis is a curving of the spine. It usually happens in girls when they are children and teens. Doctors often use x-rays to diagnose it. The x-rays give low radiation. This may increase the risk that those young women get cancer later in life. Researchers want to learn more about this risk. They will look data that has already been collected. Objectives: To study cancer risks of repeated low radiation from x-rays for scoliosis. Also, to study death risks related to certain scoliosis patient characteristics. These include causes, kinds of curvature, and kinds of treatment. Eligibility: Medical records of women from past scoliosis studies. Design: This U.S. Scoliosis Cohort includes more than 5,000 women who were diagnosed between 1912 and 1965. Data were collected on these women in the 1980s and 1990s. These came from medical records, radiology log books, and x-ray films. Researchers found out where participants were, including if they were dead. Some women were given a follow-up questionnaire. Researchers want to find out where participants are today. They want to identify new deaths of participants. They want to find out their causes of death. This data will be added to other databases.
The investigators will conduct a prospective observational cohort study to investigate factors that influence contraceptive method utilization among women with medical conditions. The investigators will also investigate how women with medical conditions access to contraception and family planning fellowship trained specialist. After the baseline questionnaire, there be a 3 month and 6 month follow up questionnaire to investigate continuation and satisfaction with the contraceptive method. This study is unique because it will allow us to explore doing collaborative family planning research at the multiple UC medical campuses.
This study is part of a larger consortium project investigating the validity and best use of next-generation sequencing (in particular, whole exome sequencing, or WES) in clinical care. This sub-project is investigating benefits and harms of providing WES diagnostic and different types of incidental findings to adult patients and parents of pediatric patients who undergo WES because they have symptoms suggesting genetic disease.
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.
Background: The field of nuclear medicine has changed a lot in the past decades. Technology has gotten better, so patients are exposed to less radiation. But now workers are doing procedures more often and using lead aprons less. So they may be exposed to more radiation. This may put them at higher risk for cancers and other health problems that are related to radiation. Researchers want to collect data from technologists to learn more about the risks and appropriate doses of radiation. Objective: To learn more about the risks and appropriate doses of radiation for nuclear medicine technologists. Eligibility: Adults who were first certified in nuclear medicine technology in the United States after 1980. They must be living in the United States. They must not be participants in the USRT study. Design: Participants will be recruited online. Participants will complete an online survey. It will take about a half hour. This will have questions about their work with nuclear medicine procedures. There will be questions about the kinds of procedures and how often they do them. Participants will give a short work history. This will include the names of current and past employers. Participants will allow researchers to get records of their film badge dose readings. These will come from dosimetry providers. Dosimetry data will not be shared with participants. Researchers can t ensure the how accurate or complete the data are.