170 Clinical Trials for Various Conditions
The primary objective of this study is to is to assess the ability of retina specialists to successfully administer, via an intravitreal (IVT) injection, a 2 mg dose of ABP 938, using the ABP 938 aflibercept prefilled syringe (PFS), compared to a 2 mg dose of aflibercept using the aflibercept PFS.
This is a pivotal phase 3 study designed to support an indication for the reduction of cardiovascular risk in patients with established CVD and elevated Lp(a)
This is a two phase project. Phase I is an online convenience sample to collect health and preference data for the intervention phase, as well as a partnership with community to co-create an intervention; Phase II. Phase II is an intervention to improve community connection and historical knowledge within Cherokee communities within the Cherokee Nation reservation involving consultation with Cherokee cultural and historical experts.
This study proposes the evaluation of a novel, first-in-human Lassa fever vaccine based on the complete Lassa glycoprotein complex (GPC) antigen. The antigen will be presented on a genetically modified and attenuated rabies vector expressing both the rabies glycoprotein (GP) antigen and the Lassa GPC. The inactivated chimeric virus is delivered with a toll-like receptor (TLR-4)-activating oil-in-water emulsion adjuvant. Studies using this vaccine administered as a prime-boost series in mice and non-human primates, and then challenged with Lassa virus demonstrated significant protection against Lassa fever. Given that the vaccine backbone is an attenuated and inactivated rabies virus expressing rabies GP, this vaccine will also be evaluated for immunogenicity against rabies virus.
Individuals with spinal cord injury have heart attacks and strokes more frequently, and much earlier in life. People with spinal cord injuries develop plaque in vessels much faster, and the reasons why are unclear. Doctors generally attributed the increased risk with weight gain and developing diabetes, but many studies have shown that even without these common factors, plaque in vessels is developing more often and faster. Endothelial cells are a single layer of cells that line all vessels in the body and plays an important role in vessel health. Damage to endothelial cells is known to lead to heart attacks and strokes. Past studies on endothelial cells of people with spinal cord injury have been unclear. The investigators have new data that these cells are unhealthy after spinal cord injury a measurement. This includes measuring endothelial health by directly altering its function using a catheter in the arm and measuring small particles in blood called endothelial microvesicles. If the project is successful, the investigators will learn important information on the health of endothelial cells after spinal cord injury. The investigators will also be able to use these markers of endothelial cell function to create treatments to improve vessel health and prevent heart attacks and strokes later in life in people with spinal cord injury.
This is a pilot randomized controlled trial to assess the impact of a first-line treatment for posttraumatic stress disorder (PTSD) (Cognitive Processing Therapy; CPT) versus waitlist control on mechanisms of cardiovascular disease (CVD) risk. Further, this study will test the hypothesis that CPT reduces CVD risk through its effects on inflammation and autonomic function and that these changes are driven by changes in stress-related neural activity (SNA)
American Indians are more likely to die from heart disease compared to other people in the United States. High levels of fat (lipids) and sugar (glucose) in the blood are related to heart disease. Young American Indians who are 18 to 39 years old have high lipid and glucose levels. This has led to heart disease later in life. This means they are likely to benefit from a program to lower these levels. In this project, researchers will work with American Indians in rural southwestern Oklahoma. The researchers will start by asking American Indians how they would like to design a program for younger members of their community. After getting permission, the researchers will take a small amount of blood from young community members. The researchers will measure lipid and glucose levels and ask those with high levels to be in the study. Then the researchers will do several measurements. These will include blood pressure, height, weight, diet, physical activity, sleep, tobacco and alcohol use, access to health care, and social support. The researchers will compare these measurements to similar measurements taken from young American Indians 20 years ago, collected through the Strong Heart Study, which is the longest running study measuring heart disease in American Indians. Next, the researchers want to know if the program they developed with the American Indian communities will work. To do this, they will put people in one of two groups. They will decide which group each person will be in using a process that is like flipping a coin (heads for one group, tails for the other group). One group will receive educational booklets about how to avoid getting heart disease. The other group will receive help from a community health worker. The community health worker will help participants to get to the doctor for treatment. They will also help participants change their diet and exercise routines and provide education about heart disease risk factors. After 9 and 18 months, the researchers will repeat the measurements to see if one of the groups has lower lipid or glucose levels. This program will support the National Heart, Lung, and Blood Institute's mission to "reduce human disease" by lowering lipid and glucose levels, which are related to getting heart disease. This will be done by using the community health worker model to help people go to the doctor and improve their lifestyle related to diet and exercise. The researchers will also be able to advance heart health in American Indians in rural Oklahoma by lowering factors related to heart disease.
Healthy School Recognized Campus is a Texas A\&M AgriLife Extension initiative that supports the delivery of school-based physical activity and nutrition programs for diverse youth across Texas. The purpose of this study is to improve the delivery of these programs and optimize the effect they have on youth's cardiovascular risk factors.
The purpose of this project is to identify the minimum effective dose (MED) of a multi-component behavioral change intervention required to increase levels of medication adherence among Black and African American individuals on primary prevention statin therapy who are at elevated risk for cardiovascular disease (CVD). The intervention will be comprised of 5 BCTs which have previously shown to be effective on increasing health behaviors: Goal Setting, Action Planning, Self-Monitoring, Feedback, and Prompts/Cues. Participants will complete a 2-week run-in period where medication adherence levels will be measured using a smart pill bottle and physical activity (PA) will be measured using Fitbit wearable devices. Then 42 participants will be randomized into 14 cohorts of 3 participants each for the intervention period. During the intervention period, participants will receive a multi-BCT intervention, the length of which varies between 1 and 10 weeks depending on the assigned dose. Assignment to doses will utilize a modified version of the Time-to-Event Continual Reassessment Method (TiTE-CRM) methodology to adjust the dose for each cohort based on the results from the previous cohort. After the intervention, there will be a 2-week follow-up period. The MED will be defined as the smallest BCT dose (defined by weeks of intervention) associated with 80% of participants having a 20% medication adherence increase between the run-in and the follow-up periods. The long-term goal is reduce incidence of CVD among Black and African American individuals by increasing adherence to primary prevention statin medications.
Implement an intensive cardiac rehabilitation program at Arkansas Heart Hospital (AHH) to find out if the AHH-ICR is equivalent to the CMS approved programs when it comes to results.
The primary objective of EMIT-2 is to use a randomized controlled trial (RCT) design to implement interventions which are known to reduce inhalation (airborne) transmission, so that the contribution of transmission by route of aerosols for influenza may be identified.
This is a prospective, single-center, open-label study to investigate the diagnostic efficacy of the TruGenome CVD test and its impact on clinical management compared to usual care in individuals with cardiovascular disease. Diagnostic yield and changes of management (CoM) will be assessed both within the WGS group and compared to a contemporaneous, matched (2:1) usual care (UC) group sourced from EHR records.
To learn if cyclophosphamide, vincristine, and dexamethasone (called mini hyper-CVD) in combination with intrathecal (delivered into the spine) chemotherapy (methotrexate, hydrocortisone, cytarabine) and compressed rituximab, blinatumomab, and inotuzumab ozogamicin (called cRIB) can help to control the disease.
This is a randomized, placebo-controlled interventional study. The main purpose of this research is to test the safety and measure the immune response of the trivalent vaccine against invasive Salmonella disease. The vaccine will be tested over a range of doses.
The overarching goal of our proposal is to reduce disparities in perinatal cardiovascular disease risk factors among Black women utilizing a community-driven, social ecological framework.
Background: People with systemic lupus erythematosus (SLE) are at risk of developing complications in their blood vessels. This can increase the risk of heart attacks or stroke. No medications have been effective at reducing this risk in people with lupus. Objective: To test whether a drug (anifrolumab) can improve blood vessel function and reduce blood vessel inflammation in people with SLE. Eligibility: People aged 18 to 80 years with SLE. Design: Participants will undergo screening. They will have a physical exam. They will have blood and urine tests. They will have a test of their heart function and a chest X-ray. They will answer questions about their SLE symptoms. Participants will visit the clinic 9 times in 8 months. After screening, visits will be 4 weeks apart. Each visit may take up to 4 hours. Participants will receive infusions from a tube attached to a needle inserted into a vein in the arm (IV). Some will receive anifrolumab. Others will receive a placebo treatment. They will not know which one they are getting. At some visits they will have additional tests: CAVI (cardio-ankle vascular index) tests blood vessel function. Participants will lie still for 20 minutes. Small electrodes will be placed on both wrists with stickers. A microphone will be placed on their chest. Blood pressure cuffs will be wrapped around their ankles and arms. FDG-PET/CT is an imaging procedure. Participants will receive a substance through an IV line. They will lie on a table for 110 minutes while a machine captures images of their body.
Among people living with HIV, heavy drinking increases the risk of heart disease and death. Studies suggest that alcohol changes the number and kind of bacteria in your gut and these changes increase the risk of heart disease and death. This randomized controlled trial will determine whether a pill containing healthy gut bacteria can increase the number good bacteria in the gut, lower levels of inflammation, and lower the risk of heart disease and death.
The purpose of this research study is to test a weakened form of an experimental dengue virus challenge at different doses to test if participants develop symptoms or circulating virus in the blood (called viremia). When volunteers are exposed to dengue on purpose, it is called a "challenge" or Dengue Human Infection Model (DHIM). The research team is collecting information about the safety of the challenge and the best dose to use. The information may help us to make a dengue challenge (a DHIM) that will test vaccines to protect people from dengue.
The addition of ponatinib to mini-hyper-CVD chemotherapy and venetoclax will improve the complete remission rate in patients with relapsed or refractory T-cell acute lymphoblastic leukemia
The investigator is testing a virtual environment to address prevention of HIV-related comorbidities.
QURE will use its CPV technology in a randomized controlled trial to measure how SomaLogic's diagnostic test (the Cardiovascular Disease in Type 2 Diabetes) changes clinical practice and improves patient outcomes.
This study is to assess LDL-C reductions at Week 52 with monthly (Q4W \[≤31 days\]) dosing of LIB003 (lerodalcibep) 300 mg administered subcutaneously (SC) compared to placebo in patients with CVD, or at high risk for CVD, on a stable diet and oral LDL-C lowering drug therapy
The study is to assess the long-term safety, tolerability, and efficacy after 48 and 72 weeks with monthly (Q4W \[\<31 days\]) dosing of subcutaneous (SC) LIB003 300 mg administered in patients with CVD or at high risk for CVD (including HoFH and HeFH) on stable diet and oral LDL-C lowering drug therapy who completed one of the LIB003 Phase 3 base studies.
This study is to assess LDL-C reductions at Week 52 with monthly (Q4W \[≤31 days\]) dosing of LIB003 (lerodalcibep) 300 mg administered subcutaneously (SC) compared to placebo in patients with very-high risk for CVD on a stable diet and oral LDL-C lowering drug therapy.
Comparison of LDL-C reductions at Week 12 of monthly (Q4W\[≤ 31 days\]) dosing of LIB003 300 mg administered subcutaneously (SC) to Q4W dosing of evolocumab (Repatha) 420 mg and alirocumab (Praluent) 300 mg in patients with CVD or at high risk for CVD on a stable diet and high intensity statin and other LDL-C-lowering drug therapy.
The purpose of this research study is to test the protection of volunteers previously vaccinated with Tetravalent Dengue Virus (TDEN) Purified Inactivated Vaccine (PIV) with alum and boosted with TDEN live attenuated vaccine (LAV) formulation against a weakened form of an experimental dengue virus challenge. The Investigators will also include people that have not received the study vaccine. The Investigators are collecting information about how the vaccine protects against a dengue virus challenge as well as adding to knowledge about the safety of the challenge.
The aim of the study is to develop the BrightBrainer G (grasp), a game-based upper-extremity motor and cognitive rehabilitation system using custom virtual reality simulations. The G model is a version of the BrightBrainer Rehabilitation System, a Class 1 Exempt medical device produced by Bright Cloud International Corp (FDA owner/operator 10050478), and listed with the FDA (registration number 3012187972);
Social distancing measures put in place to combat the COVID-19 disease pandemic may increase social isolation and impact cardiovascular disease prevention behaviors among people living with HIV (PLWH). This study builds on a previously developed nurse-led intervention to improve blood pressure and cholesterol care for PLWH. The investigators will adapt the intervention to be administered virtually in order to facilitate cardiovascular prevention care within the US health care system which has sustained long-term changes as a result of the COVID-19 pandemic. The implementation and effectiveness of the intervention will be tested in a 12-month single arm intervention study.
The purpose of this study is to determine whether a live, oral, combined Shigella-ETEC vaccine candidate, known as strain CVD 1208S-122, is safe and immunogenic.
Aim to evaluate the effects of blackcurrant supplementation on changes in gut microbiome, bone mass, and CVD risk factors in adult women.