For this study, we are recruiting 54 individuals with Parkinson's Disease and Freezing of Gait (FOG) who are planning to undergo Deep Brain Stimulation (DBS). The objective of this study is to better understand the FOG response to DBS. Prior to DBS study participants will undergo a MRI scan, behavioral assessment related to walking, a cognitive evaluation, and assessment of other Parkinson's disease symptoms. Following DBS participants will repeat these assessments at multiple timepoints over the period of one year. Overall, participants will complete a total of 7 visits over a period of approximately 1 year.
This study is an open label extension study for those who participated in the ION 682884-CS2 clinical trial for transthyretin-mediated amyloid cardiomyopathy (ATTR-CM). ATTR-CM is a disease caused by change in a protein called transthyretin (TTR) which can result in a build up of this protein in parts of the body including the heart. This build up is called an amyloid deposit, and when this occurs in the heart it can lead to a condition called cardiomyopathy. This study involves the medication eplontersen, which is considered investigational meaning it is not approved for commercial use by the Food and Drug Administration (FDA). Eplontersen is aimed at preventing production of the TTR protein to slow or reverse disease progression. Eplontersen is given as an injection under the skin in the upper arm, stomach or thigh. This study will last about 3 1/2 years and include 16 clinic visits. Study procedures include physical exams, blood work, questionnaires, hall walk tests, electrocardiograms (tracing of the heart's electrical activity), echocardiogram (ultrasound test of the heart) and taking a Vitamin A supplement.
The purpose of the study is to determine whether FINErenone reduces total (first and future) Heart Failure events and cardiovascular death compared with placebo in patients hospitalized with acute decompensated Heart Failure with Mid-Range Ejection Fraction and Heart Failure with Preserved Ejection Fraction (HFmrEF/HFpEF. The study will also look at information obtained from the tests performed as part of the study to see if subjects have improvement in symptoms of heart failure. Participation in this study will last approximately 36 months. During the study period subjects will be asked to attend regular study visits with the research coordinator. These visits will include such activities such as vitals, blood tests and questionnaires. There will be 8 visits as part of participation in this clinical trial. Participants will be randomized to either the treatment group (and receive the medication) or the control group (and not receive the medication). Subjects will have a 50:50 chance of receiving the study medication during their participation in the trial. The treatment assignment is determined by randomization, where a computer selects at random which treatment group you will be in (like flipping a coin). Neither the subject, nor the blinded personnel will know which group subjects are in. Neither the subject nor the study doctor will decide what group subjects are assigned.
The purpose of this research study is to learn how Deep Brain Stimulation (DBS), which targets a part of the brain called the subthalamic nucleus (STN), may affect thinking and memory in people with Parkinson's Disease (PD). We plan to include about 55 people with PD who have already had DBS surgery at MUSC's Clinical DBS Program.
As part of the study, participants will attend two visits after their DBS surgery. The first visit, which will last about three hours, includes going over the study information and consent form, collecting background information (demographics), and completing tests that measure thinking and memory (cognitive assessments) and speech. The second visit, also about three hours, will involve an MRI scan to look at how the brain's networks change when the DBS device is turned on and off. Participant's will also be invited to undergo an optional second scan. If participants consent, the second scan will be performed on a separate day than the first scan and therefore, there will be a total of 3 study visits.
These findings may help doctors and researchers make better decisions about which patients are most likely to benefit from DBS surgery and how to choose the best stimulation settings to reduce unwanted changes in thinking and memory.
The purpose of the study is to evaluate the safety and how well the medication sotatercept works versus placebo in treating Heart Failure with a Preserved Ejection Fraction. The study will also look at information obtained from the tests performed as part of the study to see if subjects have improvement in symptoms of heart failure. Participation in this study will last approximately 26 months. During the study period subjects will be asked to attend regular study visits with the research coordinator. These visits will include such activities as blood tests, questionnaires, physical evaluation by a study doctor, a right heart catheterization with exercise, echocardiogram, and 6 minute hall walks. There will be 35 visits as part of participation in this clinical trial.
Participants will be randomized to either the treatment group (and receive the medication) or the control group (and not receive the medication). Subjects will have a 2:1 chance of receiving the study medication during their participation in the trial. The treatment assignment is determined by randomization, where a computer selects at random which treatment group you will be in (like drawing straws). Neither the subject, nor the blinded personnel will know which group subjects are in. Neither the subject nor the study doctor will decide what group subjects are assigned. Participants from the placebo group in CADENCE who enter HARMONIZE at Visit 9a will be randomized 1:1 to one of the active treatment groups. Participants from an active treatment group in CADENCE entering HARMONIZE after Visit 9a will be allocated to continue in the same treatment group (ie, sotatercept dose level) as in CADENCE.
This study is enrolling participants with calcific aortic valve stenosis (CAVS) which is a heart valve disease. Blood pumped out of the heart goes through the aortic valve, and in CAVS, calcium builds up causing the valve to thicken over time so it is not able to open as much or as easily and over time this restricts blood flow. This study involves an investigational medication called ataciguat which is being studied to see how well it can slow the progression of CAVS. Investigational means it has not been approved for commercial use by the Food and Drug Administration (FDA). Ataciguat is taken by mouth daily.
Participation in this study will last about 3 years and include about 14 visits. Study procedures include collection of medical data, physical exams, electrocardiogram (ECG - a recording of your heart's electrical activity), bloodwork, echocardiogram (ultrasound test of the heart), CT scan, questionnaires and home monitoring of your blood pressure and heart rhythm.
Risks related to ataciguat include headache, nausea, abdominal pain, diarrhea and dizziness. Study procedure risks include radiation risks, risks of drawing blood and loss of confidentiality.
This study is enrolling participants with heart failure, a condition where the heart muscle does not pump blood efficiently, with preserved ejection fraction, meaning the heart muscle contracts (squeezes) normally but is unable to relax appropriately. The study involves implanting a pacemaker, a small device that is placed in the upper left chest, and then programming it to either standard settings or personalized settings for you based on your height and heart function. The programming is randomized, meaning assigned by chance, like flipping a coin so you do not get to choose which group you are in nor does your doctor. The study is trying to determine if using the pacemaker to control your heart rate can help you heart failure.
Your participation will last at least 18 months and may be as long as 4.5 years depending on when you join the study. The study will include about 8 visits and include the pacemaker implant procedure as well as testing such as physical exams, 6 minute walk test, echocardiograms (ultrasound test of your heart), blood work, questionnaires and pacemaker checks.
There are risks associated with the pacemaker implant procedure, risks related to study related procedures and the risk of loss of confidentiality. There may be benefit to you and to others with this condition in the future.