The purpose of this research study is to determine if an already FDA approved drug called atorvastatin can help adults, age 75 or older, live well for longer by preventing dementia, disability, or heart disease. Participants will be assigned by chance to receive either atorvastatin (study drug) or a matching placebo (a tablet that looks like atorvastatin but does not contain any medicine). Study engagement may last up to five years and involves in clinic and/or remote visits, survey questions, potential blood draws, in addition to memory and physical tests. After the first 1-2 visits performed in clinic or remote, the study team will follow-up via phone on a yearly basis to see how participants are doing. Participants will be compensated for their time and participation in this research study.
This proposal is to contribute to data registry and sample bank called Pediatrics Biorepository for Gastroenterology Clinical Research. Samples collected in this study may be used for future research which plan to advance the state of science in the hopes to develop novel diagnostic approaches and identify therapeutic targets.
This is a study for patients with relapsed/refractory large B-cell lymphoma or follicular lymphoma. Patients who have either stable disease or a partial response to CD19 CAR T-Cell therapy may be eligible. The purpose of the study is to compare groups of patients who either receive therapy after CAR T-cells and patients that do not receive further therapy after CAR T-cells.
This study will help determine the safety and effectiveness of BIIB122, compared to placebo (an inactive substance), in people with early-stage Parkinson's disease. The use of BIIB122 in this study is investigational. "Investigational" means that the study drug is currently being tested and is not approved by the U.S. Food and Drug Administration (FDA) or any other health authorities around the world for treating people with PD. The study is expected to last a minimum of 1 year to a maximum of 3 years. You may or may not receive direct medical benefit from participating in this study. Your condition may get better, worse, or stay the same. The information obtained from this study, however, could help other patients with your disease in the future.
This proposal is to contribute to data registry and sample bank called Pediatrics Biorepository for Cardiology Clinical Research. Samples collected in this study may be used for future research which plan to advance the state of science in the hopes to develop new ways to diagnose and treat children affected with heart conditions.
This study is enrolling subjects who need a pacemaker implant for a heart rhythm disorder. A pacemaker is a device implanted under the skin in the upper chest, and is designed to send electrical signals to tell the heart to squeeze (contract) through wires called leads. A conventional pacemaker has a lead placed in the right ventricle (lower chamber of the heart) which is referred to as ventricular pacing. This study will investigate conduction system pacing which is pacing from the part of the ventricle that normally carries electricity through the heart. The specific name for this part of the ventricle is the left bundle branch block area. The heart's conduction system initiates impulses that tells the heart muscle to contract in a coordinated fashion. This study will use the Solia S lead, which is considered investigational, meaning it is not yet approved by the Food and Drug Administration (FDA) for conduction system pacing. The Solia S lead is approved for ventricular pacing.
Participation in this study will last about one year and include 4-5 visits, some of which may be done virtually. The study involves collecting data from your pacemaker implant, Solia S placement, completing questionnaires, electrocardiogram, medical history and medications.
Risks include those associated with the pacemaker implant procedure such as potentially longer implant time, a tear in the interventricular septum (the wall separating the lower chambers of the heart) or unsuccessful lead placement. Other study related risks may include the risk of loss of confidentiality, risks of answering a questionnaire or unknown risks. There may be no benefit to you but the information learned may benefit others in the future who need conduction system pacing.
The protocol aims to improve standard of care, by ensuring an agile research infrastructure, with an ability to rapidly assess interventions during epidemic transmission of one or more respiratory pathogens adversely affecting public health.
Trials within this protocol can be adaptive, will be randomized, and will have superiority as the primary objective. Comparisons in the trials may be between an unlicensed agent to a blinded placebo plus standard of care (SOC), between an approved off-label agent to a blinded placebo plus SOC, among several active interventions (blinded or non-blinded; i.e., a comparative effectiveness study), or among different treatment strategies.
This project is a pilot study to determine if use of the J-Tip Needle-Free Injection System, used to administer local anesthesia, has any effects on the appearance of skin samples when viewed under a microscope compared with skin samples that have been injected with local anesthesia using a needle. If use of the J-Tip device for local anesthesia delivery is shown not to alter the microscopic appearance of skin, anesthesia for skin biopsies in the future may potentially be performed without a needle, allowing for less fear and pain.
Persistent smell loss that can include diminished or distorted smell function is a common symptom of long COVID syndrome. There are limited treatment options for long COVID-related smell loss. Our study aims to determine the efficacy of two at-home treatments, smell training and non-invasive trigeminal nerve stimulation. This study requires participants to conduct daily at-home treatment sessions, attend three in-person study visits at the MUSC Department of Psychiatry and Behavioral Sciences, and complete electronic questionnaires over the 12-week trial, and again at the six-month timepoint. Participants in this trial may benefit directly with an improvement in sense of smell. However, participation may also help society more generally, as this study will provide new information about long COVID-related smell loss and its treatment.
EEG Substudy:
Long COVID syndrome has been associated with cognitive impairment and may be related to affected emotional regulation. This study will use a electroencephalography (EEG) to examine how the body and brain responses to emotional cues in participants who are currently undergoing treatment for COVID-related smell loss. Participation will aid in the understanding of how emotional processing in long COVID is impacted by treatment for related smell loss.
Blood Analysis Substudy:
Alzheimer's Disease can be precedented by other clinical disorders or neuropsychiatric symptoms. Due to the cognitive deficits that can affect those with Long COVID, this sub study will use a blood sample to investigate if there are blood based biomarkers for Alzheimer's in those who report Long COVID symptoms.
Cannabis is the most commonly used illicit substance among pregnant and postpartum women, with the postpartum period being a common time for relapse to cannabis. Currently there are no interventions for preventing return to cannabis use during this vulnerable time. The goal of this research is to better understand risk factors such as stress, craving, anxiety, mood, sleep, and hormone levels that may contribute to return to cannabis use during the postpartum period in order to help develop targeted prevention and treatment interventions in the future.