The purpose of this study is to better understand how ear stimulation techniques may impact how people think about themselves in social situations. The goal is to identify how the addition of ear stimulation can impact cognitive processes, including the ways that people think about themselves in social situations and attend to or process social information, that underly an activity known as "self-imagery rescripting." Eligible individuals who are between the ages of 18 and 65 years will complete a variety of activities after providing consent to study participation. These include: (1) completing questionnaires on the computer, (2) completing tasks similar to a video game on the computer, (3) having an electrode attached to their ear that will stimulate nerve activity, (4) completing an interview about how they feel in social situations, and (5) engaging in an activity during which they will be prompted about how they see themselves in social situations. Throughout these activities, participants also will be asked to wear a variety of sensors, bundled together in a cap for their head and individually on other parts of their body, that will collect information about brain activity, heart rate, and eye blinking. Participation in this research study is entirely voluntary and will last approximately 3 hours during a single session at the Medical University of South Carolina in Charleston. Participants will be compensated for their time.
There are some risks associated with this study. Some survey questions ask about personal thoughts and feelings. Ear stimulation may cause tingling sensations or irritation around the ear. Thinking and talking about how one sees themselves in social situations may be distressful.
There are no direct benefits to participants. This study will help researchers better understand how ear stimulation can improve the strategies that can help the way that people think about themselves in social situations.
The aim of this study is to assess the efficacy and safety of an investigational medication, Inebilizumab, in patients with autoimmune hepatitis (AIH) who inadequately respond to at least 9 months of standard-of-care (SOC) treatment, or who are intolerant to SOC within 6 months of screening.
This study aims to evaluate the clinical development program for icotrokinra in the treatment of adult participants with moderately to severely active UC. Icotrokinra may offer additional advantages beyond injectable antibody therapies and available
oral therapies for the treatment of patients with moderate to severely active UC due to its oral route of administration, high local exposure to GI tissues, and systemic activity. Overall, the program will evaluate icotrokinra treatment in a target of 822 adult and 60 adolescent participants through at least 52 weeks but participants can participate in a long-term extension for 4 years (total duration approximately 5 years).
Adult subjects with rectal cancer undergoing sphincter sparing resection and colonic anastomosis. Post-operative follow-up will occur at 7-10 days, 30 days, 90 days, 180 days, and 270 days.
The 16-week main phase of the study is designed to assess the efficacy and safety of the once daily pitolisant, administered orally upon wakening, in comparison to a placebo. The effects of HBS-301 on excessive daytime sleepiness, sleep inertia (slow to wake up/groggy), and fatigue will be examined.
After the main phase period, there is an option to be in the second part of the study, which will span 1 year. During this period, subjects will receive open label of the active drug, HBS-301.
A germ called Streptococcus pneumoniae (also known as S pneumoniae) is a leading cause of serious diseases including infection of the lungs (pneumonia), infection of the brain lining (meningitis), infection of the blood (bacteremia) and infection of the ears (otitis). There are more than 90 different types of S pneumoniae, some of which cause more serious infections than others. 20-valent (meaning the vaccine protects against 20 different types of S. pneumoniae) pneumococcal conjugate vaccine (Prevnar 20®; 20vPnC) was approved in 2021 first in adults then in children in the United States in 2023, to prevent pneumococcal disease.
The study vaccine, 25-valent pneumococcal conjugate vaccine (25vPnC, PG4 vaccine, pneumococcal fourth-generation vaccine) contains the same components found in 20vPnC, one of which has been changed, but with 5 additional components to help expand protection against 25 types of S pneumoniae. The study vaccine is not approved by the United States Food and Drug Administration (FDA) or elsewhere around the world.
This study will look at how a new pneumococcal vaccine will work in healthy infants while expanding protection against pneumococcal disease due to the germ called S pneumoniae; and, how the new study pneumococcal vaccine will work together with recommended childhood shots.
This study will last for about 16 to 19 months and will have at least 6 visits and 1 telephone contact, about 6 months after your child's last study vaccination.
This study is trying to find out whether early repair of small Abdominal Aortic Aneurysms (AAAs) in women improves health outcomes compared to routine monitoring. An AAA occurs when a section of the aorta in the abdomen weakens and bulges outward, resembling a balloon. This condition is serious because if the aneurysm ruptures, it can cause severe internal bleeding and can be fatal. This question is important because women with small AAAs may have a higher risk of rupture than men, and doctors are not yet sure whether early repair is better than standard monitoring. Surgical repair is the elective standard of care for aneurysms above 5.5cm in size. In our study we are evaluating if earlier repair (between 4.0- 5.4 cm) might be beneficial to women with abdominal aneurysms, but it is important to note that surgical repair involves risks and could lead to other complications, including death. These risks are discussed later in this form. There is also the possibility that you may need additional procedures, including open surgery.
This study is recruiting patients receiving cancer treatment that includes a type of drug called an "alkylating agent", which may cause side effects such as damage to the ovaries (female reproductive organs). The goal of the study is to determine the feasibility of conducting a cross network, multi-site, randomized clinical trial of triptorelin among newly diagnosed adolescent and young adult (AYA) female cancer patients age <40 years (exclusive of breast cancer). The triptorelin used in this study may affect how different parts of your body work such as your liver, kidneys, heart, and blood. Participants will receive the medications through an intramuscular (IM) injection in their arm. Study participation is expected to last up to three years.
This study is for adults diagnosed with advanced melanoma (a kind of skin cancer) that has spread or cannot be surgically removed. This study includes participants with advanced melanoma from any part of the body except the eye.
The main purpose of this research study is to learn if the study drug, brenetafusp (IMC-F106C), in combination with a standard therapy (nivolumab), works better than the standard therapy (nivolumab alone or in combination with relatlimab) at making tumors stop growing (or shrink). Nivolumab and relatlimab are FDA approved, however, the study drug, brenetafusp, is still being investigated and is not approved by the FDA.
Patients may participate in this study for up to 2 years. Procedures include CT, MRI, blood tests, drug administration, and regular visits with your doctor including follow-up study visits or phone calls. There will be about 680 people taking part in this study, approximately 5 patients will be enrolled at MUSC.
Risks include cytokine release syndrome, which could include flu-like symptoms such as nausea, vomiting, fever, tiredness, headache, chills, difficulty breathing and/or low blood pressure (symptoms may include dizziness or light headedness). Participants may or may not receive a direct benefit from participating in this trial, however, information learned from the trial may help other people in the future.
To evaluate if daily oral administration of elafibranor 120 mg improves the time of event free survival compared to placebo in adults with Primary Sclerosing Cholangitis (PSC).