The purpose of this study is to find out about the safety and effectiveness of an investigation drug called Semaglutide for the treatment of NASH. (Non-Alcoholic Steatohepatitis). NASH occurs when the fat buildup in the liver leads to inflammation (hepatitis) and scarring. NASH is associated with increased risk of morbidity (medical problem or complication) and mortality (death). Currently, treatment options are few and insufficient. There is therefore an unmet medical need for effective and safe pharmacological treatment options. The study is designed to last 257 weeks (approximately 4 years and 11 months), with study visits occurring approximately every 4 weeks. Most visits will include blood work and some will include assessments such as body weight and vital signs. Most visits will include reviewing of diary entries during the course of the study. This study also includes weekly injections of semaglutide (or placebo). Semaglutide is a self-administered injection that is given under the skin. Semaglutide has built an extensive amount of data with other trials that have focused on weight management and Type 2 diabetes. Semaglutide is FDA-approved for diabetes treatment, but is investigational for this study. In these previous trials, semaglutide was found to be safe and well-tolerated. This study is randomized, double-blinded, and placebo-controlled. This means that you may receive the study drug or a placebo. Neither the study subject or the study team members will know which each subject will be receiving. Study subjects will be randomized 2:1. This means that subjects will have a greater chance (66%) of receiving the drug versus the placebo.
This study will evaluate elopement prevention kits for children with autism spectrum disorder who exhibit elopement behavior such as dashing or wandering away from safe settings. Caregivers will be asked to rate how useful individual kit items are at reducing elopement, and to provide feedback about how ESCAPE kits affect their stress levels and ability to engage meaningfully in community settings. This study will also investigate how useful kit items are for various age groups in childhood and adolescence. Information will be used to guide development of a larger elopement prevention program.
The study is being done to find out if this approach (8 sessions of the Internet-based program with education) is better or worse than the usual approach plus education only for cancer-related pain. The usual approach is defined as care most people get for cancer-related pain.
In current practice, options for venous and lymphatic malformations remain limited. Recently an oral medication, sirolimus, has been found to benefit patients when taken once or twice a day for several months. Unfortunately there are many side effects associated with this medication, some of which can be severe including, neutropenia, oral ulcerations, and lab abnormalities. The purpose of this study is to determine if once weekly dosed sirolimus will be effective for the treatment of venous and lymphatic malformations. Additionally, the study will evaluate patient satisfaction and identify adverse effects. Participants will be on the medication for 6 months with an option to continue after this time period.
The purpose of this study is to see whether oral Ozanimod is safe and effective for treating Crohn's disease. Adult participants (at least 18 years old) with moderately to severely active Crohn's disease may be eligible.
Only participants who complete the induction and/or maintenance study will be eligible to join this open-label study.
All participants in this study receive active study drug. The dose of study drug you will receive will depend on your prior study. There is no chance of placebo in this study.
This study is designed to last up to 234 weeks (4.5 years). Participants are expected to come to MUSC every 8 or 12 weeks for study visits.
The purpose of this study is to see whether Ozanimod is safe and effective for treating Crohn's disease. Adult participants (at least 18 years old) with moderately to severely active Crohn's disease may be eligible.
To do this, a comparison will be made between subjects who receive active drug and subjects who receive placebo (a ‘dummy treatment' that looks like the active drug but contains no active ingredient). The chance of being randomized (like drawing names out of a hat) into ozanimod group and receiving ozanimod is 50%. The chance of being randomized into placebo group and receiving placebo is 50%.
If participants' Crohn's disease condition get worse during the study, they will be invited to participate the open-label study, which has no placebo.
This is a one-year study, and participants are expected to come to MUSC every 8 weeks for study visits.
This study is for patients with rare Central Nervous (brain or spine) tumors. The purpose of this study is to determine whether the experimental drug, nivolumab can shrink tumors in patients with rare Central Nervous System (brain or spine) tumors or increase the time it takes for these tumors to grow or spread throughout the body.
This study is for men who have high-risk prostate cancer who plan to be treated with a combination of radiation and hormonal therapy. A tumor genomic analysis (Decipher score) will be used to divide the subjects into two groups. Those with a low genomic risk score will be randomized to either standard treatment with radiation and 24 months of hormonal therapy or to radiation with a shorter, 12 month, course of hormone therapy. Those with a higher genomic risk score or who have lymph node involvement will be randomized to standard treatment with radiation and 24 months of standard hormonal therapy or radiation with 24 months of intensified hormonal therapy.
This study is for men who have high-risk prostate cancer who plan to be treated with a combination of radiation and hormonal therapy. A tumor genomic analysis (Decipher score) will be used to divide the subjects into two groups. Those with a low genomic risk score will be randomized to either standard treatment with radiation and 24 months of hormonal therapy or to radiation with a shorter, 12 month, course of hormone therapy. Those with a higher genomic risk score or who have lymph node involvement will be randomized to standard treatment with radiation and 24 months of standard hormonal therapy or radiation with 24 months of intensified hormonal therapy.
This study is for patients that have been diagnosed with non-small cell lung cancer. The purpose of this study is to compare the usual treatment alone to using pembrolizumab plus the usual treatment. The investigational drug in this study is pembrolizumab. This drug, pembrolizumab is already approved by the FDA for use in patients with more advanced lung cancer. Participants can expect to be on treatment for up to a year. Participants will be followed for up to 10 years after completion of treatment.