Currently, there are no FDA-approved medications for the treatment of irritability associated with Autism Spectrum Disorder (ASD). This study is designed to look at the efficacy and safety of lumateperone (CAPLYTA) for the treatment of irritability associated with ASD among pediatric participants between the ages of 5 to 17 years.
It is a 6-week study, and the study drug will be compared to a placebo. Following this study, there will be an opportunity to participate in an open-label extension study where all participants will be on the active study medicine.
This study is studying the investigational medication EDG-7500 for the treatment of obstructive and non obstructive hypertrophic cardiomyoapthy. Investigational means it is not approved for sale by the Food and Drug Administration (FDA) The study will test to see if the medication can help the heart expand and fill to help its workload. The study has 4 Parts, each of varying durations. The study will last a minimum of 6 weeks to a maximum of 18 months. Study related procedures include physical exam, electrocardiogram (ECG) - a tracing of the heart's electrical activity, echocardiogram (echo) - ultrasound test of the heart, blood and urine collection, possible genetic testing, and exercise testing. Risks related to the study medication include atrial fibrillation (fast irregular heartbeat), constipation, diarrhea, dizziness/lightheadedness and upper respiratory infection. Other study related risks include loss of confidentiality, unknown risks and risks related to procedures.
This study is enrolling subjects with heart failure and a reduced ejection fraction meaning the heart does not pump enough blood to meet the body's needs. This study is researching an investigational device (study device) called the Alleviant ALV1 System. Investigational means it has not been approved for commercial use by the Food and Drug Administration. (FDA) This study will test the safety and effectiveness of the Alleviant ALV1 System. The Alleviant ALV1 System is intended to create a shunt (an opening) in the heart to allow for proper blood flow through the heart which may improve your symptoms. No device is left in your heart it is just used to create the shunt. This is a randomized study which means subjects are assigned by chance to either have the study device create this shunt or not have the study device create the shunt. Randomization is 50/50 meaning there is a 50% chance to have the study device create a shunt and a 50% chance the study device will not be used. Using the study device to create the shunt is performed during a right heart catheterization (RHC) so all subjects will undergo the RHC but only 50% will have the shunt. Neither the subjects nor the study doctor will know which group subjects are randomized to but other study staff will know in the event this information is needed. All subjects will stay overnight in the hospital after the procedure. Other study related procedures include echocardiograms - ultrasound test of the heart, electrocardiograms (ECG) - a tracing of the heart's electrical activity, blood work, questionnaires, 6 minute hall walk test, and assessments of heart failure status. Risks include risks related to the study device including blood vessel damage from placing the device in the vein to get to the heart, risks from the right heart catheterization such as bleeding or bruising, abnormal heart beats, and risks related to study related procedures. There may be risks that are not known at this time. Participation in this study is expected to last about 60 months and include approximately 15 in person visits and 3 telephone calls.
Co-occurring post-traumatic stress disorder (PTSD) and alcohol use disorder (AUD) disproportionately affects Veterans and has significant negative impacts on the safety, wellbeing, and quality of life of Veterans, their romantic partners, and their families. However, treatments that address co-occurring PTSD-AUD and restore Veterans' psychosocial functioning are lacking. This project is designed to learn more to facilitate improving treatment approaches aimed at reducing symptoms of co-occurring PTSD-AUD and improving functioning among Veterans and their partners. The goal of this project is to learn from Veterans, family members, and treatment providers in order to inform an adaptation of a brief dyadic AUD intervention to be delivered alongside integrated PTSD-AUD treatment for Veteran couples.
This research study is focused on evaluating the effectiveness of a new imaging technique for a procedure called Prostate Artery Embolization (PAE), which is used to treat an enlarged prostate. The study compares two groups of patients: one group receives PAE with advanced imaging called 3D CTA fusion, and the other group receives PAE using the standard imaging method. The goal is to determine if using 3D CTA fusion can make the procedure faster, reduce the amount of radiation exposure, and decrease the need for contrast dye during the procedure. By studying these two groups, researchers hope to identify ways to make PAE safer and more efficient​
This study is for patients that have been diagnosed with metastatic castration-resistant prostate cancer. The study is testing an investigational drug called JANX007. Investigational means it has not been approved by the United States Food and Drug Administration (FDA). The primary purpose of the study is to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of JANX007 when administered as a single agent. The drug is given to participants by IV infusion. Participants in this study can expect to be in this study until disease progression or unacceptable toxicity.
The purpose of the study is to examine whether certain neck strengthening exercises result in change in size of the neck muscles being targeted.
Musculoskeletal Ultrasound is a non invasive, safe tool that will be used to measure the size of certain muscles in your neck. This will allow us to determine if these muscles actually get bigger in response to targeted exercise. Muscle size is a factor associated with strength.
This study will help us tease out the time it takes to create neck muscle hypertrophy, or increase in muscle size, in order to develop effective protocols for neck strengthening which may be useful in the management of chronic neck pain.
Weakness in certain neck muscles may be associated with the development of neck pain and we hope to determine effective training protocols for these neck muscle groups.
This is a non-invasive, observational study aiming to collect data on the impact chest tubes have on inpatients during their hospitalizations. Sleep and activity patterns, as well as select vital signs will be tracked using an MUSC-owned Apple Watch, which subjects will wear, and an MUSC-owned iPhone, for up to seven days during admission to the hospital. Each day, a study coordinator will visit subjects to collect a brief sleep survey. Participation may last up to 7 days while subjects are admitted and have a chest tube in place. Upon completion of the study, a study coordinator will collect the Apple Watch and iPhone for data analysis.
This pilot data will provide initial information on the feasibility of collecting and performing a larger study on the inpatient mobility, activity, and sleep.
This study is enrolling subjects with tricuspid regurgitation, which is what occurs when the tricuspid heart valve on the right side of the heart does not close properly and blood leaks backwards. Over time this can lead to symptoms like shortness of breath and fluid build up in the legs, abdomen, and lungs. This study involves a new investigational device called the TricValve® Transcatheter Bicaval Valve system to treat the leaky valve. Investigational means it is not approved for commercial use by the Food and Drug Administration. (FDA) This study will last about 5 years and include about 11 visits. Study related procedures include physical exams, right heart catheterization (an invasive procedure to check pressures inside the heart), echocardiograms (ultrasound test of the heart), CT scan, blood work, questionnaires, hall walk test and procedure to place the device. Risks include those related to the device and procedure such as infection, failure of the device, worsening of your symptoms or other cardiac complications. There are also risks associated with study testing such as radiation risks, blood draw risks, loss of confidentiality and unknown risks. There is potential benefit to you and to others in the future from what is learned from this study.
This is a 28-week-long treatment study for people with Alcohol Use Disorder who want to stop or cut down their drinking. The purpose of this study is to determine whether an investigational medication, Mazdutide, affects craving for alcohol and/or alcohol drinking while taking the study drug. Participants will be randomly assigned to Mazdutide or a matched placebo