A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Lumateperone in the Treatment of Irritability Associated with Autism Spectrum Disorder in Pediatric Patients 5 to 17 years of Age

Date Added
March 25th, 2025
PRO Number
Pro00142895
Researcher
McLeod Gwynette

List of Studies


Keywords
Autism
Summary

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.

Institution
MUSC
Recruitment Contact
Jelissa Suarez
843-876-9262
suarezj@musc.edu

Safety and Efficacy of the Alleviant No-Implant Interatrial Shunt in Patients with Heart Failure and Reduced Ejection Fraction

Date Added
March 25th, 2025
PRO Number
Pro00142732
Researcher
Brian Houston

List of Studies


Keywords
Cardiovascular, Heart
Summary

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.

Institution
MUSC
Recruitment Contact
Shaquanda Goodwine
843-876-5783
shr37@musc.edu

An Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of EDG-7500 in Adults with Hypertrophic Cardiomyopathy

Date Added
March 25th, 2025
PRO Number
Pro00142239
Researcher
Jessica Atkins

List of Studies

Keywords
Drug Studies, Heart
Summary

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.

Institution
MUSC
Recruitment Contact
Cara Breunig
843-792-7519
breunig@musc.edu

CAMBRIA-2: A Phase III, Open-Label, Randomised Study to Assess the Efficacy and Safety of Camizestrant (AZD9833, a Next Generation, Oral Selective Estrogen Receptor Degrader) Versus Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) as Adjuvant Treatment for Patients with ER+/HER2- Early Breast Cancer and an Intermediate-High or High Risk of Recurrence Who Have Completed Definitive Locoregional Treatment and Have No Evidence of Disease

Date Added
March 25th, 2025
PRO Number
Pro00136956
Researcher
Abirami Sivapiragasam

List of Studies

Keywords
Cancer, Cancer/Breast, Drug Studies, Women's Health
Summary

The study is for patient that are receiving camizestrant as a treatment. The main purpose of study is to change the dosage of camizestrant from 150mg to 75mg. This change was prompted by updated, emerging data from ongoing studies showing
no difference in efficacy between the 75 mg and 150 mg doses. Subject can expect to be in this study for up to 24 months.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

A Phase 3b, Open-label, Multicenter Study to Evaluate Transmural Healing and Disease Modifying Effect of Guselkumab in Crohn's Disease Patients Transmural Healing and Disease Modifying Effect of Guselkumab in Crohn's Disease Patients REASON

Date Added
March 25th, 2025
PRO Number
Pro00136825
Researcher
Erin Forster

List of Studies


Keywords
Inflammatory Bowel Disease
Summary

This is a Phase 3b, multicenter, open-label study to evaluate transmural healing and the disease modifying effect of guselkumab in participants aged 18 years or older, with active Crohn's disease. Eligible participants must be diagnosed with luminal Crohn's disease (confirmed by radiography, histology, and/or endoscopy) for a minimum of 3 months, have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or Advanced therapy (for example, biologic or jak inhibitor), or have medical contraindications to such therapies. Participants with active moderate‐to‐severe Crohn's disease will be enrolled in this study. About 112 participants will take part in this study worldwide at approximately 90 study sites. Participants will be in the study for about 104 weeks and will need to visit the study site approximately 28 times, this number may also vary depending on the study treatment group and whether the option of self-administration of the study drug at home at certain timepoints.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
843-792-0965
recruitment@musc.edu

Advancing the Evidence for Hospital Violence Intervention Programs (HVIPs) in the Southeast: Qualitative Assessment of Patient and Caregiver Experiences After Firearm Injury

Date Added
March 24th, 2025
PRO Number
Pro00141320
Researcher
Ashley Hink

List of Studies

Keywords
Critical Care
Summary

The purpose of the study is to assess healthcare interactions and violence intervention services provided to patients and their loved ones that are treated for firearm injuries. This will be done in a 30 to 45-minute interview where participants will be asked questions about their healthcare experience, services provided by the Turning the Tide Violence Intervention Program (TTVIP), what went well with their care and services, and what could be improved. This information will be used to better understand the experiences and needs of patients and families that experience a violent injury, what is done well by trauma centers and hospital violence intervention programs (HVIPs), and what could be improved in their experience and recovery.

Institution
MUSC
Recruitment Contact
Claire Jacoby
8437691689
jacobyc@musc.edu

Complex verb-learning situations

Date Added
March 19th, 2025
PRO Number
Pro00142589
Researcher
Sabrina Horvath

List of Studies

Keywords
Children's Health, Healthy Volunteer Studies, Language
Summary

Children ages 3-4.5 years of age will watch videos designed to teach them made-up verbs. Then, they will be tested on whether they were able to learn the made-up verbs that were presented to them. Findings from this study will help researchers better understand how children learn language and what word-learning situations are easy or difficult for toddlers. This study will be conducted virtually using video conferencing software.

Institution
MUSC
Recruitment Contact
Sabrina Horvath
(843) 792-9363
horvaths@musc.edu

MIrikizumab in UC a Real-woRld prOspective multicenteR registry

Date Added
March 18th, 2025
PRO Number
Pro00142550
Researcher
Erin Forster

List of Studies


Keywords
Inflammatory Bowel Disease
Summary

The goal is to see how well mirikizumab works for people with ulcerative colitis. This involves looking at its effects in their everyday lives. Understanding its real-world benefits helps determine how effective the medicine is outside of controlled clinical trials.

Institution
MUSC
Recruitment Contact
Isabella Brookshire
8437920965
recruitment@musc.edu

A Neural Basis for Cognitive Decline Following Deep Brain Stimulation: A DBS-fMRI Study

Date Added
March 18th, 2025
PRO Number
Pro00142451
Researcher
Daniel Lench

List of Studies

Keywords
Brain, Parkinsons
Summary

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). 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.

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.

Institution
MUSC
Recruitment Contact
Niloufar Malakouti
843-792-0235
malakout@musc.edu

Dynamic motor cortical responses to subdural electrical stimulation.

Date Added
March 18th, 2025
PRO Number
Pro00142103
Researcher
Nathan Rowland

List of Studies


Keywords
Parkinsons
Summary

Current surgical treatments for Parkinson's disease have associated risks that may prevent patients from being offered surgery called "deep brain stimulation" or DBS. This is mainly because electrodes have to be placed through brain tissue to reach the target. Stimulation at the surface of the brain might be a potential alternative, but current research has not shown consistent results, and this may be because the mechanism of action is not clear. In this study, we aim to stimulate and record the brain at the surface to help answer this question and potentially improve the consistency and effectiveness of this treatment.

Institution
MUSC
Recruitment Contact
M S Zobaer
8329557191
zobaer@musc.edu



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