Drowning Risks of Patients Presenting to the Pediatric Emergency Department at MUSC's Shawn Jenkins Children's Hospital

Date Added
March 11th, 2025
PRO Number
Pro00142153
Researcher
M. Titus

List of Studies


Keywords
Pediatrics
Summary

This study is seeking to assess two known risk factors of drowning, swimming ability and water safety knowledge, in parents of children and adolescents presenting to the pediatric emergency department using questionnaires.

By collecting this data, we hope to highlight factors that contribute to disparities in drowning rates in minority racial and ethnic groups and to aid local and federal governments in developing programs that effectively combat the number one cause of unintentional injury-associated death in children ages 1-4 years. This will also provide data that may help guide pediatricians in effective anticipatory guidance for families regarding water safety. All in the effort to minimize disparities in medicine and provide more equitable care to the patients that we see.

Institution
MUSC
Recruitment Contact
M. Titus
8434753656
titusda@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

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) and speech. 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. Participant's will also be invited to undergo an optional second scan. If participants consent, the second scan will be performed on a separate day than the first scan and therefore, there will be a total of 3 study visits.

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

A Randomized, Controlled, Multiregional Phase 3 Study of Ivonescimab Combined with Chemotherapy Versus Pembrolizumab Combined with Chemotherapy for the First-line Treatment of Metastatic Squamous Nonsmall Cell Lung Cancer

Date Added
March 21st, 2025
PRO Number
Pro00138993
Researcher
Mariam Alexander

List of Studies

Keywords
Cancer, Cancer/Lung, Drug Studies
Summary

The main purpose of this study is to measure overall survival (OS) and safety of ivonescimab (study drug) when combined with chemotherapy drugs carboplatin, paclitaxel or nab-paclitaxel compared to pembrolizumab combined with chemotherapy drugs carboplatin, paclitaxel or nab-paclitaxel. Participants will undergo screening procedures done to determine if they meet the requirements to be in this study. Screening will be completed within 28 days before receiving the study drug. Many of these screening measures are likely part of regular cancer care and may be done even if it turns out that you do not participate in the research study.

Once enrolled in the study, participants will visit the clinic every three weeks for 4 cycles of ivonescimab plus chemotherapy or pembrolizumab and chemotherapy for up to four infusions, followed by ivonescimab or pembrolizumab every three weeks for up to 24 months. If a participant's physician decides to use nab-paclitaxel chemotherapy for the first 4 cycles of treatment, the schedule of treatment is different and will require that the participant comes to the clinic for this infusion on days 1, 8, and 15 of each cycle. There will be follow-up check-up visits with the study team approximately 7 days, 30 days and 90 days after the last treatment or before the participant starts a new treatment for the cancer. Ninety (90) days after the participant stops taking the study drug, there will be a call or a visit scheduled to review how the they are feeling. This is a survival call/visit and will happen every 90 days until the end of the study. Participation in this study will last about 4 years, 2 years in active treatment and 2 years in follow up.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinicaltrials@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

The Impact of a 12 Week Deep Neck Flexor Training Program on Cervical Muscle Thickness and Endurance: an Observational Study

Date Added
April 4th, 2025
PRO Number
Pro00143664
Researcher
Bryan O'Halloran

List of Studies

Keywords
Exercise, Muscle, Physical Therapy, Rehabilitation Studies
Summary

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.

Institution
MUSC
Recruitment Contact
Bryan O'Halloran
8437928224
ohallora@musc.edu

Sleep and Activity Habits of Inpatients with Chest Tubes: A Pilot Observational Trial

Date Added
April 9th, 2025
PRO Number
Pro00140546
Researcher
Christopher Gilbert

List of Studies

Keywords
Lung, Pulmonary
Summary

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.

Institution
MUSC
Recruitment Contact
Randal Neff
8437924557
Neffr@musc.edu

Randomized Phase III Trial of Neoadjuvant Immunotherapy with Response-Adapted Treatment Versus Standard-of-Care Treatment for Resectable Stage III/IV Cutaneous Squamous Cell Carcinoma

Date Added
April 22nd, 2025
PRO Number
Pro00144157
Researcher
William Albergotti

List of Studies

Keywords
Cancer/Skin, Drug Studies, Men's Health, Stage III, Stage IV, Women's Health
Summary

This phase III study evaluates whether cemiplimab can shrink or prevent the return of cancer when combined with the usual approach for skin cancer more effectively than the usual approach alone. This study will enroll adults diagnosed with stage III/IV cutaneous squamous cell carcinoma. If eligible to participate in this study participants will be randomly assigned to 1 of 2 groups. Group 1 will receive the usual surgery used to treat this type of cancer. After surgery, they may get the usual type of radiation, depending on the results from the tumor tissue removed during surgery. Group 2 will receive cemiplimab before surgery every 3 weeks for up to 12 weeks. They may also receive radiation after surgery depending on the tumor tissue results from surgery. If treated with cemiplimab before surgery, then tumor tissue results will also determine whether or not they receive cemiplimab every 6 weeks for up to 24 weeks, after surgery, and radiation if given. Participants will be asked to complete quality of life questionnaires to understand how they are feeling during treatment and the effects of the treatment. Participants will be checked for sides effects 3 to 4 months for 2 years after treatment. After that, every 6 months for 1 year and then annually. The main risks are tiredness, diarrhea or constipation, nausea, rash or itching, change in thyroid function, and risk of progression of the cancer to require earlier surgery or to become inoperable. Alternatives to this treatment is standard of care surgery and radiation. The study benefit is cemiplimab may help in shrinking or stabilizing this type of skin cancer.

Institution
MUSC
Recruitment Contact
HCC clinical trails office
843-792-9321
hcc-clinicaltrials@musc.edu

ADVENT Trial Long Term Outcomes Evaluating Atrial Fibrillation Progression ADVENT LTO Study

Date Added
May 14th, 2025
PRO Number
Pro00140422
Researcher
Jeffrey Winterfield

List of Studies


Keywords
Heart
Summary

This study is enrolling participants who completed the FARAPULSE ADVENT study and are now nearing the 3 year post atrial fibrillation ablation timepoint. Atrial fibrillation is an irregular heart rhythm caused by electrical signals misfiring. An ablation is a procedure in which those signals are targeted and destroyed to stop the atrial fibrillation. This study will consist of reviewing and collecting medical records since the ablation procedure as well as optional questionnaires and wearing a heart monitor for 7 days to capture the heart's electrical activity. There are no study related follow up visits. Study related risks include loss of confidentiality and possible skin reaction to the electrodes (sticky patches placed on the chest to detect the heart's electrical activity). Individual benefit is not expected but the information learned may contribute to knowledge in this field.

Institution
MUSC
Recruitment Contact
Chandler Schwede
843-792-5998
schwede@musc.edu

Autophagy Maintenance (AUTOMAIN) Therapy in High-Grade Serous Ovarian Cancer: A Phase II Trial

Date Added
May 20th, 2025
PRO Number
Pro00143653
Researcher
Brian Orr

List of Studies

Keywords
Cancer, Cancer/Genitourinary, Cancer/Other, Drug Studies, Women's Health
Summary

This study is for patients that have been diagnosed with ovarian cancer who are taking bevacizumab. This study is testing two investigational drugs called nelfinavir and hydroxychloroquine. "Investigational" means it has not been approved by the United States Food and Drug Administration (FDA) for the treatment of cancer. The primary purpose of this study is to see if these two medications in combination with bevacizumab are safe and effective in ovarian cancer. These drugs will be given by mouth. Participants in this study can expect to be in this study for 6 months for data collection, but may continue on the study medications longer if seeing benefit.

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



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