Vitaccess Real MG Registry

Date Added
March 28th, 2025
PRO Number
Pro00137745
Researcher
Katherine Ruzhansky

List of Studies


Keywords
Autoimmune disease
Summary

The aim of the registry is to collect data about the day-to-day impact of MG that is not routinely collected when you visit the clinic for check-ups. We will use the data in a number of registry-based studies that will allow for better information and treatments to be provided to MG patients in the future.

.You can take part in the registry if you:
• have been diagnosed with MG
• are 18 years or older
• live in the US, UK (England or Scotland only), Germany, France, or Italy, and
• have access to a smartphone/computer/laptop

Institution
MUSC
Recruitment Contact
Alison Line
8437922845
line@musc.edu

Operant conditioning of the wrist extensor motor evoked potential to target corticospinal plasticity and upper limb motor recovery after cervical spinal cord injury

Date Added
April 1st, 2025
PRO Number
Pro00138869
Researcher
Allison Lewis

List of Studies

Keywords
Central Nervous System, Nervous System, Rehabilitation Studies, Spinal Cord
Summary

Individuals with chronic cervical spinal cord injury will complete a 10-week training protocol where they receive non-invasive brain stimulation and feedback on the size of the corresponding muscle response (wrist extensor). We will assess the impact of the brain stimulation training on 1) the brain-to-spinal cord-to-muscle connection and 2) motor functions of the arm and hand. Also, brain and spine magnetic resonance imaging will be collected before and after the training. The imaging measurements will tell us about how spinal damage, brain function, and brain structure relate to motor presentation and the response to the training.

Institution
MUSC
Recruitment Contact
Blair Dellenbach
843-792-6313
stecb@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

A multi-center, double-blind, randomized, placebo-controlled trial to assess efficacy and safety of omecamtiv mecarbil in patients with symptomatic heart failure with severely reduced ejection fraction

Date Added
April 8th, 2025
PRO Number
Pro00143419
Researcher
Brian Houston

List of Studies


Keywords
Cardiovascular, Heart
Summary

The purpose of this study is to find out if the investigational drug/study medicine (omecamtiv mecarbil) can reduce the risk of the effects of heart failure (HF), hospitalization, transplantation, or death. It is hoped that the study medicine increases the heart's ability to pump blood throughout the body, but we need to learn more about its effect in patients who suffer the most from HF symptoms. "Investigational" means that the study medicine is still being tested in research studies and has not been approved by the U.S. Food and Drug Administration (FDA). The study drug will be taken by mouth twice daily.

Participation in this study will last for approximately 3 years, however, participation could last from a few weeks to a few years depending on your time of enrollment. These visits will include physical exams, blood draws, electrocardiograms (ECG), echocardiogram (Echo), blood draws, questionnaires along with receiving the study drug. Participants will receive the study drug and have a 2 week wash out period to ensure tolerance. From there, participants will be randomized to either the treatment group (and receive the medication) or the control group (and not receive the medication). The treatment assignment is determined by randomization, where a computer selects at random which treatment group you will be in (like drawing straws). Neither the subject, nor the blinded study personnel will know which group subjects are in. Neither the subject nor the study doctor or study staff will decide what group subjects are assigned.

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

cfDNA Assay Multicenter Prospective Observational Validation for Early Cancer Detection, Minimal Residual Disease, and Relapse (CAMPERR)

Date Added
April 9th, 2025
PRO Number
Pro00143358
Researcher
Gerard Silvestri

List of Studies


Keywords
Cancer
Summary

This study aims to develop a new blood test to detect and identify many different types of cancer, using a special technique that looks at tiny changes in your DNA. Some participants will be followed over time to see if this method can also find leftover cancer cells (after treatment), and if it could warn if the cancer comes back. However, this test still under development, so there are no results reported back to participants. The goal is to create a reliable tool that one day could help doctors diagnose and monitor cancer(s) more effectively.

Institution
MUSC
Recruitment Contact
Michael Balassone
843-792-6696
Balassom@musc.edu

cfDNA Assay Multicenter Prospective Observational Validation for Early Cancer Detection, Minimal Residual Disease, and Relapse (CAMPERR)

Date Added
April 9th, 2025
PRO Number
Pro00143358
Researcher
Gerard Silvestri

List of Studies


Keywords
Cancer
Summary

This study aims to develop a new blood test to detect and identify many different types of cancer, using a special technique that looks at tiny changes in your DNA. Some participants will be followed over time to see if this method can also find leftover cancer cells (after treatment), and if it could warn if the cancer comes back. However, this test still under development, so there are no results reported back to participants. The goal is to create a reliable tool that one day could help doctors diagnose and monitor cancer(s) more effectively.

Institution
MUSC Health Florence Medical Center
Recruitment Contact
Michael Balassone
843-792-6696
Balassom@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

Auxora for the Treatment of AKI and Modulation of Injurious "Crosstalk" with the Lung: A Randomized Control Trial (KOURAGE)

Date Added
April 22nd, 2025
PRO Number
Pro00143675
Researcher
Blaithin McMahon

List of Studies


Keywords
Kidney
Summary

This study is designed to help doctors understand how to safely - and at what dose – to give the study drug to patients suffering from acute kidney injury with accompanying acute hypoxic respiratory failure (AHRF). The study is testing Auxora (study drug) against placebo (a substance that has no medical effect).

Your chance of receiving a dose is 50% (for every 1 who receives placebo, 1 receives a dose of Auxora). This selection process is called randomization (like a ‘flip of a coin') and neither you nor your study doctor will know to which group you have been assigned. Every patient in the study will receive his/her dose of Auxora or placebo once a day, for 5 days in a row.

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

A prospective, multicenter clinical trial of the TricValve® Transcatheter Bicaval Valve System in subjects with severe tricuspid regurgitation.

Date Added
April 22nd, 2025
PRO Number
Pro00143868
Researcher
Nicholas Amoroso

List of Studies


Keywords
Cardiovascular, Heart, Surgery
Summary

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.

Institution
MUSC
Recruitment Contact
Natalie Drain
843-876-5037
drain@musc.edu



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