Determinants of performance in cochlear implant listeners

Date Added
February 6th, 2024
PRO Number
Pro00133091
Researcher
Kelly Harris

List of Studies


Keywords
Hearing
Summary

This project examines how to improve speech understanding with cochlear implants (CIs), particularly for older CI recipients. While older individuals benefit from CI technology, performance is poorer than that of younger implanted adults for difficult listening tasks. The mechanisms that contribute to this variability are not well-understood. The current project examines how differences in brain structure and function may contribute to success with a cochlear implant. To compare, we will also be examining how older patients without cochlear implants understand speech in difficult listening situations.

Institution
MUSC
Recruitment Contact
Kelly Harris
8437922061
harriskc@musc.edu

Comparison of Theta Burst versus 10 Hz Repetitive Transcranial Magnetic Stimulation for Craving in Smokers

Date Added
February 6th, 2024
PRO Number
Pro00121128
Researcher
Xingbao Li

List of Studies


Keywords
Brain, Healthy Volunteer Studies, Smoking
Summary

Smoking is one of the main public health problems. Smoking cessation is difficult because of nicotine dependence. Repetitive transcranial magnetic stimulation (rTMS) over the frontal head has shown to be effective in the reduction of cigarette consumption and craving. In this study, we will evaluate the efficiency of a new form of rTMS called intermittent theta-burst stimulation (iTBS) for smoking cessation.

Institution
MUSC
Recruitment Contact
Morgan Dancy
843 8765-141
maddoxm@musc.edu

OptimICE-PCR: De-Escalation of Therapy in Early-Stage TNBC Patients Who Achieve pCR After Neoadjuvant Chemotherapy with Checkpoint Inhibitor Therapy

Date Added
February 5th, 2024
PRO Number
Pro00133826
Researcher
Frank Brescia

List of Studies


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

This study for subjects that have been diagnosed with triple negative breast cancer (TNBC) and have recently completed preoperative chemotherapy in combination with pembrolizumab, followed by breast surgery. The subjects are expected to be in this study for up to 60 months.

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

REACT-AF: The Rhythm Evaluation for Anticoagulation with Continuous Monitoring of Atrial Fibrillation

Date Added
February 3rd, 2024
PRO Number
Pro00132508
Researcher
Venkateshwar Gottipaty

List of Studies

Keywords
Cardiovascular, Heart
Summary

This research is being done to assess whether it is safe and effective to stop oral anticoagulation medications (a blood-thinning medication) during prolonged periods of normal heart rhythm in participants with infrequent episodes of atrial fibrillation (AF).

You may qualify for this study if you have a history of atrial fibrillation (AF) and are currently taking an oral anticoagulant (a blood-thinning medication). You will be randomized to one of two groups: Control Group or Study Intervention Group.

If you are randomized to the Control group, you will be asked to stay on your previously prescribed oral anticoagulant. If you are randomized to the Study Intervention group, you will be asked to take the oral anticoagulant for 30 days only if a prolonged episode of AF is detected on an AF-sensing Apple smartwatch you will be provided.

Institution
MUSC
Recruitment Contact
Jacqueline Sheriod-Scott
803-254-3278
sheriods@musc.edu

REACT-AF: The Rhythm Evaluation for Anticoagulation with Continuous Monitoring of Atrial Fibrillation

Date Added
February 3rd, 2024
PRO Number
Pro00132508
Researcher
Venkateshwar Gottipaty

List of Studies

Keywords
Cardiovascular, Heart
Summary

This research is being done to assess whether it is safe and effective to stop oral anticoagulation medications (a blood-thinning medication) during prolonged periods of normal heart rhythm in participants with infrequent episodes of atrial fibrillation (AF).

You may qualify for this study if you have a history of atrial fibrillation (AF) and are currently taking an oral anticoagulant (a blood-thinning medication). You will be randomized to one of two groups: Control Group or Study Intervention Group.

If you are randomized to the Control group, you will be asked to stay on your previously prescribed oral anticoagulant. If you are randomized to the Study Intervention group, you will be asked to take the oral anticoagulant for 30 days only if a prolonged episode of AF is detected on an AF-sensing Apple smartwatch you will be provided.

Institution
MUSC Health Columbia Medical Center
Recruitment Contact
Jacqueline Sheriod-Scott
803-254-3278
sheriods@musc.edu

Examining Sex and Gender Differences in Patterns of Cannabis Use Motives and Consequences in a Community Sample of Adults Who Use Cannabis

Date Added
February 2nd, 2024
PRO Number
Pro00134281
Researcher
Kathryn Gex

List of Studies

Keywords
Aging, Mental Health, Substance Use, Women's Health
Summary

The goal of this study is to evaluate sex and gender differences across adulthood (18+) in reasons for using cannabis and the perceived severity of consequences associated with cannabis use. We are also interested in understanding how these reasons for cannabis use and perceived severity of consequences are related to other mental and physical health factors. Interested individuals will first complete a brief screening survey. Based on the results of this screening survey, eligible participants will immediately be invited to complete the survey remotely online via a secure web-link. Participants can expect to complete the survey in 30-45 minutes and will be reimbursed $30 via electronic gift card (e.g., Amazon).

Institution
MUSC
Recruitment Contact
Kathryn Gex
843-792-4904
soltisk@musc.edu

A Phase 3, Multi-center, Open-label, Single-arm Study to Assess the Safety of Apremilast (AMG 407) in Pediatric Subjects from 6 Through 17 Years of Age With Mild to Moderate Plaque Psoriasis

Date Added
January 31st, 2024
PRO Number
Pro00130368
Researcher
Lara Wine Lee

List of Studies


Keywords
Children's Health, Skin
Summary

This study is being done to learn more about apremilast (AMG 407) in mild to moderate plaque psoriasis in participants (children and adolescents) aged 6 to 17 years. It will see whether it causes any side effects. About 50 people are expected to take part in this study. The duration of the study is approximately 285 days. This includes 3 phases: 35 days of screening phase, 225 days (32 weeks) of treatment phase, and 60 days of observational follow-up phase after the last dose of study drug – this means drug is still being tested to see if it is safe and works.

Institution
MUSC
Recruitment Contact
Courtney Rowley
843-792-9784
rowle@musc.edu

A PHase 1/2 Study of the Safety and Efficacy of LX2020 Gene TheRapy in Patients with ArrhythmOgenIc Cardiomyopathy (ACM) due to a PlaKoPhilin-2 (PKP2) Pathogenic Variant

Date Added
January 23rd, 2024
PRO Number
Pro00133595
Researcher
Daniel Judge

List of Studies


Keywords
Cardiovascular, Heart
Summary

This study is seeking participants with arrhythmogenic cardiomyopathy (ACM), also known as arrhythmogenic right ventricular dysplasia/cardiomyopathy (ARVD/C), due to a genetic abnormality known as a PKP2 variant. ARVD/C is an inherited disease where the muscle tissue in the right ventricle, one of the lower pumping chambers of the heart, dies and is replaced with scar tissue. This causes a weakened heart muscle and disrupts the heart's electrical system which can lead to heart failure and/or fatal heart rhythms. This study is looking at the safety and effectiveness of an investigational medication, meaning it is not yet approved for use by the Food and Drug Administration (FDA). The study medication is a gene therapy called LX-2020, and is designed to add new PKP2 genes to replace the faulty ones so your cells can make the correct PKP2 genes. The study medication is given via an intravenous (IV) line meaning in a vein. Participation in this study involve up to 25 visits including a hospitalization over the course of 1 year with an additional 4 years of follow up afterwards. Study related procedures include a variety of heart testing like electrocardiogram (ECG), echocardiogram, a test that records a tracing of the heart's electrical activity, Echocardiogram, (echo) a test that uses ultrasound to capture moving images of the heart, magnetic resonance imaging (MRI), a test that shows an image of the heart and surrounding structures, sample collection including blood, urine, tissue, nasal mucus, saliva and stool, liver ultrasound, questionnaires, physical exams, and at least a two night stay in the hospital. Medications to suppress (meaning weaken) the immune system, before receiving the LX2020 are also required. Risks associated with gene therapy include an immune response that may cause inflammation in the liver, heart or other organs. It may damage red blood cells, cause a low platelet count or cause the formation of small blood clots. There are also risk related to the study procedures including bleeding associated with the heart biopsy, risks related to drawing blood, risks of radiation, and loss of confidentiality. There is potential benefit and in the future, others with ACM may benefit from the knowledge gained from this study.

Institution
MUSC
Recruitment Contact
Ellie Cutright
843-876-5011
cutrighe@musc.edu

A Phase 1 Dose Escalation Study of AV-380 in Combination with Standard of Care Chemotherapy in Metastatic Cancer Patients with Cachexia and Elevated GDF-15 Levels

Date Added
January 23rd, 2024
PRO Number
Pro00131570
Researcher
Toros Dincman

List of Studies

Keywords
Cancer, Drug Studies
Summary

This study involves research, and participation is voluntary. The purpose of the study is to see if a single dose and multiple doses of the study drug, AV 380, are safe and tolerated in cancer participants. This study will also help to look at how AV 380 behaves inside the human body (called pharmacokinetics), how the body responds to AV 380 (called pharmacodynamics), and how the immune system responds to AV 380 (called immunogenicity) when administered along with the standard anticancer treatment that a participant would usually receive if they were not in this study. First, the participant will have some tests to decide if it is safe for to join the study. These tests include blood and urine sampling, electrocardiogram, vital sign measurement, physical examination, cachexia assessment,which checks changes in proteins that affect appetite and computed tomography (CT) scan. If the study doctor thinks a participant is eligible to join, they will be assigned to one of 5 cohorts (a group of people with shared characteristics) (corresponding to 5 dose levels of AV 380) in which then they will receive AV 380 together with the Standard of Care treatment chemotherapy. Participants will need to visit the study site approximately every 1 week for the first 8 weeks and then every 2 weeks. In addition to the above-mentioned tests, then they will be also asked to have exercise tests and complete questionnaires during the study. Participants will also have post study treatment follow up visits 3 times after completion or discontinuation of AV 380. The total duration of the study is up to 7 months (including follow-up visits). Some reasonably foreseeable risks or discomforts with this study include chills, headache, and elevations in an enzyme called creatine phosphokinase which is found mainly in the heart, brain, and skeletal muscle. There is no direct benefit with participating in this study, but the information we get from this study will us improve treatment for people in the future.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
8437929321
hcc-clinical-trials@musc.edu

A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants with Progressive Pulmonary Fibrosis

Date Added
January 21st, 2024
PRO Number
Pro00132309
Researcher
John Huggins

List of Studies


Keywords
Interstitial Lung Disease (ILD), Pulmonary
Summary

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled clinical study that will randomize participants with Progressive Pulmonary Fibrosis to study drug BMS-986278 60mg, 120mg, or Placebo, administered orally, twice a day. Participants are allowed to continue background therapy, such as antifibrotic and immunosuppressant therapies. This study will consist of two parts (Cohort 1 and 2). Cohort 1 will enroll approximately 60 participants with Progressive Pulmonary Fibrosis to evaluate the safety and tolerability of BMS-986278 in which participants will be randomized to receive 60 mg, 120mg, or placebo and this will last approximately 52 weeks. Cohort 2 is a registrational, double-blinded study which will investigate the efficacy, safety, and tolerability of BMS-986278 compared with placebo. Based on data from Cohort 1, the study will design 2 or 3 treatment arms for Cohort 2.

Institution
MUSC
Recruitment Contact
Robyn Empey
8437920965
recruitment@musc.edu



-- OR --