Effects of a Novel mGluR5 Negative Allosteric Modulator on Alcohol Drinking, Neurochemistry, and Brain Reactivity to Alcohol Cues in Alcohol Use Disorder

Date Added
October 6th, 2020
PRO Number
Pro00102334
Researcher
James Prisciandaro

List of Studies


Keywords
Alcohol, Brain, Drug Studies, Substance Use
Summary

This Phase II clinical research study evaluates both the safety and effectiveness of an FDA-regulated medication presently in the initial stages of development for alcohol use disorder treatment (GET73), and will test whether GET73 alters brain chemicals and function, response to alcohol ingestion, and the desire for alcohol. Participants will be randomly assigned to one of two medication treatment groups (GET73 or placebo). Study medication will be taken for 8 days, with approximately 4 study visits, and a "bar-lab" procedure and 2 MRI brain imaging scans will be completed. Questionnaires and clinical interview measures will be completed at study visits along with consistent assessment of potential side effects from study medication.

Institution
MUSC
Recruitment Contact
Sara Hix
(843) 792-0572
hixs@musc.edu

Oxytocin to Enhance Integrated Exposure-Based Treatment of Co-occurring Alcohol Use Disorder and PTSD

Date Added
November 3rd, 2020
PRO Number
Pro00103198
Researcher
Sudie Back

List of Studies


Keywords
Alcohol, Mental Health, Military, Psychiatry, Stress Disorders
Summary

The purpose(s) of the research is to test a new medication in combination with a talk therapy for Veterans experiencing posttraumatic stress disorder (PTSD) and who may have alcohol use disorder (AUD). The study consists of 12 weekly therapy sessions. Once per week before each therapy session, an intranasal dose of investigational medication will be administered. The study also involves 3 and 6-month follow-up appointments and the administration of questionnaires at each visit.

Institution
MUSC
Recruitment Contact
Stacey Sellers
843-792-5807
sellersst@musc.edu

A Multicenter, Randomized Controlled Trial, Prospectively Evaluating the Clinical Utility of the Nodify XL2 Proteomic Classifier in Incidentally Discovered Low to Moderate Risk Lung Nodules

Date Added
November 5th, 2020
PRO Number
Pro00098515
Researcher
Nichole Tanner

List of Studies


Keywords
Cancer, Cancer/Lung, Lung
Summary

The purpose of this research is to evaluate if including the investigational Nodify XL2 test results in the decision-making process when planning the management of lung nodules will reduce the number of unnecessary surgical and biopsy procedures. The general study procedures include obtaining blood samples for Nodify XL2 tests, collecting relevant medical information (including test results ordered by your doctor in the management of your lung nodule), and documenting your doctor's recommendations for the treatment of your lung nodule. Participation in this research study may last up to 18 months.

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

fRVIIa for Acute Hemorrhagic Stroke Administered at Earliest Time (FASTEST) Trial

Date Added
November 16th, 2020
PRO Number
Pro00101067
Researcher
Parneet Grewal

List of Studies

Keywords
Stroke
Summary

An emergency care research study of bleeding in the brain is to be performed in this area.

The Medical University of South Carolina is joining researchers at more than 100 other hospitals across the United States and other countries to conduct a research study of bleeding in the brain called FASTEST. This research study may affect you or someone you know. FASTEST is a research study involving patients who have had bleeding in the brain, also called intracerebral hemorrhage (ICH).

ICH occurs when a weakened blood vessel in the brain breaks and bleeding accumulates in the brain. Most of this bleeding occurs within a few hours of onset of symptoms. The brain injury from ICH is usually very severe, over 40% of people with ICH die within a month, and only 20% can independently care for themselves after 6 months.

There is currently no treatment for ICH that is scientifically proven to improve outcome. The FASTEST research study is being done to determine if recombinant Factor VIIa (rFVIIa), a protein that our body makes to stop bleeding at the site of injury to a blood vessel, can slow bleeding in the brain and improve outcome. rFVIIa is approved for treatment of bleeding in patients who have inherited lack of clotting factors but is not approved for treatment of ICH.

Participants in the FASTEST research study are placed at random, that is by chance, into one of 2 groups. They have an equal chance of getting rFVIIa or placebo (no active ingredient). One group receives rFVIIa intravenously over 2 minutes within two hours of onset of symptoms and the other group receives placebo. We do not know if rFVIIa is better than placebo for patients with bleeding in the brain. The results of the FASTEST research study will help doctors discover if rFVIIa improves outcome in patients with bleeding in the brain. Medical care otherwise will be identical for the two treatment groups, including close management of blood pressure and care within an intensive care unit. Some patients will be enrolled without consent if a family member or representative is not rapidly available.

Before the research study starts, we will consult with the community and need your input as this research may affect you or someone you know, and we need to find out ahead of time what the community thinks about it. Below are links to the the FASTEST site for more information about this research study and how to give your feedback. There are no known risks involved in participating in this survey and your participation is completely voluntary. THANK YOU for your help and time in completing this survey:

Click here for more information or to decline participation in this research study: https://nihstrokenet.org/fastest/home

Click here to access the survey to provide feedback and ask questions:
https://redcap.research.cchmc.org/surveys/?s=YALHC7W838

OR To contact our research study staff at (843-792-3020).
Primary Investigator: Dr. Parneet Grewal
Study Coordinators: Caitlan LeMatty

Institution
MUSC
Recruitment Contact
Caitlan LeMatty
843-792-8606
lemattyc@musc.edu

An Open-Label, Multicenter, Phase 1/2 Study of RP1 as a Single Agent and in Combination with PD1 Blockade in Patients with Solid Tumors

Date Added
November 24th, 2020
PRO Number
Pro00105157
Researcher
John Kaczmar

List of Studies


Keywords
Cancer, Drug Studies, Men's Health, Women's Health
Summary

This study is for patients that have been diagnosed with advanced or resistant skin cancer (melanoma), non-melanoma skin cancer (NMSC), non-small cell lung cancer (NSCLC), certain types of solid tumors, or bladder cancer (UBC). The investigational drug in this study is RP1. RP1 is a herpes simplex virus (a microscopic life form commonly known as the "cold sore virus") that has been genetically changed to grow in and destroy cancer cells. This treatment will be injected directly into tumors. The purpose of this study is to test the safety and how well RP1 works when it is injected into certain types of solid tumors in combination with another cancer drug, called nivolumab. Participants can expect to be in this study for about 2 to 3 years.

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

Clinical Trial of the Fit Families Multicomponent Obesity Intervention for African American Adolescents and Their Caregivers: Next Step from the ORBIT Initiative

Date Added
January 5th, 2021
PRO Number
Pro00106021
Researcher
Mohan Madisetti

List of Studies


Keywords
Adolescents, Minorities, Obesity
Summary

The purpose of this study is to test the effectiveness of a comprehensive treatment for African-American adolescents with obesity and their overweight or obese caregiver (e.g., parent). Families who decide to participate in this study will be randomly assigned to one of two intervention groups: the FIT Families group or the Home-Based Family Support (HBFS) group. This means participants have a 50/50 chance (like flipping a coin) of being in either group. Participants randomized to FIT Families will have sessions with a community health worker (CHW) in the home or community once or twice weekly based on the family's preference for the first three months, and weekly for the second three months. Some of the sessions might occur virtually (online) if needed. Participants randomized to HBFS will receive six months of weekly family counseling in their home or community with a community health worker (CHW). Some of these sessions might occur virtually (online) if needed. Participants in both groups will receive education and support for healthier lifestyles.
The study will last 18 months. During the 18-month study period, youth and caregivers will wear a FitBit activity tracker during the six months of the intervention and then for 2 weeks at the fourth assessment, complete study assessments, have their height, weight, and blood pressure measured, and provide finger prick blood samples to be tested for blood sugar and cholesterol levels.
Potential benefits to caregivers and youth who participate in the study include: positive changes in healthy lifestyle behaviors and weight loss, decrease in health risks associated with obesity, and improved family relations, though these cannot be guaranteed.

Institution
MUSC
Recruitment Contact
Elizabeth O'Brien
843-876-0219
obriene@musc.edu

A Phase 2, randomized, open-label three-arm clinical study to evaluate the safety and efficacy of lenvatinib (E7080/MK-7902) in combination with pembrolizumab (MK-3475) versus standard of care chemotherapy and lenvatinib monotherapy in participants with recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) that have progressed after platinum therapy and immunotherapy (PD-1/PD-L1 inhibitors) (LEAP-009)

Date Added
February 1st, 2021
PRO Number
Pro00101229
Researcher
John Kaczmar

List of Studies


Keywords
Cancer, Cancer/Head & Neck, Drug Studies, Men's Health, Women's Health
Summary

This study is for patients who have been diagnosed with head and neck squamous cell carcinoma (HNSCC) that has returned (recurrent) or spread after previous treatment (metastatic). The investigational drug in this study is lenvatinib. The study will also use lenvatinib in combination with pembrolizumab, which is also experimental. The purposes of this study are to: test the safety of the study drugs, lenvatinib alone, pembro and lenvatinib together, and standard chemotherapies alone in the treatment of HNSCC; see how well the combination of pembro and lenvatinib works, compared to standard chemotherapies; and see if participants who get pembro and lenvatinib live longer than those who are treated with standard chemotherapies. Participants can expect to be on this study for about 48 months.

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

Priming the rehabilitation engine: aerobic exercise as the fuel to spark behavioral improvements in stroke

Date Added
February 2nd, 2021
PRO Number
Pro00105988
Researcher
Ryan Ross

List of Studies

Keywords
Exercise, Rehabilitation Studies, Stroke, Stroke Recovery
Summary

Stroke is a leading cause of disability in the U.S. and many Veteran stroke survivors live with severe disability. Despite recent advances in rehabilitation treatments many stroke survivors have persistent physical and mental difficulties such as reduced arm and leg function, difficulty thinking, and depression.
Developing treatments that address these problems is necessary to improve long-term recovery for stroke survivors. Aerobic exercise (AEx) can improve physical and mental function, and reduce depression. Additionally, AEx may enhance physical rehabilitation by making the brain more receptive to, and consequently improving the response to a rehabilitation treatment. Therefore, combining AEx with physical rehabilitation has the potential to improve multiple parts of stroke recovery. This study will examine the effect of combining AEx with physical rehabilitation on physical and mental function in stroke survivors. By gaining a better understanding of the effects of this combined intervention we aim to advance the rehabilitative care of Veteran stroke survivors.

Institution
MUSC
Recruitment Contact
Ryan Ross
843-792-3477
rossre@musc.edu

Pilot Trial of Belimumab in Early Lupus

Date Added
February 9th, 2021
PRO Number
Pro00104939
Researcher
Melissa Cunningham

List of Studies


Keywords
Drug Studies, Lupus
Summary

This is a study looking at the effects of Belimumab, a medication approved by the FDA to treat lupus, in people who have been recently diagnosed with lupus. It proposes that the early use of Belimumab may prevent long-term tissue damage from the disease. The study will last 2 years with clinic visits every 4 weeks.

Institution
MUSC
Recruitment Contact
Emma Hatch
843-792-4296
hatchem@musc.edu

Randomized Clinical Evaluation of the AccuCinch® Ventricular Restoration System in Patients who Present with Symptomatic Heart Failure with Reduced Ejection Fraction (HFrEF)

Date Added
February 9th, 2021
PRO Number
Pro00104312
Researcher
Daniel Steinberg

List of Studies


Keywords
Heart, Surgery
Summary

This study is being done on patients who have heart failure, a condition where the heart muscle weakens and enlarges and cannot pump blood effectively. The purpose of this study is to assess the safety and effectiveness of a new device called the AccuCinch Ventricular Restoration System and compare it to treatment with standard heart failure medications alone. The AccuCinch Ventricular Restoration System consists of anchors, which attach to your heart muscle, sliders to connect the anchors and a thread like cord that goes through the anchors and is cinched to make your enlarged heart smaller so it can pump more efficiently. The device is implanted in one of the lower pumping chambers of the heart (called left ventricle). The study will have two groups, the treatment group in which participants undergo the device implant in addition to taking heart failure medications and the control group in which participants are treated with heart failure medications alone. Participation will last up to 5 years.

Institution
MUSC
Recruitment Contact
Kavin Panneerselvam
843-792-0464
panneeer@musc.edu



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