A Phase III, Randomized, Double-blind Study to Evaluate the Effect of Balcinrenone/Dapagliflozin, Compared with Dapagliflozin, on the Risk of Heart Failure Events and Cardiovascular Death in Patients with Heart Failure and Impaired Kidney Function

Date Added
October 8th, 2024
PRO Number
Pro00138745
Researcher
Vishal Rao

List of Studies

Keywords
Cardiovascular, Drug Studies, Heart, Kidney
Summary

We are doing this study to learn more about how effective, safe and tolerable an experimental drug called balcinrenone is when used in combination with dapagliflozin for treating patients with heart failure and impaired kidney function and also to better understand the studied disease and associated health problems. Dapagliflozin is an approved drug to treat patients with heart failure, chronic kidney disease and type 2 diabetes mellitus.

Institution
MUSC
Recruitment Contact
Lauren Wakefield
843-876-5049
wakefila@musc.edu

Adapting and Piloting the Managing Emotions to Reduce Alcohol-Facilitated Aggression (MERA-A) Intervention among Veterans

Date Added
October 1st, 2024
PRO Number
Pro00139264
Researcher
Julianne Flanagan

List of Studies


Keywords
Alcohol
Summary

Rates of heavy episodic drinking (HED) among military veterans are almost double that of the general population. Veterans also experience more serious negative health consequences of HED, including high-risk behaviors such as aggression. Research shows there is a link between HED and aggression. However, no programs exist to reduce alcohol-related aggression among veterans. The purpose of this study is to examine the feasibility and acceptability of adapting a current therapy - Managing Emotions to Reduce Aggression (MERA) - to include alcohol-focused Motivational Interviewing plus Feedback (MIF). We will use a brief, four session protocol that includes an hour of talk therapy, plus completion of surveys at each of the four sessions.

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

Testing a Strategy to Improve Diagnostic and Treatment Pathways for Children with Sleep-Disordered Breathing: the REPOSE Navigation Intervention

Date Added
October 1st, 2024
PRO Number
Pro00138323
Researcher
Phayvanh Pecha

List of Studies


Keywords
Pediatrics, Sleep Disorders
Summary

This research study aims to compare usual care with a patient navigation intervention for children with sleep-disordered breathing (SDB). SDB is a range of symptoms from snoring to severe obstructive sleep apnea. In the REPOSE intervention, a centralized patient navigator will find out the dynamic individual barriers that families face in caring for their child with SDB. They will also provide resources and social support for parent-child dyads. In addition, the navigator facilitates bidirectional SDB care coordination between clinical teams and parents to achieve evidence-based care. The patient navigation intervention group will be compared to the group of children receiving standard of care.

Institution
MUSC
Recruitment Contact
Danielle Beaufort
803-378-9735
beaufoda@musc.edu

Strategy for Improving Stroke Treatment Response

Date Added
September 26th, 2024
PRO Number
Pro00136289
Researcher
Christine Holmstedt

List of Studies


Keywords
Stroke
Summary

The research is being done to determine if an investigational drug called "TS23" is safe and effective for the treatment of patients with an ischemic stroke that do not meet the criteria for standard treatments to remove the clot. The best dose of TS23 for these patients is unknown. Prior studies have shown that TS23 works without increasing safety concerns.

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

The Development of Patient-Centered Clinical AFO prescription Guidelines to Optimize Post-Stroke Function and Quality of Life

Date Added
September 25th, 2024
PRO Number
Pro00138736
Researcher
Steven Kautz

List of Studies


Keywords
Stroke Recovery
Summary

The goal of this study is to get the highest possible quality of life restuls for individuals suffering lower-limb impairment after suffering a stroke. This will be done by examining three different modern carbon fiber ankle-foot orthosis (AFO) options targeting the rehabilitation of individuals post-stroke. The study seeks to achieve the best AFO prescription that maximizes the mobility and satisfaction of the particpant.

Institution
MUSC
Recruitment Contact
Kelly Krajeck
843-792-939
krajeck@musc.edu

Randomized Phase 2 Study of Nivolumab and Ipilimumab With or Without Cabozantinib in Patients With Advanced Nasopharyngeal Carcinoma That Have Progressed After Platinum Treatment and Immunotherapy

Date Added
September 23rd, 2024
PRO Number
Pro00138505
Researcher
John Kaczmar

List of Studies


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

This study is designed to learn more about how nivolumab and ipilimumab, with or without cabozantinib effects the growth and spreading of head and neck cancer. If decided to take part in this study, participants will go through a screening period, treatment period, and follow-up period. During the screening period following signing of consent form participants will be evaluated for screening criteria and determined if they qualify for the study. During treatment period participants will be randomly assigned to either receive the combination of two immunotherapy drugs, nivolumab and ipilimumab for up to 2 years, or the two immunotherapy drugs with an additional targeted drug, cabozantinib, for up to 2 years unless your cancer gets worse or the side effects of the treatment become too severe. In the follow up period the side effects will be observed by the study team every 3 to 4 months for 2 years after treatment. The most common risks and discomforts expected in this study are diarrhea, nausea, vomiting, tiredness, weight loss, loss of appetite, changes in taste or voice, redness, pain or peeling of palms and soles, and high blood pressure which may cause blurred vision. There may not a benefit from joining the study. The head and neck cancer may improve while on this study but it may not, and it may even get worse. It will also help inform how well this combination treatment works at curing this type of cancer. The study results may be used to help others in the future.

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

Stryker PEEK Customized Implant: A Prospective Post Market Follow Up to Evaluate Safety, Performance and Effectiveness.

Date Added
September 23rd, 2024
PRO Number
Pro00136394
Researcher
Mark Miller

List of Studies

Keywords
Bone, Children's Health, Surgery
Summary

The primary objective of this study is to demonstrate the safety and effective use of Stryker's PEEK Customized Implants in patients receiving craniofacial (head and facial) surgery. Other objectives include using a CT scan to assist surgeons with providing a solution to complex and simple reconstruction challenges and reducing them to a single or two-stage procedure, thereby minimizing the overall surgery time and limiting the number of surgeries. Patient questionnaires and health information will be used during the study to demonstrate the safety and effectiveness of the implants. We will be enrolling ages 4 - 75 years old.

Institution
MUSC
Recruitment Contact
Monicagail Reyes
843-792-7333
reyesmo@musc.edu

A Research Study to Advance the CF Therapeutics Pipeline for People without Modulators

Date Added
September 18th, 2024
PRO Number
Pro00139279
Researcher
Patrick Flume

List of Studies


Keywords
Cystic Fibrosis
Summary

This is a prospective, longitudinal, multicenter, nonrandomized observational study to obtain research quality data across key outcome measures in people with Cystic Fibrosis who are ineligible and/or not taking a approved CFTR modulator and who are not receiving an investigational therapy.

Participants will be seen at study sites for research visits to include spirometry, patient reported outcomes (PROs), and blood collections on Day 0, Day 90 (3 months), Day 180 (6 months), and Day 360 (12 months). Participants will complete home spirometry as well during this period.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437920965
recruitment@musc.edu

A randomized, placebo-controlled, double-blind, multi-center study of the safety and efficacy of Niyad in patients undergoing continuous renal replacement therapy (CRRT) who cannot tolerate heparin or are at a higher risk for bleeding

Date Added
September 18th, 2024
PRO Number
Pro00135232
Researcher
Harold Szerlip

List of Studies

Keywords
Kidney
Summary

This is a research study to evaluate the safety and effectiveness of Niyad (nafamostat mesylate) as a blood thinner used during continuous renal replacement therapy (CRRT). CRRT is a standard treatment much like dialysis that is used to temporarily take the place of kidney function when one's kidneys are injured. Like your kidneys, CRRT helps to clean your blood and remove waste products.

Niyad is experimental which means that it is being tested and is not approved by the United States Food and Drug Administration (FDA). There is no guarantee that you will receive direct benefit as a result of your participation in this study. Possible benefits of Niyad include preventing your blood from clotting the dialysis filter so that the CRRT machine works more effectively and it also may reduce your need for a transfusion. The study results may help people in the future.

Participation voluntary and is expected to last up to 28 days. The length of time you may be exposed to Niyad is up to 7 days and safety assessments may last up to 28 days.

There will be no additional cost to you for procedures required in this research study. All routine clinical care that you would have undergone without participation in the study, including testing and procedures, will be billed to you/your insurance company. All study-related tests and procedures will be paid for by the Sponsor.

Some insurance plans will not pay for these services for people taking part in research studies. You will be responsible for any charges that your insurance does not cover including co-payments and deductibles.

Institution
MUSC
Recruitment Contact
Marcie Pregulman
(843) 792-8166
pregulma@musc.edu

Research and Evaluation of Nicotine-free Effects and Wellness

Date Added
September 17th, 2024
PRO Number
Pro00138934
Researcher
Amanda Palmer

List of Studies

Keywords
Smoking
Summary

While cigarette smoking is detrimental to health and a known risk factor for cancer, e-cigarettes are thought to be less harmful but not entirely risk-free, and less is known about e-cigarette use and changes to health. The purpose of the present study is to evaluate changes in health that may occur when people stop using e-cigarettes. Participants who use e-cigarettes (and who never smoked, smoked in the past, or currently smoke) will be recruited to participate in a laboratory session followed by a week of abstaining from any nicotine use. Throughout the study, participants will provide biological samples for analysis of DNA damage, immune functioning, inflammation, and respiratory functioning at the MUSC Charleston campus. Results will provide insight into the health benefits of quitting vaping.

Institution
MUSC
Recruitment Contact
Rachel Christian
(843)737-1516
chrisrac@musc.edu



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