Testing a Scalable Model of Care to Improve Patients' Access to Mental Health Services after Traumatic Injury

Date Added
May 3rd, 2022
PRO Number
Pro00112776
Researcher
Kenneth Ruggiero

List of Studies


Keywords
Depression, Mental Health
Summary

Each year, roughly 600,000 patients served in U.S. trauma centers develop posttraumatic stress disorder or depression after traumatic injury, but few receive mental health follow-up care. The Trauma Resilience and Recovery Program is a sustainable, stepped-care model that has addressed the mental health needs of over 8,000 patients in four Level I-II trauma centers and is being adopted by 8 additional trauma centers in the Carolinas. This study will examine the effectiveness and implementation of TRRP with a diverse sample of 350 patients served at The George Washington University hospital.

Institution
MUSC
Recruitment Contact
Olivia Eilers
(843) 792-0979
eilerso@musc.edu

A Phase Ib Trial of Zanubrutinib in Combination with R-PolaCHP (ZaR-PolaCHP) for Patients with Newly Diagnosed Diffuse Large B-Cell Lymphoma

Date Added
April 26th, 2022
PRO Number
Pro00119556
Researcher
Brian Hess

List of Studies


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

This study is for subjects that have been newly diagnosed with diffuse large B cell lymphoma (DLBCL). This study is testing an "investigational" (not yet approved by the Food and Drug Administration (FDA)) combination of the drug zanubrutinib (BRUKINSA™) and a standard chemotherapy treatment called R-CHOP. This study will test the how well the drug combination works and how safe it is. The subject will be given the study drug combination in 21 day cycles. At any given visit, the subject may undergo procedures, such as a physical exam, blood samples, bone marrow biopsies, and imaging scans. The subject may remain in the study for up to approximately 2 years.

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

WATCHMAN FLX versus NOAC for EMbolic ProtectION in the management of patients with Non-Valvular Atrial Fibrillation (CHAMPION-AF)

Date Added
April 26th, 2022
PRO Number
Pro00116671
Researcher
Loren Morgan

List of Studies

Keywords
Cardiovascular, Heart, Vascular
Summary

This study will compare WATCHMAN FLXTM ("DEVICE") to a category of OAC called non-vitamin K antagonist oral anticoagulation, also known as NOACs ("CONTROL"). NOAC medications include Pradaxa® (dabigatran), Eliquis® (apixaban), Xarelto® (rivaroxaban), or Savaysa® (edoxaban).The study will research the safety and effectiveness of the WATCHMAN FLXTM device compared to treatment with NOAC therapy to determine if it works for patients with your type of atrial fibrillation who require treatment for potential blood clot formation (thrombus) in the LAA.

Institution
MUSC Health Columbia Medical Center
Recruitment Contact
Jacqueline Sheriod-Scott
803-255-2927
sheriods@musc.edu

Ganciclovir to Prevent Reactivation of Cytomegalovirus in Patients with Acute Respiratory Failure and Sepsis

Date Added
April 20th, 2022
PRO Number
Pro00113274
Researcher
Andrew Goodwin

List of Studies


Keywords
Pulmonary
Summary

The purpose of this research is to find out if a drug called ganciclovir can prevent cytomegalovirus (CMV) reactivation, in which the virus wakes up from an inactive state, in patients with respiratory failure associated with severe sepsis. In order for you to take part in this study, we verified that you also have previously had an infection with a virus called Cytomegalovirus (CMV). Ganciclovir is an FDA approved drug that has been widely used for the prevention and treatment of CMV in patients with weakened immune systems. A total of 482 patients will be enrolled in this study at sites throughout the US.

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

3D-Printed versus Laboratory-Fabricated Hyrax Expanders: A Randomized Controlled Clinical Trial

Date Added
April 19th, 2022
PRO Number
Pro00115646
Researcher
Ildeu Andrade

List of Studies

Keywords
Children's Health, Dental
Summary

Maxillary expanders are orthodontic appliances that are commonly used to expand the upper jaw. The purpose of this study will be to compare the effects produced by two different maxillary expanders in children 8-13 years old. The first type of expander is made by hand in an orthodontic laboratory, and the second type of expander is designed on a computer and printed using 3D printers. Both expanders are already used in the MUSC Orthodontics Clinic. The purpose of this study is to see if the 3D printed expander is as effective as the traditional expander made by hand in the laboratory, with more comfort to the patient. Patients participating in the study will be randomly assigned to one of two groups: group A will be treated with a laboratory-made maxillary expander, and group B with a 3D-Printed maxillary expander. Information will be collected on the participants' standard clinical follow-up visits including photos, x-rays, and dental photo scans over the course of 6 months to see how the expander is working. In addition, as part of the research study, the participant will be asked to complete online questionnaires with assistance from parents or guardians about his/her quality of life and perception of possible pain and discomfort at different time points. The potential benefits of this study include the use of 3D technology to improve the quality of the orthodontic treatment, with more comfort to the patient.

Institution
MUSC
Recruitment Contact
Ildeu Andrade
843-792-3913
andradei@musc.edu

A Randomized Controlled Trial of Women Involved in Supporting Health (WISH), a Peer-Led Intervention to Improve Postpartum Retention in HIV Care

Date Added
April 18th, 2022
PRO Number
Pro00118631
Researcher
Gweneth Lazenby

List of Studies


Keywords
Obstetrics and Gynecology
Summary

The purpose of the study is to learn more about programs that can improve the health and wellbeing of mothers and their babies during the period after delivery. Women living with HIV experience diverse health problems in the period directly after delivery.

Institution
MUSC
Recruitment Contact
Jesslyn Payne
843-792-7525
paynej@musc.edu

A Phase 2, Double-blind, Randomized, Placebo controlled Study to Evaluate the Effects of Sotatercept versus Placebo for the Treatment of Combined Postcapillary and Precapillary Pulmonary Hypertension (Cpc-PH) due to Heart Failure with Preserved Ejection Fraction (HFpEF)

Date Added
April 12th, 2022
PRO Number
Pro00119299
Researcher
Daniel Silverman

List of Studies

Keywords
Heart, Pulmonary Hypertension, Shortness of Breath
Summary

The purpose of the study is to evaluate the safety and how well the medication sotatercept works versus placebo in treating Heart Failure with a Preserved Ejection Fraction. The study will also look at information obtained from the tests performed as part of the study to see if subjects have improvement in symptoms of heart failure. Participation in this study will last approximately 26 months. During the study period subjects will be asked to attend regular study visits with the research coordinator. These visits will include such activities as blood tests, questionnaires, physical evaluation by a study doctor, a right heart catheterization with exercise, echocardiogram, and 6 minute hall walks. There will be 35 visits as part of participation in this clinical trial.

Participants will be randomized to either the treatment group (and receive the medication) or the control group (and not receive the medication). Subjects will have a 66:33 chance of receiving the study medication during their participation in the trial. 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 personnel will know which group subjects are in. Neither the subject nor the study doctor will decide what group subjects are assigned.

Institution
MUSC
Recruitment Contact
Melissa Lamicq
843-876-5783
lamicq@musc.edu

Enhanced Study Recruitment for Stroke Survivors through Longitudinal Data Collection in Multiple Domains

Date Added
April 5th, 2022
PRO Number
Pro00119024
Researcher
Alyssa Chesnutt

List of Studies

Keywords
Military, Rehabilitation Studies, Stroke, Stroke Recovery
Summary

People who experience a stroke often have problems performing many different tasks during daily life. Most studies investigating stroke recovery and rehabilitation focus only on one type of task. The purpose of this research study is to measure individuals' function in many areas that can be affected by a stroke, such as their balance, mood, memory, reaching, and speech. This study will also track changes that can occur with task performance over time.

Institution
MUSC
Recruitment Contact
Alyssa Chesnutt
843-792-8171
hydar@musc.edu

Targeted spinal cord plasticity for alleviating SCI-related neuropathic pain

Date Added
April 5th, 2022
PRO Number
Pro00118771
Researcher
Aiko Thompson

List of Studies


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

The purpose of this study is to examine the relationship between reflexes in the leg and the presence of neuropathic pain. The researchers are recruiting 30 individuals with spinal cord injury (SCI) total, 15 individuals with neuropathic pain due to SCI and 15 individuals without neuropathic pain. For this portion of the study, there are 2 visits. The first visit will examine cutaneous reflexes in the leg. During the second visit, the study team will assess sensation in the leg and administer questionnaires about pain, functioning, and quality of life.

The purpose of the second part of the study is to examine the effect of reflex training in the leg to decrease neuropathic pain. For this, the researchers are recruiting 15 individuals with neuropathic pain due to spinal cord injury to participate in the reflex training procedure. The study involves approximately 50 visits with a total study duration of about 6.5 months (3 months for baseline and training phases followed by 1 month and 3 month follow-up visits).

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

Community use of wearable wrist stimulation device

Date Added
April 5th, 2022
PRO Number
Pro00118317
Researcher
Na Jin Seo

List of Studies


Keywords
Cerebral Palsey, Stroke, Stroke Recovery
Summary

Sensory stimulation has been shown to enhance rehabilitation outcomes. However, most sensory stimulation devices interfere with natural hand tasks. Thus, a new wearable stimulation device has been developed to deliver imperceptible vibration to wrist skin. This study is to evaluate the community use of the device for patients with neurologic movement disorders. Participation will include wearing the provided device and charging the device every night. The knowledge regarding community use of the device may contribute to improving the device functionality and usability for future users of the device.

Institution
MUSC
Recruitment Contact
Na Jin Seo
8437920084
seon@musc.edu



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