A Phase 3, Randomized Study of CG0070 versus Observation for the Treatment of Intermediate Risk Non-Muscle Invasive Bladder Cancer (IR-NMIBC) Following Transurethral Resection of Bladder Tumor

Date Added
November 7th, 2024
PRO Number
Pro00137188
Researcher
Robert Grubb

List of Studies


Keywords
Cancer, Cancer/Genitourinary, Drug Studies
Summary

The study is for patients that have been diagnosed with bladder cancer. Cretostimogene Grenadenorepvec is the study drug that is being utilized. The primary purpose is to evaluate the recurrence free survival (RFS) of transurethral resection of bladder tumor (TURBT) followed by cretostimogene versus TURBT followed by observation in participants with intermediate-risk non-muscle invasive bladder cancer (IR-NMIBC). The subject may remain in the study for up to 24 months. They may receive additional treatment beyond 24 months if they are tolerating and showing benefit from the treatment.

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

Impacts of drug abuse-mediated inflammatory perturbations on affinity maturation of anti-CD4 autoantibodies and poor immune reconstitution from ART in HIV

Date Added
November 6th, 2024
PRO Number
Pro00140552
Researcher
Wei Jiang

List of Studies


Keywords
Drug Studies, HIV / AIDS
Summary

This study is to understand HIV-infected cocaine users have poor immunity after anti-HIV treatment, but HIV-infected cannabis users are likely different. Cocaine use always is associated high inflammation and cannabis use is associated with low inflammation. We study how inflammation cannot be controlled in cocaine users; our goal is to develop new therapies to help cocaine users to have a better health and immunity.

Institution
MUSC
Recruitment Contact
Wei Jiang
8438762457
jianw@musc.edu

A PHASE III, OPEN-LABEL, MULTICENTER, RANDOMIZED STUDY EVALUATING GLOFITAMAB AS A SINGLE AGENT VERSUS INVESTIGATOR'S CHOICE IN PATIENTS WITH RELAPSED/REFRACTORY MANTLE CELL LYMPHOMA

Date Added
November 6th, 2024
PRO Number
Pro00135996
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 diagnosed with mantle cell lymphoma that has spread and has not responded to treatment. This study is testing an "investigational" (not yet FDA approved) study drug called glofitamab. The purpose of this study is to compare the effects, good or bad, of glofitamab (experimental arm) versus bendamustine plus rituximab (BR) or rituximab plus lenalidomide (R-Len;the control arm) on subjects with relapsed/refractory mantle cell lymphoma. Your total time in the study and the number of assessments in the follow up visits, will depend on how your MCL responds to study treatment. This could range from 1 day to more than 24 months. The screening period may last up to 28 days (4 weeks) and may involve more than one visit to the clinic.

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

Developing brain imaging biomarkers to quantify the effects of at-home taVNS treatment in ASD

Date Added
November 5th, 2024
PRO Number
Pro00140411
Researcher
Xiaolong Peng

List of Studies


Keywords
Adolescents, Anxiety, Autism
Summary

The purpose of this study is to explore whether a non-invasive form of ear stimulation called transcutaneous auricular vagus nerve stimulation (taVNS) can manage symptoms in patients with autism spectrum disorder (ASD). Additionally, this study also uses magnetic resonance imaging (MRI) to capture images of participants' brains and apply an image processing method called INSCAPE to track brain state changes during taVNS treatment in ASD. We will recruit up to 16 participants with ASD.

Institution
MUSC
Recruitment Contact
Nicole Cash
843-792-9502
cashni@musc.edu

Prospective Placebo-Controlled Trial of Intramuscular Steroid Administration for the Treatment of Unexplained Chronic Cough

Date Added
November 5th, 2024
PRO Number
Pro00140403
Researcher
Lauren Howser

List of Studies

Keywords
Throat
Summary

This study is being done to see if injections in different locations can help to minimize chronic cough. This is done through the injection of an anti-inflammatory medication (steroid) into your upper arm muscle. The procedure takes less than 5 minutes. There has not yet been a study completed using arm muscle injections. The safety profile of arm muscle injections is expected to be the same as the superior laryngeal nerve (SLN) injection which is in the neck is already used at MUSC in regular practice. This is the same medication and the same dosage as the arm injection in this study. By better understanding if this treatment helps improve chronic cough, an additional treatment option could be utilized for this patient population. SLN injections are usually only performed by fellowship trained laryngologists (an extra specialized year of training after ENT residency). However, if arm muscle injections are found to be equivalent in treating chronic cough, general ENT physicians could likely provide this treatment to their patients without the need to see a specialized laryngologist. This study will evaluate safety and effectiveness of the arm muscle injection. Steroids are investigational for the purpose of this study.

Institution
MUSC
Recruitment Contact
Kirsten Meenan
843-792-6755
meenan@musc.edu

Integrated Treatment for Opioid Use Disorder and PTSD

Date Added
November 5th, 2024
PRO Number
Pro00138487
Researcher
Tanya Saraiya

List of Studies

Keywords
Mental Health, Psychiatry, Substance Use
Summary

This study will test a therapy intervention, HOPE, for individuals with opioid use disorder and postttraumatic stress disorder. Interested individuals will need to be taking medications for opioid use disorder (e.g., suboxone, naltrexone, methadone). Interested participants will complete a 10-12 week therapy, and be asked to complete surveys.

Institution
MUSC
Recruitment Contact
Tanya Saraiya
347-961-8252
pathlab@musc.edu

Atomoxetine Effect on Attention, Executive Function, and Quality of Life in Veterans with Posttraumatic Stress Disorder

Date Added
November 5th, 2024
PRO Number
Pro00137933
Researcher
Zhewu Wang

List of Studies


Keywords
Psychiatry, Stress Disorders
Summary

The purpose of this research study is to determine the effectiveness of Atomoxetine, a medication approved for attention deficit hyperactivity disorder (ADHD), in improving quality of life as well as attention and mental skills such as memory, daily planning, and impulse control in Veterans with ADHD and post-traumatic stress disorder (PTSD). Reduced attention span, concentration difficulties, impaired inhibition and decision-making abilities, and memory problems are all symptoms of ADHD, and may be a factor in the current issue of PTSD treatment-resistance. Therefore, this study is aimed to examine the effect of atomoxetine on attention and executive function, which may lead to a significant improvement in overall ADHD and PTSD outcomes.

Institution
MUSC
Recruitment Contact
Maria Rafferty
8433371418
raffertr@musc.edu

A Multi-center, Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of Solriamfetol in Excessive Sleepiness Associated with Shift Work Disorder

Date Added
November 1st, 2024
PRO Number
Pro00138871
Researcher
Thomas Uhde

List of Studies


Keywords
Sleep Disorders
Summary

The study is designed to look at the usefulness and safety of Solriamfetol (versus placebo) for the treatment of excessive sleepiness associated with shift work disorder (SWD). Study staff nor the participants will know if they are receiving a study drug or placebo. Participants will be male or female subjects 18-65 years old with a diagnosis of SWD. The study will last approximately 17 weeks, with 6 in-person visits and 8 remote visits for each participant.

Institution
MUSC
Recruitment Contact
Jelissa Suarez
843-876-9262
suarezj@musc.edu

Phase 3 Randomized Open-label Study of Adjuvant Pembrolizumab W/WO MK2870 in Resectable Stages II-IIIB(N2) NSCLC for Patients not AchievingpCR After Receiving Neoadjuvant Pembrolizumab with Platinum-Based Doublet Chemotherapy Followed by Surgery

Date Added
October 31st, 2024
PRO Number
Pro00138712
Researcher
Mariam Alexander

List of Studies

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

This research study is testing a new treatment plan for patients with a type of lung cancer that can be surgically removed. The study focuses on patients who have not had complete success with initial treatments before surgery. The treatment plan includes a combination of chemotherapy and a drug called pembrolizumab before surgery, followed by surgery to remove the cancer, and then more pembrolizumab with or without another drug called MK-2870 after surgery.

The goal is to see if adding MK-2870 can help improve the chances of recovery and prevent the cancer from coming back in patients who didn't respond fully to the initial treatment. This study aims to find better ways to treat lung cancer and improve the survival rates of these patients.

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

Safety and Efficacy of Workflows of High-Volume Single Operators in a Left Atrial Appendage Occlusion Device Implant Procedural Day: SAFE HV

Date Added
October 30th, 2024
PRO Number
Pro00137571
Researcher
Loren Morgan

List of Studies

Keywords
Cardiovascular, Heart, Vascular
Summary

The purpose of this research is to gather information about the effectiveness and safety of Left Atrial Appendage Occlusion (LAAO) device procedures in patients using a Watchman device performed on days where doctors perform a large number of procedures.

The study primary outcome is to evaluate complications during the procedure up to 30 days after the procedure.

The final outcome is to determine successful placement within 31 - 90 days after implant.

Institution
MUSC Heart and Vascular Institute
Recruitment Contact
Jacqueline Sheriod-Scott
8032552927
sheriods@musc.edu



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