A Randomized Phase II Trial of Consolidation Therapy Following CD19 CAR T-Cell Treatment for Relapsed/Refractory Large B-Cell Lymphoma or Grade IIIB Follicular Lymphoma

Date Added
March 23rd, 2023
PRO Number
Pro00127531
Researcher
Brian Hess

List of Studies


Keywords
Cancer/Lymphoma
Summary

This is a study for patients with relapsed/refractory large B-cell lymphoma or follicular lymphoma. Patients who have either stable disease or a partial response to CD19 CAR T-Cell therapy may be eligible. The purpose of the study is to compare groups of patients who either receive therapy after CAR T-cells and patients that do not receive further therapy after CAR T-cells.

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

A Phase III, Randomized, Open-Label, Multicenter Study of Lurbinectedin in Combination with Atezolizumab Compared with Atezolizumab as Maintenance Therapy in Participants with Extensive Stage Small-Cell Lung Cancer (ES-SCLC) Following First-Line Induction Therapy with Carboplatin, Etoposide and Atezolizumab

Date Added
March 27th, 2023
PRO Number
Pro00118564
Researcher
Mariam Alexander

List of Studies

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

This study is for patients that have been diagnosed with extensive-stage small-cell lung cancer (ES-SCLC). The investigational drug in this study is lurbinectedin. Investigational means it is not yet approved by the Food and Drug Administration (FDA). The purpose of this study is to compare the effects, good or bad, of lurbinectedin in combination with atezolizumab versus atezolizumab alone in participants with ES-SCLC. Atezolizumab is already approved for treatment of ES-SCLC.

There are two phases of treatment. During the induction phase of the treatment, participants will receive 4 cycles of carboplatin, etoposide, and atezolizumab. One treatment cycle is 3 weeks long. During the maintenance phase of the treatment, participants will be placed in one of the following treatment groups: Arm A will receive atezolizumab and lurbinectedin given as an infusion (into the vein) on Day 1 of each 21-day cycle; Arm B will receive atezolizumab given as an infusion (into the vein) on Day 1 of each 21-day cycle.

During this study, participants will have visits approximately every 3 weeks while receiving treatment. Visits may last 3-6 hours. After the final dose, the study doctor will follow up about every 3 months. The total time in the study will depend on how the ES-SCLC responds to treatment. This could range from 1 day to more than 4 years.

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

A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of BIIB122 in Participants with Parkinson's Disease

Date Added
March 28th, 2023
PRO Number
Pro00123124
Researcher
Christine Cooper

List of Studies


Keywords
Parkinsons
Summary

This study will help determine the safety and effectiveness of BIIB122, compared to placebo (an inactive substance), in people with early-stage Parkinson's disease. The use of BIIB122 in this study is investigational. "Investigational" means that the study drug is currently being tested and is not approved by the U.S. Food and Drug Administration (FDA) or any other health authorities around the world for treating people with PD. The study is expected to last a minimum of 1 year to a maximum of 3 years. You may or may not receive direct medical benefit from participating in this study. Your condition may get better, worse, or stay the same. The information obtained from this study, however, could help other patients with your disease in the future.

Institution
MUSC
Recruitment Contact
Sandra Wilson
8437924616
wilsosan@musc.edu

Exploring the Burn Wound Microbiome Using Next Generation Sequencing Technology

Date Added
April 4th, 2023
PRO Number
Pro00123277
Researcher
Deepak Ozhathil

List of Studies

Keywords
Surgery
Summary

Exploring the Burn Wound Microbiome Using Next Generation Sequencing Technology study is designed to learn more about the microorganisms (bacteria and fungi such as yeast) that are present in traumatic burn wounds. We wish to learn how the make up of microbes differ between the wounded and uninjured skin. Currently, if a doctor wants to know which organisms exist in a burn wound, they would need to send a sample of the wound surface to be grown on a petri dish. Ultimately this system takes too long and may not identify all the organisms that may affect wound healing and as a result this method is no longer used for most burn wounds at most burn centers. Our study proposes to bridge this knowledge gap by using newly available techniques collectively referred to as "Next Generation Sequencing technology" or NGS for short. NGS has the potential to provide more detailed and accurate information about the make up of the burn wound and has already been used as a tool in other parts of healthcare. The information gained from this study may potentially improve the care of future burn patients.

Institution
MUSC
Recruitment Contact
Deepak Ozhathil
5086548246
ozhathil@musc.edu

Pediatrics Biorepository to Support Cardiology Clinical Research

Date Added
April 9th, 2023
PRO Number
Pro00124741
Researcher
Eric Graham

List of Studies


Keywords
Cardiovascular, Heart
Summary

This proposal is to contribute to data registry and sample bank called Pediatrics Biorepository for Cardiology Clinical Research. Samples collected in this study may be used for future research which plan to advance the state of science in the hopes to develop new ways to diagnose and treat children affected with heart conditions.

Institution
MUSC
Recruitment Contact
Eric Graham
843-792-9570
grahamem@musc.edu

A Multicenter, Adaptive, Randomized, Controlled Trial Platform To Evaluate Safety and Efficacy of Strategies and Treatments for Hospitalized Patients with Respiratory Infections

Date Added
April 12th, 2023
PRO Number
Pro00126098
Researcher
Andrew Goodwin

List of Studies


Keywords
Coronavirus, Critical Care
Summary

The protocol aims to improve standard of care, by ensuring an agile research infrastructure, with an ability to rapidly assess interventions during epidemic transmission of one or more respiratory pathogens adversely affecting public health.

Trials within this protocol can be adaptive, will be randomized, and will have superiority as the primary objective. Comparisons in the trials may be between an unlicensed agent to a blinded placebo plus standard of care (SOC), between an approved off-label agent to a blinded placebo plus SOC, among several active interventions (blinded or non-blinded; i.e., a comparative effectiveness study), or among different treatment strategies.

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

Utility and Histologic Effects of the J-Tip Device in Dermatologic Conditions Requiring Local Anesthesia

Date Added
May 2nd, 2023
PRO Number
Pro00107787
Researcher
Lara Wine Lee

List of Studies


Keywords
Cancer/Skin, Skin
Summary

This project is a pilot study to determine if use of the J-Tip Needle-Free Injection System, used to administer local anesthesia, has any effects on the appearance of skin samples when viewed under a microscope compared with skin samples that have been injected with local anesthesia using a needle. If use of the J-Tip device for local anesthesia delivery is shown not to alter the microscopic appearance of skin, anesthesia for skin biopsies in the future may potentially be performed without a needle, allowing for less fear and pain.

Institution
MUSC
Recruitment Contact
Lara Wine Lee
(843) 792-3021
winelee@musc.edu

A randomized controlled trial of smell training and trigeminal nerve stimulation in the treatment of COVID-related persistent smell loss

Date Added
May 2nd, 2023
PRO Number
Pro00127790
Researcher
Bernadette Cortese

List of Studies


Keywords
Coronavirus, Nervous System, Nose, Psychiatry
Summary

Persistent smell loss that can include diminished or distorted smell function is a common symptom of long COVID syndrome. There are limited treatment options for long COVID-related smell loss. Our study aims to determine the efficacy of two at-home treatments, smell training and non-invasive trigeminal nerve stimulation. This study requires participants to conduct daily at-home treatment sessions, attend three in-person study visits at the MUSC Department of Psychiatry and Behavioral Sciences, and complete electronic questionnaires over the 12-week trial, and again at the six-month timepoint. Participants in this trial may benefit directly with an improvement in sense of smell. However, participation may also help society more generally, as this study will provide new information about long COVID-related smell loss and its treatment.

Substudy

Long COVID syndrome has been associated with cognitive impairment and may be related to affected emotional regulation. This study will use a electroencephalography (EEG) to examine how the body and brain responses to emotional cues in participants who are currently undergoing treatment for COVID-related smell loss. Participation will aid in the understanding of how emotional processing in long COVID is impacted by treatment for related smell loss.

Institution
MUSC
Recruitment Contact
Mary Clare Koebel
843-790-3449
scent-4-longcovid@musc.edu

Impact of stress and craving on return to cannabis use in postpartum women

Date Added
May 2nd, 2023
PRO Number
Pro00128029
Researcher
Constance Guille

List of Studies


Keywords
Drug Studies, Hormones, Non-interventional, Pregnancy, Substance Use, Women's Health
Summary

Cannabis is the most commonly used illicit substance among pregnant and postpartum women, with the postpartum period being a common time for relapse to cannabis. Currently there are no interventions for preventing return to cannabis use during this vulnerable time. The goal of this research is to better understand risk factors such as stress, craving, anxiety, mood, sleep, and hormone levels that may contribute to return to cannabis use during the postpartum period in order to help develop targeted prevention and treatment interventions in the future.

Institution
MUSC
Recruitment Contact
Lisa Nunn
843-792-0476
jenkinli@musc.edu

A Randomized Trial of Cryoprobe Versus Forceps for Transbronchial Biopsy (FROSTBITE-2)

Date Added
May 9th, 2023
PRO Number
Pro00124571
Researcher
Christopher Gilbert

List of Studies

Keywords
Cancer, Lung, Pulmonary
Summary

This study is for patients scheduled for a bronchoscopy procedure for evaluation of lung transplantation, lung disease, and lung nodules. Those who give consent to participate in this study will be randomized into one of two lung biopsy sampling method groups: Group 1) 1.1 mm single-use Cryoprobe or Group 2) conventional 2.0 mm forceps. These devices are used with a bronchoscope to obtain lung tissue biopsy samples and are being evaluated to determine which is better for confirming a diagnosis. All procedures will be done via standard of care and screening will be accomplished via medical chart review. Subjects will have two in-person appointments and one follow-up telephone call. The first of which is their standard of care office visit with the doctor to go over their plan of care. The second visit is for the standard of care bronchoscopy procedure to obtain biopsy samples. Thirty days following the procedure, a member of the study team will call the subject to assess whether any adverse events may have occurred since the procedure.

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



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