Phase III Trial of Neoadjuvant Durvalumab (NSC 778709) plus Chemotherapy versus Chemotherapy Alone for Adults with MammaPrint Ultrahigh (MP2) Hormone Receptor (HR) Positive / Human Epidermal Growth Factor Receptor (HER2) Negative Stage II-III Breast Cancer

Date Added
March 5th, 2024
PRO Number
Pro00134455
Researcher
Abirami Sivapiragasam

List of Studies

Keywords
Cancer, Cancer/Breast, Drug Studies
Summary

This study is for patients that have been diagnosed with MammaPrint Ultrahigh (MP2) Hormone Receptor (HR) Positive / Human Epidermal Growth Factor Receptor (HER2) Negative Stage II-III breast cancer. The drug being used Durvalumab, Cyclophospharmide, Doxorubicin, and Paclitaxel. The study is being done to compare breast cancer event-free survival between patients randomized to standard of care neoadjuvant chamotherapy alone versus standard of care neoadjuvant chemotherapy concurrent with durvalumab.

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

Developing a method of reducing the strength of transcranial focused ultrasound (tFUS) to personalize treatment.

Date Added
March 5th, 2024
PRO Number
Pro00132894
Researcher
Mark George

List of Studies


Keywords
Vision/ Eye
Summary

Transcranial focused ultrasound (tFUS) is a new noninvasive way to stimulate the brain in an awake and alert person. We do not yet have an easily observable way to know whether we are in the right brain location with the correct dose for that person. We wonder if we can produce a transient change in someone's visual field, called a scotoma, and whether we can use that to determine the minimum tFUS dose for that person.

Institution
MUSC
Recruitment Contact
Bridgette Holland
843 876 5142
hollanbr@musc.edu

Correlation of photon Counting CT (PCCT) parameters with biomarkers in non-small cell lung cancer (NSCLC) surgical and biopsy specimens.

Date Added
March 5th, 2024
PRO Number
Pro00130202
Researcher
Dhiraj Baruah

List of Studies

Keywords
Cancer/Lung
Summary

The goal of this study is to help compare scans from the new photon counting CT scanner of a solid lung tumor with traditional lab and biopsy results. Subjects enrolled in this study will receive their normal CT scan on the new photon counting CT scanner that has the capacity to provide pictures that are better quality. These images will provide useful information that may lead to future improvements for patients with similar conditions.

Institution
MUSC
Recruitment Contact
Samuel Bidwell
843-792-2305
bidwells@musc.edu

A Randomized, Open-label, Phase 3 Study of Adjuvant Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physicians Choice in Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy

Date Added
March 1st, 2024
PRO Number
Pro00134328
Researcher
Frank Brescia

List of Studies


Keywords
Cancer, Cancer/Breast, Drug Studies, Women's Health
Summary

The study is for patients that have been diagnosed with TNBC (Triple Negative Breast Cancer). The treatment drugs being utilized are sacituzumab govitecan (Trodelvy) and pembrolizumab (Keytruda). The main purpose of this study is to determine if the combination of sacituzumab govitecan and pembrolizumab can improve outcomes and delay the return of disease in subjects with high-risk early TNBC. Subjects can expect to be in this study for up to 18 months.

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

A Phase III Randomised, Parallel-Group, Double-Blind, Placebo-Controlled, Two-Arm Study to Evaluate the Efficacy and Safety of Elafibranor 80 mg on Long-Term Clinical Outcomes in Adult Participants with Primary Biliary Cholangitis (PBC)

Date Added
February 26th, 2024
PRO Number
Pro00130418
Researcher
Don Rockey

List of Studies


Keywords
Digestive System, Drug Studies, Hepatology, Liver, Rare Diseases
Summary

The main goal of this study is to evaluate how well taking oral elafibranor 80 mg daily works, compared to a placebo, in reducing or preventing the occurrence of death, liver transplant, worsening of liver disease, and liver disease-related complications in adults with PBC.

Institution
MUSC
Recruitment Contact
Joshua Inman
(843) 876-4303
inmanj@musc.edu

Randomized, Placebo-Controlled, Multi-Site Trial of Extended-Release Naltrexone Injection/Bupropion XL Tablets in the Treatment of Methamphetamine Use Disorder

Date Added
February 14th, 2024
PRO Number
Pro00135002
Researcher
Susan Sonne

List of Studies


Keywords
Drug Studies, Substance Use
Summary

This study is designed to evaluate the safety and effectiveness of using a combination of two different medications (extended release naltrexone and bupropion) compared to matching placebo (an inactive substance) in the treatment of methamphetamine use disorder. Participants will undergo screening, and if eligible, will receive study medications along with brief medication management for twelve weeks, with follow up visits at weeks 14 and 16. The total study duration is around 19 weeks.

Institution
MUSC
Recruitment Contact
Elizabeth Chapman
864.898.2992
chapmanb@musc.edu

A Randomized Phase 3 Interim Response Adapted Trial Comparing Standard Therapy with Immunooncology Therapy for Children and Adults with Newly Diagnosed Stage I and II Classic Hodgkin Lymphoma.

Date Added
February 12th, 2024
PRO Number
Pro00133635
Researcher
Jacqueline Kraveka

List of Studies


Keywords
Cancer, Cancer/Lymphoma, Pediatrics
Summary

This study is for patients that have been diagnosed with early-stage (Stage I or II) Hodgkin lymphoma (HL)(cHL). The main purpose of this study is to compare the effects, good and/or bad, of brentuximab vedotin and nivolumab (Bv-NIVO) against standard therapy for people with HL to find out which is better. Participants can expect to be in the study for up to 54 months.

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

Phase III Randomized Trial of Immunotherapy with or without Consolidative Radiotherapy for Oligometastatic Head and Neck Squamous Cell Carcinoma

Date Added
February 12th, 2024
PRO Number
Pro00132402
Researcher
Bhishamjit Chera

List of Studies

Keywords
Cancer, Cancer/Head & Neck
Summary

In this study, the participants will take pembrolizumab for 24 months or get pembrolizumab plus a course of radiation therapy for 24 months until the cancer progresses. After the study treatment is finished, the study doctor will continue to follow the participants condition for a total of 3 years. Some risks in this study is that pembrolizumab with radiation may not be as good as the usual approach for cancer shirking or stabilizing. Some risks associated with pembrolizumab and radiation which are reduction in blood counts, mouth or throat pain and difficulty swallowing. The potential benefit of this study is that radiation and chemotherapy/pembrolizumab can be effective at shrinking or stabilizing the cancer. The purpose of this study is to compare using pembrolizumab with radiation to pembrolizumab without radiation.

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

A Phase 3 randomized, placebo-controlled, double-blind program to evaluate efficacy and safety of upadacitinib in adult and adolescent subjects with severe alopecia areata

Date Added
February 7th, 2024
PRO Number
Pro00132680
Researcher
Lara Wine Lee

List of Studies


Keywords
Adolescents, Skin
Summary

The purpose of this study is to evaluate the efficacy and safety of upadicitinib in adults and adolescents with severe alopecia areata. Participation in this research study will take approximately 168 weeks with 17 visits in that time. This research study includes three phases; a screening phase, treatment phase, and a follow-up phase. The length of the screening period varies from 1 to 35 days, depending on therapies that must be washed out or discontinued before initiation of treatment. Patients who meet all eligibility criteria will be randomized to receive upadicitinib or placebo for the first 24 weeks. At week 24, all patients will receive upadicitinib until week 160. The post-treatment follow-up visit will occur approximately 30 days after the last study drug dose.

Institution
MUSC
Recruitment Contact
Devyn Spino
843-876-2281
spino@musc.edu

Determinants of performance in cochlear implant listeners

Date Added
February 6th, 2024
PRO Number
Pro00133091
Researcher
Kelly Harris

List of Studies


Keywords
Hearing
Summary

This project examines how to improve speech understanding with cochlear implants (CIs), particularly for older CI recipients. While older individuals benefit from CI technology, performance is poorer than that of younger implanted adults for difficult listening tasks. The mechanisms that contribute to this variability are not well-understood. The current project examines how differences in brain structure and function may contribute to success with a cochlear implant. To compare, we will also be examining how older patients without cochlear implants understand speech in difficult listening situations.

Institution
MUSC
Recruitment Contact
Kelly Harris
8437922061
harriskc@musc.edu



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