A Phase III Prospective Randomized Trial Of Dose-Escalated Radiotherapy With Or Without Short-Term Androgen Deprivation Therapy For Patients With Intermediate-Risk Prostate Cancer

Date Added
August 19th, 2013
PRO Number
Pro00027510
Researcher
David Marshall

List of Studies


Keywords
Cancer, Cancer/Genitourinary, Drug Studies, Men's Health, Prostate
Summary

This study is for patients with prostate cancer. The purpose of this study is to compare the effects of dose-escalated radiation therapy with or without hormone therapy on your prostate cancer.
There are 2 treatment groups in this study:
1) Patients who receive radiation therapy only
2) Patients who receive radiation therapy plus hormone therapy
Patients will receive 44 radiation treatments over approximately 2 months. If the patient chooses to receive the brachytherapy implant, he will receive 25 daily treatments plus the implant procedure over a timeframe of approximately 6 weeks. Hormone therapy, if given, will last 6 months. After patients are finished receiving therapy, the study doctor will ask them to visit the office for follow-up exams at 3, 6, 9, and 12 months after finishing radiation treatment, every 6 months for 4 years, and yearly thereafter.

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

Developing a Novel rTMS Intervention for Transdiagnostic Psychosocial Rehabilitation: A Dose-finding Study

Date Added
October 2nd, 2018
PRO Number
Pro00082315
Researcher
Lisa McTeague

List of Studies


Keywords
Anxiety, Depression
Summary

The goal of this work is to identify the most efficacious dose for a high-dose, short-term brain stimulation intervention for anxiety and depression in veterans.

Institution
MUSC
Recruitment Contact
Lisa McTeague
8437928274
mcteague@musc.edu

Age-related changes in neuroplasticity impede recovery in post-stroke depression: a novel exercise and brain stimulation paradigm to prime neuroplastic potential

Date Added
December 4th, 2018
PRO Number
Pro00083079
Researcher
Ryan Ross

List of Studies

Keywords
Brain, Depression, Exercise, Stroke, Stroke Recovery
Summary

Stroke affects millions of Americans and is a leading cause of disability. In addition to chronic disability, many survivors experience depressive symptoms such as reductions in mood and motivation. Post-stroke depression (PSD) is associated with poorer recovery from stroke, increased health care costs and higher mortality. Additionally, PSD may interfere with the recovery of the nervous system after stroke. Effective treatment options for PSD are limited and often come with side effects, highlighting the need for alternative treatment approaches. Aerobic exercise (AEx) has positive effects on the nervous system, is a powerful anti-depressant, and has limited side effects, yet remains underutilized in stroke survivors with PSD. This study will examine the short-term effects of AEx on the nervous system in stroke survivors with and without PSD. The results will serve as a foundation for the study of AEx as a treatment for PSD.

Institution
MUSC
Recruitment Contact
Ryan Ross
843-792-3477
rossre@musc.edu

Accelerated Repetitive TMS for Affective Dysfunction: Establishing the Dose-Response Curve

Date Added
January 4th, 2019
PRO Number
Pro00084111
Researcher
Lisa McTeague

List of Studies


Keywords
Anxiety, Depression
Summary

The goal of this work is to identify the most efficacious range of doses and targeting location for a short-term (i.e., 1 week) course of high-dose brain stimulation for major depression.

Institution
MUSC
Recruitment Contact
Lisa McTeague
843-792-8274
mcteague@musc.edu

Evaluation of Trauma Center-Based, Technology-Enhanced Stepped Care Intervention for Adolescent Traumatic Injury

Date Added
August 3rd, 2021
PRO Number
Pro00111879
Researcher
Tatiana Davidson

List of Studies


Keywords
Adolescents, Mental Health
Summary

Pediatric traumatic injury is the leading cause of death and morbidity among US adolescents and are associated with mental health and health risk outcomes, including posttraumatic stress and depression, deficits in physical recovery, social functioning and quality of life, which if unaddressed, may contribute to increased use of health care services. In 2015 our team launched the Trauma Resilience and Recovery Program (TRRP) at Medical University of South Carolina, a scalable and sustainable, technology-enhanced, multidisciplinary stepped model of care – one of the few in the US - that provides early intervention and direct services to improve access to evidence-based mental health care after traumatic injury for children, adults and families. We have found this model of care to be feasible and acceptable to adolescent patients (ages 12-17) at each level of service. TRRP includes 3 major steps: (1) in-hospital education, brief risk reduction session, and tracking patients' emotional recovery via an automated text-messaging system, (2) a 30-day screen via telephone to identify patients who are good candidates for psychological treatment, and (3) providing referral to best-practice telehealth-based or in-person assessment and treatment. We have partnered with three accredited Level I and II pediatric trauma centers, Prisma-Health Upstate, Children's of Alabama, and Boston Children's Hospital, and propose a multi-site hybrid 1 effectiveness-implementation randomized controlled trial with 300 adolescent (ages 12-17) traumatic injury patients to assess the extent to which TRRP promotes improvement in quality of life and emotional recovery and gather preliminary data on the potential for TRRP to be implemented in other Level I trauma centers. This study will provide valuable data on the efficacy, preliminary effectiveness and potential for implementation of an innovative, cost-effective, sustainable technology-enhanced intervention designed to address the unique needs of adolescent injury patients and mitigate short- and long-term impact of injury on mental health, quality of life, and overall well-being.

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

Can increasing motor evoked potential size improve upper extremity motor function in individuals with incomplete spinal cord injury?

Date Added
September 7th, 2021
PRO Number
Pro00113108
Researcher
Blair Dellenbach

List of Studies

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

The purpose of this study is to examine the relationship between common clinical assessments and measurements of the function of brain-spinal cord-muscle connections. For examining brain-to-muscle pathways, we use a transcranial magnetic stimulator. This stimulator produces a magnetic field for a very short period of time and indirectly stimulates brain cells with little or no discomfort. We hope that the results of this training study will help us in developing therapy strategies for individuals, better understanding clinical assessments, and understanding treatments that aim to improve function recovery in people with SCI.

There are 2 aims for this study. The purpose of the first is to examine the relationship between assessments commonly used in therapy and doctor's offices (clinical assessments) and measurements of the function of brain-spinal cord- muscle connections. This will require 2 visits, and each visit will last approximately 2 hours.

The purpose of the second aim is to examine the effects of training on brain-spinal cord-muscle response. This will require 30 visits, and each visit will last approximately 1.5 hours.

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

Mindfulness and Neurosurgery

Date Added
November 9th, 2021
PRO Number
Pro00108093
Researcher
Alejandro Spiotta

List of Studies


Keywords
Anxiety, Stress Disorders
Summary

Mindfulness is a third wave psychotherapy that has been shown to improve focus and decrease stress and burnout in healthcare professionals. Unfortunately, no study to date has assessed the efficacy of combatting burnout and stress while also improving intraoperative focus in one of the specialties with the highest rate of burnout, neurosurgery. The lengthy time requirements of previous mindfulness interventions are not amenable to the variable schedule of a neurosurgeon. Therefore, the construction of a mindfulness intervention that is short, yet effective is essential to the proper integration of mindfulness into the workflow of neurosurgeons. The purpose of this study is to assess the efficacy of a brief mindfulness intervention on decreasing burnout and stress while improving focus in the operating room.

Institution
MUSC
Recruitment Contact
Meredith Robinson
843-792-3164
robme@musc.edu

Immunobiology of Influenza Critical Illness in Young People (PICFLU2)

Date Added
November 24th, 2021
PRO Number
Pro00112536
Researcher
Sara Rhodes Proctor Short

List of Studies

Keywords
Infectious Diseases, Pediatrics
Summary

The Pediatric Intensive Care Influenza Study #2 (PICFLU2) is a multiyear, multicenter prospective observational study in patients aged ≤ 21 years hospitalized in pediatric Intensive Care Units (PICUs) and Stepdown (or intermediate) Care Units (SDUs) in the US designed to evaluate of the immunobiology of influenza virus-related critical illness in young hosts.

Institution
MUSC
Recruitment Contact
Lauren Wakefield
843-792-0603
wakefila@musc.edu

A Phase 1/2 Study to Evaluate the Safety and Efficacy of a Single Dose of Autologous Clustered Regularly Interspaced Short Palindromic Repeats Gene-edited CD34+ Human Hematopoietic Stem and Progenitor Cells (EDIT-301) in Subjects with Severe Sickle Cell Disease

Date Added
February 8th, 2022
PRO Number
Pro00106939
Researcher
Jennifer Jaroscak

List of Studies


Keywords
Transplant
Summary

This is a research study to find out if a study drug called EDIT-301 is safe and effective in treatment of patients with severe Sickle Cell Disease (SCD). The EDIT-301 study medicine is a new investigational therapy, which in this case means this is first-in-human use of this study drug. This study medication uses patients' own stem cells, modifies the cells with genetic modification, and transplants them back to the patient (by infusion) to treat SCD.
Participation in this study is expected to last approximately 30 months, including time for screening, collection of cells, transplant, and a 24 month follow-up period after transplant. At the end of that 24 month follow-up, the participant will be asked to participate in an additional long-term follow-up study, totaling 15 years of post-transplant follow-up.

Institution
MUSC
Recruitment Contact
Brandi Day
843-792-3379
dayb@musc.edu

Randomised, double-blind, placebo-controlled and parallel group trial to investigate the effects of two doses (up-titration to a fixed dose regimen) of oral BI 685509 on portal hypertension after 24 weeks treatment in patients with clinically significant portal hypertension (CSPH) in compensated cirrhosis

Date Added
November 17th, 2022
PRO Number
Pro00121158
Researcher
Don Rockey

List of Studies


Keywords
Drug Studies, Hepatology, Liver
Summary

In this Phase II trial the efficacy of treatment in patients with clinically significant portal hypertension (CSPH), in compensated alcohol-related cirrhosis, will be assessed. This will be the first trial in the clinical development of the drug BI 685509 where patients will be treated for 24 weeks, and where the portal pressure will be assessed quantitatively via HVPG measurements. The trial will evaluate both short-term and long-term efficacy. The long-term assessment will be used to rule out any adaptation to sGC activation on portal pressure on chronic treatment. The trial will also provide supportive evidence for the planned Phase III development.

Institution
MUSC
Recruitment Contact
Bridgette Blankenship
843-876-8439
blanke@musc.edu



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