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

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

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

A multicenter randomized controlled trial to establish the impact of MeMed BV® on management of patients with suspected Lower Respiratory Tract Infections (LRTI) in the Emergency Department (ED) and Urgent Care Center (UCC) ("BV: JUPITER" TRIAL)

Date Added
March 29th, 2023
PRO Number
Pro00126966
Researcher
Gary Headden

List of Studies


Keywords
Pulmonary
Summary

1) You will be asked to provide a blood sample; up to two tubes for a total of up to 10mL (less than 2 teaspoons).
2) Samples will be processed and tested on the MeMed BV device.
3) You will be asked about your medical history, medications, and current illness, as well as demographic information (i.e. date of birth) and a contact phone number.
4) If eligible, it will be decided by chance, using a computer, if you will be put into one of two arms: the MeMed BV arm or the control arm. You have an equal chance of being placed in each group. You cannot choose your study group.
a. The MeMed BV arm: your clinician will receive the BV result, this will include a recommendation regarding antibiotic treatment
b. The control arm: your clinician will not receive the MeMed BV results and will treat you according to standard of care.
5) You will be contacted by a member of the study team at 28 (+/- 3) days after the day of consent to complete a short questionnaire regarding your current illness

Institution
MUSC
Recruitment Contact
Robert Houck
18436931860
houckr@musc.edu

A multicenter randomized controlled trial to establish the impact of MeMed BV® on management of patients with suspected Lower Respiratory Tract Infections (LRTI) in the Emergency Department (ED) and Urgent Care Center (UCC) ("BV: JUPITER" TRIAL)

Date Added
March 29th, 2023
PRO Number
Pro00126966
Researcher
Gary Headden

List of Studies


Keywords
Pulmonary
Summary

1) You will be asked to provide a blood sample; up to two tubes for a total of up to 10mL (less than 2 teaspoons).
2) Samples will be processed and tested on the MeMed BV device.
3) You will be asked about your medical history, medications, and current illness, as well as demographic information (i.e. date of birth) and a contact phone number.
4) If eligible, it will be decided by chance, using a computer, if you will be put into one of two arms: the MeMed BV arm or the control arm. You have an equal chance of being placed in each group. You cannot choose your study group.
a. The MeMed BV arm: your clinician will receive the BV result, this will include a recommendation regarding antibiotic treatment
b. The control arm: your clinician will not receive the MeMed BV results and will treat you according to standard of care.
5) You will be contacted by a member of the study team at 28 (+/- 3) days after the day of consent to complete a short questionnaire regarding your current illness

Institution
MUSC Health Florence Medical Center
Recruitment Contact
Robert Houck
18436931860
houckr@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

Advancing Couple and Family Alcohol Treatment through Patient-Oriented Research and Mentorship

Date Added
April 4th, 2023
PRO Number
Pro00127577
Researcher
Julianne Flanagan

List of Studies


Keywords
Alcohol
Summary

Intimate partner violence (IPV) is a serious public health problem that results in significant health and economic burdens including mortality, morbidity, and poor treatment outcomes. A well-developed field of research suggests that alcohol misuse and posttraumatic stress disorder (PTSD) can lead to IPV. Individuals with PTSD and/or problematic drinking behaviors are at risk for IPV because of several factors that are common symptoms of PTSD. Because individuals with PTSD often drink alcohol to "self-medicate" or cope with distressing PTSD symptoms, PTSD co-occurs with alcohol misuse and alcohol use disorder at extraordinarily high rates. However, few studies have examined the combined effects of alcohol misuse and PTSD on any form of violence.

This study will examine the effects of alcohol misuse and posttraumatic stress disorder (PTSD) on alcohol-related intimate partner violence (IPV). We will examine these associations among couples (N=70) in a controlled laboratory setting using validated, standardized methods in a 'real-world' settings using 28 days of ecological momentary assessment (EMA). EMA includes very short surveys (5 minutes or less) that participants respond to on a smartphone application. Participants will be asked to respond to these surveys in the morning and three additional times throughout the day.

Institution
MUSC
Recruitment Contact
Stacey Sellers
843-792-5807
sellersst@musc.edu

Sex Differences in the Interface between Cannabis Use and Stress among Emerging Adults

Date Added
May 2nd, 2023
PRO Number
Pro00127995
Researcher
Kevin Gray

List of Studies


Keywords
Adolescents, Drug Studies, Psychiatry, Substance Use
Summary

This study is enrolling emerging adults (ages 18-25) with cannabis use disorder (CUD) to examine sex differences in (a) cannabis withdrawal symptoms during short-term cannabis abstinence, (b) cannabidiol (CBD) versus placebo effects on stress reactivity during short-term cannabis abstinence, and (c) the relationship between stress reactivity and time to cannabis relapse after short-term cannabis abstinence. The proposed study is designed to reveal sex differences and guide the development of tailored treatments that address factors disproportionately affecting emerging adult females with CUD.

Participants will complete an assessment visit to determine eligibility. Eligible participants will be scheduled for their next visit and will be instructed to abstain from cannabis use for 3 days. Participants will be set up with a phone application (app) and given instructions on its use. This app will send twice daily, random surveys everyday throughout study participation with questions about cannabis use, cravings, and overall mood. Participants will also complete twice daily saliva samples.

At the end of the 3 days, participants will return to the clinic for their second visit. Participants will complete a urine and blood sample at each visit. After eating a snack, participants will receive one dose of CBD (800mg) or placebo and then participate in a stress task. Upon completion of the stress task, participants will complete 3 saliva samples and then be discharged after evaluation by research staff. After the completion of Visit 2, participants will continue to complete twice daily surveys for 10 days. The study will last approximately 14 days.

There are risks involved with participating in this study, including risks associated with CBD, risks associated with the stress task and study procedures, emotional distress from answering personal questions, and loss of confidentiality. There is a risk of experiencing cannabis withdrawal symptoms during the 3-day period of cannabis abstinence. Some potential risks related to CBD include dry mouth, diarrhea, reduced appetite, drowsiness, and fatigue. There is a risk of loss of confidentiality, but the researchers will code the samples and research information to protect privacy. There are no direct benefits to the participant, but we hope the knowledge gained will help us inform future clinical strategies to address cannabis use in emerging adults.

Institution
MUSC
Recruitment Contact
Sarah Bourne
843-792-5239
bourne@musc.edu



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