Quality of Pediatric Resuscitation in a Multi-center Collaborative: an Observational Study

Date Added
February 18th, 2021
PRO Number
Pro00106721
Researcher
Allison Whalen

List of Studies


Keywords
Children's Health
Summary

This observational, multi-center cohort study of pediatric cardiac arrest management will contribute to a clinical CPR Learning Laboratory. The objectives of this study are to characterize the quality of CPR and post-cardiac arrest care delivered to children across a broad spectrum of hospitals, to determine the association between quantitative CPR quality measures (depth, rate, compression release, flow fraction) and survival to hospital discharge, and to determine the association of survival with site-specific post-cardiac arrest care (PCAC). The study will enroll pediatric cardiac arrests requiring chest compressions for ≥1 minute identified as part of standard clinical operations. The CPR quantitative measures, defibrillator data (when available), monitor data (when available), and post-arrest care will be de-identified and submitted to a central database.

Institution
MUSC
Recruitment Contact
Allison Whalen
8438761361
whalen@musc.edu

Development and Evaluation of a Virtual Reality Tool for At-Risk Trauma-Exposed Young People

Date Added
February 22nd, 2021
PRO Number
Pro00105369
Researcher
Carla Danielson

List of Studies


Keywords
Adolescents, HIV / AIDS, Substance Use
Summary

Human subjects are being recruited for the proposed study to participate in usability testing for a virtual reality technology tool to be refined for assessment and prevention of risky sexual and substance use behaviors. Specifically, 15 adolescents, 15 young men, and 15 front line health care providers will participate in qualitative interviews and focus groups. Targeted enrollment is based on estimates from the existing clinical population treated by the local clinics from which participants will be recruited and the candidate's experience conducting clinical studies at these sites.

Phase 3 sample will include 20 adolescents, 20 young men, and 10 frontline health care workers. They will complete assessments/interviews, a brief emotion regulation skills training, and a simulation using a refined virtual reality tool.

Institution
MUSC
Recruitment Contact
Nathalie Slick
843) 408-6140
slick@musc.edu

Brief Computerized Intervention for Reducing Adolescent Cannabis and Alcohol Use

Date Added
March 2nd, 2021
PRO Number
Pro00106723
Researcher
Austin Hahn

List of Studies

Keywords
Adolescents, Alcohol, Substance Use
Summary

The study will test a computerized treatment with subjects ages 13-17 years who are interested in seeking treatment for alcohol and/or cannabis use. Follow-up assessments will be conducted at one- and three-months following treatment.

Institution
MUSC
Recruitment Contact
Amy Boatright
843-792-5200
boatrigh@musc.edu

RTMS manipulates imbalanced drive-reward and executive control circuitry for smoking cessation

Date Added
March 2nd, 2021
PRO Number
Pro00105723
Researcher
Xingbao Li

List of Studies


Keywords
Brain, Healthy Volunteer Studies, Smoking
Summary

Cigarette smoking is a significant public health concern. Transcranial magnetic stimulation (TMS) is a non-invasive form of brain stimulation that has already displayed remarkable potential for producing novel, non-pharmacological interventions for depression and cigarette smokers. In this study, we will use brain MRI to guide TMS therapy for smoking cessation.

Institution
MUSC
Recruitment Contact
Xingbao Li
(843) 792-5729
lixi@musc.edu

PARALLEL PHASE III RANDOMIZED TRIALS FOR HIGH RISK PROSTATE CANCER EVALUATING DE-INTENSIFICATION FOR LOWER GENOMIC RISK AND INTENSIFICATION OF CONCURRENT THERAPY FOR HIGHER GENOMIC RISK WITH RADIATION (PREDICT-RT*)

Date Added
March 4th, 2021
PRO Number
Pro00108846
Researcher
David Marshall

List of Studies


Keywords
Cancer/Genitourinary, Hormones, Men's Health, Prostate
Summary

This study is for men who have high-risk prostate cancer who plan to be treated with a combination of radiation and hormonal therapy. A tumor genomic analysis (Decipher score) will be used to divide the subjects into two groups. Those with a low genomic risk score will be randomized to either standard treatment with radiation and 24 months of hormonal therapy or to radiation with a shorter, 12 month, course of hormone therapy. Those with a higher genomic risk score or who have lymph node involvement will be randomized to standard treatment with radiation and 24 months of standard hormonal therapy or radiation with 24 months of intensified hormonal therapy.

Institution
MUSC
Recruitment Contact
Amanda Kelley
(864) 725-7125
amanda.kelley@selfregional.org

PARALLEL PHASE III RANDOMIZED TRIALS FOR HIGH RISK PROSTATE CANCER EVALUATING DE-INTENSIFICATION FOR LOWER GENOMIC RISK AND INTENSIFICATION OF CONCURRENT THERAPY FOR HIGHER GENOMIC RISK WITH RADIATION (PREDICT-RT*)

Date Added
March 4th, 2021
PRO Number
Pro00108846
Researcher
David Marshall

List of Studies


Keywords
Cancer/Genitourinary, Hormones, Men's Health, Prostate
Summary

This study is for men who have high-risk prostate cancer who plan to be treated with a combination of radiation and hormonal therapy. A tumor genomic analysis (Decipher score) will be used to divide the subjects into two groups. Those with a low genomic risk score will be randomized to either standard treatment with radiation and 24 months of hormonal therapy or to radiation with a shorter, 12 month, course of hormone therapy. Those with a higher genomic risk score or who have lymph node involvement will be randomized to standard treatment with radiation and 24 months of standard hormonal therapy or radiation with 24 months of intensified hormonal therapy.

Institution
MUSC Health Florence Medical Center
Recruitment Contact
Amanda Kelley
(864) 725-7125
amanda.kelley@selfregional.org

Weekly Sirolimus Therapy for the Treatment of Venous and Lymphatic Malformations

Date Added
April 6th, 2021
PRO Number
Pro00106369
Researcher
Chelsea Shope

List of Studies

Keywords
Adolescents, Pediatrics, Skin, Vascular
Summary

In current practice, options for venous and lymphatic malformations remain limited. Recently an oral medication, sirolimus, has been found to benefit patients when taken once or twice a day for several months. Unfortunately there are many side effects associated with this medication, some of which can be severe including, neutropenia, oral ulcerations, and lab abnormalities. The purpose of this study is to determine if once weekly dosed sirolimus will be effective for the treatment of venous and lymphatic malformations. Additionally, the study will evaluate patient satisfaction and identify adverse effects. Participants will be on the medication for 6 months with an option to continue after this time period.

Institution
MUSC
Recruitment Contact
Alexandra Richmond
7577776673
ritteral@musc.edu

An Open-label, Single-arm, Multicohort, Phase 2 Study to Assess the Efficacy and Safety of Tabelecleucel in Subjects with Epstein-Barr Virus-associated Diseases

Date Added
April 27th, 2021
PRO Number
Pro00104445
Researcher
Michelle Hudspeth

List of Studies


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

This study is for children and adults that have been diagnosed with a disease that is associated with Epstein-Barr Virus (EBV) infection.The investigational treatment in this study is called tabelecleucel (also known as ATA129), this treatment is given in the vein. Participants will receive tabelecleucel on Day 1, Day 8 and Day 15 of every 35-day (5-week) period, the number of cycles depends on the response to treatment. The purpose of this study is to assess the safety of tabelecleucel and to assess the effects of tabelecleucel on EBV disease. Participants can expect to be in this study for about 2 years for an estimated 17-20 study visits.

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

Expanded Access Protocol (EAP) for Subjects Receiving Lisocabtagene Maraleucel That is Nonconforming for Commercial Release

Date Added
May 11th, 2021
PRO Number
Pro00107699
Researcher
Brian Hess

List of Studies


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

This study is for patients who have been diagnosed with relapsed (came back) and/or refractory (not responding to treatment) large B-cell lymphoma (LBCL). The investigational product is Lisocabtagene Maraleucel and is administered by infusion. Participants will have had the blood collection (leukapheresis - a laboratory procedure where white blood cells are separated from a sample of blood) procedure, where the T cells (white blood cells) were collected and genetically modified in a laboratory in order to manufacture the lisocabtagene maraleucel T cells for disease treatment. The lisocabtagene maraleucel T cells that were produced do not meet all of the prespecified release criteria to be used as a routine prescription drug as required by the Food and Drug Administration (FDA). This is called a nonconforming lisocabtagene maraleucel. The purpose of this study is to allow participants to be treated with their nonconforming lisocabtagene maraleucel. Participants can expect to be on the study for up to 3 months following the infusion of nonconforming lisocabtagene maraleucel.

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

A Phase II Randomized Trial of Adjuvant Therapy With Pembrolizumab After Resection of Recurrent/Second Primary Head and Neck Squamous Cell Carcinoma With High Risk Features

Date Added
May 14th, 2021
PRO Number
Pro00110906
Researcher
Jennifer Harper

List of Studies


Keywords
Cancer, Cancer/Head & Neck
Summary

This study is for patients that have been diagnosed with recurrent or new head and neck squamous cell carcinoma (HNSCC). Patients either have had a recurrence (the tumor has comeback) or a new head and neck cancer in a different area of the head and neck (second primary) which has been removed by surgery. The study drug used is called pembrolizumab. The purpose of this study is to see if adding pembrolizumab to radiation or if using pembrolizumab by itself after surgery compared to the usual approaches with chemotherapy and radiation will increase life expectancy. Participants can expect to be on this study for up to 12 months and then followed for 5 years.

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



-- OR --