A Phase 3 Randomized Trial of Inotuzumab Ozogamicin (NSC#: 772518) for Newly Diagnosed High-Risk B-ALL; Risk-Adapted Post-Induction Therapy for High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and Disseminated B-LLy

Date Added
December 22nd, 2020
PRO Number
Pro00106138
Researcher
Jacqueline Kraveka

List of Studies


Keywords
Adolescents, Cancer, Cancer/Leukemia, Pediatrics
Summary

This study is for patients that have newly diagnosed High-Risk B-ALL, Risk-Adapted Post-Induction therapy for High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and Disseminated B-LLy. The treatment involves medicine called chemotherapy, which fights cancer. Some patients may also need radiation therapy depending on whether the cancer has spread to the brain and spinal fluid, or the testes for males. The investigational drug on this study is inotuzumab ozogamicin. Participants can expect to be on this study for a little over 2 years and followed for up to 10 years.

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

Priming the rehabilitation engine: aerobic exercise as the fuel to spark behavioral improvements in stroke

Date Added
February 2nd, 2021
PRO Number
Pro00105988
Researcher
Ryan Ross

List of Studies

Keywords
Exercise, Rehabilitation Studies, Stroke, Stroke Recovery
Summary

Stroke is a leading cause of disability in the U.S. and many Veteran stroke survivors live with severe disability. Despite recent advances in rehabilitation treatments many stroke survivors have persistent physical and mental difficulties such as reduced arm and leg function, difficulty thinking, and depression.
Developing treatments that address these problems is necessary to improve long-term recovery for stroke survivors. Aerobic exercise (AEx) can improve physical and mental function, and reduce depression. Additionally, AEx may enhance physical rehabilitation by making the brain more receptive to, and consequently improving the response to a rehabilitation treatment. Therefore, combining AEx with physical rehabilitation has the potential to improve multiple parts of stroke recovery. This study will examine the effect of combining AEx with physical rehabilitation on physical and mental function in stroke survivors. By gaining a better understanding of the effects of this combined intervention we aim to advance the rehabilitative care of Veteran stroke survivors.

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

Pilot Trial of Belimumab in Early Lupus

Date Added
February 9th, 2021
PRO Number
Pro00104939
Researcher
Melissa Cunningham

List of Studies


Keywords
Drug Studies, Lupus
Summary

This is a study looking at the effects of Belimumab, a medication approved by the FDA to treat lupus, in people who have been recently diagnosed with lupus. It proposes that the early use of Belimumab may prevent long-term tissue damage from the disease. The study will last 2 years with clinic visits every 4 weeks.

Institution
MUSC
Recruitment Contact
Emma Hatch
843-792-4296
hatchem@musc.edu

Endovascular Ablation of the Right Greater Splanchnic Nerve in Subjects Having Heart Failure with Preserved Ejection Fraction: Randomized Controlled Feasibility Trial- The REBALANCE-HF Study

Date Added
February 9th, 2021
PRO Number
Pro00107509
Researcher
Sheldon Litwin

List of Studies


Keywords
Cardiovascular
Summary

This study will include volunteers diagnosed with a form of heart failure that is characterized by a weakened heart muscle that appears to be pumping in a normal manner. This condition is called "heart failure with preserved ejection fraction" or HFpEF. For these individuals, it has been determined that the health problems and symptoms experienced may be due to a significant increase in the pressure of one of the chambers of the heart. This pressure build-up causes a variety of symptoms, including tiredness, difficulty breathing, and reduced ability to exercise/walk.

This study is to help evaluate a new device (the "Satera Ablation System") designed to reduce the build-up of pressure described above. The Satera Ablation system is a catheter used to ablate or destroy the splanchnic nerve on one side of the body. The Sponsor believes by destroying this nerve there may be some reduction in the symptoms caused by HFpEF. The procedure using the Satera Ablation System will be performed in the catheterization lab and does not involve surgery. Participants will stay overnight in the hospital following the procedure for observation.

The length of subject participation in the study will be approximately 24 months and includes 5 office visits, 1 phone call and 2 procedures. Participants in this research study will be randomized to either the treatment group or the control group and have a 2:1 chance of receiving the research treatment with the Satera Ablation System at the time of randomization.

This study will help us learn more about how safe and effective the Satera Ablation System is in treating the symptoms of patients with HFpEF.

Institution
MUSC
Recruitment Contact
Renee Baxley
843-792-1105
baxleyr@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

In Our DNA SC: A Helix Research Network Study

Date Added
October 19th, 2021
PRO Number
Pro00115183
Researcher
Daniel Judge

List of Studies


Keywords
Genetics, Healthy Volunteer Studies
Summary

The purpose of this project is to study DNA and its connection to your health. DNA is in your blood, your saliva, and other tissues in your body. DNA is the unique instructions you are born with that tells your body how to work. By looking at DNA, you can learn information about your health, certain traits, and even your ancestral roots. DNA is also called your genetic information. DNA is mostly the same from person to person. But everyone's DNA is slightly different. We are still learning how DNA impacts health. This study will look at the DNA of many different people from many different backgrounds and compare it to information in their health records. The goal is to understand how learning about DNA can help improve health care for individuals, families, and the community.

Participants will provide a sample for DNA sequencing. Sequencing is the process of reading the letters of your DNA. This study may sequence your whole genome. Over time, you may be asked to provide additional samples for research purposes. The research team will collect health information about you from your medical record and may ask you questions about your health using surveys or other data collection method.

Institution
MUSC
Recruitment Contact
Sarah English
(843) 876-0582
InOurDNASC@musc.edu

In Our DNA SC: A Helix Research Network Study

Date Added
October 19th, 2021
PRO Number
Pro00115183
Researcher
Daniel Judge

List of Studies


Keywords
Genetics, Healthy Volunteer Studies
Summary

The purpose of this project is to study DNA and its connection to your health. DNA is in your blood, your saliva, and other tissues in your body. DNA is the unique instructions you are born with that tells your body how to work. By looking at DNA, you can learn information about your health, certain traits, and even your ancestral roots. DNA is also called your genetic information. DNA is mostly the same from person to person. But everyone's DNA is slightly different. We are still learning how DNA impacts health. This study will look at the DNA of many different people from many different backgrounds and compare it to information in their health records. The goal is to understand how learning about DNA can help improve health care for individuals, families, and the community.

Participants will provide a sample for DNA sequencing. Sequencing is the process of reading the letters of your DNA. This study may sequence your whole genome. Over time, you may be asked to provide additional samples for research purposes. The research team will collect health information about you from your medical record and may ask you questions about your health using surveys or other data collection method.

Institution
MUSC Health Florence Medical Center
Recruitment Contact
Sarah English
(843) 876-0582
InOurDNASC@musc.edu

In Our DNA SC: A Helix Research Network Study

Date Added
October 19th, 2021
PRO Number
Pro00115183
Researcher
Daniel Judge

List of Studies


Keywords
Genetics, Healthy Volunteer Studies
Summary

The purpose of this project is to study DNA and its connection to your health. DNA is in your blood, your saliva, and other tissues in your body. DNA is the unique instructions you are born with that tells your body how to work. By looking at DNA, you can learn information about your health, certain traits, and even your ancestral roots. DNA is also called your genetic information. DNA is mostly the same from person to person. But everyone's DNA is slightly different. We are still learning how DNA impacts health. This study will look at the DNA of many different people from many different backgrounds and compare it to information in their health records. The goal is to understand how learning about DNA can help improve health care for individuals, families, and the community.

Participants will provide a sample for DNA sequencing. Sequencing is the process of reading the letters of your DNA. This study may sequence your whole genome. Over time, you may be asked to provide additional samples for research purposes. The research team will collect health information about you from your medical record and may ask you questions about your health using surveys or other data collection method.

Institution
MUSC Health Lancaster Medical Center
Recruitment Contact
Sarah English
(843) 876-0582
InOurDNASC@musc.edu

In Our DNA SC: A Helix Research Network Study

Date Added
October 19th, 2021
PRO Number
Pro00115183
Researcher
Daniel Judge

List of Studies


Keywords
Genetics, Healthy Volunteer Studies
Summary

The purpose of this project is to study DNA and its connection to your health. DNA is in your blood, your saliva, and other tissues in your body. DNA is the unique instructions you are born with that tells your body how to work. By looking at DNA, you can learn information about your health, certain traits, and even your ancestral roots. DNA is also called your genetic information. DNA is mostly the same from person to person. But everyone's DNA is slightly different. We are still learning how DNA impacts health. This study will look at the DNA of many different people from many different backgrounds and compare it to information in their health records. The goal is to understand how learning about DNA can help improve health care for individuals, families, and the community.

Participants will provide a sample for DNA sequencing. Sequencing is the process of reading the letters of your DNA. This study may sequence your whole genome. Over time, you may be asked to provide additional samples for research purposes. The research team will collect health information about you from your medical record and may ask you questions about your health using surveys or other data collection method.

Institution
MUSC Health Columbia Medical Center
Recruitment Contact
Sarah English
(843) 876-0582
InOurDNASC@musc.edu

A Phase 1 Study of SEA-CD70 in Myeloid Malignancies

Date Added
January 11th, 2022
PRO Number
Pro00117607
Researcher
Praneeth Baratam

List of Studies

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

This study is for subjects that have been diagnosed with AML (acute myeloid leukemia) and MDS (myelodysplastic syndrome). This study is testing an "investigational" (not yet FDA approved) study drug called Sea-CD70. This study will find out if the drug is safe and tolerable, and find out the maximum tolerated dose (highest dose of a drug or treatment that does not cause unacceptable side effects) or recommended dose for the next phase of clinical study. The subject will be given the study drug in 28 day cycles. At any given visit, the subject may undergo procedures, such as a physical exam, blood samples, ECG (electrocardiogram), or a bone marrow exam. The subject may remain in the study for up to approximately 3 years.

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



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