A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Apalutamide in Subjects with High-risk, Localized or Locally Advanced Prostate Cancer Who are Candidates for Radical Prostatectomy Save

Date Added
March 9th, 2020
PRO Number
Pro00095232
Researcher
Thomas Keane

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Keywords
Cancer, Drug Studies, Men's Health
Summary

This study is for patients who have been diagnosed with localized and locally advanced high-risk prostate cancer who are planned for radical prostatectomy (surgical removal of the whole prostate and surrounding tissue). This is a research study to find out if experimental medication called apalutamide (also known as JNJ-56021927) plus androgen deprivation therapy (ADT) , also known as hormone therapy, is safe and could improve the results of surgery and delay the time to when prostate cancer tumors spread to other parts of the body.

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

Reducing Disparities in Living Donation Among African Americans Save

Date Added
January 2nd, 2020
PRO Number
Pro00092908
Researcher
Derek Dubay

List of Studies

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Keywords
Diabetes, Hypertension/ High Blood Pressure, Kidney, Transplant
Summary

Kidney donation from a living donor provides the kidney recipient with the best chance of a longterm survival of the transplanted kidney. White End Stage Renal Disease (ESRD) patients are 4 times more likely to recieve a living donor kidney than are African American (AA) ESRD patients. There are many reasons for this disparity in obtaining the benefits of living donation for AAs, including lack of knowledge regarding the living donation process. This study will provide a web-based educational intervention to overcome this knowledge deficiency with the hope that there will be an increase in patient interest in living donation which will result in more living donation kidney transplant inquiries by patients' family or friends.

Institution
MUSC
Recruitment Contact
Thomas Morinelli
843-792-5405
morinelt@musc.edu

Protocol for the Comparison of Surgery and Medicine on the Impact of Diverticulitis (COSMID) Trial Save

Date Added
October 16th, 2019
PRO Number
Pro00093020
Researcher
Thomas Curran

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Keywords
Digestive System, Inflammation, Surgery
Summary

The goal of the COSMID (Comparison of Surgery and Medicine on the Impact of Diverticulitis) trial is to determine if elective colectomy is more effective than best medical management for patients with quality of life-limiting diverticular disease. The COSMID trial focuses on both patient-reported outcomes and clinical outcomes that matter to patients. The results are expected to establish an evidence-based approach to the care of millions of patients per year in the United States and help people impacted by this common condition make more informed treatment decisions.

Institution
MUSC
Recruitment Contact
Kandace Taylor
843-792-7082
taylokan@musc.edu

A Pivotal, Multicenter, Blinded, Sham Procedure-Controlled Trial of Renal Denervation by the Peregrine System™ Kit, in Subjects with Hypertension Save

Date Added
September 24th, 2019
PRO Number
Pro00091232
Researcher
Thomas Todoran

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Profiles_link
Keywords
Cardiovascular, Hypertension/ High Blood Pressure
Summary

This is a study for patients with high blood pressure. The purpose of this study is to evaluate the safety and effectiveness of renal denervation while you are still on your blood pressure medications. Renal denervation is a procedure that destroys the nerve fibers that run along the kidney blood vessels interrupting nerve signals that may cause high blood pressure.The purpose of the treatment (renal denervation) is to lower blood pressure. You will undergo renal angiography (RA), which you may or may not receive the study treatment (depending upon your study assignment). The sponsor has manufactured a new drug/device combination product called the Peregrine System™ Kit (also referred to as the Peregrine Kit). The Peregrine Kit contains a device, the Peregrine System™ Infusion Catheter (also referred to as the Peregrine Catheter), and a drug dehydrated alcohol for injection (also referred to as alcohol). Therefore, the effectiveness of the study catheter and the alcohol (Peregrine Kit) will be assessed by how well the treatment reduces your blood pressure. The participant will be asked to return to the doctor's office for follow-up visits at 4 and 8 weeks, 3, 4, 5 and 6 months, and 1, 2, and 3 years after the procedure. At the 1 year visit, the participant will find out if he/she got the treatment, and if he/she did not, they can choose to cross-over to the treatment if they still meet eligibility criteria.

Institution
MUSC
Recruitment Contact
Anthony Awkar
8438765009
awkar@musc.edu

Repository of Phase Signals for Pulmonary Hypertension Algorithm Development Save

Date Added
September 10th, 2019
PRO Number
Pro00089125
Researcher
Thomas Todoran

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Profiles_link
Keywords
Cardiovascular
Summary

The purpose of this study is to build a repository (collection) of heart signals from eligible subjects. The experimental part of this study is the collection of heart signals using a device similar to a heart monitor called the Phase Signal Acquisition System. The signals will be electronically sent to a storage center and paired with the subject's heart catheterization results for future use in research and development activities sponsored by Analytics 4 Life. The study will include up to 1500 participants at up to 20 research sites in the United States and will require approximately one hour of the subject's time. There are no follow-up visits. .

Institution
MUSC
Recruitment Contact
Anthony Awkar
7928526
awkar@musc.edu

Building a Repository of Cardiac Phase Signals for Algorithm Development Recruiting Mostly Female Subjects Save

Date Added
September 10th, 2019
PRO Number
Pro00088809
Researcher
Thomas Todoran

List of Studies


Profiles_link
Keywords
Cardiovascular
Summary

The purpose of this study is to build a repository of heart signals from eligible subjects. The experimental part of this study is the collection of the participant's heart signals using a device similar to a heart monitor called the Phase Signal Acquisition System. The signals will be electronically sent to a storage center, then compared to the results of the participant's heart catheterization and saved for future research and development activities sponsored by Analytics 4 Life. The study will include up to 2500 participants at up to 20 research sites in the United States and will require approximately one hour of the subject's time. There are no follow-up visits.

Institution
MUSC
Recruitment Contact
Anthony Awkar
7928526
awkar@musc.edu

Comparison of Quality of Life and Functional Outcomes in Adult Cochlear Implant Recipients Save

Date Added
May 23rd, 2019
PRO Number
Pro00085904
Researcher
Theodore Mcrackan

List of Studies


Profiles_link
Keywords
Hearing
Summary

The purpose of this study is to evaluate participants Quality of Life (QOL) with their Cochlear implant (CI) through a variety of questionnaires and hearing tests.

There will be a pre-surgical visit as well as 3, 6, and 12 month post-surgery visits. In this study, the participants will take surveys and hearing tests at each visit. He or she will complete surveys on the computer through REDCap and the hearing tests will be completed in sound-attenuating booth using headphones in the Walton Research building on MUSC's campus. The study participation is complete once the participant has completed all 4 study visits.

Institution
MUSC
Recruitment Contact
Cameron Thomas
843-876-7069
thomasca@musc.edu

Long-Term Prospective Registry to Evaluate Treatment Decisions and Clinical Outcomes in Patients With Favorable Intermediate-Risk Localized Prostate Cancer Following Cell Cycle Progression (CCP) Testing (Prolaris® Test) Save

Date Added
March 13th, 2019
PRO Number
Pro00085807
Researcher
Thomas Keane

List of Studies


Profiles_link
Keywords
Cancer, Prostate
Summary

The main purpose of this study is to find out if getting a test, called the Prolaris cell cycle progression test (CCP), changes decisions about how prostate cancer is treated and how these decisions affect the course of the disease. Researchers want to look at the treatments that men and their doctors choose to manage prostate cancer and how the treatments change over time.
This study is called a registry study. A registry study collects information about a group of people who have the same medical condition. This study will enroll men who have had Prolaris testing and men who have not had Prolaris testing. During the course of this registry study demographic and health information will be collected from you or from your medical records several times over the course of 8 years.
The Prolaris test would like to improve the impacts of individual risk assessment, as well as, to help researchers to better understand prostate cancer and how decisions are made about prostate cancer treatment.

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

APOL1 Long-term kidney transplantation outcomes network (APOLLO) Save

Date Added
February 19th, 2019
PRO Number
Pro00084947
Researcher
Derek Dubay

List of Studies

Silhouette
Keywords
Kidney, Transplant
Summary

Expression of APOL1 gene variants have been associated with higher likelihood of end stage renal disease in African Americans. In addition, kidney transplant recipients who have received a donated kidney from an African American expressing APOL1 variants have poorer outcomes with earlier transplanted kidney failure. This study will examine the occurance of the APOL1 gene variants in all African American donated kidneys, deceased and living, and African American recipients and recipients of African American donated kidneys, and to correlate the expression of these variants with outcome of the transplanted kidney and the kidney function of African American living donors. Samples of patients blood and urine will be acquired to measure the expression of the APOLO1 gene variants and associated kidney function, respectively.

Institution
MUSC
Recruitment Contact
Thomas Morinelli
8437925405
morinelt@musc.edu

A Double-blind, Placebo-controlled, Randomized Withdrawal, Multicenter Study of the Efficacy and Safety of JZP-258 in the Treatment of Idiopathic Hypersomnia (IH) with an Open-label Safety Extension Save

Date Added
November 13th, 2018
PRO Number
Pro00082995
Researcher
Thomas Uhde

List of Studies


Profiles_link
Keywords
Sleep Disorders
Summary

The study is designed to look at the usefulness and safety of an oxybate mixed-salts oral solution or placebo for treatment of Idiopathic Hypersomnia. Idiopathic Hypersomnia (IH) is a sleep disorder in which a person is excessively sleepy during the day and has great difficulty being awakened from sleep. Study staff nor participants will know if they are receiving study drug or placebo. Participants will be male or female subjects 18-70 years old with a diagnosis of Idiopathic Hypersomnia (IH) within the last five years, and not due to other medical conditions such as Narcolepsy, restless leg syndrome, and uncontrolled hypothyroidism. A minimum of 140 study subjects will be randomized across all sites with 72 randomized to the study drug and 72 to the placebo drug. The study treatment period from screening to follow-up will last approximately 42 weeks, requiring nine visits. An overnight stay might be required to confirm the diagnosis of IH.

Institution
MUSC
Recruitment Contact
Richard Simmons
843-792-7439
simmr@musc.edu

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