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

The "RADIANCE II" Pivotal Study A Study of the ReCor Medical Paradise System in Stage II Hypertension Save

Date Added
October 9th, 2018
PRO Number
Pro00081841
Researcher
Thomas Todoran

List of Studies


Profiles_link
Keywords
Cardiovascular, Hypertension/ High Blood Pressure
Summary

The purpose of this clinical study is to see whether a medical device called the Paradise Renal Denervation System (also called The Paradise System) can lower high blood pressure in participants who are known to have hypertension. The device and the treatment delivered by the device, which is known as renal denervation, are investigational in the United States because they haven't been approved by the FDA. Renal denervation is a procedure where a catheter is placed inside these blood vessels (renal arteries). The ultrasound energy is created when the catheter is connected to a power source known as a generator. The ultrasound energy will heat up a small area of tissue around the blood vessel to disable nerves that are surrounding the blood vessels.

Participants will stop taking hypertensive medication before the procedure and up to two months after the procedure. Participants will be randomized to the procedure or control and will be followed for 36 months. At the six month follow-up appointment, participants will learn whether they had the procedure or not. Those who did not receive the procedure can opt in to have the procedure in the future.

Institution
MUSC
Recruitment Contact
Vijay Paladugu
8438765009
paladugc@musc.edu

Odor Disturbances: Clinical Care Registry Save

Date Added
September 26th, 2018
PRO Number
Pro00080333
Researcher
Thomas Uhde

List of Studies


Profiles_link
Keywords
ADD/ADHD, Adolescents, Aging, Allergy, Alzheimers, Anxiety, Asthma, Autism, Autoimmune disease, Central Nervous System, Chronic Fatigue, Depression, Environmental Factors, Fibromyalgia, Inflammation, Memory Loss, Nervous System, Parkinsons, Psychiatry
Summary

Candidates for this study may or may not report disturbances in odor perception as their primary reason for seeking treatment at MUSC. This study is designed to collect long term, observational data from patients who are being treated with routine clinical care in health clinics at MUSC. Data from clinical questionnaires will be de-identified and stored in a database.

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

A Double-blind, Randomized, Placebo Controlled, Two Arm Multi-center Study to Assess the Efficacy and Safety of a Once Nightly Formulation of Sodium Oxybate for Extended-Release Oral Suspension (FT218) for the Treatment of Excessive Daytime Sleepiness and Cataplexy in Subjects with Narcolepsy Save

Date Added
August 28th, 2018
PRO Number
Pro00077667
Researcher
Thomas Uhde

List of Studies


Profiles_link
Keywords
Sleep Disorders
Summary

The study is designed to assess the efficiency and safety of a once nightly formulation of sodium oxybate for extended-release oral suspension or a placebo for the treatment of excessive daytime sleepiness and cataplexy, sudden and uncontrollable muscle weakness or paralysis, in subjects with narcolepsy. Study staff nor participants will know if they are receiving study drug or placebo. Participants will be male or female subjects 18 years of age or older. A total of 264 study subjects will be randomized across all sites with 132 randomized to the study drug and 132 to the placebo drug. The study treatment period from screening to follow-up will last approximately 17 weeks. Requiring 9 visits with 4 overnight stays.

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

Kidney Paired Donation Video Education Trial Save

Date Added
April 25th, 2018
PRO Number
Pro00075387
Researcher
Derek Dubay

List of Studies

Silhouette
Keywords
Education, Kidney, Transplant
Summary

Live donor kidney transplantation (LDKT) offers the most optimal survival and quality
of life benefit for those with late-stage chronic kidney disease. However, one-third of potential donors who volunteer to undergo evaluation on behalf of an intended recipient are blood-type or cross-match incompatibility. Kidney paired donation (KPD) was developed as a strategy to provide these incompatible donor-recipient pairs with an innovative opportunity for LDKT, yet its uptake by potential donors and their intended LDKT recipients is not optimal. In this study, we will evaluate the
effectiveness of a targeted video intervention designed to address common concerns
about KPD on the knowledge of KPD risks and benefits, KPD self-efficacy, and KPD
concerns in incompatible potential donors and their intended recipients.

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

The Occlusion Perfusion Catheter for Optimal Delivery of Paclitaxel for the Prevention of Endovascular Restenosis ? Above and Below the Knee Save

Date Added
February 13th, 2018
PRO Number
Pro00073943
Researcher
Thomas Todoran

List of Studies


Profiles_link
Keywords
Cardiovascular
Summary

Peripheral vascular interventions are minimally invasive options for the treatment of patients with peripheral arterial disease (PAD). Unfortunately, the effects of this procedure are short-term and there remains a high rate (40-70%) of restenosis (re-narrowing of the arteries). The purpose of this research study is to determine if the use of the catheter for the delivery of the study drug called paclitaxel, will prevent re-narrowing of the blockage of an artery to be treated in the leg.

Institution
MUSC
Recruitment Contact
Kavin Panneerselvam
843-792-0464
panneeer@musc.edu

More than Facebook Effect: Increasing opportunities for living kidney donation Save

Date Added
September 5th, 2017
PRO Number
Pro00065466
Researcher
Wendy Balliet

List of Studies


Profiles_link
Keywords
Kidney, Transplant
Summary

Kidney transplant, especially from a living donor, affords End Stage Renal Disease (ESRD) patients the opportunity for increased survival and improved quality of life. Potential recipients are not likely to identify living donors as a believed consequence of lack of awareness and limited knowledge regarding living kidney donation. We propose to utilize a social media coach to help ESRD patients to utilize Facebook to tell their ESRD story, to post accurate information and links to data on ESRD, renal transplantation and living donation with the goal of increasing interest in social media 'friends' to become a living donor.

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

Change_preferences

-- OR --

Create_login