Changes in Optic Nerve Sheath Diameter in Preeclamptic patients with Severe Features by Neurologic Criteria versus Diagnosis Without Neurologic Criteria, Compared to Controls. Save

Date Added
November 7th, 2018
PRO Number
Pro00078977
Researcher
Mary Sterrett
Keywords
Central Nervous System, Hypertension/ High Blood Pressure, Non-interventional, Obstetrics and Gynecology, Pregnancy, Women's Health
Summary

Preeclamptic patients will have an ultrasound done of their eyes, to look at the size of the nerve behind the eye. We will also recruit women without preeclampsia to be a comparison group.

Institution
MUSC
Recruitment Contact
Mary Sterrett
8434940554
sterretm@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
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

Using Portable Telemedicine to Connect homebound patients to medical and social resources (Connected Home) Save

Date Added
September 19th, 2018
PRO Number
Pro00078976
Researcher
Gayenell Magwood
Keywords
Diabetes, Hypertension/ High Blood Pressure
Summary

This is a research study to find out how acceptable and how to deliver a Home Care Tele-Visits with adults diagnosed with Diabetes Mellitus (Diabetes) and/or Hypertension (high blood pressure). This study will consist of three at home visits with a Medical Tele-Assistant. Each visit will be scheduled to accommodate the participant's schedule and will be about 2-3 weeks apart. During the 2nd and 3rd visit the participant will able to use mobile technology to visit with their doctor and community/social resources (family member or friend). Participants will not be expected to pay for these in-home visits, and will be compensated for their time and participation.

This study is a pilot project, meaning that the goal is to gather data about how easily technology can be used in the home to provide access to health care providers, and social/community resources. Participants may benefit from participating in this study, but that cannot be guaranteed. There are minimal risks associated with participating in this study, such as a loss of privacy while using the Telemedicine System.

Institution
MUSC
Recruitment Contact
Stephanie Slan
843-792-5032
slans@musc.edu

Immune response to pneumococcal vaccination in aging renal transplant recipients Save

Date Added
June 19th, 2018
PRO Number
Pro00077548
Researcher
Maria anna Westerink
Keywords
Aging, Diabetes, Geriatrics, Healthy Volunteer Studies, Hypertension/ High Blood Pressure, Immune System, Kidney, Transplant, Vaccine
Summary

We will study how well the relatively new FDA approved pneumonia vaccine can protect older renal transplant recipients against pneumococcal illness. We will specifically study the group of renal transplants in whom the cause of renal failure was either diabetes mellitus II and/or hyoertension. We will compare the findings against those we find in younger renal transplant recipients, older healthy individuals and older persons with diabetes but normal kidney function. Healthy younger individuals will serve as controls for optimal vaccine response.

Institution
MUSC
Recruitment Contact
Myroslawa Happe
843-792-2218
soloshch@musc.edu

Emergency Provider Adherence to Chronic Disease Guidelines: A Prospective Provider Inquiry Save

Date Added
June 11th, 2018
PRO Number
Pro00077839
Researcher
Walter Winders
Keywords
Hypertension/ High Blood Pressure
Summary

Research indicates that 3/4 of patients presenting to Emergency Departments (EDs) with elevated blood pressure will remain elevated at outpatient follow up, regardless of pain and anxiety. Guidelines recommend that Emergency Providers (EPs) identify these patients and secure appropriate follow up, although retrospective studies indicate that providers typically only recognize one in every ten hypertensive patients and rarely provide appropriate follow up. We plan to prospectively identify practice patterns of EPs in low acuity patients, discharged from the ED.

Institution
MUSC
Recruitment Contact
Jonathan Boland
803.338.4868
bolandj@musc.edu

Improving Healthy Outcomes through Fresh Food Access Save

Date Added
April 18th, 2018
PRO Number
Pro00073034
Researcher
Mark Humphrey
Keywords
Diabetes, Hypertension/ High Blood Pressure, Nutrition, Obesity
Summary

The proposed project recognizes the relationship between food insecurity and social determinants of health. By developing a strong clinic/organization linkage between specific Palmetto Health clinics and FoodShare, we will be able to determine if increasing access to fresh produce through an every other week produce box, participation in cooking classes, and clinician reinforcement improves health outcomes for patients who are identified as food insecure.

Institution
Palmetto
Recruitment Contact
Beverly Wilson
803-665-7800
beverly.wilson@uscmed.sc.edu

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Selonsertib, GS-0976, GS-9674, and Combinations in Subjects with Bridging (F3) Fibrosis or Compensated Cirrhosis (F4) due to Nonalcoholic Steatohepatitis (NASH) Save

Date Added
April 10th, 2018
PRO Number
Pro00076641
Researcher
Don Rockey
Keywords
Diabetes, Digestive System, Drug Studies, Exercise, Hypertension/ High Blood Pressure, Liver, Men's Health, Metabolism, Nutrition, Obesity
Summary

This is a Phase 2, randomized, double-blind, placebo-controlled study
evaluating the safety and efficacy of SEL, GS-0976, GS-9674, and
combinations in subjects with bridging fibrosis or compensated
cirrhosis due to NASH.
Subjects meeting the study's entry criteria will be randomly assigned in
a 2:2:1:1:1:1:2 ratio to 1 of 7 treatment groups, with approximately
70 subjects in each combination treatment group and approximately 35
subjects in each single agent or placebo group.

Institution
MUSC
Recruitment Contact
Megan Bickford
843-876-8439
liverstudies@musc.edu

Program to Avoid Cerebrovascular Events through Systematic Electronic Tracking and Tailoring of an Eminent Risk-factor Save

Date Added
March 27th, 2018
PRO Number
Pro00070627
Researcher
Bruce Ovbiagele
Keywords
Hypertension/ High Blood Pressure, Stroke
Summary

This racial disparity in stroke is more prominent in the Southeastern region of the US, where 3 states have long been recognized as representing the ?buckle' of a ?stroke belt'. One of these 3 states is South Carolina, where our proposed study will take place. Stroke (including recurrent stroke) is highly preventable via control of high blood pressure. Mobile health (mHealth) technology may offer a promising approach for enhancing blood pressure control after stroke. mHealth tools provide an easy-to-use self-management system that permits optimal medication adherence. PACESETTER will conduct an implementation trial of the intervention
(personalized phone text messaging and home BP monitoring) vs. usual care in 200 recent stroke patients with HTN recruited across the three main safety net hospitals in the state of SC. The project will explore whether the intervention vs. standard care is associated with a reduction in cardiovascular event-related emergency department encounters and re-hospitalizations within 12 months and whether the intervention has potential to reduce vascular events.

Institution
MUSC
Recruitment Contact
deleted
TBD
TBD

The Association between Arterial Stiffness and Cognitive Impairment Risk in non-stroke controls (TAASCIR) Save

Date Added
February 26th, 2018
PRO Number
Pro00074521
Researcher
Joy Jones buie
Keywords
Brain, Cardiovascular, Hypertension/ High Blood Pressure, Minorities, Stroke, Stroke Recovery
Summary

The purpose of this research study is to understand the association between heart and brain health in a population of 40-75 year olds. In this study, we will work to better understand blood vessel stiffness and brain function in African American and non-Hispanic white individuals. You will be asked to give blood during the study visit. Additional information will be obtained to help the researcher better understand the blood vessel and brain function data collected. There is only one study visit that last roughly 2 hours and compensation will be available.

Institution
MUSC
Recruitment Contact
Joy Jones Buie
8437926098
jonejn@musc.edu

Assessment of Surrogate Sensors for Hypertension (ASSH) Study Save

Date Added
January 23rd, 2018
PRO Number
Pro00073998
Researcher
Thomas Todoran
Keywords
Heart, Hypertension/ High Blood Pressure
Summary

The purpose of this study is to collect measurements related to the body such as blood pressure, the amount of oxygen in the blood, and heart rhythm recordings. Findings from this study may be used to help design new device-based monitoring technologies in the future.

Continuous blood pressure readings will be obtained during standard of care heart catheterization procedures that include the use of an arterial blood pressure line. Continuous readings of oxygen saturation and ECG will also be obtained. Participants will consist of subjects aged ? 18 years who are scheduled to undergo a cath-lab (cath-lab, percutaneous coronary intervention or equivalent) procedure that includes the use of an arterial blood pressure line.

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

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