COOrdinating CaRDIology CliNics RAndomized Trial of Interventions to Improve OutcomEs (COORDINATE) - Diabetes

Date Added
June 25th, 2021
PRO Number
Pro00111177
Researcher
Priya Kumar

List of Studies

Keywords
Coronary Artery Disease, Diabetes
Summary

COORDINATE-Diabetes is a cluster-randomized clinical trial to test the effectiveness of an innovative, clinic-level educational intervention to improve the management of patients with T2DM and CVD. The trial will be performed and interpreted in the context of clinical diabetes care in the U.S. using data from select electronic health record (EHR) sites. A subset of sites with EHR data available for querying in existing datamarts will be recruited to participate in two EHRfocused objectives: 1) to perform a baseline characterization of patients with T2DM and CVD, including demographics, treatment patterns and healthcare utilization such as hospitalization; and 2) to assist with the identification of patients eligible for the educational intervention trial.

Institution
Self Regional
Recruitment Contact
Heather Rich
864-943-2416
heather.rich@selfregional.org

Autologous BM-MSCs and Islet Co-transplantation to Enhance Islet Survival and Function in TP-IAT Patients

Date Added
June 15th, 2021
PRO Number
Pro00099487
Researcher
Hongjun Wang

List of Studies


Keywords
Diabetes, Pancreas, Transplant
Summary

Islet transplantation is a clinical procedure to treat patients with chronic pancreatitis after removal of their pancreases. Islet survival is influenced by several factors, including but not limited to triggering an inflammatory response. The loss of islet cells during transplantation can cause surgical diabetes, in which the patient will need insulin injections to regulate their blood sugar. The goal of this study is to test whether co-transplantation of the patient's stem cells, called mesenchymal stromal cells (MSCs), along with their islet cells, will protect transplanted islet cells from death, therefore reducing the patient's chances of getting surgical diabetes. MSCs can modulate immune cells and are a promising resource for cell-based therapy.

Institution
MUSC
Recruitment Contact
Meghan Blalock
843-792-2813
schneidm@musc.edu

Improving the Collaborative Health of Minority COVID-19 Survivor and Carepartner Dyads Through Interventions Targeting Social and Structural Health Inequities.

Date Added
May 6th, 2021
PRO Number
Pro00110062
Researcher
Gayenell Magwood

List of Studies


Keywords
Cardiovascular, Coronavirus, Diabetes, Hypertension/ High Blood Pressure, Minorities, Stroke
Summary

Underserved, racial and ethnic minority communities are experiencing higher rates of COVID-19 cases and associated mortality compared to whites due to long standing social and structural inequities that also drive disparities in chronic diseases such as stroke, cardiovascular disease, diabetes, and hypertension. Patients with underlying chronic diseases who are recovering from COVID-19 depend on the support of family and friends (informal caregivers/care partners) who are being exposed to the same pandemic and racial stressors, exposure that can affect the health and quality of life of both partners. The primary goal of this study is to test the efficacy of an adapted, telehealth-enhanced intervention that targets barriers impacting family illness management behaviors of Black/African American (AA) adult COVID-19 survivors and carepartner dyads for improved quality of life and COVID/chronic illness health related outcomes.

Institution
MUSC
Recruitment Contact
Gayenell Magwood
8437920685
magwoodg@musc.edu

A Phase 2 Proof of Concept, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy of ASP1128 (MA-0217) in Subjects at Risk for Acute Kidney Injury following Coronary Artery Bypass Graft (CABG) and/or Valve Surgery

Date Added
April 21st, 2021
PRO Number
Pro00106141
Researcher
Sanford Zeigler

List of Studies


Keywords
Cardiovascular, Diabetes, Heart, Kidney, Surgery
Summary

The goal of this study is to find out if an investigational drug called ASP1128 (also called as MA-0217) is effective and safe as a treatment to prevent acute kidney injury (AKI) and/or reduce its severity in people who are at risk for AKI after heart surgery when compared to placebo (inactive substance). Researchers will look at how ASP1128 can act in the body.

Institution
MUSC
Recruitment Contact
Morgan Overstreet
843-792-8896
overstrm@musc.edu

A PHASE 2, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, DOSE-RANGING, DOSE-FINDING, PARALLEL GROUP STUDY TO ASSESS EFFICACY AND SAFETY OF PF-06865571 (DGAT2I)ALONE AND WHEN COADMINISTERED WITH PF-05221304 (ACCI) IN ADULT PARTICIPANTS WITH BIOPSY-CONFIRMED NONALCOHOLIC STEATOHEPATITIS AND FIBROSIS STAGE 2 OR 3

Date Added
January 12th, 2021
PRO Number
Pro00100274
Researcher
Don Rockey

List of Studies


Keywords
Diabetes
Summary

The purpose of this research study is to learn if the study drugs (PF-06865571 alone or when given together with PF-05221304) improve NASH with liver fibrosis compared to placebo. The study drug is an IV infusion that would be administered in the outpatient clinic at MUSC main campus.

The medical term for this condition is nonalcoholic steatohepatitis (NASH) that has both high liver fat and inflammation (swelling) and fibrosis (scarring) that causes a stiff liver. This research study involves two investigational drugs (study drugs) being developed by Pfizer Inc. as potential options to treat participants with NASH.

This study is just over a year long and will involve 18 visits to MUSC

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

Analytical Performance Evaluation of cobas pulse

Date Added
September 9th, 2020
PRO Number
Pro00102729
Researcher
Gary Headden

List of Studies


Keywords
Diabetes
Summary

The purpose of this study is to determine whether an accurate blood glucose (blood sugar level) result can be obtained from venous (vein), arterial (artery), capillary (finger) and neonatal heel stick blood samples by Point of Care users within both critically ill and non-critically ill study populations.

Institution
MUSC
Recruitment Contact
Aja Bayo
843-792-7944
bayo@musc.edu

A PHASE III, MULTICENTER, RANDOMIZED, VISUAL ASSESSOR-MASKED, ACTIVE-COMPARATOR STUDY OF THE EFFICACY, SAFETY, AND PHARMACOKINIETICS OF THE PORT DELIVERY SYSTEM WITH RANIBIZUMAB IN PATIENTS WITH DIABETIC MACULAR EDEMA

Date Added
January 17th, 2020
PRO Number
Pro00091469
Researcher
W. Lloyd Clark

List of Studies

Keywords
Diabetes
Summary

This study will evaluate the efficacy, safety, and pharmacokinetics of the PDS in patients with DME when treated every 24 weeks compared with intravitreal ranibizumab 0.5 mg every 4 weeks.

Institution
Palmetto
Recruitment Contact
Tiffany Swinford
8034045037
tswinford@palmettoretina.com

Characterization of patient-, provider-, and clinic-level factors associated with implementation, clinical outcomes, and sustainability of diabetes remote patient monitoring

Date Added
January 3rd, 2020
PRO Number
Pro00094517
Researcher
Elizabeth Kirkland

List of Studies


Keywords
Diabetes, Hypertension/ High Blood Pressure, Minorities
Summary

The purpose of this formative research is to explore and understand patient-, provider-, and systems-level characteristics that affect the sustainability and success of remote patient monitoring technology applied to diabetes chronic care. This will be completed through evaluation and analysis of the Technology Assisted Case Management in Low Income Adults with Type 2 Diabetes (TACM-2) implementation program. TACM-2 utilizes remote patient monitoring (RPM) of diabetes and hypertension to augment regular clinical care, with the ultimate goal of improving health outcomes particularly for low-income patients regardless of geographic location.

This exploratory study's broad goal is to characterize key barriers and facilitators to RPM use over time through a mixed methods design. We will utilize data gathered as part of an ongoing quality improvement program, TACM-2, to provide quantitative data on RPM uptake and effectiveness. We will also obtain qualitative and quantitative data from participating patients and healthcare teams. Our objectives are to assess:
1) patient-level variables that are associated with sustained device use and clinical outcomes over time,
2) patterns of device uptake and data transmission across South Carolina as markers of scalability and sustainability, and
3) patient-, clinic- and system-level barriers and facilitators of RPM implementation.

Institution
MUSC
Recruitment Contact
Ryan Kruis
843-792-4703
kruis@musc.edu

Reducing Disparities in Living Donation Among African Americans

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

List of Studies


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

Cellular Therapy for Type 1 Diabetes using Mesenchymal Stem Cells

Date Added
May 21st, 2019
PRO Number
Pro00085542
Researcher
Hongjun Wang

List of Studies


Keywords
Diabetes
Summary

The goal of this study is to determine the safety and efficacy of fresh metabolically active allogeneic umbilical cord-derived mesenchymal stromal cells (UC-MSCs) for the treatment of new-onset type 1 diabetes (T1D) and to understand the mechanisms of protection. If proven effective, such a strategy can be used as a therapeutic option for T1D patients and potentially other autoimmune disorders.

Institution
MUSC
Recruitment Contact
Danielle Woodford
843-792-6280
woodfordd@musc.edu



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