A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Add-On to Standard-of-Care Study of n-Butylphthalide (NBP) Softgel Capsules for Treatment of Mild to Moderate Acute Ischemic Stroke in Adult Subjects Save

Date Added
February 22nd, 2018
PRO Number
Pro00073072
Researcher
Souvik Sen
Keywords
Brain, Nervous System, Stroke, Vascular
Summary

This study will assess patients with acute ischemic strokes being treated with n-Butylphthalide (NBP) softgel capsules. This is a phase II study to evaluate the safety of NBP treatment. The medication has the potential to reduce impairment of memory function, cerebral edema, and disruption of the blood-brain barrier.

Institution
Palmetto
Recruitment Contact
Viktoriya Duda
(803)545-6071
viktoriya.duda@uscmed.sc.edu

Longitudinal Study of Young Patients with Embolic Stroke of Undetermined Source (ESUS) Save

Date Added
July 21st, 2017
PRO Number
Pro00068368
Researcher
Souvik Sen
Keywords
Stroke
Summary

Young ESUS is a prospective registry for patients with embolic stroke of unknown source (ESUS) that occurred within the last 60 days, who are also under the age of 55. The study involves a follow up for 18 months.

Institution
Palmetto
Recruitment Contact
Kolby Redd
803-545-6078
kolby.redd@uscmed.sc.edu

PeRiodontal treatment to Eliminate Minority InEquality and Rural disparities in Stroke Save

Date Added
July 21st, 2015
PRO Number
Pro00044329
Researcher
Souvik Sen
Keywords
Periodontal Disease, Stroke, Vascular
Summary

The PREMIERS study is a proposal for conducting an adequately powered two center phase III randomized controlled trial to test whether intensive periodontal treatment reduces the risk of recurrent vascular events among ischemic stroke and TIA survivors. The study uses the resources in both states including established
dental centers, Joint Commission Certified Stroke Centers, the Schools of Public Health, and the Institute for Partnerships to Eliminate Health Disparities. The proposal addresses specific issues with regards to recruitment of African-American and rural stroke/TIA patients advocating the use of culturally appropriate strategies to educate the study subjects regarding stroke, periodontal disease and the periodontal stroke link.
The study proposes to utilize economic evaluation of the periodontal intervention from the budgetary
perspective. The focus will be on the financial sustainability of providing aggressive periodontal therapy (with
certain, although relatively low expenditures) in exchange for a reduction of uncertain recurrent vascular events
that may require high cost emergency department utilization and/or inpatient care. The sustainability of the
proposed intervention after the completion of the project is integrally linked to the health economic assessment
to show the health care cost savings. By integration with a rural primary care center, with an African American
majority and households with average incomes below the state average, the study ensures that the proposed
intervention to reduce stroke disparity is applicable to this target population.

Institution
Palmetto
Recruitment Contact
Lauren Giamberardino
8035456078
lauren.dennis@uscmed.sc.du

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