Faculty

Denise M. Harnois, D.O.

Clinical Studies

A Multicenter, Open-Label, Extension Clinical trial to evaluate Safety and Efficacy of Saroglitazar Magnesium in Participants with Primary Biliary Cholangitis (PBC) Jacksonville, Fla.
The purpose of this study is to evaluate the safety and efficacy of Saroglitazar Magnesium in participants with Primary Biliary Cholangitis.
Development of a Novel Vocal Biomarker in the Diagnosis and Management of Hepatic Encephalopathy (Vocal HE) Jacksonville, Fla.
Hepatic encephalopathy (HE) is a serious complication of cirrhotic stage liver disease. It is reported that 30-70% of all patients with cirrhosis have HE. The current diagnostic methodology for HE includes a blood lab monitoring of ammonia and neuropsychometric testing, which can define the diagnosis but cannot assess the vitally important daily variability of this complication.

There are, however, distinct cognitive neurologic findings in HE that could be mapped and exploited for quick and accurate daily assessment. Vocal changes and speech analysis may provide guidance in the diagnosis and management of HE. The computer algorithm calculating vocal changes in HE would be valuable not only for diagnosis but also for monitoring and adjusting therapy based on its results and recommendations. Currently, those diagnoses or therapeutic adjustments are made only through personal, wholly subjective assessment of ill-defined symptoms.

A Multicenter, Randomized, Double-blind, Placebo Controlled, Phase 2b/3 Study to Evaluate the Efficacy and Safety of Saroglitazar Magnesium in Subjects With Primary Biliary Cholangitis (EPICS-III) Rochester, Minn., Jacksonville, Fla.
The purpose of this study is to to evaluate the effectiveness and safety of Saroglitazar Magnesium’s optimal dose (1 or 2 mg) and placebo in subjects with primary biliary cholangitis (PBC).
A Phase 2a Double Blind, Placebo Controlled Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Efficacy of CNP-104 in Subjects Ages 18–75 with Primary Biliary Cholangitis Who Are Unresponsive to UDCA and/or OCA Jacksonville, Fla.
The purpose of this study is to assess the safety and tolerability of CNP-104, and to assess the change in Serum Alkaline Phosphatase (ALP) levels among patients treated with CNP-104 or placebo.
A Prospective, Randomized, Multi-centered, Placebo-controlled, Clinical Trial of Oral Vancomycin in Adults with Primary Sclerosing Cholangitis Rochester, Minn., Jacksonville, Fla., Scottsdale/Phoenix, Ariz.
The purpose of this study is to to assess the effects of different Oral Vancomycin (OV) doses on the clinical and biochemical course in adult patients with Primary Sclerosing Cholangitis (PSC).