96 research outputs found
Integration of Distance Learning Technology into Traditional Engineering Physical Laboratory Exercises
This paper was published in the Proc. of the ASEE SE Section Regional Conference.
The use of distance learning technology in distributed educational environments has allowed engineering courses to be delivered to locations and populations that have historically not been afforded opportunities for involvement. However, efforts to incorporate distance-learning principles into physical laboratory exercises have not led to a general mechanism or procedure for performing physical labs remotely. Removing these exercises from the course is not a satisfactory solution since physical laboratory exercises are a vital component of any educational curriculum in virtually every major field of engineering. Recently, faculty members from three universities in south Georgia have teamed up to collaboratively develop an innovative approach to integrate distance learning technology into traditional engineering physical laboratory exercises. An overview of this project and findings related to its initial phase are presented in this paper
Obeticholic acid for the treatment of non-alcoholic steatohepatitis: interim analysis from a multicentre, randomised, placebo-controlled phase 3 trial
BACKGROUND
Non-alcoholic steatohepatitis (NASH) is a common type of chronic liver disease that can lead to cirrhosis. Obeticholic acid, a farnesoid X receptor agonist, has been shown to improve the histological features of NASH. Here we report results from a planned interim analysis of an ongoing, phase 3 study of obeticholic acid for NASH.
METHODS
In this multicentre, randomised, double-blind, placebo-controlled study, adult patients with definite NASH, non-alcoholic fatty liver disease (NAFLD) activity score of at least 4, and fibrosis stages F2-F3, or F1 with at least one accompanying comorbidity, were randomly assigned using an interactive web response system in a 1:1:1 ratio to receive oral placebo, obeticholic acid 10 mg, or obeticholic acid 25 mg daily. Patients were excluded if cirrhosis, other chronic liver disease, elevated alcohol consumption, or confounding conditions were present. The primary endpoints for the month-18 interim analysis were fibrosis improvement (≥1 stage) with no worsening of NASH, or NASH resolution with no worsening of fibrosis, with the study considered successful if either primary endpoint was met. Primary analyses were done by intention to treat, in patients with fibrosis stage F2-F3 who received at least one dose of treatment and reached, or would have reached, the month 18 visit by the prespecified interim analysis cutoff date. The study also evaluated other histological and biochemical markers of NASH and fibrosis, and safety. This study is ongoing, and registered with ClinicalTrials.gov, NCT02548351, and EudraCT, 20150-025601-6.
FINDINGS
Between Dec 9, 2015, and Oct 26, 2018, 1968 patients with stage F1-F3 fibrosis were enrolled and received at least one dose of study treatment; 931 patients with stage F2-F3 fibrosis were included in the primary analysis (311 in the placebo group, 312 in the obeticholic acid 10 mg group, and 308 in the obeticholic acid 25 mg group). The fibrosis improvement endpoint was achieved by 37 (12%) patients in the placebo group, 55 (18%) in the obeticholic acid 10 mg group (p=0·045), and 71 (23%) in the obeticholic acid 25 mg group (p=0·0002). The NASH resolution endpoint was not met (25 [8%] patients in the placebo group, 35 [11%] in the obeticholic acid 10 mg group [p=0·18], and 36 [12%] in the obeticholic acid 25 mg group [p=0·13]). In the safety population (1968 patients with fibrosis stages F1-F3), the most common adverse event was pruritus (123 [19%] in the placebo group, 183 [28%] in the obeticholic acid 10 mg group, and 336 [51%] in the obeticholic acid 25 mg group); incidence was generally mild to moderate in severity. The overall safety profile was similar to that in previous studies, and incidence of serious adverse events was similar across treatment groups (75 [11%] patients in the placebo group, 72 [11%] in the obeticholic acid 10 mg group, and 93 [14%] in the obeticholic acid 25 mg group).
INTERPRETATION
Obeticholic acid 25 mg significantly improved fibrosis and key components of NASH disease activity among patients with NASH. The results from this planned interim analysis show clinically significant histological improvement that is reasonably likely to predict clinical benefit. This study is ongoing to assess clinical outcomes.
FUNDING
Intercept Pharmaceuticals
VIEW – A Virtual Interactive Web-Based Learning Environment for Engineering
The use of computer-aided and web-based educational technologies such as Virtual Learning Environments (VLE) has increased significantly in the recent past. One example of such a VLE is Virtual Interactive Engineering on the Web (VIEW). VIEW is a 3D virtual, interactive, student-centered, framework of web-based modules based on the Extensible 3D standard. These modules are dedicated to the improvement of student success and learning. In this paper, an overview of the recent developments in VIEW along with associated assessment results is presented. An experimental study was also performed to compare the learning experience and performance of students in a physical dissection activity vs. that in a virtual dissection activity using a VIEW module. The results of this study show that students can meet given learning objectives and that there is limited difference in their learning and performance irrespective of a physical or virtual setting
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