2 research outputs found

    Adult Strider

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    The goal of the Strider project was to create a mobility device that would support a person with weakened leg strength and allow them to push the device around with their legs and build more leg strength. There are many health benefits to standing and the Strider was intended to help a person with a disability experience these benefits. The Strider is a fully independent device that the user can get into and maneuver without assistance. The device is also safe, highly maneuverable, and complies with all ADA standards and requirements. The design is built around a frame that supports the user. A lowered push-off bar allows the user to push out of his wheel chair and the frame supports the user’s weight. The user then uses the transfer seat to get into the device. The transfer seat locks in the downward position so the user can sit in it while getting into the harness. Once the harness is attached, the transfer seat can be unlocked and swung back out of the way and the torso support system then is closed. At this point the harness supports the majority of the user’s weight and the user can now move the device around with his legs. Testing showed that a user can get into the device without help. However, the process is much more involved than originally believed, but with practice our user can learn how to transfer easily. The device moves very well for a person who is used to controlling their legs. However, for a person with less practice, accurately steering the Strider is a little trickier. Overall, the Strider fulfills the goals of the project. The user can get into the device and maneuver it around. The device also gives the user a workout. Future projects that are similar might want to look for alternative wheels that can provide better traction on smooth surfaces. This is especially important when the user is getting into the device and the brakes are on. As of now, the device slips a little on smooth floors while the user is getting into it. Lastly, having more adjustable arm rests would be beneficial

    Obeticholic acid for the treatment of non-alcoholic steatohepatitis: interim analysis from a multicentre, randomised, placebo-controlled phase 3 trial

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    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 oneaccompanying 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 endpointsfor 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
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