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UNLABELLED Glycerol phenylbutyrate (GPB) lowers ammonia by providing an alternate pathway to urea for waste nitrogen excretion in the form of phenylacetyl glutamine, which is excreted in urine. This randomized, double-blind, placebo-controlled phase II trial enrolled 178 patients with cirrhosis, including 59 already taking rifaximin, who had experienced two(More)
BACKGROUND Increased expression of nerve growth factor in injured or inflamed tissue is associated with increased pain. This proof-of-concept study was designed to investigate the safety and analgesic efficacy of tanezumab, a humanized monoclonal antibody that binds and inhibits nerve growth factor. METHODS We randomly assigned 450 patients with(More)
BACKGROUND German anesthesiologists have long used transcutaneous electrical stimulation of an acupuncture point near the tragus to reduce anesthetic requirement in unblinded and uncontrolled trials. This is known as auricular electrically stimulated analgesia. The authors therefore tested the hypothesis that auricular electrically stimulated analgesia(More)
Users may view, print, copy, and download text and data-mine the content in such documents, for the purposes of academic research, subject always to the full Conditions of use: are employees of Hyperion. None of the other authors have a financial interest in Hyperion, although payments were made by Hyperion to each of the study sites for services provided(More)
BACKGROUND Little prospectively collected data are available comparing the dietary intake of urea cycle disorder (UCD) patients to UCD treatment guidelines or to healthy individuals. OBJECTIVE To examine the protein and calorie intakes of UCD subjects who participated in clinical trials of glycerol phenylbutyrate (GPB) and compare these data to published(More)
Clinical management and clinical trials of patients with overt hepatic encephalopathy (OHE) are compromised by lack of standardized and reproducible tools for its clinical diagnosis or for caregiver (CG) identification of OHE manifestations which merit medical evaluation. Using an iterative Delphi method, Steering Committee and international hepatologist(More)
Current approaches to detection of drug-induced liver injury (DILI) are generally based on changes from normal in biochemical liver tests. However, limited information is available regarding the proportion of patients with normal versus abnormal biochemical tests, the expected temporal pattern of biochemical abnormalities, or the applicability of current(More)
Granulomatosis with polyangiitis (formerly Wegener's) (GPA) and microscopic polyangiitis (MPA) share many clinical and pathological features, including antineutrophil cytoplasmic antibodies (ANCA) directed against either proteinase 3 (PR3) or myeloperoxidase (MPO). These two " ANCA-associated " vasculitides (AAV) are associated with a high mortality in(More)
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