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Serological assessment of neutrophil elastase activity on elastin during lung ECM remodeling.

May 3, 2015

BMC Pulm Med

Abstract BACKGROUND During the pathological destruction of lung tissue, neutrophil elastase (NE) degrades elastin, one of the major constituents of lung parenchyma. However there are no non-invasive methods to quantify NE degradation of elastin. We selected specific elastin fragments generated by NE for antibody generation and developed an ELISA assay (EL-NE) for the quantification of […]

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Lessons learned from the clinical development of oral peptides.

May 1, 2015

Br J Clin Pharmacol

Abstract The oral delivery of peptides and proteins has been hampered by an array of obstacles. However, several promising novel oral delivery systems have been developed. This paper reviews the most advanced oral formulation technologies, and highlights key lessons and implications from studies undertaken to date with these oral formulations. Special interest is given to […]

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Pro-C5, a marker of true type V collagen formation and fibrillation, correlates with portal hypertension in patients with alcoholic cirrhosis.

May 1, 2015

Scand J Gastroenterol

Abstract BACKGROUND AND AIMS The hepatic venous pressure gradient (HVPG) is an important but invasive diagnostic and prognostic marker in cirrhotic patients. The aim of the study was to evaluate a novel biochemical plasma marker of true type V collagen formation (Pro-C5) for describing HVPG. METHODS Ninety-four patients mainly with alcoholic cirrhosis and fourteen liver-healthy […]

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Guidelines for the standardization of preanalytic variables for blood-based biomarker studies in Alzheimer’s disease research.

May 1, 2015

Alzheimers Dement

Abstract The lack of readily available biomarkers is a significant hindrance toward progressing to effective therapeutic and preventative strategies for Alzheimer’s disease (AD). Blood-based biomarkers have potential to overcome access and cost barriers and greatly facilitate advanced neuroimaging and cerebrospinal fluid biomarker approaches. Despite the fact that preanalytical processing is the largest source of variability […]

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Impact of source data verification on data quality in clinical trials: an empirical post hoc analysis of three phase 3 randomized clinical trials.

April 1, 2015

Br J Clin Pharmacol

Abstract AIM The aim of this project was to perform an empirical evaluation of the impact of on site source data verification (SDV) on the data quality in a clinical trial database to guide an informed decision on selection of the monitoring approach. METHODS We used data from three randomized phase III trials monitored with […]

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OA phenotypes, rather than disease stage, drive structural progression–identification of structural progressors from 2 phase III randomized clinical studies with symptomatic knee OA.

April 1, 2015

Osteoarthritis Cartilage

Abstract BACKGROUND/PURPOSE The aim of this study was to identify key characteristics of disease progression through investigation of the association of radiographic progression over two years with baseline Joint Space Width (JSW), Kellgren-Lawrence (KL) grade, Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain, Joint Space Narrowing (JSN), and BMI. METHODS Data from 2206 subjects […]

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Treatment of symptomatic knee osteoarthritis with oral salmon calcitonin: results from two phase 3 trials.

April 1, 2015

Osteoarthritis Cartilage

Abstract PURPOSE To evaluate the structure-modifying and symptom efficacy, as well as safety and tolerability of oral salmon calcitonin (sCT) formulated with a 5-CNAC carrier (a molecule based on Eligen(®) technology), in osteoarthritis (OA) patients with moderate to severe knee pain and joint structural damage classified as Kellgren and Lawrence (KL)2-3. METHODS AND DESIGN This […]

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The importance of extracellular matrix for cell function and in vivo likeness.

April 1, 2015

Exp Mol Pathol

Abstract OBJECTIVE Fibrotic diseases may be described as a disease of the extracellular matrix, where the balance between matrix formation and degradation has been shifted leading to an accumulation of matrix. Currently a fit for purpose model and readily available approach are adapted when doing cell cultures, which may not reflect physiology and pathophysiology optimally. […]

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Biological relevance of citrullinations: diagnostic, prognostic and therapeutic options.

March 1, 2015

Autoimmunity

Abstract OBJECTIVE Citrullination has become a hot topic within recent years due to its involvement in diseases such as rheumatoid arthritis (RA), multiple sclerosis and fibrosis. Citrullinations are the conversion of arginine to citrulline by peptidylarginine deiminase (PAD) enzymes, which affect protein properties. The aim of this review is to summarize the advances in citrullination […]

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