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Clinical Approvals Research

05:05 EDT 18th July 2018 | BioPortfolio

DNA microarray technology and bioinformatic web services.

The pan-genomic microarray technique is used for environmental and/or clinical studies. Although microarray is an accurate and sharp diagnostic tool, the expertized bioinformaticians were able to minimize the outcome biases and maximize the flexibility and accuracy of the technique. The knowledge of bioinformatics plays a key role in association with probe designing and the utilization of correct ...

Computational biomechanical analysis of postoperative inferior tibiofibular syndesmosis: a modified modeling method.

To analyze the biomechanical effect of syndesmotic screw through three and four cortices, a total of 12 finite element models simulating healthy ankles, tibiofibular syndesmosis injured ankles, and post-operative ankles by screw fixations through three or four cortices were built. A set of biomechanical data were obtained to find that screw fixation methods for inferior tibiofibular syndesmosis ca...

DRESS Following FIRES: A Clinical Conundrum.

Including gaming disorder in the ICD-11: The need to do so from a clinical and public health perspective.

The proposed introduction of gaming disorder (GD) in the 11th revision of the International Classification of Diseases (ICD-11) developed by the World Health Organization (WHO) has led to a lively debate over the past year. Besides the broad support for the decision in the academic press, a recent publication by van Rooij et al. (2018) repeated the criticism raised against the inclusion of GD in ...

Responsive Polymer Conjugates for Drug Delivery Applications: Recent Advances in Bioconjugation Methodologies.

Protein-polymer conjugates have achieved tremendous attention in the last few years, since their importance in diverse fields including drug delivery, biotechnology, and nanotechnology. Over the past few years, numerous chemical strategies have been developed to conjugate different synthetic polymers onto proteins and great progress has been made. Currently, there are a handful of therapeutic poly...

The role of "Integrated Pulmonary Index" monitoring during morphine-based intravenous patient-controlled analgesia administration following supratentorial craniotomies: a prospective, randomized, double-blind controlled study.

Morphine is commonly used in postoperative analgesia, but opioid related respiratory depression causes a general reluctance for its use. The "Integrated Pulmonary Index" is a tool calculated from noninvasively obtained respiratory and hemodynamic parameters. The aim of this prospective, randomized, double blind and placebo-controlled study is to determine more safe and effective dose for morphine ...

The benefits of practical clinical trials over traditional randomized clinical trialsfor opioid management.

The efficacy of inhaled antibiotics in non-cystic fibrosis bronchiectasis.

Non-cystic fibrosis bronchiectasis (NCFB) is considered a chronic heterogenic pulmonary disease, characterized by the permanent and abnormal enlargement and thickening of bronchial walls, impaired mucociliary clearance and suppuration. Inhaled antibiotics have been used for a long time in patients with cystic fibrosis but are seldom used in those with NCFB and few randomized clinical trials are av...

Quantitation of intracellular triphosphate metabolites of antiretroviral agents in peripheral blood mononuclear cells (pbmcs) and corresponding cell count determinations: review of current methods and challenges.

PBMCs are a critical component of the immune system and the target cells for HIV-1 infection. Nucleoside/nucleotide analogs for the treatment of HIV infection are prodrugs that require cellular activation to triphosphate (TP) metabolites for antiviral activity. A reliable method of PBMC isolation and subsequent cell counting, as well as an accurate bioanalytical determination of the TPs in PBMCs a...

Precision dosing in clinical medicine: present and future.

Clinical Profile of HLA B-27-Associated Uveitis Patients in a Tertiary Care Eye Hospital in Eastern India.

To analyse clinical profile of the patients with HLA B 27- associated uveitis in a tertiary care eye hospital in Eastern India Method: Retrospective analysis of 61 eyes of 43 patients with HLA B27- associated uveitis between 2015 and 2016.

Effect of Vitamin E Supplementation on Plasma and Urine Levels of Isoprostane F2α in Randomized Controlled Clinical Trials: A Systematic Review and Meta-Analysis.

Vitamin E can reduce the level of lipid peroxidation and the related markers such as urine and plasma levels of isoprostanes. However, effects of vitamin E supplementation on plasma and urine level of isoprostane F2α as markers of lipid peroxidation were conflicting in various clinical trials. The current meta-analysis was carried out to determine the effects of vitamin E supplementation on plasm...

Calcium and zinc tune autoinflammatory toll-like receptor 4 signaling by S100A12.

S100A12 is highly overexpressed in certain autoinflammatory diseases. Here we describe, that upon cellular release Ca and Zn can operate as molecular switch rendering S100A12 into a toll-like receptor 4-ligand to trigger sterile inflammation.

Can atlas-based auto-segmentation ever be perfect? Insights from Extreme Value Theory.

Atlas-based segmentation is used in radiotherapy planning to accelerate the delineation of organs at risk (OARs). Atlas selection has been proposed to improve the performance of segmentation, assuming that the more similar the atlas is to the patient the better the result. It follows that the larger the database of atlases from which to select, the better the results should be. This work seeks to ...

MedCo: Enabling Secure and Privacy-Preserving Exploration of Distributed Clinical and Genomic Data.

The increasing number of health-data breaches is creating a complicated environment for medical-data sharing and, consequently, for medical progress. Therefore, the development of new solutions that can reassure clinical sites by enabling privacy-preserving sharing of sensitive medical data in compliance with stringent regulations (e.g., HIPAA, GDPR) is now more urgent than ever. In this work, we ...

Drug repositioning for schizophrenia and depression/anxiety disorders: A machine learning approach leveraging expression data.

Development of new medications is a lengthy and costly process, and drug repositioning might help to shorten the development cycle. We present a machine learning (ML) workflow to drug discovery or repositioning by predicting indication for a particular disease based on drug expression profiles, with a focus on applications in psychiatry. Drugs that are not originally indicated for the disease but ...

Antisense oligonucleotides extend survival and reverse decrement in muscle response in ALS models.

Mutations in superoxide dismutase 1 (SOD1) are responsible for 20% of familial ALS. Given the gain of toxic function in this dominantly inherited disease, lowering SOD1 mRNA and protein is predicted to provide therapeutic benefit. An early generation antisense oligonucleotide (ASO) targeting SOD1 was identified and tested in a phase I human clinical trial, based on modest protection in animal mode...

Physiological responses to leptin levels in lipodystrophy: a model for other hypoleptinemias?

Brown et al. report that two weeks of exogenous leptin administration to leptin-naive individuals with lipodystrophy resulted in increased energy expenditure and lipolysis, decreased ectopic liver fat, improved hepatic and peripheral insulin sensitivity, and attenuated dyslipidemia. Leptin withdrawal in individuals with lipodystrophy did not produce reciprocal effects on these phenotypes and resul...

Reinforcing our pipeline: trainee-driven approaches to improving physician-scientist training.

A tribute to Donald W. Seldin.

Balancing dual demands on the physician-scientist workforce.

Accelerating the reversal of inflammatory pain with NPD1 and its receptor GPR37.

Resolution of inflammation is a critical process that is facilitated by specialized proresolving mediators (SPMs). In this issue, Bang et al. show that the G protein-coupled receptor GPR37 is a receptor for one such SPM, neuroprotectin D1. They also show that GPR37 activation in macrophages enhances phagocytosis, shifts cytokine release toward an antiinflammatory profile, and thereby helps to reve...

Hemophagocytic Lymphohistiocytosis: Potentially Underdiagnosed in Intensive Care Units.

Hemophagocytic lymphohistiocytosis in adults (aHLH) is a rare life-threatening hyperinflammatory syndrome caused by excessive activation of macrophages and CD8+ T-cells. Due to the clinical overlap with severe sepsis, aHLH often remains undiagnosed resulting in poor outcome. Here, we present a retrospective study of incidence, clinical findings, and the outcome of aHLH in intensive care units (ICU...

Preclinical Assessment of the Bioactivity of the Anticancer Coumarin OT48 by Spheroids, Colony Formation Assays, and Zebrafish Xenografts.

In vitro and in vivo pre-clinical screening of novel therapeutic agents are an essential tool in cancer drug discovery. Although human cancer cell lines respond to therapeutic compounds in 2D (dimensional) monolayer cell cultures, 3D culture systems were developed to understand the efficacy of drugs in more physiologically relevant models. In recent years, a paradigm shift was observed in pre-clin...

Multiplexed identification, quantification and genotyping of infectious agents using a semiconductor biochip.

The emergence of pathogens resistant to existing antimicrobial drugs is a growing worldwide health crisis that threatens a return to the pre-antibiotic era. To decrease the overuse of antibiotics, molecular diagnostics systems are needed that can rapidly identify pathogens in a clinical sample and determine the presence of mutations that confer drug resistance at the point of care. We developed a ...

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