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Compliance Research

01:04 EST 19th February 2018 | BioPortfolio

Lessons from Environmental Regulation.

Much of the most substantive and in-depth experience with formal cost-benefit analysis in the public policy realm has occurred in the context of federal environmental regulation in the United States. This experience has many important lessons to teach in the realm of synthetic biology. Indeed, many of the dangers and pitfalls that arise when decision-makers use formal CBA to evaluate environmental...

Parents' and early adolescents' self-efficacy about anger regulation and early adolescents' internalizing and externalizing problems: A longitudinal study in three countries.

The present study examines whether early adolescents' self-efficacy beliefs about anger regulation mediate the relation between parents' self-efficacy beliefs about anger regulation and early adolescents' internalizing and externalizing problems. Participants were 534 early adolescents (T1: M age = 10.89, SD = .70; 50% female), their mothers (n = 534), and their fathers (n = 431). ...

Improving patient safety during introduction of novel medical devices through cumulative summation analysis.

OBJECTIVE The aim of this study was to implement cumulative summation (CUSUM) analysis as an early-warning detection and quality assurance system for preclinical testing of the iSYS1 novel robotic trajectory guidance system. METHODS Anatomically accurate 3D-printed skull phantoms were created for 3 patients who underwent implantation of 21 stereoelectroencephalography electrodes by surgeons using ...

Optimizing case reports and case series: guidance on how to improve quality.

Case reports and case series remain an important part of journals and are often first to document medical breakthroughs. This article reviews their characteristics, aims and limitations. It provides information on how to increase the validity of the bedside decision-making process that these studies report, using tools such as validated outcomes and split body or n-of-1 trials. A section describin...

Direct Measurement of Charge Regulation in Metalloprotein Electron Transfer.

Quantifying how a protein regulates its net electrostatic charge during electron transfer (ET) is a means of directly measuring factors that contribute to either redox potential and/or reorganization energy. Charge regulation by proteins during ET has never been measured because few tools exist to measure the net charge of a folded protein in solution at different oxidation states. Here, by using ...

Practical recommendations for the evaluation of improvement initiatives.

A lack of clear guidance for funders, evaluators and improvers on what to include in evaluation proposals can lead to evaluation designs that do not answer the questions stakeholders want to know. These evaluation designs may not match the iterative nature of improvement and may be imposed onto an initiative in a way that is impractical from the perspective of improvers and the communities with wh...

Activating Embryonic Development in Drosophila.

The transition from oocyte to embryo marks the onset of development. This process requires complex regulation to link developmental signals with profound changes in mRNA translation, cell cycle control, and metabolism. This control is beginning to be understood for most organisms, and research in the fruit fly Drosophila melanogaster has generated new insights. Recent findings have increased our u...

Significance of Endothelin-1 in Glaucoma - a Short Overview.

This review article is focused on the various facets of possible endothelin's role in glaucoma; involvement of endothelin in other ocular, in particular vascular, diseases is not specifically discussed. Endothelin is an ubiquitous molecule that occurs in practically all ocular tissues. Its primary physiological function is regulation of the blood vessel diameter and hence regulation of the blood s...

The Effects of a Yoga Exercise and Nutritional Guidance Program on Pregnancy Outcomes Among Healthy Pregnant Japanese Women: A Study Protocol for a Randomized Controlled Trial.

This report provides an experimental protocol for a study designed to verify the effects of yoga exercise and a nutritional guidance program during pregnancy on several key pregnancy and birth outcomes among Japanese women.

American Society of Clinical Oncology Statement: Biosimilars in Oncology.

As many biosimilars come to market in the next several years, their use in oncology will play an important role in the future care of patients with cancer. ASCO is committed to providing education and guidance to the oncology community on the use of biosimilars in the cancer setting; therefore, ASCO has developed this statement to offer guidance in the following areas: (1) naming, labeling, and ot...

Residency Applications: Overcoming Redundancy With Disclosure.

Alteration of Epigenetic Regulation by Long Noncoding RNAs in Cancer.

Long noncoding RNAs (lncRNAs) are important regulators of the epigenetic status of the human genome. Besides their participation to normal physiology, lncRNA expression and function have been already associated to many diseases, including cancer. By interacting with epigenetic regulators and by controlling chromatin topology, their misregulation may result in an aberrant regulation of gene express...

Claimed Effects, Outcome Variables and Methods of Measurement for Health Claims on Foods Related to Vision Proposed Under Regulation (EC) 1924/2006.

Adequate visual function has a strong impact on the quality of life of people. Several foods and food components have been hypothesized to play a role in the maintenance of normal visual function and in the prevention of eye diseases. Some of these foods/food components have been the object of a request of authorization for use of health claims under Articles 13(5) or 14 of the Regulation (EC) 192...

Features and regulation of non-enzymatic post-translational modifications.

Non-enzymatic post-translational modifications of proteins can occur when a nucleophilic or redox-sensitive amino acid side chain encounters a reactive metabolite. In many cases, the biological function of these modifications is limited by their irreversibility, and consequently these non-enzymatic modifications are often considered as indicators of stress and disease. Certain non-enzymatic post-t...

The effect of "NutramilTM Complex," food for special medical purpose, on breast and prostate carcinoma cells.

NutramilTM Complex is a multicomponent food product that meets the requirements of a food for special medical purpose. As a complete, high-energy diet it consists of properly balanced nutrients, vitamins and minerals. The aim of this study was to assess the effect of NutramilTM Complex on breast and prostate carcinoma cells. Our results showed that NutramilTM Complex reduced the viability and prol...

Underestimation of spirometry if recommended testing guidance is not followed.

Lung function measured at work is used to make important employment decisions. Improving its quality will reduce misclassification and allow more accurate longitudinal interpretation over time.

Exposure and risk assessment to arsenic species in Spanish children using biomonitoring.

We present a new approach to arsenic (As) risk assessment using biomonitoring. In this pilot study we determined the levels of total and speciated urinary arsenicin 109 Spanish school children aged between 6 and 11 years, and interpreted these concentrations in a risk assessment context. The geometric mean (GM) for total As (TAs) was 33.82 μ/L. The order of occurrence and average concentratio...

HER2 testing of gastro-oesophageal adenocarcinoma: a commentary and guidance document from the Association of Clinical Pathologists Molecular Pathology and Diagnostics Committee.

The use of biologics targeted to the human epidermal growth factor receptor 2 (HER2) protein is the latest addition to the armamentarium used to fight advanced gastric or gastro-oesophageal junction adenocarcinoma. The decision to treat with the biologic trastuzumab is completely dependent on HER2 testing of tumour tissue. In 2017, the College of American Pathologists, American Society for Clinica...

Combining perceptual regulation and exergaming for exercise prescription in low-active adults with and without cognitive impairment.

Exercise adherence in already low-active older adults with and without mild cognitive impairment (MCI) remains low. Perceptual regulation and exergaming may facilitate future exercise behaviour by improving the affective experience, however evidence that this population can perceptually regulate is lacking. To explore this, we investigated 1) perceptual regulation of exercise intensity during eith...

Initiative to improve the cardiogenic safety of antipsychotic medication in community mental health patients.

Serious mental illness is reported to reduce a patient's life expectancy by 15-20 years. This disparity is thought to be related to lifestyle factors, access to healthcare, poor health monitoring and the common use of antipsychotics, which can cause serious metabolic and cardiogenic side effects. Therefore, to reduce the risk of cardiac complications, both national and local guidance recommends an...

Legal Challenges to State Drug Pricing Laws.

Human immunodeficiency virus status disclosure and education for children and adolescents in Papua New Guinea.

How to provide human immunodeficiency virus (HIV) disclosure and awareness for children and young people has not been studied in Papua New Guinea or Pacific Island countries. We aimed to determine the current practices of HIV disclosure and evaluate whether an incremental disclosure education model, as recommended by World Health Organization (WHO), would increase children's knowledge about their ...

Post-translational regulation of the maternal-to-zygotic transition.

The maternal-to-zygotic transition (MZT) is essential for the developmental control handed from maternal products to newly synthesized zygotic genome in the earliest stages of embryogenesis, including maternal component (mRNAs and proteins) degradation and zygotic genome activation (ZGA). Various protein post-translational modifications have been identified during the MZT, such as phosphorylation,...

Associations Between Emotion Regulation and Social Impairment in Children and Adolescents with Autism Spectrum Disorder.

In typically-developing (TD) individuals, effective emotion regulation strategies have been associated with positive outcomes in various areas, including social functioning. Although impaired social functioning is a core criterion of Autism Spectrum Disorder (ASD), the role of emotion regulation ability in ASD has been largely ignored. This study investigated the association between emotion regula...

Does Maternal HIV Disclosure Self-Efficacy Enhance Parent-Child Relationships and Child Adjustment?

Nondisclosure of maternal HIV status to young children can negatively impact child functioning; however, many mothers do not disclose due to lack of self-efficacy for the disclosure process. This study examines demographic variations in disclosure self-efficacy, regardless of intention to disclose, and assesses the relationship between self-efficacy and child adjustment via the parent-child relati...

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