The DSHEA is 30 years old and its place in providing legitimate protections for public health through relevant agency oversight has created a patchwork of legal and scientific requirements. In ...contrast, the European Union has rules on supplements and permitted ingredients. Given the context of a global supply chain for food ingredients any conflict between the legality of ingredients between the U.S/EU can inhibit the economic viability of international trade. The purpose of this review is to contrast these different systems of legislative oversight. The analysis of both markets demonstrates a fragmentation in what are considered legal food ingredients between country wide harmonization and state rules and related interpretation. There are many commonalities in this regard between the U.S/EU, from borderline medicinal classifications to their resultant preclusion from food use. However, the codified legal system existing within the EU and excessive guidance can be viewed as time consuming and inflexible, especially for placing new ingredients on the market. The US in contrast is in a holding pattern for legislative interpretation regarding NDIs, GRAS and possible drug preclusion laws. As we hit the anniversary of the DSHEA recent commentary from U.S./EU central authorities point to increased international co-operation in ingredient safety assessments but whether this results in friction-free access between markets is to be determined.
Ab Initio Determination of Light Hadron Masses Dürr, S; Fodor, Z; Frison, J ...
Science (American Association for the Advancement of Science),
11/2008, Volume:
322, Issue:
5905
Journal Article
Peer reviewed
Open access
More than 99% of the mass of the visible universe is made up of protons and neutrons. Both particles are much heavier than their quark and gluon constituents, and the Standard Model of particle ...physics should explain this difference. We present a full ab initio calculation of the masses of protons, neutrons, and other light hadrons, using lattice quantum chromodynamics. Pion masses down to 190 mega-electron volts are used to extrapolate to the physical point, with lattice sizes of approximately four times the inverse pion mass. Three lattice spacings are used for a continuum extrapolation. Our results completely agree with experimental observations and represent a quantitative confirmation of this aspect of the Standard Model with fully controlled uncertainties.
Arsenic exposure via drinking water increases the risk of chronic respiratory disease in adults. However, information on pulmonary health effects in children after early life exposure is limited.
...This population-based cohort study set in rural Matlab, Bangladesh, assessed lung function and respiratory symptoms of 650 children aged 7-17 years. Children with in utero and early life arsenic exposure were compared with children exposed to less than 10 µg/l in utero and throughout childhood. Because most children drank the same water as their mother had drunk during pregnancy, we could not assess only in utero or only childhood exposure.
Children exposed in utero to more than 500 µg/l of arsenic were more than eight times more likely to report wheezing when not having a cold odds ratio (OR) = 8.41, 95% confidence interval (CI): 1.66-42.6, P < 0.01 and more than three times more likely to report shortness of breath when walking on level ground (OR = 3.86, 95% CI: 1.09-13.7, P = 0.02) and when walking fast or climbing (OR = 3.19, 95% CI: 1.22-8.32, P < 0.01. However, there was little evidence of reduced lung function in either exposure category.
Children with high in utero and early life arsenic exposure had marked increases in several chronic respiratory symptoms, which could be due to in utero exposure or to early life exposure, or to both. Our findings suggest that arsenic in water has early pulmonary effects and that respiratory symptoms are a better marker of early life arsenic toxicity than changes in lung function measured by spirometry.
As more cancer patients survive their disease, concerns about radiation therapy-induced side effects have increased. The concept of radioprotection and radiation injury mitigation and treatment ...offers the possibility to enhance the therapeutic ratio of radiation therapy by limiting radiation therapy-induced normal tissue injury without compromising its antitumor effect. Advances in the understanding of the underlying mechanisms of radiation toxicity have stimulated radiation oncologists to target these pathways across different organ systems. These generalized radiation injury mechanisms include production of free radicals such as superoxides, activation of inflammatory pathways, and vascular endothelial dysfunction leading to tissue hypoxia. There is a significant body of literature evaluating the effectiveness of various treatments in preventing, mitigating, or treating radiation-induced normal tissue injury. Whereas some reviews have focused on a specific disease site or agent, this critical review focuses on a mechanistic classification of activity and assesses multiple agents across different disease sites. The classification of agents used herein further offers a useful framework to organize the multitude of treatments that have been studied. Many commonly available treatments have demonstrated benefit in prevention, mitigation, and/or treatment of radiation toxicity and warrant further investigation. These drug-based approaches to radioprotection and radiation injury mitigation and treatment represent an important method of making radiation therapy safer.
This double‐blind crossover clinical trial randomized 12 adult males to receive 200 mg of caffeine from a green coffee extract, a guayusa leaf extract, and a synthetic control to compare their ...safety, absorption, and effect on neurotransmitters. The results showed no statistically significant changes in blood pressure or heart rate from baseline to 120 min postdose of each natural source compared with changes from baseline in the control (0.094 < = P < = 0.910). The ratios of Cmax, AUC0‐4, and AUC0‐∞ of each natural source to the control were bioequivalent by US Food and Drug Administration standards (90% CI within 80–125%). The guayusa leaf extract stimulated a significantly lower increase in epinephrine compared with the control (+0.5 vs. +2.78 μg/gCr, P = 0.04), while the green coffee extract provoked an increase in epinephrine similar to the control (+3.21 vs. +2.78 μg/gCr, P = 0.569). Implications for future clinical research are discussed.
Abstract Purpose Radiographic lung changes after stereotactic body radiation therapy (SBRT) vary widely between patients. Standardized descriptions of acute (≤6 months after treatment) and late (>6 ...months after treatment) benign lung changes have been proposed but the reliable application of these classification systems has not been demonstrated. Herein, we examine the interobserver reliability of classifying acute and late lung changes after SBRT. Methods and materials A total of 280 follow-up computed tomography scans at 3, 6, and 12 months post-treatment were analyzed in 100 patients undergoing thoracic SBRT. Standardized descriptions of acute lung changes (3- and 6-month scans) include diffuse consolidation, patchy consolidation and ground glass opacity (GGO), diffuse GGO, patchy GGO, and no change. Late lung change classifications (12-month scans) include modified conventional pattern, mass-like pattern, scar-like pattern, and no change. Five physicians scored the images independently in a blinded fashion. Fleiss' kappa scores quantified the interobserver agreement. Results The Kappa scores were 0.30 at 3 months, 0.20 at 6 months, and 0.25 at 12 months. The proportion of patients in each category at 3 and 6 months was as follows: Diffuse consolidation 11% and 21%; patchy consolidation and GGO 15% and 28%; diffuse GGO 10% and 11%; patchy GGO 15% and 15%; and no change 49% and 25%, respectively. The percentage of patients in each category at 12 months was as follows: Modified conventional 46%; mass-like 16%; scar-like 26%; and no change 12%. Uniform scoring between the observers occurred in 26, 8, and 14 cases at 3, 6, and 12 months, respectively. Conclusions Interobserver reliability scores indicate a fair agreement to classify radiographic lung changes after SBRT. Qualitative descriptions are insufficient to categorize these findings because most patient scans do not fit clearly into a single classification. Categorization at 6 months may be the most difficult because late and acute lung changes can arise at that time.
A 13-month-old Korean female presented with Cushing disease and diabetes insipidus. On MRI, a 3.5-cm, focally cystic, contrast-enhancing, sellar and suprasellar mass was noted. Aside from blood ...adrenocorticotropin (ACTH) and cortisol elevation, other pituitary hormone blood levels were normal or markedly reduced. The subtotally resected lesion consisted of synaptophysin-immunoreactive lobules of (a) large, polygonal, amphophilic, PAS-positive cells immunoreactive for ACTH, β-endorphin, alpha melanocyte stimulating hormone (MSH), and keratin (CAM5.2) in some cells showing Crooke hyaline change, (b) less frequent acidophilic, growth hormone (GH) immunoreactive cells, and (c) rare luteinizing hormone (LH) and/or α subunit immunopositive cells. Also conspicuous were smaller cells resembling Rathke-type epithelium forming rosettes to sizable glands immunoreactive for EMA, keratin, S-100 protein, galectin-3 and rarely for synaptophysin and/or one of the above-noted adenohypophysial hormones. Transcription factors, including Neuro-D1 and Pit-1, were present in ACTH- and GH-producing cells, respectively, but only in occasional Rathke-type cells. The MIB-1 labeling index (LI) was 1.5% in secretory cells and 39% in Rathke-type epithelium. Ultrastructurally, the tissue resembled fetal pituitary of 10–12 weeks gestation and contained fully differentiated corticotrophs and somatotrophs, scant cells of glycoprotein-hormone producing type with small secretory granules, and glandular epithelial cells consistent with committed, but largely undifferentiated Rathke-type epithelium. We consider the tumor as a pituitary blastoma, a lesion composed of multiple cell types common to the development of the affected organ based upon (a) prominence of primitive Rathke-type epithelium, (b) disposition of secretory cells in lobules rather than acini, (c) the limited range of secretory cells represented, (d) the presence of their corresponding transcription factors, and (e) ultrastructural features indicating orderly development of the 10- to 12-week embryonic stage.
High-precision scale setting in lattice QCD Borsányi, Szabolcs; Dürr, Stephan; Fodor, Zoltán ...
The journal of high energy physics,
09/2012, Volume:
2012, Issue:
9
Journal Article
Peer reviewed
Open access
A
bstract
Scale setting is of central importance in lattice QCD. It is required to predict dimensional quantities in physical units. Moreover, it determines the relative lattice spacings of ...computations performed at different values of the bare coupling, and this is needed for extrapolating results into the continuum. Thus, we calculate a new quantity,
w
0
, for setting the scale in lattice QCD, which is based on the Wilson flow like the scale
t
0
(M. Luscher,
JHEP
08 (2010) 071). It is cheap and straightforward to implement and compute. In particular, it does not involve the delicate fitting of correlation functions at asymptotic times. It typically can be determined on the few per-mil level. We compute its continuum extrapolated value in 2 + 1-flavor QCD for physical and non-physical pion and kaon masses, to allow for mass-independent scale setting even away from the physical mass point. We demonstrate its robustness by computing it with two very different actions (one of them with staggered, the other with Wilson fermions) and by showing that the results agree for physical quark masses in the continuum limit.
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