HTX-011 reduced pain intensity and opioid consumption versus bupivacaine HCl in bunionectomy: phase III results from the randomized EPOCH 1 study.

BACKGROUND AND OBJECTIVES: There is a need for local anesthetics that provide consistent analgesia through 72 hours after surgery. This study evaluates the use of HTX-011 (bupivacaine and meloxicam in Biochronomerpolymer technology), an extended-release, dual-acting local anesthetic, in reducing both postoperative pain over 72 hours and postoperative opioid use when compared with bupivacaine hydrochloride (HCl) and saline placebo. Inclusion of low-dose meloxicam in HTX-011 is designed to reduce local inflammation caused by surgery, potentiating the analgesic effect of bupivacaine. Previously, significant synergy has been observed with bupivacaine and meloxicam with both given locally together. METHODS: EPOCH 1 was a randomized, double-blind, placebo-controlled and active-controlled phase III study in subjects undergoing a primary unilateral, distal, first metatarsal bunionectomy in which subjects received either a single intraoperative dose of HTX-011, immediate-release bupivacaine HCl or saline placebo. RESULTS: A total of 412 subjects were dosed. The results for the primary and all four key secondary endpoints were statistically significant in favor of HTX-011. HTX-011 demonstrated superior, sustained pain reduction through 72 hours, significantly reduced opioid consumption and resulted in significantly more opioid-free subjects compared with saline placebo and bupivacaine HCl. Safety was similar across groups with fewer opioid-related adverse events observed in the HTX-011 group. CONCLUSIONS: HTX-011 demonstrated significant reduction in postoperative pain through 72 hours with significant reduction in opioid consumption and a significant increase in the proportion of opioid-free subjects compared with saline placebo and the most widely used local anesthetic, bupivacaine HCl. TRIAL REGISTRATION NUMBER: NCT03295721

Environmental Risks to Public Health in the United Arab Emirates: A Quantitative Assessment and Strategic Plan

Background: Environmental risks to health in the United Arab Emirates (UAE) have shifted rapidly from infectious to noninfectious diseases as the nation has developed at an unprecedented rate. In response to public concerns over newly emerging environmental risks, the Environment Agency–Abu Dhabi commissioned a multidisciplinary environmental health strategic planning project

On Symbolic Ultrametrics, Cotree Representations, and Cograph Edge Decompositions and Partitions

Symbolic ultrametrics define edge-colored complete graphs K_n and yield a simple tree representation of K_n. We discuss, under which conditions this idea can be generalized to find a symbolic ultrametric that, in addition, distinguishes between edges and non-edges of arbitrary graphs G=(V,E) and thus, yielding a simple tree representation of G. We prove that such a symbolic ultrametric can only be defined for G if and only if G is a so-called cograph. A cograph is uniquely determined by a so-called cotree. As not all graphs are cographs, we ask, furthermore, what is the minimum number of cotrees needed to represent the topology of G. The latter problem is equivalent to find an optimal cograph edge k-decomposition {E_1,...,E_k} of E so that each subgraph (V,E_i) of G is a cograph. An upper bound for the integer k is derived and it is shown that determining whether a graph has a cograph 2-decomposition, resp., 2-partition is NP-complete

The effect of intermittent umbilical cord occlusion on elastin composition in the ovine fetus.

This study aimed to determine the effect of varying degrees of intermittent umbilical cord occlusion (UCO) on arterial elastin composition. Over 4 days, chronically catheterized late gestation fetal sheep received 5 total UCO per day lasting 1 min/h (mild group: n = 6), 2 min/h (moderate group: n = 4), 3 min/h (severe group; n = 6); or no occlusion (control group: n = 7). Each group was evaluated for elastin content of the carotid and superior mesenteric artery (SMA), the arterial pressure response to UCO, and plasma cortisol concentration. Elastin content of the carotid artery was significantly increased by severe UCO (9.5 µg/mg versus 6.4 µg/mg; P \u3c .05) and insignificantly increased in mild and moderate groups, whereas UCO had no effect on elastin content of the SMA. This dose- and site-dependent response of the vasculature appears attributable to the hemodynamic changes that accompany UCO

Initial experience with magnetic resonance imaging-safe pacemakers: A review

Due of its superior soft tissue imaging capabilities, magnetic resonance imaging (MRI) has become the imaging modality of choice in many clinical situations, as illustrated by the tremendous growth in the number of MRIs performed over the past 2 decades. In parallel, the number of patients who require pacemakers or implantable cardiac defibrillators is increasing as indications for these devices broaden and the population ages. Taken together, these phenomena present an important clinical issue, as MR scans are generally contraindicated—except in urgent situations—in patients who have implanted cardiovascular devices. Potentially deleterious interactions between the magnetic fields and radio frequency (RF) energy produced by MR equipment and implantable devices have been identified, including inhibition of pacing, asynchronous/high-rate pacing, lead tip heating, and loss of capture. New devices that incorporate technologies to improve MR safety in patients with pacemakers have recently received approval in Europe and are under evaluation in the United States. Initial data from these devices suggest that these devices are safe in the MRI environment

Male gender promotes an increased inflammatory response to lipopolysaccharide in umbilical vein blood.

OBJECTIVES: To establish gender-specific differences in maternal and fetal immune response in healthy human fetuses at term. METHODS: Forty-five women with elective caesarean sections for uncomplicated singleton pregnancies were recruited for two studies. Using a multiplex biomarker immunoassay system, unstimulated maternal and fetal plasma concentrations of interleukin (IL)-1β, IL-1ra, IL-6, IL-8, macrophage inflammatory protein (MIP)-1α, and tumor necrosis factor (TNF)-α were measured from one study population. Lipopolysaccharide (LPS)-stimulated cytokine response was measured in a second study. RESULTS: There were no significant gender differences in either maternal or fetal unstimulated plasma cytokine concentrations, but concentrations of the proinflammatory cytokines IL-1β and IL-6 were significantly greater in male fetal LPS-stimulated samples than in female fetal samples. CONCLUSIONS: Blood of male fetuses mounts a larger pro-inflammatory response to lipopolysaccharide (LPS). This heightened response could be a critical pathway in promoting premature rupture of membranes (PPROM) and may be associated with life long differential gender response to infection

The imprints of superstatistics in multiparticle production processes

We provide an update of the overview of imprints of Tsallis nonextensive statistics seen in a multiparticle production processes. They reveal an ubiquitous presence of power law distributions of different variables characterized by the nonextensivity parameter q > 1. In nuclear collisions one additionally observes a q-dependence of the multiplicity fluctuations reflecting the finiteness of the hadronizing source. We present sum rules connecting parameters q obtained from an analysis of different observables, which allows us to combine different kinds of fluctuations seen in the data and analyze an ensemble in which the energy (E), temperature (T) and multiplicity (N) can all fluctuate. This results in a generalization of the so called Lindhard's thermodynamic uncertainty relation. Finally, based on the example of nucleus-nucleus collisions (treated as a quasi-superposition of nucleon-nucleon collisions) we demonstrate that, for the standard Tsallis entropy with degree of nonextensivity q < 1, the corresponding standard Tsallis distribution is described by q' = 2 - q > 1.Comment: 12 pages, 3 figures. Based on invited talk given by Z.Wlodarczyk at SigmaPhi2011 conference, Larnaka, Cyprus, 11-15 July 2011. To be published in Cent. Eur. J. Phys. (2011

Postage stamp multiple anterior capsulorhexisotomies in pediatric cataract surgery

BACKGROUND: Capsule related complications are common following pediatric cataract surgery. We report a new technique of multiple anterior capsulorhexisotomies after lens aspiration and intraocular lens (IOL) implantation. METHODS: After performing automated lens aspiration, an IOL was implanted into the capsular bag. A bent 26 gauge needle was introduced through one side port and multiple small cuts were made in one half of the circumference of the anterior capsular rim by making a radial movement of the needle tip centripetally over the margin of the anterior capsular rim. The needle was again introduced through the other side port and multiple similar cuts were made in the other half thereby creating nearly 20 – 30 cuts at the margin of the anterior capsular rim. RESULTS: The mean size of the primary capsulorhexis was 4.33 ± 0.20 mm. A uniform enlargement of the capsulorhexis could be performed in all the eyes without peripheral extension in any of the eyes. There was no damage to the posterior capsule and no scratch mark on the IOL. In one eye, the primary capsulorhexis was slightly eccentric, though it was covering the IOL optic all around. The rhexisotomies in this eye were limited to the capsular rim that was overlapping more on the IOL optic (sectoral anterior capsulorhexisotomies). CONCLUSION: The technique of postage stamp anterior capsulorhexisotomies is a feasible technique in pediatric cataracts

risk factors associated with road traffic injuries in Mozambique: results of the 2016 INCOMAS study

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