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Objective The objective of this study was to develop metrics to assess opioid prescribing behavior as part of the evaluation of the Extended- Release/ Long- Acting ( ER/ LA) Opioid Analgesic Risk Evaluation and Mitigation Strategies ( REMS). Design Candidate metrics were selected using published guidelines, examined using sensitivity analyses, and applied to cross-sectional rolling cohorts of Medicare patients prescribed with extended-release oxycodone ( ERO) between July 2, 2006 and July 1, 2011. Potential metrics included prescribing opioid-tolerant-only ER/LA opioid analgesics to non-opioid-tolerant patients, prescribing early fills to patients, and ordering drug screens. Results Proposed definitions for opioid tolerance were seven continuous days of opioid usage of at least 30 mg oxycodone equivalents, within the 7 days (primary) or 30 days (secondary) prior to first opioid-tolerant-only ERO prescription. Forty-four percent of opioid-tolerant-only ERO episodes met the primary opioid tolerance definition; 56% met the secondary definition. Fills were deemed 'early' if a prescription was filled before 70% (primary) or 50% (secondary) of the prior prescription's days' supply was to be consumed. Five percent (primary) and 2% (secondary) of episodes had more than or equal to two early fills during treatment. At least one drug screen was billed in 14% of episodes. Stratified analyses indicated that older patients were less likely to be opioid tolerant at the time of the first opioid-tolerant-only ERO prescription. Conclusions Investigators propose three metrics to monitor changes in prescribing behaviors for opioid analgesics that might be used to evaluate the ER/ LA Opioid Analgesics REMS. Low frequencies of patients, particularly those >85 years, were likely to be opioid tolerant prior to receiving prescriptions for opioid-tolerant-only ERO. [ABSTRACT FROM AUTHOR]

Given the increased risk of Guillain-Barré Syndrome (GBS) found with the 1976 swine influenza vaccine, both active surveillance and end-of-season analyses on chart-confirmed cases were performed across multiple US vaccine safety monitoring systems, including the Medicare system, to evaluate the association of GBS after 2009 monovalent H1N1 influenza vaccination. Medically reviewed cases consisted of H1N1-vaccinated Medicare beneficiaries who were hospitalized for GBS. These cases were then classified by using Brighton Collaboration diagnostic criteria. Thirty-one persons had Brighton level 1, 2, or 3 GBS or Fisher Syndrome, with symptom onset 1-119 days after vaccination. Self-controlled risk interval analyses estimated GBS risk within the 6-week period immediately following H1N1 vaccination compared with a later control period, with additional adjustment for seasonality. Our results showed an elevated risk of GBS with 2009 monovalent H1N1 vaccination (incidence rate ratio = 2.41, 95% confidence interval: 1.14,5.11; attributable risk = 2.84 per million doses administered, 95% confidence interval: 0.21, 5.48). This observed risk was slightly higher than that seen with previous seasonal influenza vaccines; however, additional results that used a stricter case definition (Brighton level 1 or 2) were not statistically significant, and our ability to account for preceding respiratory/gastrointestinal illness was limited. Furthermore, the observed risk was substantially lower than that seen with the 1976 swine influenza vaccine. [ABSTRACT FROM AUTHOR]

Results of a radiation creep experiment conducted in the FFTF fast reactor using the MOTA-2B temperature control facility maintained at ±5°C are presented. Helium-pressurized creep tubes were constructed from a reduced activation austenitic Fe-12 Cr-20 Mn-W steel and irradiated in contact with the sodium coolant. Five hoop stress levels were employed ranging from 0 to 140 MPa. The neutron fluence reached varied from 5.3 to 5.8 × 10 n/cm ( E > 0.11 MeV) at target temperatures of 428, 519, and 599°C. The total strains were found to be strongly dependent on irradiation temperature, but not to be completely linear with stress level. The measured stress-free stains are thought to arise from both phase instability and void swelling. [ABSTRACT FROM AUTHOR]

This article describes the derivation of system transfer functions, the analysis of this using Mathematica software, and the construction of Matlab/Simulink system models. Matlab/Simulink system models developed then needed to use a negative-acceleration feedback term, in order to produce a good stabilisation performance. Negative-acceleration minor feedback loops have been used for many years, in rate and position control systems, to modify system responses. However, there is some doubt that this method of modifying system responses had been adequately analysed. [ABSTRACT FROM AUTHOR]

Ternary austenitic model alloys were modified with 0.25?wt.% titanium and irradiated in the Fast Flux Test Reactor (FFTF) at dose rates ranging over more than two orders in magnitude. While lowering of the dose rate strongly increases swelling by shortening the incubation dose, the steady-state swelling rate is not affected by dose rate. Although titanium addition strongly alters the void microstructure, swelling at about 420°C does not change with titanium additions, but the sensitivity to dose rate is preserved. [ABSTRACT FROM AUTHOR]

We summarize and review critically the existing experimental and theoretical evidence concerning both thermal and irradiation-induced high-temperature miscibility gaps in Fe-Ni based Invar-type alloys. Independent data regarding phase separation are obtained from studies on magnetic, low-expansion Invar-type alloys and model austenitic Fe-Ni based alloys studied for potential nuclear applications. The response of these alloys to long-term thermal aging is found to be inconsistent with that of single-phase alloys predicted by most accepted or proposed phase diagrams. These alloys show anomalies in numerous properties which suggest compositional or magnetic heterogeneities or both. We herein model the kinetics and thermodynamics of spinodal decomposition and nucleation in these alloys under thermal conditions. The absence of models for surface energy and gradient energy in systems with negative departure from ideality severely limits our analysis of the kinetics of both nucleation and spinodal decomposition. We can combine our calculations with those of others and also with experimental studies of decomposition to reach a conclusion that suggests a high-temperature miscibility gap for Fe-Ni alloys in the Invar regime. The gap is found to be very narrow at high temperatures but to be broadened at low temperatures by magnetic effects. Alloys in the Invar composition range have been subjected to a variety of high fluence irradiation treatments in the 725 to 1000 K temperature range. The result in most cases was large-scale decomposition into approximately 25 and 50 pet Ni phases. The apparent miscibility gap under irradiation is much wider than that observed thermally. We discuss these observations in the light of existing theories of irradiation-induced or irradiation-altered alloy decomposition. We conclude that although irradiation-enhanced diffusion speeds up phase separation, other processes must be operating to produce the greatly widened miscibility gap. [ABSTRACT FROM AUTHOR]

Radiation may affect the course of a phase transformation in many ways, ranging from such a simple effect as enhanced diffusion or solute segregation to more complex effects such as dissolving thermally stable precipitates, inducing compositional instabilities, or altering phase boundaries. In the case of Invar-type Fe-35Ni- XCr alloys, irradiation-enhanced diffusion of all elements and segregation of nickel at sinks accelerate and make observable a spinodal reaction otherwise observable only after extended thermal annealing. Moreover, irradiation apparently also expands the boundaries of the miscibility gap. Irradiation may also be used to obtain structures unattainable thermally, even through such techniques as rapid quenching from the vapor or liquid. [ABSTRACT FROM AUTHOR]

Radiation may affect the course of a phase transformation in many ways, ranging from such a simple effect as enhanced diffusion or solute segregation to more complex effects such as dissolving thermally stable precipitates, inducing compositional instabilities, or altering phase boundaries. In the case of Invar-type Fe-35Ni- XCr alloys, irradiation-enhanced diffusion of all elements and segregation of nickel at sinks accelerate and make observable a spinodal reaction otherwise observable only after extended thermal annealing. Moreover, irradiation apparently also expands the boundaries of the miscibility gap. Irradiation may also be used to obtain structures unattainable thermally, even through such techniques as rapid quenching from the vapor or liquid. [ABSTRACT FROM AUTHOR]

Six-Month Feeding Study of Fenvalerate in Dogs. Parker, C. M., PICORILLO, V. J., KURTZ, S. L., GARNER, F. M., GARDINER, T. H., AND VAN GELDER, G. A. (1984) . 4, 577–586. Groups of six male and six female Beagle dogs were fed diets containing 0, 250, 500, or 1000 ppm fenvalerate for a period of 6 months. Prominent in-life observations related to treatment were emesis, head shaking, biting of the extremities, ataxia, and tremors. One high-dose male dog was sacrificed in extremis during the study period. Mean body weights of 1000-ppm female dogs were significantly lower than those of controls. Red blood cell counts and hematocrit and hemoglobin values in high-dose male and female dogs were significantly lower than those of controls at most sampling intervals. Serum cholesterol and alkaline phosphatase levels were also increased primarily in the high-dose group. Ophthalmic examination revealed changes in retinal vessel tortuosity in some mid- and high-dose dogs. Hepatic multifocal micro-granulomata were observed in control and treated dogs microscopically. These changes increased in incidence and severity with dose and were considered to be related to treatment Histiocytic cell infiltrate in mesenteric lymph nodes in some 500- and 1000-ppm female and 1000-ppm male dogs was the only other treatment-related microscopic effect. [ABSTRACT FROM PUBLISHER]

Hydrolytic stripping is the process whereby metal ions in a loaded solvent extractant are directly precipitated as oxides or hydroxides by hydrolysis with water, typically at 130° to 200 °C. Hydrolytic stripping tests were carried out in sealed tubes at 200 °C on Versatic 10 solutions of Mg, Ca, Sr, Al, Ti, Cr, Mn, Fe, Co, Ni, Cu, Zn, and Cd, singly and in mixtures. Single solutions of Fe, Ni, Cu, Mg, and Mn precipitated αFeO, Ni(OH), CuO + CuO, Mg(OH), and γMnO, respectively, during testing. Several mixtures of iron with other metals precipitated magnetic spinel ferrites, MFeO. No other combinations of metals formed crystallographically distinctive mixed oxides. [ABSTRACT FROM AUTHOR]

A 59-year-old man with a 4-year history of light chain myeloma relapsing after two preceding autografts and salvage therapy with thalidomide underwent a peripheral blood stem cell (PBSC) transplant from his HLA-identical sister after conditioning with 100 mg/m2melphalan. Graft-versus-host disease (GVHD) prophylaxis comprised cyclosporine. Despite pulmonary infiltrates and sinusitis at the time of the allograft, it was decided to proceed with the transplant because the myeloma was refractory and rapidly progressive. Sputum cultures obtained 2 days before the allograft grew Aspergillus fumigatus 2 days post transplant. A fumigatus grew repeatedly on specimens obtained post transplant. Prompt hematologic recovery was seen with full donor-type chimerism. The fungal infection subsided gradually on a combination of amphotericin B lipid complex and itraconazole. A second aliquot of donor PBSC was infused electively on day +42 to induce graft-versus-myeloma. Complete remission of the myeloma was achieved by 75 days post transplant. No acute GVHD was seen. No chronic GVHD was seen at 16 weeks when he received the third PBSC infusion. He is currently alive and well in remission 9 months post transplant. This case demonstrates the safety and potential usefulness of allogeneic PBSC transplantation with reduced-intensity conditioning in patients with markedly compromised performance status. Bone Marrow Transplantation (2000) 26, 1231–1233. [ABSTRACT FROM AUTHOR]