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Ringe J.D.,Klinikum Leverkusen GmbH | Schafer S.,AMS Services | Wimmer A.M.,Janssen Cilag GmbH | Giesecke T.,Janssen Cilag GmbH
Wiener Klinische Wochenschrift | Year: 2012

Objective: To determine the effect of a lower starting dose of OROS ® hydromorphone compared with a higher starting dose. Design: Data from the first 15 days of treatment were compared in a combined analysis of three prospective, non-interventional studies. Setting: Non-interventional, carried out in daily routine settings. Patients: Patients had chronic severe pain due to osteoarthritis or from fragility fractures related to osteoporosis. Interventions: OROS-ANA-4001 and OROS-ANA-4002 had a daily starting dose of 8 mg of OROS ® hydromorphone; OROS-ANA-4003 had a daily starting dose of 4 mg. Main Outcome Measure(s): A post-hoc analysis to assess the effect of a low starting dose of OROS ® hydromorphone on tolerability, pain control, and treatment satisfaction overall and for subgroups of opioid-naïve patients versus patients previously treated with opioids, and patients aged>65 years versus patients aged≤65 years. Results: Treatment satisfaction and pain control improved in all studies; treatment satisfaction improved in a higher percentage ofipatients in the lower starting dose group. Gastrointestinal disorders were the most frequent treatment-emergent adverse events. Incidence ofinausea was comparable between studies. Incidence of constipation, vomiting, fatigue, and pruritus was less frequent with the lower starting dose. In elderly and opioid-naïve patients, a lower starting dose was associated with lower overall incidence of adverse events, treatment-related adverse events, and those leading to discontinuation. Conclusions: A lower starting dose was associated with better tolerability and a lower number of treatment terminations at a comparable level of pain control with high treatment satisfaction. © Springer-Verlag 2012.

Diepgen T.L.,University of Heidelberg | Pfarr E.,AMS Services | Zimmermann T.,Basilea Pharmaceutica Deutschland GmbH
Acta Dermato-Venereologica | Year: 2012

This non-interventional observational open study (TOCCATA, sponsored by Basilea Pharmaceutica Germany) investigated the use of alitretinoin to treat chronic hand eczema under daily "real life" medical practice conditions in Germany. A total of 349 dermatologists throughout Germany enrolled 680 adult patients with chronic hand eczema. Patients were prescribed and treated with alitretinoin in accordance with the summary of product characteristics. The maximum observation duration was 24 weeks, with efficacy and safety parameters evaluated every 4 weeks. Efficacy was primarily evaluated by assessing disease severity according to the Physician Global Assessment. In total, 56.7% of patients achieved a Physician Global Assessment rating of "clear" or "almost clear" hands, with only small differences in patients with different morphological forms: hyperkeratotic-rhagadiform (59.2%), fingertip (52.2%) and vesicular (47.9%). This observational study demonstrates the effectiveness and tolerability of alitretinoin in everyday clinical practice in addition to the known efficacy and safety obtained by randomized controlled clinical trials. © 2012 The Authors.

PubMed | University of Leipzig, Praxiszentrum St. Bonifatius, University of Würzburg, Rheumatologische Schwerpunktpraxis and 9 more.
Type: Journal Article | Journal: Arthritis care & research | Year: 2016

To validate standard self-report questionnaires for depression screening in patients with rheumatoid arthritis (RA) and compare these measures to one another and to the Montgomery-sberg Depression Rating Scale (MADRS), a standardized structured interview.In 9 clinical centers across Germany, depressive symptomatology was assessed in 262 adult RA patients at baseline (T0) and at 122 weeks followup (T1) using the World Health Organization 5-Item Well-Being Index (WHO-5), the Patient Health Questionnaire (PHQ-9), and the Beck Depression Inventory II (BDI-II). The construct validity of these depression questionnaires (using convergent and discriminant validity) was evaluated using Spearmans correlations at both time points. The test-retest reliability of the questionnaires was evaluated in RA patients who had not undergone a psychotherapeutic intervention or received antidepressants between T0 and T1. The sensitivity and the specificity of the questionnaires were calculated using the results of the MADRS, a structured interview, as the gold standard.According to Spearmans correlation coefficients, all questionnaires met convergent validity criteria ( > |0.50|), with the BDI-II performing best, while correlations with age and disease activity for all questionnaires met the criteria for discriminant validity ( < |0.50|). The only questionnaire to meet the predefined retest reliability criterion ( 0.70) was the BDI-II (rThe BDI-II best met the predefined criteria, and the PHQ-9 met most of the validity criteria, with lower sensitivity and specificity.

Gray P.J.,Joint Pathology Center | Zhang L.,AMS Services | Xu H.,Joint Pathology Center | McDiarmid M.,University of Maryland, Baltimore | And 2 more authors.
Microchemical Journal | Year: 2012

Isotopic ratios of urinary uranium (U) provide a decisive tool in diagnosing a patient's potential exposure to depleted uranium (DU). This study investigated the measurement of urinary 236U/ 238U and 235U/ 238U ratios of ultra trace concentrations using a sector field inductively coupled plasma mass spectrometer (ICP-MS). Uranium was separated from the urinary matrix and pre-concentrated by co-precipitation with calcium and magnesium after addition of ammonium hydroxide. The precipitates were collected, dissolved and analyzed by ICP-MS. 235U/ 238U and 236U/ 238U ratios were measured using a desolvating sample introduction system and a sector field ICP-MS. These ratios were accurately measured in samples containing as low as 5ngL -1 U. 236U measurement was hindered by abundance sensitivity limitations and uranium hydride ( 235UH) formation. Measured 235U/ 238U and 236U/ 238U ratios were about 7×10 -3 and <5×10 -6, respectively, in urine samples from patients not exposed to DU. The 235U/ 238U ratio was consistently about 2×10 -3 in 12 urine samples from patients with embedded fragments of DU, while the corresponding ratio of 236U/ 238U ranged from 9×10 -6 to 33×10 -6. This wide range in 236U/ 238U ratios might suggest different sources of depleted uranium in those DU-urine samples. It is proposed that 235U/ 238U and 236U/ 238U ratios are 7×10 -3 and <5×10 -6, respectively, in urine samples from individuals not exposed to DU, and 2×10 -3 and >7×10 -6, respectively, in urine samples from DU-exposed individuals. © 2012.

Hashemian H.M.,AMS Services | Bean W.C.,Lamar University
IEEE Transactions on Instrumentation and Measurement | Year: 2011

This paper discusses the limitations of time-based equipment maintenance methods and the advantages of predictive or online maintenance techniques in identifying the onset of equipment failure. The three major predictive maintenance techniques, defined in terms of their source of data, are described as follows: 1) the existing sensor-based technique; 2) the test-sensor-based technique (including wireless sensors); and 3) the test-signal-based technique (including the loop current step response method, the time-domain reflectrometry test, and the inductance-capacitance-resistance test). Examples of detecting blockages in pressure sensing lines using existing sensor-based techniques and of verifying calibration using existing-sensor direct current output are given. Three Department of Energy (DOE)-sponsored projects, whose aim is to develop online and wireless hardware and software systems for performing predictive maintenance on critical equipment in nuclear power plants, DOE research reactors, and general industrial applications, are described. © 2011 IEEE.

Kiger C.J.,AMS Services | Lowe C.L.,AMS Services
9th International Topical Meeting on Nuclear Plant Instrumentation, Control, and Human-Machine Interface Technologies, NPIC and HMIT 2015 | Year: 2015

Wireless technologies have increased efficiency in many industrial settings across the world by enabling a mobile workforce and improving communications. Unfortunately, the nuclear power industry has been slow to adopt wireless technology as a result of safety, security, and reliability concerns expressed by regulators and others. A Research and Development (R&D) effort is currently being conducted to address two significant technical concerns for the introduction of wireless technology in nuclear power plants which are wireless electromagnetic compatibility (EMC) and wireless coexistence. Most equipment in nuclear power plants has never been tested for vulnerability to wireless transmission. As such, the impact of modern wireless devices on nuclear safety and plant reliability is not understood. Existing guidance from the Nuclear Regulatory Commission (NRC) and Electric Power Research Institute (EPRI) rely on the use of exclusion zones to protect plant equipment which can results in exclusion zones of up to eight feet for some tablet devices rendering them ineffective for the mobile workforce. Another unknown is how different wireless devices will operate in close proximity to one another in the harsh electromagnetic environment of a nuclear power plant. These issues will be addressed through laboratory experiments to characterize the attributes of wireless devices and in-plant evaluations to identify the vulnerabilities of plant equipment. Based upon the results, test methods will be developed for laboratory qualification testing and for performing in-situ measurements to determine the immunity of plant equipment and coexistence of wireless technologies. The R&D work will provide the objective guidance for the nuclear industry in the two areas mentioned and will develop a cognitive radio system for in-plant EMC and coexistence testing. The system will assist in the seamless use of wireless technology in nuclear power plants while greatly reducing the risks wireless may introduce.

Schiffner-Rohe J.,Pfizer | Witt A.,AMS Services | Hemmerling J.,AMS Services | Von Eiff C.,Pfizer | Leverkus F.-W.,Pfizer
PLoS ONE | Year: 2016

Background: Pneumococcal community-acquired pneumonia (pCAP) is the most frequent form of pneumonia. The elderly and adults with underlying diseases are at an increased risk of developing pCAP. The 23-valent pneumococcal polysaccharide vaccine (PPV23) was licensed over 30 years ago and is recommended as the standard intervention in many countries across the globe, although its efficacy continues to be debated. We performed a meta-analysis of randomized controlled trials (RCTs) to investigate the effect of PPV23 for preventing pCAP in adults ≥60 years of age. Methods: An existing Cochrane Review was updated to Oct 2014 using a systematic literature search to select appropriate RCTs. DerSimonian and Laird random-effects meta-analyses were performed and odd ratios (OR) with 95%-confidence intervals (CI) and p-values were calculated for the descriptive analyses. Reasons for heterogeneity were explored by subgroup analyses. Results: Meta-analysis of PPV23 efficacy included four studies. Three of them did not demonstrate efficacy for PPV23. The body of evidence indicated statistically significant heterogeneity (I2 = 78%, p = 0.004) that could be explained by subgroup analysis by "study setting". Further effect modifiers for pCAP were "continent of trial" (p<0.01), and "method of pneumococcal diagnostics" (p = 0.001). Subgroup analyses revealed that the only study showing efficacy for PPV23 was an outlier. Overall, the validity of the meta-analytic PPV23 efficacy assessment was confirmed by the meta-analysis of all-cause CAP including six studies. Discussion: Inconsistencies in PPV23 treatment effects to prevent pCAP could solely be explained by one outlier study that was performed in nursing homes in Japan. The effect modifier "method of pneumococcal diagnostics" should be interpreted carefully, since methodological weaknesses are not restricted to one special method only, which would justify the exclusion of certain studies. Overall, we conclude from our meta-analysis that to date there is no proof that PPV23 can prevent pCAP in a general, community-dwelling elderly population. © 2016 Schiffner-Rohe et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Serth K.,Institute For Molekularbiologie Oe5250 | Schuster-Gossler K.,Institute For Molekularbiologie Oe5250 | Kremmer E.,Helmholtz Center for Environmental Research | Hansen B.,Institute For Molekularbiologie Oe5250 | And 3 more authors.
PLoS ONE | Year: 2015

Delta-like 3 (DLL3) is a member of the DSL family of Notch ligands in amniotes. In contrast to DLL1 and DLL4, the other Delta-like proteins in the mouse, DLL3 does not bind in trans to Notch and does not activate the receptor, but shows cis-interaction and cis-inhibitory properties on Notch signaling in vitro. Loss of the DSL protein DLL3 in the mouse results in severe somite patterning defects, which are virtually indistinguishable from the defects in mice that lack lunatic fringe (LFNG), a glycosyltransferase involved in modifying Notch signaling. Like LFNG, DLL3 is located within the trans-Golgi, however, its biochemical function is still unclear. Here, we show that i) both proteins interact, ii) epidermal growth factor like repeats 2 and 5 of DLL3 are O-fucosylated at consensus sites for POFUT1, and iii) further modified by FNG proteins in vitro. Embryos double homozygous for null mutations in Dll3 and Lfng are phenotypically indistinguishable from the single mutants supporting a potential common function. Mutation of the O-fucosylation sites in DLL3 does not disrupt the interaction of DLL3 with LFNG or full length Notch1or DLL1, and O-fucosylation-deficient DLL3 can still inhibit Notch in cis in vitro. However, in contrast to wild type DLL3, O-fucosylation-deficient DLL3 cannot compensate for the loss of endogenous DLL3 during somitogenesis in the embryo. Together our results suggest that the cis-inhibitory activity of DLL3 observed in cultured cells might not fully reflect its assumed essential physiological property, suggest that DLL3 and LFNG act together, and strongly supports that modification of DLL3 by O-linked fucose is essential for its function during somitogenesis. © 2015 Serth et al.

Brooks M.S.,AMS Services
Bulletin of the American Meteorological Society | Year: 2013

Mark S. Brooks suggests that engagement, entrepreneurship, and evaluation are the key drivers of innovative and transformative services that will help citizens, businesses, and governments manage climate risks. Innovations are needed to help citizens, businesses, and governments deal with the impacts of climate change and variability. Climate services provide decision support with climate data, future projections, applied research, and integration with other environmental or socioeconomic datasets and models. Climate services at all levels help clients manage climate-related risks and capitalize on favorable conditions. These services focus on long-term decision support early warning systems and help clients understand the impact of climate on their decisions and actions. A climate services enterprise that enables discontinuous, disruptive, and transformative innovations will help climate sensitive clients solve problems in new ways with new data products and services.

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