International Conference on Harmonisation; Guidance on M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals; availability. Notice.

Science.gov (United States)

2010-01-21

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals.'' The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance, which is a revision of an existing guidance, discusses the types of nonclinical studies, their scope and duration, and their relation to the conduct of human clinical trials and marketing authorization for pharmaceuticals. The guidance is intended to facilitate the timely conduct of clinical trials and reduce the unnecessary use of animals and other drug development resources.

Nonclinical cardiovascular safety of pitolisant: comparing International Conference on Harmonization S7B and Comprehensive in vitro Pro-arrhythmia Assay initiative studies.

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Ligneau, Xavier; Shah, Rashmi R; Berrebi-Bertrand, Isabelle; Mirams, Gary R; Robert, Philippe; Landais, Laurent; Maison-Blanche, Pierre; Faivre, Jean-François; Lecomte, Jeanne-Marie; Schwartz, Jean-Charles

2017-12-01

We evaluated the concordance of results from two sets of nonclinical cardiovascular safety studies on pitolisant. Nonclinical studies envisaged both in the International Conference on Harmonization (ICH) S7B guideline and Comprehensive in vitro Pro-arrhythmia Assay (CiPA) initiative were undertaken. The CiPA initiative included in vitro ion channels, stem cell-derived human ventricular myocytes, and in silico modelling to simulate human ventricular electrophysiology. ICH S7B-recommended assays included in vitro hERG (K V 11.1) channels, in vivo dog studies with follow-up investigations in rabbit Purkinje fibres and the in vivo Carlsson rabbit pro-arrhythmia model. Both sets of nonclinical data consistently excluded pitolisant from having clinically relevant QT-liability or pro-arrhythmic potential. CiPA studies revealed pitolisant to have modest calcium channel blocking and late I Na reducing activities at high concentrations, which resulted in pitolisant reducing dofetilide-induced early after-depolarizations (EADs) in the ICH S7B studies. Studies in stem cell-derived human cardiomyocytes with dofetilide or E-4031 given alone and in combination with pitolisant confirmed these properties. In silico modelling confirmed that the ion channel effects measured are consistent with results from both the stem cell-derived cardiomyocytes and rabbit Purkinje fibres and categorized pitolisant as a drug with low torsadogenic potential. Results from the two sets of nonclinical studies correlated well with those from two clinical QT studies. Our findings support the CiPA initiative but suggest that sponsors should consider investigating drug effects on EADs and the use of pro-arrhythmia models when the results from CiPA studies are ambiguous. © 2017 The Authors. British Journal of Pharmacology published by John Wiley & Sons Ltd on behalf of British Pharmacological Society.

Graduating med-peds residents' interest in part-time employment.

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Fix, Amy L; Kaelber, David C; Melgar, Thomas A; Chamberlain, John; Cull, William; Robbins, Brett W

2011-01-01

As part-time work is becoming more popular among the primary care specialties, we examined the demographic descriptors of med-peds residents seeking and finding part-time employment upon completion of residency training. As part of the 2006 annual American Academy of Pediatrics (AAP) Graduating Med-Peds Residents Survey, we surveyed the graduating residents of all med-peds programs about their interest in and plans for part-time employment. A total of 199 (60%) of the residents responded. Of the resident respondents applying for nonfellowship jobs, 19% sought part-time positions and 10% actually accepted a part-time position. Female residents were significantly more likely than male residents to apply for part-time jobs (26% vs. 7%, P = .034). Sixty percent of female residents immediately seeking work and 58% of those going on to fellowship reported an interest in arranging a part-time or reduced-hours position at some point in the next 5 years. Part-time employment among med-peds residents applying for nonfellowship positions after graduation is similar to the current incidence of part-time employment in other fields of primary care. A much higher percentage of med-peds residents are interested in arranging part-time work within 5 years after graduation. This strong interest in part-time work has many implications for the primary care workforce. Copyright © 2011 Academic Pediatric Association. Published by Elsevier Inc. All rights reserved.

PedAM: a database for Pediatric Disease Annotation and Medicine.

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Jia, Jinmeng; An, Zhongxin; Ming, Yue; Guo, Yongli; Li, Wei; Li, Xin; Liang, Yunxiang; Guo, Dongming; Tai, Jun; Chen, Geng; Jin, Yaqiong; Liu, Zhimei; Ni, Xin; Shi, Tieliu

2018-01-04

There is a significant number of children around the world suffering from the consequence of the misdiagnosis and ineffective treatment for various diseases. To facilitate the precision medicine in pediatrics, a database namely the Pediatric Disease Annotations & Medicines (PedAM) has been built to standardize and classify pediatric diseases. The PedAM integrates both biomedical resources and clinical data from Electronic Medical Records to support the development of computational tools, by which enables robust data analysis and integration. It also uses disease-manifestation (D-M) integrated from existing biomedical ontologies as prior knowledge to automatically recognize text-mined, D-M-specific syntactic patterns from 774 514 full-text articles and 8 848 796 abstracts in MEDLINE. Additionally, disease connections based on phenotypes or genes can be visualized on the web page of PedAM. Currently, the PedAM contains standardized 8528 pediatric disease terms (4542 unique disease concepts and 3986 synonyms) with eight annotation fields for each disease, including definition synonyms, gene, symptom, cross-reference (Xref), human phenotypes and its corresponding phenotypes in the mouse. The database PedAM is freely accessible at http://www.unimd.org/pedam/. © The Author(s) 2017. Published by Oxford University Press on behalf of Nucleic Acids Research.

Early detection of communication delays with the PEDS tools in at-risk South African infants

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Jeannie van der Linde

2016-04-01

Method: A comparative study design evaluated the accuracy of the PEDS tools to detect communication delays, using an internationally accepted diagnostic assessment tool, the Rossetti Infant-Toddler Language Scale (RITLS. A convenience sample of 201 infants was selected at primary healthcare clinics. Results: Expressive and receptive language sensitivity scores were low across all three screens(ranging between 14% and 44%. The PEDS tools had high sensitivity (71% and specificity (73% ratings for the receptive and expressive language and socio-emotional domain in combination. Conclusion: In the sample population, the PEDS tools did not accurately detect receptive and expressive language delays; however, communication delays in general were identified. Future research determining accuracy of the PEDS, PEDS-Developmental Milestones and PEDS tools for children aged 2–5 years in detecting communication delays should be prioritised.

Evaluating Nonclinical Performance of the Academic Pathologist

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Austin Blackburn Wiles MD

2018-02-01

Full Text Available Academic pathologists perform clinical duties, as well as valuable nonclinical activities. Nonclinical activities may consist of research, teaching, and administrative management among many other important tasks. While clinical duties have many clear metrics to measure productivity, like the relative value units of Medicare reimbursement, nonclinical performance is often difficult to measure. Despite the difficulty of evaluating nonclinical activities, nonclinical productivity is used to determine promotion, funding, and inform professional evaluations of performance. In order to better evaluate the important nonclinical performance of academic pathologists, we present an evaluation system for leadership use. This system uses a Microsoft Excel workbook to provide academic pathologist respondents and reviewing leadership a transparent, easy-to-complete system that is both flexible and scalable. This system provides real-time feedback to academic pathologist respondents and a clear executive summary that allows for focused guidance of the respondent. This system may be adapted to fit practices of varying size, measure performance differently based on years of experience, and can work with many different institutional values.

Reliability and Validity of the Turkish Version of the PedsQL 3.0 Cancer Module for 2- to 7-Year-Old and the PedsQL 4.0 Generic Core Scales for 5- to 7-Year-Old: The Hacettepe University Experience.

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Yıldız Kabak, Vesile; Yakut, Yavuz; Çetin, Mualla; Düger, Tülin

2016-09-05

The aim of this study was to investigate the reliability and validity of the Turkish version of the Pediatric Quality of Life Inventory (PedsQL) 3.0 Cancer Module for 2- to 7-year-old and the PedsQL 4.0 Generic Core Scales for 5- to 7-year-old in childhood cancer. The PedsQL 3.0 Cancer Module and PedsQL 4.0 Generic Core Scales were administered to children with cancer and their parents at Hacettepe University. Internal consistency was determined by using Cronbach's alpha and test-retest reliability was determined by using the intraclass correlation coefficient (ICC). Construct validity was assessed by comparing the results of the PedsQL 3.0 Cancer Module with those of the PedsQL 4.0 Generic Core Scales. Cronbach's alpha of the PedsQL 3.0 Cancer Module varied from 0.803 to 0.873 and that of the PedsQL 4.0 Generic Core Scales from 0.665 to 0.841. Test-retest ICC values of the PedsQL 3.0 Cancer Module varied from 0.877 to 0.949 and those of the PedsQL 4.0 Generic Core Scales from 0.681 to 0.824. The correlation of the PedsQL 3.0 Cancer Module with subscale scores of the PedsQL 4.0 Generic Core Scales showed that there were excellent to fair correlations between the two scales. The relationship between parent proxy-report and child self-report of the PedsQL 3.0 Cancer Module had very good correlation (r=0.694, p3.0 Cancer Module in 2- to 4-year-old and 5- to 7-year-old and the PedsQL 4.0 Generic Core Scales in 5- to 7-year-old in childhood cancer.

Reliability and Validity of the Turkish Version of the PedsQL 3.0 Cancer Module for 2- to 7-Year-Old and the PedsQL 4.0 Generic Core Scales for 5- to 7-Year-Old: The Hacettepe University Experience

Science.gov (United States)

Yıldız Kabak, Vesile; Yakut, Yavuz; Çetin, Mualla; Düger, Tülin

2016-01-01

Objective: The aim of this study was to investigate the reliability and validity of the Turkish version of the Pediatric Quality of Life Inventory (PedsQL) 3.0 Cancer Module for 2- to 7-year-old and the PedsQL 4.0 Generic Core Scales for 5- to 7-year-old in childhood cancer. Materials and Methods: The PedsQL 3.0 Cancer Module and PedsQL 4.0 Generic Core Scales were administered to children with cancer and their parents at Hacettepe University. Internal consistency was determined by using Cronbach’s alpha and test-retest reliability was determined by using the intraclass correlation coefficient (ICC). Construct validity was assessed by comparing the results of the PedsQL 3.0 Cancer Module with those of the PedsQL 4.0 Generic Core Scales. Results: Cronbach’s alpha of the PedsQL 3.0 Cancer Module varied from 0.803 to 0.873 and that of the PedsQL 4.0 Generic Core Scales from 0.665 to 0.841. Test-retest ICC values of the PedsQL 3.0 Cancer Module varied from 0.877 to 0.949 and those of the PedsQL 4.0 Generic Core Scales from 0.681 to 0.824. The correlation of the PedsQL 3.0 Cancer Module with subscale scores of the PedsQL 4.0 Generic Core Scales showed that there were excellent to fair correlations between the two scales. The relationship between parent proxy-report and child self-report of the PedsQL 3.0 Cancer Module had very good correlation (r=0.694, p3.0 Cancer Module in 2- to 4-year-old and 5- to 7-year-old and the PedsQL 4.0 Generic Core Scales in 5- to 7-year-old in childhood cancer. PMID:27095607

The PedsQL™ Present Functioning Visual Analogue Scales: preliminary reliability and validity

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Varni James W

2006-10-01

Full Text Available Abstract Background The PedsQL™ Present Functioning Visual Analogue Scales (PedsQL™ VAS were designed as an ecological momentary assessment (EMA instrument to rapidly measure present or at-the-moment functioning in children and adolescents. The PedsQL™ VAS assess child self-report and parent-proxy report of anxiety, sadness, anger, worry, fatigue, and pain utilizing six developmentally appropriate visual analogue scales based on the well-established Varni/Thompson Pediatric Pain Questionnaire (PPQ Pain Intensity VAS format. Methods The six-item PedsQL™ VAS was administered to 70 pediatric patients ages 5–17 and their parents upon admittance to the hospital environment (Time 1: T1 and again two hours later (Time 2: T2. It was hypothesized that the PedsQL™ VAS Emotional Distress Summary Score (anxiety, sadness, anger, worry and the fatigue VAS would demonstrate moderate to large effect size correlations with the PPQ Pain Intensity VAS, and that patient" parent concordance would increase over time. Results Test-retest reliability was demonstrated from T1 to T2 in the large effect size range. Internal consistency reliability was demonstrated for the PedsQL™ VAS Total Symptom Score (patient self-report: T1 alpha = .72, T2 alpha = .80; parent proxy-report: T1 alpha = .80, T2 alpha = .84 and Emotional Distress Summary Score (patient self-report: T1 alpha = .74, T2 alpha = .73; parent proxy-report: T1 alpha = .76, T2 alpha = .81. As hypothesized, the Emotional Distress Summary Score and Fatigue VAS were significantly correlated with the PPQ Pain VAS in the medium to large effect size range, and patient and parent concordance increased from T1 to T2. Conclusion The results demonstrate preliminary test-retest and internal consistency reliability and construct validity of the PedsQL™ Present Functioning VAS instrument for both pediatric patient self-report and parent proxy-report. Further field testing is required to extend these initial

PED/PEA-15 inhibits hydrogen peroxide-induced apoptosis in Ins-1E pancreatic beta-cells via PLD-1.

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Francesca Fiory

Full Text Available The small scaffold protein PED/PEA-15 is involved in several different physiologic and pathologic processes, such as cell proliferation and survival, diabetes and cancer. PED/PEA-15 exerts an anti-apoptotic function due to its ability to interfere with both extrinsic and intrinsic apoptotic pathways in different cell types. Recent evidence shows that mice overexpressing PED/PEA-15 present larger pancreatic islets and increased beta-cells mass. In the present work we investigated PED/PEA-15 role in hydrogen peroxide-induced apoptosis in Ins-1E beta-cells. In pancreatic islets isolated from Tg(PED/PEA-15 mice hydrogen peroxide-induced DNA fragmentation was lower compared to WT islets. TUNEL analysis showed that PED/PEA-15 overexpression increases the viability of Ins-1E beta-cells and enhances their resistance to apoptosis induced by hydrogen peroxide exposure. The activity of caspase-3 and the cleavage of PARP-1 were markedly reduced in Ins-1E cells overexpressing PED/PEA-15 (Ins-1E(PED/PEA-15. In parallel, we observed a decrease of the mRNA levels of pro-apoptotic genes Bcl-xS and Bad. In contrast, the expression of the anti-apoptotic gene Bcl-xL was enhanced. Accordingly, DNA fragmentation was higher in control cells compared to Ins-1E(PED/PEA-15 cells. Interestingly, the preincubation with propranolol, an inhibitor of the pathway of PLD-1, a known interactor of PED/PEA-15, responsible for its deleterious effects on glucose tolerance, abolishes the antiapoptotic effects of PED/PEA-15 overexpression in Ins-1E beta-cells. The same results have been obtained by inhibiting PED/PEA-15 interaction with PLD-1 in Ins-1E(PED/PEA-15. These results show that PED/PEA-15 overexpression is sufficient to block hydrogen peroxide-induced apoptosis in Ins-1E cells through a PLD-1 mediated mechanism.

Facilitation of the PED analysis of large molecules by using global coordinates.

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Jamróz, Michał H; Ostrowski, Sławomir; Dobrowolski, Jan Cz

2015-10-05

Global coordinates have been found to be useful in the potential energy distribution (PED) analyses of the following large molecules: [13]-acene and [33]-helicene. The global coordinate is defined based on much distanced fragments of the analysed molecule, whereas so far, the coordinates used in the analysis were based on stretchings, bendings, or torsions of the adjacent atoms. It has been shown that the PED analyses performed using the global coordinate and the classical ones can lead to exactly the same PED contributions. The global coordinates may significantly improve the facility of the analysis of the vibrational spectra of large molecules. Copyright © 2015 Elsevier B.V. All rights reserved.

The Ped-APS Registry: the antiphospholipid syndrome in childhood.

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Avcin, T; Cimaz, R; Rozman, B

2009-09-01

In recent years, antiphospholipid syndrome (APS) has been increasingly recognised in various paediatric autoimmune and nonautoimmune diseases, but the relatively low prevalence and heterogeneity of APS in childhood made it very difficult to study in a systematic way. The project of an international registry of paediatric patients with APS (the Ped-APS Registry) was initiated in 2004 to foster and conduct multicentre, controlled studies with large number of paediatric APS patients. The Ped-APS Registry is organised as a collaborative project of the European Forum on Antiphospholipid Antibodies and Juvenile Systemic Lupus Erythematosus Working Group of the Paediatric Rheumatology European Society. Currently, it documents a standardised clinical, laboratory and therapeutic data of 133 children with antiphospholipid antibodies (aPL)-related thrombosis from 14 countries. The priority projects for future research of the Ped-APS Registry include prospective enrollment of new patients with aPL-related thrombosis, assessment of differences between the paediatric and adult APS, evaluation of proinflammatory genotype as a risk factor for APS manifestations in childhood and evaluation of patients with isolated nonthrombotic aPL-related manifestations.

Phosphoprotein enriched in diabetes (PED/PEA15) promotes migration in hepatocellular carcinoma and confers resistance to sorafenib

DEFF Research Database (Denmark)

Quintavalle, Cristina; Hindupur, Sravanth Kumar; Quagliata, Luca

2017-01-01

and protein levels of PED were significantly high in HCC compared with non-tumoral tissue. Clinico-pathological correlation revealed that PED(high) HCCs showed an enrichment of gene signatures associated with metastasis and poor prognosis. Further, we observed that PED overexpression elevated the migration...

Nonclinical Profile of BLZ-100, a Tumor-Targeting Fluorescent Imaging Agent.

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Parrish-Novak, Julia; Byrnes-Blake, Kelly; Lalayeva, Narine; Burleson, Stefanie; Fidel, Janean; Gilmore, Rhonda; Gayheart-Walsten, Pamela; Bricker, Gregory A; Crumb, William J; Tarlo, K S; Hansen, Stacey; Wiss, Valorie; Malta, Errol; Dernell, William S; Olson, James M; Miller, Dennis M

BLZ-100 is a single intravenous use, fluorescent imaging agent that labels tumor tissue to enable more complete and precise surgical resection. It is composed of a chlorotoxin peptide covalently bound to the near-infrared fluorophore indocyanine green. BLZ-100 is in clinical development for intraoperative visualization of human tumors. The nonclinical safety and pharmacokinetic (PK) profile of BLZ-100 was evaluated in mice, rats, canines, and nonhuman primates (NHP). Single bolus intravenous administration of BLZ-100 was well tolerated, and no adverse changes were observed in cardiovascular safety pharmacology, PK, and toxicology studies in rats and NHP. The single-dose no-observed-adverse-effect-levels (NOAELs) were 7 mg (28 mg/kg) in rats and 60 mg (20 mg/kg) in NHP, corresponding to peak concentration values of 89 400 and 436 000 ng/mL and area-under-the-curve exposure values of 130 000 and 1 240 000 h·ng/mL, respectively. Based on a human imaging dose of 3 mg, dose safety margins are >100 for rat and monkey. BLZ-100 produced hypersensitivity reactions in canine imaging studies (lethargy, pruritus, swollen muzzle, etc). The severity of the reactions was not dose related. In a follow-up study in dogs, plasma histamine concentrations were increased 5 to 60 minutes after BLZ-100 injection; this coincided with signs of hypersensitivity, supporting the conclusion that the reactions were histamine based. Hypersensitivity reactions were not observed in other species or in BLZ-100 human clinical studies conducted to date. The combined imaging, safety pharmacology, PK, and toxicology studies contributed to an extensive initial nonclinical profile for BLZ-100, supporting first-in-human clinical trials.

Characterizing "Adversity" of Pathology Findings in Nonclinical Toxicity Studies: Results from the 4th ESTP International Expert Workshop.

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The identification of adverse health effects has a central role in the development and risk/safety assessment of chemical entities and pharmaceuticals. There is currently a need for better alignment in the toxicologic pathology community regarding how nonclinical adversity is det...

The PedsQL™ Oral Health Scale: feasibility, reliability and validity of the Brazilian Portuguese version

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Bendo Cristiane B

2012-04-01

Full Text Available Abstract Background Oral and orofacial problems may cause a profound impact on children’s oral health-related quality of life (OHRQoL because of symptoms associated with these conditions that may influence the physical, psychological and social aspects of their daily life. The OHRQoL questionnaires found in the literature are very specific and are not able to measure the impact of oral health on general health domains. Consequently, the objective of this study was to evaluate the psychometric properties of the Portuguese version for Brazilian translation of the Pediatric Quality of Life Inventory™ (PedsQL™ Oral Health Scale in combination with the PedsQL™ 4.0 Generic Core Scales. Methods The PedsQL™ Oral Health Scale was forward-backward translated and cross-culturally adapted for the Brazilian Portuguese language. In order to assess the feasibility, reliability and validity of the Brazilian version of the instrument, a study was carried out in Belo Horizonte with 208 children and adolescents between 2 and 18 years-of-age and their parents. Clinical evaluation of dental caries, socioeconomic information and the Brazilian versions of the PedsQL™ Oral Health Scale, PedsQL™ 4.0 Generic Core Scales, Child Perceptions Questionnaire (CPQ11-14 and CPQ8-10 and Parental-Caregiver Perception Questionnaire (P-CPQ were administered. Statistical analysis included feasibility (missing values, confirmatory factor analysis (CFA, internal consistency reliability, and test-retest intraclass correlation coefficients (ICC of the PedsQL™ Oral Health Scale. Results There were no missing data for both child self-report and parent proxy-report on the Brazilian version of the PedsQL™ Oral Health Scale. The CFA showed that the five items of child self-report and parent proxy-report loaded on a single construct. The Cronbach's alpha coefficients for child/adolescent and parent oral health instruments were 0.65 and 0.59, respectively. The test

Nonclinical safety and pharmacokinetics of Miglyol 812: A medium chain triglyceride in exenatide once weekly suspension.

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Buss, Nicholas; Ryan, Patricia; Baughman, Todd; Roy, Denis; Patterson, Claire; Gordon, Carolyn; Dixit, Rakesh

2018-05-28

Exenatide, a glucagon-like peptide-1 receptor agonist was originally developed as either a twice daily or once weekly injectable therapeutic for patients with type 2 diabetes. Exenatide QW suspension was developed for use with an autoinjector device, in which the microspheres are suspended in Miglyol 812, a mixture of medium chain triglycerides (MCTs). MCTs are a class of lipids whose fatty acid chains contain from six to 12 carbon atoms (medium chain fatty acids or MCFAs). While MCTs are edible oils present in many foods, including foodstuffs containing coconut and palm kernel oils, limited information is available regarding the oral and subcutaneous bioavailability of MCTs as well as safety following subcutaneous injection. These studies were designed to investigate the non-clinical pharmacokinetics and safety of MCTs. In a single dose pharmacokinetic study, MCFAs were rapidly detected in the plasma of rats following oral administration of either Miglyol 812 or tricaprylin at doses of 10 or 9.48 g kg -1 , respectively. Following subcutaneous dosing with Miglyol 812, MCFAs were rapidly absorbed with a similar profile to that following oral dosing. Furthermore, the toxicity of Miglyol 812 alone was evaluated in a 3 month repeat dose toxicology studies in cynomolgus monkeys. In this study, weekly subcutaneous doses of 0.15 g kg -1 did not elicit any treatment-related effects in cynomolgus monkeys. In conclusion, these studies alongside the available literature data show that Miglyol 812 is a safe excipient for use in subcutaneously administered therapeutics. Copyright © 2018 John Wiley & Sons, Ltd.

Regulatory aspects of the non-clinical researches in the Isotope Center

International Nuclear Information System (INIS)

Castro Alfonso, Yusniel

2017-01-01

For the quality control of radiopharmaceuticals produced by Centis and in pharmacokinetic studies carried out in this institution, scintigraphic images of animals are obtained. This allows the assessment of the distribution and behavior of these radiolabeled molecules inside the organism in order to use them in clinical trials in people having different pathologies. Besides following the CNSN regulations involving work with open radioactive sources, non-clinical research laboratory areas are subject to Biosafety Regulations particularly those established by Cecmed. The world trend to integrate the management systems in the organization processes requires the harmonization of Good Laboratory Practices, the compliance with Biosafety Regulations and International Standards concerning the ethics, when working with laboratory animals. This kind of laboratory coordinates its services directly with institutions developing drugs and with the Department of Quality Control for Products used in Nuclear Medicine in Centis. The present work is aimed at assessing the legislation and regulations related with non-clinical research area to take actions intended to improve the integrated management of biosafety for structuring a safety program. (author)

High resolution crystal structure of PedB: a structural basis for the classification of pediocin-like immunity proteins

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Cha Sun-Shin

2007-05-01

Full Text Available Abstract Background Pediocin-like bacteriocins, ribosomally-synthesized antimicrobial peptides, are generally coexpressed with cognate immunity proteins in order to protect the bacteriocin-producer from its own bacteriocin. As a step for understanding the mode of action of immunity proteins, we determined the crystal structure of PedB, a pediocin-like immunity protein conferring immunity to pediocin PP-1. Results The 1.6 Å crystal structure of PedB reveals that PedB consists of an antiparallel four-helix bundle with a flexible C-terminal end. PedB shows structural similarity to an immunity protein against enterocin A (EntA-im but some disparity to an immunity protein against carnobacteriocin B2 (ImB2 in both the C-terminal conformation and the local structure constructed by α3, α4, and their connecting loop. Structure-inspired mutational studies reveal that deletion of the last seven residues of the C-terminus of PedB almost abolished its immunity activity. Conclusion The fact that PedB, EntA-im, and ImB2 share a four-helix bundle structure strongly suggests the structural conservation of this motif in the pediocin-like immunity proteins. The significant difference in the core structure and the C-terminal conformation provides a structural basis for the classification of pediocin-like immunity proteins. Our mutational study using C-terminal-shortened PedBs and the investigation of primary sequence of the C-terminal region, propose that several polar or charged residues in the extreme C-terminus of PedB which is crucial for the immunity are involved in the specific recognition of pediocin PP-1.

PedGenie: meta genetic association testing in mixed family and case-control designs

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Allen-Brady Kristina

2007-11-01

Full Text Available Abstract Background- PedGenie software, introduced in 2006, includes genetic association testing of cases and controls that may be independent or related (nuclear families or extended pedigrees or mixtures thereof using Monte Carlo significance testing. Our aim is to demonstrate that PedGenie, a unique and flexible analysis tool freely available in Genie 2.4 software, is significantly enhanced by incorporating meta statistics for detecting genetic association with disease using data across multiple study groups. Methods- Meta statistics (chi-squared tests, odds ratios, and confidence intervals were calculated using formal Cochran-Mantel-Haenszel techniques. Simulated data from unrelated individuals and individuals in families were used to illustrate meta tests and their empirically-derived p-values and confidence intervals are accurate, precise, and for independent designs match those provided by standard statistical software. Results- PedGenie yields accurate Monte Carlo p-values for meta analysis of data across multiple studies, based on validation testing using pedigree, nuclear family, and case-control data simulated under both the null and alternative hypotheses of a genotype-phenotype association. Conclusion- PedGenie allows valid combined analysis of data from mixtures of pedigree-based and case-control resources. Added meta capabilities provide new avenues for association analysis, including pedigree resources from large consortia and multi-center studies.

The Chinese version of the Pediatric Quality of Life Inventory™ (PedsQL™) 3.0 Asthma Module: reliability and validity.

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Feng, Lifen; Zhang, Yingfen; Chen, Ruoqing; Hao, Yuantao

2011-08-07

Health-related quality of life (HRQOL) has been recognized as an important health outcome measurement for pediatric patients. One of the most promising instruments in measuring pediatric HRQOL emerged in recent years is the Pediatric Quality of Life Inventory (PedsQL™). The PedsQL™ 3.0 Asthma Module, one of the PedsQL™disease-specific scales, was designed to measure HRQOL dimensions specifically tailored for pediatric asthma. The present study is aimed to evaluate the psychometric properties of the Chinese version of the PedsQL™ 3.0 Asthma Module. The PedsQL™ 3.0 Asthma Module was translated into Chinese following the PedsQL™ Measurement Model Translation Methodology. The Chinese version scale was administered to 204 children with asthma and 337 parents of children with asthma from four Triple A hospitals. The psychometric properties were then evaluated. The percentage of missing value for each item of the scale ranged from 0.00% to 8.31%. All child self-report subscales and parent proxy-report subscales approached or exceeded the minimum reliability standard of 0.70 for alpha coefficient, except 3 subscales of Young Child (aged 5-7) self-report (alphas ranging from 0.59 to 0.68). Test-retest reliability was satisfactory with intraclass correlation coefficients (ICCs) which exceeded the recommended standard of 0.80 in all subscales. Correlation coefficients between items and their hypothesized subscales were higher than those with other subscales. The PedsQL™ 3.0 Asthma Module distinguished between outpatients and inpatients. Patients with mild asthma reported higher scores than those with moderate/severe asthma in majority of subscales. The intercorrelations among the PedsQL™ 3.0 Asthma Module subscales and the PedsQL™ 4.0 Generic Core Scales were in medium to large effect size. The child self-report scores were consistent with the parent proxy-report scores. The Chinese version of the PedsQL™ 3.0 Asthma Module has acceptable psychometric

An examination of safety reports involving electronic flight bags and portable electronic devices

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2014-06-01

The purpose of this research was to develop a better understanding of safety considerations with the use of Electronic Flight Bags (EFBs) and Portable Electronic Devices (PEDs) by examining safety reports from Aviation Safety Reporting System (ASRS),...

PedsQL relates to function and behavior in very low and normal birth weight 2- and 3-year-olds from a regional cohort.

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Palta, Mari; Sadek-Badawi, Mona

2008-06-01

To compare PedsQL scores in young children who were very low (2,500 g) and to examine the relationship of the PedsQL score to behavioral and functional scores. The PedsQL, Achenbach Child Behavior Checklist and the PEDI functional scales were telephone administered to parents of a regional cohort of 672 very low birth weight and 455 normal birth weight children, 2- and 3-years old. PedsQL scales were regressed on behavior, function and health conditions. Mean (SD) overall PedsQL score was 91 (8.4) for normal birth weight and 87 (12) for very low birth weight children, and changed little when standardized to the race/ethnicity and maternal education of corresponding Wisconsin births. Mobility function and the CBCL explained 58% of the variance in PedsQL, but the relationship was curvilinear. The PedsQL is sensitive to health problems of very low birth weight in young children. The PedsQL is quite strongly related to mobility and behavior problems, but scales these differently than do standard instruments. Parents either do not think of subtle issues with child function and behavior without specific prompting or do not perceive them as problems affecting quality of life.

The Chinese version of the Pediatric Quality of Life Inventory™ (PedsQL™ 3.0 Asthma Module: reliability and validity

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Chen Ruoqing

2011-08-01

Full Text Available Abstract Background Health-related quality of life (HRQOL has been recognized as an important health outcome measurement for pediatric patients. One of the most promising instruments in measuring pediatric HRQOL emerged in recent years is the Pediatric Quality of Life Inventory (PedsQL™. The PedsQL™ 3.0 Asthma Module, one of the PedsQL™disease-specific scales, was designed to measure HRQOL dimensions specifically tailored for pediatric asthma. The present study is aimed to evaluate the psychometric properties of the Chinese version of the PedsQL™ 3.0 Asthma Module. Methods The PedsQL™ 3.0 Asthma Module was translated into Chinese following the PedsQL™ Measurement Model Translation Methodology. The Chinese version scale was administered to 204 children with asthma and 337 parents of children with asthma from four Triple A hospitals. The psychometric properties were then evaluated. Results The percentage of missing value for each item of the scale ranged from 0.00% to 8.31%. All child self-report subscales and parent proxy-report subscales approached or exceeded the minimum reliability standard of 0.70 for alpha coefficient, except 3 subscales of Young Child (aged 5-7 self-report (alphas ranging from 0.59 to 0.68. Test-retest reliability was satisfactory with intraclass correlation coefficients (ICCs which exceeded the recommended standard of 0.80 in all subscales. Correlation coefficients between items and their hypothesized subscales were higher than those with other subscales. The PedsQL™ 3.0 Asthma Module distinguished between outpatients and inpatients. Patients with mild asthma reported higher scores than those with moderate/severe asthma in majority of subscales. The intercorrelations among the PedsQL™ 3.0 Asthma Module subscales and the PedsQL™ 4.0 Generic Core Scales were in medium to large effect size. The child self-report scores were consistent with the parent proxy-report scores. Conclusions The Chinese version of

MedAustron – Non-Clinical Research Opportunities

International Nuclear Information System (INIS)

Schreiner, T.

2013-01-01

MedAustron is a synchrotron based light-ion beam therapy centre for cancer treatment as well as for clinical and non-clinical research, currently in the construction phase in Wiener Neustadt. Whilst the choice of basic machine parameters was driven by medical requirements, the accelerator complex design was also optimised to offer flexibility for research operation. The potential of the synchrotron is being exploited to increase the maximum proton energy far beyond the medical needs to up to 800 MeV, for experimental physics applications, mainly in the areas of proton scattering and detector research. The accelerator layout allows for the installation of up to four ion source-spectrometer units, to provide various ion types besides the clinical used protons and carbon ions. To decouple research and medical operation, a dedicated irradiation room for non-clinical research was included providing two isocentres for the installation of different experiments. This presentation provides a status overview over the whole project and highlights the non-clinical research opportunities at MedAustron. (author)

Pharmacists' Perception of the Sale of Non-Clinically Proven Health ...

African Journals Online (AJOL)

Pharmacists' Perception of the Sale of Non-Clinically Proven Health Supplements in Penang, Malaysia. ... A total of 10.7 % respondents indicated that the sale of non-clinically proven products result in high profit. Only 25.0 % of the pharmacists ... Keywords: Perception, Health promotion, Urban poor, Health supplements.

Current nonclinical testing paradigm enables safe entry to First-In-Human clinical trials: The IQ consortium nonclinical to clinical translational database.

Science.gov (United States)

Monticello, Thomas M; Jones, Thomas W; Dambach, Donna M; Potter, David M; Bolt, Michael W; Liu, Maggie; Keller, Douglas A; Hart, Timothy K; Kadambi, Vivek J

2017-11-01

The contribution of animal testing in drug development has been widely debated and challenged. An industry-wide nonclinical to clinical translational database was created to determine how safety assessments in animal models translate to First-In-Human clinical risk. The blinded database was composed of 182 molecules and contained animal toxicology data coupled with clinical observations from phase I human studies. Animal and clinical data were categorized by organ system and correlations determined. The 2×2 contingency table (true positive, false positive, true negative, false negative) was used for statistical analysis. Sensitivity was 48% with a 43% positive predictive value (PPV). The nonhuman primate had the strongest performance in predicting adverse effects, especially for gastrointestinal and nervous system categories. When the same target organ was identified in both the rodent and nonrodent, the PPV increased. Specificity was 84% with an 86% negative predictive value (NPV). The beagle dog had the strongest performance in predicting an absence of clinical adverse effects. If no target organ toxicity was observed in either test species, the NPV increased. While nonclinical studies can demonstrate great value in the PPV for certain species and organ categories, the NPV was the stronger predictive performance measure across test species and target organs indicating that an absence of toxicity in animal studies strongly predicts a similar outcome in the clinic. These results support the current regulatory paradigm of animal testing in supporting safe entry to clinical trials and provide context for emerging alternate models. Copyright © 2017 Elsevier Inc. All rights reserved.

Adenoviral gene transfer of PLD1-D4 enhances insulin sensitivity in mice by disrupting phospholipase D1 interaction with PED/PEA-15.

Directory of Open Access Journals (Sweden)

Angela Cassese

Full Text Available Over-expression of phosphoprotein enriched in diabetes/phosphoprotein enriched in astrocytes (PED/PEA-15 causes insulin resistance by interacting with the D4 domain of phospholipase D1 (PLD1. Indeed, the disruption of this association restores insulin sensitivity in cultured cells over-expressing PED/PEA-15. Whether the displacement of PLD1 from PED/PEA-15 improves insulin sensitivity in vivo has not been explored yet. In this work we show that treatment with a recombinant adenoviral vector containing the human D4 cDNA (Ad-D4 restores normal glucose homeostasis in transgenic mice overexpressing PED/PEA-15 (Tg ped/pea-15 by improving both insulin sensitivity and secretion. In skeletal muscle of these mice, D4 over-expression inhibited PED/PEA-15-PLD1 interaction, decreased Protein Kinase C alpha activation and restored insulin induced Protein Kinase C zeta activation, leading to amelioration of insulin-dependent glucose uptake. Interestingly, Ad-D4 administration improved insulin sensitivity also in high-fat diet treated obese C57Bl/6 mice. We conclude that PED/PEA-15-PLD1 interaction may represent a novel target for interventions aiming at improving glucose tolerance.

PedsQLTM 4.0 Generic Core Scales for adolescents in the Yoruba language: translation and general psychometric properties.

Science.gov (United States)

Atilola, Olayinka; Stevanović, Dejan

2014-04-01

Quality of life (QOL) is a universally accepted concept for measuring the impact of different aspects of life on general well-being. Adaptation of existing QOL instruments to local cultures has been identified as a better strategy than development of new ones. To translate and adapt the Paediatric Quality of Life Inventory™ Version 4.0 Generic Core Scales (PedsQL™) to the Yoruba language and culture and to test the psychometric properties of the adapted instrument among adolescents. Psychometric properties including internal consistency reliability, construct and factorial validity of the Yoruba version of PedsQL™ were evaluated using standard procedures. The self report and proxy scales of the Yoruba PedsQL™ were developed with good cultural relevance and semantic/conceptual equivalence. Results from 527 adolescents revealed a Cronbach's coefficient which exceeded 0.7 for internal consistency reliability for all scores. The healthy subjects reported higher PedsQL™ scores than those with mental health and physical problems, which confirmed construct validity. Confirmatory factor analysis revealed a good model fit for the Psychosocial Health score, but not for the other measures. The Yoruba PedsQL™ is culturally appropriate and with good internal consistency, reliability and construct validity. More work is needed regarding its factorial validity.

PedsQL Neurofibromatosis Type 1 Module for children, adolescents and young adults: feasibility, reliability, and validity.

Science.gov (United States)

Nutakki, Kavitha; Varni, James W; Swigonski, Nancy L

2018-04-01

The objective of the present study was to report on the measurement properties of the Pediatric Quality of Life Inventory (PedsQL) Neurofibromatosis Type 1 Module for pediatric patients ages 5-25 from the perspectives of patients and parents. The 104-item PedsQL NF1 Module and 23-item PedsQL Generic Core Scales were completed in a multi-site national study by 323 patients and 335 parents (343 families). Patients were diagnosed with NF1 using the National Institutes of Health diagnostic criteria. In addition to a Total Scale Score, 18 unidimensional scales were derived measuring skin itch bother, skin sensations, pain, pain impact, pain management, cognitive functioning, speech, fine motor, balance, vision, perceived physical appearance, communication, worry, treatment anxiety, medicines, stomach discomfort, constipation, and diarrhea. The PedsQL NF1 Module Scales evidenced excellent feasibility, excellent reliability for the Total Scale Scores (patient self-report α = 0.98; parent proxy-report α = 0.98), and good to excellent reliability for the 18 individual scales (patient self-report α = 0.71-0.96; parent proxy-report α = 0.73-0.98). Intercorrelations with the Generic Core Scales supported construct validity. Factor analysis supported the unidimensionality of the 18 individual scales. The PedsQL NF1 Module Scales demonstrated acceptable to excellent measurement properties, and may be utilized as standardized metrics to assess NF1-specific symptoms and problems in clinical research and practice in children, adolescents, and young adults.

A Survey of the Non-clinical Benefits of EBVM

Directory of Open Access Journals (Sweden)

Sarah Hauser

2017-08-01

Full Text Available Objective: This study aims to add non-clinical benefits to the virtues for adopting Evidence-based Veterinary Medicine (EBVM. The objective is to quantify the commercial benefits of EBVM through an online survey of veterinary professionals, giving clear indications of the key areas of non-clinical benefits of EBVM. Further, the study aims to outline barriers to the wider implementation of EBVM and find preferred ways of overcoming those barriers.Background: A PICO-based literature review (Hauser and Jackson, 2016 found that while there are some papers suggesting a link between the practice of EBVM and better non-clinical benefits such as client satisfaction, a single study, focusing on the non-clinical benefits of EBVM, had yet to be conducted. This study builds on the findings of an exploratory study (Jackson and Hauser, 2017 outlining key areas of non-clinical benefits of EBVM: increased client satisfaction and retention, improved reputation, confidence, as well as employee engagement.Evidentiary value: This online survey of veterinary professionals (n=407 provides evidence for practitioners, universities and other veterinary staff regarding the non-clinical benefits of EBVM, the barriers to a wider adoption of the practice and ways of overcoming those barriers.Methods: The online survey of veterinary professionals was conducted during September – October 2016 and contained 23 questions. Survey participation was voluntary and the data used for analysis were de-identified.Results: The survey responses of 407 veterinary professionals provide quantitative evidence of how EBVM is put into practice, how EBVM is perceived to impact client behaviour and employee engagement, what the barriers are to practising EBVM and how these could be overcome. Key findings are that veterinary professionals are more likely to practise EBVM if they have been taught how to do so at vet school. EBVM is a way to provide value to and build trust with clients. Survey

Quality of life of asthmatic children and adolescents: Portuguese translation, adaptation, and validation of the questionnaire "Pediatric Quality of Life (PedsQL) Asthma Module".

Science.gov (United States)

Monteiro, Fernanda Pereira; Solé, Dirceu; Wandalsen, Gustavo

2017-11-01

The objectives of the study were to translate, validate, and verify the psychometric properties of the Portuguese version of the instrument "Pediatric Quality of Life Asthma Module" (PedsQL Asthma) culturally adapted for the Brazilian culture. After being translated to Portuguese and being culturally adapted, the questionnaire was answered by 200 asthmatic children and adolescents (aged 2-18) as well as the adults responsible for them. Validation required the use of the following instruments: PedsQL Asthma Children (applied to children and adolescents), PedsQL Asthma Parents (applied to adults responsible for children and adolescents), Pediatric Asthma Quality of Life (PAQLQ), Asthma Control Test (ACT) or Childhood Asthma Control Test (C-ACT), as well as socioeconomic and personal information questionnaires. A group of 45 clinically stable children repeated the questionnaires 15-60 days after answering the first questionnaire. Correlations between the scores of PedsQL Children and PedsQL Parents (r  =  0.67), PedsQL Children and PAQLQ (r  =  0.66), and PedsQL Parents and PAQLQ (r  =  0.64) were moderate and significant. Correlations were higher for men (r  =  0.72) when analyzing the children's and parents' answers to PedsQL according to gender. The 5- to 7-year-old age group had the strongest correlations with PAQLQ (r  =  0.79). Cronbach's alpha coefficient for PedsQL Children and Parents had values of 0.85 and 0.87, respectively. A high concordance was observed in both tests at different times, with kappa values of 0.89 and 0.87 for PedsQL Children and Parents, respectively. The instrument used in this study was considered valid, consistent, and reproducible and has acceptable psychometric properties for the Brazilian population.

Overexpression of the ped/pea-15 Gene Causes Diabetes by Impairing Glucose-Stimulated Insulin Secretion in Addition to Insulin Action

OpenAIRE

Vigliotta, Giovanni; Miele, Claudia; Santopietro, Stefania; Portella, Giuseppe; Perfetti, Anna; Maitan, Maria Alessandra; Cassese, Angela; Oriente, Francesco; Trencia, Alessandra; Fiory, Francesca; Romano, Chiara; Tiveron, Cecilia; Tatangelo, Laura; Troncone, Giancarlo; Formisano, Pietro

2004-01-01

Overexpression of the ped/pea-15 gene is a common feature of type 2 diabetes. In the present work, we show that transgenic mice ubiquitously overexpressing ped/pea-15 exhibited mildly elevated random-fed blood glucose levels and decreased glucose tolerance. Treatment with a 60% fat diet led ped/pea-15 transgenic mice to develop diabetes. Consistent with insulin resistance in these mice, insulin administration reduced glucose levels by only 35% after 45 min, compared to 70% in control mice. In...

A study on job satisfaction among clinical and non-clinical hospital ...

African Journals Online (AJOL)

Methods: Two hundred clinical and non-clinical hospital staff were invited to take part in the study. They completed a sociodemographic questionnaire and the Job Descriptive Index (JDI). Results: The results indicated that majority clinical and non-clinical staff were satisfied with their jobs as regards the parameters of the ...

The impact of nonclinical factors on repeat cesarean section.

Science.gov (United States)

Stafford, R S

1991-01-02

Nonclinical factors, including the setting in which health care takes place, influence clinical decisions. This research measures the independent effects of organizational and socioeconomic factors on repeat cesarean section use in California. Of 45,425 births to women with previous cesarean sections in 1986, vaginal birth after cesarean section occurred in 10.9%. Sizable nonclinical variations were noted. By hospital ownership, rates ranged from 4.9% (for-profit hospitals) to 29.2% (University of California). Variations also existed by hospital teaching level (nonteaching hospitals, 7.0%, vs formalized teaching hospitals, 23.3%); payment source (private insurance, 8.1%, vs indigent services, 25.2%); and obstetric volume (low-volume hospitals, 5.4%, vs high-volume hospitals, 16.6%). Multiple logistic regression demonstrated that these variables had independent effects after accounting for their overlapping influences and the effects of patient characteristics. The observed variations demonstrate the prominence of nonclinical factors in decision making and question the clinical appropriateness of current practice patterns.

[Strategic considerations on the design and choice of animal models for non-clinical investigations of cell-based medicinal products].

Science.gov (United States)

Lehmann, Jörg; Schulz, Ronny M; Sanzenbacher, Ralf

2015-11-01

For the development of medicinal products animal models are still indispensable to demonstrate efficacy and safety prior to first use in humans. Advanced therapy medicinal products (ATMP), which include cell-based medicinal products (CBMP), differ in their pharmacology and toxicology compared to conventional pharmaceuticals, and thus, require an adapted regime for non-clinical development. Developers are, therefore, challenged to develop particular individual concepts and to reconcile these with regulatory agencies. Guidelines issued by the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA) and other sources can provide direction.The published approaches for non-clinical testing of efficacy document that homologous animal models where the therapeutic effect is investigated in a disease-relevant animal model utilizing cells derived from the same species are commonly used. The challenge is that the selected model should reflect the human disease in all critical features and that the cells should be comparable to the investigated human medicinal product in terms of quality and biological activity. This is not achievable in all cases. In these cases, alternative methods may provide supplemental information. To demonstrate the scientific proof-of-concept (PoC), small animal models such as mice or rats are preferred. During the subsequent product development phase, large animal models (i.e. sheep, minipigs, dogs) must be considered, as they may better reflect the anatomical or physiological situation in humans. In addition to efficacy, those models may also be suitable to prove some safety aspects of ATMP (e.g. regarding dose finding, local tolerance, or undesired interactions and effects of the administered cells in the target tissue). In contrast, for evaluation of the two prominent endpoints for characterizing the safety of ATMP (i.e. biodistribution, tumorigenicity) heterologous small animal models, especially immunodeficient mouse strains

Insightfulness and later infant attachment in clinically depressed and nonclinical mothers.

Science.gov (United States)

Ramsauer, Brigitte; Lotzin, Annett; Quitmann, Julia H; Becker-Stoll, Fabienne; Tharner, Anne; Romer, Georg

2014-01-01

The aim of this pilot study was to investigate the relationship between maternal insightfulness and sensitivity and subsequent infant attachment security and disorganization in clinically depressed and nonclinical mother-infant groups. Nineteen depressed mothers with infants ages 3 to 11 months participated in this study. Twenty nonclinical mother-infant dyads were matched to the clinical sample according to infant sex and age. Maternal depression was assessed using the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (American Psychiatric Association, 1994), insightfulness using the Insightfulness Assessment (IA), and sensitivity using the Maternal Sensitivity Scales (M.D.S. Ainsworth, 1969). IA classifications and subscales were considered separately. Later infant attachment was assessed by the Strange Situation Procedure (M.D.S. Ainsworth, M.C. Blehar, E. Waters, & S. Wall, 1978). Depressed mothers tended to have less securely attached children than did nonclinical mothers. Within the clinical sample, the insightfulness categories correlated slightly moderately with attachment security, but were not related to attachment disorganization. Within the nonclinical sample, the IA categories were slightly moderately associated with attachment security and with disorganization. On IA subscales, relationship patterns differed in clinically depressed and nonclinical mother-infant dyads. These findings provide the first evidence of the predictive power of the IA categorization and subscales on subsequent infant attachment. They also may allow the development of different foci of intervention for enhancing insightful caregiving. © 2014 Michigan Association for Infant Mental Health.

Celiac disease in non-clinical populations of Japan.

Science.gov (United States)

Fukunaga, Mai; Ishimura, Norihisa; Fukuyama, Chika; Izumi, Daisuke; Ishikawa, Nahoko; Araki, Asuka; Oka, Akihiko; Mishiro, Tomoko; Ishihara, Shunji; Maruyama, Riruke; Adachi, Kyoichi; Kinoshita, Yoshikazu

2018-02-01

Celiac disease is a chronic autoimmune enteropathy caused by gluten ingestion. While its prevalence in Western countries is reported to be as high as 1%, the prevalence has not been evaluated in a large-scale study of a Japanese population. The aim of our study was to clarify the possible presence of celiac disease in a Japanese non-clinical population as well as in patients showing symptoms suggestive of the disease. Serum samples were collected from 2008 non-clinical adults and 47 patients with chronic unexplained abdominal symptoms between April 2014 and June 2016. The anti-tissue transglutaminase (TTG) immunoglobulin A antibody titer was determined as a screening test for celiac disease in all subjects, and individuals with a value of >2 U/mL subsequently underwent testing for the presence of serum endomysial IgA antibody (EMA) as confirmation. Those testing positive for EMA or with a high concentration (>10 U/mL) of TTG were further investigated by histopathological examinations of duodenal mucosal biopsy specimens and HLA typing tests. Of the 2008 non-clinical adults from whom serum samples were collected, 161 tested positive for TTG, and all tested negative for EMA. Four subjects who had a high TTG titer were invited to undergo confirmatory testing, and the histopathological results confirmed the presence of celiac disease in only a single case (0.05%). Of the 47 symptomatic patients, one (2.1%) was found to have a high TTG titer and was diagnosed with celiac disease based on duodenal histopathological findings. The presence of celiac disease in a non-clinical Japanese population was low at 0.05% and was rarely found in patients with unexplained chronic abdominal symptoms.

Overgeneral autobiographical memory bias in clinical and non-clinical voice hearers.

Science.gov (United States)

Jacobsen, Pamela; Peters, Emmanuelle; Ward, Thomas; Garety, Philippa A; Jackson, Mike; Chadwick, Paul

2018-03-14

Hearing voices can be a distressing and disabling experience for some, whilst it is a valued experience for others, so-called 'healthy voice-hearers'. Cognitive models of psychosis highlight the role of memory, appraisal and cognitive biases in determining emotional and behavioural responses to voices. A memory bias potentially associated with distressing voices is the overgeneral memory bias (OGM), namely the tendency to recall a summary of events rather than specific occasions. It may limit access to autobiographical information that could be helpful in re-appraising distressing experiences, including voices. We investigated the possible links between OGM and distressing voices in psychosis by comparing three groups: (1) clinical voice-hearers (N = 39), (2) non-clinical voice-hearers (N = 35) and (3) controls without voices (N = 77) on a standard version of the autobiographical memory test (AMT). Clinical and non-clinical voice-hearers also completed a newly adapted version of the task, designed to assess voices-related memories (vAMT). As hypothesised, the clinical group displayed an OGM bias by retrieving fewer specific autobiographical memories on the AMT compared with both the non-clinical and control groups, who did not differ from each other. The clinical group also showed an OGM bias in recall of voice-related memories on the vAMT, compared with the non-clinical group. Clinical voice-hearers display an OGM bias when compared with non-clinical voice-hearers on both general and voices-specific recall tasks. These findings have implications for the refinement and targeting of psychological interventions for psychosis.

Reliability and validity of the Chinese mandarin version of PedsQL™ 3.0 transplant module.

Science.gov (United States)

Chang, Ying; Luo, Yanhui; Zhou, Yuchen; Wang, Ruixin; Song, Na; Zhu, Guanghua; Wang, Bin; Qin, Maoquan; Yang, Jun; Sun, Yuan; Li, Chunfu; Zhou, Xuan

2016-10-05

Long-term health-related quality of life (HRQoL) of pediatric patients after hematopoietic stem cell transplantation (HSCT) is increasingly studied worldwide. However, few studies have been performed in China, where no uniform scale is available; the PedsQL™ Cancer Module 3.0 Chinese Mandarin version has been used to evaluate HRQoL of patients after HSCT in China. This study aimed to assess the reliability and validity of the Chinese Mandarin version of PedsQL™ 3.0 Transplant Module. Patients between 2 and 18 years old, who underwent HSCT from January 2006 to June 2014, were recruited in Beijing Children's Hospital affiliated to Capital Medical University, the First Affiliated Hospital of Southern Medical University and Beijing Daopei Hospital. 207 parent reports and 182 child self-reports of the PedsQL™ 3.0 Transplant Module Chinese Mandarin version were assigned, of which 362 were returned. No missing item response was observed in the returned reports. Cronbach's alpha coefficient exceeded 0.7 in total scale and every dimension. The intraclass correlation coefficient exceeded 0.8 in all dimensions of child self-reports and parent reports. Spearman's rank correlation coefficients of items and their respective dimensions were 0.6-0.94 in parent reports, and 0.62-0.93 in child self-reports, while a weak association was found between the items and other dimensions. Exploratory factor analysis indicated a good extraction effect, and construct validity of the scale was >60 %. The Chinese Mandarin version of PedsQL™ 3.0 Transplant Module has good feasibility, reliability and validity. Its use may help improve the HRQoL of children after HSCT in China.

Evaluating Nonclinical Performance of the Academic Pathologist: A Comprehensive, Scalable, and Flexible System for Leadership Use.

Science.gov (United States)

Wiles, Austin Blackburn; Idowu, Michael O; Clevenger, Charles V; Powers, Celeste N

2018-01-01

Academic pathologists perform clinical duties, as well as valuable nonclinical activities. Nonclinical activities may consist of research, teaching, and administrative management among many other important tasks. While clinical duties have many clear metrics to measure productivity, like the relative value units of Medicare reimbursement, nonclinical performance is often difficult to measure. Despite the difficulty of evaluating nonclinical activities, nonclinical productivity is used to determine promotion, funding, and inform professional evaluations of performance. In order to better evaluate the important nonclinical performance of academic pathologists, we present an evaluation system for leadership use. This system uses a Microsoft Excel workbook to provide academic pathologist respondents and reviewing leadership a transparent, easy-to-complete system that is both flexible and scalable. This system provides real-time feedback to academic pathologist respondents and a clear executive summary that allows for focused guidance of the respondent. This system may be adapted to fit practices of varying size, measure performance differently based on years of experience, and can work with many different institutional values.

Investigating antibiotic resistance in non-clinical environments

Directory of Open Access Journals (Sweden)

Fiona eWalsh

2013-02-01

Full Text Available There have been many calls for more information about the natural resistome and these have also highlighted the importance of understanding the soil resistome in the preservation of antibiotics for the treatment of infections. However, to date there have been few studies which have investigated the culturable soil resistome, which highlights the difficulties faced by microbiologists in designing these experiments to produce meaningful data. The World Health Organization definition of resistance is the most fitting to non-clinical environmental studies: Antimicrobial resistance is resistance of a microorganism to an antimicrobial medicine to which it was previously sensitive. The ideal investigation of non-clinical environments for antibiotic resistance of clinical relevance would be using standardized guidelines and breakpoints. This review outlines different definitions and methodologies used to understand antibiotic resistance and suggests how this can be performed outside of the clinical environment.

Drug safety is a barrier to the discovery and development of new androgen receptor antagonists.

Science.gov (United States)

Foster, William R; Car, Bruce D; Shi, Hong; Levesque, Paul C; Obermeier, Mary T; Gan, Jinping; Arezzo, Joseph C; Powlin, Stephanie S; Dinchuk, Joseph E; Balog, Aaron; Salvati, Mark E; Attar, Ricardo M; Gottardis, Marco M

2011-04-01

Androgen receptor (AR) antagonists are part of the standard of care for prostate cancer. Despite the almost inevitable development of resistance in prostate tumors to AR antagonists, no new AR antagonists have been approved for over a decade. Treatment failure is due in part to mutations that increase activity of AR in response to lower ligand concentrations as well as to mutations that result in AR response to a broader range of ligands. The failure to discover new AR antagonists has occurred in the face of continued research; to enable progress, a clear understanding of the reasons for failure is required. Non-clinical drug safety studies and safety pharmacology assays were performed on previously approved AR antagonists (bicalutamide, flutamide, nilutamide), next generation antagonists in clinical testing (MDV3100, BMS-641988), and a pre-clinical drug candidate (BMS-501949). In addition, non-clinical studies with AR mutant mice, and EEG recordings in rats were performed. Non-clinical findings are compared to disclosures of clinical trial results. As a drug class, AR antagonists cause seizure in animals by an off-target mechanism and are found in vitro to inhibit GABA-A currents. Clinical trials of candidate next generation AR antagonists identify seizure as a clinical safety risk. Non-clinical drug safety profiles of the AR antagonist drug class create a significant barrier to the identification of next generation AR antagonists. GABA-A inhibition is a common off-target activity of approved and next generation AR antagonists potentially explaining some side effects and safety hazards of this class of drugs. Copyright © 2010 Wiley-Liss, Inc.

RF Coupling into the Fuel Tank of a Large Transport Aircraft from Intentionally Transmitting Peds in the Passenger Cabin

Science.gov (United States)

Nguyen, Truong X.; Dudley, Kenneth L.; Scearce, Stephen A.; Ely, Jay J.; Richardson, Robert E.; Hatfield, Michael O.

2000-01-01

An investigation was performed to study the potential for radio frequency (RF) power radiated from Portable Electronic Devices (PEDs) to create an arcing/sparking event within the fuel tank of a large transport aircraft. This paper describes the experimental methods used for measuring RF coupling to the fuel tank and Fuel Quantity Indication System (FQIS) wiring from PED sources located in the passenger cabin. To allow comparison of voltage/current data obtained in a laboratory chamber FQIS installation to an actual aircraft FQIS installation, aircraft fuel tank RF reverberation characteristics were also measured. Results from the measurements, along with a survey of threats from typical intentional transmitting PEDs are presented. The resulting worst-case power coupled onto fuel tank FQIS wiring is derived. The same approach can be applied to measure RF coupling into various other aircraft systems.

An Exploratory Study Investigating the Non-Clinical Benefits of Evidence-Based Veterinary Medicine

Directory of Open Access Journals (Sweden)

Elizabeth Jackson

2017-05-01

Full Text Available Objective: As little prior research exists about the non-clinical benefits of evidence-based veterinary medicine (EBVM, this exploratory study was conducted to identify non-clinical benefits of EBVM to veterinary practices, as well as highlighting the barriers to further implementation, and ways to overcome them.Background: A PICO-based literature review (Hauser and Jackson, 2016 was conducted to establish current knowledge about the non-clinical benefits of EBVM. It found that while there are some papers suggesting a link between the practice of EBVM and better non-clinical benefits such as client satisfaction and client retention, a single study, focusing on the non-clinical benefits of EBVM, had yet to be conducted.Evidentiary value: This exploratory study provides a solid basis for the further development of a confirmatory study of the themes identified in the interviews. The impact on practice from our findings is significant as it details the key areas where the use of EBVM can yield commercial benefits from the perspective of a group of EBVM experts via interview. It is entirely possible that international veterinary environments which mirror that of the UK will find this research beneficial.Methods: Due to the paucity of data about the non-clinical benefits of EBVM, an exploratory, qualitative approach was taken to this research in order to build a platform for further confirmatory, quantitative investigation (Zikmund, 2003. In February and March 2016 interviews with 16 RCVS Knowledge Group chairs[1] were conducted. The interview guide contained broad, open-ended questions to explore existing tacit knowledge about the non-commercial benefits of EBVM. The interviews were audio recorded and transcribed verbatim and subsequently analysed using NVivo 11 software.Results: This qualitative enquiry showed that the key areas where the use of EBVM can yield non-clinical benefits are through increased client satisfaction and retention, improved

Predicting QRS and PR interval prolongations in humans using nonclinical data.

Science.gov (United States)

Bergenholm, L; Parkinson, J; Mettetal, J; Evans, N D; Chappell, M J; Collins, T

2017-10-01

Risk of cardiac conduction slowing (QRS/PR prolongations) is assessed prior to clinical trials using in vitro and in vivo studies. Understanding the quantitative translation of these studies to the clinical situation enables improved risk assessment in the nonclinical phase. Four compounds that prolong QRS and/or PR (AZD1305, flecainide, quinidine and verapamil) were characterized using in vitro (sodium/calcium channels), in vivo (guinea pigs/dogs) and clinical data. Concentration-matched translational relationships were developed based on in vitro and in vivo modelling, and the in vitro to clinical translation of AZD1305 was quantified using an in vitro model. Meaningful (10%) human QRS/PR effects correlated with low levels of in vitro Na v 1.5 block (3-7%) and Ca v 1.2 binding (13-21%) for all compounds. The in vitro model developed using AZD1305 successfully predicted QRS/PR effects for the remaining drugs. Meaningful QRS/PR changes in humans correlated with small effects in guinea pigs and dogs (QRS 2.3-4.6% and PR 2.3-10%), suggesting that worst-case human effects can be predicted by assuming four times greater effects at the same concentration from dog/guinea pig data. Small changes in vitro and in vivo consistently translated to meaningful PR/QRS changes in humans across compounds. Assuming broad applicability of these approaches to assess cardiovascular safety risk for non-arrhythmic drugs, this study provides a means of predicting human QRS/PR effects of new drugs from effects observed in nonclinical studies. © 2017 The British Pharmacological Society.

Development of the PedsQL™ Epilepsy Module: Focus group and cognitive interviews.

Science.gov (United States)

Follansbee-Junger, Katherine W; Mann, Krista A; Guilfoyle, Shanna M; Morita, Diego A; Varni, James W; Modi, Avani C

2016-09-01

Youth with epilepsy have impaired health-related quality of life (HRQOL). Existing epilepsy-specific HRQOL measures are limited by not having parallel self- and parent-proxy versions, having a restricted age range, not being inclusive of children with developmental disabilities, or being too lengthy for use in a clinical setting. Generic HRQOL measures do not adequately capture the idiosyncrasies of epilepsy. The purpose of the present study was to develop items and content validity for the PedsQL™ Epilepsy Module. An iterative qualitative process of conducting focus group interviews with families of children with epilepsy, obtaining expert input, and conducting cognitive interviews and debriefing was utilized to develop empirically derived content for the instrument. Eleven health providers with expertise in pediatric epilepsy from across the country provided feedback on the conceptual model and content, including epileptologists, nurse practitioners, social workers, and psychologists. Ten pediatric patients (age 4-16years) with a diagnosis of epilepsy and 11 parents participated in focus groups. Thirteen pediatric patients (age 5-17years) and 17 parents participated in cognitive interviews. Focus groups, expert input, and cognitive debriefing resulted in 6 final domains including restrictions, seizure management, cognitive/executive functioning, social, sleep/fatigue, and mood/behavior. Patient self-report versions ranged from 30 to 33 items and parent proxy-report versions ranged from 26 to 33 items, with the toddler and young child versions having fewer items. Standardized qualitative methodology was employed to develop the items and content for the novel PedsQL™ Epilepsy Module. The PedsQL™ Epilepsy Module has the potential to enhance clinical decision-making in pediatric epilepsy by capturing and monitoring important patient-identified contributors to HRQOL. Copyright © 2016 Elsevier Inc. All rights reserved.

An epidemiological investigation of the early phase of the porcine epidemic diarrhea (PED) outbreak in Canadian swine herds in 2014: A case-control study.

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Perri, Amanda M; Poljak, Zvonimir; Dewey, Cate; Harding, John C S; O'Sullivan, Terri L

2018-02-01

The first case of porcine epidemic diarrhea (PED) in Canada was diagnosed in January 2014 in Ontario, approximately 9 months after PED emerged in the United States. An early investigation of the Canadian outbreak suspected that the probable source of the virus was contaminated feed. The objective of this study was to evaluate the role of feed and other possible factors in the early phase of the PED outbreak in Canadian swine herds. The study period of interest for this case-control study was January 22nd to March 1st, 2014. A case herd was defined as a swine herd with a confirmed positive laboratory diagnostic test (RT-PCR) results for PED virus, along with pigs exhibiting typical clinical signs at the herd level during the study period. A questionnaire was administered to participating producers from the 22 Canadian swine herds enrolled (n = 9 case and n = 13 control herds). Case herd producers were asked to provide information from the initial day of onset of clinical signs and 30 days prior to that day. Control herds were matched to a case herd on the basis of province, herd type and approximate size. The period of interest for a control herd was matched to the initial day of clinical signs of PED for the case herd, along with the 30 days prior to this day. The questionnaire questions focused on herd demographics, biosecurity protocols, live animal movements onto and off sites, deadstock movements, feed and people movements for both the case and control herds. The questionnaire for control herds were based on their matched case's period of interest, and together with case herds formed a matched stratum. Multivariable exact conditional logistic regression and mixed multivariable logistic regression models, with the matched stratum as a random effect, were used to assess the association between various risk factors and the odds of PED introduction into a herd. After adjusting for biosecurity practices, the odds of a PED occurrence was 38.1 (95% CI: 2

Validation of Persian Version of PedsQL™ 4.0™ Generic Core Scales in Toddlers and Children

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Gheissari, Alaleh; Farajzadegan, Ziba; Heidary, Maryam; Salehi, Fatemeh; Masaeli, Ali; Mazrooei, Amin; Varni, James W; Fallah, Zahra; Zandieh, Fariborz

2012-01-01

Introduction: To evaluate the reliability, validity and feasibility of the Persian version of the Pediatric Quality of Life inventory (PedsQL™ 4.0™ 4.0) Generic Core Scales in Iranian healthy students ages 7-15 and chronically ill children ages 2-18. Methods: We followed the translation methodology proposed by developer to validate Persian version of PedsQL™ 4.0™ 4.0 Generic Core Scales for children. Six hundred and sixty children and adolescents and their parents were enrolled. Sample of 160 healthy students were chosen by random cluster method between 4 regions of Isfahan education offices and 60 chronically ill children were recruited from St. Alzahra hospital private clinics. The questionnaires were fulfilled by the participants. Results: The Persian version of PedsQL™ 4.0™ 4.0 Generic Core Scales discriminated between healthy and chronically ill children (healthy students mean score was 12.3 better than chronically ill children, Presearches. It is necessary to alternate scoring for 2-4 years old questionnaire and to find a way to increase reliability for healthy children aged 8-12 years especially, according to Iranian culture. PMID:22701775

South African Dental Students' Perceptions of Most Important Nonclinical Skills According to Medical Leadership Competency Framework.

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Van der Berg-Cloete, Sophy E; Snyman, Lorraine; Postma, Thomas C; White, John G

2016-11-01

Recent developmental frameworks suggest that dental curricula should focus on developing nonclinical skills in dental students. The aim of this study was to qualitatively map students' perceptions of the most important nonclinical skills against the Medical Leadership Competency Framework (MLCF). A representative sample of second- to fifth-year students (n=594; overall response rate 69%) from all four dental schools in South Africa participated in a cross-sectional survey in 2014-15 enquiring about nonclinical skills and dental practice management. One of the questions required students to list the four most important nonclinical skills required for a dentist. Students (n=541) most frequently noted competencies related to working with others (97.9%), personal qualities (72.3%), and managing services (42.9%) as the most important nonclinical skills. Very few students mentioned competencies related to the improvement of services (14.1%) and the provision of strategic direction (10.9%). The students' attention appeared to be on nonclinical skills generally required for clinical care with some realization of the importance of managing services, indicating a need for a stronger focus on leadership and management training in dental schools in South Africa. The results also helped to unravel some of the conceptual ambiguity of the MLCF and highlight opportunities for leadership research using the MLCF as a conceptual framework.

Serum 25-Hydroxyvitamin D Levels, phosphoprotein enriched in diabetes gene product (PED/PEA-15 and leptin-to-adiponectin ratio in women with PCOS

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Savastano Silvia

2011-11-01

Full Text Available Abstract Background Polycystic ovary syndrome (PCOS is frequently associated with hypovitaminosis D. Vitamin D is endowed with pleiotropic effects, including insulin resistance (IR and apoptotic pathway. Disruption of the complex mechanism that regulated ovarian apoptosis has been reported in PCOS. Phosphoprotein enriched in diabetes gene product (PED/PEA-15, an anti-apoptotic protein involved in type 2 diabetes mellitus (T2DM, is overexpressed in PCOS women, independently of obesity. Leptin-to-adiponectin ratio (L/A is a biomarker of IR and low-grade inflammation in PCOS. The aim of the study was to investigate the levels of 25-hydroxy vitamin D (25(OHD, and L/A, in association with PED/PEA-15 protein abundance, in both lean and overweight/obese (o/o women with PCOS. Patients and Methods PED/PEA-15 protein abundance and circulating levels of 25(OHD, L/A, sex hormone-binding globulin, and testosterone were evaluated in 90 untreated PCOS patients (25 ± 4 yrs; range 18-34 and 40 healthy controls age and BMI comparable, from the same geographical area. FAI (free androgen index and the homeostasis model assessment of insulin resistance (HoMA-IR index were calculated. Results In o/o PCOS, 25(OHD levels were significantly lower, and L/A values were significantly higher than in lean PCOS (p Conclusions Lower 25(OHD and higher L/A were associated to PED/PEA-15 protein abundance in PCOS, suggesting their involvement in the ovarian imbalance between pro-and anti-apoptotic mechanisms, with high L/A and insulin and low 25(OHD levels as the main determinants of PED/PEA-15 protein variability. Further studies, involving also different apoptotic pathways or inflammatory cytokines and granulosa cells are mandatory to better define the possible bidirectional relationships between 25(OHD, PED/PEA-15 protein abundance, leptin and adiponectin in PCOS pathogenesis.

Health-related quality of life in pediatric patients after allogeneic SCT: development of the PedsQL Stem Cell Transplant module and results of a pilot study.

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Lawitschka, A; Güclü, E D; Varni, J W; Putz, M; Wolff, D; Pavletic, S; Greinix, H; Peters, C; Felder-Puig, R

2014-08-01

With increased survival after pediatric allogeneic hematopoietic SCT health-related quality of life (HRQL) has emerged as an essential health outcome. The impact of transplant and chronic GVHD (cGVHD)-associated morbidity remains a major obstacle. In 2005, the National Institutes of Health (NIH) Consensus Conference on Criteria for Clinical Trials in cGVHD recommended HRQL tools as an independent measure of the impact of disease burden. The NIH recommendations did not provide a cGVHD-specific tool for HRQOL measures in children. This report focuses on the development of an SCT-specific instrument to assess HRQL in children and adolescents. For the assessment of generic HRQL we chose the PedsQL (Pediatric Quality of Life Inventory) Generic Cores Scales, which have been used in a large number of healthy, acutely ill and chronically ill children and adolescents. To capture SCT- and, specifically, cGVHD-related problems, we developed the PedsQL Stem Cell Transplant module by reviewing the literature, taking over some items/scales of other PedsQL modules, interviewing patients, parents and members of the health-care team, and applying the PedsQL measurement methods. The final PedsQL Stem Cell Transplant module consists of the HRQL domains: pain and hurt, fatigue/sleeping problems/weakness, nausea, worry/anxiety about disease/treatment, nutritional problems, neurocognitive problems, communication about disease/treatment, loneliness, physical functioning and additional somatic complaints (pruritus, skin inflammation, oral problems, eyes or breathing) including patients' and parents' assessment. It was tested in 35 pediatric patients, who were referred to our SCT Outpatient Clinic about 100 days post SCT. Both the generic PedsQL and the SCT-specific scales showed high internal consistency, with Cronbach alpha levels of ⩾0.70 in almost all scales. Most problems were detected within the HRQL domains of physical functioning and pain. The summary scores of the generic Peds

Depersonalization in a nonclinical population.

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Trueman, D

1984-01-01

The present study assessed the prevalence and characteristics of depersonalization phenomena in a nonclinical population. Undergraduate students (N = 388) responded to a questionnaire soliciting information regarding the experience of depersonalization, age at onset, number, frequency, duration, and intensity of depersonalization experiences, level of pleasantness/unpleasantness, diminution of experiences with and without professional assistance, and relation of depersonalization to other factors. Of the Ss, 34% reported depersonalization. No significant sex differences were noted but relationships between years of experience of depersonalization and intensity, frequency, and number of experiences were significant.

PedGenie: an analysis approach for genetic association testing in extended pedigrees and genealogies of arbitrary size

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Camp Nicola J

2006-04-01

Full Text Available Abstract Background We present a general approach to perform association analyses in pedigrees of arbitrary size and structure, which also allows for a mixture of pedigree members and independent individuals to be analyzed together, to test genetic markers and qualitative or quantitative traits. Our software, PedGenie, uses Monte Carlo significance testing to provide a valid test for related individuals that can be applied to any test statistic, including transmission disequilibrium statistics. Single locus at a time, composite genotype tests, and haplotype analyses may all be performed. We illustrate the validity and functionality of PedGenie using simulated and real data sets. For the real data set, we evaluated the role of two tagging-single nucleotide polymorphisms (tSNPs in the DNA repair gene, NBS1, and their association with female breast cancer in 462 cases and 572 controls selected to be BRCA1/2 mutation negative from 139 high-risk Utah breast cancer families. Results The results from PedGenie were shown to be valid both for accurate p-value calculations and consideration of pedigree structure in the simulated data set. A nominally significant association with breast cancer was observed with the NBS1 tSNP rs709816 for carriage of the rare allele (OR = 1.61, 95% CI = 1.10–2.35, p = 0.019. Conclusion PedGenie is a flexible and valid statistical tool that is intuitively simple to understand, makes efficient use of all the data available from pedigrees without requiring trimming, and is flexible to the types of tests to which it can be applied. Further, our analyses of real data indicate NBS1 may play a role in the genetic etiology of heritable breast cancer.

Family functioning in the families of psychiatric patients: a comparison with nonclinical families.

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Trangkasombat, Umaporn

2006-11-01

To examine family functioning in the families of psychiatric patients. Families of psychiatric patients and nonclinical families were compared. There were 60 families in each group. The instrument included a semistructured interview of family functioning and the Chulalongkorn Family Inventory (CFI), a self-report questionnaire designed to assess the perception of one's family. From the assessment by semistructured interview, 83.3% of psychiatric families and 45.0% of nonclinical families were found to be dysfunctional in at least one dimension. The difference was statistically significant (p dysfunctional dimensions in the psychiatric families was significantly higher than in the nonclinical control group, 3.5 +/- 1.9 and 0.98 +/- 1.5 respectively, p families were significantly lower than the control group, reflecting poor family functioning. The dysfunctions were mostly in the following dimensions: problem-solving, communication, affective responsiveness, affective involvement, and behavior control. Psychiatric families faced more psychosocial stressors and the average number of stressors was higher than the control families, 88.3% vs. 56.7% and 4.2 +/- 2.7 vs. 1.3 +/- 1.47 stressors respectively, p < 0.0001. Family functioning of psychiatric patients was less healthy than the nonclinical control. The present study underlined the significance of family assessment and family intervention in the comprehensive care of psychiatric patients.

Reações locais e níveis de antitoxina circulante decorrentes de administração do toxóide tetânico: estudo comparativo entre Ped-o-Jet e seringa hipodérmica Local reactions and antitoxin levels induced by the administration of tetanus toxoid: a comparative study between Ped-o-Jet and hypodermic syringe

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Ana Maria Aratangy Pluciennik

1985-06-01

Full Text Available Com o objetivo de comparar reações locais e conversão sorológica apresentadas por adultos que receberam o toxóide tetânico através de Ped-o-Jet (via subcutânea ou de seringa hipodérmica (via intramuscular, o toxóide foi administrado a 472 recrutas do Exército. Em observações realizadas 4 e 24 horas após a vacinação verificou-se que as reações locais dos indivíduos vacinados com Ped-o-Jet eram significativamente mais freqüentes e mais intensas do que aquelas dos vacinados com seringa hipodérmica, não tendo ocorrido, entretanto, reações graves. A conversão sorológica dos não imunes vacinados com Ped-o-Jet ocorreu numa freqüência maior do que nos indivíduos vacinados com seringa hipodérmica. Conclui-se portanto, que o Ped-o-Jet pode ser utilizado em campanhas de vacinação em massa contra o tétano, embora a via de administração preferencial, até o momento, seja a intramuscular.This paper deals with the administration of tetanus toxoid to 472 army recruits, 50% of which received the vaccine subcutaneously using a Ped-o-Jet pressure injector and the remaining subjects received the vaccine intramuscularly, with hypodermic syringe and needle. The objective was to draw comparative conclusions regarding local reactions and serumconvertion in those young adults. Local reactions were observed four and 24 hours after immunization. Although significantly more frequent and intense in individuals receiving the toxoid by jet injection than in those inoculated with hypodermic syringe, no serious reactions were registered. At the first observation, local reactions occured in 64% of black men vaccinated by Ped-o-Jet and in only 31% of those vaccinated by syringe; 70% of the non-black showed local reactions when vaccinated by Ped-o-Jet and 21% when vaccinated by hypodermic syringe. At the second observation, black men vaccinated by Ped-o-Jet showed local reactions in 78% of the cases and in 3% when vaccinated by syringe; 87% of

Personality Inventory for DSM-5 (PID-5) in Clinical Versus Nonclinical Individuals

DEFF Research Database (Denmark)

Bach, Bo; Sellbom, Martin; Simonsen, Erik

2017-01-01

The Personality Inventory for Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (PID-5) was developed for the assessment of pathological traits in clinical settings. However, most research on the PID-5 is derived from nonclinical samples. To date, the comparability...... with nonpsychotic disorders (81% women; mean age = 28.95), whereas a matched nonclinical sample ( n = 598) comprised community-dwelling individuals (81% women; mean age = 29.59). Measurement invariance was analyzed using a 13-step, two-group exploratory structural equation modeling approach. The results...

The Chinese version of the Pediatric Quality of Life Inventory™ (PedsQL™) Family Impact Module: cross-cultural adaptation and psychometric evaluation.

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Chen, Ruoqing; Hao, Yuantao; Feng, Lifen; Zhang, Yingfen; Huang, Zhuoyan

2011-03-23

A pediatric chronic health condition not only influences a child's life, but also has impacts on parent health-related quality of life (HRQOL) and family functioning. To provide care and social support to these families, a psychometrically well-developed instrument for measuring these impacts is of great importance. The present study is aimed to evaluate the psychometric properties of the Chinese version of the PedsQL™ Family Impact Module. The cross-cultural adaptation of the PedsQL™ Family Impact Module was performed following the PedsQL™ Measurement Model Translation Methodology. The Chinese version of the PedsQL™ Family Impact Module was administered to 136 parents of children with asthma and 264 parents of children with heart disease from four Triple A hospitals. The psychometric properties such as feasibility, internal consistency reliability, item-subscale correlations and construct validity were evaluated. The percentage of missing item responses was less than 0.1% for both asthma and heart disease sample groups. The Chinese version of the PedsQL™ Family Impact Module showed ceiling effects but had acceptable reliability (Cronbach's Alpha Coefficients were higher than 0.7 in all the subscales except "Daily Activities" in the asthma sample group). There were higher correlation coefficients between items and their hypothesized subscales than those with other subscales. The asthma sample group reported higher parent HRQOL and family functioning than the heart disease sample group. In the heart disease sample group, parents of outpatients reported higher parent HRQOL and family functioning than parents of inpatients. Confirmatory factor analysis showed that the instrument had marginally acceptable construct validity with some Goodness-of-Fit indices not reaching the standard indicating acceptable model fit. The Chinese version of the PedsQL™ Family Impact Module has adequate psychometric properties and could be used to assess the impacts of

The Chinese version of the Pediatric Quality of Life Inventory™ (PedsQL™ Family Impact Module: cross-cultural adaptation and psychometric evaluation

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Feng Lifen

2011-03-01

Full Text Available Abstract Background A pediatric chronic health condition not only influences a child's life, but also has impacts on parent health-related quality of life (HRQOL and family functioning. To provide care and social support to these families, a psychometrically well-developed instrument for measuring these impacts is of great importance. The present study is aimed to evaluate the psychometric properties of the Chinese version of the PedsQL™ Family Impact Module. Methods The cross-cultural adaptation of the PedsQL™ Family Impact Module was performed following the PedsQL™ Measurement Model Translation Methodology. The Chinese version of the PedsQL™ Family Impact Module was administered to 136 parents of children with asthma and 264 parents of children with heart disease from four Triple A hospitals. The psychometric properties such as feasibility, internal consistency reliability, item-subscale correlations and construct validity were evaluated. Results The percentage of missing item responses was less than 0.1% for both asthma and heart disease sample groups. The Chinese version of the PedsQL™ Family Impact Module showed ceiling effects but had acceptable reliability (Cronbach's Alpha Coefficients were higher than 0.7 in all the subscales except "Daily Activities" in the asthma sample group. There were higher correlation coefficients between items and their hypothesized subscales than those with other subscales. The asthma sample group reported higher parent HRQOL and family functioning than the heart disease sample group. In the heart disease sample group, parents of outpatients reported higher parent HRQOL and family functioning than parents of inpatients. Confirmatory factor analysis showed that the instrument had marginally acceptable construct validity with some Goodness-of-Fit indices not reaching the standard indicating acceptable model fit. Conclusions The Chinese version of the PedsQL™ Family Impact Module has adequate

Death Anxiety in Clinical and Non-Clinical Groups

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Abdel-Khalek, Ahmed M.

2005-01-01

The Arabic Scale of Death Anxiety (ASDA) was administered, individually, to 7 groups (N=765) of Egyptian normal participants (non-clinical), anxiety disorder patients, and patients suffering from schizophrenia (males and females), and addicts (males only). They were generally matched as groups according to age, occupation, and education. The…

Generation of high brightness ion beam from insulated anode PED

International Nuclear Information System (INIS)

Matsukawa, Yoshinobu

1988-01-01

Generation and focusing of a high density ion beam with high brightness from a organic center part of anode of a PED was reported previously. Mass, charge and energy distribution of this beam were analyzed. Three kind of anode were tried. Many highly ionized medium mass ions (up to C 4+ , O 6+ ) accelarated to several times of voltage difference between anode and cathode were observed. In the case of all insulator anode the current carried by the medium mass ions is about half of that carried by protons. (author)

Item-level informant discrepancies across obese-overweight children and their parents on the PedsQL™ 4.0 instrument: an iterative hybrid ordinal logistic regression.

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Jafari, Peyman; Allahyari, Elahe; Salarzadeh, Mina; Bagheri, Zahra

2016-01-01

Child obesity has become a major health concern worldwide. In order to provide successful intervention strategies, it is necessary to understand how obese-overweight children and their parents perceive obesity and its consequences on child's health-related quality of life (HRQoL). This study aimed to assess measurement equivalence of the PedsQL™ 4.0 across obese-overweight children and their parents. The items in the PedsQL™ 4.0 were analysed for differential item functioning (DIF) across obese-overweight children and their parents using an iterative hybrid ordinal logistic regression/item response theory approach. The sample included 647 overweight-obese children and their parents, who completed child and parent reports of the PedsQL™ 4.0, respectively. Overall, 17 out of 23 (74%) items were flagged with DIF across two groups: eight items exhibited uniform DIF and nine items non-uniform DIF. In addition, parents of obese children rated the child's HRQoL significantly lower than their children in all domains of the PedsQL™ 4.0, and this finding did not change whether or not items with uniform DIF were included. Although obese-overweight children and their parents interpret items of the PedsQL™ 4.0 in a conceptually different manner, removing or retaining DIF items in the subscales had no significant effects on group differences. Accordingly, it appears that observed differences in HRQoL scores across child and parent reports are a true difference and not a reflection of measurement artefact.

Health-Related Quality of Life and Cognitive Functioning from the Perspective of Parents of School-Aged Children with Asperger's Syndrome Utilizing the PedsQL[TM

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Limbers, Christine A.; Heffer, Robert W.; Varni, James W.

2009-01-01

HRQOL as a multidimensional construct has not been previously investigated in children with Asperger's Syndrome. The objective of the present study was to examine the initial feasibility, reliability, and validity of the PedsQL[TM] 4.0 Generic Core Scales and PedsQL[TM] Cognitive Functioning Scale parent proxy-report versions in school-aged…

Cognitive performance in both clinical and non-clinical burnout

NARCIS (Netherlands)

Oosterholt, B.G.; Maes, J.H.R.; Linden, D. van der; Verbraak, M.J.P.M.; Kompier, M.A.J.

2014-01-01

Relatively little is known about cognitive performance in burnout. The aim of the present study was to further our knowledge on this topic by examining, in one study, cognitive performance in both clinical and non-clinical burnout while focusing on three interrelated aspects of cognitive

Article Commentary: The interRAI Pediatric Home Care (PEDS HC Assessment: Evaluating the Long-term Community-Based Service and Support Needs of Children Facing Special Healthcare Challenges

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Charles D. Phillips

2015-01-01

Full Text Available The vast majority of assessment instruments developed to assess children facing special healthcare challenges were constructed to assess children within a limited age range or children who face specific conditions or impairments. In contrast, the interRAI Pediatric Home Care (PEDS HC Assessment Form was specifically designed to assess the long-term community-based service and support needs of children and youth aged from four to 20 years who face a wide range of chronic physical or behavioral health challenges. Initial research indicates that PEDS HC items exhibit good predictive validity–-explaining significant proportions of the variance in parents’ perceptions of needs, case managers’ service authorizations, and Medicaid program expenditures for long-term community-based services and supports. In addition, PEDS HC items have been used to construct scales that summarize the strengths and needs of children facing special healthcare challenges. Versions of the PEDS HC are now being used in Medicaid programs in three states in the United States.

The relationship between attachment styles and internalizing or externalizing symptoms in clinical and nonclinical adolescents

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Fernando Lacasa

2015-05-01

Full Text Available Studies regarding the relationship between attachment and psychopathology during adolescence have been performed separately for clinical and nonclinical adolescents and have used different assessment measures, which together might produce a methodological bias that increases the association between attachment and psychopathology. With the aim of avoiding this bias, the present study used identical measures to explore the relationship between attachment styles and internalizing or externalizing symptoms in clinical and nonclinical samples of adolescents. The sample consisted of 258 adolescents, 129 clinical and 129 nonclinical, aged between 14 and 18 years. The adolescents in each sample were matched for age, gender, and socioeconomic status. Attachment was assessed using the CaMir Q-sort, and psychopathological symptoms were assessed by means of the Youth Self Report (YSR. The relationships between attachment and psychopathology were similar for clinical and nonclinical adolescents. A preoccupied attachment style predicted internalizing and externalizing symptoms, somatic complaints, anxious-fearful behavior, verbal aggression, attention-seeking behavior, and thinking problems. Compared to previous studies, this research has made it possible to identify broader, stronger, and more specific associations between preoccupied attachment style and psychopathological symptoms in adolescents.

Cross-cultural adaptation, reliability, and validity of the Turkish version of PedsQL 3.0 Arthritis Module: a quality-of-life measure for patients with juvenile idiopathic arthritis in Turkey.

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Tarakci, E; Baydogan, S N; Kasapcopur, O; Dirican, A

2013-04-01

The aim of this study was to describe the cultural adaptation, validity, and reliability of a Turkish version of the pediatric quality-of-life inventory (PedsQL) 3.0 Arthritis Module in a population with juvenile idiopathic arthritis (JIA). A total of 169 patients with JIA and their parents were enrolled in the study. The Turkish version of the childhood health assessment questionnaire (CHAQ) was used to evaluate the validity of related domains in the PedsQL 3.0 Arthritis Module. Both the PedsQL 3.0 Arthritis Module and CHAQ were filled out by children over 8 years of age and by the parents of children 2-7 years of age. Internal reliability was poor to excellent (Cronbach's alpha coefficients 0.56-0.84 for self-reporting and 0.63-0.82 for parent reporting), and interobserver reliability varied from good to excellent (intraclass correlation coefficient (ICC) 0.79-0.91 for self-reporting and 0.80-0.88 for parent reporting) for the total scores of the PedsQL 3.0 Arthritis Module. Parent-child concordance for all scores was moderate to excellent (ICC 0.42-0.92). The PedsQL 3.0 Arthritis Module and CHAQ were highly positively correlated, with coefficients from 0.21 to 0.76, indicating concurrent validity. We demonstrated the reliability and validity of quality-of-life measurement using the Turkish version of the PedsQL 3.0 Arthritis Module in our sociocultural context. The PedsQL 3.0 Arthritis Module can be utilized as a tool for the evaluation of quality of life in patients with JIA aged 2-18 years.

Validity and reliability of the Iranian version of the Pediatric Quality of Life Inventory™ 4.0 (PedsQL™ Generic Core Scales in children

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Amiri Parisa

2012-01-01

Full Text Available Abstract Background This study aimed to investigate the reliability and validity of the Iranian version of the Pediatric Quality of Life Inventory™ 4.0 (PedsQL™ 4.0 Generic Core Scales in children. Methods A standard forward and backward translation procedure was used to translate the US English version of the PedsQL™ 4.0 Generic Core Scales for children into the Iranian language (Persian. The Iranian version of the PedsQL™ 4.0 Generic Core Scales was completed by 503 healthy and 22 chronically ill children aged 8-12 years and their parents. The reliability was evaluated using internal consistency. Known-groups discriminant comparisons were made, and exploratory factor analysis (EFA and confirmatory factor analysis (CFA were conducted. Results The internal consistency, as measured by Cronbach's alpha coefficients, exceeded the minimum reliability standard of 0.70. All monotrait-multimethod correlations were higher than multitrait-multimethod correlations. The intraclass correlation coefficients (ICC between the children self-report and parent proxy-reports showed moderate to high agreement. Exploratory factor analysis extracted six factors from the PedsQL™ 4.0 for both self and proxy reports, accounting for 47.9% and 54.8% of total variance, respectively. The results of the confirmatory factor analysis for 6-factor models for both self-report and proxy-report indicated acceptable fit for the proposed models. Regarding health status, as hypothesized from previous studies, healthy children reported significantly higher health-related quality of life than those with chronic illnesses. Conclusions The findings support the initial reliability and validity of the Iranian version of the PedsQL™ 4.0 as a generic instrument to measure health-related quality of life of children in Iran.

Serum 25-Hydroxyvitamin D Levels, phosphoprotein enriched in diabetes gene product (PED/PEA-15) and leptin-to-adiponectin ratio in women with PCOS.

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Savastano, Silvia; Valentino, Rossella; Di Somma, Carolina; Orio, Francesco; Pivonello, Claudia; Passaretti, Federica; Brancato, Valentina; Formisano, Pietro; Colao, Annamaria; Beguinot, Francesco; Tarantino, Giovanni

2011-11-23

Polycystic ovary syndrome (PCOS) is frequently associated with hypovitaminosis D. Vitamin D is endowed with pleiotropic effects, including insulin resistance (IR) and apoptotic pathway. Disruption of the complex mechanism that regulated ovarian apoptosis has been reported in PCOS. Phosphoprotein enriched in diabetes gene product (PED/PEA-15), an anti-apoptotic protein involved in type 2 diabetes mellitus (T2DM), is overexpressed in PCOS women, independently of obesity. Leptin-to-adiponectin ratio (L/A) is a biomarker of IR and low-grade inflammation in PCOS. The aim of the study was to investigate the levels of 25-hydroxy vitamin D (25(OH)D), and L/A, in association with PED/PEA-15 protein abundance, in both lean and overweight/obese (o/o) women with PCOS. PED/PEA-15 protein abundance and circulating levels of 25(OH)D, L/A, sex hormone-binding globulin, and testosterone were evaluated in 90 untreated PCOS patients (25 ± 4 yrs; range 18-34) and 40 healthy controls age and BMI comparable, from the same geographical area. FAI (free androgen index) and the homeostasis model assessment of insulin resistance (HoMA-IR) index were calculated. In o/o PCOS, 25(OH)D levels were significantly lower, and L/A values were significantly higher than in lean PCOS (p involvement in the ovarian imbalance between pro-and anti-apoptotic mechanisms, with high L/A and insulin and low 25(OH)D levels as the main determinants of PED/PEA-15 protein variability. Further studies, involving also different apoptotic pathways or inflammatory cytokines and granulosa cells are mandatory to better define the possible bidirectional relationships between 25(OH)D, PED/PEA-15 protein abundance, leptin and adiponectin in PCOS pathogenesis.

Validation of the PedsQL Epilepsy Module: A pediatric epilepsy-specific health-related quality of life measure.

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Modi, Avani C; Junger, Katherine F; Mara, Constance A; Kellermann, Tanja; Barrett, Lauren; Wagner, Janelle; Mucci, Grace A; Bailey, Laurie; Almane, Dace; Guilfoyle, Shanna M; Urso, Lauryn; Hater, Brooke; Hustzi, Heather; Smith, Gigi; Herrmann, Bruce; Perry, M Scott; Zupanc, Mary; Varni, James W

2017-11-01

To validate a brief and reliable epilepsy-specific, health-related quality of life (HRQOL) measure in children with various seizure types, treatments, and demographic characteristics. This national validation study was conducted across five epilepsy centers in the United States. Youth 5-18 years and caregivers of youth 2-18 years diagnosed with epilepsy completed the PedsQL Epilepsy Module and additional questionnaires to establish reliability and validity of the epilepsy-specific HRQOL instrument. Demographic and medical data were collected through chart reviews. Factor analysis was conducted, and internal consistency (Cronbach's alphas), test-retest reliability, and construct validity were assessed. Questionnaires were analyzed from 430 children with epilepsy (M age = 9.9 years; range 2-18 years; 46% female; 62% white: non-Hispanic; 76% monotherapy, 54% active seizures) and their caregivers. The final PedsQL Epilepsy Module is a 29-item measure with five subscales (i.e., Impact, Cognitive, Sleep, Executive Functioning, and Mood/Behavior) with parallel child and caregiver reports. Internal consistency coefficients ranged from 0.70-0.94. Construct validity and convergence was demonstrated in several ways, including strong relationships with seizure outcomes, antiepileptic drug (AED) side effects, and well-established measures of executive, cognitive, and emotional/behavioral functioning. The PedsQL Epilepsy Module is a reliable measure of HRQOL with strong evidence of its validity across the epilepsy spectrum in both clinical and research settings. Wiley Periodicals, Inc. © 2017 International League Against Epilepsy.

Propiedades físico-mecánicas del fruto y del sistema fruto-pedúnculo del café variedad Colombia.

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Alvarez Tobón Elizabeth

1999-12-01

Full Text Available En el Centro Nacional de Investigación de café CENICAFE, se estudió para café cereza variedad Colombia de frutos amarillos y rojos, de 2,3 y 4 años en estado de maduración verde, pintón y maduro, las propiedades físicas y mecánicas del sistema fruto-pedúnculo: dimensiones de los frutos, peso, momento de inercia con respecto a los tres ejes(x, y, z, longitud, diámetro y rigidez del pedúnculo, fuerza de tracción y momentos flectores y torsores necesarios para el desprendimiento de los frutos.

Efeitos do clampeamento do pedículo hepático nos intestinos Effects of the clamping of the hepatic pedículo in the intestines

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Abrão Antonio Sébe

2000-03-01

Full Text Available Foi realizado clampeamento do pedículo hepático de rato por diferentes tempos e estudadas as repercussões nos intestinos. Para tanto foram utilizados 40 ratos, machos, divididos em quatro grupos de 10 animais cada. O grupo S (Sham não foi submetido a isquemia, já os grupos E1, E2 e E3 sofreram isquemia de 10, 20 e 30 minutos respectivamente. Nossos resultados mostraram alterações macroscópicas quanto a cor dos intestinos nos grupos E2 (20' e E3 (30' e histopatológicas que ocorreram em cada um desses grupos. Observou-se que quanto maior o tempo de clampeamento do pedículo hepático, maior a congestão esplâncnica, sendo que aos 30 minutos ocorreu o despreendimento do revestimento epitelial das vilosidades intestinais e hemorragia.It was made a clamping of the hepatic pedicle in different lapses of time and the morphological features of this intestines were observed. 40 male rats were divided in four groups of 10 animals each. The group S (Sham was not submitted to ischemia and the groups E1, E2 and E3 suffered ischemia during 10, 20 and 30 minutes respectively. Our results showed macroscopic modifications related to the colour of the intestines in the groups E2 (20' and E3 (30' as well as histopathological changes in the same groups. It was also observed that the larger the lapse of time of clamping of the hepatic pedicle the larger was the splanchnic congestion and in the group 30' detachment of the lining epithelium was observed in the intestinal villi.

Childhood Familial Environment, Maltreatment and Borderline Personality Disorder Symptoms in a Non-Clinical Sample: A Cognitive Behavioural Perspective

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Carr, Steven; Francis, Andrew

2009-01-01

The present study sought to determine if cognitive beliefs and schemas mediated the relationship between retrospectively reported childhood events and adult borderline personality disorder (BPD) symptoms in a non-clinical sample. One hundred and seventy-eight non-clinical participants completed questionnaires measuring BPD symptoms, core beliefs,…

Determinação das propriedades geométricas, físicas e mecânicas do sistema fruto-pedúnculo-ramo do cafeeiro

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Andre L. de F. Coelho

2015-03-01

Full Text Available O método de elementos finitos tem sido empregado no projeto de máquinas e para o estudo do comportamento dinâmico do cafeeiro. Objetivou-se, neste trabalho, determinar as propriedades geométricas, físicas e mecânicas do sistema fruto-pedúnculo-ramo do cafeeiro. As dimensões foram determinadas por meio de processamento de imagens, as massas e os volumes mensurados utilizando-se balança e proveta, respectivamente. Os módulos de elasticidade foram determinados por meio de ensaios mecânicos de compressão, tração e flexão, para os frutos, pedúnculos e ramos, respectivamente. Os coeficientes de Poisson foram determinados a partir das deformações longitudinais e transversais dos frutos e pedúnculos. A razão de amortecimento foi determinada por meio das curvas de decaimento utilizando-se o método de decremento logaritmo. Concluiu-se que as dimensões e a massa dos frutos apresentaram tendência de aumento na medida em que seu estádio de maturação evoluiu. Os módulos de elasticidade dos frutos e dos pedúnculos no estádio de maturação verde foram superiores aos valores para o estádio de maturação cereja.

75 FR 80011 - Good Laboratory Practice for Nonclinical Laboratory Studies

Science.gov (United States)

2010-12-21

.... FDA-2010-N-0548] Good Laboratory Practice for Nonclinical Laboratory Studies AGENCY: Food and Drug... (FDA) is seeking comment on whether to amend the regulations governing good laboratory practices (GLPs..., 1978 (43 FR 60013). As stated in its scope (Sec. 58.1), this regulation prescribes good laboratory...

Superior sensitivity and decreased time to detection with the Bactec Peds Plus/F system compared to the BacT/Alert Pediatric FAN blood culture system.

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Sullivan, K V; Turner, N N; Lancaster, D P; Shah, A R; Chandler, L J; Friedman, D F; Blecker-Shelly, D L

2013-12-01

Here, we compare the sensitivities and times to detection (TTD) of BacT/Alert Pediatric FAN (PF) and Bactec Peds Plus blood culture bottles. Test bottles were inoculated with 2 ml of banked whole blood, 1-ml aliquots of antibiotic suspension, and organisms diluted to simulate a bacteremia level of 10 to 100 CFU/ml. The control bottles were inoculated with 3 ml of banked blood and organism suspensions only. The organism-drug combinations were Staphylococcus epidermidis and vancomycin, methicillin-resistant Staphylococcus aureus and vancomycin, Streptococcus pneumoniae, vancomycin, and ceftriaxone, Streptococcus agalactiae, ampicillin, and cefotaxime, Escherichia coli, cefotaxime, and cefepime, Pseudomonas aeruginosa, piperacillin-tazobactam, cefepime, and gentamicin, Neisseria meningitidis and ceftriaxone, and Haemophilus influenzae and ceftriaxone. The control and test bottle combinations were tested in duplicate. The bottles were incubated for 5 days; 32 control and 104 test bottles were incubated. Overall, the bacterial recovery rates for the PF and Peds Plus bottles were 37% and 62%, 94% and 100% in the controls, 19% and 50% in the test bottles, and 33% and 92% in the bottles with vancomycin, respectively. No bacteria were recovered from the bottles with S. pneumoniae, S. agalactiae, E. coli, N. meningitidis, or H. influenzae in combination with cefotaxime or ceftriaxone. The Peds Plus system detected P. aeruginosa in bottles with cefepime and piperacillin-tazobactam, but the PF system recovered bacteria only in bottles with trough levels of piperacillin-tazobactam. The mean TTD were shorter in the Peds Plus system controls (14.2 versus 18.0 h; P = 0.001) and the test bottles (14.3 versus 17.8 h; P = 0.008) than in the PF bottles. Overall, we demonstrated superior sensitivity, TTD, and antibiotic neutralization in the Bactec Peds Plus system compared to those in the Pediatric FAN system.

Measuring health-related quality of life in children with cancer living in mainland China: feasibility, reliability and validity of the Chinese mandarin version of PedsQL 4.0 Generic Core Scales and 3.0 Cancer Module

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Ji Yi

2011-11-01

Full Text Available Abstract Background The Pediatric Quality of Life Inventory (PedsQL is widely used instrument to measure pediatric health-related quality of life (HRQOL for children aged 2 to 18 years. The purpose of the current study was to investigate the feasibility, reliability and validity of the Chinese mandarin version of the PedsQL 4.0 Generic Core Scales and 3.0 Cancer Module in a group of Chinese children with cancer. Methods The PedsQL 4.0 Genetic Core Scales and the PedsQL 3.0 Cancer Module were administered to children with cancer (aged 5-18 years and parents of such children (aged 2-18 years. For comparison, a survey on a demographically group-matched sample of the general population with children (aged 5-18 and parents of children (aged 2-18 years was conducted with the PedsQL 4.0 Genetic Core Scales. Result The minimal mean percentage of missing item responses (except the School Functioning scale supported the feasibility of the PedsQL 4.0 Generic Core Scales and 3.0 Cancer Module for Chinese children with cancer. Most of the scales showed satisfactory reliability with Cronbach's α of exceeding 0.70, and all scales demonstrated sufficient test-retest reliability. Assessing the clinical validity of the questionnaires, statistically significant difference was found between healthy children and children with cancer, and between children on-treatment versus off-treatment ≥12 months. Positive significant correlations were observed between the scores of the PedsQL 4.0 Generic Core Scale and the PedsQL 3.0 Cancer Module. Exploratory factor analysis demonstrated sufficient factorial validity. Moderate to good agreement was found between child self- and parent proxy-reports. Conclusion The findings support the feasibility, reliability and validity of the Chinese Mandarin version of PedsQL 4.0 Generic Core Scales and 3.0 Cancer Module in children with cancer living in mainland China.

Tratamento cirúrgico da ginecomastia com pedículos lateral e medial

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Miguel Modolin

Full Text Available Ginecomastia é o aumento da mama masculina que pode acometer até 65% dos indivíduos deste sexo na fase infanto-puberal, compreendida entre 13 e 16 anos. Tem como principais causas hepatite ou cirrose hepática, carcinoma ou doenças inflamatórias pulmonares crônicas, carcinomas ou disfunções testiculares, tumores glandulares (pituitária, supra-renal, alterações dos níveis séricos de testosterona, síndromes genéticas (síndrome de Klinefelter, p.ex., uso de drogas como heroína, maconha ou anabolizantes e hanseníase. Podemos classificar a ginecomastia quanto ao volume, quanto aos tecidos que a compõem (gordurosa ou pseudoginecomastia, glandular e mista, ou quanto ao tratamento necessário para sua correção cirúrgica (pequena, moderada e grave. O tratamento das formas mais graves de ginecomastia é muito diferente daquele aplicado às formas mais suaves, pois nas formas graves, além da ressecção dos tecidos gorduroso e glandular, existe a necessidade de ressecção da pele em excesso e o reposicionamento do complexo aréolo-mamilar. O objetivo deste trabalho é descrever uma técnica cirúrgica específica para estes pacientes portadores de formas graves de ginecomastia, através de dois pedículos dermogordurosos, um lateral e um medial, com aproximadamente 2cm de espessura, mantendo assim a nutrição do complexo aréolo-mamilar. Esses pedículos são delimitados entre as bissetrizes dos quadrantes súpero-lateral e ínfero-lateral, e súpero-medial e ínfero-medial, tendo o mamilo como vértice. Na área de pele excessiva periareolar, obtida através do pinçamento interdigital, é realizada a desepidermização dos pedículos lateral e medial e ressecção de toda pele e tecido celular subcutâneo até a fáscia peitoral nas regiões superior e inferior aos pedículos; a síntese é realizada em dois planos, sendo periareolar a cicatriz resultante. Foram operados com esta técnica vinte pacientes com forma grave de

Linking Psychopathy and School Aggression in a Nonclinical Sample of Adolescents

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Gumpel, Thomas P.

2014-01-01

Antisocial behavior and school aggression in youth has been linked with affective, interpersonal, self-attributional, and behavioral characteristics; these traits have often been associated with psychopathic behaviors among adults. Psychopathic traits were examined in nonclinically-referred youth exhibiting antisocial and aggressive behavior.…

Computer software to assess weld thickness loss in offshore pipelines: PEDS

Energy Technology Data Exchange (ETDEWEB)

Germano, Andre Luiz Silva; Correa, Samanda Cristine Arruda [Centro Universitario Estadual da Zona Oeste (CCMAT/UEZO), Rio de Janeiro, RJ (Brazil)], e-mail: scorrea@nuclear.ufrj.br; Souza, Edmilson Monteiro de; Silva, Ademir Xavier da; Lopes, Ricardo Tadeu [Programa de Engenharia Nuclear, COPPE, Universidade Federal do Rio de Janeiro (UFRJ), Rio de Janeiro, RJ (Brazil)], e-mails: emonteiro@nuclear.ufrj.br, ademir@nuclear.ufrj.br, ricardo@lin.ufrj.br

2010-07-01

The purpose of this work is to present an initial vision about a computer software named PEDS to assess weld thickness loss in offshore pipelines through digital radiography. This software calculates the thickness loss through a data bank obtained using computational modeling based on Monte Carlo MCNPX code. In order to give users more flexibility, the computer software was written in Java, which allows it to run on Linux, Mac OSX and Windows. Furthermore, tools are provided to image display, select and analyze specific areas of the image (measure average, area of selection) and generate profile plots. Applications of this software in the offshore area are presented. (author)

The Broader Autism Phenotype and Friendships in Non-Clinical Dyads

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Wainer, Allison L.; Block, Nicole; Donnellan, M. Brent; Ingersoll, Brooke

2013-01-01

The broader autism phenotype (BAP) is a set of subclinical traits qualitatively similar to those observed in autism spectrum disorders. The current study sought to elucidate the association between self- and informant-reports of the BAP and friendships, in a non-clinical sample of college student dyads. Self-informant agreement of the BAP and…

The University of Western Ontario Pediatric Audiological Monitoring Protocol (UWO PedAMP)

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Moodie, Sheila T.; Malandrino, April C.; Richert, Frances M.; Clench, Debbie A.; Scollie, Susan D.

2011-01-01

This study proposed and evaluated a guideline for outcome evaluation for infants and children with hearing loss who wear hearing aids. The University of Western Ontario Pediatric Audiological Monitoring Protocol (UWO PedAMP) was developed following a critical review of pediatric outcome evaluation tools and was systematically examined by the Network of Pediatric Audiologists of Canada. It consists of tools to gather clinical process outcomes as well as functional caregiver reports. The UWO PedAMP was administered to a clinical population of infants and children with hearing aids. Sixty-eight children were administered the functional outcome evaluation tools (i.e., caregiver reports) a total of 133 times. Clinical process outcomes of hearing aid verification (e.g., real-ear-to-coupler difference) revealed typical aided audibility (e.g., Speech Intelligibility Index). Results for the LittlEARS® questionnaire revealed that typically developing children with hearing loss who wear hearing aids are meeting auditory development milestones. Children with mild to moderate comorbidities displayed typical auditory development during the 1st year of life after which development began to decline. Children with complex factors related to hearing aid use had lower scores on the LittlEARS, but auditory development was in parallel to norms. Parents’ Evaluation of Aural/Oral Performance (PEACH) results indicated no age effect on scoring for children above 2 years of age; however, the effect of degree of hearing loss was significant. This work provides clinicians with a systematic, evidence-based outcome evaluation protocol to implement as part of a complete pediatric hearing aid fitting. PMID:22194316

Afinal, quem é mesmo pedófilo? Who is really pedophile, after all?

OpenAIRE

Jane Felipe

2006-01-01

O presente artigo busca problematizar alguns dos aspectos pertinentes ao debate contemporâneo em torno das "novas" modalidades de experimentação dos desejos erótico-sexuais, em especial a pedofilia/o pedófilo, discutindo os modos pelos quais tais conceitos vêm sendo re-significados nos últimos anos. A partir do referencial teórico dos Estudos Culturais e dos Estudos de Gênero, numa abordagem pós-estruturalista de análise, pretendo mostrar que, apesar das tentativas de aprisionar/categorizar/ ...

The Psychopathy Q-Sort. Construct Validity Evidence in a Nonclinical Sample

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Fowler, Katherine A.; Lilienfeld, Scott O.

2007-01-01

Scant research has examined the validity of instruments that permit observer ratings of psychopathy. Using a nonclinical (undergraduate) sample, the authors examined the associations between both self- and observer ratings on a psychopathy prototype (Psychopathy Q-Sort, PQS) and widely used measures of psychopathy, antisocial behavior, and…

Detection of the pediocin gene pedA in strains from human faeces by real-time PCR and characterization of Pediococcus acidilactici UVA1

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Cereghetti Tania

2007-09-01

Full Text Available Abstract Background Bacteriocin-producing lactic acid bacteria are commonly used as natural protective cultures. Among them, strains of the genus Pediococcus are particularly interesting for their ability to produce pediocin, a broad spectrum antimicrobial peptide with a strong antagonistic activity against the food-borne pathogen Listeria monocytogenes. Furthermore, there is increasing interest in isolating new bacteriocin-producing strains of human intestinal origin that could be developed for probiotic effects and inhibition of pathogenic bacteria in the gut. In this work, we typed a new strain, co-isolated from baby faeces together with a Bifidobacterium thermophilum strain, and characterized its proteinaceous compound with strong antilisterial activity. Results The newly isolated strain UVA1 was identified as a Pediococcus acidilactici by carbohydrate fermentation profile, growth at 50°C and 16S rDNA sequencing. The partially purified bacteriocin was heat resistant up to 100°C, active over a wide range of pH (2 to 9 and susceptible to proteolytic enzymes. The molecular weight, estimated by SDS-PAGE, was similar to that of pediocin AcH/PA-1 (4.5 kDa. P. acidilactici UVA1 harboured a 9.5-kb plasmid that could be cured easily, which resulted in the loss of the antimicrobial activity. Southern hybridization using the DIG-labelled pedA-probe established that the bacteriocin gene was plasmid-borne as for all pediocin described so far. Nucleotide sequence of the whole operon (3.5 kb showed almost 100 % similarity to the pediocin AcH/PA-1 operon. The mRNA transcript for pedA could be detected in P. acidilactici UVA1 but not in the cured derivative, confirming the expression of the pedA-gene in UVA1. Using a new real-time PCR assay, eleven out of seventeen human faecal samples tested were found to contain pedA-DNA. Conclusion We identified and characterised the first pediocin produced by a human intestinal Pediococcus acidilactici isolate and

Attention as a characteristic of nonclinical dissociation: an event-related potential study

NARCIS (Netherlands)

de Ruiter, Michiel B.; Phaf, R. Hans; Veltman, Dick J.; Kok, Albert; van Dyck, Richard

2003-01-01

Individual differences in dissociative style (which is generally considered a risk factor for dissociative pathology) were studied in a nonclinical sample. It was hypothesized that high-dissociative participants would show enhanced attentional abilities toward both relevant and irrelevant stimulus

Attitudes toward health and taste of food among women with bulimia nervosa and women of a non-clinical sample.

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Koritar, Priscila; Philippi, Sonia Tucunduva; Alvarenga, Marle Dos Santos

2017-06-01

Taste preferences and health concerns play important roles in determining eating attitudes, thus influencing food choices. Disordered eating attitudes are common among women, and can lead to the development and maintenance of eating disorders (ED). Attitudes toward health and taste of food among ED patients and its comparison with non-clinical women are not well known, and this knowledge could improve eating interventions. In this study, we compared taste preferences and health concerns in 27 women with diagnosis of bulimia nervosa (BN) and 216 women of a non-clinical sample. All participants completed the Health and Taste Attitude Scale (HTAS). Using analysis of covariance we compared the HTAS scores of the BN patients with those of the college students. Risk behaviors for ED (assessed by the Eating Attitudes Test) were identified in 54 (25%) of the non-clinical sample, all of whom were therefore excluded in comparison of BN patients. Non-clinical sample, compared to patients, scored higher on the HTAS Taste domain (p Health domain (p attitudes of women of non-clinical sample are related to taste and pleasure, whereas women with BN are concerned with adopting a diet regarded as healthy, thus increasing their interest in "light" products. Therefore, the taste and health concerns must be considered in nutrition interventions for women in general, and prevention and treatment of ED as determinants of food choice. Copyright © 2017 Elsevier Ltd. All rights reserved.

A psychometric evaluation of the PedsQL™ Family Impact Module in parents of children with sickle cell disease

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Hoffmann Raymond G

2009-04-01

Full Text Available Abstract Background Caring for a child with a chronic condition, such as sickle cell disease, can have a significant impact on parents and families. In order to provide comprehensive care and support to these families, psychometrically sound instruments are needed as an initial step in measuring the impact of chronic diseases on parents and families. We sought to evaluate the psychometric properties of the PedsQL™ Family Impact Module in populations of children with and without sickle cell disease. In addition, we sought to determine the correlation between parent's well being and their proxy report of their child's health-related quality of life (HRQL. Methods We conducted a cross-sectional study of parents of children with and without sickle cell disease who presented to an urban hospital-based sickle cell disease clinic and an urban primary care clinic. We assessed the HRQL and family functioning of both groups of parents utilizing the PedsQL™ Family Impact Module. The reliability, validity and factor structure of the instrument were determined and scores from the instrument were correlated with scores from parent-proxy report of their child's HRQL using the PedsQL™ 4.0 Generic Core Scales. Results Parents of 170 children completed the module (97 parents of children with sickle cell disease and 73 parents of children without sickle cell disease. The Family Impact Module had high ceiling effects but was reliable (Cronbach's alpha > 0.80 in all scales. The empirical factor structure was generally consistent with the theoretical factor structure and supported construct validity. The Family Impact Module discriminated between parents of children with severe sickle cell disease from parents of children with mild disease or no disease in the areas of communication and worry. There were no significant differences across any of the subscales between parents of children with mild sickle cell disease and those with no disease. Parents with higher

Controle genético do comprimento do pedúnculo em feijão-caupi Genetic control of peduncle length in cowpea

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Maurisrael de Moura Rocha

2009-03-01

Full Text Available O objetivo deste trabalho foi estudar o controle genético do caráter comprimento do pedúnculo em feijão-caupi (Vigna unguiculata. Para isso, foi realizado um cruzamento entre os parentais TVx-5058-09C, de pedúnculo curto, e TE96-282-22G, de pedúnculo longo. Os parentais e as gerações F1, F2, RC1 (P1xF1 e RC2 (P2xF1 foram avaliados em delineamento de blocos ao acaso, com quatro repetições. Foram estimados: variâncias fenotípica, genotípica, ambiental, aditiva e de dominância; herdabilidades no sentido amplo e restrito; grau médio de dominância e número mínimo de genes que determinam o caráter. O modelo aditivo-dominante foi adequado para explicar a variação observada. O efeito gênico aditivo foi o mais importante no controle do comprimento do pedúnculo, que é, aparentemente, controlado por cinco genes.The objective of this work was to investigate the genetic control of peduncle length in cowpea (Vigna unguiculata L.. A short peduncle cowpea line (TVx-5058-09C was crossed with a long peduncle line (TE 96-282-22G. The parents and the F1, F2, RC1 (P1xF1, and RC2 (P2xF1 generations were evaluated in randomized block design with four replications. Genotypic, phenotypic, environmental, additive, and dominance variances for peduncle length were determined. Narrow and broad sense heritability, the degree of dominance, and the minimum number of genes determining peduncle length were estimated. The additive-dominant model was adequate to explain the observed variation. The additive gene effect was the most important in controlling peduncle length, which appeared to be controlled by five genes.

Recommendations of the Oligonucleotide Safety Working Group's Formulated Oligonucleotide Subcommittee for the Safety Assessment of Formulated Oligonucleotide-Based Therapeutics.

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Marlowe, Jennifer L; Akopian, Violetta; Karmali, Priya; Kornbrust, Douglas; Lockridge, Jennifer; Semple, Sean

2017-08-01

The use of lipid formulations has greatly improved the ability to effectively deliver oligonucleotides and has been instrumental in the rapid expansion of therapeutic development programs using oligonucleotide drugs. However, the development of such complex multicomponent therapeutics requires the implementation of unique, scientifically sound approaches to the nonclinical development of these drugs, based upon a hybrid of knowledge and experiences drawn from small molecule, protein, and oligonucleotide therapeutic drug development. The relative paucity of directly applicable regulatory guidance documents for oligonucleotide therapeutics in general has resulted in the generation of multiple white papers from oligonucleotide drug development experts and members of the Oligonucleotide Safety Working Group (OSWG). The members of the Formulated Oligonucleotide Subcommittee of the OSWG have utilized their collective experience working with a variety of formulations and their associated oligonucleotide payloads, as well as their insights into regulatory considerations and expectations, to generate a series of consensus recommendations for the pharmacokinetic characterization and nonclinical safety assessment of this unique class of therapeutics. It should be noted that the focus of Subcommittee discussions was on lipid nanoparticle and other types of particulate formulations of therapeutic oligonucleotides and not on conjugates or other types of modifications of oligonucleotide structure intended to facilitate delivery.

An assessment of dental anxiety in nonclinical setting among Saudi Arabian children using Abeer Children Dental Anxiety Scale

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Shabina Shafi

2015-01-01

Full Text Available Introduction: Dental anxiety is an abnormal fear or dread of visiting the dentist for preventive care or therapy and unwarranted anxiety over dental procedures. It is a common problem that affects people of all ages and appears to develop mostly in childhood and adolescence. The present study assesses dental anxiety among children in a nonclinical setting among Saudi Arabian children who underwent preventive treatment procedure using Abeer Children Dental Anxiety Scale (ACDAS. Materials and Methods: The children attending an oral health program were screened for oral health problems and preventive treatment such as topical fluoride applications. The dental anxiety among children was assessed using ACDAS. Results: A total of 51 children participated in the research. The results showed that maximum children were not scared of dentist in nonclinical setting and had low dental anxiety levels. Overall, 74% of the child subjects had ACDAS scores below 26. Conclusions: Knowing the degree of anxiety of dental children is important to guide them through their dental experience and carry on the preventive dental treatments at an early age in nonclinical setting. Their level of cooperation will improve, and anxiety will be reduced as well. Further research is required to compare dental anxiety levels in children between clinical and nonclinical setting.

Frecuencia de los hongos asociados al desarrollo de mohos poscosecha en el pedúnculo de la piña en dos zonas de Costa Rica

OpenAIRE

Johanny Castro Chinchilla; Gerardina Umaña Rojas

2017-01-01

La piña es uno de los principales cultivos de exportación en Costa Rica y la presencia de moho en el pedúnculo afecta su calidad en los mercados internacionales. El objetivo de esta investigación fue determinar en frutos de piña, en la cera aplicada sobre la fruta y en el aire de las cámaras de enfriamiento, la frecuencia de los principales hongos asociados al desarrollo de mohos en el pedúnculo. Se realizó un muestreo mensual de abril de 2012 a marzo de 2013 en empacadoras de Sarapiquí y Pun...

Frecuencia de los hongos asociados al desarrollo de mohos poscosecha en el pedúnculo de la piña en dos zonas de Costa Rica

OpenAIRE

Castro Chinchilla, Johanny; Umaña Rojas, Gerardina

2017-01-01

ResumenLa piña es uno de los principales cultivos de exportación en Costa Rica y la presencia de moho en el pedúnculo afecta su calidad en los mercados internacionales. El objetivo de esta investigación fue determinar en frutos de piña, en la cera aplicada sobre la fruta y en el aire de las cámaras de enfriamiento, la frecuencia de los principales hongos asociados al desarrollo de mohos en el pedúnculo. Se realizó un muestreo mensual de abril de 2012 a marzo de 2013 en empacadoras de Sarapiqu...

Factors influencing agreement between child self-report and parent proxy-reports on the Pediatric Quality of Life Inventory™ 4.0 (PedsQL™ generic core scales

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Eiser Christine

2006-08-01

Full Text Available Abstract Background In situations where children are unable or unwilling to respond for themselves, measurement of quality of life (QOL is often obtained by parent proxy-report. However the relationship between child self and parent proxy-reports has been shown to be poor in some circumstances. Additionally the most appropriate statistical method for comparing ratings between child and parent proxy-reports has not been clearly established. The objectives of this study were to assess the: 1 agreement between child and parent proxy-reports on an established child QOL measure (the PedsQL™ using two different statistical methods; 2 effect of chronological age and domain type on agreement between children's and parents' reports on the PedsQL™; 3 relationship between parents' own well-being and their ratings of their child's QOL. Methods One hundred and forty-nine healthy children (5.5 – 6.5, 6.5 – 7.5, and 7.5 – 8.5 years completed the PedsQL™. One hundred and three of their parents completed these measures in relation to their child, and a measure of their own QOL (SF-36. Results Consistency between child and parent proxy-reports on the PedsQL™ was low, with Intra-Class correlation coefficients ranging from 0.02 to 0.23. Correlations were higher for the oldest age group for Total Score and Psychosocial Health domains, and for the Physical Health domain in the youngest age group. Statistically significant median differences were found between child and parent-reports on all subscales of the PedsQL™. The largest median differences were found for the two older age groups. Statistically significant correlations were found between parents' own QOL and their proxy-reports of child QOL across the total sample and within the middle age group. Conclusion Intra-Class correlation coefficients and median difference testing can provide different information on the relationship between parent proxy-reports and child self-reports. Our findings

Frecuencia de los hongos asociados al desarrollo de mohos poscosecha en el pedúnculo de la piña en dos zonas de Costa Rica

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Johanny Castro Chinchilla

2017-01-01

Full Text Available La piña es uno de los principales cultivos de exportación en Costa Rica y la presencia de moho en el pedúnculo afecta su calidad en los mercados internacionales. El objetivo de esta investigación fue determinar en frutos de piña, en la cera aplicada sobre la fruta y en el aire de las cámaras de enfriamiento, la frecuencia de los principales hongos asociados al desarrollo de mohos en el pedúnculo. Se realizó un muestreo mensual de abril de 2012 a marzo de 2013 en empacadoras de Sarapiquí y Puntarenas, Costa Rica. En cada empacadora se muestreó: frutos luego del proceso-comercial que se realiza para exportación y almacenamiento, la cera aplicada sobre la superficie de las frutas y el aire de las cámaras de enfriamiento. Se realizó un análisis de frecuencia de los principales hongos recuperados por muestreo en cada zona, para la cáscara y el pedúnculo, la cera y el aire. Además, se comparó el crecimiento in vitro a 18°C de los hongos más frecuentes al finalizar los muestreos. El hongo más frecuente en las cámaras de enfriamiento, el pedúnculo y la cáscara de ambas zonas y en la cera de Sarapiquí fue Penicillium diversum, con valores entre 7% y 100%. Mientras que en la cera de Puntarenas únicamente destacó la presencia de un grupo de hongos de micelio blanco. P. purpureogenum, Penicillium sp., Talaromyces calidicanius y Cladosporium sp., fueron microorganismos también recuperados con alta frecuencia tanto en la fruta como en el aire de las cámaras de enfriamiento de ambas empacadoras. P. purpureogenum, P. diversum y T. calidicanius fueron las especies con mayor crecimiento in vitro. Se concluyó que el manejo integrado de P. diversum, P. purpureogenum y T. calidicanius es necesario si se desea evitar el desarrollo de moho en el pedúnculo de la piña.

www.PedRad.info, the first bilingual case-oriented publication platform for pediatric radiology

International Nuclear Information System (INIS)

Hirsch, Wolfgang; Paetzel, Martina; Talanow, Roland

2005-01-01

On the Internet, there are few pediatric radiology databases. The most important and complete Web site is PediatricRadiology.com, which provides many radiological links but does not have its own database. We present an Internet project called PedRad.info (also known as Kinderradiologie-Online). The open-source, case-oriented publication platform publishes validated pediatric radiology findings on the Internet. A comparable on-line program, even for adult radiology, does not exist, so this tool is a pioneer in the area of Web-based information technology for medical and radiological communities. (orig.)

Recombinant pediocin in Lactococcus lactis : increased production by propeptide fusion and improved potency by co-production with PedC

NARCIS (Netherlands)

Back, Alexandre; Borges, Frederic; Mangavel, Cecile; Paris, Cedric; Rondags, Emmanuel; Kapel, Romain; Aymes, Arnaud; Rogniaux, Helene; Pavlovic, Marija; van Heel, Auke J.; Kuipers, Oscar P.; Revol-Junelles, Anne-Marie; Cailliez-Grimal, Catherine

We describe the impact of two propeptides and PedC on the production yield and the potency of recombinant pediocins produced in Lactococcus lactis. On the one hand, the sequences encoding the propeptides SD or LEISSTCDA were inserted between the sequence encoding the signal peptide of Usp45 and the

Induced not just right and incompleteness experiences in OCD patients and non-clinical individuals: An in vivo study.

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Fornés-Romero, Gertrudis; Belloch, Amparo

2017-12-01

Research on incompleteness and not-just right experiences, (INC/NJREs) indicate that some OCD symptom dimensions are motivated by these experiences rather than by anxiety. Most published data are correlational, using non-clinical individuals. This study sought to examine INC/NJREs in vivo in non-clinical and OCD individuals. Study 1: Ninety-three undergraduates were randomly assigned to a INC/NJREs induction (n=44) or non-induction task (n=47). Scores on self-reports assessing INC, NJREs, OCD, Anxiety, and Depression were also recorded. Study 2: Twenty adults with OCD performed the induction task and completed the same questionnaire-packet as the non-clinical participants. Study 1: The induction-group scored higher on several DVs of the experimental task, as INC/NJREs and uncomfortable physical sensations predicted impulses/urges to do something. All the DVs correlated with INC, NJREs, and OCD symptoms. Anxiety was only related to suppressing difficulties of the most intense sensation. Study 2: Results were comparable to those found in non-clinical people. Induced INC/NJREs correlated with compulsions severity and were associated with ordering, washing, and hoarding symptoms. OCDs did not differ from non-clinical subjects in the number of induced INC/NJREs, but they were more disturbing, difficult to suppress, and instigated more urges to do in OCDs. The small group of OCDs and the lack of a non-OCD clinical group kept us from drawing conclusions about the specificity of INC/NJREs to some OCD symptoms. Findings support the role of INC/NJREs as stimuli triggering urges and/impulses to do and their impact on OCD severity. Copyright © 2017 Elsevier Ltd. All rights reserved.

Effects of state and trait anxiety on selective attention to threatening stimuli in a non-clinical sample of school children

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Jeniffer Ortega Marín

2015-01-01

Full Text Available Attentional biases, consisting of a preferential processing of threatening stimuli, have been found in anxious adults as predicted by several cognitive models. However, studies with non-clinical samples of children have provided mixed results. therefore, the aim of this research was to determine the effects of state and trait anxiety on the selective attention towards threatening stimuli in a non-clinical sample of school children (age: 8 to 13, n = 110 using the dot-probe task. This study did not reveal an effect of trait anxiety on selective attention towards threatening stimuli. However, a significant difference was found between participants with low state anxiety and high state anxiety. Nevertheless, the effect size was small. Specifically, participants with low state anxiety showed a bias towards threatening stimuli. Overall, the findings of this research with a non-clinical sample of school children suggest that attentional biases towards threatening information, which has been repeatedly found in anxious adults, are not necessarily inherent to non-clinical anxiety in children and on the other hand, the relationship between attentional biases and anxiety in this population might be moderated by other cognitive processes.

Relations of the Big-Five personality dimensions to autodestructive behavior in clinical and non-clinical adolescent populations

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Kotrla Topić, Marina; Perković Kovačević, Marina; Mlačić, Boris

2012-01-01

Aim To examine the relationship between the Big-Five personality model and autodestructive behavior symptoms, namely Autodestructiveness and Suicidal Depression in two groups of participants: clinical and non-clinical adolescents. Methods Two groups of participants, clinical (adolescents with diagnosis of psychiatric disorder based on clinical impression and according to valid diagnostic criteria, N = 92) and non-clinical (high-school students, N = 87), completed two sets of questionnaires: the Autodestructiveness Scale which provided data on Autodestructiveness and Suicidal Depression, and the International Personality Item Pool (IPIP), which provided data on the Big -Five personality dimensions. Results Clinical group showed significantly higher values on the Autodestructiveness scale in general, as well as on Suicidal Depression, Aggressiveness, and Borderline subscales than the non-clinical group. Some of the dimensions of the Big-Five personality model, ie, Emotional Stability, Conscientiousness, and Agreeableness showed significant relationship (hierarchical regression analyses, P values for β coefficients from Big-Five model are important when evaluating adolescent psychiatric patients and adolescents from general population at risk of self-destructive behavior. PMID:23100207

Precision extruding deposition (PED) fabrication of polycaprolactone (PCL) scaffolds for bone tissue engineering

Energy Technology Data Exchange (ETDEWEB)

Shor, Lauren; Gueceri, Selcuk; Chang, Robert; Sun Wei [Department of Mechanical Engineering and Mechanics, Drexel University, Philadelphia, PA (United States); Gordon, Jennifer; Kang Qian; Hartsock, Langdon; An Yuehuei [Department of Orthopedic Surgery, Medical University of South Carolina, Charleston, SC (United States)], E-mail: st963bya@drexel.edu, E-mail: guceri@drexel.edu, E-mail: rcc34@drexel.edu, E-mail: sunwei@drexel.edu, E-mail: kangqk@musc.edu, E-mail: hartsock@musc.edu, E-mail: any@musc.edu

2009-03-01

Bone tissue engineering is an emerging field providing viable substitutes for bone regeneration. Recent advances have allowed scientists and engineers to develop scaffolds for guided bone growth. However, success requires scaffolds to have specific macroscopic geometries and internal architectures conducive to biological and biophysical functions. Freeform fabrication provides an effective process tool to manufacture three-dimensional porous scaffolds with complex shapes and designed properties. A novel precision extruding deposition (PED) technique was developed to fabricate polycaprolactone (PCL) scaffolds. It was possible to manufacture scaffolds with a controlled pore size of 350 {mu}m with designed structural orientations using this method. The scaffold morphology, internal micro-architecture and mechanical properties were evaluated using scanning electron microscopy (SEM), micro-computed tomography (micro-CT) and mechanical testing, respectively. An in vitro cell-scaffold interaction study was carried out using primary fetal bovine osteoblasts. Specifically, the cell proliferation and differentiation was evaluated by Alamar Blue assay for cell metabolic activity, alkaline phosphatase activity and osteoblast production of calcium. An in vivo study was performed on nude mice to determine the capability of osteoblast-seeded PCL to induce osteogenesis. Each scaffold was implanted subcutaneously in nude mice and, following sacrifice, was explanted at one of a series of time intervals. The explants were then evaluated histologically for possible areas of osseointegration. Microscopy and radiological examination showed multiple areas of osseous ingrowth suggesting that the osteoblast-seeded PCL scaffolds evoke osteogenesis in vivo. These studies demonstrated the viability of the PED process to fabricate PCL scaffolds having the necessary mechanical properties, structural integrity, and controlled pore size and interconnectivity desired for bone tissue engineering.

Precision extruding deposition (PED) fabrication of polycaprolactone (PCL) scaffolds for bone tissue engineering

International Nuclear Information System (INIS)

Shor, Lauren; Gueceri, Selcuk; Chang, Robert; Sun Wei; Gordon, Jennifer; Kang Qian; Hartsock, Langdon; An Yuehuei

2009-01-01

Bone tissue engineering is an emerging field providing viable substitutes for bone regeneration. Recent advances have allowed scientists and engineers to develop scaffolds for guided bone growth. However, success requires scaffolds to have specific macroscopic geometries and internal architectures conducive to biological and biophysical functions. Freeform fabrication provides an effective process tool to manufacture three-dimensional porous scaffolds with complex shapes and designed properties. A novel precision extruding deposition (PED) technique was developed to fabricate polycaprolactone (PCL) scaffolds. It was possible to manufacture scaffolds with a controlled pore size of 350 μm with designed structural orientations using this method. The scaffold morphology, internal micro-architecture and mechanical properties were evaluated using scanning electron microscopy (SEM), micro-computed tomography (micro-CT) and mechanical testing, respectively. An in vitro cell-scaffold interaction study was carried out using primary fetal bovine osteoblasts. Specifically, the cell proliferation and differentiation was evaluated by Alamar Blue assay for cell metabolic activity, alkaline phosphatase activity and osteoblast production of calcium. An in vivo study was performed on nude mice to determine the capability of osteoblast-seeded PCL to induce osteogenesis. Each scaffold was implanted subcutaneously in nude mice and, following sacrifice, was explanted at one of a series of time intervals. The explants were then evaluated histologically for possible areas of osseointegration. Microscopy and radiological examination showed multiple areas of osseous ingrowth suggesting that the osteoblast-seeded PCL scaffolds evoke osteogenesis in vivo. These studies demonstrated the viability of the PED process to fabricate PCL scaffolds having the necessary mechanical properties, structural integrity, and controlled pore size and interconnectivity desired for bone tissue engineering

The Cerebellar Deficit Hypothesis and Dyslexic Tendencies in a Non-Clinical Sample

Science.gov (United States)

Brookes, Rebecca L.; Stirling, John

2005-01-01

In order to assess the relationship between cerebellar deficits and dyslexic tendencies in a non-clinical sample, 27 primary school children aged 8-9 completed a cerebellar soft signs battery and were additionally assessed for reading age, sequential memory, picture arrangement and knowledge of common sequences. An average measure of the soft…

Colgajo frontal paramediano de pedículo estrecho para reconstrucción nasal en cáncer de piel

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Jezabel De Abullarade

Full Text Available Antecedentes y Objetivos. No se pueden negar los excelentes resultados que el colgajo frontal ofrece en la reconstrucción nasal, por lo que supone una importante herramienta en el arsenal terapéutico del cirujano reconstructivo. El objetivo del presente trabajo es presentar y discutir una modificación de dicho colgajo: el pedículo estrecho del colgajo frontal paramediano, presentando las ventajas que ofrece la modificación del colgajo entre las que destaca el que permite preservar otro potencial colgajo similar para el futuro, en el caso de que éste fuera necesario. Material y método. Analizamos un grupo de pacientes en el que practicamos resección de carcinoma basocelular de piel nasal con limites quirúrgicos negativos por biopsia de congelación, y reconstrucción quirúrgica con elevación de colgajo frontal paramediano con pedículo de 1.5 cm en todos los casos, basado en el hecho de que la arteria supratroclear súperomedial es constante en su borde orbitario .Cerramos el defecto del área donante en la frente mediante sutura directa en todos los casos. Resultados. Operamos con esta técnica a 76 pacientes, 30 mujeres y 46 varones, con una edad media de 59 años. En todos los casos hicimos revisión quirúrgica para autonomización del colgajo, desgrase, cartílago, etc. No hubo necrosis del colgajo en ningún caso. Conclusiones. Comprobamos la utilidad del colgajo frontal de pedículo estrecho y sus ventajas al ser levantado, entre otras, el mantener la integridad del lado contralateral de la frente para otro potencial colgajo frontal paramediano si fuera necesario.

A Randomised Controlled Trial of a Brief Online Mindfulness-Based Intervention on Paranoia in a Non-Clinical Sample.

Science.gov (United States)

Shore, Robert; Strauss, Clara; Cavanagh, Kate; Hayward, Mark; Ellett, Lyn

2018-01-01

Paranoia is common and distressing in the general population and can impact on health, emotional well-being and social functioning, such that effective interventions are needed. Brief online mindfulness-based interventions (MBIs) have been shown to reduce symptoms of anxiety and depression in non-clinical samples; however, at present, there is no research investigating whether they can reduce paranoia. The current study explored whether a brief online MBI increased levels of mindfulness and reduced levels of paranoia in a non-clinical population. The mediating effect of mindfulness on any changes in paranoia was also investigated. One hundred and ten participants were randomly allocated to either a 2-week online MBI including 10 min of daily guided mindfulness practice or to a waitlist control condition. Measures of mindfulness and paranoia were administered at baseline, post-intervention and 1-week follow-up. Participants in the MBI group displayed significantly greater reductions in paranoia compared to the waitlist control group. Mediation analysis demonstrated that change in mindfulness skills (specifically the observe, describe and non-react facets of the FFMQ) mediated the relationship between intervention type and change in levels of paranoia. This study provides evidence that a brief online MBI can significantly reduce levels of paranoia in a non-clinical population. Furthermore, increases in mindfulness skills from this brief online MBI can mediate reductions in non-clinical paranoia. The limitations of the study are discussed.

Factors Enhancing Manpower Efficiency from the Viewpoint of Clinical and Non-clinical Faculty Members at Guilan University of Medical Sciences in 2011

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Fardin Mehrabian

2012-11-01

Full Text Available Introduction: There are various factors that affect manpower efficiency. Identification of the most important and influential factors on efficiency is quite essential. Analysis of factors affecting manpower efficiency from the viewpoint of clinical and non-clinical faculty members at Guilan University of Medical Sciences in 2011.Methods: This descriptive, analytical, cross-sectional study was performed in October and November in 2011. The study sample consisted of 186 faculty members, including 128 clinical and 58 non-clinical. Instruments used to collect library data were questionnaire and field studies. Exploratory factor analysis with Varimax rotation was utilized to determine the factors influencing manpower efficiency as well as loading level of each of the variables. Results: Among clinical faculty members, 70.66% of changes in manpower efficiency, and among non-clinical faculty members, 79.57% of changes in manpower efficiency were explained by 9 and 8 factors, respectivelyConclusion: Staff empowerment and organizational culture were recognized as the most important factors enhancing manpower efficiency from the viewpoint of clinical and non-clinical faculty members, respectively.

Non-clinical influences on clinical decision-making: a major challenge to evidence-based practice.

Science.gov (United States)

Hajjaj, F M; Salek, M S; Basra, M K A; Finlay, A Y

2010-05-01

This article reviews an aspect of daily clinical practice which is of critical importance in virtually every clinical consultation, but which is seldom formally considered. Non-clinical influences on clinical decision-making profoundly affect medical decisions. These influences include patient-related factors such as socioeconomic status, quality of life and patient's expectations and wishes, physician-related factors such as personal characteristics and interaction with their professional community, and features of clinical practice such as private versus public practice as well as local management policies. This review brings together the different strands of knowledge concerning non-clinical influences on clinical decision-making. This aspect of decision-making may be the biggest obstacle to the reality of practising evidence-based medicine. It needs to be understood in order to develop clinical strategies that will facilitate the practice of evidence-based medicine.

Measurement of nonclinical personality characteristics of women with anorexia nervosa or bulimia nervosa.

Science.gov (United States)

Pryor, T; Wiederman, M W

1996-10-01

Past research on personality and eating disorders has most often emphasized personality psychopathology and personality disorders. We further investigated nonclinical personality characteristics among women with anorexia nervosa (n = 35) or bulimia nervosa (n = 45) using the Multidimensional Personality Questionnaire (MPQ; Tellegen, 1982, 1985). The MPQ measures several personality traits that have been shown to consist of a substantial genetic component (Tellegen et al., 1988). In logistic regression analyses, women with anorexia nervosa evidenced greater degrees of control (vs. impulsivity) and general constraint, and a lower degree of absorption in sensory experiences relative to those with bulimia nervosa. Relative to the normative population (Tellegen, 1982), our sample evidenced very low scores on Well-being, Social Closeness, and Positive Affectivity and high scores on Stress Reaction, Alienation, and Negative Affectivity. Our results emphasize the importance of considering nonclinical personality features and temperament, and varying methods of assessment, in the understanding of predisposing factors for eating disorders.

Rasch analysis of the Persian version of PedsQLTM Oral Health Scale: further psychometric evaluation on item validity including differential item functioning

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Chung-Ying Lin

2016-08-01

Conclusion: PedsQL Oral Health Scale is a valid instrument to measure OHRQoL. However,our results indicated that the parent-proxy report was inferior to the student self-report, and healthcare providers should primarily use the student self-report.

Quality management of pharmacology and safety pharmacology studies

DEFF Research Database (Denmark)

Spindler, Per; Seiler, Jürg P

2002-01-01

to safety pharmacology studies, and, when indicated, to secondary pharmacodynamic studies, does not influence the scientific standards of studies. However, applying formal GLP standards will ensure the quality, reliability and integrity of studies, which reflect sound study management. It is important...... to encourage a positive attitude among researchers and academics towards these lines, whenever possible. GLP principles applied to the management of non-clinical safety studies are appropriate quality standards when studies are used in the context of protecting public health, and these quality standards...... of pharmacology studies (ICH S7A): primary pharmacodynamic, secondary pharmacodynamic and safety pharmacology studies, and guidance on the quality standards (expectations for GLP conformity) for these study types have been provided. Primary pharmacodynamic studies are the only study types that are fully exempt...

The effect of social exclusion on state paranoia and explicit and implicit self-esteem in a non-clinical sample

OpenAIRE

Stewart, C.; Rogers, F.; Pilch, M.; Stewart, I.; Barnes-Holmes, Y.; Westermann, S.

2017-01-01

Background and objectives:\\ud The relationship between self-esteem and paranoia may be influenced by social stress. This study aimed to replicate previous research on the impact ofsocial exclusion on paranoia and self-esteem in a non-clinical sample and to extend this work by examining the effect of exclusion on self-esteem at the ‘implicit’ level.\\ud \\ud Methods:\\ud Non-clinical participants (N = 85) were randomly allocated to the Inclusion or Exclusion condition of a virtual ball-toss game ...

77 FR 12312 - Electronic Submission of Nonclinical Study Data; Notice of Pilot Project

Science.gov (United States)

2012-02-29

...] Electronic Submission of Nonclinical Study Data; Notice of Pilot Project AGENCY: Food and Drug Administration... and Research (CBER) is announcing an invitation to participate in a pilot evaluation program to test.... Participation in the pilot program is open to all sponsors. The pilot program is intended to provide industry...

A General Factor of Death Distress in Seven Clinical and Non-Clinical Groups

Science.gov (United States)

Abdel-Khalek, Ahmed M.

2004-01-01

The Arabic Scale of Death anxiety (ASDA), the Death Depression Scale (DDS), and the Death Obsession Scale (DOS) were administered, individually, to 7 groups (n = 765) of Egyptian normal participants (non-clinical), anxiety disorder patients, patients suffering from schizophrenia (males and females), and addicts (males only). They were generally…

Initial validation of the Argentinean Spanish version of the PedsQL™ 4.0 Generic Core Scales in children and adolescents with chronic diseases: acceptability and comprehensibility in low-income settings

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Bauer Gabriela

2008-08-01

Full Text Available Abstract Background To validate the Argentinean Spanish version of the PedsQL™ 4.0 Generic Core Scales in Argentinean children and adolescents with chronic conditions and to assess the impact of socio-demographic characteristics on the instrument's comprehensibility and acceptability. Reliability, and known-groups, and convergent validity were tested. Methods Consecutive sample of 287 children with chronic conditions and 105 healthy children, ages 2–18, and their parents. Chronically ill children were: (1 attending outpatient clinics and (2 had one of the following diagnoses: stem cell transplant, chronic obstructive pulmonary disease, HIV/AIDS, cancer, end stage renal disease, complex congenital cardiopathy. Patients and adult proxies completed the PedsQL™ 4.0 and an overall health status assessment. Physicians were asked to rate degree of health status impairment. Results The PedsQL™ 4.0 was feasible (only 9 children, all 5 to 7 year-olds, could not complete the instrument, easy to administer, completed without, or with minimal, help by most children and parents, and required a brief administration time (average 5–6 minutes. People living below the poverty line and/or low literacy needed more help to complete the instrument. Cronbach Alpha's internal consistency values for the total and subscale scores exceeded 0.70 for self-reports of children over 8 years-old and parent-reports of children over 5 years of age. Reliability of proxy-reports of 2–4 year-olds was low but improved when school items were excluded. Internal consistency for 5–7 year-olds was low (α range = 0.28–0.76. Construct validity was good. Child self-report and parent proxy-report PedsQL™ 4.0 scores were moderately but significantly correlated (ρ = 0.39, p Conclusion Results suggest that the Argentinean Spanish PedsQL™ 4.0 is suitable for research purposes in the public health setting for children over 8 years old and parents of children over 5 years old

Measuring the executive regulation of emotion with self-rating scales in a nonclinical population.

Science.gov (United States)

Spinella, Marcello

2007-01-01

Prefrontal systems play an important role in the regulation of emotion as evidenced by clinical neuroimaging studies. Both subjective and objective neuropsychological tests provide functional evidence of executive dysfunction in emotional deregulation. The present authors evaluated these relationships here in a nonclinical community sample using the Frontal Systems Behavior Scale, Profile of Mood States (POMS), and Depression Anxiety Stress Scales (DASS). Positive correlations uniformly emerged between prefrontal system dysfunction and negative emotional states (anger, depression, anxiety, stress, confusion, and fatigue), whereas positive emotion (vigor) showed a modest inverse correlation with prefrontal system dysfunction, even after control for demographic influences. These relationships may result from cognitive strategies for managing emotion mediated by reciprocal connections between prefrontal systems and the limbic system. The findings corroborated those of other methodologies, supporting the Frontal Systems Behavior Scale (FrSBe) as a valid tool to measure prefrontal function in nonclinical populations.

Paraphilic Interests: An Examination of Sex Differences in a Nonclinical Sample.

Science.gov (United States)

Dawson, Samantha J; Bannerman, Brittany A; Lalumière, Martin L

2016-02-01

Little research has been conducted to examine paraphilic sexual interests in nonclinical samples. The little that exists suggests that atypical sexual interests are more common in men than in women, but the reasons for this difference are unknown. In this study, we explored the prevalence of paraphilic interests in a nonclinical sample of men and women. We expected that men would report greater arousal (or less repulsion) toward various paraphilic acts than women. We also examined putative correlates of paraphilias in an attempt to explain the sex difference. In all, 305 men and 710 women completed an online survey assessing sexual experiences, sexual interests, as well as indicators of neurodevelopmental stress, sex drive, mating effort, impulsivity, masculinity/femininity, and socially desirable responding. As expected, significant sex differences were found, with men reporting significantly less repulsion (or more arousal) to the majority of paraphilic acts than women. Using mediation analysis, sex drive was the only correlate to significantly and fully mediate the sex difference in paraphilic interests. In other words, sex drive fully accounted for the sex difference in paraphilic interests. The implications of these findings for understanding the etiology of atypical sexual interests are discussed. © The Author(s) 2014.

Analysis of the safety and pharmacodynamics of human fibrinogen concentrate in animals

International Nuclear Information System (INIS)

Beyerle, Andrea; Nolte, Marc W.; Solomon, Cristina; Herzog, Eva; Dickneite, Gerhard

2014-01-01

Fibrinogen, a soluble 340 kDa plasma glycoprotein, is critical in achieving and maintaining hemostasis. Reduced fibrinogen levels are associated with an increased risk of bleeding and recent research has investigated the efficacy of fibrinogen concentrate for controlling perioperative bleeding. European guidelines on the management of perioperative bleeding recommend the use of fibrinogen concentrate if significant bleeding is accompanied by plasma fibrinogen levels less than 1.5–2.0 g/l. Plasma-derived human fibrinogen concentrate has been available for therapeutic use since 1956. The overall aim of the comprehensive series of non-clinical investigations presented was to evaluate i) the pharmacodynamic and pharmacokinetic characteristics and ii) the safety and tolerability profile of human fibrinogen concentrate Haemocomplettan P® (RiaSTAP®). Pharmacodynamic characteristics were assessed in rabbits, pharmacokinetic parameters were determined in rabbits and rats and a safety pharmacology study was performed in beagle dogs. Additional toxicology tests included: single-dose toxicity tests in mice and rats; local tolerance tests in rabbits; and neoantigenicity tests in rabbits and guinea pigs following the introduction of pasteurization in the manufacturing process. Human fibrinogen concentrate was shown to be pharmacodynamically active in rabbits and dogs and well tolerated, with no adverse events and no influence on circulation, respiration or hematological parameters in rabbits, mice, rats and dogs. In these non-clinical investigations, human fibrinogen concentrate showed a good safety profile. This data adds to the safety information available to date, strengthening the current body of knowledge regarding this hemostatic agent. - Highlights: • A comprehensive series of pre-clinical investigations of human fibrinogen concentrate. • Human fibrinogen concentrate was shown to be pharmacodynamically active. • Human fibrinogen concentrate was well tolerated

Analysis of the safety and pharmacodynamics of human fibrinogen concentrate in animals

Energy Technology Data Exchange (ETDEWEB)

Beyerle, Andrea, E-mail: andrea.beyerle@cslbehring.com [CSL Behring GmbH, Preclinical Research and Development, Marburg (Germany); Nolte, Marc W. [CSL Behring GmbH, Preclinical Research and Development, Marburg (Germany); Solomon, Cristina [CSL Behring GmbH, Medical Affairs, Marburg (Germany); Department of Anaesthesiology, Perioperative Medicine and General Intensive Care, Paracelsus Medical University, Salzburg (Austria); Herzog, Eva; Dickneite, Gerhard [CSL Behring GmbH, Preclinical Research and Development, Marburg (Germany)

2014-10-01

Fibrinogen, a soluble 340 kDa plasma glycoprotein, is critical in achieving and maintaining hemostasis. Reduced fibrinogen levels are associated with an increased risk of bleeding and recent research has investigated the efficacy of fibrinogen concentrate for controlling perioperative bleeding. European guidelines on the management of perioperative bleeding recommend the use of fibrinogen concentrate if significant bleeding is accompanied by plasma fibrinogen levels less than 1.5–2.0 g/l. Plasma-derived human fibrinogen concentrate has been available for therapeutic use since 1956. The overall aim of the comprehensive series of non-clinical investigations presented was to evaluate i) the pharmacodynamic and pharmacokinetic characteristics and ii) the safety and tolerability profile of human fibrinogen concentrate Haemocomplettan P® (RiaSTAP®). Pharmacodynamic characteristics were assessed in rabbits, pharmacokinetic parameters were determined in rabbits and rats and a safety pharmacology study was performed in beagle dogs. Additional toxicology tests included: single-dose toxicity tests in mice and rats; local tolerance tests in rabbits; and neoantigenicity tests in rabbits and guinea pigs following the introduction of pasteurization in the manufacturing process. Human fibrinogen concentrate was shown to be pharmacodynamically active in rabbits and dogs and well tolerated, with no adverse events and no influence on circulation, respiration or hematological parameters in rabbits, mice, rats and dogs. In these non-clinical investigations, human fibrinogen concentrate showed a good safety profile. This data adds to the safety information available to date, strengthening the current body of knowledge regarding this hemostatic agent. - Highlights: • A comprehensive series of pre-clinical investigations of human fibrinogen concentrate. • Human fibrinogen concentrate was shown to be pharmacodynamically active. • Human fibrinogen concentrate was well tolerated

Health related quality of life in Dutch young adults: psychometric properties of the PedsQL generic core scales young adult version

NARCIS (Netherlands)

Limperg, Perrine F.; Haverman, Lotte; van Oers, Hedy A.; van Rossum, Marion A. J.; Maurice-Stam, Heleen; Grootenhuis, Martha A.

2014-01-01

The purpose of this study is to provide Dutch norm data and to assess internal consistency and construct validity for the Pediatric Quality of Life Inventory Young Adult Generic Core Scales (PedsQL_YA) in Dutch young adults aged 18-30 years. A sample of 649 young adults from the general Dutch

Relations of the Big-Five personality dimensions to autodestructive behavior in clinical and non-clinical adolescent populations.

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Kotrla Topic, Marina; Perkovic Kovacevic, Marina; Mlacic, Boris

2012-10-01

To examine the relationship between the Big-Five personality model and autodestructive behavior symptoms, namely Autodestructiveness and Suicidal Depression in two groups of participants: clinical and non-clinical adolescents. Two groups of participants, clinical (adolescents with diagnosis of psychiatric disorder based on clinical impression and according to valid diagnostic criteria, N=92) and non-clinical (high-school students, N=87), completed two sets of questionnaires: the Autodestructiveness Scale which provided data on Autodestructiveness and Suicidal Depression, and the International Personality Item Pool (IPIP), which provided data on the Big -Five personality dimensions. Clinical group showed significantly higher values on the Autodestructiveness scale in general, as well as on Suicidal Depression, Aggressiveness, and Borderline subscales than the non-clinical group. Some of the dimensions of the Big-Five personality model, ie, Emotional Stability, Conscientiousness, and Agreeableness showed significant relationship (hierarchical regression analyses, P values for β coefficients from 0.000 to 0.021) with Autodestructiveness and Suicidal Depression, even after controlling for the sex and group effects or, when analyzing Suicidal Depression, after controlling the effect of other subscales. The results indicate that dimensions of the Big-Five model are important when evaluating adolescent psychiatric patients and adolescents from general population at risk of self-destructive behavior.

The role of mental imagery in non-clinical paranoia.

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Bullock, Gemma; Newman-Taylor, Katherine; Stopa, Luisa

2016-03-01

Cognitive models of paranoia incorporate many of the processes implicated in the maintenance of anxiety disorders. Despite this, the role of mental imagery in paranoia remains under-researched. The current study examined the impact of a self-imagery manipulation in people with high non-clinical paranoia. We used a mixed design with one between-subjects variable (type of self-imagery) and one within-subjects variable (time--pre and post imagery manipulation). Thirty participants with high trait paranoia were allocated alternately to a positive or negative self-imagery condition. Scripts were used to elicit positive and negative self-imagery. All participants completed self-report state measures of paranoia, mood, self-esteem and self-compassion. Group by time interaction effects were found for each of the dependent variables. Positive imagery led to less state paranoia, anxiety and negative affect, and more positive affect, self-esteem and self-compassion, compared with the negative imagery group. This was a non-blind study, limited by allocation method and a brief time-frame which did not allow us to assess longevity of effects. We recruited a relatively small and predominantly female sample of people with high non-clinical paranoia. The study did not include a neutral control condition, a low paranoia comparison group, or a manipulation check following the imagery task. Self-imagery manipulations may affect paranoia, mood and self-beliefs. If the findings are replicated with clinical groups, and maintained over a longer period, this would suggest that imagery-based interventions targeting persecutory delusions might be usefully examined. Crown Copyright © 2015. Published by Elsevier Ltd. All rights reserved.

Psychosocial and nonclinical factors predicting hospital utilization in patients of a chronic disease management program: a prospective observational study.

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Tran, Mark W; Weiland, Tracey J; Phillips, Georgina A

2015-01-01

Psychosocial factors such as marital status (odds ratio, 3.52; 95% confidence interval, 1.43-8.69; P = .006) and nonclinical factors such as outpatient nonattendances (odds ratio, 2.52; 95% confidence interval, 1.22-5.23; P = .013) and referrals made (odds ratio, 1.20; 95% confidence interval, 1.06-1.35; P = .003) predict hospital utilization for patients in a chronic disease management program. Along with optimizing patients' clinical condition by prescribed medical guidelines and supporting patient self-management, addressing psychosocial and nonclinical issues are important in attempting to avoid hospital utilization for people with chronic illnesses.

Mediators of the Link between Autistic Traits and Marital Functioning in a Non-Clinical Sample

NARCIS (Netherlands)

Pollmann, M.M.H.; Finkenauer, C.; Begeer, S.

2010-01-01

People with ASD have deficits in their social skills and may therefore experience lower relationship satisfaction. This study investigated possible mechanisms to explain whether and how autistic traits, measured with the AQ, influence relationship satisfaction in a non-clinical sample of 195 married

Rumination as a Mediator between Childhood Trauma and Adulthood Depression/Anxiety in Non-clinical Participants

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Ji S. Kim

2017-09-01

Full Text Available Objective: Although there is strong evidence that childhood trauma is associated with the development of depression and anxiety, relatively few studies have explored potential mediating factors for this relationship. The present study aimed to evaluate the mediating role of rumination in the link between childhood trauma and mood status such as depression, anxiety and affective lability.Materials and Methods: Two hundred and seven non-clinical participants completed the Childhood Trauma Questionnaire, the Ruminative Response Scale, the Beck Depression Inventory, the State Anxiety Inventory, and the Affective Lability Scale. Structural equation modeling was used to evaluate the results.Results: Our results supported that rumination is a meaningful mediator between childhood trauma and depression/anxiety in non-clinical participants. The mediation model indicated that childhood trauma and its subtypes are linked to depression and anxiety through three subtypes of rumination, thereby supporting a significant indirect relationship (Standardized coefficient [SC] = 0.56, p < 0.001 for the path from trauma to rumination; SC = 0.67, p < 0.001, from rumination to mood. The direct relationship between childhood trauma and mood symptoms was also significant in a model including rumination (SC = 0.68, p < 0.001. The mediation effect of rumination in the relationship between childhood trauma and mood was more predominant in female participants.Conclusions: The present study found that rumination mediates the influence of childhood trauma on the development of mood symptoms in non-clinical participants. Childhood trauma appears to be a critical determinant for developing symptoms of depression and anxiety.

Virtual reality and persecutory delusions: safety and feasibility.

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Fornells-Ambrojo, Miriam; Barker, Chris; Swapp, David; Slater, Mel; Antley, Angus; Freeman, Daniel

2008-09-01

Virtual reality (VR) has begun to be used to research the key psychotic symptom of paranoia. The initial studies have been with non-clinical individuals and individuals at high risk of psychosis. The next step is to develop the technology for the understanding and treatment of clinical delusions. Therefore the present study investigated the acceptability and safety of using VR with individuals with current persecutory delusions. Further, it set out to determine whether patients feel immersed in a VR social environment and, consequently, experience paranoid thoughts. Twenty individuals with persecutory delusions and twenty non-clinical individuals spent 4 min in a VR underground train containing neutral characters. Levels of simulator sickness, distress, sense of presence, and persecutory ideation about the computer characters were measured. A one-week follow-up was conducted to check longer-term side effects. The VR experience did not raise levels of anxiety or symptoms of simulator sickness. No side effects were reported at the follow-up. There was a considerable degree of presence in the VR scenario for all participants. A high proportion of the persecutory delusions group (65%) had persecutory thinking about the computer characters, although this rate was not significantly higher than the non-clinical group. The study indicates that brief experiences in VR are safe and acceptable to people with psychosis. Further, patients with paranoia can feel engaged in VR scenes and experience persecutory thoughts. Exposure to social situations using VR has the potential to be incorporated into cognitive behavioural interventions for paranoia.

Reported parental characteristics in relation to trait depression and anxiety levels in a non-clinical group.

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Parker, G

1979-09-01

Care and overprotection appear to reflect the principal dimensions underlying parental behaviours and attitudes. In previous studies of neurotically depressed patients and of a non-clinical group, subjects who scored their parents as lacking in care and/or overprotective had the greater depressive experience. The present study of another non-clinical group (289 psychology students) replicated those findings in regard to trait depression levels. In addition, associations between those parental dimensions and trait anxiety scores were demonstrated. Multiple regression analyses established that 9-10% of the variance in mood scores was accounted for by scores on those parental dimensions. Low maternal care scores predicted higher levels of both anxiety and depression, while high maternal overprotection scores predicted higher levels of anxiety but not levels of depression. Maternal influences were clearly of greater relevance than paternal influences.

Safety of PEGylated recombinant human full-length coagulation factor VIII (BAX 855) in the overall context of PEG and PEG conjugates.

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Stidl, R; Fuchs, S; Bossard, M; Siekmann, J; Turecek, P L; Putz, M

2016-01-01

BAX 855 is a PEGylated human full-length recombinant factor VIII (rFVIII) based on licensed rFVIII (ADVATE). The applied PEGylation technology has been optimized to retain functionality of the FVIII molecule, improve its pharmacokinetic properties and allow less frequent injections while maintaining efficacy. The aim of this study was to confirm that the excellent safety profile of ADVATE remains unchanged after PEGylation. Non-clinical safety studies with BAX 855 and its respective unbound polyethylene glycol (PEG) were conducted in several species. The distribution of a single dose of radiolabelled BAX 855 was further investigated in rats. Publically available safety data on PEG alone and PEGylated biomolecules were summarized and reviewed for specific safety findings attributable to PEG or PEGylated biopharmaceuticals. Safety pharmacology studies in rabbits and macaques and repeated dose toxicity studies in rats and macaques identified no safety issues. Results of a distribution study in rats administered radiolabelled BAX 855 showed that radioactivity was completely excreted; urine was the major elimination route. A 28-day study in rats dosed with the unbound PEG constituent (PEG2ru20KCOOH) of BAX 855 showed no adverse or non-adverse effects. Safety data for PEG and PEG-protein conjugates indicate no safety concerns associated with PEG at clinically relevant dose levels. Although vacuolation of certain cell types has been reported in mammals, no such vacuolation was observed with BAX 855 or with the unbound PEG constituent. Non-clinical safety evaluation of PEG and BAX 855 identified no safety signals; the compound is now in clinical development for the treatment of patients with haemophilia A. © 2015 Baxalta Innovations GmbH. Haemophilia Published by John Wiley & Sons Ltd.

Teores de ácido anacárdico em pedúnculos de cajueiro Anacardium microcarpum e em oito clones de Anacardium occidentale var. nanum disponíveis no Nordeste do Brasil Anacardic acid content in cashew apples from Annacardium microcarpum and eight clones of Anacardium occidentale from Northeastern Brazil

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Tânia da Silveira Agostini-Costa

2004-08-01

Full Text Available O ácido anacárdico, composto fenólico presente em pedúnculos de caju e em algumas plantas medicinais, vem sendo associado a uma série de atividades biológicas específicas. O objetivo deste trabalho foi determinar o teor deste composto em pedúnculos de cajueiro A. microcarpum e em oito clones de A. occidentale var. nanum disponíveis na região Nordeste do Brasil, avaliando, também, algumas características físico-químicas e sensoriais destes pedúnculos. Os pedúnculos do clone BRS 189 apresentaram os maiores teores de ácido anacárdico. Pedúnculos da espécie Anacardium microcarpum e pedúnculos de cajueiro anão precoce, clones END 189 e 183, Embrapa 50 e 51 e CCP 09 não diferiram significativamente dos pedúnculos procedentes do clone controle, CCP 076. Pedúnculos do clone CCP 1001 apresentaram os menores teores de ácido anacárdico. As análises físico-químicas e sensoriais confirmaram evidências de que os clones CCP 09 e 1001 não são apropriados para o consumo in natura.Anacardic acid, a phenolic compound present in cashew apple and in some medicinal plants, is being associated to some specific biological effects. The purpose of this work was to determine anacardic acid content in peduncles of A. microcarpum and eight clones of A. occidentale from Northeastern Brazil, evaluating some physical-chemical and sensory characteristics of these peduncles. Cashew apples from BRS 189 clone of early cashew tree presented the highest values of anacardic acid. Cashew apples from A. microcarpum and END 189, END 183, Embrapa 50, Embrapa 51 e CCP 09 clones of early cashew tree did not differ from control CCP 076 clone. Cashew apples from CCP 1001 clone presented the minor values of anacardic acid. Physical-chemical and sensory analyses showed evidence that CCP 09 and CCP 1001 clone are not appropriate to fresh consuption.

Mediators of the Link between Autistic Traits and Relationship Satisfaction in a Non-Clinical Sample

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Pollmann, Monique M. H.; Finkenauer, Catrin; Begeer, Sander

2010-01-01

People with ASD have deficits in their social skills and may therefore experience lower relationship satisfaction. This study investigated possible mechanisms to explain whether and how autistic traits, measured with the AQ, influence relationship satisfaction in a non-clinical sample of 195 married couples. More autistic traits were associated…

Influência da irrigação na produção de pedúnculo e de castanha em clones de cajueiro-anão-precoce

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Oliveira Vitor Hugo de

2002-01-01

Full Text Available Este trabalho teve por objetivo avaliar a influência da irrigação na produção de pedúnculo e na relação peso de pedúnculo:peso de castanha em cajueiro-anão-precoce (Anacardium occidentale L.. Foram avaliados três clones (CP 09, CP 76 e CP 1001, submetidos a quatro regimes hídricos (A: testemunha sem irrigação; B: intervalo de irrigação de 1 dia; C: intervalo de irrigação de 3 dias; e D: intervalo de irrigação de 5 dias. O delineamento experimental foi em blocos ao acaso, em parcelas subdivididas, com quatro repetições, tendo-se os regimes hídricos nas parcelas e os clones nas subparcelas, cada uma com 4 plantase 3 anos de avaliação. A quantidade de água aplicada nos três tratamentos irrigados baseou-se na evaporação do tanque classe A. Os resultados levaram às seguintes conclusões: a resposta do cajueiro-anão-precoce à irrigação é genótipo-dependente; o CP 76 apresenta a maior relação peso de pedúnculo:peso de castanha, constituindo-se num clone mais apto para o consumo in natura; o CP 1001 apresenta-se como o mais promissor para o cultivo sob condições de sequeiro.

Caracterização física de pedúnculos de clones de cajueiro anão precoce em diferentes estádios de maturação Physical characterization of peduncles of early dwarf cashew clones at different stages of maturation

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Mônica Maria de Almeida Lopes

2011-12-01

Full Text Available Este estudo foi realizado para avaliar os atributos de pedúnculos de clones de cajueiro anão precoce CCP 76, CCP 09, BRS 189 e BRS 265 em sete diferentes estádios de maturação, oriundos do Campo Experimental da Embrapa Agroindústria Tropical localizado no município de Pacajus (CE. As variáveis avaliadas foram: diâmetro basal e apical, comprimento dos pedúnculos, massa total dos cajus (massa da castanha + pedúnculo, massa dos pedúnculos e das castanhas e firmeza dos pedúnculos. Considerando a homogeneidade ou não das variâncias, confirmadas pelo teste F de Fisher, as médias foram comparadas por meio do Teste t de Student ao nível de 5%. O clone CCP 76 destacou-se por possuir os melhores parâmetros físicos, a exceção da firmeza dos pedúnculos, sendo o mesmo indicado para o consumo e comercialização in natura.This study was carried out in order to evaluate the attributes of peduncles of early dwarf cashew tree clones CCP 76, CCP 09, BRS 189 and BRS 265 in seven different stages of maturation, from the Experimental Farm of Pacajus located in the city of Pacajus (CE. The data that was analyzed: basal and apical diameters, length of peduncles, cashew's total mass (cashew nut mass + peduncles mass, mass of peduncles and nuts, and peduncle's firmness. Considering the homogeneity of variances, confirmed by Fisher's F test, means were compared using the Student's t test at 5%. Clone CCP 76 stood out compared to the other for having the best physical parameters, except for the firmness of the peduncles, is suitable for marketing and fresh consumption.

Strategy for conformity of non-standard cryogenic equipment

CERN Multimedia

CERN. Geneva

2016-01-01

CERN as an intergovernmental organization establishes its own Safety Rules as necessary for its proper functioning. In particular, the CERN General Safety Instruction for cryogenic equipment requires that cryogenic pressure equipment at CERN shall comply with the European Pressure Equipment Directive (PED). However, due to the particular features of some of the cryogenic equipment required for the accelerators, as well as the existence of international collaborations with in-kind contributions from non-EU countries, full compliance with the PED may not always be achieved. This situation is foreseen in the Safety Rules, where CERN HSE will define the Safety requirements applicable to such equipment as well as any eventual additional compensatory measure as to ensure a commensurate level of Safety for our pressure equipment. Where compliance with PED may not be achieved, CERN HSE will become the de facto Notified Body and therefore be in charge of the assessment of the conformity of the equipment to the applica...

Impaired health-related quality of life in children and adolescents with chronic conditions: a comparative analysis of 10 disease clusters and 33 disease categories/severities utilizing the PedsQL™ 4.0 Generic Core Scales

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Burwinkle Tasha M

2007-07-01

Full Text Available Abstract Background Advances in biomedical science and technology have resulted in dramatic improvements in the healthcare of pediatric chronic conditions. With enhanced survival, health-related quality of life (HRQOL issues have become more salient. The objectives of this study were to compare generic HRQOL across ten chronic disease clusters and 33 disease categories/severities from the perspectives of patients and parents. Comparisons were also benchmarked with healthy children data. Methods The analyses were based on over 2,500 pediatric patients from 10 physician-diagnosed disease clusters and 33 disease categories/severities and over 9,500 healthy children utilizing the PedsQL™ 4.0 Generic Core Scales. Patients were recruited from general pediatric clinics, subspecialty clinics, and hospitals. Results Pediatric patients with diabetes, gastrointestinal conditions, cardiac conditions, asthma, obesity, end stage renal disease, psychiatric disorders, cancer, rheumatologic conditions, and cerebral palsy self-reported progressively more impaired overall HRQOL than healthy children, respectively, with medium to large effect sizes. Patients with cerebral palsy self-reported the most impaired HRQOL, while patients with diabetes self-reported the best HRQOL. Parent proxy-reports generally paralleled patient self-report, with several notable differences. Conclusion The results demonstrate differential effects of pediatric chronic conditions on patient HRQOL across diseases clusters, categories, and severities utilizing the PedsQL™ 4.0 Generic Core Scales from the perspectives of pediatric patients and parents. The data contained within this study represents a larger and more diverse population of pediatric patients with chronic conditions than previously reported in the extant literature. The findings contribute important information on the differential effects of pediatric chronic conditions on generic HRQOL from the perspectives of children and

Impaired health-related quality of life in children and adolescents with chronic conditions: a comparative analysis of 10 disease clusters and 33 disease categories/severities utilizing the PedsQL 4.0 Generic Core Scales.

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Varni, James W; Limbers, Christine A; Burwinkle, Tasha M

2007-07-16

Advances in biomedical science and technology have resulted in dramatic improvements in the healthcare of pediatric chronic conditions. With enhanced survival, health-related quality of life (HRQOL) issues have become more salient. The objectives of this study were to compare generic HRQOL across ten chronic disease clusters and 33 disease categories/severities from the perspectives of patients and parents. Comparisons were also benchmarked with healthy children data. The analyses were based on over 2,500 pediatric patients from 10 physician-diagnosed disease clusters and 33 disease categories/severities and over 9,500 healthy children utilizing the PedsQL 4.0 Generic Core Scales. Patients were recruited from general pediatric clinics, subspecialty clinics, and hospitals. Pediatric patients with diabetes, gastrointestinal conditions, cardiac conditions, asthma, obesity, end stage renal disease, psychiatric disorders, cancer, rheumatologic conditions, and cerebral palsy self-reported progressively more impaired overall HRQOL than healthy children, respectively, with medium to large effect sizes. Patients with cerebral palsy self-reported the most impaired HRQOL, while patients with diabetes self-reported the best HRQOL. Parent proxy-reports generally paralleled patient self-report, with several notable differences. The results demonstrate differential effects of pediatric chronic conditions on patient HRQOL across diseases clusters, categories, and severities utilizing the PedsQL 4.0 Generic Core Scales from the perspectives of pediatric patients and parents. The data contained within this study represents a larger and more diverse population of pediatric patients with chronic conditions than previously reported in the extant literature. The findings contribute important information on the differential effects of pediatric chronic conditions on generic HRQOL from the perspectives of children and parents utilizing the PedsQL 4.0 Generic Core Scales. These findings

[Cross-cultural Adaptation of the PedsQL Questionnaire Cancer Module, Version 3.0 for Use in Colombia].

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Fontibón, Luis Fernando; Ardila, Sandra Liliana; Sánchez, Ricardo

Quality of life is an important outcome in paediatric cancer patients. Its evaluation at different times during the clinical course of the disease is essential for clinical practice focused on the needs of the patients. There is not a specific assessment tool for this purpose in Colombia. To perform the cultural adaptation of the quality of life scale PedsQL (Paediatric Quality of Life) Cancer Module, Version 3.0 for use in Colombia. Permission for use of the scale was obtained and the algorithm steps of the Mapi Research Trust group were followed: Direct and independent translations of scale by two native Colombian Spanish speaking translators, obtaining a preliminary version from the translations. This was followed by a back translation by a native English speaking translator and a review of the process by the author of the scale, inclusion of suggestions, and implementation of the pilot study. Direct translations were similar in the instructions and response options; a consensus meeting in 8 of the 27 items was required to choose the best translation. The author made no suggestions and gave his endorsement to the implementation of the pilot, in which, 2 items were modified in order to improve their understanding. There is a Colombian Spanish version of the PedsQL questionnaire 3.0 Cancer Module, to be submitted for a validation study prior to its use in the assessment of quality of life in paediatric cancer patients. Copyright © 2016 Asociación Colombiana de Psiquiatría. Publicado por Elsevier España. All rights reserved.

Examining the associations between overeating, disinhibition, and hunger in a nonclinical sample of college women.

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Mailloux, Geneviève; Bergeron, Sophie; Meilleur, Dominique; D'Antono, Bianca; Dubé, Isabelle

2014-04-01

Binge eating (BE) has long been identified as a correlate of overweight and obesity. However, less empirical attention has been given to overeating with and without loss of control (LOC) in nonclinical samples. The goal of the present study was to examine the association of (1) established correlates of BE, namely, weight and shape concerns, dietary restraint, and negative affect, and (2) three additional correlates, disinhibition, hunger, and interoceptive awareness (IA), to overeating in a nonclinical sample of college women. Female students (n = 1,447) aged 18 to 21 years recruited from colleges in three Canadian metropolitan areas completed self-report questionnaires in class to assess sociodemographic and anthropomorphic characteristics, overeating, LOC, dietary restraint, negative affect, weight and shape concerns, IA, disinhibition, and hunger. The established correlates of BE were significant correlates of all types of overeating and explained 33 % of the variance. Disinhibition was the most strongly associated correlate of overeating. Findings suggest that established correlates of BE are associated with other types of overeating such as objective overeating (OOE), as are disinhibition and hunger.

Obsessive-Compulsive Tendencies, Self/Other Perception, Personality, and Suicidal Ideation in a Non-clinical Sample.

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Iliceto, Paolo; D'Antuono, Laura; Cassarà, Luisa; Giacolini, Teodosio; Sabatello, Ugo; Candilera, Gabriella

2017-06-01

Research on the risk factors for SI in adults with OC tendencies is limited, and it is still unclear whether the association between OC tendencies and SI in non-clinical individuals exists. The goal of the present study was to test the associations between OC tendencies, self/other perception, personality traits, depressive symptoms and SI among a non-clinical adult population. We investigated an Italian sample of 337 adults, who were administered a set of self-report questionnaires to assess obsessive-compulsive tendencies, depression, self/other perception, personality traits, and hopelessness. Confirmatory factor analyses (CFA) were performed. In the final model we found that personality, obsessive-compulsive factor and suicidal ideation were significantly correlated with each other: personality correlated negatively with obsessive-compulsive factor and suicidal ideation, while obsessive-compulsive factor and suicidal ideation resulted as strongly positively associated. Our results highlight the importance of assessing OC tendencies, negative self/other perception and SI. Understanding their role and interplay will allow for the development and implementation of more advanced prevention and treatment policies.

Associations between autistic traits and emotion recognition ability in non-clinical young adults

OpenAIRE

Lindahl, Christina

2013-01-01

This study investigated the associations between emotion recognition ability and autistic traits in a sample of non-clinical young adults. Two hundred and forty nine individuals took part in an emotion recognition test, which assessed recognition of 12 emotions portrayed by actors. Emotion portrayals were presented as short video clips, both with and without sound, and as sound only. Autistic traits were assessed using the Autism Spectrum Quotient (ASQ) questionnaire. Results showed that men ...

Non-clinical influences on clinical decision-making: a major challenge to evidence-based practice

OpenAIRE

Hajjaj, FM; Salek, MS; Basra, MKA; Finlay, AY

2010-01-01

This article reviews an aspect of daily clinical practice which is of critical importance in virtually every clinical consultation, but which is seldom formally considered. Non-clinical influences on clinical decision-making profoundly affect medical decisions. These influences include patient-related factors such as socioeconomic status, quality of life and patient's expectations and wishes, physician-related factors such as personal characteristics and interaction with their professional co...

Characterizing Adversity of Lysosomal Accumulation in Nonclinical Toxicity Studies: Results from the 5th ESTP International Expert Workshop

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Lysosomes have a central role in cellular catabolism, trafficking, and processing of foreign particles. Accumulation of endogenous and exogenous materials in lysosomes represents a common finding in nonclinical toxicity studies. Histologically, these accumulations often lack dist...

Adolescent self-report and parent proxy-report of health-related quality of life: an analysis of validity and reliability of PedsQL 4.0 among a sample of Malaysian adolescents and their parents.

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Kaartina, Sanker; Chin, Yit Siew; Fara Wahida, Rezali; Woon, Fui Chee; Hiew, Chu Chien; Zalilah, Mohd Shariff; Mohd Nasir, Mohd Taib

2015-04-08

The Pediatric Quality of Life Inventory Generic Core Scales (PedsQL) 4.0 is a generalized assessment of health-related quality of life (HRQoL) based on adolescent self-report and parent proxy-report. This study aims to determine the construct validity and reliability of PedsQL 4.0 among a sample of Malaysian adolescents and parents. A cross-sectional study was carried out at three selected public schools in the state of Selangor. A total of 379 Malaysian adolescents completed the PedsQL 4.0 adolescent self-report and 218 (55.9%) parents completed the PedsQL 4.0 parent proxy-report. Weight and height of adolescents were measured and BMI-for-age by sex was used to determine their body weight status. There were 50.8% male and 49.2% female adolescents who participated in this study (14.25 ± 1.23 years). The prevalence of overweight and obesity (25.8%) was four times higher than the prevalence of severe thinness and thinness (6.1%). Construct validity was analyzed using Confirmatory Factor Analysis (CFA). Based on CFA, adolescent self-report and parent proxy-report met the criteria of convergent validity (factor loading > 0.5, Average Variance Extracted (AVE) > 0.5, Construct Reliability > 0.7) and showed good fit to the data. The adolescent self-report and parent proxy-report exhibited discriminant validity as the AVE values were larger than the R(2) values. Cronbach's alpha coefficients of the adolescent self-report (α = 0.862) and parent proxy-report (α = 0.922) showed these instruments are reliable. Parents perceived the HRQoL of adolescents was poorer compared to the perception of the adolescent themselves (t = 5.92, p 0.05). Parent proxy-report was negatively associated with the adolescents' BMI-for-age (r = -0.152, p 0.05). Adolescent self-report and parent proxy-report of the PedsQL 4.0 are valid and reliable to assess HRQoL of Malaysian adolescents. Future studies are recommended to use both adolescent self-report and parent-proxy report of HRQoL as

Illness Attitudes Scale dimensions and their associations with anxiety-related constructs in a nonclinical sample.

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Stewart, S H; Watt, M C

2000-01-01

The Illness Attitudes Scale (IAS) is a self-rated measure that consists of nine subscales designed to assess fears, attitudes and beliefs associated with hypochondriacal concerns and abnormal illness behavior [Kellner, R. (1986). Somatization and hypochondriasis. New York: Praeger; Kellner, R. (1987). Abridged manual of the Illness Attitudes Scale. Department of Psychiatry, School of Medicine, University of New Mexico]. The purposes of the present study were to explore the hierarchical factor structure of the IAS in a nonclinical sample of young adult volunteers and to examine the relations of each illness attitudes dimension to a set of anxiety-related measures. One-hundred and ninety-seven undergraduate university students (156 F, 41 M; mean age = 21.9 years) completed the IAS as well as measures of anxiety sensitivity, trait anxiety and panic attack history. The results of principal components analyses with oblique (Oblimin) rotation suggested that the IAS is best conceptualized as a four-factor measure at the lower order level (with lower-order dimensions tapping illness-related Fears, Behavior, Beliefs and Effects, respectively), and a unifactorial measure at the higher-order level (i.e. higher-order dimension tapping General Hypochondriacal Concerns). The factor structure overlapped to some degree with the scoring of the IAS proposed by Kellner (1986, 1987), as well as with the factor structures identified in previously-tested clinical and nonclinical samples [Ferguson, E. & Daniel, E. (1995). The Illness Attitudes Scale (IAS): a psychometric evaluation on a nonclinical population. Personality and Individual Differences, 18, 463-469; Hadjistavropoulos, H. D. & Asmundson, G. J. G. (1998). Factor analytic investigation of the Illness Attitudes Scale in a chronic pain sample. Behaviour Research and Therapy, 36, 1185-1195; Hadjistavropoulos, H. D., Frombach, I. & Asmundson, G. J. G. (in press). Exploratory and confirmatory factor analytic investigations of the

Atovaquone and proguanil hydrochloride: a review of nonclinical studies.

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Pudney, M; Gutteridge, W; Zeman, A; Dickins, M; Woolley, J L

1999-05-01

Safe and effective antimalarial drugs are needed for treatment and prophylaxis of malaria. The combination of atovaquone and proguanil hydrochloride is a new antimalarial drug combination that has recently become available in many countries. Data were reviewed from nonclinical studies evaluating the microbiology, secondary pharmacology, pharmacokinetics, and toxicology of atovaquone and proguanil hydrochloride. Atovaquone is highly active against asexual erythrocytic stages of Plasmodium falciparum in vitro (IC50 0.7-6 nM) and in animal models. Proguanil per se has only weak antimalarial activity in vitro (IC50 2.4-19 microM), and its effectiveness depends on the active metabolite cycloguanil (IC50 0.5-2.5 nM). The combination of atovaquone and proguanil is synergistic in vitro. Both drugs also have activity against gametocytes and pre-erythrocytic (hepatic) stages of malaria parasites. Atovaquone is a ubiquinone antagonist that inhibits mitochondrial electron transport and collapses mitochondrial membrane potential. The proguanil metabolite cycloguanil is a dihydrofolate reductase inhibitor, but the mode of action of proguanil is unknown. In screening evaluations of secondary pharmacology, neither atovaquone nor proguanil had activity that adversely affected gastrointestinal, cardiovascular, or central or autonomic nervous system functions at clinically relevant concentrations. After oral administration, atovaquone exposure is extensive in rats but limited in dogs, while proguanil and cycloguanil exposure is extensive in dogs but limited in rats. In both species, toxicity was related to proguanil exposure, the principal manifestations being salivation, emesis, and loss of body weight. Neither atovaquone nor proguanil was teratogenic or mutagenic. An increased incidence of hepatic adenomas and adenocarcinomas was seen in mice, but not rats, after lifetime exposure to atovaquone, and appears to be related to species-specific differences in hepatic enzymatic activity

International guidelines for the in vivo assessment of skin properties in non-clinical settings: part 1. pH

Science.gov (United States)

Stefaniak, Aleksandr B; du Plessis, Johan; John, Swen M; Eloff, Fritz; Agner, Tove; Chou, Tzu-Chieh; Nixon, Rosemary; Steiner, Markus F C; Kudla, Irena; Holness, D Linn

2013-01-01

Background Skin surface pH is known to influence the dissolution and partitioning of chemicals and may influence exposures that lead to skin diseases. Non-clinical environments (e.g. workplaces) are highly variable, thereby presenting unique measurement challenges that are not typically encountered in clinical settings. Hence, guidelines are needed for consistent measurement of skin surface pH in environments that are difficult to control. Methods An expert workshop was convened at the 5th International Conference on Occupational and Environmental Exposure of Skin to Chemicals to review available data on factors that could influence the determination of skin surface pH in non-clinical settings with emphasis on the workplace as a worst case scenario. Results The key elements of the guidelines are: (i) minimize, to the extent feasible, the influences of relevant endogenous (anatomical position, skin health, time of day), exogenous (hand washing, barrier creams, soaps and detergents, occlusion), environmental (seasonality), and measurement (atmospheric conditions) factors; (ii) report pH measurements results as a difference or percent change (not absolute values) using a measure of central tendency and variability; and (iii) report notable deviations from these guidelines and other relevant factors that may influence measurements. Conclusion Guidelines on the measurement and reporting of skin surface pH in non-clinical settings should promote consistency in data reporting, facilitate inter-comparison of study results, and aid in understanding and preventing occupational skin diseases. PMID:23279097

Emotion Recognition and Social/Role Dysfunction in Non-Clinical Psychosis

Science.gov (United States)

Pelletier, Andrea L.; Dean, Derek J.; Lunsford-Avery, Jessica R.; Smith, Ashley K.; Orr, Joseph M.; Gupta, Tina; Millman, Zachary B.; Mittal, Vijay A.

2013-01-01

As researchers continue to understand non-clinical psychosis (NCP- brief psychotic-like experiences occurring in 5–7% of the general population; van Os et al., 2009), it is becoming evident that functioning deficits and facial emotion recognition (FER) impairment characterize this phenomenon. However, the extent to which these domains are related remains unclear. Social/role functioning and FER were assessed in 65 adolescents/young adults exhibiting Low and High-NCP. Results indicate that FER and social/role functioning deficits were present in the High-NCP group, and that the domains were associated in this group alone. Taken together, findings suggest that a core emotive deficit is tied to broader social/role dysfunction in NCP. PMID:23182437

Aspectos ultra-estruturais das vilosidades intestinais após o clampeamento do pedículo hepático de ratos

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Camargo Lázaro Manoel de

2003-01-01

Full Text Available OBJETIVO: Estudar a ultra-estrutura das vilosidades intestinais de ratos após diferentes tempos de clampeamento total do pedículo hepático. MÉTODOS: Foram utilizados 40 ratos, machos, divididos em quatro grupos de 10 animais cada um. O grupo Sham não foi submetido a isquemia. Os grupos E1, E2 e E3 sofreram isquemia de 10, 20 e 30 minutos, respectivamente. Ao final do experimento, fragmentos do intestino delgado (íleo foram retirados e processados para microscopia eletrônica de transmissão. RESULTADOS: Nos grupos E1 e E2 observou-se infiltração de leucócitos, dilatação vascular e áreas eletrolúcidas na lâmina própria das vilosidades. Já no grupo E3 observou-se desprendimento do revestimento epitelial, desintegração das microvilosidades e núcleos em apoptose. Na lâmina própria notamos áreas hemorrágicas, vasos sangüíneos e linfáticos dilatados e inúmeros leucócitos. CONCLUSÕES: o clampeamento do pedículo hepático hepático provoca congestão esplâncnica, tempo dependente, sendo que aos 30 minutos se nota desprendimento das células epiteliais, apoptose e hemorragia.

Reading Difficulties and Attention-Deficit/Hyperactivity Behaviours: Evidence of an Early Association in a Nonclinical Sample

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Luoni, Chiara; Balottin, Umberto; Zaccagnino, Maria; Brembilla, Laura; Livetti, Giulia; Termine, Cristiano

2015-01-01

Attention-deficit/hyperactivity disorder (ADHD) often co-occurs with reading disability. A cross-sectional study in an Italian-speaking, nonclinical sample was conducted in an attempt to document the existence of an early association between reading difficulties (RD) and ADHD behaviours. We recruited a sample of 369 children in their first year at…

The safety, efficacy and regulatory triangle in drug development: Impact for animal models and the use of animals.

Science.gov (United States)

van Meer, Peter J K; Graham, Melanie L; Schuurman, Henk-Jan

2015-07-15

Nonclinical studies in animals are conducted to demonstrate proof-of-concept, mechanism of action and safety of new drugs. For a large part, in particular safety assessment, studies are done in compliance with international regulatory guidance. However, animal models supporting the initiation of clinical trials have their limitations, related to uncertainty regarding the predictive value for a clinical condition. The 3Rs principles (refinement, reduction and replacement) are better applied nowadays, with a more comprehensive application with respect to the original definition. This regards also regulatory guidance, so that opportunities exist to revise or reduce regulatory guidance with the perspective that the optimal balance between scientifically relevant data and animal wellbeing or a reduction in animal use can be achieved. In this manuscript we review the connections in the triangle between nonclinical efficacy/safety studies and regulatory aspects, with focus on in vivo testing of drugs. These connections differ for different drugs (chemistry-based low molecular weight compounds, recombinant proteins, cell therapy or gene therapy products). Regarding animal models and their translational value we focus on regulatory aspects and indications where scientific outcomes warrant changes, reduction or replacement, like for, e.g., biosimilar evaluation and safety testing of monoclonal antibodies. On the other hand, we present applications where translational value has been clearly demonstrated, e.g., immunosuppressives in transplantation. Especially for drugs of more recent date like recombinant proteins, cell therapy products and gene therapy products, a regulatory approach that allows the possibility to conduct combined efficacy/safety testing in validated animal models should strengthen scientific outcomes and improve translational value, while reducing the numbers of animals necessary. Copyright © 2015 Elsevier B.V. All rights reserved.

Non-clinical development of CER-001.

Science.gov (United States)

Barbaras, Ronald

2015-01-01

Cardiovascular disease remains the most pressing healthcare issue for the developed world and is becoming so for developing countries. There are no currently approved therapies that can rapidly reduce the burden of unstable, inflamed plaque in the overall coronary vascular bed. High-density lipoprotein (HDL) has multiple actions that could lead to plaque stabilization, such as rapid removal of large quantities of cholesterol from the vasculature through the process of reverse lipid transport, improvement in endothelial function, protection against oxidative damage, and reduction in inflammation. Short-term infusion of HDL-mimetics in animal models as well as in humans has shown promising effects on the plaque size and morphology. Cerenis Therapeutics has developed CER-001, a negatively charged lipoprotein complex consisting of phospholipid and recombinant human apoA-I that mimics the structure and function of natural HDL. Three clinical trials using CER-001 infusions have demonstrated improvements in the carotid wall thickness of patients with familial hypercholesterolaemia and in patients with hypo-alphalipoproteinaemia, as well as an impact on coronary plaque burden measured by intravascular ultrasonography at the lowest tested dose (3 mg/kg) in post-ACS patients. Here, we reviewed the non-clinical data leading to the demonstration that CER-001 is a full HDL mimetic.

Validation of the French Version of the DSM-5 Yale Food Addiction Scale in a Nonclinical Sample.

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Brunault, Paul; Courtois, Robert; Gearhardt, Ashley N; Gaillard, Philippe; Journiac, Kevin; Cathelain, Sarah; Réveillère, Christian; Ballon, Nicolas

2017-03-01

The Yale Food Addiction Scale (YFAS) is the only questionnaire that assesses food addiction (FA) based on substance dependence criteria in the Diagnostic and Statistical Manual of Mental Disorders (DSM), Fourth Edition, Text Revision. Following recent updating of addiction criteria, a new DSM-5 version (YFAS 2.0) has been developed. Our study tested the psychometric properties of the French YFAS 2.0 in a nonclinical population. We assessed 330 nonclinical participants for FA (French YFAS 2.0), eating behaviour, and eating disorder (Binge Eating Scale, Emotional Overeating Questionnaire, Three-Factor Eating Questionnaire-R18, Questionnaire on Eating and Weight Patterns-Revised, Eating Disorder Diagnostic Scale). We tested the scale's factor structure (confirmatory factor analysis based on 11 diagnostic criteria), internal consistency, and construct and incremental validity. Prevalence of FA was 8.2%. Our results supported a 1-factor structure similar to the US version. In both its diagnostic and symptom count versions, the YFAS 2.0 had good internal consistency (Kuder-Richardson alpha was 0.83) and was associated with body mass index (BMI), binge eating, uncontrolled and emotional eating, binge eating disorder, and cognitive restraint. FA predicted BMI above and beyond binge eating frequency. Females had a higher prevalence of FA than males but not more FA symptoms. We validated a psychometrically sound French version of the YFAS 2.0 in a nonclinical population, in both its symptom count and diagnostic versions. Future studies should investigate psychometric properties of this questionnaire in clinical populations potentially at risk for FA (that is, patients with obesity, diabetes, hypertension, or other metabolic syndrome risk factors).

A short version of the revised 'experience of close relationships questionnaire': investigating non-clinical and clinical samples.

Science.gov (United States)

Wongpakaran, Tinakon; Wongpakaran, Nahathai

2012-01-01

This study seeks to investigate the psychometric properties of the short version of the revised 'Experience of Close Relationships' questionnaire, comparing non-clinical and clinical samples. In total 702 subjects participated in this study, of whom 531 were non-clinical participants and 171 were psychiatric patients. They completed the short version of the revised 'Experience of Close Relationships' questionnaire (ECR-R-18), the Perceived Stress Scale-10(PSS-10), the Rosenberg Self-Esteem Scale (RSES) and the UCLA Loneliness scale. A retest of the ECR-R-18 was then performed at four-week intervals. Then, confirmatory factor analyses were performed to test the validity of the new scale. The ECR-R-18 showed a fair to good internal consistency (α 0.77 to 0.87) for both samples, and the test-retest reliability was found to be satisfactory (ICC = 0.75). The anxiety sub-scale demonstrated concurrent validity with PSS-10 and RSES, while the avoidance sub-scale showed concurrent validity with the UCLA Loneliness Scale. Confirmatory factor analysis using method factors yielded two factors with an acceptable model fit for both groups. An invariance test revealed that the ECR-R-18 when used on the clinical group differed from when used with the non-clinical group. The ECR-R-18 questionnaire revealed an overall better level of fit than the original 36 item questionnaire, indicating its suitability for use with a broader group of samples, including clinical samples. The reliability of the ECR-R- 18 might be increased if a modified scoring system is used and if our suggestions with regard to future studies are followed up.

Clinical and non-clinical depression and anxiety in young people: A scoping review on heart rate variability.

Science.gov (United States)

Paniccia, Melissa; Paniccia, David; Thomas, Scott; Taha, Tim; Reed, Nick

2017-12-01

Heart rate variability (HRV), a measure of cardiac autonomic nervous system functioning, has emerged as a physiological indicator for emotional regulation and psychological well-being. HRV is understudied in the context of depression and anxiety in young people (10-24years old). Main objectives: (1) describe the nature and breadth of reviewed studies; and (2) synthesize main findings in the context of clinical and non-clinical populations of young people with depression and/or anxiety. The Arksey and O'Malley methodology was utilized for this scoping review. CINHAL, EMBASE, Medline, PsychInfo, Scopus, Web of Science, as well as grey literature, were searched. Two reviewers screened titles, abstracts and full papers for inclusion. A total of 20 citations were included in the final review (19 citations peer-reviewed journal articles, 1 journal abstract). Numerical and thematic analysis was used to summarize study findings. In clinical populations of either depression or anxiety, HRV was lower compared to controls. In non-clinical populations of either depression or anxiety, HRV was found to be lower in those who reported more depression or anxiety symptoms. The quality of the reviewed articles was not assessed which limits the ability to generate conclusions regarding study findings. Changes in HRV were found across the spectrum of clinical and non-clinical populations of young people with depression or anxiety. Neurophysiological research on depression and anxiety in young people can act as a first step to understanding how physiological flexibility (i.e. HRV) is related to psychological flexibility (i.e. adaptive or maladaptive responses to life events). Copyright © 2017 Elsevier B.V. All rights reserved.

International guidelines for the in vivo assessment of skin properties in non-clinical settings

DEFF Research Database (Denmark)

du Plessis, Johan; Stefaniak, Aleksandr; Eloff, Fritz

2013-01-01

There is an emerging perspective that it is not sufficient to just assess skin exposure to physical and chemical stressors in workplaces, but that it is also important to assess the condition, i.e. skin barrier function of the exposed skin at the time of exposure. The workplace environment, repre......, representing a non-clinical environment, can be highly variable and difficult to control, thereby presenting unique measurement challenges not typically encountered in clinical settings....

A sentence completion procedure as an alternative to the Autobiographical Memory Test for assessing overgeneral memory in non-clinical populations.

Science.gov (United States)

Raes, Filip; Hermans, Dirk; Williams, J Mark G; Eelen, Paul

2007-07-01

Overgeneral memory (OGM) has been proposed as a vulnerability factor for depression (Williams et al., 2007) or depressive reactivity to stressful life-events (e.g., Gibbs & Rude, 2004). Traditionally, a cue word procedure known as the Autobiographical Memory Test (AMT; Williams & Broadbent, 1986) is used to assess OGM. Although frequently and validly used in clinical populations, there is evidence suggesting that the AMT is insufficiently sensitive to measure OGM in non-clinical groups. Study 1 evaluated the usefulness of a sentence completion method to assess OGM in non-clinical groups, as an alternative to the AMT. Participants were 197 students who completed the AMT, the Sentence Completion for Events from the Past Test (SCEPT), a depression measure, and visual analogue scales assessing ruminative thinking. Results showed that the mean proportion of overgeneral responses was markedly higher for the SCEPT than for the standard AMT. Also, overgeneral responding on the SCEPT was positively associated to depression scores and depressive rumination scores, whereas overgeneral responding on the AMT was not. Results suggest that the SCEPT, relative to the AMT, is a more sensitive instrument to measure OGM, at least in non-clinical populations. Study 2 further showed that this enhanced sensitivity is most likely due to the omission of the instruction to be specific rather than to the SCEPT's sentence completion format (as opposed to free recall to cue words).

Evaluation of the Potential Risk of Drugs to Induce Hepatotoxicity in Human?Relationships between Hepatic Steatosis Observed in Non-Clinical Toxicity Study and Hepatotoxicity in Humans-

OpenAIRE

Goda, Keisuke; Kobayashi, Akio; Takahashi, Akemi; Takahashi, Tadakazu; Saito, Kosuke; Maekawa, Keiko; Saito, Yoshiro; Sugai, Shoichiro

2017-01-01

In the development of drugs, we sometimes encounter fatty change of the hepatocytes (steatosis) which is not accompanied by degenerative change in the liver in non-clinical toxicity studies. In this study, we investigated the relationships between fatty change of the hepatocytes noted in non-clinical toxicity studies of compound X, a candidate compound in drug development, and mitochondrial dysfunction in order to estimate the potential risk of the compound to induce drug-induced liver injury...

Self-perception but not peer reputation of bullying victimization is associated with non-clinical psychotic experiences in adolescents

NARCIS (Netherlands)

Gromann, P.M.; Goossens, F.A.; Olthof, T.; Pronk, J.; Krabbendam, L.

2013-01-01

Background Bullying victimization may be linked to psychosis but only self-report measures of victimization have been used so far. This study aimed (a) to investigate the differential associations of peer-nominated versus self-reported victim status with non-clinical psychotic experiences in a

Brief Report: Examining the Link between Autistic Traits and Compulsive Internet Use in a Non-Clinical Sample

Science.gov (United States)

Finkenauer, Catrin; Pollmann, Monique M. H.; Begeer, Sander; Kerkhof, Peter

2012-01-01

Individuals with autism spectrum disorders or autistic traits may profit from Internet and computer-mediated interactions, but there is concern about their Internet use becoming compulsive. This study investigated the link between autistic traits and Internet use in a 2-wave longitudinal study with a non-clinical community sample (n = 390). As…

Relations between behavioral inhibition, big five personality factors, and anxiety disorder symptoms in non-clinical and clinically anxious children

NARCIS (Netherlands)

L.J. Vreeke (Leonie); P.E.H.M. Muris (Peter)

2012-01-01

textabstractThis study examined the relations between behavioral inhibition, Big Five personality traits, and anxiety disorder symptoms in non-clinical children (n = 147) and clinically anxious children (n = 45) aged 6-13 years. Parents completed the Behavioral Inhibition Questionnaire-Short Form,

Técnica de doble pedículo lateral en reconstrucción mamaria después de tumorectomía Double lateral pedicle technique in breast reconstruction after tumorectomy

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Orlando Rafael Expósito Reyes

2007-12-01

Full Text Available Los tumores mamarios aparecen cada vez con mayor frecuencia, e igualmente las secuelas poco estéticas de la cirugía de estos. Se presenta la técnica quirúrgica de doble pedículo externo (superior e inferior en la reconstrucción mamaria después de una tumorectomía por fibroadenoma gigante de la mama izquierda. Se planificó la intervención tomando como referencia la técnica de Skoog (pedículo lateral externo, por la localización, el área ocupada por la masa mamaria (3/4 partes de la mama y para conservar la irrigación del complejo areola-pezón. Para llenar el vacío dejado por el tumor, se utilizó un segundo pedículo inferolateral que se liberó, rotó y fijó a la fascia muscular, con sutura no absorbible, en el área del cuadrante superior interno, lo cual sirvió de relleno o apoyo al complejo areola-pezón y a su pedículo. Se obtuvo un resultado estético bueno, que satisfizo las expectativas de la paciente y de los médicos, al conservarse la mama y su forma.Breast tumors are more and more frequent, as well as the little aesthetic sequelae of their surgery. The external double pedicle surgical technique (upper and lower in breast reconstruction after a tumorectomy due to giant fibroadenoma of the left breast was presented. The operation was planned taking Skoog’s technique as a reference (external lateral pedicle by the localization, the area occupied by the breast mass (3/4 parts of the breast and to preserve the irrigation of the areola-nipple complex. To fill the gap left by the tumor, it was used a second inferolateral pedicle that was released, rotated and fixed to the muscle fascia with non-absorbable suture in the area of the upper internal quadrant that served as a filling or support to the areola-nipple complex and to its pedicle. A good aesthetic result that satisfied the patients and specialists’ expectations was obtained on conserving the breast and its form.

Impulsivity and compulsive buying are associated in a non-clinical sample: an evidence for the compulsivity-impulsivity continuum?

Science.gov (United States)

Paula, Jonas J de; Costa, Danielle de S; Oliveira, Flavianne; Alves, Joana O; Passos, Lídia R; Malloy-Diniz, Leandro F

2015-01-01

Compulsive buying is controversial in clinical psychiatry. Although it is defined as an obsessive-compulsive disorder, other personality aspects besides compulsivity are related to compulsive buying. Recent studies suggest that compulsivity and impulsivity might represent a continuum, with several psychiatric disorders lying between these two extremes. In this sense, and following the perspective of dimensional psychiatry, symptoms of impulsivity and compulsivity should correlate even in a non-clinical sample. The present study aims to investigate whether these two traits are associated in a healthy adult sample. We evaluated 100 adults, with no self-reported psychiatric disorders, using the Barratt Impulsiveness Scale-11 and two scales of compulsive buying. Using multiple linear regressions, we found that impulsivity accounted for about 15% of variance in the compulsive-buying measure. Our results suggest that an association between impulsivity and compulsive buying occurs even in non-clinical samples, evidence that compulsivity and impulsivity might form a continuum and that compulsive buying might be an intermediate condition between these two personality traits.

Replication of a Modified Factor Structure for the Eating Disorder Examination-Questionnaire: Extension to Clinical Eating Disorder and Non-clinical Samples in Portugal.

Science.gov (United States)

Machado, Paulo P P; Grilo, Carlos M; Crosby, Ross D

2018-01-01

Psychometric investigations of the Eating Disorder Examination-Questionnaire (EDE-Q) have generally not supported the original scale structure. The present study tested an alternative brief factor structure in two large Portuguese samples: (1) a non-clinical sample of N = 4117 female students and (2) a treatment-seeking sample of N = 609 patients diagnosed with eating disorders. Confirmatory factor analysis revealed a poor fit for the original EDE-Q structure in both the non-clinical and the clinical samples but revealed a good fit for the alternative 7-item 3-factor structure (dietary restraint, shape/weight overvaluation and body dissatisfaction). Factor loadings were invariant across samples and across the different specific eating disorder diagnoses in the clinical sample. These confirmatory factor analysis findings, which replicate findings from studies with diverse predominately overweight/obese samples, supported a modified 7-item, 3-factor structure for the EDE-Q. The reliable findings across different non-clinical and clinical eating disorder groups provide confidence regarding the potential utility of this brief version. Copyright © 2017 John Wiley & Sons, Ltd and Eating Disorders Association. Copyright © 2017 John Wiley & Sons, Ltd and Eating Disorders Association.

I've changed, but I'm not less happy : Interview study among nonclinical relatives of long-term missing persons

NARCIS (Netherlands)

Lenferink, Lonneke I. M.; de Keijser, Jos; Piersma, Eline; Boelen, Paul A.

2018-01-01

Twenty-three nonclinical relatives of long-term missing persons were interviewed. Patterns of functioning over time were studied retrospectively by instructing participants to draw a graph that best described their pattern. Patterns most frequently drawn were a recovery and resilient/stable pattern.

A study on job satisfaction among clinical and non-clinical hospital staff in a teaching hospital in Lagos, Nigeria.

Science.gov (United States)

Coker, O O; Coker, A O; Onuoha, B

2011-12-01

Previous studies had demonstrated that continuous and effective productivity of hospital staff are linked to job satisfaction and only those who are satisfied with their job can be maximally effective and productive. This cross-sectional descriptive survey was designed to determine the levels of job satisfaction among various groups of health care professionals working in a teaching hospital in Lagos, Nigeria. Two hundred clinical and non-clinical hospital staff were invited to take part in the study. They completed a sociodemographic questionnaire and the Job Descriptive Index (JDI). The results indicated that majority clinical and non-clinical staff were satisfied with their jobs as regards the parameters of the JDI compared with those not satisfied with their jobs. The government and health policy makers should continue to pay attention to boost job morale and satisfaction of medical health workers to continue to make them to be satisfied with their job.

Memory binding in clinical and non-clinical psychotic experiences: how does the continuum model fare?

Science.gov (United States)

Chhabra, S; Badcock, J C; Maybery, M T

2013-07-01

Both clinical and non-clinical auditory hallucinations (AH) have been associated with source memory deficits, supporting a continuum of underlying cognitive mechanisms, though few studies have employed the same task in patient and nonpatient samples. Recent commentators have called for more debate on the continuum model of psychosis. Consequently, the current study investigated the continuity model of AH with reference to memory binding. We used an identical voice and word recognition memory task to assess binding in two separate studies of: (1) healthy hallucination-prone individuals and controls (30 high and 30 low scorers on the Launay-Slade Hallucination Scale-Revised) and (2) schizophrenia patient samples (32 with AH, 32 without AH) and 32 healthy controls. There was no evidence of impaired binding in high hallucination-prone, compared to low hallucination-prone individuals. In contrast, individuals with schizophrenia (both with and without AH) had difficulties binding (remembering "who said what"), alongside difficulties remembering individual words and voices. Binding ability and memory for voices were also negatively linked to the loudness of hallucinated voices reported by patients with AH. These findings suggest that different mechanisms may exist in clinical and non-clinical hallucinators, adding to the growing debate on the continuum model of psychotic symptoms.

Impaired self-monitoring of inner speech in schizophrenia patients with verbal hallucinations and in non-clinical individuals prone to hallucinations

Directory of Open Access Journals (Sweden)

Gildas Brébion

2016-09-01

Full Text Available Background: Previous research has shown that various memory errors reflecting failure in the self-monitoring of speech were associated with auditory/verbal hallucinations in schizophrenia patients and with proneness to hallucinations in non-clinical individuals. Method: We administered to 57 schizophrenia patients and 60 healthy participants a verbal memory task involving free recall and recognition of lists of words with different structures (high-frequency, low-frequency, and semantically-organisable words. Extra-list intrusions in free recall were tallied, and the response bias reflecting tendency to make false recognitions of non-presented words was computed for each list. Results: In the male patient subsample, extra-list intrusions were positively associated with verbal hallucinations and inversely associated with negative symptoms. In the healthy participants the extra-list intrusions were positively associated with proneness to hallucinations. A liberal response bias in the recognition of the high-frequency words was associated with verbal hallucinations in male patients and with proneness to hallucinations in healthy men. Meanwhile, a conservative response bias for these high-frequency words was associated with negative symptoms in male patients and with social anhedonia in healthy men. Conclusions: Misattribution of inner speech to an external source, reflected by false recollection of familiar material, seems to underlie both clinical and non-clinical hallucinations. Further, both clinical and non-clinical negative symptoms may exert on verbal memory errors an effect opposite to that of hallucinations.

Non-clinical efficacy and safety of HyVac4:IC31 vaccine administered in a BCG prime-boost regimen.

Science.gov (United States)

Skeiky, Yasir A W; Dietrich, Jes; Lasco, Todd M; Stagliano, Katherine; Dheenadhayalan, Veerabadran; Goetz, Margaret Ann; Cantarero, Luis; Basaraba, Randall J; Bang, Peter; Kromann, Ingrid; McMclain, J Bruce; Sadoff, Jerald C; Andersen, Peter

2010-01-22

Despite the extensive success with the introduction of M. bovis Bacille Calmette-Guérin (BCG), tuberculosis (TB) remains a major global epidemic infecting between 8 and 9 million people annually with an estimated 1.7 million deaths each year. However, because of its demonstrated effectiveness against some of the most severe forms of childhood TB, it is now realized that BCG vaccination of newborns is unlikely to be replaced. Therefore, BCG or an improved BCG will continue to be used as a prime TB vaccine and there is a need to develop effective boost vaccines that would enhance and prolong the protective immunity induced by BCG prime immunization. We report on a heterologous booster approach using two highly immunogenic TB antigens comprising Ag85B and TB10.4 (HyVac4) delivered as a fusion molecule and formulated in the proprietary adjuvant IC31. This vaccine was found to be immunogenic and demonstrated greater protection in the more stringent guinea pig model of pulmonary tuberculosis than BCG alone when used in a prime/boost regimen. Significant difference in lung involvement was observed for all animals in the HyVac4 boosted group compared to BCG alone regardless of time to death or sacrifice. A vaccine toxicology study of the HyVac4:IC31 regimen was performed and it was judged safe to advance the vaccine into clinical trials. Therefore, all non-clinical data supports the suitability of HyVac4 as a safe, immunogenic, and effective vaccination in a prime-boost regimen with BCG.

Measuring patient safety culture in Taiwan using the Hospital Survey on Patient Safety Culture (HSOPSC).

Science.gov (United States)

Chen, I-Chi; Li, Hung-Hui

2010-06-07

Patient safety is a critical component to the quality of health care. As health care organizations endeavour to improve their quality of care, there is a growing recognition of the importance of establishing a culture of patient safety. In this research, the authors use the Hospital Survey on Patient Safety Culture (HSOPSC) questionnaire to assess the culture of patient safety in Taiwan and attempt to provide an explanation for some of the phenomena that are unique in Taiwan. The authors used HSOPSC to measure the 12 dimensions of the patient safety culture from 42 hospitals in Taiwan. The survey received 788 respondents including physicians, nurses, and non-clinical staff. This study used SPSS 15.0 for Windows and Amos 7 software tools to perform the statistical analysis on the survey data, including descriptive statistics and confirmatory factor analysis of the structural equation model. The overall average positive response rate for the 12 patient safety culture dimensions of the HSOPSC survey was 64%, slightly higher than the average positive response rate for the AHRQ data (61%). The results showed that hospital staff in Taiwan feel positively toward patient safety culture in their organization. The dimension that received the highest positive response rate was "Teamwork within units", similar to the results reported in the US. The dimension with the lowest percentage of positive responses was "Staffing". Statistical analysis showed discrepancies between Taiwan and the US in three dimensions, including "Feedback and communication about error", "Communication openness", and "Frequency of event reporting". The HSOPSC measurement provides evidence for assessing patient safety culture in Taiwan. The results show that in general, hospital staffs in Taiwan feel positively toward patient safety culture within their organization. The existence of discrepancies between the US data and the Taiwanese data suggest that cultural uniqueness should be taken into

The Comparison of Early Maladaptive Schema’s Domains Between Successful And Non-Successful Opiate Addicts and Non-Clinical Persons

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Bahram Sahand

2009-10-01

Full Text Available Introduction: The current research was done in order to compare the early maladaptive schema’s domains between successful and non-successful opiate addicts and non-clinical persons in Tehran. Method: The research design was causal effect method. In this purpose 90 men (include successful and non-successful opiate addicts, and non-clinical persons (30 for each group, were selected by the available sampling method. Young Schema Questionnaire (YSQ-RE2R, General Health Questionnaire (GHQ, and Personal Characteristic Questionnaire were administered among selected sample. The results were analyzed by ANOVA, chi square, MANOVA, and tukey test. Results: The findings of this research indicated that there was a significant difference on “Early Maladaptive Schema’s domains” between these three groups. Conclusion: The results have important clinical interpretations. It is assumed that medical interference with the aim of modifying and correcting the “Early Maladaptive Schema’s domains” can be effective on the level of success for opiate addicts to give up their addiction.

Safety of recombinant human platelet-derived growth factor-BB in Augment® Bone Graft

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Luis A Solchaga

2012-12-01

Full Text Available This article discusses nonclinical and clinical data regarding the safety of recombinant human platelet-derived growth factor-BB as a component of the Augment® Bone Graft (Augment. Augment is a bone graft substitute intended to be used as an alternative to autologous bone graft in the fusion of hindfoot and ankle joints. Nonclinical studies included assessment of the pharmacokinetic profile of intravenously administered recombinant human platelet-derived growth factor-BB in rat and dog, effects of intravenous administration of recombinant human platelet-derived growth factor-BB in a reproductive and development toxicity study in rats, and chronic toxicity and carcinogenicity of Augment in a 12-month implantation model. These studies showed that systemic exposure was brief and clearance was rapid. No signs of toxicity, carcinogenicity, or tumor promotion were observed even with doses far exceeding the maximum clinical dose. Results of clinical trials (605 participants and commercial use of recombinant human platelet-derived growth factor-BB containing products indicate that these products are not associated with increased incidence of adverse events or cancer. The safety data presented provide evidence that recombinant human platelet-derived growth factor-BB is a safe therapeutic when used in combination products as a single administration during surgical procedures for bone repair and fusion. There is no evidence associating use of recombinant human platelet-derived growth factor-BB in Augment with chronic toxicity, carcinogenicity, or tumor promotion.

MMPI-2 Characteristics of the Old Order Amish: A Comparison of Clinical, Nonclinical, and United States Normative Samples

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Knabb, Joshua J.; Vogt, Ronald G.; Newgren, Kevin P.

2011-01-01

In the current study, we investigated Minnesota Multiphasic Personality Inventory-2 (MMPI-2) characteristics in an Old Order Amish nonclinical sample (N = 84), comparing these data with both the United States normative sample (N = 2,600) and a sample of Old Order Amish outpatients (N = 136). Consistent with our hypothesis, the Old Order Amish…

Nonclinical comparability studies of recombinant human arylsulfatase A addressing manufacturing process changes.

Science.gov (United States)

Wright, Teresa; Li, Aiqun; Lotterhand, Jason; Graham, Anne-Renee; Huang, Yan; Avila, Nancy; Pan, Jing

2018-01-01

Recombinant human arylsulfatase A (rhASA) is in clinical development for the treatment of patients with metachromatic leukodystrophy (MLD). Manufacturing process changes were introduced to improve robustness and efficiency, resulting in higher levels of mannose-6-phosphate and sialic acid in post-change (process B) compared with pre-change (process A) rhASA. A nonclinical comparability program was conducted to compare process A and process B rhASA. All doses were administered intrathecally. Pharmacodynamic comparability was evaluated in immunotolerant MLD mice, using immunohistochemical staining of lysosomal-associated membrane protein-1 (LAMP-1). Pharmacokinetic comparability was assessed in juvenile cynomolgus monkeys dosed once with 6.0 mg (equivalent to 100 mg/kg of brain weight) process A or process B rhASA. Biodistribution was compared by quantitative whole-body autoradiography in rats. Potential toxicity of process B rhASA was evaluated by repeated rhASA administration at doses of 18.6 mg in juvenile cynomolgus monkeys. The specific activities for process A and process B rhASA were 89 U/mg and 106 U/mg, respectively, which were both well within the target range for the assay. Pharmacodynamic assessments showed no statistically significant differences in LAMP-1 immunohistochemical staining in the spinal cord and in most of the brain areas assessed between process A and B rhASA-dosed mice. LAMP-1 staining was reduced with both process A and B rhASA compared with vehicle, supporting its activity. Concentration-time curves in cerebrospinal fluid and serum of cynomolgus monkeys were similar with process A and B rhASA. Process A and B rhASA were similar in terms of their pharmacokinetic parameters and biodistribution data. No process B rhASA-related toxicity was detected. In conclusion, manufacturing process changes did not affect the pharmacodynamic, pharmacokinetic or safety profiles of process B rhASA relative to process A rhASA.

Impulsivity and compulsive buying are associated in a non-clinical sample: an evidence for the compulsivity-impulsivity continuum?

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Jonas J. de Paula

2015-09-01

Full Text Available Objective:Compulsive buying is controversial in clinical psychiatry. Although it is defined as an obsessive-compulsive disorder, other personality aspects besides compulsivity are related to compulsive buying. Recent studies suggest that compulsivity and impulsivity might represent a continuum, with several psychiatric disorders lying between these two extremes. In this sense, and following the perspective of dimensional psychiatry, symptoms of impulsivity and compulsivity should correlate even in a non-clinical sample. The present study aims to investigate whether these two traits are associated in a healthy adult sample.Methods:We evaluated 100 adults, with no self-reported psychiatric disorders, using the Barratt Impulsiveness Scale-11 and two scales of compulsive buying.Results:Using multiple linear regressions, we found that impulsivity accounted for about 15% of variance in the compulsive-buying measure.Conclusions:Our results suggest that an association between impulsivity and compulsive buying occurs even in non-clinical samples, evidence that compulsivity and impulsivity might form a continuum and that compulsive buying might be an intermediate condition between these two personality traits.

Genotyping of Yersinia enterocolitica biotype 1A strains from clinical and nonclinical origins by pulsed-field gel electrophoresis.

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Campioni, Fábio; Falcão, Juliana P

2014-06-01

Yersinia enterocolitica biotype 1A (B1A) strains are considered mainly nonpathogenic. However, some studies considered strains of this biotype to be the causal agents of infections in humans and animals. In South America, there are no studies that have compared clinical and nonclinical strains of B1A typed by pulsed-field gel electrophoresis (PFGE) and none that have compared the capability of different enzymes on typing these strains. This study typed 51 Y. enterocolitica B1A strains isolated in Brazil and Chile by PFGE, testing the enzymes XbaI, NotI, and XhoI. The resulting dendrograms discriminated the strains in 47, 40, and 49 pulsotypes generated by the cleavage with the enzymes XbaI, NotI, and XhoI, respectively. The majority of the strains were grouped independently of their clinical or nonclinical origins. The high discriminatory power of PFGE confirmed the heterogeneity of B1A strains but could not divide the strains studied into clusters that differed in the frequency of some virulence genes as observed in studies using other methodologies.

The effect of social exclusion on state paranoia and explicit and implicit self-esteem in a non-clinical sample.

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Stewart, C; Rogers, F; Pilch, M; Stewart, I; Barnes-Holmes, Y; Westermann, S

2017-12-01

The relationship between self-esteem and paranoia may be influenced by social stress. This study aimed to replicate previous research on the impact ofsocial exclusion on paranoia and self-esteem in a non-clinical sample and to extend this work by examining the effect of exclusion on self-esteem at the 'implicit' level. Non-clinical participants (N = 85) were randomly allocated to the Inclusion or Exclusion condition of a virtual ball-toss game ('Cyberball'). They completed self-reportmeasures of state paranoia and self-esteem, and two implicit measures of self-esteem - theImplicit Association Task (IAT) and Implicit Relational Assessment Procedure (IRAP) -prior to and after exposure to Cyberball. Social exclusion increased state paranoia. This effect was moderated by distress associated with trait paranoia. Exclusion was also associated with decreased self-reported self-esteem, as well as reduced implicit self-esteem on the IAT. Changes in self-reported self-esteem were associated with state paranoia at post-Cyberball. The IRAP indicated that reductions in implicit self-esteem may be due to increases in 'Me-Negative' and 'Others-Positive' biases (rather than reductions in 'Me-Positive' bias). The current study involved a non-clinical sample and so findings cannot be generalized to clinical paranoia. These findings are consistent with previous evidence that paranoia is associated with negative self-evaluations, whereas positive self-evaluations can persist in paranoia. They also provide support for the suggestion that investigations of self-esteem in paranoia should extend beyond global self-esteem and might benefit from a distinction between positive and negative components. Copyright © 2017 Elsevier Ltd. All rights reserved.

OC19 - Measuring feasibility, reliability and validity of the Greek version of PedsQL cardiac module.

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Drakouli, Maria; Petsios, Konstantinos; Matziou, Vasiliki

2016-05-09

Theme: Cardiology Introduction: Measuring quality of life (QoL) in children and adolescents with congenital heart disease (CHD) is of great clinical importance. The aim of the study was: (a) to adapt the PedsQL Cardiac Module for children aged two to 18 years with CHD in a sample of the Greek population; (b) to determine its reliability and validity. Forward and backward translation methodology was used. Parents and children completed the instrument during: (a) hospitalization and (b) visits in the paediatric cardiology outpatient department. Cross-informant variance between children and parents was thoroughly assessed. Missing item responses did not exceed 5%. All internal consistency reliability coefficients for the inventory exceeded the minimum standards for group comparisons, over 0.75. Hypothesized correlations between cardiac module and core scales were statistically significant, (pModule in children with congenital heart defect (CHD).

Relations between Behavioral Inhibition, Big Five Personality Factors, and Anxiety Disorder Symptoms in Non-Clinical and Clinically Anxious Children

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Vreeke, Leonie J.; Muris, Peter

2012-01-01

This study examined the relations between behavioral inhibition, Big Five personality traits, and anxiety disorder symptoms in non-clinical children (n = 147) and clinically anxious children (n = 45) aged 6-13 years. Parents completed the Behavioral Inhibition Questionnaire-Short Form, the Big Five Questionnaire for Children, and the Screen for…

Avoidance of Affect Mediates the Effect of Invalidating Childhood Environments on Borderline Personality Symptomatology in a Non-Clinical Sample

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Sturrock, Bonnie A.; Francis, Andrew; Carr, Steven

2009-01-01

The aim of this study was to test the Linehan (1993) proposal regarding associations between invalidating childhood environments, distress tolerance (e.g., avoidance of affect), and borderline personality disorder (BPD) symptoms. The sample consisted of 141 non-clinical participants (51 men, 89 women, one gender unknown), ranging in age from 18 to…

A comparison of effectiveness of hepatitis B screening and linkage to care among foreign-born populations in clinical and nonclinical settings

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Chandrasekar E

2015-01-01

Full Text Available Edwin Chandrasekar,1 Ravneet Kaur,1 Sharon Song,1 Karen E Kim2 1Asian Health Coalition, Chicago, IL, USA; 2Division of the Biological Sciences and Office of Community Engagement and Cancer Disparities, University of Chicago, Chicago, IL, USA Abstract: Hepatitis B (HBV is an urgent, unmet public health issue that affects Asian Americans disproportionately. Of the estimated 1.2 million living with chronic hepatitis B in USA, more than 50% are of Asian ethnicity, despite the fact that Asian Americans constitute less than 6% of the total US population. The Centers for Disease Control and Prevention recommends HBV screening of persons who are at high risk for the disease. Yet, large numbers of Asian Americans have not been diagnosed or tested, in large part because of perceived cultural and linguistic barriers. Primary care physicians are at the front line of the US health care system, and are in a position to identify individuals and families at risk. Clinical settings integrated into Asian American communities, where physicians are on staff and wellness care is emphasized, can provide testing for HBV. In this study, the Asian Health Coalition and its community partners conducted HBV screenings and follow-up linkage to care in both clinical and nonclinical settings. The nonclinic settings included health fair events organized by churches and social services agencies, and were able to reach large numbers of individuals. Twice as many Asian Americans were screened in nonclinical settings than in health clinics. Chi-square and independent samples t-test showed that participants from the two settings did not differ in test positivity, sex, insurance status, years of residence in USA, or education. Additionally, the same proportion of individuals found to be infected in the two groups underwent successful linkage to care. Nonclinical settings were as effective as clinical settings in screening for HBV, as well as in making treatment options available to

Use of the Pipeline embolization device for recurrent and residual cerebral aneurysms: a safety and efficacy analysis with short-term follow-up.

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Kühn, Anna Luisa; de Macedo Rodrigues, Katyucia; Lozano, J Diego; Rex, David E; Massari, Francesco; Tamura, Takamitsu; Howk, Mary; Brooks, Christopher; L'Heureux, Jenna; Gounis, Matthew J; Wakhloo, Ajay K; Puri, Ajit S

2017-12-01

Evaluation of the safety and efficacy of the Pipeline embolization device (PED) when used as second-line treatment for recurrent or residual, pretreated ruptured and unruptured intracranial aneurysms (IAs). Retrospective review of our database to include all patients who were treated with a PED for recurrent or residual IAs following surgical clipping or coiling. We evaluated neurological outcome and angiograms at discharge, 6- and 12-months' follow-up and assessed intimal hyperplasia at follow-up. Twenty-four patients met our inclusion criteria. Most IAs were located in the anterior circulation (n=21). No change of preprocedure modified Rankin Scale score was seen at discharge or at any scheduled follow-up. Complete or near-complete aneurysm occlusion on 6- and 12-month angiograms was seen in 94.4% (17/18 cases) and 93.3% (14/15 cases), respectively. Complete or near-complete occlusion was seen in 100% of previously ruptured and 85.7% (6/7 cases) and 83.3% (5/6 cases) of previously unruptured cases at the 6- and 12-months' follow-up, respectively. One case of moderate intimal hyperplasia was observed at 6 months and decreased to mild at the 12-months' follow-up. No difference in device performance was observed among pretreated unruptured or ruptured IAs. Treatment of recurrent or residual IAs with a PED after previous coiling or clipping is feasible and safe. There is no difference in device performance between ruptured or unruptured IAs. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Validation of the Novaco Anger Scale-Provocation Inventory (Danish) With Nonclinical, Clinical, and Offender Samples

DEFF Research Database (Denmark)

Moeller, Stine Bjerrum; Novaco, Raymond; Heinola-Nielsen, Vivian

2015-01-01

Anger has high prevalence in clinical and forensic settings, and it is associated with aggressive behavior and ward atmosphere on psychiatric units. Dysregulated anger is a clinical problem in Danish mental health care systems, but no anger assessment instruments have been validated in Danish...... investigated with samples of 477 nonclinical, 250 clinical, 167 male prisoner, and 64 male forensic participants. Anger prevalence and its relationship with other anger measures, anxiety/depression, and aggression were examined. NAS-PI was found to have high reliability, concurrent validity, and discriminant...

The relation between gender role orientation and fear and anxiety in nonclinic-referred children.

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Muris, Peter; Meesters, Cor; Knoops, Miranda

2005-06-01

This study examined the relation between gender role orientation and fear and anxiety in a sample of nonclinic-referred children (N = 209) ages 10 to 13 years. Children and their parents completed questionnaires assessing children's gender role orientation, toy and activity preferences, and fear and anxiety. Results generally indicated that femininity and a preference for girls' toys and activities were positively associated with fear and anxiety, whereas masculinity and a preference for boys' toys and activities were negatively related to these emotions. Furthermore, gender role orientation accounted for more of the variance in fear and anxiety scores than the child's sex.

Impact of non-clinical community-based promotional campaigns on bowel cancer screening engagement: An integrative literature review.

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Martini, Angelita; Morris, Julia N; Preen, David

2016-10-01

This paper reviewed the relationship between non-clinical, client-oriented promotional campaigns to raise bowel cancer awareness and screening engagement. An integrative literature review using predefined search terms was conducted to summarise the accumulated knowledge. Data was analysed by coding and categorising, then synthesized through development of themes. Eighteen of 116 studies met inclusion criteria. Promotional campaigns had varying impact on screening uptake for bowel cancer. Mass media was found to moderately increase screening, predominately amongst "worried well". Small media used in conjunction with other promotional activities, thus its effect on screening behaviours was unclear. One-on-one education was less effective and less feasible than group education in increasing intention to screen. Financial support was ineffective in increasing screening rates when compared to other promotional activities. Screening engagement increased because of special events and celebrity endorsement. Non-clinical promotional campaigns did impact uptake of bowel cancer screening engagement. However, little is evident on the effect of single types of promotion and most research is based on clinician-directed campaigns. Cancer awareness and screening promotions should be implemented at community and clinical level to maximize effectiveness. Such an approach will ensure promotional activities are targeting consumers, thus strengthening screening engagement. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Mental and somatic health in a non-clinical sample 10 years after a diagnosis of encopresis.

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Hultén, Ib; Jonsson, Jakob; Jonsson, Carl-Otto

2005-12-01

The aim of this study was to assess the relation between the diagnosis of encopresis at 8 and 10 years of age, and mental and somatic health 10 years later. The importance of type of encopresis (primary or secondary) at 8 years was also studied. Subjects were a non-clinical encopretic sample (N=73) and control subjects (N=75) [2]. Seven assessment variables from conscription surveys provided information about mental and somatic health status at 18 years of age. Former encopretics (n=66) did not differ significantly from the controls (n=67) at 18 years of age, although there were consistent, small negative differences. The boys who at 10 years of age had still been encopretic did not differ significantly at 18 years of age from the boys who at 10 years had recovered from encopresis, and the signs indicating the small differences varied. For former primary and secondary encopretic boys, there were two significant differences, the men in the secondary group being more often exempted from conscription than the primary group and the control cases. The results indicate that boys with non-clinical encopresis show only small, if any, mental and somatic disturbances at the beginning of adulthood. Comprehensive investigations of encopretic patients are recommended as important clinical problems, in addition to encopresis, might be present.

Characterization of Pediococcus acidilactici strains isolated from rainbow trout (Oncorhynchus mykiss) feed and larvae: safety, DNA fingerprinting, and bacteriocinogenicity.

Science.gov (United States)

Araújo, Carlos; Muñoz-Atienza, Estefanía; Poeta, Patrícia; Igrejas, Gilberto; Hernández, Pablo E; Herranz, Carmen; Cintas, Luis M

2016-05-03

The use of lactic acid bacteria (LAB) as probiotics constitutes an alternative or complementary strategy to chemotherapy and vaccination for disease control in aquaculture. The objectives of this work were (1) the in vitro safety assessment of 8 Pediococcus acidilactici strains isolated from rainbow trout (Oncorhynchus mykiss, Walbaum) feed and larvae; (2) the evaluation of their genetic relatedness; (3) the study of their antimicrobial/bacteriocin activity against fish pathogens; and (4) the biochemical and genetic characterization of the bacteriocin produced by the strain displaying the greatest antimicrobial activity. Concerning the safety assessment, none of the pediococci showed antibiotic resistance nor produced hemolysin or gelatinase, degraded gastric mucin, or deconjugated bile salts. Four strains (50%) produced tyramine or putrescine, but the corresponding genes were not amplified by PCR. Enterobacterial repetitive intergenic consensus-PCR (ERIC-PCR) fingerprinting allowed clustering of the pediococci into 2 well-defined groups (68% similarity). From the 8 pediococci displaying direct antimicrobial activity against at least 3 out of 9 fish pathogens, 6 strains (75%) were identified as bacteriocin producers. The bacteriocin produced by P. acidilactici L-14 was purified, and mass spectrometry and DNA sequencing revealed its identity to pediocin PA-1 (PedPA-1). Altogether, our results allowed the identification of 4 (50%) putatively safe pediococci, including 2 bacteriocinogenic strains. ERIC-PCR fingerprinting was a valuable tool for genetic profiling of P. acidilactici strains. This work reports for the first time the characterization of a PedPA-1-producing P. acidilactici strain isolated from an aquatic environment (rainbow trout larvae), which shows interesting properties related to its potential use as a probiotic in aquaculture.

Use of animals for toxicology testing is necessary to ensure patient safety in pharmaceutical development.

Science.gov (United States)

Mangipudy, Raja; Burkhardt, John; Kadambi, Vivek J

2014-11-01

There is an active debate in toxicology literature about the utility of animal testing vis-a-vis alternative in vitro paradigms. To provide a balanced perspective and add to this discourse it is important to review the current paradigms, explore pros and cons of alternatives, and provide a vision for the future. The fundamental goal of toxicity testing is to ensure safety in humans. In this article, IQ Consortium DruSafe, while submitting the view that nonclinical testing in animals is an important and critical component of the risk assessment paradigm in developing new drugs, also discusses its views on alternative approaches including a roadmap for what would be required to enhance the utilization of alternative approaches in the safety assessment process. Copyright © 2014 Elsevier Inc. All rights reserved.

Mindfulness Moderates the Relationship Between Disordered Eating Cognitions and Disordered Eating Behaviors in a Non-Clinical College Sample

OpenAIRE

Masuda, Akihiko; Price, Matthew; Latzman, Robert D.

2012-01-01

Psychological flexibility and mindfulness are two related, but distinct, regulation processes that have been shown to be at the core of psychological wellbeing. The current study investigated whether these two processes independently moderated the association between disordered eating cognitions and psychological distress as well as the relation between disordered eating cognitions and disordered eating behaviors. Non-clinical, ethnically diverse college undergraduates completed a web-based s...

Use of tourmaline as a potential petrogenetic indicator in the determination of host magma: CRS, XRD and PED-XRF methods.

Science.gov (United States)

Gullu, Bahattin; Kadioglu, Yusuf Kagan

2017-08-05

Tourmaline defines a group of complex borosilicate forms as accessory mineral in igneous and metamorphic rocks and they act an important role in the interpretation of the chemical composition changes of the composition of the host fluid of the magma. The variety of tourmaline can be identified by using optical microscopy, X-Ray Diffraction (XRD) and by determining its chemical composition through Polarized Energy Dispersive X-Ray Fluorescence (PED-XRF) methods. However, microscopic investigations and XRD analyses are not quite adequate for detailed determination of tourmaline sub-groups. In addition, the use of chemical composition of tourmaline as a strict indicator of geochemical processes might be a misleading method. In this study, variable tourmaline crystals were collected from three different pegmatitic occurrences in Behrekdag, Yozgat and Karakaya granitic bodies of Central Anatolia to identify their chemical properties through Confocal Raman Spectroscopy (CRS), PED-XRF and XRD analyses. The confocal Raman spectrometry of collected tourmalines from the Behrekdag, Yozgat and Karakaya granites are in the compositions of schorl, schorl and elbaite respectively. The dominant compositional groups of these tourmalines are in the form of schorl. Raman shift values of tourmalines revealed four bands centered at almost 1050, 750, 400 and 300cm -1 . The first group of the band arises from SiO stretching, the second from BO stretching and the other two belong to bending modes of OBO and BOAl with symmetrical deformation of SiOSi. The strongest spectra near 360cm -1 should belong to the bonding of AlO. As a result, the confocal Raman studies are more sensitive for identification of tourmaline subgroup compositions and have a quite important in the explaining source of the magma. Copyright © 2017 Elsevier B.V. All rights reserved.

Use of tourmaline as a potential petrogenetic indicator in the determination of host magma: CRS, XRD and PED-XRF methods

Science.gov (United States)

Gullu, Bahattin; Kadioglu, Yusuf Kagan

2017-08-01

Tourmaline defines a group of complex borosilicate forms as accessory mineral in igneous and metamorphic rocks and they act an important role in the interpretation of the chemical composition changes of the composition of the host fluid of the magma. The variety of tourmaline can be identified by using optical microscopy, X-Ray Diffraction (XRD) and by determining its chemical composition through Polarized Energy Dispersive X-Ray Fluorescence (PED-XRF) methods. However, microscopic investigations and XRD analyses are not quite adequate for detailed determination of tourmaline sub-groups. In addition, the use of chemical composition of tourmaline as a strict indicator of geochemical processes might be a misleading method. In this study, variable tourmaline crystals were collected from three different pegmatitic occurrences in Behrekdag, Yozgat and Karakaya granitic bodies of Central Anatolia to identify their chemical properties through Confocal Raman Spectroscopy (CRS), PED-XRF and XRD analyses. The confocal Raman spectrometry of collected tourmalines from the Behrekdag, Yozgat and Karakaya granites are in the compositions of schorl, schorl and elbaite respectively. The dominant compositional groups of these tourmalines are in the form of schorl. Raman shift values of tourmalines revealed four bands centered at almost 1050, 750, 400 and 300 cm- 1. The first group of the band arises from SiO stretching, the second from Bsbnd O stretching and the other two belong to bending modes of Osbnd Bsbnd O and Bsbnd Osbnd Al with symmetrical deformation of Sisbnd Osbnd Si. The strongest spectra near 360 cm- 1 should belong to the bonding of Alsbnd O. As a result, the confocal Raman studies are more sensitive for identification of tourmaline subgroup compositions and have a quite important in the explaining source of the magma.

On “Hearing” Voices and “Seeing” Things: Probing Hallucination Predisposition in a Portuguese Nonclinical Sample with the Launay-Slade Hallucination Scale-Revised

Directory of Open Access Journals (Sweden)

Paula Castiajo

2017-07-01

Full Text Available The experience of hallucinations is a hallmark of psychotic disorders, but they are also present in other psychiatric and medical conditions, and may be reported in nonclinical individuals. Despite the increased number of studies probing the incidence of nonclinical hallucinations, the underlying phenomenological characteristics are still poorly understood. This study aimed to examine the psychometrics proprieties of the Portuguese adaptation of the 16-item Launay-Slade Hallucinations Scale (LSHS, the phenomenological characteristics of nonclinical hallucinatory experiences in a Portuguese sample, and the relationship between clinical symptoms and hallucination predisposition. Three-hundred-and-fifty-four European Portuguese college students completed the LSHS. Of those, 16 participants with high LSHS scores and 14 with low LSHS scores were further screened for clinical symptoms. A three-factor solution for the LSHS Portuguese version proved to be the most adequate. Intrusive or vivid thoughts and sleep-related hallucinations were the most common. Although, fundamentally perceived as positive experiences, all types of hallucinations were described as uncontrollable and dominating. However, the more pleasant they were perceived, the more controllable they were assessed. In addition, hallucination predisposition was associated with increased clinical symptoms. These results corroborate the lower severity of hallucinations in the general population compared to psychotic individuals. Further, they support an association between clinical symptoms and increased vulnerability to hallucinations. Specifically, increased schizotypal tendencies and negative mood (anxiety and depression may be related to increased psychotic risk.

STP Position Paper: Recommended Practices for Sampling and Processing the Nervous System (Brain, Spinal Cord, Nerve, and Eye) during Nonclinical General Toxicity Studies

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The Society of Toxicologic Pathology charged a Nervous System Sampling Working Group with devising recommended practices to routinely screen the central and peripheral nervous systems in Good Laboratory Practice-type nonclinical general toxicity studies. Brains should be trimmed ...

[JUSTIFICATION OF USING EQUIVALENCE OF THE INDICES OF QUALITY, SAFETY, AND EFFICACY IN DEVELOPING BIOANALOGS].

Science.gov (United States)

Niyazov, R R; Goryachev, D V; Gavrishina, E V; Romodanovskii, D P; Dranitsyna, M A

2015-01-01

We describe general principles of demonstrating biosimilarity, as well as selecting the biosimilarity margins. Any change in the structure of a biological molecule can modify its functional activity. Therefore, therapeutic equivalence between a biosimilar product and the corresponding reference product cannot be demonstrated using a single criterion. To demonstrate biosimilarity between two medicinal products, their various characteristics have to be evaluated which may, directly or indirectly, justify that clinically significant differences are absent. Insufficient understanding of 6ritical quality attributes brings a risk for the biosimilar product developer. This will either increase the number of non-clinical and clinical tests and trials needed or will result in awareness that the manufacturing process needs to be improved at the late stages of development, after investing significant resources in the development process. At the same time, the specification of the biological medicinal product cannot solely ensure safety and efficacy thereof. Properly characterized and controlled manufacturing process, which ensures consistency in its attributes not adequately controlled in specifications but influencing safety and efficacy profiles and showing their relevance in non-clinical tests and clinical trials, is an additional quality assurance factor. Justification of all development strategy details, including biosimilarity margins, has to be provided each time when the development process is initiated or when proceeding to the next steps. All problems encountered by the developer have to be resolved in close communication with the regulatory authority. In order to increase the quality of investigation and developer's adherence to good practices, clinical trial results should be published in detail.

Health-related quality of life in young adults in education, employment, or training: development of the Japanese version of Pediatric Quality of Life Inventory (PedsQL) Generic Core Scales Young Adult Version.

Science.gov (United States)

Kaneko, Mei; Sato, Iori; Soejima, Takafumi; Kamibeppu, Kiyoko

2014-09-01

The purpose of the study is to develop a Japanese version of the Pediatric Quality of Life Inventory (PedsQL) Generic Core Scales Young Adult Version (PedsQL-YA-J) and determine the feasibility, reliability, and validity of the scales. Translation equivalence and content validity were verified using back-translation and cognitive debriefing tests. A total of 428 young adults recruited from one university, two vocational schools, or five companies completed questionnaires. We determined questionnaire feasibility, internal consistency, and test-retest reliability; checked concurrent validity against the Center for Epidemiologic Studies Depression Scale (CES-D); determined convergent and discriminant validity with the Medical Outcome Study 36-item Short Form Health Survey (SF-36); described known-groups validity with regard to subjective symptoms, illness or injury requiring regular medical visits, and depression; and verified factorial validity. All scales were internally consistent (Cronbach's coefficient alpha = 0.77-0.86); test-retest reliability was acceptable (intraclass correlation coefficient = 0.57-0.69); and all scales were concurrently valid with depression (Pearson's correlation coefficient = 0.43-0.57). The scales convergent and discriminant validity with the SF-36 and CES-D were acceptable. Evaluation of known-groups validity confirmed that the Physical Functioning scale was sensitive for subjective symptoms, the Emotional Functioning scale for depression, and the Work/School Functioning scale for illness or injury requiring regular medical visits. Exploratory factor analysis found a six-factor structure consistent with the assumed structure (cumulative proportion = 57.0%). The PedsQL-YA-J is suitable for assessing health-related quality of life in young adults in education, employment, or training, and for clinical trials and epidemiological research.

Safety pharmacology — Current and emerging concepts

International Nuclear Information System (INIS)

Hamdam, Junnat; Sethu, Swaminathan; Smith, Trevor; Alfirevic, Ana; Alhaidari, Mohammad; Atkinson, Jeffrey; Ayala, Mimieveshiofuo; Box, Helen; Cross, Michael; Delaunois, Annie; Dermody, Ailsa; Govindappa, Karthik; Guillon, Jean-Michel; Jenkins, Rosalind; Kenna, Gerry; Lemmer, Björn; Meecham, Ken; Olayanju, Adedamola; Pestel, Sabine; Rothfuss, Andreas

2013-01-01

Safety pharmacology (SP) is an essential part of the drug development process that aims to identify and predict adverse effects prior to clinical trials. SP studies are described in the International Conference on Harmonisation (ICH) S7A and S7B guidelines. The core battery and supplemental SP studies evaluate effects of a new chemical entity (NCE) at both anticipated therapeutic and supra-therapeutic exposures on major organ systems, including cardiovascular, central nervous, respiratory, renal and gastrointestinal. This review outlines the current practices and emerging concepts in SP studies including frontloading, parallel assessment of core battery studies, use of non-standard species, biomarkers, and combining toxicology and SP assessments. Integration of the newer approaches to routine SP studies may significantly enhance the scope of SP by refining and providing mechanistic insight to potential adverse effects associated with test compounds. - Highlights: • SP — mandatory non-clinical risk assessments performed during drug development. • SP organ system studies ensure the safety of clinical participants in FiH trials. • Frontloading in SP facilitates lead candidate drug selection. • Emerging trends: integrating SP-Toxicological endpoints; combined core battery tests

Safety pharmacology — Current and emerging concepts

Energy Technology Data Exchange (ETDEWEB)

Hamdam, Junnat; Sethu, Swaminathan; Smith, Trevor; Alfirevic, Ana; Alhaidari, Mohammad [MRC Centre for Drug Safety Science, University of Liverpool (United Kingdom); Atkinson, Jeffrey [Lorraine University Pharmacolor Consultants Nancy PCN (France); Ayala, Mimieveshiofuo; Box, Helen; Cross, Michael [MRC Centre for Drug Safety Science, University of Liverpool (United Kingdom); Delaunois, Annie [UCB Pharma (Belgium); Dermody, Ailsa; Govindappa, Karthik [MRC Centre for Drug Safety Science, University of Liverpool (United Kingdom); Guillon, Jean-Michel [Sanofi-aventis (France); Jenkins, Rosalind [MRC Centre for Drug Safety Science, University of Liverpool (United Kingdom); Kenna, Gerry [Astra-Zeneca (United Kingdom); Lemmer, Björn [Ruprecht-Karls-Universität Heidelberg (Germany); Meecham, Ken [Huntingdon Life Sciences (United Kingdom); Olayanju, Adedamola [MRC Centre for Drug Safety Science, University of Liverpool (United Kingdom); Pestel, Sabine [Boehringer-Ingelheim (Germany); Rothfuss, Andreas [Roche (Switzerland); and others

2013-12-01

Safety pharmacology (SP) is an essential part of the drug development process that aims to identify and predict adverse effects prior to clinical trials. SP studies are described in the International Conference on Harmonisation (ICH) S7A and S7B guidelines. The core battery and supplemental SP studies evaluate effects of a new chemical entity (NCE) at both anticipated therapeutic and supra-therapeutic exposures on major organ systems, including cardiovascular, central nervous, respiratory, renal and gastrointestinal. This review outlines the current practices and emerging concepts in SP studies including frontloading, parallel assessment of core battery studies, use of non-standard species, biomarkers, and combining toxicology and SP assessments. Integration of the newer approaches to routine SP studies may significantly enhance the scope of SP by refining and providing mechanistic insight to potential adverse effects associated with test compounds. - Highlights: • SP — mandatory non-clinical risk assessments performed during drug development. • SP organ system studies ensure the safety of clinical participants in FiH trials. • Frontloading in SP facilitates lead candidate drug selection. • Emerging trends: integrating SP-Toxicological endpoints; combined core battery tests.

Evaluation of the Potential Risk of Drugs to Induce Hepatotoxicity in Human—Relationships between Hepatic Steatosis Observed in Non-Clinical Toxicity Study and Hepatotoxicity in Humans-

Science.gov (United States)

Goda, Keisuke; Kobayashi, Akio; Takahashi, Akemi; Takahashi, Tadakazu; Saito, Kosuke; Maekawa, Keiko; Saito, Yoshiro; Sugai, Shoichiro

2017-01-01

In the development of drugs, we sometimes encounter fatty change of the hepatocytes (steatosis) which is not accompanied by degenerative change in the liver in non-clinical toxicity studies. In this study, we investigated the relationships between fatty change of the hepatocytes noted in non-clinical toxicity studies of compound X, a candidate compound in drug development, and mitochondrial dysfunction in order to estimate the potential risk of the compound to induce drug-induced liver injury (DILI) in humans. We conducted in vivo and in vitro exploratory studies for this purpose. In vivo lipidomics analysis was conducted to investigate the relationships between alteration of the hepatic lipids and mitochondrial dysfunction. In the liver of rats treated with compound X, triglycerides containing long-chain fatty acids, which are the main energy source of the mitochondria, accumulated. Accumulation of these triglycerides was considered to be related to the inhibition of mitochondrial respiration based on the results of in vitro mitochondria toxicity studies. In conclusion, fatty change of the hepatocytes (steatosis) in non-clinical toxicity studies of drug candidates can be regarded as a critical finding for the estimation of their potential risk to induce DILI in humans when the fatty change is induced by mitochondrial dysfunction. PMID:28417920

Afinal, quem é mesmo pedófilo? Who is really pedophile, after all?

Directory of Open Access Journals (Sweden)

Jane Felipe

2006-06-01

Full Text Available O presente artigo busca problematizar alguns dos aspectos pertinentes ao debate contemporâneo em torno das "novas" modalidades de experimentação dos desejos erótico-sexuais, em especial a pedofilia/o pedófilo, discutindo os modos pelos quais tais conceitos vêm sendo re-significados nos últimos anos. A partir do referencial teórico dos Estudos Culturais e dos Estudos de Gênero, numa abordagem pós-estruturalista de análise, pretendo mostrar que, apesar das tentativas de aprisionar/categorizar/ normatizar determinados comportamentos em torno da sexualidade, a partir de campos de conhecimento específicos, estes escorregam, escapam, vazam, nos sentidos que lhes são atribuídos.This article raises questions about some aspects of the contemporary debate concerning the "new" modes of experimenting erotic and sexual desires, especially pedophilia/the pedophile. It discusses the resignification of these concepts over the last years. The starting points are the Cultural Studies and the Gender Studies, in a post-structuralist analysis approach. I intend to show that, despite the attempts of confining/regulating/ categorizing certain behaviors regarding sexuality into specific fields of knowledge, they leak, slip, escape from the meanings attributed to them.

Assessing the relationship between eating disorder psychopathology and autistic traits in a non-clinical adult population.

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Carton, Amelia Myri; Smith, Alastair D

2014-01-01

Previous research demonstrates a genetic and behavioural link between eating disorders and autism spectrum disorders, and a recent study (Coombs et al. in Br J Clin Psychol 50:326-338, 2011) extends this link to typical populations, showing a positive correlation between behaviours in typically developing children. The purpose of the present study was to examine whether this relationship continues beyond development, by studying the link between behaviours in a non-clinical adult population. We examined associations between performance on measures relating to autistic traits and disordered eating. Undergraduate students, equally balanced by gender and by subject studied (i.e. humanity or science), completed three tasks: to measure autistic traits, participants were administered the Embedded Figures Test (EFT) and the Autism-Spectrum Quotient (AQ). Eating disorder symptomatology was measured by the Eating Attitudes Test (Eat-26). Our data revealed a significant positive correlation between scores on the AQ and Eat-26. Multiple linear regressions showed that higher scores on the AQ were particularly associated with higher scores on the Bulimia & Food Preoccupation subscale of the Eat-26. EFT performance was positively related to behaviours associated with autism and eating disorders, although not reliably so. These data support the broader link between autistic traits and disordered eating in the non-clinical population, and demonstrate that it extends into adulthood (a time at which autistic behaviours can decrease). This work carries implications for the development of cognitive therapies for people with eating disorders.

Clinical and non-clinical depressive symptoms and risk of long-term sickness absence among female employees in the Danish eldercare sector

DEFF Research Database (Denmark)

Hjarsbech, PU; Andersen, Rikke Voss; Christensen, Karl Bang

2011-01-01

was stronger for each subsequent group: MDI scores of 5–9: HR=1.07 (95% CI: 0.93–1.24); 10–14: 1.38 (1.15–1.66); 15–19: 1.54 (1.20–1.98); =20: 1.96 (1.45–2.64); clinical depression: 2.32 (1.59–3.38); after adjustment for previous LTSA, age, family status, smoking, leisure time physical activity, BMI......Background: Depression has a high point and life time prevalence and is a major cause of reduced work ability and long-term sickness absence (LTSA). Less is known of the extent to which non-clinical depressive symptoms are related to the risk of LTSA. The aim of this study was to investigate how...... non-clinical and clinical depressive symptoms are prospectively associated to subsequent LTSA. Methods: In a cohort study of 6985 femaleemployees fromthe Danish eldercare sector depressive symptoms were measured by the Major Depression Inventory (MDI) and scores (0–50) were divided into groups of 0...

Specific pathologist responses for Standard for Exchange of Nonclinical Data (SEND).

Science.gov (United States)

Watanabe, Atsushi; Kusuoka, Osamu; Sato, Norihiro; Nakazono, Osamu; Wasko, Michael; Potenta, Daniel; Nakae, Dai; Hatakeyama, Hirofumi; Iwata, Hijiri; Naota, Misaki; Anzai, Takayuki

2017-07-01

The Standard for Exchange of Nonclinical Data (SEND), introduced by the US Food and Drug Administration (FDA), is a scheme for the computerization, electronic application, and screening of preclinical data. Since its establishment, related organizations have been working together to implement SEND. However, it is difficult for individual pharmaceutical companies that often outsource to achieve complete compliance with SEND; hence, the cooperation of contract research organizations (CROs) and SEND Registered Solution Providers (RSPs) is indispensable. In SEND, most data, including those on pathology findings, are converted into controlled terminology (CT), but it is not a simple process to convert findings or levels of severity in the field of pathology, which is a descriptive science. The authors have successfully completed an FDA trial submission for a toxicology test conducted at a CRO and in doing so acquired important knowledge. This article presents a clear picture of such important knowledge from a pathologist's viewpoint.

The PED-t trial protocol: The effect of physical exercise -and dietary therapy compared with cognitive behavior therapy in treatment of bulimia nervosa and binge eating disorder.

Science.gov (United States)

Mathisen, Therese Fostervold; Rosenvinge, Jan H; Pettersen, Gunn; Friborg, Oddgeir; Vrabel, KariAnne; Bratland-Sanda, Solfrid; Svendsen, Mette; Stensrud, Trine; Bakland, Maria; Wynn, Rolf; Sundgot-Borgen, Jorunn

2017-05-12

Sufferers from bulimia nervosa (BN) and binge eating disorder (BED) underestimate the severity risk of their illness and, therefore, postpone seeking professional help for years. Moreover, less than one in five actually seek professional help and only 50% respond to current treatments, such as cognitive behavioral therapy (CBT). The impetus for the present trial is to explore a novel combination treatment approach adapted from physical exercise- and dietary therapy (PED-t). The therapeutic underpinnings of these separate treatment components are well-known, but their combination to treat BN and BED have never been previously tested. The purpose of this paper is to provide the rationale for this new treatment approach and to outline the specific methods and procedures. The PED-t trial uses a prospective randomized controlled design. It allocates women between 18 and 40 years (BMI range 17.5-35.0) to groups consisting of 5-8 members who receive either CBT or PED-t for 16 weeks. Excess participants are allocated to a waiting list control group condition. All participants are assessed at baseline, post-treatment, 6, 12 and 24 months' post-follow-up, respectively, and monitored for changes in biological, psychological and therapy process variables. The primary outcome relates to the ED symptom severity, while secondary outcomes relates to treatment effects on physical health, treatment satisfaction, therapeutic alliance, and cost-effectiveness. We aim to disseminate the results in high-impact journals, preferable open access, and at international conferences. We expect that the new treatment will perform equal to CBT in terms of behavioral and psychological symptoms, but better in terms of reducing somatic symptoms and complications. We also expect that the new treatment will improve physical fitness and thereby, quality of life. Hence, the new treatment will add to the portfolio of evidence-based therapies and thereby provide a good treatment alternative for females

Atypical epidemiology of CTX-M-15 among Enterobacteriaceae from a high diversity of non-clinical niches in Angola.

Science.gov (United States)

Ribeiro, T G; Novais, Â; Peixe, L; Machado, E

2016-05-01

The objective of this study was to investigate the distribution and molecular epidemiology of ESBLs, acquired AmpCs and carbapenemases in Enterobacteriaceae from non-clinical niches in Angola, an under-researched sub-Saharan country. Eighty-one samples were recovered from healthy persons (n = 18), healthy animals (n = 33) and their environments (n = 10) or aquatic settings (n = 20) in south Angola (2013). Samples were plated onto CHROMagar™ Orientation with/without antibiotics. Standard methods were used for bacterial identification, characterization of bla genes, antibiotic susceptibility testing and conjugation assays. Clonal analysis (XbaI-PFGE, MLST and Escherichia coli phylogroups), location of bla and plasmid characterization (S1-PFGE, I-CeuI-PFGE, replicon typing and hybridization) were also performed. ESBLs (almost exclusively CTX-M-15, 98%) were detected in 21% (45/216) of the isolates, recovered from diverse non-clinical niches and belonging to different Enterobacteriaceae species (mainly E. coli). Acquired AmpCs or carbapenemases were not found. The pandemic B2-ST131 E. coli clone was not identified, but some widespread clonal complexes (CCs) from A (CC10 and CC168), B1 (CC156) or D (CC38) phylogroups were detected. blaCTX-M-15 was variably identified on typeable (29%; 100-335 kb; IncFII, IncFIIK6, IncHI2 and IncY) or non-typeable (16%; 70-330 kb) plasmids or on the chromosome (14%), while for 41% of the isolates its specific location was not determined. This study reports, for the first time in Angola, an unexpected high occurrence of CTX-M-15 in diverse non-clinical niches and Enterobacteriaceae species, and uncovers novel plasmid replicons in under-researched geographical regions. The diffusion of blaCTX-M-15 through such a high diversity of genetic backgrounds (clones, typeable/non-typeable plasmids and genetic environments) unveils an extraordinary ability for blaCTX-M-15 acquisition and mobilization favoured by unrecognized

Thinking About One's Feelings: Association Between Alexithymia and Cognitive Styles in a Nonclinical Population.

Science.gov (United States)

Rinaldi, Romina; Radian, Viorica; Rossignol, Mandy; Kandana Arachchige, Kendra G; Lefebvre, Laurent

2017-10-01

Alexithymia is described as a disturbance in the cognitive and affective processing of emotions. Little is known about the cognitive styles associated with this personality trait. In this article, we examine to what extent alexithymia is linked with poorer rational cognitive style. A total of 685 participants from a nonclinical sample completed the Toronto Alexithymia Scale-20 along with self-reported and behavioral measures of cognitive styles. Results suggest that people with a high level of self-reported alexithymia show lower rational abilities. The findings of this study extend previous work on cognitive processes underlying emotional self-regulation impairments in alexithymia, suggesting that these difficulties may be linked to a poorer use of rational process.

Value of preapproval safety data in predicting postapproval hepatic safety and assessing the legitimacy of class warning.

Science.gov (United States)

Lin, Yeong-Liang; Wu, Ya-Chi; Gau, Churn-Shiouh; Lin, Min-Shung

2012-02-01

The objective of this study was to systematically evaluate whether preapproval safety data for nonhepatotoxic drugs and hepatotoxic drugs can be compared to improve preapproval prediction of postapproval hepatic safety and to assess the legitimacy of applying class warnings. Drugs within a therapeutic class that included at least one drug that had been withdrawn from the market because of liver toxicity or had a warning of potential liver toxicity issued by major regulatory agencies, and at least one drug free from such regulatory action, were identified and divided into two groups: drugs with and drugs without regulatory action. Preapproval clinical data [including the elevation rates of alanine aminotransferse (ALT) and withdrawal due to liver toxicity, the number of patients with combined elevation of ALT and bilirubin, and liver failure] and nonclinical data (including chemical structures, metabolic pathways, and other significant findings in animal studies) were compared between the two groups. Six drug classes were assessed in this study: thiazolidinediones, cyclooxygenase-2 inhibitors, fluoroquinolones, catechol-O-methyltransferase (COMT) inhibitors, leukotriene receptor inhibitors, and endothelin receptor antagonists. In two classes (COMT inhibitors and endothelin receptor antagonists), drugs with regulatory action had significantly higher rates of ALT elevation of more than threefold and greater numbers of patients with combined elevation of ALT and bilirubin than drugs without regulatory action. Drugs with regulatory action also had chemical structures or metabolic pathways associated with the toxicity. The legitimacy of class warnings was refuted in all six classes of drugs. Preapproval safety data may help predict postapproval hepatic safety and can be used to assess the legitimacy of applying class warnings.

Which aspects of non-clinical quality of care are most important? Results from WHO's general population surveys of "health systems responsiveness" in 41 countries

NARCIS (Netherlands)

Valentine, Nicole; Darby, Charles; Bonsel, Gouke J.

2008-01-01

Quality of care research has reached some agreement on concepts like structure, process and outcome, and non-clinical versus clinical processes of care. These concepts are commonly explored through surveys measuring patient experiences, yet few surveys have focused on patient, or "user", priorities

2011 Annual Meeting of the Safety Pharmacology Society: an overview.

Science.gov (United States)

Cavero, Icilio

2012-03-01

The keynote address of 2011 Annual Meeting of the Safety Pharmacology Society examined the known and the still to be known on drug-induced nephrotoxicity. The nominee of the Distinguished Service Award Lecture gave an account of his career achievements particularly on the domain of chronically instrumented animals for assessing cardiovascular safety. The value of Safety Pharmacology resides in the benefits delivered to Pharma organizations, regulators, payers and patients. Meticulous due diligence concerning compliance of Safety Pharmacology studies to best practices is an effective means to ensure that equally stringent safety criteria are applied to both in-licensed and in-house compounds. Innovative technologies of great potential for Safety Pharmacology presented at the meeting are organs on chips (lung, heart, intestine) displaying mechanical and biochemical features of native organs, electrical field potential (MEA) or impedance (xCELLigence Cardio) measurements in human induced pluripotent stem cell-derived cardiomyocytes for unveiling cardiac electrophysiological and mechanical liabilities, functional human airway epithelium (MucilAir™) preparations with unique 1-year shelf-life for acute and chronic in vitro evaluation of drug efficacy and toxicity. Custom-designed in silico and in vitro assay platforms defining the receptorome space occupied by chemical entities facilitate, throughout the drug discovery phase, the selection of candidates with optimized safety profile on organ function. These approaches can now be complemented by advanced computational analysis allowing the identification of compounds with receptorome, or clinically adverse effect profiles, similar to those of the drug candidate under scrutiny for extending the safety assessment to potential liability targets not captured by classical approaches. Nonclinical data supporting safety can be quite reassuring for drugs with a discovered signal of risk. However, for marketing authorization

Paediatric ED BiPAP continuous quality improvement programme with patient analysis: 2005-2013.

Science.gov (United States)

Abramo, Thomas; Williams, Abby; Mushtaq, Samaiya; Meredith, Mark; Sepaule, Rawle; Crossman, Kristen; Burney Jones, Cheryl; Godbold, Suzanne; Hu, Zhuopei; Nick, Todd

2017-01-16

In paediatric moderate-to-severe asthmatics, there is significant bronchospasm, airway obstruction, air trapping causing severe hyperinflation with more positive intraplural pressure preventing passive air movement. These effects cause an increased respiratory rate (RR), less airflow and shortened inspiratory breath time. In certain asthmatics, aerosols are ineffective due to their inadequate ventilation. Bilevel positive airway pressure (BiPAP) in acute paediatric asthmatics can be an effective treatment. BiPAP works by unloading fatigued inspiratory muscles, a direct bronchodilation effect, offsetting intrinsic PEEP and recruiting collapsed alveoli that reduces the patient's work of breathing and achieves their total lung capacity quicker. Unfortunately, paediatric emergency department (PED) BiPAP is underused and quality analysis is non-existent. A PED BiPAP Continuous Quality Improvement Program (CQIP) from 2005 to 2013 was evaluated using descriptive analytics for the primary outcomes of usage, safety, BiPAP settings, therapeutics and patient disposition. PED BiPAP CQIP descriptive analytics. Academic PED. 1157 patients. A PED BiPAP CQIP from 2005 to 2013 for the usage, safety, BiPAP settings, therapeutic response parameters and patient disposition was evaluated using descriptive analytics. Safety, usage, compliance, therapeutic response parameters, BiPAP settings and patient disposition. 1157 patients had excellent compliance without complications. Only 6 (0.5%) BiPAP patients were intubated. BiPAP median settings: IPAP 18 (16,20) cm H 2 O range 12-28; EPAP 8 cmH 2 O (8,8) range 6-10; inspiratory-to-expiratory time (I:E) ratio 1.75 (1.5,1.75). Pediatric Asthma Severity score and RR decreased (pimproved therapeutics times, very low intubations and decreased PICU admissions. CQIP analysis demonstrated that using a higher IPAP, low EPAP with longer I:E optimises the patient's BiPAP settings and showed a significant improvement in PAS, RR and tidal volume. Bi

Challenges and strategies to facilitate formulation development of pediatric drug products: Safety qualification of excipients.

Science.gov (United States)

Buckley, Lorrene A; Salunke, Smita; Thompson, Karen; Baer, Gerri; Fegley, Darren; Turner, Mark A

2018-02-05

A public workshop entitled "Challenges and strategies to facilitate formulation development of pediatric drug products" focused on current status and gaps as well as recommendations for risk-based strategies to support the development of pediatric age-appropriate drug products. Representatives from industry, academia, and regulatory agencies discussed the issues within plenary, panel, and case-study breakout sessions. By enabling practical and meaningful discussion between scientists representing the diversity of involved disciplines (formulators, nonclinical scientists, clinicians, and regulators) and geographies (eg, US, EU), the Excipients Safety workshop session was successful in providing specific and key recommendations for defining paths forward. Leveraging orthogonal sources of data (eg. food industry, agro science), collaborative data sharing, and increased awareness of the existing sources such as the Safety and Toxicity of Excipients for Paediatrics (STEP) database will be important to address the gap in excipients knowledge needed for risk assessment. The importance of defining risk-based approaches to safety assessments for excipients vital to pediatric formulations was emphasized, as was the need for meaningful stakeholder (eg, patient, caregiver) engagement. Copyright © 2017 Elsevier B.V. All rights reserved.

Traditional use and safety of herbal medicines

Directory of Open Access Journals (Sweden)

Davyson de L. Moreira

Full Text Available In the European Union, traditional herbal medicines that are regarded as "acceptably safe, albeit not having a recognized level of efficacy" fit into a special category of drugs ("traditional herbal medicine products" for which requirements of non-clinical and clinical studies are less rigorous. A regulation proposal published by the Brazilian National Health Surveillance (Anvisa defines a similar drug category ("traditional phytotherapeutic products" for registration purposes. Regarding herbal medicines, both agencies seem to be lenient regarding proof of efficacy, and consider long-standing folk use as evidence of safety and a waiver of a thorough toxicological evaluation. Nonetheless, several herbal products and constituents with a long history of folk usage are suspected carcinogenic and/or hepatotoxic. Herbal products have also been shown to inhibit and/or induce drug-metabolizing enzymes. Since herbal medicines are often used in conjunction with conventional drugs, kinetic and clinical interactions are a cause for concern. A demonstration of the safety of herbal medicines for registration purposes should include at least in vitroand in vivogenotoxicity assays, long-term rodent carcinogenicity tests (for drugs intended to be continuously used for > 3 months or intermittently for > 6 months, reproductive and developmental toxicity studies (for drugs used by women of childbearing age, and investigation of the effects on drug-metabolizing enzymes.

Interaction between FKBP5 gene and childhood trauma on psychosis, depression and anxiety symptoms in a non-clinical sample.

Science.gov (United States)

de Castro-Catala, Marta; Peña, Elionora; Kwapil, Thomas R; Papiol, Sergi; Sheinbaum, Tamara; Cristóbal-Narváez, Paula; Ballespí, Sergi; Barrantes-Vidal, Neus; Rosa, Araceli

2017-11-01

Childhood trauma has been associated with a heightened risk for presenting clinical and non-clinical psychopathology in adulthood. Genes related with the stress response, such as the FK506 binding protein 51 (FKBP5), are plausible candidates moderating the effects of childhood trauma on the emergence of such symptoms later on. The present study aimed to explore the moderating role of FKBP5 genetic variability on the association of different types of childhood trauma with subclinical psychosis, depression and anxiety in a non-clinical sample. Schizotypy, psychotic-like experiences, depression and anxiety symptoms and childhood trauma were assessed in 808 young adults. Two FKBP5 haplotypic blocks were detected: block 1 (rs3800373 - rs9296158 - rs1360780) and block 2 (rs9470080 - rs4713916). Subjects were classified in two groups according to whether they carried or not the risk haplotype previously described in the literature (block 1: CAT and block 2: TA). Linear regression analyses were used to study (i) the main effects of childhood trauma and FKBP5 haplotype blocks and (ii) their interaction effects on the mentioned forms of psychopathology. All childhood trauma scales, except sexual abuse, were associated with schizotypy, psychotic-like experiences, depression and anxiety symptoms. None of the analysed symptoms was associated with the main effects of FKBP5 genetic variability. However an interaction effect between block 1 and physical abuse was observed on anxiety, with lower scores in CAT carriers. This effect was driven by SNP 1 and 2. Moreover, an interaction effect between block 2 and physical abuse was identified on the variables tapping depressive and anxiety symptoms. Specifically, non-TA carrier subjects who were exposed to physical abuse were found to be at higher risk for depressive and anxiety symptoms. These effects were driven by SNP 5. No interaction effect was observed for the other variables. Our data suggest that exposure to childhood physical

Improved parenting maintained four years following a brief parent training intervention in a non-clinical sample.

Science.gov (United States)

Reedtz, Charlotte; Klest, Sihu

2016-08-24

The aim of the present study is to evaluate whether the effects of a short, six session version of an evidence-based parent training programme (The Incredible Years), delivered in a non-clinical community sample in the northern Norway, are maintained 4 years following the initial intervention. Data were collected primarily from mothers in a randomized controlled trial (N = 117). Children's mean age at 4 year follow-up was 7.5 years. A mixed model analyses of linear change with a time by condition interaction revealed that statistically significant differences were maintained between the parent training and control groups for several outcomes. The parent training group showed a reduction in harsh disciple and an increase of both self-reported positive parenting and parental efficacy when compared to the control group who received services as usual. No significant differences between the two groups were found for child behaviour problems as measured by the ECBI Intensity scale. In addition, mixed model analyses of quadratic change were conducted to test the differences in the trajectory of change over four time points. There were significant differences in the trajectory of change for (1) the ECBI with the parent training group showing an immediate drop in the intensity of problem behaviour and (2) the positive parenting scale showing an immediate steep increase; no other significant differences in trajectory were detected. Families from a non-clinical sample who participated in a brief version of the Incredible Years Basic parent training programme maintained changes in positive parenting, harsh discipline, and parental efficacy 4 years after completion of the intervention. ClinicalTrials. gov NCT02850510 . Retrospectively registered 29 July 2016.

Using resources for scientific-driven pharmacovigilance: from many product safety documents to one product safety master file.

Science.gov (United States)

Furlan, Giovanni

2012-08-01

required by other documents. The author has identified signal detection (intended not only as adverse event disproportionate reporting, but including non-clinical, laboratory, clinical analysis data and literature screening) and characterization as the basis for the preparation of all drug safety documents, which can be viewed as different ways of presenting the results of this activity. Therefore, the author proposes to merge all the aggregate reports required by current regulations into a single document - the Drug Safety Master File. This report should contain all the available information, from any source, regarding the potential and identified risks of a drug. It should be a living document updated and submitted to regulatory authorities on an ongoing basis.

Improving retention and motivation in non-clinical dialysis employees.

Science.gov (United States)

Campbell, Anne

2004-02-01

For no additional expense, little intrusion into the schedule or duties of the day, and no additional personnel to hire, dialysis facilities can make a dramatic impact on the training, motivation, and retention of employees through the use of classes designed specifically for the needs of newly employed non-clinical personnel. In today's world where many are expected to do a task with little or no orientation to the overall values and goals of the organization and how their tasks matter, what other action can accomplish so much for employee motivation and retention for so little time and expense? At DCI Mid-Missouri this program has been successful in retaining many excellent employees over many years and has been part of an ongoing effort to increase employees' interest and commitment to their work and the organization. It has also made them much more aware of treatments, other personnel and most of all, of our patients and their needs. It fulfills the needs of humans to be valued and have meaningful work. It contains costs and helps efficiency and productivity. Most of all, it keeps excellent people on the job and enjoying their work more than they would have. Participants' words when evaluating the most recent series of classes speak for themselves in demonstrating these important benefits that can be achieved easily in dialysis facilities throughout the United States and the world.

Psychometric properties of the Dresden Body Image Questionnaire: A multiple-group confirmatory factor analysis across sex and age in a Dutch non-clinical sample.

Directory of Open Access Journals (Sweden)

Mia Scheffers

Full Text Available Body image has implications for psychosocial functioning and quality of life and its disturbance is reported in a broad range of psychiatric disorders. In view of the lack of instruments in Dutch measuring body image as a broad concept, we set out to make an instrument available that reflects the multidimensional character of this construct by including more dimensions than physical appearance. The Dresden Körperbildfragebogen (DBIQ, Dresden Body Image Questionnaire particularly served this purpose. The DBIQ consists of 35 items and five subscales: body acceptance, sexual fulfillment, physical contact, vitality, and self-aggrandizement. The main objective of the present study was to evaluate the psychometric properties of the Dutch translation of the Dresden Body Image Questionnaire (DBIQ-NL in a non-clinical sample.The psychometric properties of the DBIQ-NL were examined in a non-clinical sample of 988 respondents aged between 18 and 65. We investigated the subscales' internal consistency and test-retest reliability. In order to establish construct validity we evaluated the association with a related construct, body cathexis, and with indices of self-esteem and psychological wellbeing. The factor structure of the DBIQ-NL was examined via confirmatory factor analysis (CFA. The equivalence of the measurement model across sex and age was evaluated by multiplegroup confirmatory factor analyses.Confirmatory factor analyses showed a structure in accordance with the original scale, where model fit was improved significantly by moving one item to another subscale. Multiple group confirmatory factor analysis across sex and age demonstrated partial strong invariance. Internal consistency was good with little overlap between the subscales. Temporal reliability and construct validity were satisfactory.Results indicate that the DBIQ-NL is a reliable and valid instrument for non-clinical subjects. This provides a sound basis for further investigation of the

Psychometric properties of the Dresden Body Image Questionnaire: A multiple-group confirmatory factor analysis across sex and age in a Dutch non-clinical sample.

Science.gov (United States)

Scheffers, Mia; van Duijn, Marijtje A J; Bosscher, Ruud J; Wiersma, Durk; Schoevers, Robert A; van Busschbach, Jooske T

2017-01-01

Body image has implications for psychosocial functioning and quality of life and its disturbance is reported in a broad range of psychiatric disorders. In view of the lack of instruments in Dutch measuring body image as a broad concept, we set out to make an instrument available that reflects the multidimensional character of this construct by including more dimensions than physical appearance. The Dresden Körperbildfragebogen (DBIQ, Dresden Body Image Questionnaire) particularly served this purpose. The DBIQ consists of 35 items and five subscales: body acceptance, sexual fulfillment, physical contact, vitality, and self-aggrandizement. The main objective of the present study was to evaluate the psychometric properties of the Dutch translation of the Dresden Body Image Questionnaire (DBIQ-NL) in a non-clinical sample. The psychometric properties of the DBIQ-NL were examined in a non-clinical sample of 988 respondents aged between 18 and 65. We investigated the subscales' internal consistency and test-retest reliability. In order to establish construct validity we evaluated the association with a related construct, body cathexis, and with indices of self-esteem and psychological wellbeing. The factor structure of the DBIQ-NL was examined via confirmatory factor analysis (CFA). The equivalence of the measurement model across sex and age was evaluated by multiplegroup confirmatory factor analyses. Confirmatory factor analyses showed a structure in accordance with the original scale, where model fit was improved significantly by moving one item to another subscale. Multiple group confirmatory factor analysis across sex and age demonstrated partial strong invariance. Internal consistency was good with little overlap between the subscales. Temporal reliability and construct validity were satisfactory. Results indicate that the DBIQ-NL is a reliable and valid instrument for non-clinical subjects. This provides a sound basis for further investigation of the DBIQ-NL in a

The Italian Version of the Inventory of Interpersonal Problems (IIP-32): Psychometric Properties and Factor Structure in Clinical and Non-clinical Groups.

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Lo Coco, Gianluca; Mannino, Giuseppe; Salerno, Laura; Oieni, Veronica; Di Fratello, Carla; Profita, Gabriele; Gullo, Salvatore

2018-01-01

All versions of the Inventory of Interpersonal Problems (IIP) are broadly used to measure people's interpersonal functioning. The aims of the current study are: (a) to examine the psychometric properties and factor structure of the Italian version of the Inventory of Interpersonal Problems-short version (IIP-32); and (b) to evaluate its associations with core symptoms of different eating disorders. One thousand two hundred and twenty three participants ( n = 623 non-clinical and n = 600 clinical participants with eating disorders and obesity) filled out the Inventory of Interpersonal Problems-short version (IIP-32) along with measures of self-esteem (Rosenberg Self-Esteem Scale, RSES), psychological functioning (Outcome Questionnaire, OQ-45), and eating disorders (Eating Disorder Inventory, EDI-3). The present study examined the eight-factor structure of the IIP-32 with Confirmatory Factor Analysis (CFA) and Exploratory Structural Equation Modeling (ESEM). ESEM was also used to test the measurement invariance of the IIP-32 across clinical and non-clinical groups. It was found that CFA had unsatisfactory model fit, whereas the corresponding ESEM solution provided a better fit to the observed data. However, six target factor loadings tend to be modest, and ten items showed cross-loadings higher than 0.30. The configural and metric invariance as well as the scalar and partial strict invariance of the IIP-32 were supported across clinical and non-clinical groups. The internal consistency of the IIP-32 was acceptable and the construct validity was confirmed by significant correlations between IIP-32, RSES, and OQ-45. Furthermore, overall interpersonal difficulties were consistently associated with core eating disorder symptoms, whereas interpersonal styles that reflect the inability to form close relationships, social awkwardness, the inability to be assertive, and a tendency to self-sacrificing were positively associated with general psychological maladjustment

The Italian Version of the Inventory of Interpersonal Problems (IIP-32: Psychometric Properties and Factor Structure in Clinical and Non-clinical Groups

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Gianluca Lo Coco

2018-03-01

Full Text Available All versions of the Inventory of Interpersonal Problems (IIP are broadly used to measure people's interpersonal functioning. The aims of the current study are: (a to examine the psychometric properties and factor structure of the Italian version of the Inventory of Interpersonal Problems—short version (IIP-32; and (b to evaluate its associations with core symptoms of different eating disorders. One thousand two hundred and twenty three participants (n = 623 non-clinical and n = 600 clinical participants with eating disorders and obesity filled out the Inventory of Interpersonal Problems—short version (IIP-32 along with measures of self-esteem (Rosenberg Self-Esteem Scale, RSES, psychological functioning (Outcome Questionnaire, OQ-45, and eating disorders (Eating Disorder Inventory, EDI-3. The present study examined the eight-factor structure of the IIP-32 with Confirmatory Factor Analysis (CFA and Exploratory Structural Equation Modeling (ESEM. ESEM was also used to test the measurement invariance of the IIP-32 across clinical and non-clinical groups. It was found that CFA had unsatisfactory model fit, whereas the corresponding ESEM solution provided a better fit to the observed data. However, six target factor loadings tend to be modest, and ten items showed cross-loadings higher than 0.30. The configural and metric invariance as well as the scalar and partial strict invariance of the IIP-32 were supported across clinical and non-clinical groups. The internal consistency of the IIP-32 was acceptable and the construct validity was confirmed by significant correlations between IIP-32, RSES, and OQ-45. Furthermore, overall interpersonal difficulties were consistently associated with core eating disorder symptoms, whereas interpersonal styles that reflect the inability to form close relationships, social awkwardness, the inability to be assertive, and a tendency to self-sacrificing were positively associated with general psychological

Inactivated yellow fever 17D vaccine: development and nonclinical safety, immunogenicity and protective activity.

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Monath, Thomas P; Lee, Cynthia K; Julander, Justin G; Brown, Alicja; Beasley, David W; Watts, Douglas M; Hayman, Edward; Guertin, Patrick; Makowiecki, Joseph; Crowell, Joseph; Levesque, Philip; Bowick, Gavin C; Morin, Merribeth; Fowler, Elizabeth; Trent, Dennis W

2010-05-14

In the last 10 years new concerns have arisen about safety of the live, attenuated yellow fever (YF) 17D vaccine, in particular viscerotropic adverse events, which have a case-fatality rate of 64%. A non-replicating cell culture-based vaccine would not cause these adverse events, and potentially could be used in persons with precautions or contraindications to use of the live vaccine, including age 60 years, egg allergy, immune suppression, and pregnancy. We developed a whole virion vaccine from the 17D strain inactivated with beta-propiolactone, and adsorbed to aluminum hydroxide. The inactivated vaccine was highly immunogenic in mice, hamsters, and cynomolgus macaques. After a single dose in hamsters and macaques, neutralizing antibody titers were similar to those elicited by the live 17D vaccine (YF-VAX, Sanofi Pasteur). After two doses of inactivated vaccine, neutralizing antibody titers in hamsters were significantly higher than after a single dose of YF-VAX [geometric mean titer (GMT) 20,480 vs. 1940, respectively (Pvaccine or a single dose of YF-VAX were fully protected against hepatitis, viremia, weight loss and death after challenge with YF virus (Jimenez strain). A clinical trial of the inactivated vaccine (XRX-001) has been initiated. Copyright 2010 Elsevier Ltd. All rights reserved.

Analysis of iron acquisition and storage-related genes in clinical and non-clinical strains of Yersinia enterocolitica biovar 1A.

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Kanaujia, Pawan Kumar; Bajaj, Priyanka; Virdi, Jugsharan Singh

2015-10-01

Possession of mechanisms for iron acquisition and its storage enhances the ability of the bacteria to survive in the iron-limiting environment of the host. In this study, 81 strains of Yersinia enterocolitica biovar 1A isolated from various clinical (n = 51) and non-clinical (n = 30) sources were investigated for the presence of the genes related to iron acquisition and storage. Important genes which were present in more than 85% of the strains included hasA, foxA, bfr, bfd, ftnA, and hmsT as well as the fhuCDB, fepBDGCfesfepA, feoAB, yfuABCD, hemPRSTUV, and hmsHFRS gene clusters. Majority of these genes is being reported for the first time in biovar 1A strains and showed significant homology with genes present in the known pathogenic biovars of Y. enterocolitica. However, no significant difference was observed in the distribution of iron acquisition and storage-related genes among clinical and non-clinical biovar 1A strains. Thus, it may be suggested that the presence of iron acquisition and storage-related genes per se might not be responsible for the supposedly better ability of clinical biovar 1A strains to cause infections in humans. However, in the backdrop of this data, the need to undertake functional studies are highly recommended. © 2015 APMIS. Published by John Wiley & Sons Ltd.

Caracterização físico-química de pedúnculos e castanhas de clones de cajueiro-anão precoce nas condições do norte de Minas Gerais Physical-chemical characterization of precocious dwarf clones cashew nuts and stalks in north of the Minas Gerais State, Brazil

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Marlon Cristian Toledo Pereira

2005-01-01

Full Text Available Entre as fruteiras cultivadas, o cajueiro destaca-se no contexto socioeconômico, pelo alto valor nutritivo e comercial dos seus produtos, cuja produção e industrialização garantem expressivo fluxo de renda, além da geração de milhares de empregos. O objetivo deste trabalho foi avaliar as características físico-químicas dos pedúnculos e das castanhas de clones de cajueiro-anão precoce implantados na Região Norte de Minas Gerais. Foram analisados pedúnculos e castanhas provenientes da Unidade Experimental da Embrapa Negócios Tecnológicos, no município de Nova Porteirinha (MG. Foram utilizados os clones CCP 76, CCP 06, CCP 1001 e CCP 09, correspondendo a quatro tratamentos. O delineamento experimental utilizado foi o inteiramente casualizado com cinco repetições de campo e quatro frutos por parcela foram avaliados. Os pedúnculos foram colhidos em setembro de 2002 e transportados em bandejas de colheita para o laboratório de Fisiologia Pós-colheita da Universidade Estadual de Montes Claros (UNIMONTES, situado no Campus de Janaúba (MG. Foram realizadas avaliações de características físico-químicas, submetidas à análise de variância e ao teste de Tukey. Dentre os materiais avaliados, observaram-se, nos pedúnculos do clone CCP 76, características desejáveis para a comercialização in natura, coloração laranja intenso, formato piriforme, boas características químicas e pedúnculos com firmeza adequada, possibilitando maior conservação pós-colheita. Apesar de boas características químicas, verificou-se no clone CCP 09 pedúnculos de coloração laranja pouco intenso e baixa firmeza. Pedúnculos com maior diâmetro tendem a ser menos firmes em pós-colheita.Among the cultivated fruit trees, cashew is distinguished in social and economic context for the high nutritional and commercial value of its parts, whose production and industrialization guarantee an expressive income flow, besides generating thousands of

Maniobra de movilización del pedículo mesentérico superior

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Alejandro García Gutiérrez

2003-12-01

Full Text Available Se realiza una investigación bibliográfica, con el fin de actualizar la base anátomo-embriológica y los objetivos de la maniobra de movilización del pedículo mesentérico superior en cirugía general y determinar la prioridad en su creación, basados en el análisis de los trabajos originales referidos a esta maniobra. Se concluyó que la prioridad en su empleo correspondió a los autores Petrov y Koundadzé de Rusia, quienes la emplearon para alargar la porción del intestino utilizada en las esofagoplastias, mientras que los autores norteamericanos Cattell y Braasch la realizaron para mejorar el acceso a las porciones 3ª y 4ª del duodeno y al ángulo duodeno-yeyunal, 10 años despuésA bibliographic investigation was made aimed at updating the anatomicoembriological base and the objectives of the mobilizing maneuver of the superior mesenteric pedicle in general surgery and at determining the priority in its creation, based on the analysis of the original papers referring to this maneuver. It was concluded that the priority in its use corresponded to the Russian authors Petrov and Koundadzé, who used it to enlarge the portion of the intestine utilized in the esophagoplasties, whereas the US authors Cattell and Broasch performed it to improve the access to the 3rd and 4th portions of the duodenum and to the duodeno-jejunal angle, 10 years later

Disgust- and anxiety-based emotional reasoning in non-clinical fear of vomiting.

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Verwoerd, Johan; van Hout, Wiljo J P J; de Jong, Peter J

2016-03-01

Emotional reasoning has been described as a dysfunctional tendency to use subjective responses to make erroneous inferences about threatening outcomes in objectively safe situations (e.g., "If I feel anxious/disgusted, there must be danger/risk of becoming ill"). Prior studies found evidence for anxiety-based emotional reasoning (ER) in several anxiety disorders as well as disgust-based ER in healthy individuals scoring above the clinical cut-off on a measure of contamination fear. The current study tested whether disgust- and anxiety-based ER might be involved in fear of vomiting, a phobic disorder in which both fear/anxiety and disgust are assumed to play an important role. Non-clinical participants scoring high (>75%; n = 35) and low (emotions revealed that more pronounced ER in the high vomit fearful group was mainly driven by the emotion of disgust. Current study asked participants to imagine experienced emotions in scenarios instead of experimentally inducing real-life emotions. These findings are consistent with the view that disgust-based ER is involved in fear of vomiting. Copyright © 2015 Elsevier Ltd. All rights reserved.

Safety of ephedra: lessons learned.

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Soni, Madhusudan G; Carabin, Ioana G; Griffiths, James C; Burdock, George A

2004-04-15

The safe use of ephedra represents the best possible outcome of a convergence of variables, some with troubling potential outcomes. Commercially used ephedra and its products is prepared from Ephedra spp. and as such is subject to a variety of influences (including differences in species and strain; growth, harvest and storage conditions) all of which may influence the content of constituents (which may, in turn, affect the absorption, distribution, and metabolism of active constituents) and taken together, influences the net pharmacological effect. Further, as a natural substance with an easily perceived and desirable (i.e. weight-loss) pharmacological effect, ephedra is also susceptible to a variety of adulterants, both economic and efficacious. All of the foregoing represent potential for misadventure before ephedra even reaches the consumer. The consumer introduces a constellation of variables as well, including, but not limited to, acute and chronic diseases, inborn errors in metabolism, simultaneous use of prescription and over-the-counter drugs, dietary supplements, alcohol, illicit substances and certain foods (e.g. chocolate, caffeinated drinks), all or some of which may exert synergistic, additive or even antagonistic influences on the desired physiologic outcome. The foregoing not withstanding, the majority of the published nonclinical and clinical studies, and history of use, support the safety of ephedra at the proposed use levels. However, the reports of adverse events submitted to FDA raise concern about the risk associated with ephedra without establishing a direct causal relationship. Given the foregoing, how best can a decision on safety be made? Should the question actually be "can ephedra be as toxic as reported?"

Regulatory aspects of oncology drug safety evaluation: Past practice, current issues, and the challenge of new drugs

International Nuclear Information System (INIS)

Rosenfeldt, Hans; Kropp, Timothy; Benson, Kimberly; Ricci, M. Stacey; McGuinn, W. David; Verbois, S. Leigh

2010-01-01

The drug development of new anti-cancer agents is streamlined in response to the urgency of bringing effective drugs to market for patients with limited life expectancy. FDA's regulation of oncology drugs has evolved from the practices set forth in Arnold Lehman's seminal work published in the 1950s through the current drafting of a new International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) safety guidance for anti-cancer drug nonclinical evaluations. The ICH combines the efforts of the regulatory authorities of Europe, Japan, and the United States and the pharmaceutical industry from these three regions to streamline the scientific and technical aspects of drug development. The recent development of new oncology drug classes with novel mechanisms of action has improved survival rates for some cancers but also brings new challenges for safety evaluation. Here we present the legacy of Lehman and colleagues in the context of past and present oncology drug development practices and focus on some of the current issues at the center of an evolving harmonization process that will generate a new safety guidance for oncology drugs, ICH S9. The purpose of this new guidance will be to facilitate oncology drug development on a global scale by standardizing regional safety requirements.

The co-occurrence of autistic traits and borderline personality disorder traits is associated to increased suicidal ideation in nonclinical young adults.

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Chabrol, Henri; Raynal, Patrick

2018-04-01

The co-occurrence of Autism Spectrum Disorder (ASD) and Borderline Personality Disorder (BPD) is not rare and has been linked to increased suicidality. Despite this significant comorbidity between ASD and BPD, no study had examined the co-occurrence of autistic traits and borderline personality disorder traits in the general population. The aim of the present study was to examine the co-occurrence of autistic and borderline traits in a non-clinical sample of young adults and its influence on the levels of suicidal ideation and depressive symptomatology. Participants were 474 college students who completed self-report questionnaires. Data were analysed using correlation and cluster analyses. Borderline personality traits and autistic traits were weakly correlated. However, cluster analysis yielded four groups: a low traits group, a borderline traits group, an autistic traits group, and a group characterized by high levels of both traits. Cluster analysis revealed that autistic and borderline traits can co-occur in a significant proportion of young adults. The high autistic and borderline traits group constituted 17% of the total sample and had higher level of suicidal ideation than the borderline traits group, despite similar levels of depressive symptoms. This result suggests that the higher suicidality observed in patients with comorbid ASD and BPD may extent to non-clinical individuals with high levels of co-occurrent autistic and borderline traits. Copyright © 2018 Elsevier Inc. All rights reserved.

Validation of the Marijuana Effect Expectancies Questionnaire (MEEQ in a Non-Clinical French-Speaking Adolescent Sample

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Emilie Schmits

2016-02-01

Full Text Available Teenagers commonly use cannabis. Expectancies related to the effects of cannabis play an important role in its consumption and are frequently measured with the Marijuana Effect Expectancies Questionnaire (MEEQ. This study aims to assess the psychometric properties (factor structure, internal consistency reliability, criterion validity of the French MEEQ. A sample of 1,343 non-clinical teenagers (14–18 years were recruited to answer a self-report questionnaire; 877 of them responded twice (one-year interval. A four-factor structure was obtained: Cognitive Impairment and Negative, Relaxation and Social Facilitation, Perceptual Enhancement and Craving and Negative Behavioral Effect Expectancies. It is concluded that the French MEEQ constitutes an appropriate tool to measure cannabis effect expectancies among adolescents.

Fast nonclinical ventricular tachycardia inducible after ablation in patients with structural heart disease: Definition and clinical implications.

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Watanabe, Masaya; de Riva, Marta; Piers, Sebastiaan R D; Dekkers, Olaf M; Ebert, Micaela; Venlet, Jeroen; Trines, Serge A; Schalij, Martin J; Pijnappels, Daniël A; Zeppenfeld, Katja

2018-01-08

Noninducibility of ventricular tachycardia (VT) with an equal or longer cycle length (CL) than that of the clinical VT is considered the minimum ablation endpoint in patients with structural heart disease. Because their clinical relevance remains unclear, fast nonclinical VTs are often not targeted. However, an accepted definition for fast VT is lacking. The shortest possible CL of a monomorphic reentrant VT is determined by the ventricular refractory period (VRP). The purpose of this study was to propose a patient-specific definition for fast VT based on the individual VRP (fVT VRP ) and assess the prognostic significance of persistent inducibility after ablation of fVT VRP for VT recurrence. Of 191 patients with previous myocardial infarction or with nonischemic cardiomyopathy undergoing VT ablation, 70 (age 63 ± 13 years; 64% ischemic) remained inducible for a nonclinical VT and composed the study population. FVT VRP was defined as any VT with CL ≤VRP 400 + 30 ms. Patients were followed for VT recurrence. After ablation, 30 patients (43%) remained inducible exclusively for fVT VRP and 40 (57%) for any slower VT. Patients with only fVT VRP had 3-year VT-free survival of 64% (95% confidence interval [CI] 46%-82%) compared to 27% (95% CI 14%-48%) for patients with any slower remaining VT (P = .013). Inducibility of only fVT VRP was independently associated with lower VT recurrence (hazard ratio 0.38; 95% CI 0.19-0.86; P = .019). Among 36 patients inducible for any fVT VRP , only 1 had recurrence with fVT VRP . In patients with structural heart disease, inducibility of exclusively fVT VRP after ablation is associated with low VT recurrence. Copyright © 2018 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

Perceived problems with computer gaming and internet use among adolescents: measurement tool for non-clinical survey studies

Science.gov (United States)

2014-01-01

Background Existing instruments for measuring problematic computer and console gaming and internet use are often lengthy and often based on a pathological perspective. The objective was to develop and present a new and short non-clinical measurement tool for perceived problems related to computer use and gaming among adolescents and to study the association between screen time and perceived problems. Methods Cross-sectional school-survey of 11-, 13-, and 15-year old students in thirteen schools in the City of Aarhus, Denmark, participation rate 89%, n = 2100. The main exposure was time spend on weekdays on computer- and console-gaming and internet use for communication and surfing. The outcome measures were three indexes on perceived problems related to computer and console gaming and internet use. Results The three new indexes showed high face validity and acceptable internal consistency. Most schoolchildren with high screen time did not experience problems related to computer use. Still, there was a strong and graded association between time use and perceived problems related to computer gaming, console gaming (only boys) and internet use, odds ratios ranging from 6.90 to 10.23. Conclusion The three new measures of perceived problems related to computer and console gaming and internet use among adolescents are appropriate, reliable and valid for use in non-clinical surveys about young people’s everyday life and behaviour. These new measures do not assess Internet Gaming Disorder as it is listed in the DSM and therefore has no parity with DSM criteria. We found an increasing risk of perceived problems with increasing time spent with gaming and internet use. Nevertheless, most schoolchildren who spent much time with gaming and internet use did not experience problems. PMID:24731270

Qualidade de pedúnculo de cajueiro-anão precoce cultivado sob irrigação e submetido a difrentes sistemas de condução e espaçamento

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DAMASCENO JÚNIOR JOSÉ ADEMIR

2002-01-01

Full Text Available Este trabalho teve com objetivo estudar a influência do espaçamento sobre as características químicas e físico-químicas em pedúnculos de cajueiro-anão precoce (Anacardium occidentale L irrigado. O experimento foi conduzido na Estação Experimental do Vale do Curu, no município de Paraipaba-Ce, ocupando uma área de 1,57 ha. Foram estudados 4 espaçamentos, sendo um convencional (6,0 x 8,0 m e três adensados (4 x 3, 6 x 3 e 8 x 3 m, onde foram aplicadas podas e desbastes. Os pedúnculos para a realização das análises foram colhidos em agosto de 1998 e encaminhados ao Laboratório de Fisiologia e Tecnologia Pós-Colheita da Embrapa Agroindústria Tropical. Para a caracterização química e físico-química, foram analisados: sólidos solúveis totais (SST, açúcares solúveis totais (AST, acidez total titulável (ATT, relação SST/ATT, vitamina C e taninos (poliméricos, dímeros e oligoméricos. Não houve diferença significativa entre os tratamentos com relação às variáveis estudadas, como também os valores encontrados para essas variáveis são semelhantes àqueles encontrados na literatura.

75 FR 45697 - Safety Advisory Notice: Personal Electronic Device Related Distractions

Science.gov (United States)

2010-08-03

... INFORMATION CONTACT: Stuart Streck by telephone at (404) 832-1140 or by e-mail at [email protected] drivers. Operators of vehicles transporting hazardous materials should guard against distraction, including the use of PEDs while operating a vehicle. All CMV drivers transporting hazardous materials should...

Materials specification VGB-R 109 and processing standards. First experiences of a large-scaled power plant for quality control purposes

Energy Technology Data Exchange (ETDEWEB)

Bareiss, J.; Nothdurft, R.; Kurtz, M. [EnBW Kraftwerke AG, Stuttgart (Germany); Helmrich, A.; Hartwig, R. [Alstom Power Systems GmbH, Stuttgart (Germany); Bantle, M. [TUEV SUED Industrie Service GmbH, Filderstadt (Germany)

2009-07-01

New boilers in Europe shall be manufactured by the Manufacturer as contractor of the Customer based on PED (European Pressure Equipment Directive 97/23/EC), applicable as legal Directive since May 2002. According PED, the Manufacturer is equivalent to a legal person, responsible for calculation, design, fabrication at workshop and site, including final inspection and declaration of conformity, independent if work packages are subcontracted by Manufacturer or not. Based on Customer contract, Module G shall be used as process to prove conformity according PED. As principle, PED specifies fundamental safety requirements with main focus for materials, and fabrication. For 600 C / 620 C power plants with advanced steam conditions and considerably improving efficiency, new materials are necessary. For selection of the materials, attention has to be paid to the long term design strength values, the manufacturability of the materials as well as the corrosion and oxidation behaviour. Particularly the correct fabrication according to the state of the art closely linked to new discoveries about material behaviour for semi-finished products as well as for boiler components has to be ensured. These new materials are mainly not covered by PED respectively the harmonized standard EN 12952. For that reason and Customer contract with view on national legal directives which specifies the period of in-service inspection during the operational lifetime of the boiler, additional codes and standards shall be applied for boiler manufacturing. All these requirements shall be specified in the Quality Engineering Documents of Manufacturer. The presentation gives an overview of fundamentals of PED and describes the implementation of the requirements for materials, fabrication and inspections in the Quality Engineering Documents, both in the framework of PED and Customer contract. As part of Design Approval by NoBo according PED Module G, the Quality Engineering Documents are fundamental

Impacto da Implantação do Custo do Pedágio na BR-163 em Relação ao Transporte de Soja do Estado de Mato Grosso

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Osmar Torres

Full Text Available Resumo: Este artigo tem por objetivo a análise da concessão da rodovia BR-163, considerando as possíveis implicações sobre a competitividade no transporte da soja do estado de Mato Grosso. Esta proposição se justifica, sobretudo, porque o pedágio, a priori, representa custo ao transporte rodoviário, qualquer gasto acrescido a ela poderá comprometer a margem de lucro. Esta pesquisa foi subsidiada por revisão bibliográfica e documental, utilizando de pesquisa do tipo descritiva. Buscou-se identificar os principais componentes do custo do transporte rodoviário e o impacto da rodovia concedida na competitividade do setor. Assim, foi feita uma análise comparativa do custo do transporte de soja em rodovias pagas (concedidas e as economias com custos que são inerentes a esta modalidade de transporte, decorrente da ótima condição da pavimentação asfáltica. Para perpetrar essa verificação e contrapor os custos com pedágio, foram elencadas três variáveis, são elas: (i a economia com o combustível, (ii a economia com o custo operacional dos caminhões e (iii a economia que se faz em menor perdas de grãos de soja. O resultado encontrado após a quantificação das variáveis econômicas apontou impacto positivo, com benefícios econômicos para o estado de Mato Grosso.

International guidelines for the in vivo assessment of skin properties in non-clinical settings: Part 2. transepidermal water loss and skin hydration

Science.gov (United States)

du Plessis, Johan; Stefaniak, Aleksandr; Eloff, Fritz; John, Swen; Agner, Tove; Chou, Tzu-Chieh; Nixon, Rosemary; Steiner, Markus; Franken, Anja; Kudla, Irena; Holness, Linn

2015-01-01

Background There is an emerging perspective that it is not sufficient to just assess skin exposure to physical and chemical stressors in workplaces, but that it is also important to assess the condition, i.e. skin barrier function of the exposed skin at the time of exposure. The workplace environment, representing a non-clinical environment, can be highly variable and difficult to control, thereby presenting unique measurement challenges not typically encountered in clinical settings. Methods An expert working group convened a workshop as part of the 5th International Conference on Occupational and Environmental Exposure of Skin to Chemicals (OEESC) to develop basic guidelines and best practices (based on existing clinical guidelines, published data, and own experiences) for the in vivo measurement of transepidermal water loss (TEWL) and skin hydration in non-clinical settings with specific reference to the workplace as a worst-case scenario. Results Key elements of these guidelines are: (i) to minimize or recognize, to the extent feasible, the influences of relevant endogenous-, exogenous-, environmental- and measurement/instrumentation-related factors; (ii) to measure TEWL with a closed-chamber type instrument; (iii) report results as a difference or percent change (rather than absolute values); and (iv) accurately report any notable deviations from this guidelines. Conclusion It is anticipated that these guidelines will promote consistent data reporting, which will facilitate inter-comparison of study results. PMID:23331328

Subjective well-being among Episcopal priests: predictors and comparisons to non-clinical norms.

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Stewart-Sicking, Joseph A

2012-01-01

Few studies of the clergy have examined emotional well-being using normed measures. This study examined subjective well-being among 1,581 non-retired Episcopal priests. Subjective well-being was measured with the Positive and Negative Affect Schedule (Watson, Clark, & Tellegen, 1988) and the Satisfaction with Life Scale (Diener, Emmons, Larsen, & Griffin, 1985). Predictors of subjective well-being were measured with the Dispositional Hope Scale (Snyder et al., 1991) and scales of personal practices, social support, congregational dynamics, fit, and economic satisfaction. Participants reported more positive affect (Hedges's g = 1.19), more negative affect (Hedges's g = 0.61) and more satisfaction with life (Hedges's g = 0.73) than nonclinical norms. Hope agency was the strongest predictor for positive affect and satisfaction with life; stress was the strongest predictor for negative affect and partially mediated the effect of congregational dynamics and fit on this outcome. Results suggest that prevention programs must focus on all aspects of subjective well-being and consider the direct effects of different levels of the ecosystem to be effective.

Reduced Theta-Band Power and Phase Synchrony during Explicit Verbal Memory Tasks in Female, Non-Clinical Individuals with Schizotypal Traits.

Science.gov (United States)

Choi, Jeong Woo; Jang, Kyoung-Mi; Jung, Ki-Young; Kim, Myung-Sun; Kim, Kyung Hwan

2016-01-01

The study of non-clinical individuals with schizotypal traits has been considered to provide a promising endophenotypic approach to understanding schizophrenia, because schizophrenia is highly heterogeneous, and a number of confounding factors may affect neuropsychological performance. Here, we investigated whether deficits in explicit verbal memory in individuals with schizotypal traits are associated with abnormalities in the local and inter-regional synchrony of brain activity. Memory deficits have been recognized as a core problem in schizophrenia, and previous studies have consistently shown explicit verbal memory impairment in schizophrenic patients. However, the mechanism of this impairment has not been fully revealed. Seventeen individuals with schizotypal traits and 17 age-matched, normal controls participated. Multichannel event-related electroencephalograms (EEGs) were recorded while the subjects performed a continuous recognition task. Event-related spectral perturbations (ERSPs) and inter-regional theta-band phase locking values (TPLVs) were investigated to determine the differences in local and global neural synchrony between the two subject groups. Additionally, the connection patterns of the TPLVs were quantitatively analyzed using graph theory measures. An old/new effect was found in the induced theta-band ERSP in both groups. However, the difference between the old and new was larger in normal controls than in schizotypal trait group. The tendency of elevated old/new effect in normal controls was observed in anterior-posterior theta-band phase synchrony as well. Our results suggest that explicit memory deficits observed in schizophrenia patients can also be found in non-clinical individuals with psychometrically defined schizotypal traits.

Functional magnetic resonance imaging study of external source memory and its relation to cognitive insight in non-clinical subjects.

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Buchy, Lisa; Hawco, Colin; Bodnar, Michael; Izadi, Sarah; Dell'Elce, Jennifer; Messina, Katrina; Lepage, Martin

2014-09-01

Previous research has linked cognitive insight (a measure of self-reflectiveness and self-certainty) in psychosis with neurocognitive and neuroanatomical disturbances in the fronto-hippocampal neural network. The authors' goal was to use functional magnetic resonance imaging (fMRI) to investigate the neural correlates of cognitive insight during an external source memory paradigm in non-clinical subjects. At encoding, 24 non-clinical subjects travelled through a virtual city where they came across 20 separate people, each paired with a unique object in a distinct location. fMRI data were then acquired while participants viewed images of the city, and completed source recognition memory judgments of where and with whom objects were seen, which is known to involve prefrontal cortex. Cognitive insight was assessed with the Beck Cognitive Insight Scale. External source memory was associated with neural activity in a widespread network consisting of frontal cortex, including ventrolateral prefrontal cortex (VLPFC), temporal and occipital cortices. Activation in VLPFC correlated with higher self-reflectiveness and activation in midbrain correlated with lower self-certainty during source memory attributions. Neither self-reflectiveness nor self-certainty significantly correlated with source memory accuracy. By means of virtual reality and in the context of an external source memory paradigm, the study identified a preliminary functional neural basis for cognitive insight in the VLPFC in healthy people that accords with our fronto-hippocampal theoretical model as well as recent neuroimaging data in people with psychosis. The results may facilitate the understanding of the role of neural mechanisms in psychotic disorders associated with cognitive insight distortions. © 2014 The Authors. Psychiatry and Clinical Neurosciences © 2014 Japanese Society of Psychiatry and Neurology.

MORPHOMETRY OF THE PEDICLE OF FIRST SACRAL VERTEBRAE AND ITS APPLICATION IN POSTERIOR TRANSPEDICULAR SCREW FIXATION. Morfometría del pedículo de la primera vértebra sacra y su aplicación en la fijación posterior con tornillo transpedicular

Directory of Open Access Journals (Sweden)

Mangala M Pai

2016-03-01

Full Text Available Los objetivos del presente estudio fueron determinar los parámetros anatómicos del pedículo S1 en la población India del sur para comparar los datos con respecto a los géneros masculinos y femeninos. El estudio incluyó 50 sacros secos (25 hombres y 25 mujeres que se obtuvieron en el laboratorio de anatomía de nuestra institución. En el presente estudio se observa que la longitud media del pedículo S1 fue 49.9± 3,6 mm para los hombres y 46.3± 4,8 mm para las mujeres. La altura céfalo-caudal del pedículo S1 fue 27.2±4.0 mm y 23.9±3.7 mm para el varón y la hembra respectivamente. La anchura antero-posterior del pedículo S1 fue 7.5± 1,3 mm, 7.5± 1.7 mm en varones y mujeres, respectivamente. La distancia antero-posterior de S1, desde el promontorio sacro a la apófisis espinosa de S1 fue 52.9± 5.2 mm y 50.4± 6.8 mm en los géneros masculino y femenino respectivamente. El presente estudio demostró que la longitud y la altura de céfalo-caudal eran más altos (p0.05 en varones que en mujeres. Los datos de mujeres y varones con respecto a la anchura antero-posterior y la distancia antero-posterior de S1 no eran estadísticamente diferentes. El presente estudio ha proporcionado datos morfométricos importantes del pedículo de la primera vértebra sacra de la muestra anatómica de la población India del sur. El conocimiento de los diámetros del pedículo de S1 es crucial para la colocación segura de tornillos para la fijación transpedicular posterior. Objectives of the present study were to determine the anatomical parameters of the S1 pedicle in South Indian population and to compare the data, with respect to male and female genders. The stud­­y included 50 dry sacra (25 male and 25 female, which were obtained from the anatomy laboratory of our institution. It is observed in the present study that the mean S1 pedicle length was 49.9± 3.6 mm for male and 46.3± 4.8 mm for the female. The cephalocaudal heights of S1 pedicle

Career planning for the non-clinical workforce - an opportunity to develop a sustainable workforce in primary care.

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Tavabie, Jacqueline A; Simms, Jacqueline M

2017-03-01

Many health and social care systems worldwide have been developing a variety of navigator and signposting roles to help patients negotiate care through increasingly complex systems and multiple provider agencies. This UK project aims to explore, through a combination of job description review and workshops of stakeholders, the common competencies and features of non-clinical roles. The information is collated to develop common job descriptions at four key levels. These form the basis for a career pathway supported by portfolio-based educational programmes, embracing Apprenticeship Training Programmes. The programmes have the potential to support recruitment and retention of an increasingly skilled workforce to move between traditional health and social care provider boundaries. This offers the opportunity to release clinicians from significant administrative workload and support patients in an integrated care system.

Cannabis use and neurocognitive functioning in a non-clinical sample of users.

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Thames, April D; Arbid, Natalie; Sayegh, Philip

2014-05-01

With the recent debates over marijuana legalization and increases in use, it is critical to examine its role in cognition. While many studies generally support the adverse acute effects of cannabis on neurocognition, the non-acute effects remain less clear. The current study used a cross-sectional design to examine relationships between recent and past cannabis use on neurocognitive functioning in a non-clinical adult sample. One hundred and fifty-eight participants were recruited through fliers distributed around local college campuses and the community. All participants completed the Brief Drug Use History Form, the Structured Clinical Interview for DSM-IV Disorders, and neurocognitive assessment, and underwent urine toxicology screening. Participants consisted of recent users (n=68), past users (n=41), and non-users (n=49). Recent users demonstrated significantly (pcannabis use in the last 4 weeks was negatively associated with global neurocognitive performance and all individual cognitive domains. Similarly, amount of daily cannabis use was negatively associated with global neurocognitive performance and individual cognitive domains. Our results support the widespread adverse effects of cannabis use on neurocognitive functioning. Although some of these adverse effects appear to attenuate with abstinence, past users' neurocognitive functioning was consistently lower than non-users. Copyright © 2014 Elsevier Ltd. All rights reserved.

Objectively Measured Baseline Physical Activity Patterns in Women in the mPED Trial: Cluster Analysis.

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Fukuoka, Yoshimi; Zhou, Mo; Vittinghoff, Eric; Haskell, William; Goldberg, Ken; Aswani, Anil

2018-02-01

Determining patterns of physical activity throughout the day could assist in developing more personalized interventions or physical activity guidelines in general and, in particular, for women who are less likely to be physically active than men. The aims of this report are to identify clusters of women based on accelerometer-measured baseline raw metabolic equivalent of task (MET) values and a normalized version of the METs ≥3 data, and to compare sociodemographic and cardiometabolic risks among these identified clusters. A total of 215 women who were enrolled in the Mobile Phone Based Physical Activity Education (mPED) trial and wore an accelerometer for at least 8 hours per day for the 7 days prior to the randomization visit were analyzed. The k-means clustering method and the Lloyd algorithm were used on the data. We used the elbow method to choose the number of clusters, looking at the percentage of variance explained as a function of the number of clusters. The results of the k-means cluster analyses of raw METs revealed three different clusters. The unengaged group (n=102) had the highest depressive symptoms score compared with the afternoon engaged (n=65) and morning engaged (n=48) groups (overall Pcluster groups using a large national dataset. ClinicalTrials.gov NCT01280812; https://clinicaltrials.gov/ct2/show/NCT01280812 (Archived by WebCite at http://www.webcitation.org/6vVyLzwft). ©Yoshimi Fukuoka, Mo Zhou, Eric Vittinghoff, William Haskell, Ken Goldberg, Anil Aswani. Originally published in JMIR Public Health and Surveillance (http://publichealth.jmir.org), 01.02.2018.

Safety and immunotoxicity assessment of immunomodulatory monoclonal antibodies

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Morton, Laura Dill; Spindeldreher, Sebastian; Kiessling, Andrea; Allenspach, Roy; Hey, Adam; Muller, Patrick Y; Frings, Werner; Sims, Jennifer

2010-01-01

Most therapeutic monoclonal antibodies (mAbs) licensed for human use or in clinical development are indicated for treatment of patients with cancer and inflammatory/autoimmune disease and as such, are designed to directly interact with the immune system. A major hurdle for the development and early clinical investigation of many of these immunomodulatory mAbs is their inherent risk for adverse immune-mediated drug reactions in humans such as infusion reactions, cytokine storms, immunosuppression and autoimmunity. A thorough understanding of the immunopharmacology of a mAb in humans and animals is required to both anticipate the clinical risk of adverse immunotoxicological events and to select a safe starting dose for first-in-human (FIH) clinical studies. This review summarizes the most common adverse immunotoxicological events occurring in humans with immunomodulatory mAbs and outlines non-clinical strategies to define their immunopharmacology and assess their immunotoxic potential, as well as reduce the risk of immunotoxicity through rational mAb design. Tests to assess the relative risk of mAb candidates for cytokine release syndrome, innate immune system (dendritic cell) activation and immunogenicity in humans are also described. The importance of selecting a relevant and sensitive toxicity species for human safety assessment in which the immunopharmacology of the mAb is similar to that expected in humans is highlighted, as is the importance of understanding the limitations of the species selected for human safety assessment and supplementation of in vivo safety assessment with appropriate in vitro human assays. A tiered approach to assess effects on immune status, immune function and risk of infection and cancer, governed by the mechanism of action and structural features of the mAb, is described. Finally, the use of immunopharmacology and immunotoxicity data in determining a minimum anticipated biologic effect Level (MABEL) and in the selection of safe human

AdsorÃÃo de Ãons MetÃlicos de Efluente Aquoso Usando BagaÃo do PedÃnculo de Caju: Estudo de Batelada e Coluna de Leito Fixo.

OpenAIRE

Sarah de Abreu Moreira AraÃjo

2008-01-01

O uso de resÃduos agroindustriais puros ou modificados quimicamente para a remoÃÃo de metais em efluentes industriais aparece como uma alternativa promissora Ãs tecnologias existentes. Os agroresÃduos sÃo bastante estudados devido à sua abundÃncia, baixo custo, biodegradabilidade e a nÃo formaÃÃo de lodo. Neste trabalho utilizou-se o bagaÃo do pedÃnculo de caju (Anarcadium occidentale L.) como adsorvente para remoÃÃo de metais pesados de soluÃÃo aquosa e de efluente produzido por uma indÃstri...

Predicting borderline personality disorder features from personality traits, identity orientation, and attachment styles in Italian nonclinical adults: issues of consistency across age ranges.

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Fossati, Andrea; Borroni, Serena; Feeney, Judith; Maffei, Cesare

2012-04-01

The aims of this study were to assess whether Borderline Personality Disorder (BPD) features could be predicted by Big Five traits, impulsivity, identity orientation, and adult attachment patterns in a sample of 1,192 adult nonclinical participants, and to evaluate the consistency of these regression models across four age groups (49 years, and >50 years, respectively). In the full sample, measures of neuroticism (N), impulsivity, and anxious insecure attachment were substantial predictors of BPD features (adjusted R(2) = .38, p personality traits and disturbed attachment patterns.

Mindfulness Moderates the Relationship Between Disordered Eating Cognitions and Disordered Eating Behaviors in a Non-Clinical College Sample.

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Masuda, Akihiko; Price, Matthew; Latzman, Robert D

2012-03-01

Psychological flexibility and mindfulness are two related, but distinct, regulation processes that have been shown to be at the core of psychological wellbeing. The current study investigated whether these two processes independently moderated the association between disordered eating cognitions and psychological distress as well as the relation between disordered eating cognitions and disordered eating behaviors. Non-clinical, ethnically diverse college undergraduates completed a web-based survey. Of 278 participants (nfemale=208; nmale=70) aged 18-24 years old, disordered eating cognitions, mindfulness, and psychological flexibility were related to psychological distress after controlling for gender, ethnicity, and body mass index. Disordered eating cognitions and mindfulness accounted for unique variance in disordered eating behaviors. Finally, mindfulness was found to moderate the association between disordered eating cognitions and disordered eating behaviors.

Progress on channel spark development and application of pulsed electron beam deposition (PED) in the field of medical coating work

International Nuclear Information System (INIS)

Schultheiss, Christoph; Buth, Lothar-H.-O.; Frey, Wolfgang; Bluhm, Hansjoachim; Mayer, Hanns-G.

2002-01-01

A promising source for Pulsed Electron Beam Deposition (PED) is the channel spark. Recent improvements helped to reduce beam instabilities which up to now have limited the life time of the system. The beam power could be increased and because of better beam quality the transport length of the beam is increased from 1 to several centimeters (up to 10 cm). Together with other improvements on the triggering system and beam transport in dielectric tubes, the channel spark approaches industrial standards. An overview of actual applications in research and industry will be presented. An attractive feature of the pulsed electron beam thin film deposition is the conservation of stoichiometry even during deposition of multi-component earth-alkali and alkali glasses. Specially developed glasses like BIOGLAS registered have the ability to anchor soft living tissue at the surface. In form of a bulk material bio active glasses are brittle limiting its applications. Contrary to brittle bulk material a thin layers on medical implants exhibits reliable bio-functionality. Coating of implants with this category of materials is subject of the European INCOMED project (Innovative Coating of Medical Implants with Soft Tissue Anchoring Ability) which just has started

The frequency of Listeria monocytogenes strains recovered from clinical and non-clinical samples using phenotypic methods and confirmed by PCR

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abazar pournajaf

2013-09-01

Full Text Available Background: Listeria monocytogenes is a facultative intracellular pathogen that causes listeriosis which has extensive clinical manifestations. Infections with L. monocytogenes are a serious threat to immunocompromised persons. The aim of this study was to determine the frequency of L. monocytogenes strains recovered from clinical and non-clinical samples using phenotypic methods and confirmed by PCR. Materials and Methods: In this study, 617 specimens were analyzed. All specimens were cultured in the specific PALCAM agar. Colonies were initially identified by routine biochemical tests. Finally, PCR assays using primers specific for inlA gene were performed. Results: In all, 46 (8.2% L. monocytogenes isolates were recovered from 617 specimens. Fourteen (8.2% strains, including 4 (7.5%, 2 (5.7%, 5 (14.2% and 3 (8.5% isolates were obtained from placental tissue, urine, vaginal and rectal swabs, respectively. In addition, 9 (7.4% strains of L. monocytogenes which were isolated from 107 different dairy products originated from cheese 5 (7.1%, cream 2 (10% and kashk 2 (11.7%, respectively. Among 11 (5.2% strains isolated from 210 different meat products, 5 (5.5%, 4 (7.2% and 2 (3% strains belonged to sausage, meat and poultry extracts, respectively. Finally, 12 (9.2% Listeria strains were recovered from 130 animal specimens that included 6 (10%, 4 (8% and 2 (10% strains from goat, sheep and cattle, respectively. Furthermore, all Listeria isolates (100% were found to be carriers of  inlA gene in PCR assay. Conclusion: The present study showed that the clinical and non-clinical specimens were contaminated with L. monocytogenes. So, it seems necessary to use a simple and standard technique such as PCR for rapid detection of this organism from various sources.

Relations among behavioral inhibition, shame- and guilt-proneness, and anxiety disorders symptoms in non-clinical children.

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Muris, Peter; Meesters, Cor; Bouwman, Leanne; Notermans, Sabine

2015-04-01

This study examined relationships between the self-conscious emotions of shame and guilt, behavioral inhibition (as an index of anxiety proneness), and anxiety disorder symptoms in non-clinical children aged 8-13 years (N = 126), using children's self-report data. Results showed that there were positive and significant correlations between shame and guilt, behavioral inhibition, and anxiety disorders symptoms. When controlling for the overlap between shame and guilt, it was found that shame (but not guilt) remained significantly associated with higher levels of anxiety proneness and anxiety symptoms. Further, when controlling for the effect of behavioral inhibition, shame still accounted for a significant proportion of the variance of total anxiety and generalized anxiety scores. For these anxiety problems, support emerged for a model in which shame acted as a partial mediator in the relation between behavioral inhibition and anxiety. These results indicate that the self-conscious emotion of shame is a robust correlate of anxiety pathology in children.

Current concepts on integrative safety assessment of active substances of botanical, mineral or chemical origin in homeopathic medicinal products within the European regulatory framework.

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Buchholzer, Marie-Luise; Werner, Christine; Knoess, Werner

2014-03-01

For active substances of botanical, mineral or chemical origin processed in homeopathic medicinal products for human use, the adequate safety principles as with other human medicinal products are applied in line with the European regulatory framework. In homeopathy, nonclinical safety assessment is facing a particular challenge because of a multitude and diversity of source materials used and due to rarely available toxicological data. Thus, current concepts applied by the national regulatory authority in Germany (BfArM) on integrative safety assessment of raw materials used in homeopathic medicinal products involve several evaluation approaches like the use of the Lowest Human Recommended Dose (LHRD), toxicological limit values, Threshold of Toxicological Concern (TTC), data from food regulation or the consideration of unavoidable environmental or dietary background exposure. This publication is intended to further develop and clarify the practical use of these assessment routes by exemplary application on selected homeopathic preparations. In conclusion, the different approaches are considered a very useful scientific and simultaneously pragmatic procedure in differentiated risk assessment of homeopathic medicinal products. Overall, this paper aims to increase the visibility of the safety issues in homeopathy and to stimulate scientific discussion of worldwide existing regulatory concepts on homeopathic medicinal products. Copyright © 2014 Elsevier Inc. All rights reserved.

Associations between cognitive biases and domains of schizotypy in a non-clinical sample.

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Aldebot Sacks, Stephanie; Weisman de Mamani, Amy Gina; Garcia, Cristina Phoenix

2012-03-30

Schizotypy is a non-clinical manifestation of the same underlying biological factors that give rise to psychotic disorders (Claridge and Beech, 1995). Research on normative populations scoring high on schizotypy is valuable because it may help elucidate the predisposition to schizophrenia (Jahshan and Sergi, 2007) and because performance is not confounded by issues present in schizophrenia samples. In the current study, a Confirmatory Factor Analysis was conducted using several comprehensive measures of schizotypy. As expected and replicating prior research, a four-factor model of schizotypy emerged including a positive, a negative, a cognitive disorganization, and an impulsive nonconformity factor. We also evaluated how each factor related to distinct cognitive biases. In support of hypotheses, increased self-certainty, decreased theory of mind, and decreased source memory were associated with higher scores on the positive factor; decreased theory of mind was associated with higher scores on the negative factor; and increased self-certainty was associated with greater impulsive nonconformity. Unexpectedly, decreased self-certainty and increased theory of mind were associated with greater cognitive disorganization, and decreased source memory was associated with greater impulsive nonconformity. These findings offer new insights by highlighting cognitive biases that may be risk factors for psychosis. Published by Elsevier Ireland Ltd.

Adverse Health Consequences of Performance-Enhancing Drugs: An Endocrine Society Scientific Statement

Science.gov (United States)

Pope, Harrison G.; Wood, Ruth I.; Rogol, Alan; Nyberg, Fred; Bowers, Larry

2014-01-01

Despite the high prevalence of performance-enhancing drug (PED) use, media attention has focused almost entirely on PED use by elite athletes to illicitly gain a competitive advantage in sports, and not on the health risks of PEDs. There is a widespread misperception that PED use is safe or that adverse effects are manageable. In reality, the vast majority of PED users are not athletes but rather nonathlete weightlifters, and the adverse health effects of PED use are greatly underappreciated. This scientific statement synthesizes available information on the medical consequences of PED use, identifies gaps in knowledge, and aims to focus the attention of the medical community and policymakers on PED use as an important public health problem. PED users frequently consume highly supraphysiologic doses of PEDs, combine them with other PEDs and/or other classical drugs of abuse, and display additional associated risk factors. PED use has been linked to an increased risk of death and a wide variety of cardiovascular, psychiatric, metabolic, endocrine, neurologic, infectious, hepatic, renal, and musculoskeletal disorders. Because randomized trials cannot ethically duplicate the large doses of PEDs and the many factors associated with PED use, we need observational studies to collect valid outcome data on the health risks associated with PEDs. In addition, we need studies regarding the prevalence of PED use, the mechanisms by which PEDs exert their adverse health effects, and the interactive effects of PEDs with sports injuries and other high-risk behaviors. We also need randomized trials to assess therapeutic interventions for treating the adverse effects of PEDs, such as the anabolic-androgen steroid withdrawal syndrome. Finally, we need to raise public awareness of the serious health consequences of PEDs. PMID:24423981

Toxicology and Biodistribution: The Clinical Value of Animal Biodistribution Studies

Directory of Open Access Journals (Sweden)

Beatriz Silva Lima

2018-03-01

Full Text Available Since the human genome decoding, understanding and identification of genetic disturbances behind many diseases, including cancer, are intensively increasing. Scientific and technological advances in this area trigger the search for therapeutic (curative approaches targeting the correction of gene disturbances. Gene therapy medicinal products (GTMPs emerge in this context, bringing new challenges for their characterization. Compared to small molecules, biodistribution is fundamental to identifying target organs and anticipating safety and efficacy, may be integrated into safety and pharmacology studies, and may eventually be anticipated based on specificities of vectors and constructs. This review describes and discusses the requirements for nonclinical development and evaluation of GTMPs versus conventional ones and the needs and challenges of constructing nonclinical packages that assure GTMPs’ human safety from early development, taking into consideration usefulness and/or limitations of many conventional, preclinical models. The experience gained in the European context is referenced.

Factorial structure of the German version of the dimensional assessment of personality pathology-basic questionnaire in clinical and nonclinical samples.

Science.gov (United States)

Pukrop, R; Gentil, I; Steinbring, I; Steinmeyer, E

2001-10-01

The Dimensional Assessment of Personality Pathology-Basic Questionnaire (DAPP-BQ) assesses 18 traits to provide a systematic representation of the overall domain of personality disorders. We tested the cross-cultural stability of the prediction that four higher-order factors (Emotional Dysregulation, Dissocial Behavior, Inhibitedness, and Compulsivity) underlie the 18 basic traits. A total of 81 patients who were primarily treated for an Axis II personality disorder and N = 166 healthy control patients completed the German version of the DAPP-BQ. Results clearly confirmed cross-cultural stability of the postulated four-factor structure in both samples, accounting for 74.7% (clinical sample), and 65.7% (nonclinical sample) of the total variance. All four higher-order factors showed specific correlational relationships with dimensional assessments of DSM-IV personality disorders.

Validation of the Portuguese version of the Brief Multidimensional Measure of Religiousness/Spirituality (BMMRS-P) in clinical and non-clinical samples.

Science.gov (United States)

Curcio, Cristiane Schumann Silva; Lucchetti, Giancarlo; Moreira-Almeida, Alexander

2015-04-01

Despite Brazil's high levels of religious involvement, there is a scarcity of validated religiousness/spirituality (R/S) measures in Portuguese, particularly multidimensional ones. This study presents the validation of the Portuguese version of the "Brief Multidimensional Measure in Religiousness and Spirituality" (BMMRS) within the Brazilian context. Inpatients (262) and caregivers (389) at two hospitals of Brazil answered the BMMRS, the DUREL-p, and a sociodemographic questionnaire. The internal and convergent validity and test-retest reliability for major dimensions were good. Discriminant validity was high (except for the Forgiveness dimension). The Portuguese version of the BMMRS is a reliable and valid instrument to assess multiple R/S dimensions in clinical and non-clinical samples.

Report of the consultants' meeting on radioimmunometric assays for non-clinical applications

International Nuclear Information System (INIS)

2000-01-01

A meeting between three experts and various Agency staff with specific areas of expertise was convened to review present status of radiolabelled immunoassays i.e. radioimmunoassay (RIA) and immunradiometric assay (IRMA) and their relevance to non- clinical applications. For many years, the Agency has been active in supporting the devolution of RIA and IRMA expertise in clinical applications, particularly in the field of thyroid disease and its management. The Agency's strategy was based on a perceived need to reduce the high cost of imported reagents and the poor working practices that this encouraged. This has been achieved through the use of bulk reagents (rather than 'kits') and the transfer of existing technology. The success of the Agency's approach is evident from the high degree of self- sufficiency now available in many developing countries. In recent years, the increasing workload for clinical analyses has necessitated an increase in automation, which in turn has required a change to more non-isotopic alternatives. This change seen in the more developed countries, and beginning to be introduced elsewhere, is likely lo continue. However, RIA/IRMA will continue to be used in many parts of the world for some time to come. In recent years there has been an increasing interest in the use of immunoassay technology in non-clinical applications, e.g., environmental monitoring, quality control in food production and livestock management. RIA and IRMA continue to play a major role in research

Restrição veicular e tributação: o pedágio urbano enquanto solução urbanística e espécie tributária Vehicular restriction and taxation: the congestion charges as urban solution and kind tax

Directory of Open Access Journals (Sweden)

Nicole da Silva Paulitsch

2010-11-01

Full Text Available A grande quantidade de automóveis, principalmente nas grandes e médias cidades, tem gerado transtornosno trânsito: grandes congestionamentos, dificuldades para encontrar estacionamentos, acidentes, conflitoscom pedestres (e com outros meios de transporte não motorizados, aumento do consumo de combustíveisfósseis e da emissão de gases poluentes. Buscar solucionar esses transtornos é uma atividade que temdesafiado profissionais ligados à gestão urbana em vários países. Nesse contexto, este trabalho apresentaalgumas iniciativas que buscam a solução desse cenário caótico, enfatizando a restrição veicular, por meiode pedágio urbano, já implantado com resultados satisfatórios em Singapura e Londres; e cogitado paraimplantação em outros locais, como o caso da cidade de São Paulo. Após isso, apresenta uma análise danatureza jurídica do pedágio, controversa quanto sua espécie tributária na legislação brasileira. Esse entendimento é importante para uso desse instrumento de restrição veicular nas propostas de planejamentourbano e gestão do trânsito e das cidades.

Bioactive compounds and total antioxidant capacity of cashew apples (Anacardium occidentale L. during the ripening of early dwarf cashew clones Compostos bioativos e atividade antioxidante total de pedúnculos de caju (Anacardium occidentale L. durante o amadurecimento de clones de cajueiro anão-precoce

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Mônica Maria de Almeida Lopes

2012-06-01

Full Text Available Lately, tropical fruit consumption has increased due to a higher knowledge of its nutritional and therapeutic value. The aim of this work was to evaluate the antioxidant potential of cashew apples from different early dwarf clones during their ripening. The clones analyzed included: CCP 76, CCP 09, BRS 189 and BRS 265 in seven ripening stages. They were analyzed for vitamin C, total carotenoid, total anthocyanin, yellow flavonoids and polyphenol content and total antioxidant capacity. Clone BRS 265 ripe cashew apple presented the highest vitamin C content (279.37 mg x 100 g-1. The ripe BRS 189 cashew apple is colored bright red, and its total anthocyanin content was the highest (21.16 mg x 100 g-1. The yellow flavonoids content was higher for ripe CCP 76 and BRS 189 cashew apples with 56.32 and 50.75 mg x 100 g-1, respectively. The highest levels of extrable polyphenols and antioxidant capacity were observed in CCP 09 in the first five ripening stages. The antioxidant activity of cashew apples (Anacardium occidentale L. is mainly attributed to polyphenol content (r = 0.90; p Ultimamente, o consumo de frutas tropicais tem aumentado em razão de um maior conhecimento de seu valor nutricional e terapêutico. Neste trabalho, objetivou-se avaliar o potencial antioxidante de pedúnculos de cajus de diferentes clones de cajueiro anão precoce, durante o seu amadurecimento. Os clones analisados foram: CCP 76, CCP 09, BRS 189 e BRS 265, em sete estádios de amadurecimento. Foram analisados para a vitamina C total, antocianinas, carotenóides totais, flavonóides amarelos, teor de polifenóis e capacidade antioxidante total. O clone BRS 265 maduro obteve o maior teor de vitamina C (279,37 mg x 100 g-1. O pedúnculo maduro BRS 189, apresentou o maior conteúdo de antocianinas totais (21,16 mg x 100 g-1. O conteúdo de flavonóides amarelos foi maior para os clones CCP 76 e BRS 189 maduros, com 56,32 e 50,75 mg x 100 g-1, respectivamente. Os maiores teores

A 'Communication and Patient Safety' training programme for all healthcare staff: can it make a difference?

Science.gov (United States)

Lee, Peter; Allen, Kellie; Daly, Michael

2012-01-01

Communication breakdown is a factor contributing to most cases of patient harm, and this harm continues to occur at unacceptable levels. Responding to this evidence, the Metro South District of Queensland Health (Australia) has developed a communication skills training programme titled 'Communication and Patient Safety'. The three modules, each lasting 3½ h, cover both staff-to-patient and staff-to-staff communication issues, and an unusual feature is that clinical and non-clinical staff attend together. Following positive evaluation data from our initial pilot programme (involving 350 staff in a single hospital), the programme was expanded to all five hospitals in the district, and has now been completed by over 3000 staff. The results show that despite the significant time commitment, participants find the courses useful and relevant (Kirkpatrick level 1), they learn and retain new material (level 2), and they report changes in behaviour at individual, team and facility levels (level 3). Although it remains a challenge to obtain quantitative data showing that training such as this directly improves patient safety (level 4), our qualitative and informal feedback indicates that participants and their managers perceive clear improvements in the 'communication culture' after a workplace team has attended the courses. Improving 'communication for safety' in healthcare is a worldwide imperative, and other healthcare jurisdictions should be able to obtain similar results to ours if they develop and support interactive, non-didactic training in communication skills.

The Influence of Emotional Inhibition on Intrusive Thoughts in a Non-Clinical Sample

Directory of Open Access Journals (Sweden)

Zahra Salehzadeh Einabad

2017-06-01

Full Text Available Background Given the studies insisting on the impacts of cultural issues on the emotion regulation strategies in eastern cultures and lack of study on the effects of emotional inhibition in our culture, this research aimed to investigate the influences of emotional inhibition on intrusive thoughts in non-clinical sample. Methods A quasi-experimental design was adopted with 45 participants that were randomly assigned to 2 groups (emotional inhibition and control groups. Participants which were selected according to cluster sampling answered to some questionnaires, including depression, general health, and emotion regulation. Then, a clip and a related instruction were presented for each group. They were asked to perform according to instruction after watching movie and tick on a paper whenever the thoughts of movie come to their mind. Data were analyzed using t test in SPSS-23. Results There are not significant differences between groups in terms of mood, emotion regulation, depression, and general health in the pre-test. Similarly, results indicated that there is not a significant differences between groups. Conclusions This research showed that the usefulness of emotional inhibition depends on the culture. In fact, in Eastern cultures, using emotion regulation strategies such as suppression and emotional inhibition are common so that avoidance is a short term and useful emotion regulation mechanism.

Confiabilidade da tradução da versão brasileira do questionário PedsQL - DREA para avaliação da qualidade de vida de crianças e adolescentes

OpenAIRE

Lopes,Marcos Thomazin; Ferraro,Alexandre Archanjo; Koch,Vera Hermina Kalika

2015-01-01

ResumoObjetivo:Avaliar a confiabilidade da tradução e adaptação cultural do questionário Pediatric Quality of Life Inventory (Peds- QLTM) - Doença Renal em Estágio Avançado (DREA) - versão 3.0 - relato das crianças/adolescentes e relato dos pais para avaliação da Qualidade de Vida Relacionada à Saúde (QRVS) de crianças brasileiras portadoras de DREA.Método:Utilizou-se a metodologia proposta pelos autores da versão original dos questionários, por meio da administração dos mesmos a um grupo de ...

Confiabilidade da tradução da versão brasileira do questionário PedsQL - DREA para avaliação da qualidade de vida de crianças e adolescentes

OpenAIRE

Marcos Thomazin Lopes; Alexandre Archanjo Ferraro; Vera Hermina Kalika Koch

2015-01-01

Resumo Objetivo: Avaliar a confiabilidade da tradução e adaptação cultural do questionário Pediatric Quality of Life Inventory (Peds- QLTM) - Doença Renal em Estágio Avançado (DREA) - versão 3.0 - relato das crianças/adolescentes e relato dos pais para avaliação da Qualidade de Vida Relacionada à Saúde (QRVS) de crianças brasileiras portadoras de DREA. Método: Utilizou-se a metodologia proposta pelos autores da versão original dos questionários, por meio da administração dos mesmos a um grupo...

Investigating the role of attachment in social comparison theories of eating disorders within a non-clinical female population.

Science.gov (United States)

Bamford, Bryony; Halliwell, Emma

2009-01-01

The present study aimed to integrate attachment theory and sociocultural theory as predictors of disordered eating, thereby combining two previously distinct literatures in order to provide a more comprehensive model of eating disorder development. It was specifically proposed that women's attachment style may influence their tendency to socially compare themselves to idealized others. Participants (N = 213) were non-clinical female undergraduates. Sociocultural attitudes to appearance, social comparison, attachment and eating disorder symptomatology were assessed using self-report questionnaires. Consistent with the hypothesis, social comparison was found to mediate the relationship between attachment anxiety and disordered eating. In addition, attachment avoidance, was not significantly associated with either internalisation of cultural ideals or social comparison but was significantly related to eating psychopathology. The findings suggest that attachment anxiety and avoidance influence disordered eating via different pathways, with attachment anxiety specifically being implicated in sociocultural models of disordered eating.

Non-Clinical Models for Neurodegenerative Diseases: Therapeutic Approach and Drug Validation in Animal Models

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Caridad Ivette Fernandez

2017-12-01

Full Text Available In 2016, 19.8% of the Cuban population was aged 60 or over. As a result, age-associated degenerative diseases and other diseases have become priority targets from a prophylactic, diagnostic and therapeutic perspective. As a result, the Cuban biomedical scientific community has addressed its basic, preclinical and epidemiological research in order to rise up to the challenge. A firm step in this direction has been the international congress “State of the art in non-clinical models for neurodegenerative diseases” which has brought together preclinical and clinical researchers, technicians and regulatory staff members from different countries to review the state of the art in neurodegenerations, find unifying ideas, objectives and collaborations or partnership. The objective is to expose the perspectives of new biotechnological products from Cuba and other countries from the diagnostic, therapeutic and neuroprotective point of view. It is crucial, therefore, that the irreplaceable role of laboratory animals in achieving these objectives is understood but they must be used in rational, adequate and ethical manner. We expose the current development trends in this field, being of common interest to the work directed to the search for potential drugs, diagnostic tools and the promotion of changes in lifestyle as a preventive projection.

The Clinical and Nonclinical Values of Nonexercise Estimation of Cardiovascular Endurance in Young Asymptomatic Individuals

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Mahmoud A. Alomari

2012-01-01

Full Text Available Exercise testing is associated with barriers prevent using cardiovascular (CV endurance (CVE measure frequently. A recent nonexercise model (NM is alleged to estimate CVE without exercise. This study examined CVE relationships, using the NM model, with measures of obesity, physical fitness (PF, blood glucose and lipid, and circulation in 188 asymptomatic young (18–40 years adults. Estimated CVE correlated favorably with measures of PF (r=0.4-0.5 including handgrip strength, distance in 6 munities walking test, and shoulder press, and leg extension strengths, obesity (r=0.2-0.7 including % body fat, body water content, fat mass, muscle mass, BMI, waist and hip circumferences and waist/hip ratio, and circulation (r=0.2-0.3 including blood pressures, blood flow, vascular resistance, and blood (r=0.2-0.5 profile including glucose, total cholesterol, LDL-C, HDL-C, and triglycerides. Additionally, differences (P<0.05 in examined measures were found between the high, average, and low estimated CVE groups. Obviously the majority of these measures are CV disease risk factors and metabolic syndrome components. These results enhance the NM scientific value, and thus, can be further used in clinical and nonclinical settings.

Analysis of Patient Visits and Collections After Opening a Satellite Pediatric Emergency Department.

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Nichols, Katherine M; Caperell, Kerry; Cross, Keith; Duncan, Scott; Foster, Ben; Liu, Gil; Pritchard, Hank; Southard, Gary; Shinabery, Ben; Sutton, Brad; Kim, In K

2018-04-01

Satellite pediatric emergency departments (PEDs) have emerged as a strategy to increase patient capacity. We sought to determine the impact on patient visits, physician fee collections, and value of emergency department (ED) time at the primary PED after opening a nearby satellite PED. We also illustrate the spatial distribution of patient demographics and overlapping catchment areas for the primary and satellite PEDs using geographical information system. A structured, financial retrospective review was conducted. Aggregate patient demographic data and billing data were collected regarding physician fee charges, collections, and patient visits for both PEDs. All ED visits from January 2009 to December 2013 were analyzed. Geographical information system mapping using ArcGIS mapped ED patient visits. Patient visits at the primary PED were 53,050 in 2009 before the satellite PED opened. The primary PED visits increased after opening the satellite PED to 55,932 in 2013. The satellite PED visits increased to 21,590 in 2013. Collections per visit at the primary PED decreased from $105.13 per visit in 2011 to $86.91 per visit in 2013. Total collections at the satellite PED decreased per visit from $155.41 per visit in 2011 to $128.53 per visit in 2013. After opening a nearby satellite PED, patient visits at the primary PED did not substantially decrease, suggesting that there was a previously unrecognized demand for PED services. The collections per ED visit were greater at the satellite ED, likely due to a higher collection rate.

Bike-Ped Portal : development of an online nonmotorized traffic count archive.

Science.gov (United States)

2017-05-01

Robust bicycle and pedestrian data on a national scale would serve numerous purposes. Access to a centralized nonmotorized traffic count : archive can open the door for innovation through research, design and planning; provide safety researchers with...

Applying the Toyota Production System: using a patient safety alert system to reduce error.

Science.gov (United States)

Furman, Cathie; Caplan, Robert

2007-07-01

In 2002, Virginia Mason Medical Center (VMMC) adapted the Toyota Production System, also known as lean manufacturing. To translate the techniques of zero defects and stopping the line into health care, the Patient Safety Alert (PSA) system requires any employee who encounters a situation that is likely to harm a patient to make an immediate report and to cease any activity that could cause further harm (stopping the line). IMPLEMENTING THE PSA SYSTEM--STOPPING THE LINE: If any VMMC employee's practice or conduct is deemed capable of causing harm to a patient, a PSA can cause that person to be stopped from working until the problem is resolved. A policy statement, senior executive commitment, dedicated resources, a 24-hour hotline, and communication were all key features of implementation. As of December 2006, 6,112 PSA reports were received: 20% from managers, 8% from physicians, 44% from nurses, and 23% from nonclinical support personnel, for example. The number of reports received per month increased from an average of 3 in 2002 to 285 in 2006. Most reports were processed within 24 hours and were resolved within 2 to 3 weeks. Implementing the PSA system has drastically increased the number of safety concerns that are resolved at VMMC, while drastically reducing the time it takes to resolve them. Transparent discussion and feedback have helped promote staff acceptance and participation.

Efficacy and safety of PPC-5650 on experimental rectal pain in patients with irritable bowel syndrome

DEFF Research Database (Denmark)

Nielsen, Lecia Møller; Olesen, Anne Estrup; Andresen, Trine

2015-01-01

PPC-5650 is a new pharmacological agent that can modulate acid-sensing ion channel activity, leading to a reduction in the pain signal under up-regulated conditions. The non-clinical programme for PPC-5650 supported a role for this novel agent in the treatment of pain in patients with irritable...... bowel syndrome (IBS). In patients with IBS, the aims of the study were: (1) to assess the efficacy of a single bolus of PPC-5650 locally applied in the rectum using multi-modal stimulations of the recto sigmoid and (2) to assess the safety profile of PPC-5650. The study was a randomized, double......-blind, placebo-controlled, cross-over trial in patients with IBS, excluding females of child-bearing potential. The study consisted of a training visit, study visit 1 and 2 and a follow-up visit. Rectosigmoid electrical, thermal and mechanical stimulations were performed, pain perception was rated on a pain...

Efeito do branqueamento, processo osmótico, tratamento térmico e armazenamento na estabilidade da vitamina C de pedúnculos de caju processados por métodos combinados Effect of bleaching, osmotic process, heat treatment and storage on ascorbic acid stability of cashew apple processed by combined methods

Directory of Open Access Journals (Sweden)

Men de Sá M. SOUZA FILHO

1999-05-01

Full Text Available Pedúnculos de caju foram processados por métodos combinados. As principais mudanças verificadas nas características físico-químicas foram redução do pH, aumento no teor de sólidos solúveis e de açúcares redutores. Observaram-se, também, perdas percentuais de ácido ascórbico, em relação ao pedúnculo "in natura", de 23,3% após o branqueamento, 31,7% após o primeiro dia de osmose, 35,5% após o quinto dia de osmose, 69,0% após o tratamento térmico e 87,3% ao final de 60 dias de armazenamento à temperatura ambiente (~ 28° C.Cashew apples were processed by combined methods. Major physical and chemical changes were pH decrease, soluble solids and reducing sugars increase. Ascorbic acid loss was 23,3% after bleaching, 31,7% after one day osmosis, 35,5% after five day osmosis, 69,0% after heat treatment and 87,3% after 60 days storage at ambient temperature (~ 28° C.

Obsessive-compulsive symptoms and negative affect during tobacco withdrawal in a non-clinical sample of African American smokers.

Science.gov (United States)

Bello, Mariel S; Pang, Raina D; Chasson, Gregory S; Ray, Lara A; Leventhal, Adam M

2017-05-01

The association between obsessive-compulsive (OC) symptomatology and smoking is poorly understood, particularly in African Americans-a group subject to smoking- and OC-related health disparities. In a non-clinical sample of 253 African American smokers, we tested the negative reinforcement model of OC-smoking comorbidity, purporting that smokers with higher OC symptoms experience greater negative affect (NA) and urge to smoke for NA suppression upon acute tobacco abstinence. Following a baseline visit involving OC assessment, participants completed two counterbalanced experimental visits (non-abstinent vs. 16-h tobacco abstinence) involving affect, smoking urge, and nicotine withdrawal assessment. OC symptom severity predicted larger abstinence-provoked increases in overall NA, anger, anxiety, depression, fatigue, urge to smoke to suppress NA, and composite nicotine withdrawal symptom index. African American smokers with elevated OC symptoms appear to be vulnerable to negative reinforcement-mediated smoking motivation and may benefit from cessation treatments that diminish NA or the urge to quell NA via smoking. Copyright © 2016 Elsevier Ltd. All rights reserved.

Evaluation of the Beck Depression Inventory in a nonclinical student sample.

Science.gov (United States)

Ignjatović-Ristić, D; Hinić, D; Jović, J

2012-08-01

Depression is one of the most common psychological disorders in individuals seeking psychiatric treatment, and a frequent psychological disorder among patients who seek primary healthcare. Therefore, it is vitally important to employ reliable and valid diagnostic instruments and norms, both in clinical and research work to investigate this problem. This article is part of a larger study which has been conducted for ten years now with the aim to create a clearer picture about the level of depression which may be expected in the nonclinical population in Serbia, and in that way provide a basis for comparisons when diagnosing the clinical population. The subsidiary aims were to monitor potential changes in level of depressive reactions within the set time and to examine the psychometric properties and factor structure of the Beck Depression Inventory (BDI) scale. The sample consisted of 782 students (40% male, 60% female), mean age = 23.10 years, SD = 1.782. Mean score on the BDI-IA scale was 6.69; SD = 6.412. The study showed no significant relationships between the BDI scores and sociodemographic variables such as age, economic status, and educational profile, but showed significant differences within gender (t (780) = 3.222, p = 0.001). There was also a relatively stable level of depressive reactions in this population over the previous ten years. The Cronbach's coefficient of the BDI scale was alpha = 0.860, with the majority of item-total correlations above 0.37. The three-factor structure represents cognitive aspect, affective component of depression, and somatic problems attached to depression. The cognitive factor prevails in the entire sample, which is in accordance with the Beck theory about dysfunctional attitudes, ie cognitive vulnerability is a psychological predisposition to depression.

Newly Developed Neutralized pH Icodextrin Dialysis Fluid: Nonclinical Evaluation.

Science.gov (United States)

Yamaguchi, Naoya; Miyamoto, Keiichi; Murata, Tomohiro; Ishikawa, Eiji; Horiuchi, Takashi

2016-08-01

A two-compartment system (NICOPELIQ; NICO, Terumo Co., Tokyo, Japan) has recently been developed to neutralize icodextrin peritoneal dialysis fluid (PDF). In this study, a nonclinical evaluation of NICO was carried out to evaluate biocompatibility as well as water transport ability. Glucose degradation products (GDPs) in the icodextrin PDFs were analyzed via high-performance liquid chromatography (HPLC). The cell viability of human peritoneal mesothelial cells derived from peritoneal dialysis effluent (PDE-HPMCs) was evaluated as well as the amount of lactate dehydrogenase (LDH) released after exposure to different PDFs (NICO and EXTRANEAL [EX, Baxter Healthcare Corp., Chicago, IL, USA]) and neutralized pH glucose PDF MIDPELIQ 250 (M250, Terumo). The water transport ability of NICO, EX, and M250 was tested using dialysis tube membranes with various pore sizes: 1, 2, 6-8, and 12-16 kDa. Although cell viability decreased by 30% after 30 min exposure to NICO, it was maintained for 6 h while a significant decrease was observed after 6 h exposure to EX. However, following adjustment of the pH to the same pre-exposure pH value, there was no significant difference in cell viability within the same pH group despite a doubling of the difference in the total amount of GDPs (44.6 ± 8.6 µM in NICO and 91.9 ± 9.5 µM in EX, respectively). In contrast, a significant decrease in cell viability was observed when the pH decreased to less than pH 6. Levels of released LDH, a cytotoxic marker, were within 5% after a 6-h exposure of NICO to PDE-HPMCs. There was no significant difference in water transport ability represented as overall osmotic gradients between NICO and EX. In conclusion, neutralization of icodextrin PDF is beneficial for maintaining cell viability and minimizing LDH release while water transport ability is comparable to the conventional icodextrin PDF. © 2016 International Center for Artificial Organs and Transplantation and Wiley Periodicals, Inc.

Complicating factors in safety testing of drug metabolites: Kinetic differences between generated and preformed metabolites

International Nuclear Information System (INIS)

Prueksaritanont, Thomayant; Lin, Jiunn H.; Baillie, Thomas A.

2006-01-01

This paper aims to provide a scientifically based perspective on issues surrounding the proposed toxicology testing of synthetic drug metabolites as a means of ensuring adequate nonclinical safety evaluation of drug candidates that generate metabolites considered either to be unique to humans or are present at much higher levels in humans than in preclinical species. We put forward a number of theoretical considerations and present several specific examples where the kinetic behavior of a preformed metabolite given to animals or humans differs from that of the corresponding metabolite generated endogenously from its parent. The potential ramifications of this phenomenon are that the results of toxicity testing of the preformed metabolite may be misleading and fail to characterize the true toxicological contribution of the metabolite when formed from the parent. It is anticipated that such complications would be evident in situations where (a) differences exist in the accumulation of the preformed versus generated metabolites in specific tissues, and (b) the metabolite undergoes sequential metabolism to a downstream product that is toxic, leading to differences in tissue-specific toxicity. Owing to the complex nature of this subject, there is a need to treat drug metabolite issues in safety assessment on a case-by-case basis, in which a knowledge of metabolite kinetics is employed to validate experimental paradigms that entail administration of preformed metabolites to animal models

Women in relationships with cross-dressing men: a descriptive study from a nonclinical setting.

Science.gov (United States)

Brown, G R

1994-10-01

Over a 6-year period, 106 women involved with men who cross-dress (mostly heterosexual transvestites) completed a questionnaire regarding themselves, their male partners, and their relationships. Interview data supplemented these questionnaires for 75% of the respondents. All respondents were recruited from nonclinical settings. The "modal" female partner was a 40-year-old Protestant, Caucasian woman, who was a firstborn child, in her first marriage. She was more likely than other women her age to be childless, and to have earned at least a 2-year college degree. She was no more likely to have had lesbian experiences or substance use problems than comparably aged American women. She had been married to her cross-dressing mate for 13 years and had known of his activities for 9 years. A quarter of women reported at least occasional sexual arousal to their mate's cross-dressing. The two variables associated with low acceptance of cross-dressing were discovery of their partner's cross-dressing after marriage and lack of sexual arousal to cross-dressing stimuli. Low acceptance was unrelated to firstborn status, amount of exposure to cross-dressing activities, or having had children. This group may be more representative of women in relationships with cross-dressing men than previous reports limited to cross-dressers and spouses who are in treatment.

Symptom presentation and classroom functioning in a nonclinical sample of children with social phobia.

Science.gov (United States)

Bernstein, Gail A; Bernat, Debra H; Davis, Andrew A; Layne, Ann E

2008-01-01

This study investigates symptom presentation and school functioning in a nonclinical sample of children with social phobia (SP). Forty-five children with SP were identified via school-wide screenings and follow-up diagnostic interviews. Analyses examined types and intensity of fears, number of social situations avoided, interpersonal relationships, and classroom functioning. To identify characteristics unique to social phobic children, children with SP (n = 45) were compared to anxious children without SP (n = 56) on the above variables. Comorbidity in children with SP and factors associated with SP severity were also evaluated. Compared to anxious children without SP, children with SP feared and avoided a significantly greater number of social situations. In addition, they were significantly more likely to have trouble with making friends and to prefer being alone rather than with peers. All children with SP met criteria for at least one comorbid disorder. Significant factors explaining child-reported severity of SP were number of social situations avoided and intensity of fears. Greater severity of SP was significantly associated with poorer social skills, poorer leadership skills, greater attention difficulties, and greater learning problems in the classroom. It is important to understand the symptom presentation of SP so that children with SP are identified early and effective interventions are instituted. This is especially critical given the impact of SP on school functioning. Published 2007 Wiley-Liss, Inc.

Validation of modified forms of the PedsQL generic core scales and cancer module scales for adolescents and young adults (AYA) with cancer or a blood disorder.

Science.gov (United States)

Ewing, Jane E; King, Madeleine T; Smith, Narelle F

2009-03-01

To validate two health-related quality of life (HRQOL) measures, the PedsQL Generic Core and Cancer Module adolescent forms (13-18 years), after modification for 16-25-year-old adolescents and young adults (AYA) with cancer or a blood disorder. AYA patients and nominated proxies were recruited from three Sydney hospitals. Modified forms were administered by telephone or in clinics/wards. Analyses included correlations, factor analysis, and analysis of variance of known-groups (defined by the Memorial Symptom Assessment Scale). Eighty-eight patients and 79 proxies completed questionnaires. Factor structures consistent with those of the unmodified forms confirmed construct validity. Cronbach's alpha ranged 0.81-0.98. Inter-scale correlations were as hypothesized, confirming discriminant validity. Statistically significant differences between groups with mild, moderate, and severe symptoms (P < 0.05) confirmed clinical validity. These modified forms provide reliable and valid measures of HRQOL in AYA with cancer or a blood disorder, suitable for clinical trials, research, and practice.

78 FR 22880 - Agency Information Collection Activities; Proposed Collection; Comment Request

Science.gov (United States)

2013-04-17

... providers, empowering patients to become involved in their own self-care. Increased patient safety can... included in the burden estimates. (2) Staff Observation. Clinicians (physicians, nurse practitioners, physician assistants, nurses, medical assistants, pharmacists, and case managers) and non-clinical office...

Comparison of rat and rabbit embryo-fetal developmental toxicity data for 379 pharmaceuticals: on the nature and severity of developmental effects (Critical Reviews in Toxicology)

Science.gov (United States)

Regulatory non-clinical safety testing of human pharmaceutical compounds typically requires embryo fetal developmental toxicity (EFDT) testing in two species, (one rodent and one non-rodent, usually the rat and the rabbit). The question has been raised whether under some conditio...

76 FR 51876 - Medical Devices; Ophthalmic Devices; Classification of the Eyelid Thermal Pulsation System

Science.gov (United States)

2011-08-19

... of exposure to non- ionizing radiation; (2) Design, description, and performance data should validate.../testing should validate electromagnetic compatibility (EMC) and safety of exposure to non-ionizing.... Malfunction Non-clinical and Clinical Performance Testing. User error Labeling. FDA believes that the...

Expectations and satisfaction of academic investigators in nonclinical collaboration with the pharmaceutical industry.

Science.gov (United States)

Amiri, Marjan; Michel, Martin C

2015-06-01

In light of a growing role of research collaborations between academia and the pharmaceutical industry, we have explored expectations and experience of academic investigators with preclinical collaborations. Researchers from Western Europe, North America, and Japan with preclinical publications in the obstructed airways or diabetes fields were invited to anonymously participate in a web-based survey. A total of 134 investigators (28 % of invitees) participated in the two sequentially performed surveys with similar responses in both therapeutic areas. A secondary but prespecified subgroup analysis was based on region of residence, gender, and career level of the investigator. Across all groups, responders considered freedom to publish, obtaining funding and obtaining compounds to be the most important objectives of nonclinical collaborations with the pharmaceutical industry, whereas cultivating professional relationships, getting external scientific input, direct relationship to disease treatment, and involvement with drug development were less important. Among eight attributes of the primary contact person in the company, trustworthiness ranked highest, followed by a collaborative spirit and transparent information sharing; supportiveness, scientific qualification, accessibility, and timeliness of responses ranked lower, and friendliness, lowest. Related to their most recent collaboration, investigators also expressed the highest level of satisfaction with the trustworthiness attribute. On the other hand, the process of reaching a contract was often considered too long and difficult, for which both university and company legal departments were reported as culprits. We conclude that academic researchers are generally satisfied with their preclinical collaboration with the pharmaceutical industry but look for improved contracting procedures.

Emotional, Cognitive and Behavioral Reactions to Paranoid Symptoms in Clinical and Nonclinical Populations.

Science.gov (United States)

Carvalho, Célia Barreto; da Motta, Carolina; Pinto-Gouveia, José; Peixoto, Ermelindo Manuel Bernardo

Paranoia is a disruptive belief that can vary across a continuum, ranging from persecutory delusions presented in clinical settings to paranoid cognitions that are highly prevalent in the general population. The literature suggests that paranoid thoughts derive from the activation of a paranoid schema or information processing biases that can be sensitive to socially ambiguous stimuli and influence the processing of threatening situations. Four groups (schizophrenic participants in active psychotic phases, n=61; stable participants in remission, n=30; participants' relatives, n=32; and, healthy controls, n=64) were assessed with self-report questionnaires to determine how the reactions to paranoia of clinical patients differ from healthy individuals. Cognitive, emotional and behavioral dimensions of their reactions to these paranoid thoughts were examined. Paranoid individuals were present in all groups. Most participants referred to the rejection by others as an important trigger of paranoid ideations, while active psychotics were unable to identify triggering situations to their thoughts and reactions. This may be a determinant to the different reactions and the different degree of invalidation caused by paranoid thoughts observed across groups. Clinical and nonclinical expressions of paranoid ideations differ in terms of their cognitive, emotional and behavioral components. It is suggested that, in socially ambiguous situations, paranoid participants (presenting lower thresholds of paranoid schema activation) lose the opportunity to disconfirm their paranoid beliefs by resourcing to more maladaptive coping strategies. Consequently, by dwelling on these thoughts, the amount of time spent thinking about their condition and the disability related to the disease increases.

A systematic review of patient tracking systems for use in the pediatric emergency department.

Science.gov (United States)

Dobson, Ian; Doan, Quynh; Hung, Geoffrey

2013-01-01

Patient safety is of great importance in the pediatric emergency department (PED). The combination of acutely and critically ill patients and high patient volumes creates a need for systems to support physicians in making accurate and timely diagnoses. Electronic patient tracking systems can potentially improve PED safety by reducing overcrowding and enhancing security. To enhance our understanding of current electronic tracking technologies, how they are implemented in a clinical setting, and resulting effect on patient care outcomes including patient safety. Nine databases were searched. Two independent reviewers identified articles that contained reference to patient tracking technologies in pediatrics or emergency medicine. Quantitative studies were assessed independently for methodological strength by two reviewers using an external assessment tool. Of 2292 initial articles, 22 were deemed relevant. Seventeen were qualitative, and the remaining five quantitative articles were assessed as being methodologically weak. Existing patient tracking systems in the ED included: infant monitoring/abduction prevention; barcode identification; radiofrequency identification (RFID)- or infrared (IR)-based patient tracking. Twenty articles supported the use of tracking technology to enhance patient safety or improve efficiency. One article failed to support the use of IR patient sensors due to study design flaws. Support exists for the use of barcode-, IR-, and RFID-based patient tracking systems to improve ED patient safety and efficiency. A lack of methodologically strong studies indicates a need for further evidence-based support for the implementation of patient tracking technology in a clinical or research setting. Copyright © 2013 Elsevier Inc. All rights reserved.

Nonclinical Depression and Anxiety as Predictor of Academic Stress in Medical Students

Directory of Open Access Journals (Sweden)

Afsheen Masood

2016-05-01

Full Text Available To measure the role of anxiety and non-clinical depression as predictors of academic stress. In this study, supplementary objective had been gauging the prevalence of anxiety and depression among medical students of first year and final year, sought from six major medical colleges of Punjab. Almost all health professionals, no matter to which part of the world they belong to, face anxiety, depression and stress due to the nature of services they have to extend in medical profession such as time-pressures, workload, multiple roles and emotional issues. Quantitative research designed was employed; and cross sectional research design was used to lay out the research. The data was collected from first year and final year medical students. The duration of data collection was from Sep, 2014 to Sep, 2015. In Faculty of Medicine of five leading medical colleges, with total number of 650 students, the prevalence of anxiety and depression was found to be 83.9% and 67.9%, from first year to fourth year respectively, based on the cut-off points of both questionnaires. There was significant association among anxiety, depression and academic stress as computed through Pearson Product Moment Correlation. The regression analyses revealed that depression was significant predictor of academic stress but this was not the same for anxiety. Females were more anxiety and depression prone and reported greater academic stress than males. The study revealed significant distress among medical students, in terms of both anxiety and depression. It was inferred that the depression acts as pertinent predictor of academic stress. Furthermore, it was noticed that the prevalence of symptoms was higher among females. The findings carry significant implications for highlighting the addressing the need for psychological wellbeing of medical students in order to establish conducive environment of learning for medical professionals.

Alpha/Theta Neurofeedback Increases Mentalization and Default Mode Network Connectivity in a Non-Clinical Sample.

Science.gov (United States)

Imperatori, Claudio; Della Marca, Giacomo; Amoroso, Noemi; Maestoso, Giulia; Valenti, Enrico Maria; Massullo, Chiara; Carbone, Giuseppe Alessio; Contardi, Anna; Farina, Benedetto

2017-11-01

Several studies showed the effectiveness of alpha/theta (A/T) neurofeedback training in treating some psychiatric conditions. Despite the evidence of A/T effectiveness, the psychological and neurobiological bases of its effects is still unclear. The aim of the present study was to explore the usefulness of the A/T training in increasing mentalization in a non-clinical sample. The modifications of electroencephalographic (EEG) functional connectivity in Default Mode Network (DMN) associated with A/T training were also investigated. Forty-four subjects were enrolled in the study and randomly assigned to receive ten sessions of A/T training [neurofeedback group (NFG) = 22], or to act as controls [waiting list group (WLG) = 22]. All participants were administered the mentalization questionnaire (MZQ) and the Symptom Checklist-90-Revised (SCL-90-R). In the post training assessment, compared to WLG, NFG showed a significant increase of MZQ total scores (3.94 ± 0.73 vs. 3.53 ± 0.77; F 1;43 = 8.19; p = 0.007; d = 0.863). Furthermore, A/T training was also associated with a significant increase of EEG functional connectivity in several DMN brain areas (e.g. Posterior Cingulate Cortex). Taken together our results support the usefulness of the A/T training in enhancing mentalization and DMN connectivity.

Iowa Gambling Task with non-clinical participants: Effects of using real + virtual cards and additional trials

Directory of Open Access Journals (Sweden)

William H Overman

2013-12-01

Full Text Available Performance on the Iowa Gambling Task (IGT in clinical populations can be interpreted only in relation to established base line performance in normal populations. As in all comparisons of assessment tools, the normal base line must reflect performance under conditions in which subjects can function at their best levels. In this review, we show that a number of variables enhance IGT performance in non-clinical participants. First, optimal performance is produced by having participants turn over real cards while viewing virtual cards on a computer screen. The use of only virtual cards results in significantly lower performance than the combination of real + virtual cards. Secondly, administration of more than 100 trials also enhances performance. When using the real/virtual card procedure, performance is shown to significantly increase from early adolescence through young adulthood. Under these conditions young (mean age 19 years and older (mean age 59 years adults perform equally. Females, as a group, score lower than males because females tend to choose cards from high-frequency-of-gain Deck B. Groups of females with high or low gonadal hormones perform equally. Concurrent tasks, e.g., presentation of aromas, decrease performance in males. Age and gender effects are discussed in terms of a dynamic between testosterone and orbital prefrontal cortex.

US Pharmacopeial Convention safety evaluation of menaquinone-7, a form of vitamin K.

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Marles, Robin J; Roe, Amy L; Oketch-Rabah, Hellen A

2017-07-01

Vitamin K plays important biological roles in maintaining normal blood coagulation, bone mineralization, soft tissue physiology, and neurological development. Menaquinone-7 is a form of vitamin K2 that occurs naturally in some animal-derived and fermented foods. It is also available as an ingredient of dietary supplements. Menaquinone-7 has greater bioavailability than other forms of vitamin K, which has led to increasing sales and use of menaquinone-7 supplements. This special article reviews the chemistry, nomenclature, dietary sources, intake levels, and pharmacokinetics of menaquinones, along with the nonclinical toxicity data available and the data on clinical outcomes related to safety (adverse events). In conclusion, the data reviewed indicate that menaquinone-7, when ingested as a dietary supplement, is not associated with any serious risk to health or with other public health concerns. On the basis of this conclusion, US Pharmacopeia monographs have been developed to establish quality standards for menaquinone-7 as a dietary ingredient and as a dietary supplement in various dosage forms. © The Author(s) 2017. Published by Oxford University Press on behalf of the International Life Sciences Institute. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

Translation and validation of Pediatric Quality of Life Inventory™ 3.0 Diabetes Module (PedsQL™ 3.0 Diabetes Module) in Brazil-Portuguese language.

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Garcia, Leila F Dos S; Manna, Thais Della; Passone, Caroline de Gouveia Buff; Oliveira, Lygia Spassapan de

2017-11-14

The aim of the present study was to create a translated version of the Pediatric Quality of Life Inventory™ 3.0 Diabetes Module (PedsQL™ 3.0 Diabetes Module) in Brazilian Portuguese that was conceptually equivalent to the original American English version and to linguistically validate it in a Brazilian pediatric population with type 1 diabetes mellitus and their parents or caregivers. The instrument was translated, back-translated, and then administered to 83 children/adolescents (5-18 years) with type 1 diabetes mellitus and their family members and to 25 parents/caregivers of patients aged between 2 and 4 years. The final translated version was tested for reliability by analyzing internal consistency, intraobserver (test-retest) reliability, and concurrent validity. Cronbach's alpha coefficient for the total score of the questionnaires of children/adolescents (α=0.85) and their parents (α=0.82) was above the recommended minimum of 0.70 for group comparisons. Intraobserver reliability and concurrent validity exhibited a significant positive correlation (p3.0 Diabetes Module revealed adequate psychometric characteristics with respect to reliability and validity following administration to a sample of Brazilian children/adolescents with type 1 diabetes mellitus and their caregivers. Copyright © 2017. Published by Elsevier Editora Ltda.

Avaliação tomográfica dos pedículos vertebrais no tratamento cirúrgico dos pacientes com escoliose idiopática do adolescente Evaluación de tomografía computarizada de pedículos vertebrales nel tratamiento quirúrgico de escoliosis idiopática del adolescente Computed tomography scan evaluation of vertebral pedicles for surgical treatment of adolescent idiopathic scoliosis

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Alceu Gomes Chueire

2012-12-01

Full Text Available OBJETIVO: Determinar através de cortes tomográficos e reconstrução tridimensional a incidência de mal posicionamento de parafusos em pacientes submetidos ao tratamento cirúrgico da Escoliose idiopática do adolescente. MÉTODOS: Foram analisados exames tomográficos de 8 pacientes, tratados cirurgicamente no Hospital de Base de São José do Rio Preto-SP, realizada instrumentação posterior partindo de T2 /T4 a L4/L5 totalizando 164 parafusos. RESULTADOS: 32,9% (n=54 apresentavam posicionamento com risco potencial,ou seja desvio acima de 2 milímetros, sendo 20,1% (n=33 com invasão lateral, 9,1% (n=15 com invasão medial, 3,6 %(n=6 com invasão anterior. Dos parafusos que ofereciam risco potencial a relação com aspecto da curva foi de 46% (n=25 na concavidade, 35% (n=19 na convexidade e 19% (n=10 em vértebras adjacentes a curva. CONCLUSÃO: Os limites de penetração aceitáveis, assim como os métodos de mensuração ainda não foram padronizados, a técnica "free hand' mostrou-se segura, apesar da violação dos pedículos. A tomografia computadorizada pré-operatória, auxilia no planejamento cirúrgico e na redução das complicações.OBJETIVO: Evaluar mediante tomografía computarizada tridimensional de reconstrucción, una mala posición de los tornillos de pedículo en pacientes con escoliosis idiopática del adolescente. MÉTODOS: Se analizó cortes de tomografía computarizada de 8 pacientes sometidos a tratamiento quirúrgico en el Hospital de Base de São José do Rio Preto-SP, que se llevaron a cabo la fusión vertebral posterior de T2/T4 a L4/L5, 164 tornillos se insertaron. RESULTADOS: 32,9% (n = 54 fueron mal colocados que ofrecen riesgo potencial, que se consideraba una desviación de 2 mm, 20,1% (n = 33, la invasión lateral, el 9,1% (n = 15 invasión medial, 3,6 % (n = 6 la invasión anterior. De los tornillos mal colocados el 46% (n = 25 fueron en la concavidad, el 35% (n = 19 en la convexidad y el 19% (n = 10 se

Evidence-based policy? The use of mobile phones in hospital

NARCIS (Netherlands)

Ettelt, Stefanie; Nolte, Ellen; McKee, Martin; Haugen, Odd Arild; Karlberg, Ingvar; Klazinga, Niek; Ricciardi, Walter; Teperi, Juha

2006-01-01

BACKGROUND: Evidence-based policies have become increasingly accepted in clinical practice. However, policies on many of the non-clinical activities that take place in health care facilities may be less frequently evidence based. METHODS: We carried out a review of literature on safety of mobile

Benefits of a new pediatric triple-chamber bag for parenteral nutrition in preterm infants.

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Rigo, Jacques; Marlowe, Monica L; Bonnot, Denis; Senterre, Thibault; Lapillonne, Alexandre; Kermorvant-Duchemin, Elsa; Hascoet, Jean Michel; Desandes, Roxane; Malfilâtre, Geneviève; Pladys, Patrick; Beuchée, Alain; Colomb, Virginie

2012-02-01

The aim of this study was to evaluate the efficacy, safety, flexibility, and ease of handling and use of the Ped3CB-A 300  mL, the first ready-to-use multichamber parenteral nutrition (PN) system, with optional lipid bag activation, specially designed for administration to preterm infants. In this prospective, open-label, multicenter, noncomparative, phase III clinical trial, preterm infants were treated with Ped3CB-A for 5 to 10 consecutive days. A total of 113 preterm infants were enrolled in the study and 97 (birth weight 1382 ± 520 g; gestational age 31.2 ± 2.5 weeks; postnatal age administration 5.6 ± 6.1 days) were included in the per protocol analysis accounting for 854 perfusion days. Double-chamber bag activation was used for 32 perfusion days. Macronutrient, electrolyte, and mineral supplements were primarily administered through a Y-line or directly in the activated bag. In all, 199 additions (mainly sodium, 95%) were made to the Ped3CB-A bags on 197 infusion days (23.1%) in 43 infants (44.3%). More than 1 of these nutrients was added to the bag on only 1 perfusion day. Mean and maximum parenteral nutrient intakes were 2.8 ± 0.7 and 3.6 ± 0.8  g amino acids per kilogram per day, and 80 ± 20 and 104 ± 22  kcal · kg(-1) · day(-1). Mean weight gain represented 10.0, 21.5, and 22. 6 g · kg(-1) · day(-1) according to age at inclusion (0-3, 4-7, or >7 days of life). A visual analog scale was completed and produced positive results. No adverse events were attributable to the design of the Ped3CB-A system. Ped3CB-A provides easy-to-use, well-balanced, and safe nutritional support. Nutritional intakes and weight gain were within the recent PN recommendations in preterm infants.

Implementation of adapted PECARN decision rule for children with minor head injury in the pediatric emergency department.

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Bressan, Silvia; Romanato, Sabrina; Mion, Teresa; Zanconato, Stefania; Da Dalt, Liviana

2012-07-01

Of the currently published clinical decision rules for the management of minor head injury (MHI) in children, the Pediatric Emergency Care Applied Research Network (PECARN) rule, derived and validated in a large multicenter prospective study cohort, with high methodologic standards, appears to be the best clinical decision rule to accurately identify children at very low risk of clinically important traumatic brain injuries (ciTBI) in the pediatric emergency department (PED). This study describes the implementation of an adapted version of the PECARN rule in a tertiary care academic PED in Italy and evaluates implementation success, in terms of medical staff adherence and satisfaction, as well as its effects on clinical practice. The adapted PECARN decision rule algorithms for children (one for those younger than 2 years and one for those older than 2 years) were actively implemented in the PED of Padova, Italy, for a 6-month testing period. Adherence and satisfaction of medical staff to the new rule were calculated. Data from 356 visits for MHI during PECARN rule implementation and those of 288 patients attending the PED for MHI in the previous 6 months were compared for changes in computed tomography (CT) scan rate, ciTBI rate (defined as death, neurosurgery, intubation for longer than 24 hours, or hospital admission at least for two nights associated with TBI) and return visits for symptoms or signs potentially related to MHI. The safety and efficacy of the adapted PECARN rule in clinical practice were also calculated. Adherence to the adapted PECARN rule was 93.5%. The percentage of medical staff satisfied with the new rule, in terms of usefulness and ease of use for rapid decision-making, was significantly higher (96% vs. 51%, puse of the adapted PECARN rule in clinical practice was 100% (95% CI=36.8 to 100; three of three patients with ciTBI who received CT scan at first evaluation), while efficacy was 92.3% (95% CI=89 to 95; 326 of 353 patients without ci

One year results of anti-VEGF treatment in pigment epithelial detachment secondary to macular degeneration

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Harun Yüksel

2013-08-01

Full Text Available PURPOSE:Pigment epithelial detachment (PED may be seen in all stages of age-related macular degeneration (ARMD and may lead to poor prognosis. In this study, we retrospectively examined the effect of anti-VEGF treatments in ARMD patients with vascularized PED. METHODS:Medical records of 15 patients with PED secondary to ARMD were reviewed retrospectively. The diagnosis of PED was made with fundoscopy, fundus fluorescein angiography and optical coherence tomography. Patients were treated with intravitreal ranibizumab or/and bevacizumab and followed up for a minimum of one year. PED height and best corrected visual acuity (BCVA was obtained before the first intravitreal anti-VEGF injection and again at the 1st, 3rd, 6th and 12th month after the injection. RESULTS: The mean baseline BCVA was 0.71 ± 0.48 logarithm of the minimal angle of resolution (logMAR unit and the mean baseline PED height was 361 ± 153 µ. The mean injection count per eye was 3.9 ± 2.9. There was a significant reduce in mean PED height (247 ± 177 µ also in 2 eyes PED completely resolved at the end of the follow up period. The mean BCVA at 12th month (0,69 ± 0,37 were not different from the baseline record. CONCLUSIONS: This retrospective case series showed that intravitreal anti-VEGF therapy preserved vision and reduced PED height in PED patients in a one-year follow-up period.

OPTIMAL MANAGEMENT OF PIGMENT EPITHELIAL DETACHMENTS IN EYES WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION.

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Khanani, Arshad M; Eichenbaum, David; Schlottmann, Patricio G; Tuomi, Lisa; Sarraf, David

2018-04-24

This review aimed to determine the optimal management of retinal pigment epithelial detachments (PEDs) in neovascular age-related macular degeneration (nAMD) based on review of available evidence in the literature. A comprehensive literature review evaluates previous retrospective and prospective studies that assessed the treatment of PEDs in nAMD. Studies illustrated that anti-vascular endothelial growth factor (VEGF) therapy can be effective in eyes with PED secondary to nAMD. Similar visual outcomes are associated with different anti-VEGF treatments. Higher anti-VEGF doses may improve anatomical response, without correlation with vision improvement. Fibrovascular PEDs may be difficult to treat, but even these eyes can gain vision with anti-VEGF therapy. A retinal pigment epithelial tear may develop in 15% to 20% of eyes with PEDs after anti-VEGF therapy, especially in PEDs greater than 500 µm to 600 µm in height; however, vision may stabilize with continued therapy. Atrophy may complicate eyes with PED and nAMD after anti-VEGF therapy, especially in association with complete PED resolution. Available literature suggests that anti-VEGF therapy is safe and efficacious for PED and nAMD. Treatment should focus on vision gains rather than PED resolution because there is no apparent correlation between anatomical and functional improvement in most eyes with PED and nAMD.This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.

Prevalence and correlates of comorbid depression in a nonclinical online sample with DSM-5 internet gaming disorder.

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Wang, Hee Ryung; Cho, Hyun; Kim, Dai-Jin

2018-01-15

We investigated the prevalence and correlates of comorbid depression among patients with internet gaming disorder using the Internet Gaming Disorder scale (IGD-9) and the Patient Health Questionnaire-9 (PHQ-9) among nonclinical online survey respondents. Korean adolescents and adults from 14 to 39 years of age were selected. We compared internet gaming use patterns and sociodemographic and clinical variables between patients with internet gaming disorder who had depression and those without depression. In 2016, 7200 people participated in an online survey. Respondents with internet gaming disorder that was comorbid with depression were older, more often female, had greater Internet Addiction Test total scores, Alcohol Use Disorder Identification Test total scores, Generalized Anxiety Disorder Scale-7 total scores, Fagerstrom Test for Nicotine Dependence total scores, and higher Dickman Dysfunctional Impulsivity Instrument dysfunctional subscale scores than those without depression. The binary logistic regression analysis revealed that female gender, problematic alcohol use, anxiety, and a past history of psychiatric counseling or treatment due to internet gaming use were significant predictors for comorbid depression among participants with internet gaming disorder. Depression was a common comorbidity of internet gaming disorder. Internet gaming disorder with comorbid depression was related to more serious psychiatric phenomenology and a greater psychiatric burden. Copyright © 2017. Published by Elsevier B.V.

Childhood trauma is not a confounder of the overlap between autistic and schizotypal traits: A study in a non-clinical adult sample.

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Gong, Jing-Bo; Wang, Ya; Lui, Simon S Y; Cheung, Eric F C; Chan, Raymond C K

2017-11-01

Childhood trauma has been shown to be a robust risk factor for mental disorders, and may exacerbate schizotypal traits or contribute to autistic trait severity. However, little is known whether childhood trauma confounds the overlap between schizotypal traits and autistic traits. This study examined whether childhood trauma acts as a confounding variable in the overlap between autistic and schizotypal traits in a large non-clinical adult sample. A total of 2469 participants completed the Autism Spectrum Quotient (AQ), the Schizotypal Personality Questionnaire (SPQ), and the Childhood Trauma Questionnaire-Short Form. Correlation analysis showed that the majority of associations between AQ variables and SPQ variables were significant (p autistic and schizotypal traits could not be explained by shared variance in terms of exposure to childhood trauma. The findings point to important overlaps in the conceptualization of ASD and SSD, independent of childhood trauma. Copyright © 2017 Elsevier B.V. All rights reserved.

Preclinical good laboratory practice-compliant safety study to evaluate biodistribution and tumorigenicity of a cartilage advanced therapy medicinal product (ATMP).

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Zscharnack, Matthias; Krause, Christoph; Aust, Gabriela; Thümmler, Christian; Peinemann, Frank; Keller, Thomas; Smink, Jeske J; Holland, Heidrun; Somerson, Jeremy S; Knauer, Jens; Schulz, Ronny M; Lehmann, Jörg

2015-05-20

The clinical development of advanced therapy medicinal products (ATMPs), a new class of drugs, requires initial safety studies that deviate from standard non-clinical safety protocols. The study provides a strategy to address the safety aspects of biodistribution and tumorigenicity of ATMPs under good laboratory practice (GLP) conditions avoiding cell product manipulation. Moreover, the strategy was applied on a human ATMP for cartilage repair. The testing strategy addresses biodistribution and tumorigenicity using a multi-step analysis without any cell manipulation to exclude changes of test item characteristics. As a safeguard measurement for meeting regulatory expectations, the project design and goals were discussed continuously with the regulatory authority using a staggered scientific advice concept. Subsequently, the strategy was applied to co.don chondrosphere® (huChon spheroid), a tissue-engineered matrix-free ATMP of human normal chondrocytes. In both the biodistribution and tumorigenicity studies, huChon spheroids were implanted subcutaneously into 40 immunodeficient mice. Biodistribution was studied 1 month after implantation. A skin disc containing the huChon spheroid, two surrounding skin rings and selected organs were analyzed by validated, gender-specific, highly-sensitive triplex qPCR and by immunohistochemistry (IHC). No human DNA was detected in distant skin rings and analyzed organs. IHC revealed no direct or indirect indications of cell migration. Tumorigenicity was assessed 6 months after huChon spheroid implantation by palpation, macroscopic inspection, histology and IHC. No mice from the huChon spheroid group developed a tumor at the implantation site. In two mice, benign tumors were detected that were negative for HLA-ABC, suggesting that they were of spontaneous murine origin. In summary, the presented strategy using a multi-step analysis was confirmed to be suitable for safety studies of ATMPs.

Safety assessment of immunomodulatory biologics: the promise and challenges of regulatory T-cell modulation.

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Ponce, Rafael A

2011-01-01

Regulatory T-cell (T(reg)) modulation is developing as an important therapeutic opportunity for the treatment of a number of important diseases, including cancer, autoimmunity, infection, and organ transplant rejection. However, as demonstrated with IL-2 and TGN-1412, our understanding of the complex immunological interactions that occur with T(reg) modulation in both non-clinical models and in patients remains limited and appears highly contextual. This lack of understanding will challenge our ability to identify the patient population who might derive the highest benefit from T(reg) modulation and creates special challenges as we transition these therapeutics from non-clinical models into humans. Thus, in vivo testing in the most representative animal model systems, with careful progress in the clinic, will remain critical in developing therapeutics targeting T(reg) and understanding their clinical utility. Moreover, toxicology models can inform some of the potential liabilities associated with T(reg) modulation, but not all, suggesting a continued need to explore and validate predictive models.

Intracranial contrast transit times on digital subtraction angiography decrease more in patients with delayed intraparenchymal hemorrhage after Pipeline.

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Brunozzi, Denise; Shakur, Sophia F; Charbel, Fady T; Alaraj, Ali

2018-04-01

Background Pipeline embolization devices (PEDs) are used for endovascular treatment of cerebral aneurysms but can be associated with delayed ipsilateral intraparenchymal hemorrhage (DIPH). Changes in intracranial hemodynamics after PED are poorly understood. Objective Here, we assess hemodynamic changes after PED in patients and compare these changes in patients with and without DIPH (DIPH+ and DIPH-). Methods Records of patients with distal internal carotid artery (ICA) aneurysms treated with PED at our institution between 2012 and 2017 were retrospectively reviewed. Regions of interest were selected proximally to PED over the cavernous ICA and distally over the middle cerebral artery (MCA), and then transit times were determined using syngo iFlow software (Siemens). Ratio of MCA to ICA transit time was compared before, after treatment, and at follow-up. Ratios were also compared between DIPH+ and DIPH- subgroups. Correlations between aneurysm size, age, and ratios were investigated. Results Fifty-three patients were included. The ratio of MCA to ICA transit time decreased significantly after PED deployment (1.13 vs. 1.22, p transit time decreases following PED treatment and decreases more in patients with DIPH. These contrast transit time changes can be detected in real time immediately after PED deployment.

Qualidade de pedúnculos de caju submetidos à aplicação pós-colheita de cálcio e armazenados sob refrigeração Quality of cashew pseudofruits treated with calcium at postharvest and stored under refrigeration

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Raimundo Wilane de Figueiredo

2007-04-01

Full Text Available O objetivo deste trabalho foi avaliar os efeitos da aplicação de cálcio pós-colheita nas características químicas, físico-químicas e nos teores de cálcio em pedúnculos de cajueiro-anão precoce CCP-76, submetidos a armazenamento refrigerado sob atmosfera modificada. Os cajus foram imersos em água e em soluções com diferentes concentrações de cloreto de cálcio (0,5, 1 e 2% p/v, por dois minutos. Os cajus foram acondicionados em bandejas de isopor, envolvidos em filme de PVC e armazenados a 5±1°C e 88±3% de umidade relativa, durante 25 dias. Os teores de sólidos solúveis e açúcares solúveis diminuíram durante o armazenamento. Os pedúnculos de caju, independentemente da dose de cálcio, apresentaram tendência à diminuição da acidez e da vitamina C com o armazenamento, enquanto o pH apresentou um pequeno e gradual crescimento. Não houve variação nas antocianinas, nos pseudofrutos de caju tratados com cálcio. Verificaram-se pequenas reduções nas frações fenólicas menos polimerizadas, durante o armazenamento. O cálcio aplicado nas doses de 0,5 e 2% aumentou os teores de cálcio nos pedúnculos até o 15º dia, com diminuição posterior até o final do experimento.The objective of this work was to evaluate the effects of postharvest calcium applications on chemical and physico-chemical characteristics, quality atributes and calcium tissue concentration of early dwarf cashew pseudofruits (Anacardium occidentale L., stored under refrigeration and modified atmosphere. The cashews were immersed in water and in different calcium chloride solution concentrations (0.5, 1 and 2% (w/v for two minutes. Cashews were put in polysterene trays, packed in polyvinyl chloride (PVC and storaged at 5±1°C, 88±3% RH for 25 days. The total soluble solids (Brix and soluble sugars decreased during storage. The pseudofruits, independent of the chloride calcium concentration, showed a tendency to decrease the total titratable acidity

Ex-vivo release of Pipeline Embolization Device polytetrafluoroethylene (PTFE) sleeves for improved distal landing zone accuracy in-vivo: A technical note.

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Griessenauer, Christoph J; Gupta, Raghav; Moore, Justin; Thomas, Ajith J; Ogilvy, Christopher S

2016-12-01

Distal landing zone accuracy is critical in some intracranial aneurysms treated with the Pipeline Embolization Device (PED), and delayed opening of the distal end of the device can complicate the procedure. Here, we report a technical nuance that facilitates accurate placement of the distal end of the PED by ex-vivo, pre-implantation release of the PED Flex polytetrafluoroethylene (PTFE) sleeves. The PED Flex is partially pushed out of the introducer sheath ex-vivo, pre-implantation until the distal PED opens entirely and the PTFE sleeves are located distal to the device. Without inverting the PTFE sleeves, the PED is carefully pulled back into the introducer sheath placing the PTFE sleeves inside the device. The PED is loaded into the microcatheter and advanced toward the site of implantation. When the PED is initially deployed and pushed out of the microcatheter, it opens immediately and provides an anchor for the remainder of the deployment process. We present a video (supplementary material) that illustrates the technique along with an illustrative case. Ex-vivo, pre-implantation release of the PTFE sleeves is an option in aneurysm treatment where distal landing accuracy is critical. Even without the protection of the PTFE sleeves, our clinical observation shows that the PED can be advanced safely through the microcatheter in selected cases. © The Author(s) 2016.

Childhood sexual abuse: long-term effects on psychological and sexual functioning in a nonclinical and nonstudent sample of adult women.

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Greenwald, E; Leitenberg, H; Cado, S; Tarran, M J

1990-01-01

The purpose of this study was to explore how the experience of childhood sexual abuse is related to long-term psychological and sexual functioning in a nonclinical and nonstudent community sample of women. Questionnaires were distributed to 1,500 nurses and returned anonymously. Fifty-four women who had been sexually abused as children (age 15 or younger) responded. These subjects were then matched with 54 nonabused control subjects. Although there was no difference on a measure of self-esteem, the abused group reported more symptoms of distress on the Global Severity Index and on seven out of nine subscales of the Derogatis Brief Symptom Inventory. They also reported more disturbance on a scale which examined psychological symptoms that have been commonly reported in the literature to be particularly associated with sexual abuse. These differences between the abused and nonabused groups were evident even after controlling for differences in subjects' perceptions of parental emotional support. Unlike the results for psychological adjustment, however, the abused subjects did not differ from the control subjects on self-reported levels of sexual satisfaction or sexual dysfunction.

Emotional eating and eating psychopathology in nonclinical groups: a cross-cultural comparison of women in Japan and the United Kingdom.

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Waller, G; Matoba, M

1999-11-01

Emotional eating is associated with eating psychopathology among Western populations. It is not known whether the same conclusions hold in non-Western cultures, where norms for emotional expression differ. This study examined whether emotional eating has the same eating psychopathology correlates in different cultures. Three groups of nonclinical women were compared-Japanese living in Japan; Japanese living in the United Kingdom; and British living in the United Kingdom. They completed an Emotional Eating Scale and the Eating Disorders Inventory. There were different patterns of association between emotional eating and eating attitudes in the three groups. British women showed a strong linkage, Japanese women living in Japan showed no association, and Japanese women in the United Kingdom showed an intermediate pattern. Emotional eating may be less of an index of eating psychopathology in non-Western cultures. However, there appears to be an acculturative process, linking the two when one enters a Western culture. This cross-cultural difference may have implications for the targeting of therapies, although this conclusion requires support from further research. Copyright 1999 by John Wiley & Sons, Inc.

Family Functioning and Relationship Quality for Adolescents in Family-based Treatment with Severe Anorexia Nervosa Compared with Non-clinical Adolescents.

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Wallis, Andrew; Miskovic-Wheatley, Jane; Madden, Sloane; Rhodes, Paul; Crosby, Ross D; Cao, Li; Touyz, Stephen

2018-01-01

This longitudinal study explored family functioning and relationship quality for adolescents with severe anorexia nervosa (AN). An important outcome given healthy family functioning supports effective adolescent development. Fifty-four female adolescents and their parents, treated with family-based treatment after inpatient admission, and 49 non-clinical age-matched adolescents and their parents were compared at assessment and 6 months after session 20. At baseline, AN group mothers and fathers reported poorer family function. AN adolescents were notably similar to controls, reporting poorer function in only one domain. There were no changes for adolescents, an improvement for mothers in the AN group, but an increase in perceived impairment for fathers in both groups, with AN fathers more affected. The similarity in adolescent reports and the increase for fathers over time may indicate that normal adolescent family processes occur even in the midst of serious illness. There is a need to provide intervention to ameliorate the impact of treatment on parents. Copyright © 2017 John Wiley & Sons, Ltd and Eating Disorders Association. Copyright © 2017 John Wiley & Sons, Ltd and Eating Disorders Association.

The mPED randomized controlled clinical trial: applying mobile persuasive technologies to increase physical activity in sedentary women protocol

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Fukuoka Yoshimi

2011-12-01

Full Text Available Abstract Background Despite the significant health benefits of regular physical activity, approximately half of American adults, particularly women and minorities, do not meet the current physical activity recommendations. Mobile phone technologies are readily available, easily accessible and may provide a potentially powerful tool for delivering physical activity interventions. However, we need to understand how to effectively apply these mobile technologies to increase and maintain physical activity in physically inactive women. The purpose of this paper is to describe the study design and protocol of the mPED (mobile phone based physical activity education randomized controlled clinical trial that examines the efficacy of a 3-month mobile phone and pedometer based physical activity intervention and compares two different 6-month maintenance interventions. Methods A randomized controlled trial (RCT with three arms; 1 PLUS (3-month mobile phone and pedometer based physical activity intervention and 6-month mobile phone diary maintenance intervention, 2 REGULAR (3-month mobile phone and pedometer based physical activity intervention and 6-month pedometer maintenance intervention, and 3 CONTROL (pedometer only, but no intervention will be conducted. A total of 192 physically inactive women who meet all inclusion criteria and successfully complete a 3-week run-in will be randomized into one of the three groups. The mobile phone serves as a means of delivering the physical activity intervention, setting individualized weekly physical activity goals, and providing self-monitoring (activity diary, immediate feedback and social support. The mobile phone also functions as a tool for communication and real-time data capture. The primary outcome is objectively measured physical activity. Discussion If efficacy of the intervention with a mobile phone is demonstrated, the results of this RCT will be able to provide new insights for current behavioral

The mPED randomized controlled clinical trial: applying mobile persuasive technologies to increase physical activity in sedentary women protocol.

Science.gov (United States)

Fukuoka, Yoshimi; Komatsu, Judith; Suarez, Larry; Vittinghoff, Eric; Haskell, William; Noorishad, Tina; Pham, Kristin

2011-12-14

Despite the significant health benefits of regular physical activity, approximately half of American adults, particularly women and minorities, do not meet the current physical activity recommendations. Mobile phone technologies are readily available, easily accessible and may provide a potentially powerful tool for delivering physical activity interventions. However, we need to understand how to effectively apply these mobile technologies to increase and maintain physical activity in physically inactive women. The purpose of this paper is to describe the study design and protocol of the mPED (mobile phone based physical activity education) randomized controlled clinical trial that examines the efficacy of a 3-month mobile phone and pedometer based physical activity intervention and compares two different 6-month maintenance interventions. A randomized controlled trial (RCT) with three arms; 1) PLUS (3-month mobile phone and pedometer based physical activity intervention and 6-month mobile phone diary maintenance intervention), 2) REGULAR (3-month mobile phone and pedometer based physical activity intervention and 6-month pedometer maintenance intervention), and 3) CONTROL (pedometer only, but no intervention will be conducted). A total of 192 physically inactive women who meet all inclusion criteria and successfully complete a 3-week run-in will be randomized into one of the three groups. The mobile phone serves as a means of delivering the physical activity intervention, setting individualized weekly physical activity goals, and providing self-monitoring (activity diary), immediate feedback and social support. The mobile phone also functions as a tool for communication and real-time data capture. The primary outcome is objectively measured physical activity. If efficacy of the intervention with a mobile phone is demonstrated, the results of this RCT will be able to provide new insights for current behavioral sciences and mHealth. ClinicalTrials.gov#:NCTO1280812.

Tradução e adaptação cultural do Peds QL TM ESRD para a língua portuguesa

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Marcos Lopes

2011-12-01

Full Text Available OBJETIVO: Traduzir e adaptar a versão 3.0 do questionário Peds QL TM - End Stage Renal Disease para a língua portuguesa. METODOLOGIA: A metodologia adotada foi proposta pelo idealizador do questionário original e é composta por 4 fases: tradução da versão original, retradução para o idioma inglês, aplicação em grupos de pacientes e prova de leitura e finalização, sendo que, as traduções e a revisão foram realizadas por profissionais especialistas nas línguas portuguesa e inglesa. Os questionários são compostos pelas versões de relato da criança e do adolescente e relato dos pais, e divididos em faixas etárias de 2 a 4 anos (apenas relato dos pais, 5 a 7 anos, 8 a 12 anos e 13 a 18 anos. Ao todo, foram realizadas 35 entrevistas, sendo 15 de crianças e adolescentes e 20 dos responsáveis. CONCLUSÕES: O processo de tradução e adaptação cultural, que consistiu na equivalência semântica (equivalência entre as palavras, equivalência idiomática (expressões equivalentes não encontradas ou itens que precisavam ser substituídos e equivalência experimental (palavras e situações adequadas ao contexto cultural brasileiro, resultaram em uma versão de fácil compreensão e administração.

Use of toxicogenomics in drug safety evaluation: Current status and an industry perspective.

Science.gov (United States)

Vahle, John L; Anderson, Ulf; Blomme, Eric A G; Hoflack, Jean-Christophe; Stiehl, Daniel P

2018-04-18

Toxicogenomics held great promise as an approach to enable early detection of toxicities induced by xenobiotics; however, there remain questions regarding the impact of the discipline on pharmaceutical nonclinical safety assessment. To understand the current state of toxicogenomics in the sector, an industry group surveyed companies to determine the frequency of toxicogenomics use in in vivo studies at various stages of drug discovery and development and to assess how toxicogenomics use has evolved over time. Survey data were compiled during 2016 from thirteen pharmaceutical companies. Toxicogenomic analyses were infrequently conducted in the development phase and when performed were done to address specific mechanistic questions. Prior to development, toxicogenomics use was more frequent; however, there were significant differences in approaches among companies. Across all phases, gaining mechanistic insight was the most frequent reason cited for pursing toxicogenomics with few companies using toxicogenomics to predict toxicities. These data were consistent with the commentary submitted in response to survey questions asking companies to describe the evolution of their toxicogenomics strategy. Overall, these survey data indicate that toxicogenomics is not widely used as a predictive tool in the pharmaceutical industry but is used regularly by some companies and serves a broader role in mechanistic investigations and as a complement to other technologies. Copyright © 2018. Published by Elsevier Inc.

Pipeline embolization device for intracranial aneurysm: a systematic review.

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Leung, G K K; Tsang, A C O; Lui, W M

2012-12-01

The pipeline embolization device (PED) is a new endovascular stent designed for the treatment of challenging intracranial aneurysms (IAs). Its use has been extended to nonruptured and ruptured IAs of a variety of configurations and etiologies in both the anterior and posterior circulations. We conducted a systematic review of ten eligible reports on its clinical efficacy and safety. There were 414 patients with 448 IAs. The majority of the IAs were large (40.2 %), saccular or blister-like (78.3 %), and were located mostly in the anterior circulation (83.5 %). The regimens of antiplatelet therapy varied greatly between and within studies. The mean number of the PED used was 2.0 per IA. Deployment was successful in around 95 % of procedures. Aneurysm obliteration was achieved in 82.9 % of IAs at 6-month. The overall incidences of periprocedural intracranial vascular complication rate and mortality rate were 6.3 and 1.5 %, respectively. The PED is a safe and effective treatment for nonruptured IAs. Its use in the context of acute subarachnoid hemorrhage (SAH) should be cautioned. Its main limitations include the need for prolonged antiplatelet therapy, as well as the potential risks of IA rupture and non-IA-related intracerebral hemorrhages (ICH). Future studies should aim at identifying factors that predispose to incomplete obliteration, delayed rupture, and thromboembolic complications.

A Decade in the MIST: Learnings from Investigations of Drug Metabolites in Drug Development under the "Metabolites in Safety Testing" Regulatory Guidance.

Science.gov (United States)

Schadt, Simone; Bister, Bojan; Chowdhury, Swapan K; Funk, Christoph; Hop, Cornelis E C A; Humphreys, W Griffith; Igarashi, Fumihiko; James, Alexander D; Kagan, Mark; Khojasteh, S Cyrus; Nedderman, Angus N R; Prakash, Chandra; Runge, Frank; Scheible, Holger; Spracklin, Douglas K; Swart, Piet; Tse, Susanna; Yuan, Josh; Obach, R Scott

2018-06-01

Since the introduction of metabolites in safety testing (MIST) guidance by the Food and Drug Administration in 2008, major changes have occurred in the experimental methods for the identification and quantification of metabolites, ways to evaluate coverage of metabolites, and the timing of critical clinical and nonclinical studies to generate this information. In this cross-industry review, we discuss how the increased focus on human drug metabolites and their potential contribution to safety and drug-drug interactions has influenced the approaches taken by industry for the identification and quantitation of human drug metabolites. Before the MIST guidance was issued, the method of choice for generating comprehensive metabolite profile was radio chromatography. The MIST guidance increased the focus on human drug metabolites and their potential contribution to safety and drug-drug interactions and led to changes in the practices of drug metabolism scientists. In addition, the guidance suggested that human metabolism studies should also be accelerated, which has led to more frequent determination of human metabolite profiles from multiple ascending-dose clinical studies. Generating a comprehensive and quantitative profile of human metabolites has become a more urgent task. Together with technological advances, these events have led to a general shift of focus toward earlier human metabolism studies using high-resolution mass spectrometry and to a reduction in animal radiolabel absorption/distribution/metabolism/excretion studies. The changes induced by the MIST guidance are highlighted by six case studies included herein, reflecting different stages of implementation of the MIST guidance within the pharmaceutical industry. Copyright © 2018 by The American Society for Pharmacology and Experimental Therapeutics.

Successful outsourcing: improving quality of life through integrated support services.

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Bates, Jason; Sharratt, Martin; King, John

2014-01-01

This article examines the way that non-clinical support services are provided in healthcare settings through outsourcing partnerships. The integrated support services model and benefits to patient experience and safety as well as organizational efficiency and effectiveness are explored through an examination of services at a busy urban community hospital.

Reformulation of the Children's Eating Attitudes Test (ChEAT): factor structure and scoring method in a non-clinical population.

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Anton, S D; Han, H; Newton, R L; Martin, C K; York-Crowe, E; Stewart, T M; Williamson, D A

2006-12-01

The primary aims of this study were to empirically test the factor structure of the Children's Eating Attitudes Test (ChEAT) through both exploratory and confirmatory factor analyses and to interpret the factor structure of the ChEAT within the context of a new scoring method. The ChEAT was administered to 728 children in the 2nd through 6th grades (from five schools) at two different time points. Exactly half the students were male and half were female. To the best of our knowledge, this is the first study to empirically test the merits of an alternative 6-point scoring system as compared to the traditionally used 4-point scoring system. With the new scoring procedure, the skewness for all factor scores decreased, which resulted in increased variance in the item scores, as well as the total ChEAT score. Since the internal consistency of two factors in a recently proposed model was not acceptable (ChEAT reported by previous investigations. Intercorrelations among the factors suggested three higher order constructs. These findings indicate that the ChEAT subscales may be sufficiently stable to allow use in non-clinical samples of children.

Initial experiences in embedding core competency education in entry-level surgery residents through a nonclinical rotation.

Science.gov (United States)

Kahol, Kanav; Huston, Carrie; Hamann, Jessica; Ferrara, John J

2011-03-01

Health care continues to expand in scope and in complexity. In this changing environment, residents are challenged with understanding its intricacies and the impact it will have on their professional activities and careers. Embedding each of the competency elements in residents in a meaningful way remains a challenge for many surgery residency program directors. We established a nonclinical rotation to provide surgery postgraduate year-1 (PGY-1) residents with a structured, multifaceted, largely self-directed curriculum into which each of the 6 core competencies are woven. Posttesting strategies were established for most curricular experiences to ensure to the greatest possible extent that each resident will have achieved an acceptable level of understanding of each of the competency areas before being given credit for the rotation. By uniformly exceeding satisfactory scores on respective objective analyses, residents demonstrated an increased (at least short-term) understanding of each of the assessed competency areas. Our project sought to address a prior lack of opportunity for our residents to develop a sound foundation for our residents in systems-based practice. Our new rotation addresses systems-based practice in several different learning environments, including emergency medical service ride-along, sentinel event participation, and hospice visits. Several research projects have enhanced the overall learning program. Our experience shows that a rotation dedicated to competency training can provide an innovative and engaging means of teaching residents the value of each element.

The prevalence of novel psychoactive substances (NPS use in non-clinical populations: a systematic review protocol

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Salma M. Khaled

2016-11-01

Full Text Available Abstract Background Novel psychoactive substances (NPS are new narcotic or psychotropic drugs that are not controlled by the United Nations drug convention that may pose a serious public health threat due to their wide availability for purchase on the internet and in so called “head shops.” Yet, the extent of their global use remains largely unknown. The aim of this study is to conduct a systematic review of the prevalence of NPS use in non-clinical populations. Methods This is a systematic review of observational studies. Embase, MEDLINE, PubMed, Cumulative Index to Nursing and Allied Health (CINAHL, Cochrane Library, Lilacs, Scopus, Global Health, PsychINFO, Web of Science, and the World Health Organization (WHO regional databases will be searched for eligible prevalence studies published between 2010 and 2016. Data from cross-sectional studies that report the prevalence of NPS use (one or more types in participants (of any age from censuses or probabilistic or convenience samples will be included. Data will be extracted from eligible publications, using a data extraction tool developed for this study. Visual and statistical approaches will be adopted instead of traditional meta-analytic approaches. Discussion This review will describe the distributions of various types of prevalence estimates of NPS use and explore the impact of different population groups and study-related and tempo-geographical variables on characteristics of these distributions over the period of 2010 to 2016. Systematic review registration PROSPERO CRD42016037020

The Depression Anxiety Stress Scales (DASS): normative data and latent structure in a large non-clinical sample.

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Crawford, John R; Henry, Julie D

2003-06-01

To provide UK normative data for the Depression Anxiety and Stress Scale (DASS) and test its convergent, discriminant and construct validity. Cross-sectional, correlational and confirmatory factor analysis (CFA). The DASS was administered to a non-clinical sample, broadly representative of the general adult UK population (N = 1,771) in terms of demographic variables. Competing models of the latent structure of the DASS were derived from theoretical and empirical sources and evaluated using confirmatory factor analysis. Correlational analysis was used to determine the influence of demographic variables on DASS scores. The convergent and discriminant validity of the measure was examined through correlating the measure with two other measures of depression and anxiety (the HADS and the sAD), and a measure of positive and negative affectivity (the PANAS). The best fitting model (CFI =.93) of the latent structure of the DASS consisted of three correlated factors corresponding to the depression, anxiety and stress scales with correlated error permitted between items comprising the DASS subscales. Demographic variables had only very modest influences on DASS scores. The reliability of the DASS was excellent, and the measure possessed adequate convergent and discriminant validity Conclusions: The DASS is a reliable and valid measure of the constructs it was intended to assess. The utility of this measure for UK clinicians is enhanced by the provision of large sample normative data.

Primary care quality and safety systems in the English National Health Service: a case study of a new type of primary care provider.

Science.gov (United States)

Baker, Richard; Willars, Janet; McNicol, Sarah; Dixon-Woods, Mary; McKee, Lorna

2014-01-01

Although the predominant model of general practice in the UK National Health Service (NHS) remains the small partnership owned and run by general practitioners (GPs), new types of provider are emerging. We sought to characterize the quality and safety systems and processes used in one large, privately owned company providing primary care through a chain of over 50 general practices in England. Senior staff with responsibility for policy on quality and safety were interviewed. We also undertook ethnographic observation in non-clinical areas and interviews with staff in three practices. A small senior executive team set policy and strategy on quality and safety, including a systematic incident reporting and investigation system and processes for disseminating learning with a strong emphasis on customer focus. Standardization of systems was possible because of the large number of practices. Policies appeared generally well implemented at practice level. However, there was some evidence of high staff turnover, particularly of GPs. This caused problems for continuity of care and challenges in inducting new GPs in the company's systems and procedures. A model of primary care delivery based on a corporate chain may be useful in standardizing policies and procedures, facilitating implementation of systems, and relieving clinical staff of administrative duties. However, the model also poses some risks, including those relating to stability. Provider forms that retain the long term, personal commitment of staff to their practices, such as federations or networks, should also be investigated; they may offer the benefits of a corporate chain combined with the greater continuity and stability of the more traditional general practice.

Extended Preclinical Safety, Efficacy and Stability Testing of a Live-attenuated Chikungunya Vaccine Candidate.

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Kenneth S Plante

Full Text Available We recently described a new, live-attenuated vaccine candidate for chikungunya (CHIK fever, CHIKV/IRES. This vaccine was shown to be well attenuated, immunogenic and efficacious in protecting against CHIK virus (CHIKV challenge of mice and nonhuman primates. To further evaluate its preclinical safety, we compared CHIKV/IRES distribution and viral loads in interferon-α/β receptor-incompetent A129 mice to another CHIK vaccine candidate, 181/clone25, which proved highly immunogenic but mildly reactive in human Phase I/II clinical trials. Compared to wild-type CHIK virus, (wt-CHIKV, both vaccines generated lower viral loads in a wide variety of tissues and organs, including the brain and leg muscle, but CHIKV/IRES exhibited marked restrictions in dissemination and viral loads compared to 181/clone25, and was never found outside the blood, spleen and muscle. Unlike wt-CHIKV, which caused disrupted splenic architecture and hepatic lesions, histopathological lesions were not observed in animals infected with either vaccine strain. To examine the stability of attenuation, both vaccines were passaged 5 times intracranially in infant A129 mice, then assessed for changes in virulence by comparing parental and passaged viruses for footpad swelling, weight stability and survival after subcutaneous infection. Whereas strain 181/clone25 p5 underwent a significant increase in virulence as measured by weight loss (from 30% and mortality (from 0 to 100%, CHIKV/IRES underwent no detectible change in any measure of virulence (no significant weight loss and no mortality. These data indicate greater nonclinical safety of the CHIKV/IRES vaccine candidate compared to 181/clone25, further supporting its eligibility for human testing.

Recombinant human tripeptidyl peptidase-1 infusion to the monkey CNS: Safety, pharmacokinetics, and distribution

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Vuillemenot, Brian R., E-mail: bvuillemenot@bmrn.com [BioMarin Pharmaceutical Inc., Novato, CA (United States); Kennedy, Derek [BioMarin Pharmaceutical Inc., Novato, CA (United States); Reed, Randall P.; Boyd, Robert B. [Northern Biomedical Research, Inc., Muskegon, MI (United States); Butt, Mark T. [Tox Path Specialists, LLC, Hagerstown, MD (United States); Musson, Donald G.; Keve, Steve; Cahayag, Rhea; Tsuruda, Laurie S.; O' Neill, Charles A. [BioMarin Pharmaceutical Inc., Novato, CA (United States)

2014-05-15

CLN2 disease is caused by deficiency in tripeptidyl peptidase-1 (TPP1), leading to neurodegeneration and death. The safety, pharmacokinetics (PK), and CNS distribution of recombinant human TPP1 (rhTPP1) were characterized following a single intracerebroventricular (ICV) or intrathecal-lumbar (IT-L) infusion to cynomolgus monkeys. Animals received 0, 5, 14, or 20 mg rhTPP1, ICV, or 14 mg IT-L, in artificial cerebrospinal fluid (aCSF) vehicle. Plasma and CSF were collected for PK analysis. Necropsies occurred at 3, 7, and 14 days post-infusion. CNS tissues were sampled for rhTPP1 distribution. TPP1 infusion was well tolerated and without effect on clinical observations or ECG. A mild increase in CSF white blood cells (WBCs) was detected transiently after ICV infusion. Isolated histological changes related to catheter placement and infusion were observed in ICV treated animals, including vehicle controls. The CSF and plasma exposure profiles were equivalent between animals that received an ICV or IT-L infusion. TPP1 levels peaked at the end of infusion, at which point the enzyme was present in plasma at 0.3% to 0.5% of CSF levels. TPP1 was detected in brain tissues with half-lives of 3–14 days. CNS distribution between ICV and IT-L administration was similar, although ICV resulted in distribution to deep brain structures including the thalamus, midbrain, and striatum. Direct CNS infusion of rhTPP1 was well tolerated with no drug related safety findings. The favorable nonclinical profile of ICV rhTPP1 supports the treatment of CLN2 by direct administration to the CNS. - Highlights: • TPP1 enzyme replacement therapy to the CNS is in development for CLN2 disease. • Toxicology, pharmacokinetics, and CNS distribution were assessed in monkeys. • TPP1 infusion directly to the brain did not result in any safety concerns. • A positive pharmacokinetic and distribution profile resulted from TPP1 infusion. • This study demonstrates the feasibility of ICV administered

Recombinant human tripeptidyl peptidase-1 infusion to the monkey CNS: Safety, pharmacokinetics, and distribution

International Nuclear Information System (INIS)

Vuillemenot, Brian R.; Kennedy, Derek; Reed, Randall P.; Boyd, Robert B.; Butt, Mark T.; Musson, Donald G.; Keve, Steve; Cahayag, Rhea; Tsuruda, Laurie S.; O'Neill, Charles A.

2014-01-01

CLN2 disease is caused by deficiency in tripeptidyl peptidase-1 (TPP1), leading to neurodegeneration and death. The safety, pharmacokinetics (PK), and CNS distribution of recombinant human TPP1 (rhTPP1) were characterized following a single intracerebroventricular (ICV) or intrathecal-lumbar (IT-L) infusion to cynomolgus monkeys. Animals received 0, 5, 14, or 20 mg rhTPP1, ICV, or 14 mg IT-L, in artificial cerebrospinal fluid (aCSF) vehicle. Plasma and CSF were collected for PK analysis. Necropsies occurred at 3, 7, and 14 days post-infusion. CNS tissues were sampled for rhTPP1 distribution. TPP1 infusion was well tolerated and without effect on clinical observations or ECG. A mild increase in CSF white blood cells (WBCs) was detected transiently after ICV infusion. Isolated histological changes related to catheter placement and infusion were observed in ICV treated animals, including vehicle controls. The CSF and plasma exposure profiles were equivalent between animals that received an ICV or IT-L infusion. TPP1 levels peaked at the end of infusion, at which point the enzyme was present in plasma at 0.3% to 0.5% of CSF levels. TPP1 was detected in brain tissues with half-lives of 3–14 days. CNS distribution between ICV and IT-L administration was similar, although ICV resulted in distribution to deep brain structures including the thalamus, midbrain, and striatum. Direct CNS infusion of rhTPP1 was well tolerated with no drug related safety findings. The favorable nonclinical profile of ICV rhTPP1 supports the treatment of CLN2 by direct administration to the CNS. - Highlights: • TPP1 enzyme replacement therapy to the CNS is in development for CLN2 disease. • Toxicology, pharmacokinetics, and CNS distribution were assessed in monkeys. • TPP1 infusion directly to the brain did not result in any safety concerns. • A positive pharmacokinetic and distribution profile resulted from TPP1 infusion. • This study demonstrates the feasibility of ICV administered

Vibrational Energy Distribution Analysis (VEDA): Scopes and limitations

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Jamróz, Michał H.

2013-10-01

The principle of operations of the VEDA program written by the author for Potential Energy Distribution (PED) analysis of theoretical vibrational spectra is described. Nowadays, the PED analysis is indispensible tool in serious analysis of the vibrational spectra. To perform the PED analysis it is necessary to define 3N-6 linearly independent local mode coordinates. Already for 20-atomic molecules it is a difficult task. The VEDA program reads the input data automatically from the Gaussian program output files. Then, VEDA automatically proposes an introductory set of local mode coordinates. Next, the more adequate coordinates are proposed by the program and optimized to obtain maximal elements of each column (internal coordinate) of the PED matrix (the EPM parameter). The possibility for an automatic optimization of PED contributions is a unique feature of the VEDA program absent in any other programs performing PED analysis.

Biodistribution and safety of a live attenuated tetravalent dengue vaccine in the cynomolgus monkey.

Science.gov (United States)

Ravel, Guillaume; Mantel, Nathalie; Silvano, Jeremy; Rogue, Alexandra; Guy, Bruno; Jackson, Nicholas; Burdin, Nicolas

2017-10-13

The first licensed dengue vaccine is a recombinant, live, attenuated, tetravalent dengue virus vaccine (CYD-TDV; Sanofi Pasteur). This study assessed the biodistribution, shedding, and toxicity of CYD-TDV in a non-human primate model as part of the nonclinical safety assessment program for the vaccine. Cynomolgus monkeys were given one subcutaneous injection of either one human dose (5log 10 CCID 50 /serotype) of CYD-TDV or saline control. Study endpoints included clinical observations, body temperature, body weight, food consumption, clinical pathology, immunogenicity, and post-mortem examinations including histopathology. Viral load, distribution, persistence, and shedding in tissues and body fluids were evaluated by quantitative reverse transcriptase polymerase chain reaction. The subcutaneous administration of CYD-TDV was well tolerated. There were no toxicological findings other than expected minor local reactions at the injection site. A transient low level of CYD-TDV viral RNA was detected in blood and the viral genome was identified primarily at the injection site and in the draining lymph nodes following immunization. These results, together with other data from repeat-dose toxicity and neurovirulence studies, confirm the absence of toxicological concern with CYD-TDV and corroborate clinical study observations. Copyright © 2017 Elsevier Ltd. All rights reserved.

Patient safety: Safety culture and patient safety ethics

DEFF Research Database (Denmark)

Madsen, Marlene Dyrløv

2006-01-01

,demonstrating significant, consistent and sometimes large differences in terms of safety culture factors across the units participating in the survey. Paper 5 is the results of a study of the relation between safety culture, occupational health andpatient safety using a safety culture questionnaire survey......Patient safety - the prevention of medical error and adverse events - and the initiative of developing safety cultures to assure patients from harm have become one of the central concerns in quality improvement in healthcare both nationally andinternationally. This subject raises numerous...... challenging issues of systemic, organisational, cultural and ethical relevance, which this dissertation seeks to address through the application of different disciplinary approaches. The main focus of researchis safety culture; through empirical and theoretical studies to comprehend the phenomenon, address...

The Prevalence and Characteristics of Performance-Enhancing Drug Use Among Bodybuilding Athletes in the South of Iran, Bushehr.

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Haerinejad, Mohammad Javad; Ostovar, Afshin; Farzaneh, Mohamad Reza; Keshavarz, Mojtaba

2016-09-01

Several reports have implied progressive increase of performance-enhancing drug (PED) use among Iranian athletes. More importantly, most of the previous research in the Iranian population had mainly focused on the anabolic steroid abuse, and ignored other agents. The aim of this study was to investigate the prevalence and characteristics of PED use among bodybuilding athletes in Bushehr, south of Iran. Four hundred and fifty three male bodybuilding athletes were recruited from Bushehr gyms between February and May of 2015. Men were eligible to participate in the survey if they had regularly participated in the strength-training exercise (minimum of 1 year and 4 hour/week). Data were collected via a face-to-face interview. The survey consisted of three separate parts including demographic data, exercise pattern and PED use. According to this study, 234 (51.7%) of bodybuilding athletes had used PEDs. The PED users reported an average of 3.80 ± 4.52 agents' use in their programs and they had used PEDs for the average of 3.24 ± 3.99 years. The most prevalent agents which had been abused by the athletes were anabolic steroids (used by 185 athletes (79.4% of athletes). Furthermore, 110 (47%) of athletes reported stimulant agents' use during their routines. The most prevalent motivation for using PEDs was increasing muscle mass that was reported by 164 (70.1%) of PED users. In addition, sexual and dermatologic effects were the most prevalent adverse effects reported by the PED user athletes (114 (49.4%) and 103 (44.2%), respectively). This study showed the high rate of PED use among recreational and professional Iranian bodybuilding athletes that can expose them to the serious side effects of these agents.

Armazenamento refrigerado sob atmosfera modificada de pedúnculos de cajueiro-anão-precoce dos clones CCP-76, end-157, end-183 e end-189 Storage of cashew apples from dwarf clones CCP-76, end-157, end-183 and end-189 under refrigeration and modified atmosphere

Directory of Open Access Journals (Sweden)

Auricélia de Souza Morais

2002-12-01

Full Text Available Pedúnculos de clones de cajueiro-anão-precoce, dos clones CCP-76, END-157, END-183 e END-189, foram armazenados durante 25 dias, sob refrigeração associada a atmosfera modificada, com o objetivo de avaliar o efeito das condições atualmente utilizadas (5ºC e 85-90% de UR para conservação, transporte e comercialização de cajus in natura. Os pedúnculos foram avaliados a cada 5 dias quanto às seguintes características: perda de peso, firmeza, cor (antocianinas, sólidos e açúcares solúveis, acidez, pH, vitamina C e compostos fenólicos. O uso da refrigeração (5ºC e 85% U.R, associada a atmosfera modificada, proporcionou uma vida útil pós-colheita de 10 dias para o clone END 189, de até 15 dias para o clone END 157 e de até 25 dias para os clones CCP 76 e END 183. A temperatura de 5ºC não se mostrou adequada para armazenamento de pedúnculos de coloração mais intensa (END 157 e END 189 que a testemunha (CCP 76, provocando perda de cor (antocianinas a partir do 10º dia de armazenamento. A atmosfera modificada reduziu significativamente a perda de peso, favorecendo a aparência do produto para comercialização, independentemente do clone estudado.Apples or false fruits from early dwarf cashew clones CCP-76, END-157, END-183 and END-189 were stored for 25 days under refrigeration associated to modified atmosphere with the aim of evaluating the effect of the conditions presently adopted (5ºC and 85-90% RH for conservation, storage and commercialization of fresh cashew apples. The cashew apples were evaluated every 5 days for the following characteristics: weight loss, pulp firmness, color (anthocyannins, acidity, pH, soluble solids, vitamin C and phenolic contents. With the use of refrigeration and modified atmosphere it was possible to attain postharvest storage life of 10 days for clone END 189, 15 days for clone END 157 and up to 25 days for clones CCP 76 and END 183. It was found that 5ºC was not an adequate

Evaluation of a Zulu translation of the Parents' Evaluation of Developmental Status.

Science.gov (United States)

Van der Merwe, Maria; Cilliers, Marlé; Maré, Celesté; Van der Linde, Jeannie; Le Roux, Mia

2017-06-28

One of the greatest challenges in early communication intervention in South Africa is developing and implementing successful identification strategies in primary health care (PHC). A shortage of trained PHC personnel is one of the barriers to providing adequate health services in South Africa. This dearth of services creates the need to substitute clinician-administered developmental screening tools with parent-administered tools. To determine the accuracy of the Zulu Parents' Evaluation of Developmental Status (PEDS) in comparison with the outcome of the English PEDS. The data were collected in a clinical, non-contrived environment at Stanza Bopape Community Health Clinic in Mamelodi, City of Tshwane. The PEDS is a standardised, parent-completed questionnaire regarding the child's general development. The English PEDS was translated into Zulu by a Zulu linguist. There were 99 potential participants in the study of whom 83 met the necessary prerequisites. Of the participants whose home language is Zulu, 54% preferred the PEDS in English over the PEDS in Zulu. This indicates a skewed preference towards English, with only slight associations between language preference and age, education and home language. The Zulu PEDS displayed high positive and negative correspondences, representative of an accurate translation of the English PEDS. It is recommended that this study should be repeated in a community where the majority are Zulu home language speakers.

Evaluation of a Zulu translation of the Parents’ Evaluation of Developmental Status

Science.gov (United States)

van der Merwe, Maria; Cilliers, Marlé; Maré, Celéste

2017-01-01

Background One of the greatest challenges in early communication intervention in South Africa is developing and implementing successful identification strategies in primary health care (PHC). A shortage of trained PHC personnel is one of the barriers to providing adequate health services in South Africa. This dearth of services creates the need to substitute clinician-administered developmental screening tools with parent-administered tools. Aim To determine the accuracy of the Zulu Parents’ Evaluation of Developmental Status (PEDS) in comparison with the outcome of the English PEDS. Setting The data were collected in a clinical, non-contrived environment at Stanza Bopape Community Health Clinic in Mamelodi, City of Tshwane. Methods The PEDS is a standardised, parent-completed questionnaire regarding the child’s general development. The English PEDS was translated into Zulu by a Zulu linguist. There were 99 potential participants in the study of whom 83 met the necessary prerequisites. Results Of the participants whose home language is Zulu, 54% preferred the PEDS in English over the PEDS in Zulu. This indicates a skewed preference towards English, with only slight associations between language preference and age, education and home language. Conclusion The Zulu PEDS displayed high positive and negative correspondences, representative of an accurate translation of the English PEDS. It is recommended that this study should be repeated in a community where the majority are Zulu home language speakers. PMID:28697618

Aspectos morfológicos, morfométricos e ultraestruturais do baço de ratos após o clampeamento total do pedículo hepático Morphologic, morphometric, and ultrastructural aspects of the spleen of rats after hepatic pedicle total clamping

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S.H. Freitas

2009-12-01

Full Text Available Avaliaram-se as alterações morfológicas, morfométricas e ultraestruturais que ocorreram no baço devido à isquemia produzida pelo clampeamento total do pedículo hepático. Para tanto, foram utilizados 40 ratos machos, distribuídos em quatro grupos de 10 animais. O grupo-controle (C não foi submetido à isquemia, e os grupos tratados (E1, E2e E3 foram submetidos ao clampeamento por 10, 20 e 30 minutos, respectivamente. Fragmentos do baço foram retirados e analisados histologicamente pela microscopia de luz (hematoxilina-eosina, ferrocianeto-férrico e pela microscopia eletrônica de transmissão. Os resultados demonstraram que 10 minutos de clampeamento do pedículo hepático são suficientes para apresentar sinais de congestão esplênica e 20 e 30 minutos promovem intensa digestão de hemácias pelos macrófagos, com presença de grânulos de ferro (hemossiderina no parênquima esplênico.The macro and microscopic alterations that occurred in the spleen during an ischemia produced by the hepatic pedicle total clamping were studied. Forty male rats were distributed in four groups of 10 animals each. The control group (C was not submitted to ischemia and the treated groups (E1, E2, and E3 were submitted to the clamping during 10, 20, and 30 minutes, respectively. Spleen fragments were collected and histologically analyzed by the light microscopy (eosin-hematoxilin and ferric ferrocyanide and by the transmission electron microscopy. The results showed that 10 minutes of hepatic pedicle total clamping was enough produce signs of splenic congestion and 20 and 30 minutes promoted intense red bood cels digestion by the macrophages with the presence of iron granules (hemosiderin in the splenic parenchyma.

Development of modified piping evaluation diagram for LBB application to Korean next generation reactor

International Nuclear Information System (INIS)

Huh, Nam Su; Kim, Young Jin; Pyo, Chang ryul; Yu, Young Jun; Yang, Jun Seog

1999-01-01

Recently, the Piping Evaluation Diagram (PED) is accepted in nuclear industry for simple application of Leak-Before-Break (LBB) concept to piping system. By utilizing the PED, the LBB concept is applied before the piping layout is finalized. However, the developed PED may have to be modified to account for the difference between the material properties of the PED development stage and those of the assembly stage. The objective of this paper is to develop the modified PED which can account for the variation of material properties. For this purpose, a parametric study was performed to investigate the effect of stress-strain curve on the detectable crack length and the effect of fracture resistance curve on the LBB allowable load. Finite element analyses were also performed to investigate the effect of stress-strain curve on the LBB allowable load. Finally a modified PED is developed as a function of crack length (DLC and 2xDLC) and the allowable Safe shutdown Earthquake (SSE) load. By adopting the modified PED, the variation of material properties can be considered in the LBB analysis and the computer runs required for the LBB analysis can be considerably reduced

Response of vascular pigment epithelium detachment due to age-related macular degeneration to monthly treatment with ranibizumab: the prospective, multicentre RECOVER study.

Science.gov (United States)

Clemens, Christoph R; Wolf, Armin; Alten, Florian; Milojcic, Carolin; Heiduschka, Peter; Eter, Nicole

2017-11-01

To assess the effects of monthly intravitreal ranibizumab injections in patients with vascularized pigment epithelium detachment (vPED) secondary to age-related macular degeneration (AMD). A total of 40 patients were prospectively observed and treated monthly with 0.5 mg ranibizumab injections (ClinicalTrials.gov Ident. NCT00976222). Inclusion criterion was a treatment-naïve vPED lesion with a minimum height of ≥200 μm. Best-corrected visual acuity (BCVA) and spectral-domain optical coherence tomography (SD-OCT) were evaluated at all visits. Fluorescein angiography and indocyanine green angiography were performed at baseline and quarterly. Lesions were differentiated between serous vascular PED (svPED, group A, 29 patients) and fibrovascular PED (fPED, group B, 11 patients). Primary outcome was the effectivity of continuous monthly treatment during a 12-month period as measured in change in BCVA. Secondary outcomes were change in PED height and PED greatest linear diameter (GLD). Further secondary outcomes were the presence of subretinal fluid and prognostic markers of an impending retinal pigment epithelium (RPE) tear: PED lesion height and diameter, ratio of choroidal neovascularization (CNV) size to PED size, hyperreflective lines in near-infrared images, microrips and subretinal cleft. Mean BCVA was 56.9 ± 11.5 letters (A: 55.4 ± 10.8; B: 59.1 ± 13.4) at baseline and 55.1 ± 15.9 (A: 53.7 ± 17.0; B: 58.9 ± 12.7) at 12-month follow-up. Excluding the RPE tear patients, the svPED group showed an increase in BCVA from 56.1 ± 10.3 at baseline to 62.4 ± 10.2 at 12-month follow-up (p = 0.048). Best-corrected visual acuity in patient who developed a RPE tear was 55.8 ± 12.5 at baseline and 37.1 ± 14.9 at 12-month follow-up. The mean change in PED height was -242.1 μm ± 285.5 (A: -427.3 μm ± 299.7; B: -51.6 μm ± 99.5). The mean decrease in PED GLD was -471.8 μm ± 727.6 (A: -738.9 μm ± 788.2; B: -10.4�

Orthorexia and anorexia nervosa: two distinct phenomena? A cross-cultural comparison of orthorexic behaviours in clinical and non-clinical samples.

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Gramaglia, C; Brytek-Matera, A; Rogoza, R; Zeppegno, P

2017-02-21

Orthorexia nervosa (ON) is defined as pathological healthful eating. The aim of this study was to investigate whether there is any difference in orthorexic behaviours between clinical and non-clinical groups, and in different cultural contexts. . Recruitment involved both female patients with anorexia nervosa (AN) and healthy controls (HC) from Italy and Poland (N = 23 and N = 35 AN patients; and N = 39 and N = 39 HCs, in Italy and Poland, respectively). Assessment of orthorexic behaviours was performed with the ORTO-15 test. Statistically significant differences were found between Italian women in the AN and HC group, whereas no difference between Polish women in the AN and HC group was found. Both Italian groups scored significantly higher than the Polish ones on the ORTO-15. Differences have been found between the Italian and Polish samples, both in the percentage of individuals with orthorexic behaviours as suggested by an ORTO 15 score below the cutoff, and in the mean ORTO 15 scores in the AN and HC groups, suggesting cross-cultural differences in orthorexic behaviours, whose meaning is currently difficult to understand.

An intravenous microdose of bevacizumab for the treatment of pigment epithelial detachment associated to age-related macular degeneration refractory to intravitreal bevacizumab: a case report.

Science.gov (United States)

Wu, Lihteh; Evans, Teodoro

2011-01-01

The purpose of this study was to report the visual and anatomical outcomes of an intravenous microdose of 10 mg of bevacizumab in a patient with a vascularized pigment epithelial detachment (PED) associated with exudative age-related macular degeneration refractory to several intravitreal bevacizumab injections. Interventional case report and literature review. A 62-year-old female patient with a PED secondary to age-related macular degeneration was treated with 9 consecutive intravitreal injections of 2.5 mg of bevacizumab. Despite an initial response where the PED decreased in size, the subretinal fluid reabsorbed and the visual acuity improved; after the seventh injection, the PED started to grow in size again causing a drop in visual acuity. After an intravenous injection of 10 mg of bevacizumab, the patient experienced an improvement in visual acuity and a flattening of her PED. An intravenous injection of a microdose of bevacizumab appears to have resolved the PED with a sustained improvement of visual acuity.

Defining safety culture and the nexus between safety goals and safety culture. 4. Enhancing Safety Culture Through the Establishment of Safety Goals

International Nuclear Information System (INIS)

Tateiwa, Kenji; Miyata, Koichi; Yahagi, Kimitoshi

2001-01-01

Safety culture is the perception of each individual and organization of a nuclear power plant that safety is the first priority, and at Tokyo Electric Power Company (TEPCO), we have been practicing it in everyday activities. On the other hand, with the demand for competitiveness of nuclear power becoming even more intense these days, we need to pursue efficient management while maintaining the safety level at the same time. Below, we discuss how to achieve compatibility between safety culture and efficient management as well as enhance safety culture. Discussion at Tepco: safety culture-nurturing activities such as the following are being implemented: 1. informing the employees of the 'Declaration of Safety Promotion' by handing out brochures and posting it on the intranet home page; 2. publishing safety culture reports covering stories on safety culture of other industry sectors, recent movements on safety culture, etc.; 3. conducting periodic questionnaires to employees to grasp how deeply safety culture is being established; 4. carrying out educational programs to learn from past cases inside and outside the nuclear industry; 5. committing to common ownership of information with the public. The current status of safety culture in Japan sometimes seems to be biased to the quest of ultimate safety; rephrasing it, there have been few discussions regarding the sufficiency of the quantitative safety level in conjunction with the safety culture. Safety culture is one of the most crucial foundations guaranteeing the plant's safety, and for example, the plant safety level evaluated by probabilistic safety assessment (PSA) could be said to be valid only on the ground that a sound and sufficient safety culture exists. Although there is no doubt that the safety culture is a fundamental and important attitude of an individual and organization that keeps safety the first priority, the safety culture in itself should not be considered an obstruction to efforts to implement

The current status of biomarkers for predicting toxicity

Science.gov (United States)

Campion, Sarah; Aubrecht, Jiri; Boekelheide, Kim; Brewster, David W; Vaidya, Vishal S; Anderson, Linnea; Burt, Deborah; Dere, Edward; Hwang, Kathleen; Pacheco, Sara; Saikumar, Janani; Schomaker, Shelli; Sigman, Mark; Goodsaid, Federico

2013-01-01

Introduction There are significant rates of attrition in drug development. A number of compounds fail to progress past preclinical development due to limited tools that accurately monitor toxicity in preclinical studies and in the clinic. Research has focused on improving tools for the detection of organ-specific toxicity through the identification and characterization of biomarkers of toxicity. Areas covered This article reviews what we know about emerging biomarkers in toxicology, with a focus on the 2012 Northeast Society of Toxicology meeting titled ‘Translational Biomarkers in Toxicology.’ The areas covered in this meeting are summarized and include biomarkers of testicular injury and dysfunction, emerging biomarkers of kidney injury and translation of emerging biomarkers from preclinical species to human populations. The authors also provide a discussion about the biomarker qualification process and possible improvements to this process. Expert opinion There is currently a gap between the scientific work in the development and qualification of novel biomarkers for nonclinical drug safety assessment and how these biomarkers are actually used in drug safety assessment. A clear and efficient path to regulatory acceptance is needed so that breakthroughs in the biomarker toolkit for nonclinical drug safety assessment can be utilized to aid in the drug development process. PMID:23961847

Associations between autistic traits and fractional anisotropy values in white matter tracts in a nonclinical sample of young adults.

Science.gov (United States)

Bradstreet, Lauren E; Hecht, Erin E; King, Tricia Z; Turner, Jessica L; Robins, Diana L

2017-01-01

Whereas a number of studies have examined relationships among brain activity, social cognitive skills, and autistic traits, fewer studies have evaluated whether structural connections among brain regions relate to these traits and skills. Uncinate fasciculus (UF) and inferior longitudinal fasciculus (ILF) are white matter tracts that may underpin the behavioral expression of these skills because they connect regions within or provide sensory information to brain areas implicated in social cognition, and structural differences in these tracts have been associated with autistic traits. We examined relationships among self-reported autistic traits, mentalizing, and water diffusivity in UF and ILF in a nonclinical sample of 24 young adults (mean age = 21.92 years, SD = 4.72 years; 15 women). We measured autistic traits using the Autism-Spectrum Quotient, and we measured mentalizing using the Dynamic Interactive Shapes Clips task. We used Tract-Based Spatial Statistics and randomize to examine relationships among fractional anisotropy (FA) values in bilateral ILF and UF, age, cognitive abilities, autistic traits, and mentalizing. Autistic traits were positively related to FA values in left ILF. No other relationships between FA values and other variables were significant. Results suggest that left ILF may be involved in the expression of autistic traits in individuals without clinical diagnoses.

Dose-response effect between cannabis use and psychosis liability in a non-clinical population: evidence from a snowball sample.

Science.gov (United States)

Ruiz-Veguilla, Miguel; Barrigón, María Luisa; Hernández, Laureano; Rubio, José Luis; Gurpegui, Manuel; Sarramea, Fernando; Cervilla, Jorge; Gutiérrez, Blanca; James, Anthony; Ferrin, Maite

2013-08-01

This study aimed to explore the associations between daily cannabis use and the specific profiles of subclinical symptoms in a non-clinical population obtained through snowball sampling, taking into account alcohol use, other drug use, social exclusion and age at onset of cannabis use. We included 85 daily cannabis users and 100 non-daily cannabis users. Both the case and the control populations were identified by snowball sampling. Daily cannabis use was associated with more alcohol intake and other drug use, as well as with early onset in the use of cannabis. Daily cannabis use appeared to exert a dose-response effect on first-rank symptoms, mania symptoms and auditory hallucinations, even after adjusting for sex, age, other drug use, social exclusion and age at onset of cannabis use. The paranoid dimension was only associated with the heaviest consumption of cannabis. Initial age of cannabis use modified the effects of daily cannabis use on the first-rank and voices experiences. Daily cannabis use was associated with significantly more first-rank and voices experiences among those subjects who started to use cannabis before 17 years of age. Our study supports the association of psychotic experiences with cannabis use even among non-psychotic subjects. Copyright © 2013 Elsevier Ltd. All rights reserved.

Investigating the role of executive attentional control to self-harm in a non-clinical cohort with borderline personality features.

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Jennifer eDrabble

2014-08-01

Full Text Available Self-injurious behavior (or self-harm is a frequently reported maladaptive behavior in the general population and a key feature of borderline personality disorder (BPD. Poor affect regulation is strongly linked to a propensity to self-harm, is a core component of BPD, and is linked with reduced attentional control abilities. The idea that attentional control difficulties may provide a link between BPD, negative affect and self-harm has yet to be established, however. The present study explored the putative relationship between levels of BPD features, three aspects of attentional/executive control, affect, and self-harm history in a sample of 340 non-clinical participants recruited online from self-harm forums and social networking sites. Analyses showed that self-reported levels of BPD features and attentional focusing predicted self-harm incidence, and high attentional focusing increased the likelihood of a prior self-harm history in those with high BPD features. Ability to shift attention was associated with a reduced likelihood of self-harm, suggesting that good attentional switching ability may provide a protective buffer against self-harm behavior for some individuals. These attentional control differences mediated the association between negative affect and self-harm, but the relationship between BPD and self-harm appears independent.

Nonclinical Safety Assessment of Morus alba L. Fruits: Study of 90-D Toxicity in Sprague Dawley Rats and Genotoxicity in Salmonella.

Science.gov (United States)

Chang, Bo Yoon; Kim, Seon Beom; Lee, Mi Kyeong; Park, Hyun; Kim, Sung Yeon

2016-05-01

Morus alba L. is a traditional herb with a long history of consumption, both as an edible fruit and as medicine. However, its safety evaluation has not yet been established. The objective of this study was to evaluate subchronic oral toxicity and genotoxicity of M. alba L. fruits (MFE). The subchronic toxicity after daily oral administration of MFE at 0, 40, 200, and 1000 mg/kg for 90 d was examined in Sprague Dawley (SD) rats. MFE administration did not lead to death, adverse effects, change in food and water consumption, and body weight gain. Significant toxic effects were not found within the parameters of organ weight, biochemical values, and hematological and urine analysis between the control and the MFE group. The genotoxicity of MFE was assayed by Ames test in Salmonella typhimurium strains TA98, TA102, and TA1535. No genotoxicity was found in all the tested strains. Thus in this study, a no-observed-adverse-effect level for MFE in 90 d repeated oral toxicity study in rats was determined to be greater than 1000 mg/kg regardless of gender. The results also suggested that MFE does not have a genotoxicity potential. © 2016 Institute of Food Technologists®

Effect of ranibizumab on serous and vascular pigment epithelial detachments associated with exudative age-related macular degeneration

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Panos GD

2013-07-01

Full Text Available Georgios D Panos,1 Zisis Gatzioufas,1 Ioannis K Petropoulos,1 Doukas Dardabounis,2 Gabriele Thumann,1 Farhad Hafezi11Department of Ophthalmology, Geneva University Hospitals and Faculty of Medicine of the University of Geneva, Switzerland; 2Department of Ophthalmology, University Hospital of Alexandroupolis, GreecePurpose: To report the effect of intravitreal ranibizumab therapy for serous and vascular pigment epithelial detachments (PED associated with choroidal neovascularisation (CNV secondary to age-related macular degeneration (AMD.Methods: In a prospective study, best-corrected visual acuity (BCVA and optical coherence tomography (OCT data were collected for 62 eyes of 62 patients, with serous or vascular PED associated with CNV secondary to AMD. Intravitreal ranibizumab 0.5 mg was administered with a loading phase of three consecutive monthly injections, followed by monthly review with further treatment, as indicated according to the retreatment criteria of the PrONTO study. The change in visual acuity and PED height from baseline to month 12 after the first injection was determined.Results: Sixty-one eyes of 61 patients (one of the patients developed retinal pigment epithelial tear and was excluded from the study were assessed at the 12-month follow-up examination. There were two types of PED, including vascular PED in 32 patients (Group A and serous PED (Group B in 29 patients. The mean improvement of mean BCVA from baseline to 12 months was 0.09 logMAR (Logarithm of the Minimum Angle of Resolution in Group A and 0.13 logMAR in Group B. Both groups showed significant improvement of the mean BCVA 12 months after the first injection compared with the baseline value (P < 0.05. In relation to the PED height, the mean decrease of mean PED height from baseline to 12 months was 135 µm in Group A and 180 µm in Group B. Both groups showed significant reduction of the PED height during the follow-up period (P < 0.01. The PED anatomical response

Isotermas de adsorção do pedúnculo seco do caju Adsorption isotherms of the dry cashew apple

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Siumara R. Alcântara

2009-02-01

Full Text Available A atividade de água constitui um fator importante no processo de fermentação semi-sólida, haja vista sua relação com a quantidade de água disponível ao microrganismo responsável pelo metabolismo do produto, sendo necessário à obtenção de isotermas de sorção para caracterização do substrato. Ante o exposto, objetivou-se a construção das isotermas de adsorção do pedúnculo seco do caju (Anacardium occidentale L. nas temperaturas usuais de fermentação (25, 30, 35 e 40 ºC. Ajustaram-se as isotermas com os modelos de BET, GAB, Oswin, Henderson e Smith. Observou-se que o modelo de GAB apresentou melhor ajuste, de vez que, na faixa de atividade de água que maximiza a biossíntese do microrganismo, para produção de pectinases por Aspergillus niger, a umidade do substrato deve estar acima de 35% b.s.Water activity is a very important factor in a solid state fermentation process due to its relation with the water quantity available to the microorganism that will synthesize the product. Therefore, it is necessary to obtain the sorption isotherms for the characterization of the substrate. The objective of this study is to obtain adsorption isotherms of the dry cashew apple (Anacardium occidentale L. at normal temperatures of fermentation process (25, 30, 35 e 40 ºC. Five mathematical models were fitted to the experimental data: BET, GAB, Oswin, Henderson e Smith. The GAB model was better fitted to the product. The isotherms allowed the determination of the appropriate moisture content to obtain the water activities that maximize the biosynthesis of the microorganism for the pectin production by solid state fermentation process. The moisture content of the substrate should be above 35% d.b.

Anatomic considerations for C2 pedicle screw placement: the use of computerized tomography measurements Consideraciones anatómicas de la cocalización de los tornillos pediculares en C2: uitlización de las medidas de la tomografia computadorizada Considerações anatômicas sobre a localização dos parafusos pediculares em C2: utilização das medidas da tomografia computadorizada

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Adebukoa Onibokun

2009-03-01

Full Text Available OBJECTIVE: more detailed anatomical knowledge of the C2 pedicle is required to optimize and minimize the risk of screw placement. The aim of this study was to evaluate the linear and angular dimensions of the true C2 pedicle using axial CT. METHODS: ninety three patients (47 males, 46 females mean age 48 years who had cervical spinal CT imaging performed were evaluated for this study. Axial images of the C2 pedicle were selected and the following pedicle parameters were determined: pedicle width (PW, the mediolateral diameter of the pedicle isthmus, perpendicular to the pedicle axis and pedicle transverse angle (PTA, that is, the angle between the pedicle axis and the midline of the vertebral body. RESULTS: the overall mean pedicle width was 5.8 1.2mm. The mean pedicle width in males (6.01.3mm was greater than that in the female subjects (5.6 1.1mm. This difference was not found to be statistically significant (p=.6790. The overall mean pedicle transverse angle was 43.93.9 degrees. The mean PTA in males was 43.23.8 degrees, while that in females was 44.73.7 degrees. CONCLUSION: preoperative planning is absolutely mandatory, particularly in determining not only screw trajectory, but in analyzing individual patient anatomy and reception to a C2 pedicle screw.OBJETIVO: el conocimiento detallado de las características anatómicas del pedículo de C2 es necesario para minimizar los riesgos relacionados con la colocación de los tornillos. El objetivo del estudio fue evaluar las medidas lineares y angulares del eje axial verdadero del pedículo de C2 utilizando la tomografía computadorizada. MÉTODOS: fueron utilizadas tomografías computadorizadas axiales de 93 pacientes (47 del sexo masculino y 46 del sexo femenino con promedio de edad de 48 años. Las imágenes axiales del pedículo de C2 fueron seleccionadas para el estudio y los parámetros estudiados fueron: Ancho del pedículo (diámetro mediolateral del istmo del pedículo perpendicular al

Patient doses during intra-oral radiography in dental offices

International Nuclear Information System (INIS)

Sakaino, Rie; Harata, Yasuo; Okano, Tomohiro; Sato, Kenji; Yosue, Takashi; Nishikawa, Keiichi; Sano, Tsukasa; Kobayashi, Ikuo

2011-01-01

Measurement of patient entrance dose (PED) and dose area product (DAP) at various dental offices in the Tokyo bay area and comparison of PEDs with the existing diagnostic reference levels recommended in the United Kingdom (UK). The survey included 28 dental clinics categorized by the type of intra-oral radiography used. PED was measured by placing an optically stimulated luminescence dosimeter (OSLD) at the tip of the cone. Exposure parameters were those used for the adult mandibular molar region in the respective clinics. The OSLD readings were calibrated using an ionizing chamber manufactured according to standards of the Japan Quality Assurance Organization. The area (A), of the X-ray beam, was calculated by exposing an X-ray film placed at the tip of the cone and measuring the exposed area. Then the DAP was calculated as the product of PED times A. The PED estimated at various dental clinics differed by a factor of 120. The mean, minimum, maximum, median and third quartile values of PEDs were 4.99, 0.18, 21.7, 3.60 and 5.76 mGy, respectively. At 60-70 kV, PEDs observed in clinics using digital imaging systems were below 2.1 mGy which was lower than that of clinics using films that were E-speed or faster. It was also observed that PEDs were directly proportional to the tube current and exposure time. The mean, minimum, maximum, median and third quartile of DAPs were 13.0, 0.45, 61.4, 9.34 and 13.4 cGy cm 2 , respectively. The DAP values showed a linear correlation coefficient of 0.99 with PED values. Measurement of PED and DAP using OSLD and X-ray film can play a useful role in optimization of radiation protection for patients during intra-oral radiography. This method can be conveniently applied to set up diagnostic reference levels by carrying out mass surveys in Japan. (author)

Material-specific retroactive interference effects of the Wechsler Adult Intelligence Scale-Fourth Edition on the Wechsler Memory Scale-Fourth Edition in a nonclinical sample.

Science.gov (United States)

Ingram, Nicolette S; Diakoumakos, Jessica V; Sinclair, Erin R; Crowe, Simon F

2016-01-01

This study investigated proactive and retroactive interference effects between the Wechsler Memory Scale-Fourth Edition (WMS-IV) using the flexible approach, and the Wechsler Adult Intelligence Scale-Fourth Edition (WAIS-IV). One hundred and eighty nonclinical participants were assigned to a four (visual interference, verbal interference, visual and verbal interference, vs. no interference) by two (retroactive vs. proactive) between-subjects design. The administration order of the tests was counterbalanced (i.e., administration of the WAIS-IV prior to the WMS-IV, and the WAIS-IV administered during the delay interval of the WMS-IV). The WAIS-IV produced significant retroactive interference effects on the WMS-IV; however, no proactive interference effect was observed. The retroactive interference effect was dependent on material specificity. The results indicate that material presented within the delay of the WMS-IV can have a significant effect on subsequent delayed recall. Clinicians should carefully consider the effects associated with carry-over effects of these tests when using them in combination.

Impaired Prefrontal-Amygdala Pathway, Self-Reported Emotion, and Erection in Psychogenic Erectile Dysfunction Patients With Normal Nocturnal Erection

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Jianhuai Chen

2018-04-01

Full Text Available Background: Neuroimaging studies have demonstrated that the prefrontal cortex and amygdala play an important role in sexual arousal (SA. However, little is known about the interactions between the prefrontal and cortex amygdala, which mediate the cognitive regulation of emotion and SA.Objective: We seek to determine whether nocturnal erection of psychogenic erectile dysfunction (pED patients are normal and whether there are changes of topological organization in the prefrontal-amygdala pathway of brain network in pED. In addition, whether there are correlations between network property changes and self-reported emotion and erection.Design, setting, and participants: We used the RigiScan device to evaluate erectile function of patients and employed diffusion MRI and graph theory to construct brain networks of 21 pED patients and 24 healthy controls.Outcome measurements and statistical analysis: We considered four nodal metrics and their asymmetry scores, and nocturnal penile tumescence (NPT parameters, to evaluate the topological properties of brain networks of pED and their relationships with the impaired self-reported emotion and erection.Results and limitations: All the pED patients showed normal nocturnal penile erection, however impaired self-reported erection and negative emotion. In addition, patients showed lower connectivity degree and strength in the left prefrontal-amygdala pathway. We also found that pED exhibited lower leftward asymmetry in the inferior frontal gyrus. Furthermore, patients showed more hub regions and fewer pivotal connections. Moreover, the degree of the left amygdala of pED showed significantly negative correlation with the self-reported erection and positive correlation with the self-reported negative emotion.Conclusions: Together, these results suggest normal nocturnal erection in pED. However, abnormalities of brain network organization in pED, particularly in the left prefrontal-amygdala pathway, are associated

Impaired Prefrontal-Amygdala Pathway, Self-Reported Emotion, and Erection in Psychogenic Erectile Dysfunction Patients With Normal Nocturnal Erection

Science.gov (United States)

Chen, Jianhuai; Chen, Yun; Gao, Qingqiang; Chen, Guotao; Dai, Yutian; Yao, Zhijian; Lu, Qing

2018-01-01

Background: Neuroimaging studies have demonstrated that the prefrontal cortex and amygdala play an important role in sexual arousal (SA). However, little is known about the interactions between the prefrontal and cortex amygdala, which mediate the cognitive regulation of emotion and SA. Objective: We seek to determine whether nocturnal erection of psychogenic erectile dysfunction (pED) patients are normal and whether there are changes of topological organization in the prefrontal-amygdala pathway of brain network in pED. In addition, whether there are correlations between network property changes and self-reported emotion and erection. Design, setting, and participants: We used the RigiScan device to evaluate erectile function of patients and employed diffusion MRI and graph theory to construct brain networks of 21 pED patients and 24 healthy controls. Outcome measurements and statistical analysis: We considered four nodal metrics and their asymmetry scores, and nocturnal penile tumescence (NPT) parameters, to evaluate the topological properties of brain networks of pED and their relationships with the impaired self-reported emotion and erection. Results and limitations: All the pED patients showed normal nocturnal penile erection, however impaired self-reported erection and negative emotion. In addition, patients showed lower connectivity degree and strength in the left prefrontal-amygdala pathway. We also found that pED exhibited lower leftward asymmetry in the inferior frontal gyrus. Furthermore, patients showed more hub regions and fewer pivotal connections. Moreover, the degree of the left amygdala of pED showed significantly negative correlation with the self-reported erection and positive correlation with the self-reported negative emotion. Conclusions: Together, these results suggest normal nocturnal erection in pED. However, abnormalities of brain network organization in pED, particularly in the left prefrontal-amygdala pathway, are associated with the

Nuclear safety culture and nuclear safety supervision

International Nuclear Information System (INIS)

Chai Jianshe

2013-01-01

In this paper, the author reviews systematically and summarizes up the development process and stage characteristics of nuclear safety culture, analysis the connotation and characteristics of nuclear safety culture, sums up the achievements of our country's nuclear safety supervision, dissects the challenges and problems of nuclear safety supervision. This thesis focused on the relationship between nuclear safety culture and nuclear safety supervision, they are essential differences, but there is a close relationship. Nuclear safety supervision needs to introduce some concepts of nuclear safety culture, lays emphasis on humanistic care and improves its level and efficiency. Nuclear safety supervision authorities must strengthen nuclear safety culture training, conduct the development of nuclear safety culture, make sure that nuclear safety culture can play significant roles. (author)

Safety balance: Analysis of safety systems

International Nuclear Information System (INIS)

Delage, M.; Giroux, C.

1990-12-01

Safety analysis, and particularly analysis of exploitation of NPPs is constantly affected by EDF and by the safety authorities and their methodologies. Periodic safety reports ensure that important issues are not missed on daily basis, that incidents are identified and that relevant actions are undertaken. French safety analysis method consists of three principal steps. First type of safety balance is analyzed at the normal start-up phase for each unit including the final safety report. This enables analysis of behaviour of units ten years after their licensing. Second type is periodic operational safety analysis performed during a few years. Finally, the third step consists of safety analysis of the oldest units with the aim to improve the safety standards. The three steps of safety analysis are described in this presentation in detail with the aim to present the objectives and principles. Examples of most recent exercises are included in order to illustrate the importance of such analyses

In-situ Indentation and Correlated Precession Electron Diffraction Analysis of a Polycrystalline Cu Thin Film

Science.gov (United States)

Guo, Qianying; Thompson, Gregory B.

2018-04-01

In-situ TEM nanoindentation of a polycrystalline Cu film was cross-correlated with precession electron diffraction (PED) to quantify the microstructural evolution. The use of PED is shown to clearly reveal features, such as grain size, that are easily masked by diffraction contrast created by the deformation. Using PED, the accompanying grain refinement and change in texture as well as the preservation of specific grain boundary structures, including a ∑3 boundary, under the indent impression were quantified. The nucleation of dislocations, evident in low-angle grain boundary formations, was also observed under the indent. PED quantification of texture gradients created by the indentation process linked well to bend contours observed in the bright-field images. Finally, PED enabled generating a local orientation spread map that gave an approximate estimation of the spatial distribution of strain created by the indentation impression.

Attention network functioning in children with anxiety disorders, attention-deficit/hyperactivity disorder and non-clinical anxiety.

Science.gov (United States)

Mogg, K; Salum, G A; Bradley, B P; Gadelha, A; Pan, P; Alvarenga, P; Rohde, L A; Pine, D S; Manfro, G G

2015-01-01

Research with adults suggests that anxiety is associated with poor control of executive attention. However, in children, it is unclear (a) whether anxiety disorders and non-clinical anxiety are associated with deficits in executive attention, (b) whether such deficits are specific to anxiety versus other psychiatric disorders, and (c) whether there is heterogeneity among anxiety disorders (in particular, specific phobia versus other anxiety disorders). We examined executive attention in 860 children classified into three groups: anxiety disorders (n = 67), attention-deficit/hyperactivity disorder (ADHD; n = 67) and no psychiatric disorder (n = 726). Anxiety disorders were subdivided into: anxiety disorders excluding specific phobia (n = 43) and specific phobia (n = 21). The Attention Network Task was used to assess executive attention, alerting and orienting. Findings indicated heterogeneity among anxiety disorders, as children with anxiety disorders (excluding specific phobia) showed impaired executive attention, compared with disorder-free children, whereas children with specific phobia showed no executive attention deficit. Among disorder-free children, executive attention was less efficient in those with high, relative to low, levels of anxiety. There were no anxiety-related deficits in orienting or alerting. Children with ADHD not only had poorer executive attention than disorder-free children, but also higher orienting scores, less accurate responses and more variable response times. Impaired executive attention in children (reflected by difficulty inhibiting processing of task-irrelevant information) was not fully explained by general psychopathology, but instead showed specific associations with anxiety disorders (other than specific phobia) and ADHD, as well as with high levels of anxiety symptoms in disorder-free children.

Shame on Me! Self-Conscious Emotions and Big Five Personality Traits and Their Relations to Anxiety Disorders Symptoms in Young, Non-Clinical Adolescents.

Science.gov (United States)

Muris, Peter; Meesters, Cor; van Asseldonk, Mike

2018-04-01

This study explored the relations between self-conscious emotions, personality traits, and anxiety disorders symptoms in non-clinical youths. One-hundred-and-eighteen adolescents aged 12-15 years completed the brief shame and guilt questionnaire for children (BSGQ-C) and items of the youth self-report (YSR) to measure shame and guilt, the big five personality questionnaire for children, and the youth anxiety measure for DSM-5. Results for shame indicated that this self-conscious emotion-either measured by the BSGQ-C or the YSR-was uniquely and positively associated with a broad range of anxiety disorders symptoms, and correlated positively with neuroticism and negatively with extraversion. Guilt did not show significant associations with anxiety disorders symptoms once controlling for the influence of shame, and links with personality traits varied dependent on the assessment instrument that was used (BSGQ-C or YSR). Finally, when controlling for neuroticism and extraversion, shame consistently remained a significant correlate of anxiety disorders symptoms. Altogether, these results add to the growing body of evidence indicating that high levels of shame are clearly associated with anxiety pathology.

A portable cell-based optical detection device for rapid detection of Listeria and Bacillus toxins

Science.gov (United States)

Banerjee, Pratik; Banada, Padmapriya P.; Rickus, Jenna L.; Morgan, Mark T.; Bhunia, Arun K.

2005-11-01

A mammalian cell-based optical biosensor was built to detect pathogenic Listeria and Bacillus species. This sensor measures the ability of the pathogens to infect and induce cytotoxicity on hybrid lymphocyte cell line (Ped-2E9) resulting in the release of alkaline phosphatase (ALP) that can be detected optically using a portable spectrophotometer. The Ped-2E9 cells were encapsulated in collagen gel matrices and grown in 48-well plates or in specially designed filtration tube units. Toxin preparations or bacterial cells were introduced and ALP release was assayed after 3-5 h. Pathogenic L. monocytogenes strains or the listeriolysin toxins preparation showed cytotoxicity ranging from 55% - 92%. Toxin preparations (~20 μg/ml) from B. cereus strains showed 24 - 98% cytotoxicity. In contrast, a non-pathogenic L. innocua (F4247) and a B. substilis induced only 2% and 8% cytotoxicity, respectively. This cell-based detection device demonstrates its ability to detect the presence of pathogenic Listeria and Bacillus species and can potentially be used onsite for food safety or in biosecurity application.

Associations between ADHD symptoms and smoking outcome expectancies in a non-clinical sample of daily cigarette smokers.

Science.gov (United States)

Goldenson, Nicholas I; Pang, Raina D; Leventhal, Adam M

2016-03-01

Smoking outcome expectancies for positive reinforcement (PR: beliefs that smoking produces desirable outcomes) and negative reinforcement (NR: beliefs that smoking alleviates negative affect) are modifiable cognitive manifestations of affect-mediated smoking motivation. Based on prior data and theory, we hypothesized that NR and PR expectancies are associated with ADHD symptom levels in a non-clinical sample of cigarette smokers. (Am J Addict 2016; XX:XX -XX) METHODS: Daily cigarette smokers (N = 256) completed self-report measures of ADHD symptoms and smoking outcome expectancies. Cross-sectional associations of overall ADHD symptomatology and the ADHD symptom dimensions of inattention (IN: difficulty concentrating and distractibility) and hyperactivity impulsivity (HI: poor inhibitory control and motor activity restlessness) with PR and NR smoking outcome expectancies were examined. Higher levels of overall, IN and HI ADHD symptoms were positively associated with NR smoking expectancies after statistically controlling for anxiety, depression, alcohol/drug use problems, nicotine dependence, and other smoking expectancies. Although neither HI nor IN symptom dimensions exhibited empirically unique relations to NR expectancies over and above one another, the collective variance across IN and HI was associated with NR expectancies. PR expectancies were not associated with ADHD symptoms. Although PR and NR expectancies may be important etiological influences in the overall population of smokers, NR outcome expectancies appear to be disproportionately expressed in smokers with elevated ADHD symptoms. Cognitive manifestations of NR motivation, which may be modifiable via intervention, are prominent in smokers with elevated ADHD symptoms. Beliefs that smoking alleviates negative affect may underlie ADHD-smoking comorbidity. © American Academy of Addiction Psychiatry.

Nonclinical pharmacology and toxicology of the first biosimilar insulin glargine drug product (BASAGLAR®/ABASAGLAR®) approved in the European Union.

Science.gov (United States)

Byrd, Richard A; Owens, Rebecca A; Blackbourne, Jamie L; Coutant, David E; Farmen, Mark W; Michael, M Dodson; Moyers, Julie S; Schultze, A Eric; Sievert, Michael K; Tripathi, Niraj K; Vahle, John L

2017-08-01

Basaglar ® /Abasaglar ® (Lilly insulin glargine [LY IGlar]) is a long-acting human insulin analogue drug product granted marketing authorisation as a biosimilar to Lantus ® (Sanofi insulin glargine [SA IGlar]) by the European Medicines Agency. We assessed the similarity of LY IGlar to the reference drug product, European Union-sourced SA IGlar (EU-SA IGlar), using nonclinical in vitro and in vivo studies. No biologically relevant differences were observed for receptor binding affinity at either the insulin or insulin-like growth factor-1 (IGF-1) receptors, or in assays of functional or de novo lipogenic activity. The mitogenic potential of LY IGlar and EU-SA IGlar was similar when tested in both insulin- and IGF-1 receptor dominant cell systems. Repeated subcutaneous daily dosing of rats for 4 weeks with 0, 0.3, 1.0, or 2.0 mg/kg LY IGlar and EU-SA IGlar produced mortalities and clinical signs consistent with severe hypoglycaemia. Glucodynamic profiles of LY IGlar and EU-SA IGlar in satellite animals showed comparable dose-related hypoglycaemia. Severe hypoglycaemia was associated with axonal degeneration of the sciatic nerve; the incidence and severity were low and did not differ between LY IGlar and EU-SA IGlar. These results demonstrated no biologically relevant differences in toxicity between LY IGlar and EU-SA IGlar. Copyright © 2017 Elsevier Inc. All rights reserved.

Safety margins in deterministic safety analysis

International Nuclear Information System (INIS)

Viktorov, A.

2011-01-01

The concept of safety margins has acquired certain prominence in the attempts to demonstrate quantitatively the level of the nuclear power plant safety by means of deterministic analysis, especially when considering impacts from plant ageing and discovery issues. A number of international or industry publications exist that discuss various applications and interpretations of safety margins. The objective of this presentation is to bring together and examine in some detail, from the regulatory point of view, the safety margins that relate to deterministic safety analysis. In this paper, definitions of various safety margins are presented and discussed along with the regulatory expectations for them. Interrelationships of analysis input and output parameters with corresponding limits are explored. It is shown that the overall safety margin is composed of several components each having different origins and potential uses; in particular, margins associated with analysis output parameters are contrasted with margins linked to the analysis input. While these are separate, it is possible to influence output margins through the analysis input, and analysis method. Preserving safety margins is tantamount to maintaining safety. At the same time, efficiency of operation requires optimization of safety margins taking into account various technical and regulatory considerations. For this, basic definitions and rules for safety margins must be first established. (author)

Di-22:6-bis(monoacylglycerol)phosphate: A clinical biomarker of drug-induced phospholipidosis for drug development and safety assessment

International Nuclear Information System (INIS)

Liu, Nanjun; Tengstrand, Elizabeth A.; Chourb, Lisa; Hsieh, Frank Y.

2014-01-01

The inability to routinely monitor drug-induced phospholipidosis (DIPL) presents a challenge in pharmaceutical drug development and in the clinic. Several nonclinical studies have shown di-docosahexaenoyl (22:6) bis(monoacylglycerol) phosphate (di-22:6-BMP) to be a reliable biomarker of tissue DIPL that can be monitored in the plasma/serum and urine. The aim of this study was to show the relevance of di-22:6-BMP as a DIPL biomarker for drug development and safety assessment in humans. DIPL shares many similarities with the inherited lysosomal storage disorder Niemann–Pick type C (NPC) disease. DIPL and NPC result in similar changes in lysosomal function and cholesterol status that lead to the accumulation of multi-lamellar bodies (myeloid bodies) in cells and tissues. To validate di-22:6-BMP as a biomarker of DIPL for clinical studies, NPC patients and healthy donors were classified by receiver operator curve analysis based on urinary di-22:6-BMP concentrations. By showing 96.7-specificity and 100-sensitivity to identify NPC disease, di-22:6-BMP can be used to assess DIPL in human studies. The mean concentration of di-22:6-BMP in the urine of NPC patients was 51.4-fold (p ≤ 0.05) above the healthy baseline range. Additionally, baseline levels of di-22:6-BMP were assessed in healthy non-medicated laboratory animals (rats, mice, dogs, and monkeys) and human subjects to define normal reference ranges for nonclinical/clinical studies. The baseline ranges of di-22:6-BMP in the plasma, serum, and urine of humans and laboratory animals were species dependent. The results of this study support the role of di-22:6-BMP as a biomarker of DIPL for pharmaceutical drug development and health care settings. - Highlights: • A reliable biomarker of drug-induced phospholipidosis (DIPL) is needed for humans. • Di-22:6-BMP is specific/sensitive for DIPL in animals as published in literatures. • The di-22:6-BMP biomarker can be validated for humans via NPC patients. • DIPL

Di-22:6-bis(monoacylglycerol)phosphate: A clinical biomarker of drug-induced phospholipidosis for drug development and safety assessment

Energy Technology Data Exchange (ETDEWEB)

Liu, Nanjun; Tengstrand, Elizabeth A.; Chourb, Lisa; Hsieh, Frank Y., E-mail: frank.hsieh@nextcea.com

2014-09-15

The inability to routinely monitor drug-induced phospholipidosis (DIPL) presents a challenge in pharmaceutical drug development and in the clinic. Several nonclinical studies have shown di-docosahexaenoyl (22:6) bis(monoacylglycerol) phosphate (di-22:6-BMP) to be a reliable biomarker of tissue DIPL that can be monitored in the plasma/serum and urine. The aim of this study was to show the relevance of di-22:6-BMP as a DIPL biomarker for drug development and safety assessment in humans. DIPL shares many similarities with the inherited lysosomal storage disorder Niemann–Pick type C (NPC) disease. DIPL and NPC result in similar changes in lysosomal function and cholesterol status that lead to the accumulation of multi-lamellar bodies (myeloid bodies) in cells and tissues. To validate di-22:6-BMP as a biomarker of DIPL for clinical studies, NPC patients and healthy donors were classified by receiver operator curve analysis based on urinary di-22:6-BMP concentrations. By showing 96.7-specificity and 100-sensitivity to identify NPC disease, di-22:6-BMP can be used to assess DIPL in human studies. The mean concentration of di-22:6-BMP in the urine of NPC patients was 51.4-fold (p ≤ 0.05) above the healthy baseline range. Additionally, baseline levels of di-22:6-BMP were assessed in healthy non-medicated laboratory animals (rats, mice, dogs, and monkeys) and human subjects to define normal reference ranges for nonclinical/clinical studies. The baseline ranges of di-22:6-BMP in the plasma, serum, and urine of humans and laboratory animals were species dependent. The results of this study support the role of di-22:6-BMP as a biomarker of DIPL for pharmaceutical drug development and health care settings. - Highlights: • A reliable biomarker of drug-induced phospholipidosis (DIPL) is needed for humans. • Di-22:6-BMP is specific/sensitive for DIPL in animals as published in literatures. • The di-22:6-BMP biomarker can be validated for humans via NPC patients. • DIPL

The effect of medical trainees on pediatric emergency department flow: a discrete event simulation modeling study.

Science.gov (United States)

Genuis, Emerson D; Doan, Quynh

2013-11-01

Providing patient care and medical education are both important missions of teaching hospital emergency departments (EDs). With medical school enrollment rising, and ED crowding becoming an increasing prevalent issue, it is important for both pediatric EDs (PEDs) and general EDs to find a balance between these two potentially competing goals. The objective was to determine how the number of trainees in a PED affects patient wait time, total ED length of stay (LOS), and rates of patients leaving without being seen (LWBS) for PED patients overall and stratified by acuity level as defined by the Pediatric Canadian Triage and Acuity Scale (CTAS) using discrete event simulation (DES) modeling. A DES model of an urban tertiary care PED, which receives approximately 40,000 visits annually, was created and validated. Thirteen different trainee schedules, which ranged from averaging zero to six trainees per shift, were input into the DES model and the outcome measures were determined using the combined output of five model iterations. An increase in LOS of approximately 7 minutes was noted to be associated with each additional trainee per attending emergency physician working in the PED. The relationship between the number of trainees and wait time varied with patients' level of acuity and with the degree of PED utilization. Patient wait time decreased as the number of trainees increased for low-acuity visits and when the PED was not operating at full capacity. With rising numbers of trainees, the PED LWBS rate decreased in the whole department and in the CTAS 4 and 5 patient groups, but it rose in patients triaged CTAS 3 or higher. A rising numbers of trainees was not associated with any change to flow outcomes for CTAS 1 patients. The results of this study demonstrate that trainees in PEDs have an impact mainly on patient LOS and that the effect on wait time differs between patients presenting with varying degrees of acuity. These findings will assist PEDs in finding a

Price elasticity of demand for psychiatric consultation in a Nigerian psychiatric service.

Science.gov (United States)

Esan, Oluyomi

2016-12-01

This paper addresses price elasticity of demand (PED) in a region where most patients make payments for consultations out of pocket. PED is a measure of the responsiveness of the quantity demanded of goods or services to changes in price. The study was done in the context of an outpatient psychiatric clinic in a sub -Saharan African country. The study was performed at the University College Hospital (UCH), Ibadan, Nigeria. Aggregate data were collected on weekly clinic attendance over a 24-month period October 2008 - September 2010 representing 12 months before, to 12months after a 67% increase in price of outpatient psychiatric consultation. The average weekly clinic attendance prior to the increase was compared to the average clinic attendance after the price increase. Arc-PED for consultation was also estimated. Clinic attendance dropped immediately and significantly in the weeks following the price increase. There was a 34.4% reduction in average weekly clinic attendance. Arc-PED for psychiatric consultation was -0.85. In comparison to reported PED on health care goods and services, this study finds a relatively high PED in psychiatric consultation following an increase in price of user fees of psychiatric consultation.

Psychological mechanisms underlying doping attitudes in sport: motivation and moral disengagement.

Science.gov (United States)

Hodge, Ken; Hargreaves, Elaine A; Gerrard, David; Lonsdale, Chris

2013-08-01

We examined whether constructs outlined in self-determination theory (Deci & Ryan, 2002), namely, autonomy-supportive and controlling motivational climates and autonomous and controlled motivation, were related to attitudes toward performance-enhancing drugs (PEDs) in sport and drug-taking susceptibility. We also investigated moral disengagement as a potential mediator. We surveyed a sample of 224 competitive athletes (59% female; M age = 20.3 years; M = 10.2 years of experience participating in their sport), including 81 elite athletes. Using structural equation modeling analyses, our hypothesis proposing positive relationships with controlling climates, controlled motivation, and PEDs attitudes and susceptibility was largely supported, whereas our hypothesis proposing negative relationships among autonomous climate, autonomous motivation, and PEDs attitudes and susceptibility was not supported. Moral disengagement was a strong predictor of positive attitudes toward PEDs, which, in turn, was a strong predictor of PEDs susceptibility. These findings are discussed from both motivational and moral disengagement viewpoints.

System safety education focused on flight safety

Science.gov (United States)

Holt, E.

1971-01-01

The measures necessary for achieving higher levels of system safety are analyzed with an eye toward maintaining the combat capability of the Air Force. Several education courses were provided for personnel involved in safety management. Data include: (1) Flight Safety Officer Course, (2) Advanced Safety Program Management, (3) Fundamentals of System Safety, and (4) Quantitative Methods of Safety Analysis.

Labor unions and safety climate: perceived union safety values and retail employee safety outcomes.

Science.gov (United States)

Sinclair, Robert R; Martin, James E; Sears, Lindsay E

2010-09-01

Although trade unions have long been recognized as a critical advocate for employee safety and health, safety climate research has not paid much attention to the role unions play in workplace safety. We proposed a multiple constituency model of workplace safety which focused on three central safety stakeholders: top management, ones' immediate supervisor, and the labor union. Safety climate research focuses on management and supervisors as key stakeholders, but has not considered whether employee perceptions about the priority their union places on safety contributes contribute to safety outcomes. We addressed this gap in the literature by investigating unionized retail employee (N=535) perceptions about the extent to which their top management, immediate supervisors, and union valued safety. Confirmatory factor analyses demonstrated that perceived union safety values could be distinguished from measures of safety training, workplace hazards, top management safety values, and supervisor values. Structural equation analyses indicated that union safety values influenced safety outcomes through its association with higher safety motivation, showing a similar effect as that of supervisor safety values. These findings highlight the need for further attention to union-focused measures related to workplace safety as well as further study of retail employees in general. We discuss the practical implications of our findings and identify several directions for future safety research. 2009 Elsevier Ltd. All rights reserved.

Development of LBB Piping Evaluation Diagram for APR 1000 Main Steam Line Piping

International Nuclear Information System (INIS)

Yang, J. S.; Jeong, I. L.; Park, C. Y.; Bai, S. Y.

2010-01-01

This paper presents the piping evaluation diagram (PED) to assess the applicability of Leak-Before- Break(LBB) for APR 1000 main steam line piping. LBB-PED of APR 1000 main steam line piping is independent of its piping geometry and has a function of the loads applied in piping system. Also, in order to evaluate LBB applicability during construction process with only the comparative evaluation of material properties between actually used and expected, the expected changes of material properties are considered in the LBB-PED. The LBB-PED, therefore, can be used for quick LBB evaluation of APR 1000 main steam line piping of both design and construction

The effect of active video games on cognitive functioning in clinical and non-clinical populations: A meta-analysis of randomized controlled trials.

Science.gov (United States)

Stanmore, Emma; Stubbs, Brendon; Vancampfort, Davy; de Bruin, Eling D; Firth, Joseph

2017-07-01

Physically-active video games ('exergames') have recently gained popularity for leisure and entertainment purposes. Using exergames to combine physical activity and cognitively-demanding tasks may offer a novel strategy to improve cognitive functioning. Therefore, this systematic review and meta-analysis was performed to establish effects of exergames on overall cognition and specific cognitive domains in clinical and non-clinical populations. We identified 17 eligible RCTs with cognitive outcome data for 926 participants. Random-effects meta-analyses found exergames significantly improved global cognition (g=0.436, 95% CI=0.18-0.69, p=0.001). Significant effects still existed when excluding waitlist-only controlled studies, and when comparing to physical activity interventions. Furthermore, benefits of exergames where observed for both healthy older adults and clinical populations with conditions associated with neurocognitive impairments (all p<0.05). Domain-specific analyses found exergames improved executive functions, attentional processing and visuospatial skills. The findings present the first meta-analytic evidence for effects of exergames on cognition. Future research must establish which patient/treatment factors influence efficacy of exergames, and explore neurobiological mechanisms of action. Crown Copyright © 2017. Published by Elsevier Ltd. All rights reserved.

Linking Safety Analysis to Safety Requirements

DEFF Research Database (Denmark)

Hansen, Kirsten Mark

Software for safety critical systems must deal with the hazards identified by safety analysistechniques: Fault trees, event trees,and cause consequence diagrams can be interpreted as safety requirements and used in the design activity. We propose that the safety analysis and the system design use...

Safety of Research Reactors. Safety Requirements

International Nuclear Information System (INIS)

2010-01-01

The main objective of this Safety Requirements publication is to provide a basis for safety and a basis for safety assessment for all stages in the lifetime of a research reactor. Another objective is to establish requirements on aspects relating to regulatory control, the management of safety, site evaluation, design, operation and decommissioning. Technical and administrative requirements for the safety of research reactors are established in accordance with these objectives. This Safety Requirements publication is intended for use by organizations engaged in the site evaluation, design, manufacturing, construction, operation and decommissioning of research reactors as well as by regulatory bodies

Persistent erectile dysfunction in men exposed to the 5α-reductase inhibitors, finasteride, or dutasteride

Directory of Open Access Journals (Sweden)

Tina Kiguradze

2017-03-01

Full Text Available Importance Case reports describe persistent erectile dysfunction (PED associated with exposure to 5α-reductase inhibitors (5α-RIs. Clinical trial reports and the manufacturers’ full prescribing information (FPI for finasteride and dutasteride state that risk of sexual adverse effects is not increased by longer duration of 5α-RI exposure and that sexual adverse effects of 5α-RIs resolve in men who discontinue exposure. Objective Our chief objective was to assess whether longer duration of 5α-RI exposure increases risk of PED, independent of age and other known risk factors. Men with shorter 5α-RI exposure served as a comparison control group for those with longer exposure. Design We used a single-group study design and classification tree analysis (CTA to model PED (lasting ≥90 days after stopping 5α-RI. Covariates included subject attributes, diseases, and drug exposures associated with sexual dysfunction. Setting Our data source was the electronic medical record data repository for Northwestern Medicine. Subjects The analysis cohorts comprised all men exposed to finasteride or dutasteride or combination products containing one of these drugs, and the subgroup of men 16–42 years old and exposed to finasteride ≤1.25 mg/day. Main outcome and measures Our main outcome measure was diagnosis of PED beginning after first 5α-RI exposure, continuing for at least 90 days after stopping 5α-RI, and with contemporaneous treatment with a phosphodiesterase-5 inhibitor (PDE5I. Other outcome measures were erectile dysfunction (ED and low libido. PED was determined by manual review of medical narratives for all subjects with ED. Risk of an adverse effect was expressed as number needed to harm (NNH. Results Among men with 5α-RI exposure, 167 of 11,909 (1.4% developed PED (persistence median 1,348 days after stopping 5α-RI, interquartile range (IQR 631.5–2320.5 days; the multivariable model predicting PED had four variables: prostate disease

Nonclinical and Pharmacokinetic Assessments To Evaluate the Potential of Tedizolid and Linezolid To Affect Mitochondrial Function

Science.gov (United States)

McKee, Edward E.; Das, Debaditya; Hosako, Hiromi; Fiedler-Kelly, Jill; Passarell, Julie; Radovsky, Ann; Prokocimer, Philippe

2014-01-01

Prolonged treatment with the oxazolidinone linezolid is associated with myelosuppression, lactic acidosis, and neuropathies, toxicities likely caused by impairment of mitochondrial protein synthesis (MPS). To evaluate the potential of the novel oxazolidinone tedizolid to cause similar side effects, nonclinical and pharmacokinetic assessments were conducted. In isolated rat heart mitochondria, tedizolid inhibited MPS more potently than did linezolid (average [± standard error of the mean] 50% inhibitory concentration [IC50] for MPS of 0.31 ± 0.02 μM versus 6.4 ± 1.2 μM). However, a rigorous 9-month rat study comparing placebo and high-dose tedizolid (resulting in steady-state area under the plasma concentration-time curve values about 8-fold greater than those with the standard therapeutic dose in humans) showed no evidence of neuropathy. Additional studies explored why prolonged, high-dose tedizolid did not cause these mitochondriopathic side effects despite potent MPS inhibition by tedizolid. Murine macrophage (J774) cell fractionation studies found no evidence of a stable association of tedizolid with eukaryotic mitochondria. Monte Carlo simulations based on population pharmacokinetic models showed that over the course of a dosing interval using standard therapeutic doses, free plasma concentrations fell below the respective MPS IC50 in 84% of tedizolid-treated patients (for a median duration of 7.94 h) and 38% of linezolid-treated patients (for a median duration of 0 h). Therapeutic doses of tedizolid, but not linezolid, may therefore allow for mitochondrial recovery during antibacterial therapy. The overall results suggest that tedizolid has less potential to cause myelosuppression and neuropathy than that of linezolid during prolonged treatment courses. This, however, remains a hypothesis that must be confirmed in clinical studies. PMID:25331703

A Preliminary Study of the Effects of an Arts Education Program on Executive Function, Behavior, and Brain Structure in a Sample of Nonclinical School-Aged Children.

Science.gov (United States)

Park, Subin; Lee, Jong-Min; Baik, Young; Kim, Kihyun; Yun, Hyuk Jin; Kwon, Hunki; Jung, Yeon-Kyung; Kim, Bung-Nyun

2015-11-01

The authors examined the effects of arts education on cognition, behavior, and brain of children. Twenty-nine nonclinical children participated in a 15-week arts education program that was composed of either creative movement or musical arts. Children completed the Wisconsin Card Sorting Test, clinical scales, and brain magnetic resonance imaging before and after the intervention. Following program completion, performances on the Wisconsin Card Sorting Test, the Children's Depression Inventory scores, and conduct disorder scores were significantly improved. Furthermore, cortical thickness in the left postcentral gyrus and superior parietal lobule were increased, and the mean diffusivity values in the right posterior corona radiate and superior longitudinal fasciculus were decreased. Positive correlations between changes in cognitive measurements and changes in cortical thickness were observed. This preliminary study suggests a positive effect of arts education on executive functions in association with brain changes. However, these findings must be interpreted with caution due to the noncomparative study design. © The Author(s) 2015.

Bov-B-mobilized SINEs in vertebrate genomes.

Science.gov (United States)

Gogolevsky, Konstantin P; Vassetzky, Nikita S; Kramerov, Dmitri A

2008-01-15

Two new short retroposon families (SINEs) have been found in the genome of springhare Pedetes capensis (Rodentia). One of them, Ped-1, originated from 5S rRNA, while the other one, Ped-2, originated from tRNA-derived SINE ID. In contrast to most currently active mammalian SINEs mobilized by L1 long retrotransposon (LINE), Ped-1 and Ped-2 are mobilized by Bov-B, a LINE family of the widely distributed RTE clade. The 3' part of these SINEs originates from two sequences in the 5' and 3' regions of Bov-B. Such bipartite structure of the LINE-derived part has been revealed in all Bov-B-mobilized SINEs known to date (AfroSINE, Bov-tA, Mar-1, and Ped-1/2), which distinguishes them from other SINEs with only a 3' LINE-derived part. Structural analysis and the distribution of Bov-B LINEs and partner SINEs supports the horizontal transfer of Bov-B, while the SINEs emerged independently in lineages with this LINE.

A Survey of Graduates of Combined Emergency Medicine-Pediatrics Residency Programs: An Update.

Science.gov (United States)

Strobel, Ashley M; Chasm, Rose M; Woolridge, Dale P

2016-10-01

In 1998, emergency medicine-pediatrics (EM-PEDS) graduates were no longer eligible for the pediatric emergency medicine (PEM) sub-board certification examination. There is a paucity of guidance regarding the various training options for medical students who are interested in PEM. We sought to to determine attitudes and personal satisfaction of graduates from EM-PEDS combined training programs. We surveyed 71 graduates from three EM-PEDS residences in the United States. All respondents consider their combined training to be an asset when seeking a job, 92% find it to be an asset to their career, and 88% think it provided added flexibility to job searches. The most commonly reported shortcoming was their ineligibility for the PEM sub-board certification. The lack of this designation was perceived to be a detriment to securing academic positions in dedicated children's hospitals. When surveyed regarding which training offers the better skill set for the practice of PEM, 90% (44/49) stated combined EM-PEDS training. When asked which training track gives them the better professional advancement in PEM, 52% (23/44) chose combined EM-PEDS residency, 27% (12/44) chose a pediatrics residency followed by a PEM fellowship, and 25% (11/44) chose an EM residency then a PEM fellowship. No EM-PEDS respondents considered PEM fellowship training after the completion of the dual training program. EM-PEDS graduates found combined training to be an asset in their career. They felt that it provided flexibility in job searches, and that it was ideal training for the skill set required for the practice of PEM. EM-PEDS graduates' practices varied, including mixed settings, free-standing children's hospitals, and community emergency departments. Copyright © 2016 Elsevier Inc. All rights reserved.

[Compliance with the requirements of paediatric emergency departments in Spain: a self-assessment survey].

Science.gov (United States)

Sánchez Etxaniz, J; Luaces I Cubells, C; Benito Fernández, J

2011-08-01

Paediatric emergency medicine in Spain is practiced in differently configured departments, staffing and organisation. Our goal was to determine the situation in Paediatric Emergency Departments (PED) and their adaptation to the quality standards proposed by the Spanish Society of Paediatric Emergencies. A self-assessment questionnaire on standards performance was sent to 47 PED directors by e-mail. It consisted of 101 items, 69 considered mandatory. According to the fulfilment of these 69 items 4 PED groups were selected: group I: in the best position (met 69), group II: requiring minimal changes (meeting 62-68), group III: requiring major changes (meeting 41-61); group IV: requiring a lot of major changes (meeting less than 41). Thirty nine questionnaires were completed in full. The PED included in the study tended to an average of 35310 annual emergencies (5000-115000). No PED was included in group I, 6 in II 27 in III and 6 in IV. There was a tendency towards higher compliance with standards in larger PED, but there was no significant relationship between the number of emergencies and the number of items fulfilled. 1. Staffing and architectural and organizational aspects may not be adequate to achieve optimal patient outcome in many PED in Spain. This fact does not appear to be related to the annual patient census. 2. The areas for improvement mainly affect functional issues that must be undertaken by those responsible. 3. A significant number of PED have serious architectural and staffing deficiencies, which would require economic measures by their managers. 4. Our self-assessment questionnaire identifies improvement actions. Copyright © 2010 Asociación Española de Pediatría. Published by Elsevier Espana. All rights reserved.

A Case of Ruptured Blood Blister-like Aneurysm Treated with Pipeline Embolization Device: Clinical Significance of Fetal-type Posterior Communicating Artery.

Science.gov (United States)

Park, Ki-Su; Kang, Dong-Hun; Son, Won-Soo; Park, Jaechan; Kim, Young-Sun; Kim, Byung Moon

2017-03-01

Blood-blister like aneurysms (BBAs) are challenging lesions because of their wide fragile neck. Flow-diverting stents (FDSs), such as the Pipeline Embolization Device (PED), have been applied to treat BBAs less amenable to more established techniques of treatment. However, the use of FDSs, including the PED, in acute subarachnoid hemorrhage (SAH) still remains controversial. We report a case of aneurysm regrowth following PED application for a ruptured BBA that overlapped the origin of the dominant posterior communicating artery (PCoA), which was successfully treated after coil trapping of the origin of the fetal-type PCoA. And, we discuss the clinical significance of the fetal-type PCoA communicating with a BBA in terms of PED failure.

Biotransformation of Daclatasvir In Vitro and in Nonclinical Species: Formation of the Main Metabolite by Pyrrolidine δ-Oxidation and Rearrangement.

Science.gov (United States)

Li, Wenying; Zhao, Weiping; Liu, Xiaohong; Huang, Xiaohua; Lopez, Omar D; Leet, John E; Fancher, R Marcus; Nguyen, Van; Goodrich, Jason; Easter, John; Hong, Yang; Caceres-Cortes, Janet; Chang, Shu Y; Ma, Li; Belema, Makonen; Hamann, Lawrence G; Gao, Min; Zhu, Mingshe; Shu, Yue-Zhong; Humphreys, W Griffith; Johnson, Benjamin M

2016-06-01

Daclatasvir is a first-in-class, potent, and selective inhibitor of the hepatitis C virus nonstructural protein 5A replication complex. In support of nonclinical studies during discovery and exploratory development, liquid chromatography-tandem mass spectrometry and nuclear magnetic resonance were used in connection with synthetic and radiosynthetic approaches to investigate the biotransformation of daclatasvir in vitro and in cynomolgus monkeys, dogs, mice, and rats. The results of these studies indicated that disposition of daclatasvir was accomplished mainly by the release of unchanged daclatasvir into bile and feces and, secondarily, by oxidative metabolism. Cytochrome P450s were the main enzymes involved in the metabolism of daclatasvir. Oxidative pathways included δ-oxidation of the pyrrolidine moiety, resulting in ring opening to an aminoaldehyde intermediate followed by an intramolecular reaction between the aldehyde and the proximal imidazole nitrogen atom. Despite robust formation of the resulting metabolite in multiple systems, rates of covalent binding to protein associated with metabolism of daclatasvir were modest (55.2-67.8 pmol/mg/h) in nicotinamide adenine dinucleotide phosphate (reduced form)-supplemented liver microsomes (human, monkey, rat), suggesting that intramolecular rearrangement was favored over intermolecular binding in the formation of this metabolite. This biotransformation profile supported the continued development of daclatasvir, which is now marketed for the treatment of chronic hepatitis C virus infection. Copyright © 2016 by The American Society for Pharmacology and Experimental Therapeutics.

The Brief Core Schema Scales (BCSS): psychometric properties and associations with paranoia and grandiosity in non-clinical and psychosis samples.

Science.gov (United States)

Fowler, David; Freeman, Daniel; Smith, Ben; Kuipers, Elizabeth; Bebbington, Paul; Bashforth, Hannah; Coker, Sian; Hodgekins, Joanne; Gracie, Alison; Dunn, Graham; Garety, Philippa

2006-06-01

Traditional instruments that measure self-esteem may not relate directly to the schema construct as outlined in recent cognitive models. The Brief Core Schema Scales (BCSS) aim to provide a theoretically coherent self-report assessment of schemata concerning self and others in psychosis. The scales assess four dimensions of self and other evaluation: negative-self, positive-self, negative-other, positive-other. We analysed the psychometric properties of the BCSS using a sample of 754 students recruited by email and 252 people with psychosis recruited as part of a trial of cognitive therapy. We report the internal consistency, stability and the factor structure of the scale, and the association of the BCSS with measures of self-esteem and with symptoms of paranoia and grandiosity. The BCSS have good psychometric properties and have more independence from mood than the Rosenberg Self-Esteem Schedule. People with chronic psychosis reported extreme negative evaluations of both self and others on these scales, but their levels of self-esteem and positive evaluations of self and others were similar to the student sample. Extreme negative evaluations of self and others appear to be characteristic of the appraisals of people with chronic psychosis, and are associated with symptoms of grandiosity and paranoia in the non-clinical population. The BCSS may provide a more useful measure of schemata about self and others than traditional measures of self-esteem.

Human factors in safety assessment. Safety culture assessment

International Nuclear Information System (INIS)

Zhang Li; Deng Zhiliang; Wang Yiqun; Huang Weigang

1996-01-01

This paper analyses the present conditions and problems in enterprises safety assessment, and introduces the characteristics and effects of safety culture. The authors think that safety culture must be used as a 'soul' to form the pattern of modern safety management. Furthermore, they propose that the human safety and synthetic safety management assessment in a system should be changed into safety culture assessment. Finally, the assessment indicators are discussed

Safety and efficacy of a multi-electrode renal sympathetic denervation system in resistant hypertension: the EnligHTN I trial.

Science.gov (United States)

Worthley, Stephen G; Tsioufis, Costas P; Worthley, Matthew I; Sinhal, Ajay; Chew, Derek P; Meredith, Ian T; Malaiapan, Yuvi; Papademetriou, Vasilios

2013-07-01

Catheter-based renal artery sympathetic denervation has emerged as a novel therapy for treatment of patients with drug-resistant hypertension. Initial studies were performed using a single electrode radiofrequency catheter, but recent advances in catheter design have allowed the development of multi-electrode systems that can deliver lesions with a pre-determined pattern. This study was designed to evaluate the safety and efficacy of the EnligHTN(™) multi-electrode system. We conducted the first-in-human, prospective, multi-centre, non-randomized study in 46 patients (67% male, mean age 60 years, and mean baseline office blood pressure 176/96 mmHg) with drug-resistant hypertension. The primary efficacy objective was change in office blood pressure from baseline to 6 months. Safety measures included all adverse events with a focus on the renal artery and other vascular complications and changes in renal function. Renal artery denervation, using the EnligHTN system significantly reduced the office blood pressure from baseline to 1, 3, and 6 months by -28/10, -27/10 and -26/10 mmHg, respectively (P renal artery injury or other serious vascular complications occurred. Small, non-clinically relevant, changes in average estimated glomerular filtration rate were reported from baseline (87 ± 19 mL/min/1.73 m2) to 6 months post-procedure (82 ± 20 mL/min/1.73 m2). Renal sympathetic denervation, using the EnligHTN multi-electrode catheter results in a rapid and significant office blood pressure reduction that was sustained through 6 months. The EnligHTN system delivers a promising therapy for the treatment of drug-resistant hypertension.

Complete Resolution of a Giant Pigment Epithelial Detachment Secondary to Exudative Age-Related Macular Degeneration after a Single Intravitreal Ranibizumab (Lucentis Injection: Results Documented by Optical Coherence Tomography

Directory of Open Access Journals (Sweden)

Eleni Loukianou

2010-12-01

Full Text Available Aim:To describe a patient with a giant pigment epithelial detachment (PED secondary to exudative age-related macular degeneration (ARMD successfully treated with a single intravitreal ranibizumab (Lucentis injection (0.5 mg/0.05 ml.Methods:An 89-year-old woman presented with a six-day history of reduced vision and distortion in the left eye. Best-corrected visual acuity in that eye was 6/15. Fundoscopy revealed a giant PED and exudates temporally to the fovea. Optical coherence tomography showed a PED associated with subretinal and intraretinal fluid. Fluorescein angiography confirmed the diagnosis of an occult choroidal neovascularization. Treatment with intravitreal injections of ranibizumab (Lucentis was recommended, although the increased risk of retinal pigment epithelium (RPE rip was mentioned. Results:Four weeks after the first intravitreal Lucentis injection, the visual acuity in the left eye improved to 6/7.5, with a significant improvement of the distortion and a complete anatomical resolution of the PED confirmed by optical coherence tomography. Conclusion:Giant PED secondary to exudative ARMD can be successfully treated with intravitreal ranibizumab, despite the increased risk of RPE rip. To our knowledge, this is the first case presenting with complete resolution of PED after a single ranibizumab injection.

Propriedades antioxidantes em subproduto do pedúnculo de caju (Anacardium occidentale L.: efeito sobre a lipoperoxidação e o perfil de ácidos graxos poliinsaturados em ratos Antioxidant properties in cashew apple byproduct (Anacardium occidentale L.: effect on lipoperoxidation and on the polyunsaturated fatty acids profile in rats

Directory of Open Access Journals (Sweden)

Priscila Regina Bolelli Broinizi

2008-12-01

Full Text Available O caju (Anacardium occidentale L. apresenta substâncias fenólicas, as quais são atribuídas propriedades antioxidantes. Sendo assim, o presente trabalho objetivou verificar a capacidade antioxidante em subproduto, ou seja, no bagaço do pedúnculo do caju. O potencial antioxidante do extrato hidroalcoólico (EHAlc do bagaço do pedúnculo de caju foi avaliado em sistema de varredura do radical 2,2'-difenil-1-picrilhidrazilo (DPPH• e em ensaio in vivo. No sistema DPPH, o extrato demonstrou atividade antioxidante de cerca de 95% em sua maior concentração (1000 µg/mL. Para o estudo in vivo, foram utilizados ratos Wistar administrando oralmente EHAlc (200 e 400 mg/kg de peso corpóreo por 30 dias e analisados os tecidos plasmático, hepático e cerebral. Não houve alterações na peroxidação lipídica no plasma e no fígado dos animais tratados comparados ao grupo controle. Contudo, foi observada redução da lipoperoxidação no cérebro dos grupos tratados. Além do mais, neste tecido, os animais tratados apresentaram maior quantidade de ácidos graxos poliinsaturados (AGPI, destacando-se o ácido docosahexaenóico (DHA. Estes resultados indicam que o EHAlc contém antioxidantes naturais efetivos e que podem contribuir na redução da lipoperoxidação e preservação dos AGPICL no tecido cerebral de ratos, dando indícios da capacidade antioxidante do bagaço do pedúnculo de caju CCP-76.The cashew apple (Anacardium occidentale L. contains phenolic compounds usually related with antioxidant properties. Then, the aim of this study was to investigate its antioxidant capacity. The antioxidant capacity of the hydroalcoholic extract of the cashew apple pulp (EHAlc. was assessed for the scavenging of the 2,2-diphenyl-1-picrylhydrazyl radical (DPPH by in vitro method and by an in vivo essay. For this essay a 30-day oral (gavage, EHAlc. 200 and 400 mg/kg study was conducted in Wistar male rats, evaluating hepatic, plasma and brain tissues. In

Fundamental safety principles. Safety fundamentals

International Nuclear Information System (INIS)

2007-01-01

This publication states the fundamental safety objective and ten associated safety principles, and briefly describes their intent and purpose. The fundamental safety objective - to protect people and the environment from harmful effects of ionizing radiation - applies to all circumstances that give rise to radiation risks. The safety principles are applicable, as relevant, throughout the entire lifetime of all facilities and activities - existing and new - utilized for peaceful purposes, and to protective actions to reduce existing radiation risks. They provide the basis for requirements and measures for the protection of people and the environment against radiation risks and for the safety of facilities and activities that give rise to radiation risks, including, in particular, nuclear installations and uses of radiation and radioactive sources, the transport of radioactive material and the management of radioactive waste

Fundamental safety principles. Safety fundamentals

International Nuclear Information System (INIS)

2006-01-01

This publication states the fundamental safety objective and ten associated safety principles, and briefly describes their intent and purpose. The fundamental safety objective - to protect people and the environment from harmful effects of ionizing radiation - applies to all circumstances that give rise to radiation risks. The safety principles are applicable, as relevant, throughout the entire lifetime of all facilities and activities - existing and new - utilized for peaceful purposes, and to protective actions to reduce existing radiation risks. They provide the basis for requirements and measures for the protection of people and the environment against radiation risks and for the safety of facilities and activities that give rise to radiation risks, including, in particular, nuclear installations and uses of radiation and radioactive sources, the transport of radioactive material and the management of radioactive waste

Management of safety, safety culture and self assessment

International Nuclear Information System (INIS)

Carnino, A.

2000-01-01

Safety management is the term used for the measures required to ensure that an acceptable level of safety is maintained throughout the life of an installation, including decommissioning. The safety culture concept and its implementation are described in part one of the paper. The principles of safety are now quite well known and are implemented worldwide. It leads to a situation where harmonization is being achieved as indicated by the entry into force of the Convention on Nuclear Safety. To go beyond the present nuclear safety levels, management of safety and safety culture will be the means for achieving progress. Recent events which took place in major nuclear power countries have shown the importance of the management and the consequences on safety. At the same time, electricity deregulation is coming and will impact on safety through reductions in staffing and in operation and maintenance cost at nuclear installations. Management of safety as well as its control and monitoring by the safety authorities become a key to the future of nuclear energy.(author)

Behavioral integrity for safety, priority of safety, psychological safety, and patient safety : a team-level study

NARCIS (Netherlands)

Leroy, H.; Dierynck, B.; Anseel, F.; Simons, T.; Halbesleben, J.R.; McCaughey, D.; Savage, G.T.; Sels, L.

2012-01-01

This article clarifies how leader behavioral integrity for safety helps solve follower's double bind between adhering to safety protocols and speaking up about mistakes against protocols. Path modeling of survey data in 54 nursing teams showed that head nurse behavioral integrity for safety

Playground Safety

Science.gov (United States)

... Prevention Fall Prevention Playground Safety Poisoning Prevention Road Traffic Safety Sports Safety Get Email Updates To receive ... at the Consumer Product Safety Commission’s Playground Safety website . References U.S. Consumer Product Safety Commission. Injuries and ...

More safety by improving the safety culture

International Nuclear Information System (INIS)

Laaksonen, J.

1993-01-01

In its meeting in 1986, after Chernobyl accident, the INSAG group concluded, that the most important reason for the accident was lack of safety culture. Later the group realized that the safety culture, if it is well enough, can be used as a powerful tool to assess and develop practices affecting safety in any country. A comprehensive view on the various aspects of safety culture was presented in the INSAG-4 report published in 1991. Finland was among the first nations include the concept of safety culture in its regulations. This article describes the roles of government and the regulatory body in creating a national safety culture. How safety culture is seen in the operation of a nuclear power plant is also discussed. (orig.)

SAFETY

CERN Multimedia

Niels Dupont

2013-01-01

CERN Safety rules and Radiation Protection at CMS The CERN Safety rules are defined by the Occupational Health & Safety and Environmental Protection Unit (HSE Unit), CERN’s institutional authority and central Safety organ attached to the Director General. In particular the Radiation Protection group (DGS-RP1) ensures that personnel on the CERN sites and the public are protected from potentially harmful effects of ionising radiation linked to CERN activities. The RP Group fulfils its mandate in collaboration with the CERN departments owning or operating sources of ionising radiation and having the responsibility for Radiation Safety of these sources. The specific responsibilities concerning "Radiation Safety" and "Radiation Protection" are delegated as follows: Radiation Safety is the responsibility of every CERN Department owning radiation sources or using radiation sources put at its disposition. These Departments are in charge of implementing the requi...

Safety of nuclear power plants: Design. Safety requirements

International Nuclear Information System (INIS)

2000-01-01

The present publication supersedes the Code on the Safety of Nuclear Power Plants: Design (Safety Series No. 50-C-D (Rev. 1), issued in 1988). It takes account of developments relating to the safety of nuclear power plants since the Code on Design was last revised. These developments include the issuing of the Safety Fundamentals publication, The Safety of Nuclear Installations, and the present revision of various safety standards and other publications relating to safety. Requirements for nuclear safety are intended to ensure adequate protection of site personnel, the public and the environment from the effects of ionizing radiation arising from nuclear power plants. It is recognized that technology and scientific knowledge advance, and nuclear safety and what is considered adequate protection are not static entities. Safety requirements change with these developments and this publication reflects the present consensus. This Safety Requirements publication takes account of the developments in safety requirements by, for example, including the consideration of severe accidents in the design process. Other topics that have been given more detailed attention include management of safety, design management, plant ageing and wearing out effects, computer based safety systems, external and internal hazards, human factors, feedback of operational experience, and safety assessment and verification. This publication establishes safety requirements that define the elements necessary to ensure nuclear safety. These requirements are applicable to safety functions and the associated structures, systems and components, as well as to procedures important to safety in nuclear power plants. It is expected that this publication will be used primarily for land based stationary nuclear power plants with water cooled reactors designed for electricity generation or for other heat production applications (such as district heating or desalination). It is recognized that in the case of

Safety of nuclear power plants: Design. Safety requirements

International Nuclear Information System (INIS)

2004-01-01

The present publication supersedes the Code on the Safety of Nuclear Power Plants: Design (Safety Series No. 50-C-D (Rev. 1), issued in 1988). It takes account of developments relating to the safety of nuclear power plants since the Code on Design was last revised. These developments include the issuing of the Safety Fundamentals publication, The Safety of Nuclear Installations, and the present revision of various safety standards and other publications relating to safety. Requirements for nuclear safety are intended to ensure adequate protection of site personnel, the public and the environment from the effects of ionizing radiation arising from nuclear power plants. It is recognized that technology and scientific knowledge advance, and nuclear safety and what is considered adequate protection are not static entities. Safety requirements change with these developments and this publication reflects the present consensus. This Safety Requirements publication takes account of the developments in safety requirements by, for example, including the consideration of severe accidents in the design process. Other topics that have been given more detailed attention include management of safety, design management, plant ageing and wearing out effects, computer based safety systems, external and internal hazards, human factors, feedback of operational experience, and safety assessment and verification. This publication establishes safety requirements that define the elements necessary to ensure nuclear safety. These requirements are applicable to safety functions and the associated structures, systems and components, as well as to procedures important to safety in nuclear power plants. It is expected that this publication will be used primarily for land based stationary nuclear power plants with water cooled reactors designed for electricity generation or for other heat production applications (such as district heating or desalination). It is recognized that in the case of

Implementation of the safety culture for HANARO safety management

Energy Technology Data Exchange (ETDEWEB)

Wu, Jong Sup; Han, Gee Yang; Kim, Ik Soo [Korea Atomic Energy Research Institute, Daejeon (Korea, Republic of)

2008-11-15

Safety is the fundamental principal upon which a management system is based. The IAEA INSAG(International Nuclear Safety Group) states the general aims of a safety management system. One of which is to foster and support a strong safety culture through the development and reinforcement of good safety attitudes and behavior in individuals and teams, so as to allow them to carry out their tasks safety. The safety culture activities have been implemented and the importance of a safety management in nuclear activities for a reactor application and utilization has also been emphasized for more than 10 years in HANARO which is a 30 MW multi purpose research reactor that achieved its first criticality in February 1995. The safety culture activities and implementation have been conducted continuously to enhance its safe operation such as the seminars and lectures related to safety matters, participation in international workshops and the development of safety culture indicators, a survey on the attitude of HANARO staff toward the safety culture indicators, a survey on the attitude of HANARO staff toward the safety culture, the development of operational safety performance indicators (SPIs), the preparation of a safety text book and the development of an e Learning program for a safety education purpose.

Implementation of the safety culture for HANARO safety management

International Nuclear Information System (INIS)

Wu, Jong Sup; Han, Gee Yang; Kim, Ik Soo

2008-01-01

Safety is the fundamental principal upon which a management system is based. The IAEA INSAG(International Nuclear Safety Group) states the general aims of a safety management system. One of which is to foster and support a strong safety culture through the development and reinforcement of good safety attitudes and behavior in individuals and teams, so as to allow them to carry out their tasks safety. The safety culture activities have been implemented and the importance of a safety management in nuclear activities for a reactor application and utilization has also been emphasized for more than 10 years in HANARO which is a 30 MW multi purpose research reactor that achieved its first criticality in February 1995. The safety culture activities and implementation have been conducted continuously to enhance its safe operation such as the seminars and lectures related to safety matters, participation in international workshops and the development of safety culture indicators, a survey on the attitude of HANARO staff toward the safety culture indicators, a survey on the attitude of HANARO staff toward the safety culture, the development of operational safety performance indicators (SPIs), the preparation of a safety text book and the development of an e Learning program for a safety education purpose

Implementation of the safety culture for HANARO Safety Management

International Nuclear Information System (INIS)

Wu, Jongsup; Han, Geeyang; Kim, Iksoo

2008-01-01

Safety is the fundamental principal upon which the management system is based. The IAEA INSAG(International Nuclear Safety Group) states the general aims of the safety management system. One of which is to foster and support a strong safety culture through the development and reinforcement of good safety attitudes and behavior in individuals and teams so as to allow them to carry out their tasks safety. The safety culture activities have been implemented and the importance of safety management in nuclear activities for a reactor application and utilization has also been emphasized more than 10 years in HANARO which is a 30 MW multi-purpose research reactor and achieved its first criticality in February 1995. The safety culture activities and implementations have been conducted continuously to enhance its safe operation like the seminars and lectures related to safety matters, participation in international workshops, the development of safety culture indicators, the survey on the attitude of safety culture, the development of operational safety performance indicators (SPIs), the preparation of a safety text book and the development of an e-Learning program for safety education. (author)

Nuclear safety

International Nuclear Information System (INIS)

Tarride, Bruno

2015-10-01

The author proposes an overview of methods and concepts used in the nuclear industry, at the design level as well as at the exploitation level, to ensure an acceptable safety level, notably in the case of nuclear reactors. He first addresses the general objectives of nuclear safety and the notion of acceptable risk: definition and organisation of nuclear safety (relationships between safety authorities and operators), notion of acceptable risk, deterministic safety approach and main safety principles (safety functions and confinement barriers, concept of defence in depth). Then, the author addresses the safety approach at the design level: studies of operational situations, studies of internal and external aggressions, safety report, design principles for important-for-safety systems (failure criterion, redundancy, failure prevention, safety classification). The next part addresses safety during exploitation and general exploitation rules: definition of the operation domain and of its limits, periodic controls and tests, management in case of incidents, accidents or aggressions

Contribution to the multi-machine pedestal scaling from the COMPASS tokamak

Science.gov (United States)

Komm, M.; Bílková, P.; Aftanas, M.; Berta, M.; Böhm, P.; Bogár, O.; Frassinetti, L.; Grover, O.; Háček, P.; Havlicek, J.; Hron, M.; Imríšek, M.; Krbec, J.; Mitošínková, K.; Naydenkova, D.; Pánek, R.; Peterka, M.; Snyder, P. B.; Stefanikova, E.; Stöckel, J.; Sos, M.; Urban, J.; Varju, J.; Vondráček, P.; Weinzettl, V.; the COMPASS Team

2017-05-01

First systematic measurements of pedestal structure during Ohmic and NBI-assisted Type I ELMy H-modes were performed on the COMPASS tokamak in two dedicated experimental campaigns during 2015 and 2016. By adjusting the NBI heating and a toroidal magnetic field, the electron pedestal temperature was increased from 200 eV up to 300 eV, which allowed reaching pedestal collisionality ν \\text{ped}\\ast   <  1 at q95 ~3. COMPASS has approached conditions for the Identity experiment done at JET & DIII-D, complementing the range of scanned ρ \\text{ped}\\ast . The pedestal pressure was successfully reproduced by the EPED model. The dependence of pedestal pressure width on ν \\text{ped}\\ast and β \\text{ped ~ }\\text{pol} is discussed.

Formal Safety versus Real Safety: Quantitative and Qualitative Approaches to Safety Culture – Evidence from Estonia

Directory of Open Access Journals (Sweden)

Järvis Marina

2016-10-01

Full Text Available This paper examines differences between formal safety and real safety in Estonian small and medium-sized enterprises. The results reveal key issues in safety culture assessment. Statistical analysis of safety culture questionnaires showed many organisations with an outstanding safety culture and positive safety attitudes. However, qualitative data indicated some important safety weaknesses and aspects that should be included in the process of evaluation of safety culture in organisations.

Defining safety culture and the nexus between safety goals and safety culture. 1. An Investigation Study on Practical Points of Safety Management

International Nuclear Information System (INIS)

Hasegawa, Naoko; Takano, Kenichi; Hirose, Ayako

2001-01-01

In a report after the Chernobyl accident, the International Atomic Energy Agency indicated the definition and the importance of safety culture and the ideal organizational state where safety culture pervades. However, the report did not mention practical approaches to enhance safety culture. In Japan, although there had been investigations that clarified the consciousness of employees and the organizational climate in the nuclear power and railway industries, organizational factors that clarified the level of organization safety and practical methods that spread safety culture in an organization had not been studied. The Central Research Institute of the Electric Power Industry conducted surveys of organizational culture for the construction, chemical, and manufacturing industries. The aim of our study was to clarify the organizational factors that influence safety in an organization expressed in employee safety consciousness, commitment to safety activities, rate of accidents, etc. If these areas were clarified, the level of organization safety might be evaluated, and practical ways could be suggested to enhance the safety culture. Consequently, a series of investigations was conducted to clarify relationships among organizational climate, employee consciousness, safety management and activities, and rate of accidents. The questionnaire surveys were conducted in 1998-1999. The subjects were (a) managers of the safety management sections in the head offices of the construction, chemical, and manufacturing industries; (b) responsible persons in factories of the chemical and manufacturing industries; and (c) general workers in factories of the chemical and manufacturing industries. The number of collected data was (a) managers in the head office: 48 from the construction industry and 58 from the chemical and manufacturing industries, (b) responsible persons in factories: 567, and (c) general workers: from 29 factories. Items in the questionnaires were selected from

Antidote use in a pediatric emergency department

OpenAIRE

Martínez Sánchez, L; Almario Hernández, AF; Escuredo Argullós, L; Mação, P; Trenchs Sainz de la Maza, V; Luaces Cubells, C

2014-01-01

INTRODUCTION: Poisoning is an infrequent cause of consultation in a pediatric emergency department (PED), but it can be potentially serious. Pediatricians should know how to use the available antidotes properly. OBJECTIVES: To analyze the use of antidotes in a PED and to assess the suitability of their indications. MATERIALS AND METHODS: A retrospective review of antidote use in a PED between January 2008 and June 2012. Inclusion criteria were age younger than 18 years and cons...

Priming patient safety: A middle-range theory of safety goal priming via safety culture communication.

Science.gov (United States)

Groves, Patricia S; Bunch, Jacinda L

2018-05-18

The aim of this paper is discussion of a new middle-range theory of patient safety goal priming via safety culture communication. Bedside nurses are key to safe care, but there is little theory about how organizations can influence nursing behavior through safety culture to improve patient safety outcomes. We theorize patient safety goal priming via safety culture communication may support organizations in this endeavor. According to this theory, hospital safety culture communication activates a previously held patient safety goal and increases the perceived value of actions nurses can take to achieve that goal. Nurses subsequently prioritize and are motivated to perform tasks and risk assessment related to achieving patient safety. These efforts continue until nurses mitigate or ameliorate identified risks and hazards during the patient care encounter. Critically, this process requires nurses to have a previously held safety goal associated with a repertoire of appropriate actions. This theory suggests undergraduate educators should foster an outcomes focus emphasizing the connections between nursing interventions and safety outcomes, hospitals should strategically structure patient safety primes into communicative activities, and organizations should support professional development including new skills and the latest evidence supporting nursing practice for patient safety. © 2018 John Wiley & Sons Ltd.

Highway Safety Program Manual: Volume 3: Motorcycle Safety.

Science.gov (United States)

National Highway Traffic Safety Administration (DOT), Washington, DC.

Volume 3 of the 19-volume Highway Safety Program Manual (which provides guidance to State and local governments on preferred highway safety practices) concentrates on aspects of motorcycle safety. The purpose and specific objectives of a State motorcycle safety program are outlined. Federal authority in the highway safety area and general policies…

Safety of nuclear power plants: Operation. Safety requirements

International Nuclear Information System (INIS)

2004-01-01

The safety of a nuclear power plant is ensured by means of its proper siting, design, construction and commissioning, followed by the proper management and operation of the plant. In a later phase, proper decommissioning is required. This Safety Requirements publication supersedes the Code on the Safety of Nuclear Power Plants: Operation, which was issued in 1988 as Safety Series No. 50-C-O (Rev. 1). The purpose of this revision was: to restructure Safety Series No. 50-C-O (Rev. 1) in the light of the basic objectives, concepts and principles in the Safety Fundamentals publication The Safety of Nuclear Installations. To be consistent with the requirements of the International Basic Safety Standards for Protection against Ionizing Radiation and for the Safety of Radiation Sources. And to reflect current practice and new concepts and technical developments. Guidance on fulfillment of these Safety Requirements may be found in the appropriate Safety Guides relating to plant operation. The objective of this publication is to establish the requirements which, in the light of experience and the present state of technology, must be satisfied to ensure the safe operation of nuclear power plants. These requirements are governed by the basic objectives, concepts and principles that are presented in the Safety Fundamentals publication The Safety of Nuclear Installations. This publication deals with matters specific to the safe operation of land based stationary thermal neutron nuclear power plants, and also covers their commissioning and subsequent decommissioning

Safety of nuclear power plants: Operation. Safety requirements

International Nuclear Information System (INIS)

2003-01-01

The safety of a nuclear power plant is ensured by means of its proper siting, design, construction and commissioning, followed by the proper management and operation of the plant. In a later phase, proper decommissioning is required. This Safety Requirements publication supersedes the Code on the Safety of Nuclear Power Plants: Operation, which was issued in 1988 as Safety Series No. 50-C-O (Rev. 1). The purpose of this revision was: to restructure Safety Series No. 50-C-O (Rev. 1) in the light of the basic objectives, concepts and principles in the Safety Fundamentals publication The Safety of Nuclear Installations. To be consistent with the requirements of the International Basic Safety Standards for Protection against Ionizing Radiation and for the Safety of Radiation Sources. And to reflect current practice and new concepts and technical developments. Guidance on fulfillment of these Safety Requirements may be found in the appropriate Safety Guides relating to plant operation. The objective of this publication is to establish the requirements which, in the light of experience and the present state of technology, must be satisfied to ensure the safe operation of nuclear power plants. These requirements are governed by the basic objectives, concepts and principles that are presented in the Safety Fundamentals publication The Safety of Nuclear Installations. This publication deals with matters specific to the safe operation of land based stationary thermal neutron nuclear power plants, and also covers their commissioning and subsequent decommissioning

Safety of nuclear power plants: Operation. Safety requirements

International Nuclear Information System (INIS)

2000-01-01

The safety of a nuclear power plant is ensured by means of its proper siting, design, construction and commissioning, followed by the proper management and operation of the plant. In a later phase, proper decommissioning is required. This Safety Requirements publication supersedes the Code on the Safety of Nuclear Power Plants: Operation, which was issued in 1988 as Safety Series No. 50-C-O (Rev. 1). The purpose of this revision was: to restructure Safety Series No. 50-C-O (Rev. 1) in the light of the basic objectives, concepts and principles in the Safety Fundamentals publication The Safety of Nuclear Installations; to be consistent with the requirements of the International Basic Safety Standards for Protection against Ionizing Radiation and for the Safety of Radiation Sources; and to reflect current practice and new concepts and technical developments. Guidance on fulfillment of these Safety Requirements may be found in the appropriate Safety Guides relating to plant operation. The objective of this publication is to establish the requirements which, in the light of experience and the present state of technology, must be satisfied to ensure the safe operation of nuclear power plants. These requirements are governed by the basic objectives, concepts and principles that are presented in the Safety Fundamentals publication The Safety of Nuclear Installations. This publication deals with matters specific to the safe operation of land based stationary thermal neutron nuclear power plants, and also covers their commissioning and subsequent decommissioning

Implementation of the safety culture for HANARO safety management

Energy Technology Data Exchange (ETDEWEB)

Wu, Jongsup; Han, Geeyang; Kim, Iksoo [Korea Atomic Energy Research Institute, Daejeon (Korea, Republic of)

2008-11-15

Safety is the fundamental principal upon which a management system is based. The IAEA INSAG (International Nuclear Safety Group) states the general aims of a safety management system. One of which is to foster and support a strong safety culture through the development and reinforcement of good safety attitudes and behavior in individuals and teams, so as to allow them to carry out their tasks safely. The safety culture activities have been implemented and the importance of a safety management in nuclear activities for a reactor application and utilization has also been emphasized for more than 10 years in HANARO which is a 30MW multi-purpose research reactor that achieved its first criticality in February 1995. The safety culture activities and implementations have been conducted continuously to enhance its safe operation such as the seminars and lectures related to safety matters, participation in international workshops and the development of safety culture indicators, a survey on the attitude of HANARO staff toward the safety culture, the development of operational safety performance indicators (SPIs), the preparation of a safety text book and the development of a e-learning program for a safety education purpose.

Implementation of the safety culture for HANARO safety management

International Nuclear Information System (INIS)

Wu, Jongsup; Han, Geeyang; Kim, Iksoo

2008-01-01

Safety is the fundamental principal upon which a management system is based. The IAEA INSAG (International Nuclear Safety Group) states the general aims of a safety management system. One of which is to foster and support a strong safety culture through the development and reinforcement of good safety attitudes and behavior in individuals and teams, so as to allow them to carry out their tasks safely. The safety culture activities have been implemented and the importance of a safety management in nuclear activities for a reactor application and utilization has also been emphasized for more than 10 years in HANARO which is a 30MW multi-purpose research reactor that achieved its first criticality in February 1995. The safety culture activities and implementations have been conducted continuously to enhance its safe operation such as the seminars and lectures related to safety matters, participation in international workshops and the development of safety culture indicators, a survey on the attitude of HANARO staff toward the safety culture, the development of operational safety performance indicators (SPIs), the preparation of a safety text book and the development of a e-learning program for a safety education purpose

The impact of masculinity on safety oversights, safety priority and safety violations in two male-dominated occupations

DEFF Research Database (Denmark)

Nielsen, Kent; Hansen, Claus D.; Bloksgaard, Lotte

2015-01-01

Background Although men have a higher risk of occupational injuries than women the role of masculinity for organizational safety outcomes has only rarely been the object of research. Aim The current study investigated the association between masculinity and safety oversights, safety priority......-related context factors (safety leadership, commitment of the safety representative, and safety involvement) and three safety-related outcome factors (safety violations, safety oversights and safety priority) were administered twice 12 months apart to Danish ambulance workers (n = 1157) and slaughterhouse workers...

Leadership and Management for Safety. General Safety Requirements

International Nuclear Information System (INIS)

2016-01-01

This Safety Requirements publication establishes requirements that support Principle 3 of the Fundamental Safety Principles in relation to establishing, sustaining and continuously improving leadership and management for safety and an integrated management system. It emphasizes that leadership for safety, management for safety, an effective management system and a systemic approach (i.e. an approach in which interactions between technical, human and organizational factors are duly considered) are all essential to the specification and application of adequate safety measures and to the fostering of a strong safety culture. Leadership and an effective management system will integrate safety, health, environmental, security, quality, human-and-organizational factor, societal and economic elements. The management system will ensure the fostering of a strong safety culture, regular assessment of performance and the application of lessons from experience. The publication is intended for use by regulatory bodies, operating organizations (registrants and licensees) and other organizations concerned with facilities and activities that give rise to radiation risks

Does Employee Safety Matter for Patients Too? Employee Safety Climate and Patient Safety Culture in Health Care.

Science.gov (United States)

Mohr, David C; Eaton, Jennifer Lipkowitz; McPhaul, Kathleen M; Hodgson, Michael J

2015-04-22

We examined relationships between employee safety climate and patient safety culture. Because employee safety may be a precondition for the development of patient safety, we hypothesized that employee safety culture would be strongly and positively related to patient safety culture. An employee safety climate survey was administered in 2010 and assessed employees' views and experiences of safety for employees. The patient safety survey administered in 2011 assessed the safety culture for patients. We performed Pearson correlations and multiple regression analysis to examine the relationships between a composite measure of employee safety with subdimensions of patient safety culture. The regression models controlled for size, geographic characteristics, and teaching affiliation. Analyses were conducted at the group level using data from 132 medical centers. Higher employee safety climate composite scores were positively associated with all 9 patient safety culture measures examined. Standardized multivariate regression coefficients ranged from 0.44 to 0.64. Medical facilities where staff have more positive perceptions of health care workplace safety climate tended to have more positive assessments of patient safety culture. This suggests that patient safety culture and employee safety climate could be mutually reinforcing, such that investments and improvements in one domain positively impacts the other. Further research is needed to better understand the nexus between health care employee and patient safety to generalize and act upon findings.

Software Safety Risk in Legacy Safety-Critical Computer Systems

Science.gov (United States)

Hill, Janice L.; Baggs, Rhoda

2007-01-01

Safety Standards contain technical and process-oriented safety requirements. Technical requirements are those such as "must work" and "must not work" functions in the system. Process-Oriented requirements are software engineering and safety management process requirements. Address the system perspective and some cover just software in the system > NASA-STD-8719.13B Software Safety Standard is the current standard of interest. NASA programs/projects will have their own set of safety requirements derived from the standard. Safety Cases: a) Documented demonstration that a system complies with the specified safety requirements. b) Evidence is gathered on the integrity of the system and put forward as an argued case. [Gardener (ed.)] c) Problems occur when trying to meet safety standards, and thus make retrospective safety cases, in legacy safety-critical computer systems.

Developmental screening and parents' written comments: an added dimension to the parents' evaluation of developmental status questionnaire.

Science.gov (United States)

Cox, Joanne E; Huntington, Noelle; Saada, Adrianna; Epee-Bounya, Alexandra; Schonwald, Alison D

2010-12-01

The aim of this study was to better understand the utility of using the Parents' Evaluation of Developmental Status (PEDS) in well-child visits by analyzing themes and patterns in parents' written responses on the PEDS form. We reviewed a consecutive sample of medical records with PEDS forms for children aged 6 months to 9 years (site 1) and 3 to 5 years (site 2). We recorded the concerns that parents identified in response to the 10 PEDS questions along with demographic information. We then categorized parents' written comments about those concerns according to comment content. We used qualitative and quantitative methods for analysis. We collected 752 PEDS forms. Ninety percent of the parents endorsed at least 1 concern (94.6% on the English forms versus 69.7% on the Spanish forms; P Parents qualified 27.5% of their concerns with a written comment. In 23.9% of cases in which parents identified a concern and provided a written comment, the content of the comment did not match the question's intent; rates of mismatch were similar for the English and Spanish forms. Among comments regarding behavioral concerns, 12% reflected a misunderstanding of age-appropriate behavior. Medical concerns accounted for 14.1% of the comments; these concerns were more common on English forms (61.3%) than on Spanish forms (1.7%) (P Parents frequently used the PEDS forms to communicate additional concerns regarding their child or provide positive feedback on their child's progress. The inappropriate developmental expectations, limited health literacy, and culturally distinct comments on the PEDS forms reinforce the importance of using screening tools to enhance the care provided during visits but not to replace patient-provider communication.

Anatomical and visual outcomes of ranibizumab injections in retinal pigment epithelium tears

Directory of Open Access Journals (Sweden)

Muhammet Kazım Erol

2015-06-01

Full Text Available ABSTRACT Purpose: To report the anatomical and visual results in patients diagnosed as having retinal pigment epithelium (RPE tears after receiving ranibizumab injections. Methods: Eyes diagnosed as having RPE tears with a minimum 6-month follow-up were retrospectively evaluated. Each eye was treated with at least three doses of ranibizumab at monthly intervals. Best-corrected visual acuity (BCVA, anterior segment findings, intraocular pressure, and fundus examination results were evaluated during control visits. Color fundus photography, fundus fluorescein angiographies, fundus autofluorescence, and spectral domain optical coherence tomography (SD-OCT images were obtained. The height of pigment epithelial detachment (PED was measured by SD-OCT. Results: Twelve eyes with RPE tears were studied. Nine eyes (75% developed RPE tears during ranibizumab injections for choroidal neovascularization (eight eyes with vascularized PED and one eye with choroidal osteoma, and tears occurred in three eyes before any injections. The median number of ranibizumab injections after diagnosis of RPE tears was 3 (min 2, max 5. In the most recent follow-up visit, there was no statistically significant correlation between the grade of RPE and logMAR of BCVA (p>0.05, r=0.112. Eight of twelve eyes had PED, and seven of these had irregular PED contours before injection therapy. The mean PED height was 447 ± 122 µm. Conclusions: In this series, RPE tears developed mostly after intravitreal anti-VEGF injections for vascularized PED. Increased vertical height and irregular contours of the PEDs can be risk factors for the formation of RPE tears. The continuation of anti-VEGF therapy after tear formation is beneficial for vision improvement in eyes with RPE tears.

Safety assessment and verification for nuclear power plants. Safety guide

International Nuclear Information System (INIS)

2001-01-01

This publication supports the Safety Requirements on the Safety of Nuclear Power Plants: Design. This Safety Guide was prepared on the basis of a systematic review of all the relevant publications including the Safety Fundamentals, Safety of Nuclear Power Plants: Design, current and ongoing revisions of other Safety Guides, INSAG reports and other publications that have addressed the safety of nuclear power plants. This Safety Guide also provides guidance for Contracting Parties to the Convention on Nuclear Safety in meeting their obligations under Article 14 on Assessment and Verification of Safety. The Safety Requirements publication entitled Safety of Nuclear Power Plants: Design states that a comprehensive safety assessment and an independent verification of the safety assessment shall be carried out before the design is submitted to the regulatory body. This publication provides guidance on how this requirement should be met. This Safety Guide provides recommendations to designers for carrying out a safety assessment during the initial design process and design modifications, as well as to the operating organization in carrying out independent verification of the safety assessment of new nuclear power plants with a new or already existing design. The recommendations for performing a safety assessment are suitable also as guidance for the safety review of an existing plant. The objective of reviewing existing plants against current standards and practices is to determine whether there are any deviations which would have an impact on plant safety. The methods and the recommendations of this Safety Guide can also be used by regulatory bodies for the conduct of the regulatory review and assessment. Although most recommendations of this Safety Guide are general and applicable to all types of nuclear reactors, some specific recommendations and examples apply mostly to water cooled reactors. Terms such as 'safety assessment', 'safety analysis' and 'independent

Reactor safety research and safety technology. Pt. 2

International Nuclear Information System (INIS)

Theenhaus, R.; Wolters, J.

1987-01-01

The state of HTR safety research work reached permits a comprehensive and reliable answer to be given to questions which have been raised by the reactor accident at Chernobyl, regarding HTR safety. Together with the probability safety analyses, the way to a safety concept suitable for an HTR is cleared; instructions are given for design optimisation with regard to safety technique and economy. The consequences of a graphite fire, the neutron physics design and the consequenes of the lack of a safety containment are briefly described. (DG) [de

Re-examining psychometric properties of the Turkish form of the Guilt Inventory in a non-clinical and depression sample (Turkish

Directory of Open Access Journals (Sweden)

Burçin Akın

2018-03-01

Full Text Available Object: In the most general sense, guilt is conceptualized as a strong, intense and negative emotion that quickly emerges when people do not live up according to internal values, judgements and social standards or violate them. The aim of the present study was to investigate the factor structure of Guilt Inventory that developed by Kugler and Jones with confirmatory and explanatory factor analyses and reevaluate the psychometric properties of the new Turkish form in depression and non-clinical samples. Methods: For this purpose, 448 university students, 107 healthy controls and 56 adults diagnosed with depression were asked to fill out the questionnaire set consisted of the Guilt Inventory, Beck Depression Inventory, Disgust Scale- Revised Form and The State-Trait Anxiety Inventory-State Anxiety Form.Results: According to the results, original form of Guilt Inventory did not work at the desired level in Turkish culture. Confirmatory and exploratory factor analyzes revealed that the new form with 35 items and 3 subscales works much more appropriately. The analyses of group comparison and correlations with other scales indicated that Turkish version of the Guilt Inventory had satisfactory convergent, divergent and criterion validity. Additively, internal consistency, item-total correlations and Guttman split-half reliability coefficients showed that the Turkish form of Guilt Inventory had good reliability values which were comparable to the original version of the scale. Discussion: In conclusion, results revealed that the Turkish version of Guilt Inventory is a reliable and valid measurement tool.

Safety climate and safety behaviors in the construction industry: The importance of co-workers commitment to safety.

Science.gov (United States)

Schwatka, Natalie V; Rosecrance, John C

2016-06-16

There is growing empirical evidence that as safety climate improves work site safety practice improve. Safety climate is often measured by asking workers about their perceptions of management commitment to safety. However, it is less common to include perceptions of their co-workers commitment to safety. While the involvement of management in safety is essential, working with co-workers who value and prioritize safety may be just as important. To evaluate a concept of safety climate that focuses on top management, supervisors and co-workers commitment to safety, which is relatively new and untested in the United States construction industry. Survey data was collected from a cohort of 300 unionized construction workers in the United States. The significance of direct and indirect (mediation) effects among safety climate and safety behavior factors were evaluated via structural equation modeling. Results indicated that safety climate was associated with safety behaviors on the job. More specifically, perceptions of co-workers commitment to safety was a mediator between both management commitment to safety climate factors and safety behaviors. These results support workplace health and safety interventions that build and sustain safety climate and a commitment to safety amongst work teams.

Safety

International Nuclear Information System (INIS)

1998-01-01

A brief account of activities carried out by the Nuclear power plants Jaslovske Bohunice in 1997 is presented. These activities are reported under the headings: (1) Nuclear safety; (2) Industrial and health safety; (3) Radiation safety; and Fire protection

Daily Elevations in Dissociative Absorption and Depersonalization in a Nonclinical Sample Are Related to Daily Stress and Psychopathological Symptoms.

Science.gov (United States)

Soffer-Dudek, Nirit

2017-01-01

Dissociative experiences are associated with several psychopathological symptoms and are a hindrance to therapeutic gain. Depersonalization-derealization (DEP-DER) is positively associated with stress and anxiety, while absorption and imaginative involvement (ABS), a tendency for total, immersed attention, is commonly referred to as nonpathological dissociation, although it is positively associated with obsessive-compulsive (OC) symptoms. Previous studies in the field have been mainly cross-sectional. The present study aimed to examine these associations rigorously and attempted to determine directionality between dissociation and distress. The current study employed both variable-centered (cross-sectional) and person-centered (longitudinal, within-subjects) analyses of the associations of DEP-DER and ABS with distress. Undergraduate students (N = 184) completed trait questionnaires on dissociation, stress, anxiety, depression, and OC symptoms, and n = 78 also completed questionnaires assessing the same constructs daily for 14 days. Multiple regression and multilevel modeling analyses were conducted. In the cross-sectional phase, DEP-DER was uniquely positively related to anxiety and OC symptoms, and ABS was uniquely positively related to OC symptoms. In the daily diary phase, increases in DEP-DER were related to increases in anxiety, depression, OC symptoms, and stress, while increases in ABS were related to increases in OC symptoms and stress. In addition, time-lag analysis showed that ABS tended to temporally precede OC. ABS foretold increases in OC symptoms, at least in this nonclinical sample. Future studies on clinical samples should explore whether ABS should be referred to as "nonpathological" and its possible role in the development or maintenance of clinical-level OCD.

Deprivation and non-institutional political participation

DEFF Research Database (Denmark)

Ejrnæs, Anders

2017-01-01

This article examines how the relationship between perceived economic deprivation (PED) and non-institutional forms of political activity interacted with institutional trust during the economic crisis in 24 European countries. Using multi-level regression analysis, two broad questions are addressed......: (1) does PED have an impact on the level of non-institutional political participation among European citizens? And (2) does the level of institutional trust within countries have an impact on the relationship between PED and political activity among European citizens? The empirical analyses are based...... the opposite correlation on an individual level within the countries. Second, the analysis provides evidence that the institutional context shapes the connection between PED and political participation on the individual level. In countries with a high level of institutional trust, economically deprived...

Safety Justification and Safety Case for Safety-critical Software in Digital Reactor Protection System

International Nuclear Information System (INIS)

Kwon, Kee-Choon; Lee, Jang-Soo; Jee, Eunkyoung

2016-01-01

Nuclear safety-critical software is under strict regulatory requirements and these regulatory requirements are essential for ensuring the safety of nuclear power plants. The verification & validation (V and V) and hazard analysis of the safety-critical software are required to follow regulatory requirements through the entire software life cycle. In order to obtain a license from the regulatory body through the development and validation of safety-critical software, it is essential to meet the standards which are required by the regulatory body throughout the software development process. Generally, large amounts of documents, which demonstrate safety justification including standard compliance, V and V, hazard analysis, and vulnerability assessment activities, are submitted to the regulatory body during the licensing process. It is not easy to accurately read and evaluate the whole documentation for the development activities, implementation technology, and validation activities. The safety case methodology has been kwon a promising approach to evaluate the level and depth of the development and validation results. A safety case is a structured argument, supported by a body of evidence that provides a compelling, comprehensible, and valid case that a system is safe for a given application in a given operating environment. It is suggested to evaluate the level and depth of the results of development and validation by applying safety case methodology to achieve software safety demonstration. A lot of documents provided as evidence are connected to claim that corresponds to the topic for safety demonstration. We demonstrated a case study in which more systematic safety demonstration for the target system software is performed via safety case construction than simply listing the documents

Safety Justification and Safety Case for Safety-critical Software in Digital Reactor Protection System

Energy Technology Data Exchange (ETDEWEB)

Kwon, Kee-Choon; Lee, Jang-Soo [Korea Atomic Energy Research Institute, Daejeon (Korea, Republic of); Jee, Eunkyoung [KAIST, Daejeon (Korea, Republic of)

2016-10-15

Nuclear safety-critical software is under strict regulatory requirements and these regulatory requirements are essential for ensuring the safety of nuclear power plants. The verification & validation (V and V) and hazard analysis of the safety-critical software are required to follow regulatory requirements through the entire software life cycle. In order to obtain a license from the regulatory body through the development and validation of safety-critical software, it is essential to meet the standards which are required by the regulatory body throughout the software development process. Generally, large amounts of documents, which demonstrate safety justification including standard compliance, V and V, hazard analysis, and vulnerability assessment activities, are submitted to the regulatory body during the licensing process. It is not easy to accurately read and evaluate the whole documentation for the development activities, implementation technology, and validation activities. The safety case methodology has been kwon a promising approach to evaluate the level and depth of the development and validation results. A safety case is a structured argument, supported by a body of evidence that provides a compelling, comprehensible, and valid case that a system is safe for a given application in a given operating environment. It is suggested to evaluate the level and depth of the results of development and validation by applying safety case methodology to achieve software safety demonstration. A lot of documents provided as evidence are connected to claim that corresponds to the topic for safety demonstration. We demonstrated a case study in which more systematic safety demonstration for the target system software is performed via safety case construction than simply listing the documents.

New Safety rules

CERN Multimedia

Safety Commission

2008-01-01

The revision of CERN Safety rules is in progress and the following new Safety rules have been issued on 15-04-2008: Safety Procedure SP-R1 Establishing, Updating and Publishing CERN Safety rules: http://cern.ch/safety-rules/SP-R1.htm; Safety Regulation SR-S Smoking at CERN: http://cern.ch/safety-rules/SR-S.htm; Safety Regulation SR-M Mechanical Equipment: http://cern.ch/safety-rules/SR-M.htm; General Safety Instruction GSI-M1 Standard Lifting Equipment: http://cern.ch/safety-rules/GSI-M1.htm; General Safety Instruction GSI-M2 Standard Pressure Equipment: http://cern.ch/safety-rules/GSI-M2.htm; General Safety Instruction GSI-M3 Special Mechanical Equipment: http://cern.ch/safety-rules/GSI-M3.htm. These documents apply to all persons under the Director General’s authority. All Safety rules are available at the web page: http://www.cern.ch/safety-rules The Safety Commission

The role of probabilistic safety assessment and probabilistic safety criteria in nuclear power plant safety

International Nuclear Information System (INIS)

1992-01-01

The purpose of this Safety Report is to provide guidelines on the role of probabilistic safety assessment (PSA) and a range of associated reference points, collectively referred to as probabilistic safety criteria (PSC), in nuclear safety. The application of this Safety Report and the supporting Safety Practice publication should help to ensure that PSA methodology is used appropriately to assess and enhance the safety of nuclear power plants. The guidelines are intended for use by nuclear power plant designers, operators and regulators. While these guidelines have been prepared with nuclear power plants in mind, the principles involved have wide application to other nuclear and non-nuclear facilities. In Section 2 of this Safety Report guidelines are established on the role PSA can play as part of an overall safety assurance programme. Section 3 summarizes guidelines for the conduct of PSAs, and in Section 4 a PSC framework is recommended and guidance is provided for the establishment of PSC values

Safety of Nuclear Power Plants: Design. Specific Safety Requirements

International Nuclear Information System (INIS)

2012-01-01

On the basis of the principles included in the Fundamental Safety Principles, IAEA Safety Standards Series No. SF-1, this Safety Requirements publication establishes requirements applicable to the design of nuclear power plants. It covers the design phase and provides input for the safe operation of the power plant. It elaborates on the safety objective, safety principles and concepts that provide the basis for deriving the safety requirements that must be met for the design of a nuclear power plant. Contents: 1. Introduction; 2. Applying the safety principles and concepts; 3. Management of safety in design; 4. Principal technical requirements; 5. General plant design; 6. Design of specific plant systems.

Discussion on the safety classification of nuclear safety mechanical equipment

International Nuclear Information System (INIS)

Shen Wei

2010-01-01

The purpose and definition of the equipment safety classification in nuclear plant are introduced. The differences of several safety classification criterions are compared, and the object of safety classification is determined. According to the regulation, the definition and category of the safety functions are represented. The safety classification method, safety classification process, safety class interface, and the requirement for the safety class mechanical equipment are explored. At last, the relation of the safety classification between the mechanical and electrical equipment is presented, and the relation of the safety classification between mechanical equipment and system is also presented. (author)

Traceability of Software Safety Requirements in Legacy Safety Critical Systems

Science.gov (United States)

Hill, Janice L.

2007-01-01

How can traceability of software safety requirements be created for legacy safety critical systems? Requirements in safety standards are imposed most times during contract negotiations. On the other hand, there are instances where safety standards are levied on legacy safety critical systems, some of which may be considered for reuse for new applications. Safety standards often specify that software development documentation include process-oriented and technical safety requirements, and also require that system and software safety analyses are performed supporting technical safety requirements implementation. So what can be done if the requisite documents for establishing and maintaining safety requirements traceability are not available?

Progress in biosimilar monoclonal antibody development: the infliximab biosimilar CT-P13 in the treatment of rheumatic diseases.

Science.gov (United States)

Braun, Jürgen; Kudrin, Alex

2015-01-01

Biosimilars are biologic medical products whose active drug substance is made by a living organism or derived from it. The term is used to describe a subsequent version of an innovator biopharmaceutical product aiming at approval following patent expiry on the reference product. Biosimilars of monoclonal need to demonstrate similar but not identical quality of nonclinical and clinical attributes. Not all data of the originator product need to be recapitulated, as large numbers of patient-years of exposure data are already available. Thus, biosimilar development is largely based on the safety profiles of the originator product. The evaluation of biosimilarity includes immunogenicity attributed risks. CT-P13 (Remsima™/Inflectra™, Celltrion/Hospira), a biosimilar of the innovator drug infliximab (INF), was the first approved complex biosimilar monoclonal antibody in the EU, within the framework of WHO, EMA and US FDA biosimilar guidelines. CT-P13 has shown analytical and nonclinical features highly similar to INF including pharmacokinetics, efficacy, safety and immunogenicity profiles in ankylosing spondylitis and rheumatoid arthritis. The objective of this article is to highlight the recent biosimilar development and to review the results from the studies PLANETRA and PLANETAS, which have supported the approval of CT-P13 for several indications.

Safety design

International Nuclear Information System (INIS)

Kunitomi, Kazuhiko; Shiozawa, Shusaku

2004-01-01

JAERI established the safety design philosophy of the HTTR based on that of current reactors such as LWR in Japan, considering inherent safety features of the HTTR. The strategy of defense in depth was implemented so that the safety engineering functions such as control of reactivity, removal of residual heat and confinement of fission products shall be well performed to ensure safety. However, unlike the LWR, the inherent design features of the high-temperature gas-cooled reactor (HTGR) enables the HTTR meet stringent regulatory criteria without much dependence on active safety systems. On the other hand, the safety in an accident typical to the HTGR such as the depressurization accident initiated by a primary pipe rupture shall be ensured. The safety design philosophy of the HTTR considers these unique features appropriately and is expected to be the basis for future Japanese HTGRs. This paper describes the safety design philosophy and safety evaluation procedure of the HTTR especially focusing on unique considerations to the HTTR. Also, experiences obtained from an HTTR safety review and R and D needs for establishing the safety philosophy for the future HTGRs are reported

Safety KPIs - Monitoring of safety performance

Directory of Open Access Journals (Sweden)

Andrej Lališ

2014-09-01

Full Text Available This paper aims to provide brief overview of aviation safety development focusing on modern trends represented by implementation of Safety Key Performance Indicators. Even though aviation is perceived as safe means of transport, it is still struggling with its complexity given by long-term growth and robustness which it has reached today. Thus nowadays safety issues are much more complex and harder to handle than ever before. We are more and more concerned about organizational factors and control mechanisms which have potential to further increase level of aviation safety. Within this paper we will not only introduce the concept of Key Performance Indicators in area of aviation safety as an efficient control mechanism, but also analyse available legislation and documentation. Finally we will propose complex set of indicators which could be applied to Czech Air Navigation Service Provider.

HSE's safety assessment principles for criticality safety

International Nuclear Information System (INIS)

Simister, D N; Finnerty, M D; Warburton, S J; Thomas, E A; Macphail, M R

2008-01-01

The Health and Safety Executive (HSE) published its revised Safety Assessment Principles for Nuclear Facilities (SAPs) in December 2006. The SAPs are primarily intended for use by HSE's inspectors when judging the adequacy of safety cases for nuclear facilities. The revised SAPs relate to all aspects of safety in nuclear facilities including the technical discipline of criticality safety. The purpose of this paper is to set out for the benefit of a wider audience some of the thinking behind the final published words and to provide an insight into the development of UK regulatory guidance. The paper notes that it is HSE's intention that the Safety Assessment Principles should be viewed as a reflection of good practice in the context of interpreting primary legislation such as the requirements under site licence conditions for arrangements for producing an adequate safety case and for producing a suitable and sufficient risk assessment under the Ionising Radiations Regulations 1999 (SI1999/3232 www.opsi.gov.uk/si/si1999/uksi_19993232_en.pdf). (memorandum)

ITER safety

International Nuclear Information System (INIS)

Raeder, J.; Piet, S.; Buende, R.

1991-01-01

As part of the series of publications by the IAEA that summarize the results of the Conceptual Design Activities for the ITER project, this document describes the ITER safety analyses. It contains an assessment of normal operation effluents, accident scenarios, plasma chamber safety, tritium system safety, magnet system safety, external loss of coolant and coolant flow problems, and a waste management assessment, while it describes the implementation of the safety approach for ITER. The document ends with a list of major conclusions, a set of topical remarks on technical safety issues, and recommendations for the Engineering Design Activities, safety considerations for siting ITER, and recommendations with regard to the safety issues for the R and D for ITER. Refs, figs and tabs

Safety culture

International Nuclear Information System (INIS)

Keen, L.J.

2003-01-01

Safety culture has become a topic of increasing interest for industry and regulators as issues are raised on safety problems around the world. The keys to safety culture are organizational effectiveness, effective communications, organizational learning, and a culture that encourages the identification and resolution of safety issues. The necessity of a strong safety culture places an onus on all of us to continually question whether the safety measures already in place are sufficient, and are being applied. (author)

Safety Climate, Perceived Risk, and Involvement in Safety Management

OpenAIRE

Kouabenan , Dongo Rémi; Ngueutsa , Robert ,; Safiétou , Mbaye

2015-01-01

International audience; This article examines the relationship between safety climate, risk perception and involvement in safety management by first-line managers (FLM). Sixty-three FLMs from two French nuclear plants answered a questionnaire measuring perceived workplace safety climate, perceived risk, and involvement in safety management. We hypothesized that a positive perception of safety climate would promote substantial involvement in safety management, and that this effect would be str...

10 CFR 70.62 - Safety program and integrated safety analysis.

Science.gov (United States)

2010-01-01

...; (iv) Potential accident sequences caused by process deviations or other events internal to the... have experience in nuclear criticality safety, radiation safety, fire safety, and chemical process... this safety program; namely, process safety information, integrated safety analysis, and management...

Safety Assessment for Research Reactors and Preparation of the Safety Analysis Report. Specific Safety Guide

Energy Technology Data Exchange (ETDEWEB)

NONE

2011-11-15

The IAEA's Statute authorizes the Agency to 'establish or adopt' standards of safety for protection of health and minimization of danger to life and property' - standards that the IAEA must use in its own operations, and which States can apply by means of their regulatory provisions for nuclear and radiation safety. The IAEA does this in consultation with the competent organs of the United Nations and with the specialized agencies concerned. A comprehensive set of high quality standards under regular review is a key element of a stable and sustainable global safety regime, as is the IAEA's assistance in their application. The IAEA commenced its safety standards programme in 1958. The emphasis placed on quality, fitness for purpose and continuous improvement has led to the widespread use of the IAEA standards throughout the world. The Safety Standards Series now includes unified Fundamental Safety Principles, which represent an international consensus on what must constitute a high level of protection and safety. With the strong support of the Commission on Safety Standards, the IAEA is working to promote the global acceptance and use of its standards. Standards are only effective if they are properly applied in practice. The IAEA's safety services encompass design, siting and engineering safety, operational safety, radiation safety, safe transport of radioactive material and safe management of radioactive waste, as well as governmental organization, regulatory matters and safety culture in organizations. These safety services assist Member States in the application of the standards and enable valuable experience and insights to be shared. Regulating safety is a national responsibility, and many States have decided to adopt the IAEA's standards for use in their national regulations. For parties to the various international safety conventions, IAEA standards provide a consistent, reliable means of ensuring the effective fulfilment of obligations under the conventions

Safety Assessment for Research Reactors and Preparation of the Safety Analysis Report. Specific Safety Guide

International Nuclear Information System (INIS)

2011-01-01

The IAEA's Statute authorizes the Agency to 'establish or adopt' standards of safety for protection of health and minimization of danger to life and property' - standards that the IAEA must use in its own operations, and which States can apply by means of their regulatory provisions for nuclear and radiation safety. The IAEA does this in consultation with the competent organs of the United Nations and with the specialized agencies concerned. A comprehensive set of high quality standards under regular review is a key element of a stable and sustainable global safety regime, as is the IAEA's assistance in their application. The IAEA commenced its safety standards programme in 1958. The emphasis placed on quality, fitness for purpose and continuous improvement has led to the widespread use of the IAEA standards throughout the world. The Safety Standards Series now includes unified Fundamental Safety Principles, which represent an international consensus on what must constitute a high level of protection and safety. With the strong support of the Commission on Safety Standards, the IAEA is working to promote the global acceptance and use of its standards. Standards are only effective if they are properly applied in practice. The IAEA's safety services encompass design, siting and engineering safety, operational safety, radiation safety, safe transport of radioactive material and safe management of radioactive waste, as well as governmental organization, regulatory matters and safety culture in organizations. These safety services assist Member States in the application of the standards and enable valuable experience and insights to be shared. Regulating safety is a national responsibility, and many States have decided to adopt the IAEA's standards for use in their national regulations. For parties to the various international safety conventions, IAEA standards provide a consistent, reliable means of ensuring the effective fulfilment of obligations under the conventions

IAEA Safety Standards

International Nuclear Information System (INIS)

2016-09-01

The IAEA Safety Standards Series comprises publications of a regulatory nature covering nuclear safety, radiation protection, radioactive waste management, the transport of radioactive material, the safety of nuclear fuel cycle facilities and management systems. These publications are issued under the terms of Article III of the IAEA’s Statute, which authorizes the IAEA to establish “standards of safety for protection of health and minimization of danger to life and property”. Safety standards are categorized into: • Safety Fundamentals, stating the basic objective, concepts and principles of safety; • Safety Requirements, establishing the requirements that must be fulfilled to ensure safety; and • Safety Guides, recommending measures for complying with these requirements for safety. For numbering purposes, the IAEA Safety Standards Series is subdivided into General Safety Requirements and General Safety Guides (GSR and GSG), which are applicable to all types of facilities and activities, and Specific Safety Requirements and Specific Safety Guides (SSR and SSG), which are for application in particular thematic areas. This booklet lists all current IAEA Safety Standards, including those forthcoming

78 FR 53790 - Public Forum-Safety Culture: Enhancing Transportation Safety

Science.gov (United States)

2013-08-30

... NATIONAL TRANSPORTATION SAFETY BOARD Public Forum--Safety Culture: Enhancing Transportation Safety On Tuesday and Wednesday, September 10-11, 2013, the National Transportation Safety Board (NTSB) will convene a forum titled, ``Safety Culture: Enhancing Transportation Safety.'' The forum will begin at 9:00...

Importance of customer adjustment regions in the non-clinical property of thought: A home examination in low and high-income areas of Mashhad.

Science.gov (United States)

Fazaeli, S; Yousefi, M; Banikazemi, S H; Ghazizadeh Hashemi, Sah; Khorsand, A; Badiee, Sh

2015-01-01

Responsiveness was proposed via WHO as a fundamental sign to evaluate the enforcement of wellness practices and evaluates with a standard organization of fields that are classified to 2 principal classes "Respect as characters" and "customer adjustment". The current research included the value of customer adjustment areas in low and high-income communities of Mashhad. In the current descriptive research, an example of 923 families was chosen stochastically of 2 low and high pay areas of Mashhad. WHO survey employed for information gathering. Regular rate reviews and Ordinal Logistic Regression (OLR) applied for information investigation. In overall, respondents chose basic amenities quality as the primary area, and the path to social care networks recognized as the wicked primary area. Families in high-income states obtained higher areas of immediate notations and selection associated with low-income. There is a meaningful correlation among parameters of ages, having a part whom required care and self-imposed health via the ranking of customer adjustment areas. The investigation of the homes' viewpoint concerning the classification of non-clinical perspectives of care quality, particularly while confronted by restricted sources, can assist in managing enterprises towards topics that are more relevant and results in the development of the wellness policy achievement and fecundity.

The short-form version of the Depression Anxiety Stress Scales (DASS-21): construct validity and normative data in a large non-clinical sample.

Science.gov (United States)

Henry, Julie D; Crawford, John R

2005-06-01

To test the construct validity of the short-form version of the Depression anxiety and stress scale (DASS-21), and in particular, to assess whether stress as indexed by this measure is synonymous with negative affectivity (NA) or whether it represents a related, but distinct, construct. To provide normative data for the general adult population. Cross-sectional, correlational and confirmatory factor analysis (CFA). The DASS-21 was administered to a non-clinical sample, broadly representative of the general adult UK population (N = 1,794). Competing models of the latent structure of the DASS-21 were evaluated using CFA. The model with optimal fit (RCFI = 0.94) had a quadripartite structure, and consisted of a general factor of psychological distress plus orthogonal specific factors of depression, anxiety, and stress. This model was a significantly better fit than a competing model that tested the possibility that the Stress scale simply measures NA. The DASS-21 subscales can validly be used to measure the dimensions of depression, anxiety, and stress. However, each of these subscales also taps a more general dimension of psychological distress or NA. The utility of the measure is enhanced by the provision of normative data based on a large sample.

Nuclear safety

International Nuclear Information System (INIS)

1991-02-01

This book reviews the accomplishments, operations, and problems faced by the defense Nuclear Facilities Safety Board. Specifically, it discusses the recommendations that the Safety Board made to improve safety and health conditions at the Department of Energy's defense nuclear facilities, problems the Safety Board has encountered in hiring technical staff, and management problems that could affect the Safety Board's independence and credibility

Auto Safety

Science.gov (United States)

... Safe Videos for Educators Search English Español Auto Safety KidsHealth / For Parents / Auto Safety What's in this ... by teaching some basic rules. Importance of Child Safety Seats Using a child safety seat (car seat) ...

LFR safety approach and main ELFR safety analysis results

International Nuclear Information System (INIS)

Bubelis, E.; Schikorr, M.; Frogheri, M.; Mansani, L.; Bandini, G.; Burgazzi, L.; Mikityuk, K.; Zhang, Y.; Lo Frano, R.; Forgione, N.

2013-01-01

LFR safety approach: → A global safety approach for the LFR reference plant has been assessed and the safety analyses methodology has been developed. → LFR follows the general guidelines of the Generation IV safety concept recommendations. Thus, improved safety and higher reliability are recognized as an essential priority. → The fundamental safety objectives and the Defence-in-Depth (DiD) approach, as described by IAEA Safety Guides, have been preserved. → The recommendations of the Risk and Safety Working Group (RSWG) of GEN-IV IF has been taken into account: • safety is to be “built-in” in the fundamental design rather than “added on”; • full implementation of the Defence-in-Depth principles in a manner that is demonstrably exhaustive, progressive, tolerant, forgiving and well-balanced; • “risk-informed” approach - deterministic approach complemented with a probabilistic one; • adoption of an integrated methodology that can be used to evaluate and document the safety of Gen IV nuclear systems - ISAM. In particular the OPT tool is the fundamental methodology used throughout the design process

Safety campaigns. TIS Launches New Safety Information Campaign

CERN Multimedia

2001-01-01

Need to start a new installation and worried about safety aspects? Or are you newly responsible for safety matters in a CERN building? Perhaps you're simply interested in how to make the working environment safer for yourself and your colleagues. Whatever the case, a new information campaign launched by TIS this week can help. The most visible aspects of the new campaign will be posters distributed around the Laboratory treating a different subject each month. The Web site - http://safety.cern.ch/ - which provides all safety related information. But these are not the only aspects of the new campaign. Members of the TIS/GS group, whose contact details can be found on the safety web site, are available to give information and advice on a one-to-one basis at any time. The campaign's launch has been timed to coincide with European Safety Week, organized by the European Agency for Safety and Health at Work and the subject treated in the first posters is safety inspection. This particular topic only concerns thos...

Estudo preliminar sobre a qualidade de vida de médicos e enfermeiros intensivistas pediátricos e neonatais Estudio preliminar sobre la calidad de vida de médicos y enfermeros intensivistas pediátricos y neonatales Preliminary study about qualify of life of physicians and nurses working in pediatric and neonatal intensive care units

Directory of Open Access Journals (Sweden)

Monalisa de Cássia Fogaça

2010-09-01

Full Text Available Comparar a Qualidade de Vida (QV de médicos e enfermeiros que trabalham em UTI Pediátrica (PED e Neonatal (NEO e, também, avaliar se há diferença entre a QV na mesma categoria profissional, mas diferindo de acordo com a unidade de trabalho. Estudo descritivo com 37 médicos e 20 enfermeiros. O WHOQOL-100 foi utilizado. Médicos da PED diferiram estatisticamente no domínio VI (p=0,003, quando comparados com médicos da NEO. Médicos e enfermeiros da PED apresentaram diferença estatística significante no domínio V (p Comparar la Calidad de Vida (QV de médicos y enfermeros que trabajan en UTI Pediátrica (PED y neonatal (NEO y, también evaluar si existe diferencia entre la QV en la misma categoría profesional, aunque variando de acuerdo con la unidad de trabajo. Estudio descriptivo con 37 médicos y 20 enfermeros. Fue utilizado el WHOQOL-100. Los médicos de PED diferían estadísticamente en el dominio VI (p=0,003 en comparación con los médicos de NEO. Médicos y enfermeros de PED presentaron una diferencia estadística significativa en el dominio V (pCompare the Quality of Life (QL of doctors and nurses who work in Pediatric (PED and Neonatal (NEO Intensive Care Units, and to evaluate whether there are differences between the QL in the same job category, but differing according to the work unit. This descriptive study was performed with 37 physicians and 20 nurses. The WHOQOL100 was used. Physicians from the PED differ statistically in the field VI (p=0.003 compared with physicians from the NEO. Physicians and nurses from the PED showed a statistically significant difference in field V (p<0.01, while physicians and nurses from the NEO showed a statistically significant difference in field VI (p=0.05. The QL assessment of physicians and nurses working in pediatric and neonatal intensive care units was below the scores found in scientific literature, compared to studies that evaluated patients with chronic pain and mental health

The association between EMS workplace safety culture and safety outcomes.

Science.gov (United States)

Weaver, Matthew D; Wang, Henry E; Fairbanks, Rollin J; Patterson, Daniel

2012-01-01

Prior studies have highlighted wide variation in emergency medical services (EMS) workplace safety culture across agencies. To determine the association between EMS workplace safety culture scores and patient or provider safety outcomes. We administered a cross-sectional survey to EMS workers affiliated with a convenience sample of agencies. We recruited these agencies from a national EMS management organization. We used the EMS Safety Attitudes Questionnaire (EMS-SAQ) to measure workplace safety culture and the EMS Safety Inventory (EMS-SI), a tool developed to capture self-reported safety outcomes from EMS workers. The EMS-SAQ provides reliable and valid measures of six domains: safety climate, teamwork climate, perceptions of management, working conditions, stress recognition, and job satisfaction. A panel of medical directors, emergency medical technicians and paramedics, and occupational epidemiologists developed the EMS-SI to measure self-reported injury, medical errors and adverse events, and safety-compromising behaviors. We used hierarchical linear models to evaluate the association between EMS-SAQ scores and EMS-SI safety outcome measures. Sixteen percent of all respondents reported experiencing an injury in the past three months, four of every 10 respondents reported an error or adverse event (AE), and 89% reported safety-compromising behaviors. Respondents reporting injury scored lower on five of the six domains of safety culture. Respondents reporting an error or AE scored lower for four of the six domains, while respondents reporting safety-compromising behavior had lower safety culture scores for five of the six domains. Individual EMS worker perceptions of workplace safety culture are associated with composite measures of patient and provider safety outcomes. This study is preliminary evidence of the association between safety culture and patient or provider safety outcomes.

Olanzapine approved for the acute treatment of schizophrenia or manic/mixed episodes associated with bipolar I disorder in adolescent patients

Directory of Open Access Journals (Sweden)

Ann E Maloney

2010-11-01

Full Text Available Ann E Maloney1,2, Linmarie Sikich31Maine Medical Center Research Institute, Scarborough, ME, USA; 2Department of Psychiatry, Tufts University School of Medicine, Boston, MA, USA; 3Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, NC, USABackground: Severe and persistent mental illnesses in children and adolescents, such as early-onset schizophrenia spectrum (EOSS disorders and pediatric bipolar disorder (pedBP, are increasingly recognized. Few treatments have demonstrated efficacy in rigorous clinical trials. Enduring response to current medications appears limited. Recently, olanzapine was approved for the treatment of adolescents with schizophrenia or acute manic/mixed episodes in pedBP.Methods: PubMed searches were conducted for olanzapine combined with pharmacology, schizophrenia, or bipolar disorder. Searches related to schizophrenia and bipolar disorder were limited to children and adolescents. The bibliographies of the retrieved articles were hand-checked for additional relevant studies. The epidemiology, phenomenology, and treatment of EOSS and pedBP, and olanzapine’s pharmacology are reviewed. Studies of olanzapine treatment in youth with EOSS and pedBP are examined.Results: Olanzapine is efficacious for EOSS and pedBP. However, olanzapine is not more efficacious than risperidone, molindone, or haloperidol in EOSS and is less efficacious than clozapine in treatment-resistant EOSS. No comparative trials have been done in pedBP. Olanzapine is associated with weight gain, dyslipidemia, and transaminase elevations in youth. Extrapyramidal symptoms, neuroleptic malignant syndrome, and blood dyscrasias have also been reported but appear rare.Conclusions: The authors conclude that olanzapine should be considered a second-line agent in EOSS and pedBP due to its risks for significant weight gain and lipid dysregulation. Awareness of the consistent weight and metabolic changes observed in olanzapine

[Selective retina therapy in central serous chorioretinopathy with detachment of the pigmentary epithelium].

Science.gov (United States)

Klatt, C; Elsner, H; Pörksen, E; Brinkmann, R; Bunse, A; Birngruber, R; Roider, J

2006-10-01

Selective Retina Therapy (SRT) is a new and innovative laser treatment modality that selectively treats the retinal pigmentary epithelium while sparing the photoreceptors. This therapeutic concept appears to be particularly suitable for treating patients with acute or chronic central serous chorioretinopathy (CSC). We present preliminary results obtained in five patients who had CSC associated with pigmentary epithelium detachment (PED) and serous subretinal fluid (SRF) and who were treated with SRT. This case series was made up of five male patients (mean age 47 years) with chronic CSC and SRF resulting from PED. Examinations performed before and at 1 month and 3 months after the treatment were: BCVA, FLA, OCT (Zeiss OCT III). For SRT, confluent treatment of the PED (area of leakage) was carried out using a pulsed frequency-doubled, Q-switched Nd-YLF prototype laser (lambda=527 nm, t= 1.7 s, 100 Hz, energy = 150-250 J). Best corrected visual acuity at baseline was 0.53, while after 4 weeks it was 0.56 and after 12 weeks, 0.5. At baseline leakage was seen at the PED on fluorescein angiography in all patients. After 4 weeks leakage activity was no longer noted on angiography in 4 of 5 patients. OCT at baseline showed SRF at the edge of the PED in all patients, but in 4 of the 5 patients this was no longer detectable after 4 weeks. SRT is a safe and effective treatment for patients with CSC in which PED has caused SRF. Not a single case of rip syndrome was observed in this study, even though the PED was treated confluently. Since SRT spares the photoreceptors it is particularly suitable for the treatment of CSC, especially when the origin of leakage is located close to the fovea. The results indicate that SRT leads to reconstruction of the outer blood-retina barrier.

Transformational and passive leadership as cross-level moderators of the relationships between safety knowledge, safety motivation, and safety participation.

Science.gov (United States)

Jiang, Lixin; Probst, Tahira M

2016-06-01

While safety knowledge and safety motivation are well-established predictors of safety participation, less is known about the impact of leadership styles on these relationships. The purpose of the current study was to examine whether the positive relationships between safety knowledge and motivation and safety participation are contingent on transformational and passive forms of safety leadership. Using multilevel modeling with a sample of 171 employees nested in 40 workgroups, we found that transformational safety leadership strengthened the safety knowledge-participation relationship, whereas passive leadership weakened the safety motivation-participation relationship. Under low transformational leadership, safety motivation was not related to safety participation; under high passive leadership, safety knowledge was not related to safety participation. These results are discussed in light of organizational efforts to increase safety-related citizenship behaviors. Copyright © 2016 Elsevier Ltd and National Safety Council. All rights reserved.

Selecting of key safety parameters in reactor nuclear safety supervision

International Nuclear Information System (INIS)

He Fan; Yu Hong

2014-01-01

The safety parameters indicate the operational states and safety of research reactor are the basis of nuclear safety supervision institution to carry out effective supervision to nuclear facilities. In this paper, the selecting of key safety parameters presented by the research reactor operating unit to National Nuclear Safety Administration that can express the research reactor operational states and safety when operational occurrence or nuclear accident happens, and the interrelationship between them are discussed. Analysis shows that, the key parameters to nuclear safety supervision of research reactor including design limits, operational limits and conditions, safety system settings, safety limits, acceptable limits and emergency action level etc. (authors)

Factors associated with early neonatal attendance to a paediatric emergency department.

Science.gov (United States)

Flanagan, C F; Stewart, M

2014-03-01

To examine the demographic and perinatal factors involved in the presentation of newborn babies to a paediatric emergency department (PED) and outcome following attendance. Term babies who attended the PED of the Royal Belfast Hospital for Sick Children (RBHSC) in the first 2 weeks of life, during two separate 3-month periods in summer and winter 2010-2011 were identified retrospectively from the PED electronic database. Perinatal and demographic data were also obtained on all babies born in the Royal Jubilee Maternity Hospital (RJMH) during the same time period. A total of 223 attendances to the PED involving 208 babies were identified with almost equal distribution during summer and winter months. Almost two thirds (n=139, 62%) of babies presented out-of-hours. Over half of babies were self-referred by parent/carer. The most common presentation was feeding difficulty, vomiting or faltering growth, accounting for 36%. Significant factors associated with attendance to PED included birth weight working day. Overall, a third of babies admitted stayed less than 24 h (34%). Large numbers of babies attend the PED in the first 2 weeks of life, commonly out of hours, from deprived areas and with feeding difficulties. A quarter of babies attending are admitted to hospital, with one-third discharged following an overnight stay. Services should be reevaluated, particularly in this current financial climate, in an attempt to find new models of care for these young babies.

Screening for iron deficiency anemia in at risk children in the pediatric emergency department: a survey of Canadian pediatric emergency department physicians.

Science.gov (United States)

Berard, Roberta; Matsui, Doreen; Lynch, Tim

2007-05-01

To determine the attitudes and reported practices of physicians regarding screening for iron deficiency anemia in at-risk children in pediatric emergency departments (PEDs) across Canada. A standardized survey was mailed to 183 PED physicians at 10 tertiary care PED across Canada. The practices and attitudes regarding screening for iron deficiency anemia were collected via a questionnaire consisting of single select closed-ended items and items which required ranking in order of importance. Sixty-one percent (111/183) of physicians responded to the survey. Ninety-six percent of respondents do not routinely screen for iron deficiency anemia. One third of respondents believed that screening for iron deficiency anemia in the PED is possible. The remaining stated lack of time, difficulty with follow-up, it not being an emergent issue and cost as prohibitive factors. One third of participants stated that 21% to 40% of the pediatric patients seen in their PED did not have a primary care physician. The main considerations in deciding on whom to perform venipuncture were based on dietary history and physical examination with a history of consumption of milk greater than 24 ounces per day (94%) and conjunctival or skin pallor (97%, 94%, respectively) selected as the most important items. The results of this study indicate that Canadian PED physicians are not routinely screening for iron deficiency anemia, although they demonstrate knowledge of the risk factors for iron deficiency anemia and recognize the importance of diagnosis and treatment to prevent long-term morbidity.

Perceived organizational support for safety and employee safety voice: the mediating role of coworker support for safety.

Science.gov (United States)

Tucker, Sean; Chmiel, Nik; Turner, Nick; Hershcovis, M Sandy; Stride, Chris B

2008-10-01

In the present study, we modeled 2 sources of safety support (perceived organizational support for safety and perceived coworker support for safety) as predictors of employee safety voice, that is, speaking out in an attempt to change unsafe working conditions. Drawing on social exchange and social impact theories, we hypothesized and tested a mediated model predicting employee safety voice using a cross-sectional survey of urban bus drivers (n = 213) in the United Kingdom. Hierarchical regression analysis showed that perceived coworker support for safety fully mediated the relationship between perceived organizational support for safety and employee safety voice. This study adds to the employee voice literature by evaluating the important role that coworkers can play in encouraging others to speak out about safety issues. Implications for research and practice related to change-oriented safety communication are discussed.

Safety of Research Reactors. Specific Safety Requirements (French Edition)

International Nuclear Information System (INIS)

2017-01-01

This Safety Requirements publication establishes requirements for all main areas of safety for research reactors, with particular emphasis on requirements for design and operation. It explains the safety objectives and concepts that form the basis for safety and safety assessment for all stages in the lifetime of a research reactor. Technical and administrative requirements for the safety of new research reactors are established in accordance with these objectives and concepts, and they are to be applied to the extent practicable for existing research reactors. The safety requirements established in this publication for the management of safety and regulatory supervision apply to site evaluation, design, manufacturing, construction, commissioning, operation (including utilization and modification), and planning for decommissioning of research reactors (including critical assemblies and subcritical assemblies). The publication is intended for use by regulatory bodies and other organizations with responsibilities in these areas and in safety analysis, verification and review, and the provision of technical support.

Relationships among Safety Climate, Safety Behavior, and Safety Outcomes for Ethnic Minority Construction Workers

Directory of Open Access Journals (Sweden)

Sainan Lyu

2018-03-01

Full Text Available In many countries, it is common practice to attract and employ ethnic minority (EM or migrant workers in the construction industry. This primarily occurs in order to alleviate the labor shortage caused by an aging workforce with a lack of new entrants. Statistics show that EM construction workers are more likely to have occupational fatal and nonfatal injuries than their local counterparts; however, the mechanism underlying accidents and injuries in this vulnerable population has been rarely examined. This study aims to investigate relationships among safety climate, safety behavior, and safety outcomes for EM construction workers. To this end, a theoretical research model was developed based on a comprehensive review of the current literature. In total, 289 valid questionnaires were collected face-to-face from 223 Nepalese construction workers and 56 Pakistani construction workers working on 15 construction sites in Hong Kong. Structural equation modelling was employed to validate the constructs and test the hypothesized model. Results show that there were significant positive relationships between safety climate and safety behaviors, and significant negative relationships between safety behaviors and safety outcomes for EM construction workers. This research contributes to the literature regarding EM workers by providing empirical evidence of the mechanisms by which safety climate affects safety behaviors and outcomes. It also provides insights in order to help the key stakeholders formulate safety strategies for EM workers in many areas where numerous EM workers are employed, such as in the U.S., the UK, Australia, Singapore, Malaysia, and the Middle East.

Relationships among Safety Climate, Safety Behavior, and Safety Outcomes for Ethnic Minority Construction Workers.

Science.gov (United States)

Lyu, Sainan; Hon, Carol K H; Chan, Albert P C; Wong, Francis K W; Javed, Arshad Ali

2018-03-09

In many countries, it is common practice to attract and employ ethnic minority (EM) or migrant workers in the construction industry. This primarily occurs in order to alleviate the labor shortage caused by an aging workforce with a lack of new entrants. Statistics show that EM construction workers are more likely to have occupational fatal and nonfatal injuries than their local counterparts; however, the mechanism underlying accidents and injuries in this vulnerable population has been rarely examined. This study aims to investigate relationships among safety climate, safety behavior, and safety outcomes for EM construction workers. To this end, a theoretical research model was developed based on a comprehensive review of the current literature. In total, 289 valid questionnaires were collected face-to-face from 223 Nepalese construction workers and 56 Pakistani construction workers working on 15 construction sites in Hong Kong. Structural equation modelling was employed to validate the constructs and test the hypothesized model. Results show that there were significant positive relationships between safety climate and safety behaviors, and significant negative relationships between safety behaviors and safety outcomes for EM construction workers. This research contributes to the literature regarding EM workers by providing empirical evidence of the mechanisms by which safety climate affects safety behaviors and outcomes. It also provides insights in order to help the key stakeholders formulate safety strategies for EM workers in many areas where numerous EM workers are employed, such as in the U.S., the UK, Australia, Singapore, Malaysia, and the Middle East.

Epidemiology and vaccine of porcine epidemic diarrhea virus in China: a mini-review.

Science.gov (United States)

Sun, Dongbo; Wang, Xinyu; Wei, Shan; Chen, Jianfei; Feng, Li

2016-03-01

Porcine epidemic diarrhea (PED) is an intestinal infectious disease caused by porcine epidemic diarrhea virus (PEDV); manifestations of the disease are diarrhea, vomiting and dehydration. Starting from the end of 2010, a PED outbreak occurred in several pig-producing provinces in southern China. Subsequently, the disease spread throughout the country and caused enormous economic losses to the pork industry. Accumulating studies demonstrated that new PEDV variants that appeared in China were responsible for the PED outbreak. In the current mini-review, we summarize PEDV epidemiology and vaccination in China.

EFSA AHAW Panel (EFSA Panel on Animal Health and Welfare), 2014. Scientific Opinion on porcine epidemic diarrhoea and emerging pig deltacoronavirus

DEFF Research Database (Denmark)

Bøtner, Anette

In the last decade, many porcine epidemic diarrhoea (PED) outbreaks have been reported by several countries in Asia whereas only a few Member States of the European Union (EU) have reported PED clinical cases and/or PED virus (PEDV)-seropositive animals. This alphacoronavirus was first reported...... in the USA in May 2013, followed by rapid spread throughout the country and outbreaks reported by several countries in the Americas. The recent PEDV-EU isolates have high level of sequence identity to PEDV-Am isolates. Based on nucleotide sequencing, multiple variants of PEDV are circulating in Europe...

Safety culture : a significant influence on safety in transportation

Science.gov (United States)

2017-08-01

An organizations safety culture can influence safety outcomes. Research and experience show that when safety culture is strong, accidents are less frequent and less severe. As a result, building and maintaining strong safety cultures should be a t...

Total safety management: An approach to improving safety culture

International Nuclear Information System (INIS)

Blush, S.M.

1993-01-01

A little over 4 yr ago, Admiral James D. Watkins became Secretary of Energy. President Bush, who had appointed him, informed Watkins that his principal task would be to clean up the nuclear weapons complex and put the US Department of Energy (DOE) back in the business of producing tritium for the nation's nuclear deterrent. Watkins recognized that in order to achieve these objectives, he would have to substantially improve the DOE's safety culture. Safety culture is a relatively new term. The International Atomic Energy Agency (IAEA) used it in a 1986 report on the root causes of the Chernobyl nuclear accident. In 1990, the IAEA's International Nuclear Safety Advisory Group issued a document focusing directly on safety culture. It provides guidelines to the international nuclear community for measuring the effectiveness of safety culture in nuclear organizations. Safety culture has two principal aspects: an organizational framework conducive to safety and the necessary organizational and individual attitudes that promote safety. These obviously go hand in hand. An organization must create the right framework to foster the right attitudes, but individuals must have the right attitudes to create the organizational framework that will support a good safety culture. The difficulty in developing such a synergistic relationship suggests that achieving and sustaining a strong safety culture is not easy, particularly in an organization whose safety culture is in serious disrepair

Safety for Users

CERN Multimedia

HR Department

2008-01-01

CERN welcomes more than 8000 Users every year. The PH Department as host to these scientific associates requires the highest safety standards. The PH Safety Office has published a Safety Flyer for Users. Important safety topics and procedures are presented. Although the Flyer is intended primarily to provide safety information for Users, the PH Safety Office invites all those on the CERN sites to keep a copy of the flyer as it gives guidance in matters of safety and explains what to do in the event of an emergency. Link: http://ph-dep.web.cern.ch/ph-dep/Safety/SafetyOffice.html PH-Safety Office PH Department

Safety for Users

CERN Multimedia

HR Department

2008-01-01

CERN welcomes more than 8000 Users every year. The PH Department as host to these scientific associates requires the highest safety standards. The PH Safety Office has published a safety flyer for Users. Important safety topics and procedures are presented. Although the flyer is intended primarily to provide safety information for Users, the PH Safety Office invites all those on the CERN sites to keep a copy of the flyer as it gives guidance in matters of safety and explains what to do in the event of an emergency. The flyer is available at: http://ph-dep.web.cern.ch/ph-dep/Safety/SafetyOffice.html PH-Safety Office PH Department

The risk-based approach to ATMP development - generally accepted by regulators but infrequently used by companies.

Science.gov (United States)

Kooijman, M; van Meer, P J K; Gispen-de Wied, C C; Moors, E H M; Hekkert, M P; Schellekens, H

2013-11-01

Advanced therapy medicinal products (ATMPs) are the cutting edge of drug innovation. ATMPs have different challenges than other drug classes. To accommodate these challenges and facilitate science-driven development, flexibility in the requirements to demonstrate the safety and efficacy of this rapidly evolving drug class is necessary. To create flexibility, the European Union introduced the risk-based approach. This approach provides the possibility of omitting guideline-based studies based on risk analyses. To gain insight into the effect of the risk-based approach on the non-clinical development of ATMPs, two questions are addressed in this paper. Firstly, "Do companies use a risk-based approach for the non-clinical development of ATMPs?" and, secondly, "Does the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) accept non-clinical development programs based on the risk-based approach?" Scientific advice letters formulated by the CHMP were analyzed. The risk-based approach was used to justify deviations from the guidelines in the majority (75%) of the cases. The CHMP accepted 40% of the proposals to omit studies and stated that additional data was necessary to make an informed decision for 35% of the proposals. This indicates that the risk-based approach facilitates the science-driven development of ATMPs. Copyright © 2013 Elsevier Inc. All rights reserved.

Safety Lead Optimization and Candidate Identification: Integrating New Technologies into Decision-Making.

Science.gov (United States)

Dambach, Donna M; Misner, Dinah; Brock, Mathew; Fullerton, Aaron; Proctor, William; Maher, Jonathan; Lee, Dong; Ford, Kevin; Diaz, Dolores

2016-04-18

Discovery toxicology focuses on the identification of the most promising drug candidates through the development and implementation of lead optimization strategies and hypothesis-driven investigation of issues that enable rational and informed decision-making. The major goals are to [a] identify and progress the drug candidate with the best overall drug safety profile for a therapeutic area, [b] remove the most toxic drugs from the portfolio prior to entry into humans to reduce clinical attrition due to toxicity, and [c] establish a well-characterized hazard and translational risk profile to enable clinical trial designs. This is accomplished through a framework that balances the multiple considerations to identify a drug candidate with the overall best drug characteristics and provides a cogent understanding of mechanisms of toxicity. The framework components include establishing a target candidate profile for each program that defines the qualities of a successful candidate based on the intended therapeutic area, including the risk tolerance for liabilities; evaluating potential liabilities that may result from engaging the therapeutic target (pharmacology-mediated or on-target) and that are chemical structure-mediated (off-target); and characterizing identified liabilities. Lead optimization and investigation relies upon the integrated use of a variety of technologies and models (in silico, in vitro, and in vivo) that have achieved a sufficient level of qualification or validation to provide confidence in their use. We describe the strategic applications of various nonclinical models (established and new) for a holistic and integrated risk assessment that is used for rational decision-making. While this review focuses on strategies for small molecules, the overall concepts, approaches, and technologies are generally applicable to biotherapeutics.

Food safety performance indicators to benchmark food safety output of food safety management systems.

Science.gov (United States)

Jacxsens, L; Uyttendaele, M; Devlieghere, F; Rovira, J; Gomez, S Oses; Luning, P A

2010-07-31

There is a need to measure the food safety performance in the agri-food chain without performing actual microbiological analysis. A food safety performance diagnosis, based on seven indicators and corresponding assessment grids have been developed and validated in nine European food businesses. Validation was conducted on the basis of an extensive microbiological assessment scheme (MAS). The assumption behind the food safety performance diagnosis is that food businesses which evaluate the performance of their food safety management system in a more structured way and according to very strict and specific criteria will have a better insight in their actual microbiological food safety performance, because food safety problems will be more systematically detected. The diagnosis can be a useful tool to have a first indication about the microbiological performance of a food safety management system present in a food business. Moreover, the diagnosis can be used in quantitative studies to get insight in the effect of interventions on sector or governmental level. Copyright 2010 Elsevier B.V. All rights reserved.

Commercialization strategy of the herbal composition HemoHIM as a complementary drug for anti-cancer therapies

Energy Technology Data Exchange (ETDEWEB)

Jo, Sungkee; Jung, Uhee; Park, Haeran

2013-01-15

Ο Purpose - Establishment of strategy for the development of HemoHIM as a complementary drug for cancer therapies including non-clinical data preparation, obtainment of a research project grant, base of manufacturing process and raw material standardization Ο Research Results - Examination and confirmation of the essential requirements to develop the complementary drug for anticancer therapies by consulting with Korea FDA, and clinical CRO, and medical experts (animal efficacy study, toxicological safety test, standard analytical method, raw material standardization) - Obtainment of a governmental research project for 3 years from Ministry of Health and Welfare to develop HemoHIM as an complementary herbal drug for anti-cancer therapies - Acquisition of fundamental data on the manufacturing process and the raw material standardization for the optimal efficacy of HemoHIM Ο Expected benefit - Planning to get the approval of IND from Korea FDA by 2015 after completing the non-clinical study through the on-going project from Ministry of Health and Welfare - Planning to commercialize the product by 2017.

Commercialization strategy of the herbal composition HemoHIM as a complementary drug for anti-cancer therapies

International Nuclear Information System (INIS)

Jo, Sungkee; Jung, Uhee; Park, Haeran

2013-01-01

Ο Purpose - Establishment of strategy for the development of HemoHIM as a complementary drug for cancer therapies including non-clinical data preparation, obtainment of a research project grant, base of manufacturing process and raw material standardization Ο Research Results - Examination and confirmation of the essential requirements to develop the complementary drug for anticancer therapies by consulting with Korea FDA, and clinical CRO, and medical experts (animal efficacy study, toxicological safety test, standard analytical method, raw material standardization) - Obtainment of a governmental research project for 3 years from Ministry of Health and Welfare to develop HemoHIM as an complementary herbal drug for anti-cancer therapies - Acquisition of fundamental data on the manufacturing process and the raw material standardization for the optimal efficacy of HemoHIM Ο Expected benefit - Planning to get the approval of IND from Korea FDA by 2015 after completing the non-clinical study through the on-going project from Ministry of Health and Welfare - Planning to commercialize the product by 2017

Safety first. Status reports on the IAEA's safety standards

International Nuclear Information System (INIS)

Webb, G.; Karbassioun, A.; Linsley, G.; Rawl, R.

1998-01-01

Documents in the IAEA's Safety Standards Series known as RASS (Radiation Safety Standards) are produced to develop an internally consistent set of regulatory-style publications that reflects an international consensus on the principles of radiation protection and safety and their application through regulation. In this article are briefly presented the Agency's programmes on Nuclear Safety Standards (NUSS), Radioactive Waste Safety Standards (RADWASS), and Safe Transport of Radioactive Materials