870 resultados para regulatory-type non-clinical safety studies


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The International Federation of Societies of Toxicologic Pathologists (IFSTP) proposes a common global framework for training future toxicologic pathologists who will support regulatory-type nonclinical toxicology studies. Trainees optimally should undertake a scientific curriculum of at least 5 years at an accredited institution leading to a clinical degree (veterinary medicine or medicine). Trainees should then obtain 4 or more years of intensive pathology practice during a residency and/or on-the-job "apprenticeship," at least 2 years of which must be focused on regulatory-type toxicologic pathology topics. Possession of a recognized pathology qualification (i.e., certification) is highly recommended. A non-clinical pathway (e.g., a graduate degree in medical biology or pathology) may be possible if medically trained pathologists are scarce, but this option is not optimal. Regular, lifelong continuing education (peer review of nonclinical studies, professional meetings, reading, short courses) will be necessary to maintain and enhance one's understanding of current toxicologic pathology knowledge, skills, and tools. This framework should provide a rigorous yet flexible way to reliably train future toxicologic pathologists to generate, interpret, integrate, and communicate data in regulatory-type, nonclinical toxicology studies. (J Toxicol Pathol 2010; 23: 171-181)

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The International Federation of Societies of Toxicologic Pathologists (IFSTP) proposes a common global framework for training future toxicologic pathologists who will support regulatory-type - nonclinical toxicology studies. Trainees optimally should undertake a scientific curriculum of at least 5 years at an accredited institution leading to a clinical degree (veterinary medicine or medicine). Trainees should then obtain 4 or more years of intensive pathology practice during a residency and/or on-the-job "apprenticeship," at least 2 years of which must be focused on regulatory-type toxicologic pathology topics. Possession of a recognized pathology qualification (i.e., certification) is highly recommended. A nonclinical pathway (e.g., a graduate degree in medical biology or pathology) may be possible if medically trained pathologists are scarce, but this option is not optimal. Regular, lifelong continuing education (peer review of nonclinical studies, professional meetings, reading, short courses) will be necessary to maintain and enhance one's understanding of current toxicologic pathology knowledge, skills, and tools. This framework should provide a rigorous yet flexible way to reliably train future toxicologic pathologists to generate, interpret, integrate, and communicate data in regulatory-type, nonclinical toxicology studies. (C) 2010 Reprinted by Permission of SAGE Publications Inc. Published by Elsevier GmbH. All rights reserved.

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The increasing role for structured and personalized self-monitoring of blood glucose (SMBG) in management of type 2 diabetes has been underlined by randomized and prospective clinical trials. These include Structured Testing Program (or STeP), St. Carlos, Role of Self-Monitoring of Blood Glucose and Intensive Education in Patients with Type 2 Diabetes Not Receiving Insulin, and Retrolective Study Self-Monitoring of Blood Glucose and Outcome in Patients with Type 2 Diabetes (or ROSSO)-in-praxi follow-up. The evidence for the benefit of SMBG both in insulin-treated and non-insulin-treated patients with diabetes is also supported by published reviews, meta-analyses, and guidelines. A Cochrane review reported an overall effect of SMBG on glycemic control up to 6 months after initiation, which was considered to subside after 12 months. Particularly, the 12-month analysis has been criticized for the inclusion of a small number of studies and the conclusions drawn. The aim of this article is to review key publications on SMBG and also to put them into perspective with regard to results of the Cochrane review and current aspects of diabetes management.

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The impacts of antiretroviral therapy on quality of life, mental health, labor productivity, and economic wellbeing for people living with HIV/AIDS in developing countries are only beginning to be measured. We conducted a systematic literature review to analyze the effect of antiretroviral therapy (ART) on these non-clinical indicators in developing countries and assess the state of research on these topics. Both qualitative and quantitative studies were included, as were peer-reviewed articles, gray literature, and conference abstracts and presentations. Findings are reported from 12 full-length articles, 7 abstracts, and 1 presentation (representing 16 studies). Compared to HIV-positive patients not yet on treatment, patients on ART reported significant improvements in physical, emotional and mental health and daily function. Work performance improved and absenteeism decreased, with the most dramatic changes occurring in the first three months of treatment and then leveling off. Little research has been done on the impact of ART on household wellbeing, with modest changes in child and family wellbeing within households where adults are receiving ART reported so far. Studies from developing countries have not yet assessed non-clinical outcomes of therapy beyond the first year; therefore, longitudinal outcomes are still unknown. As ART roll out extends throughout high HIV prevalence, low-resource countries and is sustained over years and decades, both positive and adverse non-clinical outcomes need to be empirically measured and qualitatively explored in order to support patient adherence and maximize treatment benefits.

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Previous research suggests that low n-3 long-chain polyunsaturated fatty acid (n-3PUFA) status is associated with higher levels of depression in clinical populations. This analysis aimed to investigate the relationship between depressed mood and n-3PUFA status in a non-clinical population. The analysis was conducted on data collected as part of a large randomized controlled trial investigating the impact of n-3PUFA supplementation on depressed mood in a community-based population. On entry into the trial, data on depressed mood were collected using the Depression, Anxiety and Stress Scales (DASS) and the Beck Depression Inventory (BDI). Plasma concentrations of various n-3PUFAs and n-6 long-chain polyunsaturated fatty acids (n-6PUFAs) were obtained from fasting venous blood samples, and various demographics were also measured. Using regression, there was no evidence of an association between either measure of depressed mood and any of the measures of n-3PUFA status or of n-6PUFA: n-3PUFA ratios. Clear associations were also not found when demographic factors were included in the analyses. These findings suggest that n-3PUFAs may not have a role in the aetiology of minor depression. This is also consistent with the results of other studies that have not demonstrated an association between depressed mood and n-3PUFA status in non-clinical populations and epidemiological studies that have not demonstrated an association between depressed mood and n-3PUFA intake in these populations. (C) 2008 Elsevier Ltd. All rights reserved.

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A substantial research literature exists regarding the psychopathy construct in forensic populations, but more recently, the construct has been extended to non-clinical populations. The purpose of the present dissertation was to investigate the content and the correlates of the psychopathy construct, with a particular focus on addressing gaps and controversies in the literature. In Study 1, the role of low anxiety in psychopathy was investigated, as some authors have proposed that low anxiety is integral to the psychopathy construct. Participants (n = 346) responded to two self-report psychopathy scales, the SRP-III and the PPI-R, as well as measures of temperament, personality, and antisociality. Of particular interest was the PPI-R Stress Immunity sub scale, which represents low anxiety content. I t was found that Stress Immunity was not correlated with SRP-III psychopathy, nor did it share common personality or temperament correlates or contribute to the prediction of anti sociality. From Study 1, it was concluded that it was unlikely that low anxiety is a central feature of the psychopathy construct. In Study 2, the relationship between SRP-III psychopathy and Ability Emotional Intelligence (Le., Emotional Intelligence measured as an ability, rather than as a self-report personality trait-like characteristic) was investigated, to determine whether psychopathy is be s t seen as a syndrome characterized by emotional deficits or by the ability to skillfully manipulate and prey upon the others' emotions. A negative correlation between the two constructs was found, suggesting that psychopathy is best characterized by deficits in perceiving, facilitating, managing, and understanding emotions. In Study 3, sex differences in the sexual behavior (i.e., promiscuity, age of first sexual behaviors, extradyadic sexual relations) and appearance-related esteem (i.e., body shame,appearance anxiety, self-esteem) correlates of SRP-III psychopathy were investigated. The sexual behavior correlates of psychopathy were quite similar for men and women, but the esteem correlates were very different, such that high psychopathy in men was related to high esteem, whereas high psychopathy in women was generally related to low esteem. This sex difference was difficult to interpret in that it was not mediated by sexual behavior, suggesting that further exploration of this topic is warranted. Together, these three studies contribute to our understanding of non-clinical psychopathy, indicating that low anxiety is likely not part of the construct, that psychopathy is related to low levels of ability in Emotional Intelligence, and that psychopathy is an important predictor of behavior, ability, and beliefs and feelings about the self

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In this thesis the author has presented qualitative studies of certain Kdv equations with variable coefficients. The well-known KdV equation is a model for waves propagating on the surface of shallow water of constant depth. This model is considered as fitting into waves reaching the shore. Renewed attempts have led to the derivation of KdV type equations in which the coefficients are not constants. Johnson's equation is one such equation. The researcher has used this model to study the interaction of waves. It has been found that three-wave interaction is possible, there is transfer of energy between the waves and the energy is not conserved during interaction.

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The current study evaluated, in vivo, the clinical safety and the anthelmintic efficacy of 24% aurixazole (24 mg/kg), administered orally, in bovines. Two experiments were conducted: the first one evaluating the clinical safety of 24% aurixazole (24 mg/kg) in cattle, and a second one evaluating the anthelmintic efficacy of aurixazole (24 mg/kg) against gastrointestinal nematodes on naturally infected cattle. Based on the results of clinical safety, no alterations on clinical and haematological signs and on the biochemical values obtained in animals treated orally with aurixazole 24 mg/kg were observed. Regarding the results of reduction or efficacy, obtained by eggs per gram of faeces (EPG) counts, the formulation of aurixazole reached values superior to 99% (arithmetic means) in all post-treatment dates. In two occasions, this formulation reached maximum efficacy (100%). Comparing these results with the reduction percentages obtained by EPG counts, it is possible to verify that the values obtained by all three formulations were compatible with the efficacy results. Aurixazole reached maximum efficacy (100%) against Haemonchus placei, Cooperia spatulata and Oesophagostomum radiatum. Against Cooperia punctata, this formulation reached an efficacy index of 99.99%. Regarding aurixazole, no specific trials were conducted on the field in order to evaluate the behaviour of this molecule against helminths that are resistant to other molecules, specially isolated levamisole and disophenolat: Due to this fact, future studies will be necessary to assess the effectiveness of aurixazole against strains of nematodes that are resistant to levamisole and disophenolat, but the results of clinical safety and efficacy described in this study allow us to conclude that the aurixazole molecule, concomitantly with other measures and orally administered formulations, can be another important tool in the control of nematodes parasitizing bovines. (C) 2014 Published by Elsevier Ltd.

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BACKGROUND: We investigated the psychometric properties of a short questionnaire for combined assessment of different perceived stress management skills in the general population and tested whether scores relate to physiological stress reactivity. METHODS: For psychometric evaluation, we determined the factor structure of the questionnaire and investigated its measurement invariance in the participant groups and over time in three different independent samples representing the general population (total N=332). Reliability was tested by estimating test-retest reliability, internal consistency, and item reliabilities. We examined convergent and criterion validity using selected criterion variables. For endocrine validation, 35 healthy non-smoking and medication-free men in a laboratory study and 35 male and female employees in a workplace study underwent an acute standardized psychosocial stress task. We assessed stress management skills and measured salivary cortisol before and several times up to 60 min (workplace study) and 120 min (laboratory study) after stress. Potential confounders were controlled. RESULTS: The factor structure of the questionnaire consists of five scales reflecting acceptably distinct stress management skills such as cognitive strategies, use of social support, relaxation strategies, anger regulation, and perception of bodily tension. This factor structure was stable across participant groups and over time. Internal consistencies, item reliabilities, and test-retest reliabilities met established statistical requirements. Convergent and criterion validity were also established. In both endocrine validation studies, higher stress management skills were independently associated with lower cortisol stress reactivity (p's<.029). CONCLUSIONS: Our findings suggest that the questionnaire has good psychometric properties and that it relates to subjective psychological and objective physiological stress indicators. Therefore, the instrument seems a suitable measure for differential assessment of stress management skills in the general population.

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Background. Clostridium difficile infection is one of the major causes of antibiotic associated diarrhea and colitis in the United States. Currently, there is a dearth of literature on the risk factors and outcomes differences between the patients with infection due to the hypervirulent strain vs. the non-hypervirulent strains. The objective of this study was to determine the relationship between C. difficile toxin type and clinical features, severity and outcome in patients with C. difficile diarrhea. ^ Methods. The case group included 37 patients who had infections due to hypervirulent strain (tcdC deletion) and the control group included 55 patients with other toxin types (toxin A, B, binary toxin). A univariate analysis was performed followed by a multivariable logistic regression analysis to assess the differences between cases and controls. ^ Results. In the multivariate analyses, we found out that being a male was a protective factor for developing the infection due to the hypervirulent strain [OR 0.33; 95% CI 0.12-0.90]. Also, the hypervirulent group has worse clinical and economic outcomes, although the differences were small and nonsignificant. ^ Conclusions. There may likely be no predictive risk factor for acquiring infection due to the hypervirulent strain and the acquisition may be more linked to the infection control practices of the individual hospitals or location of patients. Hence, better infection control practices may prove helpful in decreasing the overall disease burden and thus improve patient outcomes. ^

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Objectives: The aims were to determine if emotion recognition deficits observed in eating disorders generalise to non-clinical disordered eating and to establish if other psychopathological and personality factors contributed to, or accounted for, these deficits. Design: Females with high (n=23) and low (n=22) scores on the Eating Disorder Inventory (EDI) were assessed on their ability to recognise emotion from videotaped social interactions. Participants also completed a face memory task, a Stroop task, and self-report measures of alexithymia, depression and anxiety. Results: Relative to the low EDI group, high EDI participants exhibited a general deficit in recognition of emotion, which was related to their scores on the alexithymia measure and the bulimia subscale of the EDI. They also exhibited a specific deficit in the recognition of anger, which was related to their scores on the body dissatisfaction subscale of the EDI. Conclusions: In line with clinical eating disorders, non-clinical disordered eating is associated with emotion recognition deficits. However, the nature of these deficits appears to be dependent upon the type of eating psychopathology and the degree of co-morbid alexithymia.

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Objective: To investigate the characteristics and satisfaction of medical doctors transitioning from a clinical into an entirely non-clinical role.

Design and setting: Wave 1 to Wave 5 data from 2008- 2012 in the Medicine in Australia: Balancing Employment and Life (MABEL) longitudinal, populationbased survey were analysed.

Participants: Medical doctors including general practitioners (GPs), specialists, specialists in training (SIT) and hospital non-specialists (HNS). Hospital nonspecialists represent doctors working in a hospital who were not enrolled in a specialty training program. The total number of participants surveyed across the 5 waves was 15,195 doctors.

Main outcome measures: The number of medical doctors making the transition from a clinical role to a nonclinical role from one wave of data to the subsequent wave of data. Individuals who responded 'Yes' to the question 'Are you currently doing any clinical medical work in Australia?' were defined as working in a clinical role. Individuals who stated that they were 'Doing medical work in Australia that is non-clinical' were defined as working in a completely non-clinical role. Each doctor's characteristics while partaking in clinical work prior to making the change to a non-clinical role were noted.

Results: Over 5 years, there were a total of 498 individuals who made the transition from a clinical role to a completely non-clinical role out of a possible 15,195 doctors. Increasing age was the strongest predictor for transition to a non-clinical role. With regards to doctor type, specialists, hospital non-specialists and specialists-in- training were more likely to make the transition to a totally non-clinical role compared to GPs. There was minimal evidence of a relationship between lower job satisfaction and making a transition, and also between higher life satisfaction and making a transition.

Conclusions: Understanding the characteristics of, and reasons for non-clinical career transition are important for workforce training, planning and development.

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Objective. The aim of the present study was to investigate non-clinical work conducted by Australian doctors.
Methods. This study was an exploratory descriptive study using data from Wave 5 of the Medicine in Australia: Balancing Employment and Life (MABEL) longitudinal survey, collected in 2012 from Australian medical practitioners (2200 general practitioners (GPs), 3455 specialists, 1270 specialists in training and 1656 hospital non-specialists). The main outcome measure was the number of hours worked per week in non-clinical work. Regression analysis was used to determine associations between non-clinical activities (i.e. education-related, management and administration and other) and personal and professional characteristics, including age, gender, job and life satisfaction, total clinical working hours, sector of practice
(public or private) and doctor type.
Results. Australian doctors spend an average of just under 7 h per week, or 16% of their working time, on non-clinical activities. Doctors who worked more hours on non-clinical activities overall, and in education-related and management and
administration specifically, were male, younger, had lower life satisfaction and generally spent fewer hours on clinical work. Lower job satisfaction was associated with longer management and administration hours, but not with time spent in
education-related activities. Specialists were more likely to work long non-clinical hours, whereas GPs were more likely to report none. Hospital non-specialists reported relatively high management and administration hours.
Conclusions. Further work is required to better understand the full range of non-clinical activities doctors are involved in and how this may impact future workforce projections.

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It has been proposed that body image disturbance is a form of cognitive bias wherein schemas for self-relevant information guide the selective processing of appearancerelated information in the environment. This threatening information receives disproportionately more attention and memory, as measured by an Emotional Stroop and incidental recall task. The aim of this thesis was to expand the literature on cognitive processing biases in non-clinical males and females by incorporating a number of significant methodological refinements. To achieve this aim, three phases of research were conducted. The initial two phases of research provided preliminary data to inform the development of the main study. Phase One was a qualitative exploration of body image concerns amongst males and females recruited through the general community and from a university. Seventeen participants (eight male; nine female) provided information on their body image and what factors they saw as positively and negatively impacting on their self evaluations. The importance of self esteem, mood, health and fitness, and recognition of the social ideal were identified as key themes. These themes were incorporated as psycho-social measures and Stroop word stimuli in subsequent phases of the research. Phase Two involved the selection and testing of stimuli to be used in the Emotional Stroop task. Six experimental categories of words were developed that reflected a broad range of health and body image concerns for males and females. These categories were high and low calorie food words, positive and negative appearance words, negative emotion words, and physical activity words. Phase Three addressed the central aim of the project by examining cognitive biases for body image information in empirically defined sub-groups. A National sample of males (N = 55) and females (N = 144), recruited from the general community and universities, completed an Emotional Stroop task, incidental memory test, and a collection of psycho-social questionnaires. Sub-groups of body image disturbance were sought using a cluster analysis, which identified three sub-groups in males (Normal, Dissatisfied, and Athletic) and four sub-groups in females (Normal, Health Conscious, Dissatisfied, and Symptomatic). No differences were noted between the groups in selective attention, although time taken to colour name the words was associated with some of the psycho-social variables. Memory biases found across the whole sample for negative emotion, low calorie food, and negative appearance words were interpreted as reflecting the current focus on health and stigma against being unattractive. Collectively these results have expanded our understanding of processing biases in the general community by demonstrating that the processing biases are found within non-clinical samples and that not all processing biases are associated with negative functionality

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Postconcussion symptoms are relatively common in the acute recovery period following mild traumatic brain injury (MTBI). However, for a small subset of patients, self reported postconcussion symptoms continue long after injury. Many factors have been proposed to account for the presence of persistent postconcussion symptoms. The influence of personality traits has been proposed as one explanation. The purpose of this study was to examine the relation between postconcussion-like symptom reporting and personality traits in a sample of 96 healthy participants. Participants completed the British Columbia Postconcussion Symptom Inventory (BC-PSI) and the Millon Clinical Multiaxial Inventory III (MCMI-III). There was a strong positive relation between the majority of MCMI-III scales and postconcussion-like symptom reporting. Approximately half of the sample met the International Classification of Diseases-10 Criterion C symptoms for Postconcussional Syndrome (PCS). Compared with those participants who did not meet this criterion, the PCS group had significant elevations on the negativistic, depression, major depression, dysthymia, anxiety, dependent, sadistic, somatic, and borderline scales of the MCMI-III. These findings support the hypothesis that personality traits can play a contributing role in self reported postconcussion-like symptoms.