870 resultados para regulatory-type non-clinical safety studies


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Studies for the food development of formulations for pets, look for key components to maintaining healthy way of life and safety of products, including these, elements capable of preventing the risk of certain metabolic disorders associated with diet. Feline urinarytract disorders, highlights the urolithiasis, have high incidence in clinical series. Studies linking dietary factors such as ingredients, digestibility and chemical composition, changing the volume, density and pH of urine and consequent induction training for urolithiasis. A highly significant correlation between the mineral composition of the diet and urine pH of cats began to be studied, using the association between the cation-anion balance of the diet (DCAB) and regulation of acid-base balance of the body. The DCAB can be defined as the difference between the total fixed anions and cations present in the diet, important tool for estimating the urinary pH and to determine the range of pH that favors the food used, thereby linking the trigger and the prevention of struvite and calcium oxalate urolithiasis in the urinary tract of cats. Thus, this review aims to clarify the effects of the nutritional composition of diet on urine pH in cats.

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Objectives. One of the concerns of Sports Sciences is the search for methodologies that can help discover potential athletes. In this sense, some initiatives have been taken in an attempt to identify and characterize the genetic profile of dermatoglyphic marks (fingerprints). The present work has the objective of understanding the distribution of quantitative dermatoglyphic indicators in basketball players with different levels of performance compared to non-players. Methods. The subjects observed constituted 125 individuals, divided into five numerically equal groups, three of which were composed of professional basketball players according to their level of participation (Brazilian Team, National Championship and São Paulo Championship) and the last two formed by weekend players and non-players, respectively. Eleven dermatoglyphic variables were analysed in the descriptive level by means of measurement of position, variability and limits of confidence of the median, and, in inferential terms, the Kruskal-Wallis statistical test was adopted. Results. The more expressive ones were: TRC, counting lines a-b and A'-d, behave differently between athletes and non-athletes. Conclusion. Studies about this kind of analysis should be continued, calling on resources that take into consideration all variables simultaneously as a multivariate study. © 2012 Revista Andaluza de Medicina del Deporte.

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This paper presents a modeling effort for developing safety performance models (SPM) for urban intersections for three major Brazilian cities. The proposed methodology for calibrating SPM has been divided into the following steps: defining the safety study objective, choosing predictive variables and sample size, data acquisition, defining model expression and model parameters and model evaluation. Among the predictive variables explored in the calibration phase were exposure variables (AADT), number of lanes, number of approaches and central median status. SPMs were obtained for three cities: Fortaleza, Belo Horizonte and Brasilia. The SPM developed for signalized intersections in Fortaleza and Belo Horizonte had the same structure and the most significant independent variables, which were AADT entering the intersection and number of lanes, and in addition, the coefficient of the best models were in the same range of values. For Brasilia, because of the sample size, the signalized and unsignalized intersections were grouped, and the AADT was split in minor and major approaches, which were the most significant variables. This paper also evaluated SPM transferability to other jurisdiction. The SPM for signalized intersections from Fortaleza and Belo Horizonte have been recalibrated (in terms of the COx) to the city of Porto Alegre. The models were adjusted following the Highway Safety Manual (HSM) calibration procedure and yielded C-x of 0.65 and 2.06 for Fortaleza and Belo Horizonte SPM respectively. This paper showed the experience and future challenges toward the initiatives on development of SPMs in Brazil, that can serve as a guide for other countries that are in the same stage in this subject. (C) 2014 Elsevier Ltd. All rights reserved.

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This work intends to investigate the use of psychoanalytical theory within the aesthetic and critical contemporary art field. To this purpose, it focuses on two philosophers who have become significant in our time: the art critic Hal Foster and the art historian Georges Didi-Huberman. This study aims to show how far the concepts generated in psychoanalytic praxis allowed interpretations that disrupt the traditional aesthetics field. This type of analysis is possible once we abandon the paradigm of “applied psychoanalysis”, which is still current in non-clinical setting. Finally, the proposal wants to argue that the category of the amorphous may clarify certain aesthetic experiences that range from the modernity of art through postmodernity.

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Objectives: This report highlights phytoconstituents present in Cissus quadrangularis (CQ) extract and examines biphasic (proliferative and anti-proliferative) effects of its extract on bone cell proliferation, differentiation, mineralization, ROS generation, cell cycle progression and Runx2 gene expression in primary rat osteoblasts. Materials and methods: Phytoconstituents were identified using gas chromatography-mass spectroscopy (GC-MS). Osteoblasts were exposed to different concentrations (10-100g/ml) of CQ extract and cell proliferation and cell differentiation were investigated at different periods of time. Subsequently, intracellular ROS intensity, apoptosis and matrix mineralization of osteoblasts were evaluated. We performed flow cytometry for DNA content and real-time PCR for Runx2 gene expression analysis.Results: CQ extract's approximately 40 bioactive compounds of fatty acids, hydrocarbons, vitamins and steroidal derivatives were identified. Osteoblasts exposed to varying concentrations of extract exhibited biphasic variation in cell proliferation and differentiation as a function of dose and time. Moreover, lower concentrations (10-50g/ml) of extract slightly reduced ROS intensity, although they enhanced matrix mineralization, DNA content in S phase of the cell cycle, and levels of Runx2 expression. However, higher concentrations (75-100g/ml) considerably induced the ROS intensity and nuclear condensation in osteoblasts, while it reduced mineralization level, proportion of cells in S phase and Runx2 level of the osteogenic gene.Conclusions: These findings suggest that CQ extract revealed concentration-dependent biphasic effects, which would contribute notably to future assessment of pre-clinical efficacy and safety studies.

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Studies show that children with Down’s syndrome have deficits in social skills, which can interfere in their social interactions and also in their academic performance. The aim of this study was to analyze the clinical significance and reliable change in repertory of social skills of a child with Down’s syndrome, from interventions in the clinic, at home and at school. A seven year old girl with Down’s Syndrome who had frequented the first year of regular school, her parents and her teacher participated in this study. They were attending in a Center of Applied Psychology, of a public university in São Paulo State. Before and after the intervention parents and teacher answered the Rating System Social Skills (SSRS). The intervention with the child had been conducted for six months, through playful activities in weekly meetings. It was discussed various topics related to social skills with parents and teacher in biweekly and monthly meetings. The results were analyzed using JT method. With parents, comparing the two assessments conducted, the data pointed to positive change reliable for four of the six skills assessed. Of the five skills assessed by the teacher, one of them was not in the clinical level since the first application. The other two went from clinical to non-clinical level, featuring reliable positive change. The study showed the importance of pre and post measures in case study, enabling the assessment of the effects of the intervention performed on the various factors of social skills. Further studies with larger populations may ratify the data obtained.

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Studies have shown that aversive conditions at the university may have great influence on academic achievement and the development of psychiatric disorders such as depression. In university context, social relations have been investigated over the years, but are scarce publications relating mental health and social skills. Thus, this paper compared a group of college students with a clinical depression with a group without clinical depression for the consequences and feelings that differents responses of social skills may have in social interactions with various interlocutors. A total of 128 students participated, 64 for clinical depression and 64 non-clinical. Questionário de Avaliação de Comportamentos e Contextos para Universitários – QHC – Universitários, Inventário de Fobia Social (Mini-Spin), Inventário de Depressão de Beck (BDI) and Entrevista clínica estruturada para o DSM-IV (SCID-I) were applied. The data were analyzed by test t of Student. The results show that students with depression have a great difficulty about the social skills regardless of which require more or less assertion and general way for all social interactions, either family, friends, roommate and partner.

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Objectives: The use of noninvasive cortical electrical stimulation with weak currents has significantly increased in basic and clinical human studies. Initial, preliminary studies with this technique have shown encouraging results; however, the safety and tolerability of this method of brain stimulation have not been sufficiently explored yet. The purpose of our study was to assess the effects of direct current (DC) and alternating current (AC) stimulation at different intensities in order to measure their effects on cognition, mood, and electroencephalogram. Methods: Eighty-two healthy, right-handed subjects received active and sham stimulation in a randomized order. We conducted 164 ninety-minute sessions of electrical stimulation in 4 different protocols to assess safety of (1) anodal DC of the dorsolateral prefrontal cortex (DLPFC); (2) cathodal DC of the DLPFC; (3) intermittent anodal DC of the DLPFC and; (4) AC on the zygomatic process. We used weak currents of 1 to 2 mA (for DC experiments) or 0.1 to 0.2 mA (for AC experiment). Results: We found no significant changes in electroencephalogram, cognition, mood, and pain between groups and a low prevalence of mild adverse effects (0.11% and 0.08% in the active and sham stimulation groups, respectively), mainly, sleepiness and mild headache that were equally distributed between groups. Conclusions: Here, we show no neurophysiological or behavioral signs that transcranial DC stimulation or AC stimulation with weak currents induce deleterious changes when comparing active and sham groups. This study provides therefore additional information for researchers and ethics committees, adding important results to the safety pool of studies assessing the effects of cortical stimulation using weak electrical currents. Further studies in patients with neuropsychiatric disorders are warranted.

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This paper provides a brief but comprehensive guide to creating, preparing and dissecting a 'virtual' fossil, using a worked example to demonstrate some standard data processing techniques. Computed tomography (CT) is a 3D imaging modality for producing 'virtual' models of an object on a computer. In the last decade, CT technology has greatly improved, allowing bigger and denser objects to be scanned increasingly rapidly. The technique has now reached a stage where systems can facilitate large-scale, non-destructive comparative studies of extinct fossils and their living relatives. Consequently the main limiting factor in CT-based analyses is no longer scanning, but the hurdles of data processing (see disclaimer). The latter comprises the techniques required to convert a 3D CT volume (stack of digital slices) into a virtual image of the fossil that can be prepared (separated) from the matrix and 'dissected' into its anatomical parts. This technique can be applied to specimens or part of specimens embedded in the rock matrix that until now have been otherwise impossible to visualise. This paper presents a suggested workflow explaining the steps required, using as example a fossil tooth of Sphenacanthus hybodoides (Egerton), a shark from the Late Carboniferous of England. The original NHMUK copyrighted CT slice stack can be downloaded for practice of the described techniques, which include segmentation, rendering, movie animation, stereo-anaglyphy, data storage and dissemination. Fragile, rare specimens and type materials in university and museum collections can therefore be virtually processed for a variety of purposes, including virtual loans, website illustrations, publications and digital collections. Micro-CT and other 3D imaging techniques are increasingly utilized to facilitate data sharing among scientists and on education and outreach projects. Hence there is the potential to usher in a new era of global scientific collaboration and public communication using specimens in museum collections.

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This study was performed with the objectives of identifying the occurrence of headache as the major cause of pain and characterizing the effect headaches have on the everyday activities of nursing undergraduate students. This cross-sectional study was performed at the College of Nursing of the Federal University of Goias, Goiania, Brazil, from May to June 2008. Participants included 203 students (mean age 21 years; s.d.=1.8), 48.5% from economic class A. Headaches were the major cause of pain for 34.5% of students; described as being of strong intensity; referred to as throbbing (74.3%), stabbing (62.9%), and causing nausea and/or vomiting (55.7%); with episodes occurring in the afternoon (52.9%), and lasting for several hours a day (51.4%). Factors related to the onset of pain were: studying (17.1%) and stress (11.4 %). The activities most affected were: their capacity to concentrate (84.3%) and their mood (84.3%) (p < 0.05). Headaches are less common in the population compared to other country studies, and they affect the students' everyday activities.

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Für die Entwicklung objektiver Testverfahren zur Messung von Angstbewältigungsdispositionen, d.h. von Tests, deren Meßprinzip für die Probanden nicht durchschaubar ist, wurde das Dot-Probe-Paradigma verwendet. Mit diesem Paradigma läßt sich das Aufmerksamkeitsverhalten gegenüber bedrohlichem Material messen. Es wurde angenommen, daß dieses Paradigma besonders gut für eine objektive Messung der Angstbewältigungsdispositionen Vigilanz und kognitive Vermeidung geeignet ist, da Vigilanz durch verstärkte Aufnahme und Verarbeitung bedrohungsbezogener Information gekennzeichnet ist, während sich kognitive Vermeidung in der Abwendung der Aufmerksamkeit von diesen Reizen zeigt. In drei Studien wurde für verschiedene Versionen des Dot-Probe-Paradigmas überprüft, ob die für den Einsatz als Testinstrument in der Persönlichkeitsdiagnostik notwendigen Gütekriterien erfüllt sind. Dabei wurde festgestellt, daß das Dot-Probe-Paradigma sowohl bei Verwendung von Wörtern als auch von Bildern als Stimuli für klinisch unauffällige Testpersonen keine reliable Messung ermöglicht. Die erhobenen Werte waren weder über eine Woche hinweg stabil, noch waren sie intern konsistent. Infolge der ungenügenden Reliabilität fanden sich in den Studien nur unsystematische Befunde zum Zusammenhang zwischen dem Aufmerksamkeitsverhalten im Dot-Probe-Paradigma und verschiedenen Fragebogenmaßen. Darüber hinaus vermag die mangelnde Reliabilität auch die in der Literatur berichteten inkonsistenten Befunde bei der Untersuchung nicht-klinischer Stichproben mit diesem Paradigma zu erklären. Mögliche Gründe für die mangelnde Reliabilität der Messung werden diskutiert.

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Ziel war die Entwicklung und Erprobung von Varianten des emotionalen Strooptests zur Analyse angstbezogener Aufmerksamkeitsprozesse bei Grundschulkindern. Dabei wurde überprüft, ob dieses kognitiv-experimentelle Verfahren zukünftig als objektives Testverfahren zur Diagnostik von Ängstlichkeit im Kindesalter geeignet ist. Ausgangspunkt waren zahlreiche Befunde für die Gruppe Erwachsener, wonach die Zuwendung auf bedrohliche Situationsmerkmalen für Ängstliche charakteristisch ist. Für das Kindesalter liegen hierzu nur wenige Studien mit zudem inkonsistenten Befundmuster vor. In insgesamt drei Studien wurde der emotionale Strooptest für das Grundschulalter adaptiert, indem Bilder bzw. altersentsprechendes Wortmaterial als Stimuli eingesetzt wurden. An den Studien nahmen nicht-klinische, nicht-ausgelesene Stichproben mit Kindern der zweiten bis vierten Grundschulklassen teil. Sowohl Ängstlichkeit als auch Zustandsangst der Kinder wurden jeweils über Selbst- und Fremdeinschätzungen (Eltern, Klassenlehrer, Versuchsleiter) erhoben. Die Ergebnisse sprechen für eine nur unzureichende Reliabilität emotionaler Interferenzeffekte. Auch ergaben sich (möglichenfalls infolge) keine substantiellen Hinweise auf differentielle angstbezogene Interferenzeffekte. Die Befunde sprechen vielmehr dafür, dass alle Kinder unabhängig von der Ängstlichkeit höhere Benennungszeiten für bedrohliche Stimuli im Vergleich zur Kontrollbedingung mit neutralen oder freundlichen Stimuli zeigten, wobei zugleich methodische Einflussfaktoren des Strooptests von Relevanz waren. Die Diskussion konzentriert sich auf entwicklungspsychologische Überlegungen sowie mögliche Bedingungen emotionaler Interferenzeffekte unter kritischer Berücksichtigung der Reliabilität emotionaler Stroopinterferenz.

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Non-invasive excitability studies of motor axons in patients with amyotrophic lateral sclerosis (ALS) have revealed a changing pattern of abnormal membrane properties with disease progression, but the heterogeneity of the changes has made it difficult to relate them to pathophysiology. The SOD1(G93A) mouse model of ALS displays more synchronous motoneuron pathology. Multiple excitability measures of caudal and sciatic nerves in mutant and wild-type mice were compared before onset of signs and during disease progression (4-19 weeks), and they were related to changes in muscle fiber histochemistry. Excitability differences indicated a modest membrane depolarization in SOD1(G93A) axons at about the time of symptom onset (8 weeks), possibly due to deficient energy supply. Previously described excitability changes in ALS patients, suggesting altered sodium and potassium conductances, were not seen in the mice. This suggests that those changes relate to features of the human disease that are not well represented in the animal model.

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OBJECTIVE: The purpose of this study was to investigate the presence of publication bias (acceptance of articles indicating statistically significant results). METHODS: The journals possessing the highest impact factor (2008 data) in each dental specialty were included in the study. The content of the 6 most recent issues of each journal was hand searched and research articles were classified into 4 type categories: cross-sectional, case-control, cohort, and interventional (nonrandomized clinical trials and randomized controlled trials). In total, 396 articles were included in the analysis. Descriptive statistics and univariate and multivariate logistic regression was used to examine the association between article-reported statistical significance (dependent variable) and journal impact factor and article study type subject area (independent variables). RESULTS: A statistically significant acceptance rate of positive result was found, ranging from 75% to 90%, whereas the value of impact factor was not related to publication bias among leading dental journals. Compared with other research designs, clinical intervention studies (randomized or nonrandomized) presented the highest percentage of nonsignificant findings (20%); RCTs represented 6% of the examined investigations. CONCLUSIONS: Compared with the Journal of Clinical Periodontology, all other subspecialty journals, except the Journal of Oral and Maxillofacial Surgery, showed significantly decreased odds of publishing an RCT, which ranged from 60% to 93% (P < .05).