870 resultados para regulatory-type non-clinical safety studies


Relevância:

100.00% 100.00%

Publicador:

Resumo:

This thesis examines the menopausal experiences of a non-clinical sample of lesbians living in Australia. Research on menopause to date has largely been conducted from a medicalised and heterosexual perspective: thus lesbians’ experiences remain unknown and invisible. Using a qualitative feminist multiple method research methodology combining content analysis and questionnaire/interview research, two hundred questionnaires were posted upon request to self-identified lesbians living in every Australian state and territory. Follow up in-depth interviews were conducted with twenty lesbians. Responses were grouped into four major themes: body image, sex and sexuality, hormone replacement therapy and health services and homophobia. The findings show that lesbians at menopause face some different and additional issues from those experienced by heterosexual midlife women. For many of the study participants, commonly discussed concerns at menopause such as weight gain and other physical signs of ageing, decreased fertility, lack of libido, sexual difficulties and hormone replacement therapy were of little relevance and importance. Lesbians in this study frequently raised other issues such as the universal assumption of heterosexuality and homophobia experienced when interacting with health professionals, which led to less than satisfactory health care and reinforced feelings of invisibility. In the Conclusion I argue that the study participants' views and experiences challenge negative, stereotypical views of both lesbians and menopause. The data thus add a new dimension to the presently narrow, heterosexist and medicalised view of women at midlife and contribute new knowledge to the body of literature on menopause. This thesis is a first important step in recording the experiences of lesbians regarding menopause in Australia. I include recommendations for further research in the area of lesbian health and improved practice, and discuss old and new obstacles lesbians face in a heteropatriarchal society in which lesbians continue to be invisible.

Relevância:

100.00% 100.00%

Publicador:

Resumo:

Objective: The Mood Disorder Questionnaire (MDQ) is a widely used self-report screening instrument for the detection of bipolar disorder in clinical populations. The aim of the present study was therefore to investigate the reliability of this instrument.

Methods: Screening results using the MDQ were compared with results obtained using the Structured Clinical Interview for DSM-IV-TR Research Version, Non-patient edition (SCID) in a community-based sample of 1066 women. Trained personnel, who were blind to the results of the MDQ screen, conducted clinical interviews.

Results: Using the MDQ, 21 women screened positive for bipolar disorder, and using the SCID diagnoses, 24 women were confirmed with a diagnosis of bipolar disorder. Six women were detected on both instruments. Compared to the SCID, the sensitivity for the MDQ was 25%, specificity 99%, positive predictive value 28%, negative predictive value 98%, and a demonstrated kappa of 0.25. The MDQ failed to detect any of the 11 participants in the study with bipolar II disorder and missed seven of 13 participants with bipolar I disorder or bipolar not otherwise specified. Of the 21 women who screened positive using the MDQ, 19 had current or past psychopathologies other than bipolar disorder.

Conclusion: The MDQ has substantial limitations for detection of bipolar disorder, in particular bipolar II disorder, in non-clinical populations.

Relevância:

100.00% 100.00%

Publicador:

Resumo:

Fournier and Grey (2000) suggest that those inhabiting the contested terrain of Critical Management Studies (CMS) share a commitment to identifying inequality and subordination in organizations and to the associated possibility of emancipation, however this is conceived. Despite their additional claim that one crucial distinction between critical and non-critical management studies is the ‘philosophical and methodological reflexivity’ of the former (Fournier and Grey 2000: 19), our review indicates limits to this reflexivity in CMS’s empirical practices – indeed, we argue these may even be counter-productive with regard to its political allegiances. To encourage wider discussion of these issues, we provide a tripartite framework of understandings of research ethics drawn from within and outside the management academy, and interrogate the opportunities and limitations of each for enriching CMS research.

Relevância:

100.00% 100.00%

Publicador:

Resumo:

Purpose – A number of interventions aimed at increasing breakfast consumption have been designed and implemented in recent years. This paper seeks to review the current research in this area with the aim of identifying common features of successful interventions and strengths and weaknesses in the current research methodology. Design/methodology/approach – A systematic review of interventions aimed at increasing breakfast-eating frequency in a non-clinical sample was conducted. Findings – A total of 11 interventions were identified and reviewed; of these, only three resulted in an increase in breakfast consumption at follow-up. The three studies that were successful in changing breakfast consumption all included a psychosocial component that was successful in increasing positive attitudes towards nutrition in the intervention protocol. Many of the breakfast-eating interventions included in this review have methodological weaknesses, including difficulties in implementing interventions, small sample sizes, and selection biases, which future researchers should consider when designing and evaluating their own interventions. Research limitations/implications – These findings highlight the importance of including psychosocial components in interventions designed to increase breakfast consumption, while also signalling issues that should be addressed when designing and reporting future interventions. Originality/value – This review was the first to investigate the efficacy of interventions aimed at increasing breakfast consumption. The identification of weaknesses in the current body of research, and of successful and unsuccessful intervention practices is an important step in developing successful interventions in the future.

Relevância:

100.00% 100.00%

Publicador:

Resumo:

Recent theories of Obsessive Compulsive Disorder have suggested that meta-cognitive beliefs, particular confidence in memory, may relate to the maintenance of symptoms. For example, individuals who worry that their memory is deficient may check in order to ensure that the doors are locked, regardless of their actual memory ability. While studies have related meta-memory beliefs to OCD symptoms, and have found that memory is affected by checking behaviours; to date, no experimental literature has attempted to ascertain whether lowered confidence in memory directly leads to greater checking behaviours. In the current study 46 non-clinical participants completed a battery of questionnaires measuring these constructs, before undertaking a “memory task” designed to manipulate their level of confidence in their memory. The effect of the manipulation on the level of checking on a visuomemory task was subsequently assessed. The questionnaires indicated that cognitive confidence predicted variation in obsessive-compulsive symptoms over-and-above the influence of depressive symptoms and other OCD-related beliefs. However, while confidence in memory was successfully manipulated, the group with increased memory confidence was not found to have lower checking behaviours. Limitations of the study are discussed and directions for further research are suggested.

Relevância:

100.00% 100.00%

Publicador:

Resumo:

Exercise based rehabilitation plays a vital role in the recovery of various conditions, such as stroke, Parkinson’s disease (PD), chronic pain, and so on. Recently, telerehabilitation has become increasingly popular quantitative nature in assessments particularly for systematic monitoring of progress as well as cost saving for the patients as well as for the health care sector at large. However, challenges do exist in implementing a distributed bio-feedback in a cost-effective and efficient way. In this paper, we present the associated conceptual framework of cloud-based tele-rehabilitation system employing affordable non-invasive Microsoft Kinect® allowing patients to perform rehabilitation exercises in non-clinical setting such as home environments without loosing the quality of patients care. More importantly, different from existing tele-rehabilitation systems, our system not only measures whether patients can perform rehabilitation tasks, but also how well they can finish the tasks. Preliminary experiments validate its potential in training healthy subject to perform exercise motions emulating the physical rehabilitation process.

Relevância:

100.00% 100.00%

Publicador:

Resumo:

In this paper, a general class of Halanay-type non-autonomous functional differential inequalities is considered. A new concept of stability, namely global generalized exponential stability, is proposed. We first prove some new generalizations of the Halanay inequality. We then derive explicit criteria for global generalized exponential stability of nonlinear non-autonomous time-delay systems based on our new generalized Halanay inequalities. Numerical examples and simulations are provided to illustrate the effectiveness of the obtained results.

Relevância:

100.00% 100.00%

Publicador:

Resumo:

BACKGROUND: Laughter Yoga consists of physical exercise, relaxation techniques and simulated vigorous laughter. It has been associated with physical and psychological benefits for people in diverse clinical and non-clinical settings, but has not yet been tested in a haemodialysis setting. The study had three aims: 1) to examine the feasibility of conducting Laughter Yoga for patients with end stage kidney disease in a dialysis setting; 2) to explore the psychological and physiological impact of Laughter Yoga for these patients; and 3) to estimate the sample size required for future research. METHODS: Pre/post intervention feasibility study. Eighteen participants were recruited into the study and Laughter Yoga therapists provided a four week intradialytic program (30-min intervention three times per week). Primary outcomes were psychological items measured at the first and last Laughter Yoga session, including: quality of life; subjective wellbeing; mood; optimism; control; self-esteem; depression, anxiety and stress. Secondary outcomes were: blood pressure, intradialytic hypotensive episodes and lung function (forced expiratory volume). Dialysis nurses exposed to the intervention completed a Laughter Yoga attitudes and perceptions survey (n = 11). Data were analysed using IBM SPSS Statistics v22, including descriptive and inferential statistics, and sample size estimates were calculated using G*Power. RESULTS: One participant withdrew from the study for medical reasons that were unrelated to the study during the first week (94 % retention rate). There were non-significant increases in happiness, mood, and optimism and a decrease in stress. Episodes of intradialytic hypotension decreased from 19 pre and 19 during Laughter Yoga to 4 post Laughter Yoga. There was no change in lung function or blood pressure. All nurses agreed or strongly agreed that Laughter Yoga had a positive impact on patients' mood, it was a feasible intervention and they would recommend Laughter Yoga to their patients. Sample size calculations for future research indicated that a minimum of 207 participants would be required to provide sufficient power to detect change in key psychological variables. CONCLUSIONS: This study provides evidence that Laughter Yoga is a safe, low-intensity form of intradialytic physical activity that can be successfully implemented for patients in dialysis settings. Larger studies are required, however, to determine the effect of Laughter Yoga on key psychological variables. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry - ACTRN12614001130651 . Registered 23 October 2014.

Relevância:

100.00% 100.00%

Publicador:

Resumo:

Cognitive-behavioural models have linked unacceptable or repugnant thoughts in obsessive-compulsive disorder (OCD) with vulnerable self-themes and fear-of-self concerns. To investigate this notion, Aardema and coworkers recently developed and validated the Fear of Self-Questionnaire (FSQ) in non-clinical samples, finding it had strong internal inconsistency, and good divergent and convergent validity, including strong relationships to obsessional symptoms and with other processes implicated in cognitive models of OCD (e.g., obsessive beliefs and inferential confusion). The current article describes two studies that aim to replicate and extend these findings in clinical OCD and non-clinical samples. Study 1 investigated the psychometric properties of an Italian translation of the FSQ in a non-clinical sample (n=405). Results of confirmatory factor analysis supported the unidimensionality of the scale; the FSQ also showed very good internal consistency and temporal stability. Study 2 investigated the role of fear of self in OCD symptoms, and unacceptable thoughts and repugnant obsessions in particular, using a clinical OCD sample (n=76). As expected, fear of self was a unique, major predictor of unacceptable thoughts independent of negative mood states and obsessive beliefs. Moreover, even when considered with obsessive beliefs, anxiety and depression, the feared self was the only unique predictor of obsessionality, providing support for the notion that self-themes could explain why some intrusions convert into obsessions, whereas others do not. Implications for current cognitive-behavioural models are discussed.

Relevância:

100.00% 100.00%

Publicador:

Resumo:

Background

Previous reviews on risk and protective factors for violence in psychosis have produced contrasting findings. There is therefore a need to clarify the direction and strength of association of risk and protective factors for violent outcomes in individuals with psychosis.

Method

We conducted a systematic review and meta-analysis using 6 electronic databases (CINAHL, EBSCO, EMBASE, Global Health, PsycINFO, PUBMED) and Google Scholar. Studies were identified that reported factors associated with violence in adults diagnosed, using DSM or ICD criteria, with schizophrenia and other psychoses. We considered non-English language studies and dissertations. Risk and protective factors were meta-analysed if reported in three or more primary studies. Meta-regression examined sources of heterogeneity. A novel meta-epidemiological approach was used to group similar risk factors into one of 10 domains. Sub-group analyses were then used to investigate whether risk domains differed for studies reporting severe violence (rather than aggression or hostility) and studies based in inpatient (rather than outpatient) settings.

Findings

There were 110 eligible studies reporting on 45,533 individuals, 8,439 (18.5%) of whom were violent. A total of 39,995 (87.8%) were diagnosed with schizophrenia, 209 (0.4%) were diagnosed with bipolar disorder, and 5,329 (11.8%) were diagnosed with other psychoses. Dynamic (or modifiable) risk factors included hostile behaviour, recent drug misuse, non-adherence with psychological therapies (p values<0.001), higher poor impulse control scores, recent substance misuse, recent alcohol misuse (p values<0.01), and non-adherence with medication (p value <0.05). We also examined a number of static factors, the strongest of which were criminal history factors. When restricting outcomes to severe violence, these associations did not change materially. In studies investigating inpatient violence, associations differed in strength but not direction.

Conclusion

Certain dynamic risk factors are strongly associated with increased violence risk in individuals with psychosis and their role in risk assessment and management warrants further examination.

Relevância:

100.00% 100.00%

Publicador:

Resumo:

The metabolic syndrome (MetS) involves a group of risk factors and is associated with a significantly higher risk of developing cardiovascular diseases (CVD) and type 2 diabetes. Recent studies have shown the importance of preventing CVD through early diagnosis and treatment of patients with MetS. The objective of our study was to determine the prevalence of MetS by different diagnostic criteria in postmenopausal women and analyze the influence of socioeconomic factors on cardiovascular risk in this sample of the population. A cross-sectional study involving 127 postmenopausal women (45 to 64 years) from Natal and Mossoró, Brazil. The study was approved by the Research Ethics Committee of the Federal University of Rio Grande do Norte. The experimental protocol consisted of applying structured interview, clinical examination and implementation of dosages blood. The diagnosis of MetS was based on NCEP-ATP III (National Cholesterol Education Program-Adult Treatment Panel III) and IDF (International Diabetes Federation) criteria. The research was accomplished with the participation of an interdisciplinary team in their several phases. The result of the sample studied had mean age of 53.9 ± 4.6 years and per capita income of 54.5 dollars. The prevalence of MetS, according to NCEP-ATP III and IDF criteria, was 52.8% and 61.4$, respectively. The agreement rate between NCEP-ATP III and IDF criteria was 81.9%, with a kappa value of 0.63 (CI 95%, 0.49-0.76), indicating good agreement between the two definitions. The most prevalent cardiovascular risk factor was HDL < 50 mg/dl, observed in 96.1% of the women analyzed, followed by increased waist circumference (≥ 80 cm) in 78.0%, elevated blood pressure in 51.2%, triglycerides ≥ 150 mg/dl in 40.9% and glycemia ≥ 100 mg/dl in 37.0% of the women. The occurrence of MetS was significantly associated with schooling and body mass index (BMI). High blood pressure was significantly associated with low family income, low schooling and weight gain. There was no significant association between the intensity of climacteric symptomatology and the occurrence of MetS. The conclusions of the research were that MetS and its individual components show a high prevalence in postmenopausal Brazilian women, and significant associations with weight gain and low socioeconomic indicators. The data point to the need for an interdisciplinary approach at the basic health care level, directed toward the early identification of risk factors and the promotion of cardiovascular health of climacteric women.

Relevância:

100.00% 100.00%

Publicador:

Resumo:

Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)

Relevância:

100.00% 100.00%

Publicador:

Resumo:

The use and the demand for substances that enhance masculinity, strength and sexual power are not novel. Over the years, this search has assisted the research directions in this area, leading to the discovery of the primary male sex hormone testosterone in 1935. Since then, numerous testosterone analogue compounds were synthesized, which are generically called Anabolic Androgenic Steroids (AAS). The AAS were produced for therapeutic purposes, but an increase in the use of these compounds for other purposes occurred over time. Initially they were used mainly to improve performance in athletes. However, recent studies have shown that the use of AAS by non-athletes with aesthetical purposes have been increasing as well. The abuse of AAS with non-clinical purposes can promote a number of physiological alterations, such as heart, liver, respiratory and psychological problems such as changes in mood, levels of anxiety and aggression. Exposure to supraphysiological doses of AAS is associated with behavioral changes, however, little is known about the effects of AAS on cognitive functions. In this work, we aimed to mimic the AAS abuse in humans with intramuscular administration of a supraphysiological dose of testosterone propionate (TP) in rats. We investigated the effects of this treatment on different aspects of cognitive function, specifically learning, memory and anxiety. Adult male Wistar rats were tested in the spontaneous alternation, novel object recognition and plus-maze discriminative avoidance tasks. The control group received intramuscular injections of vegetable oil (vehicle), and the TP group received injections of TP (10 mg/kg, i.m.). The injections were administered for 40 days, with intervals of 48 hours (chronic treatment) or in a single injection (acute treatment). In addition to the behavioral assessments, we performed biochemical analyzes as indicators of the endocrine effects of the treatment. Our results show that chronic treatment with a supraphysiological dose of TP caused memory impairments in the novel object recognition and the discriminative avoidance tasks. The spatial working memory (evaluated by spontaneous alternation task) was not affected. Also, we did not observe changes in anxiety levels. Regarding the biochemical parameters, chronic treatment increased serum levels of glutamicpyruvic transaminase, an indicator of hepatic and pancreatic lesions (as those observed after chronic use of these substances in humans). On the other hand, acute treatment with PT did not promote significant changes in any of these parameters when compared to the control group. In summary, we conclude that chronic treatment with a supraphysiological dose of testosterone propionate produces memory deficits in novel object recognition and retrieval of the discriminative avoidance task in adult male rats

Relevância:

100.00% 100.00%

Publicador:

Resumo:

ObjectiveTo compare the demographic features, presenting manifestations, diagnostic investigations, disease course, and drug therapies of children with juvenile dermatomyositis (JDM) followed in Europe and Latin America.MethodsPatients were inception cohorts seen between 1980 and 2004 in 27 paediatric rheumatology centres. The following information was collected through the review of patient charts: sex; age at disease onset; date of disease onset and diagnosis; onset type; presenting clinical features; diagnostic investigations; course type; and medications received during disease course.ResultsFour hundred and ninety patients (65.5% females, mean onset age 7.0 years, mean disease duration 7.7 years) were included. Disease presentation was acute or insidious in 57.1% and 42.9% of the patients, respectively. The course type was monophasic in 41.3% of patients and chronic polycyclic or continuous in 58.6% of patients. The more common presenting manifestations were muscle weakness (84.9%), Gottron's papules (72.9%), heliotrope rash (62%), and malar rash (56.7%). Overall, the demographic and clinical features of the 2 continental cohorts were comparable. European patients received more frequently high-dose intravenous methylprednisolone, cyclosporine, cyclophosphamide, and azathioprine, while methotrexate and antimalarials medications were used more commonly by Latin American physicians.ConclusionThe demographic and clinical characteristics of JDM are similar in European and Latin American patients. We found, however, several differences in the use of medications between European and Latin American paediatric rheumatologists.

Relevância:

100.00% 100.00%

Publicador:

Resumo:

Spirometric and haemogasimetric tests were performed in 52 patients with unifocal and multifocal progressive Paracoccidioidomycosis pulmonary diseases, in 5 patients with juvenile and 1 female internal genital forms. The age ranged from 20 to 74 years old and the duration of disease from 3 to 25 years. Dyspnea, cough, tegumentary and lymphatic manifestations were the most predominant signs observed. Fourteen of them was developed Cor pulmonale. Impaired renal function was recorded in 19 patients, cardiac symptoms were described in 7 and hyporeactor adrenal activity was showed in 13 patients. Radiological studies demonstrated mild in 16, moderate in 24 and severe pulmonary lesions types in 18 patients. The pulmonary function revealed: normal spyrographic findings in 17, pure obstructive type in 32 and mixed form in 9 of them. Hyperventilation was described in 54 individuals and all of them showed an increasing of the alveolo-arterial difference. PaO2 less than 80 mm/Hg observed in 36 of them. Statistical analysis demonstrated significative association between clinical evolution and radiological interpretation. Similar data were obtained in radiology evaluations, clinical evolutive studies and pulmonary functions described in these patients. The granulomatous reaction due to Paracoccidioidomycosis, in heavy smokers patients, gave origin to the alterations in small airways predisposing the interalveolar dissemination an impaired alveolo-arterial diffusion.