ANZCTR search results

This study aims to use an updated and more developmentally appropriate version of the Positive Thinking Skills Program to investigate the efficacy of the intervention amongst children aged 8-9 years old, in a rural setting. Rural areas have been identified to pose an increased risk of depression and other mental health problems (Kane, Day & Roberts, 2000), and therefore this program will provide a valuable mental health prevention program in an identified area of need. The program will be provided universally to children by their teachers and hence will avoid stigmatisation of children identified as at risk. This project is significant as it has the potential to impact upon the prevalence of depression amongst a much younger group of children (8- 9 years) than most of the current research demonstrates (Rooney, Roberts, Kane, Pike, Winsor, White & Brown, 2006). The potential prevention of internalising disorders in middle childhood may also result in a positive long term impact in various areas of a child’s life such as family, peer relationships academic performance and recreational activities as well as a reduction of the risk of further episodes of depression in adolescence and adulthood (Kovacs & Devlin, 1998). Hypotheses It is predicted that the Positive Thinking Skills program will be associated with fewer depressive symptoms; improved social and emotional functioning; a more positive attiributional style and fewer anxiety symptoms. H1: Compared to the control group, the intervention group will report lower levels of depressive symptomatology at post-test (as measured by the Mood and Feelings Questionnaire ) H2: Compared to the control group, the intervention group will report higher levels of social and emotional functioning at post-test (as measured by the Strengths and Difficulties Questionnaire) H3: Compared to the control group, the intervention group will report lower levels of anxiety symptomatology at post-test (as measured by the Spence Children’s Anxiety Scale) H4: Compared to the control group, the intervention group will report a less pessimistic attribution style (as measured by the Children’s Attributional Questionnaire)

Daily consumption of chocolate with high cocoa content for between 7 days and 18 weeks can significantly reduce blood pressure (BP). This anti-hypertensive effect of cocoa has been attributed to it’s high content of bioactive polyphenols, particularly the flavanol epicatechin. However, chronic (6-12 weeks) studies using flavanol rich cocoa beverages rather than the relatively higher calorie chocolate products have not yielded similar results. With similar or considerably higher daily doses of flavanols (compared to those provided in the chocolate studies) consumption of flavanol-rich cocoa beverages have resulted in relatively small reductions in BP or no change at all. This study intended to determine the required daily dose of cocoa flavanols to lower 24 hour Ambulatory BP (ABP) in a borderline hypertensive population when delivered in a (relatively lower calorie) reconstituted cocoa beverage

Difficulty performing more than one task at a time (dual tasking) is a common and disabling problem experienced by people with Parkinson disease (PD). If asked to perform another task when walking, people with PD have repeatedly shown markedly altered gait, such as taking shorter steps or walking more slowly. Currently there is uncertainty about whether clinicians should teach people with PD to avoid dual task performance or whether they should encourage them to practice dual-tasking with the hope that practice will lead to enhanced performance. This study will address this issue by comparing usual gait training to dual task gait training.

This project aims to establish the prevalence of subclinical diabetic heart disease, its relationship to myocardial fibrosis on imaging and biochemical parameters and its response to antifibrotic therapy with spironolactone. MATERIALS & METHODS Patient Selection The patient cohort will compromise apparently healthy patients with type 2 diabetes mellitus (T2DM) and suboptimal control (glycosylated haemoglobin [HbA1c] > 7%) recruited from the hospital clinics and the community. Subjects with known macrovascular or microvascular complications of type two diabetes mellitus (T2DM), hypertensive, valvular or coronary disease or other significant co-morbidities such as arrhythmias, malignancy, psychiatric or renal disease will be excluded. Pregnant and breast feeding women will also be excluded. Study design 225 patients will be recruited and undergo initial screening with echocardiography and cardiac magnetic resonance imaging for evidence of diabetic heart disease. Based on past studies at our research centre, it is predicted that approximately one third of these participants will have evidence of subclinical myocardial dysfunction. Previous work with spironolactone and hypertensive heart disease in our group has shown a significant impact on myocardial properties in patient numbers of less than 30, so a proportionate reduction should be detectable from this study group even allowing for a 30% drop-out. There are no previous studies investigating myocardial fibrosis in type 2 diabetes mellitus (T2DM) with cardiac magnetic resonance imaging on which this study can be powered. Baseline measures on all subjects will include: body mass index, hip and waist circumference and resting haemodynamic parameters. Fasting blood samples will be collected to assess haematological parameters, renal and hepatic function, lipid profile, glucose, insulin, glycosylated haemoglobin (HbA1c) and brain natriuretic peptide (BNP) concentrations. Urine collection for albumin to creatinine ratio for detection of diabetic nephropathy will also be performed. Additional plasma, serum and urine will be stored for subsequent investigation of collagen biomarkers as surrogate measures of myocardial fibrosis. All study subjects will undergo a baseline transthoracic echocardiogram to assess for evidence of systolic or diastolic dysfunction using standard echocardiographic parameters. Tissue Doppler imaging (TDI)including tissue velocity, strain and strain rate will be employed to detect further subclinical abnormalities. All subjects will then undergo a standard treadmill exercise stress test before being reimaged at peak heart rate for evidence of inducible wall motion abnormalities (indicative of ischaemic heart disease) and with tissue Doppler imaging (TDI) for subtle myocardial dysfunction which is not otherwise apparent at rest. Those with inducible wall motion abnormalities will be excluded based on their likelihood to have ischaemic heart disease. Appropriate clinical follow-up will be arranged. Patients who are found to have evidence of subclinical myocardial dysfunction and a proportion of matched controls from the original patient group will then be further investigated with cardiac magnetic resonance imaging for evidence of underlying myocardial fibrosis. Patients with subclinical dysfunction will also be randomised to anti-fibrotic therapy with spironolactone (25 mg orally per day) or placebo for 6 months with the aim of reducing the extent and progression of myocardial collagen deposition. Throughout the intervention period, patients will receive 4 weekly follow-up to monitor for adverse events and compliance. Post-intervention, anthropometric measurements, biochemical markers and imaging with resting and exercise echocardiograms and cardiac magnetic resonance imaging will be repeated. PROJECTED OUTCOMES This work aims to highlight the importance of early detection and treatment of subclinical diabetic heart disease, which, if left unaddressed, may result in an epidemic of symptomatic diabetic heart disease in the future. We also hypothesize that anti-fibrotic therapy will have a favourable effect on myocardial function and exercise capacity.

Nucleus Network Limited. The primary purpose of this study is to determine if BMS-817399 can be safely administered to human beings at dose ranges that may provide clinical benefit to patients of rheumatoid arthritis. The study has no formal research hypothesis to be statistically tested. The study will be carried out in normal healthy volunteers under close observation to determine BMS-817399 dose ranges that are safe and tolerable in human beings. Initially, BMS-817399 will be given as a single dose by mouth, with doses increasing till the highest tolerated dose that is also safe is determined. Following this, BMS-817399 will be given as more than one dose daily by mouth for a period of fourteen days, with doses increasing in amount till the highest tolerated dose that is also safe is determined. To know the amount of BMS-817399 that has entered into the body, blood will be drawn for testing. Other test will also be done to see if BMS-817399 is safe and has the expected effects in the body. During the period of dosing and testing, the patient will be confined to the clinic for close observation. Taking part in this study will not provide any medical benefit to the subjects.

The primary purpose of this study was ti investigate differences in taste sensitivity to fat, and determine how these differences influence fat and food consumption, fat perception, dietary variety and habits.

The aim of this proposed research is to test precisely whether Oxytocin (OT) potentiates learning of emotion recognition training, improving processing of emotion information, thus leading to an increase in the quality and quantity of participants' social interactions with a parent or guardian. Participants will be randomly allocated to one of two groups, (1) combined Oxytocin (OT) and emotion recognition training (ERT),(2) combined placebo and Emotion Recognition Training. Effects will be examined at three levels; 1) immediate, 2) intermediate and 3) distal. Immediate effects refer to the direct impact of combined Oxytocin and Emotion Recognition Training on the basic components of social interaction. The intermediate effects of interest refer to the social interactions recorded by parents/guardians in the extended period (24 hours) following combined Oxytocin administration and Emotion Recognition Training. Distal effects will also be determined to gauge the potential for cumulative effects of combined Oxytocin and Emotion Recognition Training over a number of consecutive administrations.

The purpose of the study is to gain information on the effectiveness of the use of robotics as a type of treatment for the recovery of movement of the upper limb (arm) for clients following a stroke. It specifically investigates whether the use of this particular robotic (Bimanutrack) in therapy, results in improved arm function following a stroke.

To determine the effectiveness of an electrotherapy device called Interactive Neurostimulation (INS), in providing pain relief following a total hip replacement. Outcome measures are pain scores, length of hospital stay, analgesic use and/or increase range of movement in the acute period following a total hip replacement. The null hypothesis is that there will be no difference in each variable between the active INS and sham groups five days after surgery. The research hypothesis is that there will be a difference in each variable between the active INS and sham groups five days after surgery.

This study aims to determine the optimal bladder filling instructions for prostate cancer patients undergoing radical radiation therapy using Image Guided Radiation Therapy (IGRT) Who is it for? You can join this study if you are undergoing radical radiation therapy using Image Guided Radiation Therapy (IGRT) as treatment for prostate cancer. Trial details Participants will be divided into two groups. One group will be asked to empty their bladder 1 hour prior to their treatment appointment time, and then consume 300mL of water at least 30 minutes prior to their treatment appointment time. The second group will be asked to empty their bladder 1 hour prior to their treatment appointment time, and then consume 750mL of water at least 30 minutes prior to their treatment appointment time. The amount of daily bladder volume variation over the course of treatment will be measured daily in week 1 of treatment, and then every 2nd day until treatment is completed. Participants will also be asked to complete some questions measuring quality of life and distress, in weeks 1, 4 an 7 of treatment. Further monitoring will occur 6months and 12 months after treatment has completed.