ANZCTR search results

The project is designed to test a) whether dexamphetamine can be used safely to treat adults with obesity, b) whether dexamphetamine is effective for treating obesity over a six month period

There is a body of evidence supporting the presence of oxidative stress states in bipolar disorder. With high levels of oxidative stress comes mitochondrial dysfunction. There is accumulating evidence that demonstrates that those with mitochondrial disease have a higher prevalence of bipolar disorder. The aim of this trial is to develop novel therapies for the depressive phase of bipolar disorder targeting the pathways of oxidative stress and mitochondrial dysfunction. This 20 weeks, double blind ranodmised, placebo controlled trial will investigate a combination treatment to enhance mitochondrial function, as well as exploring N-acetyl cysteine alone. The study will include 16 weeks of treatment with a post-discontinuation visit 4 weeks later. Participants will be randomly and sequentially allocated to one of the three treatment arms, in addition to any usual treatment they may be taking. The primary outcomes will be changes in symptoms based on the Montgomery Asberg Depression Rating Scale. Secondary outcomes include changes in HAMA, YMRS, BDRS, PGI, CGI and blood biomarkers.We will also be collecting blood samples at baseline, and week 16 from consenting participants to investigate blood markers of oxidative stress, inflammation and mitochondrial function.

In this study we aim to look at the best treatment for children presentling to the emergency department with an acute episode of asthma. Specifically, we are interested in children who have moderate severity of their symptoms on arrival. The primary purpose of this study is to determine whether there is a decreased need for hospital admission in these children when they atre treated with inhaled ipratropium bromide (IIB), inhaled salbutamol (IS) and oral steroid , compared with patients treated with Inhaled salbutamol and oral steroid alone

To examine whether 14 week administration of CDRI 08 (a special extract of bacopa) improves a range of neurophysiology, intelligence, cognitive, mood, genetic, sleep, and behavioural measures in children aged 6-14 years with symptoms of inattention and hyperactivity relative to placebo.

Regulation of the factors that control food intake, the funtion of the stomach and small intestine and release of gut hormones is complex, and our understanding of this feild is far from complete. There is increasing evidence that nutrient stimuli in the gut, especially in the small intestine, induce changes in gut motor and hormonal functions that play a central role of energy intake and blood glucose. In particular high-protien diets have been found to be very effective for weight loss and for improving blood glucose in obese subjects with and without type 2 diabetes. This study aims to investigate the effects of the amino acids, L-glutamate and L-glutamine, on gut motility, gut horone release, blood glucose control and energy intake. We hypothesise that L-glutamate and L-glutamine as building blocks of proteins, may substantially contribute to the beneficial effects of whole protein on gut functions and energy intake regulation. This has not yet been evaluated in detail and will be important in order to enhance our understanding of the mechanisms underlying the effects of dietary protein on eating control.

This study is a pilot study to determine the potential effectiveness of a community pharmacy-based service for the management of sleep disorders in the community. This study aims to pilot the role of actigraphy as an objective measure in monitoring certain sleep disorders, and to pilot the extended role of community pharmacists in managing sleep disorders in the community. It is hypothesized that those who receive an actigraph will manage their sleep problems more effectively than those undergoing standard/usual care

This is a pilot study of safety and infectivity in 2 healthy volunteers of a new Plasmodium falciparun Malaria bank (HMP02Pf) obtained from an malaria infected patient under HREC approval from both Royal Brisbane and Women’s Hospital and Queensland Institute of Medical Research. The Malaria bank was prepared under highly controlled conditions using protocols developed in conjunction with the Red Cross the US FDA and QGen. The clinical protocol is based on prior studies using the 3D7 Plasmodium falciparum isolate. The malaria bank has had full serological and PCR evaluations over 6 months meeting the criteria of ARCBS blood donation requirements. This study is to establish the safety and comparative growth kinetics of the other 3D7 malaria inoculum. The antimalarial agent used to treat the malaria is the TGA approved Riamet, which was also used to eradicated the malaria infection in the patient donor.

The purpose of this study is to determine the effect of a high potassium diet on blood vessel function. A high potassium intake is associated with reduced risk of heart disease however effect of potassium on blood vessel function is not known. We propose increased dietary potassium will improve blood vessel function.

Patients will be recruited from outpatient clinics at Royal Melbourne Hospital (3052) and St Vincent’s Hospital (3065). This research involves the development and evaluation of an online intervention designed to provide individually tailored interventions to treat Panic Disorder, Major Depression, Social Anxiety, and Generalised Anxiety associated with IBD. Research has shown that people with IBD have higher levels of Panic Disorder (PD) and Major Depression (MDE; Major Depressive Episode), Social Anxiety Disorder (SAD), and Generalised Anxiety Disorder (GAD) than people with other chronic health conditions. While research on the effectiveness of psychological interventions in IBD is encouraging to date only limited work has been done on the evaluation of these programs. The aims of the current research project are to: (1) Develop and validate an online psychological treatment program specifically designed to diagnose and treat PD GAD, SAD, and/or MDE symptoms associated with IBD, and (2) Make this specialized service available free of charge to all individuals with IBD throughout Australia and internationally. In this project a three stage development and evaluation of an online intervention for IBD: (1) Development stage where an IBDeTherapy website is developed, revised and tested; (2) Evaluation stage I where 40 IBD patients complete a 14 week intervention program online; and, (3) Evaluation stage II involves 240 individuals from an IBD outpatient hospital cohort (Intervention groups: 30 MDE, 30 PD, 30 SAD, 30 GAD; Treatment as usual control groups: 30 MDE, 30 PD, 30 SAD, 30 GAD) in a large trial of the program that incorporates changes based on the initial evaluation stage. The present project is innovative because provision of online programs for IBD sufferers has the potential to provide better psychological care to these people than previously available. In addition, the established effectiveness of online intervention programs with clinical populations suggests that an online intervention is likely to have a high uptake and thus reduce the pressure on the health system.

Engaging in regular physical activity is essential for maintaining good health and well-being. Because employed adults spend the majority of their workday waking hours in the workplace, offering exercise programs at work may be an efficient strategy to increase physical activity; a recent meta-analysis has shown that some workplace physical activity interventions can improve both health and important worksite outcomes. The emergence of compelling evidence linking prolonged sitting to detrimental health outcomes, including mortality, has prompted calls for new thinking within public health messages to include both being physically active and reducing time spent sitting. However, the extent to which changes in metabolic/cardiovascular and productivity outcomes arising from a workplace physical activity program may be enhanced through a combined intervention approach (physical activity + sedentary behaviour reduction) has not been investigated. The proposed study will investigate the efficacy of a gymnasium-based exercise program with and without the combination of individually tailored feedback to reduce sedentary time on cardiovascular health outcomes and productivity in healthy, sedentary adults. A total of 68 full-time Baker IDI staff aged 20-65 years with a BMI less than 40 kg/m2 who are typically sedentary (sit at work equal to 4 hours/d and watch television equal to 2 hours/d), are not physically active (less than 150 minutes/wk moderate-to-vigorous physical activity), not on glucose, blood pressure or lipid lowering medications, not pregnant and otherwise healthy will be recruited to participate. The proposed study will involve a two-arm parallel group randomised trial conducted over 9 months which includes three phases. Phase 1: Baseline (1 week): Following initial screening for eligibility, behavioural, metabolic and physiological measurements will be performed to establish baseline values. Phase 2: Intervention Phase (3 months): Participants will then be randomly assigned to one of two groups: 1. Gymnasium-Based Exercise Only (n=34) 2. Gymnasium-Based Exercise + Sedentary Behaviour Reduction Intervention (n=34) At the completion of three months, all behavioural, metabolic and physiological measurements will be reassessed. Participants will undertake three, one hour exercise sessions (which combine aerobic and resistance training) per week for three months. All sessions will be developed and supervised by an exercise physiologist or qualified personal trainer and will be conducted at the Baker IDI Healthy Lifestyle Research Centre research gymnasium. Participants assigned to the Gymnasium-Based Exercise + Sedentary Behaviour Reduction Intervention will additionally receive guidance and support to reduce their sedentary time at work and increase their number of breaks in sedentary time (ie: changing from sitting to standing). Phase 3: Maintenance Phase (9 months): All participants will undergo a nine month maintenance phase whereby gymnasium-based exercise will be required on at least two and up to three days per week. At the completion of the maintenance phase, all behavioural, metabolic and physiological measurements will be reassessed.Study outcomes will include: metabolic (fasting blood glucose,insulin and lipids) and anthropometric measures, blood pressure, physical activity, sedentary time and breaks in sedentary time (primary); and work productivity, self perceived general and mental health and exercise compliance (secondary). Sedentary behaviour and physical activity time will be assessed in the study using accelerometers (Actigraph model GT3Xplus), worn during waking hours on selected days and positioned over the right hip via a belt. Accelerometers are similar in size and shape to pedometers and record data on physical activity duration, frequency and intensity. Breaks in sedentary time will be assessed using inclinometers (model activPAL)) worn discretely on the upper thigh area fixed with hypoallergenic, micropore tape. Inclinometers are equivalent in size to a matchbox and measure the number of postural changes from sedentary to upright (standing). An activity diary will be used in combination with the two devices to allow participants to record when they put on/took off the devices or engaged in non- ambulatory physical activities (ie. cycling, swimming) that are not able to be recorded by the accelerometer. Participants will also enter work start/finish times in the diary on those work days the devices are worn. It is anticipated findings from the proposed research study will be used to inform future interventions targeting behavioural change across the “whole of day” (during exercise and non exercise time) in at risk populations eg. overweight/obese, diabetics, individuals with metabolic syndrome.