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Participants are invited to take part in this research study to test a new treatment combination for prostate cancer. This is because they have cancer that started in the prostate and has spread to other parts of their body. This is known as metastatic prostate cancer. Current treatment for newly diagnosed metastatic prostate cancer involves androgen deprivation therapy(ADT). Androgen deprivation therapy has two components: 1. The main component is by stopping the release of androgen from the testicles. This is mainly done by using drugs that prevent the testicles from making androgens, and therefore reducing the levels of androgens in the body to low levels. These drugs are called luteinising hormone releasing hormone analogues (LHRHA). These drugs are given as injections. This is usually part of the standard initial treatment for men in your situation. The other way of reducing androgen production by the testicles is with a surgical operation to remove both testicles. This is not part of the trial. If participants have already had this surgical procedure or it is planned to be done, they will not need to be on LHRHA, but can still take part in this study. 2. The second component of ADT is to block the effects of androgens produced in other parts of the body with antiandrogen drugs. Antiandrogen drugs block testosterone and related androgens from attaching to molecules in the cancer cell called 'androgen receptors'. Blocking this attachment prevents androgens from having their effect. This might provide additional benefit in treating the cancer although this has not yet been proven. Several different types of antiandrogen drugs are available for use already. Enzalutamide is a new antiandrogen that is not yet approved for use in Australia. This study will compare the effectiveness of enzalutamide versus the currently available antiandrogen drugs when used on a background of treatment with a LHRHA (or surgical removal of the testicles). The main aim of the study is to see which of these combinations is best at improving the survival of men in this situation. Recent studies show promising results with the use of enzalutamide in participants who had been treated with androgen deprivation therapy and were no longer responding to the standard antiandrogens, this is known as castrate resistant prostate cancer (CRPC), which is a more advanced stage than the type of metastatic prostate cancer being studied here. With this stage of metastatic prostate cancer there is no evidence yet on which treatment is best to treat it. To do this, a total of 1100 participants will participate where half the participants on the study will receive enzalutamide with a LHRHA or surgical operation to remove both testicles and the other half (550 participants) will receive already available antiandrogens (but not enzalutamide) with a LHRHA or surgical operation to remove testicles. All participants on this study will receive active therapy and no placebo treatment will be used. The study is open label, meaning that both the participants and the investigators will know the treatment the participant will receive.

This study aims to determine if treatment for insomnia also reduces anxiety in school-aged children. Compared to children in the control group, we expect children in both treatment groups to show improvements in sleep and anxiety, with greatest improvements expected for the "moderate" treatment group.

Intervention for Developmental Coordination Disorder (DCD) has been shown to be better than no intervention, however there is scarce information on the delivery of all types of intervention. This study compares different personnel and environments in service delivery. Ninety-three children from 13 South Australian schools, aged five to eight years (at time of recruitment) were recruited to participate in this RCT. Participants received a group intervention running for 13 weeks, working on fine and gross motor skills. Schools were randomised using cluster randomisation to receive one of three modes of delivery. Group one schools received the program at school run by a school assistant, group two received the program in school run by a physiotherapist and group three received the intervention in a health clinic run by a physiotherapist. Group three was considered the control group for delivery as the literature concludes group programs run by health professionals in a health setting have success in treating children with DCD. Participants were assessed pre and post-intervention, and six months after the program completion. The Movement Assessment Battery for Children (MABC), Test of Gross Motor Development – Second Edition (TGMD-2), Pictorial Scale of Perceived Competence and Social Acceptance for Young Children (PSPCSA) and the School Function Assessment (SFA) were used to assess participants, while parent and child questionnaires were used to gain information on more practical aspects of service delivery.

Heart artery disease (also known as coronary heart disease), which can lead to heart attacks, remains the leading cause of death in Australia. A significant proportion of heart attacks have been shown to be among those deemed ‘young’. This study aims to determine if siblings of young heart attack patients are likely to have significant coronary heart disease themselves even if they currently have no symptoms of it. If this were true then they maybe at an increased risk of suffering a heart attack or dying compared to the general population. This study will also explore whether currently available heart artery disease risk scoring tools are significantly less accurate in predicting the presence of CHD compared to computerised tomography (CT scan) of the heart arteries. If this is found to be true then it may establish CT as a screening test to allow early detection of coronary heart disease by visualising the heart arteries. Hence the aims are as follows: 1.To determine what proportion of siblings of young heart attack patients have coronary heart disease themselves. 2.To compare how accurate heart ultrasound scans during exercise (stress echo) are as compared to CT scans. 3.To investigate the accuracy of popular heart artery disease risk scoring tools: Framingham, Interheart and SCORE. 4.To determine the clinical outcomes of the participants who have coronary heart disease detected on their CT scans. Design and Methodology: We are aiming involve 50 siblings of young heart attack patients in this pilot study. All participants will undergo blood tests for cholesterol levels, stress echo and CT scans of the heart. Their probability of having coronary heart disease will be calculated using the aforementioned risk scoring tools. The reliability of these risk scoring tools will be compared with the findings of CT scan. The end point of the study will be two fold. Firstly, the findings of CT scan, stress echo and risk scoring tool will be compared and the proportion of participants with coronary heart disease (as detected by CT) will be determined. Secondly, participants will be followed with telephone calls for 30 days, 6 months and 12 months for any event of chest pain, hospitalisation for cardiac problem, heart attack or death. Their outcomes will be compared with their test results.

The combination of probiotics and prebiotics is known as ‘symbiotic’. This study aims to investigate whether daily consumption of symbiotic yoghurt can improve cholesterol levels and reduce blood pressure in hypercholesterolemic individuals over 8 weeks. A parallel, double-blind, randomised controlled trial involving 96 non- smoking, overweight or obese, aged 30-65 will be recruited and randomly assigned to 3 groups to consume 300g/day of either control, symbiotic or symbiotic yoghurt containing fresh pomegranate juice. Anthropometric measurements and fasting blood samples will be collected at the beginning of the study, week 4 and 8. Significance: Studies show that hypercholesteremia and hypertension are leading cause of morbidity and mortality in developed countries. Symbiotic food consumption may result in cholesterol and blood pressure reduction, thus reducing the chronic disease incidence. Previously the symbiotic effects have been investigated individually but not synergistically, and little is known about the mechanisms by which probiotics modulate hypocholesterolemic and anti-hypertensive effects. This is the first study examining the synergistic effect of this new symbiotic mixture in hypercholesteremic individuals. The findings will contribute in understanding the mechanisms of action of this symbiotic combination in improving health outcomes as well as new product development.

One of the most common types of anaesthetic used for caesarean section is a spinal anaesthetic. In order for women to be comfortable during the operation a large number of nerves are blocked. In addition to the pain nerves it is very common for other nerves to be affected, including those which are responsible for other types of sensation, movement in the legs and also those which normally help control blood pressure. Significantly low blood pressure in the mother may be associated with side-effects including nausea and vomiting, dizziness and possibly loss of consciousness and in extreme situations the baby may also receive a reduced blood supply from the placenta. For the anaesthetist to provide a safe anaesthetic it is very important to monitor these effects and especially any changes to blood pressure and how the woman’s body responds to it. This is particularly important during the first 5 to 10 minutes after the injection of the spinal anaesthetic. During this period it is usual to closely measure blood pressure, heart rate, the amount of oxygen in the blood and the electrical activity of the heart from an electrocardiogram. Recently, it has also become possible to directly observe the function of the heart relatively quickly and easily via a hand-held ultrasound probe placed on the chest – a transthoracic echocardiogram or TTE. These devices are very similar to those used for obtaining images of the baby during pregnancy. It is known from the use of these devices in other situations, including in pregnant women, that valuable information may be obtained about how the heart is performing. Until now this has not been done in healthy women having a spinal anaesthetic for an elective caesarean section. Hence, the purpose of our study is to document the effects of a standard spinal anaesthetic on the output of the heart by comparing measurements at approximately 10 minutes after the spinal injection with measurements taken immediately before the spinal using TTE. In keeping with usual practice, drugs will be given to help maintain normal blood pressure throughout. Information obtained from this study will be helpful in further understanding the impact of spinal anaesthetics on the cardiovascular system in pregnant women which is likely to help guide anaesthetists to reduce side effects and improve safety.

This is a pilot trial testing the feasibility and participants required to test the hypothesis that melatonin 5mg capsule every night will decrease the symptoms of delirium in elderly medical inpatients.

Lack of physical activity is a major health issue for people with osteoarthritis of the knee leading to increased risks of cardiovascular disease. Only about 1 in 10 people with knee osteoarthritis meets the current physical activity guidelines of at least 150 minutes of moderate intensity activity in minimum of 10 minute bouts each week. It is not known if it is safe or feasible to encourage these people to increase their physical activity level as recommended in the guidelines. This project will determine how much physical activity in the form of walking can be safely and feasibly prescribed for people with severe knee osteoarthritis in the community. Patients that attend the orthopaedic outpatients department at Eastern Health will be invited to participate. We will apply methods commonly used in drug trials to work out how much of a medication can be safely prescribed, but apply these methods to physical activity to work out the maximum tolerated dose of walking for people with severe knee osteoarthritis. The project will begin with prescribing small doses of walking, and measuring the participants’ responses to determine if the prescribed dose is tolerated safely. For example, the walking dose may cause substantial knee pain for the participant that does not settle quickly with rest. This response is termed an adverse or undesired event. If there are no adverse events, the prescribed dose of walking will be escalated in the next independent group of participants until the maximum tolerated dose is reached. This is a phase I dose response trial to characterise the safety profile of a treatment. The outcome of this study will provide evidence for the level of physical activity that can be safely tolerated by people with knee osteoarthritis, and assist health professionals to prescribe safe amounts of walking.

The propsed study will investigate the suitablity (particularly enjoyment, motivation to continue) of three formats of exercise intervention (Moderate Intensity Personal Preference; Moderate Intensity Steady State; and High Intensity Interval Training) for overweight or obese individuals with clinical depression. In essence, the proposed research will act as a feasibility/pilot study for a later study, which will be based on the results of the proposed research. In this future study a 12 week exercise program will be implemented (based on the proposed study outcomes) which will be compared to and used alongside a “gold standard” treatment of Cognitive Behaviour Therapy for depression. It is important to understand exercise preferences and motivation to continue exercise in this population prior to designing this treatment protocol. We expect that the format of exercise (high intensity vs moderate intensity; interval vs steady state vs personal preference) will differentially affect motivation and enjoyment as well as markers of inflammation, appetite, symptoms of depression and sleep quality.

This project addresses the urgent health care problem of falls in old age that affects a rapidly increasing number of people in Australia and is geared towards self-management of fall-related risk factors in old age. Technology-based solutions have potential to increase accuracy of fall prediction tools and develop standardized tailored intervention strategies. The emphasis of the project is not on laboratory research, but on active implementation of existing technologies and evidence-based fall prevention strategies for older people living in the community. The primary aim of the project is to develop and evaluate innovative home-based technologies for continuous monitoring and prevention of falls risk in older people.