ANZCTR search results

More than one in twenty Australians experience depression in a single year and it is commonly a relapsing disorder. At least 60% of people who have had a depressive episode will have another, the vast majority within two years of the index episode. For those who have had three episodes, the relapse rate is 90%. Even with guideline-based pharmacotherapy relapse is not uncommon so there is a need for non-pharmacological approaches to relapse prevention. The economic burden of depression in Australia has been estimated as perhaps 2.8 billion annually. Mindfulness-based cognitive therapy (MBCT) is an innovative psychological treatment, combining principles of cognitive therapy and mindfulness meditation. It is designed to prevent relapse in people who have recovered from depressive episodes. MBCT aims to teach people to become more aware of, and to related differently to, their thoughts, feelings and bodily sensations; in particular, to view these thoughts and feelings as passing events in the mind rather than identifying with them. Through gaining these skills in increased awareness of thoughts and feelings, participants in the treatment learn to avoid negative ruminations, which have a powerful role in triggering relapses of depression. This project will examine the effectiveness of MBCT for the first time in Australians with a history of recurring depression. The primary aim of this project is to determine if MBCT when added to existing treatment as usual (TAU) is more effective than TAU in preventing depressive relapse over a two-year period in people who have had at least three prior episodes of depression. The study also aims to establish whether the mechanisms by which MBCT is proposed to work – by decreasing rumination, increasing levels of mindfulness and self-awareness – do in fact operate. We also hope to establish whether MBCT also has any impact on anxiety, another disabling condition that commonly occurs with depression. Cost utility analysis will enable specific policy recommendations for Australia. Positive findings from this study would lead to MBCT having a high degree of evidence-based support examining its use, so that it could be considered as an intervention for which ‘high’, rather than ‘moderate’, levels of evidence exist. Hence, if outcomes are positive, this study would provide internationally significant findings to support consideration of inclusion of this treatment into guidelines for routine clinical management of the serious and disabling problem of recurrent depression.

To trial the administration of a new drug “rimonabant”, a selective cannabinoid receptor type I antagonist, to young people between the ages of 16- 30 who have a history of psychosis and have undergone a period of cannabis detoxification, to assess whether relapse to dependant cannabis use is reduced It is hypothesised that: 1.Rimonabant will reduce the effects of cannabis intoxication after cannabis detoxification. 2.In turn, this would reduce psychosis and depression, and hence reduce utilization of health services including hospitalization. 3.Rimonabant will reduce other substance use disorders including tobacco use

This prospective study will test the following hypotheses in patients with stage I-II low grade marginal zone (MZ) lymphoma: 1. Involved Field Radiotherapy will produce a complete response rate of > 90% 2. Radiotherapy will be associated with a locoregional progression of < 20% after 10 years 3. Death from MZ lymphoma will occur in < 40% of patients within 10 years of radiotherapy This study secondary objectives are: 1. To collect information on the prevalence of H. pylori in non-gastric MALT lymphoma 2. To estimate rates of acute and late toxicity of radiotherapy

This is a randomised controlled study to evaluate the effects of daily 30 g whey protein supplementation on bone structure, muscle mass and strength, renal function, cardiovascular risk factors and body composition in women aged 70-80 years at baseline.

AIMS OF THE RESEARCH Being overweight or obese is a major health issue for Australian women during pregnancy and childbirth. There are well documented risks associated with obesity during pregnancy, including for the mother high blood pressure, diabetes and caesarean section. Babies of mothers who are overweight or obese are more likely to be large for gestational age, need admission to the nursery and to require treatment for jaundice and low blood sugar levels. This randomised trial will assess whether implementing a package of dietary and lifestyle advice to overweight and obese women during pregnancy to limit weight gain is effective in improving maternal, fetal and infant health outcomes. EXPECTED OUTCOMES OF THE RESEARCH If dietary and lifestyle advice is effective this would be a highly beneficial and cost effective treatment to redice the burden of disease to mothers and their infants caused by obesity.

The treatment for recurrent bladder tumour following trans-urethral resection (TUR) continues to be problematic. This protocol is a phase ll trial of gemcitabine directly instilled into the bladder of patients with transitional cell carcinoma who have undergone a standard TUR. The objectives of the study are to determine if intravesical gemcitabine is capable of reducing the rate of tumour recurrence in the bladder. Patients with transitional cell carcinoma who are at risk of recurrence following TUR, or who have failed previous standard treatment with intravesical BCG are eligible for the study. Patients will receive weekly bladder instillation of 2000mg of gemcitabine via a catheter, followed by re-evaluation of disease at 3 months by the urologist. Toxicity is expected to be minimal. The results of this trial will allow a phase lll trial comparing intravesical gemcitabine with BCG or mitomycin C to be undertaken.

The primary purpose is to evaluate the effectiveness of a walking program, especially the ‘dose’ of walking necessary to elicit clinically significant improvements in well-being among individuals aged 40 to 75 years with early osteoarthritis (OA) and test whether walking combined with glucosamine offers improvements. Improvements in well-being are defined as reductions in pain, stiffness, depression and anxiety and increases in functional ability, and self-efficacy towards exercise.

This study aims to evaluate the effects of two food bar formulations. One of the bars is wheat bran based, and the other sesame seed based. Both formulations are high in fibre and unsaturated fats, which have been shown in previous studies to reduce heart disease risk factors such as blood cholesterol. This study is designed to assess if different dietary sources of fibre and unsaturated fats will have similar or different benefit in reducing heart disease risk factors. The study will be single-blinded with the study co-ordinator blinded to the sequence of treatment the volunteers underwent. However because of a noticeble taste difference between the two bar formulations, the volunteers will be aware of their treatment.

In Australia and New Zealand, around 5000 patients are admitted to Intensive Care Units (ICU) annually with severe infection (sepsis). Despite aggressive treatment, around 35% of these patients will not survive, making severe sepsis the most common non-cardiac cause of death in ICU patients. Even surviving patients often suffer a period of multiple organ failure. Most patients admitted to ICU receive heparin injections to prevent the formation of blood clots in the leg veins which can travel to the lungs, causing major breathing difficulties. Traditionally, the agent most commonly given to prevent blood clots was unfractionated heparin, but over the last decade, more purified forms of heparin (low and ultra-low molecular weight heparins) have become available. These more modern agents are replacing the traditional heparin for blood clot prevention because of reported increased effectiveness. Recent studies in animals, healthy humans and critically ill patients with severe sepsis have suggested that unfractionated heparin may have beneficial therapeutic effects in infection, additional to its action to prevent blood clots. These immune-active effects are related to molecular size and thus may be lost with the current trend to use purified heparin forms. If this is true, then this additional benefit may be lost as we change to more purified heparin forms. We aim to perform a pilot study to assess the feasibility of conducting a large multi-centre study to investigate whether unfractionated heparin is beneficial for patients with severe sepsis. If unfractionated heparin is shown to be beneficial in these patients, this would be a simple, cheap and widely applicable additional treatment for severe infection that could save lives world-wide, and be accessible in first to third-world environments.

Nasogastric tubes are often used in children to give them fluids or medications or to drain their stomach. This involves the insertion of a narrow tube into their nostril and then down into their stomach. We know that this is a very safe and effective way of managing a number of problems in children. However, we also know that this is a painful procedure and we are looking for a way to relieve this pain. Lignocaine is commonly used in children to provide local anaesthetic before painful procedures. It is given in many ways, as an injection, applied to the mouth as a gel and sprayed in the mouth and nose, but it has not been licensed for administration by a nebuliser. Administering a medication in this way means that it is given through a mask so that it can be breathed in. The use of lignocaine in the manner proposed in this study is experimental. However, lignocaine has been administered by a nebuliser to children having different procedures and shown to be safe. It has also been given to adults by nebuliser before the insertion of a nasogastric tube and was shown to make this less painful. We will be asking families for consent for their child to participate in this study to find out whether administering nebulised lignocaine before inserting a nasogastric tube reduces the pain that the child feels. We aim to include 52 children in this study. Half of the children (26) will get the study drug (nebulised lignocaine) while the other half will get a placebo (nebulised salt water).