ANZCTR search results

The primary purpose of this study is to evaluate the efficacy and safety of individualised dosing of dasatinib for elderly patients with chronic myelogenous leukaemia. Who is it for? You may be eligible to participate in this study if you are aged 18 years or over, and have been diagnosed with chronic myelogenous leukaemia in the chronic phase (CML-CP) in the previous three months. Study details All participants in this study will start taking dasatinib at 100mg per day. At day 7, a blood sample will be taken to measure the levels of dasatinib in the blood just prior to taking that day's dose. If the blood dasatinib level is above a certain point, then the daily dose will be decreased to 70mg per day. If the blood dasatinib level is adequately low, then the participant will continue taking 100mg per day. This process will be repeated on days 28 and 56, with further lower dose levels of 50mg per day and 50mg every other day available if blood dasatinib levels are above the specific concentration. The dose level may also be dropped at any time if signs of drug toxicity are present. Participants may also be escalated back up a dose level (up to a maximum of 100mg per day), if further blood tests every 3-6 months show that the drug has not sufficiently decreased markers of the leukaemia, i.e. treatment has not been adequately effective. Participants will continue taking the drug for the two year study period, followed by a further three years if it has proven to be safe and effective in these patients. It is hoped that the findings of this study will provide information on whether an individualised dose of dasatinib can be used in elderly CML-CP patients to minimise toxicity whilst maintaining the therapeutic effect to treat the disease.

Cardiovascular disease is the commonest cause of death while on the kidney transplant waiting list and after transplantation. Current standard care involves screening for coronary artery disease prior to waitlist entry, then every 1-2 years, according to perceived risk, until transplanted. The aim of screening is two-fold. Firstly to identify patients with asymptomatic coronary disease to enable either correction, by bypass surgery or angioplasty, or removal of the patient from the list, with the ultimate aim of preventing premature cardiovascular mortality at the time of, or soon after kidney transplantation. Secondly, from a societal perspective, to prevent mis-direction of scarce donor organs into recipients who experience early mortality. This current screening strategy is not evidence based, has substantial known and potential harms, and is very costly. Two major issues of uncertainty require addressing in sequence: (1) whether to periodically screen asymptomatic wait-listed patients for occult coronary artery disease; and (2) whether to revascularise coronary stenoses in asymptomatic patients prior to transplantation. The CARSK study seeks to address the first of these 2 issues. CARSK aims to 1. Test the hypothesis that after screening for wait list entry, no further screening for coronary artery disease (CAD) is non-inferior to the current standard care which is screening all asymptomatic wait-listed patients for CAD at regular intervals. 2. Compare the benefits and costs of not screening versus regular CAD screening from a health system perspective.

Acute low back pain (LBP) is a common presentation to the emergency department (ED). It is also a major health condition associated with high rates of absenteeism from work and more frequent use of health services. As per the international back pain guidelines, primary contact practitioner aim is to classify back pain and rule out serious pathology. The mechanical low back pain group (back pain from a musculoskeletal cause) makes up 90% of presentations to ED. Currently in ED standard treatment comprises of subjective and objective assessment (RMO/ED registrar, or Physiotherapist):,radiological investigations as appropriate for the individual. Management will include patient education and assurance, symptom relief by analgesia (NSAIDS, paracetamol & opioids if necessary), as well as recommendation to stay as active as possible including return to work. Depending on their response to the analgesia patients are discharged with gentle exercises & Physiotherapy follow-up. Despite these forms of care twenty five percent (RBWH ED statistics) of low back pain patients are admitted to the short stay unit for overnight analgesia due to difficulties coping with the pain. They are then discharged after 1-2 days. Apart from adding to the cost , this also blocks a bed for other emergency patients. Effective treatment of acute LBP is important because it prevents patients from developing chronic LBP which needs more costly and complex investigations and treatment. Presently treatment for patients presenting to ED with back pain lacks an individualised approach with respect to alleviating mechanical low back pain. We propose this may be improved with the use of a McKenzie approach to management of back pain in the ED setting. The McKenzie method of mechanical diagnosis & therapy is an active exercise approach involving repeated movements, sustained positions and therapeutic forces, it has an educational component with the purpose of minimising pain, disability, and improving spinal mobility. Currently data suggesting effectiveness of this method in an ED setup is lacking. Therefore the purpose of this study is to compare if more benefits are gained with a ‘McKenzie exercise’ approach compared to a ‘stability/mobility’ exercise approach for patients who are treated by a Physiotherapist for low back pain in ED. We anticipate the findings of the study will be informative to the best approach to management of these patients in ED.

Sleep-related breathing disorder has been commonly reported in elderly individuals with mild cognitive impairment. This project is interested in examining the prevalence of Obstructive Sleep Apnoea (OSA) in patients attending the Cognitive, Dementia, and Memory Service (CDAMS) at Northern Health and Austin Health. Also, this project aims to determine if 3 months of CPAP therapy for OSA in patients with memory impairments improves mood and memory. Firstly, patients attending CDAMS with memory impairment will be screened for OSA and patients who have a high risk of OSA will be invited to take part in Phase 1. Interested participants will be invited to attend the RMIT Sleep Laboratory for a 90-minute neuropsychological testing session and an overnight diagnostic polysomnography (PSG). Healthy age-matched controls will also undergo the same neuropsychological testing and overnight PSG to investigate differences in cognition and memory of individuals with memory impairment and healthy individuals. Patients who are diagnosed with OSA and recommended Continuous Positive Airway Pressure (CPAP) by the study physician will be invited to participate in Phase 2 the project. Participants will be randomised to either an immediate CPAP group or a 3-month wait-list group. Participants in the immediate CPAP condition will be given an auto-titrating PAP machine and asked to use their CPAP at home. After 3 months of CPAP therapy, participants will attend a second appointment at the Sleep Laboratory to complete follow-up tests and questionnaires. Patients in the wait-list condition will commence CPAP after 3 months and the same follow-up procedures will be followed as per the immediate CPAP group.

Lifestyle risk factors such as lack of regular exercise, poor diet, ageing, excess body weight, high blood fats and high blood sugar levels can lead to overall inflammation, narrowing and hardening of arteries, thus reducing the ability of blood vessels to dilate effectively. A consequence of ineffective dilation of blood vessels is poor blood flow in the brain and this can lead to memory problems, poor concentration or mood. Certain ingredients from food sources such as the long-chain Omega-3 polyunsaturated fatty acids in fish and fish oil are known to benefit heart health by increasing the elasticity of blood vessels, as well as boosting mood and mental performance. Recently, curcumin from the spice turmeric which gives curry its yellow colour is gaining attention for its anti-inflammatory activities. We believe that curcumin can reduce inflammation and in turn enhance blood vessel function. However, their direct effects on the blood vessels in the brain and resultant impact on mental performance are unknown. In this study, we are looking to determine whether supplementing the diet with fish oil or curcumin or a combination of the two nutrients for 16 weeks can enhance the ability of blood vessels in the brain to dilate. We will also explore its effects on blood pressure, blood fats, glucose and markers of inflammation, stiffness of blood vessels, pain, quality of life, mood and mental performance. WHAT ARE THE AIMS OF THIS STUDY? We aim to determine if 16 weeks of fish oil and/or curcumin supplementation can: A. enhance blood flow in the brain in response to demands and thereby improve mood and mental abilities such as short-term memory, attention and concentration B. enhance perception of quality of life. C. reduce perception of pain and stress D. reduce inflammation, blood sugar levels and blood fats. We are seeking a total of 160 overweight or obese men and post-menopausal women who have not had their period for at least 12 months, age 50 – 80 years old and who are relatively inactive (for example less than 150 minutes of exercise on average per week).

Despite the health benefits of regular participation in physical activity, the vast majority of Australian children are insufficiently active. Schools are ideally placed to promote physical activity to children; however, recent reports suggest many Australian schools do not provide children with sufficient in-school activity or ensure they have the skills and motivation to be active beyond the school setting. Additionally, there is a need for interventions that can be effectively disseminated. The aim of this project is to modify, scale-up and evaluate the effectiveness of an intervention previously shown to be efficacious in improving children’s physical activity, fundamental movement skills and cardiorespiratory fitness. The ‘Internet-based Professional Learning to help teachers support Activity in Youth’ (iPLAY) study, will focus largely on online delivery to enhance translational capacity. This project will provide the evidence and framework for government to guide physical activity promotion throughout NSW primary schools and a potential model for adoption in other states and countries.

The use of ultrasound for vascular access and regional anaesthetic techniques has become an essential tool for day-to-day anaesthesia & critical care. Ultrasound guidance helps avoid complications such as damage to surrounding important structures. It may also increase the success rate of vascular access especially in patient populations with difficult peripheral vascular access (eg. obesity, IV drug use) . Although the ‘out-of-plane’ or short axis approach has been demonstrated to be the easier technique for novice users to learn initially and require less insertion time with potentially higher success rates when compared to the “in-plane” approach, both techniques require a reasonable degree of hand-eye coordination and technical training in this skill is not straightforward. The development of an ‘in-plane’ needle guide mounted to the ultrasound probe has allowed users to ensure the needle is kept within the narrow ultrasound beam to allow better visualization of the needle. These devices have been demonstrated to significantly reduce attempt number and time for procedure when compared with free hand technique for use in ultrasound-guided central venous access. They have also been shown to reduce procedural time and improve needle visibility in an in-vitro porcine phantom study on novice users. A recent study conducted at our centre demonstrated that use of the needle guide improved needle visualization, time to successful procedure and better user satisfaction scores. CIVCO has developed a similar purpose ‘out-of-plane’ Accusite needle guidance system that consists of a reusable bracket and customizable depth needle guides (0.5-3.5cm in 0.5cm increments). We propose that this system will have a great application for peripheral and central vascular access (including PICC lines), and also catheter insertion for regional anaesthesia infusion, because these procedures commonly require out-of-plane approach when performed with ultrasound guidance. Other forms of ultrasound needle guidance systems such as passive electromagnetic and GPS tracking have been investigated showing variable significance in improving ‘out-of-plane’ ultrasound-guided procedure success. To our knowledge, there are no clinical trials comparing a simple, physical, mountable ‘out-of-plane’ needle guide device with free hand technique. Before we perform a clinical trial, we would like to carry out a pilot study to determine the usefulness of this “out-of-plane” needle guide when used in our department by anaesthetic residents, registrars and consultants with different levels of clinical experience on ultrasound-guided out-of-plane procedure. Hypothesis: The use of an “out-of-plane” needle guide decreases time to successful attempt compared with a “free-hand” technique on a phantom psyllium hydrophilic mucilloid fiber and gelatin model.

Patients with type one diabetes typically carbohydrate count and use an insulin to carbohydrate ratio (ICR) to dose their insulin. This ratio assumes a linear relationship between carbohydrate quantities to be consumed and the insulin required to maintain blood sugar levels after a meal. Recent research and reports from families with type 1 diabetes raise the question of the validity of this linear model. This study aims to define the relationship between carbohydrate quantity and the dose of subcutaneous insulin. More specifically, to demonstrate that the current linear ICR approach is too steep resulting in increased events of low blood sugar levels as the carbohydrate content increases. This research project will analyse the response of blood glucose levels after a predominantly carbohydrate based meal. Forty participants between 12 -30 years of age, with type one diabetes on intensive insulin therapy will be recruited. Participants will be fitted with a continuous glucose monitoring system (CGMS). Insulin dose will be calculated using the standard linear ICR using study liquid-meals of 20, 50, 100 and 150g of carbohydrate controlled with similar proportions of fats and protein on four consecutive days (one per day). CGMS data will be analysed to determine whether the relationship between carbohydrate intake and insulin requirements is indeed linear. It is hoped this study will provide important information in the management of type 1 diabetes in both adults and children. Results will assist in building on planned future studies of trialing a non-linear ICR if the hypothesis is supported. This research will be used in our day to day management of patients and guide the development of clinical guidelines to help minimise the occurrence of hypoglycaemia and blood glucose fluctuations after eating.

The purpose of this study is to investigate whether Metamucil and a probiotic (good bowel bacteria) is more effective than Movicol at emptying the bowel while receiving daily radiation therapy to the prostate. Who is this for? You may be eligible for this study if you are aged 50 years or more and have been scheduled to undergo external bean radiotherapy (EBRT) to the intact prostate at the Central West Cancer Care Centre at the Orange Health Service. Study details: Participants will be randomly assigned (by chance) into one of two groups. One group will be prescribed Movicol half strength and a low gas diet (current practice at the treatment facility). The second group will be prescribed Metamucil, Nutralife Probiotic (to promote good bowel bacteria and reduce bowel gas) and a low gas diet. Standard EBRT treatment for prostate cancer is delivered daily (Monday- Friday) over a 7 week period. Laxatives and probiotic use will commence 1 week prior to attending for the radiation planning appointment, then ceased and recommence one week prior to commencing radiation treatment. You will be required to take the laxatives and probiotic daily during the treatment period. In taking part in this study you will also be required to complete of a food and bowel habits diary and attend weekly review appointment with the Dietitian in addition to your usual review appointments with the Doctor or Nurse. It is hoped that results from this study will identify the most effective way to ensure an empty bowel while receiving treatment.

Nearly 50% of patients with systolic heart failure suffer sudden cardiac death (SCD). In patients with ischaemic cardiomyopathy (ICM) and an LV ejection fraction (LVEF) of <30%, primary prevention ICD implantation reduced mortality at 20 months follow-up compared to medical therapy alone. Trials in NICM patients suggested similar findings but failed to reach statistical significance - statistical significance was only achieved when both ICM and NICM groups were combined. urrent clinically based guidelines focus on the importance of symptoms (NYHA Class) and LVEF in determining suitability for ICD implantation. Nonetheless, ICD implantation, despite its mortality benefit in selected patient populations, infers significant morbidity in terms or device related complications including tamponade, infections, inappropriate device therapy (which itself has been linked to increased mortality). Consequently, uptake of prophylactic ICD therapy in Australia has been variable with many major centres failing to comply with international guidelines. Hence, many authors have called for the urgent re-evaluation of current guidelines. Clearly there is a need for further risk stratification to assess the vulnerability of the heart failure population to sudden cardiac death, and other long term morbidities associated with the condition. Myocardial fibrosis is a fundamental event in the development of cardiac failure, and is a common feature in all patients with advanced cardiac failure regardless of the aetiology of cardiomyopathy. Myocardial fibrosis in animal models is associated with worsening ventricular systolic function, abnormal cardiac remodelling and may predispose to ventricular arrhythmia. Also, increasing myocardial fibrosis results in progressive deterioration of myocardial function, with more extensive myocardial fibrosis identified histologically in the hearts of patients with advanced heart failure. Cardiac fibrosis has been identified as a key component of remodelling associated particularly idiopathic cardiomyopathy and our group has demonstrated a clear association with arrhythmogenesis (including VT and VF) in patients with systolic heart failure. For example, recently, our group published compelling data supporting the role of contrast-enhanced cardiac magnetic resonance imaging (CMR) in identifying low risk patients who meet current criteria for ICD implantation yet are unlikely to benefit this intervention. We feel that the cardiac MRI evaluation, particularly its ability to detect both regional and diffuse fibrosis, may be a useful tool in predicting the outcomes of patients with heart failure. This trail seeks to establish a long term prospective data registry to evaluate predictive value of CMR in determining the long term outcome of patients with advanced cardiomyopathy.