ANZCTR search results

To investigate the impact of a pre-discharge medication review by a hospital clinical pharmacist on 'at-risk' patients' health and quality of life.

The study is investigating the capacity of tDCS to alter ‘emotional processing bias’. Emotional processing bias refers to the interaction of cognitive and emotional processing that result in unconscious preferential processing of emotional stimuli of a certain valence (e.g. unconscious preference for positive or negative stimuli and information). We all have unconscious biases in our emotional processing. A positive emotional processing bias has been linked to aspects of mental health and maladaptive biases are a key component of many mental illnesses, such as depression. Very few studies have investigated whether tDCS can alter emotional processing bias, and due to methodological limitations the findings of those small number that have are inconclusive. Also, no studies to date have investigated the patterns of brain activity associated with tDCS and bias modification.

This study aims to describe the effect of limb compression on lymphoedema in terms of fluid distribution and soft tissue structure changes using MRI. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have a clinically detectable unilateral secondary upper limb lymphoedema arising from treatment of breast cancer. This diagnosis must be made using accepted diagnostic thresholds for bioimpedance spectroscopy (BIS) or volume measurements. You must also currently use a compression garment for management of your lymphoedema. All participants enrolled in this study will have at least one MRI scan while wearing the upper limb compression garment. Depending on participant availability, a second MRI scan on a separate visit may also be performed where participants do not wear the compression garment for that day. It is hoped that this study will contribute to a better understanding of how different levels of compression can be used in control of the lymphoedema.

Cortisol is a steroid hormone produced by the adrenal gland that is critical for life. Cortisol controls many body functions including appetite, glucose metabolism, blood pressure and immune function. Cortisol secretion varies widely among healthy individuals. Recent studies have shown that higher cortisol secretion, even within the normal range, is associated with an increase in blood glucose and risk of heart disease. How variability in cortisol secretion contributes to increased risk of diabetes and heart disease is unclear. In this study, we will investigate whether variability in cortisol production causes insulin resistance and reduces blood vessel dilation. This could be a mechanism that explains a link between heart disease and diabetes.

The rate of peripheral intravenous catheter failure at the RBWH is high (around 40%). When a catheter fails, before treatment has been completed, a new catheter is generally required, causing discomfort to the patient and considerable cost to the organisation. There are a number of reasons for catheter failure, some of which may be preventable with appropriate intervention. At present we do not have a clear idea of the causes of catheter failure at the RBWH. The proposed study will follow a cohort of patients from admission to discharge and closely monitor any IV access events associated with their stay. Patients with catheter failure will be compared to a group who do not have catheter failure, to identify opportunities for intervention.

Body Dysmorphic Disorder (BDD) affects approximately 2% of the population and involves constant worry and distress about how someone thinks and feels that they look. About 40% of people with BDD do not respond to currently available treatments. In BDD, there appear to be abnormalities in the activity of some areas of the brain, including areas responsible for visual processing. To date there have been no studies evaluating whether transcranial stimulation (TMS) is helpful for people with ongoing and distressing symptoms of BDD, including those who have not responded to other treatments. Hence, the aim of this study is to determine whether TMS is helpful in the treatment of people experiencing BDD, aged 18-65 years, who have not responded to currently available treatments. TMS uses electric currents to generate magnetic fields which can be used to stimulate the brain. This technique is non-invasive (does not require surgery or the introduction of instruments into the body) and requires no anaesthesia or hospital stay/treatment. The TMS in the study will stimulate the areas of the brain responsible for visual processing, which may be functioning abnormally in BDD, over a 6 week period. Participation in the study does not require a change or stopping of usual treatment, which may include medication and/or psychological treatment, determined by participants' consultation with their treating psychiatrists.

Orientation interventions have been recommended as being important within cognitive rehabilitation (e.g. Corrigan et al, 1985) and researchers have also suggested that environmental stimuli which may aid in reorientation, such as familiar pictures or personal possessions (Watanabe et al, 1998). However critical evaluation of how effective these interventions are has been limited to date, with only controlled studies investigating the use of daily screening (Tate et al, 2000) and the use of calendars (Watanabe et al, 1998), and none of the studies have investigated this issue in acute care. This trial will test the efficacy of a standardised reorientation program that can be administered in acute care is developed to reduce the length of time a person remains in PTA after TBI

We have recently shown that increasing fitness improves arrhythmia outcomes in patients with atrial fibrillation, a common heart rhythm disorder. In this study, we intend to evaluate a goal-directed, lifestyle based physical activity intervention for the reduction of AF burden and symptom severity. We hypothesise that our physical activity intervention will lower arrhythmia burden and improve symptom severity when compared to standard medical care alone.

In 2008 local leaders in Fitzroy Valley identified prevention, diagnosis and management of Fetal Alcohol Spectrum Disorders (FASD) and early life trauma (ELT) as a community priority. This led to the development of the Marulu Strategy which aims to address FASD prevention, diagnosis and therapy. Following the results of a prevalence study, Aboriginal community leaders also identified an urgent need for a system-wide and sustainable response to high rates of FASD and neurodevelopmental impairment. This study will investigate the effectiveness of the Alert Program (registered trademark) at improving primary school aged children’s measures of self-regulation and executive function in the Fitzroy Valley region including those children with FASD. This study will introduce the Alert Program (registered trademark) to families and community members, into school programs and child health practices in the Fitzroy Valley. The project will document a sustainable and culturally appropriate method of implementing the program through the trial site schools. It is anticipated an approach to screening and therapy for impairments in self-regulation and executive functioning will be translated into other health and educational sites. Teacher and school support staff will deliver ten Alert Program (registered trademark) lessons in their classrooms over eight weeks using a curriculum and resources provided by the study team. These materials have been developed by adapting existing Alert Program (registered trademark) activities and resources to suit the Kimberley classroom environment. Three workshops will be developed for parents and caregivers so they too can learn about Alert Program(registered trademark) and implement the concepts, activities and vocabulary of the program at home. Furthermore, this study will contribute to an emerging evidence-base of a multidisciplinary and collaborative model for children in remote and regional areas with FASD, and the development of a sustainable model of health care in the remote Kimberley region. It is also hoped this research will lead to improving the efficiency of health service delivery through utilising telehealth.

The emerging epidemic of type 2 diabetes, coupled with finite health resources, requires the treatment of hyperglycaemia to be simple and efficiently managed. Type 2 diabetes is a progressive disease and eventually most patients will require insulin at a certain stage to maintain good glycaemic control. The key to when to start insulin is to identify the appropriate glycated haemoglobin (HbA1c) target for an individual patient. If target A1C is not achieved with metformin combined with sulfonylurea, the most commonly used 2nd line oral hypoglycaemic agents, insulin therapy is usually started. In patients on sulfonylureas and metformin who are starting insulin therapy, metformin is usually continued. Part of the rationale for combination oral hypoglycaemic agents and insulin therapy is that by suppressing hepatic glucose production, the patient can retain the convenience of oral agents while minimizing total insulin requirements and, therefore, the degree of hyperinsulinemia. GLP-1 agonists, DPP-4 inhibitors, and sodium-glucose co-transporter 2 (SGLT2) inhibitors can also be continued when insulin is added, however, they are currently not PBS listed for being combined with insulin. There are no clear guidelines as to whether and at what time point SU are to be discontinued or continued when insulin is introduced. Data from the UKPDS and meta-analyses of several randomized placebo-controlled trials report modest but consistent benefits of a combination of sulfonylurea and metformin with insulin therapy compared with insulin monotherapy. However, the combination of sulfonylurea and insulin is less efficacious and results in more weight gain than metformin and insulin. Furthermore, insulin and sulfonylureas have similar effects of increasing circulating insulin levels, and the same glucose-lowering effect can usually be achieved, and at a lower cost and better prediction, with a modestly higher dose of insulin alone. Furthermore, a recent retrospective Danish study has found that patients with a combination with SU and insulin had an increased mortality compared to metformin and insulin. Studies also report increased risks of weight gain and hypoglycaemia when left on SU while starting basal or pre-mixed insulins. Based on this recent literature review, it is a concern that many patients with Type 2 Diabetes are continuing their SU together with their pre-mix insulin, with limited evidence for an added benefit, but a growing evidence of increased risk of hypoglycaemia, weight gain and possibly increased mortality. The outcome of this study will give as important information which could lead to a change in current practice guidelines. The aim of our study is to assess whether SU should be stopped, continued or replaced with a DPP4 Inhibitor once pre-mixed insulin therapy has been started. We hypothesise that SU will not have a significant additive effect on glycaemic control in patients on pre-mix insulin, but contribute significantly to increased risk of hypoglycaemia and weight gain. A similar glycaemic control can be achieved by a dose adjustment of the insulin dose, or by adding a DPP-IV inhibitor without the side effects of SU, such as hypoglycaemia and weight gain. Results of this study could have an important impact on how type 2 diabetes patients are treated safely and effectively. PRIMARY OUTCOMES: To measure the change in glycaemic control when stopping SU or replacing SU with a DPP-4 inhibitor in patients on pre-mix insulin. SECONDARY OUTCOMES To compare the side effects (weight gain) and safety (hypoglycaemia) of stopping SU or replacing SU with a DPP-4 inhibitor in patients with pre-mix insulin. This is a prospective, randomised, open label controlled single centre trial with three arms: a) Patients continue SU b) Patients stop SU c) Patients replace SU with the DPP4 inhibitor Linagliptin (5mg/day) Patient characteristics: Patients with Type 2 Diabetes treated with pre-mix insulin (NovoMix30 or HumalogMix25), at least twice daily for at least 6 months, and also treated with SU since at least 4 years. 99 patients in total (33 patients per arm) will be recruited at St Vincent’s Hospital, Sydney.