ANZCTR search results

Background: Studies have shown that antidepressants may reduce inflammation in animal models of colitis. The present trial aims to examine whether fluoxetine added to standard therapy for Crohn’s disease (CD) maintains remission, improves quality of life and/or mental health in humans with CD as compared to placebo. Methods / Design: A parallel randomised double-blind placebo controlled trial was conducted. Participants with clinically established CD, in remission or with only mild symptoms, were randomly assigned to receive either fluoxetine 20mg daily or placebo, and followed for 12 months. Participants provided blood and stool samples and answered questionnaires measuring mental health and quality of life. Linear mixed-effects models were used to compare groups on the outcome variables. Results: Of the 26 randomised participants, 14 were randomised to receive placebo and 12 to receive fluoxetine for 12 months. Overall, 14 (53.8%) participants were male. The mean age was 37.4 (13.2) years. Fluoxetine had no effect on IBD activity measured using the CDAI (F(3, 27.5) =.064, p=.978) or the calprotectin (F(3, 32.5)= 1.08, p=.371) during the 12-month period of observation. Similarly, there was no impact of fluoxetine on physical (p=.645), psychological (p=.884), social (p=.649), or environmental quality of life (QoL) (p=.992), on anxiety (p=.979) or depressive symptoms (p=.956) as compared to placebo. Conclusion: 20mg of fluoxetine daily does not appear to improve the course of CD, QoL or mental health over 12 months of observation as compared to placebo. The trial documents the difficulty of conducting antidepressant trials with human subjects suffering from CD .

The research project is aiming to understand how the body controls appetite (that is how hungry and how full we feel) after we consume foods that are made up of the main nutrients carbohydrate, protein and fat. We are also aiming to understand if this appetite control process is disrupted in adolescents who are obese compared with adolescents who are of a healthy weight. This information will be beneficial to be able to provide nutritional advice and strategies to help with the treatment and prevention of obesity in childhood.

LEAP for Life is a training package for packaged community care staff which aims to improve engagement of clients by providing more individualised conversation and activities. This single arm trial will follow staff and their clients for 18 months, 6 months before the training begins, and across 12 months of training. Staff will be trained on how to incorporate engagement strategies and activities into care plans, and how to deliver these strategies and activities into practice. They will be supported by a change champion over 12 months.

Recently there has been much interest in the capacity of non-invasive brain stimulation techniques to enhance cognitive processing. The technique that has been most often studied in this regard is transcranial direct current stimulation (tDCS) and there is now robust evidence that tDCS can be used to enhance a variety of cognitive processes. However, the potential of related techniques such as transcranial intermittent current stimulation (tICS) and transcranial random noise stimulation (tRNS) have not yet been investigated in detail, and many unanswered questions remain regarding the neurobiological underpinnings of stimulation induced cognitive enhancement. A related avenue of research is the emergence of novel cognitive training paradigms for depression. These therapies differ from traditional methods in that they target the cognitive rather than the emotional symptoms of depression. There has been much speculation regarding whether their efficacy could be further enhanced by concurrent application of non-invasive brain stimulation. The current study will investigate the capacity of three active methods of non-invasive electrical brain stimulation (tDCS, tRNS and tICS) and sham stimulation to enhance prefrontally mediated cognitive processing, in both healthy controls and individuals with major depression. It will address the following questions: 1. Which of these methods best augments cognition? 2. What impact do these methods have on cortical excitability? 3. To what degree do these brain stimulation methods impact on the neural oscillations associated with cognitive processing?

Fever is considered to be one of the most frequent complaints in children’s diseases, and is mostly reported to Emergency Department and healthcare centers. Approximately 20 percent of children’s cases reported to Emergency Department are related to a febrile illness. Many education programs have been designed to improve patient fever health information; however, no education program or material was found relating to fever management for parents with low health literacy. This study will present for the first time, a unique fever management program for parents with low health literacy. The aim of this study is to examine fever presentations in the emergency department and test a low health literacy education intervention to reduce inappropriate primary care attendance. To achieve this aim education interventions such as a DVD and Brochure have been developed from a comprehensive literature review, systematic reviews, and existing guidelines. These tools are designed to be appropriate for low health literacy parents and use symbols and pictures where possible to deliver the information. This study is being conducted in Campbelltown Hospital, Emergency Department (ED). Quantitative research design will be the cornerstone for this project. The study will be carried out in two phases. Phase one will include secondary data analysis of ED presentations for children with fever using FIRSTNET data. The second phase will use a randomised control trial, where the investigator will deliver a low health literacy education program. This design will provide the opportunity to examine the effectiveness of an education program on parents’ knowledge, practice and health service use. Prepost survey data will be collected from the intervention and control groups, including knowledge and practices relating to fever management. Study data will be analysed using descriptive and multivariate analysis techniques. It is envisaged that this program will potentially improve parent’s knowledge and reduce occasions where parents inappropriately attend ED for fever in children. This anticipated improvement may in turn save healthcare professionals time and effort, increase their productivity, and decrease staff and parents frustration

To compare whether a nurse-led model of chronic disease care in rural general practice will reduce unwanted hospitalisation

The study is evaluating whether a diagnostic technique, known as PET scanning, can provide a non invasive means of evaluating the presence of acute graft vs host disease of the gastrointestinal tract following bone marrow transplantation. Who is it for? You may be eligible to join this study if you are aged above 18 years and have suspected acute graft vs host disease of the gastrointestinal tract following bone marrow transplantation. Trial details All participants in this trial will undergo a positron emission tomography (PET) scan at the time acute graft vs host disease of the gastrointestinal tract is suspected. A PET scan involves injection of a small amount of radioactive tracer into the bloodstream followed by scanning of the whole body in a machine that looks similar to a CT scan machine for approximately 30 minutes. In addition, participants will undergo standard care, which involves a gastroscopy and colonoscopy where biopsies of the gastrointestinal tract are obtained to assess whether graft vs host disease is present or not. This study will help us to determine whether PET scanning can accurately assess non invasively the presence of acute graft vs host disease of the gastrointestinal tract following bone marrow transplantation.

The primary aim of this cross-sectional study is to determine the dietary correlates of carotid intima media thickness. Carotid intima media thickness is a measure of early atherosclerosis. Identifying dietary components which correlate with carotid intima media thickness may help to develop dietary strategies to reduce atheresclerosis development.

This study is looking at the safety of adding valproate and metformin to standard therapy used to treat patients with brain tumours called as glioblastoma multiforme (GBM) or grade 4 glioma. Who is it for? You maybe eligible to join this study if you are aged 18 years or above, and have been newly diagnosed with grade 4 glioma or glioblastoma multiforme. You should have had a surgical resection/biopsy within the previous 7 weeks. Trial details: All participants undergo standard treatment with temozolomide and radiotherapy followed by 6 months of temozolomide. In addition to standard care, all participants will receive Valproic acid (upto 4000 milligrams per day mg orally and metformin upto 2000 milligrams per day administered orally. Participants will be regularly assessed for up to 12 months in order to determine treatment response, tolerability and safety.

This is a study to find a new way to measure the cardiac output (CO), the amount of blood that leaves the heart every minute. Presently in order to measure CO we have to insert an expensive catheter into the heart which can bring complications. The present study aims to measure CO by inhaling small puffs of carbon dioxide which is normally excreted by the lung. By measuring the amount by which the blood concentration of CO2 rises we can know the blood flow through the lung.This is equal to the CO.