ANZCTR search results

This trial will establish a large multi-centre prospective cohort and tissue bio-bank of unaffected first-degree relatives (FDR) of probands with RA designed to examine the role of genetic, environmental and microbial factors influencing the development and progression of RA-related autoimmunity. FDRs will be followed annually with an expected 15% likely to develop asymptomatic autoimmunity and to progress to RA within 5 years. This population cohort with accompanying genetic, environmental and immunological data will characterise more precisely people at risk of RA, allowing detection and risk stratification prior to symptoms becoming apparent.

The aims of this study are to (1) evaluate the differences in the inflammatory cytokine response to burn injury between women and men (2) determine if obesity/ adiposity contributes to the inflammatory cytokine response to burn injury. We hypothesise that (1) a quantifiable difference in inflammatory cytokines exist between women and men with burn injury, and this correlates with clinical markers of outcome (2) obesity/ adiposity influences the inflammatory cytokine response to burn injury, and this correlates with clinical markers of outcome and survival.

Neurocognitive impairments in Obstructive Sleep Apnoea (OSA) are likely related to a combination of factors including low oxygen levels during sleep (hypoxia), sleep fragmentation and possibly elevated carbon dioxide levels (hypercapnia). The latter, unlike hypoxia, has not been explored in depth and is often viewed as an innocent bystander. Early detection of hypercapnia may be an important step in the prevention of neurocognitive dysfunction in Obesity Hypoventilation Syndrome (OSA/OHS). In this study, neurocognitive function of patients with sleep disordered breathing will be assessed before and after 3 months of positive pressure mask therapy. Hypothesis 1. Patients with OHS exhibit greater cognitive impairment than obese patients with obstructive sleep apnea (OSA), but without daytime hypercapnia. 2. Patients with sleep hypoventilation have less sleep fragmentation but greater neurocognitive impairment arising from a longer exposure to hypercapnia. 3. Although correction of hypercapnia with PAP treatment will at least partially improve cognitive function, patients with OHS may remain impaired relative to treated OSA patients without hypercapnia.

Background Impaired exercise capacity and activity due to chronic obstructive pulmonary disease (COPD) is a major threat to the health of the individual and impacts on the community at large. About 330 million people have COPD worldwide and 235,000 people have moderate or severe disease in Australia alone. These people often suffer from disabling symptoms and reduced physical capacity for many years despite best medical management. Pulmonary rehabilitation is first-line treatment in people with symptomatic COPD with a strong evidence base for improved functional status, better exercise tolerance and better longer term outcomes. Recent laboratory data show that regular, low dose opioids (such as morphine) may decrease exertional breathlessness without impairing exercise capacity. Regular, low dose sustained release morphine is a potential new approach to improve further the established outcomes of pulmonary rehabilitation in COPD. Such an intervention has not been tested in a randomised clinical trial. It is important to establish that the overall net effect is positive and that benefits outweigh any harms encountered. A particular concern for many clinicians is the theoretical risk that opioids may cause respiratory depression. In steady state, at the relatively low regular doses proposed, there are no data to support this concern, but this study will specifically monitor this issue through careful collection of non-invasive measures of respiratory function, including end-tidal carbon dioxide, regularly throughout the study. Study design This is a phase III, multi-site, randomised, double-blind, parallel arm, fixed dose, placebo controlled trial of sustained release morphine (20 mg every 24 hours) or placebo during eight weeks of pulmonary rehabilitation for COPD. Randomisation will be stratified according to the mMRC score. During the study period, therapy for constipation is also given to participants with active therapy and identical appearing laxative placebo is given in the placebo arm. Data on 260 people will be required in order to complete the study with adequate power for the primary endpoint. Study population Suitable people with spirometry-verified COPD and breathlessness (between grade three and four on the mMRC scale), who are eligible for pulmonary rehabilitation and are able to give informed consent, will be recruited to participate in the study, provided they have no contraindication for opioid use. Objectives During eight weeks of pulmonary rehabilitation, the primary objective is to compare the efficacy for improving exercise capacity measured using the six minute walking test (6MWT) of sustained release morphine compared with placebo. Secondary objectives include effect on daily activity measured using an accelerometer, safety, breathlessness, quality of life (QOL), health care resource utilization, clinical and pharmacogenomic predictors of which individuals will achieve the greatest benefit from morphine, and to establish any blinded participant treatment preference. Treatment schedule Every day, participants will take three capsules (one Kapanol 20mg or placebo in the morning, and two capsules of docusate with senna or placebo). This will occur without titration and participants will continue the allocated treatment during eight weeks of pulmonary rehabilitation. ‘As needed’ open label docusate with senna will also be provided to all study participants. Assessments Week 1: demographic and clinical data, blood sample, 6MWT, daily activity (accelerometer for seven days), severity and characteristics of dyspnoea, twice daily diary, adverse events, quality of life, and blinded treatment preference. Outcome measures are repeated at the end of week eight of pulmonary rehabilitation. For 24 hours each week throughout the study: daily diary and adverse events. Definition of response: A response will be defined as an increase of 55m or more on the 6MWT. Primary endpoint: Change between week one and week eight of pulmonary rehabilitation in distance on a standardized 6MWT. Analysis: Longitudinal repeated measures mixed models with unstructured covariance matrices, two-sample t tests, and multivariable regression models will be used. Economic analysis: This will estimate incremental costs, effects and net benefit of oral sustained release morphine relative to placebo in addition to pulmonary rehabilitation from participant level data collected over eight weeks of follow up (survival to eight weeks or death, whichever is shorter) for: * resource use including bed days spent in hospital for inpatient admissions (index admission and readmissions); * professional community support utilised at home if discharged from hospital or enrolled at home, including general practitioner and specialty care service visits, * concomitant medication use; and * effects including days of survival with response, toxicity, adverse events, health related quality of life, and compliance. Bootstrapping of patient costs and effects data will be used to model decision making uncertainty related to the net benefit of oral sustained release morphine relative to placebo.

This study aims to develop, provide and evaluate a new group based activity for people who provide care for someone with Motor Neuron Disease. The purpose of this group based activity will be to create a supportive environment to share personal experiences about changes to the caregiver's life associated with caring for a person with Motor Neuron Disease. It will also provide a supportive environment to learn about mindfulness, problem solving and other support resources available. The intervention will be administered by two psychologists to a small group of caregivers.

Currently there are low rates of employment amongst people with high functioning autism/Asperger's Syndrome (HFA/AS). This project aims to develop a protocol to assist adolescents with HFA/AS in planning what they will do when they leave school. We anticipate this will result in more individuals with HFA/AS in successful long term employment. The results from this study will inform vocational rehabilitation approaches, education practices, occupational therapy practice and employment related interventions for adolescents with HFA/AS.

Diabetic macular edema (DME) is the most common cause of visual loss in people with diabetes. Regular injections with the anti-VEGF agent Bevacizumab remain the current standard of care for DME involving the fovea, but this regimen is impractical in central Australia. Limiting injections to 4 monthly with Ozurdex may be as effective as the currently used Bevacizumab injections.

There are more than 7 million overweight or obese adults in Australia and on average only about 5% of this population achieve permanent weight reduction of any significance to their health. Many questions remain regarding the best way to achieve long-term weight loss, and how a person’s metabolic rate is affected both in the short- and long-term during dieting. The overall aim of this project is to design more effective and sustainable weight loss strategies for overweight and obese adults. This study, funded by the National Health and Medical Research Council (NHMRC), aims to compare changes in weight and health using two different dieting approaches in female participants with a small comparitive male cohort; one in which the energy intake (kilojoule value) changes every two weeks, and the other where the energy intake changes every four weeks. Throughout the intensive phase of the study, participants are provided with a healthy, balanced, energy-regulated diet delivered to their home. Measures of body composition, metabolic rate and energy expenditure, hunger and satiety, blood hormone levels, body fuel usage, and metabolic health will be taken at a number of time points throughout the study

Oxygen is necessary for life, but both too much or too little, can damage eyes, lungs and brain. The preterm infant is unique, while their ability to cope with too much oxygen (oxidative stress) is limited, they also need some oxygen after birth because their lungs are not fully developed. The Torpido2 Study aims to show that preterm infants born at less than 28 completed weeks gestation who have had delivery room resuscitation initiated with 21% (air) followed by lower oxygen targeting until admission to NICU will have improved outcomes when compared with similar infants who have had delivery room resuscitation initiated with 60% oxygen followed by higher oxygen targeting until admission to NICU.

Mindless eating or habitual eating has been described as the most plausible factor to explain why we struggle to keep our excess weight off. Once we form a habit, it can be difficult to act in non-habitual ways despite our best intentions. Therefore the primary purpose of this study is to investigate the effectiveness of 2 weight management interventions which focus on habitual behaviour and assess whether we can maintain weight loss for at least 12 months if habits are altered.