ANZCTR search results

Frailty is a common syndrome in older adults caused by a decline in reserve capacity of the body's systems used to maintain health. We are interested as to whether interventions for frailty work BEFORE the involvement of clinical services. We propose to undertake a trial of community dwelling older men to determine whether a simple package of interventions can combat this syndrome.

The primary purpose of this study is to determine whether an accurate liver fat measurement, when reviewed by a surgeon, leads to changes in surgical approaches and hospital care that result in improved outcomes for colorectal metastases patients who require liver resection. Who is it for? You may be eligible to join this study if you are aged 18 years or above, and have colorectal liver metastases requiring liver resection. Study details All patients enrolled in this safety and tolerability study will have a liver resection and will be assigned by chance to surgery with the surgeon having knowledge of accurate fat liver measurements or to surgery where the surgeon is not aware of the liver fat content prior to starting the surgery. Patient outcomes will then be assessed through medical records. It is hoped that this study will aid in developing strategies that could lead to better survival and health outcomes for colorectal metastases patients after liver resection.

Difficulty taking deep breaths or coughing are two of the breathing complications people with a neuromuscular disease and weak breathing muscles face. Over time the lungs and rib cage become stiff, lung volumes are reduced and respiratory function is compromised. Such breathing complications are one of the main causes of discomfort, disability and ultimately death in conditions such as Duchenne muscular dystrophy and motor neurone disease. Lung volume recruitment, also known as breath-stacking, is a simple and inexpensive therapy that may help. It involves taking a few breaths in without breathing out, so that a maximum amount of air is held in the lungs before exhaling. This pattern is repeated so that a group of ‘deep breathing exercises’ is performed. A type of resuscitation bag is used to assist each breath. It is thought that performing these breathing exercises daily might prevent chest stiffness, improve breathing capacity and cough effectiveness, however to date there is no strong evidence to support these ideas. This research will look at the short and medium term effects of breath-stacking exercises on the breathing system, by conducting a prospective, single-blinded randomised controlled clinical trial. This means that half of the people who choose to be involved in the study will be asked to perform breath-stacking exercises each day for three months. The other half will be asked to do ‘diaphragm breathing exercises’ (a treatment we don’t believe will have a very big effect). The type of breathing exercise each individual will be asked to do is randomly allocated, i.e. there is a 50:50 chance of being in either group. We will measure lung volumes, stiffness and cough effectiveness by breathing tests, and breathing symptoms and quality of life by questionnaires. These measurements will take place before the person begins, and then 1 month, 2 months and 3 months into the study. We will perform the 1-month and 2-month measurements in the person’s home, to reduce any potential burden or inconvenience. If breath-stacking is beneficial and lung volume, chest stiffness and cough effectiveness improve then symptoms, quality of life and potentially survival are likely to be better. Importantly, this research would add to the recommendations for the respiratory management of people with neuromuscular disorders by providing much needed evidence to support the use of this technique more widely.

This study aims to evaluate the feasibility of a peer-delivered, telephone-based intervention targeting smoking, fruit and vegetable intake and sedentary behaviour (leisure screen time). Who is it for? You may be eligible to join this study if you are registered as a consumer of Neami services, are currently living with a severe mental illness (e.g. schizophrenia, bipolar disorder), are at least 18 years of age, and can identify a health related personal goal. Study details Participants randomised to the intervention will participate in telephone sessions delivered by peer workers. These sessions focus on reducing cardiovascular disease (CVD) risks by decreasing smoking, increasing fruit and vegetable intake and reducing sedentary behaviour. The intervention involves reinforcement of change, checking on current behaviours and simple behavioural strategies over 8 telephone sessions over up to 11 weeks. Results from this study will inform the development and implementation of interventions to reduce the risk of CVD and cancer in people living with severe mental illness. By tailoring the intervention to be delivered by peer workers via telephone, Better Health Choices may become a more accessible intervention for people within mental health services, with the potential to help reduce the risk of CVD and cancer in this population.

Children diagnosed with Bell's palsy have a sudden weakness of facial muscles on one side of their face. Bell's palsy usually improves in children in about four to six weeks without treatment. However, in some children it may be a year before the facial weakness has completely resoved and in a small number of cases, the facial muscle weakness is permanent. Recent research in adults with Bell's palsy has shown that a short course of treamtent with steroids (prednisolone) led to improved recovery time. Prednisolone is believed to reduce the irritation to the facial nerve. There are no similar studies in children and, because children's bodies respond different to adults', it is not known whether a short course of prednisolone will help children to recover more quickly. Currently, some doctors treat with prednisolone and others do not resulting in confusion and variability in medical care. The study aims to answer the following question: In children presenting to Emergency Departments with recent onset of Bell's palsy, does treatment with prednisolone result in a higher proportion of children with recovery at 1 month compared with placebo. Up to 13 hospitals in Australia and New Zealand will participate in enrolling 540 children/young people, aged 6 months to 18 years, who present to ED's within 72 hours of symptom onset.

To compare ultrasound guidance for subacromial cortisone injection to blind injection of cortisone for the treatment of subacromial impingement syndrome, to see if there's any additional benefit in terms of reduction in pain and increase in shoulder function by using ultrasound to guide the injection.

This is a phase 1a, single-centre, randomized, open label study to evaluate the safety, tolerability and pharmacokinetics of a single sublingual or oral dose of GDN-1 in adult healthy volunteers. There are 6 treatment arms.

Diabetes is a chronic non-communicable and slowly progressing metabolic disease often involving multiple pathological mechanisms. Multiple mechanisms underlie the pathogenesis of diabetes including subclinical inflammation, glucotoxicity and lipotoxicity. Elevated levels of inflammation, particularly in the adipose tissue, is believed to be the primary trigger preceded by all of the above mentioned pathological mechanisms. Recent scientific literature established a strong link between inflammation and diabetes highlighting the role of inflammation as a primary pathological trigger for development of diabetes and its complications. Current therapies in the diabetes are unidimensional, targeted only to ameliorate the hyperglycaemic conditions. To date little or no attention has been paid to design pharmaceutical strategies to delay or modulate inflammatory pathways involved in reducing insulin secretion and/or action. Moreover current anti-diabetic medications have persistent side effects, such as body weight gain and hypoglycaemia in patients on sulphonylureas and insulin; gastrointestinal problems with metformin and acarbose; weight gain and bone fractures with thiazolidinediones; genital or urinary tract infections predominantly in females with sodium glucose co-transporter inhibitors. In the light of increasing prevalence and health costs associated with diabetes and its complications, there is a necessity for development of easy to comply strategies to modulate multiple metabolic targets with excellent long-term safety profile. In search of these agents, some bioactive compounds (nutraceuticals) aiming at prevention of diabetes through anti-inflammatory mechanisms have shown promising results. Extensive research has been carried out on anti-inflammatory and anti-hyperglycaemic potential of curcumin. Also the long chain n-3PUFA have been shown to possess lipid-lowering and anti-inflammatory properties by modulating multiple metabolic targets. We propose to evaluate the complimentary and/or synergistic effects of curcumin and/or n-3PUFA on pro-inflammatory mediators and insulin sensitivity in people with pre-diabetes. This is a 2x2 factorial, randomized, double blind, placebo controlled study. Eligible participants will be asked to consume 4 caps daily; placebo, curucmin plus placebo, omega 3 fatty acids plus placebo, curucmin and omega 3 fatty acids combination, for 12 weeks. Participants will be donating blood on the first day and post intervention along with information on 3 day food consumption, physical activity and other medications.

The prevalence and impact of childhood overweight and obesity is increasing and is of growing concern to the wellbeing of Australian society. Scientific literature suggests that providing an incentive scheme may improve motivation and completion of behaviour change programs, but the potential of such schemes and their optimal delivery remain relatively unexplored in children. This project will be the first RCT internationally to test the effectiveness and implementation of an incentive scheme targeting behaviour change in children. Conducting a robust study testing the impact of incentive schemes in children may open up a whole new approach for managing a range of conditions that are directly associated with health-related behaviours.

Introduction Rheumatoid arthritis is a severe destructive inflammatory arthritis that affects 1.5% of the population. They have a 50% increased risk of cardiovascular events that is directly related to the disease process although the mechanisms of this remain unclear. New effective treatments for rheumatoid arthritis called the "Biologics" have become widely available over the last decade. This has resulted in dramatic improvements in the treatment of the arthritis. However, it remains unclear whether these treatments influence the risk of cardiovascular events. Pooled analyses of the large trials have not had sufficient power and are of insufficient duration to answer this question. Meta-analysis of the combined registry data found dramatic differences in the TNF-inhibitor treated group but these effects may be explained by confounding. Studies using assessments of pre-clinical vascular disease using imaging and physiological assessments of arterial stiffness seem more likely to show treatment effects but have thus far been inconclusive. Based upon studies in hypertension it is likely that studies utilising assessments of arterial stiffness and carotid artery wall thickness would require randomised controlled trials of considerable size and duration to detect treatment effects. Earlier pathological processes in vascular disease such as endothelial dysfunction are more likely to change quickly and detectably in response to treatment. However, studies have been inconclusive possibly due to the small sample sizes, insufficient study duration and because the studies evaluated subject with established and possibly irreversible disease. The Australian PBS funds Biologic drugs for patients with rheumatoid arthritis only after they have failed to respond to 6 months conventional DMARD therapy. This 6 month period presents an opportunity to evaluate the effects of TNF-inhibition (with adalimumab) upon vascular function in a randomised controlled trial while at the same time enhancing patient care. Our consortium have already conducted a small phase 2 study (Hunter HEART-RA has already evaluating the effect of adalimumab in anti-CCP antibody positive RA. This phase 2, single-centre, double-blind randomised, placebo-controlled study will evaluate the effects of adalimumab upon endothelial function anti-CCP positive and NEGATIVE rheumatoid arthritis. Methods 1. 36 subjects with Anti-CCP Positive Rheumatoid Arthritis and ; 2. 34 subjects with Anti-CCP Negative Rheumatoid Arthritis (age>18 years) Subjects within each group will be randomised 1:1 to receive adalimumab / placebo for 24 weeks in addition to "usual care”. During the 24-week trial subjects will undergo assessments of vascular function, rheumatoid arthritis disease activity, functional impairment and work disability. Assessments will occur at 0 (baseline), 12 and 24 weeks. The primary response variable will be peripheral endothelial function as measured by EndoPAT. Secondary response variable will include: 1. Arterial stiffness (Carotid-femoral pulse wave velocity, Central Aortic Augmentation Index as measured from the radial pulse wave analysis) 2. Carotid artery ultrasound (carotid initmal medial thickness, carotid plaque score and carotid wall elasticity) 3. Disease activity (ESR, CRP, joint counts, DAS28, SDAI) 4. Functional Ability (HAQ Questionnaire) 5. Work Disability (RA-WIS Questionnaire) 6. Australian Quality of Life (AQoL) Questionnaire 7. 40-joint musculoskeletal ultrasound.