ANZCTR search results

This will be a double blind randomised placebo controlled study in 24 subjects with Ross River virus induced arthralgia. Rationale PPS is a semi-synthetic heparin like macromolecular carbohydrate that resembles glycosaminoglycans. It has been widely used for its anti-inflammatory and regenerative properties in the treatment of interstitial cystitis. PPS also has fibrinolytic, lipolytic, and anticoagulant properties and is used for the treatment of thromboembolic prophylaxis in Europe. In Germany and Hungary, PPS is also approved in oral and injectable form for the treatment of peripheral arterial occlusive disease. In a recent study in mice with Ross River virus induced joint disease, PPS administered for 10 days post infection significantly reduced the severity of joint symptoms, with reductions in joint swelling, inflammation in joints and muscle, and serum levels of mediators of inflammation which are implicated in the disease. PPS treatment also demonstrated a joint cartilage protective effect, with preservation of the thickness and structure of the joint cartilage. On the basis of this research, Paradigm intends to evaluate the safety and efficacy of PPS treatment in human patients affected by joint symptoms following Ross River viral infection The main inclusion criteria for the study will be: 1. Males and females aged 18 to 65 years (inclusive) 2. Diagnosis of Ross River virus infection based on laboratory definitive or laboratory suggestive diagnosis 3. Current Ross River virus symptoms including a minimum 2 joints involved 4. The onset of RRV infection symptoms minimum 12 weeks and maximum 52 weeks prior to Day 1 Treatment Intervention Patients will be randomised 2;1 to receive either PPS or placebo respectively. Dose schedule: 2 mg/kg administered by subcutaneous injection twice weekly for 6 weeks. Treatments will be given by medically qualified site staff, and patients will be evaluated and monitored at the regular visits during the study. Objectives The primary objective will be to evaluate the safety and tolerability of subcutaneous pentosan polysulfate sodium (PPS) in subjects with Ross River virus (RRV

The Dunedin Child Development study is tracking a birth cohort of 1,000 people born in Dunedin, New Zealand in 1972, Poor self-control was found to be a strong predictor of membership of the 20% of individuals who, over the next four decades, generated 80% of all health, social welfare and crime costs in the cohort studied. This finding has attracted considerable attention from colleagues, policy makers, media, and the public as to the importance of self-control skills mastered in childhood for success in all facets of adult life. Improved self-control could therefore be an attractive intervention target. In this vein, Healey and Halperin (2015) developed an early intervention programme called ENGAGE aimed at coaching mothers to foster the development of self-control in their difficult to manage pre-schoolers. The mothers learnt or re-learnt familiar games (Simon Says, Musical Statues etc) directed at teaching child self-control and were encouraged to implement these with their children between clinic visits. Gains were large and were maintained over a twelve month follow up period. The ENGAGE study established the practicality of this face-to-face or clinic intervention in child self-control. However, for use on a population basis, this programme would need to be automated for web-based delivery. The Clinical Research Unit for Anxiety and Depression (CRUfAD) at St Vincent’s Hospital, Sydney have developed a web-based version of the ENGAGE course called iENGAGE. The iENGAGE Program is a self-managed, 10 week online intervention consisting of 6 lessons involving participation in games to improve self-control. These games are designed to teach self-control in fun and functional ways appropriate to a child (e.g. musical statues to teach the child how to stop/stand still when asked), and as a result build the strengths of the child and bolster the child-parent relationship. The online iENGAGE programme offers the advantages of being cost-effective, widely distributed (including in rural areas), available at a time and place convenient to the user, private and confidential, self-empowering, and deliverable with high fidelity. We wish to conduct a pilot trial of iENGAGE to test feasibility, acceptability, and preliminary efficacy of the online program in improving self-control in difficult to manage children as rated by their mothers. Results will be used to improve iENGAGE before passing the augmented program to Professor Rapee at Macquarie University to conduct a randomised controlled trial to establish efficacy and safety. Once efficacy and safety are established, CRUfAD will adapt the program for a large cluster RCT in New Zealand preschools. If this is successful then CRUfAD will adapt it for use as an integral part of New Zealand early childhood services delivered by the Plunkett Society.

The aim of the study is to compare two treatment protocols for first presentations of either PTSD or depressive disorders. The 'intervention' is self-compassion combined with behavioural therapies. The 'control' or standard treatment is cognitive therapy combined with behavioural therapies.

Surgical decompression for symptomatic spinal stenosis is justified primarily upon clinical experience, expert consensus and pathophysiological considerations, not high quality clinical trials – results of past research have been significantly confounded by placebo effects of surgery. There is an urgent need to rigorously test decompressive surgery for spinal stenosis as the intervention is expensive and potentially harmful and is increasingly used reflecting our ageing community. The efficacy of surgical decompression, the most popular procedure for spinal stenosis, has not yet been proven, as it has never gone through high level of scientific scrutiny to establish its efficacy or safety beyond placebo effects. The SUcceSS trial aims to randomly allocate 160 participants with chronic, symptomatic lumbar spinal stenosis to either decompressive surgery or placebo surgery to measure the efficacy of decompressive surgery on patients' outcomes with central spinal canal stenosis.

Survival of high-risk premature babies has improved significantly in the last 20 years. Feeding intolerance is a common issue seen in extremely preterm babies, and in those with conditions such as gastroschrisis, definite necrotising enterocolitis, and short bowel syndrome. Long-term support with parenteral nutrition (PN) is crucial for these babies to provide optimal nutrition at a critical stage of development. Lipid formulations are an important component of PN, being a good source of energy, essential fatty acids (EFA), and also of long chain polyunsaturated fatty acids (LC-PUFAs). In recent years, focus on omega-3 fatty acids has stipulated that increased omega-3 LCPUFA, mainly docosahexanoic acid (DHA), supplementation may have extra beneficial effects for extremely premature babies who have higher rates and severity of neonatal diseases of prematurity, such as late onset sepsis, necrotising enterocolitis, respiratory diseases of the newborn, and as such have a higher inflammatory status. A recent study by Deshpande et al. (2014) examined the use of SMOFLipid, a lipid emulsion with higher omega-3 content, compared to ClinOleic, a lipid emulsion with low omega-3 content, and found that eicosapentanoic acid (EPA) levels, and F2-isoprostane (an inflammatory marker) were slightly decreased. However docosahexanoic acid (DHA) levels were found to be similar. Soybean lipid emulsions are associated with parenteral nutrition-associated cholestasis and liver disease and studies with using pure fish oil based emulsion showed improvement in the cholestasis. The effect on phytosterol levels by lipid emulsions has not previously been studied in extremely premature neonates. This randomised controlled trial will compare the fatty acid levels, phytosterol levels, liver function tests and conjugated bilirubin in both groups. We hypothesis that in very preterm neonates born before 29 weeks, fish oil based lipid emulsion will result in higher omega-3 fatty acids levels as compared to standard olive oil based lipid emulsion.

This study aims to determine the effectiveness of a practice change intervention in increasing the provision of best practice care for alcohol consumption during pregnancy. The study will be conducted as a stepped-wedge controlled trial, with staggered (random order) implementation of the intervention across antenatal services in three health sectors within the Hunter New England Local Health District, New South Wales, Australia. The intervention will consist of evidence-based practice change strategies including leadership support, training, performance feedback, and system prompts. The prevalence of alcohol-related best practice care at three time points in pregnancy (booking in visit, 28 week visit and 36 week visit) will be the outcomes of interest. Repeated, weekly cross-sectional measurement of these outcomes will occur for 34 months via telephone or online surveys with a random sample of women who attended the services in the previous week. An intervention effect will be demonstrated by a cumulative increase in recommended care delivery across combined sites.

The purpose of the study is to look at the effect of 3 registered phosphate binder on serum calci-protein particle formation. It is hypothesised that formation of these particles may link inflammation with vascular stiffening and calcification. In turn the class of phosphate binder used my impact the quantity of these particles produced.

Racism and racial bullying are important issues in the lives of many Australian children and young people, especially at school. This project will substantially increase understandings of bystander responses (including their extent, nature, potential, merits, benefits, constraints) as a means of countering racism and racial bullying among Australian school students. This will be achieved through examining experiences of, attitudes towards, and responses to, racism and racial bullying among school students; identifying health, wellbeing, education and social outcomes of racism and racial bullying for individuals, schools and communities; exploring the enablers and obstacles associated with bystander responses to racism and racial bullying and by developing, piloting and evaluating a school-based program to foster proactive bystander responses to racism and racial bullying.

Sleepiness and fatigue are frequent debilitating problems following stroke. Medications have not provided long-term solutions for these symptoms and there is little research into psychological treatments. Cognitive Behaviour Therapy (CBT) is a well-established treatment for insomnia and chronic fatigue in those without a brain injury. The Monash-Epworth Rehabilitation Research Centre is conducting a world first study to investigate whether CBT can be effectively adapted to reduce symptoms of fatigue and sleep disturbance after stroke. A randomised controlled trial is used to compare participants receiving 8 sessions of CBT with another group of participants receiving 8 sessions of health education for issues specifically related to stroke.

Sleepiness and fatigue are frequent debilitating problems following traumatic brain injury (TBI). Medications have not provided long-term solutions for these symptoms and there is little research into psychological treatments. Cognitive Behaviour Therapy (CBT) is a well-established treatment for insomnia and chronic fatigue in those without a brain injury. The Monash-Epworth Rehabilitation Research Centre is conducting a world first study to investigate whether CBT can be effectively adapted to reduce symptoms of fatigue and sleep disturbance after TBI. A randomised controlled trial is used to compare participants receiving 8 sessions of CBT with another group of participants receiving 8 sessions of health education for issues specifically related to TBI.