ANZCTR search results

Polyphenols contained within the cocoa in chocolate are thought to be beneficial to some aspects of health. However, no study has investigated the effect of different types of chocolate (and the associated variation in polyphenol dose) on appetite and energy intake, in postmenopausal women. This research aims to investigate the acute effect of chocolate consumption (80% cocoa [dark] versus 35% cocoa [milk] versus 0% cocoa [white]) on appetite and energy intake in postmenopausal women. The results will have implications for weight management.

Double-blind, randomized, placebo-controlled, clinical trial with the primary objective to determine the efficacy of omalizumab given to children aged 6-12 years during an acute asthma exacerbation to prevent asthma exacerbations in the subsequent six months. Subjects include male and female children aged 6-12 years presenting to Princess Margaret Hospital for Children (PMH) Emergency Department with moderate to severe acute asthma. The ‘treatment’ group (n=64) will receive one dose of omalizumab at the enrolment visit (Visit 1). The ‘placebo’ group (n=64) will receive one dose of a placebo at the enrolment visit (Visit 1). However, in accordance with the dosing table (described in the Xolair (Registered Trademark) (Omalizumab) Product Information Sheet), each participant with sufficient body weight (kg) and total IgE levels to require a second dose of Omalizumab, will need to have a second dose of either Omalizumab or placebo two weeks later. The treatment drug, omalizumab, (or placebo) will be administered at least 12 hours after the patient presents to hospital, at the enrolment visit and following treatment, the patient will be monitored for a minimum of two hours by an experienced paediatrician. All children will also receive standard asthma therapy according to the PMH Clinical Practice Guidelines. This study consists of 3-4 visits over six months (including the first enrolment and treatment visit) and 1 follow-up telephone interview at 12 months.

Delusions are characteristic of people with psychosis. Many of these people do not respond well to current drug treatments and require additional psychological treatment. This project is an investigation into the efficacy of psychological treatments for delusions in psychosis, focusing on a new therapy (MCT+) which combines cognitive-behavioural therapy for psychosis and metacognitive training. Cognitive Behavioural Therapy for psychosis develops an awareness of the implausible content of a patient’s delusion, while metacognitive training targets the problematic thinking styles underlying delusional beliefs. It is expected that MCT+ will be one of the most effective psychological treatments for reducing delusional symptoms. The first aim of the proposed project is to determine the unique contribution of an individually-administered MCT+ program, combining the important facets of MCT and Cognitive Behavioural Therapy, over a standard cognitive remediation program (HAPPYneuron) targeting only neuropsychological cognitive deficits. The second aim is to determine the persistence of any improvements due to MCT+ by including a longitudinal follow-up. In sum, this project will provide the theory-driven evidence base that is needed to inform and influence clinicians to roll-out MCT+ to improve treatment for delusional people with psychosis. Primary Hypothesis: Participants who receive metacognitive training (MCT+) will show a reduction in delusional severity whilst improving clinical and cognitive insight (relative to participants in the cognitive remediation control condition). Participants randomised to the cognitive remediation control condition will show improvements to the “cognitive symptoms” of psychosis, including improved language and memory skills (relative to participants in the metacognitive training condition).

The primary objective of this clinical research is to establish the effects of a standardised green-lipped mussel lipid extract (PCSO-524) in women and men with osteoarthritis (OA) of the knee. The study seeks to determine the effective dosage and will be conducted using an open-label design and is categorised as a Phase II clinical trial. Participants meeting the enrolment criteria will be randomised to either 200mg or 400mg daily for a 12 week period. The primary validated measurement will be the Comprehensive Osteoarthritis Test (COAT) which we developed in previous clinical trials on OA. The results will be used to inform a Phase III randomised controlled study.

As dietary patterns established in early childhood track into adulthood, interventions to improve children’s diets are a key focus of national chronic disease prevention strategies. The World Health Organization recommends the implementation of dietary guidelines in childcare settings to improve child health and prevent the development of non-communicable diseases. As such, most developed countries including Australia have sector specific regulations requiring that foods served to children attending childcare is consistent with national dietary guidelines. Research conducted by the research team, however, shows that less than 5% of Australian childcare services adhere to such guidelines. An online menu planning intervention (integrated into mandatory service operating systems) may represent a potentially effective, low-cost, and acceptable means of providing population-level support to childcare services to improve the nutritional quality of food provided in services. This study will assess the effectiveness of a web-based intervention in increasing adherence of childcare service menus to sector specific nutrition guidelines. The study will employ a parallel group cluster randomised controlled trial design with 54 long day care services in New South Wales. Services will be randomised to receive either the web-based intervention integrated into current childcare management reporting software or the control group. The primary trial outcome is the adherence to the nutrition guidelines regarding provision of fruit; vegetable; grains; milk, yoghurt, cheese (and/or alternatives); meat (and/or meat alternatives) and discretionary foods (foods high in energy, fat and/or salt) as assessed via a comprehensive menu review undertaken by a blinded dietitian or nutritionist. In a nested sample of up to 35 services child dietary intake in care will also be assessed

Water birth occurs when a baby is born fully submerged in water. There is a lack of strong (Level 1) evidence to conclusively agree on the safety or risk of water birth. We aim to determine if it is possible to run a large study that examines the safety of water birth compared to land birth in women with low-risk pregnancies. In this study, we will test recruitment parameters, research processes, and outcome measures (for mother and baby) to assess the feasibility of a main study. If this study proves feasible and funding is obtained, then we will consider an international study across multiple sites (subject to ethical approval) with the primary purpose of testing safety for babies who are born under water.

An non-randomised (single group) trial to test the safety and efficacy of the ARIA Emphysema Treatment System (ETS) for patients with Severe Emphysema and Hyperinflation of the Lung. The ETS device will be implanted in the lung and will remain insitu for the duration of the clinical trial.

This study is a clinical audit of patients undergoing implantation of a commercially-available and TGA-approved high frequency stimulator (TGA certificate DV-2011-MC-00182-3) between 1st January 2013 and 1st February 2017 for the clinical management of pain. The study will be a two-year audit of pain scores, disability index, analgesic drug consumption and patient satisfaction after implantation of a high frequency electrical nerve stimulator. Each patient will provide their informed consent for their data to be included in the clinical audit.

Stroke and dementia are two of the most common and disabling conditions worldwide, responsible for an enormous and growing burden of disease. There is increasing awareness that the two conditions are linked, with cognitive impairment and dementia common after stroke, vascular dementia accounting for about one-fifth of all dementia cases and recent evidence on the contribution of vascular risk factors to Alzheimer’s disease. Yet we still know very little about whether brain volume loss – a hallmark of dementia – occurs after stroke, and whether such atrophy is related to cognitive decline. The aim of this research is to establish whether stroke patients have reductions in brain volume in the first three years post-stroke compared to control subjects, and whether regional and global brain volume change is associated with post-stroke dementia in order to elucidate potential causal mechanisms (including genetic markers, amyloid deposition and vascular risk factors). We hypothesise that stroke patients will exhibit greater brain volume loss than comparable cohorts of stroke-free controls, and further, that stroke patients who develop dementia will exhibit greater global and regional brain volume loss than those who do not dement. An understanding of whether stroke is neurodegenerative, and in which patients, may be used to help guide the early delivery of disease-modifying therapies.

Fractures of the distal radius are the most common fractures presenting to emergency departments and orthopaedic surgeons. These fractures are more common in the elderly (due to osteoporosis and increased risk of falls) and the incidence in this age group is increasing. Considerable practice variation exists in the management of distal radius fractures in the elderly in Australia, ranging from closed reduction (manipulation of the arm to realign the fracture) with cast immobilisation, to open reduction (surgical exposure and realignment of the fracture) with plate fixation. Open reduction and (volar locking) plate fixation is currently the most common treatment provided. While there is evidence showing no significant advantage for some forms of surgical fixation over closed treatment, and no difference between different surgical techniques, there is a lack of evidence comparing the two most common treatments used in Australia: volar locked plate fixation versus cast immobilisation. Surgical management of these fractures involves significant costs (implant costs, medical costs, hospital costs) and risks (infection, implant failure, general surgical risks) compared to non-operative management (closed reduction and cast immobilisation in the emergency department). Therefore, high level evidence comparing the current treatment alternatives (plate fixation versus casting) is required in order to address practice variation, justify or avoid costs, and to provide the best clinical outcome for patients with these common fractures. This pragmatic, multicentre randomised comparative effectiveness trial aims to determine whether (volar locking) plate fixation leads to better pain and function and is more cost-effective than closed reduction with cast immobilisation in displaced distal radius fractures in adults aged 60 years and older. The trial will compare the two techniques, but will also follow patients that are unwilling to be randomised (but consent to follow up) in a separate, observational arm. Inclusion of non-randomised patients provides a more complete spectrum of fracture presentation, provides practice and outcome insights about standard care, and improves the generalisation of the results from the randomised arms. Given that plate fixation requires hospital admission and surgery, and that closed reduction with cast immobilisation is usually performed in the emergency department without admission, the findings have important implications for use of resources (theatre time, bed days, staff and implant costs) and may also reduce harms associated with plate fixation (infection, implant mal-positioning, tendon rupture and reoperation for implant removal). This trial will have significance in Australia, New Zealand and internationally, as it will address an important need for evidence supporting surgical practice.