ANZCTR search results

Vegetable consumption among children in Australia is below recommendations and most vegetables are currently consumed at home. This research aims to determine the effect on a multi-component intervention consisting of increased vegetable offering and menu architecture in Sydney metropolitan primary school canteens on vegetable sales, using a randomised controlled trial. The intervention is based on sensory and behavioural science and will consist of a new vegetable-based product, increasing vegetable content in hot meals and sandwiches and changes to the online ordering system. It is hypothesized that the intervention will increase vegetable sales in canteens.

Low dose atropine eye drops (in varying concentrations from 0.01% to 0.1% ) are a treatment strategy that has shown promise to slow or halt myopia (short-sightedness) progression in children in a dose-dependent manner, with a minimum concentration of 0.025% has been recommended for use in children as a balance between efficacy and the side effect profile. Recent studies have demonstrated that there is an increase in eye length (distance from the cornea to retina) and higher order aberrations (HOA’s; optical imperfections which degrade the image quality of the eye), and a decrease in retinal image quality when children focus their eyes at close distances. Atropine is known to reduce the focusing ability of the eye, however the effect of low dose atropine on changes in eye length, HOA's, and image quality during near focus in myopic children remains unknown and it is possible that atropine alters these changes, which may contribute to its effect in slowing myopia progression. The primary objective of this project is to examine the effect of nightly dosing of 0.025 atropine sulfate eye drops for approximately 7 nights on the changes in eye length, HOA's, focal power, pupil diameter, and image quality in myopic children during near focusing. This research is expected to provide greater understanding of the effect of low dose atropine on the focusing mechanism of the eye and associated eye changes, in addition to the potential mechanisms underpinning the myopia control effect of low dose atropine eye drops.

The aim of this clinical trial is to determine if Lucas papaw ointment assists in wound healing. Lucas papaw ointment was developed in Australia in 1906 and has been used as a topical treatment since this time. The effectiveness of Lucas papaw ointment for wound healing has not been assessed in a clinical trial. This clinical trial aims to clinically assess if Lucas papaw ointment assists with wound healing. A small wound will be created on each arm of the participants, and the Lucas papaw ointment applied to only one arm. The response on each arm will be compared using a photographic assessment tool, participant rating tools and physician assessment tools to assess the wound healing on each arm.

Functional Neurological Disorder is a common neuropsychiatric condition which is often chronic and results in debilitating symptoms such as paralysis or abnormal movement. The symptoms of Functional Neurological Disorder are not caused by structural abnormalities within the brain or nervous system but instead arise through psychological processes. Current treatments for Functional Neurological Disorder have limited efficacy. It is thought that drugs belonging to a class known as psychedelics, when administered in conjunction with a physiotherapy regime, may be particularly effective in the treatment of Functional Neurological Disorder but this therapeutic intervention has not been investigated in a clinical trial. Therefore, this study will assess the safety and feasibility of a physiotherapy regime designed for the treatment of Functional Neurological Disorder after administration of psilocybin in healthy volunteers.

Critically unwell children admitted to intensive care commonly develop fluid accumulation which is associated with prolonged time in intensive care, prolonged duration of mechanical ventilation and death. Despite this, the measurements of fluid accumulation are inaccurate or have not been previously measured, particularly for fluid accumulation in skin and tissues (oedema). In this study we aim to measure fluid accumulation in 100 children - both total body and in skin in those requiring mechanical ventilation in the intensive care. This will be performed at admission to the intensive care, at 24 hours and 48 hours after presentation. The main measurements will include total body weight, 3D imaging of the eyes/face, limb circumferences and an oedema clinical score. We will also investigate potential causes in addition to fluid administration such as injury to blood vessels and inflammation. In addition we will also look at the association between degree of fluid accumulation and intensive care outcomes such as the length of stay, duration of mechanical ventilation, organ injury and survival. This study will add valuable information about how frequent fluid accumulation is in critically unwell children, validate its measurement, explore novel methods for detection and explore many potential causes.

The SPADE study is a trial of a medication called dexmedetomidine to determine if it is effective at treating pain after spinal fusion surgery. The medication will be compared against an inactive placebo. The investigators anticipate that dexmedetomidine will be effective at reducing pain after spinal fusion surgery, but this medication has not been trialled in this setting before. The trial will involve adults having spinal fusion surgery, and will be conducted at the Royal Melbourne Hospital. If the trial shows that dexmedetomidine is effective, it will facilitate improved pain relief for patients having spinal fusion surgery. If the trial does not show that dexmedetomidine is effective, it will allow the investigators to focus on other interventions to control pain.

Total Hip Arthroplasty (THA) is a procedure commonly performed in patients who have end-stage hip osteoarthritis. The primary goal of THA is to provide pain relief, reduce disability, improve quality of life and functional status. Despite high implant success rates, up to 15% of patients remain dis-satisfied after surgery. This has been postulated to be due to several factors, including implant loosening, stem fractures and reduced functional movement, which lead to poorer patient outcomes. Recently, a new range of hip replacement devices have been engineered to address some of the shortcomings of existing stems. In particular, the Quadra-P stem has specifically been designed as a straight, triple tapered stem with a rectangular cross-section and manufactured with Ti-6Al-7Nb alloy material to increase osseointegration and reduce wear. The newly designed Quadra-P stem device was recently introduced into the Australian market, however, its radiological performance is yet to be evaluated. It is currently unknown whether the new Quadra-P device reduces or has the same level of risk of loosening, fractures and implant displacement, compared to other commercially available stems. The purpose of this current investigation will be to evaluate the radiological performance of the Quadra-P stem in providing implant stability in patients undergoing THA.

The broad aim of the study is to demonstrate that supporting active patient and family engagement in nutrition and exercise (active mobilisation and rehabilitation) during recovery from critical illness will result in better patient- and family-centred outcomes compared with usual care. Before we can assess these long-term patient- and family-centred outcomes we need to evaluate, in a Phase II trial, the feasibility, intervention acceptability and short-term effectiveness, which is the specific aim of the study proposed here. We hypothesise that the trial will be feasible (as determined by ability to recruit 80% of eligible participants, retain 70% of participants to 6-month follow-up, achieve 90% intervention fidelity and collect 75% of all outcome measures) and the intervention acceptable to patients, family members and health professionals as determined by the Theoretical Framework of Acceptability questionnaire. We also hypothesise that the trial will result in improvements in short-term outcomes including nutrition adequacy and exercise throughout the hospital stay.

Prior to the COVID-19 pandemic there was growing recognition that at-home health monitoring programs based on a digital technologies could be used to empower community-based COPD patients to independently monitor their symptoms and act on rapid declines in health status. The 'SPHERE COPD' study is an early pilot study aims to test the feasibility and user-friendliness of a newly developed portable and patient-operated disease monitoring system in a community setting, Centered around a novel smartphone application ("app"), patients can take daily measurements of their lung function, oxygen levels in their blood and track their symptoms and rescue medication use. the app will summarise the data for the participant and securely transmit it to a server for interpretation by a healthcare professional. Deteriorations in participant condition potentially indicative of an exacerbation may be identified by the healthcare professional and queried via a telephone call. The downstream implications this study to completion are broad but have the potential to alter current approaches to COPD in the community. It may empower the individual to proactively identify an exacerbation and seek early medical assistance. It may also enhance their care by s providing physicians to access to longitudinal data on their patient’s condition between visits provides a powerful new tool with which they can more accurately tailor pharmacotherapies and written COPD action plans to optimise long-term outcomes.

This study will compare clinical and quality-of-life outcomes for breast cancer patients undergoing sub-pectoral vs. pre-pectoral implant-based breast reconstruction post mastectomy Who is it for? You may be eligible to join this study if you are aged 18 and above, diagnosed with stage 0-III breast cancer and planning to undergo nipple or skin sparing mastectomy with immediate reconstruction (as recommended by your treating breast surgeon). Study details All participants in this study will be asked to provide access to their medical records regarding baseline demographic data (such as age, weight, smoking status) and any medical complications related to their breast reconstruction surgery. They will also be asked to complete a series of short surveys designed to assess quality of life and aesthetic outcomes. The data gathered will be used to compare clinical, quality of life and aesthetic outcomes between a groups of women who have one type (pre-pectoral) of implant-based breast reconstruction to another type (sub-pectoral) implant-based breast reconstruction. Participants will not be required to attend any additional appointments beyond their routine follow-up appointments at three months, one year and two years. The PRASE Study is the first study to compare these two techniques of breast reconstruction in an Australian population. It is hoped that this research will contribute to improving health outcomes for patients with breast cancer.