ANZCTR search results

This project aims to improve the quality of acute health care services provided to Aboriginal and Torres Strait Islander peoples, in line with the Australian Safety and Quality Framework for Health Care (ASQFHC) and the Aboriginal and Torres Strait Islander Quality Improvement Framework (ATSIQIF). Based across three sites (Flinders Medical Centre SA, Alice Springs Hospital NT and Royal Prince Alfred Hospital NSW), this project will highlight the immensely important role of Aboriginal liaison officers, strengthen the capability of the Aboriginal health research workforce, privilege the voices of Aboriginal people in research and ultimately improve health for Aboriginal patients in the acute care setting by improving the effectiveness of the acute care provided

In Australia, less than 4% of children aged four to five years old consume the recommended amount of vegetables. Liking and acceptance of vegetables are learnt in early childhood and habits track into adulthood, thus efforts to increase vegetable intake need to start in the early years of life. About half of Australian children aged 2-5 years attend formal early care and education. These settings, such as Long Day Care, can provide 40-60% of children’s daily food intake. Early care settings can play a pivotal role in shaping children’s dietary habits and care-based nutrition promotion has been successful in improving children’s food intake. In centres where food is provided onsite, the responsibility for menu planning and food preparation falls with the cooks. The purpose of this cluster randomised control trial is to support childcare cooks to provide healthy meals, with a focus on vegetable intake, through piloting the delivery of menu boxes direct to long day care centres. This study will evaluate the effects of menu box delivery on the provision and consumption of vegetables in long day care centres and evaluate the feasibility and acceptability of menu box delivery. Menu boxes will include recipes and ingredients tailored to the number of serves required by the centre, which meet long day care menu planning guidelines. This will be compared to an online cook’s training module supported by an online menu planning tool to increase vegetable provision in meals and snacks. South Australian Long Day Care Centres will be randomly allocated to either receive a menu box delivery (n=4-5 Centres) to provide recipes and ingredients for their menu cycle, or receive access to an online cooks training and menu planning tool (n=4-5 Centres). The intervention (menu box vs menu planning) will be conducted over 12-14 weeks (menu boxes will be delivered for 8-weeks). Evaluation data for dietary intake, menu food provision, acceptability and feasibility of the intervention will be collected at baseline and at the end of the intervention period. This project is being conducted as part of VegKIT (https://www.vegkit.com.au/), funded by Hort Innovation.

The study drug AB-729 is being developed as a potential new treatment for Chronic Hepatitis B (CHB). The main goal of the study is to determine whether AB-729 is safe and well tolerated when given at different doses. We will also measure the levels of the drug in the blood at different times. The study will be conducted in 3 parts. Study Part 1 (Healthy Subjects SAD) : Part 1 will enroll 24 healthy subjects using a SAD design consisting of 4 sequential dose groups Study Part 2 (Subjects with CHB Infection SAD): Once the safety and tolerability data from the first 2 doses of the SAD assessment in healthy subjects have been completed and it is considered safe to proceed by the SRC, Part 2 will commence in subjects with CHB infection. Study Part 3 (Subjects with CHB Infection MD): Part 3 will be an open-label, Non-Randomized, MD design and will be conducted in 35 subjects with CHB infection. Discontinuation of all HBV treatment is optional. If subjects stop all therapy, they will enter a more intensive follow-up period for 12 months and then have quarterly visits for up to 2 additional years for a total of up to 3 years of follow-up post-NA discontinuation

This study is testing a new way to monitor body temperature of premature infants (23-31 weeks' gestation) to prevent them being too hot or too cold on admission to the NICU. Specifically, it is looking at whether the left back or left armpit is a better place to keep a skin temperature probe to monitor and maintain the infants' temperature from the time they are born until they are admitted to the NICU.

Commercial physical activity apps (e.g., Strava) have widespread reach and accessibility, and hold great potential to increase physical activity engagement. The use of social components of such apps, in particular app-specific communities (connecting with other app users) and existing social media platforms (e.g., Facebook) have the potential to enhance physical activity. This study is a 3-arm pilot randomised controlled trial that aims to evaluate the efficacy of an intervention incorporating a commercially available app (Strava) and its associated social features (Strava community +/- Facebook) to improve physical activity levels.

The purpose of this study to determine whether the addition of selinexor to lenalidomide maintenance therapy post Autologous Stem Cell Transplant for multiple Myeloma patients increases the proportion of patients who are progression free 3 years post randomisation. Who is it for? You may be eligible for this study if you are an adult who has been newly diagnosed with Multiple Myeloma and are eligible for an Autologous Stem Cell Transplant. Study details Participants in this study will be randomised to receive either: Lenalidomide 10mg,orally,once a day for 21 days or Lenalidomide 10mg,orally,once a day for 21 days with Selinexor 40mg,orally, weekly Lenalidomide may be increased to 15mg orally, once a day for 21 days from cycle 4 onwards, provided good tolerance and no lenalidomide-related greater than or equal to grade 3 adverse events. Selinexor may be maintained at 40mg orally, weekly from cycle 2 onwards provided good tolerance and no selinexor-related greater than or equal to grade 3 adverse events Each cycle lasts 28 days, Patients will receive treatment until disease progression. During the trial patients will have blood tests performed and bone marrow samples taken to help determined the progress of the treatment. It is hoped that this research will help determine whether this treatment prolongs the progression free survival for patients, and what kinds of side effects/complications may occur with this treatment.

What is the problem? Esophageal food bolus is a common emergency. Majority of food boluses pass spontaneously or can be managed medically. However, in 10-20% of cases, endoscopic retrieval is necessary. However, endoscopic removal of food bolus can be challenging, due to limitation of working space within the esophagus, direct visualization of food bolus, the type or size of the food bolus and the endoscopic devices utilized. As a result, this may lead of failure or incomplete removal of food bolus and increase patient’s morbidity, even mortality. What is this study? We propose to assess the effectiveness of the transparent cap- assisted device, as a novel endoscopic technique in the management of food impaction in the esophagus in comparison to conventional endoscopic methods, given its usefulness has not been formally assessed in large randomized controlled studies to date. What is the significance of this study? We aim to compare a new technique for removing a piece of food which has become stuck in the esophagus using a transparent cap-assisted device and compare this to the established endoscopic method. We hope that this new technique will assist in complete removal of food bolus in one single piece rather than in pieces. This would reduce the time taken with patient’s safety unaltered, but this will not be known until we have completed with this research study. We hypothesized the use of a transparent cap allows complete en-bloc removal of food bolus in a shorter amount of time and less trauma to the mucosa, as compared to the conventional techniques.

Sudden unexpected death in people with epilepsy (SUDEP) is an under-appreciated tragedy. It has devastating effects on families, friends and colleagues of those who die, and the causes of SUDEP remain unknown. We will conduct an international, multicentre, prospective, case-control study of SUDEP, recruiting participants over four years. Each centre will define a cohort from which cases and controls will be prospectively identified. The cohort will comprise people with epilepsy who have been seen at the centre since a specific date (no earlier than 01/01/2015). Cases will be people with epilepsy from these pre-specified cohorts who have died from definite or probable SUDEP (with or without other co-morbidity), or resuscitated (near) SUDEP if the patient died within 72 hours of the initial collapse. Controls will be people with epilepsy who will be individually-matched by age (±2 years), sex, centre, and enrolled in the cohort at the time of death of the case (with four controls for each case). For each case, three controls will be randomly selected from all patients in the same cohort who meet the above matching criteria, using a random number generator. A fourth control will be a proxy control, who will be a spouse, relative or close friend nominated by a true control, who is randomly selected from the true-control triplet. Use of the proxy controls will allow any measurement error associated with proxy data to be quantified and corrected for. The families of cases, the control patients, and the families of controls patients (i.e. proxy controls), will be interviewed over the phone by a research coordinator or an epilepsy fellow, using a structured questionnaire. Data from the interviews will be recorded in the EpiNet database. This will include demographic data, socio-economic factors, epilepsy factors, usual sleeping arrangements, epilepsy treatments, co-morbidities, medications, alcohol, caffeine, and cigarette use, plus the use of seizure monitors, nocturnal supervision, and/or anti-suffocation pillows. For cases, relatives will be asked about the deceased's sleeping arrangements for the night of death or for the night immediately prior to death, and whether this was different from the typical sleep arrangements. Controls will be asked questions relating to their sleep arrangements on a specific nominated night's sleep (chosen randomly to be in the two weeks prior to the interview). Data neurologists, pathologists, and coroners regarding circumstances around the death, the cause of death, epilepsy and treatment factors will also be recorded if available. The data will be analysed to identify risk factors for SUDEP. Data cleaning will be performed prior to analysis. Odds ratios will be calculated using the Mantel-Haenszel method and logistic regression to control for covariates.

There is emerging evidence that dog ownership is associated with increased levels of physical activity in children, thus it is plausible that dog ownership may provide other health and development benefits for children. Dog-facilitated play and activity increases the amount of time children spend interacting and bonding with their dog and may be an important mechanism for facilitating developmental benefits such as improved self-esteem, self-regulation, empathy, autonomy, reduced stress levels and increased attachment to their dog. A key evidence gap exists around the effect of increased interaction with companion animals via pet-facilitated play and activity and its impact on both health and developmental outcomes in young children. This study aims to pilot test companion animal-based interventions for improving children’s health and developmental outcomes. We hypothesize that strategies to increase children’s active play and walking with the family dog will improve children’s health and development.

This study will prospectively follow a group of patients who undergo ACL reconstruction with the use of a fresh frozen allograft