ANZCTR search results

The gold standard of OSA management is CPAP (Continuous Positive Airway Pressure). Adherence to CPAP remains the main barrier to effective therapy due to the cumbersome nature of the mask interfaces and their propensity to leak. We aim to assess whether custom made CPAP masks, which are not common or readily available, will improve patients’ adherence to treatment and therefore improve treatment outcomes.

This is a randomised controlled study of women who require an induction of labour, to determine if excess, or inappropriate infusions of fluid given via a vein (intravenous route) is having an effect upon the duration of labour. For this study, women who require an induction of labour will be randomised to receive intravenous fluid at a rate of 40 ml/hr or 250 ml/hr. The duration of labour (in minutes), will be calculated from the commencement of an intravenous infusion of a medication to start labour (a hormone called oxytocin), until the birth of the baby.

The Paediatric Facioscapulohumeral muscular dystrophy (FSHD) Longitudinal Outcome Study (iFSHD-LOS) is designed to observe and record the natural disease progression of children and young adults aged 0-21 years diagnosed with FSHD (type 1 and type 2) through the collection of longitudinal data recording their medical, physical and psychological functioning. The study aims to: 1.Contribute to standards of care guidelines for children and young adults world-wide with FSHD. 2.Contribute to outcome measure and biomarker development to enhance clinical trial readiness. 3.Establish the cognitive and psychological profile of children and young adults with FSHD. 4.Develop a biobank of patient iPSCs to model disease and identify novel treatments in the future.

High sensitivity troponin assays have led to increased numbers of patients presented to the emergency department (ED) for suspected acute coronary syndrome (ACS) now having detectable troponin levels. For those with low level troponin elevated, there is limited evidence to guide care. It is suggested that individuals in this zone, have a higher risk of poor outcomes and the risk versus benefit of invasive coronary angiography (ICA) is less clear as the likelihood of an evolving heart attack is lower. Computed tomography coronary angiography (CTCA), being a less invasive alternate approach, may provide useful information to inform subsequent care to these lower risk patients. This randomised clinical trial aims to investigate CTCA vs. ICA in suspected ACS with low level troponin elevations in the ED. Outcomes will be assessed at 30 days and 12 months. A pilot study will be performed initially until greater funding can be sourced.

The prevalence of childhood obesity and overweight is a critical health issue in Queensland. A recent report indicated that 26% of children in Queensland are overweight (19%) or obese (7%). Although the causes of childhood obesity are complex, the intake of energy-dense, nutrient-poor food is a key contributor to obesity in Australian schoolchildren. Parental influence, role modeling, and the home environment are the strongest determinants of healthy eating in children, particularly for the younger age groups. As key role models and decision-makers regarding their child’s food intake, parents have a critical role to play in childhood dietary practices. This is especially true of parents of children aged 2-6 years as this is a formative period for the development of a child’s lifestyle habits and behaviour and a critical period for parental support seeking. Low-intensity programs that are embedded within the principles of positive parenting have shown promising results in improving health behaviours in children. Therefore, it is essential to develop interventions that target specific parenting contexts, such as parenting practices related to dietary intake. Here, we intend to evaluate the efficacy of a novel web-based program, ‘Healthy Habits for Life Triple P’, which is based on the Triple P-Positive parenting Program system of family behavioural intervention.

The ASCEND clinical trial aims to measure the effect of adding CEND-1 (a new cancer drug) or a placebo, to standard chemotherapy (gemcitabine and nab-paclitaxel) in patients who have untreated metastatic pancreatic cancer. Who is it for? You may be eligible for this study if you are aged 18 or older, you have been diagnosed with metastatic pancreatic ductal adenocarcinoma, and you have adequate liver and kidney function determined by blood tests. Study details Participants who choose to enrol in this study will be randomly allocated by chance (with 2/3 patients randomly assigned to the CEND-1 treatment) to receive either CEND1 in addition to the standard chemotherapy (gemcitabine and nab-paclitaxel), or a placebo in addition to the standard chemotherapy. Both CEND1 and the placebo will be administered by an intravenous infusion over a 28-day treatment cycle. Participants will continue to receive these treatments every 28 days until the cancer is seen to have progressed, or until treatment side effects become intolerable. Participants will undergo continuous monitoring for side effects throughout treatment, as well as completing questionnaires, blood tests and CT scans every 8 weeks for up to 18 months after starting the treatment. It is hoped that this trial will provide information on whether CEND1 is safe and effective for the treatment of metastatic pancreatic cancer.

Peanut allergy is a common allergy in Australia. As many as one in 200 children and 3 percent of infants have a peanut allergy. Reactions may occur after eating very small amounts of peanut. Reactions to peanut may be severe and life threatening. Peanut allergy is the commonest cause of severe life-threatening reactions (anaphylaxis) and death due to food allergy. Peanut allergy usually persists throughout life. Peanut oral immunotherapy (OIT) is a treatment where a person who is allergic to peanut is asked to eat peanut, starting at very low doses then increasing to a higher maintenance dose that they will then continue to take daily dose for a specified amount of time. This research is looking to recruit up to 40 participants in an open label trial where ALL participants will receive the active peanut OIT treatment over a 12month treatment period. In our previous peanut oral immunotherapy trials, children were given peanut OIT treatment over a course of 18 months. At the completion of the study we found that 80% of the participants who received the active peanut OIT were able to tolerate peanut in their diets. This new study will aim to investigate whether a 12-month treatment plan can achieve the same levels of remission in children. In this study, we want to find out if peanut oral immunotherapy treatment over the course of 12 months is: • Effective in producing tolerance in children with peanut allergies • Able to produce a long-term tolerance of up to 8 weeks

The Paediatric Research in Emergency Departments International Collaborative (PREDICT) network developed an Australasian Bronchiolitis Guideline in 2016 that provided high quality evidence that widely used interventions were ineffective. The PREDICT ‘Knowledge Translation in Australasian Paediatric Acute Care Settings: a multi-centred, cluster-randomised controlled trial comparing a tailored, theory informed Knowledge Translation intervention versus passive dissemination of a bronchiolitis guideline’ (PREDICT Bronchiolitis KT study) (ACTRN12616001567415), multicentred, cluster, randomised controlled trial found that targeted, theory-informed bronchiolitis interventions were effective in reducing the use of five inappropriate therapies (chest X-ray, salbutamol, glucocorticoids, antibiotics, and adrenaline) compared to passive dissemination of a guideline. The aim of this study is to assess sustainability of these improvements at the 26 sites which participated in the PREDICT Bronchiolitis KT study, one (2018) and two years (2019) post implementation of intervention. A retrospective medical audit will be conducted at the 26 Australian and New Zealand hospitals which participated in the PREDICT Bronchiolitis KT study. Our results will help determine the sustainability of this intervention over time, determine any improvements in control group hospitals, examine the learning and decay effects of the intervention, determine fidelity and adaptation of the intervention and explore factors which may have contributed to sustained improvements in either intervention or control group sites.

The aim of this study is to use whole genome sequencing technology to define the genetic variations present within a breast cancer patient’s tumour, prior to treatment. This information will be used to determine whether we could predict whether different therapies could elicit an improved response should the tumour not respond to the first round of drugs or if it recurs or spreads some time after initial treatment. Who is it for? You may be eligible for this study if you are aged 18 years or older, have been diagnosed with breast cancer, and are planned for treatment via a neo-adjuvant pathway. Study details Prior to starting neoadjuvant therapy, all participants will have a core biopsy taken by a qualified radiologist and give a blood sample. After neoadjuvant treatment is complete, participants will undergo their planned surgery, where a sample of the resected tumour will may be taken (if the treatment has not been completely effective). Samples will be analysed via whole genome sequencing. We will also be analysing patient blood for circulating tumour DNA and circulating tumour cells in order to predict treatment response and recurrence. A detailed health economics analysis will also take place to determine if whole genome sequencing offers a cost effective benefit to patients and the health system. It is hoped that this study will demonstrate that whole genome sequencing technology can be used to identify genetic variations in breast cancer patients that could be targetable by drug therapies. This could help to justify personalising breast cancer therapy based on whole genome sequencing analysis in future.

This pilot study will assess the feasibility and acceptability of the SMARTStart program, a group program designed to help young people make healthy choices. We will deliver weekly group programs facilitated by a psychologist and a peer worker who are trained to deliver the Self-Management and Recovery Training (SMART) program. SMART is based on cognitive-behavioural therapy and motivational interviewing and is guided by mutual aid principles. The program is designed to bring small groups of young people together (in person or online) to share their experiences and offer suggestions and support other young people with similar experiences. The aim of the program is to help young people make healthier choices, especially in areas of addiction (e.g., drugs, alcohol, tobacco, gambling, internet use, shopping, screen time, etc.). We will assess the feasibility and acceptability of the program once the program is completed (post-intervention) as the primary study outcome. Through assessment of the feasibility and acceptability of this program, we hope to collect information that will inform the delivery of a larger study designed to assess efficacy and that can be used to best adapt the current SMART program to suit the needs and desires of young people. We will also collect information about mental and physical health, and health behaviours at baseline and post-intervention.