ANZCTR search results

The aim of this pilot study in premature infants who are on nasal continuous positive airway pressure (nCPAP) is to determine if surfactant given by aerosol is safe, tolerable, and able to reduce the need for mechanical ventilation and use of instilled surfactant administered using an endotracheal tube.

Placebo-controlled, First-In-Human study assessing the safety and tolerability of PRN2246 in healthy volunteers. Participants in Part A of the study will receive a single dose of PRN2246. Participants in Part B of the study will receive one dose of PRN2246 per day for up to 10 days

Once a woman with gestational diabetes mellitus (GDM) gives birth and her GDM resolves, Little attention is paid to her future risk of developing type 2 diabetes mellitus (T2DM). Women with GDM have up to a 7 times greater risk of developing T2DM than women without GDM. Despite this increased risk, ongoing care or support programs tailored to the unique characteristics on this group are not currently available nor easily accessible. This study proposes to address this gap. We will evaluate the impact of a tailored, self-administered Internet program, with or without individualised video coaching to empower women with a history of GDM to improve their nutrition and physical activity behaviours and reduce their T2DM risk.

Soluble fibre is a source of plasma short chain fatty acids (SCFA), which are known to have antiinflammatory properties. This study will investigate the plasma short chain fatty acid (SCFA) yield over 10 hours following consumption of four different soluble fibre supplements in healthy adult males and females. This will provide a proxy for rating the antiinflammatory potential of each type of soluble fibre. This information will be used in the design of future clinical intervention trials.

The efficacy of the Grit wellbeing program, which targets psychological, emotional, and social wellbeing, will be examined in substance using populations, through a cohort analytic study, comparing Grit in combination with the a six week recovery program (at Mirikai residential rehabilitation centre) compared to the six week recovery program alone (at Logan House residential rehabilitation centre). There will be a minimum of 90 participants (45 at each site) aged 18-35. It is anticipated that those who participate in the Grit Wellbeing Program will have greater reductions in substance use and mental ill-health, show greater increases in wellbeing, resilience and social engagement than those who participate in standard treatment alone.

It is well established that physical activity is associated with many physical and psychological health benefits. Participating in regular physical activity during childhood is also vital for optimal growth and development and kids who are active show greater resilience and increased social-emotional wellbeing. However, more than 80% of adolescent girls do not meet government physical activity recommendations and there is a striking difference in activity levels between boys and girls at all ages. Current strategies to engage girls in physical activity and sports programs have had minimal impact and innovative approaches that address the underlying socio-cultural barriers that girls face are needed. Targeting fathers to take an active role in increasing their daughters’ physical activity levels may be one such innovation. The DADEE Program is an intervention which engages fathers in positive lifestyle role modelling and effective parenting strategies to improve the physical activity behaviours, physical confidence, sport skills and social-emotional wellbeing of their daughters. Importantly, DADEE also targets girls to improve the fitness and physical activity levels, and parenting skills of their fathers. The DADEE program has been previously been evaluated in an efficacy RCT (ACTRN12615000022561) and an effectiveness RCT (ACTRN12616001270404). The primary aim of this study is to research the long-term effectiveness of the DADEE program in a larger scale community roll-out. In total, 12 programs will be evaluated over three years using a non-randomized, prospective design with 12-month follow-up for each program.

BACKGROUND: The hybrid artificial pancreas or hybrid closed loop insulin pump (HCL) has been shown to be effective in improving glycaemia in individuals with type 1 diabetes (T1DM). Recently the Medtronic e-PID HCL algorithm with insulin feedback (670G 3.0 HCL system) has been modified (670G 3.1 HCL system) to enhance its effectiveness manage blood glucose levels. The impact of the modifications implemented in 670G 3.1 have yet to be demonstrated. AIMS: The study aims to compare the relative effectiveness of the two HCL systems in managing blood glucose levels METHODS: The study is a two-stage randomized crossover study in a supervised live in setting. Pump-experienced adults with type 1 diabetes will be recruited. Following a 1 week run-in, all participants will be assigned 670G 3.1 and 670G 3.0 HCL systems in random order for a period of 7 days each, with stages separated by 1 week. Interventions aimed at challenging glycaemic control hyperglycaemia will be implemented during each of the 7 days. OUTCOME MEASURES: Glucose control including CGM time in target glucose range and time in hyperglycaemic and hypoglycaemic ranges. Safety end points including number of episodes of hypoglycaemia and ketoacidosis, and system performance

This study aims to compare post-operative pain outcomes following the placement of rectus sheath catheters by surgeons and anaesthetist. A total of 72 patients will be included in this study, with 36 in each arm. One arm will receive rectus sheath catheters placed into the pre-peritoneal space intraoperatively by the operating surgeon, while the other arm will receive rectus sheath catheters placed under ultrasound guidance by an anaesthetist into the intrafasicular space. Both arms will then receive 20mL 0.2% Ropivacaine infusion through these catheters every 4 hrs for 3 days. The post-operative pain experience will be assessed by narcotic requirements which will be documented as IV morphine equivalents.

The aim of this study is to pilot test an online psychological intervention aimed at reducing anxiety, depression and fear of cancer recurrence in testicular cancer survivors. Who is it for? You may be eligible to join this study if you are aged 18 years or over and have completed active treatment for testicular cancer and are currently disease-free. Study details All study participants will receive a 12 week access to an interactive web-based intervention designed to reduce anxiety, depression and Fear of Cancer Recurrence (e-TC 2.0). e-TC 2.0 is comprised of six interactive modules, including psycho-educational material, short survivor and educational videos, and offline exercises. Modules were designed to take approximately an hour to complete, depending on level of engagement. The whole intervention is self-administered according to participants’ needs and interests, at their own pace. Participants can revisit the website at any time and use its resources. Eligible men will complete baseline questionnaires, engage with e-TC 2.0 over a period of 12 weeks and complete immediate and 3-month post-intervention questionnaires. A series of acceptability/satisfaction surveys are embedded within the website and the immediate post-intervention questionnaire. If shown to be feasible and acceptable, e-TC could be an innovative approach to delivering supportive care and could be widely disseminated for further evaluation (or as part of routine care) at little additional cost for testicular cancer survivors who are struggling to adjust and would otherwise not seek/receive help.

This study is a first-in-human, randomized, double-blind, placebo-controlled, study to evaluate safety, tolerability, immunogenicity, pharmacokinetics and pharmacodynamics of single ascending doses of IV administered ATYR1923 at doses up to 5 mg/kg in healthy volunteers. This study will include 6 separate cohorts with ascending doses.