ANZCTR search results

Is it feasible to conduct a double blind, randomised clinical trial to administer a nutritional supplement - exogenous enteral ketone ester - in critically ill, mechanically ventilated patients? We aim to find the correct dose required to maintain a participants blood ketone level between 2 and 5 mmol/L. We will also monitor for any side effects of the intervention

This study aims to assess acute safety and efficacy of a novel non-invasive neurostimulation approach in the treatment of obstructive sleep apnoea. In this study, we will assess the acute effect of transmucosal palatal stimulation on apnoea-hypopnoea index and ascertain initial safety and tolerability outcome data.

Extreme weather events attributable to climate change are occurring with increasing frequency and intensity. Whilst extreme temperatures can affect people of all ages and health status, certain populations are more vulnerable, especially older adults and those who have pre-existing chronic conditions such as cardiovascular diseases. Vulnerable populations are more sensitive to heat-related health risks and are more likely to suffer morbidity and mortality associated with heatwave exposure. As population exposure to extreme heat rises and our population ages, the associated health burden will continue to grow. The trial purpose is to evaluate whether a tailored text messaging intervention can reduce patient-reported heat symptoms, increase adoption of heat adaptive behaviours and reduce utilisation of health services during and after extreme heat days for Australian adults living with chronic conditions.

This project aims to evaluate the effectiveness of home-based tDCS for CLBP, investigate potential neurophysiological and somatosensory mediators of treatment response, and assess implementation outcomes relevant to future clinical translation. Home-based tDCS could improve the accessibility and scalability of the intervention; however, its effectiveness, underlying mechanisms, and implementation potential have not been evaluated in people with CLBP. Evaluating implementation outcomes alongside clinical effectiveness may accelerate future translation and inform the design of larger effectiveness and implementation trials for rural and remote populations.

Anxiety disorders are highly prevalent and often go untreated in young Australians due to barriers such as extensive wait times, limited access to services and trained practitioners, financial constraints, and inconvenience. While cognitive behaviour therapy (CBT) is effective, many children do not receive this evidence-based treatment. One Session Treatment (OST) for childhood phobias which involves a single prolonged exposure session has been proven to be effective, cost-efficient and acceptable to families. Drawing on the success of OST and our pilot work, We propose a Two Session exposure Treatment (TST) for transdiagnostic child anxiety disorders. Through a rigorous non-inferiority randomised controlled trial, we aim to establish the clinical and cost effectiveness of Transdiagnostic TST for a broad range of child anxiety disorders in comparison to traditional CBT. This project seeks to make treatment more accessible, cost effective and acceptable for the many young Australians suffering from debilitating anxiety disorders, ultimately bridging the current treatment gap.

This project will be the first of its kind where an intervention for body image dissatisfaction (BID) will be co-designed for patients with inflammatory bowel disease (IBD). This project is a co-partnership between SALHN clinicians and researchers within the College of Education, Psychology and Social Work at Flinders University. Eligible participants will be randomised to either usual care or the intervention, and feedback will be collected regarding their experience of the intervention. We expect that participants who receive the intervention will show greater improvements in body image and wellbeing than participants receiving usual care.

Achilles tendinopathy can cause persistent pain and reduced ability to tolerate activities that load the tendon. This study will investigate whether ankle position changes the immediate response of the Achilles tendon and calf muscle to isometric loading in healthy adults and adults with mid-portion Achilles tendinopathy. Each participant will complete two laboratory sessions in a randomised order, with loading performed in either a neutral ankle position or 25° of plantarflexion. Ultrasound, force and muscle-activity measurements will be collected before, during and after loading to assess tendon stiffness, volume and deformation, as well as calf muscle structure. Pain, acceptability, fatigue and symptoms approximately 24 hours after testing will also be recorded to help inform future research on Achilles tendon loading and rehabilitation.

Actinic keratoses (AKs) and intraepidermal carcinomas (IECs) are common precursors to cutaneous squamous cell carcinoma (non-melanoma skin cancers). This study aims to assess the feasibility, acceptability, safety and preliminary clinical activity of two doses of 5-fluorouracil (5FU) and calcipotriol treatments. Who is it for? You may be eligible for this study if you are aged 18 to 85 years, you have been diagnosed with either actinic keratoses or intraepidermal carcinomas on your face and you are willing to attend multiple study appointments. Study details Participants who choose to enrol in this study will be asked to apply each of the two treatments to opposite sides of their face twice a day for up to 6 days. The specific treatment to be applied to each side of the face will be determined randomly, by chance (similar to flipping a coin). Before and after applying the treatments, participants will be asked to have clinical photos taken of their face and will be asked to complete a series of questionnaires for up to 2 years after the treatment period. It is hoped this research will determine that the combination of 5-fluorouracil (5FU) and calcipotriol treatments is safe and acceptable to people with actinic keratoses or intraepidermal carcinomas. If this study is successful, a larger trial enrolling more people with actinic keratoses or intraepidermal carcinomas may be undertaken to determine the most effective dose combination of these treatments.

People who take insulin for diabetes can have their glucose fall too low, and if this happens while they are driving it can affect concentration and reaction time. Most now wear a continuous glucose monitor that sends readings to their phone, and since 2023 Victorian road rules have allowed drivers to view a securely mounted display showing information about their own condition, but nobody has tested whether having that reading visible actually makes a difference on real roads. In this study, Victorian drivers with insulin-treated diabetes each take part for two months: for one month, chosen at random, they drive with their phone in a dashboard mount so their glucose is visible at a glance, and for the other they drive as they normally would without it. A small GPS logger in the car records when they were driving, so their glucose readings can be matched to the times they were actually behind the wheel and each person can be compared with themselves. We want to find out whether the visible reading keeps glucose in a safer range while driving, whether it reduces time spent low at the wheel, and what drivers themselves think of it, so that better advice can be given to drivers with diabetes and to those who set road safety policy.

Upper limb injuries, including broken bones and dislocations, often need to be physically realigned in the emergency department (ED). This is painful, so clinicians use various techniques to manage pain during the procedure. The most common approach is procedural sedation (PS), where participants receive medication through a drip that makes them sleepy or unconscious. While effective, this approach requires close monitoring, dedicated staff, and a recovery period before leaving the ED. It also carries risks such as breathing problems and low blood pressure. An emerging technique in ED is ultrasound-guided supraclavicular block (UGSCB), which involves using ultrasound to guide an injection of numbing medication near the nerves above the collar bone. This numbs the injured arm without the need for sedation, allowing the participant to remain awake. Our recent research showed that this technique was an effective form of regional pain relief for managing broken wrists. However, no study has compared it to PS, which anecdotally is often preferred by emergency physicians across Australia and New Zealand. This project is a clinical trial across four ED’s that will randomly assign participants to receive either UGSCB or PS. The main measure will be reported pain levels, with additional measures including participant satisfaction, safety, time spent in ED and painkiller use. We expect the nerve block will provide equally effective and safe pain relief while allowing participants to leave the ED sooner, which could help participants and their families and reduce pressure on busy emergency departments.