ANZCTR search results

Sterile water injections are used by midwives to manage back pain during labour. The only side effect is the intense pain of the injections due to the lack of salt ions in sterile water. This placebo controlled double blind study aims to assess if a small concentration of salt added to the sterile water (0.2%) will reduce the pain of the injections. We hypothesize that the alternative low salt concentration solution will provide a more acceptable alternative to sterile water improving acceptability while maintaining clinical effectiveness.

This study is testing whether the eye drop CT2000 is safe and can help reduce eye pain in people with moderate to severe Dry Eye Disease. About 120 adults will take part. The first part will find a safe dose, and the second part will compare CT2000 with a placebo (inactive eye drop) and explore any reduction in eye pain. The main goal is to see if CT2000 is safe to use and if it can reduce eye pain.

Research indicates that Cognitive Behaviour Therapy (CBT) is an effective intervention for gambling disorder. However, few people (5-10%) with risky gambling access help services. Even then, drop-out rates remain high. We will compare AI chatbot powered inter-session homework activities in conjunction with Cognitive Behavioural Therapy (CBT) and standard care, versus CBT and standard care alone. We will assess gambling behaviour, mental health and quality of life outcomes for problem gamblers. The intended outcome of this trial is to generate preliminary evidence that will support clinically effective, safe implementation of Gabi whilst demonstrating improved gambling and quality of life outcomes.

This study will test whether using artificial intelligence (AI) to analyse heart CT scans can improve how doctors assess and treat coronary artery disease compared with usual care. The AI software automatically measures the amount and type of plaque in the heart arteries, providing more detailed information than standard visual reading alone. Participants will be randomly assigned to either AI-guided care or usual care, and all will have CT scans and blood tests at the start and again after 24 months. The main hypothesis is that AI-guided care will lead to a reduction in harmful non-calcified plaque in the coronary arteries over 24 months. The study will also assess whether AI-guided care increases doctors’ confidence in diagnosis and reduces the need for further heart tests and procedures.

This study aims to test how effective a highly-supported, personalised package of care is for young people (14-25 years) with anorexia nervosa or atypical anorexia nervosa and their carers. Treatment occurs in four-week phases. Prior to each phase, the clinical team consults with the participant (and their carer/s, where involved) to assign the modules for the next treatment phase. The modules are adapted from existing evidence-based approaches and address such therapeutic targets as motivation to change, fear of food, body image, and connectedness. Each participant’s symptoms are closely tracked throughout the study using regular assessments, which are also used to guide the personalisation of treatment modules. The study uses a single-case experimental design with multiple baselines. As such, prior to receiving the personalised package, participants first receive standard care. Each participant's symptoms are tracked closely between these two treatments, to determine whether the personalised care leads to better results than the standard treatment.

The primary objective of this protocol is to collect data from a broad range of people, about their activities, personal characteristics, circumstances, cognitive characteristics and mental health outcomes. This information will be used to inform, develop and test the TYD model of mental health. Key questions to be explored include the: 1. Relationship between the frequency of specific actions and mental health outcomes 2. Relationship between (1) and personality and demographic characteristics 3. Relationship between (1) and (2) and cognitive characteristics (for example, learning and memory, and attributional style) 4. Relationship between (1), (2) and (3) and stressors over time (longitudinal modelling). These questions will improve our understanding of the factors that mediate the relationship between our daily actions and our mental health for different groups of people. It will help determine whether there are optimal combinations of actions for different groups of people and conversely, whether there are combinations that indicate a person is at particular risk of symptoms or even chronicity of symptoms. Our ability to validly answer these questions requires large and diverse samples.

The primary purpose of the study is to provide randomised, controlled trial evidence to show whether medication adherence improves with use of a longer dispensing duration for BP-lowering medicines. The results will also provide evidence around cost minimisation. The hypothesis is that, at minimum, medical adherence will remain the same, or may improve in this population. Secondly, the results will provide evidence of longer dispensing durations bringing cost savings to the government and the majority of individuals.

This study is a randomized-controlled trial applying bench-stepping exercise as a functional training modality to improve stair walking performance in older people (65+) with increased fall risk. The main measurements will consist of motion recording using inertial measurement units and muscle activation using surface electromyography while ascending and descending stairs. We hypothesize that: (1) bench-stepping exercise will improve stair walking performance, reflected by changes in movement patterns of the center of mass. (2) these improvements will be reflected by changes in muscle activation patterns of the lower limbs.

This open-label, single-centre pilot clinical trial aims to evaluate the effects of daily supplementation with 2'-Fucosyllactose (2'-FL), a human milk oligosaccharide (HMO) prebiotic, in adults with inflammatory bowel disease (Crohn’s disease or ulcerative colitis) and in healthy adults. HMOs are a unique class of bioactive glycans naturally present in human breast milk, with 2'-fucosyllactose (2'-FL) being the most abundant (Thurl et al. 2017; Suligoj et al. 2020; Fanous et al. 2025). All participants will receive 20 grams of 2'-FL once daily for 12 weeks. Stool samples will be collected at baseline, midpoint, end of supplementation, and after a 4-week washout period to assess changes in gut microbiome composition and microbial metabolites. Blood samples will be collected at baseline (week 0), end of the supplementation (week 12), and washout (week 16) to assess systemic inflammatory biomarkers. Gastrointestinal symptoms will be assessed using participant-reported questionnaires at baseline and at the end of the supplementation. Participant adherence and safety will be monitored throughout the study. We hypothesise that daily supplementation with 2'-fucosyllactose will improve gut microbiome composition, reduce inflammation, and alleviate gastrointestinal symptoms in adults with inflammatory bowel disease, with effects that may persist after supplementation. The major questions it aims to answer are: • Can 2’-FL improve symptoms for patients living with moderately active IBD? • Can 2’-FL improve the gut microbiome composition, microbial metabolites, and anti-inflammatory immune markers in IBD patients? • Are the microbiome and anti-inflammatory effects of 2'-FL sustained beyond the supplementation period? • Does 2'-FL produce similar effects on the gut microbiome and immune biomarkers in healthy adults without known bowel disease?

This study aims to investigate whether a cream containing Queen Garnet Plum Extract can help reduce the severity of symptoms in people with mild to moderate atopic dermatitis (eczema). Atopic dermatitis is a common inflammatory skin condition characterised by itching, redness, and dry skin. The study hypothesises that regular topical application of a Queen Garnet Plum Extract-containing cream over 12 weeks may improve skin condition and reduce disease severity compared to a placebo cream without the active extract.