ANZCTR search results

This pilot study will assess the feasibility, acceptability and potential efficacy of a mobile health intervention among Out of School Hours Care (OSHC) services to improve staff health promoting behaviours, fruit and vegetable provision and physical activity environment. The study design is a parallel-group randomised controlled trial. The intervention involves a mobile application named The Eat Smart Play Smart App which is targeted at educator practices to address children’s healthy eating and physical activity. Investigators of the current project conducted a study to co-design an OSHC intervention with key stakeholders from the OSHC sector. During this study, stakeholders were presented with findings from a previously conducted state-wide quantitative survey of before and after school care services within NSW; and the stakeholders contributed to discussions around what support was needed to bring about meaningful change. The intervention piloted in this study has been developed through this collaborative process. It is hypothesised that OSHC services who participate in this intervention will increase their provision of fruit and vegetables in their OSHC service and educators from the services in the intervention group will have improved health promoting behaviours.

This project aims to examine the effect of Bruder Hygienic Eyelid Solution (Hypochlorous acid 0.02%) on ocular signs and symptoms, and eyelid microbiota in subjects with and without dry eye. This study seeks to examine: 1) The effect of a dilute hypochlorous acid (0.02%) spray on dry eye signs and symptoms and, 2) The correlation between eyelid microbiota and dry eye signs and symptoms. Study participants will attend two visits, an initial baseline visit and a 4-week follow-up visit. The OSDI score will be used to sort subjects into two groups: the dry eye group and the non-dry eye group. Participants scoring 0-12 points will be assigned to the non-dry eye group, whilst participants scoring above 12 will be assigned to the dry eye group. Both groups will receive Bruder Hygienic Eyelid Solution (Hypochlorous acid 0.02%) and participants will be instructed to use the spray twice daily on clean eyelids after normal face washing in the morning and night for 4 weeks.

The study aim is to explore the possibility of treating knee pain with focused ultrasound, optimise the study protocol and estimate the treatment effect in preparation for developing a subsequent clinical trial.

This study aims to assess the safety, tolerability and pharmacokinetics of a new cancer treatment, SGR-1505 that may be used for non-Hodgkin's lymphoma patients. The study will consist of multiple parts that will assess administration of SGR-1505 alone and in combination with another treatment, posaconazole. Who is it for? You may be eligible for this study if you are a healthy adult aged between 18 and 60 years old. Please note that this study will not be enrolling patients with non-Hodgkin's lymphoma. Study details The first sub-study will enrol participants and test single doses of SGR-1505. If a certain dose is found to be safe, a new group of participants will be enrolled to test a higher single dose of SGR-1505. The second sub-study will enrol participants and test multiple doses of SGR-1505 over a 10-day period. If a certain dose is found to be safe, a new group of participants will be enrolled to test a higher dose of SGR-1505 over a 10-day period. It is hoped this research will determine the safest dose of SGR-1505 that can be administered with non-Hodgkin's lymphoma

This study aims to: 1. Demonstrate safety and preliminary efficacy of psilocybin-assisted psychotherapy in reducing core eating disorder psychopathology and increasing motivation to change in AN as assessed by the EDE/EDE-Q and RMQ 2. Evaluate effects of psilocybin on depressive, anxious and obsessional symptoms, cognitive flexibility, quality of life and alliance between therapist and patient.

Transgender men on testosterone therapy may experience hair loss as a side effect, which can be distressing as it may not align with their gender expression. There are limited data as to what can be used to minimise hair loss in trans men. Minoxidil is approved to treat hair loss in cisgender population in topical form. The oral form has been used off-label in the cisgender population to treat hair loss as well. This study is conducted in a randomised, double-blinded manner using the sublingual form of minoxidil to see whether or not it will regrow hair on the scalp that can provide cosmetic significance and minimise distress. Furthermore, extension studies are done to assess sublingual minoxidil as a monotherapy and combined therapy. This can improve the quality of life for transgender individuals.

This study aims to pilot a general practice-led intervention to increase participation in the National Bowel Cancer Screening Program (NBCSP) within 100 general practices in two Australian states. Who is it for? You may be eligible for this study if you are an adult aged 45 years or older who is a patient at one of the participating general practice (GP) clinics and you are eligible for bowel cancer screening. Please note that the primary participants in this study are the GPs, however patients may be involved during the study whilst the screening initiatives are being trialled. Study details Participating GPs who agree to participate in this trial will be asked to continue their usual bowel cancer screening procedures for the first 5 months of this study. After 5 months, GP clinics will be randomly allocated by chance (similar to flipping a coin) to one of two groups. GPs who are allocated to the first group will be asked to incorporate a variety of strategies aimed at increasing the number of patients who take up bowel cancer screening opportunities. These strategies have been co-designed prior to the current trial and include the use of decision support tools, reminder prompts, additional education focusing on appropriate screening pathways and communication guides to address screening barriers in non-participant patients. Patients who attend one of the participating GP clinics may be exposed to one or more of these strategies during the trial period. GPs who are allocated to the second group will be asked to continue their usual bowel cancer screening procedures for the duration of the study and will not be given access to the new strategies and tools at this time. It is hoped this research will determine whether including new tools and educational materials into routine care for bowel cancer screening that occurs through GP clinics has a positive impact on the number of patients who undergo bowel cancer screening. If this trial shows that any of the strategies used are effective at increasing screening, they may be expanded to all GP clinics at a national level.

The present study aims to assess the acceptability and feasibility of a recovery-orientated well-being group therapy program for people living with bipolar disorder that was developed to be specifically designed to be delivered via telehealth (Zoom platform) by clinicians using a randomised-controlled pilot design. It was hypothesised that by assessing weekly attendance, drop-out rates, homework compliance and qualitative interview data that the zoom-delivered program would be found to feasible and acceptable program for participants living with BD and that the telehealth platform would be viable as a form of delivery.

On average, only 50% of IBS patients respond to the first-line treatment of low FODMAP diet. The non-responders may have gut microbiome dysbiosis that requires targeted treatment. Recent RCTs have shown improvement in IBS symptoms using faecal microbiota transplantation (FMT) from healthy donors in IBS symptom scores up to 3 months, with the proposed mechanism being the correction of gut dysbiosis, However, there is a lack of studies into the impact of FMT in combined with low FODMAP therapy to optimise the improvement of IBS symptoms. This study aims to investigate whether the novel therapy of FMT improves IBS symptoms for IBS patients without significant symptom improvement after a low FODMAP diet. Methods: IBS patients with moderate to severe symptoms will be enrolled into a dietician-led 3 week low FODMAP treatment. The patients who do not have symptomatic improvement will be randomised into receiving FMT or placebo. Studies suggest that altering microbial composition via FMT might also lead to improvements in cognitive function. Therefore, we will investigate cognitive function at baseline compared to follow-up in a subsample of 20 enrolled participants. In contrast to participants of the overarching clinical trial, sub study participants will undergo additional cognitive testing, which takes around 50 minutes per visit, and will be asked to fill out additional mood and quality of life questionnaires, which will add another 10 minutes to study visits. This result in a total study visit time of 80 minutes for substudy participants, as opposed to 20 minutes for participants of the overarching trial, who will only fill out two questionnaires on IBS-symptom severity. Cognitive function will be assessed via Cambridge Automated Neuropsychological Test Battery (CANTAB), a validated, computer-based, neuropsychological test battery that allows testing for cognitive changes in different cognitive domains, including memory, processing speed, and executive function. To assess the impact of mood and stress on IBS symptom severity, mood will be assess via the Depression, Anxiety and Stress Scale (DASS) and quality of life via IBS-QoL.

Extensive research has demonstrated that yoga is beneficial for general physical and mental health and well-being. However, only limited yoga-based interventions have been developed specifically for children living with Autism, with mixed results in reducing psychological distress and enhancing wellbeing. This study aims to understand the effects of a novel yoga intervention for reducing anxiety in children (aged 6 to 18) with Autism. This intervention is developed and co-designed with considerations of the special needs of children living with Autism, and it is primarily focusing on yoga postures, mindfulness awareness, breathing and relaxation training. The classes will run online, 1 hour per week for 8 weeks in a group setting.