ANZCTR search results

This pilot randomised controlled trial aims to assess the effectiveness, feasibility, and acceptability of nine single-session interventions (SSIs) compared to a waitlist control for the early intervention of eating disorders in young people aged 14–25. The findings will identify the most effective SSIs based on changes in disordered eating and secondary mental health outcomes, guiding their refinement and development. The top-performing SSIs will undergo further evaluation in a subsequent RCT. Ultimately, the final SSIs will be made freely and widely available to support early intervention efforts for eating disorders in young people. We anticipate that participants receive one of nine SSIs will have lower depression, anxiety and disordered eating scores at 1-month follow-up compared to participants in the waitlist condition.

Postural orthostatic tachycardia syndrome (POTS) is a multisystem, autonomic disorder that culminates in extensive morbidity for those affected. POTS is currently diagnosed on the basis of strict heart rate response to a standing test in addition to the presence of orthostatic symptoms for greater than 3 months unexplained by another condition. However, the heart rate criterion is confounded by multiple factors and has not previously been well validated to correlate with symptoms. Additionally, little is known about whether individuals with postural symptoms without tachycardia (PSWT) have similar symptom burden and health related quality of life impairment to those with POTS. As such, we will explore the symptom burden of PSWT patients and compare this to a POTS cohort.

This study is a Phase1, randomized, double-blinded, and placebo-controlled study. In each cohort, enrolled participants will be randomized to receive either placebo or MWN109. A total of 72 healthy volunteers are expected to be enrolled into this study. Study consists of 2 parts- Part A- Single Ascending dose (SAD) and part B- Multiple ascending dose (MAD). The entire study duration per participant is estimated to be a maximum of 8 weeks for the single ascending dose (SAD) part and 12 weeks for the multiple ascending dose (MAD) part. The end of study is defined as the date of the last visit of the last participant in the study. MWN109 is believed to be a novel recombinant fatty acid chain-modified peptide with GLP-1/GIP/GCG biological activity and a good safety profile. This proposed Phase 1 study of MWN109 will provide preliminary evidence of safety, tolerability, PK, and PD in a healthy volunteer population. These preliminary results will pave the way to quickly enter into Phase 2 proof of concept studies, where it is intended to treat patients with Type 2 Diabetes Mellitus, overweight or obese

This trial aims to test whether a Prebiotic Fibre Supplement (PFS) is tolerable and feasible in a CAR T treatment context. Who is it for? You may be eligible for this study if you are aged 18 or older and planned to receive CAR T therapy as part of standard of care. You would need to be able to take a twice daily PFS for up to 90 days. Study details Participants who choose to enrol in this study will receive standard of care CAR T and be randomly assigned to either standard supportive care or receive an oral prebiotic fibre supplement in addition to supportive care. Participants will be followed up for up to 6 months to assess for feasibility and safety, and documented for clinical response, adverse events, and gastrointestinal symptoms to CAR T therapy. It is hoped the outcomes from this study will provide insights into the relationship between diet, the microbiome and response to CAR T therapy. Ultimately, the goal is identify strategies to positively influence the gastrointestinal microbiome to improve outcomes for patients having CAR T therapy.

This study will use a RCT design to evaluate the efficacy of an online education intervention on the characteristics of healthy sleep and contributing factors in improving sleep health and negative emotional states among young adults in Australia. At the 1 week post baseline follow-up assessment, it is hypothesised that participants in the intervention group will exhibit a significantly greater improvement in sleep health, including sleep satisfaction, and negative emotional states compared to participants in the control group,

The aim of this study is to compare the use of an iPad-based app (YoDoc®, Version 2.2) to the use of conventional communication devices in communication by nonverbal post-head and neck cancer surgical patients in a crossover design. Who is it for? You may be eligible for this study if you are a male or female aged 18 to 80 years old, planned for HNC surgery, and have a strong likelihood of being nonverbal post-procedure. You must also be admitted to ICU after surgery and without any mental or physical disability which prevent the use of iPad based app. Study details The participants will use conventional communication devices (e.g., pen & paper) during one study period, and an iPad-based app (YoDoc®, Version 2.2) during the other period. The comparison will be made using a modified QUEST 2.0 survey and an exit survey. It is hoped that information provided by this study will further medical knowledge and may improve future treatment of patients after head and neck surgery who are unable to speak after head and neck surgery. It is also likely that the iPad® based app may be of use to other group of patients who are unable to speak, e.g. those who require breathing tube & breathing machine; after a stroke, etc.

This study aims to investigate whether corticosteroids can help resolve non-malignant small bowel obstruction caused by adhesions without the need for surgery. Small bowel obstruction is a common condition after abdominal surgery and is usually managed with treatments such as a nasogastric tube and fasting. Corticosteroids have anti-inflammatory properties that may reduce bowel swelling. Their use have been effective and safe in the setting of malignant bowel obstruction, but yet to be shown in non-malignant obstructions. We hypothesize that adding corticosteroids to standard non-surgical management will increase the likelihood of resolving the obstruction without surgery and improve recovery time. The study will also assess any potential side effects of corticosteroids.

Rheumatoid arthritis (RA) is currently an incurable disease of ageing. Self-management - including good mental health, exercise, a healthy diet, and smoking cessation - complements medical management. The RA-HEAL program is a six-month multidisciplinary, person-centred, blended-delivery program combining resilience, healthy lifestyle behaviours and change support for RA. The RA-HEAL trial builds on a successful pilot study to assess real-world effectiveness of RA-HEAL compared to best practice usual care in people newly diagnosed with RA. The primary outcome is health-related quality of life. Effects of the intervention, relative to standard care, on physical function, mental wellbeing, lifestyle behaviours and disease control will be evaluated at 6, 12, 18 and 24 months of follow-up. Feasibility, safety, acceptability and value for money will also be evaluated. This research will provide evidence to support a nationally-scalable approach to enable RA self-management to ultimately reduce the individual and public health burden of RA associated with distress, poor physical function, long-term complications and healthcare costs.

The primary aim of this study is to preliminarily examine the efficacy of a videoconferencing adjunct to Lights Out Online, with respect to improving sleep, anxiety and behavioural outcomes for children, as well as parental self-efficacy, parent mental health and sleep. We expect there to be improvements in each of these areas for both children and parents and also expect parents to report a general level of satisfaction with the program.

Cataracts are easily treated with surgery, but there is a small risk of damaging the endothelial cells of the cornea which can lead to corneal swelling, affecting vision. Certain conditions such as traumatic cataract increase this risk. The Quatera 700 is an innovative machine used for cataract surgery, designed to cause less damage to the corneal endothelium. As such, we aim to document recovery of 10 complex surgery cataract surgery cases performed using this Quatera 700, in particular the change in cell count of the corneal endothelium. Patients who consent to the project will undergo routine care for their complex cataracts, but will attend additional appointments to measure the endothelial cell count (non-invasive imaging), which has minimal to no adverse effects.