ANZCTR search results

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.

In this randomised, double-blind, placebo-controlled study, 80 teenagers aged 13 to 18 years, eating a diet low in fruit and vegetables and using light emitting diode (LED) screens for more than 4 hours will be randomly assigned to receive capsules containing either Lute-gen (Lutein 10 mg & Zeaxanthin-isomers 2mg) daily or a placebo for 6 months. Changes in macular pigment optical densitiy, visual memory, processing speed, attention, and sleep will be assessed over time by administering several researcher-administered assessments and participants completing validated self-report questionnaires.

We aim to determine whether the My Emotions intervention, delivered by provisional psychologists in their usual work setting, is feasible, acceptable, and effective. Therefore, in this waitlist controlled randomised controlled trial, we aim to determine whether a brief emotions intervention delivered by provisionally registered psychologists: 1. Is feasible and acceptable when delivered in real-life clinical settings (primary outcome) 2. Improves child and family functioning at 3-months post-randomisation follow-up (secondary outcome).

The Ready to Screen (R2S) trial will investigate the effect of a bundled implementation strategy on lung cancer screening recruitment strategies in primary care. Who is it for? You may be eligible to join this study if you are aged 50 and 70 years of age, have current or previous history of smoking and attend an eligible GP practice Study details GP practices in this study will be randomly allocated (by chance) to one of two groups: one group will receive and implement the Core Implementation Strategy while the other group will receive and implement the Bundled Implementation Strategy. The strategy that participants receive will depend on the GP practice they attend. Participants’ intention to participate in the upcoming National Lung Cancer Screening Program (NLCSP), uptake feasibility, adoption and implementation, cost effectiveness and maintenance of the implementation strategy will be assessed using questionnaires and data from patients, practice staff, GP and clinic practice systems. Understanding the factors that influence patients' intentions to participate in LCS programs will help inform and optimize the implementation of the upcoming National Lung Cancer Screening Program in Australia.