ANZCTR search results

Aims: To determine the feasibility of a larger study in patients with difficult intravenous access to compare short-bevelled peripheral intravenous catheters (SB-PIVCs) with standard PIVCs. Participants: 100 adult patients from medical/surgical and oncology/haematology wards. 3-4 staff PIVC inserters for process evaluation. Methods: Pilot randomised controlled trial. Patients will be randomised to have either a SB-PIVC or standard PIVC inserted to facilitate their clinical care. Patients will be visited daily by research nurses for data collection. The study will end when the PIVC is removed as clinically indicated. Small process evaluation included. Expected outcomes: It will be feasible to conduct a larger trial and first-time insertion success will be higher in the SB-PIVC group than the standard PIVC group.

This pilot study is testing a new toolkit designed with input from consumers and general practitioners (GPs) to help reduce the use of benzodiazepines and Z-drugs (medications often used for anxiety or sleep). The goal is to see if the toolkit helps GPs feel more confident talking to patients about cutting back, and starting the deprescribing process, especially those who may be more at risk—like older adults or people with mental health challenges. The study also looks at how practical it is to use the toolkit in everyday medical practice. It is hypothesised that the toolkit will assist GPs in being more willing and able to talk about reducing these medications, lead to more patients cutting back safely, and show that the toolkit can be used effectively in primary care clinics.

Cardiovascular disease is one of the leading causes of illness and death in Australia and worldwide. Around 1 in 3 people with cardiovascular disease or at higher risk of developing it also experience poor emotional health, such as anxiety or low mood. These emotional difficulties can make cardiovascular health worse and make it harder for people to change important health behaviours, like improving their diet or being more active. This study will test how practical and acceptable it is to offer a new program that supports both health behaviour change and emotional wellbeing for people with cardiovascular disease or increased risk who also experience poor emotional wellbeing. The program is a short, internet-based course that teaches skills for improving health behaviours, while also providing strategies to manage emotional wellbeing. Participants will be supported by a psychologist during the course, with optional follow-up support for up to 12 weeks afterwards. We expect that participants will find the program acceptable, will stay engaged with the treatment, and will complete the study measures. We will also gather early evidence of its effects using questionnaires and a wrist-worn device that measures movement. Participants will also be invited to participate in interviews about the program.

This study aims to co-design and assess the acceptability and feasibility of a lifestyle-based intervention to reduce cardiovascular disease (CVD) risk factors in Aboriginal and Torres Strait Islander women without CVD in the Perth metropolitan area in Western Australia. We hypothesize that a co-designed CVD risk factor reduction intervention will be acceptable to Aboriginal women at the community and the healthcare providers and will be feasible t implement.

We conducted an initial trial to test a special gel used during surgery. This gel helps stop bleeding and reduces scar tissue. It's already approved for use in sinus surgeries by health authorities in Australia and the United States. The aim of this trial was to ensure it's safe to use in spinal surgeries.

This study aims to understand how body composition (the balance of fat and muscle) in babies born moderately to late preterm affects their brain development and later outcomes. We hypothesise that these babies will have more body fat and less muscle compared to babies born at full term, and that having more muscle and less fat will be associated to larger brain size and better development. To investigate this, we will measure babies’ body composition, growth, blood hormone levels, and brain size on MRI scans around their due date, and then follow their development at 4 months and 2 years of age. Comparing these findings with babies born at full term will help us see how early growth patterns influence long-term health and learning. The study hopes to identify early markers that can guide care to support healthier growth and development in preterm and growth-restricted infants.

This study aims to assess the impact of detailed anaesthetic risk information on patient anxiety, satisfaction, and decision-making preparedness in individuals undergoing robotic gynaecological surgery. The participants will be randomised into two groups, receiving either the standard anaesthetic risk information or both the standard and detailed information sheets. Anxiety will be measured pre- and post-intervention using validated scales (APAIS and VAS). This study is designed as a mixed-methods randomised controlled trial, with both quantitative and qualitative data collection. We hypothesise that providing patients with more detailed information about anaesthetic risks before robotic surgery will not increase their anxiety, and may improve their preparedness for decision-making and satisfaction with the consent process. The findings will contribute to improving informed consent practices and enhancing the patient experience during robotic surgery.

Untreated obstructive sleep apnea (OSA) can lead to serious health, safety, and economic problems. Continuous Positive Airway Pressure (CPAP) therapy is the main treatment and it helps improve sleep quality and daytime alertness. However, about half of all people prescribed CPAP stop using it within the first year, often within the first month. Early interventions to make CPAP more effective can help improve health and quality of life. People with a low respiratory arousal threshold (who wake up easily due to minor airway narrowing) are at higher risk of not sticking with CPAP therapy. Cognitive Behavioural Therapy for Insomnia (CBTi) can help increase the arousal threshold and improve CPAP effectiveness, but it has limitations like the need for trained therapists and time commitment. Using common sleep (hypnotic) medications like zopiclone might be a cost-effective way to help promote sleep (increase the arousal threshold) and improve CPAP adherence. However, more research is needed to confirm the effectiveness of combining hypnotics with CPAP for people who wake up easily. The research project aims to test whether a medication that promotes sleep can help reduce the severity of OSA by improving the effectiveness of the first-line treatment for OSA, Continuous Positive Airway Pressure (CPAP).

IB409 is a drug being developed as a novel approach for the treatment of Myocardial Infarction (MI). Many patients who survive the initial MI event are left with heart damage, leading to a substantial risk for future cardiovascular events such as recurrent MI, death, and heart failure. Existing treatments aim to restore blood flow but fail to prevent ischemia-induced tissue damage. IB409 would offer the potential to protect cardiac tissue from ischemia/reperfusion injury before and during blood flow restoration. In this study, we will look at the safety and tolerability of IB409 in healthy volunteer participants. This study will also determine the levels of IB409 in the bloodstream when given intravenously.

The aim of this study to assess the feasibility of a functional imaging-guided short course radiotherapy boost dose for adults with locally advanced rectal cancer. Who is it for? Patients older than 18 years of age, with rectal cancer confirmed on biopsy, undergoing curative-intent radiotherapy prior to surgery may be eligible for this study. Study details Participation in this trial will require undergoing an additional MRI scan prior to starting treatment; one extra day of radiotherapy treatment prior to the usual 1 weeks of radiotherapy; and completion of brief quality of life questionnaires before, during and after treatment. Participants will also be asked if the research team may review their medical information collected as part of their treatment. A key part of the study is also to assess any treatment-related side effects and your quality of life during and after treatment to ensure the additional dose does not have any adverse effects. It is hoped that this research will help to improve proportion of patients that completely respond to radiation treatment prior to surgical removal of bowel cancer, which may reduce the need for this invasive surgery for patients in future.