ANZCTR search results

Alcohol use and related harms are increasing among older adults, indicating a critical need for alcohol prevention and brief intervention programs that are both scalable and effective when targeting this population. It is also important that these interventions include measurement of cognitive outcomes, given the established relationship between alcohol use and cognitive decline in older adults, as well as the potential for these treatments to reverse alcohol-related cognitive deficits in ageing populations. This study will investigate whether a new Internet-delivered intervention is effective in reducing alcohol consumption, cognitive decline and alcohol-related harms, as well as in improving quality of life, among a sample of older risky drinkers (n=842). Older adults aged 60-75 years who meet criteria for risking drinking based on scores from the Alcohol Use Disorder Identification Test will be included in the study. Participants must have access to a home computer and Internet and be based in Australia. The study will be a randomised controlled trial with a 12-month follow-up period. Participants will be randomly allocated to one of two groups: (1) a new internet-delivered intervention, or (2) active control condition. In both conditions, participants will be free to work through the online materials at their own pace at home on a personal computer. The period of active enrolment will be four weeks for both conditions. Outcome assessments will be conducted at baseline, 4-week follow-up and 12-month follow-up on the participant's personal computer at home. Outcomes include: (1) assessment of alcohol consumption using an online calendar-based tool, (2) assessment of cognitive functioning using a battery of computerised tests, and (3) subjective cognitive complaints using an online questionnaire. In addition, the study will assess whether a range of secondary outcomes, including alcohol-related harms and quality of life are affected by the intervention.

This sub-study will test the effect of a novel therapeutic exercise machine on MRI-derived measures of brain health in patients with Parkinson's Disease and Atypical Parkinsonism. The Reviver exercise machine simultaneously stimulates the vestibular system whilst inducing isometric exercise. We hypothesise that a 12 week intervention on the Reviver will increase brain volumes, decrease number of enlarged perivascular spaces and decrease brain iron deposition.

ePICUre is a multi-centre, observational study of nutrition in critically ill children across Australia and New Zealand. The study will review nutrition practices and resources in participating tertiary PICUs, and the nutritional status, management and associated outcomes for children aged 18 years and under admitted to the PICUs for >48 hours. Primary Aim: To develop a platform to study nutrition in critically ill children in Australia and New Zealand that will inform paediatric nutrition care and research. Objectives: Primary 1. To profile paediatric critical care nutrition management resources and practice in ANZ 2. To describe the nutritional status of children in ANZ PICUs 3. To better understand nutrition prescription and delivery in ANZ PICUs 4. To provide a benchmarking opportunity for nutrition practice in ANZ PICUs and provide participating sites with data to support quality improvement 5. To provide basic information to inform future paediatric critical care nutrition research questions and priorities Secondary 6. To identify associations between nutrition and patient outcomes in ANZ PICUs 7. To compare change in nutrition practice between the two proposed study time points Rationale: Further research is required to better understand the role of nutrition in paediatric critical care. Undernutrition has been found to be associated with poor clinical outcomes due to detrimental effects including impaired immune function, increased gut permeability and bacterial translocation, and impaired respiratory muscle function. The associated consequences of undernutrition include increased duration of mechanical ventilation, length of stay and mortality. In order to best determine future research directions, the nutritional status and nutrition management of this cohort must be described. Three large international studies of nutrition in paediatric critical care have been undertaken since 2009 however Australian and New Zealand Paediatric Intensive Care Units have not been widely represented.

Total Knee Arthroplasty (TKA) is a common interventions administered to treat severe degenerative knee joint disease conditions (such as osteoarthritis). Traditionally, prosthetic joint components have been implanted to be aligned with the mechanical axis of the femur and tibia. This is done in an attempt to restore neutral overall limb alignment and ensure long term implant survival. However, the benefits of this approach has recently been questioned with the introduction of kinematic alignment techniques. The concept of kinematic alignment (KA) aims to position knee implants to match the pre-arthritic anatomy of each individual patient. It is suggested that this will improve soft tissue balancing, reduce the need for ligament releases, and enhance functional outcome following TKA. To date, only one randomized controlled trial (RCT) has been conducted investigating patient outcomes following KA TKR performed with patient-specific guides vs mechanically aligned TKR performed with conventional instruments. This trial demonstrated a substantial benefit in post-operative pain relief in those patients who underwent KA procedures compared to those in the mechanically aligned group. Although benefits in pain relief have been demonstrated, it is currently not clear whether native restoration of individual knee angles via kinematic alignment procedures have an impact on the degree of clinical outcome, patient satisfaction and range of motion post-surgery. The aim of this study will be to assess if reproducing native hip-knee-ankle (HKA) angles via Kinematic Alignment techniques improve clinical outcomes, patient satisfaction and range of motion in patients undergoing TKA procedures.

Managing scarring remains a significant challenge despite global reductions in burn incidence and severity of burn scars over the last 30 years. Ablative fractional CO2 laser therapy and medical needling are potentially revolutionary and minimally invasive interventions to treat severe burns scars. Laser and needling produce microscopic holes in scar tissue and this process is thought to assist scar tissue remodelling. Needling may have some advantages over laser in terms of feasibility. As there has been minimal investigation of laser and medical needling in children with severe burn scars, there is an urgent need to conduct a rigorous trial within this population. A randomised controlled trial will be conducted at a specialist children’s hospital with a sample of children with severe burn scars. Children will be randomised to one of two intervention groups: ablative fractional CO2 laser therapy or medical needling. The primary outcome of this trial will be ultrasound-assessed scar thickness post-intervention.

Summary Aim: To investigate the effect of intraoperative acupuncture on postoperative pain in adults following tonsillectomy. Background: Tonsillectomy is usually accompanied by significant morbidity, including postoperative bleeding, pain, nausea, vomiting, poor oral intake and dehydration. Recent evidences in literature indicate that acupuncture may have a role in reducing postoperative pain in adults and children. Methods: This prospective randomized controlled trial is to evaluate the effectiveness of intraoperative acupuncture in reducing pain following tonsillectomy in 260 adults. All patients receive a standardised anaesthesia and surgery including intraoperative Oxycodone, Dexamethasone, Granisetron and Paracetamol. Preoperatively, all patients receive ten (10) auricular acupuncture pads in preoperative bay. In the acupuncture group, the acupuncture pads contain a small (0.15mm x 0.6mm) embedded needle in-situ. In the control group, the sham acupuncture pads look identical but the needle has already been removed prior to insertion. These are left in-situ for 5 days and removed by patients at home. Intraoperatively, in the acupuncture group, body acupuncture needles (0.18mm x 15mm) are applied at 10 specified points immediately after induction of anaesthesia. These are removed after surgery and before the patients wake up. In the control group, no body acupuncture needles are given. Postoperative pain relief consisted of regular Paracetamol and Oxycodone as required. All patients and nursing staffs are blinded. All assessors evaluated postoperative pain using the 0-10 Numerical pain scale. Pain scores were recorded at regular intervals during the first 24 hours by nurses in hospital and on day 1,2 and 5 following discharge by patients at home.

Most traumatic spinal cord injuries (e.g. resulting in paraplegia and quadriplegia) happen at the time of the injury. A very small number might, in theory, be caused when an unstable fracture of the neck bones moves, injuring the spinal cord (delayed spinal cord injury). To address this risk, it is common for ambulance services and emergency departments to place patients who they think might have an injury to the bones of their neck (cervical spine) in a protective collar. The aim is to minimise neck movement until imaging (x-rays or CT scans) can be performed. The rationale is that if there is a fracture of the neck bones, neck movement could cause the bone fragments to move resulting in damage to the spinal cord. Historically, rigid neck collars have been, and are, used. There is however no high-quality research data showing clear benefit of this approach. This practice is now being questioned. Delayed spinal cord injury is an extremely rare event, there is no evidence that rigid collars prevent it and there is growing evidence of harm caused by rigid neck collars. This includes skin damage due to the pressure they apply, the risk of inhaling food or fluids when trying to eat or drink (aspiration) and damage to nerves in the neck. Anecdotally, patients report significant pain/discomfort and that eating or drinking is difficult. A proportion of patients are not able to tolerate the collar and remove it or loosen it such that it is ineffective. Some bodies have recommended a more selective strategy for limiting neck movement, including Norwegian and Danish guidelines and the Queensland Ambulance Service. This study aims, in a prospective study, to compare use of a rigid collar (as is current practice) against the application of a soft, foam collar with an emphasis on patients’ experience – in particular the amount of discomfort experienced – as well as clinical outcomes including pressure injuries and choking (aspiration) events.

IMT has been recognised as a novel form of resistance training in recent years, generating surprising results including improved blood pressure and autonomic balance in patients with hypertension. OSA . and reductions in systemic vascular resistance in healthy young adults. The findings are impressive as each study was able to attain these results within a simple 6-week training program consisting of only 5 min/day for 5 days/week or 25 min/week total training time. There is evidence that IMT performed daily improves casual blood pressure and plasma catecholamines in adults with OSA and elevated or stage 1 hypertension. The effect IMT has on 24-hour blood pressure, a better predictor of blood pressure related end-organ damage, requires further elucidation. A recent study has found reduced systolic blood pressure with high resistance IMT in OSA patients with moderate-to-severe OSA. However, the effect of high and low resistance training on patients with OSA and existing hypertension remains unclear. We hypothesise that high-intensity IMT training will result in lower blood pressure for obstructive sleep apnoea patients with hypertension. We hypothesise that IMT will improve obstructive sleep apnoea severity in patients with hypertension. We hypothesise that IMT will be a well-tolerated device for reducing blood pressure in this group.

This is a substudy of the Cancer Molecular Screening and Therapeutics (MoST) Program, which is registered on ANZCTR with ID ACTRN12616000908437. This substudy will evaluate the activity of Entrectinib advanced cancers harbouring NTRK or ROS1 gene alterations identified using comprehensive genomic profiling. Who is it for? You may be eligible to join the study if you are aged 18 years and older, with pathologically confirmed advanced and/or metastatic solid cancer of any cell type or an earlier diagnosis of a poor prognosis cancer and have received all standard anticancer therapy, or if you have newly diagnosed metastatic non-small cell lung cancer. Your tumour will need to have an NTRK fusion or ROS1 gene alterations. Study details Participants will continue to receive Entrectinib orally at a dose of 600 mg every 28 days continuously as long as they and their doctor agree there is a benefit from treatment. Participants will undergo imaging assessments at 8 weekly intervals for 12 months and then 12 weekly, or as clinically indicated in order to evaluate tumour response. Safety and tolerability of treatment and health related quality of life during treatment will be assessed at 4 weekly intervals. We cannot guarantee that patients will receive any benefits from this study. This study is being carried out to improve the way we treat cancer patients who may have limited treatment options available to them. It is hoped that entrectinib will be well tolerated and will improve outcomes for future patients, however, there may be no clear benefit from participation in this study.

Recovering from a bushfire, drought or COVID-19 can impact individuals emotionally, physically and financially. This study is a randomised controlled trial and aims to help people recover from these impacts by randomly allocating participants to one of two groups: (i) the SOLAR program which is a low intensity psychosocial intervention involving 5 face-to-face or telehealth sessions with a “Coach” who is trained and supervised by Phoenix Australia, OR (ii) an ONLINE program where participants receive weekly emails for 5 weeks with fact sheets and links to resources. Participants will also be asked to complete self-report measures at pre-treatment, post-treatment and follow-up. We hypothesise that the SOLAR program will be more effective then the ONLINE program in reducing the severity of distress at post-treatment and follow-up. The outcomes for this study have the potential to influence large scale roll-out of the SOLAR program in disaster impacted communities.