ANZCTR search results

This is a prospective randomized controlled trial (RCT) comparing the outcome of patients undergoing primary anterior cruciate ligament reconstruction (ACLR) with either a hamstring tendon (HT) or a quadriceps tendon (QT) autograft. Patient outcomes will be collected and compared between the two surgical cohorts over a 24 month post-operative period, and will include a range of subjective and functional outcomes, knee movement and laxity measures, patient satisfaction, and kneeling tolerance.

Approximatey 50, 000 Australians suffer a new stroke each year. Survivors of stroke often leave hospital unprepared for life back in the community and without support to assist in their transition from hospital to home and self-managing the sequelae of stroke. Using a randomised controlled design, this pilot study will test a novel personalised electronic self-management support intervention consisting (a) standardised patient-centred goal setting (b) integrated e-health self-management support following stroke. Significance: We will determine the feasibility of the proposed intervention in a sample of survivors of stroke and obtain data to inform the design of Phase II and Phase III studies targeting patients with acute stroke who are discharged home from hospital.

Otitis Externa (swimmers ear) is inflammation of the ear canal and leads to significant pain. The current treatment involves ear drops which are difficult to insert and requiring regular insertion. This leads to decreased patient compliance and a notably increasing level of antimicrobial resistance. This project involves the initial assessment of a newly created thermoresponsive ear gel (a gel that is drops at room temperature and changes to a gel a body temperature) in healthy individuals. We hypothesis the ear gel will gelate in the ear canal causing minimal adverse events.

Our recent systematic review showed that both volitional and reactive step training reduce falls by approximately 50% in healthy older adults. Our recently completed randomized control trial (RCT) confirmed safety and effectiveness of home-based volitional step training in people with Parkinson’s disease (PD). We hypothesise that a combination of volitional and reactive step training will provide additional benefits, underpinned by differential motor control mechanisms of action. This is a single blind RCT using a parallel arm design including a 12-week intervention, pre- and post-intervention assessments and 6-month follow-up for falls. Our RCT will be the first to clarify the effectiveness of combined volitional and reactive step training on risk of falling in people with PD using state-of-art technology.

The purpose of this study is to assess whether skin or wound repair using ‘ablative laser resurfacing’ assists in reducing sun-induced mutations and therefore reduces the number of non-melanoma skin cancers. Who is it for? You may be eligible for this study if you are over the age of 45 and have had more than 10 non-melanoma skin cancers in your life. Study details Consenting participants will have three 2.5 x 2.5cm patches of skin devoid of skin cancer identified on one forearm. Participants will then receive ablative laser resurfacing to two patches of skin. The third patch of skin will not receive any treatment This treatment will be performed at the Princess Alexandra Hospital. After 3 months, a biopsy of the three patches of skin and a saliva sample will be taken for assessment. It is hoped that this research will show that ablative laser resurfacing reduces the amount of skin mutations and thus may reduce the chance of skin cancer formation.

This pilot randomised trial, will evaluate the effect of participating in Strength Training (ST) with Peer Support (PS) compared to ST participation without PS. The project will be conducted in collaboration with the Council on The Ageing – COTAWA and Amana Living. All exercise participants will receive an individualized ST program in their home, prescribed by a qualified physiotherapist. The peers will receive peer training (2 hour session), meet the ST participant in a face to face meeting and then phone their ST participant once a week to provide encouragement and motivation. It is hypothesized that ST participants with a peer will be more likely to continue with a ST program after the completion of the 12-week intervention than those with no peer support.

IgAN is a serious, progressive disease in which 20% to 40% of patients progress to end-stage renal disease (ESRD) within 10 to 20 years of diagnosis. As most patients are diagnosed in their 20s or 30s, they face the prospect of dialysis or the need for kidney transplantation in the prime of their lives. The purpose of the study is to analyse the change in the urine protein/creatinine ratio (UP/C), based on a 24-hour urine sample at Week 36, when comparing sparsentan to irbesartan. Patients enrolled in the PROTECT study (Protocol 021IGAN17001) will be randomly assigned in a 1:1 ratio (like flipping a coin) to sparsentan or the active control (irbesartan) at the Day 1/Randomization visit. Study medication (sparsentan and irbesartan) will be administered as a single oral morning dose. The hypothesis to be tested relates to the change in proteinuria (protein in the urine) at Week 36 for sparsentan compared to irbesartan.

The current vaccination rates for Australian children under the age of five are below the national target of 95% coverage, which is required to achieve herd immunity. Herd immunity is a pattern of immunity where the risk of an individual contracting an infection is reduced by having vaccinated or immune individuals surrounding them, hence protecting against infectious diseases such as measles and smallpox. The low vaccination rates can be attributable to vaccine hesitancy which is the delay in acceptance of a vaccine despite availability. This behaviour occurs on a spectrum and is influenced by various factors. A novel way to reduce vaccine hesitancy is by implementing strategies informed by the field of behavioural economics through SMS technology. This single blinded randomised controlled trial will enrol up to 274 new parents from King Edward Memorial Hospital. Participants will be randomised into two groups, both receiving a vaccine hesitancy survey before and after the intervention (an SMS reminder.) The outcome will be measured through a change in the vaccine hesitancy score, calculated from survey responses. The primary objective of this study is to examine the effect of negative SMS vaccine reminders on vaccine hesitancy in new parents.

A multi-center, double-blinded, randomized, placebo-controlled, single ascending dose study and multiple ascending dose study to investigate the safety, tolerability, pharmacokinetic, pharmacodynamic, and hemostatic profile of VE-01902. The single ascending dose phase will encompass a single bridging cohort across tablet strengths, and a food effect cohort.

Anxiety is under-examined in Parkinson's disease (PD) patients, yet it is a major contributor to a poor quality of life in this population. Our previous study aimed at improving diagnosis and treatment of anxiety in PD was the first to pilot Cognitive Behavioural Therapy (CBT) for anxiety in PD using a tailored, manualised and dyadic protocol involving both PD and carers. This project develops and tests CBT incorporating Virtual Reality (VR) proposed to augment anxiety treatment in PD. VR environments (in virtuo experiences) have the potential to improve the efficacy of CBT treatment with the following unique benefits: • Patients are not required to mentally reproduce the stimulus as in imaginal exposure and relaxation. This is an issue in persons with PD, as executive function and memory retrieval are often impaired even at early stages of the disease. • Multi-sensory engagement provides a tangible and ‘real’ experience, improving patient engagement in the therapy. • The environment can be tailored by the clinician based on the subcategory of anxiety. • Relaxation immersive VR (eg: Virtual Meditative Walk) assists patients to focus attention inward which is advantageous in a population of patients with compromised attention. • Current smart-phone technology is capable of running VR software to allow for home based remote delivery of VR therapy. A randomised waitlist controlled feasibility trial will be conducted comparing the new CBT-VR to treatment as usual in reducing anxiety in PD (primary outcome). Secondary outcome measures will be depression, sleep, quality of life, and outcomes for carers. The manualised CBT-VR package will comprise of eight weekly sessions of 90 minutes each conducted at the University of Queensland. Additionally, patients will be given a mobile device with headsets for VR view at home with relaxation VR applications and a smart watch for monitoring of anxiety via heartrate. Basline, post and 3 month follow-up data will be collected.