ANZCTR search results

This project aims to develop an improved understanding of how deep brain stimulation influences different motor symptoms of Parkinson’s disease. Specifically, it is anticipated that the outcomes of this research will clarify the effect of deep brain stimulation on symptoms relating to walking ability and balance, which will help to enhance the post-operative management of people with Parkinson’s disease following deep brain stimulation.

This four-month trial will compare long-acting depot buprenorphine (CAM2038) to standard of care (oral methadone) in adult males and females in custody with opioid use disorder to identify any unexpected safety and tolerability considerations specific to the adult custodial population in NSW. Analysis of routinely collected data will examine clinic-based diversion (or attempted diversion) among all inmates receiving opioid agonist therapy (depot buprenorphine, sublingual buprenorphine- naloxone film and oral methadone) as well as violent misconduct and involvement in assaults at each site and among trial participants. Further, a cost-consequence study will be undertaken to compare the costs and consequences of dosing activity recorded for all treatment types for both JH&FMHN clinical practice and CSNSW officer time. Finally, focus groups with CSNSW and JH&FMHN staff will be conducted to assess staff satisfaction and acceptability of OAT and related issues.

This is a first-in-human study of a new PLA2 inhibitor drug called c2. Who is it for? You may be eligible for this study if you are 18 or older and have prostate cancer confirmed by biopsy. Study details All participants in this study will receive the study drug (called c2), which is an oral pill. In the first part of the study, volunteers will be divided into 4 cohorts, each taking a different single dose of the medication. In the second part of the study, participants will take at a maximum of 10mg the study drug. Participants will be monitored for adverse events and medication efficacy, and provide blood and urine for analysis. It is hoped this research will provide evidence about this medication and lay the groundwork for future studies of this drug.

Eczema is the most common skin condition affecting children. With a prevalence of up to 1 in 5 children, and one that is increasing, this condition places significant burden on the health care system and affects the quality of life of both the patient and their family. Despite its frequency, eczema is often undertreated and poorly managed, resulting in tertiary level referral. Although it is well known that education is fundamental to ensure effective eczema management and long-term disease control, this is an area that is often missed in time-restricted medical consultations. The purpose of this randomised control trial is to determine if the implementation of a series of educational videos and pamphlets, aimed at parents of children with eczema, results in improved eczema severity, as determined by change in Patient-Orientated Eczema Measure (POEM) score from baseline to the clinic appointment (4 weeks later), versus those receiving standard care. Patients will be recruited from the existing allergy/immunology waiting list at Fiona Stanley Hospital and will be randomised to educational intervention or standard care. All patients will be followed up after a 4-week period. If these materials are deemed effective, demonstrating a significant improvement in disease severity, these materials will become part of standard care of all patients referred to Fiona Stanley Hospital with eczema, and potentially the wider public at a community level.

A randomised controlled trial was used to compare the effectiveness of two psychological interventions for reducing risk for cognitive decline in older adults. It was hypothesised that the more intensive intervention would show greater benefits for risk reduction.

While dietary modification is a proven method to improve glycaemic control, the magnitude of improvement is reliant on diet adherence. The proposed study will investigated the feasibility of integrate a practical strategy (time-restricted eating) that may induce improvements in glycaemic control for individuals with type 2 diabetes (T2D).

Regular consumption of traditionally allergenic foods, like egg and peanut, in solid foods can reduce food allergies, however this is too late for some infants. This PrEggNut study will determine whether the risk of developing food allergies in infancy can be reduced by a maternal diet rich in eggs and peanuts during pregnancy and breastfeeding. The intervention period is from 22 weeks gestation in pregnancy until 4 months of breastfeeding. The infants are followed up until 12 months of age. The study design is a multi-site, randomised controlled trial. It is powered for infant egg and peanut food allergy outcomes with a sample size aim of 2136 women and their infants. The primary outcome for this study will be food challenge proven IgE-mediated egg and/or peanut allergy at 12 months of age. The key translatable message from this study will be to answer the question of whether higher maternal dietary intakes of eggs and peanuts during pregnancy and breastfeeding are needed to reduce the risk of food allergies developing in infants..

The purpose of this study is to assess the efficacy of the use of TraceIT for radiotherapy in prostate cancer when compared to SpaceOAR. Who is it for? You may be eligible for this study if you are an adult who has been diagnosed with prostate cancer and is scheduled for primary curative prostate cancer radiotherapy. Study details All participants who are undergoing radiation therapy with the insertion of TraceIT as part of standard care. Using an MRI scan, we will follow up on the reabsorption of the TraceIT hydrogel over the 12 month period. This is in addition to the standard of care treatment. Participants will also be asked to complete questionnaires to assess quality of life and overall experiences. This study will assess the efficacy of the TraceIT product and further support and validate its use in our clinical practice.

Pulmonary rehabilitation (PR) is an evidence-based intervention recommended for people with chronic obstructive pulmonary disease (COPD), the second leading cause of avoidable hospitalisation in Australia. PR improves quality of life and reduces health care utilisation. However, any benefit from completing Phase 2 (“initial”) PR diminishes in the months following. Currently, participants are invited to continue attending a weekly Phase 3 (“maintenance”) program for 10 weeks. With lack of robust evidence supporting the benefits of Phase 3 PR, program funding is constantly threatened. The 2017 Australia and New Zealand Pulmonary Rehabilitation Clinical Practice Guidelines calls for further research to clarify the benefits of Phase 3 PR. Our primary aim is to compare the health-related quality of life (HRQoL) in participants receiving the extended Phase 3 PR against those not receiving the extended program. We hypothesise that in the 6 months following completion of the extended Phase 3 PR program, participants who completed the extended program will have a better HRQoL than the control group. We will randomise participants who have completed a Phase 3 PR program to either a further 6 months of the maintenance program plus unsupervised home exercise (community program) or 6 months of unsupervised home exercise (home program).

To conduct a multisite pragmatic RCT pilot study of early vision-aware and parent-directed environmental enrichment program (VISIBLE: early Vision Intervention for Seeing Impaired Babies: Learning through Enrichment) which aims to: 1. Determine the feasibility and acceptability of the VISIBLE intervention program for infants with severe CVI and high risk of Cerebral Palsy. 2. Evaluate efficacy of the VISIBLE program to lead to greater improvements of (i) visual function, (ii) developmental outcomes (developmental, motor, fine motor) and (iii) parent infant emotional and relational development, as compared to standard of care (SoC). VISIBLE is an early intervention program based on the core principles of optimising infant’s visual experience during the first phases of development. The general principles are activity-dependent learning and environmental enrichment. Parents are essential to environmental enrichment for infant learning success. They provide the environmental cues for both social and physical infant exposure. Utilizing this principle, parents will provide vision-awareness environmental enrichment – adapting the social and physical environment to allow the infant the opportunities to learn by successfully experiencing their enhanced environment. Within the context of parent-child daily goal-oriented interactions, environmental enrichment, as it relates to vision-awareness modifications, will include light, spatial distances, salience, consistency and multimodality of infant’s environment. The major hypothesis to be tested is: H1Infants with severe CVI and high risk of Cerebral Palsy who receive the VISIBLE program will have superior visual behaviour scores at 12-months of age, compared to those who receive standard care. The secondary hypotheses are: H2 Infants with severe CVI and high risk of Cerebral Palsy who receive the VISIBLE program will have superior cognitive scores on the Bayley Scales of Infant Development and/or superior motor scores on Peabody Developmental Motor Scales at 12-months of age, compared to those who receive standard care. H3Parents will find the VISIBLE program intervention feasible and acceptable to implement.