ANZCTR search results

1. What is the research project about? Babies can be born with different degrees of hearing loss. Hearing aids are generally provided to them to help them hear well. Whilst we know that hearing aids help babies with moderate or greater degrees of hearing loss, we do not know whether hearing aids are helpful for babies with mild hearing loss, even though they are often offered to these babies. This is a pilot study that will help us plan for a bigger study in the future to increase knowledge about whether hearing aids help babies with mild hearing loss.Hearing aids can help babies with moderate or greater degrees of hearing loss to hear. However,, but we do not know whether they help babies with mild hearing loss even though they are commonly offered hearing aids. . This study is a first step to collect information that we hope will lead to a larger study to helps us answer this important question. 2. Who is running the project? The study is run by a team based at the Murdoch Children’s Research Institute (MCRI) in Melbourne and the National Acoustic Laboratories (NAL) in Victoria, New South Wales and Queensland. MCRI is the research institute affiliated with the Royal Children’s Hospital in Melbourne and is the largest child health research institute in Australia. NAL is the research arm of Australian Hearing, which is responsible for looking after the hearing health of all children with hearing loss in Australia. The study is funded by a philanthropic grant from the Garnett Passe and Rodney Williams Memorial Foundation.

Probiotics are defined as live microorganisms which when administered in adequate amount confer a health benefit on the host. The probiotic efficacy relies on their ability to survive in the digestive system and proliferate in the gut. The aim of this study is to investigate the survival of LcS in the intestine of healthy Australian adults after intake of fermented milk (Yakult). A single-arm, open-label study involving 25 otherwise healthy adults will examine the recovery of live culturable bacteria from faecal samples following 7 and 14 days of Yakult ingestion.

The study will have a pretest-posttest design and will be conducted on community-dwelling people with SCI. Participants will train a partially paralysed muscle group for six weeks. The purpose of this study is to determine changes in muscle architecture of partially paralysed muscles in response to strength training. An understanding of the underlying causes of strength increases in people with spinal cord injury will help inform the development and provision of rehabilitation programs. Muscle architecture will be measured before and after training using magnetic resonance imaging (MRI) and diffusion tensor imaging (DTI). The participants will receive a strength-training program for the target muscle group three times a week for 6 weeks which will consist of both isometric and concentric contractions. We hypothesise that strength training of partially paralysed muscles will increase muscle physiological cross-sectional area

Patient reported outcomes (PRO) are increasingly used to measure the effectiveness of interventions for management of chronic conditions. Many of these instruments require respondents to describe the change in their health status from baseline to a follow-up assessment. This is often problematic for patients with chronic disease and poor recall of previous health status limits the usefulness and validity of these PRO measures. The aim of the study proposed here is to evaluate the utility of tablet computers as a technological tool to aid patients’ recall of previous responses when completing PRO measures. Our hypothesis is that the magnitude of the difference (responsiveness) will be greatest in those who saw the audio-visual recording. The feasibility assessment will be reported using descriptive statistics based on the NIHR (UK) feasibility and pilot studies criteria..

The aim of this research project is to test an online program, Uprise, in Australian tertiary students. The program is designed to improve the wellbeing of university students through a series of interactive modules informed by cognitive behavioural therapy and mindfulness. Participation involves completing four modules of the program over a 4-week period. The study also involves at least three 2-4 hour assessments, one before starting the program, one after completion of the program, and another 3 months later. All assessment sessions will be held at the Swinburne Hawthorn campus, or via telephone or video conference. Half of the participants will be randomly selected to wait a month after the first assessment and complete an additional 1-2 hour assessment before starting the program.

This study will explore the feasibility of expiratory muscle strength training (EMST), as a novel, non-invasive treatment approach to reduce drooling in people who have Parkinson's disease (PD). The intervention involves breathing into a threshold loading device. The intervention will take place over a 6 week period and will involve both supervised and unsupervised practice. We hypothesise that EMST will be feasible and well tolerated in this population and will reduce drooling in people with PD by strengthening the muscles associated with lip closure and swallowing.

This study aims to treat young children between the ages of 3-5 years who are suffering from a specific phobia. Research to date suggests that whilst older children and adults can be successfully treated with a one session psychological treatment for phobias, it is currently unknown whether pre-school aged children will benefit and have long lasting effects from this intervention. The aim of this study is to engage children in a one session exposure treatment using a play based approach, and compare long term outcomes, relative to two other conditions -- a 6 month waitlist condition (monitoring only), as well as an education support intervention. This study is a randomized controlled trial, which means children are randomly assigned to one of three different conditions. The three conditions are; (1) a one-session cognitive-behavioural intervention with play therapy (P-OST); (2) an educational support intervention (EST); and (3) a 6 month waitlist control condition. If children in the EST or waitlist conditions continue to experience their phobia, they will be offered the one session cognitive-behavioural intervention at 12 months follow-up.

This study aims to investigate whether a 12-week combined psycho-education, exercise and oral health intervention can improve general wellbeing, cognition, mental and metabolic health in individuals residing in residential aged care. The active intervention will comprise a group-based exercise and psycho-education program with immediate dental treatment. Results will be compared to an active workbook control condition, who will be offered the oral health intervention following the 12-week intervention period. We hypothesise that the combined psycho-education, exercise and oral health intervention can improve general wellbeing, cognition, mental health and metabolic health, and we may see a greater positive effect of the combined exercise and psychoeducation program in the facilitated group as compared to the active workbook control group. Furthermore, we may find that the dental treatment is more effective following the completion of the exercise and psychoeducation program rather than concurrently with the exercise and psychoeducation program.

Cardiovascular disease (CVD) is the leading cause of death in Australia . Cardiac rehabilitation (CR) programs assist recovery after a cardiac event and reduce the risk of repeat events. The uptake of CR programs is as low as 10-30% with a variety of barriers to attendance. Using technology via a smart phone app with a specific cardiac rehabilitation format may assist with overcoming some of these barriers and may be used to enhance program uptake and completion .

This is a three-arm, pharmacokinetic, safety, tolerability and immunogenicity study to compare investigational product JHL1188 versus EU and US sourced Herceptin in healthy male participants. Who is it for? You may be eligible to join this study if you are male aged 18 to 55 years old, healthy non-smoker and non-drinker Study details Approximately 159 eligible subjects will be randomized in a 1:1 ratio to receive either JHL1188 (n=53), Herceptin_EU sourced (n=64) or Herceptin_US sourced (n=53). Each subject will receive one intravenous (IV) infusions of the investigational product at the dose of 6 mg/kg on Day 1. Assessments of PK, safety, tolerability, immunogenicity will be collected over the following 70-day period. JHl1188 is developed as a biosimilar of Herceptin, Herceptin is approved for the treatment of adult patients with HER2 positive breast cancer and metastatic gastric cancer. This clinical study is intended to study the similarity between JHL1188 and Herceptin.