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A first in human study to evaluate the safety and immune response to a vaccine for the treatment of a respiratory virus, when administered into the arm in healthy adult participants.
Expand descriptionAdvanced Vaccine Laboratories Pty Ltd is developing a recombinant Respiratory Syncytial Virus (rRSV) vaccine for the protection of children (6 months to 5 years old) and the elderly from RSV infection. Human RSV infects nearly all children by the age of two years, and it is a leading cause of severe lower respiratory tract (LRT) disease in both paediatric and elderly populations as well as in individuals was immune system is profoundly compromised. The investigational product BARS13 has not previously been administered to human subjects. The purpose of this study is to evaluate the safety of, and how the body reacts to, BARS13 investigational vaccine when administered in the arm to healthy adult participants aged 18 to 45 years according to a single (at Day 0) or repeat (at Day 0 and Day 30) vaccination schedule, with follow-up occurring for 60 days after the last vaccination.
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Steroid Therapy and Outcome in Parapneumonic Pleural Effusion (STOPPE): A randomised double-blind placebo-controlled trial of intravenous steroid in the management of parapneumonic pleural effusion.
Expand descriptionThe lung and the inside of the chest wall are both covered by a thin lining called the pleura, which produces a very small amount of fluid to lubricate the lung during normal breathing. Pneumonia can cause a build-up of fluid in between the pleural linings called a parapneumonic pleural effusion. In many cases, the effusion clears up with antibiotics; less commonly, a chest tube is required to drain the fluid. Steroids are anti-inflammatory medications that have been used for many years in the management of many medical conditions such as rheumatoid arthritis and asthma. In certain serious infections, inflammation is thought to be the cause of some of the symptoms, and steroids have been used to reduce these effects. Steroids have been used in people with pneumonia in the past with some success, and importantly, few side effects. There is some evidence to suggest that parapneumonic pleural effusions occur because of excessive inflammation, which may delay recovery. A recent study in children showed that patients with a parapneumonic effusion recovered faster if they were treated with steroids in addition to antibiotics. In this study, we aim to assess whether administering steroids to adults with a parapneumonic effusion will speed up their recovery from the illness. Study participants will receive 4 doses of steroid or a placebo over 48 hours. A placebo is a medication that looks the same as the steroid but doesn't contain any active drug. This study will be "double-blind" which means that neither the participant, nor the doctor, will know which treatment is administered until the end of the study. It is a randomised clinical trial which means that each participant will be put in one of the study groups (to receive the active drug or placebo) by chance and will not be able to choose their treatment. Two-thirds of participants will receive the study drug and one third will receive placebo. The 48 hour treatment course is considered to be short, which means that there is much less likelihood of any side effects. The main side effect of steroids is high glucose levels in the blood, which typically go back to normal once the treatment is stopped. Other possible side effects include inflammation/bleeding in the stomach, suppression of the immune system and worsening infection, oral thrush and mood disturbance. In studies that have been done so far, none of these were more common in the group treated with steroids compared to those who weren’t. The outcomes that we will assess to compare the two groups will include the time to recovery from the illness, changes in blood tests and chest x-rays over time, duration of antibiotic therapy and length of stay in hospital, need for a procedure to drain the fluid, quality of life over the 30 days post-treatment, adverse events (side effects of treatments) and overall survival. The data collected will be analysed by a statistician.
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Group-based exercise physiology services for those aged over 50
Expand descriptionOur aim is to investigate the impact of short-term, group-based classes, specifically targeting multiple conditions associated with ageing (sarcopenia, osteoporosis and poor balance), on the health and wellbeing of participants. The common denominator in these classes will be the evidence-based design of the programs and delivery by accredited exercise physiologists. The hypothesis is that participants will improve in their physical capacity, exhibit less signs and symptoms of the target conditions and increase their ability to engage in activities of daily living. This increased functional capacity will be accompanied by improved measures of quality of life.
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Women's action for Mums and Bubs (WOMB): a trial of participatory women's groups to improve Indigenous maternal and child health.
Expand descriptionImproving maternal and child health (MCH) care and outcomes has an impact throughout the lifespan. Most quality improvement interventions focus on service-level action, despite evidence that up to 2/3 of the variability in quality of care might be due to factors beyond health services. Good international evidence indicates participatory planning and implementation processes in partnership with community women can deliver real outcomes for improved MCH. Community participation is the collective involvement of local people in a geographic location, making decisions about their needs and priorities, implementing strategies, and monitoring progress in partnership with health services. Such community participation has not been tested in the Aboriginal and Torres Strait Islander primary health care (PHC) setting. This WOMB trial tests the effectiveness of community participation in improving Indigenous MCH. This stepped wedge intervention will see the formation of Participatory Women's Groups (PWGs, groups of women in a community interested in MCH improvement) at 10 sites across Australia. Community participation will involve training local facilitators of PWG groups, supportive engagement with local MCH data through workshops, PWGs identifying and prioritising issues and strengths and co-implementing solutions with health services. Outcomes will be measured with yearly MCH audits, cost-effectiveness and process evaluation. The PWG intervention will be structured on the Remote Services Futures community participation framework. If successful, the WOMB trial will provide rigorous evidence supporting community participation as a means for improving MCH in Indigenous communities, moving towards closing the gap in health outcomes across the lifespan.
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Postural stability after deep brain stimulation in Parkinson disease patients
Expand descriptionThis 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.
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Assessing the safety and feasibility of depot buprenorphine in NSW custodial settings
Expand descriptionThis 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.
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Safety, tolerability, and pharmacokinetics of single and multiple doses of a PLA2 inhibitor (c2) in men with prostate cancer: A Phase 0 and limited dose-escalation trial
Expand descriptionThis 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.
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Determining the effect of early eczema education, in the form of a series of video's and pamphlet, on eczema severity in children < 6 years of age.
Expand descriptionEczema 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.
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Reducing Risk Factors for Cognitive Decline Through Psychological Interventions: A Pilot Randomised Controlled Trial
Expand descriptionA 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.
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Time-restricted eating in individuals with type 2 diabetes
Expand descriptionWhile 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).