ANZCTR search results

This study aims to evaluate the feasibility of point-of-care (POC) C-reactive protein (CRP) testing to support pharmacists’ management of respiratory tract infections (RTIs) in community pharmacies in Western Australia. POC CRP testing provides a result in less than five minutes, using a capillary blood sample from a finger prick and is a biomarker of inflammation used to assist differentiation between bacterial from viral infections in some circumstances. The study hypothesis is that CRP testing in community pharmacies, in addition to pharmacists' routine assessment, following a validated clinical guideline and protocol, is feasible in the community pharmacy setting and acceptable by consumers and pharmacists.

Injecting medicine into the eye is an effective treatment for swelling of the macular in diabetes. Aflibercept is one of two medicines approved to treat this swelling. While effective, treatment can be prolonged. After three initial monthly injections, the duration between subsequent injections varies. It can be fixed, given when the condition worsens or timed according to response. The effectiveness of injections when timed according to a person’s response is being investigated. This is known as a ‘treat and extend’ protocol. This protocol reflects real world treatment in Australia. This study will help look at the effectiveness of this approach. It will also allow us to identify the best interval between injections.

This study is being conducted to evaluate the pharmacokinetics of single oral doses of XW10172 and Xyrem in healthy volunteers under fast and fed conditions.

The purpose of this study is to test the safety and tolerability of two types of a potential breast cancer treatment called endoxifen. Who is it for? You may be eligible for this study if you are a healthy female aged 18-65. [***Please note participants who have cancer are not eligible for this study.***] Study details Participants in this study will be organised into two groups. One group will receive capsules to be taken by mouth, and the other group will receive tablets, to be taken by mouth. Within the capsule and tablet groups, participants will be randomised (by chance) to either the active drug or a placebo. Neither the participant nor investigators will know who gets the active or placebo drug. Initially, only a single capsule or tablet will be taken. After checking the results of this first day, participants may take their assigned tablet/capsule once a day for another 14 days. As part of this study, all participants will need to provide blood samples, urine samples, answer questionnaires and have a physical exam.

A prototype bio-impedance recording device called Cardia [TIP2] has been developed by Melbourne based medical device company Grey Innovation. An earlier prototype of this device [TIP1] has already undergone a clinical study (CTN-03513-1) in dialysis patients where 16 patients wore the device over 19 sessions lasting 4-6 hours each. It was found that changes in bio-impedance were reliably measured with the Cardia [TIP2] prototype - correlating with fluid removed from the participant during dialysis. This study will enable the prototype to be tested in heart failure patients, the end user population over a longer period of time. This study will provide information that will enable us to move towards an optimised device that is to be tested in a large-scale home-based trial. The home-based trial will compare those who do have the real-time volume status information to act upon against those who do not and will assess whether relevant clinical outcomes can be improved, i.e. prevention of heart failure re-hospitalisation or minimisation of time in hospital for acute decompensation. Thus, this specific project is critical in advancing the commercial and therapeutic/diagnostic potential of the device, before such a study can be considered. Our goal is that this will ultimately lead to the development of a commercially viable, low-cost (potentially disposable), non-invasive approach to assessment of fluid status to allow early intervention and increase health outcomes in heart failure patients.

One-quarter of adolescents live with regular, debilitating kneecap pain. This causes substantial pain and disability, and reduces quality of life. Kneecap pain in adolescents is not a self-limiting condition – up to 95% continue to have pain after two to eight years. This can set the scene for a lifetime of knee pain and associated health implications, with many adolescents reducing or withdrawing from sport and physical activity. The problem is the lack of evidence and clinical guidelines for effective treatments for adolescents with kneecap pain. Best-evidence treatments for adults with kneecap pain, such as exercise, are not as effective for adolescents. This may be because adolescents simply do not do their prescribed exercises. 'Off-the-shelf' shoe inserts may be the solution. These are simple, accessible, low-cost devices that are easy for adolescents to wear in their regular footwear, such as school and sports shoes. The HAPPi Kneecaps! Trial will determine the feasibility of conducting a full-scale randomised clinical trial investigating shoe inserts for adolescents with kneecap pain. Secondary outcomes will explore whether shoe inserts can improve pain, function and quality of life in this population. Findings will inform future large-scale clinical trials, with the potential to advise clinical practice guidelines providing adolescents with effective, evidence-based options for managing their kneecap pain. This study is an essential first step in identifying effective interventions for adolescents with kneecap pain, with the potential to change the persistent, chronic nature of kneecap pain at its earliest onset.

The purpose is to test a simple, effective treatment package that can be delivered by non-doctor or non-nurse personnel but who are suitably trained in the delivery of the educational resources. The focus is on health literacy to improve self-care and connect to community support. We know that a comprehensive package is of benefit, but we don’t know which components of the package drive the benefit. We hypothesize that an In-hospital intervention in an Australian public hospital context for people identified as having Type 2 Diabetes will lead to improvements in blood sugars and reductions in diabetes related distress, and ultimately a lower probability of re-admission or if admitted and an admission of shorter duration.

This study will investigate the feasibility and acceptability of an eight-week behavioural activation programme, delivered by volunteers, designed to improve the wellbeing of residents in residential aged care facilities (RACFs), a group known to experience high levels of depression. The programme will involve training approximately 10 volunteers in behavioural activation (BA) techniques over two half-day training sessions. The volunteers will then work with aged care residents twice per week for eight weeks to deliver the BA programme. Behavioural activation is a well-supported treatment for depression that aims to improve mood by using a structured approach to increasing participation in enjoyable activities. The primary aim of this study is to investigate the feasibility of an 8-week volunteer-led BA intervention for RACF residents. The secondary aim of this study is to collect preliminary data to investigate if the intervention shows promise in being effective in reducing psychological symptoms (depression, anxiety) and improving the well-being of approximately 20 aged care residents.

A double-blind study to evaluate the effectiveness of bioavailability enhancers to increase blood absorption of antioxidants and fat-soluble nutrients over a 48-hour period in otherwise healthy individuals.

This study aims to evaluate the safety and acceptability of iMove in patients undertaking Immunotherapy and to also assess the feasibility of conducting a future, definitive RCT. Who is it for? You may be eligible to join this study if you are aged 18 years or above with a diagnosis of Stage IV Melanoma and scheduled to receive Immunotherapy. Study details Participants will be randomly allocated to one of two groups, to either the intervention (iMove) or the control group (standard care, currently given to all cancer patients). For people who are allocated to the intervention group, the exercise program will run for 12 weeks and be personalised according to each participant's exercise ability. The exercise program is designed to be prescribed for when people begin receiving their immunotherapy infusions. Both the intervention and the control group will be asked to complete questionnaires at 5 time-points over three months and complete three physical assessments in the first twelve weeks. It is hoped that this research will help us assess whether exercise for people diagnosed with advanced melanoma receiving immunotherapy will be safe and feasible.