ANZCTR search results

The primary aim of this project is to examine the feasibility, consumer acceptability and behavioural outcomes associated with take-home fentanyl test strips (FTS), providing an evidence base for implementation and expansion across services in Australia. People who use heroin (n=80) will be trained in how to use FTS to test their heroin (or other illicit substances) for the presence of fentanyl, and how to interpret the results, Upon completion of the training, participants will complete a short baseline survey, and be given ten strips to take home and use as they wish. Participants will be followed-up four weeks later to assess uptake and consumer acceptability of the strips, as well as associated behavioural changes.

SCUlpTOR is a 24-month research study sponsored by the University of Sydney, evaluating the efficacy and cost-effectiveness of stem cell injections compared with placebo in people with knee OA. Currently, the medical opinion about stem cell therapy for treating osteoarthritis remains highly controversial, given the considerable cost of treatment and very limited scientific evidence of efficacy and safety. Therefore, we aim to conduct this trial to ascertain whether or not intra-articular stem cell injections improve symptoms and slow disease progression in people with mild to moderate knee OA. The stem cells being used were originally sourced from a healthy donor/master cell bank following a standard manufacturing process and release tests to optimise safety and batch to batch reproducibility.

This study will compare the ‘best possible’ treatment delivered during the COVID-19 pandemic to ‘ideal’ treatment before the pandemic for newly diagnosed early breast cancer patients Who is it for? You may be eligible to join this study if you are aged 18 and above, have been newly diagnosed with early breast cancer at Westmead Breast Cancer Institute during the COVID-19 pandemic and discussed by the Westmead multidisciplinary cancer team (MDT) between March and June 2020. Study details MDTs, consisting of surgeons, medical oncologists, radiation oncologists, pathologists, breast physicians, genetic oncologists and other specialty representatives, will discuss and assess participants’ ‘ideal’ and ‘best possible’ treatment options at team meetings. All participants assessed by an MDT will have discussions about the ‘ideal’ and ‘best possible’ treatment with their treating specialist. The reasons for any treatment that varies from ideal will be explained to the participant. When the COVID-19 pandemic finishes, the participant will be recalled to discuss further treatment if their treatment differed from the 'ideal.' At various stages of treatment, the MDTs will meet and assess participants’ treatment options. All discussions and treatment delivered will be documented in medical records. It is hoped that this research will give insight into the challenges that the COVID-19 pandemic has presented for breast cancer treatment. It will also identify participants who have not had ideal treatment and they can be followed closely in the future.

Curcumin is a well-evidenced and widely administered supplemental compound. Previous studies have demonstrated its capacity to reduce inflammation and associated physical manifestations. A large body of evidence has also confirmed that ingestion can attenuate oxidative damage. However, the bioavailability of naturally occurring curcumin is poor. Fortunately a novel curcumin formulation, using LipiSperse® technology, has been developed which increases plasma curcuminoids concentration three times compared to raw curcumin. While the safety of this novel formulation has been demonstrated (TGA listed) its effectiveness to reduce markers of inflammation and oxidative damage is not yet known. Therefore the objective of this double blind, placebo controlled trial is to investigate, in healthy humans, the efficacy of the novel curcumin formulation (with LipiSperse® technology) to reduce markers of inflammation and oxidative stress compared to both natural curcumin (without LipiSperse® technology) and a placebo control.

Auditory information is also used to shape predictions about the body. The marble hand illusion demonstrates that when vision of the hand being struck by a small hammer is paired with the sound of a hammer hitting a piece of marble, the hand starts to feel stiffer, heavier and harder, and this changes sensitivity to noxious input. Furthermore, auditory information of a creaky gate paired with back movement led to people overestimating forces applied to the back compared to pairing the movement with a smooth ‘whooshing’ sound. We wish to explore whether auditory information has an influence on pain and function using a clinical pain paradigm. The aim of this study is to examine the effect of auditory information on pain and function in people with AT. To achieve this, we will assess pain and leg stiffness with hopping in people with AT while they hop with no auditory input and compare this to a condition in which hopping is paired with auditory input that suggests enhanced functional capacity of the tendon (a springy “boing” sound) and hopping with auditory input that suggests impaired functional capacity of the tendon (a flat ”slapping” sound). To control for the confounding effect of sound we will also include a control condition in which participants hop while white noise is played through the speakers. Both studies will help inform 1) whether non-nociceptive information sources are important in influencing pain in a clinical condition and 2) reveal if changes in pain are associated with functional performance changes. Furthermore, by enhancing our understanding of how visual and auditory information influences pain intensity we will extend our understanding of the pain experience and may improve the potential utility of these types of feedback as a treatment tools.

Patients with a Cardiac Implantable Electronic Device (CIED) can undergo Magnetic Resonance Imaging (MRI) scan provided that certain device conditions are met. This requires interrogation of the device and fulfillment of conditionality checklists in the peri-MRI setting. The number of patients with a CIED is increasing and many of whom may at some stage require an MRI, it is therefore anticipated that the number of requests for CIED check in the peri-MRI setting will increase. Additionally, recent data suggests that non-conditional CIED are safe for MRI scan, and if permitted by our radiology department would further increase the burden of peri-MRI scan CIED checks. Our proposed research is to analyze the clinical burden and model of care for CIED checks in the peri-MRI setting

The study will observe patients receiving usual care for major surgery where multi day stay is likely. It will capture video footage of patients faces prior to surgery (as a baseline) and also prior to surgery after they receive opioid as part of their anaesthetic, as they begin to wake from their anaesthetic but are not yet awake, and after they receive their first dose of opioid in the post anaesthesia care unit. The video recordings will then be analysed using a computer program for artificial intelligence facial recognition and information from this analysis will be correlated with known measurements tools to evaluate whether there is correlation between: - pain intensity levels and pain intensity measured with the behavioural pain intensity scale -specific facial expressions that indicate susceptibility to prolonged requirement for opioid analgesia Our hypothesis are that 1) there is strong correlation between facial expressions as measured by 3D facial mapping and pain intensity before waking from anaesthesia 2) there is strong correlation between certain facial expressions as measured by 3D facial mapping and susceptibility to opioid as expressed by prolonged duration of opioid requirement following surgery

Irritable bowel syndrome (IBS) is a gut function disorder which causes chronic pan, bloating, diarrhoea and constipation. IBS affects 11% of the world’s population and is notoriously difficult to diagnose, because it causes no obvious structural changes. Experts recommend use of the Rome IV questionnaire about symptoms to diagnose IBS, but this gives a lot of false negatives, and is not commonly used. Typically doctors diagnose IBS by ruling out other gastrointestinal diseases with similar symptoms using colonoscopies. These are costly and invasive and still don’t provide a positive diagnosis for IBS, which leaves patients confused and reluctant to start treatment. We have developed an acoustic belt and associated software that analyses gut noises. This allows us to tell apart people with healthy guts and IBS with high accuracy. However, IBS diagnosis also involves differentiation between IBS and organic diseases, with similar symptoms. The objective of this study is to develop and test the differential diagnosis capabilities of the acoustic belt. We will collect gut sound recordings from patients with coeliac disease, Crohn’s disease and ulcerative colitis at the time of diagnosis by gastroenterologists. We will then use features from the sound recordings to build optimal models (software) that characterise the conditions. We will then test the accuracy of these models with a new set of study participants. Again, these participants will be patients newly referred to gastroenterologists by GPs or Emergency Departments for investigation of lower abdominal symptoms. All will undertake the reference standard: clinical investigations, pathology tests and scoping to arrive at a diagnosis. This is arrived at as part of routine care. They will also undertake the sound recording test (with the technicians and sound analysts blind to their condition). The results of the reference standard and the sound test will be compared to arrive at measures of accuracy for the sound test. The project is a key step in assessing the feasibility of a sound based, non-invasive approach for screening for organic disease and IBS diagnosis.

Anxiety disorders are common, cause significant impairment in childhood, and increase the risk for lifelong disability. Sadly, 30% of Australian children are unable to access evidence-based treatments. Online interventions for anxious children and adolescents improve access to care across Australia and are effective. Yet, current evidence suggests that frequent therapist support is required alongside these programs to obtain good clinical outcomes, limiting their cost-effectiveness and reach. Recent research in adult online interventions suggests that similar outcomes are possible with minimal or no therapist guidance. In this study we will compare the efficacy and cost-effectiveness of a validated online intervention, Cool Kids Online, delivered with varying degrees of therapist support. Using a gold-standard randomised controlled trial design, we will compare scheduled therapist guidance, optional (on request) therapist guidance and self-guidance (i.e. unguided) delivered using practices perfected in adult online intervention research. A waitlist condition will also be employed, and we will explore predictors and moderators of treatment outcome. The project hypotheses are as follows: Hypothesis 1a: Cool Kids Online (regardless of degree of therapist support) will result in significant reductions in diagnoses and anxiety symptoms, and improvements in quality of life immediately after treatment. Hypothesis 1b: These effects will be maintained six months following treatment. Hypothesis 2a: The three treatment conditions will show cost-efficacy compared to the control condition. Hypothesis 2b: Optional and self-guided treatment will show cost-efficacy compared to therapist guidance (mostly due to the reduced costs of therapist and supervision time in the reduced guidance conditions). Finally, we will explore demographic, diagnostic, family factors, treatment preference, and therapist support as moderators and predictors of treatment outcome, but because this study aim is exploratory no specific hypothesis can be made. However, results will inform recommendations for broad implementation of iCBT for child anxiety.

This is a substudy of the Cancer Molecular Screening and Therapeutics (MoST) Program, which is registered on ANZCTR with ID ACTRN12616000908437. This substudy will evaluate the activity of combination of vemurafenib and cobimetinib in a population of participants with newly diagnosed metastatic non-squamous small cell lung cancer (NSCLC) or other tumours harbouring BRAF V600 mutations detected using comprehensive genomic profiling. Who is it for? You may be eligible to join the study if you are aged 18 years and older, with pathologically confirmed advanced and/or metastatic NSCLC or solid tumour of any histologic type or an earlier diagnosis of a poor prognosis cancer. Your tumour will need to express a BRAF V600 mutation. Study details: Participants will receive both vemurafenib and cobimetinib treatments. The vemurafenib and cobimetinib are to be taken orally, at 960mg twice daily (days 1 to 28 in a 28-day cycle) for vemurafenib and at 60mg daily (days 1 to 21 in a 28-day cycle) for cobimetinib. Both vemurafenib and cobimetinib will be given to participants continuously as long as they and their doctor agree there is a benefit from treatment. Participants will undergo imaging assessments at 8 weekly intervals from first treatment until progression. Safety and tolerability of treatment will be assessed at 4 weekly intervals. Health related quality of life during treatment will be assessed at 4 weekly intervals and then every 8 weeks after end of treatment until progression. We cannot guarantee that participants will receive any benefits from this study. This study is being carried out to improve the way we treat cancer patients who may have limited treatment options available to them. It is hoped that vemurafenib and cobimetinib will be well tolerated and will improve outcomes for future patients, however, there may be no clear benefit from participation in this study.