ANZCTR search results

The objective of this study will be to compare the effectiveness of the currently marketed Co-phenylcaine Forte spray with a reformulated Co-phenylcaine spray incorporating taste masking and flavouring agents (Co-Phenylcaine Neo spray), when administered intra-nasally, in a group of patients undergoing nasendoscopy. The study will be an equivalence trail (10% equivalence margin) using a randomised, blinded, cross-over design with participants undergoing two nasendoscopy procedures approximately 4 weeks apart. Participants will be asked to rate the taste associated with the spray and rate any pain or discomfort they feel following insertion of the nasendoscope. It is hypothesised that both interventions will have an equivalent effect in reducing discomfort and the new formulation will have a preferred taste.

There is an imperative to find alternative care pathways for the 15% of people who are unlikely to benefit from knee total joint replacement (TJR). Chronic low back pain shares a similar multi-dimensional risk profile to knee joint osteoarthritis. Much effort has been directed to developing targeted treatment to subgroups of people with chronic low back pain who have poorer prognosis based on their group profiles. In keeping with this, this research group has developed an individualised model of care for chronic low back pain that effectively targets the multidimensional complexity of the disorder, termed ‘cognitive functional therapy’ (CFT) (Vibe Fersum, et al. 2019). Such an approach may offer a promising alternative to knee TJR in those patients at risk of poor outcome with the procedure, but before this intervention can be tested in randomised, controlled trials there is a need to explore the potential effectiveness, treatment mechanisms and moderators in this population. The main aim of this study is to test Cognitive Functional Therapy in a small but diverse sample of eight people with knee osteoarthritis who are at risk of not benefitting from a total knee replacement.

The main aim of the PIVOT study is to evaluate the effect of a simplified “one-stop-shop’ test and treat intervention on increasing the number of prisoners with hepatitis C (HCV) who initiate HCV therapy following reception. The study will be conducted in two phases: a control period and intervention period. The control period will allow observation of throughput in the HCV care cascade in the existing Justice Health & Mental Health Network (JH&FMHN) model of care. The intervention combines point-of-care finger-stick HCV testing (for HCV RNA, which tests for the virus indicating active infection), non-invasive liver fibrosis assessment (to check liver scarring), and treatment prescription (if HCV-positive), followed by linkage to ongoing hepatitis care all in the same 60-minute visit. The study will also evaluate the efficiency (time taken to each step of the care cascade) and acceptability (number of participants refusing to participate) of the intervention, as well as the rates of participants clearing the virus post-treatment, and treatment uptake. Participants will be recruited from new receptions to Mid North Coast Correctional Centre. The intervention method will be evaluated against the existing standard of care model for effectiveness, efficiency, and acceptability.

The purpose of this study is to identify the time point of peak serum potassium levels during the reperfusion phase of adult liver transplantation. We aim to assess the the changes in blood potassium levels from baseline values during reperfusion, and evaluate clinical factors that may be associated with the development of hyperkalaemia. Who is it for? This is a retrospective study evaluating potassium levels in adult patients undergoing primary orthotropic liver transplantation. Study details The aim of this study is to quantify the changes in potassium during the reperfusion phase of liver transplantation. Elevated recipient serum potassium levels have been identified as an independent risk factor for post-operative mortality in liver transplantation. Further, severe hyperkalemia at reperfusion can result in cardiac arrhythmias and cardiac asystole if not adequately monitored and treated. We consider the incidence and severity of hyperkalaemia in this setting. In addition, we will highlight the importance of evaluating the changes in potassium relevant to patients undergoing liver transplantation. It is hoped that this study will be hypothesis generating and provide valuable data for power calculations for future studies on evaluating changes in potassium values during reperfusion. Further, we will provide an in-depth insight of the changes in serum potassium levels during the reperfusion stage to guide clinicians caring for such patients.

The overall goal of this project is to investigate the effectiveness of a universal, mental health and suicide prevention program – Youth Aware of Mental Health (YAM) – for reducing suicidal ideation and increasing help-seeking. The study will test the effectiveness of the YAM intervention for decreasing suicidal ideation from baseline to post-intervention and at 3-month follow-up compared to a waitlist control group.

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of both single and multiple oral doses of an already approved drug called etifoxine. This study will run in 2 stages and involve approximately 30 participants in total. Stage 1 will evaluate the pharmacokinetics, pharmacodynamics and safety of single doses of etifoxine. This stage will enrol approximately 12 participants into a crossover design study where they will receive either etifoxine as a single dose or a placebo at the first visit and then they will receive the opposite intervention at the next visit 7 days later. Stage 2 will evaluate the pharmacokinetics, pharmacodynamics and safety of multiple doses of etifoxine. This stage will enrol approximately 18 participants who will be randomised to receive either etifoxine or a placebo given every 12 hours for 7 days.

The primary aim of this study will be to determine if a pre-operative questionnaire, the ARISE tool, can predict discharge destination to home or inpatient rehabilitation following primary total knee replacement surgery. Existing tools have been criticised for not being predictive of "moderate" scorers, only predictive of those scoring in the high or low range categories. The ARISE tool is designed to capture additional information around a patient's beliefs rather than demographic features such as age and gender etc alone.

Friedreich ataxia (FA) is a chronic, progressive, and terminal illness. Currently, there are no effective treatments and no sensitive biometrics of illness progression for FA. Oxidative stress has been proposed as a candidate molecular process that contributes to the underlying neuropathology, and/or reflects the cellular dysfunction underlying this disease. Measuring and tracking oxidative stress in the human brain using Positron Emission Tomography (PET) provides an opportunity for in vivo mechanistic characterisations disease in the human brain, and represents a novel and potentially sensitive approach to addressing the urgent need for pharmacodynamic and treatment monitoring biomarkers for use in clinical trials. The current study aims to investigate 64Cu-ATSM PET as a tool for imaging oxidative stress in the brains of individuals with FA.

In today's society, snacking has become a regular activity that is affecting the food views and lifestyles of many adults. Regular snacking may simply be the way an individual consumes what they require. But others are consuming snacks that are of poor nutritional value and high in sugar and fat. These types of “snack” foods are being consumed more often and these poor eating habits increase the likelihood of weight gain. We hypothesise that it is this type of snacking behaviour that can be targeted to improve weight mangement for those individuals motivated and able to limit the consumption of snack foods.

MenGO is a Phase III open-label randomised control study in gay and bisexual men, comparing the incidence of gonorrhoea infection in those vaccinated with Bexsero® to those who do not receive the vaccine. The study will test the hypotheses that a reduction in number of gonorrhoea infections will be seen following vaccination with Bexero. It will also investigate Bexsero®-induced antibodies that will inform rational novel vaccine design and show that Bexsero® is a safe vaccine for administration in GBM aged 18-50 years.