ANZCTR search results

Current chronic pain affects 20-33% of the US adult population (~50+ million adults) and represents a major health care crisis due its associated disabling physical and emotional problems, while resulting in US healthcare costs up to $635 billion a year. Several innovative mind-body somatic interventions have emerged as potential treatments for chronic pain, EFT being one such treatment. Existing research into EFT and chronic pain is limited although preliminary studies show promise. This study is being pursued because of the increase in need for chronic pain interventions., and is being offered online to test the ability to support people in remote and rural areas. This will also allow comparison between a live online version versus a self paced option.

The purpose of this study is to examine the safety, anti-cancer activity, and how the body metabolises a new medication called EO1001. Who is it for? You may be eligible for this study if you are aged 18 or over and have metastatic or advanced cancer. Study details All participants in this study will receive the active medication.. All participants will have a single dose of the medication to test how the body metabolises the drug. The drug is taken as an oral tablet, and the dose will depend on when the participant enrols in the study. About a week later, participants will start consuming the medication at the dose they started every day. Treatment will continue from this point, until those running the study decide to halt treatment, or the participant is unable to continue. As part of this study, participants will be required to undergo blood tests to assess safety and undergo scans to determine cancer status. It is hoped this research will demonstrate this medication is safe and effective in treating advanced cancer.

This study examined whether messages that encourage Australian drinkers to use protective behavioural strategies can successfully reduce their risk of alcohol-related harm. Three protective behavioural strategies were tested that encouraged people to (i) keep count of their drinks, (ii) decide on a drinks limit and stick to it, and (iii) to say no to an offer of an unwanted alcoholic drink. Previous research has shown that these types of messages can influence people's attitudes to alcohol and drinking intentions. The messages were tested in isolation and in combination with an existing social marketing campaign video advertisement on the harms associated with alcohol consumption. To assess whether the messages were effective, 8021 Australian drinkers were randomly assigned to eight intervention conditions. Participants in each condition completed three surveys over 6 weeks (3 weeks between each survey). Participants in conditions 1-3 were assigned to see one of the three messages, participants in conditions 4-6 saw the alcohol-harms video followed by one of the messages, participants in condition 7 were only exposed to the alcohol-harms video, and condition 8 was an active control condition. Participants were shown their message and/or the video each time they were surveyed. When completing the surveys, the participants also provided information on their demographic characteristics, use of the recommended drinking practices, attitudes to the recommended drinking practices, alcohol consumption, and experiences of alcohol-related harm. Using this information, the study will determine whether participants who were exposed to the messages changed on these outcomes, relative to participants who were not shown messages that encourage protestive behavioural strategies.

This study will investigate the effectiveness of temazepam and prolonged release melatonin (melatonin PR) on the sleep quality of patients with advanced cancer experiencing insomnia Who is it for? You may be eligible to join this study if you are aged 18 and above, have been diagnosed with advanced cancer and are experiencing insomnia Study details Participants in this study are randomly allocated (by chance) to one of three groups. Participants in one group will receive temazepam daily for 7 days. Participants in another group will receive melatonin daily for 7 days. And participants in the other group will receive placebo daily for 7 days. Sleep quality, quality of life and global impression of change will be assessed using questionnaires. Participants will have to complete two part questionnaires each day during the treatment. Part one within 2 hours of waking up in the morning and part two at bedtime. Sleep disturbance is a common and distressing problem in patients with advanced cancer. It is important to find ways to help cancer patients sleep better so that their overall quality of life is improved.

Severe SARS-CoV-2 infection requiring intensive care unit (ICU) admission is associated with a high mortality driven mainly by development of acute respiratory distress syndrome (ARDS) and massive cytokine release. Tocilizumab (TCZ) is an anti-human IL-6 receptor monoclonal antibody that inhibits signal transduction by binding soluble IL-6 receptors (sIL-6R) and membrane bound IL-6 receptors (mIL-6R) and is currently approved for rheumatoid arthritis and cytokine release syndrome in response to chimeric antigen receptor T cell (CAR-T) therapies. Initial reports have shown that TCZ may be effective in the treatment of critically ill patients with coronavirus disease 2019 (COVID-19). This study will be an open label, multi-centre, parallel group, randomised controlled trial to determine if TCZ treatment in addition to standard care within the ICU results in improved clinical outcomes compared to standard care alone.

COVID-19 is a new strain of virus in the coronavirus family which causes a respiratory illness. Patients with suspected or confirmed Coronavirus disease (COVID – 19) pose a number of challenges for anaesthetists. The more complex and rarer the situation, the more challenge posed to clinicians due to unfamiliarity, that may increase the risks to the patients. For instance, general anaesthesia (GA) for emergency caesarean deliveries, in the context of a patient with suspected or confirmed COVID – 19 infection, may be an extremely challenging situation to manage. Research questions: In a simulation environment, is there a difference in time taken for consultant anaesthetists to perform spinal anaesthesia as compared to general anaesthesia on women, with suspected or confirmed COVID-19, who require category 1 caesarean delivery? Is general anaesthesia in this context more stressful than spinal anaesthesia? This project will use a cross over design, in which participants are assigned randomly to a sequence of interventions and each participant serves as his/her own control in estimating treatment effect This simulation research project will take place in the dedicated operating theatre (OT) for suspected or confirmed COVID – 19 patients. We will include Consultant anaesthetists who regularly anaesthetise pregnant women requiring category 1 caesarean deliveries and have been doing simulations to deal with COVID – 19 patients.

Investigator initiated, single-centre, medical device, double blinded, randomised control trial to evaluate the safety, tolerability and effectiveness of topical Budesonide administered via a nebuliser at half the dose compared to Budesonide administered within a sterile saline intranasal wash in the management of chronic rhinosinusitis (CRS). A total of 54 participants will be enrolled in the study, which will allow for 27 participants in each treatment arm. Participants with symptomatic CRS who have had at least one prior sinus operation will be recruited from the Ears, Nose and Throat (ENT) Outpatient Clinic at The Queen Elizabeth Hospital. They will be randomly allocated to one of two treatment arms: either they will have daily nebulised steroid (0.5 mg Budesonide) and twice daily saline intranasal rinses for 6 weeks or, daily nebulised saline and twice daily saline rinses (one of which has 1 mg of Budesonide added) for 6 weeks. Patients will be given a 2 ml ampoule of colourless solution to add to their nebuliser solution and a 2 ml ampoule of colourless solution to add to one of their daily sinus rinses. Both of these ampoules will be over-labelled to disguise their contents (either Budesonide or sterile water depending on which arm they are recruited). Patient concurrent medication data, adverse events, symptom scores and endoscopic scores will be collected prior to initiation of trial and at the 6 week mark on completion of trial. We hypothesis that when administered via nebuliser P&S T45 TEKCELEO patented MICRONICE™ device, Budesonide will be able to be delivered to a larger surface area of sinonasal mucosa and hence be at least as, or more, effective at half the dose than when administered within an intranasal rinse. A nebulisation device will also allow patients an alternative option for self-administering topical Budesonide and decrease medication wastage.

The Bridging the Gap between Physical and Mental Illness in Community Pharmacy (PharMIbridge) Cluster Randomised Controlled Trial (C-RCT) aims to evaluate the effectiveness of an individualised, pharmacist-led support service for people living with severe and persistent mental illness (SPMI). The PharMIbridge service focuses on improving medication adherence, and mental and physical wellbeing of consumers living with SPMI. Pharmacists within study regions in three Australian states (NSW, VIC and the ACT), will be randomly allocated to deliver either the PharMIbridge intervention or standard care involving a medication management service (MedsCheck). Pharmacists and pharmacy support staff (e.g. assistants) involved in the trial will receive Blended-Mental Health First Aid training. Pharmacists delivering the PharMIbridge service will also receive further training on medication adherence, goal setting, motivational interviewing, managing physical health concerns and complex issues relating to medications used to treat SPMI. It is expected that the PharMIbridge service will lead to improvements in medication adherence. Secondary outcomes will be changes in factors associated with cardiometabolic risk and quality of life, with an emphasis on physical health and psychological wellbeing; medication-related problems; community pharmacists’ knowledge, confidence and ability to support consumers living with SPMI; and any effects on health care service acceptability, utilisation and cost-effectiveness.

This study evaluates the impact of CPAP treatment over 1 year on clinical outcomes in patients with REM-related obstructive sleep apnoea.

Olfactory dysfunction has emerged as a strong predictor of COVID-19, but data so far are based upon self-reported measures. We hypothesize that direct objective assessment of olfaction using a validated test kit will be even more highly sensitive to diagnosis of COVID-19, and that a screening test can therefore be developed for use in the general population to identify subjects who require self-isolation until COVID-19 can be excluded on nasal swab testing. For such a population-level point-of-care screening test, the most important attributes are sensitivity, safety, ease of use and reliability. Our hypothesis is that normal olfaction (normosmia) using a highly sensitive odour test will reliably exclude COVID-19, and subjects with anosmia will be referred for additional testing (nasopharyngeal swab etc) to diagnose COVID-19. Such a strategy will be ideal in the next phase of Australia’s response to COVID-19, i.e. in track-and-trace identification.