ANZCTR search results

Informed medical consent is often poorly done; it can be time consuming, there is no clear standard between different medical practitioners, and overwhelmingly, the literature provides support for standardised animations or video consent. Video animations have been shown to improve patient comprehension, take the same amount of time, or can even save time and in most cases there is an improvement in patient satisfaction and comprehension. Videos have been successfully used to consent for colonoscopy, knee arthroscopy, laparoscopic urological procedures, cataract surgery, intravenous fluorescent angiography, vascular procedures, coronary angiography, cardiac electrophysiology, urogynaecological surgery as well as for clinical trials. There are no studies evaluating video informed consent for cardiology procedures in Australia. Given the literature shows improvements in patient understanding and satisfaction, it is anticipated that the video informed consent will lead to enhanced clinical practice, including enhanced knowledge retention by patients, improved patient and physician satisfaction, improved recall of the procedure, as well as saving minutes per consultation. We aim to compare traditional doctor-patient informed consent to a video animation when consenting for cardiology procedures such as a coronary angiogram. We propose that the video consent will be superior to traditional doctor patient consent – patients will have better retention of information, comprehension and understanding and higher satisfaction.

Background: This NHMRC funded project (2018-2021) will determine how music listening impacts on language-related brain activity, brain structure and connectivity in post-stroke aphasia. Aims and Method: The specific aims of this resaerch are to (1) Determine whether daily music listening in addition to usual care will result in superior aphasia recovery compared to usual care only, as measured by standard clinical language and communication assessments. (2) Identify the effect of music listening on cognition and mood and the relationship between these factors and aphasia recovery. (3) Determine the effect of music listening on language-related brain activity, brain structure and brain connectivity using advanced imaging techniques developed for this population. (4) Determine if brain activity and structure predicts aphasia recovery in response to music listening and examine the influence of genetic factors and stress levels in recovery and response to music. 94 Participants with post-stroke aphasia will be scanned and undertake tests of language, cognition, mood, and music processing 2-4 weeks post-onset. They will then receive either usual care only or will listen to music daily (minimum 1 hour) in addition to receiving usual care until three months post-stroke. All participants will be scanned and re-tested at three months and six months post-onset. Outcomes: This approach will provide important insights into the mechanisms driving music-induced recovery of language and will identify potential responders to this treatment.

The aim of this study was to utilise a non-invasive brain stimulation technique called transcranial direct current stimulation (tDCS) to assess it's efficacy in improving symptoms of anorexia nervosa. Eight individuals with anorexia nervosa were randomised to receive tDCS to the inferior parietal lobe of the brain, or sham tDCS, for 10 days over two weeks. They completed assessments pre- and post-intervention including psychological assessments and eyetracking. The study was ceased early due to COVID-19 disruptions.

This open-label, dose-ranging clinical trial which aims to determine the feasibility, tolerability, and safety of oral ketamine (OK) for post-traumatic stress disorder. In this 10-week trial, participants will undergo 6 weeks of active treatment followed by 2 follow-up assessments (week 7; week 10) Participants (N = 50) will be receive a sub-anaesthetic dose of OK once a week over a 6-week period (according to an established titration protocol; 6 ketamine treatments in total); • All participants will be engaged with their treating doctors for the duration of the trial. • Ketamine will be used as an adjunctive treatment, meaning that participants are able to maintain or modify their current treatments under guidance of their physician. Any changes to medication will be recorded by study staff. Primary hypothesis: That a 6-week OK treatment will be efficacious in reducing PTSD symptom frequency and severity. Secondary hypotheses: That a 6-week OK treatment will be efficacious in: reducing stress, anxiety, depression, suicidal ideation; Improving cognitive, social, and occupational functioning; Improving sleep quality; Improving overall wellbeing. Additionally, this study aims to examine the cognitive, neurobiological, and neurophysiological effects of OK treatment in adult participants with PTSD. All changes outlined in this ANZCTR have been approved prior by Princes Charles Hospital Human Research Ethics Committee.

The study will follow a cohort of high risk pregnant women and assess for and treat OSA with CPAP therapy. Maternal blood pressure will be monitored throughout pregnancy and is the primary outcome between the two groups of participants (those with OSA compared with those without OSA). Quality of life will be assessed during pregnancy to determine if treating OSA improves quality of life. Placental vascular health will be monitored via ultrasound assessment at 28, 32 and 36 weeks gestational age followed by pathological examination of the placenta following delivery. Those women with a diagnosis of OSA during pregnancy will be reassessed for persistence of OSA at 6 months post partum.

Firstly, this project will investigate the number of people in South Australia who experience difficulties after sustaining a concussion/mild traumatic brain injury following a vehicular accident. In addition, these individuals will be provided assessment and intervention according to best practice guidelines and changes over time will be recorded. In addition, costs for the service will be evaluated and cost drivers determined. This analysis will then let us understand whether the early intervention is effective in preventing long term sequelae, in particular recognising and managing frontal lobe injury syndromes, and evaluating whether the costs incurred are worthwhile.

The purpose of this study is to determine whether a cream (Sirolimus) is both safe and effective in reducing the burden of skin cancer in transplant recipients. Who is it for? You may be eligible for this study if you are an adult who has received a solid organ transplant more than 12 months ago, and have been affected by many BCCs or SCCs. Study details All participants will apply the Sirolimus cream to one forearm and the placebo cream to the other forearm but they will not know the difference between each cream. Creams will be applied every night for 12 weeks. Participants in this study will be followed up over 24 weeks to assess for any changes in skin lesions via photographs, skin biopsies and blood tests. It is hoped that this research will help determine whether Sirolimus can be effective at preventing skin cancers in transplant recipients.

The study aims to reduce circulating blood lipids (fats) and inflammation, two key modifiable risk factors of dyslipidaemia; a major contributor to heart disease. Plant sterols and curcumin are potent cholesterol-lowering and anti-inflammatory agents, respectively. We have previously investigated this novel combination as dietary supplements and now pose the development of a functional food containing both ingredients. We hypothesis that the functional food containing plant sterols and curcumin will be an effective delivery mode for both bioactives, have enhanced compliance and be effective for lowering circulating blood lipids and inflammatory markers in individuals with high cholesterol.

The aim of this study is to establish a comprehensive clinical registry for patients with brain tumours in Australia. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have been diagnosed with a brain tumour. Study details Participants in this study will continue to receive routine clinical care, which will not be impacted by involvement in this study. All enrolled patients will have clinical data collected for up to 5 years. Data captured will include presentation and the disease course of brain tumours, surgical interventions, prescription of system therapies, and information regarding multi-disciplinary management and outcomes of this disease in the routine clinical practice setting. This registry will help to describe the current practice patterns and identify any deficiencies or abnormalities. By doing so, we can ensure that Australian brain tumour patients receive the best care possible.

Obesity and related cardiometabolic diseases represents an escalating global health challenge, requiring new therapeutic targets. Mineralocorticoid receptors (MRs) are hormone receptors present on fat cells, in high abundance in obese subjects. In animals, blocking the MRs by a tablet called spironolactone protects against obesity and diabetes over time. This project will investigate whether spironolactone provides long-term metabolic benefits in humans. Thirty-two young overweight/obese subjects will be recruited. Half will be randomly assigned to a 16-week treatment with spironolactone and the other half to placebo (medication-free tablet). Assessments including body-composition scan, nuclear imaging using a glucose tracer, calorimetry, blood tests, abdominal fat sampling will be undertaken before and after treatment to determine whether spironolactone improves body fat mass, tissues glucose uptake and function of fat cells. The results will help determine the novel therapeutic potential of MR blockade for management of obesity and metabolic diseases