ANZCTR search results

This is a prospective cohort study to observe the efficacy of LBB pacing, a newer pacing modality to the current gold standard of BiVentricular Pacing (BVP). All patients with heart failure and an indication for pacing/CRT will be selected and categorized into two cohorts. Intervention under study cohort - patients who will undergo LBB pacing CRT Comparator cohort - patients who will undergo biventricular pacing CRT It is a multicentre cohort study and those undergoing CRT at two centres - the Canberra hospital and the National capital private hospital will be enrolled. CRT is cornerstone of heart failure management apart from optimal medical treatment. BVP is current gold standard of delivering CRT but LBB pacing is a new modality which recruits conduction system and physiologically depolarises LV and could be more efficacious in improving LVEF, QRS duration and symptoms.. However, literature regarding this is scarce. We aim to compare these two cohorts in terms of primary outcomes including effect on LVEF and QRSd on follow up and secondary outcome including LV end diastolic and end systolic volumes and effect on NYHA class and QoL. The outcome data will help us understanding whether LBB pacing is more efficacious and will support conduction of prospective Randomized Control Trial.

This project will carry out a controlled randomised crossover trial, enrolling up to 20 healthy volunteers from ages 18-70 years over the next 3 years. The intervention involves a 3-day water-only fasting, with or without a single bout of glycogen depleting exercise on cycle ergometer. We and others have shown that prolonged fasting, turns on autophagy and proteostatic pathways via up-regulation of several “longevity genes”. However, we do not yet understand the timing and the dose-response of these beneficial cell and metabolic signalling adaptations in humans. The proposed study will determine the effects of a 3-day fast on activation of autophagy and associated stress-resistance pathways, and test the hypothesis that a single bout of exercise enhances this effect. This study is part of an ongoing research effort at the University of Sydney multidisciplinary hub ‘Charles Perkins Centre’ and Sydney Local Health District on healthy ageing and prevention of cardiometabolic diseases.

The technical advantages of the robotic surgical platform have been embraced by surgeons but scientific quantification of the advantages when compared to conventional laparoscopic platform is scarce. Accurate measurement of such mechanical advantages in specific surgical procedures such as obesity surgery will be beneficial to assist surgeons in selecting the best surgical platform or tools to perform complex bariatric procedures with the aim of achieving the best surgical outcomes. This project will analyse and compare surgical recordings of surgeons constructing gastro-jejunal anastomosis in gastric bypass surgery using the robotic surgical platform and conventional laparoscopic platform. The video analysis will be correlated against the difficulty of the procedure measured using the National Aeronautics and Space Administration Task Load Index (NASA TLX), a short survey regarding the performance of the gastrointestinal anastomosis and clinical outcome parameters. The project will be open to all bariatric surgeons in Australia with the aim of recruiting 50 patients in each group. A total of at least 42 patients in each group will provide the adequate volume to power the study to detect a difference in surgical proficiency between the platforms.

Studies have shown that individuals may search for suicide-related terms on the internet prior to an attempt. Thus, we investigated engagement with an advertisement campaign designed to reach individuals contemplating suicide. We utilised Google AdWords’ targeting features and investigated whether individuals show higher engagement with landing pages tailored to specific age groups compared to a general all-ages landing page. We hypothesise that we will see more engagement with the landing page in the tailored condition as it should relate more closely to the individual.

Mental health problems are very common in Aboriginal and Torres Strait Islander people. Aboriginal and Torres Strait Islander people’s physical and mental health continues to be negatively impacted by intergenerational trauma, socio-political policies, and socio-economic disadvantage. Mental health treatment must be cognisant of cultural understandings of communication (verbal and non-verbal) and experiences, in addition to the social determinants of health including poverty, housing insecurity, racism, discrimination, and under- and un-employment. This study will implement and evaluate the Indigenous Model of Mental Health Care (IMMHC) that has been developed following consultation with the community through our previous research. The IMMHC will combine trans-diagnostic cognitive-behaviour therapy (CBT) delivered by clinical psychologists with traditional healing delivered by traditional Aboriginal healers for a unique approach to treating mental illness in Aboriginal and Torres Strait Islander people. A mixed method, cross-sectional design will be employed, combining quantitative data collected to determine the impact of the IMMHC on depression, anxiety, substance use, and quality of life with qualitative data collected to determine the acceptability and features of value of the IMMHC. Approximately 30 people will be recruited to be recipients of the IMMHC, in addition to the Aboriginal traditional healers and the clinical psychologist who will participate in the qualitative component. Appropriate statistical tests will be applied to make sense of the quantitative data, and thematic narrative analysis will be used to analyse the qualitative data. The qualitative component of this study will assist with providing in-depth understanding of the quantitative results. Results will be disseminated through conference presentations, peer-reviewed journal articles, presentations to local mental health services, and a lay summary for the research participants.

This mixed methods RCT of telehealth PEERS® for teens aims to test the effectiveness, acceptability and feasibility of a telehealth group delivered Program for the Education and Enrichment of Relational Skills (PEERS®) for high-school aged teenagers aged 11–17 years with acquired brain injury (ABI) or cerebral palsy (CP). In this pilot randomised controlled trial, we will recruit 32 teenagers with brain injuries and their caregiver across Queensland and randomise them to receive telehealth PEERS® or be waitlisted for 6 months. Telehealth PEERS® for teens will be run for groups of 8 youths and their caregivers. Four groups will be run over a two-year period in order to deliver the program to the immediate groups and control groups after the waitlist period. Outcomes will be measured before the intervention, after the telehealth PEERS® for teens program, and then 3 months later (6 months post baseline) and 9 months later (12 months post baseline). Focus groups using semi-structured interviews will be conducted separately with teens and caregivers at the end of the program to explore experiences of participation in telehealth PEERS® for teens. Compared to care as usual, adolescents receiving PEERS® will achieve significantly greater gains in: (i) self-perceived performance of social participation goals immediately post intervention (14 weeks) on the Canadian Occupational Performance Measure (COPM) of 2 points or greater.

This research involves participants who are students enrolled in years one, two and three of the Bachelor of Physiotherapy at James Cook University. This study is particularly relevant to this group of students at JCU physiotherapy because anecdotally they report that practical exams are more stressful than other assessment items. Therefore, the purpose of this study is to find out how much practical examination related stress students experience in each academic study period, and whether practical examination related stress attenuates as students become more experienced during their progression through the degree. The researchers will recruit a sample population of students, taking biomarker and perceived stress measurements at time points in each study period until conclusion of the practical examination in study period 1, of the student’s third year of the degree. There will be two ‘non-examination’ time points, T1 in early (week 3) and T2 mid (week 8) each study period, and one before (T3), and following (T4) ‘practical examination period’ time point. This will allow the comparison of stress levels between the ‘non-examination’ and ‘examination period, and between year levels. The measurements taken, will be analysed to report students’ stress and involve: 1. Completing a short questionnaire. 2. Providing a saliva sample to measure cortisol. 3. Heart rate monitoring using a chest mounted sensor during data collection and the practical examination. Saliva and heart rate variability are known indicators of stress.

Bioelectric Meridian Therapy (BMT) is a non-invasive, drug-free intervention for pain management. It has been used clinically to manage pain, decrease inflammation and improve function with only anecdotal evidence. BMT is a combination of gentle massage by a therapist and an electrical stimulation delivered via an innovative device, called ABMMA Pro. ABMMA Pro is very similar to well-established transcutaneous electrical stimulation (TENS), yet different. There is ample anecdotal evidence supporting the analgesic effect of BMT, but there is insufficient research data on the efficacy and safety of BMT. In this randomised, sham-intervention controlled study with a cross-over design, we aim to examine (1) if BMT induces analgesia, by assessing changes in pain threshold and if BMT is safe to use; 2) if BMT induces local and / or distal analgesia effect. Thirty healthy individuals (free from ongoing pain) will be recruited to participate in the study. Each participant will receive the real and sham BMT in a random order, with one week in between the two sessions. Their pressure pain thresholds (PPT) will be measured before and after the intervention using an algometer. PPT will be measured on the calves, low back and wrists. Confounding measures that will be measured are quality of life, severity of anxiety and expectancy. One researcher will measure PPT and experimental pain, and another will deliver the intervention. The participants and the researcher measuring the PPT will be blinded to the intervention that the participants receive. Any adverse event that occurs immediately after the treatment will be recorded. The results of this study will provide essential evidence of the efficacy and safety of BMT on moderating pain in healthy volunteers. If BMT is found to be superior to sham intervention, future studies should assess its efficacy among patients with chronic pain. BMT could be a valid alternative to pain medications for many people who cannot tolerate analgesics.

Text-message based programmes have proven to be an effective public health approach to improve adolescent health behaviours, including tobacco use, and so may have promise as an approach to influence adolescent e-cigarette behaviours. Given this potential, we aim to conduct a randomised controlled trial employing a 2x2 factorial design to examine the potential effect of a text-message program targeting parents and adolescents to prevent adolescent e-cigarette use. Parent-adolescent dyads will receive a series of text messages (1/week for 1 school term, then 1 booster message per term) designed to address the factors associated with e-cigarette use (e.g. to modify perceived social norms, or correct misconceptions of risk). Adolescent intentions to use e-cigarettes will be the primary outcome, assessed via a survey. It is hypothesised that adolescents who receive the text messages (or whose parents receive them) will report lower intentions to use e-cigarettes, than those in the control condition (who don't receive the text messages).

Hepatitis B virus (HBV) infection is one of the most common infectious diseases in the world, with nearly 300 million people chronically infected worldwide. Chronic HBV infection can lead to serious complications such as cirrhosis, liver failure, hepatocellular carcinoma (HCC), and death. Approximately 820,000 people die every year due to consequences of CHB. Hepatitis delta virus (HDV) is the causative agent of chronic hepatitis delta (CHD), the most severe form of viral hepatitis. Infection with HDV is dependent on the presence of HBV infection, as it uses HBV encoded envelope proteins (HBsAg) for infection and replication HDV infection can occur either simultaneously with HBV or, more commonly, as a superinfection in patients already chronically infected with HBV. Relative to CHB infection alone, CHD co-infection is associated with more severe liver disease, causing faster progression to cirrhosis, hepatocellular carcinoma, and liver failure. Developing therapeutic strategies that deplete HBsAg levels, like monoclonal antibodies, may play a role in future regimens targeting functional cure. There is a clear need for additional treatment for CHD, particularly agents that improve response rates, are better tolerated, and simpler to administer than currently available treatments. BlueJay Therapeutics has developed BJT-778, which has the potential to provide anti HBV and anti HDV benefits by neutralizing and clearing HBV and HDV virions as well as by depleting HBsAg containing subviral particles, which may help reconstitute HBV-specific immunity and contribute to functional cure for CHB. BJT-778 is a potent, selective neutralizing monoclonal antibody for the treatment of CHB and CHD. This study will evaluate the safety, tolerability, pharmacokinetics and antiviral activity of BJT-778 in patients with CHB.