ANZCTR search results

Standard treatment of vulvar cancer includes surgery to remove the primary tumour, and if required, removal of groin lymph nodes. Groin Lymph Node Dissection (LND) can be delivered through a full inguinofemoral node dissection (removing as many nodes as possible) or through sentinel node biopsy (SNB -removing only one or two targeted groin lymph nodes). While the gold standard is often curative, groin LND is associated with debilitating long-term outcomes for virtually all women. The aim of this study is to assess the feasibility and accuracy of using high-resolution groin ultrasound as a non-invasive alternative method of identifying lymph node involvement in these patients. Who is it for? You may be eligible for this study if you are aged 18 years and over, have been diagnosed with vulvar cancer (i.e. without evidence of regional or distant metastatic disease), and are scheduled to undergo surgery to the vulva and groin(s) within the next 30 days. Study details Up to 30 days prior to their planned surgery, all participants will undergo a bilateral (i.e. on both sides) groin ultrasound. This will involve a radiologist placing a small probe on the groin to take measurements of any identified lymph nodes, and will take between 30 and 45 minutes to complete. After their planned surgery, any removed lymph nodes will be assessed by a pathologist for detection of spread of vulvar cancer cells. This will then be compared to the ultrasound measurements to determine whether groin ultrasound can be used to predict nodal involvement. It is hoped that this study may show that non-invasive groin ultrasound is a feasible and accurate method of predicting nodal involvement in vulvar cancer patients. If so, the ability to predict the absence of nodal involvement may spare future vulvar cancer patients unnecessary LND procedures to reduce complications, improve recovery time, and facilitate their return to normal daily activities.

Australian data, including ours from NSW, show that in people with diabetes weekly exercise volumes are below the Australian adult general population. In addition, when a person develops a DFU they are commonly instructed by clinicians to avoid any non-essential weight-bearing physical activity. Yet, exercise has significant benefit for people with diabetes including improved aerobic fitness and glycaemic control, reductions in all-cause mortality and possibly improved healing of ulcers. People with DFU require specialist exercise therapy to reduce plantar pressures and manage concomitant diseases. Upper limb seated cycle ergometry (UCE) involving thrice weekly sessions can improve cardiovascular fitness and does not increase plantar pressures. In addition, UCE can be complemented by resistance exercise in the upper body and open chain lower-body exercises to provide further metabolic benefit. Combined UCE and resistance exercise may be a safe and effective method for improving glycaemic control and aerobic fitness in people with DFUs. AEPs have appropriate clinical skills, in collaboration with other High Risk Foot Services (iHRFS) disciplines, to safely pre-screen and implement exercise for adults with DFUs. HYPOTHESIS Participants undertaking regular exercise will improve cardiorespiratory fitness (VO2peak), muscular strength (1RM strength) and glycaemic control (HbA1c, fasting plasma glucose). Exercise may also affect biomarkers of healing outcomes and immunophenotype. Study participants are expected to find that the exercise is a positive experience with high acceptability, which may be found to improve quality of life scores.

The objective of this project is to investigate changes in neural activity associated with a single session of psychedelic drug exposure, in particular with psilocybin or 3,4- methylenedioxymethamphetamine (MDMA). Specifically, the study aims to use electroencephalography (EEG) to measure neural activity both before and two weeks after psychedelic exposure. EEG activity during a latent inhibition task will be measured, as decreased latent inhibition has been associated with the personality trait of openness to experience, a trait which previous research has shown is increased by exposure to psychedelics. Similarly, EEG activity during an auditory oddball task will be measured, as previous research has shown that exposure to psychedelics reduces neural adaptation to familiar stimuli. Neural activity associated with processing of facial emotions will also be assessed, as this activity has been suggested to be modified by MDMA and could be a potential explanation for therapeutic effects. Additionally, resting EEG measures will be used to test whether psychedelic exposure is associated with changes to the excitation/inhibition balances that underpinning healthy neural activity. We hypothesize that the measures of neural activity listed above will differ from pre to post psychedelic exposure. Since both psilocybin and MDMA are becoming more commonly used to treat psychiatric illnesses, this study is important to both improve our understanding of the potential mechanisms of action of these drugs. As such, this study will have the potential to be highly beneficial in improving our understanding of these drugs as they transition towards broad scale implementation as therapies for psychiatric conditions.

This study aims to assess in 1500 mental health treatment seeking young people whether more personalised health care packages, linked with continuous digital feedback, deliver better functional improvements at 12 months (and follow-up for a further 12 months after cessation of active care) than digitally-supported assessment linked to standard care packages. We hypothesise that the highly personalised & measurement based care (HP&MBC) treatment packages are superior to standard care packages, by implementing continuous monitoring and care coordination through the use of digital technologies, and providing extensive feedback to the clinical service, the treating clinician and the young person and their family or carer. The continuous feedback will detect unmet care, increase the likelihood of identifying persons that do not respond to treatment and facilitate the process to optimise care and increase the engagement of young people in their own care.

SICARIO-VLC is designed to test the effect of endovascular thrombectomy (with or without thrombolysis) on three-month functional outcomes in the population defined by the size of baseline perfusion core lesion volume above 100mL. Primary outcome will be the proportion of patients with modified Rankin Scale (mRS) 0-4 (no catastrophic outcome) at 3 months.

Women normally receive Hartmann's solution in labour we wish to provide them with more energy using a dextrose solution given slowly in labour to see if we can shorten their length of labour and possibly reduce caesarean section rate

Mobile (M)-health programs hold promise as health promotion interventions: they require minimal resourcing, can be delivered at scale and have the potential to engage a wide audience, including hard-to-reach families and rural and remote populations. Text messages and social media posts have been shown to be an effective and convenient way to help people adopt healthy habits. The “Adventure & Veg” research study aims to assess the effectiveness of a text message and social media program for parents on their primary school-aged children’s physical activity and vegetable eating behaviours. Eligible participants will be asked to do a brief online survey at the beginning of the study and then at 2 months. This survey will ask questions about the participant's and participant's primary school-aged child's physical activity and vegetable eating behaviours. After completing survey 1, participants will be randomly allocated into either an intervention or control group. The intervention group will receive 8 weeks of text messages (5 messages each week) on tips for healthy lifestyle habits (e.g. physical activity, nutrition) and have access to a closed Facebook group with weekly local outdoor activity ideas. The control group will be invited to join the program in 2023, should the research study prove successful. At the completion of the study participants will be offered a $50 gift voucher as a thank you for their time.

Children living in remote/regional or low socio-economic communities have increased risk of developmental vulnerability. Executive function (EF) deficits, including those affecting inhibitory control, working memory and cognitive flexibility are common. Recent evidence indicates that individuals with pre-existing EF deficits were more vulnerable to the negative impacts of the COVID-19 pandemic and that these EF deficits have been exacerbated as a result of the pandemic. Strategies are therefore needed to provide support to mitigate the negative long-term impacts of the COVID-19 pandemic on cognitive (and executive) function in developmentally vulnerable children. This trial investigates whether a school-based digital intervention can improve key executive functions in primary school children at risk of developmental vulnerability. This parallel-group, randomised trial will recruit primary school students (aged 6-8 years) living in developmentally vulnerable communities across remote, regional and metropolitan areas of Victoria. Students will be randomised to receive 20 sessions of digital executive function training at school or to continue teaching as usual, for 7 weeks. Participants will be assessed pre-training, immediately post-training, and at a 6-week post-training follow-up. The primary outcome is post-training change in executive functioning as measured by cognitive assessments of working memory, inhibitory control and cognitive flexibility. Secondary outcomes include estimates of long-term change, and change in behavioural assessments of executive functioning and social/emotional wellbeing.

Obstructive sleep apnoea (OSA) is a prevalent disorder that affects 1 in 7 people globally. The most significant risk factor for OSA is obesity, which is increasing to epidemic levels. Nearly 70% of people with OSA are overweight or obese. It is well established that obesity contributes to OSA by promoting increased collapsibility of the upper airway anatomy. However, recent evidence suggests that several non-anatomical factors contribute to OSA. These non-anatomical traits are an oversensitive ventilatory control system (i.e. ventilatory control instability or high loop gain), poor pharyngeal muscle response and a low respiratory arousal threshold. However, it is currently unclear how obesity and, by extension, weight loss alters these traits. Weight-loss interventions such as exercise are continually recommended as a means of managing both OSA and the cardio-metabolic complications associated with obesity. Exercise interventions have been shown to modestly improve OSA severity, and improve daytime sleepiness, sleep quality and quality of life, even without significant changes in body weight in some studies. However, the mechanisms underlying the improvements in OSA severity are currently unknown. Recently, several studies have shown that increasing the work of breathing through playing musical instruments, or upper airway muscle exercises can lead to improvements in OSA severity. Based on these findings, it is assumed that the increased work of breathing strengthens the upper airway muscles and thereby reduces OSA severity. Therefore, this study will examine how high intensity exercise affects the underlying physiological mechanisms responsible for OSA. Therefore, we hypothesise that OSA improvements following exercise are driven by improvements in upper airway muscle response. As such, we hypothesise that high intensity interval training (HIIT) will result in improvements in OSA severity.

Exercise training has conventionally been considered a key factor in the multi-disciplinary approach to cardiac rehabilitation. However, recent systematic review and meta-analyses have reported a reduced effectiveness, particularly in regional areas with limited resources for exercising testing and delivery. More specifically, exercise training at a workload corresponding to the ventilatory anaerobic threshold has previously demonstrated significant improvements in cardiovascular health outcomes. However identifying such workloads requires specialized equipment including cardiopulmonary testing. Therefore, the proposed project is designed to identify submaximal field tests that can be used to prescribe exercise workloads at an individual’s ventilatory anaerobic threshold without the need for specialized equipment or expertise. It is hypothesized that the addition of participant heart rate and rating of perceived exertion will improve the accuracy of linear regression models based on field test protocols.