ANZCTR search results

This study will help us assess the effect of a high-fat meal on our blood vessels (cardiovascular health) and how naturally occurring polyphenolic compounds in plant foods could potentially affect this beneficially. An important marker of cardiovascular health is the flexibility of the blood vessels such as arteries, their ability to dilate and constrict when needed. Endothelial function can be measured using a non- invasive technique called “flow mediated dilatation” abbreviated to FMD. The health and function of an artery can be assessed by measuring someone’s FMD in the morning, after fasting overnight. Poor diet can adversely affect artery health. There is evidence that consumption of excess dietary fat contributes towards the dysfunction of our arteries. Consumption of a single, high fat meal impairs post-meal FMD and the typical western diet is characterised by a high frequency of high-fat content meals. Polyphenols are micronutrients mainly found in plant-based foods. Recently, clinical and experimental trials have focused on exploring whether polyphenols can have a beneficial effect on health. Polyphenols can protect blood vessels due to their antioxidant properties, acting directly on the endothelium. The researchers will assess how foods rich in polyphenols (blueberries and cocoa) could play a protective role in the arteries during a high-fat meal challenge by measuring FMD.

This project will evaluate two new single session interventions (SSI) designed to improve body image and compare them to an existing SSI and a control group. The two new SSIs are focused on body neutrality and body positivity, while the existing SSI is on the growth mindset. Because neither the body neutrality or body positivity SSIs have been tested before, we unsure if they will be beneficial or acceptable. However, in particular we hypothesise both will improve body image, hope, mood, and self-efficacy and decrease eating disorder psychopathology and that body neutrality will demonstrate greater effect sizes as compared to body positivity.

This is a multi-site registry-based observational study across regional Victoria for people receiving immunotherapy treatment for an unresectable locally advanced or metastatic tumour. Who is it for? You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with advanced cancer that presents as a solid tumour and you have been receiving immunotherapy for at least 12 weeks, and the cancer has started growing again in a small number of areas. Study details Participants who choose to enrol in this study will be asked to consent to having their health information reviewed and collected in a de-identified manner by a member of the research team. Participants will not be asked to attend any additional clinic appointments as part of their involvement in this study nor will they receive specific treatments as part of the study. All treatment(s) received will be the standard treatment(s) otherwise recommended irrespective of participation on this study. It is hoped this research will determine the proportion of patients who do not have cancer progression 6 months after they have completed local therapy, including surgery and/or radiotherapy, but continuing on immunotherapy. If immunotherapy is shown to have a beneficial impact on cancer progression for patients, the information gathered by this study may then be used to optimise treatment options for future cancer patients.

This study is investigating a new cancer treatment drug, ELVN-002, that may be used for patients with lung cancer. Who is it for? You may be eligible for this study if you are a healthy adult aged 18 to 60 years old. Please note that this study will not be enrolling patients with lung cancer. Study details This registration is for Part C of a 3-part study investigating ELVN-002. There are two arms in Part C of the study. Participants enrolled into the CYP3A4 Inhibitor Arm will receive two single dose of ELVN-002 (in capsule form) on separate days. First dose on Day 1 and second dose on Day 7. Participants will also be asked to take a daily dose of itraconazole for 7 days (from Day 4- Day 10). Participants enrolled into the CYP3A4 Inducer Arm will receive two single dose of ELVN-002 (in capsule form) on separate days. First dose on Day 1 and second dose on Day 17. Participants will also be asked to take phenytoin 3 times daily for 17 days (from Day 3- Day 19). Total participation will last up to 10 days for CYP3A4 Inhibitor Arm and 20 days for CYP3A4 Inducer Arm to the clinic for physical examination and vitals assessments and to collect blood and urine samples. It is hoped that this research will help determine the dose that ELVN-002 can be safely given to patients with lung cancer.

We want to answer the question, "How do we know we are sick?" by examining a range of functional measures that will capture indications of the body's early response (15 mins - 8 hours) to an immune challenge. We call this response the psychoneuroimmunological (PNI) state and it encompasses emotional, cognitive, immunological, physcial and physiological parameters. We have selected the following methods to monitor the PNI state of each individual in the proposed study: • Physical function (6-minute walk test, Timed Up and Go, and sit-to-stand tasks) • Speech and voice analytics • Executive functioning, spatial learning and memory (eye tracking, error awareness) • Physiological measures of stress and vital signs The measurement of the dynamic time course of these responses and the modelling of the PNI state has not yet been achieved by a research team. Our project will enable new methods for understanding the cognitive and socio-emotional impacts of the response using the influenza vaccination as the key trigger to the immune system. We will use a variety of methods to monitor the innate immune response of each individual involving a battery of cognitive and speech tests that will include: • The brief Psychomotor Vigilance Test (PVT), Attentional Network Task (ANT), and Emotion Processing Task (EPT), • Reading a brief paragraph aloud, • Short vowel sounds, • Speech agility, and • Reading a monologue. The cognitive battery testing will be conducted while participants are monitored with high frame video cameras and and Electroencephalograph system.

There are many studies that have shown that mild electrical stimulation delivered to the surface of the brain can improve a range of thinking skills, including learning, memory, decision-making and mathematical ability. This brain stimulation technique is called transcranial direct current stimulation (tDCS). There has been a lot of excitement about tDCS and its ability to improve peoples thinking skills, particularly their learning ability, however these improvements have largely been shown only in 'experimental' settings where improvements are seen on computerised tests in a laboratory. It is unclear whether these effects will translate to more 'real world' learning situations. One of the most common examples of novel skill acquisition in adults is that of second language learning. Research has shown that second language learning in adults is facilitated by changes in brain activity in language related brain regions, i.e. Broca's (language production) and Wernicke's (language processing) areas. Previous research has shown that tDCS to such Wernicke’s area is able to induce faster and more accurate learning in an experimental language learning paradigm, where participants were required to learn the 'meaning' of psuedowords (i.e. /glump/). While these results are promising, it remains unclear as to whether they will translate in a meaningful way to 'real world' language learning. In addition, there has been very little research looking at the neurobiological correlates of tDCS enhanced learning in healthy populations and none in naturalistic learning. In light of the above, the aims of the proposed research project are to: a. investigate the capacity of tDCS to Wernicke's area to improve the outcomes from a naturalistic second language learning program in healthy adults. b. investigate the neurobiological correlates of tDCS induced second language learning.

Paracetamol poisoning can cause liver injury; the mainstay of treatment is administration of the antidote acetylcysteine. There is a subgroup of paracetamol poisoned patients who develop liver injury despite standard treatment. Fomepizole has been proposed as an antidote due to its ability to inhibit production of paracetamol’s toxic metabolite. However, the clinical evidence for its use is limited. Hence in this study we will utilise a healthy human volunteer simulated overdose crossover model. Each volunteer will serve as their own control. We will examine both immediate and modified release paracetamol formulations at a dose of 80mg/kg. We will investigate the efficacy of fomepizole at 2 hours post ingestion. If there is a significant effect we will then examine fomepizole at 4h. This study aims to provide valuable information on the potential use of fomepizole as an antidote for paracetamol poisoning.

Endometriosis is a chronic, inflammatory condition which can lead to chronic pelvic pain and infertility. There is no cure for this condition and the gold standard for diagnosis is laparoscopy (keyhole surgery) which is costly, has long wait times and is associated with risks. This study (Imagendo) will use artificial intelligence to create a diagnostic algorithm by analysing ultrasound and MRI endometriosis scans, providing general practitioners with an earlier, easily accessed, non-invasive, diagnosis of endometriosis.

The aim of the study is to determine the feasibility of a 12-week lifestyle program on type 2 diabetes in the Indigenous community in Australia. Feasibility is defined as achieving an attendance rate over 70%. It is hypothesised that the Too Deadly program can lead to an improvement in HbA1c and/or a reduction in glucose lowering medications for Indigenous Australians with type 2 diabetes and can be achieved safely. Secondary hypotheses include: 1. Efficacy: The Too Deadly program is superior to standard care after 12 weeks in assisting participants to: (a) increase in percentage (%) of time in range (target) for blood glucose levels (3.9–10 mmol/L), (b) reduce percentage (%) of below range for blood glucose levels, defined as <3.9 mmol/L. (c) reduce percentage (%) of time below range for blood glucose levels, defined as <3.0 mmol/L. (d) reduce percentage(%) of time above range for blood glucose levels, defined by >10.0 mmol/L (e) reduce percentage(%) of time above range for blood glucose levels, defined by >13.9 mmol/L. 2. Safety: Too Deadly program will not lead to increased number of severe hypoglycaemia (ADA, 2019), defined as a severe event characterised by altered mental and/or physical status requiring third-party assistance (ADA, 2019), ambulance call out or hospital presentations from baseline to 3 months. 3. The Too Deadly program will lead to improvements in glucose time in range as determined by the Flash Libre Pro. 4. The Too Deadly program will lead to a reduction in medication dose for some individuals. 5. The Too Deadly program will lead to improvements in quality of life as measured by the EQ-5D-5L questionnaire.

Heart failure is a major burden in Australia in terms of morbidity, mortality and healthcare expenditure. While multiple guideline-based therapies are recommended for heart failure with reduced ejection fraction (HFrEF), they are underutilised and thus ineffective. Barriers to guideline adherence for HF management exist at the patient, healthcare provider, and healthcare system level. This study will develop and deploy a heart failure education program, delivered by SMS as "e-TIPs" to patients after a discharge from hospital for heart failure every week for 6 months. We aim to assess the impact and patient-acceptance of the tailored electronic message-driven patient education program in recently admitted HFrEF patients. The study hypothesises that the patient driven education program "e-TIPs" will be acceptable to patients and ehance their self-education and self-management.