ANZCTR search results

This study aims to find out if adding the medications olaparib, or olaparib + durvalumab together, to standard chemotherapy given to premenopausal women with HR-positive, HER2-negative breast cancer before surgery will do a better job of controlling the cancer. BCT is trialing a remote telehealth pre-screening process for the OLIO trial to broaden clinical trials access to regional and remote patients and improve clinical trial recruitment. Please visit https://www.breastcancertrials.org.au/research/remote-telehealth-pre-screening-process/ for further information. Who is it for? You may be eligible for this study if you are a pre-menopausal woman between 18 and 45 years of age, and have been diagnosed with HR-positive, HER2-negative early breast cancer. Trial Details. Participants will be randomised 1:1 to receive: Arm A: An olaparib tablet twice per day with water for 12 weeks, plus have an infusion of paclitaxel into a vein once per week. Arm B: An olaparib tablet twice per day with water for 12 weeks, plus have an infusion of durvalumab into a vein once every 4 weeks for 3 infusions (Week 1, Week 5 and Week 9), plus have an infusion of paclitaxel into a vein once per week. Participants will have surgery within 6 weeks after their last dose of study treatment. The following biological samples will be collected: * Tumour sample at surgery, if any tumour remains * Blood samples before starting study treatment and just after surgery. All participants will be regularly monitored throughout treatment to evaluate their health. There will be end of treatment visits 30 days & 90 days after the last dose of study treatment. Follow-up visits will occur every 6 months after surgery for years 1-3 years post-surgery (6 visits), then every 12 months for years 4-5 (2 visits). Further treatment will be at the discretion of the participant and their treating clinician. It is hoped this research will provide new treatment options for young women with HR-positive, HER2-negative breast cancer.

The aim of this RCT is to investigate whether a written self-compassion intervention can improve affect and pregnancy wellbeing in women with GDM. For this study, participants will be randomly allocated to either the self-compassion or positive distraction group. It is anticipated that participants allocated to the self-compassion reflective writing task (using expressions of self-warmth and self-kindness) will report lower levels of affect, and enhanced pregnancy wellbeing at post-intervention relative to participants allocated to the positive distraction group. The outcome measures will include self-compassion, positive and negative affect, pregnancy wellbeing, and intentions to engage in self-care and help-seeking behaviours.

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.