ANZCTR search results

The main purpose of this study is to test the safety of a new cancer therapy targeting the tumour marker Lewis Y (‘Lewis Y Chimeric Antigen Receptor T-cell Therapy’) in combination with the commonly used cancer drug nivolumab for the treatment of patients with Lewis Y-expressing solid tumours. Who is it for? You may be eligible to join this study if you are aged 18 years or older, you have an advanced incurable or metastatic cancer and your cancer expresses the marker Lewis Y on tumour biopsy. Study details All participants will receive treatment with Lewis Y Chimeric Antigen Receptor T-cell Therapy and nivolumab. Prior to treatment, participants will have blood collected to generate the T-cells required for treatment. Participants will then follow a chemotherapy regimen designed to reduce the number of the body’s T cells so that the newly generated T-cells can be administered. This will involve intravenous infusions of the drugs fludarabine and cyclophosphamide once per day for 3 consecutive days in the week prior to T-cell therapy. Patients enrolled in this study will be part of one of two groups of patients: -Dose escalation for LeY CAR T cells with nivolumab -Dose expansion for LeY CAR T cells with nivolumab The dose escalation phase is when different doses (total number of cells infused) of the cell therapy will be tested. Each participant will receive one dose only by intravenous infusion. The doses tested will be increased or decreased for additional participants enrolled until a safe dose is determined. This safe dose will then be used for the dose expansion phase, where participants may receive up to two doses of cells infused one hour apart by intravenous infusion. Nivolumab will be administered to all participants by intravenous infusion on the day prior to T-cell therapy, and on days 14, 28, and 42 after T-cell therapy. During the follow-up phase, beyond the first 8 weeks (day 56) post-infusion, imaging and blood tests will occur once a month up to one year post-infusion then every 3 months thereafter for long-term follow-up to the full study period of 5 years. It is hoped that Lewis Y Chimeric Antigen Receptor T-cell therapy in combination with nivolumab is safe, tolerable, and effective for the treatment of advanced solid cancers expressing the Lewis Y marker. This study will also help to define the dose of T-cell therapy that may be used for treatment of similar individuals in future.

The aim of this research program is to determine whether prescribed medicinal cannabis products impacts driving and cognitive/psychomotor performance and whether this can be effectively indexed and monitored through objective markers of performance. Secondly, using our high-fidelity driving simulator with simultaneous eye-monitoring technologies, we will use examine the relationship between gaze vector and driver behaviour to better understand the impact of medicinal cannabis use on driving performance in healthy adults under a variety of common formulations, preparations, and doses of medicinal cannabis products available to patients.

This study is investigating cancer-related cognitive impairment, and the impact of a cognitive training intervention. Who is it for? You may be eligible for this study if you are aged 18 years or over, living in or near the Perth/Peel regions of Western Australia, and are currently undergoing any treatment for a confirmed diagnosis of cancer. This study also needs healthy controls; that is, people aged 18 years or over, living in or near Perth/Peel regions of Western Australia, with no cancer diagnosis and no history of any cancer diagnosis. Study details Participants will be asked to complete tests of memory, attention, executive function, and processing speed, as well as other psychological factors such as quality of life, sleep, anxiety, and pain. Biological markers implicated in neurogenesis will be assessed through blood tests, direct questions, and with reference to medical history. After which, researchers will contact you if you are eligible for the second part of the study. It is hoped that findings from this study will assist researchers with optimising daily oncology care.

Management guidelines for Low Back Pain (LBP) recommend exclusion of serious pathology, followed by simple analgesics, superficial heat therapy, early mobilisation, and patient education. Our Royal Brisbane Womens Hospital Emergency Department (ED) audit revealed high rates of inappropriate medication prescription for LBP (65% of patients prescribed opioids, 17% prescribed benzodiazepine). These medications are not recommended for LBP and have serious negative consequences (dependence, poisoning, death). We also observed high inpatient admission rates (20% of ED LBP patients), delayed patient mobilisation, and inadequate patient education. In RIME, we adapt, implement, and evaluate the only intervention shown to effectively reduce inappropriate medication prescription for LBP in EDs (Sydney SHaPED trial (ACTRN12617001160325); reduced opioid prescription by 12.3% sustained over 30 months). The adapted intervention uses a formalised clinical flow chart to support clinical decision-making and changes in clinician behaviour, bolstered by clinician education, provision of alternative treatments, educational resources, audit and feedback, and implementation champions. RIME is a controlled Interrupted Time Series study evaluating the adapted intervention in our RBWH ED pre- to post-implementation and will compare findings with a control ED in the same health district. The primary outcome is the proportion of LBP patients prescribed inappropriate medications, assessed via routinely collected record data. Total sample size is 2000 patients (n=1000 intervention, n=1000 control). Secondary outcomes include inpatient admission rate, time to mobilisation, provision of patient education, imaging requests, re-presentation to ED, healthcare costs. In nested qualitative research we will understand clinicians’ perceptions of the intervention and determine how benefits will be sustained benefits over time.

The primary objective of this project is to investigate psychological, cognitive and physiological changes associated with a single session of psychedelic drug exposure with psilocybin or 3,4-methylenedioxymethamphetamine (MDMA) in a group setting. Specifically, the study aims to use measures of psychological experience, cognitive function and electroencephalography (EEG) before and after psychedelic exposure. Secondary aims are (1) to assess changes in neural activity during acute substance exposure, (2) to determine whether tolerability is similar to previous studies, (3) to determine whether any pre-post differences we detect with the primary sample are replicated in a smaller sample who enter into a cross-over arm, taking the substance they did not take in the first instance, and (4) whether exposure to psychedelic drugs impacts self-assessed therapist competency. As both psilocybin and MDMA are becoming more commonly used to treat psychiatric illnesses, this study is important to improve our understanding of the mechanisms of action of these drugs. In addition, this study will contribute to enhancing the delivery of psychedelic therapies by identifying whether psychedelic dosing in a group setting is associated with improved outcomes, and whether exposure to psychedelic medicines enhances clinical self-rated competency. As such, this study will have the potential to be highly beneficial in improving our understanding of these drugs, and how to apply them, as they transition towards broad scale implementation as therapies for psychiatric conditions.

This will be a phase 1 first-in-human study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of PTC607 at various incremental single doses in healthy volunteers.

Hip osteoarthritis (OA) is a prevalent public health problem with significant personal, social and economic costs. All clinical guidelines recommend education and physical activity, including structured exercise, in the management of hip OA, but undertaking regular exercise can be difficult for people with OA. Many people with hip OA are not receiving adequate advice or support required to incorporate regular exercise and physical activity into their daily routines. We are conducting a clinical trial to evaluate whether a digital exercise program ("My Hip Exercise"), in addition to an exercise adherence support mobile app, may be a scalable solution to overcoming barriers of exercise uptake in people with OA, compared with web-based education alone. The primary outcomes under investigation are hip pain while walking, and physical function. Participants will be randomly allocated to two treatment groups; i) Website comprising internet-delivered education, physical activity guidance and lower-limb strengthening exercise, combined with a mobile app to self-monitor and support exercise participation ii) Duplicated version of the website with internet-delivered education only Primary and secondary outcomes will be collected by web-based survey at baseline and 24-weeks after randomisation.

Critically ill patients in the Intensive Care Unit (ICU) frequently develop delirium. Delirium is extremely distressing to patients and is associated with poor outcomes. There are two forms of delirium, hyperactive and hypoactive (or a mix of both). The hyperactive form is particularly dangerous as patients may become aggressive and remove interventions that are essential for survival and/or injure themselves or staff. Given the urgency with which to treat hyperactive delirium, health care workers frequently administer potent antipsychotic medications to control delirium symptoms. However, we do not know if this is beneficial or harmful or if one antipsychotic medication is a better choice over the other. The purpose of this study is to compare the safety and efficacy (effectiveness) of the two most frequently prescribed antipsychotic medications (quetiapine and olanzapine) for hyperactive (agitated) delirium in critically ill patients.

Depression and apathy (feeling low and unmotivated) are common symptoms that accompany Parkinson’s Disease (PD). To date, few mental health programs exist to help people with PD experiencing these symptoms. The Parkinson’s disease Getting Out and Active Living (PD-GOAL) program is a 6-session intervention that aims to alleviate depression and apathy by helping those with PD identify and engage in meaningful and enjoyable activities. The PD-GOAL program is grounded in principles of behavioural activation, an approach that has demonstrated to help people become happier around the world and that is also very effective in treating depression. Together with people living with PD and their support people, the Research Team previously adapted and co-designed the PD-GOAL program for people with PD. Our goal is to test whether the PD-GOAL program alleviates symptoms of depression and apathy in people with PD. We are also interested in opinions and general feedback on the program for future research.

National statistics from Australian sources predict normal-weight adults will comprise less than one third of the population by 2025. Evidence suggests there are synergies between obesity and type 2 diabetes mellitus (T2D). Insulin resistance is common in patients with obesity and results in a 7-12 fold increase in the risk of developing T2D. It is not unusual for patients attending the Metabolic and Weight Loss Program at our hospital to have large daily doses of insulin to manage their T2D. These patients often report fatigue, poorly controlled diabetes and difficulty managing their blood glucose level. Evidence from patients indicates lifestyle changes, psychosocial issues, insulin side-effects, dietary perceptions and a lack of confidence in diabetes self-care also influences blood glucose management. Evidence focused on support networks or education programs to improve self-management of T2D for obese patients is difficult to locate. The aim of this study was to determine whether group based education led to a reduction in diabetes distress when compared to usual care.