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A TIA is a major warning sign for stroke. There is a 15% risk of stroke 90 days following initial event and the risk of cardiovascular events remains high 10-15 years post-TIA. It is best practice for TIA patients to receive secondary medical care to determine TIA cause and to commence preventative pharmacological therapy early post-event. Behaviour change programs which include education and group exercise (ie. advice and support to address modifiable CVD risk factors including hypertension, inactivity, poor diet etc) significantly reduce the odds of further cardiovascular events. These programs significantly increase the time TIA patients spend in moderately vigorous physical activity (ie. brisk walking). The latter is extremely important as increasing physical activity independently contributes to significant reductions in cardiovascular risk, with an inverse relationship between time spent in moderately vigorous physical activity and risk of cardiovascular events and all-cause mortality. Despite the evidence in support of the efficacy of behaviour change programs, TIA patients of Hunter New England Health Local Health District (HNE LHD) do not have access to an evidence based behaviour change program. It is clear that there is an unmet need in this patient population. S+SLAM-TIA, Service change and Supporting Lifestyle and Activity Modification after Transient Ischemic Attack (S+SLAM-TIA), will address this service gap. S+SLAM-TIA will bring together research active (i) stroke specialists and (ii) general practitioners (GPs), and the Community Stroke Team (CST) to embed a clinically feasible evidence based behaviour change program. This program will be delivered in a community gym and will be comprised of group education and exercise with the use of telehealth and telephone coaching. S+SLAM-TIA aims to: 1. Evaluate the development and implementation of a behaviour change program for people who have had a recent TIA or minor stroke 2. Increase the minutes/week people who have had a recent TIA or minor stroke spend in moderately vigorous physical activity 3. Improve the cardiovascular health, well-being and quality of life of people who have had a recent TIA or minor stroke 4. Determine the cost-effectiveness of this new service including the health service and community cost-savings that increasing physical activity levels in this population brings.

The study aims to explore the relationship between childhood behaviours and stuttering. This study will identify how many children who stutter have challenging behaviours, as well as determine if challenging behaviours affect stuttering therapy. In addition, one aspect of the study will implement an integrated stuttering intervention program that addresses child behaviour in addition to stuttering. The effect of addressing child behaviour in children who stutter, as a component of stuttering therapy, on stuttering outcomes, parenting and child behaviour will be examined. We anticipate that the project will provide invaluable information for future stuttering therapy, with the possibility of addressing child behaviour as a component of future therapy.

This study aims to investigate the efficacy and safety of tramadol/paracetamol combined dosing compared with paracetamol and oxycodone for pain management following major surgery in gynaecology oncology patients. Who is it for? You may be eligible to join this study if you are a female aged 18 years or more who is planned for major surgery for either benign or malignant tumours in gynaecological oncology. Study details Participants in this study will be randomly allocated (by chance) to one of two groups. Participants in one group will take oral Tramadol/paracetamol for post-operative pain management in the week following hospital discharge. Participants in the other group will take oral paracetamol and oxycodone in the week following discharge. All participants will be followed-up for 28 days in order to evaluate post-operative nausea, constipation, adverse events, hospital re-admission rates, and efficacy of pain relief. We hope to determine whether Tramadol / paracetamol is a safe, effective, and well-tolerated option for post-operative pain management.

Chronic obstructive pulmonary disease (COPD) affects approximately 20% of Indigenous Australian adults and an even greater proportion in remote regions. The prevalence of COPD is 2.5 times higher, death rate from COPD is three times higher and hospitalisation rates are five times higher in Aboriginal and Torres Strait Islander peoples than in non-Indigenous Australians. Best-practice care of COPD includes accurate diagnosis, smoking cessation, optimising medication and pulmonary rehabilitation to improve symptoms, activity levels and well-being. There is Level 1 evidence that pulmonary rehabilitation for people with COPD improves quality of life and reduces disability, reduces hospital admissions and length of stay, and is cost-effective. However, the implementation of this effective intervention into clinical practice in Indigenous communities is virtually non-existent, furthering the inequity of access to best-practice management of chronic lung disease. The research project will evaluate the implementation of an innovative program, the Breathe Easy Walk Easy Lungs for Life (BE WELL) program, in four distinct Aboriginal communities - metropolitan, regional, rural, remote- using the Knowledge to Action Framework. The BE WELL program aims to build the capacity of Aboriginal and Torres Strait Islander health workers to deliver best-practice management of COPD, Specifically, the project will evaluate the ability of the program to increase Aboriginal health workers’ knowledge and skills in managing COPD; improve exercise capacity and health-related quality of life of Indigenous people with COPD; and reduce hospital admissions and length of hospital stay for exacerbations of COPD. The resources for this program have been developed but the BE WELL program has not been implemented in Indigenous communities. We hypothesise that the BE WELL program will improve Aboriginal health worker knowledge and skills in the management of COPD and, for Indigenous people with COPD, BE WELL will improve exercise capacity and quality of life, and reduce hospital admissions and length of hospital stay. Knowledge gained from this project will be valuable for policy makers and health services in informing the future response to chronic lung disease management in Indigenous communities.

Patient's with severe infection can present with low blood pressure and require immediate treatment and sometimes cardiac output monitoring to understand how best to treat them. The primary purpose of this study is to understand their cardiac output prior to commencement of resuscitation on adult patients who have low blood pressure in hospital using a finger cuff which is non-invasive and previously shown to be validated in some patient populations. The aim of the study is to describe the range of cardiac output in patients who deteriorate in hospital. It is hoped that this will allow description of important subtypes who will benefit from specifically tailored therapies.

1 in 2 Australians will experience mental health problems in their lifetime. Mental health problems can make it hard for people to live the life they want. Lots of things can help improve mental health, but it can be hard for people to know what is the best option for them. Link-me is a randomised controlled trial that is testing a new approach to helping people find support that works for them. It is funded by the Australian Government and is being conducted by researchers at the University of Melbourne. Link-me builds on almost 15 years of research in Australian general practice. This research has shown that about one third of people attending a general practice are experiencing difficulties with their mental health. GPs currently have no systematic way of identifying the best way to tailor mental health care to each individual’s needs. In this trial, we aim to address this gap and determine whether a simple, purpose-built online tool can improve mental health outcomes in a cost-effective way. Using the tool, GP patients can: - complete an assessment - receive feedback on their results - set priorities based on these results - receive a suggested treatment option matched to their risk of future mental health problems. Reception staff at participating general practices will invite patients to complete a 2-minute survey on an iPad before they see their GP. Whether or not someone completes the survey is entirely up to them. The survey identifies whether or not a person is eligible for the trial – if so, they are invited to read the study information and provide informed consent to take part. People who are interested in participating then answer a few more questions on the iPad. The questions take about 2 minutes to answer and at the end, the iPad will randomly allocate people to one of two groups. Each group will provide us with different information about managing mental health and wellbeing. Some people will be asked for feedback on how mental health is currently managed, others might be asked to try something different (like using the internet or working with their GP clinic to find other options). People taking part in Link-me will be contacted 6, 12, and 18 months after they complete the iPad questions in their GP waiting room to complete short online surveys. Answering these surveys will help us understand whether the Link-me approach to care can help people improve their mental health. Taking part in Link-me is completely voluntary and people who do decide to take part can change their mind at any time.

This is a single-center study. The study will investigate five ascending doses of XG005 and the approximate molar equivalent doses of Naproxen and Pregabalin for clinical relevant doses of XG005. Five XG005 treatment groups of with 10 subjects/group will be enrolled sequentially. Period 1 will be single-dose, randomized, placebo-controlled, double-blind portion of the study and designed to meet the primary study objective. Period 2 will be the single-dose, open-label portion of the study designed to meet the secondary objective of the study. The four planned dose levels of XG005 are 50, 100, 250, 500, and 1000 mg. Period 1 will be double-blind and randomized with 8 subjects (1:1 allocation ratio by gender) assigned to XG005 and 2 subjects (1:1 allocation ratio by gender) assigned to placebo. Safety Monitoring Committee (SMC; consisting of three members: Investigator, Sponsor Representative, and Independent Medical Monitor) will review available safety and tolerability data from Period 1 of the current dose level before proceeding to the subsequent dose. All subjects in the dose levels of 250, 500 and 1000 mg of XG005 in Period 1 will receive Naproxen and Pregabalin in Period 2 after a washout period. In Period 2, subjects will receive the combination of approximate molar equivalents of Naproxen and Pregabalin for their corresponding XG005 doses in Period 1. Sentinel dose participants (1 for XG005 and 1 for placebo) will be included as the first dose administered at each dose level in Period 1. Safety data and available PK data will be reviewed prior to the SMC meeting. The SMC must communicate and provide approval to dose escalate prior to dosing the next dose group. The following safety data should be reviewed at each safety meeting: vital signs, ECGs, AEs, physical examination observations, safety lab data (chemistry, hematology & urinalysis) and available PK data. Based upon the data presented, a decision will be made whether to continue with dose escalation as scheduled, to alter the next dose level, or repeat the current dose level if indicated or recommend to terminate the study for safety reasons. Meeting minutes will be documented, particularly the decision to dose escalate. This document will be signed off by the Investigator and filed in the Investigator Site File. Due to the study timelines, all safety data will be reviewed in an un-monitored state, although some of the data may have been monitored by the time of the SMC meeting. Pharmacokinetic assessments will include blood (26 collection time points with 13 timepoints/Period) samples over the course of the study. A total of approximately 200 mL of blood (130 mL for PK and 70 mL for clinical labs) will be drawn from each subject during the study. The expected duration of participation for each subject following enrollment will be approximately 15 days.

The primary purpose of this project is to explore the efficacy of the Pain Course in a regional hospital clinical setting for managing symptoms of pain interference, anxiety, and depression in adults (aged 18+) living in North Queensland with chronic pain. A second purpose is to examine the acceptability of the Pain Course in a self-guided format to adults living in North Queensland with chronic pain. A third purpose is to explore the maintenance of clinical improvements at 3month followup timepoint.

This study aims to determine if a combined noradrenergic/antimuscarinic intervention changes sleep apnoea severity compared to placebo and the effects on pharyngeal muscle activity and other key sleep parameters.

This study aims to find out if the combination of trastuzumab (anti-HER2 therapy) with durvalumab (PD-L1 inhibitor) and tremelimumab (CTLA4 inhibitor) will reactivate anti-tumour immune response and improve clinical outcomes in trastuzumab-resistant, advanced HER2-positive breast cancer. Who is it for? You may be eligible for this study if you are 18 years or older, male or female, and have HER2-positive metastatic or incurable breast cancer that has progressed on previous trastuzumab treatment. Trial Details. Up to 4 weeks before starting study treatment, all participants will have either a CT Scan, MRI, or PET with dedicated CT Scan, provide a research tumour biopsy of the cancer (taken within 1 year of starting the study) and research blood tests. TREMELIMUMAB 75 mg DOSE ER-POSITIVE AND ER-NEGATIVE COHORTS: Study treatment takes place in 2 phases: 1) Induction Phase (weeks 1-16); and 2) Treatment Phase (weeks 17-52). Induction Phase During the Induction Phase, participants will receive: 1) 4 doses of durvalumab (1 dose every 4 weeks), administered intravenously; 2) 4 doses of tremelimumab (1 dose every 4 weeks), administered intravenously; 3) 16 doses of trastuzumab (1 dose every week), administered intravenously. Treatment Phase Participants will receive durvalumab and trastuzumab every 3 weeks for 12 doses (total 36 weeks). Tremelimumab will not be given. A research blood sample will be taken every 9 weeks, before each dose of study treatment. TREMELIMUMAB SINGLE 300 mg PRIMING DOSE COHORT One cycle is 3 weeks (maximum of 18 cycles). 1) Tremelimumab 300 mg Day 1, Cycle 1 only (1 dose only) 2) Durvalumab 1120 mg Day 1, Cycle 1 then every 3 weeks for up to 1 year (18 doses) PLUS 3) Trastuzumab: * 6 mg/kg Day 1, Cycle 1 then every 3 weeks for up to 1 year (18 doses) * Loading dose of 8 mg/kg Cycle 1 Day 1 if > 6 weeks since the last trastuzumab or TDM-1 dose. Research blood samples will be collected at Week 10 and Week 16. For all cohorts: Oestrogen-receptor-positive patients will also start or continue endocrine therapy (aromatase inhibitor and/or GnRH agonist). Two core biopsies, if feasible, will be taken from the same site as the initial biopsy about 3 weeks after starting study treatment. During the study heart function tests (ECHO or MUGA) will be performed every 3 months as per standard of care, or as clinically indicated. Participants will be clinically assessed before each study treatment. The full length of treatment is 52 weeks (1 year). After completing study treatment, patients will be followed every 3 months by either clinic visits or via telephone.