ANZCTR search results

The health economic impact of epilepsy is well-studied, but similar data is lacking for first seizures. First seizures are a common and important neurological disorder, with unprovoked seizures affecting up to 10% of people and acute symptomatic seizures affecting over 3% of people during a lifetime. Establishing the true cost of first seizures is important to fully appreciate their substantial impact on patients, care-givers and society. Some data exists on the direct medical costs of first seizures, that is, the cost of health care utilisation, including hospitalisation, outpatient appointments, investigations and antiepileptic drugs. Far less studied is the indirect costs of seizures and the effect of seizures on patients’ quality of life. We propose to do this by measuring work productivity activity index (WPAI) through absenteeism, presenteeism and early retirement, and informal care needs. Additionally, patient reported outcome measures (PROMS) through validated quality of life surveys including EQ-5D, QoLIE-31 will be collected. In applicable cases, we will consider the reasons guiding initiation of antiepileptic drugs, both from clinicians’ and patients’ perspectives. People with epilepsy have a far higher prevalence of mood disorders compared to the general population. Screening for depression and anxiety via the Hospital Anxiety and Depression Scale (HADS) will help determine the onset of these disorders relative to the onset of the first seizure, and if the patients later develop epilepsy, provide a baseline measure of mood disorders to compare with subsequent evaluations. Flagging mood disorders as early as First Seizure Clinic will also promote earlier diagnosis and management, and this is an important part of providing holistic and comprehensive care. By adding indirect cost data and quality of life data to the literature, we hope to more comprehensively capture the true societal burden of first seizures, as well as to prospectively study the reasons behind decision to initiate or defer antiepileptic drug therapy.

This project will test the effectiveness of a community intervention designed to increase the proportion of Aboriginal people who receive a timely diagnosis of dementia and receive best practice care. It will address community, healthcare system, and patient and family level barriers to care, and determine the impact of these strategies on quality of life and depression for Aboriginal people living with dementia and other chronic disease and their carers. ACCHSs allocated to the intervention condition will receive a 3 year multi-component community-based intervention designed to address barriers to the timely diagnosis of dementia and other chronic conditions and the provision of best practice care. If found to be effective, the community-based ACCHS focus will allow the adoption of the strategies by Aboriginal communities across Australia. Study Hypothesis: A three-year community support strategy implemented at ACCHSs will increase the proportion of Aboriginal people who receive a timely diagnosis of dementia and receive best practice care.

Each year, over 1000 children with congenital heart disease (CHD) in Australia require heart surgery. The short and long-term outcomes of these children are primarily determined by pre-existing comorbidities and genetic factors, direct impact of the surgical intervention, the response to cardiopulmonary bypass (CPB), and the consequences thereof during their intensive care stay. Neurodevelopmental disabilities remain amongst the most common, and the most damaging, outcomes in children undergoing surgery for CHD. Large longitudinal population-based studies assessing long-term outcome are lacking. One out of four infants undergoing heart surgery develop a harmful response to CPB, which leads to low cardiac output syndrome (LCOS). LCOS results in prolonged (multi-) organ dysfunction related to hypotension, organ hypoperfusion, renal failure, and brain ischemia. LCOS translates into adverse short-term outcomes (LCOS, need for extracorporeal life support (ECLS), and death), and determines adverse long-term outcomes manifesting into school age and beyond. Currently, there are no reliable, sensitive, and rapid predictors for LCOS or adverse early and long-term outcomes. In addition, the concept of LCOS remains poorly understood, and clinical evidence indicated highly variable presentations, suggestive of variability of host response. Preventive strategies to reduce LCOS remain of limited effectiveness. Thanks to rapid sequencing technology, discriminative patterns of the individual response to CPB can now be tested in real-time. Transcriptomics therefore has huge potential to unravel the mechanisms underlying adverse outcomes after CPB surgery, to reveal biological phenotypes, and to identify novel interventional strategies.

Self-regulation, a type of self-management, takes an active learning approach to rehabilitation by enhancing the person’s self-awareness and encourages self-reflection to overcome problems. Mental imagery is when a person imagines every detail of the actions required to perform a task without actually physically moving to do the task. We postulate that self-regulation and mental imagery may enhance the self-awareness and attention developed and can enhance the everyday task performance, such as dressing and cooking for people with Parkinson's disease. Objectives of the study: 1. To pilot-test the self-regulation and mental imagery program to enhance performance of everyday activities, motor function, and cognitive function for people with Parkinson’s disease. 2. To evaluate the feasibility and acceptability of the SRII program.

The main purpose of this research project is to see if immunotherapy drug pembrolizumab may shrink the tumour prior to surgery and potentially reduce the requirement of subsequent treatment such as post-operative radiotherapy (PORT) in patients with Squamous Cell Carcinoma (SCC) of the skin. Who is it for? You may be eligible for this study if you are aged 18 years or older, have a confirmed diagnosis of invasive SCC, and are a candidate for surgical resection and/or post-operative radiotherapy. Study details All participants will receive pembrolizumab intravenously once every 3 weeks for a total of 4 cycles prior to planned surgery. Depending on the effect of pembrolizumab, participants will either receive surgery, surgery and PORT, or neither, depending on the proportion of tumour cells seen on biopsy. All participants will subsequently have post-operative pembrolizumab for 12 months in three weekly visits. Your participation in this research project consists of: • A screening period of up to 28 days: After you sign this Participant informed consent form, testing will be done to determine if this research project is suitable for you. • A treatment period of approximately 64 weeks and • An end of treatment visit, approximately 30 days after the completion of the study drug treatment period. This may be because you have completed the treatment period, or you or your doctor has decided to stop you receiving the study treatment. • A post-treatment follow-up period of approximately up to 2 years or until your skin cancer returns or the study ends It is hoped that this study will help us understand whether pembrolizumab can shrink the tumour, in which patients this may be more likely to occur, and any side effects that may be experienced during this study. This may help to treat other patients with SCC of the skin in future and reduce the requirement for surgery or radiotherapy.

Currently, opioid dependency has been managed with methadone treatment per NSW Health Clinical guidelines treatment of opioid dependence. Patients are attending the clinic every day to get treatment. Methadone takes away doses creates a risk of injection and harming others. There is a need for a new medication to maintain opioid dependence and also provide takeaway doses safely. New medication will help to minimize intravenous methadone use and harming others. The Methadone Naloxone (M&Nx) has a potential medication to maintain opioid dependence and will be given as taking away doses in this study. The (M&Nx) has been tested in a patient group with opioid dependence. In this study, patients with opioid dependence were given M&Nx at different doses according to the patient’s condition and the Specialist Doctor's decision. M&Nx at 50:1 was tested for acceptability, safety, and tolerability at Drug Health Clinic and the medication was well tolerated. The clinical trial phases 1 a and 1 b for M&Nx were performed by applying multiple doses to the patients with opioid dependence. M&Nx medication needs to be investigated further to identify the utility of treatment in Drug Health clinical settings by Clinical trial phase 2a. This study aims to use M&Nx to increase the quality of patient life with enhanced harm reduction. Opioid prescribing has increased significantly, and diversion of prescribed opioids has become a major problem of drug misuse. Combining M&Nx treatment may reduce the attractiveness of selling, diverting, or injecting methadone. This trial intends to study M&Nx in the treatment of adult outpatients with opioid dependence to minimize infection transmission in the drug health clinic setting. The study aimed to promote a better approach for patients by offering potential advantages over methadone maintenance alone such as minimizing the risks of diversion, injection, and selling in the black market. Primary Objectives To compare feasibility and harm reduction of M&Nx to methadone alone standard of care in adult outpatients with opioid dependence. Secondary Objectives a)To assess patient satisfaction with treatment b) To assess treatment effects on illicit drug use other than opioids c) To assess treatment effects on quality of life and patient functioning

Kidney transplantation is the best form of treatment for patients with kidney failure, however transplant recipients are at risk of allograft rejection, because the recipient’s immune system recognises the transplanted organ as foreign. Up to 20% of kidney transplant recipients experience at least one episode of rejection. This remains a major cause of kidney transplant failure. Most episodes of rejection are diagnosed by performing a kidney biopsy on patients who have been found to have abnormalities on their blood test results. However, a significant proportion of patients have rejection despite not having abnormal blood test results. In order to detect these cases of “sub-clinical” rejection, the majority of transplant recipients are subjected to surveillance kidney biopsies at pre-determined time points, even in the absence of any clinical problems. Kidney transplant biopsies are invasive, uncomfortable and carry some risk, but remain the only reliable way of diagnosing rejection, especially sub-clinical rejection. Because surveillance biopsies are only performed at a few predetermined time points it is also possible for subclinical rejection to be present weeks or months before it is detected by such a biopsy or becomes clinically evident. Assessment of the pattern of proteins or protein fragments excreted into the urine of kidney transplant recipients may provide an alternative, non-invasive method of understanding the condition and health of the kidney. If a panel of urinary proteins that changes in the setting of kidney transplant rejection could be identified, it could potentially allow for the detection of patients with or at risk of subclinical rejection, therefore avoiding the need to subject large numbers of patients to surveillance biopsies. It might also allow earlier detection of subclinical rejection meaning that it can be treated with before damage is done to the kidney. This pilot study will be performed in collaboration between the Royal Melbourne Hospital and the Walter and Eliza Hall Institute of Medical Research . Kidney transplant recipients at the Royal Melbourne Hospital will have urine samples prospectively collected at pre-determined time points in the first year post-transplantation. These samples will be analysed at the Advanced Technology and Biology Division at the Walter and Eliza Hall Institute of Medical Research (WEHI). Urine protein patterns will be correlated with outcome data obtained in the course of routine clinical care in order to determine the existence of any patterns that correlate with rejection. Serial samples will be analysed to determine whether identification of these proteins at earlier time points can identify patients who ultimately develop rejection. Whether the lack of expression of these proteins can also identify patients who are not at risk of rejection (therefore not requiring surveillance biopsies will also be analysed.

Non-alcoholic liver disease (NAFLD) affects 20-30% of the population and significantly increases the risk of liver related all-cause mortality, transplant, cardiovascular disease and liver cancer. There are no proven safe or effective pharmacotherapies and current management targets weight loss. In the absence of optimal diet and exercise prescription effective management strategies for NAFLD require urgent attention. There are currently no established recommendations for diet or exercise prescription to achieve weight loss. Establishing an effective management strategy for NAFLD, in light of the high (~5.5 million Australians in 2021) and increasing prevalence of the condition, is a public health priority. Weight loss is the current recommendation for NAFLD and known to improve liver and cardiovascular outcomes. The Mediterranean Diet (MedDiet) is a promising intervention, improving body composition and metabolic risk factors in the absence of weight loss. These benefits are attributable to the MedDiet’s anti-inflammatory and antioxidant composition. Thus, developing a better understanding of the combined benefits of weight loss and MedDiet on body composition will facilitate the development of evidence-based interventions that can be translated into practice to improve outcomes for people with NAFLD. Rationale/Justification: The proposed research is significant as this innovative research will be the first worldwide to assess the feasibility of a web based hypocaloric MedDiet in NAFLD, in a non-Mediterranean cohort. A concept that would translate to an intervention that is novel yet simple, as well as cost effective, and can be integrated into practice.

We propose a prospective randomised clinical trial in patients with a fully recovered AF-mediated cardiomyopathy receiving ongoing heart failure therapy, given the paucity of data and the recognised reversible nature of this condition. Patients will be randomised to either staged withdrawal of neuro-hormonal therapies or their continuation and each group will crossover at 6 months for a total study duration of 12 months. Serial assessments will include cardiac imaging, exercise testing and symptom assessments throughout the study period.

Cirrhotic cardiomyopathy (CCM) is a specific type of cardiac dysfunction seen in liver cirrhosis without a primary cardiac cause. It is an important cause of morbidity and mortality before and after liver transplantation (LT). Despite its high prevalence, it is relatively understudied as the diagnosis often becomes clearer only under stressful conditions. The study aims to define early diagnosis of cirrhotic cardiomyopathy using advanced echocardiographic techniques and its clinical significance. In addition, the reversibility of cardiac dysfunction thus studied, will be assessed after LT. In a cohort of 80 consecutive cirrhotic patients, this will evaluate global myocardial work index (GWI)and global longitudinal strain (GLS) as markers of CCM under resting conditions and under pharmacologically induced stress when necessary. The study cohort will be followed-up for 12 months with respect to development of complications such as renal dysfunction, fluid overload, cardiac failure and death/ Lliver transplantation. It will provide the first ever description of GWI and GLS in the diagnosis of CCM in decompensated cirrhosis and its clinical correlation.