ANZCTR search results

The purpose of this study is to determine if a standard chemotherapy induction therapy followed by maintenance using pembrolizumab will be effective in maintaining life expectancy with minimal side effects for participants. Who is it for? You may be eligible for this study if you are an adult with has been diagnose with primary central nervous system lymphoma. Study details All participants in this study will complete a standard induction treatment followed by pembrolizumab, via a drip into the blood vessel, every 3 weeks for 2 years. Throughout the study scans will be performed at various time points such as Magnetic Reasonance imaging (MRI) and Positron Emission Tomography (PET scans) to take pictures inside your body. Blood samples will also be taken throughout the treatment period, however these are the same as you would have taken during standard treatment outside of the trial. It is hoped that this treatment will result in a better prognosis for those with primary central nervous system lymphoma, with less severe side effects.

The purpose of this study is to determine if continuous irrigation of the bladder using sterile water for at least 3 hours is feasible and safe in bladder tumour resection. Who is it for? You may be eligible for this study if you are an adult who is suspected of having bladder cancer. Study details Standard surgery for bladder tumours involves irrigation of the bladder during and after the surgery using sterile saline (salt water). If you participate in this study, you will have sterile water used for this irrigation during and for at least 3 hours after surgery instead. If irrigation using water is found to be feasible and safe, it can then be assessed further to see if it can prevent the bladder cancer. from coming back. This could have a major impact on treating bladder cancer

Stroke is the most common life threatening and debilitating neurological disorder. It is commonly caused by the flicking off of plaque from calcified arteries in the neck region in patients with atherosclerotic internal carotid artery stenosis. This study retrospectively compares the outcomes after 2 different treatment options for carotid artery stenosis: carotid artery stenting (CAS) and carotid endarterecromy (CEA). All patients who underwent either procedure performed by the primary surgeon, in 4 locations will be included. Specific outcome measures are: (1) post procedure occurrence of further clots in the arteries supplying the brain and (2) post procedure occurrence of external carotid (a branch of the artery being operated on) occlusion. In order to measure these outcomes, we will compare the clinical examination findings as well as imaging (MRI, ultrasound, CT angiography) results pre and post operatively. As CEA is currently the gold standard for treating this condition, we predict that long term outcomes are better in CEA as compared to CAS.

This study aims to compare how effectively a closed-loop automated insulin delivery system maintains an individual’s glucose levels in a healthy range compared with insulin delivered via a pump with doses determined in a manual way together with continuous glucose monitoring (CGM) via a glucose sensor. All participants will undertake the study over a 9 to 11-month period, completing two study stages in random order, each of 4-month duration 1) Closed-loop with automated basal insulin delivery, 2) Open-loop with manual insulin delivery via pump and CGM.  Outcomes of interest include glucose levels and other non-glucose parameters such as physical well-being, cognitive functioning, psychosocial well-being, sleep, glucose patterns while driving and caregiver burden.  These results will help us to understand whether automated insulin delivery systems may benefit an older cohort, and help to further refine systems for future iterations.

This observational study will compare evening meal plate wastage between a group receiving an a la carte dinner menu and a group receiving a cyclical dinner menu (pre-ordered) on two maternity wards at St John of God Subiaco Hospital, Perth, Western Australia. The hospital has initiated a three-month trial of a new menu model (a la carte). Researchers will observe the impact of this change, and compare with cyclical menus with regards to the main reasons for plate wastage (i.e. food and drink uneaten) from a patient’s perspective. At the conclusion of data collection and analysis the data will be assessed and used to provide average plate waste and average nutrient intake data, as well as patient comments analysed to assist with the evaluation of the new hybrid room service model (a la Carte menu) trial. Primary research hypothesis: Patients who consume an a la carte dinner will have less plate wastage compared to those on the 14-day cyclical menu.

The purpose of this study is to investigate the safety, tolerability and effectiveness of pharmaceutical grade cannabis for the management of pain. Who is it for? You may be eligible for this study if you are an adult who has been prescribed NanaBis™ for either cancer-related or non-cancer related pain. Study details All participants will be followed up by their doctors on a monthly basis for 12 months. These follow ups will involve completion of surveys and provision of information regarding the administration of NanaBis™. Participants will not be asked to undergo any procedures or tests as part of this study. It is hoped that this study will help determine whether pharmaceutical grade cannabis is an options for pain management.

Limited health literacy has great impact on patient health outcomes; poorer knowledge of disease is linked with suboptimal self-care, reduced treatment adherence and increased use of emergency services. Studies conducted to assess health literacy and patient understanding amongst patients living with chronic hepatitis B (CHB) have revealed gaps in disease-specific knowledge. Despite this, there are few studies evaluating strategies to improve patient knowledge of hepatitis B. The 'teach-back' strategy is a communication tool that has been shown to be successful in improving disease-specific knowledge in other areas of health. 'Teach-back' ensures the health provider checks for understanding with patients and then allowing opportunity for clarification. This study hypothesises that there is a poor baseline understanding amongst patients living with CHB and that the teach-back method will improve disease-specific knowledge. This would form the foundation for future studies to evaluate how improved understanding translates into greater health outcomes.

Childhood inattention has been linked with poor academic outcomes, as well as increased risk of social, occupational and psychological problems later in life. Children with an Acquired Brain Injury (ABI) are particularly susceptible to attention deficits following their injury and may benefit from interventions aimed at enhancing attention. Training Attention and Learning Initiative (TALI Train), an adaptive cognitive training program, is a novel approach to improving attention capacity in young children. The impetus to develop this training program came from both the lack of suitable non-invasive, non-pharmacological treatments for young children with attention difficulties, and mounting evidence that targeted training can have a positive lasting impact on cognitive functions. TALI Train is yet to be trialled in children with an ABI and as such, its efficacy in this group is unknown. The primary objective of this study is therefore to evaluate whether the TALI Train program is able to reduce attention difficulties in children with an ABI. It is hypothesised that the training intervention will promote greater gains in cognitive attention (selective, sustained and attentional control) than the active control program. Secondary objectives include assessing comparative effects of the intervention and active control program on untrained areas including academic achievement, working memory and social functioning. In addition, this study will examine the potential predictors of training outcomes in children with an ABI including baseline attention abilities, the family environment, socioeconomic status, and parental mental health. Participants in this double blind, randomised controlled trial will be children with an ABI, aged between 4 years and 9 years 11 months. They will be randomly allocated to either (a) TALI Train (intervention group) or (b) an active control group using a program that is non-adaptive and has limited attention training potential. Both programs are delivered on a tablet, and children complete one 20 minute training session at home five times a week for a five week period. The efficacy of TALI Train compared to the placebo program will be assessed at pre-training and post-training, as well as at a 3-month and a 6-month follow-up.

Just over 180,000 people in Australia are living with chronic hepatitis C (CHC) and at risk of liver disease, liver cancer and death. Since 2016, medicines for CHC can be prescribed by GPs, which cure >95% of patients and prevent ongoing liver damage. So far 10% of GPs in Australia have prescribed CHC medicines, but to meet World Health Organisation targets for hepatitis C elimination all GPs will need to identify patients in their practice with the disease and recall them for treatment. NPS MedicineWise has developed an educational intervention delivered by their field force of clinical service specialists (CSS) to general practice staff to support GPs in the diagnosis and management of CHC. The intervention includes a 1-hour educational small group meeting at the general practice, a personalised ‘audit and feedback’ report from the MedicineInsight program, that includes data specific to their practice, benchmarked against all practices, and an online audit tool. The intervention aims to raise awareness, provide education and increase confidence in management of CHC, as well as facilitating links between GPs and specialists who can provide approval for treatment and support GPs while they increase their experience in CHC management. During the 1-hour meeting, in addition to discussing the feedback reports, the education will include a case study, educational materials developed by ASHM, and an action sheet completed by the CSS during the visit. The intervention also includes encrypted patient lists from MedicineInsight identified as requiring follow-up at the practice. This cluster randomised controlled trial will evaluate whether the NPS MedicineWise educational intervention, with data-based insights from MedicineInsight, is effective at improving case finding, assessment and treatment of patients with CHC. We will test the hypothesis that compared to control practices, those practices randomised to receive the NPS MedicineWise educational intervention will have a higher number and proportion of patients with CHC initiating direct acting antiviral (DAA) therapy and a higher number of patients being tested with an HCV (hepatitis C virus) RNA PCR test for diagnosis. Data will be evaluated using the general practice data program, MedicineInsight. MedicineInsight is a leading large-scale primary care data set of longitudinal de-identified electronic health records (EHR) used for quality improvement and research. The results of this trial will help inform future initiatives in Australia as well as internationally to continue the treatment momentum to help eliminate CHC.

The aim of this randomised control trial is to evaluate the effectiveness of methods to recruit schools to an app-based nutrition program, called SWAP IT. The trial will evaluate whether recruitment via invitation emails from the app provider, Skoolbag, is as effective as usual recruitment via a Health Promotion Officer employed through the state health department. The trial will run for approximately 4 weeks. 76 schools in the Hunter New England region will be randomly allocated to the intervention (Skoolbag recruitment) or control (usual methods). The trial aims to provide evidence to inform recruitment methods for broader dissemination if the program is deemed to be effective.