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COVID-19 is a global pandemic and has limited cost-effective early treatments. There is some evidence that the use of Vitamin C, Vitamin D and Zinc may be of benefit in conjunction with Ivermectin and Doxycycline. The second phase of the illness is inflammatory and it is possible that Famotidine may help this phase and reduce people needing hospitalisation. This randomised multi-centre outpatient trial aims to ascertain whether therapy with Ivermectin, Doxycycline, Vitamin C, Vitamin D, and Zinc with or without Famotidine reduces hospitalisation.

The RPAH Cystic Fibrosis Service will be conducting an Exercise and Glucose (blood sugar) Control study, comparing glucose levels during supervised exercise at the RPA Exercise Lab and unsupervised exercise that participants perform on their own. We will assess the frequency of low glucose levels during exercise before and after TrikaftaTM, for those who are eligible for this drug if/when it becomes available on the PBS. The study is to elicit whether low glucose after exercise is a common feature in patients with cystic fibrosis with existing glucose metabolism abnormalities, and whether this is changed when starting potent gene modulators in the form of Trikafta.

People with kidney failure suffer a variety of symptoms and poor quality of life. Common symptoms include pain, itch, nausea, anorexia, restless legs, difficulty sleeping and fatigue. There are few treatments available, and many symptoms do not respond or go untreated. Cannabinoids, derived from cannabis, have a wide range of therapeutic effects, including showing promise as treatments for pain, itch, and nausea. This makes them promising treatments for some symptoms of kidney failure. Also, cannabinoids are predominantly hepatically metabolized, with the limited available data suggesting their pharmacokinetics may not be substantially affected by reduced kidney function. However, no studies testing these agents in people with kidney failure have been published. The two best studied, and most widely used cannabinoids are tetrahydrocannabinol (THC), which has psychoactive and muscle relaxing actions and may also be analgesic and antiemetic, and cannabidiol (CBD), which has anti-convulsant, anti-inflammatory, and anxiolytic actions. CBD is typically better tolerated and minimises the potentially adverse psychoactive actions of THC. Combined formulations of the two cannabinoids are common in clinical practice. Before embarking on studies of the efficacy of cannabinoids on symptoms in people with kidney failure it is important to first show that they are safe and well tolerated. Hence, the aim of the present study is to determine the safety and tolerability, and pharmacokinetic parameters of cannabinoids in people with kidney failure. The staggered initiation of CBD, is designed to permit assessment of the safety and tolerability of CBD alone, in a manner that minimises the potential for adverse effects in this vulnerable population. The experience gained with this canabidiol will inform the design of future studies.

The Draw-Care study aims to improve the lives of culturally and linguistically diverse (CALD) family carers and people living with dementia using animations, digital fact sheets, and a multilingual chat-bot, collectively titled “The Draw-Care Intervention”. The three primary objectives of the study are addressed in three interconnected components comprising the overall trial. In Study 2, the intervention will be trialled and tested for effectiveness in reducing care burden experienced by carers of people living with dementia -- both of a CALD background up to 12 weeks after they receive the resources and will be compared with an active control group who won't receive the resources at the same time. The third component of the trial overall is to evaluate cost-effectiveness of the intervention from a societal perspective compared to a control which models usual standard care. The outcomes of the Draw-Care study are significant and measurable in terms of effectiveness of the resources developed, that is, 1) whether care burden is reduced 2) whether there are improvements in family carer's mood and quality of life 3) whether there are improvements in the quality of life for the person living with dementia. A range of online questionnaires including previously validated tools and interviews with carers and people living with dementia will be used to capture exposures and views and experiences using the Draw-Care intervention complement of resources.

Children are often diagnosed with type 1 diabetes (T1D) too late, with 1 in 3 admitted to ICU with life-threatening diabetic ketoacidosis (DKA). This start to disease is traumatic and has lifelong implications for cognitive impairment, long-term blood glucose levels, and the risk of serious complications. Early diagnosis and starting treatment are essential to prevent DKA, reduce trauma and improve long-term health. Up to 90% of those who will develop T1D have no family history of the condition. Therefore, the only way to identify most children early is through general population screening. Our overarching vision is that general population screening for T1D will be implemented in Australia to decrease the burden of DKA and its health consequences. Australia is ideally suited to screening programs, given our centralised healthcare system with screening federally mandated, funded and managed. Several screening models have been proposed in research trials internationally, however, the optimal model for the Australian setting is unclear. The National Type 1 Diabetes Screening Pilot: Feasibility and Acceptability Study will compare three different models to determine the most appropriate model for routine screening of the Australian paediatric general population. Model 1) Newborn Screening via genetic analysis of a dried bloodspot taken in hospital at the same time as the current newborn screening sample. Genetically ‘at-risk’ children will be offered follow-up autoantibody bloodspot testing from 12 months of age. Model 2) Infants aged 6-12 months will be screened via genetic analysis of a saliva sample. Genetically ‘at-risk’ children will be offered follow-up autoantibody bloodspot testing from 12 months of age. Model 3) Children aged 2, 6 or 10 years old will be screened for islet autoantibodies using a dried bloodspot sample. Children with two or more autoantibodies are considered to have early stage T1D. We are aiming to recruit 9,000 children, with 3,000 children in each group from across Australia. Each screening model will run in a unique geographical area with public awareness and engagement campaigns, and targeted mail-out invitations to participate. The three screening models will be compared to see which was the most feasible, acceptable, and cost-effective. Collectively, this is a pivotal first step in achieving our overarching vision for general population screening for T1D to be implemented into routine healthcare across Australia, with the principal aim of reducing the burden of DKA and its lifelong health consequences for children.

We aim to investigate the efficacy of a small group exercise program, which consists of two 45-minute sessions twice per week for 12 weeks, for improving cognition in older adults with dementia.

Almost 1million Australian adults (5.3% of the population aged over 18years) have type 2 diabetes (T2D). The benefits of exercise for people with T2D include improved glycaemic control, reduced body fat, increased fitness, and reduced pain. These benefits can be observed even with once weekly supervised sessions. Medicare subsidises eight group exercise classes annually for people with T2D. However, barriers such as lack of transport, financial cost and living in regional centres can preclude people from participating in-person. Telehealth may be an alternative approach to overcome these barriers. In response to COVID-19, Medicare are now subsidising one-on-one videoconference exercise services; this funding has not been extended to group services. In people with T2D, being physically active with others is an important motivator; specifically, the accountability, increased enjoyment, and sense of community that accompanies group training improves adherence, which ultimately improves health outcomes. The feasibility and efficacy of group services delivered via telehealth have not been evaluated in T2D, though a small study in liver transplant recipients has shown it to be an appropriate alternative to in-person services. Given the unique provision of care in T2D with the availability of subsidised group exercise sessions, investigating the application of telehealth in this context is crucial. Therefore, the aims of this study are to: 1. Establish the feasibility (i.e., practicality, recruitment, attendance, retention, safety, and acceptability) of delivering group exercise interventions via telehealth, compared with in-person, in people with T2D 2. Evaluate the preliminary efficacy of an 8week telehealth group exercise intervention on behavioural (physical activity levels) and clinical (bloods, body composition, physical function) outcomes, compared with an in-person group intervention, in people with T2D 3. Evaluate the impact of the mode of service delivery on behavioural and clinical outcomes 16weeks following an 8week group exercise intervention in people with T2D 4. Determine the validity and reliability of in-person clinician-measured versus telehealth-supervised participant self-measured assessments

The NEO-IMPACT study will assess the safety of combining standard chemotherapy (modified FOLFIRINOX) with immunotherapy (durvalumab) in patients with early stage pancreatic adenocarcinoma who are considered suitable for surgery. Who is it for? You may be eligible for this study if you are an adult aged 18 or older, you have been diagnosed with pancreatic cancer that is suitable for surgery (resectable or borderline resectable) and your kidneys, liver and bone marrow are considered healthy enough for you to take both chemotherapy and an immunotherapy drug. Study details All participants who choose to enrol in this study will undergo 6 treatment cycles every 2 weeks (for a total of 12 weeks) of combined immuno-chemotherapy (durvalumab with modified FOLFIRINOX). The chemotherapy (modified FOLFIRINOX) will be administered as a day patient in hospital. It is given via an intravenous (into a vein) infusion on day 1 of each cycle. One of the chemotherapy drugs (5-FU) will be given as a continuous infusion over 46 hours via a portable pump therefore you will return to the hospital on day 3 to have this pump disconnected , The immunotherapy drug (durvalumab) will be given via an intravenous infusion on day 1 of each second cycle i.e. cycles 1, 3 and 5. At the end of the 6 treatment cycles, participants will be assessed for their suitability for surgery. After surgery all participants will then undergo an additional 6 treatment cycles of chemotherapy alone (modified FOLFIRINOX). All participants will be monitored for 12 months after their surgery, This will include a medical review, blood tests and imaging with a CT scan every 3 months. It is hoped this research will determine if adding immunotherapy to standard chemotherapy affects how well the treatment is tolerated, and whether it will affect how much of the planned treatment can be completed (due to potential side effects). If the combined treatments are shown to be safe, they may be prescribed to future pancreatic cancer patients.

The trial is testing a new therapy to treat the virus known as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which causes COVID-19. The new treatment is called T cell immunotherapy. It aims to use T cells, a type of immune cell, to fight disease. This therapy is given via infusion into the bloodstream (intravenous infusion). Researchers at QIMR Berghofer Medical Research Institute have grown T cell therapies from blood samples donated by healthy people who have an immune response against SARS-CoV-2. These blood donors tested positive for SARS-CoV-2 more than a year before their blood donation, so their immune system has a memory of the virus and is able to fight it. Their anti-viral T cells have been grown in the laboratory to large numbers, and then frozen in single doses for the treatment of future patients. The main purpose of this clinical trial is to see if the T cell therapy is safe for people who have tested positive for SARS-CoV-2 and are at risk of developing severe COVID-19 because they have either received a transplant, chemotherapy, or a treatment that suppresses their immune system. We will recruit 20 participants in the trial. They will be matched with the most suitable batch of T cell therapy and then receive two intravenous infusions of T cells approximately 2 weeks apart at Royal Brisbane and Women’s Hospital. Monitoring of participants includes physical assessments, blood tests and nasal swabs. There will be five study visits over an approximately 3-month period.

The current study seeks to determine the effects of a in-person and interactive online group mindfulness-based parenting intervention for parents of young children (ages 3-7 years) experiencing anxiety. Mindfulness is the awareness that arises when we pay attention in a particular way, on purpose, to the moments in our lives, non-judgmentally. Mindfulness is not something you can learn by talking or reading about it, and therefore mindfulness-based interventions introduce participants experientially to a variety of mindfulness practices. Coping with parenting is demanding, both in terms of caring for parents own wellbeing, and the wellbeing of children. Mindfulness may be a useful tool/skill to manage the demands, associated stresses and challenges of parenting. Mindful parenting groups are suitable for parents who experience parenting stress (everyone!) as well as parents who have had mental health problems, or whose child/children experiencing emotional or behavioural problems. This study aims to understand any changes in parents (and their children) following parent’s participation in a mindful parenting group (children will not participate in the group). An improved understanding about cognitive/thinking, emotional and behavioural processes and parent characteristics, and how these are affected by a mindful parenting intervention is important for helping us develop more effective treatment and targeted support for parents of young children with anxiety. We also seek to better understand participants’ perceptions about the mindful parenting course and course components, as this will allow us to develop a more effective mindful parenting course program. Hypotheses: We expect that this program will be feasible to implement, and that parents will report improvements in their parenting stress, enhanced mindfulness in parenting, and improvements in their child's wellbeing.