ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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31415 results sorted by trial registration date.
  • Type 1 Diabetes National Screening Pilot: Feasibility and Acceptability Study

    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.

  • Move Your Mind: Preliminary efficacy of a small group exercise intervention for older adults with dementia.

    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.

  • The feasibility, safety, and efficacy of GRoup Exercise for people with type 2 diAbetes using Telehealth: The GREAT Study

    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

  • NEO-IMPACT: NEO-adjuvant chemo-IMmunotherapy in PAnCreaTic cancer

    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.

  • SARS-CoV-2-specific T cell therapy for COVID-19

    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.

  • Effectiveness of a Mindful Parenting Intervention

    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.

  • The Effects of an Intervention to Optimise Quality Use Of Medicines In Older People in Hospital

    Polypharmacy is the use of five or more regular medicines. In some patients taking polypharmacy, the current risk of some of their medicines may outweigh the benefits. This is called ‘inappropriate polypharmacy’. We have developed several tools, presented as a bundle, to reduce inappropriate polypharmacy for inpatients. Using a stepped wedge randomised control trial, we aim to use these tools, supported by a stewardship pharmacist, to optimise medicines use in the hospital and improve outcomes for older people across six hospitals in Northern Sydney and Central Coast NSW. By later obtaining linked data from the Centre for Health Record Linkage, we will investigate whether the bundle can reduce hospital readmissions, Emergency Department presentations and mortality within 28 days and 12 months of the patients' baseline hospital stay. Additionally, we will investigate whether the bundle improves the patients' experience of medication review in hospital and their quality of life after hospital discharge.

  • A trial of integrated arm and language rehabilitation in people living in the community with arm and communication impairments 3 to 24 months post stroke.

    A large proportion of stroke survivors experience loss of arm and communication functions at 3 months post-stroke. These effects are extremely debilitating and can result in long term disability. The aim of this study is to identify the most promising model of arm and communication rehabilitation for people 3 to 24 months after stroke who are living in the community. It is hypothesised that at least one promising UPLIFT model of rehabilitation combining upper limb and language rehabilitation can be identified and taken forward to further clinical trials and translation into the clinic. Participants shall complete some baseline assessments to determine their level of disability, then undertake a 4 week intervention program. The intervention will be intensive daily training (2 or 4 hours/day), either in person or via telerehabilitation, involving both arm training and communication training. Rehabilitation focuses on combining impairment and functional training for tasks such as reaching to pick up a cup of coffee, with contextual everyday communication such as asking for a cup of coffee, and integration of the two, i.e. reaching to pick up a cup of coffee and saying ‘thank you’ while doing it. Baseline assessments will be repeated at the conclusion of the 4 week intervention period. Participants shall be closely monitored for adverse events throughout the intervention program.

  • Replenishing a vital molecule in stiff heart failure patients and examining effect on heart stiffness, blood pressure, and exercise tolerance

    We recently discovered a deficiency of oxidized nicotinamide adenine dinucleotide in the hearts of patients with stiff heart failure. We have shown that replenishing heart levels of this molecule in a mouse model of stiff heart failure can completely rescue this disease. Now, we will deliver the same precursor of this molecule, as used in mice, to human patients with this disease, for three months. At the end of the three months, we will determine if they have had any benefits in heart stiffness, exercise tolerance, blood pressure, and glucose tolerance.

  • Personalised liver stereotactic body radiation therapy using magnetic resonance imaging for liver cancer

    The purpose of this study is to evaluate the "PRISM approach" where MRI imaging is used to improve radiation therapy treatment for liver cancer. Who is it for? You may be eligible for this study if you are aged 18 years or older, and have been diagnosed with liver cancer (either hepatocellular carcinoma or liver metastases). Study details All participants will undergo liver stereotactic body radiation therapy and MRI scans as standard of care. There will also be an additional MRI scan during SBRT, and liver function blood tests at three times: before, during, and 3 months after SBRT. Each MRI scan will take no longer than 1 hour and each blood test for liver function will take no more than 40 minutes. The results from these tests will be used to make maps of liver function, to optimise the delivery of radiation to the liver. It is hoped that this research can determine if the PRISM approach is feasible, and thus improve the effectiveness of liver cancer radiotherapy.

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