ANZCTR search results

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

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32107 results sorted by trial registration date.
  • 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.

  • The enrolment of Total Hip (THA), Total Knee (TKA) or Partial Knee Arthroplasty (PKA) patients performed using either Stryker Mako Robotic-Arm Assisted Technology (Mako) or non-Mako techniques into an outcomes data registry.

    The purpose of this registry is to compare the clinical outcomes of primary total hip, total knee and partial knee arthroplasty patients operated with Mako and non-Mako techniques. Outcome data entered by patients will be collected electronically via an app (called myrecovery) or websurvey link. The secondary purpose is to monitor the early use of this platform (in terms of questionnaire completion rates achievable with the app) that is expected to aid in the data collection process and ultimately achieve high dataset completion rates. Patients will be recruited (retrospectively and prospectively) across Australian sites and data will be collected pre-operatively, peri-operatively and at 6-weeks, 3-months, 6-months, 1-year and 2-years post-operatively with a minimum of 500 patients at 1-year and 250 patients at 2-years (across all procedures). Retrospective patients provided consent to the collection of their data in the same way as prospective patients via the myrecovery app, after being invited to use the app by their surgeon. This took place at the time of their pre-operative visit and patients had time to consider and ask questions. Thus, for the use of their Data in this registry a waiver of consent may be applied.

  • INTERgenerAtional Clinical Trial In at risk Older adults and pre-school childreN (INTERACTION Trial)

    Our ageing population alongside job-related migration has resulted in reduced interaction between grandparents and grandchildren. Increasing evidence suggests that structured intergenerational interaction can mutually benefit community-dwelling older adults and young children. Two community-based sites (St Nicolas’ Anglican Church and St Augustine’s Anglican Church) and associated preschools (St. Nics’ Christian Preschool) in Coogee and (Neutral Bay Preschool) in Neutral Bay are partnering with researchers to evaluate a co-designed intergenerational programme targeted at preschool children and local older adults. This programme will utilise the church hall and preschool facilities based in the local communities. This research is essential/significant because, despite growing public interest (as shown by our pilot work (Kenning et al., 2021), there is almost no empirical evidence to support the anticipated benefits of community-based intergenerational initiatives (Peters et al., 2o21). Our research takes important first steps in evaluating the impact of an intergenerational programme on preschool children and community-dwelling older adults. By doing so, we will be able to estimate the effect sizes needed to power a definitive follow on trial across multiple sites. We have recently completed a small pilot project that showed an appetite for such research in the community and provided initial data on acceptability, allowing us to refine our intervention and delivery of the intergenerational practice program.

  • Cool water foot immersion, skin wetting and fan use as low-cost, at home cooling strategies for older adults during heat waves

    Our laboratory has been conducting research in collaboration with the Montreal Heart Institute, Montreal, CA. examining the effect of fan use with and without skin wetting on thermal and cardiovascular strain in older adults with and without CAD during a 3-hour simulated heatwave. These data demonstrate that fan use during a hot and humid heatwave (38°C, 60% humidity) mitigates the rise in core temperature and heart rate compared to no fan use. During a hot and dry heatwave (45°C, 10% humidity), wetting the skin with 18°C water mitigates the rise in core temperature and heart rate compared to no cooling intervention. This study is is the second phase of identifying low-cost cooling strategies for older adults who are healthy and have heart disease to use in home during heat waves. In this study we aim to investigate whether there is an additional benefit of cold-water foot immersion when combined with fan use during a simulated hot and humid (38°C, 60% humidity) heat wave. A secondary aim of this study is to investigate whether there is an additional benefit of cold-water foot immersion when combined with skin wetting during a simulated hot and dry (45°C, 10% humidity) heatwave.

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