ANZCTR search results

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

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31097 results sorted by trial registration date.
  • Hypnotherapy for Pain, Itch and Anxiety in Burned Children: A feasibility and effectiveness study

    Hypnotherapy can be effective and superior to distraction techniques in reducing children’s pain and anxiety during painful procedures and may be beneficial in treating itch experienced after procedures. Hypnotherapy can be used in different settings, with different individuals, in varied delivery modes and durations without high technical requirements. Little is known regarding the feasibility of examining hypnotherapy with burned children in an acute setting. This research aims to find out if it is feasible to examine hypnotherapy for pain, itch and anxiety following the use of hypnotic suggestibility tests in burned children.

  • Understanding the Early Natural History of Cerebral Palsy

    This study aims to describe the early natural history of cerebral palsy (CP) by mapping the development of infants with, or at-risk of CP, over the first two years of life. Infants will be assessed in their homes by a trained therapist at regular intervals up to 24 months of age, across a variety of developmental domains (such as movement, thinking skills, language, and more). This will provide, for the first time, comprehensive developmental trajectories of this group. This will contribute to the existing knowledge of CP development, which will assist clinicians and therapists in: 1) accurate diagnosis and prediction of CP, 2) providing targeted early interventions at the 'just-right' challenge, and 3) aiding in the early monitoring and prevention of secondary impairments (for example contracture and hip dislocation). Where indicated, individual participants' results from this study will be used to inform their therapy. A cost analysis of healthcare resources will also be applied as a part of the study. This study is intended to form part of a larger multi-site international study.

  • Cytology-based Circulating Tumour Cell (CTC) Testing in cancer patients and for early detection screening: The ISET-CTC study

    This trial consists of two components recruiting people who have been diagnosed with cancer, and people who may be at high risk of cancer, for example because of family history. Cancer patient study: This study will determine whether there is a difference between the number and type of circulating tumour cells in cancer patients before and after treatment. Who is it for? You may be eligible to join this study if you are aged 18-80 years, diagnosed with any cancer and have received treatment at least 3 weeks ago or will receive treatment within one week. Cancer patient study details The study aims to establish the Circulating Tumour Cell (CTC) detection method using the ISET (Isolation by SizE Of Tumour cells) device (Rarecells, France) in conjunction with cancer therapies including those offered at NIIM. There will be no changes to the participants’ cancer treatment plans. Participants will be required to provide a blood sample at the beginning of their treatment and 3-4 weeks after commencement of treatment. The blood will be processed using the ISET technology to determine the number and types of Circulating Tumour Cells. Early detection screening study: This component of the study aims to determine whether the ISET screening blood test can be used for early detection of cancer. Who is it for? You may be eligible to join this part of the study if you are aged between 18-80 years and have a family history of cancer, or have been diagnosed with chronic disease, or are attending a health check. Early detection screening study details: Participants in this part of the study will undergo a blood test at baseline and at 3-12 months following the baseline test. The ISET test has the potential to detect potentially malignant cells, and other illness causing rare cells. Additional cancer marker testing can tell, whether cancer cells are from the prostate (in men) or breast (in women). In 2023 we introduced viral activation testing using viral markers to test in chronic fatigue patients for reactivation of dormant Epstein-Barr-Virus, Cyto-Megalo-Virus, or Herpes Simplex Virus reactivation, as a high number of Circulating Rare Cells (CRC) may be linked to viral reactivation and a suppressed immune system. It is hoped that this research using a simple blood test will assist in determining both cancer treatment efficacy, and early detection of cancer when used as a cancer screening tool by measuring the presence of cancer-specific cells. Furthermore, additional marker testing on the same patient's blood sample may shed light on the origin of cancer cells, or assess potential reactivation of dormant viruses.

  • Healthy Pregnancy Project: Effect of behavioural and lifestyle changes on the amount of weight gain in pregnant women with obesity

    This service (commenced at Monash Health in 2015) applies systematic review evidence into practice for obese women (with a BMI of greater than or equal to 35 kg/m²) who are booked to birth at Dandenong Hospital, with the aim of reducing excess weight gain and preventing complications.

  • Cancer Molecular Screening and Therapeutics (MoST) Program Substudy Addendum 11 substudy 25-26: Tildrakizumab

    This is a substudy of the Cancer Molecular Screening and Therapeutics (MoST) Program, which is registered on ANZCTR with ID ACTRN12616000908437. This substudy will evaluate the activity of Tildrakizumab in patients 18 years or older, with pathologically confirmed advanced osteosarcoma or soft-tissue sarcomas. Who is it for: You may be eligible to join the study if you are aged 18 years and older, with pathologically confirmed advanced and/or metastatic cancer of any histologic type, including haematological cancers, or an earlier diagnosis of a poor prognosis cancer and have confirmed molecular markers. Molecular profiling will be performed and assessed by the Molecular Tumour Board who will confirm if you have the right molecular markers for this study . Study details: Eligible participants will receive Tildrakizumab at a dose of 200mg every 28 days continuously via subcutaneous injection as long as they and their doctor agree there is a benefit from treatment. Tildrakizumab works by targeting a protein called IL-23, and recent research conducted at Garvan Institute has shown that IL-23 may be involved in growth of sarcomas and osteosarcomas. Tildrakizumab is approved in Australia and is used to treat psoriasis. However, tildrakizumab is not approved to treat bone or soft tissue sarcoma and is therefore an investigational treatment for these advanced and rare cancer types. Clinical and safety assessments are scheduled prior to registration and then every 4 weeks during treatment. Clinical assessments will continue until treatment is stopped. We cannot guarantee that patients will receive any benefits from this study. This study is being carried out to improve the way we treat cancer patients who may have limited treatment options available to them. It is hoped that Tildrakizumab will be well tolerated and will improve outcomes for future patients, however, there may be no clear benefit from participation in this study.

  • The Yoga & Exercise for Mental Health Study

    Almost half of Australians will have a mental health condition in their lifetime, with 3 million adults having anxiety and/or depression in any year. Exercise has recently received a lot of attention for its ability to help prevent and manage symptoms of depression, as well as improving physical health. Mindfulness, which is attention to the present moment, also demonstrates positive effects on mood and mental health, however, not much is known about the effects of combining the two activities on mood in people with depression/anxiety. Yoga is an increasingly popular activity in Australia, and essentially combines exercise and mindfulness together in varying combinations, depending on the type of yoga practiced. We are interested in the effect of different combinations of exercise and mindfulness, such as exercise without mindfulness (cycling), mindfulness without exercise (yin yoga) and exercise and mindfulness combined (vinyasa yoga), has on mood state in people with depression and/or anxiety. This study involves doing a 30-minute bout of different combinations of yoga, exercise and mindfulness each week, and goes for 6 weeks in total. We are interested in measuring mood state, depression, anxiety & stress scores, sleep quality, expectation of the condition’s effectiveness, as well as some basic physical health measures such as blood pressure and blood glucose levels, before and after each session. The primary aim of this study is to investigate and compare changes in mood in people with diagnosed depression/anxiety after engaging in 30 minutes of physically active yoga (vinyasa) or non-physically active yoga (yin). The hypotheses for the study are: 1. Physically active yoga (vinyasa) will have a greater effect on improving mood in people with depression/anxiety than mindfulness-based yoga (yin). 2. Physically active yoga (vinyasa) will have a greater effect on improving mood in people with depression/anxiety than sham control and attention control. 3. Mindfulness-based yoga (yin) will have a greater effect on improving mood in people with depression/anxiety than sham control and attention control. Secondary questions that we intend to explore are: 1. Are acute changes in mood present 24 hours post yoga? 2. What are the acute effects of vinyasa and yin yoga on cardio-metabolic health measures (central blood pressure, augmentation index, blood glucose levels)? 3. Which condition scored the highest on the credibility expectancy questionnaire?

  • A randomized double-blind placebo-controlled trial of oral ivermectin for outpatient treatment of those at high risk for hospitalization due to COVID-19

    A randomized double-blind placebo-controlled trial of oral ivermectin for outpatient treatment of those at high risk for hospitalization due to SARS-CoV-2.

  • The End Rheumatic Heart Disease in Australia Study of Epidemiology (ERASE) Project

    The 2017 ‘Closing the Gap’ report suggests that Indigenous health gains are off target, with the Federal government emphasising the need for verifiable data that can be compared across the nation to provide a clearer picture of progress. Acute rheumatic fever (ARF) and Rheumatic Heart Disease (RHD) are preventable, yet prevalence in some Indigenous Australian communities is one of the highest recorded globally. The ‘End RHD’ Centre for Research Excellence (CRE) (NHMRC 1080401) is developing a roadmap for how RHD can be eliminated as a public health problem in Australia. Robust data are critical to support the CRE’s policy recommendations to jurisdictional and federal governments. In particular, there is a need for: 1. Definitive baseline data and targets for evaluating progress towards goals; currently data on ARF/RHD burden are fragmented and methods under-developed nationally 2. Disease progression data: little is known outside of the Northern Territory (NT); there are no conclusive national data to determine whether current strategies are working. 3. Detailed population-wide studies of hospital utilisation and costs in acute rheumatic fever (ARF)/RHD to enable comprehensive economic evaluation. 4. Data on technical and health system challenges need to be documented at regional and national levels to optimise the interventions and strategies to control ARF/RHD in Australia. Linked administrative data from RHD registers, hospital admissions and deaths are used to build a cohort of ARF/RHD cases around Australia. This data will be augmented by data from additional datasets relating to specific sub-studies. For example, the ANZSCTS ED data, Perinatal datasets. The study aims to align existing datasets to track progress of implemented RHD elimination strategies in Australia. This includes determining the RHD baseline burden and assessing the impact of existing health interventions and strategies on ARF and RHD rates.

  • Pilot study of the Online Personalised Training in Memory Strategies for Everyday (OPTIMiSE) intervention program for older adults

    The overarching aim of this study is to develop and evaluate an online memory intervention program for older adults with memory concerns – the Online Personalised Training in Memory Strategies for Everyday (OPTIMiSE) program. Face-to-face memory groups that teach strategies for managing memory issues in daily life are known to improve memory and functional independence of older adults. Demonstrated participant benefits include improved strategy knowledge and use, memory ability, and memory contentment. Although we know that memory interventions for older adults are effective, widespread translation to practice has been hampered by issues with sustainability of service delivery as well as accessibility; many older adults who would benefit from memory interventions are unable to attend face-to-face courses due to mobility issues or distance. The OPTIMiSE project is significant in addressing these issues, providing a translatable format for disseminating research knowledge regarding effective memory strategies for older adults. This aims to provide participants with increased self­-efficacy regarding memory and increased functional independence. The specific aims of the project are: • To develop an online memory intervention program – Online Personalised Training in Memory Strategies for Everyday (OPTIMiSE) – for older adults with memory concerns. • To evaluate whether OPTIMiSE is acceptable to older adults with memory concerns. • To evaluate whether it is feasible to run OPTIMiSE on a larger scale. • To evaluate whether OPTIMiSE achieves similar outcomes to face­-to-­face groups.

  • Investigating the effect of diet and exercise lifestyle interventions on cognitive performance and dementia risk in older people.

    The study aims to determine if a combination of following a Mediterranean style of diet and walking-based exercise, slows the decline in brain function (cognition) that is commonly associated with older age. A study we recently conducted is the only clinical trial to investigate the effect of a combined Mediterranean diet and exercise lifestyle intervention on cognition in older people. This small (pilot) study showed improved memory and thinking in a sub-group of older participants adhering to a combination of Mediterranean diet and daily walking for 6 months. We are now extending the pilot trial, into a 2-year, definitive clinical trial involving over 364 participants, across 28 sites in Victoria and South Australia. Translating this knowledge into a lifestyle program for behaviour change for the prevention of dementia could be physically, socially and economically significant. This study will investigate the effects of diet and exercise on memory, attention and other mental functions. We will also investigate: mood, stress, fitness and wellbeing. While memory and other brain functions have been shown to normally decline over the lifespan, poorer diet and lack of exercise has been linked with a faster decline in brain functions. This research is aimed at investigating the effectiveness of a combined Mediterranean diet and walking intervention (MedWalk), on cognitive decline in an older population, living independently without cognitive impairment. The study will examine participants’ memory and attention, heart and artery health, mood and wellbeing, and biological markers in blood and faeces following a 24-month lifestyle intervention.

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