ANZCTR search results

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

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31611 results sorted by trial registration date.
  • Efficacy of assigning treatment for participants with Chronic Myelomonocytic Leukaemia based on their individual molecular results (lenzilumab plus azacitidine versus sodium ascorbate plus azacitidine).

    This study is investigating the efficacy of assigning targeted therapy to Chronic Myelomonocytic Leukaemia (CMML) patients based on their individual molecular profile. Who is it for? You may be eligible if you are aged 18 years or over with a confirmed diagnosis of CMML with detection of TET2 and/or RAS pathway mutations during the genetic testing component of this study. Study details Participants will be assigned to each arm based on their individual molecular results: Arm 1: lenzilumab plus azacitidine (for participants with RAS-pathway mutations, or participants harbouring both TET2+RAS Pathway mutations) Arm 2: ascorbate plus azacitidine (for participants with TET2-only mutations) Each arm involves 24 cycles of treatment. Each cycle is 28 days. Participants who complete 24 cycles of active treatment will then enter the follow-up phase of the study where they will be followed up every 6 months for 24 months for survival, disease status and further CMML-related treatment. For participants who have confirmed progressive disease or relapse during the active treatment phase of the study, further treatment will cease. They will remain on study and be followed up for survival, disease status, and further CMML-related therapy every 6 months until 48 months from Cycle 1, Day 1. The results of this clinical trial will inform a rational targeted therapy management approach for a rare disease and will potentially be used to update clinical guidelines and inform healthcare providers.

  • The Country Heart Attack Prevention (CHAP) Project: implementation of a four-step cardiac rehabilitation model of care for rural and remote patients in South Australia

    Historically, CR has been delivered face-to-face to groups in acute hospitals or community centres. The content and length of CR programs varies considerably in Australia and national quality indicators are yet to be determined. Alternative methods for provision of CR have been shown to be effective but few have been implemented into practice. Therefore, we would argue that the evidence for strategies to modify risk factors is strong but the evidence for the mode of delivery has become outdated. The Country Heart Attack Prevention (CHAP) project will use a translation methodology combining a prospective case control designwith a Model for Large Scale Knowledge Translation, and comprehensive economic evaluation to implement evidence-based CR into rural and remote practice. The CHAP model includes; 1) endorsement of CR by clinicians 2) an auto-referral system, 3) a choice of mode of delivery, and 4) long term support for heart health from primary carers. In the 3 years of this study we will implement the CHAP model (Year 1) and evaluate the clinical and cost effectiveness (Year 2-3). We hypothesize that patients receiving CHAP will have higher rates of attendance and completion of CR; higher rates of risk factor modification higher rates of evidence base pharmacotherapy and experience lower rates of morbidity and mortality at 30 days and 12 months and the model will demonstrate cost effectiveness for both services and patients.

  • ASPiRATION - An observational cohort study assessing the clinical impact of comprehensive genomic profiling in people with newly diagnosed metastatic lung cancer.

    What is ASPiRATION? ASPiRATION is a clinical trial that is testing a new approach to providing personalised treatments for patients with newly diagnosed lung cancer through comprehensive genomic testing of patient’s tumour tissue. The ASPiRATION study is being conducted as part of a larger research project called the Molecular Screening and Therapeutics (MoST) Program. In Australia, standard of care tumour testing for lung cancer patients has the ability to identify changes in three genes: EGFR, ALK & ROS1, for which drugs are available on the Pharmaceutical Benefits Scheme (PBS). If a patient is suitable for ASPiRATION, their tumour will also be tested using a technique called comprehensive genomic profiling (CGP), often referred to as molecular screening and/or profiling. This technique allows to look at changes in hundreds of genes in a single test. After a patient’s tumour is tested, a report is sent to the referring oncologist with information on (i) Any genetic biomarkers that were identified in the tumour and (ii) The types of treatment that may be suitable. Who is it for? a. Adults (>= 18 years of age) with newly diagnosed pathologically confirmed non-squamous non-small cell lung cancer and sufficient tumour tissue for “molecular” testing b. Fit to be able to have treatment Study details: A small part of your tumour tissue, which was collected previously, will be used to identify a biomarker by doing a laboratory analysis (‘molecular screening’). You will be asked to provide information about your and your family’s health background, to donate a blood sample and complete some questionnaires. Results from molecular screening will be returned to all participants. These results may have implications for your treatment if a suitable biomarker is found. It is hoped this research will determine whether additional molecular screening can be feasibly integrated into Australian clinical practice for patients with metastatic non-squamous non-small cell lung cancer (mNSCLC).

  • A scalable school-based physical activity intervention for adolescents with disability: The Burn 2 Learn adapted (B2La) pilot feasibility trial

    The primary purpose of the trial is to assess the feasibility of a scalable school-based physical activity intervention (known as Burn 2 Learn adapted) for students with disability. Teachers will be trained to deliver 2-3 weekly HIIT sessions (approx. 10 minutes) for a period of 2-months. We hypothesise that the intervention will be feasible for delivery in the school setting. Further, the intervention will be adapted from a previous intervention (Burn 2 Learn) to suit the needs of students with disability.

  • Effects of intraduodenal administration of quinine on appetite, energy intake and gut hormone release, in response to a standardized buffet-style meal, in humans with type 2 diabetes.

    The purpose of this trial is to investigate the dose-related effects of intraduodenal administration of the bitter agonist, quinine, a non-nutritive (calorie-free) compound, on energy intake at a subsequent ad libitum buffet style meal, plasma gut hormone concentrations, and appetite perceptions in people with type 2 diabetes. We have found in one of our recent studies that quinine, given as a bolus in doses of 300 or 600 mg (in 10 ml water), potently slowed gastric emptying and lowered postprandial blood glucose. Moreover, we observed more potent blood glucose lowering effects when quinine was administered intraduodenally than intragastrically, suggesting that interaction of quinine with small intestinal receptors is required for potent effects. Therefore, based on these findings, this study aims to characterise the dose-related effects of intraduodenal quinine at these doses, on energy intake.

  • Patients' Attitudes Towards The Use Of Artificial Intelligence In Their Emergency Care

    Aim: To provide descriptive statistics about Western Australian health consumers attitudes towards the use of artificial intelligence (AI) in their emergency care. Justification: Over the last decade a combination of exponential increases in computing power, the digitalisation of medical data, and advances in AI algorithms has led to a renaissance in AI research. There exists both optimism and excitement over the potential for AI to improve society, and valid apprehension and concerns over potential failings or malicious uses of AI. If current trends continue AI technologies are likely to improve over the coming years and become increasingly integrated into the practice of emergency medicine in the near future, resulting in increasing patient exposure to such technologies. There is currently no data about how patients in Western Australia accessing emergency care feel about the use of AI in their care. Project design: Cross sectional survey Methods: We will survey patients in three large emergency departments in Perth Western Australia to assess their attitudes and concerns towards the use of artificial intelligence in their emergency care. We have developed our survey input from emergency physicians, computer scientists, and consumers. We will survey around 385 patients in order to provide an accurate representation of the combined South Metro Health Service, North Metro Health Service, and East Metro Health Service catchment areas. Hypothesis 1. Health consumers will be supportive of AI in their emergency care 2. Health consumers will trust humans more than AI 3. Health consumers will be willing to interact with some form of AI Expected outcome: This survey will provide the first high quality data on West Australian health consumers attitudes towards the use of AI in their emergency care.

  • ARORA: Advanced Hormone Receptor Positive Breast Cancer Registry in Australia

    This is a multi-centre prospective cohort study to collect data related to management of Hormone Receptor positive, HER2 negative advanced breast cancer in a real-world patient population. Who is it for? You may be elgible for this study if you are aged 18 years or older, of any gender and you have been diagnosed with metastatic, or inoperable histologically confirmed HR+, HER2- breast cancer (either metastatic at diagnosis or relapsed), after 1st January 2020. Study details All enrolled participants will contribute health data to the development of the registry. Participants will not have to attend additional appointments or undergo additional blood tests or scans outside of their routine treatment. Information collected from participants will include duration of therapy, the rationale for any change in treatment and uptake of targeted therapies or immunotherapy. This study will also collect data on any treatment received in the (neo) adjuvant setting, including chemotherapy and endocrine therapy as this does impact subsequent treatment decisions and treatment order in the metastatic setting. It is hoped this research will contribute important information about all patients with HR+, HER2- advanced breast cancer and help to inform future treatment decision-making for clinicians.

  • Impaired right ventricular deformation to predict acute kidney injury in patients having heart surgery

    This research project is investigating how a right ventricular strain, also known as deformation, obtained during trans-oesophageal echocardiography, may be used to predict kidney failure in patients who are placed on cardiopulmonary bypass for heart and lung surgery. Right ventricular strain may be calculated from echocardiographic images, already taken during heart surgery. Trans-oesophageal ultrasound is an established bedside ultrasound investigation that is used on most patients having heart and lung surgery. Recent technological advancements have allowed us to look at the heart in more detail with the aim of improving the outcomes of these patients. Kidney failure is a major problem after heart and lung surgery and increases post-operative mortality. It also results in longer hospital stays, invasive investigations, invasive treatments, and may result in the patient needing long term dialysis and transplantation. Our understanding of how right ventricular strain relates to kidney dysfunction is currently very poor. This research project will improve our understanding and our aim is that this will enable us to direct treatments to preserve kidney function in at risk patients and improve the burden of kidney failure on the patients affected and on the hospitals taking care of them.

  • Early Years Initiative Evaluation: the impact on children, families and communities of community-driven, evidence-informed actions to improve outcomes in children from birth to the start of full-time school in four diverse Western Australian communities.

    The aim of the Evaluation of the EYI is to determine whether the EYI improved the reach of community supports, programs, and services in the partner communities over the term of the EYI; and how this may have influenced the development, health, and learning of children from conception to age four.

  • An investigation of electromagnetic field exposure on sleep quality in healthy adults.

    Since 2010, there has been an increase in the prevalence of sleep difficulties in adults which coincides with the use of digital devices (Adams, Appleton, Taylor, McEvoy, & Antic, 2016). This is thought to be due to the time spent surfing the internet and/or to exposure to blue light known to impact circadian entrainment, melatonin secretion, alertness, sleep regulation and the pupillary light reflex (Bauer et al., 2018; Touitou, Touitou, & Reinberg, 2016). There is also a growing body of research investigating the impact of pulse-modulated radiofrequency electromagnetic field exposure on sleep quality, however the majority of these studies involve near head exposures to mobile phones in a sleep laboratory (Loughran, McKenzie, Jackson, Howard, & Croft, 2012; Lustenberger et al., 2013; Lustenberger et al., 2015; Schmid et al., 2012) which do not represent real world scenarios to wireless devices typically used in the home so the clinical significance to the larger population is essentially unknown. It is hypothesized that poorer subjective and objective sleep quality would be found during RF-EMF exposure compared to placebo exposure. Adams, R., Appleton, S., Taylor, A., McEvoy, D., & Antic, N. (2016). Report to the Sleep Health Foundation 2016 Sleep Health Survey of Australian Adults: The Adelaide Institute for Sleep Health: University of Adelaide. Bauer, M., Glenn, T., Monteith, S., Gottlieb, J. F., Ritter, P. S., Geddes, J., & Whybrow, P. C. (2018). The potential influence of LED lighting on mental illness. World J Biol Psychiatry, 19(1), 59-73. doi:10.1080/15622975.2017.1417639 Loughran, S. P., McKenzie, R. J., Jackson, M. L., Howard, M. E., & Croft, R. J. (2012). Individual differences in the effects of mobile phone exposure on human sleep: rethinking the problem. Bioelectromagnetics, 33(1), 86-93. doi:10.1002/bem.20691 Lustenberger, C., Murbach, M., Dürr, R., Schmid, M. R., Kuster, N., Achermann, P., & Huber, R. (2013). Stimulation of the Brain With Radiofrequency Electromagnetic Field Pulses Affects Sleep-Dependent Performance Improvement. Brain Stimulation, 6(5), 805-811. doi:https://doi.org/10.1016/j.brs.2013.01.017 Lustenberger, C., Murbach, M., Tüshaus, L., Wehrle, F., Kuster, N., Achermann, P., & Huber, R. (2015). Inter-individual and intra-individual variation of the effects of pulsed RF EMF exposure on the human sleep EEG. Bioelectromagnetics, 36(3), 169-177. doi:doi:10.1002/bem.21893 Schmid, M. R., Loughran, S. P., Regel, S. J., Murbach, M., Bratic Grunauer, A., Rusterholz, T., . . . Achermann, P. (2012). Sleep EEG alterations: effects of different pulse-modulated radio frequency electromagnetic fields. J Sleep Res, 21(1), 50-58. doi:10.1111/j.1365-2869.2011.00918.x Touitou, Y., Touitou, D., & Reinberg, A. (2016). Disruption of adolescents' circadian clock: The vicious circle of media use, exposure to light at night, sleep loss and risk behaviors. J Physiol Paris, 110(4 Pt B), 467-479. doi:10.1016/j.jphysparis.2017.05.00

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