ANZCTR search results

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

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32834 results sorted by trial registration date.
  • A study to test whether images taken by a new handheld medical imaging device can be used to detect the microscopic presence of cancer during breast cancer surgery.

    The purpose of this study is to see if a handheld imaging device (MEprobe) can accurately detect the microscopic presence of cancer in breast surgery patients. Who is it for? You may be eligible for this study if you are female, aged 18 or over and have been diagnosed with an invasive or localized breast cancer. Study details All Participants in this study will have a surgical probe take images of the breast tissue during their breast surgery. Your breast surgeon will also send the breast tissue removed during surgery to pathology for routine laboratory testing to determine the characteristics of the breast cancer (including the size of the cancer as well as diagnostic factors such as tumour margins and hormone receptor status). The images from the device will be assessed by a reading centre following the procedure, to ascertain the accuracy of the probe acquired images. The images from the device will not be used to make any treatment decisions. It is hoped this research will demonstrate that surgical imaging incorporated into the MEprobe is capable of creating high quality images that can be used during breast surgery to identify residual breast cancer and guide future protocols using this device.

  • Effect of Assertiveness Training on Social Anxiety in a Virtual Reality Setting: A Pilot

    The proposed project is a pilot study that aims to implement virtual realtiy assertiveness training within a socially anxious population. The proposed research examines the feasibility of delivering assertiveness training within a VR environment, alongside examining the effectiveness of assertiveness training in reducing social anxiety and increasing assertiveness using this modality. Based on previous literature on VR and assertiveness, it is predicted that individuals in the virtual reality condition will show a clinically significant reduction in anxiety and increased assertiveness compared to individuals in the control condition.

  • 30 day study of 3 different combinations of a medication (AD-036) versus placebo in people with obstructive sleep apnoea

    The purpose of this study is to investigate the longer-term tolerability and efficacy (treatment effect) of the drug combination known as AD036 at standard doses over an approximately 30 day period. This study will also include lower doses of AD036 that have not been studied previously. We know from previous studies that single standard doses of the combination of AD036 reduces sleep apnoea severity. Thus, these findings are expected to provide guidance on the ideal dose and a deeper understanding on the safety and tolerability of the use of these medicines in people with sleep apnoea.

  • Steps to Recovery: a randomised trial aimed at increasing physical activity in hospitalised cancer patients

    The purpose of this study is to see if physical activity in hospitalised patients can be increased using a commercially available ‘smart watch’ device that monitors activity levels. Who is it for? You may be eligible for this study if you are aged 18 or over and have been admitted to St Vincent’s Hospital in Sydney under the care of an oncology or haematology team, with a cancer diagnosis. Study details Participants in this study will be randomised by chance (like flipping a coin) into two groups. Participants in both groups will wear a commercially available smart watch (Samsung Galaxy S3) for the duration of their inpatient stay. One group will have daily goal-setting session with a physiotherapist, and be encouraged to use the smart watch to monitor their activity levels and achieve the set goals. The other group will have standard physiotherapist visits, and will wear the watch and have activity monitored, but will be unable to use the watch as it will be locked. All participants will also wear a step counter on the thigh for certain periods of the trial, and will complete questionnaires at the end of their inpatient stay. Participants in the active group will also be interviewed to obtain feedback on the intervention. It is hoped this research will provide some preliminary evidence about the feasibility of using smart watches to promote physical activity in hospitals.

  • The relative impact of menu labelling versus tailored feedback on the purchase of healthier food from primary school online canteens: A cluster randomized controlled trial

  • The Effects of Vegetable Soup on the Gut Microbiome

    The microorganisms that live in and on us are called our microbiome and they are critical to our health and wellbeing. Dietary macronutrients (fat, protein, carbohydrates, fibre) influence the gut microbiome, which has been found to interact with several bodily systems including the digestive, immune, nervous, endocrine and cardiovascular. The purpose of this study is to determine whether the consumption of vegetable soups can lead to improvements in the gut microbiome as well as blood biomarkers for metabolic health.

  • Paediatric Donor Site Wounds in Australasia

    The donor site wound (DSW) in paediatric split-thickness skin grafts (STSG) is an often-overlooked area of wound management; with most attention typically on the STSG itself rather than the iatrogenic DSW. This survey seeks to determine the opinions and practices of burns surgeons in Australia and New Zealand, with respect to their treatment of the donor site wound in children as a consequence of skin grafting. To some degree this has been done before, by Australasian Plastic Surgeon Patrick Lyall. [1] A similar survey, though with different questions, was carried out in the United Kingdom (UK) in 2012. [2] Properties of an ‘ideal’ DSW dressing have been investigated at a world level by survey of practising clinicians. [3] While this survey had a small number of respondents only, most agreed an ‘ideal’ DSW dressing did not currently exist. Desirable qualities included lack of adhesion to the wound bed, pain-free dressing changes, absorbency, and ease of removal. This study forms part of the PhD thesis of the primary investigator. It is part of a suite of publications in the field of paediatric donor site wounds. [4-7] The study is an electronic survey of Australasian Burns Surgeons practising in centres treating children with burns. [1] Lyall PW, Sinclair SW. Australasian survey of split skin graft donor site dressings. Aust N Z J Surg 2000;70:114–6. [2] Geary PM, Tiernan E. Management of Split Skin Graft Donor Sites–Results of a National Survey. Clinics in Plastic Surgery 2012;39:77–84. doi:10.1016/j.cps.2011.09.012. [3] Lars PKLP, Giretzlehner M, Trop M, Parvizi D, Spendel S, Schintler M, et al. The properties of the “ideal” donor site dressing: results of a worldwide online survey. Ann Burns Fire Disasters 2013;26:136–41. [4] McBride CA, Patel B, Stockton KA, Kapoor V, Kimble RM. Alginate dressings for donor sites of split-thickness skin grafts. Cochrane Database of Systematic Reviews 2018;49:129–18. doi:10.1002/14651858.CD013048. [5] McBride CA, Kimble RM, Stockton KA. Prospective randomised controlled trial of Algisite™ M, Cuticerin™, and Sorbact® as donor site dressings in paediatric split-thickness skin grafts. Burns Trauma 2018;6:1028. doi:10.1186/s41038-018-0135-y. [6] McBride CA, Kimble RM, Stockton K. Three donor site dressings in paediatric split-thickness skin grafts: study protocol for a randomised controlled trial. Trials 2015;16:557. [7] McBride CA, Kempf M, Kimble RM, Stockton K. Variability in split-thickness skin graft dept

  • Cancer Molecular Screening and Therapeutics (MoST) Program Substudy Addendum 6 substudy 14-15: Larotrectinib

    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 Larotrectinib in patients with advanced tumours harbouring NTRK1-3 rearrangements 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 solid cancer of any cell type or an earlier diagnosis of a poor prognosis cancer and your tumour harbouring somatic NTRK1-3 rearrangements. You will also have to receive all standard anticancer therapy. Study details: Participants will continue to consume 100mg of Larotrectinib, twice daily, for as long as they and their doctor agree there is a benefit from treatment. Participants will undergo imaging assessments at 8 weekly intervals or as clinically indicated in order to evaluate tumour response. Safety and tolerability of treatment and health related quality of life during treatment will be assessed at 4 weekly intervals. We cannot guarantee that participants 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 Larotrectinib will be well tolerated and will improve outcomes for future patients, however, there may be no clear benefit from participation in this study.

  • A feasibility study to evaluate the safety of the DiscSeal device in the treatment of lower back pain for patients with Discogenic Disease (including Degenerative Disc Disease (DDD), Intervertebral Disc Disease (IDD), and/or non-specific discogenic disease) of the lumbar spine.

    The primary objective of this study is to evaluate safety of the DiscSeal device in the treatment of lower back pain for patients with Discogenic Disease (including Degenertative Disc Disease (DDD), Intervertebral Disc Disease (IDD), and/or non specific discogenic disease) of the lumbar spine. It is hoped that the device will alleviate pain and delay more aggressive surgical interventions

  • Edith Cowan University (ECU) Lifestyle and Biomarker controlled intervention study of Jamie's Ministry of Food WA participant experience

    This study will use a quasi-experimental pre-post design consisting of an intervention group of participants undergoing a 7-week cooking program in Western Australia and a control group comprising of participants from the program wait-list. Intervention participants will be surveyed at three time points: before the start of the cooking program (IT1), on program completion (IT2), and six months after program completion (IT3). The control group will comprise participants from the program wait-list and they will be surveyed at two time points: 5 weeks prior to program commencement (CT1) and on entry to the program (CT2). Jamie's Ministry of Food (JMOF) Australia is a community-based program teaching basic cooking skills to help people prepare simple, fresh, healthy food quickly and cheaply. The program involves a 7-week mobile kitchen program that is inclusive for any members of the community who are 18 years and over. This study aims to evaluate the immediate impacts and longer term outcomes of the program in Western Australia and whether this impacts participants' physical health and well-being and chronic disease. risk. Therefore, the ultimate aim of this project is to help combat the rise in obesity and diet-related diseases in Western Australia. The primary evaluation aims to determine whether the program improves individuals' cooking confidence and cooking and eating behaviours (self-efficacy). The secondary evaluation aims to determine whether this impacts lifestyle and biomarkers of chronic disease risk. The study hypothesises that participation in a program to develop basic cooking skills and nutrition knowledge will impact physiological and mental health and well-being and the underlying mechanisms that lead to positive health.

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