ANZCTR search results

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

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31134 results sorted by trial registration date.
  • 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.

  • Cancer-Related Fatigue: A combined Physical Activity and Mindfulness program

  • An Effectiveness Trial of Online Stepped-Care for Adults with Posttraumatic Stress Disorder

    The current study will investigate the feasibility and effectiveness of a stepped care approach for treating posttraumatic stress disorder (PTSD) in adults. Stepped care is defined as a hierarchy of evidence-based therapies where clients can be matched to an intervention level that suits their current needs. In an open trial, participants will initially complete a self-guided PTSD program online (This Way Up, developed by the Clinical Research Unit for Anxiety and Depression, CRUfAD, St Vincent’s Hospital, Sydney) that involves modest clinician involvement. Participants who show risk of disengagement and/or dropout, or do not make significant clinical gains will be offered traditional, one-to-one, PTSD treatment (Cognitive Processing Therapy) via telehealth. Outcome measures will be assessed at pre- and post-treatment and at a 3-month follow-up. Primary outcomes are PTSD (diagnosis, good end-state achievement, severity reduction) and treatment retention. Important secondary outcomes include comorbid conditions, quality of life, feasibility (i.e., ease of delivery), acceptability as rated by clients, and cost effectiveness. It is hypothesised that this approach will be both accessible and cost-effective as we predict that most clients will achieve good end state functioning without needing to be "stepped-up" to CPT.

  • A Prospective, Multicentre Study of Low Dose Targeted Drug Delivery (TDD) for Chronic Back Pain Patients who have Failed Spinal Cord Stimulation

    The purpose of this study is to evaluate the effectiveness of low dose targeted drug delivery (TDD) therapy for chronic back pain patients who have failed spinal cord stimulation.

  • Kisqali Access Registry for Metastatic Breast Cancer in Australia

    The primary objective of the study is to describe real world clinical and tumour characteristics of patients with HR+ HER2–ve MBC in Australia who have received ribociclib in combination with an AI as part of the ribociclib MAP and/or SPARK access program, and treatment details of AI + ribociclib. Who is it for? You may be eligible to join this study if you are aged 18 years or above, and have been diagnosed with metastatic or advanced HR positive, HER2 –ve breast cancer, for which you have received combination treatment with ribociclib and an aromatase inhibitor as part of the Novartis ribociclib MAP/SPARK program between the period of 1 May 2017 to 30 June 2018. Study Details The information will be collected from the medical records of patients who were prescribed ribociclib in combination with an aromatase inhibitor as part of the ribociclib MAP and/or SPARK access program. We hope that this information will give is an opportunity to improve our understanding of real world ribociclib treatment in Australia.

  • trips4health: Incentivising adults to use public transport for physical activity gain

    Efforts to correct the physical inactivity pandemic have focused on leisure-time physical activity (PA) with limited impact. Public transport (PT) users accumulate more PA than motor vehicle users, yet intervention studies to increase PA through transported-related behaviour are sparse. Further, incentive-based strategies have demonstrated some promise for increasing leisure-time PA, but their impact on other types of PA, such as transport-related PA, is unclear. This study aims to fill a knowledge gap by determining the impact of an incentive-based strategy to increase transport-related PA by increasing PT use in a regional Australian setting. It is hypothesised that incentivising bus use will increase bus use and reduce motor vehicle use leading to PA gain.

  • WalkBack - Effectiveness and cost-effectiveness of a progressive individualised walking and education program for the prevention of a recurrence of low back pain.

    WalkBack is a pragmatic randomised controlled trial comparing a walking and education program prescribed over 6 session by a physiotherapist, with a usual care control group. 698 participants, who have recently recovered from an episode of non-specific low back pain, will be recruited through the community and primary care clinicians (GPs, physiotherapists and chiropractors). Participants will be followed up for a minimum of 12 months. The primary outcome will be days from randomisation to first self-reported recurrence of an episode of activity-limiting LBP (somewhat or greater activity limitation measured using an adaptation of item PI9 of the PROMIS item bank to measure pain interference). The secondary outcomes will be days from randomisation to first self-reported recurrence of (i) an episode of non-specific LBP (intensity equal or greater than 3/10 on the numeric pain rating scale, lasting at least 24 hours), (ii) an episode of care seeking (with consultation to a health care provider) LBP and back pain related-disability measured by the 24-points Roland-Morris Disability Questionnaire (RMDQ). An assessment of effectiveness and cost effectiveness of the walking and education program compared to usual care will then occur.

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