ANZCTR search results

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

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31201 results sorted by trial registration date.
  • The FREER Pilot Study (Family in Rehabilitation: EmpowERing carers for improved nutrition outcomes)

    To support healthy ageing, interventions to improve the nutritional status of older adults and the integration of formal and family care systems are critical research areas of the United Nations 21st Century Research Agenda (items 2.6.10 and 2.10.7). Our observational pilot research identified that one in two older Australians admitted to rehabilitation in Murwillumbah were malnourished, and that they remained malnourished throughout their admission and for at least 12-weeks in their own homes following discharge. Compared with well-nourished patients, malnourished patients were more likely to be admitted to residential aged care and be rehospitalised. Supported by feasibility studies which utilised the “theoretical domains framework”, the proposed pilot intervention project evaluates efficacy of the FREER (Family in Rehabilitation: EmpowERing carers for improved nutrition outcomes) intervention: a low-cost model of care for malnourished older rehabilitation patients which harnesses the under-utilised expertise/skills of family carers to synergise with the existing nutrition workforce support. Through providing malnutrition counselling in rehabilitation, telehealth follow-up and supportive resources after discharge, FREER aims to cost-effectively empower family carers to improve patient and carer health-related outcomes. Using a historically controlled, two-arm intervention trial design, the FREER Pilot Study aims to determine: In n=30 malnourished older rehabilitation patients and their adult family carers, does the FREER intervention, compared with usual care, improve a) patient nutritional status, b) physical function, c) quality of life, d) service satisfaction, e) hospital and aged care admission rates during rehabilitation admission and up to 3-months post-discharge? As a pilot study, this project also aims to evaluate the feasibility and intervention fidelity to inform a larger RCT. The intervention group will be compared with n=30 historical control participants with the same eligibility criteria collected from Ballina and Murwillumbah rehabilitation units from 2013-2014.

  • ENdoscopIc Sleeve Gastroplasty Efficacy (ENvISaGE) Study in Obese Adults.

    A new type of procedure for managing obesity has recently become available in Australia: Endoscopic Sleeve Gastroplasty (ESG), which stimulates weight loss by reducing gastric volume. Unlike the widely implemented laparoscopic sleeve gastrectomy (LSG), the less invasive and incisionless ESG is performed endoscopically and trans-orally. Therefore, the ESG will reduce surgery-related complications and recovery time. Therefore, a non-inferiority prospective cohort study will be undertaken to determine the weight loss efficacy, safety, and effect on comorbidity risk factors and quality of life of obese adults receiving Endoscopic Sleeve Gastroplasty (ESG) compared with Laparoscopic Sleeve Gastrectomy (LSG). 106 participants will be consecutively recruited from Weight Loss Solutions Australia on the Gold Coast. The primary outcome will be excess weight loss at 6-months post-procedure, and secondary outcomes will examine body composition (via DXA), quality of life, complications related to the procedure, lipid profile, blood pressure, comorbidities, blood pressure, and allied health use.

  • Circulating Tumour DNA Analysis Informing Adjuvant Chemotherapy in Early Stage Pancreatic Cancer: A Multicentre Randomised Study (DYNAMIC- Pancreas)

    Pancreatic cancer cells have DNA mutations that are not present in normal cells. For some people, cancer-specific DNA can be found circulating in their bloodstream after they had surgery to remove their pancreatic cancer. This tumour-specific DNA may be evidence that some cancer cells have escaped before the pancreatic cancer was removed. The DYNAMIC-Pancreas study aims to see whether a test called “circulating tumour DNA” can be used to decide the type and duration of post-surgery chemotherapy. Who is it for? You may be eligible to join this study if you are aged 18 years or more and have undergone curative surgery for localised pancreatic cancer and have been recommended adjuvant chemotherapy. You will still be eligible if you had neoadjuvant treatment prior to surgery. Study Details. All participants in this study will have blood drawn for circulating tumour DNA analysis during week 4-6 post-surgery, and throughout chemotherapy treatment (up to 3 times). Participants that had neoadjuvant therapy prior to surgery, will be randomly allocated to one of two treatment groups, where the choice of chemotherapy regimen will be made prior to randomisation: One group will receive the standard of care treatment of modified FOLFIRINOX – a combination of fluorouracil (5-FU), leucovorin, irinotecan and oxaliplatin. The other group will have their treatment based on their circulating tumour DNA blood test results. Patients with a positive test will be offered an alternative chemotherapy than the standard treatment. Patients with a negative test will be offered a shorter duration of the standard treatment. Participants that did not have neoadjuvant therapy prior to surgery, will be placed in a separate, non-randomised group. All participants in this group will have their treatment selection based on their circulating tumour DNA blood test results. Patients with a positive test will be offered an alternative chemotherapy than the standard treatment or a longer duration of the standard treatment. Patients with a negative test will be offered a shorter duration of the standard treatment. All patients will be followed up every 3 months for 2 years, then every 6 months up to year 5. Follow up includes blood tests and radiological assessments. It is hoped that this study will provide evidence that using a test to look for the presence or absence of circulating tumour DNA can help guide the type or duration of adjuvant chemotherapy used after pancreatic cancer surgery.. This test may reduce the number of patients that have detectable circulating tumour DNA after completing adjuvant chemotherapy, compared to standard of care treatment. This may in turn demonstrate that management of pancreatic cancer based on circulating tumour DNA results is superior to the current standard of care treatment.

  • Are falls associated with psychological issues in patients undergoing orthopaedic total knee or hip replacement surgery?

    The aim of the study is to determine whether falls, pain catastrophising, anxiety and depression are associated with poorer post-operative outcomes including falls risk, number of falls, physical function, functional mobility, length of stay, and the need for extra rehabilitation services in patients undergoing total joint replacement. Key research questions are: Does falls risk, anxiety and depression preoperatively predict post operative poor outcomes following joint replacement surgery? Do psychological and physical components have an association in the prediction of falls in the preoperative and post operative periods in the patients having total joint replacement?

  • Treating adolescent anxiety and depression within the Child and Youth Mental Health Service, Children's Health QLD.

    The current project aims to: " Use principles of Implementation Science to promote uptake of, and confidence in using the Unified Protocol for Adolescents (UP-A) by CYMHS clinicians with anxious and/or depressed adolescents in the real world setting of a CYMHS community clinic. " Evaluate the UP-A compared to treatment as usual (TAU). It is hypothesised that by the end of the proposed project: " The confidence of CYMHS clinicians in the utility and delivery of the UP-A with anxious and/or depressed adolescents will have increased following a sequence of targeted implementation processes to support uptake of the EBT in community Clinic A; and " The UP-A will produce superior outcomes on measures of adolescent anxiety and depressive symptomatology compared to TAU.

  • Trial of URsodeoxycholic acid versus RIFampicin in severe early onset Intrahepatic Cholestasis of pregnancy: the TURRIFIC study

    Severe early-onset intrahepatic cholestasis of pregnancy (ICP), a recognised rare disease of pregnancy, is associated with increased rates of stillbirth, preterm birth and neonatal morbidity. The optimal treatment and management of women who are diagnosed with this condition are not known. We plan to compare a standard treatment used for cholestatic itch outside pregnancy (rifampicin) with a standard treatment of ICP (ursodeoxycholic acid - UDCA) to determine comparative safety and efficacy.

  • A Community Jury on initiating weight management conversations in Primary Care

    There is a growing body of evidence that identifies obesity as a major risk factor for a number of diseases, including Type 2 diabetes, cardiovascular disease and some cancers. In Australia, the prevalence of overweight and obesity has been increasing; 63% of adults were classed as overweight or obese in 2014-15, up from 57% in 1995. The National Health and Medical Research Council clinical practice guidelines for the management of overweight and obesity in adults, adolescents and children in Australia identifies primary care as playing an important role in weight management. Obesity has also recently been classified as a disease by the Royal Australian College of General Practice (RACGP), and there are increasing calls for primary care to screen for overweight and obesity. Previous studies suggest few patients attending general practice in Australia are weighed, and few at risk patients are given advice or referred to other services. Identified barriers include concerns about upsetting patients and perceptions that effective interventions are lacking. Few studies have evaluated the impact of weight management interventions delivered by primary care practitioners, but there is some evidence that GP referrals to programmes outside of the primary care setting can be effective, though studies are limited. Initiating weight management conversations in primary care is therefore a controversial issue, and there is a need to explore the views of those directly affected by overweight and obesity. Community Juries are a deliberative democracy technique that involve providing a jury, made up of community members, with expert information about both sides of a controversial issue. The jury then deliberate amongst themselves, and are asked to form a consensus or majority “verdict” on the topic question, which can influence health policy decision-making. The aim of this Community Jury is to elicit the views of well-informed people with overweight and obesity about the role of GPs in initiating conversations about weight management.

  • Preventing obesity and promoting healthy body image in Australian secondary schools

    This study will develop and test a new program called SHINE, and builds on a significant body of work from our successful team of international collaborators. SHINE will deliver universal education about healthy nutrition and physical activity for all adolescents. At the same time, it will dynamically tailor content to provide additional advice for the targeted/selected young people with weight and shape concerns who are at risk of developing disordered eating behaviours and attitudes. It will also provide specific guidance for those who are overweight or obese, where intervention is indicated. Using machine learning predictive models to deliver individually customised advice, SHINE provides core health messages and, where indicated, additional information to optimise intervention engagement and efficacy. The program is tailored to increase the potential to improve body image and weight-related problems; improve nutrition and physical activity; help prevent the development/progression of obesity; and thereby decrease the associated morbidities in later life. The effectiveness of SHINE will be compared with the usual health curriculum.

  • Cognitive impairment in people with COPD or heart failure - effect of one session of exercise training

    An amendment to the ethics committee to include people with heart failure was submitted on 28/11/2018 and approved on 17/12/2018. The aim of the study is to determine if one session of exercise on a treadmill or cycle ergometer will alter the cognitive function in people with COPD or heart failure Patients wit COPD or heart failure will be recruited from pulmonary rehabilitation and randomised via computerised randomisation generation to either the treadmill/cycle group or the quiet sitting group. Participants complete the MoCa Version 7.1 and COPD participants will be asked to walk on the treadmill for 20 minutes at 80% of the average six-minute walk test speed calculated from the better of two six-minute walk tests. Participants with heart failure will be asked to cycle on a stationary cycle ergometer for 20 minutes at 60% of their peak exercise capacity calculated from the better of two six-minute walk tests. At completion of the exercise, participants will rest until oxygen saturation, heart rate and breathlessness returns to pre exercise levels. At this point participants will be asked to complete the MoCa Version 7.2, For the quiet sitting, participants will complete the MoCa version 7.1 and then be asked to sit in a quiet room and listen to music of their choice for 20 minutes, following which they will complete MoCa version 7.2. Two version of the MoCa will be used to control for test familiarity of repeated testing.

  • Evaluation of ocular signs and symptoms following contact lens wear

    To evaluate the ocular signs and symptoms following 2 hours of contact lens wear following soaking with 3 commercially available contact lens care multipurpose disinfectant solutions. Two types of lens materials will be used - a hydrogel lens (Etafilcon A) and silicone hydrogel lens (Comfilcon A). Both the dispensing investigators and the contact lens wearers will be masked.

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