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.
  • Hookworm Therapy for young people at high risk for colorectal cancer

    This study aims to evaluate low-dose hookworm therapy in adults who are at a high risk of developing colorectal cancer (CRC). The study will assess how useful the hookworms are in improving the richness and diversity of bacterial species within the gut, which may be a preventive measure against the development of CRC. Who is it for? You may be eligible to join this study if you are aged 18- 55 and have a cumulative history of 2 or more conventional colorectal polyps. Study details All participants will have 10 hookworms applied to their skin and then again 4 weeks later, this will provide a mild infection to the gut. The study will involve taking a variety of biological samples before the infection (including, blood, stool and rectal tissue specimens) and again after approximately 6 and 12 months. These specimens will be subjected to laboratory analysis to determine if the hookworm infection changed the types of bacteria within the gut and how this relates to gut inflammation. If any pre-cancerous tissue is identified during the surveillance period, it will be removed and similarly inspected for bacteria and inflammation. All participants will be required to undertake quality of life questionnaires and blood samples will be carefully analysed by commercial pathology providers to monitor safety of the hookworm infections.

  • Controlling device Occlusion by needleless ConnectOr design. A pilot randomised control trial (COCOA Trial)

    Peripheral intravenous catheters (PIVCs) are the most frequently used vascular access device to provide intravenous treatment to hospitalised patients. A needleless connector (NC) allows a PVC to be connected to an administration set or syringe without the use of needles. Many hospitals (including the Royal Brisbane and Women’s Hospital) use a negative pressure NC. This device, on the completion of access or flushing, creates a negative displacement allowing a small amount of blood to move back into the catheter. Manufacturers have recently created complex NCs comprised of mechanical valves with neutral pressure (no fluid displacement). This randomised controlled trial will test the efficacy, cost effectiveness and acceptability to patients of a neutral pressure NC. Sample: 200 adult patients in the cancer care, general medical and surgical wards of the RBWH. Primary outcomes: (1) feasibility (2) device failure.

  • Perioperative use of steroids in knee arthroplasty trial

    This study will consist of a prospective randomised control trial comparing standard perioperative care for primary total knee replacement with and without the addition of a perioperative dose of methylprednisolone. We aim to determine the best peri-operative pain control for patients undergoing this painful procedure whilst limiting the risks. This is hypothesised to allow early gains in range of movement, hospital discharge and reduction in post operative nausea and vomiting, postural hypotension, post operative analgesia requirements and an improvement in knee scores. Patients will be assessed daily during their inpatient stay and then at 2 and 6 weeks for pain control, satisfaction, signs of infection and range of movement. The study will be conducted over a three month time frame. This information will be used to enhance pain control for future patients whilst reducing risks. It is also expected to enhance the patient journey for those undergoing TKA at SJOG Murdoch.

  • Feasibility and acceptability of a personalised healthy diet versus a medical nutrition therapy ketogenic diet in reducing migraine frequency and severity

    Our aim is to determine which of two dietary approaches is more effective in reducing migraine frequency, severity and duration in individuals within the community who identify as migraine sufferers. In a randomised cross-over trial, we will evaluate the feasibility, acceptability and efficacy of a ketogenic diet (high in fat, low in total carbohydrate) compared to an ‘anti-headache diet’ we have developed based on common triggers identified by our review of the research evidence. The value of this study will be the potential to improve quality of life, reduce functional impairment and reduce the need for or dose of medications in individuals who experience frequent or severe migraine. Clinicians will also benefit from an increased knowledge of food triggers and dietary strategies that can aid in the management of migraine.

  • Outcomes from a psycho-behavioural treatment for maintenance of weight loss.

    Despite huge investments the obesity epidemic persists, treatments are failing and new thinking is urgently needed. Less known is the equally alarming increase in disordered eating – e.g. one in 10 Australians now reports regular binge eating - and the increase in both is more rapid than either alone. Could well-known solutions for disordered eating aid weight loss recidivism? People are known to typically lose weight well to 12 months with the loss plateau commencing thereafter. However, this is the period when intensity of treatment recedes and habitual patterns in maladaptive thinking and behaviours (e.g. binge eating, and emotional overeating) emerge or resurface. We will evaluate outcomes, and their moderators and mediators, following a group-based psycho-behavioural intervention, HAPIFED–M, delivered in this crucial period. This will be embedded in a current service providing opportunities for future partnered translational health care funding. HAPIFED-M incorporates evidence-based treatments for disordered eating as well as a novel cognitive remediation therapy to improve self-efficacy and organizational/problem solving skills. Key outcomes will be improved weight loss maintenance, physical and mental health, adaptive function and reduced health care utilization/costs. Major mediators tested will be reduced eating disorder symptoms and binge eating and an increased capacity for decision making.

  • Testing patients visiting a general practice suspected of having Influenza using an in-home test for influenza vs. PCR gold-standard test

    The overall aim of the Australian arm of the Seattle Flu Study is to evaluate the accuracy of the flu@home self-test for influenza by recruiting patients who present with an influenza-like illness to a GP or nurse practitioner who is a member of ASPREN for national influenza surveillance activities. Flu@home test results will be compared to PCR test results, which is considered to be the gold-standard for detection of influenza.

  • Effects of endogenous bile acids on postprandial glucose levels in health and type 2 diabetes

    Bile acids are increasingly recognised to play a critical role in the regulation of glucose homeostasis. The proposed study extends our novel findings on the effects of exogenous bile acids and capitalises on our capacity to aspirate endogenous bile and target nutrient infusions to specific regions of the small intestine in humans, to define the role of endogenous bile acids in postprandial glucose metabolism in type 2 diabetes (T2DM), and to clarify the relative importance of exposure of different regions of the gut to bile acids. Specifically, we will evaluate the hypothesis that small intestinal exposure to endogenous bile acids will reduce postprandial glycaemic excursions, associated with augmented secretion of glucagon-like peptide-1 (GLP-1) and insulin and suppression of glucagon in patients with T2DM and that these effects will be potentiated by diversion of bile acids from the proximal to the distal small intestine.

  • A pilot study to characterise the in vivo safety and infectivity of a Plasmodium falciparum 3D7-GL master cell bank in healthy subjects

    The induced blood stage malaria (IBSM) model provides an attractive tool to test the efficacy of vaccines and drugs for non-immune subjects in a rapid and cost effective manner. The purpose of this pilot clinical trial is to characterise the P. falciparum 3D7-GL MCB as a malaria challenge agent for use in future IBSM studies. Another aim of this study is to investigate advanced imaging techniques in malaria infection. Nuclear medicine imaging techniques, particular hybrid PET/CT and PET/MRI have a central role primarily in oncology for assessing the biodistribution and activity of malignancy. The ability of these techniques to detect and locate biological and biochemical changes have more recently been applied to other medical fields including Infectious Diseases, though there are no studies in malaria.

  • The Safety, Feasibility and Effectiveness of the Young Men's Christian Association (YMCA) Cancer Survivors' Program

    This study will evaluate the safety, feasibility and effectiveness of the YMCA Cancer Survivors’ Program. The program will look at the effects of exercise on cognitive function in patients diagnosed with cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or more, have been diagnosed with cancer (of any type). All participants must have gained medical clearance from doctor with completed medical form. Study details: All participants in the study will receive usual care, which is 12-weeks of waiting performing your normal daily activities. Then all participants will receive a 12-week exercise intervention by a trained YMCA facilitator at a designated YMCA Fitness Centre (current locations: Bowen Hills, Jamboree Heights, Victoria Point). The program will consist of a warm-up, aerobic exercise and resistance based exercise. All exercise interventions will consist of 2 one-hour session per week for 12-weeks in a group-based training session. Cognitive and exercise induced changes will be evaluated through a number of functional assessments, including quality of life questionnaire and physical scans at baseline, post usual care, after the intervention and a follow-up period of 6 and 12-months post intervention. It is hoped that this research will contribute to the growing body of evidence to advocate for all cancer survivors to participate in physical activity. It is hoped that study can assist the YMCA to expand Cancer Survivors’ to other sites and improve the lives of more survivors.

  • Concentrated Albumin Prior to Rescue Infliximab (CAPRI) in Acute Severe Ulcerative Colitis (ASUC)

    Double blinded randomized controlled trial (RCT) comparing administration of IV albumin versus placebo prior to rescue infliximab in Acute Severe Ulcerative Colitis (ASUC). We hypothesise that administration of intravenous albumin prior to rescue infliximab will increase serum albumin levels and the amount of IFX that is protein-bound, therefore reducing IFX clearance and increasing drug exposure and efficacy.

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