ANZCTR search results

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

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32704 results sorted by trial registration date.
  • Inflammation and Colchicine use in patients with ESRF undergoing Dialysis

    This study aims to look at the inflammatory processes in patients with kidney disease who require haemodialysis. It has been shown that there is a pro-inflammatory process in this cohort of patients and this study intends to look at the specific mechanisms, immune cellular function and inflammatory molecules involved in this process. It also intends to look at the effect of Colchicine, an anti-inflammatory agent on the level of inflammatory molecules

  • Can a smartphone app help older people with arthritis pain manage their pain better?: DigiTech Pain Project.

    Arthritis is a major cause of illness and disability, particularly among older people. It is estimated that 70% of community dwelling older people experience unrelieved arthritic pain. As with any other chronic conditions, people living with chronic arthritic pain are required to self-manage their condition adopting various pharmacological and non-pharmacological strategies. Therefore, innovative and cost-effective approaches are necessary to build older people’s pain self-management capabilities. One of such approaches is the use of digital technologies such as smartphone apps. In this study we aim to explore the suitability of a pain self-management App in assisting older people living in the community to more effectively manage their arthritic pain. English speaking older people (i.e. those aged 65 years or over); living with arthritis related pain in the community; who use a smartphone or a tablet-computer, will be invited to participate. Interested older people will be asked to sign a written consent form. A meeting (M1) will be organized with consenting participants for App download and study questionnaire completion. With the assistance of one of the researchers, participants will be asked to download the freely available Pain self-management App to their smartphone or tablet, and to complete a questionnaire. Participants will be instructed to use the App for Two weeks, after which another meeting (M2) will be scheduled for completion of the follow-up questionnaire. It is estimated that this meeting will take up to 45 minutes and can be carried out face-to-face or via telephone. Face-to-face meetings will take place at a mutually convenient location. This will be followed by data analysis process and reporting the results. We expect that the results of this study will help develop recommendation for future pain interventions designed to optimise older people’s pain management capabilities in the community

  • Functional assessment using the Glitttre Endurance Test in chronic obstructive pulmonary disease (COPD)

    Chronic Obstructive Pulmonary Disease (COPD) is a highly prevalent condition affecting approximately two million Australians (14% of the population over 40 years). It is estimated that the overall costs of COPD is $8.8 billion per annum in direct health costs and indirect costs such as lost productivity. One of the most effective interventions for managing COPD is pulmonary rehabilitation which reduces symptoms of breathlessness and fatigue, increases functional exercise capacity, improves quality of life and reduces hospital admissions. To ensure that pulmonary rehabilitation programs are achieving appropriate outcomes, valid but easily available and inexpensive tests are needed. The Glittre ADL test is a relatively new test of functional activities. However, to show improvement on the Glittre ADL, patients need to be able to increase the speed of activities. Often people with COPD after a pulmonary rehabilitation program, cannot significantly improve the speed with which they perform activities but may be able to perform the activities for longer (i.e greater endurance), with less breathlessness and fatigue. We are interested to trial a modification of the Glittre ADL test to better reflect endurance capacity for functional tasks. We also wish to determine how this measure relates to levels of daily activity since higher levels of physical activity have been associated with better health outcomes in people with COPD. The aims of this project are: a) To develop and evaluate the a new test, the Glittre Endurance test, in people with COPD; b) To determine the relationship between the Glittre Endurance test and levels of daily physical activity measured by an activity monitor; c) To evaluate the responsiveness of the Glittre Endurance test as an outcome measure following pulmonary rehabilitation.

  • Investigation of a long-term continuous glucose monitor in type 1 diabetes

    Achieving optimal glucose control in type 1 diabetes requires frequent monitoring of glucose which can be burdensome for many patients. The most common methods for self-monitoring glucose involve frequent "finger-pricking" or continuous glucose monitors inserted under the skin which last up to 1-2 weeks and require at least daily calibration with finger-pricks. The device under investigation is an implantable long-term glucose sensor that measures an individual’s glucose every 3 minutes and sends data to a receiver outside the body. Following implantation, the sensor requires no user interaction, and the receiver only needs to be kept close by. The only maintenance required of the receiver is battery changes and data downloading.  This study aims to collect glucose information from the implanted sensor to optimise sensor signal processing and improve sensor performance.

  • Intake of free sugars and micronutrient dilution in Australian adults

    There has been an increasing concern on the possible negative effects of excessive sugar intake, particularly added sugar, on the quality of diet and health status. Added sugar was found to be associated with poorer nutrient intake. A similar impact on micronutrient dilution was expected from free sugar as an estimation of approximately 10 g difference between added sugar and free sugar intake was found in the Australian population. The hypotheses of the current analysis include: a) the WHO cut-offs were not suitable for assessing micronutrient dilution; and b) micronutrient dilution is not evident until %energy from free sugars reaches 25% or above.

  • Comparison of dynamic development between embryos originating from oocytes collected using single lumen and double lumen needle: a randomised sibling oocyte study

    This study aims to assess the efficacy of single lumen needle compared to the double lumen needle which has been routinely used at Fertility North. Each ovary of patients undertaking oocyte collection as part of their IVF/ICSI treatment is aspirated by either a single lumen or double lumen needle after randomisation in randomised order. Subsequent oocytes and resulting embryos are tracked according to their origin, and fertilisation and time-lapse embryology parameters are compared between 2 groups..

  • An online intervention to prevent and treat mental health problems in university students

    This project aims to evaluate a virtual clinic (the Uni Virtual Clinic, or UVC) to improve mental health in university students. We want to know whether the UVC is feasible, acceptable, useful, and effective at helping students with their mental health, specifically symptoms of depression. To do this, we will ask university students attending the Australian National University in Canberra, Australia to participate in a pilot trial, which will involve using the UVC website and completing three brief surveys comprising demographic measures (pre-intervention only), depression symptoms, anxiety symptoms (generalised anxiety, panic, social anxiety), quality of life, disability/days out of role, alcohol use, help-seeking, and adherence and satisfaction (post-intervention only).

  • Oral peanut immunotherapy with a modified dietary starch adjuvant for treatment of peanut allergy in children aged 10-16 years.

    Childhood peanut allergy is increasing, affecting 3% of Australian children. It is the food allergy that persists into adult life, and the most likely to be associated with death due to accidental exposure. It involves the allergy antibody, IgE, which stimulates allergy cells to release chemicals that cause allergic symptoms. There is no current cure. Management is by avoidance with emergency plans and medication in case of accidental exposure. Immunotherapy (IT) is thought to be the most likely strategy to offer a “cure” for food allergy. Immunotherapy has been shown to be effective in the management of aeroallergen and venom allergy. This technique involves regular and prolonged exposure to the allergen in question, initially starting with very small doses and then increasing the dose over a period of time to a level where the person does not respond with an allergic reaction when re-exposed to it. Food immunotherapy trials have so far only had a few participants and often achieved only temporary desensitization which is lost rapidly when treatment is stopped, and also have a high rate of side effects. Gut microbes are implicated in food allergy. They can increase the levels of small chain fatty acids (SCFA), namely acetate, butyrate and propionate, in the gut by fermenting fibre- leading to significant changes to bacteria present in the gut (i.e. the gut microbiome), with increased beneficial bacteria promoting a non-allergic environment. Experiments in mice fed a high-fiber diet or SCFAs found they were protected from food allergy. In particular, they had increased oral tolerance to peanuts with an increase in the number and function of immune cells important in controlling allergic reactions . This study aims to examine whether using a dietary fibre supplement which is high in a key short chain fatty acid- butyrate -whilst using small and increasing daily doses of peanut in peanut allergic children and teenagers will provide them with sustained unresponsiveness to peanut and render them non allergic (or tolerant ) to peanut.

  • Evaluating the effectiveness of mind-body skills training based on yoga techniques in children on the Autism Spectrum

    The present study will assess whether for children on the autism spectrum, teaching them the new skills to practice gentle breath-centered movement practices and mindful attention training based on the principles of yoga, will influence and promote their self-regulation of behavior, emotions, improve their cognitive control of executive functions, their emotion and body awareness, and benefit sleep, in those children with parent-identified sleep difficulties in the initial assessment. The study will explore the benefits of active involvement of parents in sessions, assess whether psychologists, with little or no experience in yoga, can deliver the modified, age-appropriate, user-friendly, and simple yoga-based exercises effectively as a training tool. It will examine whether a modified and manualized yoga skills training program is suitable and effective for this population and their parents and whether it can be used as an adjunct to existing treatment. 60 children on the autism spectrum between the ages of 8-12 years will be randomly assigned to either an intervention group or a wait-list control group. The intervention group will receive the 6-week yoga-based intervention program delivered once per week/6weeks. The intervention program will be delivered face-to-face by the lead researcher and two other facilitators. The wait-list control group will wait for 12 weeks before receiving the intervention.

  • A study of a new drug, NPI-001 in healthy volunteers to test its safety and tolerability

    This trial is being undertaken to evaluate the safety and tolerability of oral doses of a new drug NPI-001 in healthy volunteer subjects. It will determine the effect of NPI-001 on their vital signs, and they will undergo physical examinations and clinical laboratory tests. Blood samples will be taken to determine where the drug goes in the body and how long it stays in the body following single and multiple doses. The study is randomized, and double blinded. In each group of subjects some will receive the new drug in a sugar solution and 2 will receive just the sugar solution - a placebo.

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