ANZCTR search results

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

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31130 results sorted by trial registration date.
  • Ear Explorers: Join us for a journey inside the middle ear. A study to compare still images and videos of the middle ear to diagnose middle ear infections.

    The Ear Health team currently runs a number of community-based ear health epidemiology, health promotion and telehealth projects. One of the key challenges faced for these projects is having the right equipment to obtain a clear otoscopic image of an ear drum that can be interpreted remotely by specialists.. Effective telehealth programs need appropriate equipment that can provide high-quality images of the ear and be easy to use, as the staff using the equipment may be nurses or health workers with little previous experience of performing otoscopy (ear examinations). During Ear Portal visits, otoscopy is conducted remotely by assistants and transmitted via a store and send method to specialists for review. If remotely provided otoscopic images are of poor quality, the ability to make a diagnosis is hindered resulting in the need for repeat assessment and delays in provision of care. This is a prospective sub-study which is linked to the PCH Ear Portal main study. Participants will be recruited opportunistically at community events including Telethon Weekend and the Cockburn Integrated Health NAIDOC event in October 2019 . Otoscopic still images and short videos will be obtained using the HearScope. The results will be saved and stored for later review and comparison by ENT/Audiologists along with supporting screening questionnaires and tympanometry. The sub-study results will be used to inform best technique (images or video) for obtaining views of the eardrum by research assistants during the Ear Portal main study to facilitate telehealth assessment by the multidisciplinary team (MDT).

  • The safety and disposition of metformin in people with liver disease

    Metformin is the first drug chosen to treat type 2 diabetes mellitus. However, the regulatory label warns against it use in people who also have chronic liver disease but there is little published data to support this warning. This study will investigate the safety and pharmacokinetics of metformin in patients with chronic liver disease (CLD) with or without type II diabetes mellitus (T2DM) who will be prescribed metformin (500 mg, immediate release, twice daily) for up to six weeks. We hypothesis that metformin at doses adjusted based on renal function can be safely administered to patients with CLD. Further, the pharmacokinetics of metformin in patients with CLD will be similar to those reported in patient with T2DM and no CLD.

  • Brain health in trained and untrained middle aged to older adults

    Normal ageing is associated with a marked structural and functional reduction in the cerebrovascular system, which is linked to cognitive decline and dementia. Given the rapid increase in ageing and life expectancy, and the related medical costs associated with treatment of age-related disorders, identifying effective interventions to stop or delay the normal decline in cerebrovascular function are critical. Research has demonstrated that regular aerobic endurance exercise is associated with improved health of blood vessels in the brain in men aged 18-79 years, potentially also improving cognition and mood. This finding in endurance trained men may therefore help explain why there is a lower risk of cerebrovascular disease in this population. However, this research was undertaken in a small sample of male older adults and the function of the blood vessels in the brain to cognitive and chemical stimuli was not evaluated. Accordingly, we will investigate cerebrovascular function, mood and cognition in aerobic endurance trained and untrained middle-aged and older (50-80 years) adults. The significance of this project is that it may be the first research study to demonstrate that regular aerobic endurance training is associated with improved brain blood vessel health, cognitive function and mood in a population that is at risk of cerebrovascular disease, which is linked to cognitive decline and dementia.

  • Diurnal variations of melatonin and ocular parameters in healthy young adults

    Globally, by 2050, every one in two people will be myopic. It is in fact a vision-threatening public health issue. Interestingly, it has been found that there is seasonal variation in ocular growth with less growth during summer months. Additionally, ocular parameters such as eye length have also been reported to exhibit a diurnal rhythm. This observational study aims to investigate variations in ocular parameters over 24 hours and to evaluate their associations with the body clock and daily light exposure among healthy young adults.

  • Can an app-based intervention targeting parents, with or without additional support, improve the nutritional quality of foods and drinks packed in lunchboxes of primary school aged children.

    The aim of this randomised control trial is to evaluate the efficacy of a lunchbox program on the nutritional content of student lunchboxes. The program will run for approximately 10 weeks. Ten primary schools in the Hunter New England, Central Coast and Mid North Coast regions of NSW will be randomly allocated to one of two intervention arms or a waitlist control group. The program aims to support parents/carers to swap what is packed in lunchboxes from sometimes to everyday food, through the use of weekly support messages delivered through a school communication app, with or without additional support.

  • Does Strength Training Enhances Recovery After Surgery: The STERAS Project

    The purpose of the study is to determine if a strength-focused exercise program prior to surgery can improve participant’s physical function, reduce time in hospital and complications from surgery, and help restore physical function and quality of life post-surgery. Who is it for? You may be eligible for this study if you are an adult who is having surgery due to head and neck cancer at Fiona Stanley Hospital in Western Australia. Study details Participants in this study will receive one of three different treatments: 1. A ‘pre-habilitation’ exercise program, involving a strength and aerobic exercise program prior to surgery. Participants in this group will also receive an education program. 2. The same pre-habilitation program as group 1, plus an additional 6-week post-surgery rehabilitation program. 3. Usual care including an education program, and routine post-operative care. Participants in this study will be randomly allocated to one of these treatment groups, and will also need to complete a battery of physical function tests including a timed up and go test, grip strength, step test and DEXA scan. You will also need to complete a number of self reported questionnaires relating to your quality of life, quality of recovery and functional ability. It is hoped that this research will help determine if a pre-habiltiation program is effective at improving post-surgery outcomes in head and neck cancer patients.

  • How accurate and reliable are wearable inertial measurement units (IMUs) in assessing athletic change-of-direction and landing movements

    Accurate quantification and analysis of jumping and landing technique is one method to improve sport performance. The current gold-standard method for quantifying movement is three-dimensional biomechanical analysis in a motion analysis laboratory. However, due to financial, time, and logistical constraints, this method is frequently inaccessible to the wider sporting population. Wearable inertial measurement units (IMU) – consisting of micro-sensors– have been used as a cost-effective, accessible option that can provide real-time feedback of performance. To further promote wearable IMU use, it is important to evaluate the validity and reliability compared to the previously established method of motion analysis – three-dimensional biomechanical analysis. Study hypothesis: that wearable IMUs are a valid and reliable alternative to quantifying jumping and landing movements compared to three-dimensional biomechanical analysis.

  • Melatonin for sleep disturbance in breast cancer patients

    The purpose of this study is to see if melatonin supplementation can help improve sleep in women receiving hormone blocking therapy for breast cancer. Who is it for? You may be eligible for this study if you are aged 18 or over, have stage 1-3 breast cancer, are taking hormone blocking therapy and have trouble sleeping. Study details Participants in this study will be randomised by chance into two groups. One group will take melatonin tablets every evening before bed for 12 weeks. The other group will take a placebo tablet every evening before bed for 12 weeks. Neither the participants nor the researchers will know which participants are taking which tablets. All participants will complete questionnaires, complete a medication diary and wear an atigraph watch to measure your sleep. It is hoped this research will demonstrate the usefulness of melatonin in improving sleep in breast cancer patients.

  • The Efficacy of Virtual-Reality Augmented Mindfulness in Reducing Acute Experimental Pain

    Considering the dearth of research in VR augmented mindfulness in general, and in the use of VR for the management of pain, it is necessary first to trial the training in healthy controls. Therefore, the aim of this study is to generate data on the feasibility and acceptability of VR-augmented mindfulness. We will test the relative efficacy of VR-augmented mindfulness, compared to mindfulness without VR augmentation, an experience of the VR environment without the mindfulness instruction (VR only) and a natural history control (tested with no training). These conditions will be well matched in terms of using the same audiotape (mindfulness and VR-augmented mindfulness) and the same VR scenes (VR-augmented mindfulness and VR-only). This would allow us to generate data on the effect sizes of VR-augmented mindfulness vs mindfulness; and VR-augmented mindfulness vs VR-only on which to power a definitive clinical trial. We hypothesize that VR-augmented mindfulness will be acceptable, feasible and associated with larger effects than mindfulness alone, and that the VR-only group will find the condition credible, but less effective than the two active training groups.

  • A multi-centre, randomised, phase IV study to compare the efficacy of oxycodone/naloxone verses oxycodone prolonged release tablets in patients with advanced cancer

    This study aims to evaluate two pain relief medications, oxycodone/naloxone prolonged-release (OXN PR) and oxycodone alone prolonged-release (Oxy PR). The study will assess how effective these medications are at relieving pain and reducing constipation in patients with advanced cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or older and have metastatic cancer (Stage IV) and moderate to severe pain. Study details All participants will be randomly assigned (by chance) to either receive a combination drug of oxycodone/naloxone or oxycodone alone. In both groups participants will take two tablets a day, however this dosage may be adjusted if needed by your treating clinician. The study will involve a variety of questionnaires exploring Pain, Quality of life and Bowel movement over a 5 week period initially and if you decide to continue on the study for a total of 11 weeks. It is hoped this study can provide insight into the clinical effectiveness between the two pain medications and their effect on sustained analgesia and bowel function. This study may provide greater knowledge into how pain is treated in patients with advanced cancer.

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