ANZCTR search results

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

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33074 results sorted by trial registration date.
  • Collection and banking of fresh tumours for frozen storage for patients undergoing planned excision of tumours

    The objective of this project is to collect tumour tissue from patients undergoing elective surgery for the removal of primary tumour or metastases. Who is it for? You may be eligible to participate in this project if you are aged 18 years or above and are planning to undergo surgery as routine treatment for cancer from which tumour can be sourced. Study details: Participants in this project will undergo routine tumour removal surgery as planned. A tumour sample is obtained from this surgery and put into long term frozen storage for up to 3 years. The tissue may be used for potential manufacture into an autologous therapeutic cancer vaccine for use within the same patient, at a time in the future should that patient’s medical oncologist recommend this treatment. This future treatment is a separate project.

  • The Combination of High-Intensity Interval Aerobic and Resistance Training versus Current Recommendations in Patients with Type 2 Diabetes Mellitus

    Exercise is seen as a vital component for the prevention and treatment of type 2 diabetes mellitus due to its ability to regulate blood sugar levels with little to no unwanted side effects. Physical exercise also has a number of other benefits which improve overall health and well-being. Furthermore, exercise training also lowers the risk of developing other diseases which could eventuate as a result of type 2 diabetes such as cardiovascular disease. While it is suggested that patients with type 2 diabetes exercise at a moderate intensity for at least 210 minutes per week, this is often unachievable as patients struggle to find the time to fit in 210 minutes of exercise into their busy schedules. Therefore, as an alternative, exercise that is of a high-intensity has been suggested as it requires less time to be completed but offers similar benefits. A further problem to time is the effectiveness of an exercise programme outside a supervised setting. While a training programme is effective in a supervised setting with a high rate of attendance, away from a supervised setting exercise levels are not maintained and improvements achieved quickly diminish. However, because motivation and time are often the barriers to exercise away from a supervised setting, reducing time required to exercise and increasing motivation may lead to better exercise adherence away from a supervised setting. The objective of the study is to investigate the effectiveness of short duration high-intensity interval aerobic + resistance training compared to training using the current recommendations of 210 minutes of exercise at a moderate intensity per week on blood glucose control in patients with type 2 diabetes mellitus. Furthermore, this study will also investigate the effectiveness of a novel technology-based program designed to help maintain exercise and fitness after the completion of a supervised 8-week training period. Hypotheses: Combined short-duration high-intensity interval aerobic and resistance training will be as effective as current recommendations in reducing glycated haemoglobin level (HbA1c). A novel technology-based program will improve adherence and help maintain exercise and fitness after the completion of a supervised 8-week training period.

  • A randomised controlled trial evaluating the effectiveness of a one module eHealth wellbeing program (THRIVE) on increasing wellbeing and decreasing stress.

    A simple randomised controlled trial (RCT) design will be used to evaluate the effectiveness of a brief ehealth program designed to increase wellness and decrease stress (called THRIVE eHealth). The THRIVE eHealth program will be placed within the Federation University eHealth Platform. People who visit the website, either directly or through seeing the program advertised, will be invited to take part in the THRIVE eHealth evaluation study. Those that consent will be randomly allocated to the THRIVE eHealth program (immediate access group) or a wait control group (delayed access group). The delayed access group will receive the intervention following a 6-week waiting period. THRIVE eHealth is essentially a one module ‘tools’ based program, split into 6 key psycho-educational areas (i.e., relaxation, sleep, nutrition, exercise, goal setting and life balance) designed to help people enhance their mental and physical wellbeing. The entire module will take about 20 minutes to read, with an additional 60 minutes if all the wellbeing ‘tools’ are accessed (e.g., guided audio). Participants will also receive automated emails (e.g., to remind them to log on, when to complete post/follow-up questionnaires) and will be asked several questions during the study period to monitor their progress. Participants randomised to the THRIVE eHealth (immediate access) group will complete a pre-intervention assessment (Week 0), during intervention (Week 1-2) assessment, post-intervention assessment (Week 3) and a 1 month follow-up assessment (Week 7). Participants randomised to the delayed access group will complete the same assessment phases and will be given access to THRIVE eHealth program following the 1 month follow-up assessment (Week 7). However the delayed access group will be asked to complete the post intervention assessment after they completed the THRIVE eHealth program (Week 9). It is expected that people who undertake THRIVE will show increases in mental wellbeing and optimism and reductions in negative affect at post and follow-up time points.

  • The effect of 30 day krill oil supplementation on cardiovascular risk factors

    The health benefits of long-chain n-3 polyunsaturated fatty acids are associated with the incorporation of EPA and DHA into the cell membrane which then alters the membrane structure and cell functions. Consequently they reduce plasma triglyceride level, inhibit inflammatory response, suppress thrombosis process. Krill oil and fish oil are rich sources of EPA and DHA. The bio-availability of these fatty acids from the two oils maybe different due to chemical structure of the oils. This study will evaluate the incorporation of EPA and DHA into the red blood cell membrane. In addition the effects on cardio-metabolic risk factors will also be investigated.

  • Determining the effectiveness of different forms of interpretation bias training on pain outcomes in healthy university students.

    This study aims to explore the effect of pain-related interpretation bias training on interpretation biases to pain and the experience of acute pain. Participants will complete one of 4 types of interpretation bias training, and will also complete questionnaires, 3 computer based interpretation bias measurement tasks and an experimental pain task.

  • Imaging of Retinal Amyloid Plaques in Alzheimer’s disease – Longitudinal Study.

    Alzheimer’s disease is characterised by the presence of beta- amyloid plaques in the brain. More recently it has been proposed that these beta- amyloid plaques may first appear in the retina, at the back of the eye, before the plaques are detectable in the brain. This longitudinal study will investigate if the amyloid plaques identified in the retina increase in number and size over time. Curcumin, found in the spice turmeric, is a food additive that has molecular and optical properties that enable us to image amyloid plaques in the retina. Participants will be asked to have eye imaging done before and after taking curcumin for 7 days. The participant's image will be compared with other results from their participation in the NVI 1003 and AIBL studies. In addition, the results from participants with Mild Cognitive Impairment will be compared to the results from Healthy Control participants.

  • Insulin-induced weight gain in type 2 diabetes

    This project aims to determine: 1. the prevalence of weight gain in patients with T2DM who are treated with insulin at RMH; 2. the impact of weight gain on clinical variables such as blood pressure and lipid levels; and 3. to find factors that predict the occurrence of weight gain in people with type-2 diabetes treated with insulin. Hypothesis:Weight gain prevalence will be greater than 60% in the studied population of type 2 diabetics treated with insulin. This weight gain will be variable depending on baseline characteristics such as starting weight, insulin characteristics and use of oral hypoglycaemics. Patients who gain weight will show a worsening of their cardiovascular risk profile when compared to those who do not.

  • Evaluating the efficacy of a brief parental education program to aid parents' communication with children about sexuality.

    This study aims to evaluate the efficacy of a brief, group-based parenting intervention for parents of children ages 3 to 10. The parenting intervention aims to assist parents in enhancing their knowledge about child sexuality, improving their communication of age-appropriate sexuality topics to their children and increasing parental confidence and self-efficacy in this area. It is expected that participating in a group-based parenting intervention has the potential to increase parental knowledge, skills and confidence as well as improve parent-child communication about sexuality. Research has shown that increased parent-child communication, parental involvement and monitoring is associated with later onset of sexual intercourse and reductions in risky sexual behaviours in adolescence.

  • The Watermemories Swimming Club for People with Dementia: Cluster Randomised Controlled Trial

    This research will determine the effectiveness of a non-pharmacological intervention, aquatic exercise (WSC), designed to reduce behavioural and psychological symptoms of dementia (BPSD) compared to an attention control. The WSC aims to rekindle positive memories of swimming in people with dementia and get them involved in a safe, regular physical activity. Swimming is an activity that has the capacity to address physical health needs, because it involves exercise; psychological health needs, because it is fun and relaxing; and social health needs, because it involves interactions with other people. The WSC is designed for municipal swimming pools that are widely available in Australian communities. A training manual and DVD are available to address safety and incontinence issues and to support feasibility and sustainability.

  • An association between changes in the intestinal microbial flora and the alteration of sleep in Chronic Fatigue Syndrome: A pilot open label trial with use of the antibiotic erythromycin

    Recent important discoveries reinforce the idea that CFS is associated with gut flora imbalances. However, the idea that this can have a major effect on sleep and daytime functioning requires further supporting research. This project will determine whether those participants with CFS who, at baseline, are highly gram-positive (determined via stool analysis and indicative of abnormal gut functioning) and respond to antibiotic treatment (such that the amount of gram positive flora is reduced below a certain threshold) also demonstrate significant and ongoing improvements in sleep, daytime activity, mood and self-reported fatigue symptoms. Eligible participants will follow a baseline, treatment and follow up protocol, across a total of 22 days. The treatment phase involves taking a course of the antibiotic, Erythromycin, for 6 days. This is an open label pilot research program which aims to determine whether this treatment leads to improvements during treatment and follow up phases, compared to assessments made in the baseline phase. A second Bioscreen stool analysis will also determine whether reduced gram-positive status has been achieved in the gut.

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