ANZCTR search results

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

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32712 results sorted by trial registration date.
  • A prospective, double-blind, double-dummy, randomised controlled trial to compare pain relief from intravenous paracetamol and oral paracetamol in acute pain patients presenting to the Emergency Department

    Randomised control trial of IV and oral paracetamol to assess the efficacy of pain relief. This project could act as a pilot study to form a basis for more extensive research to support the introduction of IV paracetamol for certain ED populations We hypothesize that patients receiving the IV paracetamol will have a more rapid reduction in pain score, larger reduction in pain scores and require less rescue analgesia than patients in the oral paracetamol group.

  • A ‘open study’ evaluation trial of the LIFE FLeX eHealth wellbeing program for anxiety and depression.

    A cognitive behavioural and biopsychosocially-based program for decreasing symptoms of anxiety and depression (called LIFE FLeX) will be evaluated. The LIFE FLeX eHealth program will be placed within the Federation University eHealth Platform. People who visit the website will be invited to take part in the LIFE FLeX eHealth evaluation study. Those that consent will be given access to the LIFE FLeX program website immediately. LIFE FLeX is designed to provide people with information and strategies to address their anxiety and depressive symptoms and contains six ‘core’ modules, plus an Introduction module delivered over 7 weeks. There will also be a short ‘Booster’ Module released after post-assessment. Each module will take approximately 25 minutes to complete. In addition, in order to reinforce the module-based information, there are 20-30 minutes of offline activities each week. 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 at the beginning of each week, to monitor their progress. Modules include text, graphics, audio, video, editable forms and downloads. Modules can be accessible via web, mobile or tablet devices. Participants will complete a pre-intervention assessment (Week 0), during intervention (Week 1-7) assessments, post-intervention assessment (Week 8) and a 1 and 3 month follow-up assessment (Week 12 & Week 20 respectively). It is expected that people who undertake LIFE FLeX will show reductions in anxiety and / or depressive symptoms at post and follow-up time points as well as increases in positive affect and emotional regulation.

  • A open trial evaluation of the Benzodiazepine (information and reduction) eHealth program (BDZ eHealth) for people using benzodiazepines.

    A simple open trial will be used to evaluate the effectiveness of the Benzodiazepine eHealth program (BDZ eHealth) that provides psycho-education and gradual reduction information. BDZ eHealth can be accessed on multiple devices (desk top, tablet and mobile). People, who visit the website, either directly or through seeing the study advertised, will be invited to take part in the BDZ eHealth evaluation study. BDZ eHealth is designed to provide people with information and strategies to address their benzodiazepine use via five ‘core’ modules, plus an Introduction module. Each module will take approximately 20 minutes to complete. Participants will receive automated emails (e.g., on completion of a module, when to complete post/follow-up questionnaires) and will be asked several questions at the beginning of each week, to monitor their progress and activities. During the course of the study we strongly encourage participants to work with their doctor should they decide to reduce their benzodiazepine dosage as well as seek specialist benzodiazepine telephone support from Reconnexion. Participants will complete a pre-intervention assessment (Week 0), during intervention (Week 1 - 5) assessments, a post-intervention assessment (Week 6) and a 1 and 3 month follow-up assessment (Week 10 & Week 18 respectively). Participants will continue to have access to the program for the duration of the trial. Participants will be asked questions to ascertain reasons for engagement or lack of engagement with the program. It is expected that people who undertake BDZ eHealth will show reductions in their benzodiazepine dependency, anxiety and / or depressive symptoms at post and follow-up time points

  • Effectiveness of a telephone-based weight management program in overweight or obese patients with lower back pain waiting for orthopedic consultation.

    Many patients with chronic low back pain are referred for orthopaedic surgical consultation despite most having no indication for surgical intervention. A high percentage of these patients are overweight or obese and would likely benefit from weight management care, however such care is rarely offered to these patients. Instead, patients wait for extended periods of time for consultation during which their pain symptoms and health decline. This study aims to evaluate the effectiveness of a telephone-based weight management program in decreasing weight and pain in overweight or obese patients with chronic low back pain waiting for consultation with an orthopaedic surgeon. We hypotheses that the patients who receive the telephone-based weight management program will achieve an average weight loss of 5kg and decrease their pain score by an average of 1.5 out of 10 from baseline, compared to the control group receiving usual care.

  • A multi-country, Observational, cross-sectional study to characterise advanced Parkinson’s Disease patients in Movement Disorder Centres.

    This multi-country, observational study will primarily determine the proportion of PD patients treated at Movement Disorder Centers (MDC), who are identified as advanced PD patients. This study will also compare the proportion of PD patients identified as “advanced” based on routine clinical practice (physician’s judgement) to the proportion of “advanced” patients identified based on a set of consensus criteria generated by Delphi method. The main purpose of this study is to enhance the understanding of the proportion and patient characteristics of advanced PD patients in Movement Disorder Centers in different regions and to evaluate any regional differences.

  • 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.

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