ANZCTR search results

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

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31593 results sorted by trial registration date.
  • Is fish intake or fish oil supplementation better for people with coronary heart disease? An Australian secondary prevention trial.

    We conducted a randomised cross-over dietary intervention trial to compare the effects of 1g EPA+DHA per day from two different sources – fish and fish oil capsules. Subjects were randomised to begin on one arm of the intervention for 12 weeks, followed by a 12-week washout period and finally the alternate arm for another 12 weeks. Various cardiovascular risk markers were measured at each time point. Statistical analyses were performed to compare changes with each intervention, and the changes between the two treatment arms. 11 participants (10 males and 1 female) with a mean age of 50.9 years were recruited from St. Vincent’s Hospital, Melbourne from September 2008 to May 2009. Both treatments increased erythrocyte omega-3 index significantly, while the fish treatment also appeared to have beneficial effects on blood pressure.

  • ‘ReCaPTure LiFe’: A phase II cluster-randomised controlled trial of a psychological intervention to support young people with cancer and their families to make a positive transition from cancer patient to survivor.

    This study looks at the effectiveness of a psychological therapy designed to support young people with cancer and their families to make a positive transition from cancer patient to survivor. Who is it for? You can join this study if you are a young cancer survivor aged 15-25 who has finished treatment for either a primary or secondary cancer in the past 12 months. Trial details: Participants will be divided into two groups. One group will take part in 'ReCaPTure LiFe', a cognitive-behavioural program designed to help people build skills to return to normality after cancer treatment. This will take place in six 90-minute group sessions, delivered weekly over the internet. Participants will complete a 1-week, 3-month and 12-month follow-up. The second group will take part in an open discussion forum with the same schedule. The study aims to monitor the distress, psychological adjustment and coping after cancer treatment.

  • Effectiveness of an enhanced multidisciplinary community based group program for Parkinson's disease.

    This study aims to evaluate quality of life, physical, cognitive and language outcomes for a holistic new model of care for people living in the community with Parkinson's disease. The model incorporates physical, cognitive and speech activities into one program and compares outcomes between the enhanced multifactoral program with a traditional exercise program. Longer term outcomes will also be assessed at intervals up to six months with an aim to evaluate the optimum time for introduction of a maintenance program to people with Parkinson's disease.

  • The effect of genetic background on blood pressure response to weight reduction

    The effectiveness of treatments to reduce heart disease risk can vary a great deal between individuals. This is partly due to an individual’s genetic makeup. Fatty acid metabolites called cytochrome P450 metabolites of arachidonic acid (CYP450-AAM) can act on blood vessels and the kidney to regulate blood pressure. One of these metabolites (20-HETE) is known to be affected by body weight. We will study volunteers with two different genetic make-ups that have different effects on the levels of 20-HETE, to see if they affect blood pressure and heart disease risk. We will assess whether having either genetic make-up causes a different blood pressure and plasma and urinary 20-HETE response when volunteers reduce their weight.

  • Mechanism of cardiovascular benefits of omega-3 fatty acids in hypertensive and normotensive subjects

    This study is testing the hypothesis that improvements in cardiovascular health with omega-3 fatty acid supplements are attributed to improvements in vascular function.

  • Feasibility of Online Adaptive Radiotherapy for Muscle Invasive Bladder Cancer

    The principal objective of the trial is to test the hypothesis that Online Adaptive Radiotherapy for Muscle Invasive Bladder Cancer is feasible across multiple Radiation Oncology departments.

  • An 8 week randomised, double-blind, placebo controlled trial investigating the role of adjunctive bioactive lipids specifically; docosahexaenoic acid (DHA) versus eicosapentaenoic acid (EPA) in Major Depressive Disorder - with a 6 week open label extension of DHA in patients aged 18-65years.

    The primary objective is to evaluate the effectiveness of DHA versus placebo and compare the difference between DHA and EPA on the symptoms of depression. Effectiveness will be measured by the mean change in total scores on the HAM-D from baseline to double-blind end point at week 8. Patients with a 50% reduction in HAM-D scores or who have a score equal to or less than 8 will be considered to be in full remission whilst patients with a score of 12 or less will be considered to have improved; (from baseline to Week 8 or dropout). A secondary aim of the study will be to compare the levels of BDNF at baseline and at the completion of the double-blind phase of the study in the patients treated with DHA versus the comparator EPA and placebo. An additional aim will be to measure the change from baseline in cognitive functioning using a brief cognitive battery which assess 5 cognitive domains. Mean change from baseline scores to week 8 will also be used to measure patients Global Assessment of Functioning, sleep and levels of suicidal ideation using Item 3 on the HAM-D.

  • Incorporating mindfulness into an internet-based intervention for female sexual dysfunctions.

    This study aims to implement and evlaluate an internet-based cognitive-behavioural therapy program for females with sexual dysfunctions. It is anticipated that this study will increase treatment success and lower attrition rates by addressing the limitations of previous internet-based interventions and incorporating mindfulness techniques. Evaluation of the program will be conducted using data collected at pre-treatment, post-treatment and at a 3-month follow-up. A waitlist control group will be included for comparisons. This study will help to determine the efficacy of internet-based treatment options for female sexual dysfunctions and further elucidate the role of mindfulness in female sexual dysfunction interventions.

  • Comparison of blood levels of factors involved in resolving inflammation in individuals with features of the metabolic syndrome versus matched healthy controls

    The hypothesis is that in humans dietary omega-3 fatty acids and aspirin augment the formation of the potent anti-inflammatory metabolites resolvins and protectins. We aim to measure resolvin and protectin levels in individuals with features of the metabolic syndrome compared with matched healthy controls, after omega-3 fatty acids alone and in combination with aspirin;

  • The effect of sugammadex on the allergic component of rocuronium

    Muscle relaxants are the most common cause of allergic reactions in patients having an anaesthetic. One of the most commonly used muscle relaxants is rocuronium. Recently sugammadex has been made available that reverses the effects of rocuronium by encapsulating the drug and preventing it binding at the neuromuscular junction. No one knows the role of sugammadex in someone who has developed an allergic reaction to rocuronium. It is our hypothesis that when sugammadex is combined with rocuronium the allergenic component of rocuronium is covered. If this is true sugammadex may play an important role in the management of patients who have developed an allergic reaction to rocuronium. We will investigate this by skin testing rocuronium alone and the combination of rocuronium and sugammadex in patients who are rocuronium allergic. We will see the effect on skin testing of the combination of the two drugs. Should the combination cause a negative skin test one could conclude that the allergenic component of rocuronium has been covered by the sugammadex.

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