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.
  • Identifying why some people consume excess fat. A twin study.

    Obesity is a major health issue that is currently affecting millions of Australians, in addition to having a high economic cost both in this country and around the world. Some individuals are more susceptible to obesity than others; one factor may be variance in the taste system due to genetic and environmental factors such as diet. The present study aims to identify and investigate the mechanisms linking individual differences in taste with obesity. The mechanisms thought to be in play relate to our sense of taste, including taste receptors and their responsiveness to fatty acids, satiety levels resulting from consuming high fat foods, and food preferences. It is predicted that for susceptible individuals, consuming a high fat diet will negatively influence their responsiveness to fatty acids, increase their preference for high fat foods and decrease their hormonal and perceived satiety levels following food consumption. Each of these mechanisms has the potential to lead to an increase in dietary fat consumption, and BMI. Previous research has indicated that within pairs of BMI discordant monozygotic twins, the twin with the higher BMI has significantly lower taste responses to fatty acids, indicating that their diet may be related to their fatty acid taste sensitivity. This study aims to include 100 twin pairs (half monozygotic and half dizygotic) recruited from the Australian Twin Registry. These participants will be over 18 years of age. Twin pairs will be randomized into one of two weight maintenance diets (high- or low-fat). Participants will consume this allocated diet for eight weeks, with weekly diet diaries being assessed for compliance, in addition to weekly satiety questionnaires. Prior to baseline testing, participants will complete a four-day diet diary, the Cancer Council of Victoria food frequency questionnaire, the restrained eaters questionnaire, and a like-dislike questionnaire. Further testing will occur at baseline, week four and week eight. Each testing session will include a 24-hour dietary recall, taste function assessment, a fat-ranking task using custards, saliva samples, papillae density testing, preference testing for seven regular and low fat foods, anthropometry and a fungiform papillae biopsy. During baseline testing, participants will also be tested for PROP sensitivity, which is a heritable trait. Results will be compared at each time point to determine the effect of a high- or low-fat diet on fatty acid taste responses and satiety.

  • Apolipoprotein E driven therapeutics for Alzheimer’s disease

    The ApolipoproteinE-e4 allele is the most consistent genetic risk factor associated with sporadic Alzheimer’s Disease (AD). ApolipoproteinE has an important influence on beta-amyloid clearance and recent studies have shown that while there are no differences in beta-amyloid production between healthy controls and sporadic AD patients, in the latter beta-amyloid clearance is reduced by 30%. Novel therapeutic approaches targeting beta-amyloid clearance are being tested. A single oral administration of bexarotene, an FDA approved anti-cancer drug, to a mouse model of AD resulted in enhanced clearance of soluble beta-amyloid in an ApoE-dependent manner and a >50% reduction of beta-amyloid plaque area within just 72 hours. In vivo imaging of beta-amyloid pathology by positron emission tomography (PET) is facilitating research into causes, diagnosis and treatment of major dementias, such as Alzheimer’s disease (AD), where beta-amyloid plays a role. This project aims to use brain amyloid imaging NAV4694 PET scans, for the in vivo assessment of the effect of bexarotene treatment on beta-amyloid burden and its relation to cognition in very early AD and mild AD patients.

  • ASR Hip Resurfacing, Chrome and Cobalt Levels and Effect on Vision

    The study aims to measure blood levels of Chrome and Cobalt in patients with an ASR Hip replacement in situ and to see if these patients have visual disturbances

  • ‘Beating The Rush’: A web-based assessment and brief intervention for amphetamine use

    The aim of this current study is to establish whether a web-based CBT intervention is effective in treating amphetamine use and its associated harms. Of particular interest is the potential role that contingency management may have on treatment success. Another aim of this research is to identify predictors of treatment outcome for amphetamine users (self-efficacy and impulsivity). It is hypothesised that i) participants who undertake the Internet-delivered CBT intervention in combination with contingency management (monetary incentives for remaining in treatment) will show greater reductions in their use of amphetamines as well as reductions in harms associated with use, higher rates of abstinence and will remain in treatment longer in comparison to the waitlist control group, ii) treatment retention and outcomes will be influenced by self-efficacy and an impulsive temperament.

  • Impact of pacemaker on cardiac function

    Introduction: Right ventricular apical (RVA) pacing results in abnormal left ventricular (LV) electrical and mechanical activation and is associated with adverse effects on left ventricular systolic function. The comparative effects of right ventricular outflow tract septal (RVOTS) pacing on cardiac structural remodeling are unknown. Our aim is to therefore examine the long-term effects of septal RVOT versus RVA pacing on ventricular and atrial structure and function using cardiac magnetic resonance imaging (CMR). Methods/Design: A multicenter randomised controlled trial in which 180 patients with an indication for ventricular pacing using a permanent pacemakers (PPM) will be randomized to pacing either from the RVA or RVOT septum. All patients will have a baseline CMR, Echocardiogram, 6-minute walk test, quality of life scoring e.g. SF36, Minnesota Living with Heart Failure Score (MLWHF) and blood tests such as NT pro-BNP, HsCRP and biomarkers of myocardial fibrosis e.g. MMP-9, TIMP-1. The tests will be repeated at 12 months, 24 months and 36 months. The following clinical outcomes will be used: Primary Endpoint: Investigate the effect of apical and septal right ventricular site pacing on left ventricular structural change and ejection fraction using cardiac MRI. Secondary Endpoint: Clinical Parameters: New York Heart Association Functional class, Quality of life assessed by a subjective validated patient scoring algorithm (SF36/ MLWHF), 6 min walk test. Biologic Parameters: N-terminal pro-hormone brain natriuretic peptide (NT pro-BNP), High sensitivity C reactive Protein (HsCRP), Biomarkers of myocardial fibrosis e.g. MMP-9, TIMP-1. Combined clinical end point: New-onset atrial tachyarrhythmia, new onset heart failure, heart failure related hospitalizations. CRT-P, CRT-D or AICD upgrade. The Effect of cardiac remodeling on its hemodynamics. Lead-related complications such as lead dislodgement, myocardial perforation, lead Will integrity failure The impact of ventricular pacing site to right ventricular and atrial remodeling. Conclusion: The results of the study will provide new information about the potential benefits in mechanical function and consequent clinical endpoint(s) of septal versus apical pacing.

  • A Pilot Study: The effect of in-office irrigation with 5% povidone-iodine to reduce the duration of adenoviral conjunctivitis

    The primary purpose of this pilot study aims to determine the effectiveness of treating this particular viral eye infection (adenoviral conjunctivitis) with a one-time in-office irrigation of the eye with 5% povidone-iodine. We aim to determine whether this treatment reduced the period of infection as well as improving patient’s symptoms'.

  • Paroxetine for Anxiety in Patients with Chronic Obstructive Pulmonary Disease(emphysema).

    An association between increased dyspnoea scores, mood disorders and anxiety levels in patients with COPD has been well established. On a neurochemical level, this association has been further explained in rat models showing that prolonged hypoxia affects the areas of the brain involved in mood control. The understanding of mechanisms of mood control by antidepressants has evolved over time. The strong antidepressant activity of Tricyclic Antidepressants (TCAs) has supported the role of both norepinephrine and serotonin (5-HT) in mood disorders. The next generation of antidepressants included the Selective Serotonin Reuptake Inhibitos (SSRIs), further supporting the role of serotonin. Furthermore, antidepressants have been hypothesised to work in COPD patients by decreasing autonomic over-activity, or detaching excessive distress associated with COPD, thus enabling patients to better endure increased physical activity and physiological changes. Hence, our hypothesis is that subjects recruited from public hospitals with COPD and clinically significant depression and/or anxiety that are given paroxetine 20 mgs daily for 4 months will: (Hypothesis 1: principle hypothesis): have a significant reduction in their anxiety symptoms as compared with the placebo at 4 months follow-up, and; (Hypothesis 2): these improved levels of anxiety will be associated with: improved quality of life and exercise capacity, and (Hypothesis 3): these improved levels of anxiety will be associated with: a.) a reduction in hospital bed utilisation, and; b.) a reduction in health care costs in relation to existing practice in long term (12 months)

  • Cerebral blood flow and cognition in diabetes: A pilot cross-sectional investigation

    People with type 2 diabetes are at increased risk of developing arterial disease. Arteries stiffen with advancing age and this process is exacerbated in type 2 diabetes and other risk factors for heart disease. Increasing stiffness of arteries in the brain may impede regional blood flow, thus impairing brain function; those with poor mental abilities appear to have stiffer blood vessels in the brain compared to healthy individuals. This may account for the increased prevalence of cognitive decline associated with type 2 diabetes. However, no studies have yet investigated whether arterial function in the brain is related to the mental abilities of adults with type 2 diabetes. This project will be the first of its kind to evaluate whether artery stiffness in the brain and biomarkers of insulin resistance and type 2 diabetes are indicators of impaired mental abilities, such as attention, concentration and memory. The introduction transcranial Doppler ultrasound (TCD) enables us to readily assess the pulsatility of blood flow in the middle cerebral artery, a measure of arterial stiffness in the brain. Moreover, we will also measure cerebrovascular responsiveness (CVR), i.e. the ability of blood vessels in brain regions to dilate in response to psychological stimuli. Thus, at the same time as evaluating the cognitive abilities of people with type 2 diabetes, we can assess the ability of their arteries to supply more blood to the brain during the mental tests. We will compare these capabilities in type 2 diabetes with age and gender matched healthy controls. We will also examine their relationship to indicators of the severity of diabetes, viz. insulin resistance and glycated haemoglobin. We hypothesise that a) cerebral blood flow pulsatility will be higher and CVR to cognitive stimuli will be lower in type 2 diabetes patients than in healthy controls; b) both measures will correlate with the severity of insulin resistance/diabetes and the extent of cognitive decline. The results will indicate the extent to which impaired artery function in the brain is a potential risk factor for decline in mental abilities in type 2 diabetes and will help us to devise early intervention strategies to prevent future loss of mental abilities in this at-risk population.

  • A computerised psychological treatment for problematic cannabis use and depression in an early psychosis treatment service

    The aim of the project is to trial the use of a computerized psychological treatment for problematic cannabis use in Early Psychosis. Cannabis use is associated with an increased risk of psychosis and cannabis use is high in people presenting for treatment of first episode psychosis (FEP). Cannabis use is also associated with high relapse rates in FEP. Therefore, it is vital that Early Psychosis Treatment Centers (EPTC) address cannabis use. This project aims to trial the SHADE computerized treatment package among an FEP sample presenting to an EPTC at Bondi Junction Community Mental Health Centre and Campbelltown Community Mental Health Centre, to determine whether the addition of this resource is effective in reducing cannabis use over the treatment period.

  • Botulinum toxin injection for vocal cord dysfunction in asthma

    The study aims to provide proof-of-concept support for the use of botulinum toxin in difficult-to-treat asthma with vocal cord dysfunction.

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