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

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33074 results sorted by trial registration date.
  • The Effect of a Supervised Hospital Based Exercise Program on Sleep Quality in Recently Discharged Heart Failure Patients

    Despite favourable trends in survival, heart failure (HF) remains a leading cause of mortality and morbidity across the developed world. Consequently, emphasis has been placed upon identifying solutions for the treatable co-morbidities associated with this chronic, incurable disease. Sleep disorders are one of the most commonly reported features of HF. Sleep disorders are a group of syndromes which are characterised by disturbance in the amount, quality, timing or architecture of sleep. The most frequent and troubling of these in HF includes Obstructive Sleep Apnoea (OSA) syndrome, Central Sleep Apnoea syndrome (CSA), periodic limb movement disorder and insomnia. These disorders impair quality of life (QOL) and are linked with repeat health care visits. Exercise is an important component of the multidisciplinary management of HF and has recently been established in the ACTION:HF study as an effective means of improving the QOL of HF patients. Exercise is also thought to improve sleep in this population however this theory remains controversial in light of small number of studies conducted in the area to date. The hypothesis that exercise improves sleep in HF patients has been developed in reflection of the positive effect of exercise on sleep seen in elderly populations and patients with other chronic diseases. These studies are valuable sources of information as the typical HF patient shares many of the co-morbidities seen in patients studied. The common theme established in these publications is that physically active patients have improved sleep duration and quality when compared to their sedentary counterparts. Physical activity has been identified to relieve problems associated with frailty and disease co-morbidities and lacks many of the negative side-affects related to sleep medications such as confusion and falls. It is linked with improvements in vitality, symptom severity, daytime sleepiness, depression, QOL, pain and strength. Physically active patients also exhibit improved ventilatory capacity, reduced vascular resistance and improvements in endothelial dysfunction. Polysomnography (PSG) is the current gold standard device for the examination of sleep disorders but is expensive, labour intensive and limited in its availability. Reliance on quantitative measures to identify sleep disturbance may not be practical in this population given the limited availability of PSG combined with the fact that HF is an increasingly common disease with correspondingly high rates of sleep disorders. In addition, as it is often the individual’s perception of their sleep state which motivates them to seek treatment, examination of sleep quality may be cost-effective, convenient alternative to ensure the prompt identification of sleep disturbance. Appropriate medical management of HF is thought to alleviate sleep disturbance however studies suggest that treatments produce only minor improvements in sleep in this population. The most common non-pharmacological form of treatment for diagnosed sleep apnoeas is continuous positive airway pressure (CPAP). Several studies have found that although CPAP may decrease the number of apnoeas and hypopneas and improve sympathetic activity it fails to improve cardiovascular variables or overall survival in HF. CPAP machines are also difficult to use and cause significant patient discomfort. Given issues associated with current screening and treatment methods of sleep disorders and in light of increasing demand on the health care resources in this population there is a need to identify alternative solutions for sleep problems in HF patients. Exercise presents a potential therapeutic alternative given poor CPAP compliance and limited alternative treatment options. The examination of the effect of exercise on sleep quality in contrast to sleep architecture is important as an outcome of improved sleep is one which carries a real meaning for patients and is likely to improve compliance with exercise regimes. In addition, the improvement of sleep through exercise is expected to have direct physiological benefits for HF patients and may improve cardiovascular variables and overall survival.

  • Implementing a Minimal Intervention Dentistry Clinical Protocol for adolescent public dental patients at high risk of dental caries: a pilot study.

    Dental caries (tooth decay) is the second most costly diet-related disease in Australia. Its economic impact is comparable with that of heart disease and diabetes with an increasing total expenditure for dental services from $4.4 billion per annum (6.1 % of total health expenditure) in 2001 to more than $5.3 billion per annum (10% of total health expenditure across Australia) in 2007. Research has demonstrated that placing dental fillings does nothing to manage the dental caries disease process. Minimal Intervention Dentistry (MID) is a multi-pronged approach which focuses on the management of dental caries as a diet related, transmissible, infectious disease. It comprises measures that range from prevention, early intervention, and treatment. The proposed research will be undertaken with a group of adolescent public dental patients (concession-card holders). The current direct-service delivery model does not place specific emphasis on the management of dental caries through caries risk assessment, prevention or early intervention. The overall goal of this project is to undertake a pilot study to test the impact on caries-risk status of implementing a MID clinical protocol to a group of adolescent public dental patients (aged 13-18 years) who are at high risk to dental caries.

  • Intralesional Autologous Platelet Rich Plasma Injection Compared to Corticosteroid Injection for the Treatment of Chronic Plantar Fasciitis. A Prospective, Randomised, Controlled Trial.

    This study aims to compare the efficacy of ultrasound guided intralesional injection of autologous platelet rich plasma (PRP) with corticosteroid injection for plantar fasciitis present for more than six weeks that has failed to settle symptomatically with conservative management.

  • The use of non invasive methods to predict drug handling and toxicity of Irinotecan

    Observational pharmacology/pharmacogenomic/imaging study in patients receiving standard FOLFIRI ± Avastin for advanced incurable colorectal cancer. Patients will undergo baseline nuclear hepatic functional imaging with IDA scans and bloods will be taken for metabolic/pharmacodynamic pharmacogenomics. Bloods will be taken for Irinotecan PK in course 1. Toxicities will be documented in the first 4 cycles and patients will be restaged at the end of cycle 4 (i.e. 8 weeks). No trial involvement beyond 4 cycles is required and treatment beyond this point will be at the discretion of the treating clinician.

  • The use of non invasive methods to predict drug handling and toxicity of Sunitinib

    Suntinib is a drug with variable PK and toxicity profile that impacts upon its clinical use. This study will be targeted to patients receiving Sunitinib for the treatment of advanced renal cell cancer or GIST. Patients will have functional hepatic imaging and blood taken for pharmacogenomic studies of drug handling and drug target enzyme genes. During treatment patients will be monitored for response and toxicity and have bloods taken for steady state PK. We will then try to correlate PK, toxicity and response with liver imaging and genomic parameters in an attempt to develop doing nomograms.

  • A Single Patient Multiple Cross-Over Study To Determine The Efficacy Of Paracetamol In Relieving Pain Suffered By Patients With Advanced Cancer Taking Regular Opioids.

    The aim of this study is to determine the efficacy of paracetamol in relieving pain suffered by patients with advanced cancer taking regular opioids. It is hypothesised that 1. Paracetamol prescribed in addition to regular opioids will not improve analgesia compared to opioids alone in patients with pain from advanced cancer, and; 2. combining n-of-1 trials from multiple subjects provides a feasible variation on randomised controlled trials (RCTs) in palliative care (PC) to produce population evidence of high quality.

  • Can pain words hurt? A randomised trial comparing comfort versus pain scores following caesarean section

    The purpose of this study is to determine if the use of the word ‘pain’ when asking for pain scores in the post-anaesthesia review after caesarean section results in higher scores than if the word ‘comfort’ is used instead.

  • Effectiveness of dental local analgesia among children for dental extractions

    The aim of the study is to determine if adequate local analgesia can be obtained to undertake dental extractions of permanent teeth in the upper jaw among children by buccal administration of local analgesia only without the need for palatal administration of local analgesia.

  • A study to examine the effects of rye bread on gastrointestinal bacteria in humans

    The consumption of rye foods has been shown to improve some markers of bowel and metabolic health in humans. However, the effects of rye foods on the activity and numbers of bacteria of the large bowel, which are increasingly being shown to be important mediators of gut health and health more broadly, are poorly understood. It is the primary objective of this study to determine whether the consumption of a rye bread selectively stimulates the growth of the bacteria Bifidobacteria and Lactobacilli in the large bowel of humans.

  • Pressure limit selection during neonatal assist control volume guarantee ventilation: A randomised crossover trial

    The purpose of this project is to study how ventilators (breathing machines) support babies. We are investigating how we use the ventilator with the aim of better matching the babies' natural breathing patterns. The ventilator can vary the pressure it uses to adjust to your baby’s breathing. We set a maximum inflation pressure limit for how high it can go. Previous experience suggests that this having this limit set higher means babies can get a mixture of higher and lower pressures which may irritate some babies. Setting the limit lower means the ventilation pressures are more even. If the ventilator senses that the pressure limit is too low it will sound an alarm.

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