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A first-in-man study to compare an investigational ropinirole transdermal patch formulation with a ropinirole oral tablet (Requip [Registered Trademark] XL [Trademark]) in healthy volunteers.
Expand descriptionThe purpose of this research study is to compare the concentration of Ropinirole in the blood after application of the patch to the concentration of Ropinirole in the blood after taking the tablet formulation. The study will also look at how safe the Ropinirole patch is, as well as how well subjects tolerate the dose delivered transdermally (study drug is absorbed through the skin).
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Continuous infusion antipseudomonal beta-lactams for acute infective exacerbations in cystic fibrosis: a prospective randomised controlled trial
Expand descriptionCystic fibrosis (CF) is an inherited disorder which results in increased thickness of secretions, especially in the lungs. By adulthood, the majority of patients with CF will have a bacteria living in their lungs, called Pseudomonas aeruginosa which can cause lung infections. This usually results in worsening respiratory symptoms and often an acute deterioration in their lung function. They are usually treated with antibiotics that target the Pseudomonas aeruginosa. These antibiotics are typically given as short intravenous infusions several times a day. This study aims to compare the standard method of giving these antibiotics with a different strategy of giving these antibiotics to see if this can improve the outcomes of treatment of these infections and reduce the amount of Pseudomonas aeruginosa in the lungs of these patients. This strategy consists of giving the same antibiotics continuously, to ensure there is always enough antibiotic in the bloodstream and the lung to be able to kill the bacteria.
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Relationships between oral and gastrointestinal sensitivities in response to fat and protein, and body mass index (BMI).
Expand descriptionThis study has been designed to investigate how isocaloric loads of protein (whey protein hydolysate), or fat (intralipid (10%)) differentially affect gastrointestinal motility, gastrointestinal hormone release, and appetite sensations in male individuals with a range of BMI (between 18-35 kg/m2). Further, the sensitivity of these individuals to the presence of protein or fat in the oral cavity will be measured and related to their gastrointestinal responsiveness to protein and fat, respectively. Relationships between BMI, gastrointestinal and oral sensitivities and habitual macronutrient and energy intake will also be assessed. Thus, the specific aims of this study are to determine: the effects of small intestinal lipid and protein, infused at a rate comparable to that of average gastric emptying, on antropyloroduodenal motility, gut hormone release, appetite and energy intake across a range of BMI oral fatty acid, and glutamate, sensitivity across a range of BMI And to assess the relationships between: oral sensitivity to oleic acid and glutamate and gastrointestinal responsiveness to fat and protein, respectively energy intake with oral taste sensitivity and/or gastrointestinal responsiveness, to fat and protein BMI with oral taste thresholds, and gastrointestinal sensitivity, to fat and protein habitual intake, BMI and oral and/or gastrointestinal sensitivity to fat and protein.
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Effects of protein on gastric emptying and hormones, and appetite and energy intake in healthy older individuals
Expand descriptionAgeing is associated with a physiological reduction of appetite and energy intake, which has been called the “anorexia of ageing”. Dietary supplementation with liquid protein preparations is now used frequently to increase energy and protein intake in older adults in both institutionalized and community-dwelling populations. Although the latter would appear a logical approach, evidence for success of increased energy intake in older individuals is limited. It is well established that the ingestion of nutrients induce a number of changes in gastrointestinal (GI) function, which are associated with the modulation of appetite and energy intake. These changes include the slowing of gastric emptying, which sustains gastric distension and is associated with proximal gastric relaxation. Urgent investigation is warranted to determine the optimal load of protein that can be incorporated into their diet to assist in sparing muscle mass without reducing their appetite. The study aims to characterise in healthy older individuals, the effect of different oral protein loads on energy intake, appetite, antral area, gastric emptying, plasma concentrations of amino acids, hormones (i.e. CCK, PYY, ghrelin, GLP-1, GIP, glucagon and insulin) and glucose, and to determine the relationship between the suppression of appetite and energy intake by protein with ‘intragastric’ and ‘small intestinal’ mechanisms.
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Physical activity and exercise in adults with congenital heart disease
Expand descriptionThis study will investigate the effects of exercise training in adults with congenital heart disease. Thirty patients with congenital heart disease will be randomised to either a 12 week exercise training program, or control group who will mainatin their usual activities, to review the effect on vascular function, cardiorespiratory fitness, muscle strength and quality of life.
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Oxidative Stress in Coronary Artery Surgery
Expand descriptionPost-operative atrial fibrillation (POAF) is one of the most common complications after coronary artery surgery, affecting 20-50% of patients. It is a serious post surgical complication that is associated with increased morbidity and long-term health care costs. The development of this arrhythmia after surgery is multi-factorial and reliable pre-operative predictors have not been found. The inability to reliably predict patients at risk means that current methods of preventing POAF remain suboptimal. Mounting evidence suggests that increased reactive oxygen species and oxidative stress play a major part in POAF development, opening the possibility of antioxidant supplementation as a preventative measure. During cardiac surgery with cardiopulmonary bypass (CPB), increases in reactive oxygen species occurs after blood contact with the CPB circuit, the inflammatory response syndrome, ischemia-reperfusion and hyperoxia resulting in oxidative damage to myocytes. In addition there is also a reduced antioxidant response. Some of the primary antioxidants rely on appropriate levels of trace elements for normal function. One such trace element is selenium, which is required by the antioxidant glutathione peroxidase. Reductions in selenium during and after surgery are associated with increased mortality. This observational study will measure oxidative stress levels (by malondialdehyde), as well as selenium levels, pre-, intra- and up to 5 days post-operatively, to determine if an association exists between these levels and the development of POAF. The study will separate participants into patients at low risk of post-operative mortality and those at high risk. In this way we hope to better define the effect of pre- and intra-operative low levels of selenium (and increases in oxidative stress) on events such as POAF. Understanding the pathophysiological differences of low selenium between various patient risk groups may lead to targeted pre-operative antioxidant therapies that have better success at preventing POAF.
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Novel Treatments of Phobias in Children and Teenagers
Expand descriptionThe aim of this trial is to examine whether Attention Bias Modification Training can augment a single session of graded exposure therapy in children and adolscents with a specific phobia. Cognitive-experimental studies show that anxious children display biased attention allocation to threat stimuli. This is a robust finding in anxious adults and consistent with cognitive models of anxiety. Attention Bias Modification Training is a promising treatment for anxiety disorders delivered via a computer.
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Melatonin versus placebo for prevention of delirium in inpatients with advanced cancer
Expand descriptionThis study will determine the feasibility and acceptability of using melatonin for the prevention of delirium in patients with advanced cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or above, and have a diagnosis of advanced cancer defined by the intent of treatment being no longer curative. You need to also be an inpatient at a palliative care or oncology facility. Trial details Participants in this trial will be randomly (by chance) allocated to one of two groups. Participants in one group will take 2mg of melatonin by mouth every night for the duration of inpatient admission, and those in the other group will take a placebo (sham) treatment instead. Participants will not know which group they are in. Participants will be assessed during their admission to evaluate the efficacy of melatonin in preventing delirium events and to evaluate any effects on sleep quality, toxicity and other health outcomes.
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Complications associated with two power-injectable Peripherally Inserted Central Catheters (PICCs).
Expand descriptionThe proposed study will evaluate the safety and costs associated with use of two PICC designs. The primary aim is to ascertain whether a new anti-thrombotic design is associated with less adverse events and need for removal than third-generation polyurethane. Additionally costs associated with using this new technology will be evaluated.
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Threshold respiratory muscle training in people with cervical spinal cord injury: a randomised double-blind placebo controlled trial.
Expand descriptionThe purpose of this study is to strengthen the muscles that people with a spinal cord injury uses to breathe. The training would involve taking deep breaths in and out through a small handheld device to exercise the muscles used to breathe. The training will be in addition to the usual care received by each person. The training will be carried out by an experienced and qualified person for 15 minutes, twice a day, five times a week for a duration of 6 weeks. It is hypothesized that this training will strengthen the muscles used to breathe resulting is fewer lung complications while in hospital and at home. Outcomes will be reassessed after one year.