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A randomized controlled trial comparing the impact of continuous subcutaneous insulin infusion (CSII) therapy and multiple daily injection (MDI) regimens upon indices of behaviour, cognition and glycaemia in children and adolescents with type 1 diabetes.
Expand descriptionStudies have also shown that children with Type 1 diabetes mellitus (T1DM) have much higher rates of problems with behaviour and cognition (learning, understanding, attention, memory etc) which can affect their health and quality of life. In particular, youth who have more problems with behaviours such as aggression and conduct (called ‘externalising’ behaviours) have been shown to have much higher rates of poorer mental health outcomes and poor long-term diabetes control. It is known that despite having regular insulin injections, individuals with T1DM can have large swings in blood glucose levels (from very high to very low or vice versa) over the course of a day. These high and low levels of glucose not only give rise to uncomfortable symptoms, but have also been shown to result in an increase in externalising behaviours and impaired mental functioning. ‘Intensive insulin therapy’ regimens involve either multiple daily injections (MDI) of insulin or continuous subcutaneous insulin infusion (CSII) using an insulin pump. These regimens aim to better mimic the work of the pancreas and therefore to reduce the large swings in glucose found in T1DM. A previous study that followed up 32 youth who commenced use of CSII showed significant improvements in their scores of behaviour & cognition after 6-8 wks. Improvements in behaviour have persisted to 2 years in those using CSII. Of note however, there was no control group in this pilot study and so results can not be generalised. If however, similar results were found when comparing CSII and MDI, then CSII would offer additional health and wellbeing benefits for youth with T1DM. The aim of this randomised controlled trial is to assess whether, in a group of youth already using MDI, commencement and continued use of CSII results in improvements in indices of behaviour and cognition, and if so, whether these changes are as a result of improved glucose profiles. The study will run at both the Royal Children’s Hospital Melbourne (VIC) and the Children’s Hospital Westmead, (NSW). Children and adolescents aged 9-16 years who are on the waiting list to commence CSII (i.e willing to use CSII and assessed by the diabetes team as capable of doing so) will be invited to participate. Assessments performed will include standardised behaviour questionnaires and cognitive tests (supervised and scored by a trained psychologist) as well as 6 days of continuous glucose monitoring (using a probe inserted under the skin which continuously records glucose measurements) and HbA1c (a standard monitoring test of glucose control). Following baseline assessments, 110 youth will be randomly assigned to either continue MDI or to commence and continue CSII. All participants will then have standard diabetes care until assessments are repeated at the end of a 4month period. Differences between outcomes in the 2 study groups at 4 months will be compared. Between group difference in scores of externalising behaviour at 4 months is the primary outcome of interest. Differences in scores of mood, cognition and markers of glucose control at 4 months are secondary outcomes of interest. Since all participants will be recruited from the CSII waiting list, at the end of the 4 month study period, those randomised to continue MDI will be commenced on CSII.
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Boosting the Cognitive Capacity and Mental Wealth of Working Australians.
Expand descriptionCognitive brain training, which involves repeated exercise on a range of cognitive problems, may help improve cognitive function and slow age-related mental decline. Previous studies of brain training have mainly focused on clinical populations, and so its effectiveness in healthy, working age individuals is not known. We therefore propose to measure the effectiveness of brain training across a wide range of outcomes with scientific, business and health relevance, including cognition, psychological wellbeing and workplace productivity.
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A Double-blind, Randomised, Placebo-controlled, Flexible-dose of 50 mg/day to 400 mg/day, Phase IIIb Study of the Efficacy and Safety of Quetiapine Fumarate (Seroquel XR) as an Add-on Therapy in Patients with Chronic Somatoform Pain Disorder
Expand descriptionThe main rationale for this study is to evaluate the analgesic effect of Quetiapine XR in conjunction with non-opioid analgesic/s and/or nonsteroidal anti-inflammatory drugs (NSAIDs), with or without an antidepressant in treating patients with Chronic Somatoform Pain Disorder (CSPD), who have not responded adequately to their existing pain management therapy alone.
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A randomised, double-blind, placebo-controlled study to determine the effects of enterically coated, nutrient-containing (CTM#3) pellets on the release of gastrointestinal peptides, glycaemic control, gastric emptying and sensations of appetite in patients with type 2 diabetes, when given concurrently with sitagliptin.
Expand descriptionThe purpose of the study is to determine the effects of enterically coated, nutrient-containing (CTM#3) pellets on glycaemic control, the release of gastrointestinal peptides, gastric emptying and sensations of appetite in patients with type 2 diabetes, when given concurrently with the dipeptidyl dipeptidase IV inhibitor, sitagliptin.
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Gait and postural control to change the knee loading in patients with knee osteoarthritis (OA).
Expand descriptionThe primary hypothesis is that participants randomised to the 1 month gait training program will reduce KAM and improve symptoms of OA compared to the control group. Osteoarthritis is the most common musculoskeletal disorder affecting Australians and is the leading cause of pain and disability. OA is caused by rapid degeneration of articular cartilage. Knee osteoarthritis reduces physical activity level due to the associated pain, impaired gait and balance and lower-extremity muscle weakness. Osteoarthritis treatment is typically driven by a pharmacologic approach to provide analgesia and reduce inflammation, rather than employment of disease-modifying agents, or risk factor reduction, with knee replacement surgery the only option in advanced cases. Gait retraining and postural control is theoretically far more targeted to the impairments in knee OA. The primary hypothesis that participants randomised in the 1 month gait program will have a significant reduction in the KAM compared to the control group, and have a significant improvement in symptoms of OA such as pain.
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Sleep Disturbances in Moderate to Severe Chronic Obstructive Pulmonary Disease
Expand descriptionPatients with chronic obstructive pulmonary disease (COPD) have previously been shown to complain of poor sleep, daytime fatigue and sleepiness. This has been seen in large studies based on questionnaires, however a US study of over 2,000 participants with mild COPD found little sleep disturbance. This study will measure sleep quality and symptoms of sleep disturbance in a group of participants with moderate to severe COPD and correlate perceived with actual sleep disturbance. Thirty participants with moderate to severe COPD (defined as at least 1 standard deviation below the lower limit of their predicted function) will complete questionnaires measuring quality of life, symptoms of respiratory and sleep disturbance and daytime sleepiness. They will be required to have a stable regimen of treatment for their lung disease and no significant medical or psychological conditions which could prevent them completing the study. Standard clinical spirometry will be performed and an in-laboratory sleep study carried out. This sleep study will monitor sleep, airflow, oxygen and carbon dioxide (CO2) levels during the night, as accumulation of CO2 during the night in these patients may contribute to sleep disruption and fragmentation. Participants will be asked to describe the quality of their sleep and this will be compared to the measured sleep, as sleep perception is thought to be poor in these patients. The outcomes of the study will be a description of sleep architecture, including the number of changes in sleep stage. It is thought that sleep stage transitions are important for daytime sleepiness. The degree of sleep fragmentation will be correlated with the sleep questionnaire outcomes and also with the severity and other measures of the respiratory function.
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Physical activity levels of patients with cystic fibrosis admitted to hospital with an acute pulmonary exacerbation
Expand descriptionTo determine objectively how inactive cystic fibrosis patients are during and after a hospital admission for an acute pulmonary exacerbation by assessing them using a highly accurate physical activity level monitor. The study also seeks to determine whether exercise tolerance and skeletal muscle strength are reduced during periods of hospitalisation for an acute exacerbation.
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Fish oil as adjunct therapy for periodontitis.
Expand descriptionPeriodontitis is a chronic inflammatory condition affecting 1 in 5 Australian adults. Current treatment involves intensive cleaning although treatment does not completely resolve the associated inflammation. The long chain omega-3 polyunsaturated fatty acids (omega-3) from fish oil help reduce inflammation in several chronic conditions. Regular consumption of food rich in omega-3 may benefit periodontal health. Studies suggest that omega-3 metabolites may serve as “stop signals” for preventing neutrophil-mediated tissue damage, a key component of periodontal disease. Studies in rodents show a positive, modulating effect of omega-3 on gingival inflammation, which can be mediated through reduced expression of pro-inflammatory cytokines. Other reports that are less positive have used limited treatment periods which may have been insufficient to induce substantial incorporation of omega-3 into cell membranes. The aim of this study is to see whether supplementation with different types of fish oil improves the efficacy of standard periodontal treatment (scaling and debridement) in patients with newly diagnosed, but not aggressive periodontitis. We will also investigate the involvement of anti-inflammatory mechanisms.
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Study of orBec (Registered Trademark (R)) With Prednisone Therapy in the Treatment of Patients With Graft Versus Host Disease (GVHD)
Expand descriptionUse of an oral topically-active glucocorticoid with limited side effects will control the gastrointestinal inflammatory process of GVHD and minimize glucocorticoid exposure.
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Earlier diagnosis and management of Chronic Obstructive Pulmonary Disease (COPD) in general practice
Expand descriptionCOPD is a common problem for current or ex smokers but is often undiagnosed or diagnosed late when the condition has deteriorated significantly. Effective treatment is available so early diagnosis is very important. In this study practice nurses will identify patients who are at risk of COPD and undertake case finding. Patients newly diagnosed with COPD who attend the “intervention practices” will be offered a management involving the GP and practice nurse working in partnership. The patients who attend the “control practices” will receive usual care from their GPs. We will then primarily examine the impact of the “intervention” or the “usual care” on patients' quality of life, health status and lung function and draw a comparison between the two groups in order to asses the effectiveness of the intervention.