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CanChange: A psychosocial and lifestyle intervention for colorectal cancer survivors
Expand descriptionThis study looks at the feasibility and usefulness of a telephone-delivered lifestyle and psychosocial supportive care program for patients with cancer of the back passage (rectum) or large bowel (colon). CanChange: A psychosocial and lifestyle intervention for colorectal cancer survivors Who is it for? You can join this study if you have been diagnosed with first primary colorectal cancer between 01/07/08 and 01/07/09, and this has been notified to the Queensland Cancer Registry. Trial details Participants will be randomly divided into two groups. Participants in one group (the intervention group) will receive a telephone-delivered lifestyle and psychosocial supportive care program. The program will be delivered over 6 months and include up to 12 sessions two weeks apart for approximately 30 minutes each. Participants in the other group (the control group) will receive the standard care and will be posted a range of colorectal cancer and lifestyle materials. This study will implement and evaluate a telephone-delivered cancer rehabilitation program (CanChange) for colorectal cancer survivors. It is hypothesised that, compared with usual care participants, CanChange participants will have decreased psychological distress and cancer-related fatigue and will show improvements in quality of life, symptom management, nutrition and physical activity.
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Wellness Study
Expand descriptionThe Wellness Study will evaluate 6 weeks of very low dose Escitalopram (50 micrograms) compared to placebo on fatigue, anxiety and depression in chronic medical illness. Following a 3 week baseline run in-phase, participants will be randomised 'double blind' to the active or placebo treatment, incorporating 4 study centre visits in all. Associated clinical benefits may include improvements in sleep, weight reduction, heart rate and blood pressure. Although serotonin re-uptake inhibitors have never previously been studied at such a low dose, clinical results to date appear encouraging.
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Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab versus Tocilizumab plus Non-biologic disease modifying antirheumatic drugs in Patients with Active Rheumatoid Arthritis
Expand descriptionThis phase IIIb study will include adult patients, 18 years or older,body weight 150kg or less, with moderate to severe active rheumatoid arthritis (RA) of duration 6 months or more, who are inadequate responders to DMARDs or anti-TNF therapies. The primary objective is to assess the safety and tolerability of tocilizumab (TCZ) monotherapy or in combination with non-biologic disease-modifying antirheumatic drugs (DMARDs). The secondary objectives is to assess the efficacy of TCZ monotherapy or in combination with non-biologic DMARDs. The study is designed so that patients would be on the study for 24 weeks, receiving 6 x 60min infusions of TCZ every 4 weeks. AEs and other safety variables will be analyzed using descriptive statistics. Safety and study data will be collected on an electronic CRF.
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Using Exercise Bands to Provide Physical Activity for People with Diabetes and Poor Mobility
Expand descriptionThis is a randomised controlled trial of a home-based resistance training program using resistance exercise bands, for people with type 2 diabetes who are limited in their ability to perform aerobic exercise due to other co-morbidities.
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Prospective consecutive series, assessing Chrome and Cobalt metal ions in patients after single level Lumbar Disc Arthoplasty
Expand descriptionThis study will follow 50 patients for 12 months who undergo Total Disc Replacement in their lumbar spine using the Stryker Flexicore intevertebral disc. The Stryker Flexicore intevertebral disc is a single unit, all metal device. Pre-operatively the patients will have a clinical examination, x-rays, blood test, and complete three patient questionnaires (VAS, SF-12 and Oswestry). The study follow up visits will be at 6 weeks, 3 months, 6 months and 12 months post-operatively. These visits involve standard follow up care x-rays and clinical examination, in addition there will be three questionairres (VAS, SF-12 and Oswestry) for the patient to complete, and a blood test at the 12 month visit. The study aims to compare the Chrome and Cobalt metal ions level in the patient's blood after 12 months as well as assess the patient's pain and activity level outcomes pot-op.
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Intal and Singulair, alone and in combination in asthma provoked by inhalation of a sugar.
Expand descriptionThe protection provided by sodium cromoglycate, against airway narrowing provoked by mannitol, is incomplete. This is likely due to the failure of SCG to prevent release of leukotrienes from cells other than mast cells. The protection against airway narrowing in response to mannitol will be more complete using a combination of SCG and a leukotriene antagonist.
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The REGISTER Study: A multicentre phase II study of risk evaluation in gastrointestinal stromal tumours (GIST) with selective therapy escalation for response
Expand descriptionThe REGISTER study aims to maximise the treatment potential of Glivec (Registered trade mark) (also known as imatinib) in patients with metastatic or unresectable Gastro-intestinal Stromal Tumour (GIST) by individualising treatment. Treatment for each patient will be determined according to the biological features of their tumour when examined in the laboratory. We know that tumours with certain findings are less likely to do well on standard treatment. Patients with these types of tumours will be treated with an increased dose of Glivec (Registered trade mark). Patients with tumours that we know are more likely to do well will be treated with a standard dose of Glivec (Registered trade mark) but will move on to an increased dose when the standard dose stops being effective. The response to treatment will be measured using Computerized axial Tomography (CT) scans. Early response will be measured using Fluorodeoxyglucose Positron Emission Tomography (FDG PET) scans.
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Home based rehabilitation to reduce falls and disability in Parkinson's disease (PD)
Expand descriptionFalls and movement disorders are both common and disabling in people with idiopathic Parkinson's disease (PD), which affects more than 80,000 Australians. Whereas one-third of community dwelling elders fall every year, the incidence in people with PD is as high as 50-68%. Many people with PD experience repeated falls and over 25% sustain a hip fracture (as the result of falling) within 10 years of diagnosis. Along with balance impairment, movements progressively become slower and scaled down in size. Anti-PD medications initially provide effective symptomatic relief although movement disorders and postural instability again become problematic with disease progression. Preliminary trials have shown that hospital based movement rehabilitation programs are an effective adjunct to pharamacological therapy in the short term. Nevertheless hospital inpatient and outpatient programs are costly and can be inconvenient for some people who do not have transport. This randomised controlled trial will compare the outcomes of home based “integrated rehabilitation” with a control intervention in a sample of 180 people with PD. Participants in the treatment group will receive a 6 week home-based rehabilitation program comprising movement strategy training, progressive strengthening and education regarding falls and mobility, delivered by an experienced physiotherapist. The control group will receive a “life-skills” home program delivered by an allied health professional (physiotherapist, PD nurse or occupational therapist). The life-skills program will provide participants with education on relevant topics including PD pathology, medications and relaxation techniques, without falls education, strategies or exercises. Participants will undertake all assessments and interventions associated with this trial within their own home.
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Absolute risk trial in general practice
Expand descriptionThis is a cluster randomized controlled trial, aiming to investigate both the feasibility of using this model and the impact of CVAR assessment and management on general practice clinical processes and patient care. This trial will be conducted in general practices in Sydney, involving GPs, other practice staff and patients aged 45-69 without existing CVD. 32 practices (40 GPs) and 1600 patients will be recruited. Randomization will be conducted at the practice level. The intervention group of GPs will be trained to use a CVAR implementation model while the control group of GPs will continue usual care. Study variables include clinical processes, patient risk, use of lifestyle intervention and prescribing of antihypertensive and lipid lowering medications. Data will be collected and analyzed using mixed methods. Study variables before and after the intervention will be compared, and the two groups be also compared after adjusting for baseline difference and clustering factors. Results of this study will help improve the primary prevention of CVD and inform guidelines for clinical practice and the implementation of other health initiatives.
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Ruling-out Coronary Artery Disease utilising non-invasive investigations in place of Invasive Coronary Angiography: a comparison between Computer Tomography Angiography and Myocardial Perfusion Imaging in patients with an intermediate probability of coronary artery disease
Expand descriptionThe aim of this study is to assess the clinical applications of the proven diagnostic abilities of Computer Tomography Coronary Angiography (CTCA). Specifically, in patient groups with an intermediate probability of coronary artery disease is there a difference between computer tomography coronary angiography and myocardial perfusion imaging in ruling out significant coronary artery disease.