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Ultrasound scanning with contrast enhancement to assess disease activity in Crohn's disease
Expand descriptionThe primary purpose of this study is to determine whether measurements obtained from an ultrasound scan of the bowel with the use of a contrast agent provides useful information on the disease activity of patients with Crohn's disease.
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The use of advanced organ imaging in radiotherapy of the upper-abdomen for kidney response assessment and treatment optimisation
Expand descriptionRadiotherapy to the upper-abdomen is challenging due to the presence of the kidneys. We will couple single photon emission computed tomography (SPECT) with X-ray computed tomography (CT) to determine the effect of radiotherapy on kidney function. Combining the imaging with information on delivered radiation dose will enable us to examine the complex interactions between radiation and kidney response in order to develop unique models for optimizing radiation dose delivery and predicting outcomes.
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Effect of reducing dietary salt intake on the way blood vessels work
Expand descriptionCardiovascular disease is a major disease burden, accounting for over 45% of all deaths. Obesity, and its consequences, the metabolic syndrome and type 2 diabetes increase the risk of heart disease potentially leading to early death or disability. Reducing dietary salt is a neglected, valuable intervention with the potential to reduce cardiovascular events. The primary aim of the study is to determine, in a 12 week study the effect of a reduced salt diet (6g salt/day, 100mmol Na/day) compared to a usual salt diet (10g salt/day, 166mmolNa/day) on blood vessel function, as assessed by the ultrasound measurement of blood flow in overweight people with and without the metabolic syndrome who are at increased risk of heart disease. The expected outcomes are that a lower salt intake will have a beneficial effect on the way blood vessels work and reduce an individual’s risk for heart attack. The results will support moves to reduce salt in the food supply thereby reducing heart disease risk in the general community as well as in individuals at higher risk. Data from this study will provided a very strong incentive to reduce dietary salt.
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The Control of Diabetes through Weight Loss in Indigenous Diabetes
Expand descriptionThe hypothesis of this study is that the LAGB procedure and the aftercare program would be acceptable and feasible and engender sufficient compliance that a group of Indigenous people with type 2 diabetes will benefit from the weight loss with remission of type 2 diabetes equal to that observed in a Caucasian group of the Melbourne RCT trial. To ascertain success-factors for the LAGB procedure and give appropriate health education with a view of improving their compliance to obtain the hypothesised results the study would assess the perceptions and beliefs of diabetes patients and their health care service providers. The central aim of the study is to achieve a substantial and durable weight loss. The principal outcome is the frequency of remission of type 2 diabetes in response to this weight loss. Additional outcomes would include measure of side effects and complications, compliance, acceptability and costs.
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A Randomised Control Trial of people with psychosis taking Risperdal Consta compared to people with psychosis taking Risperdal Consta and receiving Collaborative Therapy (a psychoeducational program) in a naturalistic setting
Expand descriptionThis study aims to see whether providing an educational program to people with psychosis who take a stable anti-psychotic medication do better than people with psychosis on a stable anti-psychotic medication who recieve usual care from their General Practitioner or case manager. We are particularly interested in people's engagement with treatment, psychiatric symptoms and everyday functioning.
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Whole Body Vibration Training for Mitochondrial Respiratory Chain Disorders and Rett Syndrome
Expand descriptionIn the majority of individuals with mitochondrial respiratory chain disorders there is a steady decline with time of muscle mass and strength, and with reducing mobility there is a high risk of reduced bone mineral density and fracture. There are currently no therapies that have been shown to be consistently effective in this cohort of patients. Rett syndrome is a severe neurodevelopmental disorder. Amongst other clinical problems there is a high risk of reduced bone mass, primarily related to reduced mobility and nutritional intake, and poor perfusion of lower limb extremities. Aims: 1. To investigate if whole body vibration training is effective and well tolerated over the medium-term in patients with mitochondrial respiratory chain disorders or Rett syndrome. 2. A medium-term home based training program in patients with mitochondrial respiratory chain disorders will evaluate if whole body vibration training influences: a. Muscle power and force b. Muscle mass c. Bone mass 3. A medium-term home based training program in patients with Rett syndrome will evaluate if whole body vibration training influences: a. Muscle mass b. Bone mass c. Lower limb skin blood flow
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A nurse led psychosocial intervention with peer support to reduce psychosocial needs in women with gynaecological cancer
Expand descriptionThis study involved the development and pilot / phase I testing of a psychoeducational intervention involving tailored nursing consultations combined with peer telephone support to address the psychosocial needs of women with gynaecological cancer being treated with radiotherapy. The intervention was found to be feasible and acceptable to patients and clinicians. This intervention was then further modified and is being tested in a larger RCT to identify whether the support program reduces psychological distress, unmet supportive care needs, psychosexual difficulties, and improves quality of life and adherence to dilator use. The ACTRN is the initial development & pilot testing phase is: ACTRN12609000312246. A second ACTRN is for the phase III trial for which this study was the initial development & pilot testing phase has also been submitted: ACTRN12611000744954.
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Breast reconstruction for breast asymmetry by tissue engineering
Expand descriptionStudy hypothesis: The human body has a natural capacity to regenerate and to grow new tissue to fill an empty space. This study applies a new method of breast reconstruction using the patient’s own regenerative capacity. This method provides an alternative to current breast reconstruction techniques and also an opportunity for patients who have no other option for reconstruction. In the operation an acrylic spacer, shaped according to the breast defect, will be placed under the skin of the chest wall to allow a piece of fat with a blood supply to grow over time (3-6 months) to fill the space created by the acrylic spacer. The small piece of fat with a blood supply will be sourced from well-known existing donor sites for breast reconstruction (chest or abdomen). Because the amount of tissue is small the expected donor site scars will be smaller compared with the usual reconstruction methods.
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Efficacy of the Cathrx ablation catheter for right atrial flutter ablation
Expand descriptionThis research project is assessing a new burning catheter, the modular ablation catheter, this catheter will burn the irregular electrical connection that causes an irregular cardiac arrthymia. The catheter is being assessed to ensure that is not inferior to a conventional catheter. The trial catheter has benefits for the clinician in that it can be more adaptable during the clinical procedure than standard catheters and hence it is not inferior to current technology it should provide an attractive catheter choice for the clincian.
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A study to determine the safety, tolerability and process by which ibuprofen is absorbed, distributed, metabolized, and eliminated by the body over a 5-7 minute infusion.
Expand descriptionThis research study is being conducted for the pharmaceutical company Cumberland Pharmaceuticals Inc. You are being asked to take part in this research study because we want to determine the safety, tolerability and pharmacokinetics (the way the body absorbs the drug) of a single dose of ibuprofen administered intravenously (in the vein) over 5-7 minutes. A screening procedure will determine if you are eligible to enter the study. If you are accepted, you will be required to attend the study centre for 2 treatment visits. When you return to the research center, you will be randomised into one of two treatment sequences. Randomised means you will be assigned to a group by chance. The two treatment sequences in this study are: Sequence A: A single dose of intravenous ibuprofen (IVIb) and an oral (capsule) placebo (starch filled capsule) given concurrently on Day 1 of the Treatment Period followed by a single dose of oral ibuprofen (capsule) and intravenous (IV) placebo (saline solution) given concurrently on Day 8 of the Treatment Period. Day 2-7will be a washout period. During the washout period no study drugs or study tests will be done. Sequence B: A single dose of oral ibuprofen and intravenous (IV) placebo given concurrently on Day 1 of the Treatment Period followed by a single dose of intravenous ibuprofen (IVIb) and oral placebo given concurrently on Day 8 of the Treatment Period. Blood samples will be collected in treatment visits 1 and 2 (16 samples per visit) by either cannula (small plastic tube inserted into a vein in your arm) or venipuncture. Approximately a total of 222 mL of blood will be collected during the study, which includes the amount required for the clinical laboratory tests and for the measurement of Ibuprofen in your blood.