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An international trial with a new standard of care for patients with AL amyloidosis.
We propose to test in a phase III study (oral melphalan and dexamethasone (MDex), the standard therapy for AL patients who are not autologous candidates for stem cell transplant (ASCT), against bortezomib added to MDex (BMDex). The hematologic response rate with MDex is 60% with 30% complete responses. The median overall survival with MDex is 5.1 years and the median progression free survival is 3.8 years. The basis for the combination of BMDex includes the high activity of bortezomib in AL, particularly the high complete response rate and the rapidity of hematologic response to bortezomib and dexamethasone, and the large clinical experience in phase II and phase III studies with bortezomib, melphalan and prednisone in myeloma. Untreated patients diagnosed with AL who are not candidates for stem cell transplant with melphalan 200 mg/m2 are the target population. Patients who are eligible for SCT with melphalan 200 mg/m2 but who decline the procedure can be enrolled in the study as a subgroup with stratified randomization. Because many newly diagnosed AL patients present with limited organ reserve, the eligibility criteria take into consideration the impact of cardiac involvement on overall survival using cardiac biomarker staging. Stage I and II patients will be eligible and stage III patients will be enrolled in an ancillary phase II study.
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Resveratrol in the prevention of colorectal polyps
This study aims to determine whether Resveratrol (contained in red wine) may prevent colorectal cancer in people with a family history of the disease. Who is it for? You can join this study if you are aged 18 years or more and are a carrier of hereditary non-polyposis colorectal cancer (HNPCC). Trial details Participants in this trial will eat a controlled diet developed by the CSIRO for a period of 3 weeks. They will then be randomly (by chance) divided into two groups. One group will consume 100ml of dealcoholised red wine containing 50 mg resveratrol daily with their evening meal for a period of 6 weeks. Participants in the other group will consume a placebo (sham) drink containing no resveratrol. Participants will not know which group they are in. Blood and rectal biopsy samples will be taken from participants at the beginning and end of this study to assess any changes in markers associated with colorectal cancer.
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The impact of rotavirus vaccine introduction in SA
This project aims to assess the impact of rotavirus vaccine introduction on severe gastroenteritis in South Australian children. Prevalence of rotavirus coded hospitalisations and all-cause gastrenteritis hospitalisations will be compared for a two year period prior to introduction of the vaccine and a two year period following introduction of the vaccine. Severity of rotavirus coded admissions during the periods will also be assessed.
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Evaluation of a brief parenting intervention for parents of children suffering asthma or eczema
Every day, thousands of Australian children suffer the effects of asthma and eczema and families struggle with illness management and children's behavioural and emotional adjustment. Many parents experience difficulties with their caregiving role and lack confidence in their ability to manage their child's illness and ensure their wellbeing. This study aims to evaluate the efficacy of a brief, group-based parenting intervention for parents of children with asthma or eczema. It is expected that participating in a group-based parenting intervention has the potential to reduce ineffective and coercive parenting practices, and lead to improved child behavioural and emotional adjustment, better family wellbeing, and healthier children.
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Exercise in combination with a diet and diet alone on agouti-related peptide and Interleukin-6 in obese and overweight sedentary female
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The Out-and-About trial: Improving quality of life after stroke
The Out-and-about trial aims to change the practice of rehabilitation teams working with people with stroke in New South Wales, as well as increasing community participation in people with stroke. The trial will compare different types of education provided to 20 community rehabilitation teams and 300 people with stroke who they see over 12 months. It is hypothesised that teams that receive one type of education will perform better than teams that receive the other type of education.
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Effectiveness of continuing medical education and feedback to altering diabetes at a population level. A randomised controlled trial.
To test whether population-level effects can be achieved by implementing best-evidence practice change strategies for the care and management of diabetes. The study will test whether a rural GP-focused intervention involving Continuing Medical Education (CME), reminders & feedback can: i. Improve patterns of diabetes care as measured by frequency of testing for blood lipids, haemoglobin A1c (HbA1c) and urinary albumin ii. Improve clinical outcomes as measured by glycaemic control, blood lipid control and urinary albumin control. iii. Be cost-effective in terms of cost per Quality Adjusted Life Year (QALY) gained as a result of improved clinical outcomes
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Pharmacokinetic Study of the Modern Chinese Medicine Dantonic in a healthy Western Population
This study aims to examine the pharmacokinetics of herbal medicine T89 in healthy western adults. Based on the similar study in Chinese people, it is hypothesised that following an oral administration, T89 will be detectable in the circulation at ~15 minutes, peaked at 60 minutes to 2 hours, significantly reduced at 6 to 8 hours, and undetectable after 12 hours. It is removed from the body through the urine, which starts at ~2 hours and completes within 24 hours following the administration.
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Adrenergic blockade in adult burns patients
Post burn injury, survivors undergo a “hypermetabolic” response resulting in loss of muscle mass and increase in fat tissue, increased cardiac work, and delays in wound healing. Consequently these patients have weakness, increased length of hospital stay decreased functional ability and delayed return to work rates. One way to counteract this problem is by pharmacological blockade ie using medication to block the hypermetabolic response. One drug that has been trialled extensively in paediatrics are beta - blockers which decrease the work of the heart. The studies in children have shown these drugs can improve donor site and graft healing, attenuate muscle mass loss, prevent loss of lean muscle mass, improve immune function and decrease in the high temperature, high heart rate, increased cardiac work, and fatty infiltration of the liver. There have been two small trials in adults who did not blind investigators, investigate long term factors and included patients with burns less than 30% total body surface area. We plan to complete a single blinded, randomized trial on beta -adrenergic blockade in large severe adult burns patients investigating a number of important long term outcomes including lean muscle mass, cardiac function, wound healing, exercise capacity and metabolic profile. The specific aim is to investigate whether Propranolol)1mg/kg/day) a nonselective beta(1,) beta(2)-receptor antagonist, can prevent the loss of lean muscle mass and improve cardiac function, wound healing, exercise capacity and metabolic profile following severe thermal injury
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Comparison of magnetic resonance imaging (MRI) and angio computed tomography ( Angio CT) in the characterization of liver lesions in patients with colorectal cancer and possible liver metastases
This study aims to compare the accuracy of two different diagnostic tests used to examine liver lesions in patients with colorectal cancer. Who is it for? You can join this study if you are aged 18 to 85 years and have colorectal cancer liver metastases for which you are considering surgery. Trial details Participants in this trial will undergo an Angio CT scan and an MRI with Primovist scan. The Angio CT is a very useful standard test which is used to detect lesions within the liver. The test is also very good at showing the relationship of the lesions to the important blood vessels within the liver. However, sometimes this CT picks up lesions which might not be colorectal cancer metastases (a deposit of colorectal cancer within the liver). It is important to know this so that patients are not excluded from surgery because they have too much disease. It is thought that MRI with Primovist may be better at characterising the liver lesions, i.e. MRI with Primovist is better at deciding whether a lesion seen is a colorectal metastases or not. There has never been a study that directly compares Angio CT with MRI with Primovist. This study would aim to make this comparison. It would help us decide which is the better test in different circumstances to assess the liver disease in a patient with colorectal cancer.