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The Arthroplasty and Bariatric Surgery study in obese patients with osteoarthritis
The Arthroplasty and Bariatric Surgery (ABS) study intends to examine the clinical outcomes and cost effectiveness of preceding total knee replacement (TJR) with laparoscopic adjustable gastric banding (LAGB) in a randomised controlled trial (RCT). This will be a 4 year multi-institutional randomized controlled trial in severely obese patients with end stage osteoarthritis. The study will recruit 120 severely obese people with osteoarthritis who are on the waiting list for TKR and randomly allocate them to receive the current standard of care for TKR or a combination of LAGB followed by TKR. We plan to measure weight loss, pain and function, quality of life and complications, as well as the cost effectiveness of a strategy that combines LAGB +TKR, compared to TKR alone. Participants will all be followed for one year at which time the benefits in terms of, weight loss, clinical and health improvements, adverse events and costs would be measured.
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Comparison of depot versus daily vitamin D3 for supplementation in refugees in Western Australia
After arrival in Western Australia resettled refugees undergo an initial health assessment that includes testing for 25(OH) vitamin D. An internal audit in 2007/8 revealed that of the 2400 patients assessed, 45% were vitamin D deficient (25(OH)D:<27.5 nmol/L) and 54% insufficient (25(OH)D:27.5-78 nmol/L). The use of high-dose depot vitamin D therapy is increasing, but there are few data on its use in children. OBJECTIVE: To compare the efficiency and safety of daily versus depot oral vitamin D supplementation in refugee children METHODS: Refugee children aged 0-16 years with 25(OH)D levels <78 nmol/L were recruited through a refugee tertiary clinic and randomized as follows: those with vitamin D deficiency received either vitamin D3 200,000 IU depot or 5000 IU daily and those with vitamin D insufficiency 100,000 IU depot or 2500 IU daily. 25(OH)D measurement was repeated 6-8 and 14-16 an 22-24 weeks later and treatment continued if levels were <78 nmol/L. Other biochemical parameters included calcium and alkaline phosphatase (ALP). Data on sun exposure, season , diet, country of origin and skin pigmentation were collected. RESULTS: A first analysis looking at 84 subjects with complete data sets revealed significant improvements in 25(OH)D between visits (p<0.05) without difference between depot and daily treatment groups. Sun exposure and oral calcium intake were very low. The study is ongoing. CONCLUSIONS: Supplementation with both daily and depot vitamin D3 resulted in similar improvements and could normalize vitamin D levels during the initial treatment phase. Depot vitamin D3 therapy was a safe and well accepted therapeutic option. It was difficult to achieve long term improvement even under controlled conditions. Support by public health initiatives is required.
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MiTii: A randomised trial of novel web-based upper limb intervention for congenital hemiplegia
This randomized comparison trial will test the efficacy of a novel rehabilitation (MiTii: Move it To improve it) which involves the use of a web-based, intensive and individualized, multimodal therapy program with therapists acting as 'virtual trainers', over a 20 week period, and comparing this approach to standard care received in children with congenital hemiplegia.
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Pancreatic Enzyme Replacement Therapy in Pancreatic Cancer - A Randomized Controlled Trial
This research project is aimed at people who have known cancer of the pancreas, who may have symptoms or signs of pancreatic exocrine insufficiency (PEI). Pancreatic exocrine insufficiency (PEI) occurs when diseases of the pancreas prevent it from functioning properly. In the healthy state the pancreas releases substances in into the intestinal system to breakdown ingested fats. In patients with cancer of the pancreas this process can be impaired due to blockage of the pancreatic duct or due to poor function of the pancreas. This means that some patients with pancreatic cancer cannot breakdown fats and so they cannot absorb fats from their food. This results in: - Weight loss - or inability to gain weight - Non-absorption of essential vitamins found in fats (for example vitamin A, D, E and K) - Unpleasant fatty diarrhoea which is frequent, foul smelling and difficult to flush Pancreatic enzyme replacement therapy (or PERT) is a medication that these patients can take which replaces the most important of the body’s natural pancreatic enzymes and therefore allows better breakdown and absorption of fats. This helps patients with pancreatic cancer to maintain a healthy weight, and have reduction in the unpleasant side effects of frequent diarrhoea. This is important for this patient group as it reduces time spent in hospital towards the end of their life due to complications arising from low weight and malnutrition and improves their quality of life. Good nutrition is also important if patients are going to be able to tolerate other treatment, for instance chemotherapy. This research project will involve patients with known cancer of the pancreas. They will be randomly allocated into two groups. Each group will be given a supply of tablets, to be taken at home for a period of 4 weeks. Neither group will know what medication the tablets contain. Group A will receive PERT tablets, and group B will receive a placebo tablet (meaning a completely harmless tablet with no medication in it). The patients will be required to keep a bowel chart whilst taking the medication. Patients will be able to contact a dietician for support if they require it throughout the 4 week period. Both at the start and at the end of the 4 week study period, patients will be weighed, and they will also have their stool tested. The stool testing requires two samples only (i.e. One at the start and one at the end of the study period), and can be done at a time which is convenient for the patient. Patients will also complete a questionnaire relating to their quality of life, both before and after the 4-week medication period. PERT medication is already used to help alleviate some of the unpleasant symptoms associated with pancreatic cancer, however not all doctors prescribe it routinely. The results of this study may support or refute its use in patients with pancreatic cancer, and will therefore give doctors good evidence for prescribing or not prescribing PERT to help their patients with this condition.
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A randomised, double blind, parallel group, comparative Phase I study to evaluate the safety and pharmacokinetics of a single intravenous dose of GB221 compared to Herceptin Registered Trademark (trastuzumab) in healthy volunteers.
This study is a randomised controlled trial to evaluate the safety and pharmacokinetics of a single intravenous dose of the new drug GB221, compared to the drug Herceptin (also known as trastuzumab, Registered Trademark) in healthy volunteers. Who is it for? This trial is open to males aged between 18 and 45 years of age, with additional details listed in the Inclusion Criteria section of this form. The trial has been designed to look at how safe and well-tolerated GB221 is when administered to humans intravenously as compared to Herceptin Registered Trademark. The study will also look at how quickly GB221 is absorbed into the blood, how much of it is absorbed and how long it takes to body to remove it (this is known as the study of pharmacokinetics) when compared to Herceptin (Registered Trademark). You will be randomised to one of two intervention arms, where in one arm you will receive a dose of the new investigational drug being tested, GB221, administered as a single IV injection (8mg/kg) over 90 minutes. In the other arm, you will receive Herceptin (trastuzumab) at a dose of 8mg/kg administered as an IV infusion over 90 minutes. 10 weeks following this intervention, you will be assessed on various safety outcomes to determine the usefulness of the drug.
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Prostate Health Improved Through Training: a home based resistance training program for men with prostate cancer.
Participation in physical activity (PA) helps relieve side effects of prostate cancer treatment, reduces depression and anxiety, enhances quality of life and importantly, improves prostate cancer (PCa)-specific survival. There are few existing exercise programs to promote and support behaviour change designed specifically for this cohort and the few available are generally not home-based or widely available. The intervention proposed here addresses these challenges in a cost-effective manner.
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Measuring cognition and brain volume in people with mild cognitive impairment and Alzheimer's disease
The overall purpose of this study is to develop magnetic resonance imaging methods to measure degeneration of brain regions and to validate new cognitive tools for early diagnosis of Alzheimer's disease. We expect that people in the control group will perform better on the cognitive tasks than people in the mild cognitive impairment and Alzheimer's disease groups (Part A). We also expect that people's performance on the cognitive tasks will be correlated with their brain volume as measured by the MRI (Part B) and that people's MRI screens will be predictive of Alzheimer's disease diagnosis (Part C).
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Randomised controlled trial comparing anal fistula closure rates between anal fistula plug insertion and ligation of intersphincteric fistula tract in patients with complex anal fistula of cryptoglandular origin
Multiple surgical techniques have been described in the surgical literature for the treatment of high anal fistulas. High anal fistulas include a large proportion of the anal sphincter muscles and therefore, laying open these fistula tracts (which is the most effective way to treat a fistula) is not an option due to the high likelihood of faecal incontinence. The anal fistula plug is a technique used to induce fistula tract healing and closure by plugging the internal opening. This has gained popularity in the past 5 years. The Concord Hospital Colorectal Unit published the outcomes from anal fistula plugs in 2010 and reported a success rate of 35%. A new technique called Ligation of the Intersphincteric Fistula Tract or 'LIFT' was described in 2007 for treating high anal fistulas. This also aims to disrupt the fistula tract but does so by tying off the tract close to its internal opening without injury to the surrounding anal sphincter muscle mechanism. Success rates of this technique in published case series range between 54 to 94%, although followup and definitions of successful fistula closure varies between studies. Both techniques are simple procedures that involve no muscle division. The aim of this project is to assess and evaluate the rates of successful fistula closure comparing the two techniques of the anal fistula plug versus the 'LIFT' procedure. To allow effective comparison between techniques, we are conducting a randomised trial on patients with high anal fistulas at Concord Hospital.
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Comparison of dexamethasone route of administration on ankle block duration and analgesia for foot and ankle surgery
Post operative pain following ankle and foot surgery is troublesome. It is common practice for regional anaesthetic blockade to be used to prolong post operative pain relief for about 14 hours. Dexamethasone has been shown to prolong regional blockade in the upper limb, but this has not been investigated in the lower limb. The optimal route of administration for dexamethasone has not been investigated and it is unknown whether there is advantage to administering dexamethasone intravenously, or mixed with the block. We aim to investigate whether dexamethasone can prolong regional anaesthesia in the lower limb and determine if there are differences in effect when administered intravenously compared with when it is added to the block.
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A pilot study of mindfulness based stress reduction in total joint arthroplasty patients.
The objectives of this project are to: (1) identify currently levels of distress in a waiting list for Total joint arthroplasty (TJA), and (2) administer an eight-session group mindfulness training intervention to 30 volunteers on the TJA waiting list. It is hypothesised that (1) levels of pain will be adversely associated with depression, anxiety and lower Quality of Life; (2) the intervention will lead to better tolerance of symptoms, an improved quality of life. Mindfulness is “the awareness that emerges through paying attention on purpose, in the present moment, and non-judgmentally to the unfolding of experience moment by moment”. Training involves instruction in a number of meditation techniques as well as teaching on how to remain focused on the present moment in day to day activities. There is now extensive scientific evidence showing that mindfulness training leads to an improvement in emotional and physical symptoms in a variety of disorders such as chronic pain, cancer, depression, anxiety and substance use among others. To our knowledge, this technique has not previously been used with TJA patients. 135 participants (waiting list of TJA-surgery patients [Currently: 78 knees and 57 hips] who do not have a date for surgery as yet) will be mailed a PICF and study questionnaire (with pre-addressed-stamped envelope). Those who wish to participate in the 8 weekly group mindfulness intervention will indicate their interest on the study questionnaire and contacted by the researchers to organize the intake interview and commencement intervention details. 30 volunteer patients who identify as experiencing pain and emotional distress associated with their TJA who are on the St Vincent’s TJA surgery wait list will be recruited. Participants who wish to complete the study questionnaires, but not part of the mindfulness intervention will also be recruited; this treatment-as-usual group will provide a comparison to the TJA mindfulness group. All participants will be aged 18 years or more, and will be fluent in English. Participants will be excluded if: (1) they experience psychotic symptoms, delirium or dementia, (2) they suffer drug or alcohol dependence; or (3) they have a diagnosis of intellectual disability. Based on the results of this study it is planned to apply for grant to conduct a randomized controlled trial of the piloted intervention. Surgical date will not be adversely impacted upon, if participants do (or do not) participate in this pilot study. In addition to the initial questionnaire data, participants will also be asked to complete the questionnaire again at the program completion, three months following the intervention, and 3 months post-surgery.