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A pilot multicentre blinded randomised controlled clinical trial of frozen platelets vs. conventional liquid-stored platelets for the management of post-surgical bleeding
Expand descriptionPlatelets are cells in the blood that help to stop bleeding. The transfusion of platelets can be an essential and life-saving managment for patients bleeding after surgery or trauma. The purpose of this study is to assess the safety and efficacy of cryopreserved (frozen stored) platelets compared to conventional liquid platelets for the treatment of bleeding in cardiac surgical patients. Hypothesis - That cryopreseved platelets will be at least as effective and safe as conventional liquid stored platelets in the manangment of active bleeding related to surgery.
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Antidepressant, antioxidant and anti-inflammatory effects of curcumin in adults diagnosed with major depression
Expand descriptionThis is a double-blind, placebo controlled study assessing the antidepressant, antioxidant and anti-inflammatory effects of curcumin in 60 adults suffering from major depression (mild to moderate severity). Participants will be randomly allocated into either a curcumin (BCM-95 'Registered Trademark' - 500mg twice daily) or placebo group and changes in depression, anxiety and general health will be measured over an 8-week period. The aim of this study is also to investigate potential mechanisms of action of curcumin so urine, saliva and blood samples will be collected at the beginning and completion of the study. Levels of cortisol, kynurenine pathway metabolites (measure of inflammation) and oxidative stress markers will be assessed over time.
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Bread n' Butter... Gluten Free of Course! An online intervention to improve gluten free diet adherence, coping, and quality of life in coeliac disease
Expand descriptionAn online intervention to improve gluten free diet adherence, coping, psychological symptoms and quality of life in adults with coeliac disease. The intervention modules are based on the theory of planned behaviour and cognitive behaviour therapy. It was hypothesised that relative to the waitlist control group the intervention group would evidence greater improvements in gluten free diet adherence, psychological symptoms, and quality of life from baseline to immediate post-intervention.
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Red light (670nm) treatment to prevent retinopathy of prematurity (ROP)
Expand descriptionRetinopathy of prematurity is a common complication of very premature delivery (less than 30 weeks gestation) and without appropriate screening and treatment can lead to retinal detachment and blindness. It is the leading cause of blindness in children. While in the uterus the fetus and the retina is developing in an environment where the partial pressure of oxygen is only 25-35 mmHg. Following premature delivery the retina is then exposed to partial pressures of oxygen of 60 mmHg and above. ROP has been shown to occur as a result of this hyperoxic exposure, and despite tight control on oxygen saturations which has led to a significant reduction in the disease, ROP still occurs in some part due to the fact that the retina is not meant to develop in this hyperoxic environment. Exacerbating this situation is that many of the neonates at most risk of ROP have significant lung disease of prematurity and as a consequence have recurrent episodes of hyper and hypoxia which occur despite attempts at tight control of oxygen delivery. 670nm red light is thought to act on the cytochrome c oxidative pathway (within cells of the body), which reduces the presence and production of oxygen free radicals. 670nm red light has been shown to reduce ROP in a mice and rat animal model. It has been used safely in the treatment of soft tissue injuries and mouth ulcers following radiation treatment and studies are ongoing with its use in diabetic retinopathy and age-related macular degeneration. This study aims to look at whether 670nm red light reduces the incidence of any stage of ROP and the incidence of ROP requiring laser surgery.
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Exercises targeted at the hip to improve non-specific low back pain
Expand descriptionThe primary aim of this current study was to assess which type of exercise targeted at the hip is effective in people with low back pain. Due to the relationship of reduced hip rotation range of movement and low back pain, patients were included in the study if they displayed reduced hip rotation range of movement. Hip rotation exercises were compared to additional hip stretching and hip strengthening exercises to determine which group would improve in pain and function. A secondary aim of this study was also to investigate whether an increase in hip rotation range of movement positively correlated to an improvement in low back pain outcomes.
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Mifipristone and misoprostol compared to misoprostol alone in the treatment of first trimester miscarriage. A randomised control trial.
Expand descriptionWe are doing this study to determine the most effective medication for treating women who have a miscarriage during the first three months of their pregnancy. Our clinic offers different treatment options for managing miscarriage. The first involves a single medication (Misoprostol) and the second, two separate medications (Misoprostol and Mifepristone). At present there is no evidence to show that one works better than the other. Currently, the treatment you are given depends on the women’s choice and which one the treating doctor feels will be best for the patient. Currently, it is not clear if one treatment is better than the other . We hope that this study will if adding mifepristone to the treatment improves its effectiveness so that we can better manage miscarriage.
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Everolimus Treatment in patients with Pancreatic Cancer
Expand descriptionThe aim of this study is to estimate the treatment effect of Everolimus in patients with pancreatic neuroendocrine tumours (PNET). Who is it for? You may be eligible to join this study if you are aged over 18 years and have newly diagnosed locally advanced or metastatic confirmed pancreatic neuroendocrine tumour (NET) of intermediate grade. Trial details All participants will receive treatment with Everolimus. This is a drug that can block activity of a protein called mTOR, and can slow the growth of different tumours including pancreatic NETs in the laboratory. Large studies in patients with pancreatic NET have shown that Everolimus treatment decreased the rate of tumour growth and increased patient survival. Two tablets of 5 mg Everolimus will be given daily for 6 months. Participants will be assessed regularly throughout the treatment period, and every 3 months after treatment has stopped in order to determine treatment effect. CT and PET scans will be used to measure tumour response and questionnaires will also be supplied to patients to assess symptomatic response to treatment.
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The effect of protein/fibre drinks on glucose control in people with type 2 diabetes
Expand descriptionThis study aims to test the ability of a high protein / high soluble fibre drink to reduce the rise in blood glucose levels in people with type 2 diabetes following a high carbohydrate meal when taken 15 minutes before that meal, and subsequently show that daily supplementation of the drink can reduce blood glucose levels in the long term (3 - 6 months).
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An open-label, phase 2, single centre, randomised, crossover study of two doses of Androfeme in healthy postmenopausal women
Expand descriptionIn healthy reproductive-aged women, circulating testosterone is produced by the ovaries and adrenal glands. The main cause of lowered testosterone levels in women is the natural decline with age, hypopituitarism, adrenal insufficiency, premature ovarian failure, bilateral oophorectomy, oral glucocorticosteroid therapy, and oral oestrogen therapy. Biological data support important physiological effects of testosterone in women. Studies have shown testosterone therapy in women who have low testosterone levels and a reduced libido improves sexual desire and general well-being. Testosterone replacement therapy has been used for many years utilising different routes such as injection, cream, gel and implant. Transdermal administration of testosterone has the advantages of avoiding the potential hepatic toxicity of oral androgens, is easily discontinued, and allows more physiological control of testosterone levels than subcutaneous implants. However, transdermal administration of testosterone in the form of a cream has the potential advantages of greater flexibility of dose adjustment and the absence of discomfort and irritation which may occur with other transdermal therapy such as a patch. Androfeme cream is currently the only available testosterone product in Australia with widespread use in clinical practice. No study has investigated the pharmacokinetics of the current dispensing method for Androfeme. Androfeme is supplied with a dose applicator calibrated in 0.5ml graduations. Each 0.5ml delivers a 5mg dose of testosterone. The patient should be directed to measure the appropriate dose using the graduated applicator and then apply to the skin. Presently patients are asked to commence with a 0.5ml dose (5mg) but we have no idea whether this dose is sufficient or whether a 1.0ml dose (10mg) is needed to achieve the desired blood levels for a therapeutic effect. This study will, for the first time, compare the pharmacokinetics of two doses of Androfeme in postmenopausal women: 0.5ml (5mg) and 1.0ml (10mg).
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Intravenous iRon or placebO for aNaeMiA in iNtensive care: The Ironman Randomised Controlled Trial
Expand descriptionBackground Between 17 and 45% of patients admitted to an Intensive Care Unit (ICU) are reported to receive a red blood cell (RBC) transfusion and these transfusions comprise almost 20% of all RBC use in Australia. Although RBC transfusion may be life-saving in patients with major haemorrhage, the majority of patients transfused in the ICU receive RBCs for other indications including minor haemorrhage, anaemia and augmentation of cardiac output. Observational studies in critical illness identify RBC transfusion as an independent and dose-dependent risk factor for mortality and serious morbidity including transfusion-related lung injury, transfusion-associated circulatory overload, transfusion-related immunomodulation and infection. In addition to the associated risks, transfusion is also costly. The product cost of transfusing a single RBC unit in Western Australia (WA) is $370 and the total cost is $875 and increasing. There is evidence that current ICU clinical practice complies with the National Health and Medical Research Council (NHMRC) Guidelines on restrictive RBC transfusion thresholds. As such, there is little scope to reduce transfusion through better compliance with existing evidence. Novel interventions to reduce transfusion requirement in critically ill patients are therefore required urgently. Intravenous (IV) iron has been shown to be effective for the management of iron-restricted erythropoiesis, reducing RBC transfusion, in multiple well conducted RCTs in a number of patient groups. If IV iron reduces transfusion requirement in patients admitted to the ICU it will represent a promising candidate intervention to also reduce mortality and serious morbidity. However, its clinical and cost-effectiveness in patients who are critically ill in the ICU is uncertain. Aim The primary aim of the study is to determine if the administration of IV iron compared with placebo to patients admitted to an ICU and who are anaemic reduces RBC transfusion prior to hospital discharge. The secondary aim is to determine if a phase III RCT of IV iron is warranted with such a trial having the aim of determining whether IV iron, compared to placebo, results in improved patient-centred outcomes. Objectives To determine whether the administration of IV iron in patients who are admitted to an ICU and are anaemic will: 1. Reduce the mean number of transfused RBC units 2. Improve clinical outcomes including mortality at hospital discharge and duration of admission to hospital and ICU 3. Be cost-effective Methods The proposed study will be a blinded, parallel group, phase II randomised trial comparing IV iron with placebo in patients admitted to the ICU and who are anaemic. Participants will be eligible if they are within 48 hours of admission to the ICU, have had one or more measurements of Hb <100g/L within the preceding 24 hours, are expected to require ICU care beyond the next calendar day, and fulfil none of the exclusion criteria. Participants will be randomised in a 1:1 ratio to the intervention or placebo group. Participants randomised to the IV iron group will receive 500mg of ferric carboxymaltose. Participants who are randomised to the control group will receive an equivalent volume of IV 0.9% saline. The intervention will be blinded to study staff and clinical staff caring for the patient. The study will be conducted in 4 metropolitan ICUs in Perth WA comprising Fremantle Hospital, Joondalup Hospital, Royal Perth Hospital, and Sir Charles Gairdner Hospital. Outcomes The primary end-point is the mean number of RBC units transfused. The study will also investigate the effect of intravenous iron on mortality and major morbidity as well as the costs and cost-effectiveness of IV iron.