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Reducing cost and enhancing access to disease management programs after an acute coronary event
Expand descriptionACS patients discharged from RPH from 1st April 2011- 31st March 2012 will be compared to those discharged 1st April 2013- 31st March 2014 . The study will compare 2 models of cardiac rehabilitation: traditional cardiac rehabilitation vs a new alternative model implemented in April 2013. The proportion that access cardiac rehabilitation and secondary prevention programs plus cost effectiveness will be compared. Cardiac rehabilitation is defined as having an initial assessment and individualised plan within 2 weeks , education, and follow up at 3 months. Between April 2012 - March 2013 changes to referral processes and RPH cardiac rehabilitation program delivery were implemented using information sought from staff and patient surveys and focus groups. The study will compare readmssion rates and mortality of both ACS cohorts at 12 months after discharge.
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A placebo-controlled, randomized, double-blind trial of the effects of modified release 4-aminopyridine on upper limb impairment in Multiple Sclerosis
Expand descriptionThis study involves a new drug, Fampyra (modified release 4-aminopyridine) which has recently become available for the treatment of walking disability in MS. It is not yet known whether the drug could also be helpful in treating other symptoms of MS such as upper limb dysfunction or visual problems. In addition, it is not known how Fampyra works and why it seems to work better in some people than others. This study seeks to answer some of these questions by testing the effects of the drug on upper limb impairment and using a selection of clinical and electrical tests of nerve function.
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The use of ultraviolet light photochemotherapy Polarised Ultra Violet A [PUVA] in the oral cavity in conjunction with a oral photo-sensitiser [5-methoxypsolaren or 8-methoxypsoralen] for oral graft-versus- host disease [GVHD] in allogeneic bone marrow transplant patients [ABMT].
Expand descriptionPatient will recieve a controlled exposure of UVA using a Spectraline wand with a an oral photosensitiser such as 8 MOP or 5 MOP. Exposure to the UVA starts at 15 sec and increments by 15 secs once a week to a maximium exposure of 60 secs. All patients will be offered a total of 40 treatments of the combined therpay. Patients will be evaluated by their specialist at treatments 1, 10, 20 and at treatment 40 or termination/withdrawal. Early conclusion or treatment or temporary interuptions are permitted if remission is attained.
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Impact of pharmacogenomics and metabolism on the effectiveness and toxicity of racemic ketamine in palliative care and chronic pain patients
Expand descriptionThe primary purpose is to determine whether the effectiveness of ketamine and its toxicity are related to the circulating plasma concentrations of ketamine and/or its active metabolite norketamine. The study hypothesis is that there is a plasma concentration window for ketamine, below which it is ineffective to control pain and above which it produces adverse effects, and that the concentration is dependent on the patient's genotype for CYP2B6
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Tranexamic Acid in Lower Limb Arthroplasty Pilot Trial
Expand descriptionThe aim of this pilot trial is to evaluate the feasibility of conducting a large multi-centre trial which will investigate the efficacy and safety of tranexamic acid in patients undergoing lower-limb arthroplasty. Tranexamic acid has been approved for use in lower limb arthroplasty in Australia. Although there is evidence to support its efficacy in reducing bleeding, trials examining the incidence of uncommon but serious thrombotic complications in patients receiving TXA for arthroplasty procedures have been small and heterogeneous. A large randomised controlled trial is required, and this pilot study is designed to enable the refining of trial methodology and to determine the feasibility of conducting trial procedures in a smaller group.
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Eating As Treatment (EAT): A stepped wedge, randomised control trial of a health behaviour change intervention provided by dietitians to improve nutrition in head and neck cancer patients undergoing radiotherapy
Expand descriptionThis study is evaluating the effectiveness of a dietitian delivered health behaviour intervention to reduce malnutrition in head and neck cancer patients undergoing radiotherapy. Who is it for? This study is taking place within six Australian Hospitals. You may be eligible to join this study if you are aged 18 years or more, and have a confirmed diagnosis of cancer involving the nasopharynx, oropharynx, oral cavity, larynx, or hypopharynx requiring definitive or postoperative radiotherapy with curative intent. Trial details All sites will begin in the ‘control’ condition – dietitians will provide ‘treatment as usual’. Participants recruited during this phase will receive treatment as usual by trained dietitians according to standard hospital practice. At a randomly determined time point, researchers will attend the hospitals to provide training to the dietitians. Dietitians will then provide ‘EAT’ (Eating as Treatment) as part of standard dietetic consultations (weekly during treatment, fortnightly for six weeks and then ‘as needed’). You will not be aware of whether you are participating in the 'control' or 'intervention' phase. EAT is a dietitian delivered health behaviour change intervention designed to improve health behaviours of head and neck cancer patients and maintain their nutrition over the course of their radiotherapy. Of particular interest are behaviours related to sufficient daily nutritional intake, either orally or via feeding tube. Participants will be regularly assessed for up to 12 weeks post radiotherapy treatment in order to evaluate nutrition status. Information about mood, smoking and alcohol use, therapeutic alliance and radiotherapy side effects will also be collected from participants. Medical records will be reviewed to collect a range of information including total radiotherapy treatment time, unplanned hospital visits, length of stay, dietitian contact and referral to appropriate services for depression.
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The assessment of local response to topical menthol gel and capsaicin gel applied with and without microneedle pretreatment
Expand descriptionThe study is investigating the sensations that people feel when different menthol or capsaicin gel is placed on their skin over a 15-minute time frame and whether the onset of these sensations occurs more quickly when the skin is pretreated with microneedles (tiny needles that push a very short distance into the skin). We hypothesise that the microneedles will increase permeation of the applied drugs across the skin giving faster and more intense sensations.
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Feasibility Study to assess the performance of IntellaTip MiFi™ XP Temperature Ablation Catheter System for the treatment of Subjects with Sustained or Recurrent Type I Atrial Flutter
Expand descriptionThe ablation procedure uses tools called catheters to treat the atrial flutter. Ablation catheters are thin, flexible plastic tubes that use electrical energy to stop abnormal heart rhythms by heating (ablating) and destroying a small area of tissue to break the abnormal pathway. The purpose of this study is to evaluate the safety, performance and effectiveness (success) of a new ablation catheter that is used to treat atrial flutter. The new catheter is called the Intellitip MiFi XP Ablation Catheter. The catheter is made by the company Boston Scientific Corporation, who is also the sponsor of this research study.
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Randomised controlled trial of a combination of Dexamethasone and Adrenaline for infants with Bronchiolitis
Expand descriptionBronchiolitis is a common viral infection of the lungs. It is mostly seen in children less than 1 year old, but it does affect children up to 2 years of age. Each year an average of 100 children with severe bronchiolitis need to be admitted for treatment in the intensive care unit. These children experience significant breathing difficulty and many are ill enough to need a machine to help them to breathe. The standard treatment for these children is to support their breathing, and to give them adequate nutrition and fluids. There are no other medications that have been shown to benefit children with bronchiolitis. Steroids and adrenaline are two medicines that are commonly used to treat children with severe croup or asthma, and recent research suggests that they may help children with mild bronchiolitis. Steroids are an anti-inflammatory medicine, and adrenaline helps to expand inflamed narrowed airways. It is possible that using a combination of these medicines may reduce the amount of respiratory support required for those children admitted to the intensive care unit with bronchiolitis. Some doctors already use this medicine in intensive care because they believe it works, but other doctors do not use this medicine because they do not think there is enough evidence that it works in intensive care patients. The purpose of this research project is to see whether dexamethasone (a type of steroid) and adrenaline makes a difference in the treatment of children with bronchiolitis in intensive care. Adrenaline and dexamethasone are medicines that are approved for use in children by the Therapeutic Goods Administration, Australia. We will compare a group of children who receive the standard treatment for bronchiolitis with a group of children who receive the standard treatment plus steroids and adrenaline. We will compare the amount of respiratory support needed, the duration of mechanical ventilation and the length of stay in intensive care and in hospital in both groups. We aim to study a total of 305 children from The Royal Children’s Hospital, Melbourne. This research will also take place at Princess Margaret Hospital for Children in Perth and the Starship Hospital and Middlemore Hopsital in New Zealand.
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Subconjunctival dexamethasone in routine cataract surgery
Expand descriptionFor many years, some eye surgeons have given patients having cataract surgery an injection of dexamethasone (a type of cortisone or steroid) into the surface of the eye (subconjunctival) at the end of surgery. Dexamethasone is approved in Australia to treat inflammation of the eye during and following eye surgery. Some surgeons believe the injections are not needed because: 1. The steroid drops are usually enough to help the eye recover 2. The injection can occasionally hurt Others surgeons use the injection because: 1. It seems to makes patients’ eyes more comfortable for the first few days after surgery 2. It may help vision to improve faster after surgery by reducing the risk of macular oedema (swelling of the central part of the retina) This study will not determine whether a patient receives a dexamethasone injection but will look at the outcomes of surgery. From this, we hope to show how useful it is to give a subconjunctival injection of dexamethasone at the time of cataract surgery.