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Comparison of the safety and efficacy of a morphine-alfentanil mixture versus morphine alone for the management of severe pain in the Emergency Department
This study will compare the safety and efficacy of morphine-alfentanil mixture with morphine alone for the treatment of severe pain in the emergency department at the Lyell McEwin Hospital. Alfentanil is a short acting opiate with rapid onset, where morphine is a longer acting opiate which is slower in its onset of action. It has previously been shown, in post-surgical patients, that a mixture of alfentanil and morphine can safely reduce the time to comfort when compared with morphine alone. We hypothesize that within the emergency department, the alfentanil-morphine mixture will safely reduce the time to effective analgesia.
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Watch with Alarm for Timed-voiding in Children (WATCH) Study
Daytime urinary incontinence is very common in children and impacts on self-esteem, socialisation opportunities and quality of life, with the potential to lead to adult urinary incontinence with associated psychosocial comorbidities. The estimated annual cost for urinary incontinence in Australian children aged 5-15 is at least $116.1 million (extrapolating from 2001 adult data of $387 per person in 10% children aged 5-15). Timed voiding is an effective, non-pharmacological treatment for treating DUI in adults, but is less effective in children, possibly due to poor compliance. The use of a personal alarm watch may enhance the effectiveness of timed voiding in children. A randomised controlled trial is the best research method to definitively answer the question of whether timed voiding aided by an alarm watch is superior to timed voiding alone. If found to be successful, incorporating a personalised alarm watch to aid timed voiding will provide a simple, inexpensive but effective non-pharmacological treatment for managing daytime urinary incontinence in children. If the alarm watch does not improve timed voiding, this knowledge will reduce unnecessary financial costs for families.
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Long term follow up of patients with severe Systemic Sclerosis (SSc) and Rheumatoid Arthritis (RA) who have undergone Haematopoietic Stem Cell Transplantation (HSCT).
This trial aims to assess the safety and efficacy of Haematopoietic stem cell transplant (HSCT) for severe systemic sclerosis (SSc) and rheumatoid arthritis (RA). HSCT is reserved for patients with severe disease who have failed multiple previous therapies. Numerous lines of evidence have suggested that HSCT may have a role to play in these autoimmune conditions as a way of suppressing the inflammatory condition but also by possibly re-educating the immune system, especially, the thymus. This study aims to assess if the HSCT has been successful ( as measured by standard response criteria) and safe in these patients. Secondly it aims to assess if the thymus has a role to play in those who respond. This will be assessed by flow cytometry on stored specimens (collected with informed consent via a tissue bank consent form) with a particular emphasis on oligoclonal T cell subsets.
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Fitness in specialist schools: Increasing the opportunities for aerobic activity in young people with cerebral palsy, a pilot randomised controlled trial.
The physical impairments characterised by cerebral palsy, which make movement more difficult, put young people with cerebral palsy at risk of reduced habitual physical activity and increased sedentary time, the long term effects of which can include a greater risk of developing secondary health problems. We aim to complete a high quality phase one randomised controlled trial to establish if an innovative school-based aerobic exercise programme is both realistic and feasible in the specialist school setting, as well as being effective in increasing fitness, physical activity and participation for children and adolescents with cerebral palsy.
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Periocular Squamous Cell Carcinoma – An International Multicentre Review
To review the clinical features, management, pathology and outcomes of periocular squamous cell carcinoma (SCC). To specifically look for clinical or histologic features that may correlate with lymph node metastasis, distant metastasis and death. To assess the prevalence of high risk periocular SCC treated in tertiary referral oculoplastic centres.
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The acute effects of Yohimbine on fear conditioning and the neural processing of emotional images, and on delayed extinction learning and memory for the images.
This study aims to examine sex differences in the effects of Yohimbine on the neural processing of, and delayed memory for, emotional images. Sex differences will also be explored in the effects of Yohimbine on fear conditioning, and whether this impacts the rate of extinction learning after a delay. Participants will be randomly assigned to recieve either Yohimbine or Placebo. Participants will first undergo a fear conditioning procedure in which they will be presented with coloured circles and a particular colour will be paired with a mild electrical stimulus. Rate of conditioning (or associative fear learning) will be measured via skin conductance responses across trials. Subsequently, in an fMRI scanning machine, all participants will view a series of emotional and neutral images. Two days later, participants will return and undergo a surprise memory test for the images. Following the memory tests, participants will undergo an extinction learning procedure in which skin conductance will be recorded across trials in which the same circles will be presented without any reinforcement (electrical stimulus). The hypothesis is that Yohimbine will enhance amydgala activation during the processing of emotional images, and be associated with superior memory for the emotional images. It is predicted that Yohimbine will enhance the rate of fear conditioning, particularly in women. It is also predicted that the administration of Yohimbine will result in strong amygdala activation during the processing of emotional images as well as the deactivation of prefrontal regions of the brain in participants with higher levels of endogenous cortisol. Finally, it is believed that participants in the Yohimbine group will experience a slower rate of extinction learning after the delay (and particularly in women). All participants and research staff will be blind to the drug contition of the subject until after the study is completed.
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MITCHEx-11: An extension trial to assess long-term serum metal ions in patients recruited in the MITCH Metal Ions Study.
The aim of the study is to analyse the serum metal ions for the MITCH system throughout the steady state phase after surgery. This study extends the current MITCH Metal Ions Study from an endpoint of 2 years to a longer post-operative time point of 5 years. The results will be used as a direct comparison to other research completed for hip resurfacing components on the Australian Market. This study also forms part of the post-market surveillance activities of the Sponsor.
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A controlled trial of Acamprosate to reduce the severity of neurocognitive impairment during alcohol with
This study seeks to compare the prevalence of cognitive impairment in a population of alcohol dependent patients randomly allocated to have either Acamprosate or a Placebo during inpatient alcohol withdrawal. Acamprosate is thought to stabilise Glutamate mediated NMDA receptors and reduce hyper excitatory neurotoxicity in the neurons on which they occur. These neurons are thought to play an important part in neuroplasticity and working memory. Sensitive computerised psychological testing which has been shown to detect neurocognitive impairment in patients during medicated alcohol withdrawal will be used to compare the response in the test and placebo groups. A standard measure of ataxia will also be used to compare the two groups.
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A randomised, open-label study to evaluate the efficacy and safety of maraviroc (MVC) as a switch for either nucleoside or nucleotide analogue reverse transcriptase inhibitors (N(t)RTI) or boosted protease inhibitors (PI/r) in HIV-1 infected individuals with stable, well-controlled plasma HIV-RNA while taking their first N(t)RTI + PI/r regimen of combination antiretroviral therapy (cART): MARCH study
MARCH is an international, multicentre trial planning to enroll 560 HIV-1 infected patients who are currently on 2N(t)RTI + PI/r regimen and virologically suppressed. Participants will be randomized (1:2:2) to one of three treatment groups: to continue their current treatment regimen, maraviroc dose at 150 mg twice daily with PI/r, or maraviroc at 300 mg twice daily with 2N(t)RTI. As the participants population have HIV RNA <200 copies/mL, the phenotypic assessment of tropism cannot be used to determine tropism, instead we will employ the genotypic assessment of tropism by sequencing the V3 loop of the HIV envelope. The main aim of this study is to investigate whether switching to maraviroc, in combination with either RTI or PI/r, is as good at keeping the HIV viral load undetectable as the combination of RTI with PI/r. The other aim is to see if switching to these combinations with maraviroc will improve some of the side effects that can be seen when people take combination therapy including RTI and PI/r. The study hypothesis is that in stable, virologically suppressed (plasma HIV-RNA <200 copies/mL) patients with no history of prior virological failure, a switch to either MVC dosed at 300mg twice daily (bid) combined with the same 2N(t)RTI backbone regimen or MVC dosed at 150mg twice daily (bid) with the current PI/r (or 300mg bid at the discretion of the investigator if the PI/r is fosamprenavir/r) provides similar (non-inferior) antiretroviral efficacy compared to continuation of the current 2N(t)RTI + PI/r regimen.
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Using a biodegradable polyurethane foam in comparison with Granufoam (black, non-biodegradable foam) with Vacuum-Assisted Closure in the management of decubitus ulcers (pressure sores)
Comparison of new biodegradable foam against commercially available non-biodegradable foam under topical negative pressure dressings for safety and efficacy in transmitting the vacuum to the wound bed.