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A study to evaluate a new treatment protocol for post operative orthopaedic constipation
The aim of the study is determine whether the administration of polyethylene glycol (Movicol) to post operative total hip and total knee replacement patients results in faster return to normal in the intervention group.
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Stent Trial for Coarctaion of the Aorta to evaluate the safety and efficacy of the Large Diameter Advanta V12 Covered Stent for treatment of native and recurrent coartation of the aorta with primary endpoint being a significant reduction in the gradient across the coarctation at 12 months
The primary objective is to evaluate the safety and efficacy of the Large Diameter Advanta V12 Covered Stent for treatment of native and recurrent aortic coarctation of the aorta in selected children and adolescents.
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Intranasal ketamine for moderate to severe pain in children- a dose finding study.
This study aims ot assess the effectiveness of ketamine as an pain reliever when administered into the nasal passages in doses that do not produce sedation or anaesthesia in a group of paediatric emergency department patients coming to hospital with moderate to severe pain. We hypothesise that ketamine will reduce pain effectively without significant sedation at the proposed dose. The data from this study will be used to calculate sample size and design a study comparing the effective dose of ketamine to other pain relivers currently administered by the nasal route to children.
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Antibiotics for bronchiectasis exacerbations in children - The Bronchiectasis Exacerbation Study (Study 1).
Our national study aims to improve the management of acute exacerbations of bronchiectasis in children, a lung condition that is common in Indigenous people worldwide, and also occurs in non-Indigenous people. This study aims to discover whether treating acute exacerbations of bronchiectasis with oral antibiotics is effective at resolving the exacerbation more quickly than not treating with antibiotics. The results of this study will impact on national and international guidelines and substantially advance knowledge on exacerbations of childhood bronchiectasis.
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Antibiotics for treatment of bronchiectasis exacerbations in children - The Bronchiectasis Exacerbation Study (Study 2).
Our national study aims to improve the management of bronchiectasis in children, a lung condition that is common in Indigenous people worldwide, and also occurs in non-Indigenous people. This study aims to discover whether treating respiratory exacerbations with one of two different oral antibiotics is more effective at resolving the exacerbation. The results of this study will impact on national and international guidelines and substantially advance knowledge on exacerbations of childhood bronchiectasis.
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Oxygen as Second-Line Therapy for Obstructive Sleep Apnoea.
We aim to develop alternative treatments in patients refusing CPAP therapy. We hypothesize that 2 months of low-flow oxygen compared with room air, each delivered via nasal cannulae will improve sleep-disordered breathing, hypoxia during sleep, symptoms and maladaptive cardiovascular response in patients with OSA refusing CPAP treatment. Secondly, we hypothesize that patients with higher loop gain will derive a greater benefit (reduction in apnoea-hypopnoea index) from oxygen therapy.
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Lymphoedema Prevention Following Inguinal or Ilioinguinal Dissection for Metastatic Melanoma
This study aims to determine whether compression garments and self massage can prevent or reduce lymphoedema (fluid retention) following groin dissection for metaststic melanoma. Who is it for? You may be eligible to join this study if you are a male or female aged 18 years and over with confirmed metastatic melanoma. You should be able to attend regular follow-up appointments over a period of 2 years. Trial details. Participants in this trial will be randomly (by chance) allocated to one of two groups. Participants in one group will wear compression stockings 12 hours a day for 6 months and conduct daily self massage for a period of 6 months following post operative removal of drains. Participants in this group will receive 1:1 training in self massage over 3 half hour sessions. They will also receive education and training to ensure they (or their carer) are able to safely put on and remove the compression garment. Participants in the other group will be monitored via 3 monthly assessments. If lymphoedema arises, they will be offered comprehensive treatment (as is standard treatment). All participants will be assessed every 3 months to determine the incidence/severity of lymphoedema and quality of life, and whether this differs between groups.
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A comparison of the number of Lucentis injections(eye injections) required for patients who receive a combination treatment of laser bypass (chorioretinal venous anastomosis) and Lucentis or sham laser bypass and Lucentis for the treatment of macular oedema (swelling at the back of the eye) that has occurred as a result of a central retinal vein occlusion.
Macular oedema that is secondary to central retinal vein occlusion (CRVO) has conventionally been treated with laser photocoagulation. The outcomes of this treatment show a slight improvement in visual acuity. Recently various therapeutic agents such as Triamcinolone, Pegaptanib, Bevacizumab and Ranibizumab have been injected intravitreally into the eye. Bevacizumab and Ranibizumab in particular have been shown to reduce macular oedema in the short term, however, repeated injections are required. The Central Vein Bypass Study, where a high intensity laser is used to create an anastomosis between the a retinal and a choroidal vein as a means of bypassing the obstruction to venous flow (L-CRA), is the only study to date that has addressed the causal pathology of macula oedema secondary to CRVO, rather than simply addressing the sequelae of the retinal venous obstruction. Patients who received the L-CRA had significantly improved visual acuity compared to the sham L-CRA treatment group. In this study patients will either be treated with the L-CRA or sham L-CRA. Both groups will receive monthly injections of Ranibizumab for 6 months. Patients will be assessed for a further 18 months, and may/may not receive further injections depending on whether the retreatment criteria have been met. The primary aim of the study is to show that L-CRA treated patients will require fewer Ranibizumab injections in the 12-24 month phase of the study compared to sham L-CRA treated patients. The use of Ranibizumab in the short term and the long term treatment effects of the L-CRA may prove to be an effective treatment for macular oedema that is secondary to CRVO. A recent study showed that 56% of patients had persistent macular oedema requiring an average of 5.9 injections in the 4th year. The study protocol has been amended to follow the two treatment groups bimonthly or once every four months for a further 24 months. Patients will be assessed according to the retreatment criteria for further injections. The extension study will provide long-term follow up data.
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Does standing improve bowel function in people with spinal cord injury? A randomised controlled trial.
The majority of individuals with spinal cord injury (SCI) have neurogenic bowel dysfunction. Severity of the condition is dependent upon the completeness and the level of lesion. Constipation and faecal incontinence are common problems experienced by individuals with SCI and have significant impact on their physical, social and psychological lives. People with SCI rate bowel care as one of the most disabling aspects of SCI and of more importance to them than the inability to walk. It is therefore appropriate that research attention be directed at improving bowel care. People with SCI claim that regular standing improves bowel regularity and bowel function. However, there is no high quality evidence to substantiate these claims. A recent Cochrane review noted that there is still limited research on the management of neurogenic bowel dysfunction and it is not possible to draw any recommendation from the trials included in the review. It is important to determine whether regular standing is therapeutic because it is a costly and time consuming activity. Hence the primary aim of this study is to determine the benefits of regular standing on bowel function in people with spinal cord injury or lesion. The null hypothesis is that regular standing will have no effect on bowel function in people with spinal cord injury or lesion.
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Sodium Bicarbonate for kidney protection in patients undergoing liver transplantation
Acute renal failure is a common and serious postoperative complication of orthotopic liver transplantation. The reported incidence ranges from 17% to 95% and severe renal failure requiring renal replacement therapy occurs in 5% - 35% of patients after transplantation. Renal failure requiring haemodialysis post liver transplant, irrespective of pre-transplant dialysis status, is a profound risk factor for death. Identifying the risk factors for renal dysfunction after liver transplantation and developing therapeutic approaches to prevent, halt, or ameliorate de novo renal dysfunction or retard the progression of preexisting renal dysfunction should be fundamental goals in managing these patients. Sodium bicarbonate is a drug in common use for the prevention of contrast nephropathy and has been shown to be effective in preventing acute kidney injury in patients undergoing cardiac surgery. It is used to effectively treat severe metabolic acidosis in critically ill patients. It is possible that sodium bicarbonate might reduce the oxidative stress which occurs during liver transplantation and so decrease or prevent acute kidney injury in these patients. This is an investigator initiated, pilot, double-blind, randomized controlled trial. The purpose of this study is to determine whether administration of sodium bicarbonate reduces the risk of kidney injury, and also reduces some of the cellular changes and oxidative stress known to cause kidney injury after orthotopic liver transplantation. Adult patients undergoing orthotopic liver transplanation will be randomized to receive either sodium bicarbonate or placebo for the duration surgery. Primary outcome: a rise in the serum creatinine to > 1.5 times the baseline value or decreased GFR > 25% (RIFLE class ‘R’) measured 72 hours postoperatively. Secondary outcomes: To examine changes in peak serum and urinary NGAL and peak serum cystatin C (sensitive biomarkers of acute renal injury) compared to baseline, peak changes in delta creatinine, acid– base status. Other outcomes collected will include duration of ICU stay, duration of hospital stay, all adverse events including institution of renal replacement therapy and hospital mortality. Recruiting hospitals: Austin Hospital Number of participants planned: 60