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Randomised controlled trial comparing ligation of the intersphicteric fistula tract vs advancement flap for complex anorectal fistulas requiring intial seton drainage
A new method of treating difficult anorectal fistulae was compared with the traditionally accepted approach. Management of this condition is known to have a relatively high recurrence rate. Treatment also carries a risk of faecal incontinence. Our results show after seton drainage of infection the new method ligation of the intersphicteric fistula tract (LIFT) is at least as good as traditional anorectal advancement flap method with regard to recurrences.
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A Phase I/IIa trial of HA-Irinotecan, a formulation of hyaluronic acid and irinotecan, in the treatment of extensive stage small cell lung cancer and its effect on tumour stem cells.
This study looks at whether the addition of HA-Irinotecan to standard carboplatin chemotherapy improves disease response and quality of life as well as targeting possible lung cancer stem cells in advanced small cell lung cancer. Who is it for? You can join this study if you are 18 years or older, have Histologically or cytologically confirmed small cell lung cancer, and fill all of the rest of the inclusion criteria for this study (please see the inclusion criteria field earlier in this form). Trial details Participants will be randomised to one of two treatment arms, (1) HA-Irinotecan, a formulation of hyaluronic acid and Irinotecan at 150 mg/m2 combined with carboplatin AUC 5 administered as an intravenous infusion on day one of a 21 day cycle for a maximum of 6 cycles, or (2) Irinotecan at 150 mg/m2 and carboplatin AUC 5 administered as an intrvenous infusion on day one of a 21 day cycle. Maximum of 6 cycles. The trial will aim to investigate the usefulness of these drug combinations on the treatment of extensive stage small cell lung cancer, the level of their toxicity, and its effect on tumour stem cells.
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Achieving Diabetes Action and Collaborative Change - A cluster RCT in Aboriginal Health
ACCHOs have an important role to play in reducing the impact of diabetes on Indigenous people. This study aims to trial a strategy for helping ACCHOs improve screening for diabetes and diabetes care. Existing data such as rates of HbA1c testing and outcomes of these tests will be used to assess whether the strategy is successful
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A Safety and Efficacy Trial to Assess Green-Lipped Mussel extract in the treatment of Osteoarthritis of the Knee
The purpose of the study is to assess whether a high dose, stabilised green-lipped mussel extract is effective in the treatment of osteoarthritis of the knee, assessed by pain, mobility, gastrointestinal function and quality of life measures. We hypothesis that altered gut function (i.e. such as constipation, diarrhoea, reflux, bloating) may affect how successful green-lipped mussel is in improving the knee pain and mobility. Gut function may be altered due to the underlying condition of osteoarthritis, medication intake or altered gut flora.
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Vitamin D status in heart surgery patients and effects on clinical outcomes
Vitamin D deficiency and insufficiency has been detected in the general community and is likely to be present in cardiac intensive care unit patients. This may impact recovery from surgery and rehospitalisation risk. The primary aim of this study is to identify the prevalence of vitamin D deficiency and insufficiency in cardiac ICU patients presenting to the Alfred Hospital. Secondary aims are to identify whether vitamin D deficiency or insufficiency is associated with longer ICU stay, longer ventilation time and/or APACHE 3 scores showing deterioration. And also to ascertain whether supplementation with 4000IU of vitamin D daily restores serum levels to within normal range.
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A randomised trial of ibuprofen in addition to usual care for cellulitis of the lower limb.
Cellulitis is a common, painful and disabling condition where bacterial infection spreads under the skin to cause a red, hot swollen leg. The current standard treatment of cellulitis is antibiotics to kill the responsible bacteria. This treatment is usually successful, however, most people require antibtiotic treatment, rest and time off work for 10-14 days. A single unblinded small RCT of ibuprofen as adjunctive therapy has previously shown that patients receiving ibuprofen had substantially more rapid regression of cellulitis than those receiving antibiotics alone, with no increase in adverse effects. We plan to conduct a pilot double-blinded randomised controlled trial of adjunctive ibuprofen versus placebo in patients with uncomplicated lower limb cellulitis to determine if this strategy leads to more rapid resolution of inflammation than standard therapy alone.
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Does Riluzole reduce the incidence of chemotherapy-induced nerve injury in patients with colorectal cancer?
This study aims to determine whether a drug called Riluzole can prevent chemotherapy-induced nerve injury in patients with colorectal cancer. Who is it for? You can join this study if you are aged 18-80 years and are scheduled to undergo chemotherapy with the drug, oxaliplatin, for the treatment of colorectal cancer. Trial details In this study, participants are randomly (by chance) divided into two groups. One group will take the study drug, Riluzole, at a dose of 50 mg oral tablet twice daily for the duration of chemotherapy treatment (4-6 months), and for 2 weeks following treatment cessation. The other group will receive a placebo (sham) treatment consisting of lactose tablets. During the trial, participants will not know whether they are receiving the active drug or placebo. Participants will be assessed at regular intervals over 2 years to assess their nerve function, quality of life, and cancer-related outcomes.
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Treatment of recently acquired hepatitis C infection study
ATAHC II is a prospective longitudinal study of natural history and treatment outcomes following response-guided treatment of recent HCV infection. The main aim of the study is to identify the optimal therapeutic strategy for patients with recently acquired HCV infection. Eligible subjects will be offered HCV treatment with pegylated interferon alfa-2a with or without ribavirin, depending on their HIV status and their duration of infection. The duration of treatment will be guided by the subject’s virological response to treatment and will range from 8 weeks to 48 weeks. Subjects who are not eligible for HCV treatment or chose not to receive HCV treatment will be followed at regular intervals for 2 years
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The OASIS study: Observational Australian Study Investigating the epidemiology, outcomes and management of non-traumatic Subarachnoid haemorrhage.
Subarachnoid haemorrhage (SAH) accounts for 5% of all strokes, yet 30% of people affected with SAH will die within 90 days and survivors are often disabled. Unlike ischaemic stroke, there is a relatively higher risk of SAH in younger age groups, yet risk factors are ill-defined. Therefore, determining health service variables impacting on outcomes will inform policy and practice. It is now feasible to examine SAH care and its outcomes on a large scale at a relatively modest cost. We will analyse linked routinely collected morbidity and mortality data to explore outcomes and patterns of care in SAH on a large scale. The study will describe discharge destinations and readmissions and be able to quantify the effect of hospital services according to different models of care, resources and settings (eg principal and non-principal referral, neurosurgical vs non-neurosurgical) and neurovascular interventions. Such a large-scale analysis of services and care patterns will be of international significance informing bed-side care and health service planning to improve individual, health service and societal outcomes. We hypothesise that the risk of 30-day, 90-day and 12 month all-cause mortality will be correlated with health service delivery for patients with SAH. Specifically, patients with SAH admitted to a hospital offering a neurosurgical unit will have a reduced risk of all-cause and disease-specific mortality and spend less time in hospital in the year after a SAH. There will be significant variation in all-cause and disease-specific mortality and hospital re-admission according to: hospital type (eg principal referral versus other, rural versus urban location), caseload, and patient and disease characteristics. We will identify emergency presentations and hospital separations for SAH in New South Wales from July 2000 until June 2010. Data from these sources will be linked to the NSW Registry of Birth, Deaths and Marriages (fact of death) and ABS Causes of Death data.
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Blood pressure and salt intake: Translating the benefits of salt reduction into practice
A high salt intake is a neglected risk factor for heart disease and stroke. Recently attention has been drawn to the potential reduction in death and disease a decrease of 3g salt/day can bring. The aim of this study is to translate knowledge into practice by substantiating dietetic practice in salt reduction in individuals with hypertension at increased risk of cardiovascular disease. Cardiovascular disease is a significant burdens for individuals and for the Australian health care system potentially leading to early death or disability. Keeping blood pressure well controlled has a key role in the prevention of cardiovascular disease. Salt reduction can greatly assist blood pressure control but there are no studies evaluating the most effective education strategies to help people with hypertension implement and maintain salt reduction. This study will help fill this gap. The expected outcomes are that a lower salt intake of 6g/day is sustainable and will reduce blood pressure by 3-5mmHg SBP/day.