ANZCTR search results

Osteoarthritis is a common joint disorder for which there is no cure. Curcuma longa (commonly known as Turmeric) has anti-inflammatory, cartilage and bone protective properties, and can potentially be used to treat osteoarthritis patients with an inflammatory form of osteoarthritis. Previous studies of Curcuma longa have been of dubious quality and did not select patients with knee swelling, which is a clinical indication of inflammation. The aim of this clinical trial is to determine the efficacy of Curcuma longa extract for treating knee osteoarthritis symptoms and effusion-synovitis (assessment of excess joint fluid using MRI). If successful, treatment with Curcuma longa can be easily implemented as it is inexpensive, safe and available over-the-counter.

Diabetic retinopathy is one of the most debilitating complications of diabetes. Diabetic Macular Oedema (a retinopathy) may be related to a combination of inflammatory and angiogenic cytokines that exist in the blood and aqueous fluid in the eye. The main objective of the study is to assess if aqueous and plasma cytokine concentrations of angiogenic/ inflammatory cytokines correlate with the change in mean best-corrected visual acuity from baseline to 12 months

Insomnia is the most common sleep disorder. Australian surveys have shown that 13-33% of the adult population have regular difficulty getting to sleep or staying asleep. Previous studies have shown the benefit of synthetic delta-t-tetrahydrocannabinol (THC) and medical cannabis for a range of sleep disorders, however these trials were mainly targeted to investigate outcomes in other conditions such as pain and multiple sclerosis. The aim of this study is to provide preliminary evidence for orally delivered medical cannabis for the treatment of sleep disorders due to insomnia. This trial will enrol 24 participants aged (25-70) inclusive who have insomnia defined as self-reported difficulty initiating and/or maintaining sleep for 3 or more nights per week for at least 3 months. Participants will also be screened with a clinically validated questionnaire for insomnia by an Investigator team member before being recruited into the trial. Participants involvement in the trial will be for approximately 8-11 weeks (depending on their availability to take the assessments). After completing a series of health asessments and questionnaires relating to their sleep, participants will commence the trial with a 2 week period of baseline measures (without investigational product or placebo) where they will need to wear a wrist-worn device to measure their quantity and quality of their sleep, as well as complete a sleep diary. On the final night of the 2 week period (night 14) they will have an overnight sleep study at the sleep centre site using a non-invasive measuring device to measure sleep patterns and assessments with questionnaires about their sleep by the Investigator team. Following a 1 week break, participants will be randomly allocated (by chance) to receive investigational product or placebo. Each of the treatment phases of both investigational product and placebo will be for 2 week periods including a 1 week break in between the treatments. The same requirements including measurements and assessments as per the baseline will be requried for each of the 2 week periods of investigational product and placebo. This trial will provide information on the efficacy of medical cannabis for the treatment of sleep disorders due to insomnia.

This study seeks to determine the safety of applying the potent corticosteroid dexamethasone in a slow release hyaluronic acid gel formulation directly to exposed nerve branches of the facial nerve during standard parotidectomy and neck dissection surgery. Who is it for? You may be eligible to join this study if you are aged 18 years or over and are undergoing parotidectomy (malignant or benign) or neck dissection surgery. Study details Consenting patients will receive the dexamethasone in a slow release gel formulation directly to the exposed nerve during surgery, in which the surgeon will coat exposed branches of the facial nerve with the formulation once. Consenting participants will undergo their standard clinical treatment involving parotidectomy or neck dissection surgery which includes an initial consult involving facial nerve function assessments, parotidectomy or neck dissection surgery and follow-up visits assessing wound healing/infection and facial nerve function over 2 months.

This trial is a dose escalation study to determine the maximal tolerable dose of human amnion stem cell for the treatment of acute ischaemic stroke (focal brain ischaemia from blood clot obstructing the vessel lumen).

In COPD, inhaler capability may be impaired due to advanced age, comorbid illness and airway mechanics. Observational study - looks at COPD patient characteristics and how they relate to inhaler capability in acute COPD exacerbation and recovery phase. Interventional study - published pharmaceutical trials predominantly compare drug effects on lung function without accounting for differing inhaler devices or exploring outcomes reflecting chronic disease morbidity. This trial specifically compares two devices in terms of clinical outcomes.

Amongst the attributable factors, hypertension is the predominant risk leading to atrial fibrillation (AF) and premature cardiovascular events. As compare to brachial blood pressure, central blood pressure and aortic stiffness assessment even in “normotensives”, has shown improve predictability of cardiovascular outcomes including atrial fibrillation. Cardiovascular risk stratification based on central blood pressure indices can be more relevant as it demonstrates the central pulsatile load an organ is exposed to and reveals early vascular remodelling of central arterial tree resulting in aortic stiffness. Non-invasively derived central hemodynamic indices have been demonstrated to predict cardiovascular outcomes in a variety of settings. We propose a single blinded, randomised prospective trial to risk profile our AF patients according to their non-invasive assessment of peripheral or central blood pressure including aortic stiffness estimate. The impact of central or peripheral blood pressure treatment , on AF outcomes will be analysed. In addition, the relationship between central or peripheral high blood pressure and non-invasive indicators of end organ (cardiac, vascular, renal and retinal) injury will be explored.

About 25% of very preterm infants in the neonatal intensive care unit will develop a suspected infection, or late onset sepsis. Current empirical late onset sepsis treatment regimens usually include vancomycin, however this antibiotic is associated with the development of drug resistance. Antimicrobial resistance threatens the effective prevention and treatment of infections and is a serious threat to public health. Patients with infections caused by drug-resistant bacteria are at increased risk of worse clinical outcomes and consume more health resources. The aim of this study is to lead to the development of a safe and effective antibiotic regime for late onset sepsis in preterm infants using a randomised controlled trial design. Preterm infants <29 weeks with suspected late onset sepsis will be randomised to receive either a vancomycin or cephazolin containing antibiotic regimen, both of which should appropriately treat common bacterial causes of late onset sepsis. The trial results will potentially lead to reduced vancomycin use in Australasia and subsequently reduce the development of multi drug resistant organisms, and an overall reduction in health care costs.

Smoking rates are extremely high among people cycling through Australian prisons, estimated at 74% of prison entrants in 2015. Indigenous Australians and people with mental illness are markedly over-represented in prisons and experience increased smoking-related health inequalities compared to both their community counterparts and non-Indigenous prisoners. Around one in two people entering prison in Australia who smoke expresses a desire to quit smoking. As a result, correctional authorities in Australia and elsewhere are implementing smoke-free policies that prohibit tobacco smoking on prison grounds for prisoners and prison staff. On 1 July 2015, a total smoking ban was introduced in all Victorian prisons. This randomised controlled trial (RCT) aims to test the effect of an intervention that promotes tobacco abstinence after release from prison among previously-smoking adults subjected to enforced abstinence in smoke-free prisons in Victoria. 200 participants will be recruited in prison (within 6 weeks of release) and will complete a baseline survey. Following baseline assessment, participants will be randomised 1:1 to intervention or usual care; randomisation will be stratified by intention to quit. Australian Community Support Organisation (ACSO) case workers will deliver a brief intervention to intervention group participants at three time points: prior to release, on the day of release and 2 weeks post-release, supplemented by a telephone calls from Quitline in the first 28 days post-release. Participants will receive a nine-day supply of nicotine spray on the day of release and again during the 2-week post-release intervention contact. ACSO staff will encourage participants to see a GP to discuss smoking cessation and access PBS-subsidised NRT patches if appropriate. The aims of this study are to evaluate the effects of a brief smoking cessation intervention on: 1. Prevention of smoking relapse, defined as the combination of (a) self-report of not smoking for any 7 consecutive days since release from prison, (b) self-reported 7-day abstinence at follow-up, and (c) biochemically verified (carbon monoxide breath test) point prevalence abstinence at follow-up, measured at 1 and 3 months following release from prison 2. Among those reporting relapse (defined as smoking for 7 or more consecutive days), recovery from relapse, defined as the combination of (a) 7-day period prevalence abstinence at follow-up, and (b) biochemical validation (carbon monoxide breath t of point prevalence abstinence at follow-up,measured at 1 and 3 months following release from prison 3. Utilisation of abstinence supports in the first three months after release from prison: Quitline, GPs, nicotine replacement therapy (NRT), measured at 1 and 3 months following release from prison

A hybrid closed-loop (HCL) system or ‘artificial pancreas’ provides automated control of basal insulin delivery, with ongoing requirements for manual boluses of insulin for meals. These systems offer the potential to reduce significant glucose excursions outside of a healthy glucose range compared with current available therapies. Some people with type 1 diabetes have difficulty recognising when they are having a hypoglycaemic episode, which is called hypoglycaemic unawareness. This often leads to fear of exercise due to the unpredictable changes in glucose levels that can occur with exercise. It is known that short intense bursts of exercise (anaerobic exercise) may initially increase glucose levels, whilst less intense exercise (aerobic exercise) tends to reduce glucose levels. This study aims to collect information on how well the HCL system controls glucose levels in people with type 1 diabetes and hypoglycaemia unawareness when they undertake anaerobic and aerobic exercise. Outcomes of interest will include time spent in healthy glucose range, and time spent in hypoglycaemic range. Insulin and counter-regulatory hormones will also be measured providing insights into changes in glucose levels with exercise in this group of people.