ANZCTR search results

Despite optimal medication, people with Parkinson's disease living in the community experience frequent and recurrent falls. These falls result in major adverse consequences both personally and economically for the person with Parkinson's disease and their families. Poor balance, reduced leg muscle strength and and freezing of gait have been found to be independent predictors for falls in people with Parkinson's disease. This randomised controlled trial aims to determine the effect of a 6 month support-group based exercise program on falls risk as well as balance, lower limb muscle strength and freezing of gait in people with Parkinson's disease who are falling or at risk of falling. Any reduction in falls rates has the potential to improve the quality of life of individuals with Parkinson's disease and their families as well as reduce the financial costs to them and the health care system.

Phase I This is a trial of adoptive immunotherapy as treatment for nasopharyngeal carcinoma, stage 2, 3 and 4. Who is it for? You can join this study if you have cancer of the nasopharynx (an area in the back of the nose toward the base of skull) (NPC), stage 2, 3 and 4. Trial details Blood cells are taken from participants who's tumour tissue is Epstein-Barr Virus (EBV) positive. T-cells are isolated from the blood and cytotoxic T-lymphocytes (CTL's) are grown in the laboratory, in the presence of an EBV latent membrane protein and used for ‘adoptive immunotherapy’ – a treatment used for cancer in which an individual's own white blood cells are coupled with a naturally produced growth factor to enhance their cancer-fighting capacity. Some 20–200 million cytotoxic T lymphocytes will be injected into the patient at 2 week intervals (minimum of three and up to six infusions). The study aims to look at the tolerability and safety of treatment, changes in blood immune results measured at intervals, and tumour response. Radiotherapy and chemotherapy are standard palliative treatments for people with advanced NPC. This trial assesses the safety and toxicity of adoptive immunotherapy in people with EBV positive tumours.

The primary purpose of the ICON 7 study is to evaluate the safety and efficacy of adding bevacizumab, a humanised monoclonal antibody against Vascular Endothelial Growth Factor (VEGF), to standard chemotherapy with carboplatin and paclitaxel for patients with ovarian cancer.

Orotracheal intubation of newborn infants requiring respiratory support is difficult and often requires multiple attempts. Oral intubation may be performed using an endotracheal tube on its own or with an introducer (stylet) to help guide the insertion. We hypothesise that intubation is more frequently successful and performed quicker using an endotracheal tube with an introducer (stylet) than without and may be the preferred method of intubating newborn infants.

This randomised trial will compare the effectiveness of two types of orthoses - a customised orthosis and a prefabricated orthosis - in management of medial exertional shin pain.

This study is intended to investigate whether starting at a fraction of the full dose of interferon beta-1a (Avonex) treatment for relapsing and remitting Multiple Sclerosis and increasing up to the full dose over a month produces fewer flu-like symptoms than starting at the full dose of the same treatment

This study is a prospective, 3-armed cluster-randomised trial to determine the effect of the use of two different kinds of face masks on the transmission of influenza and other respiratory viruses. The starting point will be patients with influenza-like illness (ILI), whose households will then become the focus of the study. Index cases with ILI will be identified using the emergency department of the Children's Hospital at Westmead and their families will be approached to give their consent. In two arms of the study, adult contacts in the household will be provided with one of two types of face mask (surgical masks or P2 masks) to be worn when in the same room as the index case. Families in the third arm of the study will receive only education about infection control. Several measures will be used to measure compliance, including observation by family members within the household, self report through the use of diary cards, and interviews with a random selection of participants. There will be two main outcomes: ILI and laboratory diagnosis of influenza or other respiratory viruses (as determined from nasopharyngeal swabs and blood samples), and impact on influenza transmission within the household.

Brief Lay Summary of the Project: This study concerns the safety and tolerability of the intravenous form of levetiracetam, when compared with standard available therapy. In the hospital setting, people at risk for seizures may not be able to take medication by mouth to prevent the seizures, and so may need to be given a medication to prevent seizures by another route, most often directly into the vein (intravenously). A given patient may respond to one seizure preventing medication, but not so readily to another, and such specific response cannot readily be predicted. Also, a particular patient may not be able to take a particular medication safely, because of side effects with that medication in the past, or because they are taking other medications which do not mix with it. It is best that ongoing regular tablet medication and any intravenous medication a patient is given to stop seizures from happening, be the same drug known to work for that person. So it would be best to have a range or choice of intravenous seizure preventing medications to cover different patients’ needs, like there is with tablets now. These intravenous medications would need to be tested against each other to see whether they are as safe as medications already being used for the same thing, also to make sure that they work as well as the other medications, and to see whether certain people would benefit more from some medications than others. Until very recently, there has been little choice in seizure preventing medication to give intravenously in Australia. The mainstays have been benzodiazepine medications (which are not generally used longterm for seizure prevention, and cause drowsiness); and phenytoin , which can be continued as a tablet. Phenytoin generally works well for preventing seizures, but may have side effects, which can be serious, and must be given carefully, at just the right dose and speed. Levetiracetam is a newer seizure prevention medication, which has been widely used in tablet form, which can now be given in another form directly into the bloodstream by injection or 'drip' into the vein. It is the only specific seizure preventing drug available for intravenous use in Australia apart from phenytoin. Given in tablet form, levetiracetam has been shown to be very good at preventing seizures, has few side effects which generally are mild, and does not seem to interact with other medications that patients might be taking. This study aims to assess whether the intravenous levetiracetam medication has less side effects than the intravenous phenytoin, while working just as well to prevent seizures. Little difference is expected in the ability of the two drugs to prevent seizures, as they are both known to be very effective. Patients in hospital who need intravenous seizure preventing medication will be given an effective medication, either phenytoin or levetiracetam, for as long as they need it. This would usually be followed by at least three months of treatment with the same medication by mouth. Side effects and seizure frequency, will be recorded at three intervals – three days after starting medication, on leaving hospital, and three months after leaving hospital. The patient's treating doctors will make all the medical decisions regarding the patient's care, even if that means a patient has to stop the study. The results will be statistically analysed to compare the results for the two medication. In this way, the project hopes to tell whether levetiracetam is as safe and effective as phenytoin, when given intravenously to these types of patients.

This study aims to evaluate the effectiveness of a video exercise program for preventing falls, functional decline, and hospital re-admission amongst older adults who walk with a walking aid and have recently been discharged from hospital.

Our study aims to understand the health, economic and social costs associated with caring for patients with advanced pulmonary disease (APD) and to determine health, economic and social impact of improving the skills of caregivers of patients with APD has on patients and their carers. Patients with APD are a large population at high risk of health resource use, unnecessary medication use and emergency admission to hospital or residential care facilities. Although previous research has identified difficulties experienced by caregivers of the elderly in general, very little research has been undertaken with carers of patients with APD. The study will compare the usual practice of educating patients with APD who commence home oxygen therapy (HOT), and their carers, against a more detailed and individually targeted education program that increases the skills of patients and carers. This study has the potential to reduce hospital/residential care readmission, reduce carer distress, improve patient outcomes, reduce adverse effects of oxygen therapy and medication use, and minimize inappropriate presentation to tertiary care emergency departments.