ANZCTR search results

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.

Phase 3 This is a trial of the drug E7389 (eribulin) versus oral capecitabine in advanced breast cancer which has been treated with an anthracycline drug and a taxane drug. Who is it for? You can join this study if you are a woman with breast cancer which is locally advanced or has spread to secondary distant sites (metastases), and this has been treated previously with an anthracycline drug and a taxane drug. Trial details Capecitabine given orally twice daily for 14 days followed by a week's rest is widely-used treatment for people with breast cancer with progressive disease after anthracycline and taxane treatments. E7389 (eribulin) is a new drug derived from a marine sponge which stops cancer cells growing in the laboratory and has slowed cancer growth in some cancer people. Participants will be randomly divided into two groups. One group receives oral capecitabine (standard treatment). The other receives E7389 (eribulin) given intravenously on Days 1 and 8 every 21 days. The study aims to look at the effectiveness of the new treatment compared with capecitabine, and measures patient survival, whether the tumour responds and for how long.

Over 22,000 pregnant women in Australia each year (7.7% of pregnancies) develop Borderline Gestational Diabetes Mellitus (GDM). The primary aim of the IDEAL Study is to assess whether dietary and lifestyle advice and treatment given to pregnant women who have borderline gestational diabetes on screening for gestational diabetes (defined as a positive oral glucose challenge screening test (OGCT) followed by a normal oral glucose tolerance test (OGTT)), reduces neonatal complications and maternal risks. The primary hypothesis of the study is that dietary and lifestyle advice and treatment given to women who have borderline gestational diabetes on screening for gestational diabetes will reduce the incidence of large for gestational age infants defined as birthweight above the 90th centile for gestation and fetal sex on standardised birthweight charts. If treatment of these women is effective this would reduce the burden of disease for women and their babies, with implications for improved health through childhood, adolescence and adulthood.

This is a study of a cancer vaccine known as Stimuvax for treating non-small cell lung cancer (NSCLC) at stage 3, where this cannot be operated on surgically. Who is it for? You may be suitable for this study if: • You have stage 3 non-small cell lung cancer that cannot be operated on. • You have received primary platinum chemoradiotherapy. • The cancer is stable or responsive. Trial details Participants will be randomly divided into two groups. Four weeks after the last chemoradiation treatment, one group receives one infusion of cyclophosphamide followed by weekly subcutaneous vaccination with Stimuvax for 8 weeks and then injections are given once every six weeks until any progression of the cancer. The other group will receive a non-active compound. The study aims to monitor survival time and time to any progression of symptoms. Currently there is no standard prescribed treatment for these people following chemoradiotherapy. Stimuvax is designed to stimulate the immune system to respond to a protein found in many cancers including NSCLC. This trial will determine if Stimuvax has beneficial effects after participants cease chemoradiation.

Hepatocellualr carcinoma (HCC) is a highly lethal disease with few effective treatment options. It has been established that clofazimine can control the growth of HCC cell lines in vitro and in pre clinical animal models. This study aims to treat patients with unresectable primary HCC with escalating doses of clofazimine delivered in Lipiodol and administered via the hepatic artery under computerised tomography (CT) guidance. The maximum tolerated dose will be established using cohorts of one to six patients. Safety and tolerability will also be assessed in eligible patients. Each cycle of treatment will be 28 days in length and patients may receive up to 4 additional treatments if the study treatment is well tolerated. This study commenced recruitment in January 2003 and is currently recruiting patients into the final dose level cohort.

The purpose of this study is to assess the virologic activity, safety, tolerability and pharmacodynmaic profile of SCH 532706 when codminstered with a dose of Ritonavir that could be observed during the treatment of patients with HIV.

Despite the importance of preventing overweight and obesity in children, few primary prevention interventions have been shown to be effective. We propose a randomised controlled trial (RCT) of an original community-based home visiting intervention designed to improve family and behavioural risk factors for childhood overweight and obesity for first-time mothers in the most socially and economically disadvantaged areas of Sydney. It addresses the key research question: Will an intensive home-based early intervention over the first two years of life increase healthy feeding and physical activity, enhance parent-child interaction and lead to reduced levels of overweight and obesity among children aged 3 years?

The purpose of the study is to evaluate a general-practice based referral strategy to improve access to community-based health organisations among people with chronic illness. It is hypothesised that greater access to these organisations is associated with a range of benefits in terms of chronic illness self-management and health related quality of life.