ANZCTR search results

Aim: This project will assess the safety, effectiveness and patient acceptability of administering the medication, flumazenil, to treat benzodiazepine dependence by means of subcutaneous (under the skin) infusion rather than by intravenous infusion. Background: Benzodiazepines are a group of sedative drugs which are commonly prescribed for anxiety and insomnia. Examples include “valium”, “serepax”, and “mogadon”. Dependence on this group of drugs can occur rapidly with regular use, and successful withdrawal and treatment is very difficult. Long-term dependence on benzodiazepines, either prescribed or obtained illicitly through diversion, is therefore recognized as a major public health issue. Current treatment for benzodiazepine dependence usually involves a slow reduction in the benzodiazepine dose over weeks, but is frequently unsuccessful because of the withdrawal symptoms of anxiety and agitation that occur, and so patients remain on benzodiazepines long-term. Flumazenil is a medication that has recently been successfully used to treat benzodiazepine dependence by giving it as an intravenous infusion over several days. Unfortunately, using this method of intravenous infusion is complex and resource intensive, and this limits the availability of this form of treatment for many patients. This project is a pilot study to determine whether giving flumazenil by the simpler subcutaneous route would be an effective alternative that could make treatment available to many more patients.

People with brain metastases from melanoma are offered different treatment options after local treatment of their brain metastases via surgery or stereotactic irradiation. Depending on the treating institution and the clinician involved a patient may or may not be offered whole brain radiotherapy (WBRT) after their brain metastases are excised or treated with stereotactic irradiation. This trial seeks to determine if WBRT reduces the spread of brain metastases and lengthens the time to recurrence. The trial also examines the effect of WBRT on quality of life and brain functions such as memory, speech and concentration. Participants will be randomised after local treatment of their brain metastases to either WBRT or observation. 200 people will be recruited from sites in Australia, Norway, the UK, the US and other international sites.

Exercise is used to make a diagnosis of exercise induced bronchoconstriction (narrowing of the airways) in children and adults with a history of breathlessness during or after exertion. We are aiming to find out how much change in exhaled nitric oxide occurs after exercise and whether the amount of exhaled nitric oxide is related to exercise induced cough.

People with melanoma that has spread from the skin to the lymph nodes or internal organs respond differently to chemotherapy drugs. But it often takes several months of chemotherapy to determine if a particular drug is working. The aim of this study is to see whether doing tests on a tumour that has been removed from the body after 1 cycle of chemotherapy can help predict if an individual will benefit from that chemotherapy.

In any year, there are approximately 48,000 stroke events amongst Australians. Most patients will experience severe cardiovascular de-conditioning after a stroke and around 21% will experience a decline in mobility which leads to a disruption in usual functioning and may affect social reintegration. For this reason, improving physical fitness may both counteract the deficits frequently resulting from a stroke and play a role in the secondary prevention of cardiovascular disease. While recent Australian clinical guidelines for rehabilitation after stroke have recommended that programmes should include interventions to improve cardiovascular fitness, they provide no information on the components of the most effective programme. Water-based exercise is possible for patients who are non-ambulatory or have balance issues and previous studies have demonstrated high levels of adherence to water-based programmes. The study will compare higher intensity water-based exercise with gym-based exercise of similar intensity for patients within three years of their first stroke. Given the susceptibility of this patient group to functional deterioration, this trial will inform the current debate on the optimal features of programmes designed to improve function and physical fitness following stroke. The current lack of scientifically rigorous research in this area ensures that its results would have immediate application to the content of rehabilitation programmes overall. It is anticipated that the water environment will allow patients to exercise at a higher level than would have been possible on land, translating into greater improvements to function.

The study is a prospective investigation analyzing the outcomes of patients with unicompartmental osteoarthritis undergoing osteotomy (HTO). We will compare the outcomes of patients undergoing HTO alone, to those undergoing the combined procedure of HTO and MACI resurfacing of the arthritic femoral and tibial surfaces of the involved compartment. It has been shown previously that some articular surface regeneration can occur with HTO alone, although the amount and quality of this regenerate is not well defined. The next stage in evolution of regeneration would seem to be to directly promote this by chondrocyte transplantation. Techniques such as MACI have successfully improved patient outcomes in the treatment of isolated chondral defects. The next step would be to show these improvements are possible in patients with more advanced osteoarthritis. Before advocating this however, it is important to show objective advantages of this technique over HTO alone. The outcomes will be assessed radiologically and clinically, and if the combined procedure is shown to have superior results, this would provide greater evidence for increased application of this technology. In addition, this would demonstrate a clear advantage of the MACI technique over periosteal patch techniques due to the difficulty of application of periosteal patches to diffuse arthritic defects.

Sexuality and fertility concerns confront men and women post allogeneic haematolpoietic stem cell transplant (HSCT). Surviving a transplant is much more likely today due to better supportive care and better medications. Improving the lives of people who have had transplants is increasingly the main focus of ongoing care. Many of the problems that occur after a transplant are related to graft versus host disease (GVHD). GVHD can affect the vagina and is an important post transplant adverse event. This study uses a questionnaire to formally evaluate how a structured gynaecology service for women who have had a transplant assists in the prevention and early treatment of this complication. It will also assess the information needs of women in order that better resources might be made available to women in this area of currently unmet need.

Traumatic brain injury (TBI) results in disabling impairments of attention and speed of information processing, which prevent patients from returning to previous life roles. Methylphenidate primarily acts upon dopaminergic and noradrenergic neurotransmitter systems which mediate attentional processes, and are disrupted by TBI. Previous treatment study findings with methylphenidate have been mixed, and many have recruited patients many years post-injury. This study aims to investigate the efficacy of methylphenidate in the amelioration of attention deficits during the acute rehabilitation phase. Forty participants with TBI and 40 healthy controls were seen for a one-off two hour baseline assessment session in order to identify the nature of attentional impairment following TBI. The TBI group were then recruited into the randomised, crossover, placebo controlled drug trial of two weeks duration.

This study looks at the effectiveness of the pain-killing drug ketamine in people with widespread cancer who are receiving palliative care and have difficult cancer pain that does not respond well to opioid drugs. Who is it for? You can join this study if you have widespread cancer and are receiving palliative care, and have difficult cancer pain that does not respond well to opioid (morphine-like) drugs. Trial details Participants will be divided into two groups. One group will receive five days of treatment with increasing doses of ketamine given under the skin (sub-cutaneously), and the other will receive a non-active compound (placebo) also given under the skin. Blood samples will be collected. The study will assess pain control, quality of life, side effects from ketamine, and reduction in the need for usual pain medicines. The study nurses and the doctors and nurses in the ward will monitor all participants closely for any unexpected problems and to ensure that pain is managed appropriately. Ketamine may be helpful for pain related to cancer, especially pain resulting from nerve damage. However studies to date are incomplete and evidence is needed to support continued clinical use. It is hoped that after this study, if ketamine is proven safe and effective in difficult cancer pain, it will become more easily available for Australian cancer patients.

The aim of this study is to develop and test a rigorous acupuncture study design that will determine if acupuncture has a significant therapeutic effect in the treatment of depression. This will increase the understanding of how acupuncture can be effectively used as an adjunct therapy to treat depression and may lead to reduced drug dependency and side effects for patients. Subjects will need to be medically diagnosed as having major depression and be taking serotonin uptake inhibitors (prescribed medication). They will also be screened for the Traditional Chinese Medicine (TCM) diagnostic pattern of liver qi stagnation. Subjects will be treated with acupuncture and the outcomes of the treatment assessed using standard questionnaire/assessment tools.