ANZCTR search results

This study looks at the effectiveness of the drug tamoxifen in treating breast cancer which is classified as triple negative (oestrogen receptor alpha negative, progesterone receptor negative, HER-2 negative) and oestrogen receptor beta positive, where the cancer has spread to distant sites (metastases). Who is it for? You can join this study if you are a woman with triple negative metastatic breast cancer that is oestrogen receptor beta positive and chemotherapy and/or radiotherapy is currently not considered appropriate. Prior to entering the study, a sample of metastatic tumour must be tested and confirmed to be oestrogen receptor beta positive. Trial details Some breast cancer cells contain receptors which the female hormone oestrogen binds to, causing the cancer to grow. The study aims to find out whether tamoxifen may be useful for treating metastatic breast cancer that contains the oestrogen beta receptor. Tamoxifen is an anti-oestrogen drug which is frequently used to treat breast cancers that contain the oestrogen alpha receptor but has not been used specifically to treat breast cancers that contain the oestrogen beta receptor. Participants will all receive one oral tablet (20mg) of tamoxifen daily, unless they suffer unacceptable side effects, or their breast cancer progresses.

IVD insertion is the most common invasive healthcare procedure with approximately 14 million IVDs used in Australia each year. IVDs alone are inadequate to deliver most therapy and require connection to an administration set. These IVD administration sets (AS) refer to infusion systems comprised of some or all of: tubing, fluid containers, pressure monitoring transducers, blood sampling ports, measuring burettes and extension tubing. IVDs and their AS break the natural defence barrier of the skin, and are the single most important cause of healthcare acquired blood stream infection (BSI). Most IVD's are replaced every 3 -4 days , however preliminary research suggests routine replacement of AS every 4 days costs Australia about $1 billion annually, and some studies suggest 7 day use would reduce costs with no threat to patient safety.

Significance of the study: Femoral fracture is an important clinical problem and is associated with high morbidity and mortality, especially in the elderly. Whilst opioids are the most commonly used analgesic by emergency medical services (EMS) there is some evidence that these may be inferior to alternate analgesic methods such as femoral nerve blocks. Studies to date have not evaluated the feasibility or effectiveness of paramedics performing this analgesic alternative. Alternatives like femoral nerve blocks could prevent complications of opioids although these agents are well tolerated and have a low complication rate when administered in this setting. The aim of this research is to assess the feasibility and efficacy of paramedics performing fascia iliaca compartment blocks (FICB) in the prehospital setting with adult patients with suspected or confirmed femoral fractures. The effectiveness of FICB will be compared to intravenous morphine.

This study looks at different ways of presenting information to women who are considering whether to have genetic testing around the time they are diagnosed with breast cancer. Who is it for? You can join this study if you are a woman who has recently been diagnosed with breast cancer, and you have a high risk of inherited breast cancer and you are interested in genetic testing. Trial details Participants will be randomly divided into two groups. One group will receive information about treatment-focused genetic testing (TFGT) in a face-to-face standard care consultation at a familial- cancer clinic (control), while the second group (intervention) will receive a brief educational pamphlet. Participants take part in four surveys assessing outcomes over 12 months. All participants will be offered the opportunity to have genetic testing and to discuss their results with a genetics specialist. The study aims to find the best way to deliver information about TFGT because this testing may be offered more routinely in the future and the results can influence treatment, including the type of surgery undertaken.

Hysteroscopies and cystoscopies are typically done under general anaesthesia in our hospital network. TRUS biopsies are typically done under deep sedation. While these methods are considered very safe as practised in Australia, they still carry risks (including obstruction of the airway and cessation of breathing.) Dexmedetomidine is a sedative agent that is considered stable as far as the airway and breathing is concerned. This study will assess whether these procedures can successfully be performed using a regimen based on dexmedetomidine. When having a general anaesthetic, patients require an artificial tube to be placed into the back of their throat or windpipe. When using a regimen based on dexmedetomidine, it is predicted that patients will not need that tube, and will be able to breath without it.

The main objective of the study is to determine whether the comprehensive exercise program leads to better neurological recovery than the upper body training program. Both programs are likely to lead to improvements in health and fitness

The purpose of the study is to evaluate the impact of a structured weight managment program as part of the management of atrial fibrillation. It is also intended to assess the effect of weight reduction on the efficacy of atrial fibrillation following catheter ablation and the effect of weight and risk factor management on autonomic tone/pro-arrhythmic substrate.

Lay Summary: Support of the blood circulation during heart surgery using the heart-lung bypass machine is inevitably associated with organ damage and associated reduced function. This is due to reduced blood flow (ischemia), the effects of restoration of flow (reperfusion injury) and the subsequent inflammation that is caused. The body has its own way of protecting itself against reduced blood flow and oxygen by a mechanism known as preconditioning. In essence, brief periods of mild ischemia are protective against a subsequent more severe episode of ischemia. These periods of mild ischemia can be of the organ itself or of another organ in the body. For example ischemia of the leg can protect the heart against ischemia, so called “remote preconditioning”. We have shown in animal and human models that remote preconditioning using a tourniquet (or blood pressure cuff) placed around a thigh for brief periods (similar in duration to when taking blood samples from children) reduces the amount of injury to heart muscle by 50% and also leads to improved heart and lung function. We have shown that remote preconditioning in a similar way protects the organs of a heterogeneous group of children undergoing cardiac surgery, resulting in better function of the heart and lungs and also a reduction of the inflammatory response to the heart-lung machine. This could potentially reduce the problems in looking after children after surgery and also reduce the amount of time spent in the intensive care unit. We will study paediatric patients undergoing heart surgery inorder to identify key protein and metabolic changes that occur within this 'heart-protection' protocol. All interventions will be performed during the period of routine general anaesthesia at the time of surgical repair. We will study the degree of organ injury induced by heart-lung bypass using standard intensive care parameters and equipment for measuring lung function. The degree of plasma and blood cell metabolic function will be assessed by laboratory tests. Blood samples will be taken from indwelling catheters routinely placed at the time of surgery and not require additional venepuncture. Measurements will be made prior to surgery and also at set time intervals in the first 24 hours postoperatively to determine the evolution of effects. Primary Objective: Does remote ischemic preconditioning (RIPC) modify the global plasma proteomic and mitochondrial response in patients undergoing congenital heart surgery? Hypothesis: RIPC induces significant changes to global proteomic response in plasma and the metabolic function in heart muscle and lymphocyte mitochondria of patients undergoing congenital heart surgery. Aims: To assess in blood plasma and lymphocyte/myocardial mitochondria the impact of RIPC on the global proteomic and mitochondrial metabolic function response to heart surgery with cardiopulmonary bypass support. Secondary Objectives: Does RIPC modify clinical markers of injury and cardiopulmonary function post-Cardiopulmonary bypass in patients undergoing congenital heart surgery? Hypothesis: Remote IPC reduces post-cardiopulmonary bypass release of markers of cellular injury and permits recovery of cardiac pump function with less complication including inotrope requirement in patients undergoing congenital heart surgery. Aims: To assess the impact of remote IPC on lactate release, inotrope requirement, and standard clinical cardiopulmonary assessments in response to heart surgery with cardiopulmonary bypass support. This small randomised, blinded, surgical trial of preoperative therapy with highly regulated, brief, non-invasively-induced, localised leg ischaemia and reperfusion, will test for the capacity to invoke remote ischemic preconditioning-related molecular signalling (proteomic and metabolic) changes. The study will recruit 40 paediatric tetralogy of patients to RIPC treatment or SHAM RIPC (Placebo control) treatment groups and is expected to be completed by the end of March 2012.

Observational evidence suggests that vitamin D deficiency may have a role in the causes of osteoarthritis (OA) and there are biologically plausible mechanisms to explain this. There is, however, no evidence which shows that intervening with vitamin D supplementation can slow the progression of OA. This study will compare knee OA structural changes in patients receiving vitamin D supplementation with those receiving a placebo. Use of MRI will provide sensitive measures of knee OA changes.

Visual loss following stroke impacts significantly on activities of daily living and is an independent risk factor for becoming dependent. Routinely, allied health clinicians provide training for visual field loss, mainly with eye movement based therapy. The effectiveness of the compensatory approach to rehabilitation remains inconclusive largely due to difficulty in validating functional outcome with the varied type and dosage of therapy received by an individual patient. This study aims to determine which treatment is more effective, a standardized dosage approach or individualized therapy in patients with homonymous hemianopia post stroke.