ANZCTR search results

The primary purpose of this study is to assess the impact of a multicomponent education package (concerning non-pharmacological management of anxiety and insomnia) on GP registrars’ benzodiazepine prescribing. We hypothesize that an appropriately targeted educational package will improve adherence to evidence-based guidelines regarding prescription of benzodiazepine and non-pharmacological management of anxiety and insomnia for patients by GP registrars participating in a vocational training program.

This research is about ensuring accurate diagnosis of children and adults in Victoria with poor immune systems (or “immune deficiency”). One method for assessing the way the immune system can fight infection is to see how well people respond to immunisations. People with immune deficiencies may respond poorly to immunisation; this information can help their doctors diagnose and treat their conditions. Recently the way the testing is performed has changed, and this study seeks to confirm the new test can be relied upon to accurately diagnose immune deficiency. Pneumovax®23 is a key vaccine used to assess immune system function. It is a licenced vaccine that is given to people who are at risk of infection with the pneumococcal bacteria, and is recommended for all Australians over the age of 65 years. It is not routinely given to healthy people. The Royal Children’s Hospital does the testing for response to Pneumovax®23 for all patients from Victoria and many from across Australia. By giving the Pneumovax®23 to healthy people and testing their blood levels before and 4-6 weeks after immunisation, we will be able to tell if the new lab test is accurate.

Study Aims This study aims to assess the impact of a computerised cognitive training program on the neurotoxic effects of chemotherapy on cognition in breast cancer patients. Who is it for? You may be eligible to participate in this study if you are aged 21 years or older, have been diagnosed with Stage I-III breast cancer and are scheduled to receive chemotherapy treatment. Study details Participants will be randomly assigned (by chance) to receive either the computerised cognitive training program, or continue with standard care. Those in the computerised cognitive training group will undergo 3 x 45 minute sessions for the duration of their chemotherapy (minimum of 18 weeks) The standard care group will be provided with details of the computerised cognitive training program. All participants will undertake a series of clinical assessments, including cognitive, mood, sleep, physical activity, quality of life tests and questionnaires. Potential study outcomes It is hoped this research will inform the treatment of breast cancer patients presenting with detrimental cognitive changes as a result of chemotherapy, and this research may lead to better quality of life for patients.

Total knee arthroplasty (TKA), or total knee replacement surgery, is a successful operation in alleviating pain and improving function for the majority of people with end-stage knee osteoarthritis. However, up to 20% of patients undergoing TKA report some dissatisfaction following their surgery. Dissatisfaction after TKA is multi-factorial, but the surgical causes are commonly related to imbalance of the ligaments (soft tissues) that surround the knee at the time of surgery or slight malalignment of the upper and lower leg bones. Current thinking in the field of total knee replacement centres around optimising the balance of the ligaments as the prostheses are implanted, because it is generally agreed that this equilibrium is associated with the best outcomes for patients. Traditionally, surgeons have decided whether a knee is balanced during surgery by using their experience to manually assess the feel of the joint. Other methods used to balance the knee have involved measuring the space between the femur (thigh bone) and tibia (shin bone) based on ligament tensioning and using computer navigation to assess the stresses across the joint. Since the introduction of wireless sensor technology, surgeons have another tool to measure soft tissue balance and the ways in which the bones move against each other. Intra-operative pressure sensors use micro-electronics to calculate pressure loads in the compartment between the femur and tibia as the knee is bent and straightened out. Surgeons can use this information to appropriately align the implants for optimum balance. The intra-operative device used in this study is called the Verasense pressure monitor, and it is used by some surgeons in knee replacements operations outside this study. It is important to state that there has been no rigorous research to date that shows an association between using the Verasense device and better outcomes such as less pain, more function and overall satisfaction. The aim of this study is to investigate whether there are such benefits to using intra-operative sensors to achieve balance. Participants will be randomly assigned to either a manual balancing (MB) group or a sensor-guided balancing (SGB) group. For patients in the MB group, surgeons will use standard methods to achieve soft tissue balance. For patients in the SGB group, surgeons will use readings from the Verasense device to achieve soft tissue balance. Participants will be followed closely over the course of two years to monitor the progress in each group. The results of this trial will aim to inform future clinical practice with regard to soft-tissue balance and alignment in total knee arthroplasty

During anaesthesia and intensive care multiple physiological measurements are made such as electrocardiogram, arterial blood pressure, pulse oximetry, capnography, lung inflation flows and pressures and processed EEG. The increasing availability of sophisticated signal processing techniques and the computing power to undertake them means that novel indexes can be developed to enhance the effectiveness of the monitors and promote deeper insights into patient wellbeing.. This study will use an observational, opportunisic methodology to assemble a set of deidentified waveforms during anaesthesia and intensive care management. This library will then be available for ad-hoc testing of various signal processing strategies.

General anaesthesia is a very important component of modern surgery, and is necessary for many procedures ranging from kidney transplantation to total hip replacement. Anaesthesia requires the careful delivery of anaesthetic drugs, with constant monitoring of the patient by specialized doctors. To facilitate effective anaesthesia neuromuscular blocking agents (NMBAs) such as rocuronium are often used. These drugs relax muscle, enabling surgery to be performed without patient movement. In the vast majority of individuals these drugs are effective and safe, but in rare cases they can produce a severe life-threatening reaction. This severe allergy-like reaction can make the circulation fail, and during surgery can have potentially fatal consequences. This severe drug reaction has similar features to the allergic response termed anaphylaxis. Anaphylaxis can be seen with food allergies, for example in peanut-sensitive individuals, in whom exposure to peanuts can be life-threatening. The similarity of this response seen with neuromuscular blocking drugs suggests a shared common mechanism. In anaphylactic reactions, the body generates an allergic antibody (called IgE) that interacts with the substance to which the patient is allergic to stimulate special immune cells called mast cells and basophils. These cells then release numerous chemicals, such as histamine, that produce the severe symptoms of anaphylaxis. Whilst this IgE mechanism is important to some drug allergy, there are also cases where no specific IgE can be found to explain the reaction. Recently, a new mechanism has been revealed whereby certain drugs, such as rocuronium, can directly stimulate a receptor protein on the surface of mast cells leading to their activation. Despite this advance, key questions remain - why are only some people affected? Secondly, by understanding this new mechanism - can we identify individuals who are likely to suffer these reactions, sparing them from potentially devastating consequences? This project aims to answer these questions and in so doing provide a more individualised and safer approach to the use of muscle relaxant drugs during surgery.

The purpose of this trial is to investigate the dose-related effects of intragastric administration of the bitter agonist, quinine, a non-nutritive (calorie-free) compound, on energy intake at a subsequent ad libitum buffet style meal, plasma gut hormone concentrations, and appetite perceptions.. The relationship between outcomes and the ability to detect bitter in the oral cavity will also be investigated. We have found previously that specific dietary nutrients, when given into the small intestine in small amounts (and so not contributing significantly to overall energy intake) have the unique ability to substantially stimulate gastrointestinal functions leading to marked energy intake suppression and improvements in postprandial blood glucose. There has been a recent interest in the effects of bitter compounds, some of which also occur in the diet, including thio-urea compounds in certain vegetables or fruit, or quinine in tonic water, with reported effects on gut functions and energy intake suppression. This study aims to characterise the dose-related effects of quinine, when delivered intragastrically, in an effort to identify an optimal dose for beneficial effect on the outcomes mentioned herein. This may then guide future research to evaluate hypotheses that observed effects may be further enhanced by combining nutrients with quinine

The purpose of this trial is to investigate the dose-related effects of intragastric administration of the bitter agonist, quinine, a non-nutritive (calorie-free) compound, on gastric emptying, gut and gluco-regulatory hormone, postprandial blood glucose and appetite responses to a subsequent meal.. The relationship between outcomes and the ability to detect bitter in the oral cavity will also be investigated. We have found previously that specific dietary nutrients, when given into the small intestine in small amounts (and so not contributing significantly to overall energy intake) have the unique ability to substantially stimulate gastrointestinal functions leading to marked energy intake suppression and improvements in postprandial blood glucose. There has been a recent interest in the effects of bitter compounds, some of which also occur in the diet, including thio-urea compounds in certain vegetables or fruit, or quinine in tonic water, with reported effects on gut functions and energy intake suppression. This study aims to characterise the dose-related effects of quinine, when delivered intragastrically, in an effort to identify an optimal dose for beneficial effect on the outcomes mentioned herein. This may then guide future research to evaluate hypotheses that observed effects may be further enhanced by combining nutrients with quinine

Inflammatory bowel diseases (IBD), comprising Crohn's disease (CD) and ulcerative colitis (UC), are chronic incurable inflammatory disorders of the gastrointestinal tract that cause a global health burden. A major advance in the management was the development of biological therapies to treat IBD. This class of drugs, in the form of monoclonal antibodies, target the proinflammatory cytokine tumor necrosis factor (TNF). Several randomised controlled trials (RCT) have shown that infliximab, adalimumab, certolizumab pegol are efficacious in inducing and maintaining clinical remission in moderate-to-severe Crohn’s disease, and for ulcerative colitis, infliximab, adalimumab, and golimumab are effective in inducing and maintaining clinical remission in patients with moderate-to-severe disease activity in whom conventional therapy has failed. Despite the high effectiveness, rates of primary non-response to TNF-a inhibitors in RCTs range between 20 and 40%. Moreover, up to 40% of patients initially responding to TNF-a inhibitors develop intolerable side-effects or lose response overtime. Thus new treatment strategies are needed. The concept of leucocyte migration into inflamed intestinal tissue has been the target for the development of new biologic therapies. a4ß7-integrin is an adhesion molecule expressed on the surface of gut-specific lymphocytes; by binding to mucosal vascular addressin cell adhesion molecule-1 (MAdCAM-1) on intestinal venules it plays a critical role in the mediation of leukocyte trafficking to the gut. Vedolizumab selectively binds to the a4ß7 integrin. The efficacy and safety of vedolizumab in UC and CD has been demonstrated in three pivotal phase III RCTs (GEMINI 1, GEMINI 2 and GEMINI 3) evaluating patients with moderate-to-severe UC or CD who had previously failed at least one prior therapy (e.g. corticosteroids, immunomodulators, TNF-a inhibitors). The combination of an immunosuppressive agent (e.g. azathioprine or its metabolite, 6-mercaptopurine ) with TNF-a inhibitors has proven to be more effective than monotherapy with an immunosuppressive agent or monotherapy with the TNF-a inhibitors. The main role of concomitant immunosuppressive agents is to suppress antibody formation to biological therapies and maintain adequate circulating drug levels. Because of concerns on adverse effects (infections, skin cancers and lymphomas), safety and costs of combination therapy, clinicians always consider withdrawal of therapy once remission is achieved. A recent systematic review on de-escalation of an immunomodulator from combination therapy in IBD showed that in patients discontinued an immunomodulator after combination therapy in CD the rates of relapse did not differ from those of patients who continued taking the drug (55%–60% had disease relapse 24 months after they stopped taking the immunomodulator). The only study in patients with ulcerative colitis supported continued immunomodulator use. Although no difference in efficacy

The purpose of this study is to test the safety and tolerability of the medication ‘enoxaparin’ for the prevention of blood clots in patients receiving anti-cancer treatment. Who is it for? You may be eligible for this study if you are an adult patient with lung or gastrointestinal cancer that is planned to commence anticancer therapy as an outpatient. Study details All consenting patients will have blood tests to assess their risk of developing a blood clot. Patients identified as ‘high risk’ will be randomised to their usual cancer treatment with or without enoxaparin for clot prevention. Patients identified as ‘low risk’ will be observed and then re-assessed one month after commencement of cancer therapy, and if fulfilling requirements for ‘high risk’, will be randomised and included in the study. Participants will be followed up at 1, 3, 6 and 12 months after randomisation, and yearly thereafter until the study is closed. Study aims It is hoped that this research will demonstrate that routine clot risk assessment and personalised preventative interventions can reduce the incidence of blood clots and improve patient outcomes.