ANZCTR search results

Total Knee Replacements are associated with a frequent incidence of intense postoperative pain, particularly during early attempts at mobilisation. This trial will investigate the effective of adding Ketamine to a Morphine Patient Controlled Analgesia (PCA) system in order to improve analgesic efficacy, focusing on the first 48 hours. It will also measure side effects that might emerge from adding Ketamine to a Morphine PCA, the level of patient satisfaction with their PCA, and whether the addition of Ketamine leads to less PCA use.

The purpose of this study is to evaluate a newly developed information booklet for women about breast cancer screening. Who is it for? People may be eligible to join this study if they are women aged 48-50 years residing in NSW. Women will not be eligible if they have a personal or strong family history of breast cancer, or if they have undergone any mammogram in the past 2 years. Potentially eligible participants will be randomly selected from the electoral roll and contacted by researchers. Study details Women in this study will be randomly (by chance) allocated to receive one of two different versions of a booklet. The booklets aim to provide clear and useful information about the benefits and harms of breast cancer screening, in order to enable women to make an informed decision about screening. The researchers will look at how women understand and interpret the information, as well as how it affects their screening attitudes, decisions, and experiences.

The evaluation of the soft tissue level outcome of implants placed and restored in the anterior –premolar regions using a “one abutment one crown at one time concept “ compared to the traditional protocol of multiple abutments and crowns (temporary and permanent). The soft tissue parameters will be evaluated using the papilla score, pink esthetic score, plaque and bleeding on probing upto 1 year after the placement of the definitive/ permanent restoration. Research hypothesis The soft tissue formation and stabilization around single dental implants in the esthetic zone is achieved in a faster and more predictable way when the “one abutment, one crown at one time“ protocol is used.

Adopting a healthy diet is an effective way to reduce overweight and obesity and associated diseases, including some cancers. Dietary habits are primarily established and maintained in family environments, with influence potentially disseminating across generations and across diverse types of family relationships, although these processes may differ between ethnic groups. Additionally, genetic and environmental risk factors for overweight and disease cluster in families, making them an important target for dietary-focused disease prevention. The study will test the effectiveness of provision of family health history infromation as a motivator for diet and lifestyle improvement. This study will also assess how influence processes within family networks can best be harnessed to promote healthy dietary behaviour, across some of Australia’s largest ethnic groups.

Psoriasis is a chronic and lifelong autoimmune disease which affects the skin and for one in four sufferers also results in arthritis. Tumour necrosis factor (TNF) is believed to play a role in psoriasis by acting as a regulator of inflammation. Exercise, fat loss and muscle gain have been proven to reduce chronic inflammatory state in the body as well as lower TNF levels. Exercise and dietary modification may enhance the effectiveness of pharmaceutical therapies such as Humira, a TNF blocker which has been very effective for the management of psoriasis and other autoimmune diseases. Our main aim is to find out if an exercise and nutritional support program can reduce body fat, improve physical fitness and function, lower inflammatory status, and improve the cardiometabolic risk profile of patients receiving Humira for psoriasis.

Executive Summary Alemtuzumab is a highly effective treatment for multiple sclerosis which has been demonstrated by three major clinical trials. However there are significant safety concerns arising from both the nature of the treatment and the results of the clinical trials. The principal risk is the late development of other treatable autoimmune diseases, such as immune thrombocytopenia. It is likely that by monitoring treated patients with regular blood tests, including monthly platelet counts, patients who develop such autoimmune diseases can be identified and potentially treated in some cases before catastrophic clinical sequelae occur. The risk of treatment with alemtuzumab will be thereby mitigated. However current real world (off-trial) clinical systems for ensuring patients actually get monthly blood tests and that the results are checked for early deviations from the norm are not adequate. This study proposes the development of a semi-automated Clinical Decision Support System (CDSS) using international IT pathology standards that checks for the presence of results, analyses the results and determines the need for automated or human alerts as required. Another risk is that associated with the immunosuppression and the attendant increase in infections and to a lesser extent certain malignancies. Fortunately in the trials this has not been a major problem other than herpes simplex virus which required a trial amendment for prophylaxis. However the trials did not include patients with prior immunosuppressive MS treatment which will occur in the real world. This study proposes the qualitative comparison of a specific patient education module and a standardized risk assessment module extended safety screening system to the procedures used in the CAMMS protocol. The aim of this study is to develop systems that help mitigate the risk associated with use of alemtuzumab and thereby improve the relationship between benefit and risk from this medication. It is proposed that this study be commenced and the systems developed now as the study anticipates potential regulatory concerns and the systems proposed may help in addressing regulatory concerns and in mitigating post regulatory approval risks of treatment.

The aim of this study is to assess the efficacy and cost-effectiveness of an interactive web-based psychological intervention for people with cancer and elevated psychological distress. Who is it for? Participants will be identified through notifications received by the Queensland Cancer Registry (QCR), or be referred through Cancer Council's Information and Support service 131120. Participants will be aged 18 years or above, live in Queensland, have been diagnosed with malignant melanoma or colorectal cancer within the past 6 months (QCR) OR have been diagnosed with cancer (131120), are experiencing elevated psychological distress and have phone and internet access. Study details Participants in this study will be randomly (by chance) allocated to one of two groups. Participants in one group will have access to an interactive, individualised, internet based cognitive behavioural intervention. The intervention aims to provide information and support to patients, to help them adjust to a diagnosis of cancer and reduce their cancer-related distress. The intervention will include educational information and videos with self-management tools and interactive tasks tailored in response to users' needs as determined by their input. Participants in the other group will receive access to a static education website, containing information on stress management skills, problem solving approaches to cancer-related concerns, and patient education about a healthy lifestyle to promote wellness and optimise quality of life. All participants will be asked to complete a number of questionnaires at baseline, 2, 6, and 12 months, in order to assess their psychological distress and quality of life.

This project aims to improve patient care by putting evidence into practice. Secondary gains include improving ultrasound practices, establishing robust predictive values,and eventually reducing certain unnecessary xrays. This technique, once validated, will be of particular use in regional Australia. Many older persons present to the emergency department complaining of breathlessness. This can be an important forewarning of heart failure, but is present in many conditions. In most cases, several tests are carried out to identify those patients with heart failure. Despite these investigations, heart failure is initially misdiagnosed in up to one quarter of patients. The interpretation of chest xray by treating physicians is notoriously fallible. Many European hospitals use bedside lung ultrasound(LUS) to improve their recognition of heart failure, but as the European practice model is significantly different from the Australian, the practice is not common here. The method is cheap, rapid, safe, readily available and causes trivial interference to current management. Our pilot study has already tested the lung ultrasound method in parallel with conventional investigation, without allowing it to influence management. Now we aim to incorporate it within the testing paradigm, by unblinding the treating doctor. We wish to see if the augmented assessment paradigm has a superior diagnostic accuracy to the conventional assessment paradigm. We will start by teaching a cohort of emergency trainee doctors to perform the test. Older patient who present with breathlessness to the ED will be randomised to either conventional or augmented investigation paradigm, track the emergency doctor's diagnosis after lung scan and again after full workup, and then compare the accuracy of these diagnosed in each group against a reference standard of delayed expert chart audit (which includes all prior and subsequent tests and course of disease). The primary endpoint is the difference in diagnostic accuracy between the LUS augmented investigation and the conventional investigation of breathlessness in the emergency department. Secondary endpoints are the sensitivity and specificity of LUS for differentiation of breathlessness. Exploratory endpoints will be the difference in length of stay in hospital between the groups, and the proportion of cases where chest xray contributed extra informationabove that contributed by the LUS.

Spinal cord injury (SCI) results in permanent paralysis and significant disability. In addition, some spinal cord injured people experience postural hypotension, a large drop in blood pressure when assuming the upright position, associated with dizziness and fainting. For someone with SCI who is wheelchair dependent, fainting can have significant consequences such as further injury from falling out of the chair, reduced independence and limited vocational outcomes, thus poorer overall physical and psychological well-being. In SCI, interruption of nervous communications, along with the loss of muscle pump in the legs, results in the impaired ability to maintain blood pressure on getting upright. Such persons have an abnormal pattern of blood pressure, whereby the blood pressure does not drop overnight, unlike the usual pattern. In some cases, there is even a higher blood pressure during the night than during the day – opposite to the normal pattern. Higher night time blood pressure leads to increased night time urine production, leaving the body with relatively less circulating blood volume in the morning, at the time that one is about to get out of bed, further contributing to postural hypotension. This study aims to examine the effects of treatment with captopril, a blood pressure lowering medication, at night, in a person with SCI who experiences symptoms of postural hypotension; we hypothesise that lowering night time blood pressure will reduce night time urine production, therefore increase blood pressure during the day, and reduce symptoms of postural hypotension, allowing the ability to stay upright during the day to carry out activities. In this placebo controlled crossover study, participants will receive either the drug treatment or a placebo (dummy pill) for 8 weeks, and then switch to the other pill to determine if there is a difference in effects between the two. Each treatment period will be separated by two weeks where the participant is not on either pill. Before and after each treatment, assessments include: measurements of blood pressure profile over 24 hours using an automatic portable monitor, recording urine volumes for 4 days, analysis of urine and blood samples. Current treatment for such blood pressure disturbances and symptoms of low blood pressure are inadequate, and this study will help to determine whether this novel treatment is effective.

This study will provide useful data on the importance of three sensory characteristics possibly used by humans in meal planning. Knowledge in this area will then be incorporated as part of the overweight and obesity treatment, or in the prevention of weight gain. We hypothesize that visual, olfactory, and food form cues are important determinants of expected satiation and food portion size selection.