ANZCTR search results

Anxiety is the most common psychological problem reported by children and adolescents. Among young people with a physical and/or intellectual disability, prevalence rates for clinically significant anxiety problems are significantly higher relative to the general population. With child-focused cognitive behavioural therapy (CBT) regarded as the gold-standard treatment for child anxiety, youth with disabilities often miss out on the evidence-based treatment of choice. Recent research has focused on the possibility of working through parents to address anxiety in children. The current project builds on this work with a population of families who are frequently under-served when it comes to the treatment of their children's anxiety. The purpose of the proposed project is to evaluate the efficacy and acceptability of the half-day Fear-less Triple P workshop (involving parents only) in its capacity to reduce the anxiety symptoms of children with high levels of anxiety and a physical and/or intellectual disability. A naturalistic waitlist group will be built into the study design to allow comparison of this group with the active Fear-less workshop.

This study will determine the effect of resveratrol - a plant derived polyphenol - on blood clot formation in patients undergoing liver resection for cancers Who is it for? You may be eligible to join this study if you are aged 18 years old or above and have colonic cancer secondary to the liver or cholangiocarcinoma requiring liver resection Study details Participants in this study are randomly allocated (by chance) to one of two groups. Participants in one group will receive resveratrol capsules (2 capsules with a total of resveratrol 1g/day) in the morning daily for 7 days before surgery, whilst participants in the other group will receive a placebo (2 capsules of fine sugar ~1g/day) in the morning daily for 7 days before surgery. Blood taken from participants before and after surgery will be used to analyse blood clot formation in participants. The proposed study is an essential step before a larger confirmatory phase II clinical study including important patient-centred outcomes can be initiated. A larger phase II study will provide the much needed information about the benefits and harms of using resveratrol in major cancer surgery.

Obesity is a major health concern both globally and in Australia. A key contributor to excess weight gain is unhealthy food choices, which are deeply ingrained and difficult to change due to underlying cognitive mechanisms. Two of these mechanisms are approach bias (a tendency to think about and move toward unhealthy foods) and steep delay discounting (a preference for smaller, immediate rewards over larger, delayed rewards), which can be modified using cognitive training techniques, i.e., approach-avoidance training (AAT) and episodic future thinking (EFT). This study aims to test the effects of these two cognitive training techniques (i.e., AAT and EFT) compared to a control (i.e., no-training) group, on cognition (approach bias, delay discounting), and behaviour (healthy food choices) in people with excess-weight. The primary aim is to compare each of the active interventions with a control to establish their cognitive mechanisms and determine which of them has a greater impact on food choice. It is hypothesized that compared to participants in the control condition, participants in the: 1) AAT condition will show a greater increase in approach bias for healthy food and a decrease in approach bias for unhealthy food, 2) EFT condition will show a greater decrease in delay discounting rates, and 3) AAT and EFT condition will choose a greater proportion of healthy foods.

The aim of this project is to investigate the effects of CDX-301 on the safety, clinical activity, and immune priming of glembatumumab vedotin combined with pembrolizumab or nivolumab in adult patients with locally advanced or metastatic melanoma. Who is it for? You may be eligible to join this study if you are aged 18 years or over and have unresectable, histologically confirmed Stage 3 or 4 melanoma not responding to pembrolizumab or nivolumab treatment. Study details: All participants will receive CDX-301 and glembatumumab vedotin in combination with either pembrolizumab or nivolumab. CDX-301 is administered by subcutaneous injection, whereas glembatumumab vedotin, pembrolizumab and nivolumab are administered intravenously, i.e. directly into the vein. CDX-301 will be given on Days -6 to -2 of a 3-weekly study cycle, for a total of two cycles. Glembatumumab Vedotin will be given on day 1 of each 3-weekly study cycle. In addition patients will receive either Pembrolizumab on day 1 of each cycle every 3 weeks OR Nivolumab every 2 weeks. Participants continue with Glembatumumab Vedotin, Pembrolizumab or Nivolumab, unless there is protocol-defined progression of disease or intolerance of one or more of these drugs We will collect blood samples from your vein before you receive the study treatments and between each of the study treatments. These blood samples will be analysed in the laboratory for the presence and character of specialised white blood cells, which may have been mobilised into the blood by the CDX-301 and glembatumumab vedotin treatment. A sample of your original melanoma biopsy tissue may be compared with additional (optional) melanoma tissue biopsies taken during the course of the study. These melanoma samples will be examined in the laboratory for evidence of any new immune reaction that may be caused by the action of CDX-301 and glembatumumab vedotin. This study will help in determining whether CDX-301 is safe to administer in combination with glembatumumab vedotin and with either pembrolizumab or nivolumab. .

The primary purpose of the study is to examine the effect of resistance exercise training and its associated adaptations on the human GI microbe profile. It is hypothesised that 12 weeks of resistance exercise training will significantly alter the composition and diversity of the gut microbiota when compared to a non-exercise control group. This research may enable for the development of exercise guidelines focused on gut microbiota health and play an integral role in furthering exercise physiology practice.

Chronic post-surgical pain (CPSP) is among the most common and debilitating complications of major surgery, with enormous long term costs to the economy and patients’ quality of life. Primary prevention is now seen as the “Holy Grail” of anaesthesiology. There is a well established physiological and pharmacological basis for the proposition that the widely used, potent analgesic ketamine given perioperatively reduces the development of CPSP in patients undergoing major surgery, and this is supported by meta-analysis of data from small placebo controlled published studies. The potential benefits in reducing the healthcare cost and the quality of life burden of chronic pain in the community are substantial. A large clinical trial of perioperative ketamine analgesia is urgently needed in patients undergoing general anaesthesia for major surgery. Proof of effectiveness would transform routine anaesthetic practice worldwide with huge economic and humanitarian benefits.

Although previous studies on aggressive and disruptive behaviours in residential aged care homes (RACHs) suggests that these types of incidents are common, aggressive interactions between residents has received little attention in the research literature. These incidents between residents are referred to as resident-to-resident elder mistreatment (R-REM). RACHs house the frailest of older people, and even small injuries can have major negative consequences. Therefore, it is important to protect older residents from R-REM and nurses should play an essential role in identifying and managing R-REM to prevent serious harm. However, many nurses may not recognise these behaviours as forms of abuse. Thus, the aim of this study is to implement and evaluate an education program for nursing staff caring for older people on recognizing, reporting, managing and preventing R-REM. This is a Cluster Controlled Trial. There will be a control group and an intervention group. Firstly, participants will document, on small note pads provided, incidents of R-REM that occur during all shifts worked for a four-week period. After that, the intervention group will attend three educational sessions of approximately 45 minutes duration that will be held in the Education building at BECC. They will also complete a short questionnaire before and after each educational session and an evaluation after the last educational session. Following the educational sessions, the intervention group will again document, on small note pads provided, all incidents of R-REM for a four-week period. The educational sessions for the control group will be delivered at the end of the research project. In addition, both groups will document, at 1 and 3 months later, an evaluation of the implementation of the R-REM activities to prevent or reduce these types of incidents between older residents. This educational program will improve health and well-being of older resident living in RACHs and it will assist nursing staff in preventing and reducing R-REM by protecting vulnerable older people experiencing R-REM in RACHs.

Background: Sensorineural hearing loss is one of the most prevalent chronic conditions affecting older adults, and its occurrence is expected to increase with advancing age. Hearing aids have been proven to be a successful intervention for alleviating sensorineural hearing loss. Previous Research: A recent neuroimaging study has found that this type of hearing loss may cause parts of the brain to atrophy. Older adults suffering from brain atrophy associated with hearing loss will likely struggle to understand speech. Some of the psychosocial consequences of sensorineural hearing loss include depression and social isolation. There is also evidence that brain atrophy is correlated with the recruitment of compensatory mechanisms for auditory and language processing. Research is needed to focus on determining how this compensatory recruitment relates to cognitive decline. Study Objective: This study will use MRI techniques to determine whether hearing aids do have an effect on brain structure and cognitive function in older adults with sensorineural hearing loss. This will be established using a combination of auditory and visual stimuli to characterise participants hearing abilities. Method: Study participants will consist of older adults between 55 and 90 years with either mild or moderate symmetric sensorineural hearing loss. Consented participants will undergo hearing assessments, complete paper-based questionnaires, perform cognitive tests and undergo MRI scans at the time of recruitment (and again at 6 months). Participants will belong to one of 2 groups: first-time hearing aid users and long term hearing aid users. Study Hypotheses 1. Comparing the results of the cognition tests and the two MRI scans of the long-term and first-time hearing aid users over a 6 month period, it is expected that initially cognitive abilities will be less preserved in first-time hearing aid users than in long-term hearing aid users, but the wearing of hearing aids by first-time hearing aid users is expected to reduce this disadvantage within 6 months. 2. Also, both first-time hearing aid users and long-term hearing aid users are expected to practice lip reading in order to supplement their language processing, resulting in the use of both the auditory and visual components of the brain during the initial MRI sensory integration task. However differences are expected in terms of the plasticity within the visual and auditory cortex of long-term and first-time hearing aid users. 3. After wearing hearing aids for 6 months, it is expected that first-time hearing aid users will experience a decreased reliance on the visual networks of the brain for language processing with no change for long-term hearing aid users. Results from the study will inform strategies for aural rehabilitation, hearing aid delivery and future hearing loss intervention trials and neuroimaging studies. Results of this study will be published in a peer-reviewed journal.

Iron deficiency and anaemia are common conditions. They are treated by increasing your body’s iron levels . The most common way is by mouth as an iron tablet or liquid. Some people may need iron to be given directly into the blood through a vein, and this is called an intravenous (IV) iron infusion. An IV iron infusion is used when tablets or liquids do not work for a person or when they cause side effects such as stomach upset. In the past, iron polymaltose (a type of IV iron) was only given as an IV infusion over 4 hours. These days, it can be given faster and safely over 1 hour (for doses up to 1500 mg) thanks to the results of recent studies. Another type of IV iron, ferric carboxymaltose, is frequently used and can be given over just 15 minutes. However, it is more expensive and can only deliver a maximum dose of 1000 mg per week. Most people need around 1500 mg to completely top-up their iron and to last them for months or even up to a year. Previous studies suggest that how quickly IV iron is given has no effect on how well this treatment is tolerated. For this reason, the goal of this study is to test the safety of iron polymaltose given over 30, and then potentially over 15 minutes. Safety results will be compared to the slower infusions and to the other type of IV iron, ferric carboxymaltose. If no difference in safety is found, then this could be a better option because patients can be treated with a complete iron top-up and have it done over a shorter period of time. Infusion centres and hospitals would also benefit with reduced nursing time, larger number of patients treated and reduced direct medication costs. Iron polymaltose has been approved in Australia to treat iron deficiency anaemia since 27 May 1999. However, it is not approved for infusion rates over 15 or 30 minutes. Therefore, it is an experimental method of giving this treatment for iron deficiency anaemia. This means that it must be tested to see if it is as safe as the usual way of giving it over 1 or 4 hours.

Background: Children undergoing heart surgery require cardiopulmonary bypass. This is a technique which takes over the work of the heart and lungs so the surgeon can perform the operation. The use of cardiopulmonary bypass often causes a reaction in the child called systemic inflammatory response (or SIRS for short). Children who develop SIRS are much more likely to have complications in intensive care (cardiac arrest, need for time on a breathing machine, prolonged intensive care stay and even death). Doctors and nurses at the Royal Children’s Hospital are very interested in studying and preventing SIRS. Peritoneal dialysis is a therapy often used in children after heart surgery; it is also used in children and adults to provide artificial kidney function. It involves placing fluid in the abdomen and using the lining to remove fluids and substances. We have observed that the early use of this therapy soon after heart operation is associated with improved outcomes. Peritoneal dialysis might reduce the risk of SIRS. Proposed study: We plan to study the role of early peritoneal dialysis in preventing the complications of SIRS in babies less than six months of age. The study will be conducted in the Cardiac Intensive Care Unit at the Royal Children’s Hospital, Melbourne. We have calculated we will need 312 infants in the study and hope to find out if early peritoneal dialysis helps reduce complications of SIRS following cardiac surgery. Babies will either get early peritoneal dialysis or normal care. Early peritoneal dialysis will start within an hour of arriving in the intensive care unit after heart surgery and will continue for 24 hours. Normal care babies will only get peritoneal dialysis if they need it for artificial kidney function. Potential implications for child health: This study will help to answer the question: “Does early peritoneal dialysis really help babies after heart surgery ?”.It will help make decisions about treatments after heart surgery. This is important for doctors and nurses working in intensive care units around the world. Peritoneal dialysis is a low cost treatment and if early commencement of this therapy after surgery is shown to positively influence outcomes it will have important implications for children born with congenital heart disease.