ANZCTR search results

More than one third of hip fracture patients are likely to be malnourished; these patients routinely fail to meet energy and protein intake requirements after surgery. Malnutrition results in poor nutritional, patient and healthcare outcomes. International trials targeting strategies to adequately address these issues are inconsistent and data relevant to the Australian context is lacking. Baseline data on patients admitted for surgical intervention of an acute hip fracture has suggested a number of barriers to nutritional assessment, diagnosis and delivery in this population. This study will aim to define barriers to nutrition care; the treating team will then collaboratively develop and implement changes to usual clinical practice to overcome these. Before and after measurements will be used to evaluate the success of these changes to routine clinical care. A positive outcome may lead to significant improvements in nutritional, patient and healthcare outcomes.

Insomnia constitutes a significant societal burden, and is thought to affect a significant portion of the adult population, with research citing between 5-20% of the population is affected by these symptoms. In particular, issues with falling asleep seem to be the most frequent complaint. Current treatments available for insomnia include medications such as benzodiazepines and antidepressants. However, long-term use of these has significant limitations, such as addiction, daytime carry-over effects, and a re-bound insomnia effect when medication use is suspended. Additional and/or alternative treatments include Cognitive Behaviour Therapy (CBT) or relaxation, where patients are taught to remedy symptoms through learning more adaptable coping skills. Although both treatment options are efficient, they can often be hard to access due to lack of access to scarce resources, time, motivation and the overall cost. When sleep architecture is clinically assessed, people typically undergo a sleep study. Patients are assessed using a number of physiological measures that indicate the time it takes them to get to sleep, how well they are able to maintain sleep, and whether they wake up during the night. Normally, as a person falls asleep, there are noticeable changes in these physiological measures, compared to when they are awake. In particular, when a person is drowsy and about to fall to sleep, slow eye blinks (slow eye closure) feature and these are thought to indicate the start of sleep. The current study is aiming to examine the use of volitional initiation of slow eye closure to see if attempts to manipulate the speed and time at which they occur might accelerate the start of sleep, coupled with self-distraction techniques, when compared to receiving information only about self-distraction alone. This intervention will be tested in insomnia patients over a period of approximately two weeks. First, participants will need to wear a sleep-activity monitoring watch for one week. This acti-watch will assess sleep and activity levels for a period of 7 days. After the one-week period of monitoring activity-sleep is complete, the participant will need to stay in the sleep laboratory at the Austin Hospital for one night. During the stay in the sleep laboratory, participants in the ‘treatment group’ will be instructed in a method of slow eye closure, using an electronic metronome to appropriately time eye closure, and will have a session with a trained sleep specialist about the use of self-distraction strategies. To test the effectiveness of this intervention, a control group will also be used. The control condition will involve taking part in a ‘self-distraction information only’ session. After the participant has learned either the combined self-distraction and eye closure technique or self-distraction-only technique in the laboratory, they will wear the watch for another week while practicing these strategies at home. After the week of wearing the sleep-monitoring watch, the researcher will collect the watch and also have the participant fill in few questionnaires, as well as a feedback sheet about their experience of the research. This feedback will assist in future, larger-scale version of this study and help to identify how the study may be improved.

This study is evaluating the effect of using T cell immunotherapy following standard chemotherapy for the treatment of nasopharyngeal cancer (NPC). Who is it for? You may be eligible to join this study if you are aged 18 years or above and have been diagnosed with metastatic nasopharyngeal cancer and your clinician is planning to treat you with standard chemotherapy. Trial details All participants in this study will receive standard chemotherapy with gemcitabine and cisplatin according to their clinician’s standard clinical care. Following this, they will undergo the experimental immunotherapy. This involves infusing Epstein-Barr Virus (EBV) specific T-cells intravenously (i.e. directly into the vein) up to 6 times, at fortnightly intervals. Participants will be regularly assessed for up to 38 weeks in order to evaluate their response to treatment, and the safety and tolerability of treatment.

This randomised control trial (RCT) investigates whether targeting specific psychological drinking profiles in alcohol dependent patients is clinically more effective than generic psychological treatment.

This study aims to test the efficacy of the Reframe-IT program in reducing suicidal ideation, hopelessness and depression in school students. The study also aims to determine if the program leads to increased confidence and perceived skill, and / or changes in practice among school wellbeing staff who are implementing the program. The program is a personalised and interactive website which delivers 8 modules of cognitive behavioural therapy over approximately 8 weeks. The program is delivered via a series of videos depicting an adult 'host' and 4 young people who post a weekly video diary reflecting on their experiences. There are weekly activities, a message board and adjunctive therapist involvement. The program differs from existing Internet-based programs in that it: has been purpose-designed for young people; is interactive rather than text-based; and is designed to be a tool for student wellbeing staff to use specifically with suicidal students. The program has been subject to a pilot study (ACTRN12611000866909) which used a before-and-after design. Findings have shown an overall reduction in suicidal ideation, depressive symptoms and hopelessness among participants over the course of the program. We will now test its efficacy in a randomised controlled trial with 170 students from up to 28 Melbourne high schools. Participants will be assessed at baseline, post-intervention (10 weeks) and 12-week follow-up. Hypotheses are that, when compared to treatment as usual, the program will lead to: 1. Reduced suicidal ideation 2. Reduced depressive symptoms 3. Reduced hopelessness 4. Reduced symptoms of anxiety 5. Increased problem solving skills

The aim of the study is to see if the two sterile water injection technique is as effective as the standard four injection technique in relieving lower back pain during labour and birth. If the difference in pain relief between the two techniques, thirty minutes after injection(s) is no greater or less than 1 centimeter on the VAS, the trial will have proven it's hypothesis

The study is investigating whether patients with Down syndrome and Transient Myeloid Disorder (TMD) who are at a higher risk of developing Myeloid Leukaemia of Down syndrome (ML-DS), including Acute MegaKaryoblastic Leukaemia (AMKL) can be identified through prospective GATA-1 gene mutation testing. Who is it for? This study is open to children born with Down syndrome or mosaic Down syndrome who are up to 2 years of age. The trial is currently open in NSW and may be extended to other states in the future. Children with typical physical characteristics of Down syndrome are eligible for consent before cytogenetic confirmation of diagnosis is made. Trial details Participants in this trial will be observed from birth/consent up to until 4 years of age in order to assess the levels of GATA-1 gene mutations and their association with subsequent progression to TMD and/or AMKL. Blood collection requirements Observation for signs of potential progression to TMD and/or AMKL will be performed by analysis of periodic full blood counts (FBC). The FBC will be assessed at local laboratories. Blood collected for study purposes will be stored at a tumour bank. The sample will be studied for GATA-1 gene mutations. It is hoped that results from the study of GATA-1 gene mutations will be used to develop a test that will in the future help predict which children with Down syndrome are more at risk of developing AMKL (acute megakaryoblastic leukaemia). Participants who do not develop TMD will have blood collected at 3,6,12,18,24,36 and 48 months. Participants who develop TMD will have additional blood collections to those stated above at 9, 30 and 42 months. These extra blood collections are required for monitoring the TMD. Participants who develop AMKL will have a final blood collection for study purposes at time of AMKL diagnosis. Blood collection for study purposes will cease at this point.

This randomised controlled trial aims to determine whether a primary total hip replacement prosthesis with a larger 36 mm diameter metal on highly cross-linked polyethylene articulation is associated with significantly greater polyethylene wear and acetabular component migration. This study utilises radiostereometric analysis, the most sensitive radiographic technique available to measure wear and migration in vivo.

The aim of this research is to investigate the optimal conservative approach to the treatment of patients with shoulder pain. There is evidence to demonstrate that exercise alone is better than a wait and see approach and also that one treatment session of a specific manual therapy and tape improves movement in people with shoulder pain. It is hoped that information gathered from this project will help to contribute to knowledge of an optimal conservative treatment approach to shoulder pain that limits a person’s ability to carry out many activities of daily living and to participate in work and sport.

This study aims to investigate the effects of morphine on obstructive sleep apnoea (OSA). Specifically, we will measure the effects of a common clinical dose of morphine on sleep, respiratory control, and upper airway physiology.