ANZCTR search results

The aim of this pilot study is to determine the effects of a therapeutic songwriting protocol on a range of wellbeing measures for people who are undergoing inpatient rehabilitation and those who are 0-24 months post discharge from acquired brain injury (ABI) or spinal cord injury (SCI) rehabilitation. A pre­-post design will determine whether therapeutic songwriting can assist people who have sustained long­term injuries resulting from traumatic injury (such as workplace or road accidents) to work through issues of identity. This guided therapeutic process may include exploring a new identity that integrates the old pre­injured self with a new identity that integrates the residual physical/cognitive/and psychosocial effects of the injury. The main purpose of this pilot project is to test the feasibility of the study protocol, establish the appropriateness of the measures for answering the research questions, and collect data that will capture the factors of efficacy.

This study seeks to investigate the effectiveness of simulated driver rehabilitation methods in reducing time taken and success in return to driving following an Acquired Brain Injury (ABI). No commonly agreed best-practice guidelines are currently available to guide the assessment and rehabilitation of driving ability post-ABI in Australia and worldwide. Many current driving assessment and retraining procedures used post-ABI are generic and the reliability, validity and clinical effectiveness of these procedures have yet to be established. In order to develop reliable and valid driving assessment and re-training procedures, a clear evidence-base identifying which specific driving interventions are effective post-ABI is needed. To date, studies investigating rehabilitation methods for driving post-ABI suggest that a functional, top-down approach (involving the full activity of driving a car) generalizes better than less comprehensive to improved driving performance on on-road tests. Due to modern advances in technology, production of and access to sophisticated driving simulators has increased. Given limited and inconsistent evidence surrounding the utility and effectiveness of driving simulators for rehabilitation after ABI, further exploration is warranted. In this study, participants will be recruited from the Epworth HealthCare Occupational Therapy Driving Assessment and Rehabilitation service. Their decision to participate, or not to participate, will not impact on their treatment. All participants will be involved in standard outpatient rehabilitation (as part of their regular clinical care) however participants allocated to the simulator-training group will dedicate 6 extra hours of their time (8 x 45 minute sessions) to complete the simulator program, in contrast to the standard rehabilitation group, who will not complete the program. While we do not anticipate or advocate for simulators to completely replace on-road driving rehabilitation, we propose that simulator-based training may improve pass rates for on-road assessment and reduce the total number of costly on-road rehabilitation sessions required by people returning to driving. Furthermore, simulators may act as a starting block for drivers who either lack confidence or are judged too risky to engage in on-road driving rehabilitation, and facilitate increased engagement in driving rehabilitation as a result.

This study will investigate whether immunonutrition can improve patient recovery following surgery for colorectal cancer. Who is it for? You may be eligible to join this study if you are aged 18 to 85 years, and have a confirmed diagnosis of colorectal cancer for which you plan to undergo elective curative surgery. Study details Participants in this study will be randomly allocated (by chance) to one of two groups. Participants in one group will receive a pamphlet containing information on healthy eating for surgery. Participants in the other group will receive the pamphlet, as well as a beverage called IMPACT Advanced Recovery. This beverage is made by Nestle and contains special nutrients (immunonutrients) which may enhance the immune system in patients having major surgery. Participants allocated this treatment will be instructed to take 3 x 237 mL drink packs a day, for 5 consecutive days before their operation, with the last drink to be taken two days before their operation. All participants will be followed-up for 30 days post-surgery in order to evaluate the incidence of any complications, such as infection, and to measure various immune markers in the blood. It is hoped that immunonutrition will reduce infections after surgery for bowel cancer and improve patient recovery.

This study is designed as an open label, single dose combination of HSK3486 and etomidate in healthy adult male subjects. The study will evaluate the anesthetic/sedation effect of the combination of the 2 drugs and the safety profile including pain on injection, hypotension, tachycardia or bradycardia effects (HSK3486), and involuntary muscle movements, nausea and vomiting potential and adrenal suppression (etomidate). All subjects will be administered HSK3486 plus etomidate. Subjects will be confined to the study unit from the evening of Day -1 until the morning of Day 2, then will be required to return for a follow up visit on Day 7. Intensive PD, PK, safety and tolerability and assessments will be performed prior to dosing on Day 1 until 24 hours post-dose (Day 2).

The primary purpose of this trial is to evaluate the effectiveness of melatonin in preventing delirium in hospital inpatients with advanced cancer. Who is it for? You may be eligible to enrol in this trial if you are aged 18 or over and have been diagnosed with advanced cancer for which the intention of treatment is not to cure, and have been admitted to an acute or sub-acute inpatient hospital facility within the previous 48 hours. Study details All participants enrolled in this trial will be randomly allocated (by chance) to receive either melatonin tablets or placebo (sham) tablets, once per day at night time until delirium occurrence, discharge from the hospital facility, or for a maximum of 3 weeks after any acute medical issues with a delirium risk have been resolved. All participants will be asked to complete a number of questionnaires once per day for the duration of their melatonin/placebo treatment to evaluate levels of delirium and effects on sleep, and researchers will also review medical records to evaluate healthcare resource use. It is hoped that the findings from this trial will provide information on the efficacy of melatonin as a preventative treatment for delirium in advanced cancer inpatients.

Paracetamol is one of the commonest medications taken in overdose worldwide and is the leading cause of acute liver failure in the developed world. The antidote acetylcysteine which replenishes liver glutathione was developed in the 1970’s however the regimen (20 hours duration) was never subjected to either a randomised controlled trial or any dose ranging studies. The regimen gives a large loading dose and the remainder of the infusion (20 hours) is given to mirror the average time taken for paracetamol to be cleared by the liver. This time is only an average and depends on the degree of liver damage. We now know that this half-life is variable. For normal or undamaged livers it is much shorter (12 hours). The aim of the study is to compare acetylcysteine given over 20 hours compared to 12 hours for patients presenting early with paracetamol overdose to see if it provides the same protection against liver damage. The research design will be a multicentre non inferiority per protocol unblinded randomised controlled trial of a 20 hour versus a 12 hour regimen of acetylcysteine in paracetamol overdose. The study will be undertaken at the Princes Alexandra, Calvary Mater Newcastle and Prince of Wales hospitals. Eligible patients will be paracetamol overdoses less than 30g presenting within 8 hours of ingestion. The primary outcome will be a comparison between the standard and the experimental arm of the absolute difference between the liver function test alanine aminotransferase (ALT) on admission and 24 hours post ingestion. This difference will be analysed per protocol by student’s t­test or non­parametric equivalent depending on the distribution of the data.

Cerebral palsy is a permanent disorder of posture and movement caused by disturbances in the developing brain. It is the most common form of childhood physical disability. People with cerebral palsy may also have problems with speech, vision and hearing, intellectual difficulties and epilepsy. Health and therapy services are frequently required throughout life, and this care should be effective and evidence-informed; however accessing and adopting new research findings into day-to-day clinical practice is often delayed. This study employs a before and after design to evaluate if a multi-strategy intervention can improve research implementation among allied health professionals (AHP) who work with children and young people with cerebral palsy, and to establish if children’s health outcomes can be improved by routine clinical assessment. The intervention comprises (1) knowledge brokering with AHP, (2) access to an on-line research evidence library, (3) provision of negotiated evidence-based training and education, and (4) routine use of evidence-based measures with children and young people aged 3-18 years with cerebral palsy. The study is being implemented in four organisations, with a fifth organisation acting as a comparison site, across four Australian states. Effectiveness will be assessed using questionnaires completed by AHPs at baseline, 6, 12 and 24 months, and by monitoring the extent of use of evidence-based measures. Children’s health outcomes will be evaluated by longitudinal analyses.

Methamphetamine addiction is a major and growing problem in Australia, with a considerable individual, family and community burden. The current trend is a rapid increase in the use of crystal methamphetamine, the most addictive form, from 10% of users in 2010 to over 50% in 2014. Current treatment options for methamphetamine addiction are all based on Cognitive Behavioural Therapy (CBT) and have very low rates of durable abstinence. There are no proven pharmacotherapy options to assist in attaining and maintaining abstinence. The rapid increase in the use of high purity, highly addictive forms of methamphetamine, coupled with a lack of effective treatment, portends a public health catastrophe in Australia as outlined in the National Ice Action Strategy announced in April 2015. The key focus of treatment is to stop addicted individuals succumbing to the intense drug cravings on exposure to “drug cues”: anything that evokes drug memories eg places or people associated with their methamphetamine use. The treatments based on CBT aim to alter the individual’s response to drug cues but the igniting of these intense cravings is outside of conscious control. A more effective treatment strategy is to weaken the intensity of drug cravings with anti-craving medication. Baclofen is a strong candidate for methamphetamine addiction treatment due to its proven effectiveness in suppressing drug cravings for cocaine, another stimulant drug which, like methamphetamine, acts via the dopamine reward pathways of the brain. A 2014 study on cocaine addiction used functional MRI (fMRI) to objectively study the brain activation patterns in cocaine addicts in response to cocaine associated images (drug cues). The subjects treated with baclofen showed a dramatic and specific suppression of activation of the brain’s reward pathways compared to the placebo group. This provides a mechanistic explanation for the clinical effectiveness of baclofen in suppressing cravings for and the use of cocaine in addicted individuals. The study proposed in this application will reproduce the fMRI/cocaine study in 18 methamphetamine addicted subjects to test the effectiveness of baclofen (vs placebo) in suppressing reward pathway activation in response to methamphetamine drug cues. If baclofen is effective, it would provide the foundation for clinical trials of baclofen therapy combined with standard CBT treatment for methamphetamine addiction. This study seeks to rapidly establish if baclofen has an anti-craving action in the methamphetamine addicted brain. A positive result will accelerate baclofen treatment being adopted into current treatment programs for methamphetamine addiction with the aim of increasing durable abstinence rates.

The primary purpose of this study is to evaluate whether the flow cytometric residual disease (MRD) test can effectively predict relapse in patients with acute myeloid leukaemia (AML) who are undergoing an allogenic stem cell transplant (SCT). Who is it for? You may be eligible to participate in this study if you are aged over 18 years and have been diagnosed with AML for which you are scheduled to undergo SCT. Study details All participants enrolled in this trial will have a bone marrow sample taken at 1 month prior to SCT and 1, 3 and 6 months following the SCT. The MRD test will be run on all of these samples. Only the MRD results from your treating institution will be made available to your treating physician, which may be used to guide relapse-prevention therapy. This is in accordance with current standard of care. The results of the MRD tests at each timepoint will be compared to the time of any relapses in AML which occur up to 12 months following the SCT. It is hoped that this study will provide information on whether MRD can effectively predict relapse in AML following SCT, and whether it can help to guide preventative therapy prior to relapse.

Students who experience ongoing failure in upper-primary and lower-secondary school face a myriad of difficulties in pursuing post-school options and societal contribution through employment and aware citizenship. Those who exhibit consistent weaknesses in basic skills, such as the recall of number facts are particularly vulnerable. The QuickSmart Numeracy program is focused on improving the speed and accuracy of basic arithmetic computation. This intervention has demonstrated efficacy within quasi-experimental research trials. The purpose of this study is to test the intervention efficacy using a randomized-controlled experimental design. The aim of this study is to investigate the impact of a numeracy based program, QuickSmart Numeracy, on the numeracy levels of year 4 and 8 students with low proficiency in mathematics. Participants are asked to undertake additional tuition (3 x 30 minute sessions / week within school hours) across 3 school terms (30 weeks). QuickSmart tuition is focused on improving the speed and accuracy of basic arithmetic computation. Evaluation of the primary outcome is via a cluster randomized controlled trial (wait-list control) involving parallel comparison of matched pairs within the same class. The primary outcome is the age scaled score on the Progressive Achievement Test (mathematics version).