ANZCTR search results

Excessive gestational weight gain (EGWG) or weight gain during pregnancy is associated with poor child and maternal health outcomes, including preeclampsia, gestational diabetes, complications with labour and delivery, and babies who are born either small or large for gestational age. There is also an increased likelihood of postpartum obesity in both mothers and their children, which in turn leads to an increased risk of chronic disease later in life. Estimates from one off studies indicate the prevalence of EGWG in Australia could lie between 38 and 67%. The NSW Get Healthy Service (GHS) is a telephone based coaching service available to all adults in NSW aged 18 years and over. The NSW Office of Preventive Health (OPH) and NSW Kids and Families have collaborated to develop a service enhancement or “module” for the GHS specifically aimed at supporting pregnant women to achieve appropriate gestational weight gain. An initial pilot phase for the module is proposed to assess effectiveness of the coaching program, through conduct of a randomised controlled trial. This RCT will compare the effectiveness of a telephone based coaching program versus provision of information alone in supporting pregnant women to achieve appropriate gestational weight gain and prevent postpartum weight retention. The hypothesis is that compared with participants who only receive information, pregnant women enrolled in the coaching program will be less likely to achieve excessive gestational weight, and be more likely to have returned to their prepregnancy weight 12 months after giving birth. A stratified cluster randomised design will be used, with stratification by prepregnancy BMI (normal and overweight/obese) and clustering by hospital. Four hospitals will be invited to participate, with two allocated to the control arm and two to the intervention arm. Pregnant women will be invited to participate in the trial on their first booking visit with a midwife, and allocated to an arm depending on the hospital they attend. Anthropometric (e.g. weight gain or retention) and behavioural (e.g. fruit and vegetable consumption) outcomes for each group will be compared at 36 weeks gestation and 12 months post birth. Additionally, qualitative feedback on the feasibility and acceptability of the module (information and coaching components) will be sought from participants and midwives.

This research project is aiming to determine the effects of 3 months supplementation with a proprietary spearmint extract, on cognitive functioning in healthy individuals. Participants will be required to complete 4 testing sessions and 1 screening session. During these sessions they will be asked to complete a variety of measures assessing cognitive function and general health. Participants will be asked to take one of the following treatments for a 90 day period: - Proprietary spearmint extract - Matched placebo

Hendra Virus Monoclonal Antibody (mAb m102.4) is an experimental drug product which is administered through a drip (infusion) into a vein in the forearm. It is a human monoclonal antibody which has been man-made and is being developed as a potential treatment for Hendra virus infection. This product is not a vaccine against Hendra virus infection. The purpose of this study is to test the safety of monoclonal antibodies designed to act against Hendra virus. Our aim is to find out more about mAb m102.4 when it is administered to healthy individuals. The main objective of the study is to evaluate the safety and tolerability of mAb m102.4. That is to find out how it makes people feel and whether there are any side effects or changes to laboratory results. We will also determine the amount of mAb m102.4 in your blood at various times during the study, its effect on your immune system as well as the extent of its anti-virus activity.

Renal replacement (RRT) dose intensity may affect patient and kidney outcomes in severe acute kidney injury (AKI) but randomized controlled trial (RCTs) have been contradictory for mortality and inadequately powered for renal outcomes. The Investigation, Management, Prognosis, Recovery, Observation, Value and Evaluation of Acute Kidney Injury (IMPROVE-AKI) collaboration brings together investigators from current randomised clinical trials of RRT dose intensity in AKI to perform IPDMA of the effects of RRT dose intensity.

Kidney disease is a significant health issue, with around 2500 new patients requiring treatment every year (Australian data). Around half of these patients will need a surgical connection between their artery and vein (an “arteriovenous fistula” or “AVF”) to facilitate being connected to a machine that functions like a kidney (a haemodialysis machine). There are many methods of providing anaesthesia for the creation of an AVF including a local anaesthetic-based technique to numb the entire limb where the AVF will be created, or a general anaesthesia-based technique where consciousness is lost. It is currently not known whether any particular anaesthetic technique is superior. Theoretical advantages of a local anaesthetic-based technique (also known as a “regional anaesthetic”) include the avoidance of a low blood pressure and better surgical conditions by making the artery and vein larger which may prolong the life of the fistula. On the other hand, potential disadvantages of a regional anaesthetic include the risk of nerve injury. There have been no good quality studies evaluating both these issues, although smaller studies have suggested benefit of a regional anaesthetic technique. The aim of this study is to obtain prospective data from four hospitals regarding the six-week outcomes for patients having their first AVF created under a regional anaesthetic or a general anaesthetic. Patients will be recruited over two years. All four hospitals perform a significant number of regional anaesthetics for this procedure. The main purpose of this study is to determine the number of patients that would be eligible for a future comparative looking at the outcomes of AVF failure and peripheral neural injury; and to determine whether there are appropriate infrastructure mechanisms to collect relevant data for a future comparative trial. Another purpose of this study is to determine the direction of benefit (if any) of using a regional anaesthetic technique over a general anaesthetic technique for this surgery. This data will allow us to assess the feasibility of implementing a future trial where patients will be randomly allocated to receive either a regional anaesthetic or a general anaesthetic for this operation. Determining the impact of anaesthetic technique on six-week outcomes is important as it has the potential to change anaesthetic practice significantly. Reducing the overall complication rate is beneficial to patients with end stage kidney disease. This will facilitate a smooth transition into haemodialysis after initial AVF creation.

A randomized controlled trial will be conducted in 60 people with injury to their balance organ and/or balance nerve. We have developed a safe, non-invasive, ‘incremental’ rehabilitation technique that after a single 15 minute session increases the vestibular (balance) response many times more than current best practice, which takes 6-8 weeks to see any increase. We have shown that the technique can be successfully administered using a small portable device under a controlled setting. This project will determine the long–term (minimum of 24 months) changes in vestibulo-ocular reflex (VOR), balance and gait function in vestibular patients that train once daily (i.e., fixed dosage).

There are currently no approved pharmacological treatments for methamphetamine dependence. There is a theoretical basis that drugs similar to methamphetamine, such lisdeamfetamine, may allow dependent users to stablise their use. Currently, there is no data on what dose of lisdexamfetamine is safe for people who are habituated to methamphertamine use. This study aims to ascertain the safety of giving a higher dose, while also looking for any change in methamphetine use or risk behaviours while taking the study drug.

Prescribing errors are a known cause of adverse patient outcomes. The objective of this study was to assess the effect of (1) targeted pharmacist feedback and education and (2) an e-learning prescribing module, on prescribing error rates by junior doctors in the inpatient general medical setting.

The purpose of the study is to determine whether intermittent energy restriction is as effective as continuous energy restriction in achieving weight loss in people with type 2 diabetes

The etiology of mental ill-health is commonly complex and can often involve not one but a chain of genetic, environmental, social and psychological risk factors. Understanding these risk factors is essential to being able to identify children at risk of developing future mental health difficulties, planning appropriate timing of an intervention and ascertaining necessary treatment components for any intervention. Risk factors may be individual, familial and environmental characteristics that increase the likelihood of adverse developmental outcomes. Although no single risk factor is either necessary or sufficient in the development of a specific disorder, the commonly indicated risk factors in young children are parental psychopathology, temperament and prior symptomology. Parental psychopathology is commonly accepted as a risk factor for both genetic and environmental pathways towards childhood mental health problems. Family aggregation studies of both the offspring of clinically diagnosed parents and parents of children with mental health difficulties have demonstrated the heritability of mental disorders Connell and Goodman’s meta-analytic review investigated the associations between parental psychopathology and internalizing and externalizing disorders in their children. Based on the 230 articles identified on parental mental health concerns and childhood internalizing difficulties, the authors found that both maternal and paternal psychopathology significantly predicted childhood symptomology. It should be noted, however, that weighted mean effect sizes in this study were small. Additionally, it was found that effects were moderated by child factors, including age and gender, as well as type of parental diagnosis. These findings suggest that the relationship between parental psychopathology and child psychopathology is not a simple direct linear association. Rather, the interaction of parental influences and child influences is more likely to determine future symptomology. Despite an exponential increase in resilience research for children, there is currently a lack of evidence exploring how adult resilience affects the development of childhood resilience. As the link between vulnerability factors, protective factors and wellbeing in psychopathological pathways is unclear, it cannot be assumed that the heritability and modeling of psychopathology between parent and child directly indicates a similar link relationship for parent and child resilience. As such, this study will to explore both the relationship between parent-child resilience and symptomology and how resilience enhancement in parents affects children’s resilience and symptomology intervention outcomes.