ANZCTR search results

In response to the onset of significant inflammatory signalling following severe traumatic brain injury, ascorbate (vitamin C) concentrations rapidly fall to levels associated with severe deficiency. Without replacement, the ascorbate levels remain reduced for the duration of the inflammatory response. There is mounting evidence that replacing ascorbate plasma levels during an inflammatory response may be beneficial, particularly to the brain. Ascorbate is known to be an essential co-factor in several brain metabolic processes. These processes include reducing oxidative stress, maintaining microcirculatory homeostasis and maintaining normalm function of several key enzyme systems, including endothelial nitric oxide synthase (eNOS). In addition, ascorbate is involved in brain energy production, and is required for the production of a significant number of neurotransmitters. It is clear from multiple animal and human studies that deficiency in ascorbate leads to a pro-inflammatory state and worsening organ failure. In response to traumatic brain injury, brain ascorbate levels fall markedly in line with body concentrations. The magnitude of plasma level ascorbate decrease, which often reaches levels associated with scurvy in critical illness, has been shown to correlate with severity of both neurological injury and more general injury severity. Ascorbate supplementation has been shown to reduce the severity of secondary brain injury in multiple animal studies. There is a need to further evaluate the role of intravenous sodium ascorbate in the setting of human brain injury. To this end the authors propose to conduct a small feasibility study in the Australian setting to establish the efficacy of the proposed intervention and to evaluate the effect of intravenous sodium ascorbate on patients suffering from severe traumatic brain injury.

Sleep deprivation / disruption is common across various population cohorts and is linked to poor health, decreased productivity and higher stress. Animal and human studies report a variety of changes to the immune system in response to sleep disruption/deprivation which may underpin the associated adverse health outcomes. Probiotic supplements have a strong evidence base for reducing gastrointestinal and respiratory illness and may be useful in a range of other diseases. These beneficial effects of probiotics are proposed to be via modulation of immune parameters. This study aims to investigate the effects of probiotic supplementation on alterations in indicies of immune and gut health associated with sleep disruption in an adult population. A double-blind placebo-controlled parallel group three-arm study will be undertaken in 90 adults who experience disrupted sleep due to shift work. A range of biological markers (reflecting immune and gut health) will be assessed before and after supplementation in association with sleep disruption.

The impact of parental feeding practices on weight outcomes in young children is unclear. This is an analysis of data from mother-child dyads participating in four childhood obesity prevention trials across Australia and New Zealand were pooled (n=776) to determine whether 1. feeding practices used by mothers when their child was less than 2 years of age were related to overweight status at ages 3.5 and 5 years and 2. investigate whether these associations were moderated by early weight status

This project aims to test the effectiveness of a new online cognitive rehabilitation program known as S.M.A.R.T (Strengthening Mental Abilities with Relational Training) in children with Cerebral Palsy. The study will consist of a randomised controlled trial involving 60 participants, assigned to either the intervention group or a waitlist control. By the end of the study, all participants will have received access to the program. We predict that the S.M.A.R.T. program will be associated with improvements in performance on tests of intellectual functioning, academic achievement, and executive function, as well as measures of emotional and behavioural difficulties. Outcomes will be assessed at baseline, immediately after treatment ends (20 weeks post baseline) and at 40 weeks, to measure retention.

The primary purpose of this trial is to evaluate the efficacy of an internet program, iAdapt for depression and anxiety in men who are living with HIV. Who is it for? You may be eligible to participate in this study if you are aged 18 or over, suffer from anxiety or depression and have a diagnosis of HIV. Study details All participants enrolled in this study will be randomly allocated (by chance) to receive the iAdapt program soon after enrolment or 12 weeks later. The iAdapt program is a 12 week online program which involves learning about tackling depression with a form of therapy called Cognitive Behavioural Therapy (CBT). CBT looks at improving how we manage our thoughts, actions and feelings. There are 6 lessons, each one taking up to an hour to complete, with the recommendation to do a new lesson every 1 – 2 weeks. There will also then be additional activities to do for around 3 hours per week. Participants will complete a number of important questionnaires to assess their depression and anxiety levels among other psychological factors, at the beginning of the program, mid-way through, then again at the end of the program and the last time is 3 months after finishing the program. Participants will also be asked to complete a short questionnaire before every lesson. It is hoped that the findings of this trial will provide information regarding the efficacy of the iAdapt program in reducing depression and anxiety for men who are living with HIV

The study will be a randomised, placebo-controlled, double-blind parallelgroup trial over a 24 week period. The primary objective is to examine the clinical efficacy of the add-on treatment of Metformin XR for people newly commenced on clozapine. Specifically, it is hypothesised, that participants allocated to the active arm (2000mg once daily) Metformin XR will have lower mean body weight at week 24 compared to individuals taking placebo, adjusted for baseline body weight (ANCOVA).

This study aims to compare the efficacy of three methods of regional anaesthesia in shoulder arthroscopy, as well as to compare patient satisfaction with the three methods. People undergoing shoulder arthroscopy will be invited to take part in the trial and will be randomised to one of three groups if they accept. The three groups comprise an Interscalene block, inserted by an anaesthetist; a combined suprascapular & axillary nerve block inserted by an anaesthetist;and the combined block inserted by the treating surgeon during the procedure. Outcomes examined by this study include pain levels after the operation (in the recovery room, the next day & out to a week later), how much pain relieving medication was used and how satisfied the participants were with their experience of regional anaesthesia (through use of a survey form). The findings of this study will be utilised to guide clinical practice in the use of regional anaesthesia in arthroscopic shoulder procedures.

Exercise Physiology (EP) based physical activity interventions for older adults have been shown to be effective; however, no studies have investigated whether EP in residential aged care facilities leads to maintenance or improvement in physical or cognitive function. The organisation concerned is currently running a funded exercise program with the intention of improving the cognitive and physical functionality of Residents. Exercise Physiologists (EPs) specialise in clinical exercise interventions for persons at high risk of developing, or with existing, chronic and complex medical conditions and injuries. As a relatively new profession, EPs are developing ways to work effectively with the specific needs of older people, including those living in residential aged care. The organisation has been running an EP-led student clinic for residents in one facility, including delivering services to people with high-level needs in a secure dementia unit. This work has provided initial evidence around the positive impact exercise has on a range of chronic conditions (including dementia). Observed improvements include increased functional capacity and improved cognitive function. The positive impact on residents' wellbeing, as a result of improved function, is perceived to have had a ripple effect on family members: e.g. better quality of life for their loved ones. Staff also responded positively to the changes they saw in residents. This project aims to conduct an evidence-based evaluation of the project 'EP in Aged Care', exploring the effects of exercise primarily for residents with cognitive decline. The evaluation will take a person-centred approach.

A) Aims and Objectives This project aims to investigate the role of the neurotransmitter dopamine in complex decision making, and how three prescription stimulant medications that modulate dopamine levels in the brain in slightly different ways can affect the quality of complex decision making. These medications (dextroamphetamine, methylphenidate and modafinil) are increasingly used by healthy people for non-medical, cognitive enhancement purposes, however their effects on basic cognition are often found to be inconsistent, and their effects on more naturalistic, complex optimisation behaviours are not known. B) Key Question(s) Do stimulant medications, that increase dopamine in the brain, enhance, or have a deleterious effect, on the completion of a complex decision making task. More specifically do they; * Affect the amount of time taken to solve a problem? * Increase or decrease the likelihood that a participant will find the correct solution to the problem (the computational performance)? * Increase or decrease the computational distance between the participant’s solution and the correct solution (the economic performance)? * Affect the variety of search paths that participants take through the space of possible solutions? C) Research Design This study will utilize a double-blinded placebo-controlled crossover design. We will recruit 32 healthy participants with no history of neurological, psychiatric or heart conditions. Each one will participate in an initial assessment session and four testing sessions, each at least one week apart to allow for pharmaceutical washout. At each session, the participant will receive either a single dose of the three pharmaceuticals or the placebo. After a 90-minute waiting period, during which the participant fills out number of demographic and personality surveys, the participant will complete a series of computerised complex optimisation tasks and basic cognition tasks. Data collected includes the sequence and timing of the selection of items for each task solution, key variables from the more basic cognitive tasks and the answers to the survey questions.

Q-122 is being developed by QUE Oncology as a treatment for vasomotor symptoms (hot flashes) in female breast cancer patients/survivors. Q-122 has been studied in three Phase 1 clinical trials in cancer patients, healthy volunteers, and breast cancer survivors taking anti-estrogen therapy who were experiencing VMS. This study is designed to determine the effect of food on Q-122 pharmacokinetic (PK) parameters (Part 1) and PK parameters following a once daily or twice daily dosing regimen.