ANZCTR search results

ASD is characterized by: i) social deficits and ii) repetitive and restrictive patterns of behaviours and interests (RRPBIs). RRPBIs has been less researched in the scientific literature than the more salient social deficits. However, RRPBIs lead to severe impairments in cognitive flexibility skills and daily functioning. Some of the characteristics of RRPBIs include inflexible routines (e.g., not eating food that is coloured green or going outside without a favourite pair of shoes), rigid adherence to rules, resistance to change, obsessions, and difficulties adapting to new social contexts. Additionally, people with ASD showing highly rigid behaviour and thinking may persevere obsessively in a conversation topic or get very upset when their routine changes (e.g., always going to the shops the same way). These problems are intimately related to failures of emotional self-regulation, which is used to control one's behaviour, particularly when experiencing intrusive thoughts and negative emotions, and is thus essential for adaptive social interactions and daily functioning. Cognitive inflexibility and impairments in emotional self-regulation may also lead to increased levels of parental stress and negative parenting styles that decreases quality of life for both children and parents. Inflexible and perseverative behaviours can be measured using reversal learning paradigms whereas emotional self-regulation is usually measured using cognitive reappraisal tasks. These two processes are widely distributed across the brain. Recent cognitive neuroscience research has revealed that a single brain region within the frontal lobe, the ventrolateral prefrontal cortex (vlPFC) is primarily responsible for monitoring cognitive flexibility and controlling negative emotions, thoughts, and behaviours. Moreover, recent evidence from brain scanning techniques demonstrate abnormal activity within the vlPFC in ASD. Thus, the vlPFC is a clear target for neurobiological treatment of cognitive inflexibility and impairments in emotional self-regulation in ASD. 20 participants between 16–30 years with ASD will be recruited. Participants will undergo 1 day of pre-testing; 4 consecutive days of 20 minutes anodal or sham HD-tDCS stimulation (depending on order of administration); half-a-day of post-testing the day after the last stimulation session; a 2-week follow-up assessment. After a 4-week washout period, participants repeat the prior process in the opposite treatment condition they commenced with (anodal or sham HD-tDCS). The is a randomised, double-blind, crossover trial that aims to (a) investigate the safety of using HD-tDCS within ASD and (b) to investigate the efficacy of using HD-tDCS to reduce impairments in cognitive flexibility and emotional self-regulation skills among individuals with ASD. We will examine a range of clinical, neuropsychological and neurophysiological features. Participants’ experience of HD-tDCS, including any side effects will be collected.

Study will develop and test a group-based intervention for adult female survivors of sexual assault utilising the underlying framework and core skills and techniques of Compassion-Focused Therapy. The main question the study will seek to answer is whether or not a compassion-focused therapeutic group program, with its focus on increasing self-compassion, is effective in reducing feelings of shame and other post-traumatic symptoms in adult female survivors of sexual assault. It will be hypothesised that 1) participation in the program will result in an increase in self-reported self-compassion, 2) Participation in the program will result in a reduction in self-reported shame and self-criticism, fear of compassion, post-traumatic stress disorder symptoms, and measures of depression, stress, and anxiety, and 3) a negative association will be observed between self-compassion and all dependent measures.

KZR-616 is an experimental drug being developed by Kezar Life Sciences for the potential treatment of multiple autoimmune and inflammatory diseases. KZR-616 will be administered either by subcutaneous injection or by intravenous infusion. In this study, single ascending doses and multiple ascending doses of KZR-616 will be assessed in healthy volunteers. Assessments of safety, tolerability, pharmacokinetics, and pharmacodynamics parameters following administration of KZR-616 will guide decisions to further develop the drug.

Chronic obstructive pulmonary disease (COPD) is an irreversible lung disease characterised by airflow obstruction. Symptoms of COPD include breathlessness, a chronic cough and sputum production. COPD is complicated by the number of other diseases experienced by patients, particularly anxiety disorders and depression. Psychological distress is experienced by a large number of people with COPD, with international evidence estimating 37% of COPD patients suffer from anxiety and 40% from depression. Furthermore, COPD patients with anxiety disorders have a poorer quality of life, higher death rates, more hospitalisations and emergency visits, and are a greater economic burden. An effective approach to reduce anxiety disorders is cognitive behavioural therapy (CBT). There are currently no data in Australia on the effect of CBT for COPD patients for anxiety disorders and depression. Furthermore, with the recent advances in technology, there is potential for electronic communication to become a complementary self-management tool with CBT or as a stand-alone resource which can provide COPD patients with coping skills for anxiety and depression. Therefore, a randomised control trial will be conducted to determine the efficacy of CBT and/or simulation-based learning resources on COPD patients on anxiety disorders, depression, health outcomes and healthcare costs. The aims of the project are: Aim 1: To determine the impact on healthcare utilisation of treating anxiety disorders in COPD patients. It is expected that treating anxiety disorders amongst COPD patients will reduce WA hospital bed days and emergency department visits in COPD patients. Aim 2: To demonstrate the use of CBT and/or a simulation-based learning resource improves health outcomes amongst COPD patients It is expected that individually CBT and simulation-based learning resources will reduce anxiety disorders and depression among COPD patients. However, compared to CBT or simulation-based learning resources, combining both methods will reduce anxiety disorders to a greater extent amongst COPD patients.

Traumatic brain injuries are common, estimated to affect 107 in 100,000 Australians per year. Of these 80% sustain a mild-moderate traumatic brain injury (mTBI). A wide range of cognitive, behavioural and affective symptoms occur as a result of the biomechanical forces to the brain. The acute and long lasting impact of mTBI on brain activity is not well characterised. Combined transcranial magnetic stimulation (TMS) with electroencephalography (EEG) can be used as a tool to identify the neurophysiological mechanisms associated with mTBI symptoms. Furthermore, it allows the association between cognitive impairments and the functional integrity of the neural areas underlying these symptoms to be investigated. Thirty mTBI participants and 30 age and gender matched controls will attend three testing sessions across a 6 month period to capture acute, sub-acute and chronic symptoms post injury. A neuropsychological assessment and TMS/EEG recording will be conducted at each time point. Analyses will be conducted between groups to assess for differences in brain activity and within groups to investigate recovery in mTBI and test-retest reliability in controls. By improving our understanding of how changes in brain activity relate to impairments and recovery of function, targeted therapeutic strategies to modulate these may be developed. In summary, the aim of this study is to investigate changes in cortical activity, and the relationship with cognition, during recovery post mTBI using TMS-EEG.

To Evaluate the Absorption Efficacy Characteristics and Further Safety Over a 6-hour period of Coenzyme Q10 [100 mg administered as ONE dose orally] from SIX study Preparations to Healthy Participants. The study aims to find out whether; 1) Different Over The Counter (OTC) Coenzyme Q10 products absorb differently as assessed by blood serum levels 2) Different modes of Coenzyme Q10 oral preparations [i.e. as a liquid or capsule] can provide the best delivery vechile 3) and what forms of Coenzyme Q10 such as liquids, capsules or other forms are acceptable to participants

The primary purpose of this trial is to evaluate the efficacy of an oral capsule containing plant-derived tetrahydrocannbinol (THC) and cannabidiol (CBD) for the prevention of chemotherapy-induced nausea and vomiting (CINV). Who is it for? You may be eligible to participate in this trial if you are aged 18 or over and have been diagnosed with any cancer for which you are scheduled to receive at least three further chemotherapy cycles using intravenous chemotherapy of high or moderate emetic risk. Study details We will first enrol 80 participants in a pilot trial and if the data from these participants shows the medicine works and is well tolerated, a further 170 participants will be enrolled, this is called the definitive trial. Participants enrolled in the pilot trial will be randomly allocated (by chance) to receive the study drug for the first five days of their first chemotherapy cycle following enrolment, followed by a placebo capsule for the first five days of the next chemotherapy cycle, or to receive the placebo first followed by the study treatment. All participants will then choose which treatment they would prefer to take for the first five days of the third chemotherapy cycle. Participants will be asked to complete a number of questionnaires relating to their nausea and vomiting, quality of life and any side effects of the treatment. Participants enrolled in the definitive trial will be randomly allocated (by chance) to receive the study drug or the placebo for the first five days of their next three chemotherapy cycles following enrolment, Participants will be asked to complete a number of questionnaires relating to their nausea and vomiting, quality of life and any side effects of the treatment. It is hoped that this trial will provide preliminary information on the efficacy of THC and CBD capsules for the prevention of CINV, which will inform further clinical trials.

Introduction and Background: Intravenous access via peripheral intravenous catheters (PIVC) in the hand or arm is frequently required during hospital care to administer hydration fluids, medicines, blood transfusions and nutrition, and to withdraw blood for testing, It is estimated up to 85% of hospital patients require infusion therapy with up to 70% of patients requiring a PIVC. Historically, research and practice has focused (understandably) reducing blood stream infection rates, particularly in central venous catheters (CVCs). Catheter related blood stream infection (CRBSI) rates in PIVCs are extremely low (0.01)6, whereas PIVC failure rates due to dislodgement, occlusion, infiltration or phlebitis sit at 26% in Australia, 38% in Spain and 53% in the USA. Occlusion and infiltration account for 35% of failure. Australian and US Standards of Practice on PIVC maintenance include statements pertaining to securement, monitoring and flushing to maintain patency and function. A range of strategies to prevent or reduce PIVC complications exist. These include preventing failure through continuous or intermittent flushes of saline or heparin saline solution, and use of heparin, antibiotic and/or ethanol locks left inside the PIVC in between uses, continuous infusion and intermittent flushing. The Infusion Nurses Society's Infusion Nursing Standards of Practice clearly define three purposes of catheter flushing; to assess catheter function, to maintain catheter patency, and to prevent contact between incompatible medications or fluids that could produce a precipitate. For effective catheter flushing, the nurse must have an understanding of technique and the equipment used within his/her institution as well as the type of catheter in use. Specific to flushing current practice recommendations included aspiration of blood prior to flush administration to ascertain patency, flushing pre and post drug administration, use of 0.9% sodium chloride solution, amount of flush to at last equal that of device, use of single dose prefilled device, administration via syringe no smaller than 10mL to minimise applied pressure. There were varied recommendations for frequency of flushing. However, clinical trials and practice surveys have identified little if any adherence to these recommendations. Translation and evaluation of current evidence for flushing of PIVCs is urgently required to reduce the unacceptably high failure rate of PIVCs. Aims and Hypothesis. The aim of this implementation study is to evaluate the impact, feasibility and acceptability of a multifaceted intervention tailored to improve post insertion PIVC maintenance - specifically, patency and flushing. Primary hypothesis: the rate of PIVC failure (as measured by a composite of occlusion , infiltration, dislodgement, phlebitis and infection) in patients who receive recommended flushing practice will be lower than those patients who receive standard care.

Objectives - The aim of this study was to evaluate the effectiveness of pharmacists completing the medication management plan in the medical discharge summary for preventing medication errors. Design - We conducted a cluster randomised controlled trial comparing pharmacist completed medication management plans in the discharge summary to standard medical discharge summaries among patients discharged following an inpatient stay under a general medical unit. Setting - This trial was conducted at an adult major referral hospital in metropolitan Melbourne, Australia with an annual Emergency Department (ED) attendance of approximately 60,000 patients Participants The evaluation included patients’ discharge summaries written in the period of 16th March 2015 to 27th July 2015. Interventions - Patients randomised to the intervention had their medication management plan completed by a pharmacist. Main outcome measures - The primary outcome variable was an erroneous discharge summary related to a medication error as identified by an independent assessor, who was not part of the patient’s admission process.

Discs in the spine are shock absorbers and are the subject of wear and tear, and on occasions collapse and pinch nerves that deliver severe pain into the leg or arm. This research is designed to look for "germs" that may be present in disc fragments that are removed at surgery. If a connection is found between "germs" and disc wear then a larger study will be planned to verify the finding. Ultimately a therapy may be used to counter the infiltration.