ANZCTR search results

In order to investigate the equi-efficacy of DHEA (orally administered via oral strip technology) versus standard troche delivered DHEA. Oral Strip Technology (OST) encompasses a rapid drug releasing product that is presented as a dissolvable strip orally applied. This technology has been used for local action, rapid release products and for bucco-adhesive systems that are retained for longer periods in the oral cavity to release a drug in a controlled fashion. OST offers an alternate platform for molecules that undergo first pass metabolism and for delivery of compounds.

Evidence demonstrates the effectiveness of behaviorally based therapeutic interventions for families where child behavior is of concern. Behaviorally based programs, also known as Behavioural Family Intervention and Parent Management Training commonly identify parents as the potential mechanisms of change in child behaviour. The interventions achieve change through the engagement of parents in one of two distinct modes. They either involve 1. the delivery of parenting information to parent(s) in session in the absence of their children, assessment of which is undertaken session by session via parental self-report 2. the direct coaching of parents as they interact with their children, the assessment of which is undertaken session by session via self-report in conjunction with observational coding during session The current study seeks to trail a combination of both sessional engagement of parents on their own and direct coaching of parents and their children. Drawing on clinic referred children aged between one and three years, and undertaken at UTS: Family Child Behaviour, the current study seeks to assess the potential to increase treatment response by combining these two distinct modes of treatment delivery in a clinic referred population. It is hypothesised that as a result of inclusion in this trrial: Participants will show a decrease in self-reported levels of parental depression, anxiety and stress from baseline to follow up Participants will show an increase in self-reported levels of parenting confidence will be evident from baseline to follow up Participants will show an increase in indices of observed appropriate parental engagement will be evident from baseline to follow up Participants will show a reduction in parent-report levels of child behavioural difficulties evident from baseline to follow up Participants will show a reduction in daycare report of child behavioural difficulties evident from baseline to follow up Methodology: This research will be undertaken as a within subject’s trial, the participants of which will be parents of children aged 1-3 years from NSW Australia. Parents who are referred into the program will be informed about the program, screened for inclusion into it and, if eligible, provided with the option to participate in the research. Parents will then be provided with information about the research and its requirements prior to seeking their informed consent.

The aim of this project is to determine the effect of a Mediterranean diet with lean fresh pork in comparison with a low fat diet on risk factors for CVD and cognitive function, mood and wellbeing in a randomised crossover dietary intervention trial in a population of men and women at risk of CVD. The primary outcome is home measured blood pressure (BP). Secondary outcomes include the Framingham heart risk score, dementia risk score, mood, wellbeing, cognitive performance (memory, executive function, speed of processing visual spatial and attention), blood lipids, insulin, glucose, insulin resistance, C Reactive Protein, erythrocyte fatty acids, apolipoprotein E4, body mass index, abdominal adiposity and body composition, weight, waist:hip ratio, gut microbiome profile, clinic blood pressure, dietary intake data and Mediterranean dietary adherence and low fat dietary adherence. This is a randomised crossover dietary intervention trial with 39 men and women aged 45-75 years at high risk of CVD. They will be included if they have systolic blood pressure greater than 120mmHg PLUS at least two risk factors for CVD including : BMI >25kg/m2 (overweight), abdominal adiposity, impaired glucose tolerance, dyslipidemia, family history of CVD or type 2 diabetes. Half the group will be randomly allocated to commence with either a Mediterranean diet with pork (MedDiet) or a lowfat diet (control current best practice) for 8weeks, then move to a washout diet for 8 weeks (habitual diet) then move to the other diet for the remaining 8weeks. At the start and end of each 8 week dietary phase volunteers will have all outcomes measured. Following an overnight fast, volunteers will attend their clinic visit and will have the following outcomes measured prior to breakfast: Height, weight Waist/hip circumference Blood pressure 40mL blood sample DEXA scan to assess body composition Following a light standard continental breakfast; Cognitive performance will be measured. Volunteers will meet with the dietitian and receive instructions regarding their dietary prescription for the next 8 weeks. They will be issued a diet checklist to ensure they are complying with the diet and receive some food staples. During this appointment volunteers will return items that were issued to them 1 week prior; their blood pressure monitors and 6day readings, together with their 3day weighed food record, faecal specimen and questionnaires. All volunteers will be asked to maintain their usual exercise pattern throughout the study.. Volunteers will be asked to return fortnightly during each diet phase to see the dietitian.

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.