ANZCTR search results

We are undertaking one of the first seaweed dietary fibre and food ingredient studies on people with gut health concerns. The onset of chronic health disorders such as Type II Diabetes Mellitus are potentially related to reduced gut health. If seaweed dietary fibres can help improve the gut condition then it may be one option for preventing diabetic and other growing health concerns related to the gut. Previous research in other laboratory studies and in animal trials with seaweed dietary fibres, have shown significant reductions in inflammation, glucose & insulin stress, as well as positive shifts in gut flora composition. Despite the well-established evidence for the safety of consumption of the identified seaweeds and their dietary fibre extracts, very few studies have investigated the health outcomes in human trials. We will test if an Australian species seaweed, dietary-fibre extract and food ingredient can help the gut health condition, as well as assess changes to blood health indices and quality of life.

There is a dearth of research which takes a multi-compound approach to dietary interventions, in humans, aimed at improving outcome measures of cognition. Animal research in particular points towards fatty acids and flavonoids having a potentiating effect on each other, and possibly even being synergistic. Thus, study products will be administered in the present trial comprising both of these compounds, with a view to investigating their potential effects on cognition in older adults with mild cognitive impairment (MCI) or subjective memory impairment (SMI). In addition, a group of 20 healthy control participants were studied at baseline only to allow researchers to explore hippocampal integrity within the continuum of cognitive decline from healthy, to subjective memory impairment, to mild cognitive impairment.

Mindfulness is an approach showing promise for youth, but at present the methodological quality of studies in this domain is low. This study is an extension of a pilot study and seeks to compare an 8 week mindfulness programme, the .b mindfulness in schools curriculum, with a control group and with a group receiving the mindfulness curriculum PLUS parental support (an information session and weekly updates regarding lesson content and practices taught). The inclusion of the latter is aimed at improving compliance with home practice, with evidence suggesting that this is positively related to improved outcomes. Hypotheses 1. It is predicted that the primary outcome measures of anxiety, depression and weight/shape concerns will be lower in the parental enhanced mindfulness group compared to the standard mindfulness group, which will in turn be lower than in the control group at post-intervention and follow-up. 2. It is predicted that the primary outcome measure of wellbeing will be higher in the parental enhanced mindfulness group compared to the standard mindfulness group, which will in turn be higher than in the control group at post-intervention and follow-up. 3. It is predicted that the mindfulness interventions (both groups) will be more effective in improving the primary outcome variables (anxiety, depression, wellbeing, and weight/shape concerns) in those with high levels of anxiety, depression, and weight/shape concerns (i.e., in those who need it most). Additional moderators will also be examined (socioeconomic status, gender, lesson length - which varies across schools) however no prediction is made as to the direction of influence for these variables. 4. It is predicted that the parental enhanced mindfulness group will report higher levels of homework practice than the standard mindfulness intervention. 5. It is predicted that improved outcomes in the parental enhanced mindfulness group will be mediated at least partially by level of homework practice. 6. No prediction is made as to which facets of mindfulness (as measured on the CHIME-Youth scale) act as mediators for improvements in outcome measures.

Mindfulness, a form of mental skills training that originally derives from Eastern philosophy, shows promise as a prevention programme targeting a range of mental disorders (anxiety, depression and eating disorders) that often emerge in adolescence. Mindfulness involves learning to become fully aware of our present moment experience (both external events, and internally – thoughts, feelings and body sensations). This skill allows us to switch from automatic, habitual reactions, and more consciously/skilfully choose how to respond. Mindfulness training also teaches participants to approach all experience, pleasant and unpleasant (which is a normal part of life) with curiosity, friendliness and acceptance. This fosters an ability to sit with strong negative emotions, without resorting to maladaptive avoidant behaviour, e.g., binge eating or drug abuse. Robust evidence exists for mindfulness interventions with adults for reducing stress, anxiety and depression (Baer, 2003; Grossman et al., 2004; Khoury et al., 2013). Mindfulness in youth is a much newer field. Evidence to date is promising in terms of similar effects (Burke, 2010; Meiklejohn et al., 2012) but stronger empirical evidence is required. One recent study, by Kuyken and colleagues (2013) used the mindfulness in schools “.b” (dot be) curriculum which is an 8-9 lesson, once a week, programme. Across 522 students aged 12-16 years, results showed significant reductions in depression at programme completion in the group receiving the intervention. At 6 months follow up, reductions in depression had been maintained, and effects had broadened to also include decreased stress and increased wellbeing. Raes et al. (2013) found similar effects in their study of 408 school students (mean age 15) using an adolescent mindfulness intervention, with decreased depression and fewer new cases of depression in the intervention group both at programme completion and at 6 month follow up. Our current study seeks to replicate these results in an Australian context. In addition, we will broaden the outcome factors to include not only depression and wellbeing but also anxiety and eating disorder risk factors to investigate the programme’s potential as a prevention strategy across a range of mental health issues. In addition, for the first time, the proposed study will investigate the mechanisms by which mindfulness exerts its effects in adolescents in order to identify specific active components that could be amplified up to improve the effects. We will also investigate moderation, that is, for whom this intervention works. This pilot study, commencing in July 2014, will involve 400 students. These students will receive the full 8 lesson curriculum. We will trial an adult, multifactor mindfulness measurement tool for assessing mechanisms of change, as youth measures are single factor scales which do not allow finegrained analysis of the different elements of mindfulness as potential mediator pathways. Schools will be randomised at the classroom level to intervention or control groups.

The purpose of this study is to assess the PD and PK of Hospira’s pegylated filgrastim, HSP-130 and two pegfilgrastim preparations: US-approved Neulasta and EU-approved Neulasta. You may be eligible to join this study if you are aged between 18 and 65 years, are a non-smoker and have a BMI between 19 and 30 kg/m2, inclusive, and body weight of not less than 50 kg or more than 100 kg. Participants in this study will all receive a single dose of three drugs in a random order (by chance). Each dose will be injected at 6 mg into the shoulder region. This study is designed to demonstrate three things: - that HSP-130 has similar levels in the blood as the same dose of one or both of the approved pegfilgrastims. - that HSP-130 has the same effect on increasing the specific kinds of white blood cells in study subjects as one or both of the approved pegfilgrastims - that HSP-130 has a similar safety profile as both of the approved pegfilgrastims

Broken bones and thin bones are common in people with cerebral palsy. This is due to a number of factors including reduced activity and standing, poor nutrition, use of medications for epilepsy and reduced sex hormones. Thin bones are becoming more of a problem as adults with cerebral palsy are getting older. In older women and men with thin bones, there are good drug treatments available to reduce their risk of breaking a bone. One such treatment is zoledronic acid, which is given as an intravenous infusion once a year. This drug is currently being used and registered in Australia for treatment of osteoporosis (thin bones) in older women and men. The aim of this study is to see if zoledronic acid can be used in adults with cerebral palsy to improve their bone strength and reduce their risk of breaking bones. This drug has not be used in a study of adults with cerebral palsy before.

The aim of this study is to compare the clinical and microbial changes occurring in chronic periodontitis patients receiving non-surgical treatment alone or with systemically administered azithromycin or with amoxicyllin and metronidazole. The hypothesis is that non-surgical periodontal treatment in combination with systemically administered azithromycin will have superior effects on treatment outcomes (clinical and microbial parameters) than non-surgical periodontal therapy alone or in combination with systemically adminstered amoxicillin and metronidazole.

Stroke is a disease with severe consequences for the survivor and the unexpected carer. Carers experience tremendous changes and challenges from role reversal to financial struggle and subsequent increased burden, low mood, and poor overall health. In Australia, there are approximately 60,000 new strokes per year; a decrease in stroke mortality as a result of improvements in medical and surgical management mean people are living longer with the residues of stroke, and that carers increasingly face long-term burden. Eighty percent of individuals who experience stroke return home with varying degrees of neurological, behavioural and psychological symptoms. At home, they often rely on informal carers for their physical and emotional support. Previous psychosocial interventions to support informal carers of stroke survivors have shown promising results; however none have sought to integrate carer interventions with care coordination. To address this, the Stroke and Carer Optimal Health Program (SCOHP) has combined a 8-week individualised Collaborative Therapy with a booster session 1 month later. This research will assess the feasibility and cost-effectiveness of improving the mental and physical health, social connectedness and health service utilisation of the carers of stroke as well as stroke survivors. This model will be designed with the intention of being readily adapted and applied in the context of other physical and also mental diseases. The findings of this randomised control trial will investigate the impact of SCOHP on increasing carer and stroke survivor self-efficacy and quality of life.

Preoperative cleansing of the skin with antiseptic preparations at the site of surgical excisions (preoperative skin antisepsis) is common practice before every surgery worldwide, and aims to reduce surgical site infection. However, in most contexts, no definitive scientific consensus exists regarding which preoperative skin antiseptic preparations are most effective. This randomised controlled trial aims to close an existing gap in the evidence base surrounding optimal preoperative skin antisepsis before clean surgery - a practice most general practitioners carry out several times per week when they perform skin excisions. It is currently suspected on the basis of incomplete and methodologically inconsistent evidence that alcoholic antiseptic preparations are likely to be more effective than aqueous preparations for the prevention of surgical site infection (SSI) after clean surgery. This study aims to find definitive proof for this theory by determining whether there is a difference in the incidence of SSI after minor skin excisions in general practice when alcoholic chlorhexidine is used for preoperative skin antisepsis by comparison to when aqueous chlorhexidine is used. It is hypothesised that use of alcoholic chlorhexidine will reduce SSI by comparison to aqueous chlorhexidine. To implement this study, multiple general practices in the Mackay region which perform large numbers of skin excisions each year will be recruited. Consecutive patients over the age of 18 presenting to participating practices will be asked to participate in the trial and those that agree to partake will be randomised by a computer-generated random number table to receive preoperative skin antisepsis with either 0.5% chlorhexidine dissolved in 70% alcohol or 0.5% chlorhexidine dissolved in water. All other techniques and materials used for both preoperative skin antisepsis and the skin excision itself, as well as all aspects of post-operative care, will be kept constant between the two groups, and will align with a pre-specified surgical and wound protocol. Following their excision, patients will be assessed for the presence or absence of SSI by their treating doctor or nurse when they present for removal of sutures, or at any other time if they re-present due to suspicion of SSI or for any other reason. Rates of SSI will then be recorded, calculated and compared between the two groups using the statistical analysis software SPSS to determine if there is a significant difference in effectiveness between aqueous and alcoholic chlorhexidine. Hopefully the results of this study will help to provide direction to doctors regularly carrying out clean surgery, who at present have little definitive evidence to guide their choice of preoperative skin antiseptic preparations. Looking further, if a difference is found between aqueous and alcoholic chlorhexidine, we would aim for this research to impact current guidelines on preoperative skin antisepsis and evoke behaviour change from doctors and nurses which leads to a reduction in SSI rates in general practice.

The research aims to learn more about the potential benefits of methylphenidate (Ritalin) as people recover from traumatic brain injury. Ritalin is a stimulant medication, most-widely known for its use in children with Attention Deficit Hyperactivity Disorder. It works by increasing the concentrations of certain neurotransmitters within the brain, especially those involved in attentional processes. Past studies have shown that methylphenidate has been effective in patients with a traumatic brain injury in improving attention. This study looks at whether it not only improves attention but also day to day function and sense of well-being after three months.