ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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31330 results sorted by trial registration date.
  • Does a pre-school day with less sitting result in acute health benefits in 4-5 year old children?

    Excessive and prolonged sitting may be detrimental to the healthy growth and development of young children. We have shown in Phase 1 of the Standing Preschools Project, that 3-5 year old children spend around 50% of their day at childcare (˜180mins) sitting. The aim of this study is to assess the acute effects of a “reduced-sitting pre-school day” on energy expenditure, musculoskeletal health, and executive function in preschoolers’, using the whole room calorimeter.

  • The use of a low carbohydrate, high fat diet for the treatment of epilepsy in adults

    Epilepsy affects an estimated 225,000 Australians. Approximately one-third of people with epilepsy still experience seizures whilst on medications. They may be on maximum therapy or are unable to tolerate the side-effects of anti-seizure medications. There is emerging evidence to show a very low carbohydrate diet, known as the Modified Atkins Diet for Epilepsy (MADE), may improve seizure control, with relatively low side-effects. The use of this dietary therapy has not previously been studied in Australian adults. This research aims to investigate if Australian adults with epilepsy are able to comply with the dietary modifications of the MADE and to assess if participants experience a reduction in the number of seizures whilst on the diet. Participants will be seen regularly during the study by a Neurologist to monitor for any side-effects of the diet. A Dietitian will provide education, support and resources for those participating in the study on a regular basis. We anticipate most participants will be able to implement the dietary modification of the MADE. It is expected participants will experience up to half the number of seizures than normal whilst on the diet with minimal side-effects. A reduction in seizures can significantly improve the quality of life and overall health status of people with epilepsy who do not respond to medication management.

  • A play-based intervention to improve the social play outcomes of children with Cerebral Palsy: A pairwise randomised controlled trial

    Children with cerebral palsy (CP) have a number of limitations that contribute to social play and pragmatic language restrictions. Effective social play skills and pragmatic language are necessary for psychosocial development. Well developed social emotional skills and good quality relationships are protective factors that promote resilience and quality of life. The aim of this study is to evaluate the effectiveness of a peer-to-peer play based intervention to improve social play skills and pragmatic language in children with unilateral (i.e. affecting one side of the body) CP. It is expected that following the intervention children with UCP will have improved social play and communication skills and improved ability to establish and maintain friendships. Findings from this study will be directly translated into clinical practice.

  • The epigenetic effect of curcumin as measured in the blood and seen within lifestyle, for the prevention of Alzheimer's disease.

    This study examines the effect of curcumin taken orally, within a broader study investigating curcumin in the prevention of Alzheimer's disease. Participants will be allocated to either, no treatment or curcumin, for a period of 3-6 months. At the beginning and conclusion of the study, they will be required to undertake a brief cognitive assessment, answer lifestyle questions and donate blood. A once only mouth swab will also be taken. The intention of the study is to measure the influence of curcumin on the expression of inflammatory genetic markers, to examine if it is useful in reducing inflammation, by measuring associated proteins in the blood. The influence of curcumin on existing lifestyle patterns including sleep, activity levels and nutrition will also be examined through questionnaires at the end of the study.

  • Interval sprinting and fat loss in overweight women

    Being overweight causes increased risk for type 2 diabetes. We have shown that participation in regular interval sprinting reduces diabetic risk in young adult females. However, no examination of older women appears to have been carried out. Thus, we hypothesize that 8 weeks of interval sprinting will significantly reduce insulin resistance in middle-aged women, Twenty overweight women will be assigned to a 8 week interval sprinting exercise group and 20 to a control group. All women will be screened for entry to the study. Exercise will involve 3 x 20 minute sessions of interval sprinting for 8 weeks. Fitness (sub max test), body composition (DEXA), metabolic status (GTT, insulin), autonomic state (heart rate variability, baroreceptor sensitivity), cardiovascular (blood pressure, arterial stiffness, muscle blood flow, cardiac output, stroke volume), and blood markers (insulin, natriuretic peptides, cytokines) will be assessed before and after the 8 week intervention.

  • First-in-Human, Single Ascending Oral Dose Study of DV-928 in Healthy Volunteers

    This research project is being conducted to look at how safe and well tolerated a new drug called DV-928 is when different amounts are given to healthy volunteers. The pharmacokinetics of DV-928 will also be studied; this is done by measuring the amount of DV-928 in the blood at different times throughout the initial 2 days following administration, allowing us to evaluate how DV-928 is handled by the body (for example how quickly it gets into the blood stream).

  • Better management of weight in general practice

    This study tests an intervention to improve overweight patients' health literacy for weight loss and assist them to attend community-based weight management lifestyle modification programs. Study hypotheses: 1. Compared to practice nurses in control practices, those in intervention practices will demonstrate greater improvement in their self-reported behaviour and confidence in assessing obese patients with low health literacy and providing advice and referral to them for weight loss. 2. Compared to similar patients attending control practices, obese patients with low health literacy attending intervention practices are, at six months, more likely to report: *having received assessment, advice and referral for weight management *having attended/used community-based weight management lifestyle modification programs referred to. 3. Compared to similar patients attending control practices, obese patients with low health literacy attending intervention practices are, at 12 months, more likely to have improved their health literacy related to weight management.

  • Omega-3 supplements for treating dry eye disease

    Dry eye disease is a common condition, affecting up to 30% of adults. Common symptoms of dry eye disease include eye irritation (e.g., burning, grittiness, scratchiness, wateriness) and/or fluctuations in vision. Currently, the main form of treatment for dry eye disease is the use of artificial tears (lubrication drops), which can assist in reducing these symptoms by supplementing the deficient tear fluid. However, as artificial tears fail to address the underlying cause of dry eye disease, for many patients they are inadequate in completely relieving symptoms. New and enhanced therapeutic treatments are therefore needed. Inflammation plays an important role in the development of dry eye disease. There is growing scientific evidence that dietary supplementation with omega-3 essential fatty acids, may be of benefit in reducing inflammation throughout the body, including in the eye. A well recognised source of omega-3s is fish oil, which has undergone some preliminary investigations in relation to treating dry eye disease, however further research is needed to substantiate these findings. The aim of this ‘proof-of-concept’, single site clinical trial is to evaluate the benefit of phospholipid form omega-3 supplements for the treatment of dry eye disease, and whether this form of omega-3 provides any benefit over triglyceride omega-3s. The effects of both forms of omega-3 supplements will be compared with a control group, who will consume an olive oil supplement.

  • Treating substance use and traumatic stress among adolescents: A pilot study

    Post traumatic stress disorder (PTSD) and substance use disorder (SUD) are chronic, debilitating disorders that frequently co-occur. There is a critical need to intervene early to prevent the long-term problems associated with this comorbidity. However, there are currently no empirically validated treatments available for adolescents. This pilot study aims to examine an innovative exposure-based treatment for traumatic stress and substance use among adolescents (COPE-A). Ten adolescents (aged 12-17yrs) with comorbid traumatic stress and substance use (and their primary caregivers) will be recruited and offered the 16-session COPE-A intervention. Participants will undergo interviews at baseline and post-treatment. Measures of therapeutic compliance, treatment acceptability and feasibility, and treatment outcome will be analysed.

  • Pharmacist demonstration of EpiPen and Anapen autoinjectors to simulated patients: assessment of accuracy.

    Successful treatment of anaphylaxis in the community relies on early and correct use of epinephrine autoinjectors. Community pharmacists supply these devices with and without prescription and have a crucial role teaching patients how to use them. Supply of epinephrine autoinjectors in Australia increased 70-fold in the past decade. New EpiPen and Anapen autoinjectors were launched in Australia in 2011 and 2012, with the potential to cause confusion. However there is no information about how pharmacists demonstrate epinephrine autoinjectors to patients. Therefore the aim of this study was to assess real-world community pharmacist demonstrations of EpiPen and Anapen. We also sought to identify consultation-based predictors of accurate demonstration.

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