ANZCTR search results

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

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32707 results sorted by trial registration date.
  • Yogurt Gastrointestinal Upset Reduction Trial for Children on Antibiotics

    This study aims to assess if yogurt (containing the probiotics LGG, Bb12 and La5) can reduce the incidence of gastro-intestinal upset associated with antibiotics administration in children aged 1-12

  • Amoung obese adolescents, does a multidisciplinary intervention (Curtin Activity, Food and Attitudes program) lead to improved mental health status?

    The study aims to help obese adolescents develop activity, food and attitude habits for improved health and happiness. Adolescents and their parents participate in a multidisciplinary program for 8 weeks with two sessions each week. The study hypothesis is that the mental health of the adolescent will be improved after the intervention and this improvement will be maintained at 3 and 6 months post intervention.

  • Does access to electronic games decrease physical activity in children?

    Background Increasing physical activity (PA) is a major health priority in Australia and internationally due to the associated health burden. It is widely believed that access to electronic games decreases PA in children. Whilst there is considerable research on the impact of TV viewing on PA and obesity, there is little research specific to electronic games. The available evidence suggests electronic games and TV have different associations with PA. Playing electronic games is an important discretionary leisure activity for the majority of Australian children, yet the impact of this on PA has not been tested experimentally. Further, the influence of different game technologies and child characteristics on the impact is not known. Finally, whilst it is assumed playing electronic games displaces more vigorous activities, this has not been demonstrated. Aims This project will assess the impact of electronic game use on PA in children by: 1) comparing PA and energy expenditure in a home-based RCT where children have either no electronic games or access to traditional electronic games. We hypothesise that PA and energy expenditure will be reduced when children have access to traditional electronic games. 2) comparing PA and energy expenditure in a home-based RCT where children have access to either traditional electronic games or new active electronic games. We hypothesise that PA and energy expenditure will be greater with new active electronic games, but still less than no games. 3) examining responses of different children to explore whether the impact of access to electronic games is greater in some children. We hypothesise a stronger effect on children with poor coordination skills, greater adiposity, poor social confidence, more positive attitudes to technology and less positive attitudes to PA. 4) examining displacement of sedentary and active leisure activities by electronic games. We hypothesise that all electronic games will displace active non-electronic leisure activities.

  • The effect of zoledronate on cardiovascular protection in osteoporotic elderly patients who have suffered a hip fracture.

    This is a one year study to identify the effect of Zoledronate on endothelial dysfunction, a marker or cardiovascular risk.

  • A Phase I intratumoural trial of Coxsackievirus A21 (CAVATAK) in late stage Head and Neck Cancer patients

    This study assesses the safety and effectiveness of intratumoural CAVATAK treatment of squamous cell carcinoma (SCC) of the head and neck. Patients can join the study where: - they have recurring or relapsed SCC after standard chemotherapy, - their tumour cells are shown to bear ICAM-1 receptors. Patients will receive one, three or six doses of CAVATAK injected directly into a tumour. the injected tumour and other non injected tumours will be measured by calipers and CT scans to assess the effect of the treatment. Patients will be monitors for 127 days after treatment. CAVATAK is a benign cancer killing virus that preferentially attacks tumour cells that are expressing the ICAM-1 receptor. The aim of the study is to investigate the safety and effectiveness of CAVATAK in the treatment of head and neck cancer

  • The effect of vitamin supplementation, genotype and homocysteine on migraine frequency and severity in females diagnosed with migraine with aura.

    This study aims to determine whether vitamin therapy is an effective complementary or alternative therapy for reducing migraine disability, and whether nutritional supplementation targeted to a gene specific mutation associated with migraine is proven to be effective

  • The effect of simvastatin, omega-3 fatty acids and antioxidants on lung function in ex-smokers with symptomatic airflow obstruction

    In this study, we aim to examine two interventions that could potentially slow disease progression in middle aged ex-smokers with mild to moderate chronic lung disease. There is evidence that some individuals experience a progressive decline in lung function even after ceasing smoking. This may be related to persistent lung inflammation. We will examine whether omega-3 fatty acids and nutrient antioxidants and/or statins, a treatment used to lower cholesterol, can slow the rate of decline of lung function in people with COPD. Levels of nutrient antioxidants and omega-3 fatty acids have been shown to be related to levels of lung function in epidemiological studies. Statins, which are widely used as cholesterol lowering drugs, are known to have anti-inflammatory effects. Patients with COPD who are taking statins appear to have a lower risk of death than those not taking statins. Other retrospective studies have shown that statins slow the rate of lung function decline. We propose that nutrient antioxidant and omega-3 fatty acid supplementation and statin treatment will reduce inflammation, and hence slow the progressive decline in lung function in people with obstructive lung disease. This randomised controlled trial will test both nutrient supplements (lycopenes and omega 3-fatty acids) and simvastatin treatment in patients with COPD. Eligible participants will be 35- to 60-year-old ex-smokers with post-bronchodilator airflow obstruction, a history of lower respiratory tract illness in the last 12 months or a history of chronic cough, sputum production or breathlessness in the last 12 months and C-reactive protein = 3 mg/L. There will be four study groups: Group A (active nutrient supplement intervention, active statin treatment), Group B (active nutrient supplement intervention, no statin treatment), Group C (placebo nutrient supplement intervention, active statin treatment), and Group D (placebo nutrient supplement intervention, no statin treatment). Duration of treatment will be 6 months in the pilot study and 4 years in the main study. In the pilot study, we aim to recruit a total of 40 participants from the community through advertising. The aim of the pilot study is to assess feasibility of recruitment, implementation of interventions and measurement of outcomes. The number of participants for the final multi-centre study will be determined, in part, by information obtained in the pilot study. Patients will be seen before treatment commences and then 6, 12 and 24 weeks after treatment commences for the pilot study. The primary outcome is the change in lung function (FEV1 and FVC) over 6 months (24 weeks). Secondary outcomes include systemic inflammatory markers (hs-CRP), questionnaire (regarding quality of life, breathlessness, and exacerbations), exhaled nitric oxide, induced sputum, and exercise capacity. The first hypothesis to be tested is that statins and omega-3 fatty acids/ antioxidants have a synergistic beneficial effect (multiplicative) on outcomes. If this is not supported, the second hypothesis that the two interventions, separately, have an effect on the outcomes. Relationships between the change in lung function and inflammatory markers will also be explored.

  • International Study to Predict Optimised Treatment in Children and Adolescents with Attention Deficit/Hyperactivity Disorder

    The primary purposes of the iSPOT-A study are 1) to identify objective markers of ADHD, using cognitive, brain and genetic markers, and 2) to identify objective markers that predict treatment response to short-acting methylphenidate using cognitive, brain and genetic markers.

  • An open trial of a Cognitive Behavioural Therapy (CBT)-based smoking cessation plus Varenicline intervention in people with a psychotic disorder

    Rates of smoking are very high (>70%) amongst people with psychotic disorders such as schizophrenia, and this contributes to overall cardiovascular disease and other health risk, and contributes to premature morbidity. Current treatments targeting smoking in this group have had unsatisfactory outcomes, leaving a major gap in service provision. This study aims to evaluate a validated cognitive-behavioural smoking cessation intervention together with Varenicline, a novel smoking cessation medication. Given that this agent has the potential to have psychiatric side effects in people with a predisposition to mental illness, comprehensive safety checks will be put in place to ensure safety of participants.

  • The effect of daily versus depot vitamin D3 supplementation on vitamin D deficiency in Aboriginal children and adolescents in metropolitan and rural Western Australia

    The aims of the study are: 1. To examine if vitamin D deficiency is common problem in Aboriginal children in Western Australia (WA) 2. To determine if depot and daily vitamin D therapy have the same therapeutic outcomes. 3. To examine the relationship between vitamin D levels and childhood infections. 4. To determine the predictors of vitamin D deficiency in Aboriginal children We hyypothesize that: 1. Vitamin D deficiency is a common problem in Aboriginal children in WA 2. Depot vitamin D therapy results in better therapeutic outcomes than traditional daily vitamin D therapy. 2. Children with lower vitamin D levels have a higher burden of childhood infections. 3. Age, sun exposure, skin pigmentation and nutrition will influence vitamin D levels in children

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