ANZCTR search results

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

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32882 results sorted by trial registration date.
  • Mobile 'App' to Improve Iron and Zinc Intake, Iron and Zinc Status, Cognition, Mood and Fatigue in Premenopausal Women

    Premenopausal women are at increased risk of iron deficiency due to iron losses in menstrual blood and increased requirements during pregnancy. Additionally, inadequate consumption of dietary iron or over-consumption of compounds that impede absorption of iron (e.g. phytate) can result in iron requirements not being met. In addition, women who have a low dietary intake of iron and a low iron level are frequently at risk of a low intake of zinc. Rich dietary sources of iron also tend to be rich sources of zinc. Currently very little is known about the zinc status of Australian women. The aim of this study is to investigate the use of technology to improve iron status, by determining if the dietary advice delivered by the mobile apps can 1) increases intake of bioavailable iron and zinc compared to a control "healthy diet" group; and 2) results in a significant improvement in iron and zinc status and markers of cognition, mood and fatigue compared with a control "healthy diet" group. We hypothesise that: The use of a mobile phone app to optimise intakes of bioavailable iron and zinc over a 16-week period in premenopausal women with low serum ferritin will result in: a) higher dietary intake of bioavailable iron and zinc; b) a greater improvement in iron status; c) a greater improvement in cognition, mood (including indicators of depression and anxiety), fatigue and sleep compared to a control "healthy diet" group.

  • Phase III randomised trial of high dose Cyclophosphamide, Epirubicin, Vincristine and Prednisolone (CEOP) chemotherapy regimen & Filgrastim versus standard dose CEOP chemotherapy regimen in patients with non-Hodgkin’s lymphoma

    This study evaluated the effectiveness of high dose Cyclophosphamide, Epirubicin, Vincristine and Prednisolone ifosfamide (CEOP) chemotherapy regime with Filgrastim, and standard dose CEOP chemotherapy regime in patients with non-Hodgkin's lymphoma (NHL). Who was it for? Patients were eligible to join this study if they were aged 16 years or more, had been diagnosed with NHL (Histological types: Follicular large cell (Group D), Diffuse mixed small cleaved and large cell (Group F), Diffuse large cell (Group G) or Large cell immunoblastic (Group H)), and had not received previous chemotherapy or radiation therapy for NHL. Trial details Participants in this trial were randomly (by chance) allocated to one of two treatment groups. Participants in group 1 received a high dose CEOP chemotherapy regime with Filgrastim which involved 1500mg/m2 of Cyclophosphamide intravenously on day 1, 150 mg/m2 of Epirubicin intravenously on day 1, 1.4 mg/m2 (maximum of 2.0mg) of Vincristine intravenously on day 1, 100 mg/day of Prednisolone orally from days 1 to 5, and 5 micrograms/kg/day of Filgrastim subcutaneously from day 2 until Absolute Neutrophil Count was greater than 10 x 109/L for a maximum of 14 days. This treatment regime was repeated every 3 weeks and was administered to participants 6 times. Participants in group 2 received standard dose CEOP which included 750mg/m2 of Cyclophosphamide intravenously on day 1, 75mg/m2 of Epirubicin intravenously on day 1, 1.4mg/m2 (maximum of 2.0 mg) of Vincristine intravenously on day 1, and 100 mg/day of Prednisolone orally from days 1 to 5. Similarly to group 1, this treatment regime was repeated every 3 weeks and was administered to participants 6 times. All participants were assessed prior to treatment, after 3 courses of the treatment, at completion of the 6 courses of the treatment, at 3 months post treatment, at 6 months post treatment and at 5 years post treatment to assess the effectiveness of the treatment regimes.

  • Prevention of avoidable hospital admissions of older people living at home in Western Australia: a pilot randomized control trial.

    There is published evidence for avoidable hospital admission of older people. However no effective intervention has been adopted as routine practice. A pilot randomized controlled trial is proposed for initial evaluation of a complex intervention, comprising multidisciplinary input into the care of older people at risk of hospital admission for unmet need. Older people will be identified by a review of admission records and further described using a set of measures assessing for physical, social and psychological needs. The needs of those assigned to receive the intervention will be reviewed and addressed by a general practitioner supported by a multidisciplinary team. The study will generate data on: 1)Identifying and engaging at-risk patients 2)Operating a multidisciplinary team- including primary care practitioners who are not formally employed in general practice 3)The relevant interventions that are funded by Medicare and the logistics of delivering those interventions 4)The uptake of such interventions by patients 5)Developing the role of GP as care coordinator within a multidisciplinary team structure. This project will address the recommendations of a recent Cochrane review on reducing hospital admissions. The intervention will be developed with reference to published Australia data and the UK Medical Research Council framework for the development and evaluation of complex interventions. This pilot study is a forerunner to a multi-centered, fully powered randomized controlled trial.

  • Prospective Validation Study of the International Classification of Functioning, Disability and Health Score in Crohn’s disease and ulcerative colitis.

    The central hypothesis is that the IBD-DI is an objective measure of disability in IBD that correlates with work absenteeism. The primary objective of the study was to design and validate a numerical scoring system for the IBD-DI to measure IBD disability using standard statistical techniques. Secondary endpoints include identification of the extent of severe disability, correlation of disability with work absenteeism, and identifying predictors of employment status.

  • Effects of L-leucine (alone or in combination with L-tryptophan or lauric acid) on gut functions, gastric emptying, gut hormone release and blood glucose control in healthy, and obese humans with type 2 diabetes

    There is increasing evidence that nutrient stimuli in the gut, especially in the small intestine, induce changes in gut motor and hormonal functions that play a central role in the control of energy intake and blood glucose. Previous research by our group has shown individual amino acids (L-tryptophan) and free fatty acids (lauric acid) to markedly reduce energy intake at a subsequent meal when administered intraduodenally or orally, respectively. This study aims to investigate the effects of the amino acids L-leucine, alone or in combination with L-tryptophan or lauric acid, on gut motility, gut hormone release, blood glucose control and energy intake in healthy lean individuals and obese patients with T2DM. We hypothesise that L-leucine, administered in combination with L-tryptophan or lauric acid, will take advantage of the several pathways activated by these two classes of nutrients enhancing their potency and thus, resulting in a marked improvement in the beneficial effects on gut functions and energy intake regulation previously associated with these nutrients alone.

  • Testing the effectiveness of a mindfulness-based intervention to reduce distress in people with diabetes

    Mindfulness-based intervention programs are a promising intervention in the treatment of psychological distress in a range of clinical populations including pain disorders, cancer and other medical problems. There is, however a paucity of studies that have examined mindfulness in people with diabetes. The few studies that have been undertaken have shown the intervention to result in improvements in emotional well-being (anxiety and depression), improved self-care behaviours and decreased HbA1c values. This study will assess the effects of a mindfulness-based intervention undertaken and self-directed in people with diabetes at home over an eight-week period. This study will seek to determine whether a mindfulness-intervention undertaken in the patients’ home can: Reduce anxiety and depression Reduce perceived diabetes –specific stress Improve diabetes self-care and management Improve glycemic control (HbA1c) Increase mindfulness strategies (acceptance and action) in relation to diabetes

  • An Intervention to Increase Meaningful Occupation After Traumatic Brain Injury: The Participation, Engagement and Productive Alliance (PEPA) Program

    Participation in the workforce is often not possible for people who have sustained a severe traumatic brain injury (TBI). Furthermore, a large proportion of those who are unable to return to work also do not engage in any meaningful occupation in lieu of work. Such people generally have sustained major impairments of the cognitive functions essential to the development of meaningful occupational activities; specifically the ability to plan, initiate action, and to monitor and/or sustain activity. They often require structure and support if they are to develop a program of meaningful activities. This project specifically addresses the issue of diminished meaningful occupational activity for those who have sustained a TBI and are unable to return to work. Using single case experimental design methodology this study will provide individual intervention specifically aimed at increasing the person’s engagement in meaningful activity.

  • The Maternal Pertussis Study: best practice for the communication of pertussis (whooping cough) booster vaccine recommendations to new mothers.

    The cocooning strategy, which was implemented in Australia in 2009, can have a strong protective effect (indirect) against pertussis in infants. To achieve high maternal coverage, understanding maternal attitudes and other potentially influential factors is important. In this study, we examined the influence of baseline attitudes, modifiable factors and health message framing on pertussis booster vaccine uptake among postpartum women in the public hospital setting.

  • A Randomised, Placebo-Controlled, Double-Blind, Single Dose Escalation Study to evaluate the Safety, Tolerability and Pharmacokinetics of Betahistine Dihydrochloride Following a Single Intranasal Dose in Healthy Male and Female Volunteers.

    Betahistine dihydrochloride administered off-label intranasally is an experimental drug being investigated for its potential as a treatment for otitis media with effusion for this clinical trial. lt is hoped that this information will lead to improved clinical management of this condition.

  • Effects of Vitamin D-enriched mushrooms, Vitamin D and mushroom controls on cognition and mood in older adults

    Vitamin D deficiency is prevalent in the elderly and Vitamin D status has been correlated with cognitive performance in a number of epidemiological studies. However, the potential benefit of correcting Vitamin D status on cognition is unknown. The Vitamin D content of mushrooms can be increased to biologically useful levels by a short exposure time to UV light. The aim of this study is to determine if increasing vitamin D status by consumption of either Vitamin D2-enriched mushrooms (VDM) or Vitamin D3 supplement, will improve cognitive function and affect depressive symptoms in healthy aged people (Primary Outcomes). Controls will include a placebo and also standard mushrooms (low Vitamin D) so as to resolve the effects of Vitamin D2 per se from other mushroom-derived nutrients, including micro-nutrients and neurotrophic factors, which have some evidence for benefits to cognition per se.

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