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.
  • Buckle up safely: pre-school based interventions for appropriate use of child restraints

    The purpose of this study is to see if hands-on demonstration of child restraints, seat distribution and explanation of the right child restraint for a pre-school child can increase the use of appropriate child restraints in children aged 3-5 years. This program will be given to parents and guardians in their child’s pre-school. We will determine whether it works by comparing 14 pre-schools who get the program to 14 pre-schools who do not at the end of the school year. The number of children correctly using appropriate child restraints will be compared between the two arms of the study. It is known that a large proportion of pre-school aged children are not in appropriate child restraints, and/or are not restrained correctly, increasing their risk of injury in road crashes. We will develop and evaluate an educational intervention to increase correct and appropriate child restraint use in 3-5 year olds. The study design is a cluster randomised controlled trial and this type of design is considered a gold standard for evaluating the effectiveness of an intervention. Each of 28 pre-schools involved in the study will be randomly allocated to either receive the intervention or to continue with usual road safety programming. This randomised trial will be one of a small number of similar studies conducted internationally and the findings of this study will contribute important evidence for policy makers and road safety educators.

  • Helping to Understand Nutritional Gaps in the Elderly: An observational study to identify and prioritise risk factors for poor nutritional intake in hospitalised older adults

    This study will try to identify and prioritise causes of poor intake in a representative older medical inpatient population. Approximately three hundred consecutive patients aged 65 years and over admitted to the general medical units at Royal Brisbane and Women’s Hospital will be studied. Information on potential causes of poor intake (identified from the literature and through expert clinical consultation) including poor appetite, swallowing difficulties, delirium, depression, dietary limitations, and need for feeding assistance will be collected on day 3 and 7 of the hospital stay. On each of these days, dietary intake will be determined. Standard statistical modelling techniques will be used to identify which factors predict poor (<60% recommended) intake, after adjusting for important confounders such as age, sex and burden of illness. These results will be supplemented by detailed interviews with a smaller selection of patients and their carers in order to ensure the patients experience is adequately represented in the research.

  • Health and Unflued Gas Heaters Study: The Impact of Unflued Low NOx Gas Heaters on Lung Function and Respiratory Symptoms in Schoolchildren.

    The aim of this project is provide the NSW Department of Education and Training (DET) and other current or potential users of low NOx emission heaters with independent, reliable and unbiased evidence of their short-term impact on exposure to pollutants, symptoms and function in primary school-age children.

  • Relationship between time course and dose of vitamin E and oxidative stress in haemodialysis patients: a randomised controlled trial

    Background: Oxidative stress and inflammation are associated with increased cardiovascular morbidity and mortality particularly in patients with end stage kidney disease. Observational data support the contention that increased antioxidant intake with nutrients such as vitamin E is correlated with reduced cardiovascular morbidity and mortality in the general population. Unfortunately, most clinical intervention trials using vitamin E have failed to support this relationship. The SPACE study conducted in hemodialysis patients had a positive outcome however this has not been translated into clinical practice perhaps because of the negativity generated from studies in the general population. The failure of studies using vitamin E other than the SPACE study may simply be as a consequence of choosing the wrong form of Vitamin E, prescribed at the wrong dose, for the wrong duration to the wrong patients. Future research in this area should focus on treating patients with established measured abnormalities of oxidative stress, with a safe vitamin E formulation that is proven to be effective, at least in part, in reversing the observed oxidative stress abnormalities. Methods: Therefore, the aim of this study is to investigate the effect of different doses of vitamin E supplementation on oxidative stress markers in hemodialysis patients with proven abnormalities of oxidative stress. The study will consist of a time-course study and a dose-ranging study. In the time course study eight patients will be required to take 1600 IU/day natural (RRR) alpha tocopherol for 20 weeks. Blood will be collected every two weeks and analysed for a marker of oxidative stress (plasma isoprostanes) and alpha tocopherol. The optimum time period to decrease oxidative stress (by 50%) will be determined from this study. It is hypothesised that this will occur within 16 weeks. In the dose-ranging study 48 patients will be randomised to either placebo, 100IU/day, 200IU/day, 400IU/day, 800IU/day or 1600IU/day of natural (RRR) alpha tocopherol for a time period determined from the time course study. Blood will be collected at baseline and at the end of the study and analysed for a plasma isoprostanes and alpha tocopherol. It is hypothesised that doses =800 IU of vitamin E will be required to decrease oxidative stress by 50%.

  • Breast support education improves bra knowledge and bra wearing behaviour in young female athletes: a randomised trial

    This study aimed to investigate whether an educational intervention could improve the bra knowledge and bra-wearing behaviour of active adolescent females. It was hypothesised that, compared to a control group who did not receive an intervention, the experimental group would significantly improve their: (i) knowledge of bra fit and bra design, and (ii) ability to select a supportive, correctly fitted bra appropriate to their level of sport and breast size.

  • Treating acute psychotic symptoms in an inpatient service using Acceptance and Commitment Therapy

    The aims of the project are: -to evaluate Acceptance and Commitment Therapy (ACT) as a form of therapy in treating psychotic symptoms in an Acute Inpatient Service -to develop and administer a four-session intervention of ACT to treat psychotic symptoms in an Acute Inpatient Service -to evaluate the long-term effects of an ACT intervention in an Acute Inpatient Service -to replicate the findings of previous research in an Australian population The aims of the ACT treatment are: -to reduce rehospitalization rates for people with psychotic disorders -to reduce believability of positive symptoms -to increase commitment to value-based behavioural goals by people with psychotic illnesses

  • The CONNECT Program Pilot Study: Evaluation of a nurse delivered telephone supportive care interventon for post-operative patients with colorectal cancer

    This trial is the pilot randomised controlled trial to trial ACTRN12608000252314. The pilot randomised controlled trial (RCT) will test a novel telephone-based supportive care intervention for people with colorectal cancer. The intervention involves five structured calls from a nurse to the patients over the 6 month period after discharge from surgery. The intervention aims to improve psychosocial outcomes for patients. This pilot study aims to assess the feasibilty and acceptability of the intervention and determine any impact on patient outcomes. If the results are positive, this telephone intervention will be evaluated in a multi-centre randomised controlled trial (RCT) and could be implemented broadly in both metropolitan and rural areas, and could be adapted for other groups of carers.

  • Carisbamate Retention Study (CaReS): Comparative Study on the Long Term Effectiveness, Safety and Tolerability of Carisbamate Compared to Two Other Frequently Prescribed Anti-Epileptic Drugs (AEDs) in Patients With Epilepsy.

    This study has resumed recruitment following a protocol amendment. This is a randomized, double-blind, parallel-group, active-comparator, multi-center study. The study consists of 5 phases: pretreatment (screening), double-blind titration phase, double blind maintenance phase, a transition phase, and an open-label phase. Patients who are not eligible or choose not to enter the transition and open-label phases of the study will complete an exit phase following double-blind treatment.The primary outcome variable is long term retention rate and safety of adjunctive therapy with carisbamate vs. topiramate and levetiracetam over a six month period. This primary endpoint is a clinically meaningful measure of efficacy, safety and tolerability over time, reflecting the therapeutic effectiveness of antiepileptic drugs (AEDs). Safety evaluations including adverse event monitoring, blood tests, and vital signs will be conducted throughout the study.The hypothesis is that the 3 study medications at a minimum will have similar treatment retention rates, but based on their distinct efficacy and side effect profiles, will have discernible differences in the rates of selected adverse events and reasons for treatment discontinuation in patients with partial onset seizures. Patients must be on at least 1, but not more than 2, baseline AEDs for 30 days prior to screening. By end of week 8 patients must have reached the following minimum dosages of study drug to be permitted to continue: carisbamate 400 mg/day, topiramate 200 mg/day, or levetiracetam 1000 mg/day. Double-blind phases last approximately 12 months. Carisbamate 800 mg/day, topiramate 300 mg/day and levetiracetam 2000mg/day will be administered orally in two equally divided doses.

  • A prospective observational study - understanding the burden of adverse drug reactions and their impact on symptoms at end of life

    There is a need to quantify the extent and severity of adverse drug reactions in palliative care to inform intervention strategies to reduce the burden of harm and pharmacovigilance as new drug therapies are introduced for the management of symptoms at end of life. This study will review the case notes of all patients admitted to participating palliative care units over a 3 month period, and then to seek permission to interview 30 participants from each site for symptoms, the burden of the symptoms, medications and health service use from the time of admission until death or end of study in February 2010. 1. To analyse the contribution of adverse drug reactions to referrals to Palliative Care Services 2. To determine the nature and frequency of adverse drug reactions in patients referred to palliative care services 3. To explore the relationship between adverse drug reactions and common symptoms experienced in palliative care 4. To undertake patient interview to determine their experience of adverse drug reactions and their perception of the impact of adverse drug reactions. To describe the resource utilisation of those patients in the subset of patients interviewed with the symptoms and index medicines of interest who experience an adverse drug reaction.

  • A pilot study evaluating the effect of platelet transfusion using an electromechanical infusion pump versus conventional gravity flow method

    Our current practice at the Launceston General Hospital (LGH) and many centres in Australia is to administer platelets via a free flowing gravity line. However there are a few reports that employ a pump during platelet-administration as an acceptable practice. Administration of platelets via a pump would ensure the platelets are infused in a timely fashion but in the meantime, we should ensure that the pumping action will not damage the platelets. There are 2 pumps currently available on the oncology ward at the LGH and used for red cell transfusion; the Graseby 3000 and the Imed Gemini PC-1 and PC-2 (double pump). Furthermore the pump offers wellcontrolled infusion rate, accurate volume measurement and an alarm system for monitoring infusion. There is very little data, if any, comparing the effect of the above two recognised methods on platelet-increment after transfusion. This pilot study is aiming to determine whether infusion method influences the quality and quantity of platelets transfused. Also to determine the most efficient procedure for the administration of platelets.

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