ANZCTR search results

This study will evaluate the safety, including blood sampling for pharmacokinetic monitoring, of a new topical anti-infective (NEO101) applied to each nostril. A single dose will be applied on Day 1 and Day 7 of the study, and three-times-daily doses will be applied on Days 4, 5 and 6.

Trial will involve 80 obese subjects with BMI above 30. It will be randomised placebo controlled trial. Subjects will take Chinese herbal capsules for 12 weeks. The endpoints will be evaluated every 2 weeks.

Main purpose of this study is to identify if there is a need to offer of a large print label, on eye medications, to glaucoma patients that display certain visual function and disease characteristics. In turn, this may assist these patients in adhering to their prescribed treatment.

Gout is an inflammatory condition caused by the deposition of urate crystals in tissues/joints. Allopurinol is a common and effective treatment to prevent gout. Probenecid, although less common used, is also effective, but may be less effective in patients with impaired renal function. In patients with tophaceous gout or those unresponsive to allopurinol/probenecid alone, the combination is sometimes prescribed. Studies in healthy subjects have shown that although the elimination of oxypurinol (active metabolite of allopurinol) is increased when probenecid is taken concurrently with allopurinol, the combination therapy has a greater therapeutic effect (decreased plasma urate concentrations). The relevance of these findings for gouty patients is unknown. Thus, this project will examine the interaction between allopurinol and probenecid in gouty patients and determine the therapeutic effect in patients with a range of renal function.

Aims - To refine treatment selection for women with non-low risk DCIS to optimise disease control & minimise toxicity - Clinical: To evaluate outcomes after breast conserving surgery by investigating two factors - Addition of tumour bed boost to whole breast RT - Dose fractionation - QoL To compare QoL, psychological distress, perceived risk of invasive disease & perceived cosmetic outcomes amongst treatment arms - Biological: To identify biomarkers/molecular signatures of DCIS predictive of invasive recurrence for therapy individualisation

Obstructive sleep apnoea (OSA) is a relatively common condition in children with a peak incidence between 2-6 years, coincident with the maximal size of adenotonsillar tissue relative to the upper airway. OSA has effects on neurocognition and behaviour which may be reversed by adenotonsillectomy. However, surgical treatment carries risks which are increased in children with OSA and children under the age of 3 years. Recent studies have suggested that anti-inflammatory treatment with nasal corticosteroids or with anti-leukotriene agents may be an alternative to surgery. Montelukast is an anti-leukotriene receptor antagonist with minimal risk of adverse effects. A randomised double-blind placebo-controlled trial of montelukast for the treatment of OSA related to adenotonsillar hypertrophy in children is proposed. Following a sleep study (PSG) showing mild OSA, children will be randomised to a once daily dose of Montelukast or placebo for 8 weeks. At the end of treatment a repeat sleep study will be performed as well as measures of disease-specific quality of life, behaviour, attention and cognition.

The primary purpose of the study is to test whether a supplement containing a specific component of cocoa (called flavanol) will decrease blood pressure, improve the function of the lining of blood vessels and increase sensitivity to insulin if consumed for 24 weeks.

This is a TROG multicentre feasibility study of APBI using 3D CRT in selected women with node-negative breast cancer treated by breast conserving surgery with negative margins. This is a one-arm feasibility study in which the primary endpoint is the feasibility rate for APBI using 3D CRT. This is defined as the proportion of eligible patients treated without a major protocol deviation. Secondary endpoints include radiation toxicity, cosmetic outcome, quality of life, time to ipsilateral breast recurrence, disease-free survival and overall survival. Primary objectives: To evaluate the technical feasibility and reproducibility of APBI limited to the region of the tumour bed using 3D CRT following breast conserving surgery. Secondary objectives: - To assess the acute and long term toxicity of APBI using 3D CRT. - To examine the cosmetic outcome of women with breast cancer treated by breast conserving surgery and APBI using 3D CRT. - To determine the time to ipsilateral breast recurrence, disease free survival and overall survival of women with node-negative breast cancer completely resected by breast conserving surgery followed by APBI using 3D CRT. - To assess the quality of life of women with node-negative breast cancer treated by breast conserving surgery and APBI using 3D CRT

This trial is designed primarily to determine whether maximal androgen deprivation, prior to and during radiation therapy, reduces the rate of local failure and appearance of metastases that takes place after radiation therapy. A secondary aim is to determine whether a short period of androgen deprivation (3 months) is as effective as a longer period (6 months). A tertiary aim to see whether the tumour shrinkage caused by androgen deprivation prior to radiation therapy leads to any noticeable reduction in the long-term side-effects of subsequent radiation therapy. By defining the tolerability of and compliance with the regimens used, the final objective is to determine whether androgen deprivation as produced in this study is applicable for widespread use outside of the randomised clinical trial setting.

This study examines the effect of a high energy intake on inflammation in asthma. We hypothesise that a high energy diet will cause an increase in both systemic and airway inflammation. Subjects are randomly assigned to a high energy or low energy diet for 24 hours. Systemic and airway inflammation will be assessed at 0, 4 and 24 hours.