ANZCTR search results

The ablation procedure uses tools called catheters to treat the atrial flutter. Ablation catheters are thin, flexible plastic tubes that use electrical energy to stop abnormal heart rhythms by heating (ablating) and destroying a small area of tissue to break the abnormal pathway. The purpose of this study is to evaluate the safety, performance and effectiveness (success) of a new ablation catheter that is used to treat atrial flutter. The new catheter is called the Intellitip MiFi XP Ablation Catheter. The catheter is made by the company Boston Scientific Corporation, who is also the sponsor of this research study.

Bronchiolitis is a common viral infection of the lungs. It is mostly seen in children less than 1 year old, but it does affect children up to 2 years of age. Each year an average of 100 children with severe bronchiolitis need to be admitted for treatment in the intensive care unit. These children experience significant breathing difficulty and many are ill enough to need a machine to help them to breathe. The standard treatment for these children is to support their breathing, and to give them adequate nutrition and fluids. There are no other medications that have been shown to benefit children with bronchiolitis. Steroids and adrenaline are two medicines that are commonly used to treat children with severe croup or asthma, and recent research suggests that they may help children with mild bronchiolitis. Steroids are an anti-inflammatory medicine, and adrenaline helps to expand inflamed narrowed airways. It is possible that using a combination of these medicines may reduce the amount of respiratory support required for those children admitted to the intensive care unit with bronchiolitis. Some doctors already use this medicine in intensive care because they believe it works, but other doctors do not use this medicine because they do not think there is enough evidence that it works in intensive care patients. The purpose of this research project is to see whether dexamethasone (a type of steroid) and adrenaline makes a difference in the treatment of children with bronchiolitis in intensive care. Adrenaline and dexamethasone are medicines that are approved for use in children by the Therapeutic Goods Administration, Australia. We will compare a group of children who receive the standard treatment for bronchiolitis with a group of children who receive the standard treatment plus steroids and adrenaline. We will compare the amount of respiratory support needed, the duration of mechanical ventilation and the length of stay in intensive care and in hospital in both groups. We aim to study a total of 305 children from The Royal Children’s Hospital, Melbourne. This research will also take place at Princess Margaret Hospital for Children in Perth and the Starship Hospital and Middlemore Hopsital in New Zealand.

For many years, some eye surgeons have given patients having cataract surgery an injection of dexamethasone (a type of cortisone or steroid) into the surface of the eye (subconjunctival) at the end of surgery. Dexamethasone is approved in Australia to treat inflammation of the eye during and following eye surgery. Some surgeons believe the injections are not needed because: 1. The steroid drops are usually enough to help the eye recover 2. The injection can occasionally hurt Others surgeons use the injection because: 1. It seems to makes patients’ eyes more comfortable for the first few days after surgery 2. It may help vision to improve faster after surgery by reducing the risk of macular oedema (swelling of the central part of the retina) This study will not determine whether a patient receives a dexamethasone injection but will look at the outcomes of surgery. From this, we hope to show how useful it is to give a subconjunctival injection of dexamethasone at the time of cataract surgery.

This research is designed specifically to compare the performance before and after exposure to the Ambu Ascope in the clinical setting for scope guided intubation. Endpoints will be GRS score, success in intubation and time taken for intubation on the first and 5th attempts with Ascope. The null hypothesis for this research project is that there is no difference in GRS score before and after 5 attempts with Ambu Ascope

The adoption of healthy school canteen policies has been recommended as a strategy to prevent excessive weight gain. A number of jurisdictions in Australia and internationally have policies requiring school adoption of healthy canteen strategies. Despite this, internationally, schools have failed to adopt healthy canteen practices consistent with such policies. If the benefits of obesity prevention initiatives are to be realised, policies recommended to prevent overweight must be implemented. However, research measuring the effectiveness of interventions to facilitate widespread implementation of health promoting policies and practices in schools is limited. The aim of the research is to assess the effectiveness of a population wide implementation intervention in increasing canteen practices consistent with the mandatory NSW government healthy canteen policy (‘Fresh Tastes @ School’). The study will employ a randomised trial design. Seventy primary schools will be randomised to receive a 12 month intervention, or a no intervention comparison group. The effectiveness of the intervention will be determined by comparing post intervention differences between canteen menus audited by Dietitians in: i) the proportion of schools with a canteen menu containing foods or beverages restricted (‘red’ items) under the policy and; ii) the proportion of schools where healthy canteen items (‘green’) represent the majority (>50%) of products listed on the menu as recommended by the policy. The proposed research will be the first RCT of its kind, addresses a questions of particular policy relevance and will make an important contribution to reducing the burden of obesity.

The primary aim of this study is to investigate the efficacy and safety of adjunctive N-acetylcysteine (NAC) in the treatment of adults (n=80) with DSM-IV diagnosed OCD in a 16-week randomised, placebo-controlled trial. The primary outcome will be between group differences the severity of OCD symptoms on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS).

CardioCel is a new method to prepare and treat biological tissues used in human surgical procedures. This means that the tissue (here bovine pericardium) used to close or repair defects associated with congenital heart disease has not been approved for this purpose in Australia or in other parts of the world. This project is going to allow us to show if the CardioCel integrity is maintained. We believe the CardioCel to be equivalent to currently available patches used to repair congenital heart disease

Griseofulvin inhibits ferrochelatase (FECH). Inhibition of FECH in the red cell prevents the growth of malarial parasites. We plan a trial using griseofulvin to treat volunteers infected with malaria. This current proposed trial is a pharmacokinetics trial with two different regimen of griseofulvin, 500mg bd or a one-off bolus of 2g. The concentration of griseofulvin in red cells will be measured daily as will the ability of malarial parasites to infect cells taken from griseofulvin-treated volunteers. Haematological and clinical biochemical parameters will be followed.

A prospective, single arm, single centre, open label, clinical trial to evaluate the safety and efficacy of the Perceval S Sutureless aortic valve prosthesis. More specifically to assess: Functional performance of the valve through echocardiograms pre-operatively, intra-operatively and 5 days, 6, 12 and 24 months and 5 years post-operatively Quality of life with the SF36 pre-operatively, 6 weeks and 6 and 12 months post-operatively Mortality

Penthrox® (methoxyflurane) is an analgesic/device combination product, which is currently registered and marketed in Australia. Methoxyflurane belongs to the fluorinated hydrocarbon group of volatile anaesthetics. It is inhaled as a vapour at low (sub-anaesthetic) concentrations to provide analgesia in stable, conscious patients. hERG studies have indicated a potential for QT prolongation, a known property of this pharmacological class. However, clinical history has provided no indication that methoxyflurane may cause ventricular tachyarrhythmia or Torsades de Pointes (TdP) under conditions of use in analgesia. This study is specifically design to assess drug effects on the QT interval.