ANZCTR search results

The aim of this pilot trial is to evaluate the feasibility of conducting a large multi-centre trial which will investigate the efficacy and safety of tranexamic acid in patients undergoing lower-limb arthroplasty. Tranexamic acid has been approved for use in lower limb arthroplasty in Australia. Although there is evidence to support its efficacy in reducing bleeding, trials examining the incidence of uncommon but serious thrombotic complications in patients receiving TXA for arthroplasty procedures have been small and heterogeneous. A large randomised controlled trial is required, and this pilot study is designed to enable the refining of trial methodology and to determine the feasibility of conducting trial procedures in a smaller group.

This study is evaluating the effectiveness of a dietitian delivered health behaviour intervention to reduce malnutrition in head and neck cancer patients undergoing radiotherapy. Who is it for? This study is taking place within six Australian Hospitals. You may be eligible to join this study if you are aged 18 years or more, and have a confirmed diagnosis of cancer involving the nasopharynx, oropharynx, oral cavity, larynx, or hypopharynx requiring definitive or postoperative radiotherapy with curative intent. Trial details All sites will begin in the ‘control’ condition – dietitians will provide ‘treatment as usual’. Participants recruited during this phase will receive treatment as usual by trained dietitians according to standard hospital practice. At a randomly determined time point, researchers will attend the hospitals to provide training to the dietitians. Dietitians will then provide ‘EAT’ (Eating as Treatment) as part of standard dietetic consultations (weekly during treatment, fortnightly for six weeks and then ‘as needed’). You will not be aware of whether you are participating in the 'control' or 'intervention' phase. EAT is a dietitian delivered health behaviour change intervention designed to improve health behaviours of head and neck cancer patients and maintain their nutrition over the course of their radiotherapy. Of particular interest are behaviours related to sufficient daily nutritional intake, either orally or via feeding tube. Participants will be regularly assessed for up to 12 weeks post radiotherapy treatment in order to evaluate nutrition status. Information about mood, smoking and alcohol use, therapeutic alliance and radiotherapy side effects will also be collected from participants. Medical records will be reviewed to collect a range of information including total radiotherapy treatment time, unplanned hospital visits, length of stay, dietitian contact and referral to appropriate services for depression.

The study is investigating the sensations that people feel when different menthol or capsaicin gel is placed on their skin over a 15-minute time frame and whether the onset of these sensations occurs more quickly when the skin is pretreated with microneedles (tiny needles that push a very short distance into the skin). We hypothesise that the microneedles will increase permeation of the applied drugs across the skin giving faster and more intense sensations.

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