ANZCTR search results

We will test a new approach to a form of heart failure (HF) with no current treatment proven to reduce death rates or hospitalisations. Over a third of HF cases have preserved ejection fraction (HFPEF) often on a background of high blood pressure (BP). These “stiff” hearts pump strongly but fill inefficiently resulting in poor exercise capacity and high death rates. Treatments that help when heart pumping action is poor are of no benefit in HFPEF. Recently a simple catheter procedure removing excess nerve signals to and from the kidneys (“renal denervation”; RDN) has been able to reduce BP in patients with high BP resistant to multi-drug treatment. Through removing excess nervous drive to the kidneys, heart and circulation this treatment has promise in HF. We will compare effects of RDN and standard medical treatment on heart function, exercise capacity and quality of life in 144 patients with HFPEF.

Clinical study aiming to assess how the pharmacokinetics (i.e. the way the body absorbs, distributes and gets rid of a drug), safety, and tolerability of the drug siponimod are influenced by the presence of specific genetic characteristics (namely CYP2C9 genotypes).

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, many schools have not adopted healthy canteen practices consistent with mandated policies. One reason why many schools are yet to adopt healthy canteen policy is that current interventions aiming to improve practice cannot feasibility be extended to large numbers of schools, in particular to those in rural and remote communities. A promising solution to support population wide practice change of school canteens is audit and feedback. However, currently no evaluation of audit and feedback has been conducted in this setting. The aim of this research is to assess the effectiveness of an audit and feedback intervention to increase the adoption of canteen practices consistent with the mandatory NSW government healthy canteen policy (‘Fresh Tastes @ School’). Seventy-two primary schools that provide canteen services to students will be recruited to participate. Schools will be randomised to an intervention group receiving a 12 month audit and feedback intervention delivered via telephone and written report, or a no intervention comparison group. The effectiveness of the intervention will be determined by comparing post intervention differences between canteen menus audited by Dieticians 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 is the first evaluation of an audit and feedback intervention in primary schools. The study is of relevance to the efficient delivery of population wide services, particularly to those in rural and remote communities, aiming to reduce the burden of obesity.

The study is evaluating the effectiveness of structured interventions to improve quality of life in head and neck cancer survivors. Who is it for? You may be eligible to join this study if you are aged 18 years or more, and have a diagnosis of head and neck cancer for which you have completed treatment within the past month at one of the participating sites. Trial details: Participants in this trial are randomly (by chance) allocated to one of three groups. Participants in group 1 will receive a written resource, “Facing the future: Living with confidence after treatment for head and neck cancer” in addition to usual care. The 61 page publication was developed by a number of health professionals involved in the treatment of people with head and neck cancer, and contains detailed information and recommendations about coping with issues such as diet and swallowing problems, oral health, fatigue, pain, stress, emotional concerns and communication. Participants in Group 2 will continue to receive usual care and the resource “Facing the future: Living with confidence after treatment for head and neck cancer”. In addition they will meet with an oncology nurse who has undergone specific training in developing a tailored survivorship care plan. The face-to-face meeting will take between 30 and 60 minutes and will focus on issues which are of concern to the patient. For example the care plan might include a graded approach to improving fatigue, or a plan about how to get into a routine to manage oral health. It might include details about how to cope with social interactions and relationship concerns, or fear of eating in public. The care plan will be designed to not just list information – it will be designed to enable participants to work out how to feel more in control of their health, deal with anxiety and give them confidence about when and how to get professional advice as needed. Once the survivorship care plan is complete the patient will receive a written copy so that they can keep working on the issues in it. A copy will also be sent to their General Practitioner so that the GP is familiar with the issues the patient is working on and can provide ongoing assistance as necessary. Participants in Group 3 will continue to receive only the standard care provided at the clinic where they received treatment. Participants will be asked to complete some questionnaires at the start of the study, and 3 and 6 months later in order to assess their quality of life. Feasibility and cost-effectiveness of the two interventions will also be assessed.

Study is designed to evaluate and examine pain levels, mechanical force and peak pressure in natural, reconstructed and augmented breast tissue with and without a new orthosis designed for reduction of displacement, compression and loading forces through the breast tissue during prone activities.

Obese individuals are known to suffer from significant cognitive deficits, especially in the area of executive function, leading to poor planning, impulse control and decision making deficits. Research in this field has identified a point at which an intervention could interrupt this vicious cycle. This project aims to examine the relationship between cognition and obesity through a randomized controlled trial (RCT) testing the efficacy of a novel cognitive remediation therapy (CRT) in obese individuals to reduce these deficits and aid weight loss maintenance

Research suggests that carrier proteins may unpredictably enhance or reduce immune response to the polysaccharide antigens; therefore administering dTpa before, with, or after MCV4 is an important matter with regard to immune response to vaccines. There are no data Adults on whether the receipt of dTpa before, after or concomitantly with MCV4 and PCV13 would enhance or suppress immune response. Therefore, we would like to explore further means in order to optimise immunity and maximise immunogenicity of these vaccines in Hajj or Umrah pilgrims. In addition to optimising the immunogenicity of the recommended vaccines, this study will also explore the pilgrims’ pre-travel health seeking behaviour and assess their Knowledge Perception and Attitude (KAP) towards the recommended vaccines.

The purpose of Part 3 of the study is to determine what the highest dose of DSM265 (study drug) is that can be safely given to people. This will be determined by how it makes people feel, how the body absorbs, processes and gets rid of DSM265 when receiving DSM265 every day for 3 days in increasing doses for the treatment of malaria. This trial is to be conducted under the Australian Therapeutic Goods Administration (TGA) Clinical Trial Notification Scheme (CTN).

Escherichia coli (“E. coli”) and Klebsiella are bacteria which are common causes of infections in your blood stream. Patients with bloodstream infections due to either E. coli or Klebsiella, can commonly be treated with antibiotics called third generation cephalosporins, such as the antibiotic ceftriaxone. When the blood stream infection is resistant to these antibiotics, the antibiotics meropenem and piperacillin/tazobactam have been shown to be effective alternatives for treatment. The purpose of this study is to work out whether these two other antibiotics, meropenem and piperacillin/tazobactam, are equally effective in the treatment of these antibiotic resistant bloodstream infections. These antibiotics have never been compared “head to head” in order to establish the best available treatment for these serious infections. This research project has been designed to make sure the researchers interpret the results in a fair and appropriate way and avoids study doctors or participants jumping to conclusions.

During shoulder surgery patients are positioned into an upright sitting position for optimal access to the shoulder joint. In some patients blood pressure may decrease and a concern of the anaesthetist is whether sufficient blood reaches the brain during such surgery. Even though this can be routinely treated with cardiac drugs, the exact effect of this treatment on the brain is unknown. This study plans to investigate the changes in flow to the brain when patients are anaesthetised and placed upright. The surgery will be performed using the anaesthetic technique that we use for the majority of the surgeon’s cases. Special monitoring of the oxygen level within the brain, using reflected light waves, will be used. This technique is non-invasive and presents no harm to the patient. The study will investigate whether the administration of medication to gently increase blood pressure has an effect on blood flow to the brain, and on recovery following surgery. A number of commonly used drugs will be studied by infusing them into a large vein within the arm. By agreeing to the study patients will give us permission to make these extra measurements during anaesthesia. This will help us understand whether we are protecting the brain during surgery.