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During surgery on the bowel it is routine to replace blood and fluid loss with intravenous fluids. However, it is still unclear what the optimal amount and method is to replace this loss. This study compares giving a smaller amount of fluid, called fluid restriction, to giving fluid guided by a cardiac output monitor, called targetted fluid administration. We will assess the impact these two methods have on patient's recovery and also the effect on observed clinical signs such as cardiac output at the end of the operation.

The aim of this project is to assess the efficacy of an online system designed for patients and health care consumers, called Healthy.me, to support health management. Healthy.me provides patients and consumer condition specific information, as well as online tools to manage their care including a personal health record. Our primary hypothesis is that use of Healthy.me for patients with asthma will increase possession and uptake of a written asthma action plan. This randomized controlled trial will also specifically test whether system use is associated with the following secondary outcome measures: i) significant improvement in asthma control, ii) increased compliance according to written asthma action plan, iii) reduced unplanned utilization of health services, iv) reduced frequency of exacerbations, and iv) improved quality of life over 12 months. Patients and consumers are increasingly using online systems to make health decisions and manage their health but we still know little about their patterns of use and impact. This study will make a specific and significant contribution to our understanding of the effectiveness of online systems for patients and healthcare consumers.

To evaluate the safety and effectivness of the VIBRYNT PREVAIL Paragastric Implant System for the treatment of morbid obesity. Efficacy will be demonstrated if the average percent excess weight loss (%EWL) among those participants implanted with the PREVAIL System is found to be not inferior to the %EWL observed amoung participants implanted with the REALIZE Adjustable Gastric Band-C.

F-652 is intended for the treatment for Alcoholic Hepatitis which results in the inflammation of the liver. This is a single dose escalation study testing evaluating dose levels of 2.0, 8.0, 30.0, 120.0 and 250.0 microgram/kg. This is the first time F-652 is tested in humans and that is to establish safety and tolerability, to evaluate how the body handles the drug (pharmacokinetics) and what the drug does to the body (pharmacokinetics) compared to when the drug was tested in animal models.

Early dental decay causes much pain and suffering to very young Aboriginal children. Unfortunately dental services for many of these communities are very limited, so it is vital to utilise local health care workers to give parents advice on how to prevent dental decay. Simple dietary changes,especially night time bottle use and ealy introduction of fluoride toothpaste can greatly reduce dental decay. We wish to recruit Aboriginal Health Workers to take on this educaton program as they are well known in their communities and have an existing committment to health promotion. In addition we will be teaching them how to screen for ealy signs of decay, so children with dental problems can be fast tracked for the appropriate care. Our pilot work has led to the development of a culturally acceptable program which the AHWs feel is practical and sustainable. This trial seeks to determine whether the program will actually reduce the prevalence of dental decay in young Aboriginal children and is acceptable to parents and the AHWs.. If successful Aboriginal Medical Services will have evidence based information on which to base their dental preventive programs.

Type 1 diabetes is a condition treated with lifelong insulin injections and requires multiple daily injections. These injections are usually well tolerated but cause discomfort in some patients. A new jet injector device for painless injections of insulin without needles has been developed. This has been trialled in subjects without diabetes and shown to be an effective way of delivering insulin. Initial studies also show that the insulin appears to be absorbed more rapidly using this device compared with the usual subcutaneous injections. This is of potential benefit to patients with Type 1 Diabetes who often find that blood glucose levels rise too rapidly after meals using conventional subcutaneous injections of insulin. This study is designed test the safety and efficacy of the InsuJet device in patients with type 1 diabetes, and to measure the rise in blood glucose levels after a meal using Insujet to administer the insulin as compared with standard subcutaneous injections.

Background. It is estimated that over 300,000 Australians have heart failure (HF) at any given time and the incidence increases with increase in life expectancy. The point prevalence of chronic heart failure (CHF) has been about 1% in people aged 50–59 years, 10% in people aged over 65 years, and over 50% in people aged above 85 years. Despite therapeutic advances, HF remains a disease with unacceptably high mortality rates, poor quality of life and massive socioeconomic cost. Heart failure with preserved ejection fraction (HF-PEF) previously known as diastolic heart failure accounts for about 50% of patients with heart failure. HF-PEF refers to a clinical syndrome of symptoms and clinical signs of HF, normal or near normal left ventricular (LV) systolic function (EF> 50%) and evidence of diastolic dysfunction in the form of abnormal LV filling and elevated filling pressures. This can be objectively confirmed on echocardiogram. There is no difference in morbidity between patients with heart failure with reduced ejection fraction and those with preserved ejection fraction and some studies have shown similar mortality in the two conditions. The efficacy for beta blockers, angiotensin converting enzyme inhibitors (ACE-I), angiotensin receptor blockers (ARB) and aldosterone antagonists is well established in the treatment of HF with reduced EF. The efficacy for these drugs in HF-PEF is not well established. The I-PRESERVE trial studied the effects of Irbesartan (ARB) in symptomatic patients with HF-PEF. 4128 patients were enrolled and followed up for 4 years. There was no improvement in outcomes in patients on Irbesartan. The CHARM preserved trial studied Candesartan in 3000 patients with HF-PEF for a period of 3 years. There was only a small reduction in hospital admissions for heart failure in the Candesartan group. The PEP-CHF trial assessed the efficacy of Perindopril (ACE-I) in 850 patients over the age of 70 with HF-PEF. At one year there were fewer unexpected hospital admissions for heart failure in the perindopril group although the trial when completed showed no difference in its primary end point. Although therapies have proven effective in reducing morbidity and mortality from heart failure with reduced ejection fraction, mortality from HF-PEF remains unchanged. No therapies thus far have been proven to correct the abnormalities seen in HF-PEF, halt its progression, reduce its mortality or conclusively reduce its morbidity. Rationale. Reducing heart rate with Ivabradine will improve symptoms, exercise tolerance and LV relaxation in patients with HF-PEF Objectives. The primary objective of the study is to trial a novel agent in the treatment of HF-PEF as patients continue to be symptomatic on currently available medications. We propose to use Ivabradine which is a selective heart rate lowering agent in patients with HF-PEF and assess the effect on symptoms, exercise tolerance, echocardiographic and Cardiovascular Magnetic Resonance (CMR) imaging parameters of heart failure.

Trial of addition of adjuvant (immune enhancer) to improve effectiveness of seasonal influenza vaccine and trial of Stratis needleless injector device versus standard injection

Obesity has become a worldwide public health problem and severe obesity causes among other things, impaired quality of life above and beyond the impact of medical complications of the disease. Evidence links obesity with low self-esteem, poor body image, sexual dysfunction, and poor quality-of-life, while lifestyle changes and weight loss may improve these parameters. The aim of this study is to examine sexual function and overall quality of life among men with obesity. There is currently little known about the obesity-related health problems that are specific to Australian men, and we think it is likely that men have significant health concerns. We also believe that weight loss after bariatric surgery may significantly improve men’s health, sexual function and quality of life. In order to investigate this, we are asking men who are planning to have bariatric surgery to complete a set of surveys before their surgery and again 1-year after their surgery.

Increased ventilation during exercise has been proposed to induce osmotic (Hallstrand et al., 2005) and thermal (Tan and Spector, 2002) changes in the airways during and after exercise, resulting in airway narrowing in susceptible people with asthma. Previous study showed that Acu-TENS could alleviate the post exericse bronchoconstriction in people with asthma (Ngai et al., 2009). Thus, the main aim of this study is to evaluate the effectiveness of Acu-TENS, when compared with ventolin, on alleviating the level of bronchoconstriction after Eucapnic voluntary hyperventilation (EVH), a diagnostic test for exercise induced bronchoconstriction. People with asthma who meet the inclusion and exclusion criteria will be recruited. After informed consent, each participant will attend 4 visits to the laboratory. On each visit, participants will perform one EVH test. On the second to fourth visit, participants will receive one of the following intervention protocols: 1) Acu-TENS and placebo ventolin, 2) Placebo-TENS and placebo ventolin; 3) Placebo-TENS and ventolin, in a random order generated by a computer randomisation software, before the EVH test. The intervention will be applied by an investigator who is not involved in data collection. Both assessor and patients will be blinded to the intervention protocol. The change in FEV1 before and after EVH test obtained in each of the 4 visits will be compared. The findings of the study will elucidate whether or not Acu-TENS could alleviate exercise induced bronchoconstriction when compared with ventolin.