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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.

The LEAD study is a multi-centre, double-blind, randomised, sham-procedure controlled, clinical trial designed to investigate the safety and efficacy of nanosecond laser microsurgical intervention as a treatment for early age-related macular degeneration. In addition, the study will provide information on visual function measures as a predictor for development of, and progression to advanced, AMD.

This trial will assess age-related changes to the meibomian gland in a population aged between 25 and less than 65 years of age

Negative Pressure Wound therapy (NPWT) has been used in surgery for over 15 years for a whole range of wounds with good outcomes and many advantages to promote wound healing. Recent technological advancements have led to the production of a single use NPWT device designed for small to medium size wounds with low-moderate levels of exudates. Early uses of the dressing in literature have shown through individual case studies the potential use of Pico dressing for skin grafts leading to an earlier discharge date. However, there have been no broader studies of the use of Pico dressing in this specific treatment group. The Pico dressing is a type of single use negative pressure wound therapy produced by company Smith and Nephew. The study has been designed as a randomised control prospective trial. The main hypothesis to be tested is that the use of a single use negative pressure wound therapy with early discharge from hospital will have equal efficacy in wound healing to the current protocol of wound therapy.

This is a research study of a new treatment device designed to discourage snorers from sleeping on their back, when snoring is mainly a problem when asleep on the back. The hypotheses of this project are that by avoiding sleeping on their back, snorers would have (1) reduced frequency and intensity of snoring episodes, (2) reduced overnight cardiovascular system disturbances, and (3) lower daytime blood pressure.

This project aims to determine whether the use of non-sterile clean boxed gloves in comparison to the existing guidelines of using sterile gloves in minor skin excisions has an effect on surgical site infection (SSI). Hypothesis: The use of non-sterile clean boxed gloves in minor skin excisions in general practice will not have an effect in increasing surgical site infections (SSI) compared to use of sterile gloves.