ANZCTR search results

The primary purpose of the study is to test the efficacy of HFNP WHO compared to standard oxygen therapy (cold low flow) in the treatment of acute moderate bronchiolitis using time to event data (time to oxygen weaning) as the primary outcome. Three supporting safety outcomes and several exploratory outcomes are included in this single site clinical trial.

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 greater than 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. 1. That the addition of the phosphodiestrase-5 (PDE-5) inhibitor tadalafil will improve symptoms, exercise tolerance, pulmonary arterial pressure, right ventricular (RV) function 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. 1. We propose to use the PDE-5 inhibitor tadalafil which selectively dilates pulmonary vessels and has beneficial effects on RV function in patients with HF-PEF and assess the effect on symptoms, exercise tolerance, echocardiographic and Cardiovascular Magnetic Resonance (CMR) imaging parameters of heart failure.

This project involves an investigation amongst noise-exposed professional orchestral musicians into the usability of an electronic hearing protection device. The device is specifically designed for musicians and apparently capable of delivering hi-fidelity sound to the ear at a level that will protect the wearer from noise-induced hearing loss in a performance or rehearsal setting. Twenty-four musicians selected from two professional orchestras will be fitted with the device and be closely monitored for both their reaction to and their use of the device over a period of four weeks during ‘at-risk’ activities. The actual attenuation provided by the device will be determined in each subject using standard audiological test techniques. The device will also be subjected to laboratory testing to determine if manufacturer’s claims of attenuation and fidelity are reproducible.

Background: Uncontrolled asthma during pregnancy is associated with the maternal hazards of disease exacerbation, and perinatal hazards including intrauterine growth restriction and preterm birth. Interventions directed at achieving better asthma control during pregnancy should be considered a high priority in order to optimise both maternal and perinatal outcomes. Poor compliance with prescribed asthma medications during pregnancy and suboptimal prescribing patterns to pregnant women have both been shown to be contributing factors that jeopardise asthma control. The aim is to design and evaluate an intervention involving multidisciplinary care for women experiencing asthma in pregnancy. Methods/Design: A randomized controlled trial testing a Multidisciplinary Approach to Management of Maternal Asthma (MAMMA[copyright]) which involves education and regular monitoring. Pregnant women with asthma will be recruited from antenatal clinics of one maternity hospital in Victoria, Australia. Recruited participants, stratified by disease severity, will be allocated to the intervention or the usual care group in a 1:1 ratio. Both groups will be followed prospectively throughout pregnancy and outcomes will be compared between groups at three and six months after recruitment to evaluate the effectiveness of this intervention. Outcome measures include Asthma Control Questionnaire (ACQ) scores, oral corticosteroid use, asthma exacerbations and asthma related hospital admissions, and days off work, preventer to reliever ratio, along with pregnancy and neonatal adverse events at delivery. The use of FEV1/FEV6 will be also investigated during this trial as a marker for asthma control. Discussion: If successful, this model of care could be widely implemented in clinical practice and justify more funding for support services and resources for these women. This intervention will also promote awareness of the risks of poorly controlled asthma and the need for a collaborative, multidisciplinary approach to asthma management during pregnancy. This is also the first study to investigate the use of FEV1/FEV6 as a marker for asthma control during pregnancy.

This study aims to assess the agreement between the laboratory measurement of blood haemoglobin and that obtained from two devices which measure haemoglobin at the patients bedside thus providing rapid results which can be used to guide management. One is the HemoCue 'Registered Trademark' device measures Hb concentration from very small amounts of blood either from a finger prick or the veins, the other is the Masimo Pronto-7 'Registered Trademark' spectrophotometry device measures Hb concentration non-invasively using light sensors on a finger probe similar to those used to measure the amount of oxygen in the blood.

Frailty is a condition in elderly people where there is increased vulnerability to acute illness and poor recovery. Elderly people with long-term respiratory diseases such as COPD or asthma are more likely to be frail or to become frail as compared to elderly people without respiratory disease. Frailty can be screened for, and with appropriate management, the progression of frailty may be prevented, slowed, or even reversed. This study aims to demonstrate that screening and managing frailty in elderly respiratory patients will improve their health outcomes over 12 months.

Exercise has been identified as an important element in the management of neck pain but it is not known which type is the most optimal. Virtual reality training might be of benefit. Various sensorimotor and kinematic impairments have been identified in patients with neck pain, and should be addressed in treatment. This research aims to investigate the effect of two types of exercise regimes on neck impairments. One regime will include balance, repositioning, eye and kinematic exercises tailored to the patients. The other exercise regime will include this as well as interactive VR training fascilitating cervical motor control and quick mobility in patients with neck pain.

The research project aims to show by offering a relatively flexible and straightforward dietary regimen low in carbohydrate (replaced with protein and/or unsaturated fat) to poorly controlled type 2 diabetes patients (HbA1c >7.5%), HbA1c will be significantly reduced over a period of 6 months in the absence of weight loss.

Queen Garnet Plum (QGP) is a result of a Queensland Government innovative breeding project. Agri-Science Queensland, a service of the Department of Agriculture, Forestry and Fisheries (DAFF) has shown QGP to have 5-10 times higher antioxidant levels compared to all other varieties of plums. We hypothesize that antioxidant rich QGP may lead to decreased platelet and clotting activity, reducing inflammation and improving lipid profile by influencing fat metabolism in normal healthy population as well as under increased oxidative stress conditions. The aims of the present double blind crossover interventional study are to compare and examine effectiveness of the 4 weeks supplementation of Queen Garnet Plum with commercial Bickford prune juice and a colour and sugar matched placebo on platelet and haemostatic function as well as inflammation markers and lipid profile in normal healthy population. We wish to prove our hypothesis that due to high antioxidant (anthocyanin) content these fruits may be instrumental in preventing cardiovascular disorders by attenuating platelet and haemostatic activity. For the first protocol of the study, 20 volunteers will be screened for recruitment to the study based on inclusion and exclusion criteria. Each participant will undertake 3 oral supplementation treatments for 4 weeks each with a washout period of two weeks between each treatment. A pre and post treatment fasting blood and urine sample will be collected to evaluate the efficacy of each treatment and comparison between placebo and two types of plums. Each blood sample will be tested for full blood examination, 3 different types of platelet function tests, coagulation profile, inflammation marker, lipid profile, uric acid and full blood + urine antioxidant levels with specific polyphenol quantitative screen. Second protocol will be similar to first protocol but with only 2 oral supplementation treatments of 4 weeks each with one 2 week washout period between them. The participants will be tested for VO2max by physician trained in exercise science prior to starting this protocol of the trial. A fasting blood and urine sample will be collected from each participant both pre and post induced oxidative stress by 45 min – 60 min exercise at 70% of maximal aerobic power (VO2max) before and after 4 weeks consumption of QGP and placebo. Testing protocol will be similar but including some specialised testing of platelet surface markers and thrombolytic pathways to examine the mechanistic pathways affected by the plum supplementation in reducing the thrombotic risk factors.

This is an observational registry to assess the long-term safety and efficacy of the HiQCell procedure in patients who have been prescribed the procedure to treat joint arthritis following a registered medical specialist consultation.