ANZCTR search results

The primary purpose of this study is to determine whether ocular comfort can improved in symptomatic contact lens wearers by using a lens/solution combination which offers consistent performance

Many people with severe to profound, high-frequency sensorineural (permanent) hearing losses obtain minimal benefit from hearing aids, but do not meet the criteria for standard cochlear implantation. An Electric Acoustic Stimulation (EAS) device, also known as a Hybrid device, combines acoustic amplification in the low frequencies where hearing can be effectively aided, with electric stimulation in the high frequencies where hearing loss is profound, all within one implantable system. Fitting an Electric Acoustic Stimulation (EAS) device may be an effective treatment option for people with severe to profound high frequency hearing losses. As this technology becomes commercially available and the number of recipients increases, an understanding of how to best fit and combine the acoustic and electric stimulation to maximise outcomes for recipients is crucial. Although a significant amount of EAS research has been conducted over the last 10 years, the main focus of reported work has been on the post-operative hearing preservation outcomes and perceptual benefits of this intervention. To date the approach to fitting these devices has been highly variable and no systematic attempts have been made to optimise the fitting for maximising outcomes for recipients. The main aims of the proposed study are: 1. To optimise EAS devices as implemented in the Cochlear Hybrid System, which consists of a Nucleus Hybrid L24 cochlear implant and a Hybrid sound processor. 2.To evaluate the effect of systematic variations of acoustic to electrical stimulation on speech perception, music perception, localisation and functional performance in real life. The findings will be used as the basis to develop a prescription for devices that combine electric and acoustic stimulation.

The study is intended to assess the feasibility and safety of the BIOTRONIK drug-eluting balloon Pantera Lux for the treatment of narrowing cardiac arteries where those arteries branch out into side arms. The study will assess both immediate success of this treatment as well as whether those arteries remain open after 9 months.

This study will investigate the safety profile and efficacy of a standardised extract of Panax ginseng with a focus on quality of life improvements in adults with moderate chronic obstructive pulmonary disease. The study is a multi-centre, randomised, double-blind, placebo-controlled clinical trial. The study will consist of three phases: a run in period of 4 weeks, 24 weeks of treatment and 24 weeks of follow-up.

The data in this study offer evidence for the value of the referral writer, a computerised, interactive referral pro forma in improving the utility of referral letters when patients are referred for a specialist opinion. Comprehension referral letters, based on the evidence for the predictive value of various elements of the history and examination have a significant value in ensuring that the patient is seen by the right specialist at the right time.

This is a randomized, single-institution double-blind, placebo-controlled clinical trial. Enrolled patients with a diagnosis of RDEB-GS will be randomized to receive either cell therapy with intradermal injection of cultured allogeneic fibroblasts in transport media or placebo (i.e. transport media alone) on two to eight symmetrical wounds on each side of their body (arms, trunk, upper and lower legs). Up to 5 patients will be enrolled. All patients will undergo clinical examination, photography and skin punch biopsies for immunofluorescence and electron microscopy studies (if not previously done). The efficacy endpoint for the primary objective is median healing time of lesions for each treatment group (fibroblast-treated versus placebo). Secondary efficacy end points are percentage change in size, change in appearance score (VAS), pain score (VAS) and pruritus score (VAS) of wounds for each treatment group. The efficacy endpoint for the co-primary objective are quantitative change in expression of collagen VII on immunofluorescence mapping and change in electron microscopy ultrastructure (i.e. numbers and appearance of anchoring fibrils) after cell therapy.

This trial is a prospective randomised controlled trial comparing outcomes in patients who have undergone median sternotomy fitted with the QualiBreath sternal brace postoperatively with those who have not. Pain, sternal instability, patient satisfaction and functional activity level will be assessed.

Background People with Cystic Fibrosis (CF) have abnormally slow clearance of mucus from their airways. This causes chronic lung infection with obstruction of the airways by mucus. The chronic lung infection is characterised by (A) periods of acute worsening of the infection known as exacerbations, (B) progressive deterioration in lung function outside periods of exacerbation, (C) reduced quality of life, and (D) reduced ability to exercise. A strong, sterile, salt-water solution known as hypertonic saline is commonly used to assist clearance of mucus from the airways of people with CF. We know that long-term use of hypertonic saline where the concentration of salt is 7% produces significant benefits for people with CF in terms of (A) exacerbations, (B) lung function, and (C) quality of life. Some patients find 7% hypertonic saline difficult or impossible to tolerate. Some of these patients use lower concentrations of saline, although it is not known whether these are as effective, nor even whether they are more effective than doing nothing. Some patients often skip doses of hypertonic saline because the delivery is time consuming. Faster nebulisers are now available. The efficacy and tolerability of hypertonic saline delivered through these new nebulisers have not been formally assessed. Also, hypertonic saline has not been tested in patients with very badly affected lungs. Aim One aim of the study is to determine the benefits of 6% and 3% hypertonic saline when delivered via a new, fast nebuliser, in people with CF. Another important aim is to determine whether hypertonic saline is tolerable when delivered via a fast nebuliser. A final aim is to compare the response to hypertonic saline among those with very badly affected lungs with the response to those with mildly and moderately affected lungs. Method 140 people with CF will be enrolled in the study. For the first time, patients with very badly affected lungs will be eligible to enrol. All will be required to be in a stable clinical condition. At enrolment, lung function, quality of life, and some other relevant measures will be assessed. Participants will then be randomised to inhale either 6%, 3% or 0.9% saline. All other standard care will continue in all groups. Participants will be regularly assessed during the 16-week period over which they will inhale their allocated saline solution, twice a day, via a fast nebuliser. The progress of the groups inhaling the different concentrations of saline will be compared in terms of (A) exacerbations, (B) lung function, (C) quality of life and (D) exercise capacity. The tolerability of the solutions will also be recorded. We will also compare the response to the saline among those with very badly affected lungs to those with milder disease.

The aim of this study is to examine the effect of weight loss plus oral supplementation of Omacor (Fish Oil) on postprandial lipid and lipoprotein transport in obese subjects. We hypothesis that in obese subjects, triglyceride production will be further reduced with Omacor oral supplementation in addition to weight loss in the postprandial state. All eligible participants will be on a weight loss period for 12 weeks followed by a weight maintanence period of 4 weeks. During these 16 weeks, each participant will be randomised into either weight loss alone (Group 1) or weight loss plus Omacor oral supplementation (Group 2).

Our research has shown that patients with inflammatory symptoms (fevers, sweats and weight loss) and/or elevated inflammatory markers have slower clearance of chemotherapy and experience worse toxicity, as well as worse response and survival. We recently confirmed that UK based lymphoma patients with inflammatory (also known as B) symptoms experienced worse chemotherapy related leucopenia and thrombocytopenia, however we were not able to explore whether this resulted in more neutropenia, febrile neutropenia, treatment related hospitalisation or deaths, because of gaps in the UK data set. We plan to evaluate these issues in Australian lymphoma patients by re-evaluating stored de-identified data collected as part of several ALLG national lymphoma trials. Using the same data, we will also evaluate the prognostic significance of a new inflammatory marker (the neutrophil/lymphocyte ratio (NLR)) in lymphoma patients. We have shown this marker to be prognostic for survival in mesothelioma and colorectal and lung cancer patients. To our knowledge, it has not been evaluated in patients with NHL.