ANZCTR search results

This is a randomized cross over trial. Patients with type 1 diabetes will have their glucose levels controlled by either a closed loop (artificial pancreas) system, or sensor augmented pump therapy with low glucose suspend. During closed loop patients will still use the bolus function of their pump for meals. The study will start in hospital for 2 days and nights, and then the participants will continue in the home for a further 5 days. Then, after a washout for at least a week, they will cross over to the opposite intervention for a further 7 day period. Our primary outcomes are the ammount of time spent euglycaemic (3.9 - 10mmol/L), and hypoglycaemic events (<3.3mmol/L). We will recruit 14 participants.

The risk of developmental delay in the preterm population increases as gestational age decreases. As milder delays often go undetected, the challenge in premature infant follow up is early detection without over servicing. The primary aim of this study is to determine if early clinical assessment completed by 16 weeks post term will allow robust prediction of typical development and mild developmental delay at 2 years corrected age. Earlier prediction will enable clinicians to safely plan discharge for low risk infants from follow up services and facilitate the prioritisation of resources towards infants identified as likely to have mild to moderate or more severe outcomes. As developmental progress is dependent upon many variables, a combination of clinical tools including neurological assessment, motor assessment and parent questionnaires will be used to predict outcome at 2 years. Likewise a comprehensive selection of outcome measures will be used at 2 years to enable identification of subtle delays. Early findings will be compared to development at 2 years corrected age to determine any predictive relationship for typical outcomes and mild developmental delay. As families, clinicians and health services continue to want and need more immediate information regarding the short and long term outcomes of preterm infants, finding the best clinical biomarkers has the potential to streamline and effectively prioritise premature infant follow up programs.

This study will assess the safety and PK of single and multiple doses of the oral drug NP202 in healthy volunteers. Results from this study will help determine the development of NP202 as a treatment for preventing cardiac remodelling post acute myocardial infarction.

This study aims to investigate the efficacy of stereotactic ablative radiation therapy for treatment of Stage I non-small cell lung cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have a diagnosis of Stage I non-small cell lung cancer. You must be able to lie flat and comply with the requirements of simulation and treatment. Participants in this study will be treated with stereotactic ablative radiation therapy with one of three dose and fractionation regimens. For peripheral lesions treatment dose will be 48 Gy in 4 fractions or 54 Gy in 3 fractions, depending on tumour size. For central lesions 50 Gy will be administered in 5 fractions. Overall treatment duration will vary from 11 – 14 days. Local control at 24 months is the primary endpoint of the study and is assessed by CT scans. Patients will be followed up until 5 years post treatment. A total of 100 patients will be recruited in this study.

Obstructive sleep apnea (OSA) is a condition consisting of intermittent upper airway obstruction during sleep, leading to periods of hypoxia (reduced oxygen levels) and acute hypertension (high blood pressure). It has been hypothesized that in OSA, physiological changes can result in retinal ischemia (restriction in blood supply to tissues) and associated retinal vascular changes and progression of glaucomatous damage to the optic nerve. In a previous study, we did not find an increased prevalence of optic disc edema or other optic neuropathies in the OSA population. However, retinal vascular changes were more common in patients with severe OSA, independent of blood pressure, suggesting that OSA patients should undergo ophthalmologic screening. Despite this, the risk for various ocular disorders among patients with OSA remains unclear, particularly because in prior studies only static (single) measures of retinal vessels were considered. Additionally, these studies did not adequately control for potential confounders of these associations, such as obesity and hypertension. The aim of the current study is to investigate dynamic (real time videos) retinal vasculature characteristics in OSA patients and determine any associated changes of the retina in this group of patients. This will provide a new-insight into specific OSA related changes in the eye.

We aim to develop a smartphone application (app) for supporting weight loss maintenance and evaluate the efficacy of the app in a 12 week clinical trial with 12 week follow up. The overall objective of this project is to develop and validate our app which aims to support people to maintain the weight losses they have achieved.

The purpose of this study is: 1. To determine whether Novel Transforming Powder, Altrazeal (TM) dressing will consistently reduce patient’s experience of pain compared with Calcium Sodium Alginate, Kaltostat (TM). 2. To determine if there is a difference in rate of healing of the donor site between Novel Transforming Powder, Altrazeal (TM) and Calcium Sodium Alginate, Kaltostat (TM). 3. To compare Novel Transforming Powder, Altrazeal (TM) and Calcium Sodium Alginate, Kaltostat (TM) dressings in terms of cost-effectiveness, wound infection rate and cosmetic outcome.

Pregnancy related pelvic girdle pain (PPGP) has been reported to affect 71% of women who are pregnant and receive care at Westmead Hospital (Pierce et al. 2012). Pelvic girdle pain during pregnancy often causes a reduced ability to transfer, stand and walk and is thought to be related to non-optimal stability of the pelvic girdle (Vleeming et al. 2008). People with PPGP are often referred to physiotherapy but few clinical trials have evaluated the effectiveness of physiotherapy treatments in this disabling condition (Elden et al. 2005). The aim of this randomised cross-over repeated measures study is to determine whether there is a measurable difference in outcomes for pain and function in patients receiving therapist-assisted exercises compared to a control intervention. Ethical approval has been granted for this project at Westmead Hospital, Sydney NSW (Western Sydney Local Health District). This study will directly affect physiotherapy practice by determining the efficacy of a commonly used exercise intervention for the management of PPGP.

To properly manage type 1 diabetes, individuals are required to measure blood glucose levels (BGL's)regularly and adjust the amount of insulin to be given accordingly. This has been done by matching the amount of insulin with the amount of carbohydrate in a meal. Recent studies have shown that meals high in protein can also significantly increase the BGL. There are recommendations that additional insulin be given with meals containing high levels of protein to prevent post prandial hypergycaemia (elevated BGL's after a meal). However, at this time there is insufficient data to determine how these additional insulin doses should be calculated. A current algorithm used to calculate additional insulin based on protein content in a meal has been shown to cause unacceptable levels of hypoglycaemia. We will recruit 32 people with type 1 diabetes between the ages of 7 and 40 years diagnosed for more than 1 year, using either insulin pump therapy or multiple daily injection therapy. Participants will have a glycated haemaglobin of <8.0% and body mass index <97th centile. Exclusion criteria will be those with co-existing medical conditions. The aim of this study will be to: Define the impact of variable protein loads on post prandial BGL's up to 8 hours. The participants will be contacted daily for the first week to monitor BGL's and adjust insulin doses. A continuous glucose monitoring system (CGMS) which provides continuous measurement of BGL's will be inserted on the first day. For 6 consecutive days participants will be instructed to eat a standardised evening meal containing consistent quantities and type of carbohydrate. The participant will give a standard insulin bolus for the carbohydrate in the meal. They will then be instructed to eat a test meal (protein shake containing 30g of carbohydrate) 4 hours after the evening meal. The participant will fast over night and check the BGL in the morning prior to eating breakfast. If the participant has has a BGL <3.5 mmols/L or has symptoms of hypoglycaemia at any time they will eat 15 grams of carbohydrate as per their usual management. During the test meal study days exercise and evening food will be standardised.

To determine if there is a difference when providing information about seeking management for depression using a narrative documentary Entertainment-Education (EE) approach compared to an instructional EE approach, on older adults knowledge and motivation levels. We hypothesise that there will be a greater knowledge uptake and increased motivation levels to seek assistance for managing depression in the group who view the narrative video compared to those who view the didactic video.