ANZCTR search results

The aim is to develop a method to safely and accurately control the water state of patients in a minimally invasive and reliable fashion. The ultimate goal is to reduce complications of inappropriate fluid administration that result in patient harm. An intermediate step is to develop a model of water balance that can inform clinicians of current water state and hence recommend appropriate rates of intravenous 5% dextrose.

Women who experience the pregnancy disease pre-eclampsia, and in particular those who develop the disease before 38 weeks of a pregnancy, are more likely to have high blood levels of the chemical homocysteine. They are also at higher risk of pre-eclampsia in a subsequent pregnancy. High levels of homocysteine have been shown to make blood vessels more prone to clog up, one of the underlying processes of pre-eclampsia. High blood levels of homocysteine can usually be reduced by taking the vitamin folic acid. It is not known, however, whether this can effect the chances of pre-eclampsia happening again. This study will help to determine whether taking a folic acid supplement can prevent recurrent pre-eclampsia in women with high homocysteine levels. Women in the trial will receive either folic acid or a placebo tablet. Neither the women nor their carers will know which treatment they are receiving.

This is a first in man trial with ZYAN1. The primary aim of this study is to establish the safety and tolerability while the secondary aim is to understand the pharmacokinetics, pharmacodynamics, gender and food effect of ZYAN1 in healthy volunteers.

Buprenorphine-Naloxone (BNX) sublingual film is the preferred preparation for buprenorphine substitution treatment of opioid dependence. However, the smallest dose available in the BNX film preparation is 2mg. Experience with buprenorphine has shown that some patients who wish to taper and cease buprenorphine find the transition from 2mg to zero difficult due to severity of withdrawal symptoms, and therefore continue in maintenance treatment (Winstock, Lintzeris, & Lea, 2011). In order to investigate these concerns we propose to use Temgesic sublingual tablets which are Buprenorphine only tablets however they are available in 200 microgram (0.2mg) tablets, and as such allow for smaller dose reductions than Subutex tablets which are only available at 400 microgram (0.4mg). This pilot study specifically aims to provide subjective and objective measures of withdrawal, when there is a 1mg reduction from 2mg of Temgesic sublingual tablets (SL), by using the measurements of withdrawal proposed below, in order to conduct a power analysis to determine the number of participants required for a larger pilot study.

To compare the current model of care for Transplant recipients and Chronic Kidney disease patients, which is face to face consultation with specialist Kidney Doctor with a new model of care which will consist of up to 75 % of these visits done from patients home or nearby telehealth facility. We are expecting that conducting some medical consultations by telemedicine will be feasible and non-inferior to standard model of care and the patients will be happy with this new model of care

Pregnant women with a body mass index (BMI) > 40 may be recommended to have an epidural inserted early in labour. One reason given, is to avoid a general anaesthetic. However a pilot study showed that these women are 2.47 times more likely to receive an alternated technique. This study aims to compare the use of epidurals at caesarean section in women with a BMI > 40, with the use in women with a BMI <30. The results may affect the advice given to obese women in the antenatal period and change their anaesthetic management.

To determine if a silver impregnated wound dressing has any clinical benefit over using a similar silver free control dressing, when managing individuals with diabetes-related foot ulcers. Wound healing rates, signs of infection, and need and duration of antibiotic therapy will be compared between the cohort of individuals receiving a silver based dressing and those receiving a similar silver free dressing. Outcomes will also be assessed regarding any clinical benefit in using a silver impregnated wound dressing as compared to a similar silver free control dressing on wounds that are both (1) clinically infected (purulent discharge or 2 or more of redness, pain/tenderness, swelling, warmth) at the outset as well as (2) those that have no signs of infection.

The primary aim of this study is to determine the effectiveness of bubble­-PEP device compared to the active cycle of breathing technique (ACBT) or no intervention in clearing secretions in people with non­-CF bronchiectasis. The hypothesis is that the bubble­PEP is not inferior to the ACBT and is superior to no intervention in clearing secretions. Secondary aims will be to evaluate the acceptability and perceived benefits of the bubble­PEP device by participants.

This project is a pilot study that aims to evaluate the accuracy of digital X­ray radiogrammetry (DXR) in determining bone mineral density (BMD), as compared to BMD by dual energy X­ray absorptiometry (DXA). Participants will be women aged fifty years or older who are postmenopausal and are attending for a follow up mammogram. DXR is a method that can be used to estimate BMD from plain digital hand X­ray images. It assesses BMD from images of the mid 2nd, 3rd and 4th metacarpals. The data is then transmitted in deidentified fashion to Sectra, a Swedish company that has developed the ‘OneScreen’ technology, that combines both mammography and digital X­ ray radiogrammetry. A BMD in g/cm2, a T­score and a Z­score are then transmitted back within minutes. A number of studies have demonstrated that T and Z­scores derived from such DXR examinations correlate closely to values derived by DXA, which is considered the gold standard for screening or follow up bone densitometry. BMD by DXR has been shown to predict fracture risk, similarly to DXA. Women over the age of 50 who are postmenopausal may already have low BMD and are at risk of further BMD reductions. Women who attend for follow up mammography are, in addition, a group who may require breast surgery and possibly aromatase inhibitors that eliminate sex steroid production and increase fracture risk. The addition of a digital hand X­ray for DXR analysis to the mammography examination requires no additional equipment and takes only a few seconds. If DXR is shown to correlate closely to DXA in our local population, it has potential to be used in osteoporosis screening for women who may require aromatase inhibitors. If cost effective, it might even be considered as a screening tool when women attend for routine mammography, because women screened for breast cancer are the same group who may benefit from awareness of low BMD. After ethical approval of this study and after participants have provided informed consent, data will be collected from women over the age of 50 who are post­menopausal and who present for a second mammogram after having a positive screening mammogram in the community. The women will complete a short questionnaire following which DXR of the hand will be performed immediately after mammography and the DXR images will be transmitted for analysis. This de­identified data is generally returned within 5 minutes with BMD Z and T­scores. Participants will also undergo a DXA examination of the forearm, hip and spine to allow a comparison of the DXR measurements. Participants with results by DXA that indicate a BMD in the osteopaenic range will be provided with a letter which can be taken to their general practitioner for further discussion. Any participant with a BMD in the osteoporotic range will be given a letter for their general practitioner who will also be informed of the result by telephone. For participants with T­scores less than ­3 (indicating osteoporotic­range BMD at or greater than 3 standard deviations below the mean), referral to a specialist will also be suggested. While physicians associated with this study will be available to discuss any result with a participant, they will not be involved in ongoing management for ethical reasons. To date, DXR using the Sectra system has not been used in Australia, but has undergone evaluation at single sites in the UK, Sweden and the USA. If the technique proves accurate for BMD evaluation in this pilot study, wider application for BMD evaluation in women undergoing mammography might be considered. Compared to DXA, it would be more simple and convenient, is lower radiation and may be cost effective enough to consider as a screening tool in either specific circumstances (such as follow up mammography) or for general postmenopausal evaluation.

This project aims to evaluate the 'real-world' implementation of a digital health program that is aimed to improve type 2 diabetes self-management. The trial will determine: i) the program’s reach, adoption, implementation and maintenance amongst persons with diabetes (PWDs) type 2; ii) clinical, psychosocial, and behavioural outcomes for PWDs provided with the program; and iii) the costs and value for money of the program.