ANZCTR search results

This project aims to evaluate the efficacy of a manualised psychological treatment for adults with Separation Anxiety Disorder (SAD). SAD has only recently been accepted as legitimately occurring during adulthood in the DSM-5. As such, no evidence-based treatments have yet been trialed to address this debilitating condition. We hypothesise that adult subjects diagnosed with SAD who receive 8 sessions of specialized psychological treatment will report lower levels of anxiety, greater symptom improvements, and less impairments in their day-to-day life after treatment, compared to a a group who do not receive the treatment for 8 weeks. Project outcomes will indicate whether this treatment program is useful in reducing symptoms and distress caused by separation anxiety disorder.

A pilot study of maternal and neonatal outcomes of pregnancies complicated by gestational diabetes, including significant maternal hypoglycaemia and lack of neonatal hypoglycaemia: the main hypothesis is that these will not differ when receiving treatment aimed at achieving ‘very tight’ blood glucose targets, compared with treatment aimed at achieving ‘tight’ blood glucose targets

This study will evaluate the safety and effect of a new treatment known as TargomiRs in patients with malignant pleural mesothelioma (MPM) and non-small cell lung cancer (NSCLC). Who is it for? You may be eligible to join this study if you are aged 18 years or above, and have a confirmed diagnosis of MPM or NSCLC, with evidence of Epidermal growth factor receptor (EGFR) in tumour tissue. Study details: All participants in this study will receive treatment with a new targeted therapy known as TargomiRs. Treatment will be administered by injection into the vein (i.e. intravenously) at a frequency of once or twice weekly until it is clear that you are not benefitting from the treatment. Initially a low dose will be administered to participants. If this dose is tolerated, then it will be increased in the next group of patients and so on until the maximum tolerated dose is determined. All participants will be regularly monitored for safety and toxicity of the treatment for 24 hours after each treatment in the first 2 weeks and 3 hours after treatment from week 3 onwards. They will also be required to complete QoL questionnaires each treatment and have PET scans and lung function tests approximately once every 8 weeks in order to evaluate treatment effect and quality of life. It is hoped that the treatment offered will cause the diseased tissues to respond in a way that will block uncontrolled tumour growth resulting in tumour control and give patients a longer life.

This study aims to evaluate the feasibility of an online resource to promote sexual well-being for both cancer patients and their partners. Who is it for? You may be eligible to join this study if you are aged 18 years or above, and either you or your partner has had a cancer diagnosis. You will also need to be at least 6 months past your primary treatment. Study details: Participants in this study will be randomly (by chance) allocated to one of three groups. Participants in the Rekindle and Rekindle Plus groups will use the online resource. This involves first completing some screening questions, and then working through some self-led exercises tailored to participant needs and sexual concerns. Participants in the Rekindle Plus group will also receive three telephone support calls delivered by a qualified, trained provider to encourage their ongoing participation and engagement with the intervention. The duration of the intervention period is approximately 10 weeks. Participants in the third group will receive a program which is designed to replicate usual care, within the design and formatting of the Rekindle website. We will monitor completion of the prescribed intervention in order to determine which mode of Rekindle is the most feasible.

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.