ANZCTR search results

Snoring and mild sleep disordered breathing (SDB) are a common consequence of increased upper airway resistance during sleep. Habitual snoring (every night or almost every night) without overt obstructive sleep apnoea hypopnoea syndrome (OSAHS) is common in the community. Increasingly it is recognized that snoring and mild SDB are not just an annoying social problem but may pose real risks to health. Emerging research is highly suggestive of an independent role in the occurence of hypertension, stroke, coronary and carotid atherosclosis. The aim of this study is to further explore the linkage between heavy snoring with mild SDB and early carotid artery atherosclerosis by looking for regression or stabilisation of early changes of carotid atherosclerosis in heavy snorers with mild non-hypoxic SDB when snoring and SDB are prevented by the use of nasal continuous positive airway pressure (CPAP).

Diabetes is the commonest cause of adult onset blindness. Vision loss, which is irreversible, is a most feared complication of diabetes. A blood fat lowering drug called fenofibrate, available in Australia, has been shown to reduce eye damage in people with Type 2 diabetes by 35-40%, and to prevent eye damage in Type 1 diabetic animal models. This study will evaluate the potential benefits of fenofibrate in 450 adults with Type 1 diabetes who are at high risk of eye damage.

The aim of this study is to determine whether the consumption of lutein with milk increases exercise-self efficacy, leading to increased exercise participation in older adults. The overall purpose is to provide scientific substantiation for a novel nutritional supplement aimed at increasing physical activity to improve health and reduce disability in an ageing population. Preliminary research in rats demonstrated that the consumption of lutein-fortified milk increased the duration of voluntary wheel running. This increased wheel running was associated with enhanced muscle development and reduced body fat. The mechanism by which the lutein-fortified milk stimulated the rats to increase the volume of wheel running is not known, but it seems likely that there was some change in their mood which promoted exercise behaviour. If this supplement were to elicit a similar effect in people being encouraged to undertake regular physical activity this might result in them undertaking a greater volume of exercise and thus potentially achieving health benefits.

A two arm randomised controlled trial in more than 1500 preterm babies less than 1500 grams to compare standard feeding regimens versus adding BLF to feeds on the incidence of death and major disability in VLBW infants.

This study aims to evaluate the safety and efficacy of combining panitumumab with the standard cisplatin and gemcitabine treatment for advanced biliary tract cancer. Who is it for? You may be eligible to join this study if you are 18 years or above and have been diagnosed with biliary tract cancer. You should have locally advanced or metastatic disease that is not suitable for removal by surgery OR disease which has come back after previous surgical treatment or radiotherapy. It has been shown that in other cancer types, panitumumab may be less likely to have an effect if the cancer cells have any mutation detected in a particular gene. That gene is known as KRAS. As part of screening for this study, you will be asked to consent to a test to find out whether your cancer cells have a KRAS mutation. If you consent, cells taken from a previous diagnostic procedure will be sent to a central lab for the KRAS test. Only patients with cancer that does not have any mutation in the KRAS gene can participate in this study. Trial details The patient population that may participate in this trial would routinely be treated with a combination of the chemotherapy drugs gemcitabine and cisplatin. Participants in this study will additionally receive panitumumab; so that the outcomes associated with treatment using the 3 drugs together can be evaluated. Participants will be monitored closely for side effects (toxicity) and for tumour response to treatment. Treatment will continue until disease progression, unacceptable toxicity, investigator discretion or patient request to cease. Once off study treatment, participants will be followed up for 30 days, then every 12 weeks until disease progression or commencement of new treatment, then according to best practice until death. Data from this trial can inform us about how safe and tolerable the treatment is, and we can make some comparisons to other trials of chemotherapy alone for this disease. If positive, this study may lead to improved treatment for patients with biliary tract cancer. If negative, it will still give information regarding the biology of the disease, including the incidence of KRAS mutation in this tumour type.

When patients are established on CPAP treatment they must first undergo a titration study of some description which determines the pressure required to hold the upper airway open. Titration studies are commonly performed using a nasal mask but some patients may prefer a full-face or oronasal mask. This study looks at therpeutic pressures for full-face and nasal masks and patient preferences.

Acceptance and Commitment Therapy (ACT; Hayes, Strosahl & Wilson, 1999) is a third-wave behavioural therapy that has been receiving greater attention in the empirical literature in recent years. ACT is a mindfulness, acceptance and values-based psychotherapy which proposes different processes of change and outcome compared to traditional cognitive and behavioural treatments (Hayes, Masuda, & De Mey, 2003). In ACT, acceptance, mindfulness and values strategies are used to create a context for an individual to engage in effective and valued behaviours, even in the presence of difficult thoughts and emotions. Within an ACT framework, two key processes are seen as contributing to the development and maintenance of many forms of psychopathology: experiential avoidance (i.e. behavioural and psychological attempts to avoid an unpleasant experience) and cognitive fusion (i.e. responding to a thought or feeling as if it were the actual event it describes; Hayes, Strosahl, & Wilson, 1999; Hayes, Wilson, Gifford, Follette, & Strosahl, 1996). Chronic worry and rumination are key cognitive processes associated with the onset and maintenance of generalised anxiety disorder (GAD) and depression (Hoeksema, Wisco, & Lyubomirsky, 2008; Watkins, 2008). Worry and rumination have been considered by researchers to be forms of both experiential avoidance and cognitive fusion. The literature on clinical interventions for rumination is surprisingly scarce, and although there are currently a number of efficacious cognitive behavioural treatments for chronic worry and GAD, it is evident that there is room for improvement as only about half of those treated are achieving high end state functioning (Hayes, Orsillo & Roemer, 2010). To date, beyond case studies (Ruiz, 2010) there has been no research specifically investigating ACT for chronic worry and rumination amongst sufferers of GAD and Depression. A randomised control trial comparing ACT to CBT will address this gap in the literature and inform the treatment and management of anxiety and depression. Furthermore, investigating the mechanisms of change, specifically that of acceptance of psychological experience and greater behavioural engagement with valued areas of life, will enhance our understanding of the predictive elements of ACT and improve its application in the treatment of mood and anxiety disorders.

The TARGET Study is a prospective, randomised controlled trial, evaluating two standard techniques of tracheal puncture during insertion of percutaneous tracheostomies: the traditional landmark method versus the ultrasound guided method. Percutaneous Dilatational Tracheostomy (PTD) is a frequently performed invasive procedure in the Intensive Care setting, where complications both immediate and short term can contribute to significant morbidity and mortality. It is increasingly recognised that lateral (off midline) and cranio­caudal (too high up or too low down) malposition of PDTs may result in greater incidence of both short and long term complications. The use of ultrasonography in placing tracheostomies is well described in the literature. We aim to evaluate the use of real­time ultrasound guidance for the tracheal puncture, which is the most important determining element in positioning the tracheostomy, to determine which method results in better midline and cranio­caudal placement. Better midline and cranio-caudal placement in turn may decrease complications and improve clinically significant surrogate markers of outcome.

ENCHANTED is an independent, investigator initiated, international collaborative, quasi-factorial randomised controlled trial involving a package of 2 linked comparative randomised treatment arms, which aims to address 4 key questions in patients eligible for thrombolysis in the acute phase of ischaemic stroke. (1) Does low-dose (0.6 mg/kg) intravenous (i.v.) recombinant tissue plasminogen activator (rtPA) provide equivalent benefits compared to standard-dose (0.9 mg/kg) rtPA? (2) Does intensive blood pressure (BP) lowering (130-140 mmHg systolic target) improve outcomes compared to the current guideline recommended level of BP control (180 mmHg systolic target)? (3) Does low-dose (0.6 mg/kg) intravenous (i.v.) recombinant tissue plasminogen activator (rtPA) reduce the risk of symptomatic intracerebral haemorrhage (sICH)? (4) Does the addition of intensive BP lowering to thrombolysis with rtPA reduce the risk of any intracerebral haemorrhage (ICH)?

Research regarding weight loss in people with asthma is limited. Although preliminary research suggests weight loss improves clinical outcomes in asthmatic subjects, it is mostly of poor quality and better studies are justified. In addition, there is no research examining the mechanism by which weight loss results in these improvements. Our previous cross-sectional data suggests that neutrophilic airway inflammation is increased by obesity, which may worsen asthma. It is therefore important to conduct intervention trials to determine whether this airway inflammation is reversible through weight loss and/or fat loss. This will enable a better understanding of the association between obesity and asthma and would play an important role in asthma management and prevention. AIM: To examine the effect of weight loss, via body fat reduction, on systemic and airway inflammation and clinical outcomes in obese asthmatics. HYPOPTHESIS: Weight loss, specifically body fat reduction, will reduce inflammation and improve clinical outcomes in obese asthmatics.