ANZCTR search results

This project aims to evaluate the effect of anthocyanins, an antioxidant derived from fruits and vegetables, as an anti-thrombotic prophylaxis in normal healthy individuals versus obese pro-thrombotic individuals (predisposed to heart attacks and stroke). Increased platelet activity is an important contributor to thrombosis in vascular diseases. Antioxidants have been shown to act on several platelet activation pathways, reducing inflammatory responses thereby mimicking antiplatelet and anti-inflammatory drugs. We have previously shown that antioxidants in the form of a plum juice have potential to alleviate thrombotic risk in normal healthy population by reducing platelet aggregation, platelet activation and improving coagulation profile. Furthermore it has been demonstrated that anthocyanins target similar platelet activation pathways as aspirin (cyclooxygenase-1 pathway) and clopidogrel (ADP P2Y12 pathway), the commonly used antithrombotic drugs. In spite of the effectiveness of these drugs, prolonged usage has been associated with a number of side effects. We believe that anthocyanins have the potential to be used in the pro-thrombotic, drug resistant/non-responsive patient population either as a replacement or complementary therapy in prevention of cardiovascular diseases (CVD). The outcome of this project will significantly support a therapeutic alternative to currently used therapeutics, leading to effective prevention and treatment of oxidative stress induced metabolic syndrome conditions, providing fiscal and health benefit to society.

Recent unemployment represents a significant risk factor for the development of mental health problems, such as depression, and suicidal behaviour. This relationship may be affected by age and gender with working age males at particular risk. Interventions which target recently unemployed working age males to reduce mental health stigma and improve mental health literacy skills may be effective in this population to reduce depression symptomatology and suicidal ideation. The Contact&Connect intervention will be a series of digital ‘brief contact interventions’ (BCIs) with male unemployed construction workers aged 30-64 years. BCIs are defined a structured contacts using a variety of modalities that seek to provide support, education and maintain long-term contact with individuals. The BCIs will be delivered to workers’ smartphones via SMS rich text messages. These messages will include embedded hyperlinks to other digital resources the project will make available on the internet, including microsites, videos, and digital wallet cards. In terms of stigma reduction, the intervention will largely be educational. Content will flow across three main themes: de-bunking myths and stereotypes, normalisation, and empowerment.

This is a double-blind, placebo controlled study assessing the antidepressant effects of curcumin or curcumin/saffron in 160 adults suffering from depression (mild to moderate severity). Participants will be randomly allocated into one of four groups (1) curcumin (BCM-95 'Registered Trademark' - 250mg twice daily); (2) curcumin/ saffron (BCM-95 'Registered Trademark' - 250mg + 15mg saffron twice daily); (3) curcumin (BCM-95 'Registered Trademark' - 500mg twice daily); (4) placebo. Changes in depression and anxiety will be measured over a 12-week period. The aim of this study is also to investigate potential mechanisms of action of curcumin so urine and blood samples will be collected at the beginning and completion of the study. Levels of markers associated with inflammation and oxidative stress will be assessed over time.

This is a double-blind, placebo controlled study assessing the therapuetic effects of curcumin in 60 youth suffering from ADHD or significant attentional problem. Participants will be randomly allocated into either a curcumin (BCM-95 'Registered Trademark' - 250-500mg twice daily) or placebo group and changes in ADHD symptoms and general behaviour will be measured over a 12-week period.

Diagnostic and therapeutic procedures performed in interventional radiology can provoke anxiety and may be painful. Mild sedation with analgesia is administered by the interventional radiologist to calm patient anxiety, reduce unwanted movements and alleviate patient discomfort. Central line placements are common, (including Hickman line placement, tunnelled dialysis catheter placement, injectable port implantation) and intravenous sedation would typically be used for these procedures. The most commonly used drug for sedation in radiology is midazolam, a benzodiazepine. Midazolam has a short half-life of 2-6 hrs, but very powerful anxiolytic (anti-anxiety), amnestic, hypnotic, anticonvulsant, skeletal muscle relaxant, and sedative actions. It is administered at 1 milligram per dose to the desired response, has a 2 minute onset time and duration of 45 to 60 minutes. The most common analgesic used is fentanyl, a short acting opioid that is administered at an incremental dose of 25 micrograms and repeated every 5 minutes to a maximum dose of 100 micrograms. Its onset time is 2-3 minutes and it has a duration time of 30-60 minutes. Midazolam and fentanyl are usually administered concurrently, with 1 milligram midazolam and 25 micrograms fentanyl being the standard single dose. Multiple doses are titrated carefully to achieve and maintain adequate sedation and alleviation of anxiety, while preserving cardio-respiratory function, protective reflexes and the ability to respond appropriately to verbal and/or tactile stimulation. Doses are given incrementally, often starting with a double dose with at least 5 minutes interval before the next dose to allow evaluation of drug effect. Oxygen saturation, blood pressure, heart rate, and respiratory rate are monitored continuously and documented every 10 minutes. Neurological response is also monitored continuously by observing the patients response to command or conversation. Reversal "antidote" agents for these medications are flumazenil and naloxone respectively. The current practice is that the radiologist takes a history from the patient, looking for patient factors that may affect the safety and practice of sedation. These would include patient size, age, prior cardiac and respiratory disease, diabetes, renal failure, obesity, allergies, drug interactions, previous anaesthetic history, and airway issues. There will be assessment of the patient’s level of anxiety and expectation of procedural discomfort. The radiologist will then decide on the appropriateness of midazolam/fentanyl sedation, and choose an initial dose. As the procedure starts, the level of sedation is assessed, and if needed, further aliquots of midazolam/fentanyl are administered at the radiologists’ discretion. Our hypothesis is that this practice has problems in that there is a fear of the effects of oversedation (eg low blood pressure or slower respiratory rate), and this results in many patients being undersedated. The patient may be apprehensive to ask for more sedation and thus their overall experience of the procedure is suboptimal. Based on prior evidence in the literature in other medical settings, we believe that by giving the control of sedation to the patient (within a safe dose and lockout period), that the patient is more likely to seek sedation when required and hence will be at less risk of undersedation. We expect that this will lead to an overall greater experience for the patient. The medical procedure being performed (ie insertion of a tunnelled central line) will not be affected by this study.

This study will examine the efficacy of collaborative case conceptualization (CCC), a novel assessment approach (based on the Maudsley Model of Treatment for Adults with Anorexia Nervosa), compared to standard assessment as usual (AAU) for adults with Anorexia Nervosa. It is hypothesized that, relative to usual care, CCC will result in improvements in general psychopathology and quality of life 12-month follow-up. This study will also examine post-assessment outcomes and potential mediators of the effect of CCC (i.e., obsessive-compulsive and perfectionistic behaviours and cognitions, avoidant behaviours and cognitions, pro-anoretic beliefs and responses of close others).

This is a pilot evaluation of the ability of a web and text-book based training program to train medical scribe students to be ready to commence work as a trainee medical scribe in an Emergency Department

Sacral Neuromodulation or SNM is a well-established treatment for bowel leakage, also known as faecal incontinence. It uses a small device (a stimulator) that is implanted under the skin in the upper buttock area. It then transmits electrical pulses through a small wire that is positioned close to the sacral nerve to improve bowel control and function. Despite being very successful for the treatment of faecal incontinence, the exact mechanism by which it works remains unknown. It is possible that SNM influences the way that the brain and gut interact by ‘resetting’ its function back to normal, a bit like restarting a computer after it ‘crashes’. If this is true, long-term SNM may not be necessary to control symptoms. The aim of this study is to assess the impact of SNM on bowel symptoms and bowel control, particularly when SNM is switched off. The group studied will include patients with faecal incontinence who have successfully been stimulated for at least 6 months. A total of 20 patients will be recruited and randomised into two groups; each group will have two cycles of different exposure. Each cycle will last for 6 weeks and will involve either turning the stimulator Off or On. Patients and assessors will be unaware whether the stimulator is On or Off, so as to reduce the effect of bias. At each 6-week cycle, all patients recruited will attend the hospital to adjust their stimulator and to complete a questionnaire and undergo physiology tests to measure bowel control and function. At the end of the study the SNM will be switched back to the original setting. Study outcomes will involve assessment of bowel symptoms, severity of faecal incontinence, quality of life scores and anorectal physiological function. This study will provide important information in understanding and treating disorders of bowel function and bowel leakage.

Finger-prick capillary glucose levels typically inform insulin administration in T1D. RT-CGM involves using a subcutaneous sensor to measure interstitial fluid glucose levels continuously and provides the person with the glucose level in real-time, as well as the rate and direction of change in the glucose. There is an increasing body of evidence indicating that RT-CGM in combination with an insulin pump results in an improvement in glycaemia and reduces hypoglycaemia, compared with finger-prick glucose measurement and multiple daily injections with insulin in people with T1DM. However, data is limited regarding the use of RT-CGM in conjunction with multiple daily insulin injections. The study aims to evaluate the user acceptance of the RT-CGM device in patients with T1D, as well as to evaluate its' impact on glycaemic control.

Falls are the leading cause of injury-related hospitalisation in older people in Australia. Older people are at increased risk of falls after hospital discharge and these falls can lead to injury and loss of independence and quality of life. However older people have been found to have low levels of knowledge about falls and may be reluctant to engage in falls prevention activities, such as exercise. The primary aim of this trial is to determine if providing tailored falls prevention education that includes the provision of multimedia materials as well as individual health professional consultations and reinforcement in hospital and after discharge reduces falls rates in older people after discharge from hospital. A randomised trial will compare outcomes between a group that receive the education in addition to usual care and a group that receive social visits in addition to usual care.