ANZCTR search results

The study will evaluate the effect of the study drug, AB-506, on the single dose pharmacokinetics of an oral contraceptive in healthy female participants. The duration of the study will be approximately 7 weeks, including the screening period.

This research aims to evaluate the effect of the Fearless Me! program on anxiety for children and adolescents with intellectual disabilities. The Fearless Me! program is a Cognitive Behaviour Therapy treatment which has been specifically adapted for the needs of children with mild and moderate intellectual disabilities. The Fearless Me! program is a weekly, ten session therapy program that aims to teach children and adolescents skills to manage and reduce their anxiety, and involves face to face therapy sessions, as well as an online website to practice skills. It is hypothesised that the program will reduce anxiety for those with clinical or subclinical levels of anxiety, and improve overall quality of life.

Hysterectomy (removal of the womb) may be performed to try and improve quality of life for women experiencing benign (non-cancerous) conditions that can cause pelvic pain, heavy bleeding and prolapse. As it is an irreversible surgery after which the woman can no longer carry a pregnancy the decision to undergo hysterectomy may be difficult for both patients and their clinicians. We are interested in how and why women make the decision to undergo hysterectomy, how it changes their quality of life and experience of symptoms, if at all, and whether it is associated with significant relief or regret. We especially want to know if age and number of children a women has had at the time of hysterectomy influence their feelings of relief and/or regret. This information will help guide women and their clinicians considering hysterectomy as an option. We will contact women who have had a hysterectomy for benign conditions and ask them to complete a questionnaire to explore their feelings or relief and regret, and also get information about their medical history, decision making about hysterectomy, symptoms and quality of life after hysterectomy as well as current levels of stress and personality type. This information will be used to examine the relationship age and parity (number of children had) have with regret and relief after hysterectomy as well as look at other factors that influence this.

The proposed study aims to evaluate the efficacy of a stress-reduction intervention for unhealthy and disordered eating behaviours. The study will be conducted as a randomised control trial, with a wait-list control group and two intervention groups; one intervention group will be prompted to use the intervention, whilst the other will not. All groups will complete a baseline survey, followed by four weeks of ecological momentary assessment to obtain data regarding their eating behaviours and affect. During this time, the intervention groups will also be provided with brief stress-reduction activities via smartphone application that they can complete when stressed. Participants in the intervention groups will also complete a four-week follow-up survey. The study will recruit at least 183 women, aged 18 years and over, who report stress-related unhealthy or disordered eating. It is expected that use of the intervention will reduce the momentary and longer-term risk of disordered eating.

The Health4Life intervention uses web- and app-based technology to improve the physical and mental health of Australian teenagers. Unhealthy behaviours, such as eating poorly, smoking, risky alcohol use and physical inactivity, are known risk factors for serious chronic disease, the leading cause of death worldwide. Previous research has shown that these risk behaviours are well established by late adolescence and commonly co-occur as clusters. It has also been shown that these ‘risk clusters’ are associated with more immediate harms among young Australians, including anxiety, depression and psychological distress. To address these problems, we developed the Health4Life intervention. The Health4Life study utilises online technology and interactive cartoons to encourage young people to adopt six key health behaviours (“the Big 6”): healthy eating, healthy sleep, physical activity, limiting sedentary recreational screen time and being alcohol and smoke-free. By increasing knowledge and improving skills, this program aims to prevent or improve these behaviours before they become entrenched. The Health4Life program will recruit 7200 Year 7 students from 72 schools across Australia in 2019. It is anticipated that this intervention will improve both physical and mental health during adolescence, whilst also halting a potential trajectory towards chronic disease later in life. In addition, the Health4Life Biomarker Checkpoint will re-recruit a subsample of Health4Life participants (approx. 200) when they are in year 10, to assess any differences in anthropometric measurements, in depth dietary intake, C-reactive protein, and other heart-health biomarkers between intervention groups as part of a related sub-study for a PhD project.

Nerve conduction studies is the study of motor and sensory nerve function by measuring electrical parameters, e.g. velocity and amplitude, of peripherally (e.g. arm or leg) stimulated nerves. Stimulation and recording is typically performed by surface electrodes (metal conductors applied to the skin). Abnormalities on nerve conduction studies can usually be detected in established neuropathy but in early neuropathy nerve conduction studies may remain normal. F-waves are electrical responses stimulated and recorded at the periphery (e.g. hand or feet) that travel from the periphery (e.g. hand or feet) to the spinal cord and back similar to a rebound or boomerang. F-waves are more sensitive at detecting changes consistent with early diabetic neuropathy when examination of other nerves is normal. Preliminary evidence has shown that the study of F-waves using a fine needle in a muscle, so-called ‘single fibre F-waves’, is more precise and sensitive than surface electrodes in detecting early neuropathy in patients with diabetes. The purpose of this trial is to ascertain the utility of single fibre F-waves in comparison to nerve excitability testing and routine nerve conduction studies in patients with neuropathy or risk factors for neuropathy (i.e. diabetes/impaired glucose tolerance).

Chronic pain (3 months) occurs in up to two-thirds of patients after open-cardiac surgery. This is predominantly neuropathic pain; a consequence of nerve damage during instrumentation. Previous studies have shown pregabalin effectively reduces acute pain after cardiac surgery. There is, however, a lack of research regarding chronic pain. The PRACS (pregabalin for the prevention of chronic pain after open-cardiac surgery) trial aims to reduce chronic pain and improve quality of life for cardiac patients. This randomised, double-blind, placebo-controlled trial is a collaboration between anaesthetics, ICU and cardiothoracic surgery at Monash Medical Centre. We aim commence the trial in early 2019 with a target sample of 200 patients. The intervention group will receive active pregabalin (150mg before surgery and 75mg 12-hourly for 48 hours after surgery) while the control group will receive matching placebo. Participants will be monitored in hospital and at the 3 and 6 month mark

Alcohol use disorders are a leading cause of morbidity and mortality. Existing pharmacological treatments for alcohol use disorders have limited success rates. New research is expanding the focus of development for the treatment of substance use disorders, attempting to identify the underlying neurobiological mechanisms that maintain addiction, rather than more traditional approaches of agonist based treatments or management of acute withdrawal symptoms. Recently, a series of animal studies have shown that rapamycin, an mTORC1 inhibitor, may provide ongoing protection against the expression of addiction and relapse behaviours. The aim of this study is to examine the safety and feasibility of everolimus, an mTORC1 inhibitor, in the treatment of alcohol dependence, whilst also looking for any change in alcohol use whilst taking the study drug and during a four week follow up period.

Cancer cachexia is a complex, multifaceted syndrome that remains both challenging to diagnose and treat. In addition to negatively impacting patients’ quality of life and decreasing physical function, cachexia may worsen cancer treatment side-effects and significantly impact patient prognosis. Exercise has been shown to be an effective strategy to manage the adverse effects of cancer and its treatment. However, whether these benefits extend to individuals with cancer cachexia has been underexplored. This project will therefore aim to evaluate whether an individualised, 12 week supervised exercise training program is safe, feasible and effective as a management strategy for cancer cachexia. Who is this study for? You may be eligible to join this study if you have a diagnosis of locally advanced or metastatic cancer and are experiencing involuntary weight loss. Study details: Participants will be randomly assigned (by chance) to one of two groups: 1) an immediate exercise group; or 2) a delayed exercise group. Both groups will continue to receive standard medical care. The immediate exercise group will commence a 12 week exercise program (36 sessions) plus protein supplementation (three days/week) immediately following enrollment. The delayed exercise group will receive usual care (i.e. no change to their current lifestyle) following enrollment and will be offered participation in an identical exercise intervention 12 weeks after randomisation. In-person testing will be conducted at baseline, 12-weeks and 24 weeks. Testing will involve, strength and aerobic tests, a body scan, questionnaires and a fasted blood sample. Questionnaires will also be administered at 6-weeks but can be completed at home (online or paper copies). In addition, participants will be invited to complete optional assessments, which involve providing a muscle biopsy (sample of muscle tissue) and/or an evaluation of resting metabolic rate. This research is a critical first step in to determine the most feasible and effective ways to utilise exercise as a strategy to counteract the burden of cachexia in individuals with advanced cancer and therefore lay the foundation for future research.

An endotracheal tube (ETT) is used to safely and securely manage a patient's airway during anaesthesia. Sometimes these can be difficult to insert, requiring the use of an introducer - something smaller and solid that fits inside the ETT, and is easier to insert into the trachea ('wind pipe') than the tube initially. One of the problems that exists with this technique is that any gap between the ETT and the introducer can lead to the ETT getting caught on structures around the vocal cords as it is railroaded over the introducer. Our study uses a novel ETT/guidewire system that was developed to overcome these problems. The ETT has a channel for the guidewire in its wall, and the rate of deformation of the ETT matches the rate of deformation of the guidewire. This allows the ETT to follow the path of the guidewire easily. We will use an accepted technique of visualising the vocal cords (using a video laryngoscope) to pass the guidewire into the 'wind pipe', and then railroad the ETT over the guidewire under vision. Our hypothesis is that this system will have a very low rate of ETT hold-up or impingement on entering the 'wind pipe', and therefore provide reliable and atraumatic intubation. We will record the incidence of all complications, including trauma to any airway structures, misplacement of the tube, difficulty placing the tube in the 'wind pipe', problems with oxygen levels during the procedure, and the time taken for the procedure. We expect the system to be very effective and reliable, based on preliminary studies on manikins and cadavers, and also based on one human study done overseas using this system.