ANZCTR search results

To quantify inspiratory muscle endurance, through the Fatigue Resistance Index method, in healthy people. Poor respiratory muscle endurance is a consequence of invasive mechanical ventilation for patients in intensive care (1,2). Over the past 10 years, researchers including ourselves (2,3) have used the ‘Fatigue Resistance Index’ (FRI) method to quantify the endurance of the respiratory muscles of intensive care patients. This involves inhaling through a hand-held device for 2 seconds, then breathing against resistance for 2 minutes, and then inhaling maximally through the hand-held device again. The FRI is a feasible alternative to more complex invasive methods of analysing diaphragmatic endurance. However, to our knowledge, this method of quantifying endurance has not been tested in a normal population. Following our publication in 2015 (1), we wish to measure FRI in normal healthy subjects to allow us to compare our data from intensive care patients with age and gender matched healthy participants. REFERENCES: 1. Bissett B, Ledtischke IA, Boots R & Paratz J. Weaned but weary: one third of adult intensive care patients mechanically ventilated for 7 days or more have impaired inspiratory muscle endurance after successful weaning. Heart and Lung. 2015; 44: 15 – 20. 2. Chang AT, Boots RJ, Brown MG, Paratz J, Hodges PW. Reduced inspiratory muscle endurance following successful weaning from prolonged mechanical ventilation. Chest. 2005; 128: 553 – 559. 3. Bissett BM, Leditschke IA, Paratz JD, Boots RJ. Protocol: inspiratory muscle training for promoting recovery and outcomes in ventilated patients (IMPROVe): a randomised controlled trial. BMJ Open. 2012:2e000813.

What is this study about? The purpose of this study is to investigate how safe and tolerable repeat doses (applied daily for 7 days) of ZYN002 transdermal gel is in healthy volunteers and patients with epilepsy. The study will look at how the body absorbs, distributes, breaks down and then removes the study drug from your body. This will be done by analysing the levels of ZYN002 in your blood and urine at various times following drug administration. Your skin at the application sites and your hands will be checked to see if there is any irritation or reactions present after ZYN002 application. The study will also investigate neuropsychological effects that ZYN002 may have by administering a number of neuropsychological tests. Who is if for? You may be eligible to join this study if you are aged between 18 and 55 years and are either in general good health or have epilepsy with partial onset seizures that is stable. Study details: This study will investigate various doses of ZYN002 compared to a placebo gel (a treatment with no active ingredients which looks like the real thing but it is not). This study is ‘double-blind’ which means you and your study doctor, together with the study staff administering the study treatment will not know whether you are receiving ZYN002 or placebo gel. What does study participation involve? Your participation in the study includes A screening visit, which could be up to 28 days before your study treatment. One confinement period starting on the evening before dosing and lasting until 36 hours after the last study treatment on the 8th study day. This will require eight (8) nights in the clinic. Two out-patient clinic visits following the confinement period on Days 9, Day 10, Day 11 and the End of Study Visit on Day 13. These visits will be at 48, 72, 96, 72 and 144 hours after the last application of the study treatment on Day 7. Additional out-patient visits may be required if there is any skin irritation present at the study treatment application sites. Throughout the study you will have various medical tests (physical examinations, vital signs measured, ECG measured, neuropsychological tests) and will have several blood and urine samples collected for laboratory analysis.

Cannabis is the most widely used illicit drug and is associated with considerable health related morbidity. About 1 in 10 cannabis users become dependent on the drug leading to high-level of treatment seeking. There is increasing interest in the idea that severe cannabis dependence might be effectively treated by substituting smoked cannabis for a safer, more benign cannabinoid agonist medication. Recent laboratory studies suggest this approach holds promise as an effective therapy in dependent users. Our team has recently published the first ever-clinical trial of the cannabinoid agonist medication Sativex in alleviating cannabis withdrawal. This world first study demonstrated the safety and efficacy of Sativex relative to Placebo in an inpatient setting. This project proposed the first ever outpatient randomised controlled trial (RCT) to test the efficacy, safety and cost effectives of Sativex for treating cannabis dependence the community. Sativex will be given to severely cannabis dependant patients who have not previously responded to conventional treatment. Subjects (n=142) will be randomly allocated to a 12-week course of Sativex or placebo, with standard counselling and clinical reviews across both groups, and a 12-week follow up after the completion of maintenance dosing. This proposal presents an exciting innovation in the embryonic field of clinical research into the world’s most prevalent illicit drug. As well as examining the efficacy of this medication, the trial will address a range of issues important in any future translation of Sativex use into routine clinical practice. The development of an effective medication for treating cannabis dependence would have wide reaching clinical and public health benefits.

Aims: The aim of this project is to assess the effects of water-based exercise training in people with stable heart disease. This study is being conducted in conjunction with an acute study assessing the physiological effects of a single submerged session compared to a single session of matched intensity land-based exercise. Justification: Exercise is an important component of rehabilitation and preventing recurrent heart problems in people with heart disease. However, exercise participation is sub-optimal in this population and increasing the range of exercise options for people with heart disease may increase exercise participation. For example, water-based exercise may be more appealing to people with heart disease who have other health issues, such as arthritis or obesity, which may make land-based exercise difficult or painful. Furthermore, preliminary research suggests that water-based exercise may have additional vascular and brain benefits due to the effects of water immersion on blood flow. However, this has not previously been investigated in people with heart disease. Participants: Patients who have had a heart attack or bypass surgery at least six months prior to enrolment, or documented blockages in the arteries of their heart based on the results of an angiogram (a scan of the heart) will be recruited to the study. Participants must be medically stable prior to participation and not be undertaking a formal exercise program. Design and methods: 60 participants will be randomised into one of three groups for the duration of a 12 week program: *12 weeks of land-based exercise * 12 weeks of water-based exercise * A control group who will maintain their usual activities for 12 weeks. Strength, fitness, vascular function, brain blood flow, body composition, blood profiles and aspects of cognition will be assessed before and after the 12 week period. Vascular function will be assessed fortnightly during the 12 week period in a subgroup of participants.

This pragmatic research project aims to expand and evaluate a recently established paediatric multidisciplinary weight management service and investigate, develop and support proposals for ongoing sustainability. This service focuses on the treatment and management of obesity in children and adolescents, and is being disseminated under real-world conditions by specialist clinicians at the Lady Cilento Children's Hospital in Brisbane, Queensland. It is anticipated that this dedicated, multidisciplinary tertiary clinic for children who are overweight and obese will improve measures of body composition, anthropometric measures, nutritional intake, self-reported physical activity, and health-related quality of life over an intensive four month management period, with positive outcomes maintained at 6 months, 12 months and 24 months. Patient satisfaction with the service is anticipated to be both positive and constructive. This model of service will also be transferable to other non-tertiary hospital sites, to help in continuing to improve the health and well-being of children, adolescents and their families. Evaluation of the model will also ensure its sustainability

The study is a pilot randomised proof-of-concept trial that aims to identify potential cognitive markers by utilising a 10-week social and creative, gallery-facilitated "Art & Dementia" program to examine its relationship with memory and learning tasks in adults with dementia. Specifically, we hope to ascertain whether: a) there are clinical predictors of benefit associated with an art program, b) there is improvement in visuospatial cognitive skills associated with an art program, and c) an art program is associated with improved wellbeing and reduced carer burden. We will compare the efficacy of this program to a waitlist group.

Psychotic illnesses usually first emerge in young people and result in widespread suffering, protracted disability, premature death, and a huge economic burden. Early intervention represents a vital strategy to reduce this burden. Psychotic disorders are preceded by a prodromal period of distress, impaired functioning and subthreshold psychosis. Although the evidence from 11 Randomised Controlled Trials indicates that interventions can reduce the risk of transition to psychotic disorders by more than 50%, clinicians remain unclear how to select the best sequence of treatments to prevent progression and maximize recovery. This research will conduct a sequential multistage randomized clinical trial to build individualised “adaptive” treatment strategies to reduce the risks for a range of outcomes. Ultra high risk of psychosis participants will be recruited from Orygen Youth Health and four ‘headspace’ youth mental health services. The ‘headspace’ youth mental health service has already delivered care to over 100,000 young people with emerging mental disorders, of whom 40% are considered as having an ultra high risk of developing psychosis. Orygen is Australia’s largest mental health research facility, and specialises in early intervention in young people. The main aim of this study’s sequential multi-stage design is intended to produce evidence to guide a stepwise clinical approach to treatment of ultra high risk of psychosis patients and reduction of risk for psychosis and other deleterious clinical and/or functional outcomes.

The aim of this project is to assess whether the administration of dexmedetomidine either before or during a child's operation affects the incidence of post-hospitalisation behavioural change (PHBC). It has been reported that PHBC occurs in over 50% of children undergoing a general anaesthetic(1) and manifests as behaviours such as sleep and eating disorders, defiance of authority, nightmares, enuresis and temper tantrums. The effect is usually short-lived, however in 5-10% of children these behaviours can last up to 12 months. The risk factors for developing PHBC include underlying anxiety in the child or parent, a traumatic experience at induction of anaesthesia, emergence delirium and pre-school age. A recent meta-analysis of alpha-2 agonists found that they effectively reduce the incidence of emergence delirium but none of the studies looked at longer term outcomes (2). This study aims to answer the question of whether dexmedetomidine, an alpha-2 agonist, can reduce the incidence of PHBC. Pre-school age children requiring general anaesthesia for common day-case procedures will be randomly assigned to one of three groups: A dexmedetomidne pre-medication group, an intraoperative dexmedetomidine group and a control group. Baseline anxiety levels of the child and parents will be recorded using validated tools and the anxiety of the child during induction of anaesthesia will also be recorded. The primary outcome will be maladaptive behaviours after hospitalisation and these will be measured using the Post Hospitalisation Behaviour Questionnaire for Ambulatory Surgery (PHBQ-AS) and the Strengths and Difficulties Questionnaire (SDQ). These questionnaires on children's behaviour will be administered to the parents by a blinded researcher at day 3, 14 and 28 post surgery. 1. Kain ZN, Mayes LC, O'Connor TZ, Cicchetti DV. Preoperative anxiety in children:Predictors and outcomes. Arch Pediatr Adolesc Med. 1996; 150:1238-45. 2. Pickard A, Davies P, Birnie K, Beringer R. Systematic review and meta-analysis of the effect of intraoperative a2-adrenergic agonists on postoperative behaviour in children. BJA. 2014; 112(6):982-90.

Psychological factors are often underrepresented although important in medication adherence. Interventions geared towards education may help facilate adherence. Two questionnaires were administered to screen IBD patients. The Medication Adherence Rating Scale (MARS) questionnaire screened for non-adherence and consisted of four questions on a Likert-type scale. The Beliefs about Medications Questionnaire (BMQ) addressed necessity and concerns. The BMQ consisted of ten questions on a 5-point Likert scale The first five questions addressed patient necessity towards medications and the last five questions addressed patient concerns regarding medications totalling a maximum of 25 points per domain. High necessity and concerns was determined with a score of >15/25 in each corresponding domain. Patients with MARS scores below 17 were classified as non-adherers and were offered a structured personalised counselling session with an IBD pharmacist addressing misperceptions, concerns, risk and other queries. Adherers were recruited as controls. All patients were followed up with the MARS and BMQ questionnaire on a three-monthly basis for a maximum of two years or until the study period had elapsed. The primary outcome was adherence measured by the MARS score. Secondary outcomes were medication necessity, concerns and acceptance. Medication acceptance was defined as high necessity >15/25 and low concerns score <16/25.

This research project is testing the safety, tolerability and pharmacokinetics (looking at the amount of drug in your blood to evaluate the way the body processes the drug), pharmacodynamics (the response of your body to the drug) and immunogenicity (your immune response to the drug) of a new drug called M012 when it is given as a single dose. M012 is an injection into the skin of your abdomen to be administered by a trained professional.