ANZCTR search results

The proposed research aims to complete a comprehensive assessment of the physical health of Vietnam Veterans with and without posttraumatic stress disorder (PTSD) to improve the understanding of the illnesses associated with PTSD. Assessment of organ function in each group will be carried out to provide information regarding which conditions are associated with PTSD and how these relate and are inter-related. Mechanisms by which these proposed associations may be explained will be explored. This will include investigation of mechanisms which have been proposed as causing physical health damage in PTSD. These include dysregulation of the hypothalamic pituitary axis (HPA), chronic activation of the sympathetic nervous system and chronic inflammation. In addition, neurogenetic and epigenetic studies will be included to identify the genes and their genetic and epigenetic variants that contribute to the susceptibility to either PTSD or to physical damage associated with PTSD.

This is the first clinical trial of HSK3486 and will be conducted in healthy volunteers to determine the safety, tolerability (including pain on injection), and PK(only to be assessed for subjects who are randomized to HSK3486 in Cohorts 3 to 8)and PD and profiles of HSK3486 administered as a single IV injection. Results from this study will supports further clinical development of HSK3486. This study will be performed in compliance with the protocol, International Conference on Harmonization Good Clinical Practice (ICH GCP) and local regulatory requirements. Aspects of the study concerned with the investigational product will meet the requirements of Good Manufacturing Practice (GMP).

The purpose is to investigate whether interactive digital technology (using the Xbox Kinect system) is feasable to use to improve the volume of activity that stroke survivors can undertake, and to determine if there are benefits to upper limb function or mobility using this technology

Hip osteoarthritis (OA) is associated with significant personal and societal burden, which is rising with increased life expectancy. Early hip OA is commonly seen during hip arthroscopic surgery, and can affect younger adults (age<55 years) with peak work and family commitments. Whilst hip arthroscopy is commonly undertaken for pain associated with early hip OA, no studies have examined best practice for post-operative rehabilitation. An effective intervention for early-onset hip OA will potentially have great personal and societal impact. The primary aim of this study is to establish the feasibility of a randomised clinical trial (RCT) of physiotherapy, targeted to improve hip joint range and hip-related symptoms in early-onset hip OA. This study is a blinded pilot RCT conforming to CONSORT guidelines. Twenty people with early hip OA who had hip arthroscopy surgery six to 12 months previously will be recruited and randomized to the intervention group (individualized manual therapy, exercise therapy and education) or the control group (education only). Eight interventions will occur for both groups over three months, with outcomes collected at baseline and three months. Primary outcome measure - feasibility of a full scale RCT. Secondary outcome measures - symptoms, quality-of-life and range-of-motion.

The aim of the proposed study is to formally pilot an evaluation of the effectiveness of a psychological resilience training intervention called READY (Resilience for Everyday Life) for adult patients with congenital heart disease at The Prince Charles Hospital.

Despite the development of anaesthesia management guidelines, perioperative respiratory adverse events (PRAE) remain a major cause of morbidity and mortality during paediatric anaesthesia, causing more than three quarters of critical incidents and nearly one third of all perioperative cardiac arrests. In paediatric anaesthesia, obesity is a significant problem with obese children not only having anaesthesia-relevant co-existing diseases like asthma or hypertension, but also having a higher incidence of anaesthesia related complications. Many factors encountered during general anaesthesia such as supine positioning (lying down, face up), anaesthetic agents and the type of surgery affect the functioning of the respiratory system and in particular lung volumes and respiratory mechanics. These anaesthesia related changes in lung function are expected to be even more pronounced in obese patients. The incidence of obesity is rising steadily in Australia with 25% of children being overweight or obese in 2011-2012 according to the Australian Bureau of Statistics. A better knowledge of lung health and the changes in lung function caused by anaesthesia and the impairment of respiratory mechanics by obesity will help improve the management of these high risk patients. We therefore aim to assess lung function changes as well as the incidence of PRAE in healthy and overweight/obese children. We hypothesise that 1.The incidence of PRAE will be higher in obese/overweight children compared to normal weight children. 2.Obese or overweight children will have a significantly different respiratory resistance (Rrs) and reactance (Xrs) compared to normal weight children. 3.The state of consciousness (being awake or anaesthetised) and the body position (being seated or supine) will affect the respiratory resistance and reactance and that this effect with be more pronounced in overweight and obese children compared to children with a healthy weight. We will recruit 110 children between the ages of 6 and 16 that have a BMI between the 5th and 85th percentile for the healthy population (n equal to 55) and more than or equal to the 85th percentile for the obese/overweight population (n equal to 55). Lung function testing consisting of Forced Oscillation Technique (FOT) and Multiple Breath Washout (MBW) will be completed on all patients on the day of their procedure. All patients will be monitored closely during and following their procedures and any respiratory events will be recorded. We are hoping to get a better understanding of the lung health of the obese and overweight population of children in order to improve the anaesthetic management of this high risk group.

Heart failure is a disorder where right or left ventricular function is affected and the heart fails to pump blood efficiently around the body. The purpose of this study is to identify whether a nurse-led, community based heart failure management service (SmartHeart) improves self-management and quality of life. Participants in the study will be patients with a recent hospital admission due to heart failure as a primary or secondary diagnosis who are less than 85 years of age. The experimental group will compromise patients who are admitted to a tertiary hospital with links to a community-based heart failure management service and subsequently referred to that service. The control group will be comprised of a similar cohort of patients, matched for gender, age and functional class who are admitted to a different tertiary hospital without links to a community-based heart failure management service. The Self-Care Heart Failure Index (SCHFI) will be utilized to measure self-management behaviours and self-efficacy. Quality of life will be determined using the Short Form 36 and Minnesota Living with Heart Failure Questionnaire. The findings from this study will help guide evidence-based practice for nurse-led management of heart failure in the sub-acute period.

Depressive symptoms are common and undermine the quality of life of people with Alzheimer’s disease (AD). Cholinesterase inhibitors and antidepressants have all but no effect on the mood of patients, and their use is associated with greater risk of adverse events compared with placebo. The use of traditional psychotherapeutic interventions, such as cognitive behavioural therapy, is hindered by the presence of cognitive impairment. Cognitive bias modification (CBM) is a novel, simple and safe intervention that targets attentional and interpretative biases associated with anxiety, dysphoria and depression. CBM operates through implicit learning systems, which are spared until late in the course of the dementia illness. CBM is effective at reducing depressive symptoms in adults without cognitive impairment and our pilot data indicate that this is a feasible and, most likely, efficacious treatment for people with depression in AD (DAD). Moreover, CBM is safe and unlikely to be associated with significant adverse events in this vulnerable population. RAPID will evaluate this innovative intervention in a carefully designed trial that brings together an accomplished team of investigators with expertise in ageing research, depression, dementia, CBM, randomised trials and translation of research findings into clinical practice. This study will produce definitive high quality evidence for the benefits of CBM in improving the quality of life of people with DAD.

Among the rheumatological diseases, Systemic Sclerosis or Scleroderma (SSc), a multi-organ autoimmune disease characterized by increased scarring or fibrosis of tissues and narrowed blood vessels, carries the greatest burden of case-based mortality, reducing the average patient’s life expectancy by 34 years. One of the major causes of SSc related death is Pulmonary Arterial Hypertension (PAH) which develops in 10-15% of patients with SSc. PAH is a condition that narrows the blood vessels in the lungs making blood flow through the lungs more difficult and causing increased strain on the heart and as a result it can cause heart failure and death. Although new specific vasodilator therapies have become available in the last 10 years to treat PAH, some patients still experience poor health outcomes with the 3 year survival of patients with SSc-PAH being about 70%. Blood clot formation in the blood vessels that supply the lungs has been implicated as one of the events that occur in the complicated pathway leading to the development of PAH. For this reason, researchers have begun to consider whether the use of anticoagulant medications that can prevent blood clot formation, would be beneficial to patients with SSc-PAH. International clinical guidelines recommend the use of anticoagulant medication for some types of PAH, but due to a lack of convincing evidence, this therapy has not become part of standard care for SSc-PAH. The purpose of this study is to determine whether there are any health benefits to be gained from the addition of an oral anticoagulant medication, apixaban, in patients with SSc-PAH who are already prescribed advanced PAH therapy. This study is the first of its kind. Apixaban is approved in Australia for the prevention of blood clots in patients who have undergone elective total hip or total knee replacement surgery and to prevent stroke in some patients with Atrial Fibrillation/Flutter, however it is not approved to treat SSc-PAH. Therefore, it is an experimental treatment for SSc-PAH. The study will be a double blind placebo controlled study and will continue for 3 years. The primary outcome measure will be the time to clinical worsening of PAH. Secondary outcomes will include quality of life measures and health resource use.

This study aims to determine if a community-based exercise program for people with COPD is economically beneficial and associated with improvements in exercise capacity and quality of life