ANZCTR search results

This study will compare the impact and acceptability of a digital strategy utilising IBD specific smart phone apps, to standard IBD practice, in the delivery of care to patients from a regional area in Queensland, Australia. We aim to determine the impact of a digital monitoring strategy on quality of life, disease symptoms and costs of care. Participants will be recruited from a regional IBD clinic in Queensland Australia. The trial will run for approximately 15 months. We anticipate that the Implementation of the digital strategy will be non-inferior to standard of care in terms of both patient symptoms and quality of life, whilst reducing health care associated costs.

An 8-week randomized feasibility trial will be conducted to investigate motor and non-motor responses to high-intensity interval training utilizing a combined arm and leg ergometer in individuals with mild to moderate Parkinson's disease (PD). control group will receive usual care. Primary hypothesis High-intensity combined arm and leg ergometry added to usual care will lead to increases in habitual gait speed in people with PD compared to usual care.

There is currently no disease-modifying agents available for knee osteoarthritis and treatment focuses on relief of symptoms such as pain and stiffness. There is limited placebo controlled randomised clinical trial data for a number of procedures to improve symptoms of knee osteoarthritis to improve function. These include steroid injections into the joint and blocking the nerves that supply the joint. These interventions have not been adequately studied against placebo. This study will look at comparing the effectiveness and safety profile of these two technqiues agents against a shared placebo group to see if they are effective. A further exploratory outcome is how well these interventions compare against each other if they prove effective against placebo.

Premature cardiovascular disease is the leading cause of death in people living with type 1 diabetes. Semaglutide, a long-acting glucagon-like peptide-1 receptor agonist, has been shown to reduce cardiovascular events and improve weight and glycaemia in type 2 diabetes. Semaglutide may offer cardioprotective and metabolic benefits in type 1 diabetes. Our study hypothesis is that semaglutide will reduce carotid femoral pulse wave velocity, a measure of arterial stiffness. Arterial stiffness has been shown to be an appropriate surrogate marker of cardiovascular risk in this population. Subjects will receive semaglutide 1.0mg weekly or matched placebo for 26 weeks. Potential mechanisms for metabolic changes will also be explored including insulin sensitivity determined by hyperinsulinaemic-euglycaemic clamp; and incretin and pancreatic hormone levels determined by mixed meal tolerance test. We will also study incretin and pancreatic hormones determined by mixed meal tolerance test in a group without diabetes to compare to the group with type 1 diabetes.

Cardiac arrest is a common and catastrophic event. Among survivors of cardiac arrest, many have ongoing problems in thinking and performing normal activities of daily living. Such difficulties may arise from lack of oxygen to the brain causing injury that occurs as a result of the cardiac arrest. Therapeutic interventions that can be applied to lessen the degree of brain injury after cardiac arrest are warranted and desperately needed. Insulin-like growth factor-1 (IGF-1) is a major growth factor and has been shown to play a role in recovery from ischemic damage due to its anti-cell death signaling activity. Scp776 is a first-in-class targeted growth factor therapeutic that selectively activates and prolongs insulin-like growth factor-1 receptor (IGF-1R)-driven pro-survival signaling in damaged tissues containing large numbers of apoptotic cells. As such, by conducting a multi-centre randomsied trial, we aim to determine whether treatment with scp776, compared to placebo, decreases the extent of brain injury as calculated by automated assessment of brain magnetic resonance (MR) imaging (RAPID Software) at 72 – 96 hours following randomisation in comatose adults resuscitated after out-of-hospital cardiac arrest. This study will enrol a total of 40 evaluable participants from 5 - 10 hospitals in Victoria, Australia. The primary outcome will be ascertained between 72 - 96 hours after randomisation. Study participants will be followed-up for 180-days post-randomisation, or death, whichever is earlier.

Myocardial infarction (MI) affects -57,000 Australians every year and almost half a million Australians have had a heart attack at some point in their lives. While mortality after MI has been declining over the last few decades, it is in the group of young patients that it has lagged. Data on the biological and pathophysiological factors related to MI in the young is scarce. In addition, there are gaps in quality of care due to the perceived risk for MI being low. The study aims to characterise the clinical presentation, risk factors, angiography findings, underlying aetiology, quality of care and sex differences, of young patients with MI (age <50 years). This is an investigator-initiated, observational, single-centre clinical registry study. Approximately 500 patients under the age of 50 years with MI will be either recruited Prospectively from Westmead Hospital.

Prosthetic joint infection (PJI) is a catastrophic complication of orthopaedic joint replacement surgery that is increasing in incidence despite current best-practice. The success rate of treating Prosthetic Joint Infections (PJI) ranges from 0 to 89%, and the median cost per patient in Australia is $34,800, with a 156% increase in treatment cost when the treatment fails. Emerging evidence suggests that Gut dysbiosis i.e altered gut microflora is associated with absence or reduced abundance of beneficial microorganisms, increased abundance of pathogens and could predispose patients to a higher risk of PJI post orthopaedic procedures. Supplementaion with suitable prebiotics (non-digestable carbohydrates) results in production of short chain fatty acids that alters gut microbiome favourable. Hence, in this study, we will be investigating the effect of modifying gut microbiome with an in-market prebiotic supplement on surgical outcomes and recovery in PJI patients.

Currently, specialised early interventions are not accessible for a majority of youth with Bipolar Disorder (BD) who seek care. To address this gap, we have developed a bipolar-specific model of care for those with early-stage BD (BLEND) integrating: (i) evidence-based psychological strategies delivered through digital and face-to-face sessions; (ii) psychopharmacological interventions; (iii) relapse prevention strategies, and (iv) online peer support networking. We will conduct a randomised trial to evaluate the effectiviness of BLEND, compared with an enhanced form of standard care (ESC). We will include young people aged between 15 and 25 years, seeking specialised help for Bipolar Disorder types I or II. After informed consent, we will randomise 125 such young people (1:1) to BLEND or ESC. Interventions will be delivered over 4 months and assessments will be conducted at Baseline, 2, 4, 6 and 8 months from Baseline.

People with severe asthma experience high symptom burden and frequent severe asthma attacks (termed exacerbations). In the last decade new biologic (antibody) treatments, including mepolizumab, have become available for severe asthma. Clinicians now recognise that mepolizumab treatment results in almost complete suppression of symptoms and exacerbations, termed remission, in around a quarter of patients. Remission of severe asthma is a relatively new concept, and further understanding of numerous aspects of remission is now required to promote remission as a clinical target and to further raise remission rates on treatment. To address this, in this study we aim to understand the clinical, immunological, economic and health literacy characteristics of long-term remission of severe asthma treated with mepolizumab.

This study aims to continue the pursuit of therapy approaches that view the client holistically, and do not just focus on their overt stuttering. Swift Group Improv Therapy uses group improv to support clients to positively participate and continuously engage in the activities and social situations that are important to them. Focusing on increasing the awareness of one’s own communication abilities in a risk-free supported environment guided by experts in the field of stuttering has the potential to improve long term outcomes for participants. Currently, relapse following treatment is estimated to occur in 30% to 60% of stuttering clients. This research will contribute to identifying specific factors that lead to favourable and less favourable outcomes among this group.