ANZCTR search results

The aim of this study is to evaluate safety and tolerability of SVT-1B149 as a treatment for chronic functional constipation together with preliminary efficacy. The treatment consists of carefully selected bacterial species. Bacteria are naturally found in the digestive tract and are a research focus for their important role in many conditions related to gut health. Bacteria play an important role in the function of the immune system, digestive health, inflammation and have anti-microbial properties. Several research studies have found treatment with beneficial bacteria to relieve constipation and related symptoms. This study will help determine how safe and effective SVT-1B149 is as a stand-alone therapy in treating constipation and reducing symptoms.

Empagliflozin is a sodium glucose transporter-2 (SGLT2) inhibitor drug, a class of diabetic medication. Interestingly, there is survival benefit in patients with heart failure. There are similarities between heart failure and the complications of severe liver disease, termed cirrhosis. As a result, it has been suggested that the SGLT2 inhibitors, may be of benefit in managing cirrhosis. While safe in liver disease in single dose studies, there is no long-term safety data in patients with cirrhosis. The aim of the study is to assess the safety of empagliflozin in three different groups (n=5) of increasing degrees of severity of cirrhosis and healthy controls (n=8). If this small pilot study demonstrates empagliflozin to be safe, then we will be able to do a larger study to assess the benefit of this medication in cirrhosis. This would be a significant advance in the treatment of cirrhosis.

This novel implementation study represents a major step towards improving management of sleep disorders in primary care (PC). The two most common sleep disorders, chronic insomnia and obstructive sleep apnea (OSA), affect >4 million Australians, and are associated with broad ranging negative physical and mental health outcomes, as well as reduced safety and productivity, costing over $66 billion annually. People with sleep disorders commonly receive care that is far from best practice and potentially dangerous. A lack of sleep-specific training for GPs contributes to widespread under recognition of sleep disorders, and an over-reliance on specialist care. Long waiting periods for specialist OSA care have led to a rise in vertically integrated business models from pharmacy/corporate treatment device suppliers, without adequate medical input to manage these disorders, and often complete separation from a person’s usual medical care. Our research group and others, have demonstrated in randomised trials that GPs and PNs can manage OSA, producing equivalent patient outcomes to those in specialist centres at significantly lower cost. Similarly, for insomnia, despite clinical guidelines recommending cognitive behavioural therapy (CBTi) as the first line treatment, the majority of patients receive sedative/hypnotic drugs with potentially dangerous side effects, and do not get access to the CBTi that would address the underlying cause of their insomnia. To address this, our study will utilise a simplified Model of Care for screening, diagnosis and treatment of OSA and chronic insomnia in PC, and a suite of practice change support tools. These tools are currently being developed and will be translated through our NHMRC CRE (GNT1134954) – National Centre for Sleep Health Services Research, and include simple clinical guidelines, education modules, eHealth decision support tools, and referral pathways. This will facilitate and demonstrate the uptake, efficacy and cost-effectiveness of the new sleep health services model. We hypothesise that our implementation strategy for improving sleep disorder management in PC settings will result in management that is: a) better aligned with recommendations of evidence based clinical guidelines; b) more cost-effective in terms of patient outcomes/waiting times and cost when compared with usual care; c) feasible and acceptable from the perspective of GPs, PNs and patients, indicating viability for up-scaling the project.

The present project is a feasibility study which aims to examine the effect of an 11-­week exercise intervention on the sleep of sedentary Australian pregnant women.

The primary aim of this study is to map the sensory distribution pattern and area of sensory overlap of the posterior antebrachial, medial antebrachial and lateral antebrachial cutaneous nerves (PABCN, MABCN, LABCN) of the forearm following an ultrasound-guided local anaesthetic block. The secondary aim is to map any sensory block that occurs in the hand. Results from the study will enhance our current understanding of the variability of cutaneous sensory innervation. It may clarify why some local anaesthetic nerve blocks do not produce the expected area of cutaneous sensory anaesthesia. It will benefit pain physicians when investigating and managing the cause of symptoms of injury to the cutaneous nerves of the forearm. Forearm flaps are often used by plastic surgeons to repair soft tissue defects. Sensory deficits often occur over the skin at the donor site. The results of this study will help with sensory matching when designing forearm flaps for reconstructive surgery

For quality assurance and research, this project aims to evaluate burn scar outcomes following treatment with the Lumenis® UltraPulse® Fractionated CO2 ablative laser at the Royal Adelaide Hospital (RAH). Similar laser therapy is currently available for the paediatric population in SA, however, until recently, there was no access to this treatment for adults in SA. As comparison burn units around Australia and internationally have been successfully using this therapy for over 4 years to improve patient outcomes without negative long-term effects, the RAH Adult Burn Service decided to investigate offering this modality as a scar management option for our patient population. As part of introducing this new procedure, we are interested in evaluating the outcomes to ensure there are meaningful clinical benefits for patients that complement our current scar management. We also aim to add to the research knowledge base by comparing subjective and objective scar properties and outcomes. And finally, we would like to also evaluate patient-reported outcomes and the effect on psycho-social well-being of both laser treated and non-laser treated scars.

We will conduct a two-centre randomised control study designed to assess the impact of transesophageal (TOE)- guided lead placement on the development of new or worsening tricuspid regurgitation (TR). All eligible patients will have a TOE at the time of randomisation, as an exclusion criteria is inadequate TOE images. In the treatment arm, the implanter will be guided by the images obtained on the TOE in order to place the lead in a favourable commissural position so as to minimise tricuspid regurgitation. In the control arm, the implanter will be blinded to the findings on TOE and use fluoroscopy to guide lead placement as is standard practice. The projected duration of the study is 2 years and it is expected that we will enrol 125 patients during this period who require the implantation of a pacemaker (PPM) or automated implantable cardioverter-defibrillator (AICD) as deemed clinically appropriate by their treating cardiologist. The follow-up to assess the primary and secondary endpoints after lead implantation will be at 6-months during a routine clinical follow-up with the treating specialist

The project's aim is to conduct a pilot randomised controlled trial to determine the efficacy of PATHFINDER on outcomes for heart failure with reduce ejection fraction over a 6-month period. Two hundred patients with CHF will be randomised to receive the PATHFINDER Heart Health Plan or control (usual care). For the PATHFINDER group, the project’s Nurse Practitioner (NP) will help facilitate the transition from tertiary to primary care including a Heart Health Plan, and be a point of contact for GPs needing support for medication titration. Referrals for cardiac rehabilitation program or exercise training program will be facilitated by the NP, with input from other Allied Health Professionals. Complex issues will be triaged for cardiologist support through the Advanced Heart Failure and Cardiac Transplant Service (FSH) . Primary outcome includes proportion of patients adhering to guideline-recommended treatment at 6 months post-enrolment. Secondary outcomes include proportion of patients receiving the guideline-recommended treatment independently at 6 months post-enrolment; exercise training program or cardiac rehabilitation program adherence by 6 month post-enrolment, 6 minute walk test distance, patient-reported outcome includes Kansas City Cardiomyopathy Questionnaire-short version (KCQ12), Patient Health Questionnaire (PHQ-2),Medication Compliance Questionnaire at baseline following enrolment and 6 month post-enrolment, ;PROMIS Physical Function Short Form 4a, Self-care of Heart Failure Index at 6 months post-enrolment.

We aim to evaluate the attitudes of mental health professionals towards MDMA-therapy trials by a comparison of attitudes to a neutrally-labelled pharmacotherapy, using a double-blind, randomised controlled vignette study design. We hypothesise that mental health professionals will have the following differences in attitudes towards MDMA-therapy, when compared a neutrally-labelled pharmacotherapy: 1) higher concerns for safety; 2) Lower predicted efficacy; 3) stronger objections to participation and/or lower levels of recommending participation. By assessing professional attitudes towards MDMA-therapy for PTSD using an experimental study, we can understand if there are any biases that may be inhibiting conducting research in this area, or inhibiting the uptake of this potential new treatment by clinicians.

All patients receive the POP device app as part of standard of care practices for under going Total Hip Arthroplasty procedures, irrespective if they are enrolled in the study. This is is a pilot, observational, prospective study to assess patient satisfaction of a mobile phone application (App) as a means of delivering information on post-operative treatment program, rehabilitation and research tools for patients undergoing total hip or knee replacement. Follow up of Patient Reported Outcome Measures (PROMs) is essential to auditing practice and undertaking research in arthroplasty. Traditionally, PROM data is collected via paperwork. Similarly, patient education about post-operative regimens has been in the form of verbal discussions and multiple sheets of paper. The Patient Optimised Pathway application (POP-App) has been designed to reduce this paperwork burden. It is hoped this app will improve the surgical patient journey. 30 participants will be enrolled into a single arm of the study (no control group). Participants will be shown how to use the app and fill out the PROMs prior to operation. They will then be asked to fill out PROMs and Patient Satisfaction surveys pre-operatively and at Day 1, 2 weeks, 6 weeks, 3 months and 6 months post-operatively. Data collected will confirm acceptability of the app.