ANZCTR search results

An Australian Double-Blind Randomised Controlled Trial of Genotype-guided versus Standard Psychotropic Therapy in People with Treatment Resistant Depression. The study intervention consists of a pharmacogenomic (PG) test with resulting recommendations for which antidepressants may work better for that participant. Eligible participants will be randomised to one of two arms. 1. PG-informed treatment arm: The treatment plan for their antidepressants will be informed by participant’s PG results. 2. Standard treatment arm: The treatment plan for their antidepressants will follow current treatment guidelines but will not be informed by participant’s PG results. Both groups will be recommended medications that follows current treatment guidelines for moderate to severe treatment resistant depression. To test the hypothesis that pharmacogenomic-guided treatment compared to standard treatment improves clinical outcomes in treatment-resistant MDD Study Procedures Pharmacogenetic testing PG-informed or standard care antidepressant treatment Clinical outcome assessments and questionnaires at baseline, and week 2, 4, 12 and 24

Almost half of patients with heart failure may be frail and previous studies suggest that frail heart failure patients are less likely to receive evidence-based heart failure specific treatment. The prevalence of frailty among heart failure patients who needs hospitalisation in Australia is unknown. This study aims to determine the prevalence of frailty in heart failure patients and will also determine whether clinical outcomes among patients who received heart failure medications were different when compared to those who did not receive treatment.

This prospective study will monitor ANCA levels in patients with ANCA vasculitis. The purpose of this study is to Identify if ANCA rises are associated with relapse of ANCA vasculitis. Study hypothesis: two and four-fold ANCA rises will precede clinical relapses within the prior 6 months

This is a single centre, investigator-led study of venous compliance in patients with heart failure (heart failure with reduced ejection fraction: HFrEF and heart failure with preserved ejection fraction: HFpEF) and the relationship with central haemodynamics.

Burn wound progression can be variable after the initial injury has occurred. Tissue oedema as a result of the injury can compromise microcirculation resulting in this progression. Pressure applied to this area through NPWT is known to squeeze oedema fluid out of the interstitial space. It is plausible that applying NPWT within this initial timeframe may halt or limit burn wound progression. The use of Negative Pressure Wound therapy (NPWT) in the treatment of burns has increased over the past decade. It is common practice at the Pegg Leditschke Children’s Burns Centre, Queensland Children’s Hospital to apply NPWT post-split thickness graft to improve take of the graft and more recently it’s efficacy in acute burns has been tested using the Renasys Go. More recently the Renasys Go has been trialled in the unit for burns less than 5% TBSA within 1 week of injury. This study found improved clinical outcomes, especially when applied within 48 hours. However, parents reported a burden due to the size of the Renasys Go and need for recharging accessories. There is lack of information regarding the use of the smaller, battery operated NPWT device, PICO, as a primary treatment for acute burns. Applying NPWT could greatly improve the final outcome of a burn wound. This could have multiple implications as improved time to re-epithelialisation can impact on overall cost of treatment, requirements for scar management as well as possible reconstructive requirement in the future. This study will address the paucity of knowledge of “ultra portable” negative pressure devices for use in acute burn wound care. This will build on knowledge recently acquired in a randomised controlled with a larger device (Smith and Nephew – Renasys Go). This study aims to establish the feasibility and safety for the use of the ultra-portable PICO negative pressure device in children with burn injuries.

The purpose of this study is to test a drug called GDD3898 Topical Gel on participants with Sebaceous Hyperplasia. Sebaceous hyperplasia is a disorder in which sebaceous glands become enlarged, producing flesh-coloured or yellowish, papules on the face. Lesions of sebaceous hyperplasia do not resolve spontaneously and are resistant to a variety of treatments. They are subject to irritation with shaving and patients frequently complain about their appearance. Sebaceous hyperplasia occurs in 1-2% of the population. Current treatment options include, but are not limited to, the use of topical retinoids, electrocauterisation, photodynamic, laser, or cryotherapy, etc.; however there is currently no approved pharmacological treatments for Sebaceous Hyperplasia. Animal studies have shown that GDD3898 can decrease sebaceous gland size and inhibit cell growth, which may translate into therapeutic benefits in people with Sebaceous Hyperplasia. The main aims of this trial are: • To assess the effect of the study drug on Sebaceous Hyperplasia • To assess the safety and tolerability of the study drug

Pre-clinical studies indicate that insufflation using dry-cold carbon dioxide (DC-CO2) leads to peritoneal cellular damage, inflammation and hypothermia compared humidified warm-CO2 (HW-CO2). These parameters were explored in patients undergoing surgery for colorectal cancer.

Haemorrhoids are enlarged veins in the anus or lower rectum, which can cause bleeding, itching, pain and prolapse outside of the anal canal. The disease is commonly managed using rubber band ligation (RBL), where a band is placed around the base of the haemorrhoid, preventing blood flow to the haemorrhoid and causing it to fall off and pass through the anal canal. The most common complication of RBL is pain. Currently, surgeons vary widely in their approach to preventing pain in these patients, owing to a lack of quality evidence supporting one strategy over another. Surgeons may inject local anaesthetic at the site where the band is placed, or use it to block the nerve supplying the anus and lower rectum. Some patients receive no local anaesthetic, and rely on standard postoperative medications such as paracetamol, anti-inflammatories, and opioids. There is a need for quality research to determine the best strategy for pain management in patients undergoing this common procedure. In our study, participants undergoing RBL will be randomly assigned to receive either local anaesthetic at the banding site, a nerve block, or standard postoperative medications only. These pain management strategies are all routinely used in practice and are safe procedures common in many operations. At several timepoints following the procedure, participants will be asked to report their pain on a scale (up until 2 weeks post procedure). Participants’ use of pain medications in recovery; the time taken for participants to be discharged after their procedure; participant satisfaction with their procedure; the time it takes for participants to return to work after their procedure; and procedure associated complications, will also be recorded. These outcomes will then be used to determine which strategy is best for managing pain in patients undergoing RBL. We hypothesise that both pudendal nerve block and submucosal infiltration of local anaesthetic will be superior to no local anaesthetic for post-procedural pain management.

Whether the use of Point-Of-Care Ultrasound (POCUS) bladder scan reduced the time taken to collect a clean catch urine sample in non-toilet trained children

The Care Navigation intervention is a 6-month program of support for adult patients with depression and/or anxiety referred by a GP to the Black Dog Institute (BDI) Psychiatry Services. It aims to assist participants in navigating the mental health system and implementing the treatment plan written by their BDI psychiatrist, and to subsequently improve their mental health outcomes. The primary aim of this pilot trial is to determine the feasibility and acceptability of the Care Navigation intervention for adults with depression and/or anxiety and to identify necessary improvements. Acceptability will be assessed by participants’ ratings of satisfaction and by interviews with participants, Patient Care Navigators and BDI clinical staff. A further aim of this pilot trial is to conduct a preliminary examination of the efficacy of the Care Navigation intervention in improving clinical outcomes, including symptoms of depression (PHQ-9) and anxiety (GAD-7), functional impairment, mental health self-efficacy and health care utilisation. Changes in these outcomes from pre-intervention will be examined within the Care Navigation group at both mid-intervention (3 months) and post-intervention (6 months).