ANZCTR search results

Pelvic exenteration is a life-changing surgical procedure for patients with advanced or recurrent pelvic cancers. This procedure is associated with significant postoperative morbidity and increased level of pain. To manage this, oxycodone is currently the mainstay opioid used for postoperative pain control. However, this drug is commonly associated with serious side effects, slowing patient recovery, and increasing the length of hospital stay. A new pain management strategy, using sublingual buprenorphine, may improve outcomes and contribute to better patient recovery. However, the comparative effectiveness of this drug has not been evaluated in a clinical trial. Therefore, we will conduct the first pilot randomised controlled trial, to determine the feasibility and acceptability of administering sublingual buprenorphine when compared to oral oxycodone following pelvic exenteration surgery.

This is a prospective single-arm interventional study evaluating the combined use of the Novoglan medical device and topical corticosteroid (Betamethasone valerate 0.05%) in adult men with phimosis. Participants will be recruited from the Monash Health circumcision waitlist and treated for 8 weeks. The study aims to assess foreskin retractability, symptom improvement, patient satisfaction, treatment adherence, and safety outcomes. Participants will undergo baseline and post-treatment assessments. The ethics application has been submitted to Monash Health HREC and is currently under revision following requested modifications.

This study is evaluating the efficacy and safety of IRX211a for Breakthrough Cancer Pain in Opioid Tolerant Cancer Patients Who is it for? You may be eligible to join this study if you are aged 18 years or above with a current diagnosis of cancer and experiencing breakthrough cancer pain (BTcP - sudden, intense pain that occurs even when a person is already taking regular strong painkillers like opioids) Study details There are 2 parts to this study: a titration phase (Part A) to determine the effective individualised dose for administration in the placebo-controlled RCT phase (Part B). After an initial screening and 14-day baseline observation period, all participants in this study will complete the titration phase where participants receive their initial IRX211a dose (1 mg; 2 actuations administered via a pressurized metered dose inhaler) under medical supervision in-clinic at Day 0. Participants then continue to administer increasing increments of IRX211a (1 actuation per increment) per episode until they reach their effective individualized dose, which is defined as the lowest IRX211a dose that provides adequate pain relief with tolerable side effects across two consecutive BTcP episodes, or until maximum dose of 3.5mg (7 actuations). Participants who cannot identify an effective dose by the end of the 3-week titration period are discontinued. The titration phase will occur over a maximum of 3 weeks. For those participants who establish an effective dose in Part A enter Part B. In Part B, each participant receives 10 numbered pMDI inhalers in a pre-randomized sequence (7 containing active IRX211a and 3 containing matching placebo). Over a period of up to 4 weeks, participants treat one BTcP episode per day using their individualized dose, up to 10 episodes. Pain intensity and relief are recorded before and after each administration at multiple time points. Adherence to the intervention in this study is primarily monitored through a detailed electronic diary (e-Diary) system, patient training, and scheduled follow-up visits. Participants are trained at the screening visit on how to accurately use the study medication (IRX211a inhaler) and complete the e-Diary using a web-based interface. The main goal is to find out whether IRX211a can provide fast and effective pain relief for BTcP. The study hypothesis is that IRX211a will provide better and faster pain relief than placebo when used as an additional treatment for these sudden pain episodes.

This study will evaluate whether using the Stomal Sponge, a soft, absorbent insert placed inside a stoma bag, can help reduce leakage and improve skin health in babies with high-output stomas. The study will be conducted in the Mater Mothers’ Neonatal Critical Care Unit in Brisbane and will involve 15 babies using the Stomal Sponge, compared with a group of 15 similar babies who did not use the sponge in the past. The researchers will measure how often stoma bags need to be changed due to leakage, how long the bags stay in place, and whether the skin around the stoma remains healthy. Parents will also be asked about their experience with stoma care. The Stomal Sponge is already approved for use in Australia and is being used in this study in line with its intended purpose. The study aims to assess its potential clinical benefits in a neonatal hospital setting.

This study is to look at how safe and well tolerated PRX-101 is and to assess how much PRX-101 gets into the blood. PRX-101 is being developed as a possible treatment for paroxysmal supraventricular tachycardia which is a heart condition where the heart suddenly starts beating much faster than normal for a short period of time. The main hypothesis of this study is that PRX-101 is safe and well tolerated in a healthy adult population and that the pharmacokinetic profile (the amount that gets into the blood and how long it takes to be cleared from the body) is the same as that of an intravenous formulation of verapamil hydrochloride. A secondary hypothesis is that PRX-101 will have effects on blood pressure and heart rate.

This study is to look at how safe and well tolerated PRX-101 is and to assess how much PRX-101 gets into the blood. PRX-101 is being developed as a possible treatment for paroxysmal supraventricular tachycardia which is a heart condition where the heart suddenly starts beating much faster than normal for a short period of time. The main hypothesis of this study is that PRX-101 is safe and well tolerated in a healthy adult population and that the pharmacokinetic profile (the amount that gets into the blood and how long it takes to be cleared from the body) is the same as that of an intravenous formulation of verapamil hydrochloride. A secondary hypothesis is that PRX-101 will have effects on blood pressure and heart rate.

Healthy and nutritious foods and meals can help to manage or improve diet-related conditions like type 2 diabetes (T2D), but access to healthy food can be challenging. FareShare is a large food relief organisation in Abbotsford, Melbourne, that cooks and freezes meals ready to be delivered to organisations to distribute to the community for free. FareShare and The George Institute for Global Health (TGI) are conducting the FareShare Medically Tailored Meals Pilot Program (or, FareShare MTM) with two community health organisations in Melbourne—cohealth and Holstep Health. You are invited to participate in this pilot study, which will test the feasibility of delivering ‘diabetes-friendly’ meals for free to individuals in the community to help improve diet and T2D. This information will help develop and expand future MTM programs for T2D in Australia. We aim to enrol 40 participants.

To determine if the new drug TT-20 is safe and well tolerated when given intravenously in different doses to healthy adults, either as a single dose or over 48 hours.

The aim of this study is to describe a sample of residential aged care facility (RACF) residents who died in hospital (in emergency, in the acute ward or in the palliative care unit) or at the RACF to quantify easily measurable components of quality end-of-life care. Specific objectives are as follows: 1. To understand the sociodemographic details of end-of-life care patients from residential aged care facilities, including diagnosis, age, sex, cultural and linguistically diverse background, and type of RACF placement. 2. To describe quality indicators of end-of-life care in patients from residential aged care facilities, such as the presence of an advanced care directive, congruence of place of death with preferences, and symptom management. 3. To understand the specialist palliative care and end-of-life care needs of patients from residential aged care facilities, including level of engagement with the various arms of the specialist palliative care service and use of end-of-life care medications. 4. To understand the factors associated with transfer from a residential aged care facility to hospital for end-of-life care. 5. To understand barriers to quality end-of-life care in residential aged care facilities.

Peripheral arterial disease management costs AUD $884 million per year. Post-operative duplex ultrasound surveillance is commonly used, despite limited evidence, based on theoretical benefits. International guidelines explicitly highlight this as a priority research area. This RCT is proposed to definitively evaluate whether ultrasound surveillance provides clinical benefits (preventing vessel occlusion, major adverse limb events or death) following femoropopliteal endovascular intervention compared to clinical surveillance alone. Both surveillance and peripheral arterial disease are costly, and the opportunity to identify cost-effectiveness is significant. This landmark study will provide urgently needed evidence to guide clinical practice, improve patient outcomes, and ensure cost-effective health-resource use.