ANZCTR search results

Patients recovering from cardiac surgery often experience significant pain, anxiety and distress in the first few days after their operation. Previous studies suggest that playing relaxing music and positive therapeutic suggestions to patients while they are under general anaesthesia may help improve recovery after surgery. This pilot study will investigate whether delivering relaxing music and recorded therapeutic suggestions through noise-cancelling headphones during cardiac surgery is feasible and acceptable for patients and clinical staff. Participants undergoing cardiac surgery will be randomly assigned to receive either standard care or standard care plus the headphone intervention, which will begin after induction of anaesthesia and continue until the breathing tube is removed in the intensive care unit. The main aim of this pilot study is to determine whether the intervention can be successfully delivered and whether patients can be recruited and followed up reliably. Information from this pilot study will be used to plan a larger clinical trial to test whether this intervention improves recovery after cardiac surgery, including pain, quality of recovery, and other postoperative outcomes.

COPD OUT is the first study to see if it is possible to run a clinical study testing two different dosages of physiotherapy treatments that are traditionally provided to adult patients admitted to hospital for treatment of an emphysema or chronic bronchitis flare up. Results of this study are vital to help future researchers design the best study possible to successfully test if physiotherapy is effective in faster resolution of symptoms, improving recovery, and long-term quality of life, in adults admitted to hospital with an acute exacerbation of COPD.

Vestibular migraine is a syndrome characterised by recurrent episodes of vertigo or other dizziness-related symptoms causing imbalance, nausea, and disruption to daily functioning, There is currently no standard treatment to prevent these episodes. Doctors commonly prescribe medications based on treatments for other types of migraine which have not been specifically studied in people with vestibular migraine, including amitriptyline (often used for migraine and chronic pain) and cyproheptadine (used in children for allergic conditions and sometimes for migraine). Early research suggests both may be helpful, but no direct comparisons exist, This study aims to compare these two medications versus a placebo medication (folic acid) in a randomised controlled trial to better understand which is more effective and better tolerated for reducing the number and severity of vestibular migraine episodes. It is hypothesised that cyproheptadine will have better treatment outcomes and less side effects than amitriptyline for vestibular migraine.

The study aims to collect blood pressure readings via conventional cuffed BP machines and concurrently collect blood pressure readings cuff-lessly via a novel device called Ora Connect that has been developed by the Zaplutus IQ company. Tilt Table Testing and an alternative Posture and Exertion procedure will be used as these procedures commonly induce a change in blood pressure for the participant. By collecting comparative blood pressure readings, the intent is demonstrate that cuff-less blood pressure is as accurate as cuffed blood pressure.

The aim of this study is to provide proof of concept that the perceived exertion from exercising at a fixed intensity can be modified by manipulation of the observed load. We will address this aim by asking healthy participants to undertake a number of sets of a bilateral leg press exercises while wearing a VR headset, which blocks (occludes) the real-world environment from the user. The actual load will stay constant, but the load visualised in the VR headset will vary. Participants will be asked to rate the perceived exertion of the randomly presented conditions at the end of each set

This is a Phase II, open-label, multicentre study evaluating the safety, tolerability, pharmacokinetics, and activity of SIR2501 in participants with amyotrophic lateral sclerosis (ALS) and in participants with solid tumours receiving paclitaxel chemotherapy to prevent or reduce chemotherapy-induced peripheral neuropathy (CIPN). The study consists of a dose-escalation component (Part A) and an expansion component (Part B). Approximately 88 participants will be enrolled across both study parts. The primary objective is to assess safety and tolerability of SIR2501, with secondary objectives including pharmacokinetic evaluation and preliminary efficacy assessments. Participants will receive study treatment and will be followed according to protocol-defined schedules for safety and outcome evaluation. This study aims to evaluate the safety, tolerability, pharmacokinetics, and activity of SIR2501 in participants with amyotrophic lateral sclerosis (ALS) and in participants with solid tumours receiving paclitaxel chemotherapy to prevent or reduce chemotherapy-induced peripheral neuropathy (CIPN). Who is it for? You may be eligible for this study if you are a male or female aged 18–70 years with a diagnosis of amyotrophic lateral sclerosis (ALS), or aged 18–75 years with a diagnosis of a solid tumour receiving paclitaxel-based chemotherapy and at risk of developing chemotherapy-induced peripheral neuropathy. Study details For those who choose to enrol in this study, they will take the study medicine SIR2501 by mouth once daily. Part A (dose escalation): Participants will receive increasing dose levels of SIR2501 (30 mg, 45 mg, or 60 mg) to determine the safest dose and the recommended dose for further study. Part B (dose expansion): Participants will receive SIR2501 at the selected dose to further evaluate safety, tolerability, pharmacokinetics, and activity. Participants with ALS will receive treatment for up to 24 weeks. Participants receiving paclitaxel chemotherapy will receive treatment for approximately 12–18 weeks. During the study, participants will attend regular clinic visits where assessments may include physical examinations, questionnaires, blood tests, pharmacokinetic (PK) blood sampling to measure drug levels, safety laboratory tests, and monitoring for any side effects. It is hoped that the results of this study will help determine whether SIR2501 is safe and may provide benefit for people with ALS and for people receiving chemotherapy who are at risk of developing peripheral neuropathy.

Fundamental to the prevention and control of sexually transmissible infections (STIs) is accessible, rapid and accurate diagnosis. We have been developing novel portable, point-of-care tests (PoCTs) for diagnostics using CRISPR technology, which offers a novel and viable alternative to laboratory-based diagnostic methods. In this project we will assess the performance of CRISPR-PoCTs for the STIs, gonorrhoea and chlamydia. Sexual health clinics in Melbourne and Darwin will identify and recruit participants presenting with symptomatic urethritis which can be caused by Neisseria gonorrhoeae and/or Chlamydia trachomatis infection. In addition to standard of care, participants will have a study sample collected for testing on the CRISPR-PoCTs, and clinical data already collected for standard of care will be shared in a coded manner with researchers for comparison with the CRISPR PoCTs.

This study is evaluating Talking Heads, an online information and support program designed specifically for young adults who have experienced a stroke. Many young stroke survivors live with “invisible” challenges such as fatigue, brain fog, mood changes, and difficulties adjusting to life after stroke, and there are limited age-appropriate resources available. Talking Heads was co-designed with young survivors, family members and clinicians to provide clear, practical information through short videos, podcasts, tip sheets and online info sessions. In this feasibility study, participants will access the program over 12 weeks and complete questionnaires and interviews to help us understand whether it is helpful, accessible and acceptable. The results will inform improvements to the program and guide the development of a larger future trial.

Brief description of the study purpose This study aims to find out whether prostate and kidney cancer surgery can be performed safely and reliably using a newer robotic surgical system called the Toumai® MT-1000. Surgeons already perform these procedures using other robotic platforms, but the Toumai system is new to Australia, so it needs to be carefully evaluated in real clinical settings. Who is it for? You may be eligible for this study if you are aged 18 years or older and are scheduled to have prostate cancer surgery (radical prostatectomy) or kidney cancer surgery (partial nephrectomy or nephroureterectomy) at Concord Repatriation General Hospital. You must be considered suitable for robotic surgery by your treating surgeon, able to understand the study information, and able to provide written consent. Only patients having an elective (non-emergency) operation are eligible. Study details Participants will undergo prostate or kidney cancer surgery assisted by the Toumai® MT 1000 robotic surgical system. The surgery itself is the same type of operation they would receive as part of standard care; the difference is that the surgeon uses a newer robotic platform to assist during the procedure. Following surgery, participants will be monitored as part of routine clinical care and will be followed in the months after their operation to assess recovery. This includes monitoring safety outcomes and collecting information on symptoms, quality of life, and functional recovery. The aim is to find out whether this new robot allows surgeries to be completed safely without needing to convert to an open operation, and whether recovery is similar to patients who have had surgery using other robotic systems.

Overconsumption causes significant environmental harm, yet many people find it difficult to change their everyday buying habits, even when they care about climate change. This study will test an online program, "Better Choices for People and the Planet: Breaking up with Belongings 2.0", designed to help adults reduce unnecessary buying and make more sustainable choices. The program includes five self-paced modules that each target different aspects of self-control processes to aid in behaviour change. Modules focus on motivation, managing emotions, reducing attachment to possessions, and building confidence to change behaviour. Ten participants will take part in the study using a single subject non-concurrent multiple baseline design, where each person serves as their own comparison over time. Participants will complete weekly questionnaires before and during the program to track changes in behaviour, emotions, and daily functioning. The primary aim is to determine whether the program reduces climate-related interference in daily life and promotes more sustainable consumption behaviour. A second key aim is to assess when and how changes in the targeted self-control mechanisms occur across modules, and whether these changes correspond with module content. This will clarify the temporal sequence of change processes and identify which mechanisms drive improvements in sustainable behaviour.