ANZCTR search results

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.

This will be a prospective, dose-escalation, CHIM study that aims to evaluate the capacity of N. gonorrhoeae isolate AUSMDU00053933 to induce a safe and tolerable oropharyngeal gonorrhoea infection in healthy participants, and determine the dose required to produce an infection rate of 60-80%. Only healthy participants who are assigned male at birth and do not have sex with individuals assigned female at birth, aged 18-50, who meet the eligibility criteria described in the protocol will be enrolled in the study. The trial population will include 20-35 participants, enrolled in consecutively inoculated cohorts of 5, until either 20 participants have been challenged with the target dose, or until reaching a maximum of 35 participants. Study participants will be allowed to develop an oropharyngeal gonococcal infection, and upon confirmation of symptomatic gonorrhoea infection, participant request or at the end of the 5 day experimental infection period, participants will receive an intramuscular dose of ceftriaxone. Participants will return for follow up visits 1-, 3-, 7- and 14-days post-treatment for exploratory sample collection and confirmation of cure, with additional safety follow-up visits will occur 30- and 90-days post-inoculation.

The purpose of this study is to determine whether a new treatment, called Targeted Osmotic Lysis (TOL), is a safe and tolerable treatment for patients with well-differentiated cutaneous squamous cell carcinoma, a specific type of skin cancer. Who is it for? You may be eligible for this study if you are an adult between the ages of 40-75 who has been diagnosed with well-differentiated cutaneous squamous cell carcinoma on the head, neck, mid-upper anterior chest or arms. Study details All participants in this study will be asked to take digoxin, a well established medication, and attend sessions every 6 days for 3 weeks to receive TOL treatment. TOL treatment will include laying in the CPEFG unit for 2 hours each treatment, while also taking a daily dose of digoxin orally during the active treatment period. During each session, participants will be monitored via ECG and using photographs, as well as for any side effects that may occur. Participants will also be followed up for 30 days after the final session for any additional side effects, to monitor their cancer and complete questionnaires. It is hoped that this research will help determine if TOL is a safe and effective treatment option for those who have been diagnosed with diagnosed with well-differentiated cutaneous squamous cell carcinoma.

This study is testing a nasal spray called SDS089 in adults who have been newly diagnosed with pulmonary arterial hypertension (PAH), a condition that affects blood flow in the lungs. Participants will receive a single dose of the nasal spray during a routine heart catheterisation procedure, allowing researchers to measure how it affects blood pressure and circulation in the lungs before and after treatment. The study also aims to assess the safety and tolerability of the treatment. The study hypothesises that a single dose of SDS089 will reduce resistance in the lung blood vessels, improving blood flow shortly after administration.