ANZCTR search results

Cellular immunosuppression – an acquired dysfunction of the cellular component of the immune system which predisposes to nosocomial infection – has been described as part of the inflammatory response to sepsis. While it has been postulated that such a phenomenon might also occur following major surgery (due to the mechanistic similarities between the innate immune response to sepsis and trauma), this hypothesis has not been proven. PRISM is a prospective observational study that will explore the effects of cardiopulmonary bypass on cellular immune function in the immediate postoperative period and the time course of any observed phenomenon. If we can demonstrate that impaired cellular immune function occurs following cardiac surgery on cardiopulmonary bypass, we will have sufficient equipoise to trial new therapies in this population to restore immune function and potentially reduce the risk of postoperative nosocomial infection.

This study will evaluate the Supporting Child Mental Health (SCMH) training program, which aims to improve adults’ knowledge, skills and confidence in providing mental health first aid to primary school children. The program includes self-paced eLearning and live instructor-led sessions that teach adults how to recognise child mental health problems, respond to crises, and support help-seeking. Adults from schools and organisations will be randomly allocated to receive the training immediately or after completing all study surveys. The hypothesis is that adults who receive the training immediately will show greater improvements in knowledge, skills and confidence than those in the waitlist group.

The purpose of this study is to see if virtual reality immersion therapy can be further tested as a potential therapy for alleviating symptoms in intensive care patients while in hospital. The information obtained will help us to learn strategies, such as time and frequency of usage of therapy, to potentially help many patients in the future. Study participation: Participants will undergo virtual reality immersion sessions daily while in the Intensive Care Unit (ICU), in addition to standard medical care. Daily symptom assessments will be conducted by the investigating team. An experience related questionnaire will be applied from day 3 during hospital stay (or after discharge if that happens sooner). Symptom assessments: Participants will be invited to answer verbally a questionnaire grading a variety of symptoms from 0 to 10 daily. These will last between 2 to 5 minutes. From day 3, they will be asked, only once, questions related to the experience with Virtual Reality immersion up until then including tolerability and the device and duration of therapy. This questionnaire is expected to last between 10 and 15 minutes. Risks and side effects of the therapy are uncommon, but may include dizziness, vertigo nausea, vomiting, anxiety and discomfort. The benefits might include symptom improvement but will certainly help us learning more about this possibly helpful tool.

This project aims to evaluate massed delivery of Narrative Exposure Therapy (NET) for refugees with Posttraumatic Stress Disorder (PTSD). The research questions/hypotheses that this study seeks to address are: Does massed NET reduce PTSD symptoms in refugee participants? Is massed NET feasible and acceptable to refugee participants? We hypothesize that massed NET will be feasible and acceptable to refugee participants, and will result in significant reductions in PTSD symptoms.

OCT has been used for decades in ophthalmology to visualise small blood vessels at the back of the eye (retina), but we have recently modified it and developed breakthrough and novel ways to assess the diameter, velocity and blood flow through blood vessels in the skin that are around the size of a human hair. Microdialysis is a technical approach that involves embedding a small plastic tube containing a semi-permeable membrane beneath the skin surface. This permits delivery of very small doses of specific drugs directly into a small patch of human skin, above which imaging is performed. The delivery of these drugs, which stimulate or block specific biochemical pathways, provides a way to study individual mechanisms that may be responsible for microvascular dysfunction and cardiovascular disease development in humans. This approach is sometimes referred to as pharmaco-dissection. By combining microdialysis with OCT imaging, we will establish an unprecedented and powerful new platform to provide insights into the specific physiological mechanisms controlling microvascular function in humans.

This is a double-blind, placebo-controlled, First-In-Human Study of the safety, tolerability, pharmacokinetics, and pharmacodynamics of ZE74-0282 in Healthy Volunteers. Who is it for? You may be eligible for this study if you are aged between 18 to 55 years old and are in good general health without a clinically signifcant medical history. Study details The study will be conducted as a single ascending dose (SAD) study, which will enrol groups of 8 healthy participants at a time to receive a single dose of the study drug. Participants will be divided in up to 5 groups, with each subsequent group receiving a higher dose than the previous one. The study drug is either ZE74-0282 or matching placebo which will be administered only once under fasting or fed conditions with a cup of water. The dose will be increased as we move from Cohort 1 to Cohort 5. Participants will be enrolled in the next dose cohort only after ensuring the previous dose level was safe and well tolerated. The total maximum study duration for participants is 37 days, inclusive of screening and visit windows. It is hoped this research will determine the maximum dose of ZE74-0282 that can be administered safely without causing severe reactions. Once the dose of ZE74-0282 has been determined in healthy volunteers, a trial investigating the efficacy of ZE74-0282 as a treatment for patients with Myeloproliferative neoplasms (MPNs) may proceed.

The aim of this study is to determine whether the provision of sunscreen pump packs with personalised prescription labels, toothpaste tubes, and personally labelled containers to store toothpaste and sunscreen together, in combination with written, illustrated information about facial sun protection, will improve adherence with daily sunscreen application for patients with a high risk of developing skin cancers over 3 months. Who is it for? You may be eligible for this study if you are an adult patient who has had a history of at least histologically confirmed 2 skin cancers (melanoma, basal cell carcinoma, squamous cell carcinoma, squamous cell carcinoma in situ) within the past 5 years. Study details Participants will be randomly allocated to either a control or intervention arm. Participants in the intervention arm will receive sunscreen and a personalised prescription label attached. Participants in the intervention arm will also receive toothpaste and a personalised prescription-labelled plastic container to hold the sunscreen and toothpaste together. The intervention group will also receive verbal and colour-illustrated written information advising daily use of facial sunscreen each morning after toothbrushing. Participants in the control group will receive identical sunscreen only (without a prescription label) and verbal information to apply sunscreen to their face every morning after toothbrushing. It is hoped that the findings from this study will show that linking sunscreen application on the face with an established morning habit (brushing teeth),and emphasising the medical need for facial sunscreen in this high risk group, will enhance adherence and facilitate habit formation within three months.

The purpose of this study is to evaluate the efficacy, safety, and PK of atumelnant in participants with ADCS. This study will consist of 3 parts: Part A, Part B (not described in this registration), and Part C (not described in this registration). Part A has 4 groups: -Part A Arm 1: Open-label part: All participants will receive atumelnant by mouth for up to 12 weeks with oral GC therapy as needed. - Part A Arms 2, 3 and 4: Double-blind, randomized, placebo-controlled part: Participants receive study drug (atumelnant or placebo) by mouth in a 1:1:1 ratio. Whether a participant receives atumelnant or placebo will be determined by chance (like drawing straws). A placebo looks like medication but contains no active ingredient. All participants also receive steroid medication or steroid placebo. After participation in Part A of the study, participants might be able to stay in the study in Part C (open-label extension where all participants will receive atumelnant and steroid replacement therapy) if, in the Investigator’s opinion, they would benefit from it.

Coronary artery disease (CAD) accounts for 50% of all heart disease cases and 9.2% of all deaths in Australia. Supplementation with omega-3 fatty acids from fish oil shows promise for reducing adverse cardiovascular events. However, current guidelines for omega-3 supplementation vary in their recommended doses, and the optimal dose for better cardiovascular outcomes remains unclear in the literature. In this study, participants will undergo a 12-week period of individualised dose of supplementation with either a placebo or omega-3 fatty acids (fish oil) to determine whether this strategy improves vascular health. Outcome measures will be assessed at baseline, mid-intervention and after completion of the interventions.

Rationale: Coronary angiography is the gold standard test for identifying the presence of significant coronary artery disease, however the procedure is invasive and has risks which drive anxiety, pain and discomfort for patients. Many operators routinely use conscious sedation during invasive procedures including coronary angiography and device insertions, to help mitigate these symptoms. Important risks associated with these pharmacological agents, including respiratory depression, nausea and vomiting, hypotension, paradoxical agitation and post- procedural delirium. In light of these, options for non- pharmacological methods of anxiolysis are increasingly being considered as an adjunct to current practice. Music in the catheter laboratory can be used to create a more relaxed clinical environment, which in turn can help to put the patient at ease. This study aims to investigate whether playing music in the catheter laboratory can reduce patient anxiety and improve the overall patient experience The objective of this study is to determine whether and how the use of music in the catheter laboratory influences the patient experience. The study design is a prospective randomised controlled trial. The study population consists of participants undergoing best practice coronary angiography, percutaneous intervention or device insertion at Gosford Hospital, John Hunter Hospital, Coff’s Harbour Hospital, Port Macquarie Base Hospital, Tamworth Hospital and Dubbo Base Hospital who consent to become enrolled in the trial. The main study endpoints include the primary outcome of self-reported anxiety levels, as measured by the STAIS-5 (Short-Form State-Trait Anxiety Inventory). Secondary outcomes include patient reported pain, adverse outcomes (MACE: Major Adverse Cardiac Events), dosages of sedative medications required, radial artery spasm, haemodynamic data, operator anxiety, complications.