ANZCTR search results

This is a prospective study to collect different human specimen types to be used in the test development, optimisation, analytical validation and clinical validation of new diagnostic tests for a range of infectious diseases. Primary Objectives: To optimise novel diagnostic tests for different infectious diseases. This will use a range of negative human specimen types as a clinical matrix with spiked-in microorganisms. Secondary Objectives: To undertake analytical test performance testing in early-stage validation studies using mock-infected human samples. Tertiary Objectives: To undertake clinical validation using the samples provided as negative controls. Investigational products: The sample obtained from this study are used in the test development, optimisation, analytical validation and clinical validation of new diagnostic tests for a range of infectious diseases. The point-of-care diagnostic tests are based on DNA/ RNA nucleic acid amplification, as well as lateral flow antigen/ antibody detection methods. These tests are for a range of infectious diseases including respiratory pathogens (e.g., SARS-CoV-2, influenza, tuberculosis), sexually transmitted infections, viral hepatitis (e.g., Hepatitis B, Hepatitis C), insect-borne disease (e.g., dengue, malaria), infectious viral diseases (e.g., monkeypox), and vaccine-preventable diseases (measles, tetanus). Comparator: The other sample will be used for gold-standard comparator test methods run in a laboratory. For example, laboratory-based RT-qPCR analysis, and serological assays (ELISA, IFA, CFA, agglutination assay, western blot). Outcome Measures: Samples obtained in this study will be used as a clinical matrix to optimise sample processing methods, reagent composition, result algorithms, and to ascertain early insights into test performance including sensitivity, specificity, and reproducibility. A subset of samples will be used as negative controls for clinical validation purposes, to estimate sensitivity and specificity.

A Phase I/IIa, first-in-human study of EDV nanocells packaged with SARS-CoV-2 spike protein and alpha galacosylceramide adjuvant (COVID-EDV) as a COVID-19 vaccine in immunocompromised patients. COVID-EDVs are being developed as a potential anti-COVID-19 vaccine to protect COVID-vulnerable people such as those suffering from cancer and who have a compromised immune system. This trial is a follow-up of the previous healthy volunteer trial ACTRN12621001159842. The primary objective of this trial is to assess the safety and tolerability of COVID-EDVs administered intramuscularly (IM) in non-COVID-19-infected immunocompromised patients. The study follows an open label, non-randomised study design using a COVID-EDV dose level that was determined previously in a healthy volunteer trial. The study is designed to assess the ability of COVID-EDV to stimulate and support the body’s immune response to produce antibodies that can fight COVID-19. The COVID-EDV vaccine will be administered as three injections on Day 1, 21 and at 4 months. Each participant must have a immunocompromised condition and will be involved in the study for 9 months. A total of 100 participants will be recruited to the study.

Interstitial lung disease (ILD) is a term for a group of lung conditions that are incurable, characterised by inflammation and scaring of the airways, persisting respiratory symptoms and progressive respiratory failure. People with interstitial lung disease often experience severe, long-term breathlessness, however there are few treatments specifically aimed at relieving this distressing symptom. Nasal high flow (NHF) therapy delivers heated, humidified air alone (or with entrained oxygen), thus enabling patients to tolerate high flows of up to 60L/min, which cannot normally be tolerated. NHF washes out carbon dioxide from airway dead space in the lungs to improve ventilation and also generates a low-level positive airway pressure that reduces airway resistance to reduce the work of breathing. NHF is an established treatment of hospitalised patients with acute respiratory failure. Given the lack of effective interventions to reduce breathlessness in people with ILD, NHF may be useful to alleviate this distressing symptom. However, the role of NHF in people with ILD patients and severe breathlessness (but without severe hypoxaemia) has not been formally investigated. This phase 3 crossover randomised controlled trial aims to: 1. investigate long-term domiciliary NHF therapy use in patients with ILD and severe breathlessness, who do not qualify for home long-term oxygen therapy (administered for >16 hours/day). However, portable oxygen therapy (used only on exertion) is permitted. 2. explore if domiciliary NHF therapy affects breathlessness, sleep, activity, and quality of life in people with ILD. 3. evaluate the feasibility, acceptability and utility of remote monitoring devices to support clinical trials being delivered entirely within the patient’s home. 4. investigate the inflammation pathways in ILD and to explore if NHF mediates inflammatory response in people with ILD.

Chronic pain affects millions of Australians and is the leading cause of disability globally. Frequently however, chronic pain is underdiagnosed and undertreated. In this pilot randomised controlled trial, we are investigating a co-designed, internet delivered mindfulness-based cognitive therapy (iMBCT) for chronic pain program to overcome these access barriers. From the inception of this research, we have adopted a community-based participatory research framework, which is a patient-centred and community driven approach that is well suited to treatment adaptation to improve access and uptake. Consumers and consumer representatives – including our partner, Chronic Pain Australia – are the grassroots voices that have shaped the development of this iMBCT program. In this trial, participants will be randomised to iMBCT or a delayed treatment control for process evaluation, and to determine the preliminary efficacy of iMBCT for reducing pain intensity (primary outcome) and improving quality of life indicators (secondary outcomes). We will also examine potential mediators and moderators underlying the expected improvements in pain-related outcomes.

This is a single centre, single arm study primarily examining the the safety, feasibility and acceptability of psilocybin-assisted psychotherapy in treatment resistant depression patients who are on concurrent psychotropic medication.

Despite strong evidence for getting patients up and moving in hospital to prevent functional decline and other common complications, patients spend only 8-14% of daytime hours standing or walking. Our recent work has identified numerous patient, staff, ward and organisational barriers which prevent patients being active during their hospital stay. In this study, we will design a mobility strategy with key stakeholders from across the Health Service and will implement this mobility strategy in 10 medical wards across four hospitals. To determine the effectiveness of the mobility strategy, we will evaluate patient activity levels, adoption of the mobility strategy and other clinical outcomes at baseline and follow up.

Corneal nerve disease (neuropathy) can negatively impact quality-of-life due to associated ocular surface disease, which promotes chronic pain and impaired vision, particularly in severe cases. Corneal neuropathy impairs the trophic and sensory functions of the corneal nerves, leading to reduced corneal sensitivity and disruptions to ocular surface integrity. The currently available techniques to measure corneal nerve function and structure are available only in research settings. Moreover, the techniques measuring corneal nerve function are primarily a measure of mechanical corneal sensation and not a composite measure of the corneal sensations. This is a major barrier to early-stage diagnosis and management of corneal neuropathy. So, robust measures of corneal nerve integrity that could be performed routinely in the clinic need to be developed. The main aim of this project is to investigate a new method for assessing corneal nerve integrity. Our approach involves quantifying subjective corneal sensory responses and the interaction between immune cells and nerves in the cornea (using non-invasive corneal imaging) in response to stimulating the cornea with sterile salt solutions. These approaches will be compared between healthy (control) corneas and corneas with nerve changes from LASIK. These findings will provide a foundation for determining whether these aspects of corneal nerve function might have the potential to be used in the future as a marker of corneal neuropathy. The identification of a suitable non-invasive biomarker of corneal nerve fibre integrity has the capacity to be translated into the clinic, for enhanced early detection of corneal nerve damage.

[ Why Are We Doing This Research? ] The purpose of this study is to implement and test the effectiveness of a new care model that will be coordinated by specialist cancer nurses while also involving medical specialists (oncologists, and general practitioners/GPs) for follow-up care of people with neuroendocrine neoplasms. [ Who Is It For? ] You may be eligible for this study if you are aged 18 or older and have a neuroendocrine neoplasm [ Study Details ] Participants in this study will be randomly allocated to one of two groups. Participants in one group will be receiving usual, specialist-led follow-up care and information from Neuroendocrine Cancer Australia for up to 5 years. The other group will undergo the nurse-coordinated care model. This involves 1) a 1-hour nurse-led consultation with a specialist neuroendocrine nurse (SNN) to develop a survivorship care plan, 2) a multidisciplinary case-conference involving the GPs, nurses (including a SNN) +/- another hospital-based allied health professional (depending on patients’ needs) to finalise the survivorship care plan, and 3) a GP and specialist follow-up schedule for 12 months, and up to 5 years. As part of the study all participants will answer a series of questionnaires at baseline, 6 months, and 12 months. It is hoped this research will demonstrate that the new model of care increases patient quality of life and health care experience and improve follow-up care for people living with neuroendocrine neoplasms.

The overarching goal of this research is to develop and evaluate a digital exposure-focused intervention (the Courage Quest intervention) for children aged 8 to 12 years with one or more anxiety disorders. We are aiming to answer the following research question: Does the Courage Quest intervention reduce anxiety symptoms and result in greater remission of anxiety and related disorders for children aged 8 to 12 years compared to children participating in an active control intervention? The “Courage Quest” intervention will be developed as a parent guided intervention with therapist support. We aim to evaluate this through a randomised controlled trial comparing the efficacy of the "Courage Quest” intervention to an active control condition. The control condition will use the Raising Healthy Minds intervention before being given access to the “Courage Quest” intervention. Hypotheses of this study are that both groups will show reduction in anxiety symptoms and disorders at post-treatment and delayed follow-up. Further, we hypothesise that children in the intervention group completing the Courage Quest intervention will show significantly greater reduction in children’s anxiety symptoms and disorders (parent and child reported) than children in the control condition at post-treatment. Lastly, due to the control group’s access to the “Courage Quest” intervention, we hypothesise that children in the control group’s reduction in children’s anxiety symptoms and disorders at delayed follow-up will be similar to that of children in the intervention group.

While grief is a normal reaction to loss, 30% of cancer carers are reported to experience prolonged grief disorder. Patients with prolonged grief require grief-focused intervention in addition to the depression-focused treatment. Psilocybin-assisted psychotherapy is an experimental intervention that could reduce grief-related distress and suffering. PARTING is a single-arm (open-label) study of a psilocybin-assisted psychotherapy trial. This study aims to determine whether this new treatment is acceptable to and safe for participants and to establish an initial impression of its effectiveness in treating people with prolonged grief. It will include approximately 15 participants. Bereaved carers of people with cancer who meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria for prolonged grief disorder will be invited to take part in PARTING. Potential participants will undergo rigorous screening before enrolment to meet general medicine and psychiatric eligibility criteria. The intervention will include three psychotherapy sessions in preparation for one psilocybin dosing session and then four post-experience psychotherapy integration sessions. All participants’ sessions will involve a trial psychologist and assistant therapist being present. Baseline and follow-up survey and clinical assessments will measure prolonged grief symptoms i.e. the outcome for the future full-scale trial. Following participants’ final intervention session, participants will complete a semi-structured evaluation interview about their experience. Responses will be transcribed and qualitatively analysed using thematic analysis. The 15 evaluation interviews with participants will provide information about intervention acceptability and a qualitative initial impression of efficacy and will be used to refine the intervention. As a secondary analysis of potential efficacy we will also explore changes in grief scores. We postulate that the treatment will be well tolerated and accepted and grief symptoms will be substantially reduced.