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An Open-Label Phase 1b Study Evaluating the Safety, Tolerability, Immunogenicity and Antiviral Activity of Multiple Doses of CLB-3000 in Subjects with Chronic Hepatitis B Who is it for? You may be eligible for this study if you are a healthy adult aged between 18 and 60 years old. The study population allows for the inclusion of subjects with all possible HBV genotypes Study details This is a Phase 1b, open-label, multicenter, multiple-dose study of Intramuscular (IM) administration of CLB-3000 in noncirrhotic subjects with chronic hepatitis B (CHB) on stable doses of NUCs at study. This study is designed to assess the safety, tolerability, immunogenicity, and antiviral activity of repeated administration of multiple dose levels of CLB-3000 in adults with Chronic Hepatitis B taking stable doses of standard of care nucleoside/nucleotide analogues (NUCs) for viral suppression. Eligible participants will receive 5 monthly Intramuscular (IM) injections of CLB-3000 on Days 1, 30, 60, 90, and 120. The end of the study is defined as the last subject last visit at Day 300. The estimated duration of the study is approximately 11 months (28-day Screening period, 150-day Treatment period, and 150-day Safety follow-up period).

Smoking imposes a wide range of impacts on women of reproductive age, beginning with its effect on fertility and extending throughout pregnancy and beyond. A comprehensive, and culturally appropriate smoking cessation interventions are needed to achieve a healthy generation. 44% of Aboriginal women continue to smoke during the first 20 weeks of pregnancy. Only one in ten Aboriginal women who smoke manage to quit successfully during pregnancy. This statistic is largely attributed to the lack of culturally relevant support, leaving many Aboriginal women longing for assistance to overcome the health risk posed to their babies and their own well-being. Over the past 4 years the Which Way? project has worked in partnership with Aboriginal and Torres Strait Islander women and communities to develop an Indigenous-led evidence base for smoking cessation care. Our goal is to provide Aboriginal and Torres Strait Islander women access to high quality, evidence based and meaningful smoking cessation care to empower smoke-free generations. This program has been built based on requests from Aboriginal and Torres Strait Islander women for group-based supports. This program was developed using a co-designed approach in partnership with Birra-Li Aboriginal Maternal Infant Health Service and Waminda South Coast Women’s Health and Welfare Aboriginal Corporation and the University of Newcastle. This program has been designed to provide communities with key information, resources, and strategies to support their smoking cessation journey in a group-based setting.

Difficulties getting to sleep, staying asleep and waking up too early, characterising insomnia, are widely prevalent in aging populations, with over 30-48% older adults reporting sleep issues. Sleep problems are often left untreated as it is viewed as part of the normal ageing process. Further, there are many barriers such as long waitlists, high financial costs and limited availability of trained service providers to accessing first-line treatments to insomnia like cognitive-behavioural therapy for insomnia (CBTi). Moreover, CBTi is found ineffective for 30-40% of the population. Thus, there is a critical need for alternative and accessible interventions to reduce the high health and financial burden that insomnia in older adults causes. Mindfulness-based therapy for insomnia (MBTi) which potentially targets both the cognitive arousal (e.g. dysfunctional beliefs about sleep) and metacognitive processes (e.g. bias in attention to sleep-related thoughts) that maintain insomnia may be a feasible alternative. MBTi has also been linked to improvements in mood and cognitive functioning. Overall, MBTi may have high clinical utility for older adults by reducing the cognitive-emotional arousal caused by aging and its related comorbidities. Further digitally-delivered MBTi in older adults have yet to be tested. A feasible, online intervention could potentially become a widely-disseminable, financially accessible and effective treatment for older adults. This would reduce the pressure on limited face-to-face service providers and allow a stepped-care approach to treatment.

Posttraumatic stress disorder (PTSD) is a serious debilitating disorder that negatively impacts a person’s daily life, and can result in diminished cognitive and psychosocial functioning, fractured relationships, inability to maintain employment, substance abuse, high-cost healthcare utilisation, increased depression and other mental and physical health co-morbidities. MDMA-assisted therapy has shown to be effective for the treatment of PTSD as it reduces defenses and fear of emotional injury, enhances communication, and increase empathy and compassion. The subjective effects of MDMA create a productive psychological state that enhances the therapeutic process. The purpose of this study is to investigate the safety and feasibility of delivering MDMA-assisted psychotherapy to patients with PTSD.

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.