ANZCTR search results

Introduction Individuals with co-morbid chronic pain (CP) and PTSD report greater symptom severity, anxiety, depression, disability, and opioid use than those with only one of these conditions. Deficits in emotion regulation (ER) and autonomic disturbance, represented through Heart Rate Variability (HRV), are both evidenced to interact with and perpetuate the symptoms of CP and PTSD. Furthermore, theoretic models suggest that autonomic dysfunction leads to psychophysiological inflexibility, reducing capacity for regulated emotional responding. This predisposes an individual to respond to potential threat with anxiety. Focusing on these trans-diagnostic factors, which may account for aspects of the comorbidity of symptoms between CP and PTSD, presents valuable treatment targets to interrupt the perpetuating cycle of both. While HRV biofeedback has been reported to improve autonomic flexibility and the symptoms of CP and PTSD separately, it is unclear whether these positive results would be replicated in people with both conditions. Furthermore, while the association with HRV and ER is well documented, it remains unclear whether change in self-reported ER mediates improvement in CP and PTSD symptoms through HRV biofeedback. Consequently, the study aims to answer the following research questions: a) does modifying HRV through biofeedback change symptoms of co-occurring CP and PTSD, b) do changes in ER mediate change in symptoms of CP and PTSD, and c) does change in HRV precede change in ER. Methods A six-week randomised wait-list control HRV biofeedback intervention will be conducted with 50 participants who have both a chronic pain diagnosis and PTSD symptoms. Participants will be instructed to practice at home daily for 40-minutes, as well as attending three, fortnightly training sessions. ECG and psychometric data will be collected at baseline, two mid-points during the intervention (week 2 and 4), as well as end of intervention and three month follow-up. Short daily portable ECG recordings and adherence to biofeedback training will also be collected.

Long-COVID is characterized by symptoms including sleep dysfunction, fatigue, depression, anxiety, anosmia, memory problems, confusional states and others. There is substantial evidence that impaired circadian function contributes to the development of these symptoms. On this basis, a novel approach to treating these symptoms may well be implemented by presenting intense light at a critical time during the light/dark cycle as is achieved with disorders such as season affective disorder (SAD) and Parkinson’s disease. It is hypothesized that this would realign circadian phase and thereby mediating remission in many symptoms of Long-COVID. In view of the breadth of symptoms shared by Long-COVID and prodromal PD alike, we predict that that LT has the potential of providing valuable therapeutic intervention for Long-COVID. While any preliminary results obtained from this case series study will need verification in a controlled trial with a larger sample, this work may provide prima facia evidence that both Long-COVID and PD share a common neuropathological element. This work sets the stage for the expedient development of minimally invasive, effective strategy for treating Long-COVID.

This is a randomised, double-blind, placebo-controlled, single ascending dose treatment, multi-cohort study. The study will evaluate 5 dose levels of the investigational product, OLX72021, in 5 cohorts. Dose levels will be evaluated in a sequential manner starting at the lowest dose level. Healthy male volunteers with mild to severe androgenetic alopecia (AGA), aged 18 to 75 years of age (inclusive) at the time of screening are eligible for recruitment. The total maximum study duration for participants in this study is 87 days (approx. 12 weeks). This includes a screening period (Day -28 to Day -14) and 56 days (± 3 days) post-treatment follow-up. Androgenetic alopecia has been linked to an imbalance of androgen hormones. OLX72021 is designed to target the androgen receptor (AR) gene, leading to reduced AR protein expression in the body. Because androgenetic alopecia could be caused by an imbalance of androgens, blocking the AR gene helps to reduce these harmful responses and allow hair growth to return to normal. The information learned from this study may help future participants with androgenetic alopecia.

The goal of our study is to assess the effects of translingual GTN on exercise capacity as assessed by cardiopulmonary exercise testing (CPET) and 6-minute walk tests (6MWT), in LVAD recipients. GTN is a medication that relaxes the vessels and makes the work of the LVAD and the native heart easier. Additionally, this medication is cheap and readily available. Patients will perform 2 tests each (both CPET and 6MWT), one with a pre exercise dose of GTN and one with a dose of placebo. Patients and investigators will be blind to the treatment assigned to avoid biases. Our main hypothesis is that exercise capacity will be better with a pre exercise dose of GTN as compared to placebo. If this hypothesis is confirmed, GTN could potentially be used in rehabilitation programs for LVAD recipients.

This study aims to identify one or more liver cancer specific microbial based biomarkers using a range of blood, stool (faecal) and oral samples from people who have a confirmed diagnosis of primary liver cancer and people who are at high risk of developing liver cancer due to chronic liver disease. Who is it for? You may be eligible for this study if you are an adult aged 18 years or older who has been diagnosed with chronic liver disease and/or primary liver cancer. Study details All participants who choose to enrol in this study will be asked to provide blood, stool and oral samples at 6 month intervals for up to five years post-enrolment. The study investigators will aim to collect these samples during a routine scheduled clinic visit so that participants do not need to attend additional study visits. It is hoped this research will identify and validate a liver cancer specific biomarker model for early diagnosis of liver cancer. If successful, tests for identified biomarkers may then be used to diagnose liver cancer earlier in at-risk patients, which may lead to better outcomes for future liver cancer patients.

Evidence supports the use of intra-operative antiseptic rinse in breast implant surgery to minimize the risk of capsular contracture or other complications. However, there is limited consensus or standardization of antiseptic rinse in practice. Having already determined contemporary trends in antiseptic rinse use in primary breast device surgery in Australia, we will use observational Australian Breast Device Registry (ABDR) data to analyse antiseptic rinse effects on clinical outcomes.

Bowel management in the Intensive Care Unit is a generally overlooked issue. Both constipation and diarrhoea appear common in critical care patients. Their causes are multi-factorial and associated with adverse outcomes. In the intensive care unit at the Austin Hospital, two approaches to bowel management are typically used and are reflective of practice in other intensive care units worldwide. These two approaches are either an ‘early aperient use’ or a ‘delayed aperient use’ approach. However, the evidence to support either approach is not of high-quality. Thus, clinicians remain uncertain about which approach is best for critically ill patients. In response, we will perform a single-centre, cluster double crossover trial. We will include all adult patients (aged 18 years or older), who are receiving mechanical ventilation and are enterally fed via a feeding tube. Over a 12-month period, that includes four 3-month treatment periods, pods within the intensive care unit will be allocated to regimen of 'early aperient use' commencing on day 1 of admission or to a 'delayed aperient use' regimen commencing on day 6 of admission. We estimate that 880 patients will be included in the trial. Data collected for this trial will be that of standard routine care data extracted from electronic data sources. Research findings will be used to help reduce practice variation and may be used to inform the design and conduct of future ethically approved research in the area of bowel management for critically ill patients.

Hepatitis B virus (HBV) infection is one of the most common infectious diseases in the world, with nearly 300 million people chronically infected worldwide. Chronic HBV infection can lead to serious complications such as cirrhosis, liver failure, hepatocellular carcinoma (HCC), and death. Approximately 820,000 people die every year due to consequences of CHB. Hepatitis delta virus (HDV) is the causative agent of chronic hepatitis delta (CHD), the most severe form of viral hepatitis. Infection with HDV is dependent on the presence of HBV infection, as it uses HBV encoded envelope proteins (HBsAg) for infection and replication HDV infection can occur either simultaneously with HBV or, more commonly, as a superinfection in patients already chronically infected with HBV. Relative to CHB infection alone, CHD co-infection is associated with more severe liver disease, causing faster progression to cirrhosis, hepatocellular carcinoma, and liver failure. Developing therapeutic strategies that deplete HBsAg levels, like monoclonal antibodies, may play a role in future regimens targeting functional cure. There is a clear need for additional treatment for CHD, particularly agents that improve response rates, are better tolerated, and simpler to administer than currently available treatments. BlueJay Therapeutics has developed BJT-778, which has the potential to provide anti HBV and anti HDV benefits by neutralizing and clearing HBV and HDV virions as well as by depleting HBsAg containing subviral particles, which may help reconstitute HBV-specific immunity and contribute to functional cure for CHB. BJT-778 is a potent, selective neutralizing monoclonal antibody for the treatment of CHB and CHD. This study will evaluate the safety, tolerability, pharmacokinetics and antiviral activity of multiple doses of BJT-778 in participants with Chronic HBV Infection (CHB).

Regular exercise helps people with chronic obstructive pulmonary disease (COPD) to remain independent, stay out of hospital and live longer. However, current COPD clinical guidelines don’t provide clear, evidence-based recommendations around what intensity people with COPD should exercise at. Recommendations provided are based on healthy adults and don’t consider the limitations to breathing and high levels of breathlessness experienced by people with COPD. This may mean people with COPD exercise at intensities too high, causing intolerable breathlessness and negative exercise experiences, or too low, not eliciting health benefits. This study will evaluate the benefits of using respiratory-specific parameters to guide exercise prescription in COPD. We will compare the benefits of three, 6-week exercise training groups: (1) usual care, defined as 25 minutes of continuous cycle exercise at a breathlessness intensity of 3 (moderate) to 5 (severe) on Borg's 0-10 category ratio scale; (2) 25 minutes of continuous cycle exercise based on respiratory-specific parameters; (3) high intensity interval exercise training (HIIT, 4 lots of 4 minute exercise periods, interspersed with 3 minute rest periods) based on respiratory-specific parameters. Specifically, this study aims to answer two research questions: 1. Do people with COPD achieve greater adherence and health benefits from 6 weeks of continuous exercise prescribed based on respiratory specific parameters compared with current exercise training practices (usual care)? 2. Is it safe and feasible for people with COPD to perform HIIT prescribed based on respiratory specific parameters, to further maximise health benefits from an exercise training program?

Lung health is mostly measured by “blowing tests”, known as spirometry. These types of tests can give useful information about lung health, but they can’t show exactly where in the lung any disease may be present. Other tests like computed tomography (CT) can give doctors useful and detailed information about the structure of the lungs, but this is different information to measuring how the lung is actually working as you breathe. We are trialing a new test called XV LVAS which will show how well different areas of the lung are working. This test is not currently approved for use in children but might help doctors to treat conditions like cystic fibrosis. We are recruiting children with healthy lungs and children with cystic fibrosis and other chronic lung diseases to decide if this test should be used with other lung tests to help doctors treat lung diseases like cystic fibrosis.