ANZCTR search results

This is an open label prospective phase 2 clinical trial of 25 adult patients diagnosed with uncontrolled eosinophilic chronic rhinosinusitis (eCRS) with NP treated with Dupilumab for a 26 week plus a post-treatment visit at three months. At baseline and every 2 weeks patients will have a clinical assessment and complete a series of questionnaires. A blood sample and a nasal mucosal biopsy will be collected every 4 weeks. Protein and RNA analysis will be performed using the GeoMx™ DSP /CosMx™ single cell SMI platforms on tissue samples at baseline, week 4, week 12 and week 26. The objective of this study is to identify and assess the tissue histopathological changes in response to mepolizumab and/or dupilumab therapy in patients with nasal polyp eosinophilia.

The purpose of this study is to assess safety, reactogenicity (reactions that occur to the body soon after vaccination), and immunogenicity (the ability of a vaccine to provoke an immune reaction in the body) of a COVID-19 vaccine, HN-0001. The HN-0001 vaccine will be administered via intramuscular injection. A COMIRNATY (Pfizer) COVID-19 vaccine will be used as a comparator and will be administered via intramuscular injection. This study will be conducted in healthy men or women, 18-65 years of age. Across up to six groups, participants will receive escalating doses of the HN-0001 vaccine (3mcg, 10mcg, 30mcg, 50mcg, and 100mcg) or with a 30mcg dose of COMIRNATY (Pfizer) COVID-19 vaccine across cohorts 1, 2, 3, 4, and 5, Cohort 6 will receive a 30mcg dose of COMIRNATY (Pfizer) vaccine. 68 participants will be enrolled in the trial.

Lung transplantation aims to extend the lifespan and improve the quality of life for people living with end-stage lung disease. Most lung transplants now involve thoracotomy incisions between two ribs and spreading of the ribs to allow for removal, insertion, and attachment of lungs. Thoracotomies can be very painful for weeks and in many patients can result in longer term nerve pain that can have significant negative impacts on quality of life. Two novel techniques to manage pain for lung transplant patients have been introduced to supplement morphine-type pain medications: a catheter that delivers local anaesthetic to the area and cryotherapy to temporarily freeze and numb the nerves in the area. This study aims to assess if either technique leads to a shorter time in intensive care, better recovery, and better pain relief from the incision in the short term and potential nerve pain in the longer term. It is hypothesised that there will be no differences between these two techniques. The study will also be looking for side effects with each technique.

A critical part of an anaesthetist’s job is to make sure that the cells of a patient’s body continue to receive the right amount of oxygen. Oxygen delivery can't be directly measured, and anaesthetists rely on the surrogate measure of blood pressure. The pressure field software is real-time monitoring software which enables anaesthetists to understand how the heart and the body’s vessels are working together to generate blood pressure. This information, combined with a treatment algorithm, assists an anaesthetist in understanding what fluids or drugs will most help a patient. This may be particularly helpful for anaesthetists when they are caring for elderly patients, in whom it can be more challenging to know what fluids or drugs will work best. A large clinical trial evaluating the impact of the pressure field method on patient outcomes is being planned and this feasibility trial will 'road test' key elements of the planned large trial.

This intervention study is designed to assess and quantify the effect of flax and chia seeds, which are high in alpha-linolenic acid (ALA) which can theoretically be converted into the long chain omega 3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). The population will be those habitually following a low fat, whole food plant-based diet. This population has been selected as they have a low total, and omega-6 fat intake, which can compete with ALA for conversion to DHA and EPA. The proposed study will consist of a randomised controlled intervention for 8 weeks in a population following a low fat (<20% of total energy intake) whole food plant-based diet including: 1) Flax and chia seeds (22.5 grams of flax seeds and 22.5 grams of chia seeds containing ~10.25 grams of ALA + habitual low fat whole food plant-based diet Or 2) Continued habitual low fat whole food plant-based diet. It is hypothesied that the chia/flax intervention will not induce a significant difference in omega-3 indices

The study aims to examine the short-term effectiveness of a brief reminiscence (mastery experience) intervention on self-efficacy to do prescribed exercises despite pain and adherence to prescribed exercises for patients recovering from total knee replacement (TKR). Participants who receive the intervention are expected to have higher self-efficacy to complete exercises despite pain, higher self-reported exercise adherence, and greater reduction in pain intensity than those in the waitlist control group.

Aortic stenosis is a common valvular abnormality in adults. Its incidence increases with age. The only effective treatment options for severe aortic stenosis are surgical aortic valve replacement (SAVR) or transcatheter aortic valve implantation (TAVI). TAVI represents a less invasive alternative to SAVR. In patients with high surgical risk TAVI has been associated with increased 1-year survival compared with SAVR, along with reduced risk of death and hospitalisation compared with conservative management. More recently, TAVI has also been shown to result in significantly lower rates of death, stroke or rehospitalisation compared with SAVR in patients with low surgical risk. As such, we can expect an increase in the number of TAVI procedures in future. Infective endocarditis is a potential complication following TAVI insertion. The rate of infective endocarditis following TAVI has been variably reported between 1 and 3%, which is similar to the rate of prosthetic valve endocarditis (PVE) following SAVR. However, the microbiology of post-TAVI endocarditis is notably different from PVE or native valve infective endocarditis, with a predominance of Enterococci. The reasons for this difference have not been elucidated but may relate to the transfemoral approach utilised for the majority of TAVIs. This raises the possibility of periprocedural bacteraemia and subsequent seeding of the newly placed valve prosthesis. To date there have been no studies investigating the rate of periprocedural bacteraemia in patients undergoing TAVI. There is a paucity of literature surrounding antibiotic prophylaxis for TAVI procedures. The European Society of Cardiology guidelines advise that antibiotic prophylaxis should be considered in patients undergoing TAVI but give no recommendation as to the agent or duration. Cefazolin is frequently used as prophylaxis for cardiothoracic surgery and a number of institutions have extrapolated this to TAVI prophylaxis. However, little is known about the pharmacokinetics (PK) and pharmacodynamics (PD) of antibiotics including cefazolin in the TAVI population, in whom there are presumably dramatic changes in haemodynamics and organ perfusion periprocedurally. Furthermore, the predominance of Enterococci in post-TAVI endocarditis would suggest that cephalosporins are a suboptimal prophylactic antibiotic. In this study, we aim to explore the incidence of periprocedural bacteraemia in patients undergoing TAVI as a possible explanation for the unique microbiological profile of infective endocarditis in this group. Additionally, we will examine demographic and procedural data for associations with any observed bacteraemia. Given the unique haemodynamic changes observed during TAVI procedures we will also examine the PK profile of prophylactic antibiotics and correlate this with any observed bacteraemia.

Coeliac disease and gluten sensitivity are common illnesses that are associated with unpleasant symptoms caused by the consumption of gluten. These symptoms can greatly impair a sufferer’s quality of life. How gluten causes symptoms is poorly understood. This study aims to understand the bodily processes that are important in the development of symptoms to gluten. This information will be important for the development of treatments that can prevent or treat gluten-induced symptoms. We aim to identify markers in the blood that can be used by doctors to help in the diagnosis of gluten sensitivity and also for monitoring the effect of new treatments for coeliac disease.

This study recruits from a larger Australian cohort and aims to evaluate the value and impact of incorporating personalised risk scores (PRS) into melanoma risk assessments in a high-risk cohort. Who is it for? Individuals who participated in an existing study (the Australian Centre of Excellence in Melanoma Imaging and Diagnosis (ACEMID) Study) and provided a saliva sample for genetic analysis within that study, were eligible to participate. Study details Participants were randomly allocated to either receive a ‘traditional’ melanoma risk scores based on clinical and environmental risk factors (control group), or ‘personalised’ melanoma risk scores based on PRS, clinical, and environmental risk factors (intervention group). Participants received their melanoma risk scores in the form of an information booklet and are offered a follow-up appointment to discuss the results. Individuals in the control group are were offered a personalised risk booklet after 12 months. Participants were asked to complete questionnaires regarding their the perceived utility of the information, any psychosocial impact following receipt of results and the impact on sun-protective and screening behaviours. It is hoped that findings from this study will provide insight regarding the utility of personalised risk information for melanoma and the impact on psychosocial and behavioural outcomes, particularly capturing the relative utility of personalised risk scores which incorporate both PRS and traditional risk factors, compared to risk scores based purely on traditional risk factors.

Functional mitral regurgitation in patients with or without atrial fibrillation without left ventricular dysfunction and/or dilatation, namely, atrial functional mitral regurgitation (AFMR), has been increasingly recognized. It occurs in the setting of left atrial dilatation and or atrial fibrillation in patients with heart failure with preserved ejection fraction (HFpEF). However, there are very limited published data regarding therapeutic strategies of AFMR. We aim to understand the optimal therapeutic options by investigating the outcomes of previously treated patients when this concept was not well recognized.