ANZCTR search results

This study aims to further understand the difference in teaching formal and informal mindfulness practices, and the effect on dose of formal and informal practices on wellbeing outcomes. Additionally, this project aims to further examine dose-response in mindfulness programs, by in particular focusing on instructions of formal and informal practice, and whether participants follow guidance of formal and informal practice in different ways, and/or develop their own informal practices from being given instructions on different types of practice.

Social anxiety is prevalent among university students. As a result, a sizeable proportion of the student body is left under-prepared for their future careers. To offer effective and scalable support in building these essential skills, we will evaluate a cognitive behaviour therapy (CBT) program for social anxiety called ASTUTE (Anxiety Skills Training in UniversiTy Education). The program will be implemented in two forms: (1) in-person, clinician-facilitated groups (ASTUTE) and (2) online, guided self-help (ASTUTE-Digital). The latter provides a highly scalable means of supporting students overcome social anxiety, which is important given the high prevalence of social anxiety in the university setting. To evaluate the impact and acceptability of these programs, participants will complete questionnaires assessing their psychological functioning at baseline, end-of-program (two months later) and follow-up (four months later). To provide input regarding the ongoing design of the programs, participants will also be asked to take part in focus groups at the four-month time point.

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. This study will be conducted in healthy men or women, 18-65 years of age. This study will compare effects seen in participants receiving the study drug at the moderate dose (30mcg) with effects seen in participants who receive an equivalent dose of the comparator COMIRNATY Omicron XBB.1.5 vaccine. 20 participants will be enrolled in the trial.

This study is designed as a 3-part study in healthy participants to test the drug-to –drug interaction of experimental drug, JNT-517 with itraconazole, midazolam and pravastatin, respectively. JNT-517 is believed to reduce levels of phenylalanine in the by increasing its removal with urine and reducing uptake of phenylalanine in the gut.

Previous trials have treated individuals with migraine associated neck pain as homogenous. However our research identified cervical musculoskeletal dysfunction in about 40% and pain hypersensitivity in about 50% of participants with migraine. This indicates the presence of four subgroups in this population: i) with cervical musculoskeletal dysfunction and pain hypersensitivity, ii) only cervical musculoskeletal dysfunction, iii) only pain hypersensitivity, iv) neither. We hypothesise that physiotherapy intervention should therefore be individualised according to these subgroups but such individualisation of management is novel in this population. Therefore the primary aim of this study is to establish the feasibility of conducting an efficacy trial on individualised physiotherapy management of patients with migraine and neck pain, including patient perspectives on preferred primary outcomes and meaningful effect sizes. The secondary aims are to describe this novel individualised treatment program and explore the effects and possible underlying mechanisms.

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