ANZCTR search results

In this randomised, double-blind, parallel-group, placebo-controlled study, 120 overweight/ mildly obese adults (body mass index between 25 and 35 kg/m2) experiencing high stress and low energy will be randomly assigned into one of two groups comprising either a twice-daily intake of capsules containing a Withania somnifera (Ashwagandha) extract or a placebo for 12 weeks. We will assess changes in stress, fatigue, quality of life, and interest in sexual activity using several self-report questionnaires. Changes in sex hormone concentrations, oxidative stress, inflammation, blood glucose regulation will be assessed from a venous blood collection. A blood sample will also be collected to measure changes in liver and renal function, and complete blood count. Changes in heart rate variability will also be assessed over time. Finally, changes in strength will be determined using a hand-held dynamometer, which is an indicator of overall body strength. It is hypothesised that, compared to the placebo, ashwagandha supplementation will be associated with a greater reduction in stress, improvements in energy, quality of life, and endocrine/ physiological markers.

The main aim of this study program will be to develop the current understanding of the chronic stress response to a non-severe burn injury (less than or equal to 20% total body surface area (TBSA)) in adult patients, with the addition of the novel approach of metabolic flexibility assessment to better characterise this response. Specifically, we aim to determine the interaction of the systemic metabolic, inflammatory, musculoskeletal and cardiovascular responses, aiming to present a compete image of the chronic response post non-severe burn injury, as well as the effects of common treatments in the form of surgery and nutritional support. The primary objective of this study will be to determine the state of metabolic flexibility in acute non-severe burned patients (less than or equal to 20% TBSA) across a 12-month period of analysis of recovery at four time points. Secondary objectives of this study will be to analyse the acute stress response of non-severely burned patients across the same 12 month period post injury, looking specifically at metabolic, inflammatory, musculoskeletal and cardiovascular responses, as well as to examine the acute effects of surgical intervention on metabolic rate in non-severely burned patients. We hypothesise that non-severely burned patients will experience a state of metabolic inflexibility throughout their post injury recovery, while also displaying a similar physiological stress response to what is seen in larger burns injuries.

The main purpose of this study is to investigate the feasibility of Stereotactic Ablative Body Radiation (SABR), a method of delivering palliative radiotherapy, for patients with head and neck cancers. Who is it for? You may be eligible for this study if you are an adult aged 18 or older, you have been diagnosed with either primary head and neck cancer, or another cancer that has metastasized to your head and neck, and you have been assessed as unsuitable for curative-intent surgery and/or radiotherapy by the Head and Neck multidisciplinary team. Study details Participants who choose to enrol in this study will undergo a series of 5 radiotherapy treatment sessions over two weeks, with a minimum of 48 hours between each session. After the treatment sessions your radiation oncologist and the study team will follow up at 3 monthly intervals intervals to examine any side effects, the overall effectiveness and your quality of life. All participants will be assessed at regular intervals post treatment for up to two years. It is hoped this research will provide more knowledge and understanding of the use of SABR in head and neck cancers in Australia. This information may then be used to improve health outcomes for future patients with head and neck cancers

Background: Ischemic stroke is a leading cause of mortality and disability globally. Atrial fibrillation (AF) is a major cause of stroke. Because AF-related strokes can largely be prevented by oral anticoagulation, an active search for underlying AF is essential in patients with ischemic stroke. In recent years, there has been a surge in the number of health and medical apps for smartphones. Various smartphone apps for heart rhythm monitoring are now available. FibriCheck is one of those smartphone apps that can be used for heart rhythm monitoring and AF detection. It is the first medical smartphone app approved by the United States Food and Drug Administration for heart rhythm disorders. FibriCheck has been shown to have good accuracy in detecting AF. FibriCheck use the phone’s flashlight and built-in camera to register heart rhythm via photoplethysmography technology. To the best of our knowledge, there is no published study on the use of FibriCheck for AF detection after ischemic stroke or transient ischemic attack. Hypothesis: The FibriCheck app could be a convenient and effective rhythm monitoring strategy for the detection of AF in patients with recent ischemic stroke or transient ischemic attack. Aims: • To assess the ease of use of FibriCheck for rhythm monitoring strategy in patients with acute stroke • To evaluate the compliance to FibriCheck monitoring schedule in patients with acute stroke • To determine the AF detection yield of FibriCheck in patients with acute stroke • To compare the accuracy of FibriCheck for AF detection to other rhythm monitoring strategies Procedure: Participants will be recruited in the wards and clinics of the Neurology Department of the Royal Adelaide and Calvary Hospital. 196 patients will be recruited into this observational study. All participants will be asked to take at least 3 measurements daily for 3 months. The FibriCheck app will be provided to the participants free of charge for the duration of the study. All participants will also received a standard of care heart rhythm monitoring using Holter monitor/HeartBug.

Telomere shortening is one of the hallmarks of ageing and short telomeres are linked to a host of degenerative diseases (e.g. atherosclerosis, dementia, type 2 diabetes). Exercise training is associated with long telomeres, such that those who exercise regularly and individuals with high cardiorespiratory fitness typically possess longer leukocyte telomeres compared to their sedentary counterparts. Indeed, exercise training may preserve telomere length by up regulating an enzyme, namely telomerase. Telomerase reverse transcriptase (TERT) is the major protein component and rate-limiting molecule of telomerase, and plays an important role in healthy ageing. Whilst exercise training seems to up-regulate TERT and telomerase activity, the optimal exercise prescription (e.g. intensity) that leads to increases in TERT are unclear. Therefore, we will determine the influence of a single bout of: 1) low intensity and moderate intensity aerobic training on white blood cell telomerase/TERT gene activity in young and older adults. The findings from the study will help us identify the whether exercise intensity (low versus moderate intensity) is associated with changes in white blood cell telomerase/TERT.

Scar formation following a burn or surgery is a considerable health issue worldwide. Current options to manage established scars are mostly invasive and include cryotherapy, scar revision surgery or laser therapy. Lysyl oxidase (LOX) a novel compound is a copper-dependent amine oxidase that plays a critical role in the biogenesis of connective tissue matrices by crosslinking the extracellular matrix proteins, collagen and elastin. Recent studies have revealed a crucial role for LOX in skin fibrosis including the potential to reduce scar formation. This study aims to investigate the safety and tolerability of PXS-6302 for the amelioration of scars in a formulated topical cream.

We will conduct a pilot of ‘GenE Compass’, an information linkage service for families of a child with a suspected or confirmed diagnosis of a developmental and epileptic encephalopathy (DEE). GenE Compass answers caregivers’ questions about their child’s DEE: for example expected co-morbidities, natural history information, support resources, what current research is being conducted on that condition. Primary outcomes 1. Is GenE Compass acceptable to caregivers and healthcare professionals? 2. Is GenE Compass feasible to deliver? Secondary outcomes 3. What is the potential impact of GenE Compass, if any, on caregivers, healthcare professionals and the healthcare system? We will include caregivers who have a child (<18 years of age) with a suspected or confirmed diagnosis of DEE (e.g. SCN2A-encephalopathy , WWOX- encephalopathy), who are new or existing patients of the Sydney Children’s Hospitals Network and speak English. We will also include healthcare professionals who have been nominated by the caregiver to receive the reports. Following consent, caregivers will complete Questionnaire 1. They will then be provided access to GenE Compass. Our linker service will triage questions (Level A or B). Level A questions are defined as out of scope of GenE Compass, can be best responded to by a known alternative service/organisation, or simple response required OR consists of a clinical question which will need to be addressed by one of the child’s clinicians as greater context is required. For Level A questions, the linker will respond to the caregiver via email within a few business days to inform them it is either outside the scope of GenE Compass or the more appropriate organisation to support them (e.g. Reframing Disability for questions related to NDIS access). Level B queries are defined as related to information about a DEE or comorbidities, but not direct patient care (i.e. within scope of GenE Compass). For Level B questions, the linker will conduct a rapid literature search and consult with our expert multidisciplinary team. We will then send caregivers and their nominated healthcare professionals (Neurologist, Paediatrician and/or GP) back a report within 5-10 business days. After 3-months of access to GenE Compass, we will invite caregivers to complete Questionnaire 2 and an optional telephone interview. We will also invite the nominated healthcare professionals to complete a questionnaire at study close.

The QoVax SET research pilot study is designed to investigate intrinsic and extrinsic host and viral determinants of vaccine safety, immunity and efficacy in Queensland. Specifically, the QoVax SET Program seeks to determine whether the vaccines administered by Queensland Health facilities are safe and effective in the Queensland community to; • Induce SARS-CoV2 immunity, • Limit the severity of virus-induced disease, and • Sustain immunity and protection from SARS-CoV2 disease in QLD.

This is First in human, open label, single centre, exploratory study to determine safety and PK characteristics of INS018_055 after a single IV microdose administration in healthy participants. This study will enrol 8 eligible adults. The study will consist of 3 periods: Screening-(Day -28 to Day-1)- After completion of ICF and eligibility check participants will be enrolled in the study. Treatment period (Day-1 to Day -2)- On Day 1, baseline and safety assessments will be performed and participants will be administered a single dose of IP via IV injection and monitored for safety. Blood for PK analysis will be collected pre and post dosing. Follow up (Day 8[± 1day]- Participants will return to CRU on Day 8 to undergo safety assessments.

Antiva is developing ABI-2280, a potent human DNA polymerase inhibitor, for topical treatment of several precancerous conditions related to human papillomavirus (HPV) infection, including high grade squamous intraepithelial lesions (HSIL) of the cervix. The purpose of this study is to assess the safety, tolerability and PK of ABI-2280 Vaginal Gel and Tablet, applied to the cervix of healthy female participants. The study will be conducted in two parts: Part A (Single Ascending Dose) and Part B (Multiple Ascending Dose). Part A There will be 4 Cohorts in this part, A1 -A4, each consisting of 8 participants. 6 participants will receive a single dose of ABI-2280 and 2 will receive a single dose of placebo. No participant will be enrolled in more than one cohort. Participants will be screened up to 49 days prior to dose administration. Participants may be admitted to research unit on Day -1 or morning of Day 1 and remain admitted until Day 2. On Day 1 participants will receive a single dose of ABI-2280 Vaginal Gel or Tablet or placebo. They will return to the clinic on Day 4 for safety follow up visit and Day 8 for end of study visit. Part B Up to approximately 16 participants will be enrolled into two cohorts- B1 and B2. Each cohort will consist of 8 participants (6 to receive ABI-2280 Vaginal Gel or Tablet and 2 to receive placebo). Participants will be screened up to 49 days prior to Day 1 dose administration. For cohorts B1 and B2, participants may be admitted to the research unit on Days -1 and 4 and discharged on Days 2 & 6 or if feasible, may be admitted through Day -1 to Day 5 and discharged on Day 6. On Days 1 & 5, they will receive the first and last doses of ABI-2280 Vaginal Gel or Tablet or placebo. Participants will have safety assessments and ABI-2280 or placebo administration on Days 3, safety follow-up visit on Day 9, and the End of Study (EOS) visit on Day 15.