ANZCTR search results

The SCARF study will be an observational prospective study conducted over a period of three years.Our primary endpoint is the development of SCAF in these participants defined as ‘the incidence of asymptomatic atrial fibrillation’, lasting at least 30 seconds, as diagnosed by a AliveCor KardiaMobile ECG [AliveCor Inc., Mountain View, Calif, US], and previously not documented during the clinical history of the participants. Our primary endpoint is defined as ‘SCAF’ and will be assessed across 10 haemodialysis sessions using 6-lead ECG monitoring via the KardiaMobile device of the enrolled study participants (at beginning of haemodialysis session, at 1.5 and 2.5 hours into the haemodialysis. and at the end of the haemodialysis session). Additional ECGs (via the Kardia Mobile device) will be taken should the participants complain of palpitations during the haemodialysis. Should AF be detected on the basis of symptoms in these participants, it will be defined as “Symptomatic Atrial Fibrillation”. Participants enrolled in the study will be on regular maintenance haemodialysis, therefore we plan to screen participants for at least 10 haemodialysis sessions to increase the sensitivity of detecting SCAF. Secondary endpoints will be assessed using data collected from clinical records, the administration of widely used cognitive test, via the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS).

This is a non-interventional multi-site observational study intended to record data from the real-world use of cannabidiol medicines for treating pain and/or stress across Australia. The study treatments being comprised of botanical extract CBD (MC-1020) and synthetic CBD (MC-1023), which are delivered as oro-buccal sprays

The Anti-Mullerian hormone (AMH) test is currently being promoted misleadingly by online companies and fertility clinics as a fertility test for women. Importantly, research has demonstrated the test is not predictive of current or future fertility potential. It is vital women receive evidence-based information about this test free from commercial interests in order make informed decisions regarding their reproductive planning. This study aims to co-design an evidence-based information guide with key stakeholders (clinicians and consumers) and evaluate it with two samples of women, living either in Australia or The Netherlands. The information guide will be tested using an online randomised experimental design to assess the impact of the information on women’s intention to have the test, knowledge about AMH, attitudes towards the blood test and psychosocial outcomes. Hypothesis: It is hypothesised that women who receive the intervention (evidence-based info) will have lower interest and intention in getting an AMH test, and have higher knowledge, than women who receive the control information (misleading information currently online). Potential significance of the current study: Given the plethora of misleading information about the AMH test online, this study will produce crucial, evidence-based information for consumers, with the goal of improving informed decision-making and reducing inappropriate test usage.

This study investigates two different treatment schedules for an existing evidence-based speech pathology treatment (Dynamic Temporal and Tactile Cueing, DTTC, Strand, 2020) for children with Childhood Apraxia of Speech (CAS). DTTC is one of the few treatments with demonstrated efficacy for CAS (Murray et al., Maas et al., 2014). DTTC has previously been researched in high-intensity contexts, with therapy across 3-5 days per week (e.g Maas & Farinella, 2012; Strand & Debertine, 2000). DTTC involves watching the clinician and receiving tactile cues and is only suitable for in-person treatment. For families, particularly those in rural and remote areas, attending sessions 3-5 times/ week is not practical (Dew et al., 2012). This study will investigate two different session frequencies (3 times/ week and one 3-hr session/ week) while maintaining cumulative intervention intensity at 24 hours of therapy across 8 weeks. The quantitative data about the child's speech outcomes will be supplemented with qualitative information collected via semi-structured interviews with families and clinicians. The quantitive data will be collected using a Multiple Baselines Across Participants design, with 3-5 baseline sessions, 3 treatment phase probe sessions and 3 follow-up sessions (1-day post, 1-week post, 4 weeks post and 3 months post). The probe data set will include each child's individualized 20 treatment items and a 42-item generalisation probe (common to all children). The primary outcome measure is the whole word accuracy (including segmental and prosodic accuracy) and secondary outcome measures include percentage of consonants correct (PCC), % lexical inconsistency (as measured by the Inconsistency Severity Percentage, Iuzzini-Seigel, 2017), intelligibility (as measured by the Intelligibility in Context Scale, McLeod et al, 2012), and functional outcomes (As measure by the functional outcomes in children under six (FOCUS 34, Thomas-Stonell). The qualitative data will be collected using semi-structured interviews with carers and clinicians to explore perceptions of session length and frequency on the ease of therapy and the ability to accommodate therapy with other priorities. The qualitative data will be analysed using reflexive thematic analysis. (Braun & Clarke, 2020)

The purpose of this study is to investigate the safety, tolerability and efficacy of pharmaceutical grade cannabis-based medicines (MC-1019 and/or MC-1022), prescribed by eligible doctors to patients who meet the clinical criteria for the administration of MC- 1019 and/or MC-1022 for chronic conditions with a focus on chronic pain in clinical practice (i.e. general practices and/or specialty medical practices). Who is it for? You may be eligible for this study if you are an adult who has been prescribed MC-1019 and/or MC-1022™ for chronic conditions with a focus on chronic pain in clinical practice (ie. general practices and/or specialty medical practices). Study details All participants will be followed up on a monthly basis for up to 24 months. These follow ups will involve completion of surveys and provision of information regarding the administration of MC-1019 and/or MC-1022. Participants will not be asked to undergo any procedures or tests as part of this study. It is hoped that this study will help determine whether pharmaceutical grade cannabis is an options for pain management.

The aim of this study is to determine if Mediterranean diet can be followed by diagnosed cancer patients about to commence immunotherapy. Who is it for? You may be eligible for this study if you are aged 18 years or older, and are about to commence immunotherapy (with or without chemotherapy). Study details All participants will attend a 1-2 hour session with a dietitian to develop a diet plan, where the participant’s existing diet will be modified to meet the requirements of a Mediterranean diet through addition of extra virgin olive oil and nuts to the diet as well as setting goals to meet vegetables, fruits, fish, legumes, meat and dairy requirements. This diet plan will be followed from the time of commencement of immunotherapy treatment until 12 weeks from commencement. Throughout the 12-week study period, participants will be monitored for immune related adverse events through through data collection from medical records. Before and after commencing the dietary intervention, participants will also complete questionnaires regarding their dietary intake, and will have blood samples taken for the assessment of inflammatory markers. These outcomes will be compared to a cohort of 53 cancer patients from a similar setting who received no dietary intervention in the past. It is hoped that this study may show that a Mediterranean diet can be successfully followed by the participants and reduces the degree of immune related adverse events and markers of inflammation in patients undergoing immunotherapy for cancer.

The purpose of this study is to determine how well the Cxbladder urine test detects bladder cancer in patients who have blood in their urine. Who is it for? You may be eligible to join this study if you are aged 18 years or older, and have recently been confirmed to have blood in your urine. Study details All participants will be asked to provide a urine sample, to be used for standard urine testing and the Cxbladder test. Cxbladder results will not be shared, and will not affect the treatment or further diagnostic procedures provided to participants. Instead, participants will be diagnosed and treated as per current standard of care. Medical records will be reviewed for up to 24 month in order to compare the standard-of-care diagnosis with the Cxbladder diagnosis. It is hoped that this study will show how well the Cxbladder test is able to diagnose bladder cancer compared to current standard practices, and lead to improved bladder cancer testing services available for people who have blood in their urine.

A mixed method, waitlist-randomised controlled trial with 200 older adults in rural and remote areas in Australia will be conducted. The aim of the program is to implement an intervention to improve dementia risk, dementia awareness and cognition. Participants will be assigned to either the multidomain behaviour change group or a waiting-list control group and assessed when they initially register for the program, 3 and 9 months after the intervention. The waiting-list control group will receive the intervention after 12 weeks. The primary outcome is dementia risk score, measured by the LIBRA index. Secondary outcomes include dementia awareness and cognitive performance. An impact/outcome evaluation, which will involve semi-structured interviews, will be conducted at the end of the trial including participants from both multidomain behaviour change group and control groups to examine the feasibility and acceptability of the intervention. The aim of this intervention is to increase awareness of dementia, decrease risk of dementia through reducing lifestyle factors and improve brain health in the long-term.

Vocal cord dysfunction/inducible laryngeal obstruction (VCD/ILO) is common but seldom recognised at first since patients experience intermittent breathlessness leading in most cases to a diagnosis of asthma and treatment with inhaled corticosteroids (CS). Diagnosis of VCD/ILO is further complicated by coexistence of asthma and VCD/ILO in 20-40% of asthmatics and VCD/ILO can make asthma seem more severe leading to over-treatment with high-dose inhaled or oral CS. To date a swift diagnosis is seldom achieved. The current gold-standard for diagnosis of VCD/ILO is laryngoscopy and the quintessential abnormality is inspiratory closure of the vocal cords and formation of a diamond-shaped small opening or ‘chink’ posteriorly. Laryngoscopy requires expertise that may not be available within a reasonable time-frame and the procedure can be technically challenging or fail if a patient is breathless and distressed. Consequently, laryngoscopy may be delayed or not performed. Laryngoscopy in expert hands remains the definitive diagnostic modality but innovations in diagnostic imaging have created alternative options. Present-day imaging technologies with superior spatial and temporal resolution have made it possible to visualise not only anatomical features, but also movement and function of a particular organ. We have developed dynamic CT larynx to detect and quantify laryngeal movement, a technology that can be applied wherever cardiac CT is performed. We hypothesised that dynamic CT larynx would have comparable diagnostic accuracy to laryngoscopy in VCD/ILO, when performed contemporaneously and when utilised in a real-world clinical context.

This project is testing the safety, tolerability and brain delivery of INB-01, an intranasal formulation of a currently marketed MRI contrast agent. You may be eligible for this study if you are a healthy adult man or woman aged between 18 and 55 years old. Participants will be randomised (assigned randomly, like flipping a coin) to one of two stages. In Stage 1 you will receive a single intranasal dose of placebo. In Stage 2 you will receive a single intranasal dose of INB-01, the active experimental contrast agent. It is hoped that this research will help determine the safety of INB-01 when given to healthy men or women and to see if it gets to the brain tissues