ANZCTR search results

This mixed methods RCT of telehealth PEERS® for teens aims to test the effectiveness, acceptability and feasibility of a telehealth group delivered Program for the Education and Enrichment of Relational Skills (PEERS®) for high-school aged teenagers aged 11–17 years with acquired brain injury (ABI) or cerebral palsy (CP). In this pilot randomised controlled trial, we will recruit 32 teenagers with brain injuries and their caregiver across Queensland and randomise them to receive telehealth PEERS® or be waitlisted for 6 months. Telehealth PEERS® for teens will be run for groups of 8 youths and their caregivers. Four groups will be run over a two-year period in order to deliver the program to the immediate groups and control groups after the waitlist period. Outcomes will be measured before the intervention, after the telehealth PEERS® for teens program, and then 3 months later (6 months post baseline) and 9 months later (12 months post baseline). Focus groups using semi-structured interviews will be conducted separately with teens and caregivers at the end of the program to explore experiences of participation in telehealth PEERS® for teens. Compared to care as usual, adolescents receiving PEERS® will achieve significantly greater gains in: (i) self-perceived performance of social participation goals immediately post intervention (14 weeks) on the Canadian Occupational Performance Measure (COPM) of 2 points or greater.

This research involves participants who are students enrolled in years one, two and three of the Bachelor of Physiotherapy at James Cook University. This study is particularly relevant to this group of students at JCU physiotherapy because anecdotally they report that practical exams are more stressful than other assessment items. Therefore, the purpose of this study is to find out how much practical examination related stress students experience in each academic study period, and whether practical examination related stress attenuates as students become more experienced during their progression through the degree. The researchers will recruit a sample population of students, taking biomarker and perceived stress measurements at time points in each study period until conclusion of the practical examination in study period 1, of the student’s third year of the degree. There will be two ‘non-examination’ time points, T1 in early (week 3) and T2 mid (week 8) each study period, and one before (T3), and following (T4) ‘practical examination period’ time point. This will allow the comparison of stress levels between the ‘non-examination’ and ‘examination period, and between year levels. The measurements taken, will be analysed to report students’ stress and involve: 1. Completing a short questionnaire. 2. Providing a saliva sample to measure cortisol. 3. Heart rate monitoring using a chest mounted sensor during data collection and the practical examination. Saliva and heart rate variability are known indicators of stress.

Bioelectric Meridian Therapy (BMT) is a non-invasive, drug-free intervention for pain management. It has been used clinically to manage pain, decrease inflammation and improve function with only anecdotal evidence. BMT is a combination of gentle massage by a therapist and an electrical stimulation delivered via an innovative device, called ABMMA Pro. ABMMA Pro is very similar to well-established transcutaneous electrical stimulation (TENS), yet different. There is ample anecdotal evidence supporting the analgesic effect of BMT, but there is insufficient research data on the efficacy and safety of BMT. In this randomised, sham-intervention controlled study with a cross-over design, we aim to examine (1) if BMT induces analgesia, by assessing changes in pain threshold and if BMT is safe to use; 2) if BMT induces local and / or distal analgesia effect. Thirty healthy individuals (free from ongoing pain) will be recruited to participate in the study. Each participant will receive the real and sham BMT in a random order, with one week in between the two sessions. Their pressure pain thresholds (PPT) will be measured before and after the intervention using an algometer. PPT will be measured on the calves, low back and wrists. Confounding measures that will be measured are quality of life, severity of anxiety and expectancy. One researcher will measure PPT and experimental pain, and another will deliver the intervention. The participants and the researcher measuring the PPT will be blinded to the intervention that the participants receive. Any adverse event that occurs immediately after the treatment will be recorded. The results of this study will provide essential evidence of the efficacy and safety of BMT on moderating pain in healthy volunteers. If BMT is found to be superior to sham intervention, future studies should assess its efficacy among patients with chronic pain. BMT could be a valid alternative to pain medications for many people who cannot tolerate analgesics.

Text-message based programmes have proven to be an effective public health approach to improve adolescent health behaviours, including tobacco use, and so may have promise as an approach to influence adolescent e-cigarette behaviours. Given this potential, we aim to conduct a randomised controlled trial employing a 2x2 factorial design to examine the potential effect of a text-message program targeting parents and adolescents to prevent adolescent e-cigarette use. Parent-adolescent dyads will receive a series of text messages (1/week for 1 school term, then 1 booster message per term) designed to address the factors associated with e-cigarette use (e.g. to modify perceived social norms, or correct misconceptions of risk). Adolescent intentions to use e-cigarettes will be the primary outcome, assessed via a survey. It is hypothesised that adolescents who receive the text messages (or whose parents receive them) will report lower intentions to use e-cigarettes, than those in the control condition (who don't receive the text messages).

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 BJT-778 in patients with CHB.

Post COVID-19 condition is a debilitating illness with over 200 symptoms across 10 organ systems and is presently impacting millions worldwide. The National Institute for Health and Care Excellence recommends a multidisciplinary treatment approach including person-centred self-management strategies, however evidence for specific programs is lacking. The Take Charge intervention is a person-centred, self-management rehabilitation approach that has been effective in recovery after stroke, but not yet tested in post COVID-19 condition. This study is a prospective, single-centre, parallel, 2 group, mixed methods, randomized controlled trial with embedded process evaluation of the Take Charge intervention in individuals living with post COVID-19 condition. Participants will be at least 18 years of age, have a confirmed diagnosis of post COVID-19 condition with ongoing symptoms, and be known to a hospital clinic for assessment and treatment of patients with post-acute sequelae of COVID-19. The primary outcomes are the Modified COVID-19 Yorkshire Rehabilitation Scale and the COVID-19 Core Outcome Measure for Recovery. The secondary outcomes include physical and self-report measures, and feasibility measures. Qualitative interviews will also be conducted to understand the clinicians’ and participants’ experiences. Statistical analysis will be performed on an intention-to- treat basis using a multivariate mixed-effect linear regression model.

This study aims to assess whether a single dose of 177 Lutetium-PSMA-targeted therapy is safe and effective as a treatment for men who have developed biochemical failure after having a radical prostatectomy. Who is it for? You may be eligible for this study if you are a male aged 18 years or older who has recently undergone a radical prostatectomy (surgery to remove the prostate) due to a diagnosis of high or very high risk prostate cancer. Participants will undergo blood tests and MR imaging to determine whether they meet the additional criteria of biochemical failure. Study details All participants who choose to enrol in this study will receive a single dose of 177 Lutetium-PSMA-targeted therapy that will be administered intravenously (through a vein). Please note that any participants who are eligible for this study will need to pay out-of-pocket for the study treatment (177-Lu-PSMA-I&T) as well as the post-operative mpMRI (multiparametric Magnetic Resonance Imaging of the prostate). It is anticipated that the single dose will be administered over a 10-minute period followed by a saline (neutral fluid) flush. Participants will then be asked to provide blood samples at 3 months post-dose, and then every 4 months for up to 3 years post-dose. Participants will also be asked to complete a questionnaire about their health at 30 days, and then every 3-6 months for up to 3 years post-dose. Additional imaging scans will also be collected at 3 months post-dose, with the potential for further imaging to be determined by the treating clinician. It is hoped this research will determine whether a single dose of 177 Lutetium-PSMA-targeted therapy is safe and whether it has a positive impact on resistant prostate cancer. If this study does show that the drug is safe and effective, a larger study to examine potential benefits in more patients may proceed.

This study will look at the effects on muscle protein synthesis (rates of building new muscle) when people undertake resistance training while consuming 2 different types of diet for 2 weeks. One will restrict energy intake using an intermittent fasting restriction (2 days per week of severe dietary restriction), and the other will meet individual energy requirements. Generally, energy restriction results in lower muscle protein synthesis, however energy restriction is usually undertaken every day, rather than over 2 days per week. It is hypothesised that that rates of muscle protein synthesis rates will not be significantly different between groups.

EMVision’s EMView study is a 3 stage, multicentre, study of the EMVision Gen 1 Brain Scanner to collect clinical data for hardware verification and software advancement for the imaging of acute stroke. The imaging software, once finalised, will be able to differentiate between stroke/no stroke, classify stroke as either haemorrhagic or ischaemic and localise the stroke event to a specific quadrant of the brain. The first stage of the study will gather data from 30 healthy participants, to establish an age-matched baseline against the target stroke patient population for ‘healthy brain’/no stroke. The second stage will gather data on 150 patients presenting to hospital emergency with symptoms suspected to be stroke, including a minimum of 15 haemorrhagic stroke, 15 ischaemic stroke, 10 stroke mimics with migraine, 10 stroke mimics with seizure and other stroke mimics. Data from the second stage will be used to estimate the final sample size necessary to advance the software algorithms to clinically useful performance levels. The third stage will gather data on up to 30 patients presenting to hospital emergency with symptoms suspected to be stroke and who are confirmed to have had a haemorrhagic stroke. Due to the nature of streamlined code-stroke protocols and timing of diagnosis and EMVision scan, other patients who present to hospital with suspected stroke will continue to be recruited until the haemorrhagic stroke group minimum target is met. The data from all stages of the study will allow the EMVision to finalise software algorithms that identify, classify and localise stroke. It is anticipated that EMView Study will enroll approximately 320 patients with stroke and stroke mimics in the second and third stages of the study.

Background & Aim: Myofascial pain or jaw muscle pain is a common orofacial pain resulting in impairment of jaw function, and high health-care costs. It is most common in the 20–40-year age range. The aim of this study is to evaluate the feasibility, acceptability, and effectiveness of yoga in adult students experiencing myofascial pain. Methods: Subjects were recruited from a university student population and invited to learn more about the study through advertisements by email. Those interested were provided a jaw health screening questionnaire and if self-reporting facial pain they were invited for clinical examination to confirm orofacial myofascial pain (using standardised Research diagnostic criteria for Temporomandibular disorders [RDC/TMD]). 25 students with diagnoses of myofascial pain volunteered for this double-blind randomized controlled study. Participants undergoing other management for facial pain and TMDs were excluded. Participants were randomized to one of two interventions, either a yoga inclusive management programme or an active control standard care programme. Both groups received the intervention for 28 days. The outcome measures analysed were the change in pain intensity on an 11-point numerical rating scale and change in pain location and distribution using digitalized pain mapping software. Jaw mobility, oral health related quality of life and cognitive factors related to the participant’s understanding of pain were determined at baseline, at 14 days and at the end of 28 days. Change in outcome measures between baseline and (outcome points) were analyzed using Mann- Whitney test. Hypothesis That there will be a statistically significant difference in the treatment benefits between a yoga exercise inclusive management program as compared to active control standard care for the management of jaw muscle pain.