ANZCTR search results

Concussion is the most common form of brain injury, making up 75-90% of all brain injuries. Concussions generally resolve within 7-10 days, however, up to 25% experience delayed recovery which may interfere with return to pre-injury activities (e.g. work) and cause significant stress for months and sometimes years after injury. Persisting concussion symptoms are thought to reflect a range of factors beyond the original injury to the brain including stress and anxiety and physical factors such as injury to the neck, visual and/or balance systems. Given that multiple factors may be contributing to the persistence of symptoms after concussion, an interdisciplinary approach to management is now recommended in clinical practice. Therefore, we aim to evaluate an interdisciplinary intervention that incorporates expertise from psychology, physiotherapy, and medicine to target the primary factors thought to contribute to persisting concussion symptoms. As part of our interdisciplinary intervention, participants with persistent concussion symptoms will be offered 8 sessions each of psychological and physiotherapy treatment over 12 weeks as required based on the initial interviews (face-to-face or Telehealth). Medical management of persistent post-concussion symptoms will comprise of one consultation with the physician which may include pharmacological management of symptoms as well as advice regarding return to activities (e.g. work, sport, school).

Prostate cancer is the most commonly diagnosed cancer in Australian men. PSMA PET-CT (“prostate specific membrane antigen positron emission tomography computed tomography”), or “PSMA PET” for short, is increasingly being used for the imaging of prostate cancer. For this imaging technique, PSMA (prostate specific membrane antigen) is bound to a small amount of a radioactive imaging tracer. Two different imaging tracers are available in Western Australia, based on Gallium 68 (Ga 68) and Fluorine 18 (F18) compounds. This purpose of this study is to: • Evaluate the consistency of PSMA PET scans when the same type of scan is repeated within a short time frame (approximately one week). • Compare results of a Ga68-PSMA PET scan with results from a F18-PSMA PET scan, when both are performed within a short time frame (approximately one week apart). Who is it for? You may be eligible for this study if you are a male aged 18 or older and have been diagnosed with metastatic prostate cancer, you have not had a change in your cancer treatment in the last 12 weeks and have been referred by your treating physician to have a PSMA PET scan. Study details All participants in this study will have one additional PSMA PET within 2 weeks of the first scan. You will be allocated to receive either two Ga68-PSMA PET scans, two F18-PSMA PET scans or one scan with each radiotracer (ie: one Ga68 PSMA PET and one F18 PSMA PET scan). At each scan you will have one of the radioactive tracing agents injected into your arm, followed by a 1-2 hour wait before the scan is performed. You will then be positioned on the bed of the scanner to get PET and CT pictures of your body from head to thighs. The time in the scanner is around 20 minutes. In total, participation in the study will involve one additional visit to hospital in order to have a second PSMA PET. The time required for this visit will be 2 – 3 hours after which time you can return home without further assessments.

A range of challenges faced by children and adolescents with asthma contribute to their increased experience of psychological distress and lower quality of life than peers without asthma. Psychological interventions such as cognitive and behavioural therapies (CBT) may provide young people with techniques and strategies to manage symptoms of psychological distress and therefore symptoms of asthma, to avoid exacerbations. However, reports indicate low uptake of psychological intervention in this age group, with youth preferring to seek help themselves via internet sources. To improve access to and uptake of evidence-based treatments for elevated psychological distress in adolescents (aged 13-17 years) with asthma, this project will evaluate mixed reality technology (augmented reality, virtual reality, holographic technology) as a delivery mechanism for a component of CBT. Development of mixed reality tools will be guided by a comprehensive protocol for health program development, with direction from experts in Design, Information Technology, Respiratory Medicine, and Psychology. The acceptability of these technologies for use by youth, their parents/guardians, and health professionals will be explored through qualitative research via one-on-one interviews. This study will provide essential pilot data to guide development of a fully powered randomised controlled trial.

The BALANCE study is a randomised clinical trial comparing 7 to 14 days of antimicrobial therapy for bacteraemia. This sub-study is designed to determine whether patients enrolled in the main study, with a urinary source of their bacteraemia (urinary sepsis/urinary-tract infection), are as likely to be cured from their urinary-tract infection when treated with a short duration (7d) antimicrobial therapy, as compared with a longer duration (14d) of therapy. Demonstrating a clinical cure of the primary source of infection is important in UTI. If microbiological cure of the infection is not achieved, patients remain at increased risk of recurrent urinary tract infection and sepsis. If the BALANCE study demonstrates non-inferiority of 7 days duration antimicrobial therapy, further data supporting non-inferiority of cure for UTI will enhance the generalisability and clinician acceptance of reduced duration antimicrobial therapy.

Anorexia nervosa (AN) is a serious, debilitating psychiatric disorder, with numerous physical and psychological health impacts (Lock, 2012; Katzman, 2005). Typically diagnosed in young people, individuals with AN are 12 times more likely to die and 57 times more likely to commit suicide compared to same-age peers (Keel et al., 2003). Illness duration may extend to over 20 years for more than half of those afflicted (Fichter et al., 2017), highlighting marked chronicity. It is essential that evidence-based treatment for this disorder is delivered efficiently and effectively. Family-based treatment (FBT) is the most efficacious treatment currently available for young people with AN (Le Grange et al., 2016; Lock & Le Grange, 2019). FBT is an outpatient behavioural treatment which emphasises the parents as the primary resource in the recovery of young people with AN (Anderson et al., 2017). However, there is a concerning inequity in access and treatment outcomes for people with AN, particularly among those in regional and rural populations. Telehealth offers a viable, scalable solution to this critical issue, and preliminary research in the USA demonstrated equivalent outcomes for FBT delivered via telehealth compared to face-to-face therapy (Anderson et al., 2017). The proposed study sets out to build on this vital research, testing the efficacy, feasibility, acceptability and cost-effectiveness of delivering FBT via telehealth to 30 young people and their families living in regional and rural New South Wales. This pioneering study brings together a multidisciplinary team of national and international experts to address both the treatment needs of regional and rural families; and the needs of regional and rural health services. Further, it will inform future efforts designed to improve the health of all Australians impacted by this debilitating disorder.

This study aims to find out if receiving intravenous iron ferric carboxymaltose (FCM) will reduce the incidence of anaemia while patients are receiving chemotherapy before or after surgery for breast cancer, and whether this is associated with an improvement in quality of life (QoL) and exercise tolerance. Who is it for? This study may be suitable if you are 18 years or older and will be starting adjuvant or neoadjuvant chemotherapy to treat early or locally advanced resected breast cancer. Trial Details Participants will be randomly allocated to receive either: 1) Iron ferric carboxymaltose (FCM) intravenously at baseline and further FCM if functional iron deficiency criteria are met OR 2) Standard of care during chemotherapy according to local guidelines. All participants will be regularly monitored every 5-6 weeks (depending on the type of chemotherapy) throughout treatment to evaluate their health. There will be a final treatment visit 3 weeks after the last dose of chemotherapy. Follow-up visits will occur at 3 months, 6 months and 12 months after the last dose of chemotherapy. Further treatment will be at the discretion of the participant and their treating clinician. At each visit, all participants will: * Complete online functional assessments to assess cognitive function, daily function and quality of life, using the PROMIS Cognitive Function Short Form 8a (PROMIS-Cog 8a), Daily Cognition and Mood (DCAM) cognitive assessment, and FACT-An * Complete a 6 Minute Walk Test to evaluate exercise tolerance * Have blood samples collected for additional assessments of iron parameters in the blood. It is hoped that this research will improve the quality of life of women undergoing adjuvant or neoadjuvant chemotherapy for breast cancer.

The purpose of this study is to assess the safety and tolerability of REVx-99, as well as the Pharmacokinetics (PK- how your body uses the study drug) and pharmacodynamics (PD - how the study drug carries out its actions on the body). We are doing this study in healthy men and women to find out: - Does the drug have any side-effects and is it well tolerated when given as a single dose? - How much of the drug gets into the blood stream, and how long does the body take to get rid of it? This study will compare REVTx-99 with placebo. A placebo has no active drug in it. One group of participants will receive REVTx-99 and another group will receive the placebo. The effects seen in participants receiving the study drug will be compared to the effects seen in participants who receive placebo. We will be testing a single dose of the study drug in up to 40 healthy volunteers who will be divided into 5 cohorts of 8 people each and testing multiple doses in a single cohort of 8 people. Each single dose cohort is planned to receive an increasing dose of REVTx-99.

This is a seamless Phase 1b multicentre study to evaluate safety, tolerability, and efficacy of SER-301 in adult participants with active mild-to-moderate UC. SER-301 is a live microbiome therapeutic – a designed set of diverse, human-commensal bacterial strains, administered as oral capsules. This study has a seamless design, as it is composed of two study parts, each with different objectives, with an operationally seamless transition in between. Participants will be enrolled into either Part 1 or Part 2. Part 2 is randomised, double-blind, placebo-controlled. Approximately 50 participants will be randomised 2:3 to receive either 10 weeks of once-daily placebo following 6 days of placebo (4 times daily) or 10 weeks of once-daily induction treatment with SER-301 following 6 days of vancomycin pre-conditioning (4 times daily), respectively.

The Pasifika Preventing Diabetes Programme (PPDP) primarily aims to test whether a community activation and peer support delivered lifestyle programme across churches in the Greater Western Sydney and South Eastern Sydney Pacific communities can improve a blood marker called HbA1c, an indicator of glucose (sugar) level in the blood. The programme also aims to improve other clinical measures such as weight, waist circumference and blood pressure, through changes in lifestyle behaviours particularly healthy eating and physical activity. The aim is also to see if the programme can help the body weight of children in the church families. This programme is an expansion of a pilot study, Le Taeao Afua (LTA) where the same lifestyle and peer support programme was delivered through three Sydney Samoan Churches. The PPDP is a much larger trial testing the LTA intervention into atleast 48 Sydney Pacific churches over the next 51 months.

Total Hip Arthroplasty (THA) is a procedure commonly performed in patients who have end-stage hip osteoarthritis. The primary goal of THA is to provide pain relief, reduce disability, improve quality of life and functional status. Despite high implant success rates, up to 15% of patients remain dis-satisfied after surgery. This has been postulated to be due to several factors, including implant loosening, increased wear, dislocation and reduced functional movement, which lead to poorer patient outcomes. Medacta have recently developed a new acetabular cup device called the Mpact 3D Metal Monocer, designed for use in Total Hip Replacement (THA), the acetabular cup is one component of a THA. The Mpact 3D Metal Monocer device is a cementless hemispherical acetabular shell that comes pre-assembled with a ceramic bearing surface. Pre-assembly may show to have several advantages compared with traditional modular cups used for total hip replacement procedures, including allowing the use of a larger femoral head diameter which can reduce the risk of hip replacement dislocation and reduced wear rates. The Monocer cup is also manufactured with a 3D-Printed titanium alloy material on the back-side to enhance osseointegration and thereby improve implant stability in the bone. The newly designed Mpact 3D Metal Monocer cup device has recently obtained European CE Mark approval. CE Marking allows the Medacta to supply the Mpact 3D Metal MonoCer device in the European Union (EU). The Medacta Mpact 3D Metal MonoCer acetabular cup is not yet approved by the TGA. Thus, the purpose of this study is to investigate the Monocer cup efficacy (survival) at 2, 5 and 10 years post-surgery and ensure that it performs just as well as other commercially available acetabular cups. The hypothesis for this investigation is that the 2, 5 and 10 year percent revision rate (need to re-implant) is not inferior (comparable) to the average performance of all other cementless cups currently in use in the Australian Market.