ANZCTR search results

The finding of a PI-RADS 4 or 5 lesion on mpMRI carries a high index of suspicion, and probability, of the lesion being clinically significant PCa. However, the sensitivity and specificity is not sufficient to make a definitive diagnosis of PCa without biopsy. Early literature shows that PSMA PET-MRI is superior to mpMRI alone at detecting clinically significant prostate cancer. A positive PSMA PET-MRI lesion is therefore even more likely to correlate with histopathological confirmation of clinically significant PCa. Given that size of the lesion can impact on the successful confirmatory sampling, and detection on PSMA PET, a minimum size of 10mm would make it highly unlikely that the lesion would be missed on biopsy or PET scan. This work has the potential to identify a select group of men who could potentially proceed to definitive surgical treatment without the need for prostate biopsy. Study Details All participants in this study will undergo a mpMRI which is a standard of care investigation, and an 18F-PSMA PET-CT as the research investigation after which a transperineal prostate biopsy of identified lesions will take place as is standard of care, All participants will be recruited via clinics of and by Urologists with scans and biopsies performed at the SAH. Within 2 weeks post biopsy; participants will follow-up with their urologist for discussion of results. For the subset of patients proceeding to radical prostatectomy, histopathological concordance with identified lesions on each of the imaging modalities will be analysed. The proportion of men with change in Gleason grade group following radical prostatectomy will also be recorded.

This trial aims to investigate the relative impact of two online professional development activities for physiotherapists on clinical practice and their patients outcomes. Physiotherapist learners will be randomised to participate in either online clinical mentoring or online pre-recorded lectures. The primary outcome evaluated will be the effect on the physiotherapist learners patients with spinal pain as measured by the 'patient specific functional scale'. Secondary outcomes will be the effect on other patient health outcomes as well as the physiotherapist learners confidence, self-reflection and satisfaction. The clinical mentoring group participants will also complete semi-structured interviews which will be thematically analysed using a phenomenological approach.

Males are at higher risk of death by suicide than females in Australia, and among men, blue-collar males are at higher risk compared to the rest of the male working population. In response to this issue, MATES in Construction developed a workplace suicide prevention program for the construction sector in 2007 that has been widely implemented in Australia. In the current project, this program is being adapted and trialled in the manufacturing sector. The aims of the MATES program are to improve suicide prevention literacy, and help-seeking intentions, and helping behaviours. The program will be evaluated using a cluster randomised-controlled trial design with wait list controls across up to 20 manufacturing worksites in New South Wales. We hypothesise that after 6 months of the MATES in Manufacturing program, there will be significantly greater improvements in help-seeking intentions (primary outcome) compared to wait-list controls. The project is led by Deakin University in collaboration with the University of Melbourne, and in partnership with MATES in Construction.

Chronic pain after a musculoskeletal injury is a chronic pain syndrome characterised by a persistent chronic pain that persists following injury to the musculoskeletal system. Currently, the commonly recommended pain medications carry risks relating to side effects (in particular opioids). This trial aims to study the oral formulation, ZTL-106, in patients with chronic pain as a result of a previous musculoskeletal injury of the knee or hip. The study is a double-blind, placebo controlled, phase 2a study to determine the effect of ZTL-106 on pain, quality of life, emotional state and function, in people with chronic pain that follows a prior knee or hip musculoskeletal injury. Eligible participants will be randomised to receive ether ZTL-106 or Placebo. The investigational treatments will be administered as an oral oil twice daily, once in the morning and once in the evening for each participant for up to 6 weeks. Throughout the study participants will complete a range of patient reported outcome measures (PROMs) that assess their pain interference and severity, as well as the effect of their pain on their quality of life, the frequency of pain flares, and their emotional wellbeing. In addition, blood samples will be taken at several time points throughout the study.

The Care Navigation intervention is a 6-month program of support for adult patients with depression and/or anxiety referred by a GP to the Black Dog Institute (BDI) Psychiatry Services. It aims to assist participants in navigating the mental health system and implementing the treatment plan written by their BDI psychiatrist, and to subsequently improve their mental health outcomes. The aim of this study is to compare outcomes (symptoms of depression and anxiety, and social and occupational functioning) at 3 months, between adult patients of the BDI Psychiatry Services with depression and/or anxiety who received the Care Navigation intervention, and those who did not (ie the matched comparison group). Participants in both groups will have been referred by a GP to the BDI Psychiatry Services for an assessment by a BDI psychiatrist, and had a treatment plan provided to their GP. However, only participants in the intervention group will also receive the Care Navigation intervention.

The use of pre-fabricated, customized and bioresorbable medical grade scaffolds is a significant development in this field of tissue engineering. Medical grade polycaprolactone (PCL) is a highly biocompatible and completely bioresorbable polymer. These scaffolds have been shown to be dimensionally accurate and stable, adaptable to a range of defects and conducive for bone regeneration. These scaffolds, are yet to be clinically assessed clinically. The objective of this proof of principle study is to report on the efficacy of a 3D printed custom manufactured medical grade polycaprolactone (PCL) scaffold that is loaded with anorganic bovine bone mineral (ABBM) and particulate autogenous bone (AB) in reconstruction of alveolar ridge defects.

AIM The primary aim of this study is to determine whether use of adaptive ventilation mode (AVM2) which uses an automated mechanical power algorithm leads to a decrease in driving pressure in patients with moderate to severe ARDS. HYPOTHESIS We hypothesized that, when compared to “traditional” Lung protective mechanical ventilation based on low tidal volume ventilation, ventilator settings selected by AVM2 will have a lower driving pressure DESIGN A single centre feasibility / physiological / proof of concept study in 20 ARDS patients within 24 hours of intubation (moderate to severe ARDS). Study design will be a prospective randomized cross-over study in 20 critically ill patients on controlled mechanical ventilation- with randomized 6 hours of LTV and 6 hours of AVM2. Study period 2 years Setting Single Centre study conducted in the Intensive care unit (ICU) at Flinders Medical Centre, Australia Population Inclusion: who are 'greater than and equal to' 18 years of age, intubated, and within 48h of a diagnosis of moderate/severe ARDS (PaO2/FiO2 <= 200 mmHg, PEEP >= 5 cm H2O, bilateral opacities on chest X-ray and respiratory failure not fully explained by cardiac failure or fluid overload) Exclusion: patients with active bronchospasm or a history of significant chronic obstructive pulmonary disease or asthma, lack of consent (treating physician or next of kin), inevitable and imminent death, pregnancy, those receiving ECMO, or involvement in other prospective clinical studies. Intervention AVM2 which uses an automated mechanical power algorithm. Comparator Usual care, with a tidal volume-based approach as per the ARDSnet protocol Sample size 20 patient – feasibility study STUDY ENDPOINTS Outcomes The Primary outcome is driving pressure. Other secondary outcomes will include delivered tidal volume, mechanical power, PaO2/FiO2 ratio, PaCO2, pH, lung dead space and patients hemodynamic (hemodynamic data on MAP and HR were averaged during the last 5 min of each hour of the 6-h period)

Participation in the Mind Your Nose Trial may be associated with gains in aspects of visual and olfactory based memory. Gains in other outcomes such as mood and psychological wellbeing are also possible. It is hypothesised that olfactory based memory training may lead to gains in both olfactory memory and visual memory. This study will contribute to the current understandings of how we might prevent and treat olfactory and cognitive difficulties in older adults. Findings may have implications for improving functional abilities of older adults, enabling them to lead fulfilling and independent lives. In a very small number of cases, it is possible that participation in the current study will identify a need to refer a participant for more a detailed neuropsychological assessment which may reveal signs of cognitive decline which could turn out to be due to a neurodegenerative condition. It is therefore possible that through participation in this study, earlier detection of cognitive changes will lead to an earlier diagnosis of relevant conditions associated with older age.

Adolescence and young adulthood (‘young people’) is a time when health-compromising (‘risk’) behaviours such as substance use emerge and sexual activity commences – 1 in 4 will have a mental health condition. The Royal Australian College of General Practitioners Guidelines recommend evidence-based health checks for young people to detect risk behaviours such as substance use, unsafe sexual practices, assess weight and diet, and identify mental health conditions early enough to reduce morbidity and prevent escalation of behaviours. GPs can intervene by counselling, STI screening, referring to dieticians, prescribing contraception and initiating mental health plans. Yet, general practice is failing young people: only 15% have an annual chlamydia test; only 6% are prescribed the most effective contraception, and; only one third of the those with a mental health condition have a mental health plan initiated. Consultation time is the key obstacle. To address this, there are calls for a Medicare rebate to fund a longer consult so that the assessment can done. However, without RCT evidence that such a rebate would be ‘value for the patient’ and ‘value for the health system’, a rebate is unlikely to be recommended. We will conduct a cluster RCT to determine whether a rebated health assessment for patients aged 14 to 24 years in general practice is cost-effective. A total of 42 clinics will participate and be randomised to receive a rebate payment the same as is available for the 45-49 year check. The primary outcome is detection of risks and health conditions because this is the first step required to get GPs to initiate an action to improve patient outcomes whether this be testing (e.g. STI screening), prescribing (e.g. contraception), managing (e.g. common mental condition), referral (e.g. mental health, dietetics) or education/counselling (e.g. alcohol).We will recruit a cohort of 1,000 16 to 24 year old patients from the clinics to collect information about the impact of the health assessment on their quality of life. This information will inform our economic modelling which will investigate the impact of rebates on downstream health outcomes.

In a recent pilot study (ACTRN: 12620000604909) evidence was promising for the feasibility, acceptability and efficacy of an online skills training for people in chronic pain (internet-delivered dialectical behavioural therapy skills training; iDBT-Pain). We now aim to further investigate the effectiveness of iDBT-Pain in a Randomised Control Trial (RCT). iDBT-Pain is an online training to teach skills for more effective emotion regulation. iDBT-Pain utilises evidence-based protocols for DBT skills training and will be administered according to the DBT Skills Training manual (Linehan, 2015). The intervention includes eight group-based sessions delivered to participants via Zoom, and access to a web app. It is hypothesised that the iDBT-Pain intervention will significantly reduce emotion dysregulation in people with chronic pain. It is further hypothesised that there may be changes in secondary outcomes related to chronic pain, including, pain intensity, pain interference, trauma, depression, anxiety, stress, sleep quality, harm avoidance, coping behaviours, and satisfaction with life.