ANZCTR search results

OV350 is a brain penetrant, small molecule activator of the neuron-specific K+-Cl- co-transporter 2 (KCC2). KCC2 plays a critical role in maintaining chloride homeostasis in neurons through extrusion of chloride ions, thus ensuring the inhibitory function of GABAergic neurotransmission. Dysregulation of KCC2 can lead to an imbalance in excitatory and inhibitory signalling, contributing to disinhibition of neural circuits and downstream neuroinflammation. By directly activating KCC2, OV350 has the potential to restore abnormal neuronal excitatory/inhibitory balance notable in disease states, including psychosis of Neuronal a-Synuclein Disease (NSD). Part A will consist of approximately 5 cohorts, comprising 8 participants each. Dosing will be initiated at 50 mg/day. Subsequent cohorts will be dosed as recommended after the safety, tolerability and PK of IV OV350 from the previous cohort has been assessed. Doses will not increase more than 2x the previous dose tested. It is anticipated that Part B will consist of 4 planned cohorts comprising 8 participants each, using different doses of OV350.Dose levels for Part B (including starting dose) will be determined based on the overall safety and tolerability profile, PK data, and potentially EEG of OV350 after single ascending bolus dose(s). It is anticipated that the starting dose in MAD will be the second SAD dose but will be confirmed once the initial 2 SAD cohort data have been reviewed by the study sponsor, study PI, medical monitor, and pharmacokineticist. Participants will be dosed for a total of 7 days.

This is an observational study to identify MND incidents over a 3-year period in NSW. A telehealth consultation between the participant, their GP and a neurologist is set up for the neurologist to identify patients with MND. MND cases captured will be used to calculate the incidence and prevalence of MND in NSW.

The prospective portion of this study will evaluate this deep learning AI system for opportunistic detection of osteoporosis on chest radiographs in a community setting. This study will recruit participants 50 years of age or over, who have undergone a chest x-ray in the preceding 6 weeks. Osteoporosis affects one million Australians and is associated with an increased risk of minimal trauma (“fragility”) fractures. There are effective medications for treating osteoporosis, and timely intervention can reduce the risk of future fractures by up to 70% and mortality by 11%. However, a significant treatment gap in osteoporosis exists, and the majority of patients that present to hospital with a minimal trauma fracture are neither assessed nor appropriately managed for osteoporosis. The gold-standard for diagnosing osteoporosis is by measuring bone mineral density (BMD) using dual energy X-ray absorptiometry (DEXA) or bone densitometry. Access to DEXA scanners depends on the limited availability of equipment and Medicare rebate restrictions. Therefore, opportunistic screening for osteoporosis using Artificial Intelligence (AI) technology represents an approach for identifying patients at higher risk of osteoporosis and more likely to benefit from having a DEXA BMD study. The retrospective portion of this study will continue the development of AI technology for analysing chest X-rays to estimate BMD. The prospective portion of this study will evaluate this deep learning AI system for opportunistic detection of osteoporosis on chest radiographs in a community setting. This study will recruit participants 50 years of age or over, who have undergone a chest x-ray in the preceding 6 weeks.

This study aims to test the benefit of an online tinnitus management program. In this research, adults living with bothersome tinnitus will complete a set of questionnaires measuring tinnitus severity and wellbeing. We will use randomisation to decide who joins the program right away and who waits. By comparing those who start the program immediately with those who wait, we can accurately see if the program really works and how it might help people. Participants in both groups complete follow-up questionnaires at six weeks and three months to what changes occur. It is expected that participants who receive the program in this time will have reduced tinnitus distress following intervention, compared to the control group.

Telehealth has become part of routine pregnancy care largely due to circumstance – the onset of the COVID-19 pandemic, and the associated public health advice,1 led most maternity providers in Victoria and elsewhere to commence providing some pregnancy care as telephone and/or video health. Emerging evidence of safety is conflicting regarding clinical outcomes, and there is a lack of prospectively collected evidence of the benefit or potential harms associated with telehealth for routine pregnancy care. This study aims to carefully evaluate the use of telehealth for routine pregnancy care in a randomised controlled trial (RCT) and test the safety and efficacy, the cost implications, and explore women’s experiences. This RCT will test whether the practice of offering a minimum of one up to a maximum of five routine pregnancy care visits via video-based telehealth is no less safe (i.e., the outcomes are not worse) than the pre-pandemic ‘usual’ pregnancy care, which was all face-to-face, and to find out if having access to some telehealth in pregnancy improves women’s experiences and access to care.

Currently, Prolonged Exposure (PE) therapy is considered the gold-standard treatment for PTSD. Emerging evidence suggests that the Unified Protocol (UP) may offer an alternative treatment option. Research indicates that UP may work in a slightly different way than PE, prompting further exploration into which factors influence treatment outcomes. In this trial, participants will complete assessments to gather a holistic picture of their symptoms and PTSD presentation, after which they will be randomly allocated to either the Unified Protocol (UP) or Prolonged Exposure (PE) therapy which are delivered in a massed format. Ultimately, the goal of this research is to improve the matching of individuals to the PTSD treatment that will be most effective for them based on the factors uncovered in the assessments.

This observational study aims to investigate the influence of FUT2 secretor status on the genitourinary and gut microbiota, as well as on the incidence of genitourinary infections. The hypotheses tested are: 1) whether genitourinary and gut microbiota differs between secretors and non-secretors, and 2) whether FUT2 secretor status or specific microbial profiles are associated with genitourinary infections. The study will also examine the effects of lifestyle and behavioural exposures on the vaginal microbiota. The study findings will improve our understanding on the biological and external factors that shape the microbial communities in the genitourinary tract and gut, as well as the bacterial interactions associated with the development of genitourinary infections.

Paramedics are routinely exposed to traumatic and high stress situations, making them particularly vulnerable to mental health challenges, reduced job satisfaction, burnout and potential additional time off work. Brain imaging research now shows that excess empathy (“feeling with”) someone who is distressed or in pain can turn into “empathic distress” (personal distress). Whereas compassion (focusing on how to alleviate the other’s suffering) protects against empathic distress and is associated with feelings of warmth, concern, reward and affiliation. Compassion improves the wellbeing and resilience of the giver. Compassion training involves practices designed to transform empathy into compassion, strengthen compassion, emotional regulation, resilience and protect against burnout. This trial will test whether compassion training can improve compassion, resilience, overall mental health and reduce burnout for Ambulance Victoria paramedics.

This study will investigate a new technique, immediate lymphaticovenous anastomosis (ILA), to preserve lymphatic drainage and prevent the development of breast cancer–related lymphedema. Who is it for? You may be eligible for this study if you are a female diagnosed with breast cancer and require axillary lymph node dissection (ALND). Study details During ALND, a fluorescent dye will be used to map the lymphatic vessels, which will then be joined to adjacent veins under high magnification using supermicrosurgical techniques. Follow-up data on the incidence of post-operative breast cancer–related lymphedema and any other surgical complications will be collected up to 12 months post-operatively. It is hoped that findings from this study will help identify new methods to manage the incidence of breast cancer–related lymphedema in those undergoing axillary lymph node dissection.

Substance use significantly contributes to disease burden among Australians, with harms exacerbated among Aboriginal and Torres Strait Islander peoples by colonisation-related factors like stigma and trauma. Addressing this gap requires culturally acceptable, valid and reliable screening tools, available in a familiar language to the participant, to identify and provide support for those at-risk. This study aims to assess the validity, reliability and clinical utility of a culturally-adapted digital screening tool — the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) — translated into Pitjantjatjara, to detect risk of substance-related harm among Aboriginal Australians.