ANZCTR search results

There is some evidence that A2 beta-casein versus A1/A2 beta-casein milk has beneficial effects on immunity, inflammation, gut health, and cognition function through multiple blinded RCTs (Trivedi 2017; Jianqin 2015; Ho 2014; Deth 2015). We hypothesise that consumption of A2 milk will reduce markers of inflammation and improve gut health and cognitive performance in healthy individuals. This study will test the effect of A2-only beta-casein milk as compared to A1/A2 beta-casein containing milk in a double-blind, randomised controlled trial. Healthy young adults will be randomised to recieve either cow's milk containing only A2 beta-casein protein, or cow's milk containing both A1/A2 beta-casein for 14 days. Participants will be asked to complete questionnaires, have a blood sample collected, and provide a faecal sample at the start and end of each intervention period. Participants will also be asked to follow a standardised diet for the entire study and will have their main meals provided, including during a run-in period (14 days), during each intervention period (2 x 14 days), and washout period between interventions (14 days).

Depressive symptoms are common in young people with early or emerging psychosis (YPEEP), occurring in up to 75% of this client group. It is essential to establish safe, effective and acceptable treatments for depression in YPEEP as depression is associated with poor outcomes. Meta-analyses show that Behavioural Activation (BA) therapy is as effective in the treatment of depressive symptoms as Cognitive behavioral therapy (CBT) in the general population. "BA is a structured, brief psychotherapeutic approach that aims to: (a) increase engagement in adaptive activities (which often are those associated with the experience of pleasure or mastery), (b) decrease engagement in activities that maintain depression or increase risk for depression, and (c) solve problems that limit access to reward or that maintain or increase aversive control”(Dimidjian et al. 2011:3-4). Theoretically, BA may also help depressed YPEEP reconnect with positive experiences by using activity monitoring and goal-led activity scheduling. Importantly, BA is an intervention that can be delivered high levels of fidelity by non-specialist clinicians and requires minimal training, which would be of particular benefit in areas with a lack of psychologists, such as the NT. The project will establish the feasibility of clinician delivered BA as an adjunct to usual care for young people with early or emerging psychosis (YPEEP). This will inform the design of a subsequent full, appropriately powered randomized controlled trial.

There is some evidence that A2 beta-casein versus A1/A2 beta-casein milk has beneficial effects on immunity, inflammation, gut health, and cognition function through multiple blinded RCTs (Trivedi 2017; Jianqin 2015; Ho 2014; Deth 2015). Another component of milk, lactoferrin, is thought to have immuno-modulating properties (Kell, 2020). When consumed orally, lactoferrin is mostly absorbed, with a small amount reaching the lower bowel (Yamuchi, 2006). In humans, orally consumed bovine lactoferrin has improved systemic and gut immunity (Sachdeva, 2009; Yamuchi, 2006). We hypothesise that consumption of A2 milk, in conjunction with lactoferrin, will reduce markers of inflammation in healthy individuals. This study will test the effect of A2-only beta-casein milk fortified with bovine lactoferrin, as compared to A1/A2 beta-casein containing milk without lactoferrin fortification in a double-blind, randomised controlled trial. Healthy young adults will be randomised to recieve either cow's milk containing only A2 beta-casein protein plus lactoferrin, or cow's milk containing both A1/A2 beta-casein without lactoferrin for 14 days. Participants will be asked to complete questionnaires, have a blood sample collected, and provide a faecal sample at the start and end of each intervention period. Participants will also be asked to follow a standardised diet for the entire study and will have their main meals provided, including during a run-in period (14 days), during each intervention period (2 x 14 days), and washout period between interventions (14 days).

ConsCIOUS-3 is a single site, randomised control trial, using the trial drug dexmedetomidine or placebo given during general anaesthetic induction. The primary objective of this study is to determine whether a commonly used anaesthetic drug and sedative, dexmedetomidine, may reduce rises in the Bispectral Index. Healthy participants, aged 18-40, will be recruited from surgical lists and enrolled prior to surgery. Data collection will occur intra-operatively, post-operatively in recovery and at 24-hours and 7-days post-operation.

On March 11th, 2020, the World Health Organization declared the outbreak of SARS-CoV-2 to be a pandemic. With case numbers rising sharply, Australian state and territory governments began introducing restriction measures including limitations on social gatherings, closure of non-essential services and social distancing rules with the aim of mitigating spread of the virus. The Victorian state government imposed a less stringent set of restrictions in March 2020, followed by a period of eased restricted and then a second, harsher set of restrictions in July 2020. It has been observed that there has been a reduction in the rate of preterm birth in women exposed to restriction measures implemented to mitigate SARS-CoV-2 transmission; an effect that is more pronounced in women who have previously experienced a preterm birth. We propose a two-arm randomized controlled feasibility clinical trial to be conducted in Monash Medical Centre (Melbourne, Australia). We will study pregnant women who are enrolled in the antenatal clinics and who have previously had a preterm birth (<34 weeks). Eligible participants will be randomized into two groups: the intervention group, where participants will be required to adhere to restriction measures originally imposed to mitigate transmission of the SARS-CoV-2 virus until birth or the control group, where participants will undergo standard pregnancy care. The primary outcome of this trial will be feasibility, which will be assessed by measuring patient eligibility rate, recruitment rate, compliance rate and data completion rate. The secondary outcome measures of this trial will be the rate of preterm birth (<34 weeks), maternal quality of life and pregnancy outcomes. We will aim to recruit up to 100 pregnant women, 50 of whom will be randomized to the intervention and 50 of whom will be randomized to the control group. The aim of this study is to establish feasibility and we acknowledge that the sample size is not significant enough to prove an effect on the rate of preterm birth. This study will establish a foundation upon which to conduct a larger randomized controlled trial, investigating the effects of restriction measures on the reduction of the rate of preterm birth and therefore play a role in preventing the significant health and economic consequences of preterm birth.

The objectives of HALOS is to: 1) evaluate the impacts of treating hearing loss on health (quality of life, cognition, depression/mood, functional status etc.), relationships, education, and work/employment outcomes. 2) examine differences in patterns/trajectories of long-term outcomes within and between groups [Hearing-aid (HA) versus Cochlear implant (CI)] of hearing device users. 3) determine the impact from the timing of intervention (initiation of HA use or implant of CI) and the effectiveness of earlier intervention on outcomes 4) evaluate the cost-effectiveness of early intervention/rehabilitation for hearing loss. Adults aged 40 years and over who use either a Hearing Aid and/or Cochlear Implant will be recruited from participating hearing service providers and hearing loss support groups. Participants will complete an online survey and brief online cognitive assessment at three time-points, (1) baseline, (2) 24-month follow-up, and (3) 48-month follow up. Audiological, health, psychosocial, and functional outcomes will be measured using validated instruments. Audiometric data will be obtained from hearing service providers for participants who have provided consent. The collected data will include audiometric thresholds, information about when the participant first presented to the clinic and the type of amplification device used. Participants will also be invited to complete a semi-structured interview at baseline only which will investigate the experiences of the patient journey and the navigation of the hearing health service pathway.

The research team has designed an intervention that they have called "ACTIVE-DAY". It uses a personalised and health coaching approach. with the goal of helping older adults sit less and move more and sleep well, while in hospital for rehabilitation and in the early period following discharge home. The hypothesis is that ACTIVE-DAY will be acceptable and feasible because of its sound theoretical evidence base, personalised approach and adaptability to people with different capabilities. If ACTIVE-DAY can substantially reduce time spent in sedentary behaviours (which is inevitably replaced by time spent being physically active and/or sleeping because of the limit of each 24-hour day), we hypothesize that improvements in other clinical outcomes should follow.

The objective of this observational study is to examine whether there is a change or improvement in standardised and validated patient reported outcome measures, whilst using a standardized and pharmaceutical oral formulation of medicinal cannabis (MC) oil to treat Musculoskeletal (MSK) chronic pain over a 12-week period, or until they cease taking the medication. The study will also record any adverse outcomes that result whilst taking the medication. It is hoped conclusions will be drawn as to whether or not this particular medication warrants further and more rigorous clinical trial investigation as an interventional treatment for chronic pain, in this patient cohort.

This research seeks to conduct a pilot Randomised control trial to determine the feasibility and acceptability of two evidence-based models of individual-focused interventions aimed at improving wellbeing and decreasing burnout amongst critical care healthcare professionals. The project aims to conduct a feasibility and acceptability study of two interventions: Combined Individualized Management Plan (IMP) and Problem-Solving Peer debrief, compared to only Peer Debrief. Models of these interventions have been thoroughly investigated in an umbrella review and expert opinion and designed specifically for critical care healthcare professionals.

This study aims to investigate whether daily self-use (for one month) of four apps designed to ameliorate four of the main symptoms of PTSD (anxiety, insomnia, medically unexplained symptoms and decreased self-confidence) can facilitate reduced symptoms.