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). 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.

This study aims to determine whether delivery of bowel preparation instructions for a colonoscopy through dynamic multimedia instructions (scheduled SMS, smartphone application, video instructions, and email) has an impact on the quality of bowel preparation, diagnosis rate and colonoscopy procedure times compared to instructions that are given verbally, in hard copy or via email only. Who is it for? You may be eligible for this study if you are aged 45 years or older, you have been scheduled to attend a colonoscopy as an outpatient to screen for potential colorectal cancer and you have access to a smartphone. Study details All participants will be instructed to take either a ‘Standard Bowel Preparation’ or 'Enhanced Bowel Preparation' depending upon their bowel habits. The only difference between the groups is how the instructions for bowel preparation will be delivered. All participants who choose to enrol in this study will be randomly allocated by chance (similar to flipping a coin) to receive their bowel preparation instructions either by SMS, video and through a smartphone app, or to receive their instructions verbally, in paper/hard copy format or email only. Participants who are allocated to the SMS/smartphone group will receive 1-3 daily reminders throughout the week prior to their colonoscopy and will be asked to enter details about their preparation each day for 1 week prior to the colonoscopy. This should only take 2-5 minutes per day. Participants who are allocated to the paper/email group will receive a copy of the instructions once only and will not receive any reminders prior to their colonoscopy. All participants will be asked to complete a series of questionnaires after their colonoscopy, this is anticipated to take 10 minutes. It is hoped this research will demonstrate whether a more interactive delivery of instructions for colonoscopy has any impact upon the ability to diagnose bowel cancer and the ease of the procedure itself. If this method is successful, it may be implemented on a larger scale which could improve the diagnosis and treatment of bowel cancers.

This is a randomised double-blind, placebo controlled, ascending dose, multi-cohort trial. The study will be conducted in three parts: • Part A: A single ascending dose (SAD) part where dose levels will be evaluated in a sequential manner starting at the proposed lowest dose level in healthy volunteers. • Part B: A multiple ascending dose (MAD) part where dose levels and final numbers of subjects will be evaluated depending on SAD results in healthy volunteers. • Part C: Evaluation of a single dose in healthy male and female volunteers between 50 and 75 years of age. Part A will enrol up to 40 healthy volunteers in a total of 5 cohorts. Each cohort will enrol 8 participants with 6 participants randomised to receive GXV-001 and 2 participants randomised to receive placebo. Part B will enrol up to 48 healthy volunteers will be enrolled in a total of 3 cohorts. Each cohort will enrol a minimum of 8 and a maximum of 16 participants with up to 12 participants randomised to receive GXV-001 and 4 participants randomised to receive placebo. Part C (Elderly Cohort) will enrol approximately 8 healthy volunteers between 50 and 75 years of age (inclusive) in a single cohort, with 6 participants randomized to receive GXV-001 and 2 participants randomized to receive placebo. Up to three dose levels will be evaluated in Part B. The starting dose and number of participants enrolled in MAD cohorts for Part B will be selected following completion of Part A. The total maximum study duration for participants in Part A is 43 days (for SAD Cohorts 1, 2, 3, 4 and 5), inclusive of visit windows. For SAD Cohorts 1, 2, 3, 4 and 5, this includes a screening period of up to 28 days (Day -35 to Day -8), outpatient sleep control period (actigraphy) from Day -8 to Day -1, confinement to the clinical facility over 2 nights (Days -1 to Day 2) and one outpatient visit at the end of the study (Day 7 ±1 day). The total maximum study duration for participants in Part B is 44 days (for MAD Cohorts 6, 7 and 8), inclusive of visit windows. This includes a screening period of up to 28 days (Day -28 to Day -1), confinement to the clinical facility over 7 nights (Days 1 to Day 8) and one outpatient visit at the end of the study (Day 15 ±1 day). The total maximum study duration for participants in Part C is 36 days inclusive of visit windows. This includes a screening period of up to 28 days (Day -28 to Day -1), confinement to the clinical facility on Day 1 and one outpatient visit at the end of the study (Day 7 ±1 day).