ANZCTR search results

Low muscle mass (sarcopenia) is emerging as a significant risk factor for non-alcoholic fatty liver disease (NAFLD) and there is evidence to suggest this risk may be even higher in those with obesity. While weight loss, through hypocaloric diets and aerobic exercise is currently the mainstay of NAFLD prevention and management a concurrent loss of muscle (lean) mass often occurs with this approach. Studies conducted in non-NAFLD participants have indicated weight loss in conjunction with a higher protein intake and/or progressive resistance training (PRT) may improve or attenuate the associated loss of muscle (lean) mass during weight loss interventions. Yet, no study to date has assessed the feasibility of a higher protein intake from predominately plant-based sources in conjunction with exercise incorporating AT plus PRT in a NAFLD cohort. Uptake and adherence to community and clinic-based exercise programs is typically poor. Telehealth has emerged as an encouraging intervention delivery method to expand participant reach and accessibility by shifting treatment from clinics and hospitals to patients’ homes for people with chronic disease such as NAFLD and T2D. For example, telehealth facilitates contact to and overcomes several barriers to traditional exercise and nutrition interventions, including access to evidence-based programs anytime and anywhere, cost, transport and issues related to geographical location. Furthermore, telehealth allows regular follow-ups with healthcare professionals and can be individualised according to each patient’s needs. However, few lifestyle focused telehealth programs have been conducted in NAFLD cohorts, and before they can be widely implemented further research is required required to assess the feasibility, adherence, and effectiveness of telehealth as a model of healthcare delivery for people with NAFLD . Therefore the aim of this 12-week randomsied controlled trial is to evaluate whether a telehealth intervention focused on increasing daily protein intake (predominately from plant-based sources) combined with a smart device exercise app to promote regular muscle strengthening exercise is safe and feasible for middle aged and older adults with NAFLD. Secondly, whether the above mentioned telehealth lifestyle intervention can improve lifestyle behaviours related to overall physical activity and diet quality and functional muscle strength.

This study aims to develop, implement and pilot a parent-based intervention called Parents in Play (PiP) for enhancing pre-school children’s self-regulation. PiP is designed to support parent-child play to foster children’s self-regulation. This randomised control trial (RCT) pilot evaluation seeks to investigate the effects of PiP on parents’ autonomy supportive guiding behaviours, as well as on children’s self-regulation during everyday play activities.

This is a single arm prospective trial that will evaluate the ability of a novel imaging agent (68Ga-NTA-14) to detect metastatic castration resistant prostate cancer cells within the prostate and other tissues. Who is it for? You may be eligible for this study if you are a male aged 18 years or older and you have been diagnosed with prostate cancer that is metastatic and castration resistant (has not responded to surgical removal). Study details Participants who choose to enrol in this study will receive a single administration of 68Ga-NTA-14 (into a vein) 1 hour prior to Positron Emission Tomography (PET)/Computed Tomography (CT) imaging on Day 1. Between Day 3-8, a single administration of 68Ga-PSMA I&T will be administered (into a vein) 1 hour prior to PET imaging. PET/CT scans will be performed at 1 hour and 3 hours after administration of NTA-14 imaging agent and 1 hour after 68Ga-PSMA imaging agent. Participants will undergo safety monitoring which will include assessment of any side effects at 4 hours after administration of 68Ga-NTA-14. Participation will require up to 8 days including screening (Day -30 to 0), imaging with 68Ga-NTA-14 (Day 1), and imaging with 68Ga-PSMA I&T (Day 3-8). Participants will be followed up 1 hr post 68Ga-NTA-14 administration for evaluation of side effects. It is hoped this research will demonstrate that 68Ga-NTA-14 can be administered to patients without serious side effects, and that the images produced by this agent will be similar to or of better able to detect metastatic castration resistant prostate cancer cells compared to 68Ga-PSMA I&T images.

Acute-on-chronic-liver failure has a rising global healthcare burden with both 28-day mortality and 30-day readmission rates greater than 30%. Compared to other chronic conditions, those with ACLF have reduced access to coordinated ambulatory care. LivR Well is a multidisciplinary, home-based liver optimisation program implemented in the first 28 days after an ACLF admission. Components will include pharmacy, dietetics, physiotherapy, neuropsychiatry and social work in addition to medical and nursing input. This randomised controlled trial aims to demonstrate an improvement in mortality and readmission through early intervention in this cohort.

This is first in human, study of Clofazimine (CFZ) inhalation suspension (MNKD-101) in healthy adult participants The study is comprised of two parts (Part A and Part B) to investigate the safety, tolerability, and pharmacokinetic of MNKD-101 Part A (Single Ascending Dose): There are total 3 cohorts in Part A of the study and each cohort will enroll approximately 8 participants Part B (Multiple Ascending Dose): There are total 2 cohorts in Part B of the study and each cohort will enroll approximately 8 participants Oversight of the study will be provided by a Safety Monitoring Committee (SMC) comprising the Investigator, the local Medical Monitor (MM), and the Sponsor’s Chief Scientific Officer (CSO). The total duration of participation in the study for each participant in Part A is up to 43 days, and up to 57 days for Part B, both inclusive of a Screening period of up to 28 days.

Anxiety and depressive disorders are amongst the most prevalent psychological disorders worldwide. Young people are at the highest risk of developing depression and anxiety as adolescence is a key developmental stage in which these disorders tend to emerge. Psychological intervention is the leading approach to treatment, however the efficacy of available approaches is limited and the right support is not available when and where it is needed most. Improving the efficacy of treatment might be achieved by providing access to digital interventions via smartphones which can provide support at key moments in daily life. Based on the above rationale, a novel smartphone intervention was developed called Mello. Mello is the world’s first smartphone intervention providing targeted, personalised support for young people with depression and anxiety in daily life. The primary aim of this pilot RCT is to evaluate the feasibility and acceptability of Mello in a community sample of young people who experience depression and/or anxiety, with secondary aims examining whether using the app leads to improvements in mental health symptoms.

Whilst high-grade atrioventricular block (HGAVB) occurs in a significant proportion of patients after transcatheter aortic valve implantation (TAVI), there are currently no sensitive and specific methods for predicting this adverse outcome. This study aims to determine the utility of both novel and previously published electrophysiological predictors of HGAVB including rapid right atrial pacing and HV interval testing before and after TAVI. This study will use implantable loop recorders to detect delayed HGAVB after TAVI.

The Enhance study is a randomised placebo-controlled double-blind proof of concept clinical trial to analyse whether using a daily supplement can improve egg quality. Women between the age of 36 and 42 requiring IVF trying to conceive will be randomised for the use of NR at the dosage of 250mg, 1000mg, or placebo, once a day for six weeks before the trigger (36 hours before the egg collection) in an IVF cycle. A primary outcome will be analysing the number of day 5 blastocysts and secondary outcomes: number of oocytes retrieved, final estradiol level, fertilisation rates, number of embryos surviving to D3, pregnancy rates and outcomes, and NR safety. We will also be evaluating the bioavailability of NAD in blood and follicular fluid and oocyte quality.

Rapid Syllable Transition Treatment (ReST; McCabe et al., 2017) is a motor speech intervention that aims to improve speech intelligibility. It involves the use of non-words to practice and improve the ability to say syllables and words fluently using the right sounds and beats. ReST uses principle of motor learning which have been shown to promote motor skill acquisition in motor speech interventions (Maas et al., 2005). This study aims to investigate if ReST improves speech intelligibility and the child’s ability to take part in daily conversations, referred to as communication participation. The hypothesis is that ReST will improve speech intelligibility and communication participation in children with cerebral palsy more than usual care.

The purpose of this study is to examine implementation of a tool for addressing fear of cancer recurrence (FCR) in oncologists who treat patients with early breast cancer. Who is it for? You may be eligible for this study if you are a currently practicing Medical oncologist, Radiation oncologist, or senior trainee with greater than 6 months training in clinical oncology, who treats women with early stage breast cancer. Study details All participants will be given access to online CIFeR training hosted on the Thinkific platform, featuring didactic material on the prevalence, severity, clinical features and outcomes of FCR, description of the CIFeR (the Clinician Intervention to Reduce Fear of Recurrence (CIFeR) intervention) intervention and evidence supporting its efficacy captured in short videos of the study team, and videos of clinicians and patients modelling intervention delivery. After they have completed the training, they will be asked to complete a post-training measure of self-efficacy to manage FCR. They will then be asked to use CIFeR with suitable patients for the next 6 months. Participants will complete a number of questionnaires at 3 and 6 months post-completion of the training, in order to assess clinician-rated adoption, acceptability, appropriateness, feasibility, fidelity, and self-efficacy. Barriers and facilitators to implementation of the tool will be assessed through semi-structured interviews. Cost of administering the tool and penetration of the intervention will also be determined. It is hoped that this research will demonstrate that the CIFeR tool is easily adopted and considered acceptable by clinicians for use in their treatment of patients with early breast cancer who have a fear of cancer recurrence.