ANZCTR search results

The primary purpose of this study is to describe progression-free survival for patients with stage I-II follicular lymphoma treated with radiotherapy alone compared with radiotherapy plus immunotherapy. Who is it for? The registry will collect information on patients with stage I-II low grade follicular lymphoma treated with curative intent radiotherapy after staging, who received either no additional therapy or systemic therapy containing immunotherapy as part of planned combined modality therapy. Study details: Eligible patients will be identified using local patient databases, and local medical records will be reviewed. Information on demographics, staging procedures (bone marrow, CT, PET imaging), disease characteristics including WHO tumour grade (1-3b) and extranodal site, radiation treatment delivered (RT dose and method, e.g. IFRT, Involved Site RT(ISRT)), systemic therapy delivered (immunotherapy details if given and other systemic therapies if given) and follow-up information will be collected and contained within a RedCap database. It is anticipated that in coming years, new cohorts of patients with stage I-II follicular lymphoma treated with immunotherapy will become available for inclusion and that outcomes for existing cohorts will be updated. For this reason, a registry will be established, both to enable research to be conducted on retrospectively acquired data from cohorts of patients already documented and to enable updated outcome data to be uploaded for these existing cohorts. The registry will also accommodate new patient cohorts as they become available as immunotherapy becomes more widely used. Hence the registry will ultimately include a combination of retrospective and prospective elements. The registry's utilization can contribute to demonstrating the efficacy of systemic therapy in reducing the risk of death or progression and informing therapeutic decisions to enhance health outcomes in managing follicular lymphoma, where immunotherapy's historical underutilization in stage I-II FL has resulted in a lack of notable improvement in overall survival.

Children commonly display restless and irritable behaviours (known as emergence delirium (ED)) when awakening from general anaesthesia. Usually this is a short-lived and self-limiting problem however it can cause harm if wounds are disrupted, or intravenous lines are dislodged. Additionally, it can be distressing for parents and carers. Ways of reducing the risk of ED have been investigated but none has been shown to reliably prevent it from occurring. Some risk factors are known (for example, younger age, male sex, particular types of anaesthesia and surgery). The microbiome offers a potential insight into various psychological and behavioural conditions, and we wonder whether this might also be the case for ED. If particular microbiome profiles can be associated with different risk profiles and identified in advance of exposure to general anaesthesia, then perioperative management may be altered to reduce the risk of ED.

The aim of this pilot study is to obtain data regarding the safety and tolerability of tirzepatide 15mg subcutaneous injection weekly for the treatment of obesity in adults with ESKD. Adults on haemodialysis with a BMI of 30kg/m2 or above who are potential candidates for kidney transplant will be recruited. All participants will receive tirzepatide once weekly, starting at a dose of 2.5mg and increasing every 4 weeks to a maximum dose of 15mg. Participants will receive tirzepatide treatment for a total of 24 weeks.

Study details This registration is for Step 1 of a 2 step study investigating CNT201. CNT201 is a recombinant collagenase product being developed by the Sponsor, which is being studied for the treatment of Dupuytren’s Contracture (DC) This is an adaptive clinical study design containing 2 steps (Dose escalation and Dose expansion). Step 1 (dose escalation) uses an open-label design. Participants will be enrolled to a dose cohort with the CNT201 dose to be administered determined by the cohort to which the participant is enrolled; Afte a screening period of upto 30 days, eligible participants will be enrolled into 1 of 4 cohorts (provisional 5th cohort) and will be administered a single dose of CNT201 at 1 of 4 CNT201 dose levels: First-, low-, intermediate-, or high-dose (Cohort 1 to Cohort 4, respectively) within a treatment cycle. The treatment period will consist of an intralesional injection of CNT201 (Day 1), followed by a series of safety, efficacy, PK, and immunogenicity evaluations for 28 days (until Day 29) with primary efficacy assessed on Day 29 with an additional 28 days of safety follow-up thereafter (until Day 57). If there are no safety concerns on Day 57 as assessed by the investigator, Day 57 will serve as the End-of-Study (EOS) visit for Step 1. Cohort 1 will enroll 4 participants; all other cohorts will enroll 8 participants.

Disorders of Brain Gut Interaction (DGBIs) are extremely common affecting up to onein three Australians. These conditions are chronic, resulting in reduced quality of life for patients and are responsible for substantial health care utilisation. This is largely due to the fact that routinely available treatments do not provide the required symptom relief and long-term improvement of quality of life. In recent times, small intestinal dysbiosis has been identified as a potential cause for DGBI. Small intestinal bacterial dysbiosis refers to an expansion of unfavorable or harmful bacteria in the small intestinal tract. While antibiotics such as rifaximin are proven to improve symptoms in patients with DGBI, there are concerns in relation to antibiotic resistance and antibiotics are not suitable for long term treatment. Previous data suggest that simethicone can be beneficial in DGBI patients and our recent in-vitro data reveal a suppression of growth of bacteria obtained from the small intestine. Thus, we aim to conduct a randomised placebo-controlled trial to test the readily available (over the counter) treatment Simethicone as a means to target the imbalance of bacteria lining the small intestine in patients with DGBI.

ENVISAGE-Families ( ENabling VISions And Growing Expectations) comprises five weekly online workshops for caregivers of children with a neurodevelopmental disability. Workshops provide caregivers with early exposure to current thinking and best practices around childhood disability and encourage information-sharing and connections among families and service providers. Our aim is to compare the effects of ENVISAGE-Families on family empowerment compared to ‘service as usual’ experienced by a waitlist control group at 6 weeks and 18 weeks post randomisation. Our secondary objectives are to: (i) examine the effects of ENVISAGE-Families on caregivers’ self-reported measures of parenting confidence, family functioning, caregiver health, caregiver wellbeing, psychological functioning, and child’s quality of life at 6 weeks and 18 weeks post randomisation; and (ii) determine if primary and secondary effects of ENVISAGE-Families are maintained at 17-18 weeks post-randomisation. Qualitatively, we seek to understand the impact of ENVISAGE-Families on: (i) how participants describe their child and family; and (ii) how this program might be relevant to them and impact their experiences of parenting a child with a disability.

Sleep disturbance is common in both community and hospital settings, affecting adverse health outcomes such as delirium. Despite this, consideration of inpatients’ sleep quality is not universally integrated in patient treatment in most hospitals. Research aiming to improve sleep for hospitalised patients has largely focused on environmental behaviour changes rather than implementing sleep assessment and guidelines. By implementing sleep quality assessment (asking patients how they slept), the impact of interventions to improve sleep can be more accurately determined. A numerical sleep self-assessment incorporated in the electronic medical record and a comprehensive sleep guideline (e.g., creation of a nocturnal environment conducive to sleep; reducing nocturnal sleep medication prescribing; and empowering patients to practice sleep hygiene) will be implemented. Implementation will be maximised by using effective methods for changing practice. Evaluation will include patient sleep quality, prevalence of delirium, and prescriptions for sleep medications in six months before and after implementation.

The EMBO-02 study is a first-in-human study for treatment of chronic subdural hematomas, which is a collection of blood and blood breakdown products, like a blood clot. A hematoma that is subdural is located between the surface of the brain and its outermost covering (the dura). A subdural hematoma develops when tiny blood vessels that run between the dura and surface of the brain tear and begin to leak. Participants in this study may benefit from “embolisation” to stop the blood vessels from leaking. This research study is testing a new investigational device that is an embolic agent called the NeoCast Embolic System (“NeoCast”).

Our research will evaluate the feasibility of the delivery and evaluation of a program aimed at reducing falls in older people from culturally and linguistically diverse communities (Arabic speaking, Chinese and Italian). The program that is being evaluated (MOVE Together: Reduce falls) has been designed with people from CALD communities, clinicians and researchers to optimise its potential for success. Participants who take part in the research will be older people from Arabic speaking, Chinese and Italian communities. Those in the intervention arm will receive the MOVE Together Program. The aim of the program is to support participants to achieve 3 hours of exercise per week, including exercises that challenge balance and strength through movements that are used in everyday activities (e.g. as standing up). The program includes behavior change strategies (e.g. goal setting and review, education, modelling of the behaviour, instruction, and social support) to support long term engagement. The individualized program is delivered by a physiotherapist over 10- 12 sessions. Each session will run for 30-45min in participants’ homes, either in-person via a home visit or via telehealth (video or phone call), a centre based option is also available if participants prefer to undertake their physiotherapy sessions there.

No evidence exists on whether different tackle techniques could reduce injury risk such as concussion, breast or shoulder injuries. Our tackle behaviour re-education intervention is empirically-based on our pilot research (Edwards et al., 2021) and the theoretical framework of the Behaviour Change Wheel (D’Lima et al., 2020) to maximise the intervention’s efficacy (Sullivan et al., 2021). Our success to change in-game tackle behaviour will be assessed using industry standard best practice of qualitative video analysis to measure in-game tackle technique proficiency (Aim 1). We will then use gold standard 3D motion analysis to accurately measure tackle-induced forces and 3D tackle technique in the laboratory across a season (Aim 2). This will provide critical mechanistic understanding of how tackle technique influences these impulse forces to the head (i.e. inertial head kinematics), as there is limited 3D tackle motion studies. By using these technologies, we can establish if impulsive forces delivered to the head during a tackle (i.e., concussion risk exposure) can be reduced by re-training in-game and laboratory tackle behaviour. We will focus on Indigenous players, given no published injury research has taken an Indigenous athlete-centred approach despite the higher proportion of National Rugby League (NRL) players identifying as Indigenous/Pasifika (57% vs 3% general population) (League, 2017). We will employ a blended Indigenous pedagogy approach with Western ways of teaching and learning (Yunkaporta, 2009) and will be taught by an Indigenous expert rugby codes coach. The outcomes from this research will enable the translation of our empirically validated results into policy and practice in new coaching manuals on how to teach players to change their tackle behaviour that minimise their head impact exposure and injuries (including breast injuries).