ANZCTR search results

Coronary artery disease is a leading cause of death globally, nationally and locally. Currently in South Western Sydney Local Health District Interventional Cardiologists perform Percutaneous Coronary intervention (PCI) procedure which opens coronary arteries that are narrowed or blocked by the build-up of atherosclerotic plaque. PCI may also be used to relieve symptoms of coronary heart disease or to reduce heart damage during or after a heart attack. With new technology, engineering and training development, a technology-assisted percutaneous coronary intervention (PCI) device has the potential to increase procedural accuracy, reduce radiation exposure to patients and staff, improved ergonomics, and reduce major adverse cardiac events. To date we are not aware of any randomised controlled trial data supporting this technology

The purpose of this study is to establish preliminary clinical safety, effectiveness, and useability data for the ES360 expandable/retractable introducer sheath in transcatheter aortic valve replacement (TAVR) procedures. It is anticipated that the device will reduce major vascular injury and major bleeding events associated with transfemoral TAVR procedures. The device is also hypothesised to reduce the number of sheath insertions required during the procedure when used with TAVR delivery systems.

The current study aims to conduct a nation-wide, RCT of the efficacy of the multi-technology intervention that trains parents to be ‘ERP coaches’ for their children via four self-directed web-based modules and videoconference group sessions with a therapist (i.e., FAST-CBT: Families Accessing online Skills Training in CBT) relative to Waitlist Control (WLC) for children (4-12 years) with subclinical and clinical OCD. Primary outcomes include symptom severity, OCD-related impairment, family accommodation and cost effectiveness, assessed at post-treatment (2 month following baseline) and at the primary end point 6 months following treatment (FAST-CBT condition only). Diagnostic status over time will be examined to determine intervention effects and the prevention of clinical diagnoses (for sub-clinical children) at 6 months follow-up. Secondary aims will be to explore predictors of treatment response, including child age, OCD severity, co-morbid symptoms (internalising and externalising), and family functioning (accommodation, parental depression/ anxiety/stress, parenting practices/family functioning). Based on the primary aims, it is hypothesised that relative to WLC, FAST-CBT will: (a) be associated with significantly greater reductions in OCD severity, OCD-related impairment, and family accommodation at post-treatment and follow-up; (b) will result in significantly fewer sub-clinical children at baseline converging into clinical range at post and follow-up.

This phase 1 study is a randomized, placebo-controlled, double-blind, trial of an oral drug called NB-4746 vs. placebo in normal healthy volunteers. The study will assess the safety and tolerability in single and multiple ascending dose cohorts.

In this randomised, double-blind, placebo-controlled study, 100 adults aged 40 to 70 years with self-reported memory complaints will be randomly assigned to receive capsules containing either a Bacopa Monnieri extract (Bacumen) (150mg twice daily) or a placebo for 12 weeks. We will assess changes in cognitive performance, mood, and fatigue using self-report questionnaires. Changes in blood markers associated with neuronal activity (brain-derived neurotrophic factor and acetylcholinesterase) and free radical damage (Malondialdehyde will be assessed over time.

The purpose of this study is to determine if parkrun is an acceptable and enjoyable type of physical activity for cancer survivors or those currently with cancer. Who is it for? You may be eligible for this study if you are an adult who has survived any type of cancer, or if you are currently undergoing treatment for any type of cancer. Study Details All participants in this study will complete a 4 week review period to monitor activity levels, before registering with parkrun and being encouraged to join in their local parkrun walk event each Saturday morning, or at their own discretion depending upon their health status, for 6 months. Physical function will be measured before and after the intervention. Participants will then be asked to complete questionnaires to determine whether parkrun is an acceptable and enjoyable physical activity, and to assess impact on physical and mental health. It is hoped that the study may provide much-needed evidence that parkrun is accessible, inclusive, supportive, safe and effective, and that it can provide real benefits for patients that can be translated into clinical practice.

This trial will assess the acceptability, feasibility and potential efficacy of the SAMSON digital platform, which is designed to support patients who are taking oral cancer medications by targeting their medication adherence to the treatment and medication errors. Who is it for? You may be eligible for this study if you are aged 18 years or over and have received a confirmed diagnosis of any-stage haematological, lung or melanoma cancer, for which you are scheduled to commence oral anti-cancer treatment as part of routine care or commencing treatment/currently treated with the medication for less than 12 months. Study details Participants will be randomly assigned to either the SAMSON intervention group or a standard-of-care group over the 12-week study period. Those in the intervention group will receive access to the SAMSON apps which record medication adherence and side effects, as well as structured counselling sessions with healthcare professionals at the beginning for the study and weeks 1, 4, 8 and 12. Those in the standard-of-care group will receive usual care, including a clinician consultation, initial pharmacist consultation and be followed-up by a nurse for medication side effects. Participants will be asked to complete surveys over the course of the study. It is hoped that this research will help provide an effective way of managing medications during cancer treatment.

This study is a healthy volunteer study assessing anorectal function during defecation. The balloon expulsion study is one of the diagnostic tests used to assess dyssynergic defecation - condition where there is a poor coordination of pelvic floor muscle resulting in impaired defecation. In this study, participants will be asked to undergo anorectal ultrasound, anorectal manometry followed by rectal balloon expulsion tests in three different positions. Balloon expulsion time and the ease and comfort of balloon expulsion will be compared between different positions and environments. Result from this tests will contribute to further refining the interpretation and performing balloon expulsion test.

This study aims to determine whether Barrigel (hyaluronic acid gel) can delineate the tumour bed after breast cancer surgery Who is it for? You may be eligible to join this study if you have been diagnosed with early breast cancer and planned for wide local excision (WLE) and sentinel lymph node biopsy (SLNB) Study details All participants in this study will have both Barrigel and standard surgical clips applied following wide local incision of the breast cancer. Approximately 4-6 weeks after surgery (or after chemotherapy if needed), participants will undergo computed tomography (CT) scans and magnetic resonance imaging (MRI) scans to visualise the gel and clip placements. A group of doctors will then independently contour out where they think the tumour bed is, and the degree of overlap of each contour will help determine its efficacy. Participants will then be assessed annually for up to 2 years using routine surveillance breast mammography and ultrasound to determine gel presence and characteristics over the long-term. It is hoped that this research project will provide us more information about alternative ways to improve the accuracy of post-operative radiotherapy planning and treatment in early breast cancer, especially as MRI guided planning and treatment becomes more prevalent.

This study aims to assess the feasibility and acceptability of an integrated care model focusing on awareness, education, empowerment and behavioural change using a digital health platform for those experiencing the menopause transition. It will assess feasibility and acceptability outcomes for those allocated to one to one coaching ( + digital content), group coaching ( + digital content) or digital content alone using a mixed methods approach.