ANZCTR search results

The VITATOPS study is an international multi-centre, randomised, double-blind, placebo-controlled, clinical trial designed primarily to examine the efficacy and safety of multi-vitamin (folate, B6, B12) therapy in the prevention of ‘stroke, myocardial infarction, or death from any vascular cause’, among patients randomised within seven months of a stroke or transient ischaemic attack (TIA) of the eye or brain. Secondary outcomes include TIA, dementia, depression unstable angina and revascularization procedures of the coronary, cerebral and peripheral circulations. It is planned that 8,000 patients will be randomised and followed up for a mean period of 2.5 years (range 1-8 years) by the end of 2009.

The ASPIRE is looking at the effectiveness and safety of giving low-dose aspirin to prevent recurrent deep vein thrombosis (DVT) or pulmonary embolism (PE) in patients with a first episode of unprovoked venous thromboembolism (VTE) who have completed initial anticoagulant treatment with heparin and warfarin. Recruitment has now closed, with 822 patients enrolled from centres in Australia, New Zealand, Singapore, India and Argentina. The ASPIRE study addresses a question of major clinical and public health importance with several million patients at risk of recurrent VTE worldwide. If aspirin is found to be beneficial, this safe, inexpensive, and practicable intervention could be very widely applied and prevent thousands of patients from experiencing recurrent venous thromboembolism each year. In Australia alone, a 30% reduction in risk of recurrent VTE could conservatively be expected to prevent 375 to 525 cases of venous thrombosis and save 56-80 lives in the first year.

This study aims to compare the effects of an in-person physiotherapist-led lifestyle-focused pain care intervention with a virtual multidisciplinary lifestyle-focused pain care intervention on pain impact in people with musculoskeletal conditions and lifestyle risks. Adults residing in rural and regional locations in New South Wales (AUS) with musculoskeletal conditions (low back, knee or hip pain) recruited from hospital outpatient services (physiotherapy, emergency or orthopaedics) or in response to social media advertisements. Eligible consenting participants will be randomised in a 1:1 ratio to receive either in-person physiotherapy lifestyle intervention or the virtual enabled multidisciplinary intervention. Randomisation will be conducted using an electronic central randomisation service to ensure concealment of treatment allocation. Participants in both arms (in-person and virtual care) will have up to 10 consultations over six months and follow similar principles based on the previous Healthy Lifestyle for Pain (HeLP) intervention, but differ in their mode of delivery and access to multidisciplinary care. Participant data will be collected at baseline and weeks 12, 26, 39 and 52. The primary outcome will be Pain Impact measured using the Patient-Reported Outcomes Measurement Information System (PROMIS-29). The secondary outcomes will include participant's health behaviors and mediating outcomes, economic outcomes, process outcomes and adverse events.

Participants with severe tricuspid regurgitation may require heart surgery to repair or replace the tricuspid valve. However, there is a high risk associated with these surgeries and it is often not feasible for elderly patients or those with other medical conditions. The goal of this clinical investigation is * To assess the safety of the investigational device "Pivot Extend" in participants aged 18 years or over with severe and clinically symptomatic Tricuspid Regurgitation (TR) deemed suitable for percutaneous valve intervention * To evaluate device success, procedural success and clinical outcomes in improving TR symptoms following implantation of the "Pivot Extend" device

The purpose of this study is to check how well LY35327021 works and how safe it is for controlling nausea and vomiting caused by chemotherapy. Participants who join this study will be in it until all parts are finished, which could take about 2 months.

This is a Phase 2, multicenter, randomized, placebo-controlled study to evaluate the safety and efficacy of infigratinib in participants \< 3 years old with ACH. The purposes of the SAD and Phase 2 portions are to identify and confirm the dose of infigratinib to be used in the Phase 2b portion, based on safety and PK. The purpose of the Phase 2b, placebo-controlled portion is to evaluate the safety and efficacy of infigratinib in children \< 3 years old with ACH at the selected dose.

A Phase 1, Open-Label Study of the Safety, Tolerability,Pharmacokinetics, Pharmacodynamics and Clinical Activity of AP601 in Patients with Solid Tumours.The study is designed to find the highest dose of AP601 that can be given safely. Participants will be assigned to one of six cohorts. Each cohort will receive a different dose of the study medication, AP601, based on the body weight. Each cohort will initially enrol 1-3 participants. If no serious side effects are seen in the first participant(s), the next cohort will receive the next dose level.