ANZCTR search results

The purpose of this study was to design and trial a group, the Carers Count group, involving the stroke survivor and their carers on a stroke rehabilitation ward which aimed to promote inclusion of carers in rehabilitation and increase therapy dose. Our study aims were to (1) evaluate the implementation of an exercise group for stroke survivors and their carers on a stroke rehabilitation ward and (2) to understand the experiences of stroke survivors and their carers in participating in the group.

This is a multicentre, placebo controlled, randomized, double blind, adaptive study to evaluate the reduction in infection incidence and severity of SARS-CoV-2/ COVID-19 infection among high-risk participants by enhanced trained immune response through VPM1002 vaccine. Participants who fulfil the criteria for high-risk of COVID-19 infection will be enrolled. The Investigator/site staff at each site will inform the healthcare workers (HCWs) about the clinical trial while other high-risk participants will be recruited through referral via COVID-19 clinics or within medical centres/aged care facilities. Follow-up information must be entered by the participants regularly via a study specific mobile App using a phone/tablet/laptop. Participants will receive reminders to enter the data, including temperature reading to indicate the occurrence of fever. During the follow-up, if any participant experiences fever AND cough and/or shortness of breath, all attempts should be made to obtain a throat (nasopharyngeal and/or oropharyngeal) swab or any appropriate sample as directed by the treating physician. Participants can consult/visit the study site anytime during the study for emergencies or any safety concerns. Interim analyses are planned at 2-monthly intervals during the study to assess the efficacy and futility based on which the study will be stopped. An independent Data and Safety Monitoring Board (DSMB) will be appointed to review the safety and primary endpoint data for efficacy/futility. Safety data pertaining to incidences of SARS-CoV-2/COVID-19 infections, hospitalizations, ICU admissions and deaths and interim analysis data will be provided to the DSMB who will provide their observations to the sponsor with recommendations as to whether there are safety concerns and whether the study should continue without change, be modified, or terminated.

The Iron Infusion in Haemodialysis Study – Intravenous iron polymaltose versus no iron in maintenance haemodialysis (MHD): a prospective open-label blinded endpoint randomised controlled trial – will assess the safety and effectiveness of intravenous iron treatment among Indigenous MHD patients with anaemia, high ferritin and low transferrin saturation. All patients 18 years or older on MHD for greater than or equal to 3 months will be eligible for screening and recruitment. We will randomise 576 patients across the Northern Territoy to achieve study power of greater than 80% in detecting a 30% reduction in time to the first of hospitalisation with infection or death. Secondary outcomes will be all serious adverse events, hospital admissions, infection rates, differences in haemoglobin levels over 6 to 12 months, and death. A cost analysis will be performed looking at the costs of treatment, hospital admissions and procedures between the intervention arm versus the control.

Stroke is a leading cause of cardiovascular-related morbidity and mortality in Australia, with approximately one third of strokes being cryptogenic, meaning that they are of undetermined cause. The majority of these are due to embolic stroke of undetermined source (ESUS). Unfortunately, little is known about the underlying causes of ESUS and effective strategies for primary and secondary prevention of recurrent stroke in this population. The purpose of this trial is to determine whether aggressive risk factor modification compared to usual care in patients with embolic stroke can significantly reduce the occurrence of major cardiovascular events. Risk factors including, obesity, hypertension, dyslipidemia, glucose intolerance or diabetes, obstructive sleep apnoea, physical inactivity, alcohol excess and tobacco use will be systematically targeted.

Depression is the single major unmet need in bipolar disorder and current therapies are more efficacious in mania than depression. Key biological factors in the pathophysiology of bipolar disorder may be targeted by the AT1R antagonist, candesartan. Candesartan reduces stress reactivity, impacts the HPA axis, oxidative and inflammatory stress and enhances neurogenesis; all documented pathological markers. The CADET-BD study will test the efficacy of candesartan 16 mg/day as an adjunctive treatment for bipolar depression. CADET-BD is a multi-site, double-blind, randomised, placebo-controlled 16-week trial of candesartan as an add-on to treatment as usual. We plan to recruit 240 participants aged 18 years and above with moderate to severe bipolar depressive disorder.

Study purpose: The purpose of this study is to evaluate the failure rate of this N95 FFP in a group of anaesthetists and anaesthesia nurses. At Austin Health, it is standard practice for the anaesthetist and anaesthesia nurse who are performing tracheal intubation on COVID19 patients to wear a N95 filtering facepiece (FFP). This protects the anaesthetist and nurse from small aerosolized particles and large droplets. To work effectively a N95 FFP must create a tight seal with the user’s face. However due to different facial characteristics, a tight seal may not be achieved with the brand of N95 FFP(BSN Medical Australia ProShield® N95 Medium and Small) that Austin Health is mandating. Fit testing is a rigorous process to ensure that the N95 FFP being used has the ability to form a tight seal. This process is mandatory in the USA and UK and is a requirement specified in Australian Standard AS/NZS 1715-2009. The fit testing method complies with the published protocol of OSHA (Occupational Safety and Health Administration, USA). Who is it for? This research involves fit testing for anaesthetists and anaesthesia nurses who are directly involved in performing tracheal intubation on COVID19 patients. This is a small team of highly trained and skilled medical personnel, who are charged with providing this specialised clinical service for all patients at Austin Health who require tracheal intubation. Study details: At a convenient time that does not impact on clinical care commitments; the participant will attend the department for fit testing. As per standard Austin Health guidelines for PPE training, all participants will have already undergone extensive training and education in donning the N95 FFP. Using the BSN Medical ProShield®N95 FFP size that has been assigned to the participant, a fit test will be performed using internationally accepted fit testing protocol. The fit test will be conducted using the TSI Portacount 8038/8048 machine. Participants who do not pass the fit test will be re-educated on how to put on the FFP using the ‘real time’ mode on the TSI Portacount machine. This will allow the user to see how different adjustments to the N95 FFP can affect the seal in real time. The participants who do not pass fit testing will be offered a different sized BSN Medical ProShield®N95 FFP and retested. ' If the participant is unable to be fitted with either of the BSN Medical ProShield®N95 FFP, an alternative FFP or elastometric respirator will be provided. The testing will be conducted in the Department of Anaesthesia. The duration of tetsing will be approximately 15 minutes.

This is a Phase Ib study to investigate the safety, tolerability, efficacy and PK of ZL-1102 in subjects with mild-to-moderate chronic plaque psoriasis (CPP). The study consists of 2 Parts: Part A Part A is open-label. After a 30-day screening period, six (6) subjects with CPP will receive a single topical treatment with ZL-1102 to a suitable psoriatic plaque followed by a 1-week observation period for safety/tolerability. Part B Part B is a double-blind, two-arm comparison of ZL-1102 Gel vs. Vehicle (placebo only). Approximately 44 subjects with CPP will be randomized in a 1:1 ratio to receive study medication of ZL-1102 Gel or Vehicle.

Foot ulcers are a common consequence of diabetes due to the development of peripheral neuropathy, peripheral vascular disease, limited joint mobility and foot deformity. Nearly 34% of persons with diabetes will develop a foot ulcer in their lifetime. This can lead to infection and amputation. Diabetes is the main reason for non-traumatic amputation. Reducing plantar pressures is considered a key factor for wound healing and prevention of ulcer recurrence. Footwear and insoles are an important treatment modality for off-loading these pressures. There is no existing, evidence-based recommendation for overall footwear design with all technical specifications to off-load the neuropathic diabetic foot. Hence this study will explore the design and modification features of footwear and insole that can reduce risk of neuropathic plantar forefoot ulceration in people with diabetes.

Within Sydney Local Health District (SLHD), stable patients with mild COVID-19 symptoms are being isolated at home or Special Health Accommodation (health hotels) and managed by the Royal Prince Alfred Virtual Hospital. In addition, people without COVID-19 requiring isolation, are being accommodated in health hotels under the care of SLHD staff and services. Both groups experience significant loss of normal routines, lack of exercise, heightened anxiety and reduced opportunities to eat their usual diet. The aim of this study is to evaluate the effects of a Health Package of exercise, anxiety management and nutritional advice on the physical and mental health of those isolated and whether such an intervention can enhance their experience of care. We hypothesise that the Health Package will benefit the participants in terms of physical and mental health and will enhance their experience of care during isolation.

This is a multi-center, randomized, double-blind, placebo controlled study designed to assess the efficacy, safety and tolerability of HXP124 when administered topically to the great toenail of otherwise healthy participants with mild to moderate Onychomycosis. All participants will be instructed to apply HXP124 topical solution or vehicle to one target great toenail and any other infected toenails, following bathing and towel drying. Up to 132 eligible adult participants will be enrolled to one of three dosing cohorts and will be randomly assigned to receive treatment with either HXP124 topical solution or vehicle (at 3:1