ANZCTR search results

This research project is being conducted to look at evaluate the Pharmacokinetics (PK) and Safety of Two Formulations of a 7-Day Application of Memantine Transdermal Delivery System (TDS) Compared to Oral Administration of NAMENDA XR and to assess TDS adhesion in Healthy 50-80 year old Volunteers

This research project is being conducted to look at the Pharmacokinetics (PK, how the human body processes a substance), Pharmacodynamics (PD, how body systems are affected by a substance), and Safety of up to Four Formulations of a 7-Day Application of Donepezil Transdermal Delivery System (TDS, a patch) in Healthy Female Volunteers. It is anticipated that Donepezil TDS could be a treatment for Alzheimer's Disease.

Changing the scheduling of existing programs in childcare centres may represent an effective strategy which is suitable to ‘scale-up’ for population-wide implementation. Unstructured outdoor free play (as opposed to structured, staff-guided play) has been consistently associated with greater child physical activity. The study hypothesise when compared to children attending control services, where outdoor play is scheduled within a single continuous period, children attending intervention services will spend an additional 10 minutes in moderate-to-vigorous physical activity per day at childcare. An increase of 10 minutes of moderate-to-vigorous physical activity in preschool-aged children has been found to have clinically important effects on fat mass and peak bone mass.

This RCT will evaluate the acceptability and efficacy of a multi-day online ABM program targeting insomnia symptoms by comparing an active ABM intervention with a control ABM task. It will also examine whether improvements in insomnia lead to reduction in comorbid anxiety/depression symptoms and appraise the longer-term therapeutic effects of ABM on insomnia and comorbid anxiety/depression.

Humeral neck fractures account for 5% of fractures of the appendicular skeleton and are the 3rd commonest osteoporotic fracture occurring with an incidence of 6.6 per 1000 person year. There is a unipolar age distribution with most occurring in the elderly independent population with osteoporosis who fall from a standing height. This incidence is set to increase in the next 20 years as a result of population growth. 49-85% of proximal humeral fractures are minimally displaced and are usually treated non-operatively with most having good outcome regardless of comminution. The poorer outcomes associated with displaced, multi-part fractures has led surgeons to investigate operative alternatives. Studies have not shown a clear benefit from surgical fracture fixation using a variety of implants compared to non-operative treatment because of fracture severity and the difficulty in achieving stable fixation in osteoporotic comminuted (fragmented) bone. Newer fixation devices (locking plates), which have some advantages in osteoporotic bone, have been subject to randomized trials, but have not been shown to improve outcome. Replacement of the fractured humeral head (hemiarthroplasty) is another treatment option, but has not been shown to be clearly superior to non-operative treatment or plate fixation. Recently, reverse total shoulder arthroplasty (replacement) has been used to treat these fractures, with several case series published. This prosthetic design negates the effect of tuberosity malunion and nonunion that are common after internal fixation or hemiarthroplasty by creating a mechanical advantage for the deltoid muscle to allow active forward elevation and abduction. Studies comparing reverse total shoulder arthroplasty to hemiarthroplasty have shown improved pain scores and functional outcomes after reverse shoulder arthroplasty. As a result the use of reverse shoulder arthroplasty for the treatment of proximal humeral fractures is increasing. Reverse shoulder arthroplasty has been reported to have a high complication rate including instability, loosening, poor rotation and radiological notching. The risk of complications and prosthetic longevity limits the use of reverse shoulder arthroplasty in young patients with most prostheses being inserted in patients over 65. No comparative trial has been performed to test the effectiveness of reverse total shoulder arthroplasty against non-operative treatment.

Recent work undertaken at Griffith University (the LIFTMOR trial) has revealed that brief exposure to a bone-targeted heavy progressive resistance training program is both safe, and effective for enhancing musculoskeletal health and function, in postmenopausal women with low to very low bone mass. Similar claims have been made by the developers of the bioDensity system, designed around the premise that low volume machine-based isometric resistance training produces beneficial effects on balance, physical function, muscle strength and bone mass. Whether dynamic or isometric resistance training will be more effective in middle-aged and older men with reduced bone mass at the hip and spine remains to be seen.

In high income countries, improvements in first aid and acute specialised care have resulted in reduced mortality from major burn injuries (from approximately 25% to less than 9%). Although specialised care has significantly improved outcomes for these patients, the near universal complication of burn-related scarring persists as a constant reminder of limitations of care. For burn survivors, the development of painful, restrictive and disfiguring scarring, known as hypertrophic scarring (HS), has an incidence ranging from 30-70% in reviewed epidemiological data. The treatment of scarring has, thus far, been unable to keep pace with the advancements in resuscitation and other acute therapies. The consequences of scar formation are many and varied, including joint contractures and stiffness, chronic pain, itching, and anhydrosis. Additionally, the emotional repercussions can be significant, with many patients reporting stigmatization and discrimination due to their burn scars. As the mortality of acute burn injury continues to diminish, the burden of scarring may continue to rise. Current treatment options for hypertrophic scarring are not yet sufficient to significantly reduce its associated morbidity. Burn clinicians and researchers are focused on understanding scarring in more depth and discovering potential ways to improve patient outcomes. Within this field of innovation, laser resurfacing techniques are gaining greater interest and are currently being utilised in several centres worldwide for the treatment of HS. The aim of this study is to investigate if the early use of laser treatment helps minimise scar, decreases the time required in pressure garments, improves range of motion and thus results in fewer episodes of expensive reconstructive surgery. A 10,600nm fractional carbon dioxide laser supplied by Lumenis Ltd is the device to be used in this study. This laser has FDA approval for over 100 applications including the management of scars. It has the ability to deliver precise high energy in short-pulses to thickened scars, and has a good record for safety and outcomes. The Burns Service of WA has been using this laser for over 18 months for the management of scars, and the health professionals involved have received the appropriate safety training. Participants will receive 3 laser treatments 4-6 weeks apart. Outcome measures will be conducted before laser treatment, after the last treatment of laser and 3 months post laser treatment.

Chronic obstructive pulmonary disease (COPD) is now considered a multisystem disease, in which comorbidities feature prominently. COPD guidelines recommend holistic assessment and management of relevant comorbid diseases but there is limited information as to how this is best achieved. This pilot study aimed to explore the views of stakeholders, including patients and the healthcare team, on the feasibility, acceptability and barriers to a collaborative, multidisciplinary team-based care intervention (TEAMcare) to improve health outcomes in COPD patients, within the context of a local hospital outpatient clinic.

The aim of the study is to investigate whether an intervention to reduce sitting time in the childcare setting will result in less sitting time for preschoolers aged 3-5 years and to assess whether a reduction in sedentary time has a positive effect on childrens' executive function. Childcare services will be randomised to either a control or intervention after baseline data is collected. The three-month intervention will introduce a number of strategies to encourage preschoolers to sit less or stand more during the school day by breaking up or reducing sitting time.

This project will use a cluster randomised trial design to assess the effectiveness of an implementation program designed to increase proportions of patients with stroke receiving a documented assessment for rehabilitation. Hospitals (clusters) will be randomly assigned to receive a multifaceted intervention or an education-only intervention. The multifaceted intervention consists of a decision-making tool, education, audit and feedback, reminders and a tailored implementation package consisting of identification of barriers and facilitators and development of site-specific strategies for implementation (identified in a workshop with health professionals as participants) to help improve rehabilitation assessment practices. The education-only intervention consists of a single education session and provision of a decision-making tool. Observations will be conducted at sites assigned to the multifaceted intervention to observe how assessment are occurring prior to the intervention prior to the intervention. Focus groups will be held at all sites after the implementation period to explore how staff assess and refer patients with stroke for rehabilitation Medical records will be audited pre- and post-intervention at all hospitals to assess proportions of patients assessed for rehabilitation, and proportions of patients who access rehabilitation.