ANZCTR search results

Children with cerebral palsy (CP) participate less in physical activity and have high levels of sedentary behaviour (sitting still) compared to children without CP. Our aim is to pilot a physical activity behaviour-change intervention in 12 children with CP under eight years old. Our trial is innovative because it aims to intervene earlier in the development of sedentary behaviour and will be the first to include children who cannot walk independently. The intervention is grounded in evidence-based theories of health behaviour change. The 8 week face-to-face, highly tailored intervention will be delivered by a paediatric physiotherapist or occupational therapist, with the aim to increase participation in community physical activities and reduce sedentary behaviour. It is important that we pilot some of the outcome measures to be used in the trial including accelerometers, because we don’t have good information about their ability to detect change in this population. Anticipated outcomes of this project will include: information about the feasibility and tolerability of the intervention and outcome measurement; pilot evidence of how effective the therapy is; and information about the behaviour-change mechanism of the intervention.

Recent preliminary findings suggest markers of neuronal damage (neurofilament light and tau) are associated with general anesthesia and surgery, which in turn may be associated with the clinical outcomes of delirium and postoperative cognitive dysfunction. Specifically, in a pilot study we observed that people undergoing cardiac surgery showed greater increases in plasma neurofilament light and tau than those undergoing non-cardiac surgery. The aim of this investigation is to compare the plasma levels of NFL and tau after cardiac compared to non-cardiac surgery and relate these levels to the subsequent neurocognitive outcomes in the postoperative period. Cognitive and memory testing will take place prior to surgery, at 7 days after surgery and at 3 months after surgery. Tests for delirium and collection of blood samples will also be conducted during the participants' time in hospital.

Intradermal delivery of insulin has been shown to be safe, well tolerated and to improve the pharmacokinetics of rapid insulin analogs compared with conventional subcutaneous administration in patients with type 1 diabetes and type 2 diabetes as well as in healthy individuals. It is associated with more rapid insulin absorption with faster time to maximum insulin concentration and faster offset of action compared to subcutaneous insulin administration. Med-Jet H4 (Medical International Technologies Canada, Montreal, Quebec, Canada) is a needle-free injector device which can deliver the drugs intradermally. The Purpose of this study is to compare the pharmacokinetics, pharmacodynamics, safety and tolerability of insulin aspart delivered by intradermal injection with Med-Jet H4 device versus subcutaneous injection with FlexPen® in healthy non-diabetic individuals.

The primary aim of this study was to determine if the addition of concurrent visual feedback, via a tablet computer, would increase adherence to an upper limb home exercise program in people with stroke. A secondary aim was to assess the feasibility of use of upper limb accelerometry as a method of monitoring upper limb activity during a home exercise program in people with stroke.

No study has compared post-procedural body composition and bone density changes via dual-energy X-ray absorptiometry (DXA) for patients electing bariatric surgery in Australia. This prospective cohort study, aims to: 1) test the feasibility and acceptability of conducting bone mineral density and body composition assessment via DXA scan at pre-procedure, 6-months and 12-months post-procedure; and 2) compare bone mineral density and body composition changes relative to weight loss over 12-months. It is hypothesised that loss of bone mineral density will be evident by 12-months post-procedure, particularly in females and that both fat mass and lean mass will reduce over the 12-months post-procedure

A recent Australia-wide survey found that many general practitioners recommend unnecessary imaging and surgical referrals for a common type of shoulder pain (rotator cuff tendinopathy). We hypothesise that educating patients with rotator cuff related pain directly about their condition and recommended care has the potential to reduce inappropriate imaging and surgery, increase adherence to recommended care and ultimately improve healthcare outcomes. The proposed study is a three-arm, parallel group, pilot and feasibility randomised controlled trial. Participants will be randomised to one of three trial arms; Group (i) standard advice and exercise via online printable pamphlet (comparator); (ii) A combination of online printable pamphlet and video, plus a "virtual physiotherapist" whereby participants enter their exercise and symptoms into the website and it tailors their exercise; (iii) A combination of online printable pamphlet, video and "virtual physiotherapist" plus a weekly telerehabilitation session with a physiotherapist.

Anaesthesia and surgery commonly contribute to low blood pressure during and after an operation through a variety of mechanisms. Adequate blood pressure is essential to allow for blood flow and oxygen delivery to organs throughout the body such as the heart, brain and kidneys. There is an accumulating body of evidence that low blood pressure after surgery is very common and is likely underrecognised. These episodes of low blood pressure have been linked to increased rates of organ injury, complications and death following surgery. Midodrine is a drug used to help increase blood pressure. The METEORITE trial has been designed to determine if the use of midodrine before and after surgery is able to reduce the occurrence of low blood pressure in the time following an operation. In this trial, one group of patients will receive midodrine before and for two days after surgery and another comparison group will receive standard care (no midodrine). Both groups will then be followed during and after their surgery to determine if there is a difference between the two groups with respect to important outcomes such as the number of times low blood pressure occurs and the requirement for medical emergency team review. Data on complications following surgery will also be collected. Finally, as this is a pilot study, a number of specific outcomes to assess the feasibility of performing a larger multi-centre study will also be collected and reported. If the study hypothesis is correct, patients who receive midodrine before and after their scheduled surgery will have fewer episodes of clinically significant low blood pressure following their operation and will be less likely to require unplanned medical emergency team review. This may result in improved outcomes after surgery.

The purpose of this study is to test a gel with blood-controlling properties called Purastat. This gel may be useful because bleeding a risk after endoscopy, especially if the patient uses anti-clotting medications Who is it for? You may be eligible for this study if you are aged over 18, are undergoing an endoscopic resection procedure for colorectal lesions and use an anti-clotting medication. Study details All participants in this study will undergo their procedure as scheduled. During the procedure the endoscopist will apply a few millilitres of the Purastat gel to the site of the resection. The procedure will otherwise be a per standard procedures. There will be no additional requirements from patients as part of this study – all patients will have routine care post-procedure. It is hypothesised this gel will reduce the rate of post-resection bleeding and improve outcomes for patients at risk of bleeding after endoscopic resections.

This study aims to evaluate the Safety, Tolerability of VG161 in the treatment of people with advanced malignant tumours that have not responded to conventional therapies. Who is it for? You may be eligible to join this study if you are aged 18 years or older and have late stage carcinoma which is refractory/relapsed and/or intolerant of standard therapies or for which no standard therapy exists. Eligible participants must have at least 1 injectable cutaneous or subcutaneous lesion greater than or equal to 20 mm in longest diameter. Study details: Part A of this study involves up to 3 increasing dose levels of VG161. The treatment will be given as a single dose, and the dose level will not be increased until the lower dose has been determined to be safe. Part B will test up to 3 increasing dose levels of VG161 given as multiple doses. Treatment will be given in cycles of 28 days, with VG161 given once daily on days 1-5, followed by a 23- day observation period each cycle. Participants from Part A will be able to take part in Part B only if eligibility criteria are still met. The study will also involve taking a variety of biological samples including, blood, urine, and tissue. The samples will be used to assess your eligibility to participate in the study, your safety profile during study participation, and to evaluate how the study drug is metabolised in the body. It is hoped that this study can provide greater insight to novel treatments that may stimulate anticancer immunity and help fight cancer. Furthermore it is hoped this treatment can improve control of disease.

Many patients with type 2 diabetes exhibit exercise intolerance (decreased capacity to exercise) and this is often associated with poorer insulin and glucose (glycaemic) control, accelerated disease progression, reduced quality of life, and decreased longevity and survival. However, the primary causes behind exercise intolerance and poor glycaemic control in these patients are not well understood. Using modern biochemical and ultrasound imaging techniques this project aims to determine whether skeletal muscle microvascular dysfunction (impaired blood flow through small blood vessels), is the main underlying cause behind exercise intolerance and poor glycaemic control. Furthermore, this study will investigate whether a 3-month home-based exercise program can improve muscle microvascular function, glycaemic control and exercise tolerance in patients with T2D.