ANZCTR search results

Background: Knee osteoarthritis (OA) is a significant and increasing cause of pain and disability in the Australian population. So far, interventions aimed at structural modification have been disappointing. OA affects the whole joint, and inflammation of the joint lining (synovitis and joint fluid) is now recognised as a key part of OA. Animal studies suggest that krill oil is anti–inflammatory. Pilot data in humans shows that krill oil reduces knee pain and systemic inflammation after 30 days, suggesting that an approach targeted at specific mechanisms of disease may be effective for OA. However, this study was of short duration, did not collect any data on structural factors, and included patients with a variety of disorders. Longer, larger follow up studies are required. Aim: To compare, using a randomised, placebo–controlled double–blind design over six months, the efficacy of krill oil vs identical placebo to treat knee osteoarthritis (OA) (both pain and structure) in 260 patients with clinical knee OA, significant knee pain and effusion on imaging. Primary hypothesis: 1) Krill oil decreases pain (assessed by 100mm VAS) by 10mm more than identical placebo over 24 weeks in patients with clinical knee OA, significant knee pain and effusions. 2) Krill oil decreases effusion size by 20% over 24 weeks in patients with symptomatic OA of the knee and knee effusion. Significance and Innovation: If krill oil can both improve symptoms and decrease effusion in OA it has the potential to slow progression to joint replacement. The proposed study represents an innovative approach to this and lends itself to easy implementation as krill oil is already available over–the–counter in Australian pharmacies.

The primary aim of the present project is to determine whether introducing cough reflex testing, when embedded into an established clinical pathway, will reduce the incidence of aspiration pneumonia and subsequent length of stay for acute stroke patients in comparison to patients who did not receive the testing. The secondary aims are to evaluate to the clinical feasibility of implementing cough reflex testing as part of standard initial swallowing assessment for all new stroke patients, the patient’s tolerance and clinician satisfaction. It is hypothesised that individuals who receive the testing will demonstrate reduced rates of aspiration pneumonia and decreased average lengths of stay in comparison to patients who did not receive the testing. This hypothesis is based on the assumption that those at a high risk of silent aspiration, will be identified from the cough reflex testing prior to receiving any oral diet or fluids, thus preventing aspiration from occurring. It is also hypothesised that implementation of the cough reflex testing will result in minimal cost to the organisation, high patient tolerance and high clinician satisfaction. Therefore it is anticipated that cough reflex testing will be a clinically feasible and viable tool when implemented as standard practice for all swallowing assessment in stroke patients.

This was a multicentre multisurgeon prospective doubleblinded randomized and controlled trial looking at the effectiveness of single dose intravenous administration of Tranexamic Acid (TXA) in patients undergoing shoulder arthroplasty. The aim of this study was to extend Level I category evidence of the known benefits of TXA to shoulder arthroplasty. The primary objective of this study was to test the hypothesis that systemic use of Tranexamic acid improves operating conditions, decreases blood loss, postoperative pain and complications such as haematoma and need for transfusion. The secondary objective was to carry out subgroup analysis between reverse and anatomical shoulder arthroplasty with the hypothesis that reverse causes more blood loss than anatomic. All consecutive patients presenting to an elective orthopaedic consultation with a failed nonoperative management of shoulder arthritis indicated for shoulder arthroplasty were considered eligible for this study. After having been screened for inclusion and exclusion criteria, read the information sheet and signed the consent form, patients were blindly randomized to one of 2 groups: Systemic TXA or Control. Patients’ general demographic characteristics such as age, sex, dominance, diagnosis, BMI, American Society of Anaesthesia (ASA) score and other relevant comorbidities were collected in a deidentified database locked on a password-protected computer. During the surgery, patients were administered either 2mg of intravenous TXA or a placebo equivalent (saline solution). Analysed outcome variables included: surgeon’s rating of surgical field visibility and overall appreciation of the complexity of the procedure, operative time, pre- and postoperative haemoglobin and haematocrit levels, drain output at 6,12 and 24 hours, need for transfusion, occurrence of postoperative haematoma, postoperative pain Visual Analog Scale (pVAS), time spent in recovery room and hospital room.

In Australia, 1800 new cases of dementia are diagnosed each week (Alzheimer's Australia, 2015). Despite the alarming prevalence of dementia no medications are available that reverse, or even slow the effects of the disease on the brain. This bleak outlook is only brightened by the likelihood that some dementia is preventable. Modifiable risk factors—including lifestyle practices such as smoking, exercise and a healthy diet—have recently been proposed to be responsible for 66% of all Alzheimer's, which is the most common form of dementia (Xu, Wei et al, 2015). In 2014, a large group of dementia experts asserted that if the population were to adopt a healthy lifestyle, 20% of dementia would be prevented (Yaffe, Kristine et al. 2014). Specifically, regular exercise and diets high in plant foods have been shown to reduce the risk of cognitive impairment (Ahlskog et al, 2011; Lourida et al. 2013). The proposed full trial seeks to be the first to examine in a controlled fashion whether Intensive Therapeutic Lifestyle Change (ITLC), specifically in the form of a lifestyle intervention known as the Complete Health Improvement Program (CHIP), can affect the progression of Cognitive Decline in people with newly diagnosed dementia or mild cognitive impairment. The study will be conducted over a four-year period and will involve people with newly diagnosed dementia, or MCI, self-selecting to participate in an ITLC group (who will participate in a 2 month intensive CHIP intervention followed by monthly follow-up sessions). Cohort randomisation is proposed, the control group receiving care as usual. The pilot study is to test the feasibility of conducting the larger study and assess issues of implementing ITLC with cognitively impaired individuals. ITLC, because of the “number and difficulty of behaviours required by those delivering and receiving the intervention” is a complex intervention according to the UK Medical Research Council guidance. Therefore this pilot study will specifically test the feasibility of recruitment techniques and the appropriateness and acceptability of the intervention (are numbers of people with cognitive decline and their supporters willing to change their lifestyle?), the feasibility of the logistics and timing of adherence and coaching methods, and retention rates in the 10 months after the intense intervention. The pilot will assess the utility of the ad hoc instruments used to measure adherence and the domains of dementia. Data integrity and handling will be assessed. Finally the quality of the results recorded by the researchers in the intended primary outcome of the full trial, the change in cognitive decline and behaviour, will be assessed by the geriatrician. Because this is a pilot study with no control group and the number of participants is expected to be small, the results will be reported without analysis. Results will not be carried forward into the full study.

The primary purpose of this study is to evaluate whether the presence of two antibodies, eIF4E and p53, in samples of tissue from the edge of surgically removed tumours in the head and neck may correspond with cancer progression and recurrence. Who is it for? You may be eligible to participate in this study if you are aged 18 or over, and have been diagnosed with mucosal head and neck squamous cell carcinoma with negative surgical margins on histopathology at the Royal Darwin Hospital or the Christian Medical College, Vellore (India). Study details: All participants enrolled in this study will have tests carried out on tissue samples which were taken at the time of surgery, and which have already been shown to be tumour-free. These tests will assess for the presence of the two antibodies eIF4E and p53. Participants will then be followed-up for minimum of 12 months - end of study period by review of medical records, to see if any correlation exists between presence of the antibodies and cancer recurrence. It is hoped that the findings of this study may provide information on whether these antibodies may be used as a marker for prognosis in head and neck cancer patients at the time of surgery.

The study aims to evaluate the effects and safety of FLX-787 in patients with MS who experience muscle cramps and spasms. We aim to assess the effect of FLX-787 on muscle spasms/cramps. FLX-787 is self administered morning and evening. Flex Pharma hypothesizes that activating Transient Receptor Potential (TRP) ion channels, which are known to exist in primary sensory neurons in the mouth, oesophagus and gut increase inhibitory tone in the spinal cord and prevents repetitive firing of alpha neurons thereby relieving the cramp. This study investigates whether the ingredients in FLX-787 activate the TRP ion channels relieve muscle cramps in paitents with MS

This trial aims to determine whether the efficacy of standard bowel preparation for colonoscopy can be improved by the addition of an osmotic laxative, Movicol. Who is it for? You may be eligible to participate in this trial if you are aged 18 or over and have been referred for an outpatient colonoscopy procedure. Study details: All participants in this trial will be randomly allocated (by chance) to either the Movicol group or the standard care group. Participants in the Movicol group will receive 8 sachets of Movicol to be mixed with water and consumed once/twice per day (according to a strict schedule) in the 5 days leading up to the colonoscopy procedure. On the morning of the procedure, these participants will also consume one preparation of the standard care Prepkit C. Participants in the standard care group will be given the usual care low residue White Diet (for 2 days prior to the day of the procedure ) and Prepkit C (consisting of a first sachet of PICO PREP and one sachet of GLYCOPREP taken the day before the procedure, and a second sachet of PICO PREP the morning of the day of procedure. Participants will be asked to complete a form indicating when each dose was taken, and will be asked to complete a questionnaire on arrival at hospital for the procedure. The doctor performing the procedure will be asked to rate the quality of the bowel preparation. It is hoped that this trial will provide information on the efficacy of Movicol as an addition to standard care preparation for colonoscopy.

The primary purpose of this pilot randomised controlled trial is to determine the acceptability and feasibility of a novel approach to the treatment of childhood obesity. The approach has two components: 1) an assessment of obese 3-12 year old children's weight-related health by a trained paediatrician, and 2) an in-home intervention where the research team will work with these children's families to make a series of small 'nudge' modifications to the home environment that encourage healthier decision making (eg replacing plates with smaller versions to counter unintentional overconsumption). We hypothesise that the approach will be acceptable to children, parents and paediatricians and feasible to deliver. If so, this pilot study will inform the development of a larger trial designed to test whether the approach is effective.

Prader-Willi syndrome (PWS) is a rare genetic disorder that causes individuals with the disease to have an insatiable appetite, which often leads to the development of morbid obesity. The only way that this appetite can be controlled is through constant vigilance, behavioural restraints and environmental modifications; there is currently no pharmacological treatment for excessive appetite in PWS. A single injection of exenatide, a GLP-1 hormone agonist, has been shown to increase feelings of fullness after a meal in adults with PWS. The effects of the long term administration of a GLP-1 agonist on appetite and weight management in PWS, however, have not been studied. The proposed study aims to redress this by assessing changes in gastric emptying rate, fullness, hunger, food-related behaviours, appetite hormones, cognitive function and body weight in a cohort of 20 adults with PWS treated for 12 weeks with the GLP-1 agonist Bydureon. Study participants will undergo a meal study prior to beginning Bydureon treatment to assess their response of hormones and appetite to food intake. As there have been some studies demonstrating that Bydureon slows gastric emptying, participants’ gastric emptying rate will be also be assessed by scintigraphy so that changes in gastric motility can be monitored for tolerance, with a normal gastric emptying range established from 10 lean control individuals and 10 obese control individuals. If PWS particpants’ gastric emptying rate falls within the normal range, they will begin a 12-week Bydureon treatment period with weekly injections of the drug. After 4 weeks of Bydureon treatment, gastric emptying rate will be measured again. If it has slowed below the normal range, treatment will be discontinued. Otherwise, treatment will be continued up to 12 weeks, after which PWS participants will undergo a further meal/scintigraphy study to determine the effect that Bydureon treatment has had on appetite, weight, behaviour and cognitive function. Body weight will be measured again 12 weeks after completion of the treatment period.

The application of allogeneic haematopoietic stem cell transplantation (HSCT) is hampered by procedure-related morbidity and mortality, including transplant-associated thrombotic microangiopathy (TA-TMA), sinusoidal obstructive syndrome of the liver (SOS), idiopathic pneumonia syndrome (IPS) and acute graft vs host disease (aGVHD). While the aetiology of many of these conditions is not known, it has been postulated that endothelial toxicity related to the chemotherapy conditioning is an early event common to all of them. We hypothesise that endothelial toxicity is associated with complement dysregulation, and leads to a prothrombotic state with impaired fibrinolysis, which manifest as the clinical complications listed above. In this study, we aim to document laboratory evidence of changes in coagulation and fibrinolytic potential occurring after allogeneic HSCT, and to correlate this with prospectively identified clinical and laboratory manifestations of endothelial toxicity. A total of 30 participants will be recruited, of which a minimum of 15 will have received the busulfan / cyclophosphamide regimen. Blood samples will be taken from recipients immediately prior to commencement of the conditioning regimen, on the day of transplantation, and on post-transplant days 7, 14 and 21. Additional blood samples will be taken for therapeutic dose monitoring from recipients of busulfan conditioning. Diagnoses of TA-TMA, SOS, IPS and aGVHD occurring up to post-transplant day 28 will be made according to specified criteria using diagnostic information collected as part of standard care.