ANZCTR search results

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.

The anterior cruciate ligament (ACL) is an important stabilizing ligament of the knee. It is also the most common knee ligament injury requiring surgery, with an annual incidence of approximately 1 in 3500 in the general population. Numerous technological advances have been made in recent times in the surgical techniques for ACL reconstruction but, in spite of this, the failure rate remains approximately 7-15% and many people do not return to full function in their knee after ACL reconstruction. The anterolateral ligament (ALL), a structure located in the anterolateral part of the knee, has recently been identified as an important contributor to rotational stability of the knee in addition to the ACL. Loss of ALL integrity may be responsible for some cases of failure post-operatively. Although intra-articular ACL reconstruction remains the current gold standard for operative management, it does not address the extra-articular ALL deficiency and therefore does not restore normal knee kinematics. The aim of this study is to compare the return to function and re-rupture rates following combined ACL reconstruction with lateral extra-articular tenodesis versus an isolated intra-articular ACL reconstruction. Participants will be randomly allocated to one of two treatment arms by opening a sealed envelope. They will then undergo either i) ACL reconstruction using a 4-strand hamstring ACL graft and iliotibial band (ITB) lateral extra-articular tenodesis, or ii) isolated intra-articular ACL reconstruction with a 4-strand hamstring graft. Following surgery, clinical reviews will be conducted at 6 weeks, 3 months, 6 months, 12 months and 2 years post-operatively during which the physiotherapist will make an assessment using a variety of objective knee scoring systems and a patient satisfaction survey. Any post-operative complications will also be recorded. Comparison will then be made to determine which technique has better functional outcome and lower re-rupture rate.

Our research team has recently been awarded an Australian Mental Health Award by Beyondblue and the Movember Foundation, that will fund a program of research aimed at developing and evaluating a range of new e-health interventions for working men, termed ‘Men@Work’. One of the first parts of this program is the development of a new smart-phone application that will allow men to screen themselves for both symptoms and risk factors for common mental health problems. The working title for this new smartphone application is ‘Mindgauge’. This registration covers one part of the development process; the testing of the relative appeal of different feedback texts, language, measurement tools, and content style with an early prototype of the ‘Mindguage’ application. The testing of different features and content styles within an early prototype or minimum viable product (MVP) is considered a usual early stage in the development of complex new smartphone applications. The specific questions that this research project (and registration application) will aim to answer are: a) What feedback texts are most persuasive for convincing participants to follow links to recommended interventions? b) What mood widget measurement is most appropriate? And does it map onto other standardised tools? c) Are app notifications acceptable to users? d) How interested are people in finding out about their risk? Does it impact engagement? Data collection Participants will complete quizzes pertaining to: Mood and anxiety symptoms (K6 questionnaire) and Wellbeing (WHO 5 Well-being Index) and sliding scales measuring alcohol use quantity; hours slept; perceived stress; physical and social activity. Participants who are deemed at-risk of mental health problems on the quizzes will be randomly allocated to receiving one of the following feedback types: normative positive, normative negative, theory-driven, humour-driven. The outcome measure is number of clicks to external interventions. They will be reassured that techniques are available to help improve these factors and immediately following their feedback will be provided information and a link to a variety of online self help or information sites. Participants then use the app to monitor mood and alcohol quantity, sleep quality, stress, and physical and social activity. They have the option of finding out their current risk of mental health problems. In a subsequent randomisation participants will receive one of five different mood measurement gauges, outcomes will include engagement (quantity and frequency of check-ins with app) and Signal quality (correlation of signal to weekly k6 scores and accuracy of a baseline linear classifier trained to predict k6 score from mood signal.

It has become routine for any adult who had undergone abdominal surgery to have physiotherapy treatments such as deep breathing, incentive spirometry, encouraging mobilisation (getting out of bed) and other specific chest physiotherapy techniques manual techniques. It is thought that this physiotherapy will prevent post-operative pulmonary complications. The research in adults has shown that of these techniques, early upright mobilisation is most effective in reducing length of stay in hospital for adults who have undergone abdominal surgery (Browning et al 2007). There is very little published evidence to support the use of physiotherapy to prevent post-operative complications in children who have undergone abdominal surgery. Current medical, physiotherapy and nursing care after abdominal surgery at Princess Margaret Hospital (PMH) advocates for early mobilisation. These recommendations for children are based on findings on adult patients. As a result, there are no clear guidelines of how much, how often, and how best to encourage mobilisation in children after they have had abdominal surgery. This uncertainty leaves clinicians working in this clinical area partly dependant on their own clinical experience when making decisions regarding individual patient management and results in variation in clinical care (Morris et al 2003). This uncertainty and variation in clinical practice is one of the driving forces behind the development and evaluation of the Up and Go Goodie Bag. AIM: We wish to evaluate whether patients supplied with a self-directed early mobilization and deep breathing incentive goodie bag (Up, and Go Goodie Bag ) after abdominal surgery facilitates early mobilisation, early discharge and prevents post op pulmonary complications. This information will be used to develop mobilisation guidelines for children who have undergone abdominal surgery.

This is a single-subject research design involving three participants. Recruitment will occur through Dreamfit and Ability Centre (which are affiliated) via dissemination of information to families. Screening of potential participants by a physiotherapist will occur to determine their suitability. Weekly assessment of outcome measures will occur during a 5-week baseline and 12-week intervention period, and at 4-week follow-up. These assessments will include lower limb range of movement (ROM), lower limb muscle strength, timed up and go assessment (TUG), heart rate during exercise, enjoyment (using a 5-point Smiley Scale) and a 2-minute walk test (2MWT). Probes (at the beginning and end of each phase) will include: the Canadian Occupational Performance Measure (COPM), and the Cerebral Palsy Quality of Life Questionnaire (CP-QOL). The trampoline intervention will involve twice weekly sessions at Dreamfit, where the bungee trampoline is located. The sessions will be run by the student (AG, one session a week) and a physiotherapist (one session a week), with an individualised programme suitable for each participants abilities and goals. At the conclusion of the program, an additional ‘exit’ interview will help to establish the usability of the adaptive bungee trampoline.