ANZCTR search results

Shoulder impingement is a common diagnosis referred for physiotherapy treatment. Patients complain of pain when lifting their arm and difficulty with functions such as washing their hair or when reaching for objects. (Michener, McClure et al. 2003) suggest “it is the most common disorder of the shoulder, accounting for 44-65% of all complaints of shoulder pain during a physician’s office visit.” In addition, approximately one-fifth of all disability payments for musculoskeletal disorders are for shoulder disorders (Michener, Walsworth et al. 2004) These statistics indicate that a large portion of the general community may be affected by a shoulder disorder and that it causes significant discomfort and limitation to their function. Physiotherapists use past clinical experience in addition to a thorough examination to identify physical characteristics causing signs of impingement and which are able to be modified (Sorohan and Mc Creesh 2009). A study has been completed (JCU ethics approval number H3945) which took an homogeneous group, aged 40 to 60 years, presenting with positive shoulder impingement signs and symptoms of gradual onset and without trauma, and compared these physical characteristics to a matched asymptomatic group in age and physical activity level. Significant differences between groups were found in upper back (thoracic) posture, range of upper back (thoracic) movement and tightness in the back of the shoulder. No significant differences were found in shoulder muscle strength or shoulder blade positioning. This prospective, randomized double blinded,control trial will compare the clinical efficacy of two evidence based physiotherapy treatment approaches (one directed at the thoracic spine and one directed at the posterior shoulder) as compared to ultrasound treatment. The results of this project will result in the development of an evidence based program to manage shoulder impingement.

The primary aim of this trial is to develop and evaluate a risk model to aid doctors to identify head and neck cancer patients who are most at risk of developing hearing loss as a result of treatment. Who is it for? You may be eligible to participate in this trial if you are aged 18 or older and have been diagnosed with a head or neck squamous cell carcinoma for which you have been scheduled to receive radiotherapy at the Princess Alexandra Hospital. Study details All participants in this study will first be allocated to one of the two study groups based on their risk of developing hearing loss during treatment. Those identified as minimal risk will receive standard radiotherapy care. Those identified as high risk will receive a new protocol of radiotherapy care following the guidelines developed by these researchers. This care includes tighter radiation dose tolerances for your ear structures and the use of a validated, audiology contouring atlas to ensure more accurate definition of your ear structures on your radiotherapy planning scan. These recommendations are expected to be followed unless it is not in the best interest of treatment of the cancer. All patients will have hearing test visits before treatment, at week 5 of treatment, at 3 months and at 1 year after finish of treatment. Outcomes will be assessed using results of these hearing tests and by questionnaires completed by participants. It is hoped that the findings of this study will provide more information on the radiotherapy dose required to induce hearing loss, any links to specific chemotherapy drugs which may increase risk of hearing loss and the efficacy of the risk profiling tool to identify patients at greatest risk of developing hearing loss.

Delayed cord clamping (DCC) is slowly becoming common practice in the management of uncomplicated births in Australia, however it is unclear how the administration of maternal uterotonics such as oxytocin as part of the active management of the third stage of labour have on the newborn DCC. Oxytocin is administered prophylactically as it has been shown to significantly decrease the risk or post partum haemorrhage (PPH). PPH occurs in more than 5% of births and is most commonly caused by uterine atony, the failure of the uterus to adequately contract after birth. Oxytocin causes contractions of the uterus, which helps to reduce this risk. In Australia and New Zealand, an intramuscular (IM) or intravenous (IV) injection of Syntocinon ('Registered Trademark'), a synthetic form of the hormone, oxytocin, is administered as the anterior shoulder of the fetus is delivered. There are currently no guidelines indicating how to prophylactically treat PPH during delayed cord clamping. Current standard practice of care allows for the provision of early or delayed cord clamping. however, if cord clamping is delayed a maternal IM injection of 10IU oxytocin is routinely administered with delivery of the anterior shoulder of the fetus. Therefore DCC is currently being performed under the influence of oxytocin without an understanding of the potential effects of uterotonic administration prior to cord clamping on the newborn. This clinical trial aims to determine the effect of maternal IM Syntocinon ('Registered Trademark') administration during delayed umbilical cord clamping on neonatal arterial oxygen saturation (SpO2) and heart rate (HR) at vaginal birth.

This study will determine the effect of personal ultraviolet radiation (UVR) devices and the SunSmart phone application on sun protection habits in adult volunteers from the general community. Who is it for? You may be eligible to join this study if you are aged 18 – 35 years old, own a private mobile phone, have Fitzpatrick skin type 1-3 and no previous melanoma. Study details Participants in this study are randomly allocated (by chance) to one of three groups. Participants in one group will be asked to wear a UVR dosimeter feedback device on daily basis for 1 month. Participants in another group will be asked to download and use the the SunSmart phone application on their phone for 1 month. While the third group will not be given access to either technology and will continue their normal everyday activities. Participants will be asked to use the technologies daily for 1 month. Participants will be followed up at 1 week and 3 months after the intervention commences with questionnaires to determine changes in sun protection and exposure habits, sunburn incidence and satisfaction with use of technologies.

The primary aim of this study is to investigate the effects of eating unsalted almonds on major cognitive domains (attention/concentration, executive function, working memory, secondary memory, spatial memory) and the secondary aims are to explore potential cardiovascular, metabolic and inflammatory mechanisms underpinning cognitive enhancement following 12 weeks of almond consumption.This study will be a 12 week randomized, controlled, parallel arm study that investigates the effects of unsalted almond consumption or alternative snack food (at 15% of energy intake) on cognitive function and established and emerging cardiometabolic biomarkers of disease in healthy participants in a free living environment. Participants will be asked to continue with their usual lifestyle whilst avoiding consumption of other nuts or nut butters apart from study foods. At the start of the study and after 12 weeks of eating almonds or the alternate snack food we will examine cognitive function in a computerised cognitive test battery, as well as cardiometabolic biomarkers (lipids, glucose regulation), vascular function (blood pressure, arterial compliance, circulating adhesion molecules) and markers of systemic inflammation.

One third of patients affected by severe trauma die from uncontrolled bleeding. Many of these patients are found to have abnormalities of the clotting system collectively known as ‘acute traumatic coagulopathy’ (ATC). The two most important abnormalities in ATC are a low fibrinogen and increased clot breakdown. It has been hypothesised, and there are some non-randomised studies that show that treatment with fibrinogen therapy in trauma patients who are bleeding can stop bleeding more effectively than standard care, reduce transfusion needs and may reduce death rates. This study will look at the effects of infusing fibrinogen concentrate (FgC, a concentrated source of fibrinogen) to adult trauma patients as early as possible (within 45 minutes of admission to hospital). It has been shown in a large trauma randomised controlled trial that treatment for bleeding has better outcomes if delivered to patients quickly. This study will evaluate whether it is possible to enrol patients, deliver and infuse drug within 45 minutes and will also look at laboratory and clinical outcome measures.

This project aims to investigate if a high intensity interval training (HIIT) program offers greater improvements, than moderate intensity continuous exercise, for intra-abdominal fat, fitness, inflammation, cardiovascular risk factors, and exercise adherence. The project will also investigate whether HIIT can be successfully integrated into a hospital-based cardiac rehabilitation program as a practical and safe alternative to moderate intensity exercise. We expect high intensity interval training will be a safe and practical option. This will lead to the, development of a protocol to guide cardiac rehabilitation programs on how to incorporate HIIT as a standard exercise option for patients.

This primary purpose of this study is to evaluate the safety and efficacy of AZD4547 for the treatment of malignant mesothelioma which has progressed following first line chemotherapy. You may be eligible to participate in this study if you are aged 25 years or over, and have been diagnosed with mesothelioma which has progressed following first or second line chemotherapy with pemetrexed and cisplatin and/or carboplatin. Study details All participants in this study will receive two oral doses of the study drug, AZD4547 per day for 6 months, with appointments with study staff every 3 weeks throughout this period to monitor side effects and adherence to the medication. Researchers will examine disease progression and survival at 6 months, as well as side effect data from the three-weekly appointments to determine the efficacy and safety of the drug. Information from this study will then be used to inform researchers on whether continued study of this drug is both worthwhile and safe, in the hope that it may provide a safe and effective second line therapy for mesothelioma in patients whose disease has progressed following first line chemotherapy.

Peripherally inserted central catheters (PICCs) were developed to provide short to medium term vascular access for patients requiring the infusion of vessel irritant medications, or frequent blood sampling. While PICC’s provide necessary, reliable and accessible vascular access; they are associated with biological, mechanical or infectious complication. These complications result in delayed treatment, need for reinsertion, and delayed treatment of the underlying complication - causing extended admission time, increased healthcare costs, venous depletion and increased morbidity and mortality. Microbial biofilm formation makes treatment of infections more complicated since the detached microbial cells from the biofilm can repeatedly infect the blood, and these microorganisms are highly resistant to many antimicrobial agents, frequently requiring PICC removal and antibiotic treatment. Maintaining catheter function is vital for the safe provision of treatment. BioFlo (trademark) PICC (by Angiondynamics; NY) claims to provide a novel solution and the manufacturers claim the material is resistant to blood products and biofilm development, reducing the risk of standard PICC complications including infection, fracture, thrombosis, leakage, localised swelling, accidental removal and dislodgement . These PICCs are now being used intermittently, on the basis of some clinician preference, at the LCCH, the PAH and elsewhere. The effectiveness of this product at reducing PICC-associated complications as previously described has not been undertaken. At LCCH we plan to undertake a randomized controlled trial. Children or parents and guardians who consent to participate in the trial will be randomly assigned to either study group. The primary aim of this research is to evaluate the feasibility of launching a full-scale efficacy trial, using pre-defined feasibility criteria for recruitment, retention and protocol fidelity. The secondary aim is to compare the effectiveness of this new PICC technology compared to older generation PICC relating to failure and complication due to infection, occlusion, dislodgement, thrombosis, or breakage, for children with PICC in acute care.

Fatigue is experienced by more than 50% of stroke survivors, and leads to reduced independence and quality of life. It persists even after other symptoms have resolved. In spite of its importance to stroke survivors, there are no proven means of minimizing this fatigue. We plan to conduct a novel randomised controlled trial (RCT) to establish whether a 10-week intervention that increases the frequency and duration of physical activity after stroke will reduce fatigue and improve quality of life. The intervention has 4 key elements: personalised physical activity plans, goal setting, daily feedback and peer support. Our aim is to increase habitual activity levels through long-term behaviour change; the intervention is not reliant on specialised equipment or services. Outcomes will be assessed before and after the intervention period. In addition to the primary outcomes of fatigue and quality of life, we will assess physical activity levels, sleep, fitness, muscle strength, depression and anxiety. Currently, there is uncertainty about whether to prescribe exercise or rest to stroke survivors with fatigue. Evidence that physical activity improves post-stroke fatigue has the potential to change practice, translating directly into clinical guidelines.