ANZCTR search results

Hallux Rigidus is the most common arthritic condition of the foot, causing pain and stiffness of the 1st metatarsophalangeal (MTP) joint. Consideration of surgical management following failure of nonoperative treatment is based on multiple factors including age and activity level of the patient, as well as the severity of the arthritis. An arthrodesis of this joint is regarded as the gold standard for treatment of end stage hallux rigidus. The goal of this procedure is to relieve pain and improve functional status. Our study aims to collect information regarding the outcomes of surgery from a patients perspective. This information will allow surgeons to ensure that patients are fully informed of the implications of surgery.

This pilot research will test the study’s feasibility in an Intensive Care Unit (ICU) setting whilst contributing new information on IP, peak flow and tissue perfusion in healthy and critically ill populations. The study will determine the role that patients’ Body Mass Index (BMI), severity of illness, positioning, age and risk of pressure injury (PI) development play on pressure displacement and importantly, tissue reperfusion, in the ICU population. This is noted as the only study in the international literature to map full-body IP, peak pressure and Doppler (LDPM) tissue reperfusion in a variety of positions (30 degree semi-recumbent with knee elevation of 10 degree and lateral 1/4 turn position where pillows support the body position and the bed is tilted 10 degree) in ICU patients. The prone position will also be tested only in healthy participants to explore the peak pressure locations and their reperfusion times. This study will inform nursing practice with a view of reducing PI and thus length of stay, patient morbidity and current activity based funding penalties for PIs. The study brings together a multidisciplinary team (nursing, rehabilitation engineering, physiotherapy, biostatistics, medical imaging/sonography) where members contribute a unique skills-set to address a complex but common clinical research question. It translates existing technology and measurement skills used in wheelchair populations to a new population (ICU patients) which share limitations in mobility and skin integrity issues. The team is led by an experienced researcher and nurtures research skills development in two clinical areas seeking to grow a research base (rehabilitation engineering and intensive care nursing) and evidence. Information from this pilot study will inform both clinical practice within the ICU and further research.

Effects on Migraine Frequency using Combined Anti-oxidant Therapy: N-acetylcysteine, Vitamin E and Vitamin C (NEC): The MIGRANT study. Lay title: Using a combination of anti-oxidant supplements N-acetylcysteine, Vitamin E and Vitamin C to reduce the frequency of migraines. Summary: Migraine affects 15% of Western Australians and is a leading cause of suffering and disability in our community. Research suggests that inflammation of the brain’s coverings (meninges) by nerve cell inflammation and the release of ‘free radicals’, is a cause of migraine. N-acetylcysteine, Vitamin E and Vitamin C are powerful anti-oxidants (free-radical scavengers) that reduce brain inflammation and nerve activity. It is therefore possible these anti-oxidants could reduce the number and severity of migraines. We will study 90 subjects to see if a combination of N-acetylcysteine 600 mg, Vitamin E 250 IU and vitamin C 500 mg (NEC) taken twice daily for 12 weeks, will reduce migraine attacks. This safe vitamin-based therapy has never been studied and if effective, will play an important role in migraine prevention.

This project aims to determine if there is a dose-related effect of dietary derived quercetin-3-O-glucoside (commonly found in plant-based fruits and vegetables) on blood vessel function in human volunteers. Quercetin glucosides are the main form of quercetin in the human diet. Quercetin is a flavonoid found in foods such as apples and onions. Our previous short term studies using pure quercetin, or apples, show improved blood vessel function. We now wish to determine if there is a dose related response prior to conducting a large intervention trial. The doses of quercetin-3-O-glucoside to be given are 0mg, 50mg, 100mg, 200mg and 400mg. All of these doses are achievable through dietary changes.

This is a clinical trial to assess the visual performance of a new (prototype) soft contact lens for astigmatism compared to commercially available soft contact lenses. Astigmatism is a common eye condition where images at all distances can be blurred to variation in the shape of the surface of the eye. To assess the visual performance we wish to monitor your eyes' response to the products and what you think of them.

The purpose of this pilot study is to assess the feasibility of conducting a larger Phase III study. The outcomes that will be measured to assess whether the trial is successful are 1) enrollment of 20 patients across 4 sites in six months, and 2) at lease 60% of enrolled patients progressing to study completion. Who is it for? You may be eligible to join this study if you are aged 18 years or above, and are experiencing pain related to cancer or it’s treatment with an average pain score of 3/10 or greater on the Brief Pain Inventory-short form (BPI-SF) in previous 24 hours. Study details: Participants in this study will all receive dexamethasone oral 8mg daily for 5 days. Participants concurrent medication use, background opioid use, co-analgesics, any rescue medication, The Edmonton Symptom Assessment System score, Brief Pain Inventory, Australian Karnofsky Performance Scale, EORTC QLQ-C30/15 will be collected by the research nurse following review of the patient each day of study intervention. The patients global impression of change will be collected on D6 and follow up D14 visit. Many doctors believe dexamethasone is helpful in relieving cancer related pain and it has been used in this way, in addition to strong pain medications, for many years. However, there is limited clinical evidence to support this use of dexamethasone, which is why this study is being conducted.

Sacral Nerve Stimulation(SNS) has revolutionised the management of urinary and faecal incontinence over the past 20 years. SNS is now embraced worldwide as a first line treatment for patients with urinary and faecal incontinence in whom conservative measures have failed. However, despite extensive experience with the stimulator and research in the field, its mechanism(s) of action remains elusive. Recently it has been suggested that SNS works by changing the way the brain functions by 'restarting' its normal function, akin to 'restarting a computer'. In this study we aim to lend scientific support for this hypothesis by investigating the impact of SNS on brain function using functional MRI (fMRI).

The primary purpose of this study is to assess the feasibility and accessibility of a series of interventions which aim to increase participation in advance care planning (ACP) for patients who have been diagnosed with cancer. ACP involves patients discussing and documenting their preferences for future medical care in case they are not able to communicate these later. Who is it for? You may be eligible to participate in this study if you are aged 18 or over, have been diagnosed with cancer of any kind and are receiving care from participating oncology outpatient clinics. Study details Participants in this study will be randomly allocated (by chance) to receive either the usual care regarding ACP, or to receive a number of prompts to encourage them to participate in ACP. These prompts include a letter from their oncologist and access to a website and DVD which all outline the purpose and benefits of ACP and provide information and worksheets to get started, as well as two text message prompts to encourage use of these tools. Participants will be asked to complete surveys regarding their use of the tools and how useful they were. It is hoped that the findings of this study will provide information as to whether these prompt strategies are feasible for increasing the uptake of ACP among cancer patients.

Background: Sodium bicarbonate is a compound often used in food and baking, and has been associated with improvements in high intensity exercise of different modalities, including running, swimming and cycling (Burke and Pyne, 2007). Ingestion of sodium bicarbonate results in an increased blood alkalosis (measured via blood pH and blood bicarbonate concentration), which can aid in buffering hydrogen ions, and act to delay the onset of fatigue in high-intensity exercise (Carr et al., 2011). Sodium bicarbonate is most often ingested at a dose of 0.3 grams per kilogram of participants’ body mass, a dose that has been found to have the greatest effect on performance (McNaughton et al., 1992). Phosphate is an essential mineral that is obtained in the diet, and is a component of phosphocreatine and adenosine triphosphate, important components in oxygen transport within the red blood cell (Brewer et al., 2013). Phosphate can be ingested in the form of sodium phosphate, which has been associated with enhancements in endurance exercise performance (Cade et al., 1984) and peak aerobic capacity (Folland et al., 2008). The recommended dose of sodium phosphate is 50 mg per kg of participants’ fat free mass. Mechanisms associated with sodium phosphate supplementation include an increase in 2,3-diphosphoglycerate content in the blood, which can aid with the release of oxygen to the muscle, as well as an increased buffering capacity (Brewer et al., 2014). Participants: One hundred and twenty well-trained, male and female cyclists will be recruited to complete this study. Experimental Design: Experimental Testing Overview: Participants will visit the laboratory on three occasions. The first visit to the laboratory will require participants to complete a DEXA scan and simple anthropometric measures (height, mass and sum of 7 skin folds) to assess body composition, as well as a graded exercise test to determine maximal oxygen consumption (VO2max), and a familiarisation with the cycling performance test. The remaining two visits will require participants to complete cycling performance trials. For the second laboratory visit, participants will complete a baseline cycling performance test. The third laboratory visit will require participants to complete the same cycling performance test, under one of four supplementation conditions, assigned in a parallel groups design. The four experimental conditions are: 1) sodium phosphate and placebo, 2) sodium phosphate and sodium bicarbonate, 3) sodium bicarbonate and placebo, 4) placebo and placebo. Capillary and venous blood samples will also be taken during the second and third laboratory visits.

Intermittent fasting (IF) is any strategy where participants severely restrict caloric intake on one or more days of the week with 'normal' eating on non-fasting days, and has recently gained popularity for weight loss. Intermittent fasting compares well with other traditional nutritional interventions such as long term calorie restriction, with higher levels of dietary adherence reported over time. High intensity interval training (HIIT) has also been reported as an effective and time efficient exercise strategy for weight loss, as well as improvements to markers of cardiovascular and metabolic disease. Individually IF and HIIT are effective, however, their combined effects are unknown. This study intends to examine the short and long term impacts of IF, specifically a 2:5 ratio of fasting days to normal eating days, and HIIT on weight loss and cardio vascular and metabolic health. The influence of these interventions will be monitored separately, or in combination, on body composition, metabolic and cardiovascular health, fitness and quality of life. In addition, the study will identify changes in serum miRNA’s expression. To achieve these aims, overweight and obese individuals will undergo 1 of 3, 16 week interventions including: 1) 5:2 diet intermittent fasting diet, 2) supervised high intensity interval training (HIIT) performed 3 days a week, and 3) a combination of both interventions. Body composition, arterial stiffness, blood pressure, aerobic capacity (VO2 max) and quality of life will be measured at 0, 8 and 16 weeks. Additionally, blood samples will be taken and measured for lipid profiles, fasting plasma glucose, insulin resistance, markers of inflammation and expression levels of microRNA. Participants will also be asked to continue the interventions for a further period of 8 months self-directed, with follow up measurements performed at the 24, 36 and 52 weeks. Effective dietary and exercise interventions that promote long-term adherence and sustained beneficial effects on metabolic and disease markers are required to reduce the increasing rates of obesity.