ANZCTR search results

The primary purpose of this trial is to evaluate the safety and efficacy of methadone for the treatment of chronic cough in cancer patients in palliative care. Who is it for? You may be eligible to participate in this trial if you are aged 18 or over, suffer from chronic cough following diagnosis of cancer, and are currently in palliative care. Study details Participants enrolled in this trial will receive 3 days treatment with methadone and 3 days treatment with a placebo (sham) treatment with a no treatment day in between (total of 7 days).. The order in which these are given is randomly allocated (by chance). Each treatment period involves taking two tablets per day, and there will be a break period of 1 day between each of the two treatments. Participants will be asked to complete a number of questionnaires relating to the severity of their cough, and provide a blood sample at the end of each 3 day treatment period. It is hoped that this trial will provide information on whether methadone is a safe and effective treatment for cough in cancer patients, which may be used to inform a larger clinical trial in the future.

The study aims to evaluate the effects and safety of FLX-787 in patients with Motor Neuron Disease who experience muscle cramps and spasms. We aim to assess the effect of FLX-787 on pain/intensity and insomnia. Active/Placebo ODT is self administered morning and evening.

The trial will follow a randomised, double-blind, placebo-controlled parallel group design. After providing written, informed consent, each subject will attend the Nuclear Medicine Department in the morning (0800) after an overnight fast under “baseline” conditions (day 0). If the subject is normally prescribed metformin, this will be held while fasting and will be taken with the first meal following gastric emptying study. The investigators will confirm the prescribed metformin dose and check that this remains stable at each visit. A standardised meal will be provided the evening before the study. An intravenous cannula will be inserted in each forearm, one for blood sampling and the other for IV infusion of glucose tracer (initial bolus of 28 micromol.kg-1 6,6-2H2 glucose, followed by continuous infusion at a rate of 0.28 micromol.min-1.kg-1 from t = -210 until t = 240 min). At t = -5min, a meal will be given while the subject sits against a gamma camera, consisting of 300ml 25% dextrose labelled with 20MBq 99mTc-calcium phytate, and also containing 1.5g [U-13C] glucose, and 1000mg paracetamol to measure gastric emptying simultaneously by the paracetamol absorption test. The meal will be consumed within 5 minutes. Gastric emptying will be assessed from the time of ingestion of the meal and for 240 min afterwards. Venous blood (~3 mL) will be sampled at t= -210, -20, -10, 0, 15, 30, 45, 60, 90, 120, 150, 180 and 240 min for subsequent analysis of blood glucose and plasma glucose tracer concentrations, and additional samples (~10 ml volume) at t = -210, -30, 0, 15, 30, 60, 90, 120, 150, 180 and 240 min, for measurement of plasma insulin, C-peptide, and glucagon. A further sample (5 mL) will be collected at t = -210 min to measure HbA1C and fructosamine. Heart rate and blood pressure will be monitored every 3 minutes between t = -60 min and t =240 min using an automated recording device ((DINAMAP ProCare 100, GE Medical Systems, Milwaukee, WI, USA). At the conclusion of the study, subjects will be offered a light meal before they leave the laboratory. On the following day (day 1), each subject will then commence a 56 day (8 week) intervention consisting of lixisenatide or matching placebo (saline) administered subcutaneously once daily, 30 min before breakfast, as detailed below. On the final day (day 56), he or she will return to the department for a second gastric emptying study that will be identical to the study protocol for day 0, other than for administration of the final dose of lixisenatide or placebo 30 min before meal ingestion. Intervention The intervention will consist of 56 days treatment with either lixisenatide or placebo (saline). Dosing of lixisenatide will be “stepped up” according to the following schedule: - 5 mcg days 1-7, 10 mcg days 8-14, 20 mcg days 15-56

This pilot study aims to investigate the effects of a maintenance Tai Chi intervention on exercise capacity and quality of life in people with chronic obstructive pulmonary disease (COPD). This will be a prospective cohort study where people with COPD will be recruited from two sites in Sydney, Concord Repatriation General Hospital and Mona Vale Community Health Centre. All participants will be asked to undertake an eight-week, twice weekly, supervised Tai Chi exercise program using Sun- style Tai Chi at one of the sites. On completion of the supervised program, participants will then be asked to continue with a home-based, unsupervised maintenance Tai Chi exercise program five times weekly for a six-month period. Outcomes will be measured at baseline, at eight weeks following the supervised Tai Chi program and again at three and six months into the maintenance Tai Chi program. Outcomes will include exercise capacity, quality of life, physical activity, balance, participants’ attitudes to management of their health care, compliance with short and long-term Tai Chi training, and satisfaction with the maintenance Tai Chi training.

Approximately half of all survivors of stroke experience memory impairment, which can significantly impact functional independence and quality of life. Two different approaches have typically been implemented in an effort to rehabilitate memory: restoration (computer based training) and compensation (group based training). Overall, there is no clear consensus as to whether either computer-based training or compensatory approaches to memory rehabilitation are effective or efficient for stroke patients. As a result, many survivors of stroke are purchasing costly computer training programs with unknown effectiveness. At Monash University, we are currently running a randomised controlled trial to explore the efficacy and cost efficiency of different approaches to memory rehabilitation post stroke. Eligible participants will be randomised into a waitlist control,memory group or computer training group and will receive free memory rehabilitation over a six week period. In doing so we aim to explore the most cost-efficient and effective way in which memory can be rehabilitated post stroke, thereby addressing a clear gap in service provision.

The project aims to determine if the two commonly used drug regimens for soft food impactions in the oesophagus are better than placebo for passage of the obstructing bolus. Retrospective data from small and poorly-designed studies have led to the recommendations for the trial of glucagon, glyceryl trinitrate (GTN) or a combination of both in soft food bolus impactions as first line management prior to endoscopy. Retrospective data from a recent audit carried out at Freemantle has demonstrated that the rate of clinical resolution was not appreciably different between patients treated with drugs and patients not treated with drugs and that a strategy of proceeding straight to endoscopy might be preferable In order to definitively answer the question, we propose to prospectively assign patients to either a drug regimen of a) glucagon and GTN or b) placebo and observe the outcomes after 30 minutes after which the pharmacological properties of the drugs excludes a drug effect.

The objectives of this study are to determine if leucoreduction is effective in reducing the incidence of transfusion associated microchimerism in major trauma patients and analyse the immune response and cytokine profiles to determine if immunosuppressive conditions enhance the formation of TAM.

Falls are common among people with multiple sclerosis (MS). About 60% of people with MS (PwMS) experience at least one fall each 6 months and about 30% have multiple falls. Increased fall risk and fear of falls have been shown to significantly affect quality of life and curtail activities among people with MS. Therefore, effective interventions to reduce fall risk in PwMS are urgently needed. Fall prevention and treatment strategies in MS are still at an early stage. Studies on falls in MS reveal important balance, coordination and cognitive determinants of falls. Based on these results, we propose a randomised single-blind controlled trial (RCT) to evaluate a step training intervention designed to prevent falls in PwMS. The proposed trial will enrol approximately 500 PwMS over a period of 36 months. Recruitment will initially take place in NSW and will be extended to other Australian states if required. It is expected that if the research confirms effectiveness of treatment strategies, implementation of clinical interventions will contribute to reduced fall rates in PwMS and associated injury-associated costs, reduced fear of falls and improved quality of life for PwMS.

The complex ecosystem of the adult intestinal microflora is estimated to harbour at least 500 different anaerobic bacterial species. Several reports have indicated that five genera account for most of the viable forms of anaerobic bacteria: Bacteroides, Eubacterium, Bifidobacterium, Peptostreptococcus, and Fusobacterium. Some of these species are considered potentially harmful because of their capacity to produce toxins, invade mucosal cells and activate carcinogens and inflammatory responses. There are, however, known strains with health-promoting properties, principally Bifidobacteria and Lactobacilli. This study will examine the capacity of a human-isolated probiotic strain of bacteria to influence the composition of the gut microbiome in healthy adult human volunteers and to examine what health benefits may be associated with daily consumption of the strain in the form of freeze-dried powder in capsules. The strain that will be tested in this study is Lactobacillus fermentum VRI-003, referred to as “PCC(Registered Trademark)”. PCC(Registered Trademark) has been sold as a dietary supplement in capsule and powder form for over ten years worldwide with no reported adverse effect. The study is a proof of concept, single centre, randomised, double-blind placebo controlled, parallel group study. A total of 60 healthy adult subjects (no diagnosed GI disease) will be randomised in a 1:1 ratio to receive either PCC(Registered Trademark) or placebo over a 6 month treatment period. Each active capsule contains a minimum of two billion live organisms. There will be 4 study visits in total. Subjects will provide three faecal samples: at Visit 2 (baseline, Day 1), Visit 3 (day 90) and Visit 4 (day 180). The samples will be analysed by 16S RNA analysis to monitor the composition of the gut microbiome. Subjects will be asked to complete a daily diary regarding their bowel habits. Subjects will also be asked to complete a general health questionnaire (SF-36) on three occasions. Weight will also be recorded.

The primary purpose of this study is to compare the efficacy of denosumab treatment with placebo in preventing bone decay in premenopausal women being treated with ovarian suppression and aromatase inhibition for breast cancer. Who is it for? You may be eligible to enrol in this trial if you are a premenopausal woman aged 18 to 55 who has been diagnosed with oestrogen-receptor positive, non-metastatic breast cancer (TxNxM0) for which you are scheduled to begin ovarian suppression and aromatase inhibition therapy which is intended to last for at least 12 months. Study details All participants enrolled in this trial will be randomly allocated (by chance) to receive either denosumab once every 6 months by subcutaneous injection or to receive placebo once every 6 months for a 12-month study period. Participants will be followed-up at 6 and 12 months after starting the trial drug/placebo with scans, blood tests and questionnaires which will be used to measure bone density and structure, body composition, blood markers of bone health and cardiovascular risk and quality of life. It is hoped that the findings from this trial will provide information on the extent of bone decay which occurs as a result of ovarian suppression and aromatase inhibition therapy, and the efficacy of denosumab in preventing this decay in premenopausal women with oestrogen-receptor positive breast cancer.