ANZCTR search results

To assess the safety and effectiveness of percutaneous transluminal angioplasty (PTA) for the treatment of extracranial and/or azygous vein stenosis in MS patients as measured by clinical parameters of physical and mental disability progression.

This study is a randomised controlled trial for patients with metastatic or locally advanced pancreatic cancer, comparing a drug named Creon - which acts as a pancreatic enzyme supplementation - to placebo, in order to determine its influence on change in weight. We will also look at the drug's effect on quality of life, nutrition and survival, with our expectation being that Creon will decrease the rate of weight loss, improve quality of life, nutrition and length of life. This study is being performed due to previous research showing a benefit to pancreatic enzyme supplements in patients with pancreatic cancer with a bile duct stent in place to relieve a blockage caused by the cancer. It is known that pancreatic cancer causes weight loss, and thought that poor absorption of nutrients may contribute to that weight loss. This study aims to assess whether aiding the aborption of nutrients leads to better nutrition, weight stabilisation, improved quality of life and improved survival. Trial details In this study you will be randomly assigned to either the active medication (the Creon drug made of pancreatic enzyme), or to an identical, but non-active placebo capsule. In either group, you will take 2 capsules of Creon/placebo with meals, and one capsule with snacks every day. After one month and depending on how you have tolerated the drug, the dosage may be increased to 3 capsules with meals and/or two capsules with snacks, depending on whether you are feeling bloated, flatulent and/or have diarrhoea. Overall, you will continue the treatment for at least 2 months. During the study will be assessed by study personnel including the doctor, nurse and dietitian. The assessments are weight measurement, questionnaires about nutrition, symptoms and quality of life. These visits will be monthly for 2 months, then every three months while you and other participants remain on the study. Who is it for? You may be eligible for this study if you have metastatic or locally advanced pancreatic cancer and aged 18 and over. Full details of whether or not you can participate can be found in the Inclusion Criteria section of this record.

This is a Phase 3, multicenter, open-label, extension study to evaluate the safety, tolerability, efficacy, and immunogenicity of long-term epratuzumab treatment in subjects with SLE. Subjects who complete 1 of the Phase 3, double-blind, placebo controlled studies, SL0009 or SL0010, or terminate prematurely (at Week 16 or later) due to lack of efficacy, are eligible to enroll in SL0012. The study consists of an Open-Label Treatment Period and a Safety Follow-Up Visit. During the Open-Label Treatment Period, all subjects will receive epratuzumab 600mg delivered QW via slow iv infusion for a total of 4 consecutive weeks (CMD 2400mg) over eight 12 week treatment cycles (ie, Weeks 0, 1, 2, 3, 12, 13, 14, 15, 24, 25, 26, 27, 36, 37, 38, 39, 48 (Year 1), 49, 50, 51, 60, 61, 62, 63, 72, 73, 74, 75, 84, 85, 86, and 87 (Year 2) [96 weeks total duration]). A Safety Follow-Up Visit will occur approximately 4 weeks after Week 96 (ie, no later than Week 100) for subjects who complete the study, or 13 weeks after the final dose of study drug for subjects who discontinue early. Study drug treatment is in addition to the subjects’ existing standard care of oral corticosteroids and any immunosuppressants or antimalarials continued from Baseline in the subjects’ prior study.

The use of topical ocular non-steroidal anti-inflammatory drugs (NSAIDs) has been limited by the common side effects of burning and stinging. It has been reported that lowering the temperature of lubricant eye drops results in improved ocular comfort. This research project is to determine if refrigeration of 0.5% ketorolac tromethamine prior to administration improves patient tolerability of the commercially available preparation. These findings may lead to an improved method of delivery that will reduce the adverse effect profile of topical NSAIDs, increase patient compliance and influence future prescribing trends.

Considering the increasing popularity of mixing energy drinks with alcohol and the very little research to-date, it is imperative that further research is carried out. The aim of the present study is to extend the available research exploring the effects of the combination of energy drinks with alcohol. Specifically, the study aims to investigate the effects of the combination of alcohol and Energy Drink on cognition and mood compared to Energy Drink alone, alcohol alone and placebo. The design of the current study is a randomised, double-blind, placebo-controlled and crossover trial administering 0.6g/kg alcohol and 250ml Energy Drink plus water to form 500 ml. Participants will be randomly allocated to an alcohol, Energy Drink, alcohol and Energy Drink combination, and placebo sequence with a washout period of seven days between each condition. Participants will undergo a practice session where they complete the cognitive task twice and the mood questionnaires once to ensure there are no practice effects in the testing sessions.

Context: The Bindjareb Yorgas Health Program (BYHP) project addresses the high prevalence of health issues experienced by Aboriginal women and their families (Thomson et al., 2010) through the establishment of a holistic community owned and developed health and wellness program. The BYHP is being developed at the request of the Bindjareb women from the Murray District Aboriginal Association in Pinjarra, following the success of a 2011 seed project, “The Deadly Koolinga Chefs” (DKC). The DKC program was conducted by the study’s PhD student and funded by the Community Development Foundation (CDF). The project engaged a group of 12 year old Bindjareb children in a 12 week nutrition and cooking adventure, where they learned how to plan, shop for and prepare a healthy meal for four. Each week the children took home their prepared meals, together with their new skills and knowledge, to share with their family. This resulted in a request by the Bindjareb women for a broader health promotion program to address the health and wellbeing of the community’s women and by association, their families. In collaboration with the Bindjareb women, using an aboriginal approach based on “unity’ and “wholeness” (Wingard & Lester, 2001) a suite of programs is being developed (see Appendix A). The BYHP, for which Healthway funding is being sought, is the first of these to be undertaken and comprises four components: group fitness and exercise sessions; nutrition education and cooking classes; vegetable growing and Nyungar lore, communicated through Kaartdijin yarning sessions. This combination was agreed upon as it specifically addressed the Bindjareb women’s concerns regarding the need for a more culturally appropriate approach to health promotion to address health issues being experienced in their community. Objectives: This intervention aims to extend knowledge surrounding existing health promotion initiatives previously designed in Aboriginal communities by implementing a program that ensures community ownership and development of the program. It will focus specifically on three action areas for undertaking health promotion: creating supportive environments to encourage equitable access; strengthening community actions to enable empowerment; and the development of personal skills in achieving and maintaining wellness. Methods: The intervention has been developed using a multi-faceted approach to promoting healthy eating and improved fitness within the context of Nyungar lore. To ensure a culturally appropriate means, of assessing the outcomes, a holistic descriptive case study method (Yin, 2009) will be used, where the researchers will seek to narratively explore the impact on participant’s health behaviours in relation to the development of, and participation in, the BYHP. The data will be collected with the assistance of the Aboriginal Health Worker (AHW) and the Aboriginal Research Associate (RA). Data sources will therefore include yarning groups, interviews, direct observations and participant-observations and will be collected over the course of the intervention and the year to follow. The program will take place during the school terms in the Mother of All Sheds (MOASH) building, a community centre provided by the CDF and, situated on the grounds of the Pinjarra Primary School. Expected benefits: This intervention project, whilst facilitating community ownership and leadership of an Aboriginal health promotion program aims to provide both short and long term improvements in the physical activity and healthy eating habits that will translate into improved fitness and weight loss, and empowerment through increased health knowledge. These have important implications for the health and well-being and the social and community capacity of the Bindjareb community in Pinjarra and may also serve as a template for similar health promotion programs in other communities. In addition, identifying environments that encourage Aboriginal participation and are nurturing to both attitudes and aptitudes of good health behaviours may have positive implications on future policy development and infrastructure planning related to Aboriginal health.

This qualitative study will investigate the effects of second generation antipsychotics on weight gain, and the enblers and barriers to physical activity for adults with serious mental illness.

Patients with cirrhosis frequently experience painful muscle cramps which can affect the hands, legs, feet, neck, back, sides and abdomen. They may last for several hours, often occur at night and may require opiates or presentation to accident and emergency to control the pain. The available therapies have limited efficacy. This study aims to determine the efficacy of oral taurine supplementation in reducing the frequency and intensity of painful muscle cramps in this group. It is a randomised control, crossover, blinded study where participants will receive either taurine supplements or placebo for a period of one month and then cross over to the other group. Participants will be asked to complete a questionnaire about muscle cramps prior to entering the study, at the cross over (1 month after entry) and at completion of the study. Participants will be asked to keep a diary of cramps prior to entry into the study and for the duration of the study. In addition to the usual blood taken when attending clinic, a small amount of blood will be taken for amino acid analysis, taurine in particular, and TNF and IL-6

The aim of the current pilot study is to identify the efficacy of different pharmacological approaches for the management of experimentally induced nocioceptive pain in patients currently receiving opioid substitution treatment in the form of methadone or buprenorphine (+/- naltrexone) maintenance treatment (sublingual film or tablet). The pharmacological interventions to be assessed are (a) increasing maintenance opioid dose by 30%, (b) adding opioid agonist (oxycodone equivalent to 30% of the daily opioid maintenance dose, and (c) adding gabapentin to the usual maintenance dose. The primary outcome measure is change in pain response using a cold pressor model for acute pain. Measures of safety, including physiological and cognitive measures, will also be examined.

The T4DM study will investigate whether treatment with testosterone in combination with a lifestyle program normalise glucose tolerance in men with either pre-diabetes or newly diagnosed type 2 diabetes, in comparison to placebo and a lifestyle program in men aged 50-74 years. See www.t4dm.org.au for details