ANZCTR search results

Gluten is believed to be poorly tolerated by many Australians and is often blamed for causing a wide range of gastrointestinal and psychological symptoms. Commonly reported gastrointestinal symptoms include; abdominal pain, bloating, flatulence and altered bowel habit, as frequently reported by people suffering from irritable bowel syndrome. Commonly reported psychological symptoms include; anxiety, depression and a reduction in quality of life. The best studied ‘gluten intolerance’ is coeliac disease. Coeliac disease is an auto-immune condition that occurs in 1% of the Australian population. The only available treatment for coeliac disease is life-long strict avoidance of gluten containing foods (including wheat, rye and barley). While the average daily gluten intake in a Western diet is 10-20 g (equivalent to 2-5 slices of wheat-bread), in people with coeliac disease, 50 mg (equivalent to 1/100th of one slice of wheat-bread) gluten can cause damage to the lining of the small intestine. Non-coeliac Gluten Sensitivity: There is another (much larger) group of individuals, however, who believe that gluten can also cause these types of symptoms and yet, after extensive investigations by doctors and specialists, are shown not to have coeliac disease. This group of people are often referred to as having ‘non coeliac gluten sensitivity’. This condition, however, is very poorly understood and recognised by the medical profession. Evidence for the Existence of Non-coeliac Gluten Sensitivity: Recently completed dietary studies undertaken by our research team have found conflicting evidence for the induction of gastrointestinal symptoms following the ingestion of gluten in people believing they have ‘non-coeliac gluten sensitivity’. While an original study found good evidence that gluten can indeed cause gastrointestinal symptoms in some individuals who do not have coeliac disease this finding was not confirmed in subsequent studies. Furthermore, our most recent study showed convincing evidence for a specific effect of gluten on mental health. In this study results indicated that short term exposure to gluten specifically induced current feelings of depression. Such findings suggest that a major effect of gluten amongst this population may be on mental health and not necessarily on gastrointestinal symptoms. This finding would also explain why participants report feeling better on the gluten-free diet despite the continuation of gastrointestinal symptoms. Outcomes and Significance: The purpose of this study is to investigate the role that gluten has in causing gastrointestinal symptoms and changes to mental health in people who believe they have ‘non-coeliac gluten sensitivity’. The results from this study will provide us with a more comprehensive understanding of the relationship between gluten and its influence on gastrointestinal symptoms and mental health.

APL-2 is an experimental drug being developed by Apellis Pharmaceuticals Inc for the potential use as a treatment for people with a broad range of blood disorders (including paroxysmal nocturnal hemoglobinuria (PNH)) and certain types of auto-immune diseases). PNH is caused by a small change to the individual’s genes, which results in red blood cells being broken down prematurely. People with PNH typically feel tired and often see some blood in their urine. The condition is unfortunately progressive with sufferers needing increasing medical care, with an average life expectancy of only 10 years after diagnosis. The currently available treatments are insufficient to deal with this complex disease with most patients not fully responding to the treatments. APL-2 works in a different way to the drugs that are currently approved, and has been shown in laboratory studies to prevent the breakdown of red blood cells and keep them healthy. It is hoped that APL-2 will help improve the quality of life and reduce the severity of the condition for PNH sufferers. This study will be first study of APL-2 in humans. The assessments of the safety, tolerability, pharmacokinetics, and pharmacodynamics following administration of single doses of APL-2 will guide decisions to further develop the drug.

Assess whether routine vitamins supplementation, that is appropriate for Chronic Kidney Disease (Kidney Vital) improves patients nutritional status and quality of life.

Exercise per se has recently been shown to be effective in the management of fatty liver, independent of weight loss. Sustained weight loss is becoming increasingly recognised as an unrealistic and unsustainable outcome of lifestyle intervention. There are currently no practical guidelines for physical activity in fatty liver disease. This research aims to examine the components of regular exercise which result in an hepatic benefit by comparing i) low-intensity/low energy expenditure aerobic exercise training (LO-LO); ii) low-intensity/high energy expenditure aerobic exercise (LO-HI) iii) high-intensity/low energy expenditure aerobic exercise training (HI-LO) iv) progressive resistance (PRT) and v) a placebo control on hepatic and visceral fat, liver enzymes, and other health outcomes in overweight and obese sedentary individuals with pre-diabetes. We hypothesize that: the high-intensity/low energy expenditure aerobic exercise training will result in greater improvement in liver fat content than a) low-intensity/low energy expenditure aerobic exercise training b) low-intensity/high energy expenditure aerobic exercise training and c) placebo control; that the progressive resistance training will result in greater improvement in liver fat content than a) low-intensity/low energy expenditure aerobic exercise training b) low-intensity/high energy expenditure aerobic exercise training and c) placebo control; and that all exercise training groups will result in greater improvement in liver fat content than the placebo control group

This study aims to determine optimum surgical management of patients with melanoma spread to their groin lymph nodes. Who is it for? You may be eligible to join this study if you are aged 15 years or above and have been diagnosed with primary cutaneous melanoma or stage III melanoma with metastases (i.e. tumour spread) in the groin area. Study details Participants in this study will be randomly (by chance) allocated to one of two surgery types. Participants in one group will be undergo Inguinal Lymphadenectomy (IL), which is removal of the easily accessible superficial groin lymph nodes (LNs) and has a median LN retrieval of 11. Participants in the other group will undergo Ilio-inguinal Lymphadenectomy (I-IL) which involves removal of the same superficial groin LNs but also combined with the more surgically complex removal of the ipsilateral pelvic LN. About twice as many LN are removed with I-IL compared to IL. Currently surgeons have polarized opinions as to whether to perform a limited or more extensive lymphadenectomy and there is no evidence of which is the best option. Participants will be followed-up for a period of up to 10 years in order to evaluate disease response, survival and quality of life outcomes. The results of this study may standardise care globally, lead to better cancer outcomes, reduce surgical morbidity and reduce economic burden for the health sector.

Alcohol misuse has significant impact on user's lives. This proposal refines and tests an innovative motivational treatment (‘Functional Imagery Training’), based on the applicants’ Elaborated Intrusion Theory of desire. A key focus is on individually tailored imagery to consolidate motivation, interfere with craving, rehearse coping strategies and enhance self-efficacy. The proposal develops a mobile phone app that cues commitment and coping when alcohol control is under threat, using pictures, icons and brief descriptions. This study is an uncontrolled pilot with 12 participants, following them over 6 months, and collecting alcohol-related outcomes and qualitative responses.

This study aims to determine whether zoledronic acid or denosumab are efficacious in reducing back pain and size of Modic lesions in persons with back pain and Modic changes. Primary hypothesis is that either drug will be different to placebo for pain and size of Modic lesion at 6 months. The design is a double-blind placebo-controlled trial. Participants will be randomised to receive zoledronic acid or denosumab or placebo, and will be observed for 6 months.

Alcohol misuse has significant impact on user's lives. This proposal refines and tests an innovative motivational treatment (‘Functional Imagery Training’), based on the applicants’ Elaborated Intrusion Theory of desire. A key focus is on individually tailored imagery to consolidate motivation, interfere with craving, rehearse coping strategies and enhance self-efficacy. This study is an uncontrolled pilot that tests a phone-delivered version of FIT with 30 participants, following them over a 6-month period, and collecting alcohol-related outcomes and qualitative responses. Results underpin a planned NHMRC Project Grant application for 2014.

The purpose of the study is to help determine whether, in high risk patients undergoing cardiac surgery, a device known as an intraaortic balloon pump placed prior to surgery to support the heart, reduces serious postoperative complications. The study will also help determine whether a large study to definitively answer this question is feasible.

This project will evaluate the effectiveness and cost-effectiveness of the “Toolbox” which consists of a website for young people to access a personalised, ongoing recommendation service for evidence based tools and applications (apps) to support their wellbeing and mental health. Our project will evaluate the Toolbox by assessing changes in the participant’s wellbeing levels before and after using the website and associated apps.