ANZCTR search results

This study is investigating the ability of a means of gentle electrical stimulation to the abdomen in improving bowel function in patients with constipation. This is called trans abdominal electrical stimulation (TES). It is used successfully in the treatment of urinary incontinence, but a side effect is diarrhoea. It has been used in a study on children with constipation where it improved bowel function and quality of life. We believe it will also improve bowel function in adults with constipation. This stimulation is administered through 4 sticky electrodes where 2 are on the front of the abdomen and 2 on the back. The current passes diagonally through from front to back on both sides. We will split participants into two groups where one receives the stimulation the correct way, and the other where the current does not go diagonally, but from right front to right back, the same on the left. It is believed this is not therapeutic. Participants will not know which way is the correct way, so we hope that those who do receive it the correct way will show an improvement over those that don’t. The study will run for 6 weeks for each participant. Participants will keep a diary and answer a questionnaire before, halfway through and at the end of the study. Further contact for this information will also be at 3 months and one year after the study. Before and after the study tests on the function of the rectum and anus will be done, as will a colon transit time study, which looks at how quickly the colon works.

Heart disease is the single biggest cause of death for Aboriginal and Torres Strait Islander people and the main reason for the difference in life expectancy between Indigenous and non-Indigenous Australians. Indigenous Australians are 3 times more likely to suffer “heart attacks” than non-Indigenous Australians and are 1.5 times more likely to die as a result. Recent studies suggest that Omega 3 polyunsaturated fatty acids (PUFAs) may help prevent “heart attacks” in people who already have coronary artery disease. Coronary artery disease is caused by plaque building up along the inner walls of the arteries of the heart, which narrows the arteries and reduces the blood flow to the heart. Omega 3 oil is a polyunsaturated fatty acid (PUFA) found in some plants, seafood, and, to a lesser extent, eggs and meat. Omega-3 is seen as "essential" because the human body can't produce it and so we must get it from foods or supplements. Several studies around the world have shown a decrease in the risk of sudden cardiac death (SCD) associated with increased consumption of fish or fish oils. This study is likely to be very important for understanding the main cause of death and life expectancy gap for Aboriginal people, as well as providing evidence to guide policy and clinical practice. The purpose of this study is to test the effectiveness of Omega-3 Long Chain Polyunsaturated Fatty Acid supplementation in Aboriginal adults with established coronary artery disease (CAD) to determine effects on factors implicated in adverse cardiovascular (CV) events including: atherogenic and protective lipid factors, Inflammatory factors, factors associated with thrombus formation, arrhythmic risk as measured by heart rate variability, and major adverse cardiovascular events (MACE). The Aboriginal Cardiovascular Omega 3 (AC Omega 3) trial aims to find out if Aboriginal patients who have coronary artery disease will be better protected from having “heart attacks” by taking an Omega 3 oil supplement and if so how does it help do this.

Hypothesis: MSCs are safe in COPD. Aims of trial ; To track MSCs post-infusion in the lung To ensure safety of MSCs We will infuse labelled MSCs and track them with nuclear imaging. We will then do a second infusion of MSCs to monitor safety

Aim of pilot study: To evaluate the impact of an 8-week school-based intervention examining High Intensity Interval Training (HIIT) vs. a Body Weight Exercise Program (BWEP) on various physical and psycho-social outcomes for low active year 9-10 students from the Newcastle region. i. Can an 8-week school-based HIIT program improve cardio-respiratory fitness (primary outcome) in comparison to a BWEP for low active students? ii. Can an 8-week school-based HIIT program improve secondary outcomes (e.g., Body composition, BMI, Muscular fitness, physical self-description, executive function) in comparison to a BWEP for low active students? iii. Will a school-based HIIT program be a feasible and acceptable method to improve fitness outcomes and psycho-social outcomes of students? Implementation of Pilot Study: Implementation of the 3-arm 8-week HIIT vs. BWEP intervention will occur during term 3, 2014. After randomisation has occurred: *Group A (n=20 participants) will proceed as the HIIT intervention group; *Group B (n=20 participants) will proceed as the BWEP intervention group; and, *Group C (n=20 participants) will act as the comparison (‘wait-list control’) group. The program will be replicated for group C once the intervention and all follow-up assessments have been completed by all groups. The intervention and wait-list control groups will receive the program at school, during school hours (i.e., sessions will be conducted during recess and lunch breaks, using school-based facilities, three days per week during term 3). Setting and Participants: The program will be held during school hours (i.e., recess and lunch breaks) utilising facilities available at the school. Equipment for the activity sessions will be sourced from the school and the University of Newcastle PE store room, if required. This pilot study will involve three separate groups within one secondary college in the Newcastle region, aiming to recruit a total of 60 participants (Intervention condition A (N=20 participants); Intervention condition B (N=20 participants); Wait list control (N=20 participants)). Intervention: This intervention is designed for year 9-10 students from a secondary college in the Newcastle region. The intervention will involve delivery of an 8-week school-based program conducted within school hours (e.g., recess and lunch breaks). The program will consist of: *Each week students randomised to the intervention conditions will participate in 3 x 8 minute HIIT or BWTP sessions, which will include a combination of core, upper body and lower body exercises. Sessions will be conducted by trained facilitators (e.g., qualified physical education teachers). *Sessions will be held in the school gym or another appropriate area within the school campus during recess/lunch breaks on three days per week. *All sessions will be delivered in a comfortable environment (e.g., indoors, air-conditioned, sufficient space, motivational music, basic equipment) to ensure continued participation and engagement of students. Physiological and psycho-social assessments will be conducted at baseline and post-intervention.

Babies who have deprived of oxygen during birth can be at risk of brain damage because the blood rushes to the brain to compensate for the lack of oxygen. Cooling has been show to help prevent brain damage. Currently all babies are cooled for 72 hours but it is thought that some babies may benefit from being cooled for longer. Babies in this study will have more frequent ultrasound scans through the soft spot on the head (fontanelle) to monitor blood flow to the brain. Ultrasound scans will occur before cooling, daily whilst cooled, and every hour during rewarming (this takes around 12 hours). Whilst being treated the baby will be monitored by a patient monitor that monitors blood pressure, heart rate and respiration rate and an electroencephalograph (EEG) monitor which records electrical brain activity. The data from the patient monitor and EEG will be collected and analysed for the research. Pathology results and MRI’s may also be included in the research. When the baby is 2, it is normal practice to invite parents of HIE babies to an interview with a Paediatrician to discuss their developmental progress and this study will use the information from this developmental review.

Invasively measure haemodynamics (right heart catheterization and arterial line) at rest and during exercise (Ex 1) in patients with presumed HFPEF and to repeat these measures after random allocation to milrinone or placebo

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