ANZCTR search results

We have previously demonstrated the effectiveness of a multidimensional assessment and individualised management approach in older people with obstructive airways disease, showing that such a programme leads to significant improvement in health outcomes. The current study aims to continue this new model of management in a different population of people with severe persistent asthma. People with severe persistent asthma continue to suffer a significantly high burden of disease despite maximal pharmacotherapy. Despite this, few trials seeking to improve management of severe asthma, have been performed. The current study aims to improve the management and outcomes for people severe persistent asthma, with the goal of reducing morbidity, improving health status and informing clinical guidelines. This study will aim to test a novel model of management in severe asthma using multidimensional assessment and individualised management (MDAIM) including inflammometry and case management. We hypothesize that treatment of severe asthma that is targeted to co-morbidities, inflammatory and other immunological biomarkers delivered using a case management approach will improve severe asthma outcomes specifically asthma control, exacerbations, medication use and health related quality of life.

Selenium (Se) - an essential trace micronutrient, and green tea - the most common beverage consumed worldwide, have numerous biological properties that may protect against various cancers, including colorectal cancer (CRC). Despite promising results in preclinical settings, current clinical trial data are not convincing enough to allow general recommendation for using Se or green tea as an effective agent for chemoprevention of cancer in humans. This is a pilot study on the possible effects of Selenium (Se) in preventing bowel cancer in healthy individuals. 3 or 4 of our staff members will take part in this trial, prior to the launch of a full study once results have been gathered from this pilot study. Who is it for? This pilot study on Brazil nuts will be performed on 3 or 4 of our staff. They will take 6 Brazil nuts daily (which will provide 48 micrograms Se/day) for 4 weeks. Their blood samples (on 2 occasions) will be collected at the baseline and after intervention. We believe this pilot study will provide important information as to how many Brazil nuts will be required per day to increase plasma Se levels, as we expand the research into an upcoming, full study. Background Information There is growing evidence that a combination of dietary agents may synergistically or additively improve the chemopreventive efficacy than any single dietary agent. Our previous studies in mouse CRC model have shown that Se activate apoptosis (Cancer Res. 2008 June 15;68(12):4938-44), whereas green tea up-regulates DNA repair enzyme. Our recent animal studies have further shown that combining Se and green tea is more effective in suppressing colorectal oncogenesis than either Se or green tea alone, and is associated with regulation of genetic and epigenetic biomarkers implicated in colonic carcinogenesis (submitted to Clinical Cancer Research). Se and green tea are particularly interesting as a combination not only because they can be co-administered in the diet but also because they have potentially complementary mechanisms of action. We now plan to expand our study to human subjects and determine if a combination dietary supplementation of Se and green tea provides greater health benefits than can be achieved from a single dietary agent of Se or green tea by regulating molecular biomarkers. We have used selenium-enriched milk protein as the Se source in our previous human trials (Br J Nutr 2011 Aug;106(4):572-82). It was our intention to continue using dairy Se product for our upcoming human trial. Unfortunately, the production and supply of selenium-enriched milk protein has been stopped by Tatura Milk Industries (VIC, Australia). We have to seek an alternative Se source from food, and have decided to use Brazil nuts because it is the richest known food source of Se. A previous randomized controlled human trial has shown that 2 Brazil nuts per day (provided 53micrograms Se/day) is as effective for increasing plasma Se status as 100 micrograms Seasselenomethionine during 12 weeks of intervention, reaching maximum plasma Se levels at 6 weeks (Am J ClinNutr 2008;87:379-3840). Se concentration in Brazil nuts (supplied from Charlesworth, Australia) has recently been analysed by National Measurement Institute (Australia Government, VIC), the average Se concentration in Brazil nuts is relatively low (2.7 micrograms Se/g) compared to that of the report by Thomson et al, where the Se concentration is 6.4 micrograms Se/g (Am J ClinNutr 2008;87:379-3840).

Cardiac resynchronization therapy pacemaker devices are now an established therapy for heart failure patients. However the optimal method to set up these devices is as yet uncertain. We aim to use echocardiography to optimize these devices on a patient specific basis. We will examine no optimization vs. resting optimization vs exercise optimization in a systematic manor to determine the superior method in terms of functional and cardiac improvment.

The aim of this clinical trial is to determine whether a novel starch (butyrylated high amylose maize starch, Starplus B) can protect against colorectal cancer. Butyrate is normally produced in the colon by the fermentation of dietary fibre, and Starplus B can increase the concentration of butyrate in the colon. Laboratory and animal experiments suggest butyrate from dietary Starplus B may reduce the risk of developing colon cancer. The study is a double blind, randomised controlled trial involving 120 volunteers likely to develop a genetic form of colon cancer (familial adenomatosis polyposis, FAP). FAP patients usually have most of their colon surgically removed by their early 20’s, and require regular follow-up colonoscopies to ensure they do not develop tumours in their residual rectum. After a baseline colonoscopy the FAP volunteers consume either Starplus B or placebo starch for 6 months, and then undergo a colonoscopy to assess the number and size of polyps and to sample the lining of the colon for analysis. The volunteers then consume the other starch for 6 months, and undergo a further colonoscopy. As the FAP gene mutation also occurs in the majority of sporadic (common) colorectal cancer, the study may identify a dietary chemo-preventative supplement which is likely to benefit the wider community who are at risk of developing sporadic colorectal cancer.

The CELSIUS Study is a prospective observational study of temperature measurement in critically ill patients with acute brain injury and sepsis in Australia and New Zealand. In these patients we are evaluating commonly used methods of temperature measurement (tympanic, axillary, nasopharyngeal) with assessment against a pragmatic gold standard of urinary bladder temperature (intravesical) measurement.

This is a Phase I, open-label study of the safety and biodistribution of two escalating doses of PEG-AVP0458, labeled with 3-5 mCi of 124I for PET imaging. This is the first study of PEG-AVP0458 in humans. PEG-AVP0458 is an experimental molecule, meaning that it is not approved for use in Australia or other parts of the world outside of this trial. The ultimate purpose of this research is to find better ways to detect and treat prostate and ovarian cancers. The product under investigation, PEG-AVP0458, has been designed to attach to a specific protein called TAG-72, which is found on the surface of some types of cancer cells however it is not a treatment for cancer. The aims of this study are to determine the safety of PEG-AVP0458 at the doses studied, and to demonstrate that PEG-AVP0458 can attach to the TAG-72 protein on prostate and ovarian cancer cells in humans. To enter the study patients with prostate or ovarian cancer need to screen as positive for TAG-72 and have disease deemed likely to be assessable by PET scan. An ECOG performance status of 0-1 and an expected survival of at least 3 months are also requirements for study entry. At screening participants must be of at least 18 years of age, provide informed consent to participate and show appropriate blood parameters. Patients with ovarian or prostate cancer are ineligible to participate if any of the exclusion criteria noted in the exclusion criteria section above. Trial Details PEG-AVP0458 will be combined with a low dose radioactive iodine particle by a process called radiolabelling, and injected. The radiolabel acts as a tracer, which means that it can be detected in tissue by a special scanning system called a PET scan. This study is designed to assess the safety and targeting ability of PEG-AVP0458, and no direct therapeutic benefit from the infusion of PEG-AVP0458 is anticipated. The first group of 3 participants enrolled will be allocated to the 1mg/m2 dose group. If any Dose Limiting Toxicities (DLTs) are seen for these 3 participants, the second group of 3 participants will also receive 1mg/m2. If no DLTs are seen in the first group of 3, the second group of 3 participants will receive the 10mg/m2 dose. If any DLTs are seen for these 3 participants, the third group of 3 participants will also receive 10mg/m2. If no DLTs are seen in the second group of 3, the third group of 3 participants (alongside a further 3 participants, total of 6) will receive either the 1mg/m2 or 10mg/m2 dose level, as determined by the outcome of the interim analysis.

The primary aim of this six-month randomised controlled trial (RCT) is to determine whether access to a cardiometabolic health nurse (CHN) results in improved primary care for the prevention and treatment of cardiometabolic disorders such as cardiovascular disease and diabetes, compared to usual care in a regional Queensland mental health service. The secondary aim is to determine whether the CHN group demonstrate improvements in objectively-assessed and self-reported physical and mental health. We hypothesise that: 1. Greater numbers of primary health care services for cardiometabolic health disorders will be provided to the CHN care group than the usual care group during the six-month intervention. 2. Greater improvements in measures of physical and mental health will be observed in the CHN care group over the six-month intervention compared to the usual care group, and the CHN care group will also demonstrate improvements in health behaviours.

This study aims to assess the safety and efficacy of combined infusion of immune cells and vaccination to boost immunity to infection after bone marrow transplantation. Who is it for? You may be eligible to join this study if you are undergoing bone marrow transplantation for any type of non-malignant condition or haematological malignancy including but not limited to acute and chronic leukaemia, myelodysplasia, non Hodgkins and Hodgkins lymphoma or myeloma. Trial details Participants in this trial will be allocated to one of three groups. The first group will receive multi-infection specific T-cells intravenously (via the vein) 28 days after bone marrow transplantation. The second group will also receive this treatment in addition to the Fluvax vaccination. The third group will undergo the immune cell infusion, Fluvax vaccination and Varivax vaccination. All participants will be assessed regularly over a period of 12 months in order to determine the safety of this treatment, and to determine whether it can prevent viral and fungal infection following allogeneic blood or marrow stem cell transplantation.

At least 20% of older people that are seen in a hospital emergency department and discharged will reattend the ED within 28 days. There are many negative consequences associated with ED reattendance and rehospitalisation soon after discharge. We will conduct a randomised trial to determine whether referral to and intervention by a Complex Needs Coordination Team after discharge can reduce the risk of ED reattendance.

The peak plasma propofol levels of endoscopy patients (Derived mathematically from the 3 measurements) along with the context sensitive half time of propofol (determined by the length of infusion) will allow the researchers to determine the time taken for plasma propofol levels to drop below levels known to cause driving impairment and thus estimate how long it takes for patients to drive safely after receiving a propofol only anaesthetic.