ANZCTR search results

The overall aim of this study is to improve treatment outcomes for patients with ulcerative colitis (UC) primarily focusing on improved patient care and empowerment through patient involvement in the decision making around their disease management. It aims to trial the first decision aid for UC which explains the risks and benefits of treatment in a clear, understandable and balanced way to greatly enhance patient understanding of their disease and management options. This in turn is expected to improve medium-term quality of life by better patient empowerment and quality of decision making in UC. Improvements in anxiety, adherence to chosen therapy, disease outcomes and prevention of complicatons will ideally follow. This will be the first study in the world to trial a decision aid developed to help decision making in UC treatment, making this a highly significant research project with the potential to contribute to routine UC care worldwide.

With increasing demands of patients concerning their refractive outcome after cataract surgery, a variety of advanced technology intraocular lenses have become available in the last years. The modifications include advanced optic designs, improved haptic materials and designs and combinations of both. A new era of cataract surgery has entered the market recently, the femtolaser-assisted cataract surgery (FLACS). This advanced technique replaces various steps of cataract surgery which had to been done manually or by ultrasound devices. The femtolaser can do highly precise incisions for access to the crystalline lens which needs to be replaced in cataract patients. The capsulorrhexis, the manual opening of the capsular bag can be replaced by a high precision capsulotomy with the laser. Furthermore, many FLACS devices can divide the opaque natural lens in mini-fragments which can easily be aspirated afterwards. This step was traditionally performed with phacoemulsification using ultrasound. Furthermore, the correction of mild astigmatism by arcuate incisions can be performed with these types of laser which was done manually, based on nomograms, before. Major advantages of FLACS are the improved ability of planning and controlling incisions and capsulotomy, the higher precision with regards to size and shape and the lower amount of energy induced in the eye, compared with ultrasound phacoemulsification. In parallel to the development of the FLACS technology a new lens type has been developed: the FEMTIS. The highly precise execution of the laser allows to exactly predict the size and position of the capsulotomy. The FEMTIS has been designed to be locked in place in the opening of the capsule. In traditional lens implantation, the IOL was placed in the capsular bag and kept in place by the back-pressure of the capsule against the haptics. Capsular shrinkage and fibrosis increases the pressure on the haptics which can lead to decentration, tilt and rotation of the lens, resulting in induced higher order aberrations which decrease the optical quality of the visual system. If a lens, like the FEMTIS is locked in place in the capsular bag opening, IOL decentration, tilt and rotation should be minimized, which should result in a higher predictability and refractive precision. In this study we will investigate the stability of lens position and the visual outcome after implantation of the new FEMTIS® Comfort using FLACS capsulotomy. The FEMTIS® Comfort is a rotational asymmetric refractive lens with a sector-shaped IOL part providing an addition of 1.5 dioptres. The extended depth of focus should effected a higher visual acuity for far and intermediate distances with greater spectacle independence.

Amyotrophic Lateral Sclerosis (ALS) is a devastating disease, characterised by a progressive degeneration and loss of motor neurons, and is currently incurable. The reduction or avoidance of physical activity by patients with ALS (pALS) exacerbates the loss of physical function attributable to the disease itself, and sets up a deleterious cycle of progressive impairment. One potential way to break this cycle is exercise. The main aim of this proposal is to provide the first physiological evidence of the beneficial effect of exercise training in pALS, by counteracting the muscle weakness, due to cardiovascular deconditioning and muscle disuse, caused by the avoidance or reduction of physical activity in these patients. Our primary hypothesis is that involvement in a moderate-intensity, aerobic and strength training program will be tolerated and will attenuate reductions in physical performance (muscle strength and aerobic capacity) and physical function in pALS, and will consequently improve their quality of life. If the proposed hypothesis is confirmed, this study will change the role of physical activity in the clinical management and treatment of pALS.

Knee osteoarthritis (OA) is a major public health problem. Exercise is recommended by all clinical guidelines for managing pain in knee OA, however, effects of exercise on pain and function outcomes are only modest. This may be due to poor exercise adherence amongst knee OA sufferers. There is evidence that the use of text messaging as a behaviour change adherence tool can be effective in the healthcare setting for a variety of conditions. To date the use of SMS messages as an adherence tool for exercise has not been assessed in the knee OA population. Our primary aim will therefore be to investigate the effects of adding a behaviour change embedded text message intervention, to a 6 month home based exercise program for knee osteoarthritis. Participants who complete a previous RCT (ACTRN 12617001013358) will be randomly allocated to one of two groups: i) SMS adherence intervention - a home based exercise program completed three times weekly for 24 weeks PLUS an automated, semi-personalised, mobile phone text message intervention, embedded in behaviour change theory to promote adherence to the exercise program. ii) No adherence support control - a home based exercise program completed three times weekly for 24 weeks, independently with no adherence support. Primary outcomes are self-reported adherence measures and secondary outcomes include self-reported pain and function. The primary timepoint is 24 weeks.

This study will look at the safety and feasibility of endoscopic ultrasound (EUS) guided portal vein blood sampling as an ultimate staging procedure in patients with pancreatic cancer. Who is it for? You may be eligible to join this study if you have been diagnosed with metastatic pancreatic cancer, locally advanced pancreatic cancer, or resectable pancreatic cancer. Study details All study participants will undergo endoscopic ultrasound (EUS) guided portal vein blood sampling. EUS is a procedure that safely allows the imaging of the digestive tract and surrounding tissue through ultrasound testing. The use of EUS is currently the preferred method for sampling pancreatic masses. The portal vein is a blood vessel that provides blood to the pancreas, and other gastrointestinal organs. Blood samples taken from the portal vein can be used to determine if pancreatic cancer cells are present, providing a useful technique for diagnosing pancreatic cancer. This procedure will involve finding portal vein under EUS guidance, and EUS portal vein sampling is done via a trans-hepatic approach that allows the liver tissue to act as a cushion that seals the needle tract, reducing the risk of bleeding complications. Blood samples will be analysed to count circulating tumour cells, which can be used for molecular characterisation of pancreatic cancers. A way to detect these is to analyse the % of mutated KRAS; a specific protein found in over 90% of patients with pancreatic cancer. Unfortunately, techniques cannot reliably detect small numbers of mutant KRAS copies. In peripheral blood samples, there is only a reported sensitivity of approximately 50% in patients with pancreatic cancer. This may be higher in portal venous samples where there is no filtering by the liver. All participants will also be monitored for safety for up to 7 days post procedure. Final follow-up will occur at 6 months. It is hoped that EUS guided portal vein blood sampling could represent the most sensitive technique for biological staging in pancreatic cancer.

This multi-site parallel groups randomised controlled trial will aim to recruit 300 alcohol-dependent patients (aged 18-65) admitted for inpatient detoxification at De Paul House (St. Vincent’s Hospital Melbourne), Wellington House (Eastern Health) or Windana Drug and Alcohol Recovery. The primary aim is to determine the effectiveness of CBM training during inpatient alcohol detoxification in terms of increased abstinence rates 2 weeks following discharge,relative to controls who receive sham training. We also aim to explore rates of abstinence, 3, 6, and 12 months post-discharge as a secondary outcome. Another secondary aim is to determine if pre-training levels of approach or attentional bias moderate the effectiveness of CBM, based on the hypothesis that those who drink due to strong cognitive biases are likely to benefit from treatments targeting these biases, while those with low cognitive biases, whose drinking is driven by other factors (e.g. relief from distress) may benefit less from CBM. We also aim to measure the difference between groups in rates of use of further inpatient withdrawal and acute health services during the year following discharge to assess whether CBM training leads to cost savings to the health system, and to measure differences between groups in cue-induced desire for alcohol following CBM training. We hypothesise that, compared to those receiving sham training, participants receiving CBM training will show significantly higher rates of abstinence from alcohol at all followups. We also anticipate that stronger baseline attention and approach bias will be associated with a larger effect of CBM (i.e., baseline attention/approach biases will moderate CBM’s effect on abstinence). We expect significant net cost saving in the CBM group compared to controls in terms of reduced cost of repeated inpatient detoxification treatment and acute health care use during the year following discharge (after accounting for the costs of implementing CBM training in the CBM group). Compared to those receiving sham training, participants receiving CBM training will show significantly reduced cue-induced desire to alcohol images (but not to images of non-alcoholic beverages). We expect that this interaction will remain, with similar effect size, when analyses are restricted to images not included in the training task, demonstrating generalisation of reduced cue-induced desire beyond the specific stimuli that participants were trained to avoid.

Cardiovascular disease remains a leading cause of death and disability in our community, with atherosclerosis being the major disease process underlying the majority of heart attacks. Atherosclerosis is a disease in which plaques made up of fat (cholesterol) builds up in the wall of an artery. As plaque builds up it can narrow the coronary artery and reduce blood flow to your heart muscle. There is also a risk that the plaque may rupture causing a sudden blockage of the artery. This can cause a heart attack, which results in permanent damage to heart muscle. However, there is little understanding of how plaques grow in the arteries and what makes certain plaques at high-risk of causing a heart attack. Recent experimental data has suggested that the force the blood exerts on the wall of the artery (shear stress) may be important in promoting plaque growth and even rupture. Measurement of shear stress in humans is challenging and is currently performed via a coronary angiogram combined with specialist invasive imaging. These images allow us to create a three-dimensional model of the arteries to the heart on a computer. Shear stress can then be calculated using highly specialist software that models blood flow in the arteries. At present, shear stress calculations can only be performed following an invasive medical procedure. This means we cannot calculate shear stress for the majority of patients with suspected coronary artery disease. CT coronary angiography (CTCA) is an established, safe, rapid and convenient non–invasive method to diagnose the presence of coronary artery disease. CTCA also provides useful information on the size and composition of coronary plaque. However, the ability of CTCA to calculate shear stress in coronary arteries is unknown. If this project is successful, then shear stress calculations could be performed based on CTCA images, which would allow clinicians to explore whether this force is responsible for plaque growth or rupture in humans.

This study aims to investigate the utility of the use of whole blood for point of care testing for B-hCG to rapidly differentiate pregnant and non-pregnant patients. This is important in time-critical conditions such as ruptured ectopic pregnancy. It would also expedite things in the situation where medical imaging involving ionising radiation is delayed until pregnancy can be excluded. The current testing options are a urine point of care test, or a serum sample sent to the pathology lab. The point of care test pack inserts state that whole blood cannot be used with them, but in practice they have been used that way and expedited decision-making. A convenience sample of female patients of reproductive age presenting to the Emergency Department who would typically have their pregnancy status checked, will be recruited to the study. A whole blood B-hCG (point of care), a urine B-hCG (point of care), and a serum sample for quantitative hCG will be tested. The blood sample will be sent to pathology for a quantitative serum B-hCG result, and will be used as the standard for comparison. A result of <1.2 units/L is a negative pregnancy test. The results from the urine and whole blood point of care tests will be compared against this, to determine their sensitivity and specificity in a separate analysis. The time taken to obtain a result from the point of care B-hCG testing using urine and whole blood will be compared against the time taken to obtain a result from the sample sent to the lab. We will then be able to compare the differences between length of time taken to obtain a urine or blood sample, and the differences between length of time taken to obtain test results for each of these samples.

Purpose of the research Significant weight gain and poorly controlled blood pressure are commonly seen in patients with end stage renal disease on intermittent hemodialysis. There is evidence that these complications are due to not enough salt being removed from the body during hemodialysis. The hemodialysis machine currently uses a standard strength of sodium during each hemodialysis session. If this concentration is reduced, this may improve blood pressure control and decrease the amount of weight gained between dialysis sessions. The reason we are doing this research is to find out if the low sodium fluid is better than the regular concentration that is currently being used.

It is well recognised that rates of T2DM are increasing at dramatic rates in Australia. A number of interrelated factors are associated with increased risk of developing the condition, however, much of the cause can be attributed to obesity as a result of high energy, high fat and high animal protein diets along with a lack of regular physical activity. Currently, there is no known medical cure for the condition. However, studies conducted on participants enrolled in a number of lifestyle modification programs suggest that the symptoms of T2DM are reversible where energy intake is reduced resulting in improved body weight and Body Mass Index. Previous studies conducted on individuals with abnormal blood glucose levels also indicate that the adoption of the Complete Health Improvement Program (CHIP) lifestyle intervention significantly reduced blood sugar levels in compliant individuals. This study will investigate: The effect of the CHIP intervention on obesity, blood sugar and medication levels of a group of participants with established T2DM. It will also examine the cost benefit of such an intervention. This will be done by evaluating the following: The blood sugar, HBA1c, cholesterol and blood pressure readings in those participating in the CHIP intervention delivered over a period of 12 weeks with additional monthly follow up for another nine months compared to a control group receiving their usual diabetes care. The levels of compliance over a 12-month period in those participating in the CHIP intervention delivered over a period of 12 weeks with an additional follow up for another nine months compared to a control group receiving their usual diabetes care. The cost benefit (over a 12-month period) of implementing the CHIP intervention delivered over a period of 12 weeks with an additional follow up for another nine months compared to a control group receiving their usual diabetes care. The outcomes of this study have the potential to inform decisions about patient treatment and potentially provide an incentive for the provision of funded lifestyle based preventive and restorative programs for patients diagnosed with T2DM.