ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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32856 results sorted by trial registration date.
  • ADHERE study: Behaviour change SMS messages to promote longer term adherence to exercise for knee osteoarthritis.

    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.

  • Endoscopic Ultrasound Guided portal vein sampling as an ultimate staging procedure in patients with pancreatic cancer: a feasibility study.

    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.

  • A randomised controlled trial of Cognitive Bias Modification training during early recovery from alcohol dependence.

    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.

  • Non-invasive validation of shear stress measurements in patients with coronary artery disease

    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.

  • Utility of Whole Blood Point of Care Beta human Chorionic Gonadotrophin (BhCG) Testing using Urine Pregnancy Assay

    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.

  • Effect of low dialysate sodium on interdialytic weight gain (IDWG) and hypertension in patients undergoing chronic intermittent haemodialysis – a prospective study in The Townsville Hospital and the North Ward haemodialysis units

    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.

  • Protocol for a randomized clinical trial investigating the clinical effectiveness and cost benefit of a lifestyle intervention targeting Type 2 Diabetes Mellitus.

    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.

  • Neural Repair and Sleep in Traumatic Brain Injury ('TBI'): an observational study to investigate the recovery of sleep after TBI.

    The purpose of this study is to investigate the brain signalling in sleep after TBI. We want to know if sleep problems improve as time passes after the brain injury, and whether the recovery of sleep, sleep quality, and cognition are related. It is also possible that some patients after a severe TBI have breathing problems in sleep. It is possible that breathing problems in sleep could affect their recovery. The sleep study will include monitoring for breathing disorders during sleep.

  • A Head to Head Comparative Pilot Trial of Endoscopic ultrasound-guided (EUS) Core Biopsy Needles in solid pancreatic lesions: ProCore vs Shark Core and Acquire

    The primary purpose of this trial is to compare the efficacy of three types of core biopsy needles used for Endoscopic Ultrasound-Guided (EUS) fine needle biopsy. Who is it for? You may be eligible to enroll in this trial if you are aged 18 years old or older and require endoscopic ultrasound and tissue sampling of solid lesions in the pancreas, which are suitable for EUS fine needle aspiration. Study details All participants enrolled in this trial will have tissue sampling performed using three different biopsy devices: the ProCore, the Shark Core and Acquire devices. The order in which each device is used will be randomly allocated (by chance). Only a single pass (i.e. a single attempt at sampling) will be completed for each device. The tissue obtained using each device will be stored and analysed by cytologists and pathologists to determine the diagnosis and adequacy of samples obtained using each device. It is hoped that the findings from this trial will provide information on which of the three devices provides the most sufficient samples for analysis and diagnosis of pancreatic lesions.

  • Investigation into the sustained impact of food advertising on children’s dietary intake and its potential to influence children’s weight

    The aim of this research was to investigate the direct effects of children’s exposure to food advertising on their dietary intake and its potential influence on the development of childhood overweight. Across a series of six-day holiday camps, children (n=160, aged 7-12 years) were exposed to food and non-food advertising in an online game and/or a television cartoon in a randomised within-subject, cross-over, counterbalanced design. The primary aim of the study is to explore whether short-term increases in snack intake following food advertising exposure are compensated for at a subsequent lunchtime meal; and hence identify if food advertising contributes to a positive energy balance likely to contribute to childhood overweight.

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