ANZCTR search results

In previous studies, we and others have observed that the levels of plasmalogens (a class of phospholipid (blood fat)) are lower in obese people and people with type 2 diabetes and cardiovascular (heart) disease. In one of our studies we have shown that dietary supplementation of alkylglycerol (fats found in the liver of most animals and fish) can increase levels of plasmalogens. This increase is associated with a reduction of athersosclerosis (artery blockage) in mice. In separate experiments, after treating mice on a high fat diet with alkylglycerols, we observed a reduction in the inflammation caused by obesity. In this project we will observe the effect of alkylglycerol (Alkyrol) supplementation (in the form of a capsule) on overweight/obese males. The study will involve a cross-over design, where participants will take a supplement of Alkyrol (shark liver oil capsule) or placebo (dummy capsule) for three weeks, a wash out (no supplementation) period of three weeks and cross over to Alkyrol or placebo for three weeks. Over this time blood will be collected at certain points and then analysed to observe the effect of alkylglycerol on plasmalogens and the effect of inflammation. We will recruit 10 overweight/obese men (Body Mass Index (BMI – a measure of body fat based in relation to your height) of 28-35kg/m2), not being treated for hypertension (high blood pressure), diabetes or cardiovascular (heart) disease or taking any fish oil supplements. This study represents the first proof of concept (demonstration) human trial that alkylglycerols can modify circulating plasmalogen levels and influence inflammation. If positive, this randomised clinical trial will support therapeutic approaches targeting plasmalogen modification for the prevention of type 2 diabetes and cardiovascular disease.

Patients undergoing laparoscopic Nissen fundoplication were randomly assigned to undergo division or no division of the short gastric blood vessels. The study sought to determine whether or not dysphagia was the same in each group

During Nissen fundoplication, hiatal repair undertaken either in front or behind the oesophagus

The project is a efficacy trial to evaluate the enhanced version of Aussie Optimism: Social Life Skills and Optimistic Thinking Skills Program. This research project builds on recent information about emotional competence and cognitive skills in the pre-adolescent period to promote and enhance mental health benefits for grade 6 children. Students aged 10-11 years of age from 63 government primary schools in Perth, Western Australia, participated. Schools were randomly selected to one of the three conditions: 1) Aussie Optimism with teacher training, 2) Aussie Optimism with teacher training plus coaching, and 3) a usual care or control condition that received the regular Western Australian Health Education Curriculum. The findings showed that Aussie Optimism with teacher training plus coaching was associated with best outcomes: 1) a significant increase in student-reported pro-social behaviour from pre-test to post-test 1(maintained at post-test 2) and significantly lower incidence rates from suicidal ideation at post-test 2 and follow-up. These findings suggest that the Aussie Optimism Program with Teacher Training along with coaching has the potential to prevent mental health problems in the pre-adolescent years.

The purpose of this study is to assess the use of Prostate-Specific Membrane Antigen (PSMA) PET/CT scans to identify if men with increased Prostate Specific Antigen (PSA) in the blood have prostate cancer cells in the prostate bed alone, elsewhere in the body, or both. The second phase of the study will evaluate the effectiveness of using the Calypso (Registered Trademark) tracking system for radiation therapy. Who is it for? You may be eligible to join this study if you are a male aged 18 years or above, and have undergone radical prostatectomy. To be eligible for the second phase, the PSMA PET scan result must show localised recurrence or be negative for disease. There should be no evidence of metastatic disease on the PSMA-PET. Study details: The study will be divided into two phases. During the first phase all participants will undergo 68Ga-PSMA PET/CT test. This test uses a medical imaging technology called Positron Emission Tomography (PET), a highly sensitive technique using specialised ‘tracer’ particles to detect PSMA. The tracers are given by injection, usually into a vein in the arm. A PET/CT scanner is used to obtain an image showing distribution of the tracer within the body. The PET scan routinely involves a low level CT scan performed at the same time. There is no preparation for a PSMA PET scan. The scan can take 2-3 hours. Before the test, a needle will be inserted into a vein in your arm or hand. A small amount of radioactive tracer will be injected. You will be asked to rest quietly (45-90 minutes). You will then be taken to the PET/CT scanner bed and asked to lie still on the bed while the PET/CT images are taken. This will take about 30 minutes. You will not feel anything while the images are taken. Some people benefit from a sedative if they suffer from a fear of enclosed spaces (claustrophobia). This must be arranged before the scan. Should you need any form of sedation, you will need to fast for 6 hours (nothing to eat or drink) before scan. The amount of radioactivity used for the scan is small and there are no known side effects to the injection. For the second phase of the study, only participants that show no evidence of metastatic disease will receive radiotherapy. Participants with a negative PSMA will be treated to 70Gray (Gy) in 35 fractions at 5 fractions per week with the Calypso tracking system. Participants with a PSMA that is positive for local recurrence only will receive an additional 4Gy in 2 fractions (total dose = 74Gy in 37 fractions at 5 fractions per week). This therapy will use the Calypso tracking system. It uses radiofrequency emitting beacons implanted within the area being treated, allowing tracking of any movement during delivery of radiation. This means that we can make the margins around the cancer smaller thus reducing the side effects of radiation therapy. Participants who are ineligible for Calypso beacons will receive standard radiotherapy (described above), but without Calypso beacons.

The AGOG Epidemiology Study will study genes, lifestyle and environmental factors in people with and without brain tumours in order to identify who are at risk of developing these tumours. Who is it for? You may be eligible to join this study if you are aged 18 to 79 years and were diagnosed with glioma between January 2013 and June 2016. Study details This is an observational study, meaning that no treatment is given to participants as part of this study. Participants and up to two family members are asked to provide a blood (or saliva) sample and complete three questionnaires regarding their lifestyle and family history of glioma. Researchers will use this information, along with disease and treatment information from hospital records to identify patterns between patient lifestyles, family histories, genetics and disease treatment and outcomes. It is hoped that the findings of this study will provide a research platform for further studies into predictive factors of glioma and glioma outcomes, and for the identification of future treatment options for glioma.

This study is evaluating the activity and efficacy of Stereotactic Ablative Body Radiotherapy (SABR) for the treatment of kidney cancers. Who is it for? Age > 18 years old All patients must have a biopsy confirmed diagnosis of renal cell carcinoma with a single lesion within a kidney 1. ECOGperformance of 0-2 inclusive. 2. Life expectancy > 9 months 3. Either medically inoperable, technically high risk for surgery or decline surgery. 4. Multidisciplinary decision for active treatment Study Details: Definitive external beam radiotherapy (EBRT) is often used to treat medically inoperable patients with cancers in many different organs, including the kidneys. However, renal cell carcinoma (RCC) is conventionally considered “radioresistant” to fully fractionated EBRT. In an effort to overcome the perceived “radioresistance” of RCC, severely hypofractionated EBRT in the form of stereotactic radiotherapy has renewed interest in the management of renal cell carcinoma with radiotherapy. Participants in this study will be allocated to receive either multi-fraction SABR (3 fractions over 2 weeks) or single fraction SABR (1 fraction only). All participants will be assessed at regular intervals post treatment in order to estimate the activity and efficacy of the technique, evaluate tolerability, estimate survival, estimate distant failure rate, and renal function change after SABR. The follow-up visits occur at 4 weeks and every 3 months in the 1st year post treatment, then every 6 months in the second year and then yearly until study closure (2 years after the last participant finishes study treatment).

This randomised controlled trial (RCT) aims to compare clinical outcomes for patients with severe respiratory distress who receive continuous positive airway pressure (CPAP) in addition to usual care to those who only receive usual care in the pre-hospital setting. CPAP is a central part of treatment for patients with severe respiratory distress in the emergency department (ED) and in hospital. The evidence for the use of CPAP in the pre-hospital setting is weak and studies have measured outcomes such as in-hospital mortality that can be attributed to in-hospital care. Furthermore, there is a paucity of robust studies from pre-hospital settings that do not rely on physician or critical care specialist managed care. Robust studies are essential to demonstrate the benefit of CPAP in the pre-hospital setting before the widespread introduction of the therapy into Australian prehospital clinical practice. The study will be conducted in the Perth metropolitan area. St John Ambulance (SJA-WA) provides all road-based emergency ambulance services in WA. All emergency calls for an ambulance in WA are received by SJA-WA service operations centre located in Perth. Ambulances are staffed by paramedics with advanced life support skills. This study will use dyspnoea scores as a primary outcome. Dyspnoea (respiratory distress) is a highly distressing symptom: patients describe a sensation of air hunger or suffocation. Alleviating suffering from severe breathlessness is a top priority in the care of patients with severe respiratory distress. The American Thoracic Society stress dyspnoea can and should be measured. Dyspnoea scales have been shown to predict hospital admissions, in-hospital mortality and early readmission in acute exacerbations of COPD. As such, dyspnoea scales are an appropriate primary outcome measure for pre-hospital research in patients with respiratory distress. Any pre-hospital study that demonstrates a reduction in patient distress is likely to change ambulance practice in the same way that interventions that reduce pain would be implemented. In summary, severe respiratory distress is a medical emergency. CPAP improves outcomes in patients with severe respiratory distress in the ED and in-hospital setting but there is a paucity of information on the efficacy of CPAP initiated early in the Australian pre-hospital setting. It is incorrect to assume that interventions applied in-hospital have similar efficacy pre-hospital, due to the differences in capacity and capabilities between the two settings. Therapies shown to be efficacious in hospitals need to be evaluated in the pre-hospital setting to ensure their safety and effectiveness prior to introduction. This information is critical to establishing the evidence base underpinning this therapy prior to ambulance services incorporating CPAP as routine clinical practice.

Background and study aims The hip joint has two bones that fit together like a ball in a socket. In some people these bones press against each other and can cause pain called "femororacetabular impingement" (FAI). Parts of the hip called the 'labrum' and 'cartilage' cushion the hip joint and allow the smooth friction-free movement. FAI can injure both the labrum and cartilage and also cause pain. There is good evidence to suggest a link between FAI and the development of premature osteoarthritis of the hip, but we do not know the best treatment for FAI. There has been a rapid increase in the use of keyhole surgery to treat this condition called 'hip arthroscopy'. During hip arthroscopy the patient is put to sleep and the surgeon passes a small telescope and tools into the hip joint through small cuts in the skin. The tools are used to reshape bone around the hip to prevent further impingement. Many patients have already undergone surgery and had improvements in pain and hip function in the short to medium term. However, this research was not compared to conventional care and it is possible that they may have similar levels of improvement without an operation. An alternative treatment option for patients is a course of best conventional care (a structured programme of exercise-based care supervised by a physiotherapist - this has been called personalised hip therapy) aimed at improving the muscle strength and control around the hip joint. There are fewer risks associated with this type of treatment and it is less expensive. We therefore propose a study to find out which of these two treatments is most effective for treating patients with FAI up to 12 months after treatment. Who can participate? The study aims to recruit 140 patients in Australia with hip pain, aged 16 and above. What does the study involve? Patients are randomly allocated to either undergo arthroscopic surgery or receive usual care. Participants will receive their allocated treatment and will then be required to complete some questionnaires at baseline, 6 and 12 months. Participants will be asked about further procedures required for their hip condition at 2 and 3 years following recruitment. At 12 months we will conduct our first analysis to measure the effectiveness of the two treatments. Australian FASHIon study participants will have specialised MRI scans using a contrast agent (gadolinium) used to investigate changes in the hip joint cartilage health. We will ask participants to have these scans when they join the study and after 12 months. Participants at the Melbourne study centres will be asked to attend the gait laboratory at the University of Melbourne where hip range of motion, muscle strength and movement patterns will be assessed. These measures will be taken at baseline and 12 months. An addition subset of 20 participants will be asked to perform some functional tasks with fine wires inserted in their muscles to provide information about their muscle activity.

Conversion disorder is a health condition in which a person experiences problems with moving parts of their body or other nervous system symptoms that can’t be explained by a medical assessment. These symptoms are thought to be due to stress. This project wants to determine if different conversion disorder symptoms are associated with particular patterns of feeling and thinking, and managing stress and relationships. We also want to test whether a breathing technique aimed at reducing stress when practiced for 20 minutes a day for a month leads to greater calmness and a reduction in conversion disorder symptoms A useful treatment for those with Conversion Disorder is regular weekly Psychotherapy for the purpose of understanding a patient’s problems. It does not normally, however, involve specific breathing techniques. This study wants to find out if using the breathing techniques before and potentially during up to 2 years of “talking” psychotherapy makes the psychotherapy more effective in reducing conversion disorder symptoms. We also want to compare the way symptoms and stress change with standard Neurology treatment versus psychotherapy alone or with combined Neurology and psychotherapy treatments.