ANZCTR search results

Objectives of this study are to assess the effects of the remote ischemic preconditioning (RIPC) on the primary graft failure (PGF), heart function and multi-organ protection after heart transplantation. This is a prospective, multi-centre, double-blind randomized controlled clinical trial (RCT). The outcome of the study is expected to determine if significant protection by the RIPC previously achieved in animal study can be translated into clinical heart transplantation. Study Duration: Three years. Intervention is the RIPC stimulus (also referred to as ‘protocol’) which consists of four five-minute cycles of arm ischemia with intervening five minutes of reperfusion following induction of standard anaesthesia in the operating room, prior to heart transplantation (HT). Inflating a standard blood pressure cuff to a pressure exceeding systolic by 20 mmHg will interrupt blood flow. The cuff would be deflated during reperfusion. Control patients will have sham placement of cuff without inflation. Participants will be monitored after HT and an analysis of blood samples (involving an examination of markers of myocardial damage, i.e., troponin I) collected as a part of standard care will be used to determine if there are protective effects due to the RIPC protocol used. Number of Subjects: 50. Population: Adults and children aged >15 years undergoing heart transplantation for the first time.

This randomised placebo-controlled trial will recruit 210 patients following an acute myocardial infarction (MI). They will be randomised to colchicine 0.5mg once daily or matching placebo for 30-days. Patients, health-care providers, data collectors and outcome adjudicators will be blinded to treatment allocation. Randomisation will occur within 7 days of the index MI and will be stratified by study centre. Baseline clinical data, including concomitant medications, serum biochemistry, full blood count and creatine kinase will be recorded. These blood tests will be repeated at 30 days. Levels of C-reactive protein (CRP) will also be measured at baseline and at 30-days. Patients with a type 1 MI (using the 3rd universal definition) will be eligible for inclusion unless they have a know contraindication to, intolerance of or clear indication for treatment with colchicine. The primary aims of this study are to provide data regarding the feasibility, tolerability and safety of low-dose colchicine after acute MI. The secondary end-points relate to the ability of colchicine to reduce CRP. Data from this trial will be used to inform the design of a larger outcome trial.

The primary purpose of this study is to examine the fertility-related quality of life and psychological distress in young cancer patients and their parents/carers compared to individuals of the same age receiving a fertility consultation for fertility problems which are not related to cancer. Who is it for? You may be eligible to participate in this study if you are aged 15-25 and have been diagnosed with any cancer in the previous [0-90 days from diagnosis], or are receiving a fertility consultation for fertility problems which are not related to cancer. Parents/carers/partners of enrolled cancer patients may also participate. Study details: Cancer patients and non-cancer related fertility problem groups will complete one questionnaire at enrolment into the study, and then the same questionnaire at 12 months and three years’ post-treatment. Participants will also complete two sixty-minute semi-structured telephone calls at the enrolment, 12 months and 3 year time points. Parents/partners of cancer patients will complete one questionnaire and two-sixty minute semi-structured telephone interviews at three different time points which will include: at the patient’s cancer diagnosis, 12 months and three years post-treatment. All participants will be asked about their quality of life and psychological distress related to their infertility or their child's/partner’s infertility. Researchers will use the data collected from questionnaires and interviews to investigate the short and long term effects on mental health, quality of life and meaning of parenthood in these young adults. It is hoped that the findings of this study will inform healthcare providers of the psychological effects of cancer-related infertility in young people.

We will conduct a cluster randomised trial (60 groups of older people) to evaluate two healthy ageing strategies among community-dwelling people who attend established community-based groups. The primary objective is to measure the effectiveness of: a) a physical activity and fall prevention intervention including telephone-based health coaching and written information on physical activity and falls over a 12 month period, and b) a nutrition intervention including telephone-based health coaching and written information on eating habits over 12 months. The trial also aims to establish the impact of the interventions on physical activity guideline adherence, eating habits, body mass index, goal attainment, mobility confidence, quality of life, fear of falling, risk taking behaviour, wellbeing and mood.

People who have had a stroke and are living at home spend 75% of their waking hours sitting down, which is much higher than people of a similar age without stroke. Spending long periods of time sitting down each day increases the risk of cardiovascular disease, including stroke, putting this population at particularly high risk. About a third of people who have had one stroke will have a second or third stroke, so it is important that we look for ways to reduce this risk. In studies of people without stroke, breaking up prolonged sitting time with regular activity breaks (walking or simple strengthening exercises) leads to significant reductions in cardiovascular disease risk factors such as glucose metabolism and blood pressure. The effects of breaking up sitting time in people with stroke, and the optimal type of activity break for this group is not known. Not getting enough physical activity is the second highest risk factor for stroke, but achieving the recommended amount of daily physical activity, particularly for those people who find it difficult to walk, is near impossible for many stroke survivors. Therefore, reducing sitting time is a promising, innovative, low cost intervention to reduce the risk of having another stroke. We will conduct a study that will help us to understand the impact of prolonged sitting time on stroke risk factors, and will assess the effectiveness of two ways of regularly breaking up sitting time in people with stroke. We will recruit 19 stroke survivors who have difficulty walking. Each survivor will complete all 3 experimental conditions in a random order, under the direct supervision of research staff at HMRI. The 3 conditions will be (1) prolonged sitting without breaks (control), (2) breaking up sitting time by walking at a comfortable speed overground (ie not on a treadmill) for 3 minutes every 30 minutes, and (3) breaking up sitting time with 3 minutes of simple exercises in standing every 30 minutes. Participating stroke survivors will have blood samples taken at regular intervals throughout the duration of the study, and will have their blood pressure continually monitored. Our study outcome measures will include glucose and insulin measures (primary), blood pressure, plasma fibrinogen (secondary) as well as safety and feasibility indicators. This study will be first to assess the effects of breaking up prolonged sitting time in people with stroke. We aim to build on this work in the future by testing different types of activity breaks (eg standing only, seated exercises) at varying frequencies and durations in different sub-groups of stroke survivors (eg people who walk well, and those that cannot walk at all). BUST-Stroke will also inform future research to assess the effect of reducing daily sitting time in people both early (in hospital) and later after stroke.

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.