ANZCTR search results

This study will investigate the health effects of using CPAP to treat sleep apnoea in conjunction with a weight loss program. We hypothesise that using CPAP to treat sleep apnoea in conjunction with a weight loss program, compared with a weight loss program alone for 3 months, will better improve glucose tolerance, insulin sensitivity, abdominal and total fat mass and cholesterol, central blood pressure and 24 hour blood glucose levels. These hypotheses will be tested in 2 groups of patients with OSA, pre-diabetes and obesity using a three month randomised controlled trial (RCT) design, followed by a 9 month optional weight maintenance follow up period. The first group will receive CPAP plus a Very Low Energy Diet (VLED) for 3 months. Participants assigned to this group will then be offered sleep apnoea support and weight maintenance support for 9 months. Participants assigned to the second group will receive a VLED alone for 3 months. They will then be offered a 3 month trial of CPAP with the option of continuing on CPAP by themselves. They will also be offered sleep apnoea support and weight maintenance support for 9 months. The primary outcome will be the difference in glucose tolerance between CPAP and non-CPAP treated groups at 3 months.

Each year, over 2000 children are born with congenital heart disease in Australia, of which the majority requires surgical intervention. Congenital heart disease ranks still within the top causes of infant mortality in industrialized countries. Despite considerable advances over the past decade, the exposure to cardiopulmonary bypass (CPB), which is needed for most surgeries, remains responsible for major side effects: The exposure of patient blood to large artificial surfaces in the CPB circuit triggers a very strong systemic inflammatory syndrome, which leads in a third of patients to low cardiac output syndrome (LCOS). LCOS is defined as a condition with a reduced oxygen delivery to end organs due the postoperative heart not being able to meet the circulatory demand. LCOS manifests with severe organ dysfunction such as respiratory and renal failure, and can lead to brain hypoperfusion, cardiac arrest, and death. Survivors are at increased risk for long term neurological impairment. Patients with LCOS require increased length of respiratory support, prolonged length of stay in intensive care and hospital, resulting in significantly increased health care costs, and translating into lifelong costs due to neurological impairment. Previous attempts to reduce the detrimental inflammatory effects of CPB using immunomodulating drugs such as corticosteroids have failed to show a demonstrable benefit. Nitric oxide is a endogenous anti-inflammatory mediator, with direct actions on endothelial bed and immunologically active cells. Previous studies suggest that the delivery of gaseous nitric oxide (NO) to bypass circuits results in myocardial protection and in a reduction in bypass-induced inflammation. We have therefore performed a randomised controlled single centre pilot trial and showed that the delivery of gaseous nitric oxide (NO) to the oxygenator of the CPB circuit for children undergoing cardiac surgery for congenital heart defect resulted in a twofold reduced incidence of LCOS, and improved patient-centred outcomes including less need for extracorporeal life support post surgery, and shorter duration of mechanical ventilation, with a trend to improved mortality. In order to confirm these single centre pilot data we aim to investigate in a multicentre randomised controlled trial if NO reduces length of mechanical ventilation as a primary outcome, and reduced LCOS/ECLS/death as secondary outcomes.

The purpose of this study is to compare the visual performance (defined by visual acuity measurements and subjective ratings) between two optically similar designs that only differ by lens material. To achieve this, participants will each wear both lens types for a minimum of 5 days. Outcome measures will comprise visual acuity and subjective ratings. Our hypotheses are there will be no differences between lens type for either visual acuity or subjective ratings.

The purpose of this study is to compare the visual performance (defined by visual acuity measurements and subjective ratings0 between a new commercially-available contact lens design which utilise digital zone optics (DZO), two prototype Extended Depth-of-Focus (EDOF) contact lens designs which utilise higher-order spherical aberration terms and a commercially-available single vision contact lens (SV). To achieve this, participants will wear each of the 4 lens designs for a minimum of 5 days. Outcome measures will comprise visual acuity and subjective ratings. Our hypotheses are there will be no difference between lens designs for either visual acuity or subjective ratings.

Safety and tolerability of experimental hookworm infection in humans with metabolic disease: Proof of Concept (Phase 1b) clinical trial Aims: 1. To establish the acceptability, safety and tolerability of experimental infection with the hookworm Necator americanus (Na) in young obese adults with features of the metabolic syndrome (MetS). 2. Conduct exploratory studies into the impact of hookworms on stabilizing or improving immune/inflammatory, metabolic and microbiological parameters associated with metabolic disease Background: Central obesity and subsequent type 2 diabetes (T2DM) are causing a global epidemic of disability and premature death which threatens to bankrupt health systems even in wealthy countries. The vast majority (80%) of all diabetes cases and 88% of deaths occur in low to middle income countries, many of which still have a significant infectious disease burden. T2DM and several associated chronic conditions are increasingly recognized as having common pro-inflammatory pathways and it is these effects which account for much end-organ damage, especially in the liver, muscle, kidneys, vascular endothelium and brain (Calle et al, 2012). Animal studies and more recently, human observational reports from those transitional populations with high prevalence of helminth exposure and metabolic illness, suggest that helminth infection protects against T2DM and MetS (Hayes, 2015; Tracey, 2016). A plausible biological pathway for this effect has been demonstrated in animal models, where helminth infection stimulates a T helper Type 2 (Th2)-type immune response that, in concert with worm-induced regulatory T cell responses may improve insulin sensitivity, either directly or via suppression of pro-inflammatory Th1/Th17 immune responses. There is evidence that this effect is mediated, at least in part, by changes induced by the worm to the host gut microbiota. Members of the team (AL, PG) have established that experimental inoculation with the human hookworm Necator americanus is safe and efficacious in the treatment of humans with celiac disease (CeD), and which is currently in use in a NHMRC-funded multi-centre clinical trial (ref protocol, Croese 2016). Previous studies have demonstrated that these controlled hookworm infections are associated with a biased Type 2 cytokine response (Gaze at al 2012), with concomitant regulatory T cell responses (Croese et al 2015) that fit the profile of an agent that may be effective at treating the dysregulated inflammation associated with MetS or T2DM. Thus, we propose to use this experimental human infection model in a proof-of-concept phase 1 trial of safety in healthy young adults with central obesity and features of the Metabolic Syndrome (MetS). Hypotheses: That experimental hookworm infection 1. will be tolerated and safe in otherwise healthy obese young adults; 2. will induce a biased Type 2 and regulatory immune response and suppression of systemic pro-inflammatory Type 1 immune responses

Objective: To investigate whether an App-based supplemental exercise program in orthopaedic rehabilitation will be feasible and acceptable to participants, increase activity levels and improve functional outcomes. Design: Single-centre, single-blind pilot randomised control trial Setting: Inpatient private general rehabilitation unit Participants: Twenty individuals admitted for orthopaedic rehabilitation over four week duration. Intervention: Participants were randomised to receive supplemental exercise via an App (PTPalTM) on a tablet device additional to usual care or usual care alone. Main Outcome Measures: Primary outcome measures were participant satisfaction with App-based supplemental exercise, total repetitions of each activity and time in supplemental exercise programs. Secondary measures were 10 Metre Walk Test (10MWT); 6 Minute Walk Test (6MWT); Timed Up and Go (TUG); Functional Independence Measure and length of stay assessed by a blinded assessor.

This study will evaluate the feasibility of pre-treatment Prostate Specific Membrane Antigen Positron Emission Tomography (PSMA-PET) scan and Magnetic Resonance Imaging (MRI) for men with high-risk prostate cancer requiring radiotherapy. Who is it for? You may be eligible to join this study if you are Male, aged 18 years or above and have been assessed as having a high-risk prostate cancer requiring high-dose radiotherapy. In addition, a PSMA PET scan and a MRI will also be used to assessed your eligibility to participate. Study details The PSMA PET scan and the MRI will be used to identify cancer sites prior to the high dose radiotherapy treatment. The radiation oncologist and urologist will use the PSMA PET scan and the MRI to map and than target external beam radiotherapy and brachytherapy towards these cancer sites. Participants will be asked to complete a quality of life survey prior to and at 6 weeks, 3, 6, 12, 24 and 36 months post-radiotherapy to determine quality of life following the procedure. They will also be assessed at 1, 3, 6, 12, 24 and 36 to determine clinical outcomes. A follow up PSMA PET scan and MRI will also be performed at three years post radiotherapy treatment determine if any cancer sites are still present.

The purpose of this study is to evaluate the feasibility of using a newly available combined PET-MRI platform to identify hypoxic areas in patients with glioblastoma (GBM) to target during surgery. Who it is for? You may be eligible to join this study if you are aged 18 years or above and have suspected high grade glioma for which surgery is planned. Study details All participants in this study will undergo PET/MRI (Positron Emission Tomography / Magnetic Resonance Imaging) at Herston Imaging Research Facility (HIRF). A qualified Nuclear Medicine Technologist will insert a tube into a vein in your arm and give you an injection of a radioactive substance called F-MISO. You will then be required to wait for 2 hours, called the uptake time, before emptying your bladder and proceeding to have your scan. The scan involves lying flat with knees supported. Fifteen minutes after the start of your scan a qualified Nuclear Medicine Technologist will give you a further injection of a radioactive substance called F-DOPA. The PET camera and MRI will scan your head including your whole brain. The scan time will be approximately 90 minutes and the scan is painless. The experience of the scan itself will be similar to an MRI which you may already have had. Hypoxic areas identified in the PET/MRI will subsequently be targeted during surgery. Key outcomes include feasibility, and comparison of PET/MRI results to biopsies taken during surgery. Demonstrating feasibility of pre-operative combined PET/MRI for glioma would of itself be useful for patients as it reduces the overall number of scans they have to attend in the limited time between presentation and resection.

Insulin therapy for people with type 1 diabetes has a risk of hypoglycaemia when insulin delivered is in excess of the individual's requirements. Hypoglycaemia is a major contributor to the failure to achieve glycaemic targets in type 1 diabetes. The device under investigation is a non-invasive wearable device designed to detect hypoglycaemia. The device consists of a wrist band connected by a flexible wire to a ring. Parameters monitored by the device include microtremor and temperature. This study aims to investigate the performance of the device to alert the wearer to the presence of hypoglycaemia overnight. A non-invasive wearable device able to alert for hypoglycaemia may improve the health and well-being of people with type 1 diabetes.

The aim is to confirm if Stratamed and Strataderm are effective in the prevention and treatment of abnormal scarring in infants following cardiac surgery. These products have already been approved for use in children by the Therapeutic Goods Authority (TGA). Stratamed is a medically used silicone-based scar therapy dressing in the form of a gel. Stratamed is different from other silicone gels because it can be applied to fresh wounds. This means that prevention and treatment of scarring can start much earlier. Strataderm silicone-based gel is applied on a healed wound. A total of 200 children will be randomly allocated into two equal groups: the treatment group and the current standard treatment (control group). Allocation will occur using opaque sealed envelopes at time of surgery. Parents will be told which group their child has been randomly allocated into after the operation. Participants in the control group will receive the standard treatment currently used in The Heart Centre for Children. A Comfeel dressing will be placed onto the wound after it has been sutured. The dressing will be removed 4-7 days post-surgery. Nothing should be applied to the wound until 2 weeks post-surgery. Parents will then start applying Sorbolene with Vitamin E cream to the scar once a day for 3 months. If at the end of 3 months there are signs that the child’s scar is healing abnormally, your child’s doctor may advise parents to continue applying the cream for up to 12 months as continuing the treatment may improve scarring overtime. Participants in the treatment group will have Stratamed applied to the sternotomy wound directly after the wound has been sutured. A secondary dressing known as Comfeel will be placed over the Stratamed. The dressing will be removed 4-7 days post-surgery. After the dressings are removed, Strataderm will be applied to the wound. Parents will then need to apply Strataderm once a day to the wound for 3 months. If the child’s wound is not fully healed when the dressing is removed, then Stratamed will be applied twice a day until Day 14 post-surgery, at which point Strataderm can be commenced daily. If at the end of 3 months there are signs that the child’s scar is healing abnormally, then the child’s doctor may advise parents to continue applying the gel for up to 12 months as continuing the treatment may improve scarring over time. Parents will be provided training and written instructions about how to apply the allocated scar management. As part of the data collection for this study, photographs of the child’s wound/scar will need to be taken throughout the study period. We would like parents to take the photos on their own smartphone and send them back to the hospital via email or mobile phone MMS. The first photo will be taken after the dressing is removed, while participants are still in hospital and at this time, parents will be given a Photography Instruction Sheet and the research team will guide parents on the best methods.