ANZCTR search results

Patients with an OPA1 mutation inherit a condition called dominant optic atrophy (DOA) which causes vision loss over time. A medication called idebenone has been shown to decrease the vision loss in patients with a similar condition, called Leber's Hereditary Optic Neuropathy, and thus this trial will investigate whether similar results can be seen in patients with dominant optic atrophy. The study will be a blinded randomised placebo-controlled study. One arm of the study will include participants with DOA who will receive idebenone, and the second arm will include participants with DOA who will receive a placebo. At the end of 12 months, the groups will be investigated to see if there is a between group difference in the rate of visual decline.

CanaCare is a clinical trial incorporating a multi disciplinary team with interventions that utilise structured physical activty under the guidance of an Exercise physiologist, a nutritional educational intervention with a registered Dietitian, and a mindfulness/meditation component. The participants are anyone involved in Cana communities, a non government organaisation that supports members of our community that experience mental health issues, substance use disorders or any other social marginalisation. The primary outcome measurement is a happiness/quality of lfe scale measured at numerous timepoints up to six months. (The Oxford Happiness Questionnaire). Public Hypothesis. The primary aim of the CanaCare program is to utilise a person-centred approach to care planning and delivery, provided in collaboration with an interdisciplinary team with the overall aim of improving the health and wellness for all participants.

Spontaneous coronary artery dissection (SCAD) is a dissection of the coronary artery with formation of an intramural haematoma or ‘false’ lumen. The resultant obstruction to myocardial blood supply leads to acute coronary syndrome (ACS) or sudden death. SCAD has a strong female predominance, with up to 90% of cases women; the majority young and healthy without cardiovascular risk factors. It is this predilection for younger women that has played a part in SCAD being universally under-recognised and under-researched. Whilst we now appreciate that SCAD is not a rare disease, the bigger problem is that we know little about how to prevent or treat it. Clinical SCAD research is urgently needed if we are to uncover more than just the tip of the iceberg in this complex and life-threatening disease. This project will pilot the first ever Australian-New Zealand Spontaneous Coronary Artery Dissection (ANZ-SCAD) Registry. 850 SCAD patients will be recruited from 10-15 hospitals across Australia/NZ with both retrospective (historical cases) and prospective case enrolment. These patients will be recruited from the study sites. Patients will be identified using their medical records and hospital admission with a diagnosis of SCAD. Background medical history (including known pre-disposing genetic conditions), cardiovascular risk factors, medications at baseline and on discharge, presentation, triggers, investigations ( i.e. scans, angiogram, including management (including revascularisation) and in-hospital outcomes. In-hospital pathology results and diabetic profiles will be collected from the medical records. For Prospectively recruited participantst follow up- information such as patients detailed family and medical history, excercise, stress pre- and post- SCAD, quality of life will be collected via questionnaires for a duration of 5 years. No follow up will be performed for retrospectively recruited participants, with all data about treatment and survival taken from medical records.

Mobilisation alarms are a staple in hospitals to prevent falls, but there is uncertain evidence for their effectiveness and they can take up to 11% of all falls prevention management costs. This study aims to produce definitive evidence for their effectiveness. Selected hospital wards will remove or reduce their mobilisation alarms, and the rate of falls and falls-related outcomes will be measured and compared to hospital wards that continue to use the alarms as usual. It is hypothesised that removing or reducing mobilisation alarms will not lead to an increase in falls and falls-related injuries.

Patency of the ductus arteriosus in preterm infants is dictated primarily by Prostaglandin E2 (PGE2) and the non-steroidal anti-inflammatory medications that have long been used to promote ductal closure act by reducing prostaglandin production through cyclooxygenase enzyme inhibition. There is evidence that corticosteroids may also promote ductal closure through at least two mechanisms that impact PGE2 levels. This includes increasing phospholipase A2 inhibitor production with resultant decreased PGE2 synthesis and inhibition of 15-PGHD with resultant increased PGE2 break-down. More importantly, the vast majority of randomised controlled trials evaluating administration of early systemic, inhaled, or intra-tracheal corticosteroids to very preterm infants have found decreased rates of patent ductus arteriosus (PDA) diagnosis, medical treatment of PDA and/or surgical ductal ligation in exposed infants, suggesting a possible effect on early ductus arteriosus closure. What remains unclear is whether the mechanism behind decreased rates of PDA diagnosis and treatment is a direct effect due to corticosteroids promoting early ductus arteriosus closure, or an indirect effect of corticosteroids providing a respiratory benefit that results in clinicians being less inclined to pursue or treat a PDA. The PLUSS Trial is a multicentre, two-arm, parallel, double-blind randomised clinical trial designed to evaluate the effect of early intra-tracheal budesonide (a corticosteroid) mixed with surfactant on survival without BPD in extremely preterm infants born <28 weeks’ gestation (n = 1060). The PLUSS-HEARTS sub-study will utilise the double-blind randomised methodology of PLUSS in select participating sites to measure rates of early ductus arteriosus closure following exposure to intra-tracheal corticosteroids, compared with no exposure. This will hopefully shed light on the true effect of intratracheal corticosteroids on PDA diagnosis or treatment in this high-risk patient population.

An important marker of cardiovascular health is the flexibility of the blood vessels, which is defined as their ability to dilate and constrict. Conversely, blood vessel stiffness, caused by endothelial dysfunction, is associated with cardiovascular disease risk. This is measured using a non-invasive technique called “flow-mediated dilation” (FMD). The risk of developing cardiovascular disease can be indicated by measuring someone’s FMD in the morning, after fasting overnight. This study will help identify dietary and lifestyle factors which may influence endothelial dysfunction (an early marker of cardiovascular disease).

This study is designed to test the hypothesis that HD-MAP application to the skin using a small number of healthy adult subjects with a well characterised measles rubella (MR) vaccine results in comparable safety / local skin reaction to conventional subcutaneous vaccination. This study represents the first time that HD-MAPs with an active measles rubella vaccine will be applied to humans. Therefore, this study will assess both systemic and the local reaction to application of the MR HD-MAPs delivering a low and high doses measles and rubella vaccine virus, in comparison to uncoated MAPs, and SC administration of the standard adult human dose of MR vaccine (Serum Institute of India). The local skin response will be monitored for up to 56 days. On-site clinic assessments will be performed up to 2 hours post application and at day 3, 7, 28 and 56 days post application. Phone calls will be made at Day 1 and Day 14

High protein diets are effective at helping individuals maintain a healthy weight due to being highly satiating compared to other macronutrients. Supplementing protein into staple foods that are easily affordable, such as bread, is an easy way to incorporate added protein into a diet. However, it is difficult to recommend increasing protein intake at a population level because current farming practises that produce high-protein products from livestock are not sustainable, especially when considering climate change and increasing populations worldwide. Due to this, high-protein products made from livestock are becoming more expensive and less attainable. Proteins produced from sources other than livestock, such as plants and insects, are becoming more favourable as their production has a lower ecological footprint. However, the satiating effects of proteins are not necessarily equal, and it is unclear whether proteins from plants and insects are able to add a significant satiating effect when supplemented into staple foods. This study will assess the satiating effects plant and insect proteins within a staple food product compared to proteins derived from livestock. Participation in this study will involve attending four 30-minute morning sessions at the CASS Food Research Centre in Deakin University Burwood Campus. Before each session, participants will: • Need to fast for at least 10 hours (overnight). During each session, participants will: • Have their height and weight assessed (this will only occur during the first session). • Be provided with a moderate serving of bread which will be based on their estimated energy requirements which they will need to eat in its entirety. • Complete questionnaires about their liking of the bread and their appetite (approx. 2 minutes). After each session, participants will: • Complete additional appetite questionnaires every 30 minutes over the next 3 hours (approx. 2 minutes each). • Refrain from eating, drinking anything other than water, or doing any moderate to vigorous physical activity during this 3-hour period.

The aim of this study is to determine whether a natural product can improve hangover symptoms and several physiological changes that occur with hangover (i.e. liver function, inflammatory stress and stress hormone levels). A total of 44 participants aged 25-55 years old will complete this trial. The supplement contains a mix of vitamins and amino acid, which have been shown to improve the breakdown of alcohol-related toxins and/or improve hangover symptom severity. The combination of these ingredients has not been previously assessed in relation to hangover. Many biological changes occur with a hangover and contribute to hangover symptoms. We are particularly interested in the effects of hangover on liver function, inflammatory stress measured by cytokine levels, and stress according to cortisol levels. We will be measuring the effects of the supplement, compared to a placebo, using self-report assessments of hangover severity, anxiety, sleep quality and fatigue, cognitive functioning (e.g. response times, concentration, etc.) and physiological changes following an evening of alcohol intake to a quantity that would typically be consumed resulting in a hangover. We will also measure alcohol metabolism by asking participants to wear a wristband to measure alcohol in sweat, along with asking participants to undergo breathalyser and blood and urine tests for alcohol levels.. A subset of participants will be invited to participate in a brain imaging component using Magnetic Resonance Imaging (MRI).

Breast cancer-related lymphoedema (BCRL) is a common complication after breast cancer surgery which involves the accumulation of fluid in the arm. It affects breast cancer survivors causing discomfort, reduced function and quality of life. It occurs due to the unnecessary sacrifice of the lymphatics of the arm during sentinel lymph node biopsy (SLNB) and axillary lymph node dissection (ALND) procedures. A SLNB is a procedure in which the sentinel lymph node (SLN) is identified, removed, and examined to determine whether cancer cells are present. A SLN is defined as the first lymph node to which cancer cells are likely spread into. An ALND is a procedure to remove lymph nodes from the axilla. Axillary reverse mapping (ARM) is a technique used to distinguish lymphatic drainage of the arm from that of the breast in the axilla by allowing surgeons to visualise lymphatic channels and nodes which drain the arm using a fluorescent tracer. The axilla and breast have mostly separate drainage pathways. ARM may allow for minimal disruption of the arm lymphatics in order to reduce the risk of BCRL during SLNB and ALND. This study aims to perform ARM using a tracer called indocyanine green (ICG) with near-infrared fluorescence imaging on patients with a positive SLNB who are undergoing ALND. Who is it for? You may be eligible for this study if you are an adult who has been diagnosed with early breast cancer and is undergoing axillary lymph node dissection. Study details: All participants in this study will complete axillary reverse mapping using ICG during the axillary lymph node dissection. This procedure will take approximately one to two hours and will be completed by a breast surgeon. Participants will then undergo removal of the tumour as standard of care, with the surgeon using an approach which has been discussed with the patient prior to surgery. This may involve removal of the tumour alone or additionally removal of the affected breast depending on the extent of the breast cancer and the patient's preferences. It is hoped that this research will aid in the understanding the anatomical relationship of ARM nodes and lymphatics, which could help predict patients at risk of lymphoedema.