ANZCTR search results

A novel hydration strategy will be investigated as an aid for the maintenance of hydration status in austere environments. The novel hydration strategy (beverage) employs resistant starch (in the form of high amylose maize) as well as glucose and electrolytes. Previous research has shown that resistant starch may increase water absorption in the large intestine, capable of absorbing upwards of 6L/day. This study aims to assess: -Whether a hydration drink containing resistant starch improves the hydration of personnel immediately before training and during recovery -Whether a hydration drink can improve gut health It is hypothesised that the resistant startch hydratation drink will improve the hydration status of military personnel undertaking high levels of physical activity in a hot tropical environment.

Procedures performed in interventional radiology are often quick and minimally invasive, however some procedures traditionally require increased pain relief and sedation than local anaesthetic alone. For these procedures, we have previously used intravenous medications (midazolam and fentanyl) for sedation and pain relief; however, dosing of these medications is controlled by your nurse or doctor which can lead to under or over dosing of medications, or delayed pain relief due to delays in administration of medication. We believe that letting the patient control how much medication and how often can be effective.

This study aims to assess the safety and potential effectiveness of a new treatment combining two different cancer treatments, a T cell-based immunotherapy and pembrolizumab (a drug that is used to prevent cancer cells from hiding from T cells), for glioblastoma multiforme (GBM) or astrocytoma grade 4. Who is it for? You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with GBM or astrocytoma Grade 4 brain cancer and you have been exposed to a common virus called cytomegalovirus (CMV) at some point in your life, this exposure will be determined by a blood test. Study details In this trial, based on the patient tissue type, the best-matching T cell therapy available will be selected and given to patients over four infusions, followed by 18 doses of pembrolizumab (at an interval 6 weeks between each treatment). The main aims of this clinical trial are to see whether this CMV-specific T cell therapy combined with pembrolizumab is safe for people with GBM/astrocytoma grade 4, and it if can show effectiveness against this type of tumour. The trial is being conducted in two parts. Phase I of this trial aims to work out the highest dose of T cells that does not have serious side effects. Participants will be enrolled firstly into the lowest T-cell dose group, if there are no serious side effects noted then enrolment into the higher T-cell dosing groups will occur. Once the maximum tolerated dose is determined, the second part (Phase II) will begin enrolling participants. Phase II of the trial is used to gather additional safety data and determine the efficacy of four infusions of the maximum tolerated dose (determined in phase I) of allogeneic CMV-specific T cells in combination with pembrolizumab. Participants enrolled in either Phase I or Phase II will be asked to undergo routine blood tests and MRI scans to determine any impact the combined treatments may be having on their cancer. Overall participation is not expected to exceed approximately 26 months. It is hoped this research will determine the maximum safest dose of T-cell therapy that can be administered to brain cancer patients together with pembrolizumab. Once a safe dose has been determined, a larger trial enrolling more cancer patients may be undertaken to further assess the efficacy of the combined treatments.

Our healthcare system urgently needs a major boost in efficiency to manage hospital bed shortages and lengthening waiting-lists for primary and secondary care consultations. Once a winter issue, the unrelenting pressure on our healthcare system by our ageing, multi-morbid population now persists across all seasons and is exacerbated by the recent pandemic and its aftermath. The safe@home project is a potential solution. Safe@home aims to reduce emergency department (ED) presentations (ambulance ramping), readmission and length of stay (hospital avoidance), out-of-hospital mortality and improve access to primary care (clinic block) and self-care. With a focus on chronic conditions with high healthcare utilisation (diabetes, COPD, heart failure and hypertension), Safe@home will use the Model for Large Scale Knowledge Translation combined with co-design methods and a prospective, non-blinded pragmatic randomised Usual Care led trial (RCT) and economic evaluation to test and implement a daily home telemonitoring model of care supported by health professionals, for people living with chronic disease in low socio-economic neighbourhoods. We will evaluate the intervention’s effectiveness and cost-effectiveness. It is the clinical decisions and actions taken based on information obtained by monitoring that will alter patient wellbeing and outcomes, rather than the monitoring itself.

The overall aim of this study is to evaluate the clinical and economic impact and implementation of a service model (intervention) delivered by community pharmacists in NSW and 5 pharmacies in ACT, e-supplying specific oral contraceptive pills for a specific patient cohort over a 12-month study period. Women must be aged between 18 to 35 years (inclusive), taking the pill for contraception purposes only, and has seen their GP/nurse practitioner for a review of their low-risk oral contraceptive pill in the last two years. Specific objectives are to: 1. Assess the accessibility and acceptability for patients managed and/or treated by community pharmacists. 2. Assess implementation uptake of the intervention including the reach, fidelity and adoption of the intervention in community pharmacies, participant characteristics, and variation in uptake by geographic region. 3. Assess the clinical and experience outcomes for patients managed and/or treated by community pharmacists. 4. Assess the safety of the intervention and identify any risks that need to be addressed for future implementation. 5. Qualitatively assess the acceptability and feasibility of the intervention to pharmacists, other care providers and participants using the service. 6. Identify contextual enablers and constraints to access, adoption, fidelity delivery, impact, sustainability, and generalisability of the intervention. 7. Conduct a health economic evaluation to determine the economic benefits from the intervention. The study will use a cohort study design to assess the clinical and economic and implementation of the intervention in NSW and ACT over a 12-month study period. The intervention is multicomponent including Pharmacist training and support and a Pharmacy consultation, using an IT program, applying a clinical management protocol. Pharmacies and pharmacists must meet the criteria of an 'approved pharmacy' and an 'approved pharmacist' outlined in the NSW Health Authority to participate. Primary outcomes will be accessibility and acceptability of the service (based on self-report at 7-day follow up).

This research project, called the OPAL-3 Study will help us determine the best dose of omega-3 supplements to give pregnant women, who have a moderate level of omega-3. Omega-3 fatty acids (DHA and EPA) are found in fish and fish oils and thought to have several health benefits including maintaining a pregnancy to full term (>37 weeks). Previous studies have shown that women who are low in omega-3 fatty acids are at increased risk of having a premature baby. This risk can be reduced by taking an omega-3 supplement containing DHA and EPA. Studies have also shown that women who have sufficient levels of omega-3 fatty acids have a lower risk of giving birth to a premature baby and do not need to take supplements. What is not clear from the research is the best advice to provide women with moderate omega-3 levels. The aim of this study is to work out the dose of omega-3 fatty acids (DHA and EPA) needed to best match the fatty acid levels of women who are sufficient in omega-3 fatty acids. This study will compare women who have moderate levels of omega-3 and taking different doses of study supplements to women who have sufficient levels of omega-3. We will also compare with women who have low levels of omega-3 and are taking the recommended dose to correct their low levels. This will be done by looking at the omega-3 levels in blood spot samples throughout pregnancy.

This research will examine the impact of implementing a point of care (PoC) lactate machine on the administration of antibiotics in paediatric patients presenting with potential sepsis in the Emergency Department (ED). Elevated lactate levels are proven to be an accurate prognostic factor in predicting morbidity among patients with sepsis. Current practice requires that serum lactate samples are collected via intravenous cannulation or venepuncture, a distressing procedure for children and parents and challenging and time-consuming for staff . The PoC lactate machine is a portable, single-operator handheld device requiring finger prick blood sampling to obtain accurate lactate results. This negates the need for intravenous cannulation or venepuncture to obtain objective data to aid clinical decision-making. This may result in the earlier recognition of sepsis, administration of antibiotics and transfer to definitive care.

This double blind, placebo controlled, first-in-human study will assess the safety, tolerability of single and multiple oral doses of MRX-5 tablets in healthy men or women of non -child bearing potential and also to assess the pharmacokinetic (PK) profile of MRX-5 and its metabolite MRX-6038, and to compare the PK of a single dose of MRX-5 administered fed vs. fasted conditions. Who is it for? You may be eligible for this study if you are a healthy adult aged between 18 and 55 years old. Approximately 84 healthy participants will be enrolled in this study. (60 subjects in Part 1 and 24 subjects in Part 2) The total participation in the study will last around 5 weeks which consists of Screening visit, Admission and treatment period and Follow up visit.

This study will look at the effects of wearing surgical and N95 masks have in patients with respiratory failure currently using non-invasive ventilation. The aim of the study is to see whether this affects your oxygen or carbon dioxide levels as well as measures of comfort. The hypothesis of this study is there will not be a clinically important change in oxygen saturation and Transcutaneous carbon dioxide when wearing a surgical mask and N95 mask compared to no mask. There may be some changes in subjective comfort and breathlessness.

The prevalence of ocular allergies is increasing worldwide, affecting individuals’ quality of life and causing a significant socioeconomic burden. Allergic conjunctivitis can be managed using a range of treatment options. Ocular inflammatory cell (e.g., dendritic cell) play a substantial role in initiating the immune response in the setting of ocular allergies. The proposed study will be single centre, double-blinded, randomised, placebo-controlled, parallel group clinical trial. All participants will go through a washout period for 1 week using topical 0.25% polyethylene glycol 400 eyedrops (lubricant eyedrops) before starting the trial interventions. This study consists of three arms; arm 1 will be given topical ketotifen 0.025% eyedrops; arm 2 will be given prednisolone sodium phosphate 0.5% eyedrops; the placebo group will be given topical 0.4% polyethylene glycol 400, 0.3% propylene glycol eyedrops. All participants will remain on the trial interventions for 14 days. Assessment of the trial outcomes will take place pre-treatment, 24 hours, 7 days and 14 days after starting the treatment, 7 days and 14 days post-treatment. Both investigators and participants will be double-blinded to the group and treatment allocation until the results have been analysed.