ANZCTR search results

To test the addition of personally tailored medical nutrition therapy (MNT) telehealth counselling into Prima Health Solution’s current online Healthy Weight for Life™ (HWFL) program, on diet quality over 18-weeks while optimising weight loss.

The aim of this open-label, randomised, dose-comparison, pilot feasibility trial with two parallel arms is to determine the feasibility of using low and moderate doses of Curcutex (Meriva® Curcumin Phytosome®) for the management of EoE in adults. Primary Objective Evaluate the feasibility of using low and moderate doses of Curcutex (Meriva® Curcumin Phytosome®) for EoE in adults. Secondary Objectives 1. Ascertain whether Curcutex (Meriva® Curcumin Phytosome®) is safe in adults with EoE at low and moderate doses. 2. Assess whether Curcutex (Meriva® Curcumin Phytosome®) improves EoE-related symptoms in adults with EoE in low versus moderate doses. 3. Determine whether Curcutex (Meriva® Curcumin Phytosome®) improves Quality of Life in adults with EoE in low versus moderate doses. 4. Ascertain whether Curcutex (Meriva® Curcumin Phytosome®) reduces absolute eosinophil count in adults with EoE in low versus moderate doses. Current evidence suggests that orally administered Meriva®, at a dose of 500-1000 mg twice daily (or 1-2 g per day) for 12 weeks is safe and effective at reducing inflammation and pain in chronic inflammatory diseases such as EoE.

One of the major constituents of mammalian blood is haemoglobin. Haemoglobin is a protein complex bound to red blood cells, and is responsible for the delivery of oxygen to, and removal of carbon dioxide from the tissues. A shortage of haemoglobin is called ‘anaemia’. If a patient has anaemia before or after major surgery, they are more likely to develop a complication after their operation, and more likely to die. The worse the anaemia, the worse the risk. The prevention and treatment of anaemia is therefore of great importance to patients and their clinicians alike, especially patients who have required cardiac surgery, as the incidence of postoperative anaemia in these individuals is very high. However, anaemia is a symptom of a broader problem, not a diagnosis in and of itself. It has many, many potential causes, and while we suspect that anaemia after cardiac surgery is driven by a combination of blood loss and inflammation, this is yet to be proven. In general, the treatments that are available for anaemia that was present after an operation are effectively limited to blood transfusion. However, blood transfusion itself is associated with an increased risk of poor outcome. Because of the lack of treatment options, specialists have been generally incurious about what drives anaemia following an operation. However, over the last ten years, our understanding of the drivers of anaemia in general has improved markedly, which in turn has resulted in the development of several new therapies. Clinicians, therefore, have options that could be useful to treat anaemia after major surgery, including cardiac surgery. However, to apply these new treatments effectively, we must first understand what causes anaemia after cardiac surgery, and for how long this process lasts. The MOSAICS study has been designed with this conundrum in mind and will explore and define the many possible causes of anaemia after cardiac surgery. Volunteers having cardiac surgery at two hospitals will have their blood tested several times following their operation (both in hospital and for the first nine weeks after the operation) to examine the resolution of inflammation postoperatively, and to determine how this influences changes in the body’s handling of iron (a key component of haemoglobin), and the body’s ability to generate new haemoglobin to replace that which was lost during the operation. By determining the underlying cause of anaemia, we can design new studies that will target this cause. If successful, MOSAICS will provide important insights into the causes of postoperative anaemia and identify the best targets for novel treatments for this major problem, that continues to affect outcomes and quality of life for patients who are undergoing cardiac surgery.

The Affinity trial aims to assess the efficacy of an enhanced version of the moderated online social therapy (MOST) digital therapeutic social networking platform in reducing suicidal thoughts and behaviours in young people attending outpatient care. Participants randomized to the intervention condition will also have the option of participating in a fortnightly online psychosocial recovery group and to invite their caregivers to participate in caregiver online psychoeducation sessions. It is expected that the Affinity intervention condition will be faster at, and have greater maintained effects in, reducing levels of suicidal ideation than the treatment as usual condition. Effects of therapeutic mechanisms of action, as well as health economic aspects will also be assessed.

Dose CF Kids aims to characterise the pharmocokinetics (PK) and pharmacodynamics (PD) of the intravenous antibiotics used to treat pulmonary exacerbations requiring intensive therapy (PERIT) in children with CF. This information will help to clarify the optimal use of intravenous antibiotics in children with CF. Target therapeutic concentrations for IV antibiotic for PERITs in children with CF that are associated with maximal short- term improvement in lung function (measured by FEV1) will be determined. This will be used for modelling to inform optimal antibiotic dosing. It is hoped the data will allow development of an antibiotic dosing calculator. Dose CF Kids also aims to determine the specificity of novel kidney markers to detect drug- related kidney injury.

The STEPCARE-trial is a 2x2x2 randomised trial studying patients who have been resuscitated from cardiac arrest and who are comatose. It will include three different interventions focusing on sedation targets, temperature targets and mean arterial pressure targets. The purpose of this trial is to find out if continuous sedation, fever management with a cooling device and a higher blood pressure target is associated with improved clinical outcomes after a cardiac arrest, compared with minimal sedation (early awakening), fever management primarily with medications, and a lower normal blood pressure target.

This pilot project tests whether the use of Artificial Intelligence (AI) Chatbots is an acceptable and helpful alternative to human support during an online intervention for perfectionism. Perfectionism is a risk factor for anxiety, depression and eating disorders. Participants (N=54) will be receive a self-guided perfectionism workbook to undertake 11 modules at their own pace over 4 week. Groups will be randomly assigned (27 in each group) to (1) receive instructions on how to use the AI Chatbot of their choice to support the workbook, or (2) requested to not use AI support for this task, Participants in the active group will feed back regarding acceptability of this approach. We will compare the impact on module completion between groups together with mental health outcomes: perfectionism, anxiety, depression, stress and eating disorder risk. Effects will also be compared to similar studies using human guidance.

Bridge to Better Health aims to improve preventative health actions to people with intellectual disability. The project intervention will support practice nurses at General Practices by providing educational resources and access to a specialised disability nurse to assist in facilitating health assessments. We will collect quantitative data from medical and hospital records in order to explore changes in preventative health actions, and potentially avoidable hospitalisation for people with intellectual disability. Qualitative data will be in the form of interviews/surveys for practice nurses/staff and people with intellectual disability to understand their experiences either completing the health assessment or being the patient during the intervention. Expected outcomes are an increase in preventative health actions for people with ID; a decrease in potentially avoidable hospitalisations for people with ID; an increase in practice nurses' knowledge, attitudes and confidence towards patients with ID.

This double blind, placebo controlled, first-in-human (FIH) study will assess the safety, tolerability, PK, PD, and immunogenicity of TX000045 in healthy men or women of non-childbearing potential. This study will establish doses of TX000045 that are safe, well tolerated, and exhibit appropriate PD effects to warrant further clinical investigation. 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 75 healthy participants will be enrolled in the study. The duration of participation in the study is approximately 3 months (inclusive of a 27-day screening window, 1-day baseline period, and a 57- day follow-up period after dosing) across 6 cohorts of 8 participants each. The study will be conducted in 2 parts, as follows: • Part A: single ascending doses • Part B: repeat single 150 mg SC dose cohort In Part A, each participant will receive a single dose of TX000045 or matching placebo, randomized in a 3:1 ratio per cohort, via at least a 30-minute intravenous (IV) infusion or subcutaneous (SC) injection. In Part B, each participant will receive repeat single 150mg SC doses of TX000045 or matching placebo randomised in 3: 1 ratio administered on Days 1.

consumers prescribed Clozapine suffer from constipation; essentially double that of the general population. Clozapine consumers are 3 times more likely to develop constipation, compared to their contemporaries prescribed other antipsychotics. Ongoing questioning and screening by mental health professionals is strongly recommended, in order to detect and treat constipation in a timely manner. In my experience as a mental health case manager, and more recently as a Clozapine coordinator, the screening, detection, and management of clozapine induced constipation is severely lacking. Non-pharmacological interventions are considered the first and most important step in managing constipation. One hour of exercise, five days a week; increased fibre and fluid intake. These can be achieved with minimal support clinically, and financially. Clozapine clinics have been seen as a place to develop health agency and providing education during clinics, with a view to have the consumers engage in their own treatment interventions for constipation would be the goal. I would aim to incorporate the peer workforce and current consumers prescribed clozapine in the development of the education aspect. This RCT will consist of a control and intervention group. The control group will receive current health practices, which include 3 monthly screening and assessment for constipation by a registered nurse and /or physician. The intervention group will receive an hour of education, targeted at improving their knowledge and understanding of constipation, and given them lifestyle interventions to manage it. All participants will complete a 2 weekly constipation self-report measure called the PAC - SYM to collect data.