ANZCTR search results

Metabolic acidosis refers to any process that elevates the concentration of hydrogen ions in the body, and is commonly encountered in critical illness. Lactic acidosis, diabetic ketoacidosis, and hyperchloremic acidosis are major examples seen in the intensive care unit (ICU). Metabolic acidosis may impair cardiac function, and sodium bicarbonate can be used to normalise blood pH. Despite being in common clinical usage, the clinical efficacy of sodium bicarbonate is still uncertain. Previous studies exploring the effects of sodium bicarbonate therapy have been limited and of variable quality. The trial aims to assess if the infusion of sodium bicarbonate in vasopressor-dependent patients with moderate metabolic acidosis admitted to the ICU increases the number of vasopressor-free hours at day 7.

The objective of this study, in adults with moderate to severe TBI, is to use machine learning and determine and compare the univariate and multivariate associations between neuroimaging biomarkers, blood biomarkers, clinical data and neurological outcomes. Specific aims are as follows: 1. To identify neuroimaging biomarkers of TBI, measured as structural and functional damage on brain MRI, on discharge from ICU/HDU (or if not admitted to ICU, once the participant is stable on the ward)and changes in structural damage and neuro-inflammation during recovery at 3- and 6-months after injury. 2. To determine the multivariate associations between neuroimaging biomarkers of TBI and neurological outcomes 3- and 6-months after injury, using a combination of deep learning and other machine learning methodologies. 3. To determine correlations between neuroimaging biomarkers, blood biomarkers (ccfDNA, exosomes, clinical data and neurological outcomes of TBI on discharge from ICU and at 3- and 6-months after injury. 4. To determine correlations between 3-month and 6-month changes in neuroimaging biomarkers, blood biomarkers, clinical data and neurological outcomes. 5. To determine the independent predictors of neurological outcomes at 3- and 6-months after injury using deep learning. 6. To assess aims 2-4 in the subgroup of patients who have MRI scans (during their ICU/HDU admission) as part of their clinical care

This study is investigating the safety, progression-free survival and overall survival of Lutetium-177 (Lu) prostate-specific membrane antigen (PSMA) radioligand therapy for the treatment of newly diagnosed high-risk prostate cancer patients. Who is it for? You may be eligible to participate in this study if you are aged 18 years or older, have been recently diagnosed with prostate cancer (localised to the prostate) and are scheduled to be treated with surgery (prostatectomy). Study details Participants enrolled in this study will undergo a digital Gallium-68 PSMA positron emission tomography/computed tomography (PET/CT), imaging of the body to ensure cancer is localised to the prostate. Participants will then receive one dose of LuPSMA by intravenous infusion 1-2 weeks prior to scheduled prostatectomy. Then 7-9 weeks following surgery, patients will undergo another LuPSMA treatment. It is hoped that this research will determine that LuPSMA is safe and effective as an adjunct to surgery in treatment of patients with high-risk prostate cancer and can improve outcomes for future patients.

Background: Iron is a fundamental micronutrient for numerous human processes. However, approximately one third of the population is iron deficient. A deficiency in iron stores has been linked to significant decreases in work capacity, which, if left untreated, can progress to states of anaemia, whereby there is further detriment to work capacity and quality of life. Prevalence rates of iron deficiency in female athlete populations have been calculated to be higher than that of the general population (~50%), therefore, it is common for such individuals to utilise iron supplementation strategies to maintain iron homeostasis. However, the effects of iron repletion strategies on physical performance and quality of life continue to remain latent to modern research. This study therefore aims to elucidate such effects. Methods: The IRONWOMAN trial will utilise a double blind, randomised control design to investigate the effects of IV iron therapy on performance outcomes, quality of life and mood states in iron deficient recreational female athletes. Potential participants will be screened from the general population at universities and sporting events via the use of a female health questionnaire. Participants, who provide informed consent, will undergo familiarisation followed by baseline testing, which will involve a graded exercise test (GXT), survey completion, and a total haemoglobin mass test, using the optimised carbon monoxide rebreathing technique. Venous blood samples will be collected both prior to and post-GXT. Following this, participants will be randomly assigned to either an IV therapy group (to receive 20 mg/kg of body weight ferric derisomaltose) or a placebo group (receiving 100 ml/saline). Follow up assessments utilising the baseline test protocol will occur at 4 days post-, 4 weeks post-, and 6 months post- intervention. Discussion: The outcomes of this research will generate the necessary empirical evidence to resolve the divergence of current literature. Indeed, results of this clinical trial will contribute towards the identification of a threshold value which elucidates the ability of IV iron therapy to improve the performance of a given individual, depending on markers of iron status. As a result, more informed decisions can be made regarding athlete iron supplementation strategies.

This is a multicentre, double-blind, phase II study to evaluate the efficacy, safety and tolerability of BP101, administered as two nasal sprays once daily for 28 days, in pre-menopausal women with HSDD. Participants will be randomly assigned to receive one of three different doses of BP101, or placebo. Study assessments include safety checks including vital signs, physical exam and blood tests, and questionnaires to determine whether BP101 can improve sexual function and desire.

COVID-19 response in Australia relies on people getting tested should they experience symptoms; however, national data indicate suboptimal uptake. This study aims to improve the uptake of COVID-19 testing by addressing peoples’ specific reasons for not getting tested. We will test the following research questions: (1) Can we improve understanding of government testing messages, by making the messages simpler? (2) Can we improve peoples’ intention to get tested by tailoring prevention information to their specific testing barriers, and making the messaging more persuasive? (3) Can we increase the number of people getting tested using action plans tailored to their specific testing barriers?

Aims: The aim of this study is to demonstrate clinical proof of concept of tobramycin inhaled dry powder formulation using the Orbital device in a Phase I clinical trial. Tolerability, safety (including pharmacokinetic (PK) assessments) and efficacy will be evaluated and compared to inhaled tobramycin using the standard care capsule-based TOBI Podhaler Pulmosphere therapy. Specifically, the study aims to collect information about the efficacy, tolerability and safety, of the Orbital DPI in comparison to the TOBI Podhaler. The results of this study will be used to inform a larger trial in the future. Hypotheses: It is hypothesised that the use of the Orbital Device with multi-breath inhalation manoeuvres of the same dose will be better tolerated in terms of decreased coughing generally associated with DPIs, and overall convenience in device use when compared to the TOBI Podhaler. The single dose disposable Orbital DPI device is expected to be as effective (comparable FEV1 change and decrease in Pseudomonas density), safe (maximum blood concentration – Cmax not exceeding 2µg/mL) as well as more tolerable for patients (Cough Severity Scale and Tolerability Questionnaire) which will lead to improved adherence.

This feasibility study aims to determine whether a drug screening model can be created using tumour cells from patients with metastatic colorectal cancer that have not been responsive to previous treatments. Who is it for? You may be eligible for this study if you are aged 18 years or older, and have been diagnosed with metastatic colorectal cancer (cancer that has spread to another part of the body) that has so far been unresponsive to or has progressed through other cancer treatments. Study details Participants in this study will undergo a tumour biopsy procedure. For this procedure, a tissue sample will be taken under radiological imaging, by an experienced doctor. The tissue sample will then be used in laboratory tests by the research team to determine how the cells react to different types of drugs. Participants will also have information about their specific disease characteristics, treatments administered and the outcome of each treatment collected by their doctor as is usual practice. This information will also be shared with the research team to further their understanding of disease-drug interactions. It is hoped this research may be used to improve health outcomes for future patients with metastatic colorectal cancer by determining whether it is possible to create a specific tumour cell drug screening model to test the effectiveness of cancer drugs.

We are performing a cross-sectional and longitudinal analysis of airway oscillometry after lung transplantation. We aim to define airway oscillometry indices in patients who are: Stable, have acute lung allograft dysfunction, baseline lung allograft dysfunction and chronic lung allograft dysfunction. We are interested to define early airway closure and elastic recoil properties of the lung allograft.

The purpose of this research is to test if a brief Virtual Reality session reduces anxiety levels in people having elective surgery. Managing anxiety in people having surgery is important because high levels of anxiety can lead to increased pain, surgical infection, poorer wound healing and delayed recovery. Previous research that has used VR has shown that it reduces surgery-related anxiety and leads to better surgical outcomes. This is a randomised controlled trial which means that participants are randomly allocated to either receive the Virtual Reality session or not. Everyone who agrees to participate will be asked to: 1- Have heart rate taken at 3 time-point, two times while you wait in the preoperative waiting area and again when you recover from the anaesthetic. 2- Rate your anxiety level on a 100-points scale (zero means you don’t feel anxious, and 100 means you feel extremely anxious) two times while you wait in the preoperative waiting area and again when you recover from the anaesthetic. 3- Provide a saliva sample at 3 time-points to test your stress levels two times while you wait in the preoperative waiting area and again when you recover from the anaesthetic. The saliva is taken from your mouth using a cotton swab by yourself, and instruction of use will be provided to you. 4- Rate your pain level on a 100-points scale (zero means you don’t have any pain, and 100 means you feel the worst pain) two times while you wait in the preoperative waiting area and again when you recover from the anaesthetic. 5- Complete a 39 item satisfaction questionnaire before you are discharged from the hospital. 6- Allow the researcher to access your medical record to extract the following information: type of surgery, type of anaesthesia, any medications given before surgery and length of hospital stay. Those people randomly allocated to receive the Virtual Reality session will be asked to: 1- Use a Virtual Reality device to watch and listen to a nature scene for 5-10 minutes in the waiting area before surgery. 2- Complete a 13 item questionnaire after the virtual reality session asking about any side effects. Those people randomly allocated to the control group will receive: 1- Routine preoperative care only.